Clinical Pharmacy- Simple Notes.pdf s5z18

-: CLINICAL PHARMACY:DEFINITION: Clinical pharmacy is the branch of pharmacy in which doctor of pharmacy provide patient care that optimizes the use of medication and promotes health, wellness, and disease, prevention. Clinical pharmacists care for patients in all health care settings but the clinical pharmacy movement initially began inside hospitals and clinics. Clinical pharmacists often work in collaboration with physicians, nurse practitioners, and other healthcare professionals.

Education and credentialing: •

•

•

Clinical pharmacists have extensive education in the biomedical, pharmaceutical, socio-behavioural and clinical sciences. Most clinical pharmacists have a Doctor of Pharmacy (Pharm-D.) degree and many have completed one or more years of post-graduate training. (for example, a general and/or specialty pharmacy residency). In the United States, clinical pharmacists can choose to become Boardcertified through the Board of Pharmacy Specialties (BPS), which was organized in 1976 as an independent certification agency of the American Pharmacists Association. The BPS certifies pharmacists in the following specialities: ambulatory care pharmacy, critical care pharmacy, nuclear pharmacy, nutrition pharmacy, oncology pharmacy, paediatric pharmacy, geriatric pharmacy, pharmacotherapy, and psychiatric pharmacy.

SCOPE OF CLINICAL PHARMACY:

1. Preparation of patient medication histories: •

•

Any hypersensitivity's or allergies to specific drugs observed in the past, any particular drug or food habits, drug dependence or intoxication with chemicals due to occupational hazards, all of which are likely to interfere with the therapy. This will help in saving physicians time and efforts and thus will result in faster and more accurate selection of drug therapy.

T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP.

Page 1

2. Rational prescription: The clinical pharmacist can suggest the physician and help him in selecting the right drug. Some of the examples of irrational combinations identified by pharmacist are: E.g.:-Haloperidol + Diazepam + Amitriptyline, Reserpine + Sintamil. 3. Bioequivalence and generic equivalence of pharmaceutical formulations: Number of factors influences the bioavailability of drugs from the dosage forms. Selection of proper drug therapy based on bioequivalence studies on different dosage forms of the same drug moiety. 4. Patient monitoring: Observes the signs and symptoms of that indicate the need for reaction to drugs. Clinical pharmacist who knows correct route of istration, the signs and symptoms of over dosages, contraindications, desired effects, undesired effects and side effects can help in monitoring the drug therapy for safety and efficiency, a necessity with the increasing applications of potent and toxic chemicals and drugs. Drugs with narrow therapeutic index, or When drugs istered in patients, who are critically ill or suffering from chronic diseases. 5. Adverse drug reactions and drug interaction: The clinical pharmacist: • • •

Can compile and process data using computers and make it available to the medical staff. May suggest an alternate therapy if applicable. Identify drug effect modifications due to interactions with several foods, alcohol, smoking, environmental chemicals, as well as due to pregnancy.

6. Drug Information Specialist: • • •

A clinical pharmacist being an expert on drugs may operate a drug information service. Through effective utilization and retrieval of clinical drug literature, the pharmacist can actively communicate drug information. He can help during medical emergencies, by providing immediate information on antidotes in case of poisoning or overdosing.

7. Retail pharmacy stores: •

Many OTC drugs have the potential to interact with prescription drugs.


Page 2

•

•

A clinical pharmacist at retail drug stores can maintain patient drug profiles, family drug profiles and family records based upon which the pharmacist can counsel the patient each time while filling the prescription. He can determine the patient’s responses to drug therapy and help him in the selection and use of OTC drugs.

8. Discharge counselling and patient compliance: •

• •

The compliance to drug therapy can be improved several times, by educating and counselling the patient at the time of discharge from hospital or while dispensing the prescription at the retail counter. The patient may be made aware of the purpose of medication, proper mode of istration, dosage schedule and storage conditions. He may be told of any potential adverse or side effects to expect and any food or activities to be avoided during therapy.

9. Clinical research and continuing education program: • • •

The clinical pharmacist can participate in an evaluation program on investigational drugs. He can help in conducting clinical trials based on sound principles of biostatislical methods of evaluation. He can also develop training programs for pharmacists, nurses and interns.

10. Medical Audit: Medical audit is a logical and necessary procedure within organized teamwork. The clinical pharmacist is either the initiator or a very active member of a functioning committee. Following are the activities, concerning medical audit: 1. Legislation. 2. Contractual obligation. 3. Regulation and registration of pharmacotherapy orders and istration. 4. Regulation of clinical experiments with drugs. 5. Information per subject and per patient. 6. Pharmacotherapy-committee policy. 7. Regulation of information from the pharmaceutical industry. 8. Local or regional micro symposia per patient. 9. Formulary policy.


Page 3

10. Retrospective study of drug use patterns. 11. Medical auditory committee work. (i) Legislation: The pharmacist is responsible for the quality of the medicines he dispenses. (ii) Contractual obligation: The authorized pharmacist should be charged with the supervision over the maintenance of the organization included involving the storage, the distribution and the registration of drugs, regardless they are in the pharmacy or elsewhere in the institution. (iii) Regulation and registration of pharmacotherapy orders and istration: Clinical pharmacy must provide the means for pharmacotherapy. The follow-up should be reviewed by pharmacist with head nurses and the medical director. Specific problems should be discussed with the concerned of the health care team and regulated. (iv).Regulation of clinical experiments with drugs: Regulation of clinical trials is necessary

1. To ensure that there are no ethical problems that may harm patients. 2. To control trials. 3. To control pharmacotherapy through: • Registration and processing of requests for the use of uned drugs. • Purchasing. • Control of stock and turnover. • Quality control. • Supply. • Compounding. • Control of code and key of "blind" experiments. • Reporting of deviation of standard operating and registration procedures to the directorate.

(v) Information per subject and per patient:


Page 4

Information per subject and per patient may be provided by clinical pharmacy. Information is a service and should be given unasked for when deemed necessary. (vi) Pharmacotherapy-committee: In this information specific subject policy is prepared within a multidisciplinary team and produced as advice. Clinical pharmacists can recommend, motivate and must ensure the continuity of pharmacotherapy-committee work. (vii) Regulation of information from the pharmaceutical industry: Promotional activities of the pharmaceutical industry are primarily physician oriented. Part of their information may be essential. Clinical pharmacists and physicians have different requirements for additional information. Thus, it is possible to select information and representatives from industry for the discussion of specific subjects with clinical pharmacists and physicians.

Functions of Clinical Pharmacists: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15.

Taking the medical history of the patient. Patient Education. Patient care. Formulation and management of drug policies. Drug information. Teaching & training to medical and paramedical staff Research and development. Participation in drug utilization studies. Patient counselling. Therapeutic drug monitoring. Drug interaction surveillance. Adverse drug reaction reporting. Safe use of drugs. Disease management cases. Pharmacoeconomics.

Development of clinical practice: 1. In pharmacy the emergence of clinical pharmacy as a form of practice has been attributed to the poor medicines control systems that existed in hospitals during the early 1960s (Cousins and Lacombe, 1995).


Page 5

2. Although provoked by similar hospital centred problems, the nature of the professional response differed between the USA and the UK. In the USA, the approach was to adopt unit dose dispensing and pursue decentralisation of pharmacy services. 3. In the UK, the unification of the prescription and the istration record meant this document needed to remain on the hospital ward and required the pharmacist to visit the ward to order medicines. 4. Clinical pharmacy thereby emerged from the presence of pharmacists in these patient areas and their interest in promoting safer medicines use. This was initially termed ‘ward pharmacy’ but participation in medical ward rounds in the late 1970s signalled the transition to clinical pharmacy. 5. Medication safety may have been the spur but clinical pharmacy in the 1980s grew because of its ability to promote cost effective medicines used in hospitals. 6. This role was recognised by the UK government, which, in 1988, endorsed the implementation of clinical pharmacy services to secure value for money from medicines. Awareness that depended, to an extent, on the quantification of actions and cost savings led several groups to develop ways of measuring pharmacists' clinical interventions. 7. Coding systems were necessary to aggregate large amounts of data in a reliable manner and many of these drew upon the eight steps of the drug use process (DUP) indicators. 8. The data collected from these early studies revealed that interventions had very high physician acceptance rates, were made most commonly at the ‘select regimen’ and ‘need for drug’ stages of the DUP, and were influenced by hospital ward type (intensive care and paediatrics having the highest rates), pharmacist grade (rates increasing with grade) and time spent on wards. Despite the level of activity that intervention monitoring revealed, together with evidence of cost containment and a broadly ive health care system, frustrations began to appear. 9. These, in part, stemmed from a lack of certainty about the fundamental purpose of clinical pharmacy and from tensions between the drive towards specialisation in clinical pharmacy and the need to improve services of a more general level in hospitals and other care settings.


Page 6

INTRODUCTION TO DAILY ACTIVITIES OF A CLINICAL PHARMACY: A.DRUG THERAPY MONITORING. Therapeutic drug monitoring (TDM) refers to the measurement and interpretation of principally blood plasma drug concentration measurements with the purpose of optimising a patient’s drug therapy and clinical outcome while minimising the risk of drug-induced toxicity. TDM involves tailoring a dose regimen to an individual patient by maintaining the plasma or blood concentration within a particular range. To achieve optimal drug therapy 3 objectives should be met: 1. To attain desired pharmacological effect of the drug. 2. To reach the maximal effect in shortest possible time. 3. To decrease the risk of toxicity. TDM is useful in drugs: 1. 2. 3. 4.

With a narrow therapeutic index. Which is highly protein bound. Which are liable to interact? In which the metabolite might be toxic.

ROLE OF PHARMACIST: A reliable and responsive TDM service depends on team work between nurses, doctors, pharmacist, scientist and technical staff. The clinical pharmacist should provide advice to medical staff on the appropriate use and timing of TDM and assist with the interpretation of results. In addition the pharmacist maybe involved in: 1. Initial selection of drug regimen. This may involve decisions about drug choice, dose, dosing interval, route of istration and dosage form of the drug, taking into factors such as sex, age, body weight, race, metabolism T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP.

Page 7

2. 3.

4. 5.

status, renal function, plasma albumin concentration, use of other drugs and laboratory results. Adjustment of the dosage regimen based on TDM results and the patients clinical response,. Assessment of possible causes for unexpected results, such as non- compliance, bioavailability problems, medication errors, drug interactions or pharmacogenetic variability. Dose adjustment for patients on haemodialysis or peritoneal dialysis. Provision of poisons information.

MEDICATION CHART REVIEW:

• • •

It is a fundamental responsibility of a pharmacist to ensure the appropriateness of medication orders. It serves as starting point for other clinical pharmacy activities (medication counselling, TDM, DI, and ADR). Organising information according to medical problems (example disease) helps breakdown a complex situation into its individual parts.

GOALS: 1. To optimise the patients drug therapy. 2. To prevent or minimise drug related problems/medication errors. PROCEDURE: • The patient’s medical record should be reviewed in conjugation with the medication istration record. • Recent consultations, treatment plans and daily progress should be taken into when determining the appropriateness of current medication orders and planning each patient’s care. • All current and recent medication orders should be reviewed. COMPONENTS OF MEDICATION ORDER REVIEW: It includes: 1. Checking that medication order is written in accordance with legal and local requirements. 2. Ensuring that the medication order is comprehensible and unambiguous, that appropriate terminology is used and that drug name are not abbreviated. Annotate the chart to provide clarification as required. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP.

Page 8

3. Detecting orders for medication to which the patient may be hypersensitive/ intolerant. 4. Ensuring that medication order is appropriate with respect to: a) The patient’s previous medication order. b) Patient’s specific considerations e.g. disease state, pregnancy. c) Drug dose and dosage schedule, especially with respect to age, renal function, liver function. d) Route, dosage form and method of istration. 5. Checking complete drug profile for medication duplication, interactions or incompatibilities. 6. Ensuring that istration times are appropriate e.g. with respect to food , other drugs and procedures. 7. Checking the medication istration record to ensure that all ordered have been istered. 8. Ensuring that the drug istration order clearly indicates the time at which drug istration is to commence. 9. special considerations should be given especially in short course therapy as in antibiotics and analgesics. 10. Ensuring that the order is cancelled in all sections of medication istration record when the drug therapy is intended to cease. 11. If appropriate follow up of any non-formulary drug orders, recommending a formulary equivalent if required. 12. Ensuring appropriate therapy monitoring is implemented. 13. Ensuring that all necessary medication is ordered. E.g. premedication, prophylaxis. 14. Reviewing medication for cost effectiveness. 15. Identification of drug related problems.

a) b) c) d) e) f) g) h)

Untreated indication. Inappropriate drug selection. Sub therapeutic dose. Adverse drug reaction. Failure to receive drug. Drug interactions. Drug use without indication. Over dosage.

Medication chart Endorsement. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP.

Page 9

1. Another important goal of treatment char review is to minimise the risk of medication errors that might occur at the level of prescribing and / or drug istration. 2. A medication error is any preventable error that may lead to inappropriate medication use or patient harm. 3. To prevent potential morbidity and mortality associated with these errors, pharmacists should systematically review the medication chart and write annotations on the chart where the medication orders are unclear.

CLINICAL REVIEW: Clinical review is one of the integral components of medication review and should preferably be performed on a daily basis. It is the review of the patients’ progress for the purpose of assessing the therapeutic outcome. The therapeutic goal for the specific disease should be clearly identified before the review. GOALS: • •

The primary aims of the clinical review are to: Assess the response to drug treatment.

• • • •

Evaluate the safety of the treatment regimen. Assess the progress of the disease and the need for any change in therapy. Assess the need for monitoring, if any. Assess the convenience of therapy (to improve compliance).

PHARMACIST INTERVENTIONS: Clinical pharmacists can audit their impact on patient care by intervention monitoring. Some hospitals undertake these audits at regular intervals and present the results internally or to the multidisciplinary team. Data collection forms or electronic hand-held systems are used to collect the relevant data on a pharmacist’s interventions to improve patient care. Examples of data collected for this purpose include the following. 1. 2. 3. 4.

Patient details and demographics. Area of work/specialization. Written details of the intervention. Date of intervention.

T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 10

5. 6. 7. 8. 9. 10. 11. 12.

Other healthcare professionals ed. Evidence used to the intervention. Who initiated the intervention — e.g. pharmacist, doctor, nurse, or patient. Possible effect the intervention would have on patient care. Outcome of the intervention. Actual outcome on patient care that the intervention had. Significance of intervention. Category of intervention.

Examples of the categories of pharmacist interventions in drug therapy: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22.

ADRs Allergy Additional drug therapy required Medication error Medication without indication Untreated condition or undertreated condition Minimal or no therapeutic effectiveness Therapeutic duplication Patient adherence, compliance, or drug istration issue Patient education Communication with prescriber Incorrect medication prescribed Inappropriate or suboptimal dose, schedule, or route Optimization of drug therapy, including improving cost-effectiveness Dose advice Advice on drug choice Drug–drug, drug–food, or drug–disease interaction Side effect/toxicity Therapeutic monitoring for toxicity or effectiveness Formulation Compatibility Formulary or protocol adherence

An example of an intervention monitoring form is shown in Table.


B) WARD ROUND PARTICIPATION: A ward round is a visit made by a medical practitioner, alone or with a team of health professionals and medical students, to hospital inpatients at their bedside to review and follow up the progress in their health. Usually at least one ward round is conducted every day to review the progress of each inpatient, though more than one is not uncommon. In certain practice settings such as psychiatry, the “ward round” may be conducted away from the patient’s bedside in a non-traditional fashion, where the team meets elsewhere to review each case. Goals and objectives for clinical pharmacists on ward rounds: As an important member of the healthcare team, pharmacists should attend ward rounds and clinical meetings whenever possible. This enables pharmacists to contribute prospectively to patient care through the provision of drug therapy. The goals of a clinical pharmacist’s participation in ward rounds are to:

• • • • •

Gain an improved understanding of patient’s clinical status and progress, current planned investigations and therapeutic goals. Provide relevant information on various aspects of the patient’s drug therapy such as pharmacology, pharmacokinetics, drug availability, cost, drug interactions and adverse reactions. Optimize therapeutic management by influencing drug therapy selection, implementation, monitoring and follow-up. Investigate unusual drug orders or doses. Assimilate additional information about the patient such as co-morbidities, medication compliance or alternative medicine use that might be relevant to their management.


• •

Detect adverse drug reactions and drug interactions. Participate in patient discharge planning.

The Ward round participation also provides many learning opportunities for pharmacists. It allows pharmacists to see first-hand how drugs are used and prescribed and to see the effects of these drugs on patients. With time, pharmacists develop an appreciation of how the patient’s own wishes and their social, cultural and economic circumstances may influence therapeutic choices. Even for experienced clinical pharmacists in teaching hospitals, it is very rare to finish a ward round without gaining new perspectives on some aspect of therapeutics or patient care. For those involved in academia and research, ward rounds allow identification of cases for clinical teaching and publication. Not the least, ward round participation strengthens the inter-professional relationship among various health professionals, leading to better healthcare practice and research.

C) ADRs MANAGEMENT: The ADRs are can be managed by following methods: 1. Assess the nature and severity of the reaction: Whether an urgent action is required or can be managed by primary care. E.g.: whether an anaphylactic shock or something minor. 2. Review on the presenting symptoms: Timing: Time of start of the reaction after giving the drug; Time taken to abate after the stopping of drug or reducing the dose. Relationship to dose: Whether reaction minimized with reducing the dose; symptoms resolve when the medicine withdrawn and recur when reintroduced. Other possible causes: Possibility of underlying illness or other disease; other medications (including OTC and Herbals); drug interactions (including diet). 3. Take complete drug history - Review any History of Allergy or previous ADR: When the drug was started, dose, other drugs, OTC and herbal. Past ADRs Long


duration of action or long term use effect can be expected for some drugs. Review the adverse effect profile of the drugs, and check how common it is. 4. Further Examination and Investigations if required: Specific investigations and laboratory tests required. E.g.: Liver and Renal Function Tests. ROLE OF PHARMACIST IN THE MANAGEMENT OF ADRs: 1. Monitoring the patients who are at greater risk of developing ADR’s 2. Monitoring the patients who are prescribed with drugs highly susceptible to cause ADR’s 3. Assessing and documenting the patient’s previous allergic status 4. Assessing the patient’s drug therapy for its appropriateness 5. Assessing possible drug interactions in case of multiple therapies 6. Assessing health care professionals in detection and assessment of ADR’s 7. Encouraging/ stimulating healthcare professionals in reporting on ADR 8. Documentation of suspected reported reactions for future reference 9. Follow up of patients to assess the outcome of the reaction and management 10. Obtaining about the reported reaction 11. Educating healthcare professionals about the importance of an ADR 12. Educating patients.

D) DRUG INFORMATION AND POISON INFORMATION: Drug information: • •

It is the current, relevant, critically examined data about drug and drug use for given patient or situation. Many institutes run DIC (Drug Information Centre) for the provision of drug information, to every group/kind of people from any place.

HISTORY: 1. First DIC was developed in University of Kentucky in 1960. In United states 80% of the Hospitals having DIC. 2. INDIA, in infancy stage with a few centres. 3. In India beginning has been made by the professor of pharmacology Mumbai at a govt medical college. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 14

4. CMC and Hospital Vellore have been trying in this direction earlier. Need of drug information: 1. The no of drugs in the international market has increased very much. 2. The newer drugs are generally more potent & selective, and formulations becoming increasingly complex. 3. The literature on drugs has also expanded and covers a wide range of information. 4. To introduce a new drug into the practice, the professionals need to evaluate the given information. 5. A simple, quick reference to a pharmacopoeia or formulary is no longer sufficient. Aims and objectives of drug information services. 6. The provision of information to health professionals on specific problems related to the use of drugs in particular patients; 7. The provision of information to officials in government agencies to optimize the decision making process; 8. The preparation and development of guidelines and formularies; 9. To improve patient compliance and to provide a guide to responsible selfmedication; 10. To develop and participate in continuing education programs; 11. To participate in undergraduate and graduate teaching programs; 12. To develop educational activities regarding the appropriate use of drugs for patients in the community; 13. To prepare and distribute material on drugs to health personnel in the form of a drug Information bulletin and/or other media; 14. To develop and participate in research programs; The Sources of information/Resources available: 1. Primary Source: • •

Information is presented by authors without any evaluation by a second party. Provides must current information about drugs.

Examples; articles published in journals (e.g. British Medical Journal), thesis etc. 2. Secondary source:


• •

The original source has been evaluated by second party other than the publisher. Modified and rearranged form

Examples; review articles like LexisNexis, Medline etc. 3. Tertiary source: •

• • •

Information obtained from primary and secondary source and arranged in a manner to represent a composite of the available information. Examples; Representative form Pharmacopoeias - BP, USP, IP, BNF etc., Encyclopaedias, Dictionaries, Guides, text books and Other Sources: a) The DIC also receives information from b) The public and hospitals about the Adverse effects of any drug c) Local drug lists d) National Formularies e) Hospital Formularies Internet Phone calls to Manufacturers Government and Non-government organizations And also to other DIC’s.

DRUG INFORMATION SKILLS: • •

Drug informer should understand the nature of the question and should ask all the needed questions to get the ultimate question. Most specialists today use the modified systematic approach designed by ‘Host and Kirkwood’, these are:

Step I ; Secure demographics of the requestors: • • • •

Who requests? Med/non med personnel Educated/un educated personnel Name/location/phone/email etc., of requestor This determines the type of response that will be given

Step II; Obtain background information: • • •

Where the requestor heard/read about the drug? Is he/she taking medicine? Why? Is he/she a caregiver/wants to take medicine?


•

This helps determining what additional information should be provided.

Step III; determine and categorize the ultimate question: Putting the pieces of information together to form ultimate question and once it has been determined; the next step is to categorize the question. Step IV; Develop strategy and conduct research: Strategies should be developed with a typical algorithm with three essential components; tertiary-secondary-primary literature. Step Perform evaluation, analysis & synthesis: Provider should take time to evaluate the info, analyse and then synthesize it into a good reply. Step VI; Formulate and provide response: • •

An outline should be established to help formulate a response to the drug info request. It’s important to have; introduction, body and conclusion.

Step VII; Conduct follow-up and documentation. • •

Checking with the requestor to make sure his/her question has been sufficiently and completely answered. Of vital importance is to document all the steps taken in this process.

DRUG LITERATURE EVALUATION: 1. Among the skills of drug information is knowledge of drug literature evaluation which allows one to provide a critical analysis of the literature and have a better understanding of the studies done in health and medicine. 2. It is a key component to provide a good quality answer to a requester. 3. Being able to separate good data from poor data is essential. 4. Knowing the limitations of any study can help in evaluating the usability of its data. 5. Drug information specialists will often use some standard questions to help in this process. 6. Several references provide guides to evaluate the medical and pharmacy literature. GENERAL GUIDELINES FOR RESPONSES TO DRUG INFORMATION: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 17

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Do not guess Take several ethical issues into Patient privacy must be maintained Patient-physician relation cannot be breached Response is not necessary if the inquirer intends to misuse or abuse the information that is provided. Organize information before attempting to communicate the response to the inquirer. Tailor the response to the inquirer’s background. Tell the inquirer where the information was found. Alert the inquirer of a possible delay when it takes longer than anticipated to answer the question. Ask if the inquirer’s question is answered by the information.

Drug information canters: 1. Drug information canters (DICs) in general, are service providers, which provide drug information relating to therapies, Pharmacoeconomics, education, and research programs. 2. It provides unbiased information to health care professionals and/or patients and consumers. 3. Many centers also provide workshops or other forms of training to enhance the skills of healthcare professionals. 4. A drug information center is usually a unit located within and/or d with a larger organization (i.e., a pharmaceutical association, a hospital etc.). STAFFING: 1. Pharmacist; specialists with proper knowledge of drug and actions associated with it with academic degree. (They provide drug information) 2. Pharmacy Technicians & Students (They assist pharmacists in providing drug information like literature searching, retrieval of data, resources updating etc.) 3. People trained in library science with computer knowledge (They are ing staffs in DIC for their own expertise) 4. The center should have specific hours of operation (24hrs preferably) and adequate technological resources (i.e., computers, phone lines, faxes, etc.) T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 18

5. The drug information center should have the latest publications and ideally publish a newsletter or other informational updates. 6. Role of Pharmacist Must be a part of DIC, should be “ready to go” for information all the time. 7. ‘The Drug-Information Pharmacist’ is at interface of vast amount knowledge on onside and the persons needing the knowledge on other. 8. Should provide proper information irrespective of the informer’s status, but accordingly with informer’s status. Drug information bulletin: 1. It publishes the latest developments in medical sciences, the newly introduced drugs, new indication and other information regarding drugs. 2. One of the PTCs duties is to assist the pharmacist in conducting a teaching program within the hospital through a pharmacy publication. 3. The methods employed to disseminate interdepartmental information are usually bulletins, bulletin board notices and committee meetings. 4. The bulletin normally publishes the latest development in the medical sciences, the newly introduced drugs, new indications for certain drugs, newer drug delivery systems, updates on drug interactions and ADRs. 5. Pharmacist is normally held responsible for its publication however; contributions are obtained from pharmacists, physicians and nursing and other interested groups like therapeutic dietician for food drug interactions for publishing the bulletin. 6. The contents should however be educative and informative.

POISON INFORMATION: HISTORY: 1. The first centers were instituted in North America and Europe during the 1950’s. 2. The International Programme on Chemical Safety (IPCS) was established in 1980 as a collaborative programme of the International Labour Organization (ILO), the United Nations Environment Programme (UNEP), and the World Health Organization (WHO) in order to provide assessments of the risks to human health and the environment posed by chemicals.


3. The IPCS provides guidance on the use of such assessments and seeks to strengthen the capacity of each country to prevent and treat the harmful effects of chemicals and to manage emergencies involving chemicals. 4. Its work on prevention and treatment of poisoning is undertaken in collaboration with the World Federation of Associations of Clinical Toxicology Centers and Poison Control Centers and its member associations. 5. The aims of the European Commission (EC) in the field of poison control are similar to those of the IPCS and many activities are undertaken tly by the two bodies. POISON INFORMATION SERVICES: PCC (Poison control center); • •

For the provision of service regarding poison and related danger, and to manage with the poisoning Cases Concept initiated in Chicago in 1953

PCC were established for two reasons: • •

To provide rapid access to information valuable in assessing and treating poisonings. To assist with poisoning prevention

STAFFING: 1. Pharmacy team: • Pharmacist; specialists trained in poison information and in the management of poisoning emergencies. • Pharmacy Technicians & Students. 2. Medical team: Toxicologists specializing in medical toxicology are also available for consultation. 3. ing team: a. People trained in library science with computer knowledge. b. The poison information centre is a specialized unit providing information on poisoning, in principle to the whole community.


c. Its main functions are provision of toxicological information and advice, management of poisoning cases, provision of laboratory analytical services, Toxicovigilance activities, research, and education and training in the prevention and treatment of poisoning. b) As part of its role in Toxicovigilance, the centre advises on and is actively involved in the development, implementation, and evaluation of measures for the prevention of poisoning. c) It also plays an important role in developing contingency plans for, and responding to, chemical disasters, in monitoring the adverse effects of drugs, and in handling problems of substance abuse Assess and treatment recommendations during poisoning via 24-hour emergency telephone services d) Provide public and professional educational programs. e) To collect data on poisonings. f) To perform research g) Assist the public and health care providers during hazardous material spills h) Drug information and Pharmacovigilance i) Substances of abuse j) Environmental toxicology k) Contingency planning for chemical incidents and disasters l) Cooperation and interrelationships. TEACHING AND TRAINING : • •

•

The experience gained in a poison information centre can be an important source of human and animal toxicological data. The application and communication of this knowledge are vital for improving the prevention and management of poisoning. Centers thus have educational responsibilities that extend to the training of medical practitioners and other professional health workers likely to encounter cases of poisoning, and to communication with the local population and the mass media. Later sections of these guidelines include advice on the training needs of centers as well as on their teaching and training functions.

TOXICOVIGILANCE:


•

•

•

•

Toxicovigilance is an essential function of poison information centers. It is the active process of identifying and evaluating the toxic risks existing in a community, and evaluating the measures taken to reduce or eliminate them. Analysis of enquiries received by centers permits the identification of those circumstances, populations, and possible toxic agents most likely to be involved, as well as the detection of hidden dangers. The role of a centre in Toxicovigilance is to alert the appropriate health and other authorities so that the necessary preventive and regulatory measures may be taken. This role enables them to make a major contribution to the prevention of poisoning through their collaboration with the health and other appropriate authorities.

ENVIRONMENTAL TOXICITY: •

•

•

Poison information centres, particularly in countries where there is no other readily accessible source of information on toxic chemicals, are being asked to provide information on the effects of environmental contaminants, on the risks associated with toxic wastes, and on safe levels of chemicals in the environment and in food and other consumer goods. Medical practitioners must also be provided with data on the possible effects of exposure to environmental contaminants, and information on the types of biological and other samples that should be collected and analysed. Mechanisms for the systematic collection, validation, and follow-up of data should be established; it is also essential that the data are comparable, both nationally and internationally, so that they may be used for the benefit of all.

CONTINGENCY PLANNING FOR CHEMICAL INCIDENTS AND DISASTER: •

•

Poison information centers can contribute to the handling of major chemical incidents and disasters by providing appropriate information in the event of an emergency and by taking an active part in contingency planning and in education and training. They should also take part in epidemiological follow-up studies and other research initiatives, where appropriate, collaborating and acting in concert with other bodies involved in accident prevention and control.


•

A national or regional poison information centre can serve to centralize and coordinate such activities.

BENEFITS: 1. Service provided by poison information centers offers considerable direct health benefits by reducing morbidity and mortality from poisoning and enabling the community to make significant savings in health care costs. 2. Mild poisoning cases that can be treated by first-aid measures alone or by nonhospital medical personnel are quickly recognized. Specific antidotes, therapeutic agents, and medical equipment can be made more easily available through coordination of stocks, so reducing costs and saving lives. Centers can also help to prevent the unnecessary use of special antidotes and of sophisticated and expensive treatments. 3. The case data collected by centers provide an epidemiological basis for local Toxicovigilance and contribute to the international fund of knowledge about human toxicology and management of poisoned patients. 4. The education and training provided by poison information centers enable professional health workers and the general public to recognize and avoid the dangers of poisoning and to take effective action when poisoning incidents occur.

E) MEDICATION HISTORY: INTRODUCTION: An accurate medication history provides a foundation for assessing the appropriateness of a patient’s current therapy and directing future treatment choices. It can prevent medication errors and during the process of obtaining a history other pharmaceutical issues such as poor or non-adherence can be identified. It is important, as part of your clinical role as pharmacists, that the medication histories you undertake are accurate to ensure patients’ current and future therapy is safe and effective. Definition of Medication History Interview: A structured critical examination of a patient’s medicines by a healthcare professional: • • •

reaching an agreement with the patient about treatment optimizing the use of medicines minimizing the number of medication-related problems


•

Avoiding wastage.

Regular medication review maximizes the therapeutic benefit and minimizes the potential harm of drugs. It ensures the safe and effective use of medicines by patients. Medication review provides an opportunity for patients to discuss their medicines with a healthcare professional. Medication review is the cornerstone of medicines management. What does medication review involve? • • • • • • • • • • • • • •

A structured critical examination of a patient’s medicines (prescription and other medicines, including alternatives) by a healthcare professional. Identification, management, and prevention of ADRs or drug interactions. Minimizing the number of medication-related problems. Optimizing the use of medicines. Simplification of regimen. Ensuring all drugs is appropriate and needed. Avoiding wastage. Medication counselling. Adherence counselling — to encourage patients to adhere to their drug regimens. Assessment of ability to self-medicate. Education of patient or carer — to help them understand their drugs better. Education of the patient on safe and effective medication use. Forum for suggesting effective treatment alternatives. Recommendation of compliance aids.

Principles of medication review: • • • • • •

Patients must be informed that their medication is being reviewed. Patients should have the opportunity to ask questions and highlight and problems with their medicines. Medication review should improve the impact of treatment for an individual patient. A competent person (e.g. pharmacist) should undertake the review in a systematic way. Any changes resulting from the review are agreed with the patient. The review is documented according to local policy (e.g. in the patient’s notes).


•

The impact of any change is monitored.

Levels of medicine review: • Level 3 (clinical medication review) • •

Face-to-face review of medication with the patient and their notes, specifically undertaken by a doctor, nurse, or pharmacist. Provides an opportunity to discuss what medication the patient is actually taking and how medicine-taking fits in with the patient’s daily life.

Level 2 (treatment review) •

Review of medicines, with reference to the patient’s full notes, in the absence of the patient and under the direction of a doctor, nurse, or pharmacist.

Level 1 (prescription review) •

Technical review of a list of the patient’s medicines in the absence of the patient and under the direction of a doctor, nurse, or pharmacist.

Level 0 (ad hoc review) •

Unstructured, opportunistic review of medication.

Who to target: • • • • •

Patients on multiple medications or complicated drug regimens. Patients experiencing ADRs. Patients with chronic conditions. Elderly patients. Non-adherent patients.

Potential benefits of medication review: • • • • • •

Identification, management, and prevention of ADRs. Ensuring patients have maximum benefit from their medicines. Decreases the risk of drug-related problems. Increases the appropriate use of medicines. Improved clinical outcomes. Cost-effectiveness.


• • • • • •

Increases the quality of life. Optimizing therapy. Decreases the waste of medicines. Enables patients to maintain their independence. Decreases the issions to hospital. Decreased in drug-related deaths.

Problems identified during a medication review: • • • • • • • • •

Potential ADRs. Potential interactions (drug–drug or drug–food). Suboptimal monitoring. Adherence/lack of concordance issues. Misunderstanding of dose directions. Impractical directions. Incorrect/inappropriate dosages. Drugs no longer needed (e.g. one medication used to treat the side effects of another). Difficulties with using certain dose forms (e.g. inhaler or eye drops).

F) PATIENT COUNSELLING: Providing information to patients and their representatives regarding disease, drug therapy, and duration of therapy, side effects, and life style modifications. Outcomes of patient counselling: • • • • • •

Patient recognizes the importance of their wellbeing. It encourages the patient to establish a working relationship with a pharmacist & foundation for continual interaction and consultation. Improves the coping strategies to deal with medication side effects and drug interactions. Motivates the patient to take medicine for improvement of his/her health status. The patient becomes an informed, efficient and active participant in disease treatment and self-care management. Develops the ability in patient to take appropriate medication related decision concerning the compliance or adherence to their medication regimen.


Stages in patient counselling: • • • •

Introduction. Content. Process. Conclusion.

Introduction: • • • • •

• •

Review the patient record prior to counseling. Conduct an appropriate patient counseling introduction by self and patient. Explain the purpose of counseling session. Obtain pertinent initial drug related information. E.g.: drug allergies, and other medications. Warn the patient about taking other medications including OTC drugs, herbals, or botanical drugs and alcohol which could inhibit or interact into the prescribed medication. Asses the patient understandings of reason for therapy. Assess any actual or problems of importance to the patient.

Counseling contents item: 1. Discuss the name and indication of the medication. 2. Explain the dosage regimen including duration of therapy when appropriate. 3. Assist the patient in developing a plan to incorporate the medication regimen into his/her daily routine. 4. Explain how long it will take for the drug to show its effect. 5. Discuss storage and refilling information. 6. Emphasize the benefits of completing the medication as prescribed. 7. Discuss the potential side effect. 8. Discuss how to prevent or manage the side effects of the drug. 9. Discuss the precautions. 10. Discuss the significant drug-drug, drug-food, and drug-disease interaction. 11. Explain precisely what to do if the patient misses the dose. 12. Explore the potential problems of the patient. Counseling process items: •

Use the language the patient can understand.


• • • •

Use the appropriate counseling aids to counseling. Present the fact and order in a logical order. Use open-ended question. Use both verbal and non-verbal behavior.

Counseling conclusion steps: • • • •

the patient understanding via . Summaries by acknowledging or emphasizing key points of information. Provide an opportunity for final concerns or questions. Help the patient to plan, follow up and next consecutive steps.

Barriers to patient counseling:

The barriers that come in the way of conducting patient counseling are: 1. Environment: ✓ A busy pharmacy ✓ Lack of privacy ✓ Noise ✓ Physical barrier 2. Patient factors ✓ Physical disabilities ✓ Comprehensive difficulties ✓ Illiteracy 3. The pharmacist 4. Time. Environment: ✓ Community pharmacy, hospital OP pharmacy and hospital ward are all areas where pharmacist uses their communication skills in a professional capacity. ✓ None of these areas are ideal but an awareness of the limitation of the environment goes part the way to resolving some of the problems. A busy pharmacy: ✓ This may create the impression there appears to be little time to discuss personnel matter with the patients. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 28

✓ The pharmacist is supervising number of difficult activities at the same time and is unable to devote his/her full attention to an individual matter. ✓ It is important that pharmacist organize their patterns in such a way as to minimize their impression. Lack of privacy: ✓ Both community and hospital outpatient departments have counseling rooms/ areas but may have not, many hospital wards could be linked to a busy thorough fare. ✓ For good communication to be it is often necessary for the consultation to take place in a quite environment, free of interruptions. ✓ The above mentioned condition in which pharmacist frequently work require additional skills to overcome the lack of ideal facilities. Noise: ✓ Noise levels within the working environment are an obvious barrier to good communication. ✓ People strain to hear what is said. Comprehension is made more difficult, particularly problem exist for hearing impaired patients. Physical barriers: ✓ The distance between people where communication occurs is significant. ✓ Pharmacy counters and OP dispensing hatches are physical barriers. This in turn can create problems in developing effective communication.

Patient factors: ✓ One of the main barriers to good communication in a pharmacy can be patient expectations. ✓ In many cases, they have become used to seeing a good pharmacy as one where their prescription is dispensed quickly. ✓ They are not expecting time t be spent with them for checking, understanding of medicines or health related matters.


✓ Once the purpose of communication is explained most patients realize its importance. Physical disabilities: ✓ Dealing with patients who have sight or hearing impairments will require the pharmacist to use additional communication skills. Comprehensive difficulties: ✓ Not all people come from the same educational background and care must be taken to assess patient’s level of understanding and choose appropriate language. ✓ In many cases, the lack of ability to comprehend may be because English is not the patient’s first language. ✓ Pharmacist working in areas where there is high proportion of non-English speakers may find it useful to stop / develop their own information leaflet in appropriate language. Illiteracy: ✓ High proportion of people in India is illiterate. Obviously for these patients any written materials will be meaningless. As well as, it is not always easy to identify illiterate patient because patient may feel ashamed and are unlikely to it it. ✓ However, if pharmacist identifies any patient who have reading difficulties, pictorial labels can be used and additional verbal advice can be given. Pharmacist: ✓ Not all pharmacists are natural good communicators but identifying their strength or weakness will assist in improving our communication skills. ✓ Some of the weakness which can be barrier to good communication are listed below: ✓ Lack of confidence. ✓ Lack of interest ✓ Laziness ✓ A pharmacist who is not prone to delicate responsibilities. ✓ If any of these characteristics is present, the reason for it should be identified and resolved if possible. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 30

Time: ✓ In many instances, time or lack of it can be major problem for good communication. ✓ Try developing a meaningful conversation with someone who constantly looks at his watch. ✓ Similarly, a patient who is worried about missing a bus or concerned that a car is parked on double yellow lights is unlikely to give undivided attention.

G) Drug use evaluation (DUE): Drug use evaluation (DUE) is a system of on-going, systematic, criteria-based evaluation of drug use that will help ensure that medicines are used appropriately (at the individual patient level). If therapy is deemed to be inappropriate, interventions with providers or patients will be necessary to optimize drug therapy. A DUE is drug- or disease-specific and can be structured so that it will assess the actual process of prescribing, dispensing or istering a drug (indications, dose, drug interactions, etc.). DUE is the same as drug utilization review (DUR) and are used synonymously. Medication use valuation (MUE) is similar to DUE but emphasizes improving patient outcomes and Individual quality of life; it is, therefore, highly dependent on a multidisciplinary approach involving all professionals dealing with drug therapy. An MUE will assess clinical outcomes (cured infections, decreased lipid levels, etc.). The goal of a DUE or MUE is to promote optimal medication therapy and ensure that drug therapy meets current standards of care. Additional objectives may include: • • • • •

•

creating guidelines (criteria) for appropriate drug utilization evaluating the effectiveness of medication therapy enhancing responsibility/ability in the medicine use process controlling medicine cost preventing medication related problems, for example adverse drug reactions, treatment failures, over-use, under-use, incorrect doses and non-formulary medicine use Identifying areas in which further information and education may be needed by health-care providers.


•

Once the main problem areas have been identified, (from aggregate data, health facility indicators, qualitative studies, other DUE studies, or even recommendations from DTC ), a DUE system can be established relatively quickly.

The steps of a DUE: The steps of a DUE are as follows. An example is shown in box 6.7. STEP 1 Establish responsibility: It is the responsibility of the DTC to establish procedures for the implementation of a DUE programme; this includes appointing a responsible member of the DTC or a subcommittee to monitor and supervise the DUE process in the hospital or clinics. Ideally the DTC should establish annual plans, outlining which medicines or clinical conditions will be a part of the DUE process. STEP 2 Develop the scope of activities and define the objectives: The DTC should decide upon the objectives of the DUE and the scope of the activities necessary. The scope can be very extensive or it can focus on a single aspect of drug therapy and will depend upon the type of problem identified, for example: • • • •

overuse of a more expensive medicine when a cheaper equivalent is available, as revealed in aggregate data incorrect use (indication, dosage, istration) of a particular drug, as revealed in patient charts, medication error reports, ADR reports inappropriate choices of antibiotic, as revealed in antibiotic sensitivity reports a poor dispensing process, as revealed by patient complaints or .

Due to the large number of medicines available at a hospital or clinic, the DTC must concentrate on those medicines with the highest potential for problems in order to get the most return on the work involved. These high-priority areas include: • • • • •

• • • •

high-volume drugs expensive drugs drugs with a narrow therapeutic index drugs with a high incidence of ADRs critically important therapeutic categories, for example cardiovascular, emergency, toxicology, intravenous drugs, chemotherapy and narcotic analgesics antimicrobial drugs, prophylactic and therapeutic drugs undergoing evaluation for addition to the formulary drugs used for non-labelled indications drugs used in high-risk patients


•

Common clinical conditions often poorly treated.

STEP 3 Establish criteria for review of the medicine: An Establishing DUE criterion are extremely important, and is the responsibility of the DTC. DUE criteria are statements that define correct drug usage with regard to various components, as shown in box 6.6. Criteria for the use of any medicine should be established using the hospital’s STGs (assuming that they have been correctly developed). In the absence of hospital STGs, criteria may be based on recommendations from national or other locally available satisfactory drug use protocols, other relevant literature sources, and/or recognized international and local experts. Credibility, and staff acceptance, of the DUE relies on using criteria that have been developed from reading established evidence-based medicine information from reputable sources and that have been discussed with prescribers. COMPONENTS OF DRUG USE FOR DUE CRITERIA: • • • • • • • • •

uses: appropriate indication for drug, absence of contraindications selection: appropriate drug for clinical condition dosing: indication-specific dosing, intervals and duration of treatment interactions: absence of interactions - drug-drug, drug-food, drug-laboratory preparation: steps involved with preparing a drug for istration istration: steps involved in istration, quantity dispensed patient education: drug and disease-specific instructions given to patients monitoring: clinical and laboratory outcome, for example: decreased blood pressure, blood glucose, asthma attacks

Reviewing many criteria will make the DUE process more difficult, and may impair successful completion of the review. Therefore the number of criteria established for each medicine is often between 3 and 5. Once the criteria are established, thresholds or benchmarks are decided for each criterion in order to define the expectations or goals for compliance with the criteria. Ideally one would like 100% of all cases to comply with the criteria, but in reality this may not be possible, and a DTC might decide to set a threshold of 90-95% compliance below which they would instigate corrective action. STEP 4 Data collection: Data may be collected retrospectively, from patient charts and other records, or prospectively, at the time a medicine is prepared or dispensed. Retrospective data collection may be quicker and is best accomplished away from the patient care areas and distractions. The advantage of a prospective review is that the reviewer can intervene at the time the medicine is dispensed to prevent errors in dosage, indications, T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 33

interactions or other mistakes. A particular example of this is the computerized systems used in some pharmacies; here the computer warns the pharmacist if patient data being entered into the computer fails to meet established criteria and requires them to correct the problem(s) noted. Such a system can also provide a large database for use retrospectively. Data must be collected from a suitable random sample of charts or prescription records from the health-care facility, usually selected by pharmacy personnel, but also by nurses or medical records personnel. The treatment of at least 30 patients, or 100 patients for common clinical conditions, should be reviewed per health facility or hospital. The larger the facility and the more practitioners, the larger the number of records needed for review and analysis. Data collection forms based on the criteria can be configured into simple ‘yes/no’ questions or may involve the filling in of open questions. Sources of data include patient charts, dispensing records, medication istration records, laboratory reports, ADR reports, medication error reports, antimicrobial sensitivity reports, and documented staff and patient complaints. STEP 5 Data analysis: Data are tabulated in a form that corresponds to the criteria chosen for the DUE. The percentages of cases that meet the threshold for each criterion should be calculated and summarized for presentation to the DTC. A report of all DUE programmes that are being conducted should be prepared on a quarterly basis. STEP 6 to the prescribers and making a plan of action: After information is presented (for example: on inappropriate drug use or unacceptable patient outcome), the DTC should develop conclusions about the differences between actual and desired results. In other words, how do the actual results vary from the desired benchmark or threshold levels? The DTC should then decide what follow-up action is necessary and whether to continue, discontinue or expand the functions of the DUE in question. Recommendations should include specific steps to correct any drug use problem that is evident from performing the DUE. For example, if a specific medicine is being prescribed at too high a dose, the recommendations need to specify in detail how the dosing of this medicine can be improved. Interventions to improve drug use would include to the prescribers and may also include: • • • •

education, for example letters, in-service education, workshops, newsletters, face-to-face discussions institution of drug order forms institution of prescribing restrictions changing the formulary list and/or manual


• •

changing the standard treatment guidelines Using another DUE or continuing the present one.

STEP 7 Follow-up: In every DUE, follow-up is critical to ensure appropriate resolution of any problems. Did an intervention achieve its objective? If an intervention is not evaluated, or drug use problems are not resolved, then the DUE will have been of no use. As a part of a followup plan the DTC must assess the need to continue, modify or discontinue the DUE. Thus, DUE activities should be evaluated regularly (at least annually) and those that do not have a significant impact on drug use should be redesigned in order to provide measurable improvements. Common problems associated with DUEs include unclear responsibilities for different activities, poor prioritization of problems, lack of documentation, lack of personnel and inadequate follow-up. If follow-up is adequate, prescribers are likely to improve their performance in all areas knowing that they may be reviewed in the future! DRUG USE EVALUATION AT A US HOSPITAL: In 1993 the quality assurance coordinator reported to the DTC that the rate of postoperative infections for abdominal surgery was considerably higher than the national average. The pharmacy director reported that ceftriaxone, a costly and inappropriate drug, was used for these patients. He advised that current formulary drugs, either cefoxitin or cefotetan, would be more appropriate. The DTC decided to undertake a DUE for prophylaxis of abdominal surgery wound infection. The chief surgeon was a member of the DTC and he agreed with their decision to conduct a DUE using criteria developed from recently published recommendations in the Medical Letter. • • • •

Data collection period: January-December 1994 Total number of cases: 162 Date of report: January 1995 Number of cases reviewed: 120 (74%).

Conclusions after the first quarter: •

•

Criterion 1: non-first choice antibiotics (e.g.ceftriaxone) for the indicated procedure were being used instead of recommended ones (e.g. cefoxitin or cefotetan) Criterion 2: unnecessarily high doses of antibiotics were being prescribed


•

• •

Criterion 3: preoperative doses were being delayed because the current pharmacy procedure was to send antibiotics to the operating room rather than the preoperative area Criterion 4: patients not meeting the criteria for dirty surgery were also receiving antibiotics Criterion 5: relatively high postoperative infection rate may be reduced with increased compliance with criteria

Recommendations •

• •

•

Send letter to all surgeons with information about (1) current postoperative infection rates versus the national average, (2) criteria and recommendations from the Medical Letter, (3) results of the DUE data collection, (4) estimated cost impact of inappropriate drug selection and unnecessary drug use Remove cefoxitin from the formulary because of its disadvantages (cost and short half-life) compared with cefotetan Change procedures to ister preoperative doses in the preoperative area rather than the operating room, and instruct nursing and pharmacy staff accordingly Add approved antibiotics to the floor stock in the preoperative area for emergencies

Actions: • • • • •

Chief surgeon informed the surgical committee about the DUE and the criteria in 1994 A letter was sent to all surgeons in April 1994 detailing the rationale for using cefotetan, not ceftriaxone, for prophylaxis of abdominal wound surgery Cefoxitin was removed from the formulary: ceftriaxone could not be removed due to its use for other indications New procedures for istration were adopted in June and staff training started in July 1994 Antibiotics were added to preoperative floor stock in July 1994


Follow-up • • •

•

• •

Criterion 1: Benchmark met in 4th quarter - education of surgeons led to an improvement in selection Criterion 2: Benchmark met in 4th quarter - education of surgeons led to an improvement in dosing Criterion 3: Benchmark was not met in 4th quarter despite all the activities and was considered unrealistically high because of many factors in emergency procedures; it was therefore reduced to 93% Criterion 4: Education decreased unnecessary postoperative antibiotics for a short time; then surgeons began to return to old practices. The DTC sent individual letters to specific surgeons and the practice improved but still did not reach the benchmark. Cases of non-compliance were to be reported to the DTC for peer review and recommendations Criterion 5: Benchmark met in third quarter Criterion 6: Allergic reactions increased in the third quarter because of the change in floor stock procedures and the preoperative nurse failing to screen for patient allergies (previously the pharmacy screened for allergies before dispensing). Nurses then received in-service training and allergic reactions decreased, meeting the benchmark in the 4th quarter.

DRUG UTILIZATION REVIEW: Drug utilization review (DUR) is defined as an authorized, structured, on-going review of prescribing, dispensing and use of medication. DUR encomes a drug review against predetermined criteria that results in changes to drug therapy when these criteria are not met. It involves a comprehensive review of patients' prescription and medication data before, during and after dispensing to ensure appropriate medication decisionmaking and positive patient outcomes. As a quality assurance measure, DUR programs provide corrective action, prescriber and further evaluations. WHY DUR IS IMPORTANT: DUR programs play a key role in helping managed health care systems understand, interpret, evaluate and improve the prescribing, istration and use of medications. Employers and health plans find DUR programs valuable since the results are used to foster more efficient use of scarce health care resources. Pharmacists play a key role in this process because of their expertise in the area of medication therapy management. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 37

DUR affords the managed care Pharmacist the opportunity to identify trends in prescribing within groups of patients whether by disease-state such as those with asthma, diabetes or high blood pressure, or by drug-specific criteria. Pharmacists can then, in collaboration with prescribers and other of the health care team, initiate action to improve drug therapy for patients. DUR is classified in three categories: • • •

Prospective - evaluation of a patient's drug therapy before medication is dispensed Concurrent - ongoing monitoring of drug therapy during the course of treatment Retrospective - review of drug therapy after the patient has received the medication

1. Prospective DUR: Prospective review involves evaluating a patient's planned drug therapy before a medication is dispensed. This process allows the pharmacist to identify and resolve problems before the patient has received the medication. Pharmacists routinely perform prospective reviews in their daily practice by assessing a prescription medications dosage and directions while reviewing patient information for possible drug interactions or duplicate therapy. When part of an online claims adjudication process, prospective DUR often relies on computerized algorithms to perform key checks including drug interactions, duplications or contraindications with the patient’s disease state or condition. Issues Commonly Addressed by Prospective DUR: • • • • • • • •

Clinical abuse/misuse Drug-disease contraindications (when a prescribed drug should not be used with certain diseases) Drug dosage modification Drug-drug interactions (when two or more different drugs interact and alter their intended effects, often causing adverse events) Drug-patient precautions (due to age, allergies, gender, pregnancy, etc.) Approved by AM Board of Directors November 2009 Formulary substitutions (e.g., therapeutic interchange, generic substitution) Inappropriate duration of drug treatment


Example: Identification of drug-drug interactions are a common outcome of a prospective DUR. For example, a patient being treated with warfarin to prevent blood clots may be prescribed a new drug by another specialist to treat arthritis. If taken together, the patient could experience internal bleeding. Upon reviewing the patient's prescriptions, the pharmacist would note the potential drug interaction and the prescriber to alert him/her to the problem. 2. Concurrent DUR: Concurrent review is performed during the course of treatment and involves the on-going monitoring of drug therapy to foster positive patient outcomes. It presents pharmacists with the opportunity to alert prescribers to potential problems and intervene in areas such as drug-drug interactions, duplicate therapy, over or underutilization and excessive or insufficient dosing. This type of review allows therapy for a patient to be altered if necessary. As electronic prescribing becomes more widely adopted, the concurrent DUR process may be performed by the prescriber at the time of prescription transmission to the pharmacy, allowing interventions before the drug is dispensed. An important component of DUR will require complete and current drug and allergy records for the patient, as well as knowledge of appropriate therapeutic interchanges for individuals. As a safety net, pharmacists will perform a similar role as prescribers on the dispensing side of these transactions. Issues Commonly Addressed by Concurrent DUR: • • • • • •

Drug-disease interactions Drug-drug interactions Drug dosage modifications Drug-patient precautions (age, gender, pregnancy, etc.) Over and underutilization Therapeutic Interchange

Example: Concurrent DUR often occurs in institutional settings, where patients often receive multiple medications. Periodic review of patient records can detect actual or potential drug-drug interactions or duplicate therapy. It can also alert the pharmacist to the need for changes in medications, such as antibiotics, or the need for dosage adjustments based on laboratory test results. The key prescriber(s) must then be alerted to the situation so corrective action can be taken.


3. Retrospective DUR: A retrospective DUR reviews drug therapy after the patient has received the medication. A retrospective review aims to detect patterns in prescribing, dispensing or istering drugs. Based on current patterns of medication use, prospective standards and target interventions can be developed to prevent recurrence of inappropriate medication use or abuse. Outcomes of this review may aid prescribers in improving the care of their patients, either individually or within a certain target population (e.g., patients with diabetes, asthma, or high blood pressure). Issues Commonly Addressed by Retrospective DUR: • • • • • • • • •

Appropriate generic use Clinical abuse/misuse Drug-disease contraindications Drug-drug interactions Inappropriate duration of treatment Incorrect drug dosage Use of formulary medications whenever appropriate Over and underutilization Therapeutic appropriateness and/or duplication.

H) Quality Assurance of Clinical Pharmacy Services: Definition: Quality assurance can be defined as the procedures which are used to set, promote, maintain and monitor the desired standards for services and products. Significance: •

The implementation of a quality assurance programme will provide confidence that defined tasks are carried out efficiently, effectively and according to the accepted standards of professional ethics and knowledge


•

It is a professional responsibility to ensure that appropriate standards of clinical pharmacy services are documented and maintained.

•

The implementation of a quality assurance programme will provide confidence that defined tasks are carried out efficiently, effectively and according to the accepted standards of professional ethics and knowledge

•

It is a professional responsibility to ensure that appropriate standards of clinical pharmacy services are documented and maintained.

Goals: •

To monitor and evaluate the quality of clinical pharmacy services and standards of practice

•

To identify areas for improvement (questions existing practice)

•

To provide a mechanism through which action is taken to make and maintain these improvements

•

To motivate clinical pharmacists by involving them in the assessment and evaluation of their service.

Establishment of a Quality Assurance Programme: Key requirements: •

istrative

✓ Establishment of appropriate departmental goals ✓ Selection of pharmacists who are suitably qualified and experienced to perform clinical activities ✓ Commitment to continuing education of pharmacists providing clinical services ✓ Allocation of resources necessary to perform quality assurance. ✓ Quality Assurance Co-ordination Committee: Consists of pharmacists providing clinical services should define: ✓ The objectives and scope of the programme ✓ Acceptable standards of practice T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 41

✓ Methods of evaluation and documentation to be used ✓ The review time table. Determining Priorities: •

Priority should be given to those aspects of clinical pharmacy which have the greatest contribution to patient care (e.g. TDM, patient counseling, medication chart review)

•

Each aspect of a section should be examined in detail to determine the critical components that must be monitored, the ways in which quality can be monitored or promoted and what prerequisites are required.

•

Areas to be targeted should include: ✓ Personnel: e.g. Training and education, clinical acumen ✓ Materials and products: e.g. patient profiles, drug utilization review reports, ADR reports ✓ Facilities: e.g. drug information ✓ Procedures: e.g. Documentation of interventions and clinical services.

Setting of Standards: • •

Setting of standards and criteria should be based on current practice Should be formulated and endorsed by pharmacists to whom they apply.

Methods: • • •

Documentation of Procedures Evaluation of Compliance Audit of Documentation ✓ Patient drug profiles ✓ Endorsement on patient drug charts and prescriptions ✓ Written drug information answers ✓ Drug utilization reports ✓ Therapeutic drug monitoring reports ✓ ADR reports ✓ Pharmacy intervention record.


•

• • • •

Accompanied Visits ✓ evaluation on one to one basis using a checklist based on previously agreed standards Questionnaire and /or Interviews Random Audits Personnel Evaluation. Peer Review by ✓ Promoting professional development ✓ Improving knowledge base ✓ Providing a mechanism to establish, monitor, review and maintain standards of practice ✓ Identification and resolution of problems ✓ Promoting liaison and communication between pharmacists involved in clinical services.

Conclusion: • • •

Quality Assurance Programme ensures that Quality of Health care is achieved and maintained in the given clinical setting It also provides professional satisfaction to the pharmacists Quality Assurance should be an integral part of clinical pharmacy services.

PATIENT DATA ANALYSIS: A) THE PATIENT’S CASE HISTORY: DEFINITION: A case history is defined as a planned professional conversation that enables the patient to communicate his/her symptoms, feelings and fears to the clinician so as to obtain an insight into the nature of patient’s illness & his/her attitude towards them. THE STRUCTURE OF PATIENT’S CASE HISTORY: 1. Medication history T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 43

• • • • • • • • • • • •

Chief complaint History of the present illness Systems review Nursing assessment Allergies Medications Past medical history Family history Social history Psychiatric history Progress notes Mnemonics a. b. c. d.

SAMPLE OPQRST SOAP COAST MAP

2. Physical examination a) General/IPPA • Inspection • Auscultation • Palpation • Percussion b) Vital signs • Temperature • Heart rate • Blood pressure • Respiratory rate c) HEENT • Oral mucosa • TM Eyes (Ophthalmoscopy, Swinging-flashlight test) • Hearing (Weber, Rinne) d) Respiratory • Respiratory sounds • Cyanosis Clubbing e) Cardiovascular • Precordial examination • Peripheral vascular examination T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 44

• •

Heart sounds Other Jugular venous pressure, Abdominojugular test, Carotid bruit Ankle-brachial and pressure index f) Abdominal: ▪ Digestive ✓ Liver ✓ Span ✓ Rectal Murphy's sign ✓ Bowel sounds ▪ Urinary ✓ Murphy's punch sign g) Extremities/t • Back (Straight leg raise) • Knee (McMurray test) • Hip Wrist (Tinel sign, Phalen maneuver) • Shoulder (Adson's sign) • GALS screen h) Neurological • Mental state • Mini–mental state examination • Cranial nerve examination • Upper limb neurological examination i) Neonatal • Apgar score • Ballard Maturational Assessment j) Gynaecological • Well-woman examination • Vaginal examination • Breast examination • Cervical motion tenderness 3. Assessment • •

Medical diagnosis Differential diagnosis.

4. Pharmaceutical care plan. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 45

Common medical and abbreviations used in clinical practices:

A 1. ABSCESS -a local collection of pus in the tissue ACIDOSIS -the depletion of alkaline reserve in the body 2. ACUTE -a sudden, poignant illness of short duration but with severe symptoms 3. ADDICTION -the state of being given up to some habit, as a drug habit 4. ADENITIS -inflammation of a gland 5. ADHESION -the normal ing of tissues by a fibrous band usually resulting from inflammation of injury ADIPOSE -fatty 6. ADRENAL GLAND -a ductless gland at the upper end of the kidney 7. ALBUMIN -a protein substance found in animal and vegetable tissues 8. ALBUMINURIA -presence of albumin in the urine 9. ALIGNMENT -the state of being arranged in a line 10. ALIMENTARY CANAL -the age leading from the mouth, the stomach and the intestines to the outer opening of the rectum 11. ALLERGY -an exaggerated sensitivity of an individual to a substance 12. ALLEVIATE -to lessen or make easier to endure 13. ALOPECIA -loss of hair from skin where it normally appears 14. ALVEOLI -air cells of the lungs 15. AMBULATORY -walking or able to walk 16. AMENORRHEA -absence or abnormal stoppage of menstruation 17. AMNESIA -loss of memory 18. AMPUTATION -cutting of an extremity or other part of the body 19. ANALGESIC -relieving pain 20. ANAPHYLAXIS -increased susceptibility or hypersensitivity to a drug following its parenteral injection ANASTOMOSIS -the ing together of two normally distinct spaces or organs 21. ANEMIA -deficient quantity or quality of the blood 22. ANESTHETIC -a substance that produces loss of feeling or sensation 23. ANGINA PECTORIS -paroxysmal thoracic pain 24. ANKYLOSIS -abnormal consolidation of a t which prevents motion 25. ANOMALY -a deviation from the normal 26. ANOREXIA -lack or loss of appetite 27. ANOXIA -a decrease of oxygen below the normal level in the body tissues T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 46

28. 29. 30. 31. 32. 33. 34. 35.

36. 37. 38. 39. 40. 41. 42. 43. 44. 45. 46. 47. 48.

ANTHELMINTIC -an agent that destroys worms ANTIBODY -a specific blood substance that neutralizes foreign bodies ANTIDOTE -a remedy that will counteract or remove the effect of poison ANTI-EMETIC -an agent that prevents or relieves nausea and vomiting ANTI-PYRETIC -an agent that relieves or reduces fever ANTISEPTIC -a substance that inhibits the growth of microorganisms without necessarily destroying them ANTISPASMODIC -an agent that relieves muscular pain ANTITOXINS -substances found in the blood and other body fluids that counteract the harmful effect of toxins or the poisons to which they are allied with ANURIA -total suppression of urine APATHY -indifference APEX -the bp. Point or end of anything APHAGIA -inability to swallow ABNORMAL -contrary to the usual structure, positions, or condition ABRASION -a scraping or rubbing off the skin APHASIA -inability to express oneself by speech or writing APHONIA -loss of voice APNEA -a temporary cessation of breathing APOPLEXY -a paralysis commonly referred to as ”stroke” resulting from cerebrovascular accident (CVA) ARRHYTHMIA -absence of rhythm particularly in relation to the abnormality in the rhythm of the heart ARTERY -any one of the vessels through which the blood es from the heart to all different parts of the body ARTHRITIS -t inflammation ARTICULATION -the junction between two or more bones of the skeleton.

B 1. 2. 3. 4.

BACTEREMIA -the presence of bacteria in the blood BENIGN -doing no harm, not malignant BILIARY -pertaining to bile, the liver, the gall bladder and the associated duct BIOPSY -removal of a piece of a body tissue for diagnostic examination, usually microscopic 5. BLOOD PRESSURE -the pressure of the blood on the elastic walls to the arteries 6. BRADYCARDIA -abnormally slow heart action T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 47

7. BRIGHT’S DISEASE -a kidney disease accompanied by albumin in the urine 8. BRONCHITIS -inflammation of the bronchial tubes 9. BRONCHOSCOPE -a lighted instrument used for the examination of the interior of the bronchi 10. BUCCAL -pertaining to the cheek or mouth.

C 1. CACHEXIA -a state of weakness and emaciation 2. CALCULUS -an abnormal concretion, usually composed of mineral salts, occurring within the body CALLOSITY -a hardening and thickening of the skin 3. CANCER -exceedingly harmful. Usually rapid growth of cells 4. CARCINOMA -a cancer 5. CARDIAC -pertaining the heart 6. CARDIOGRAPH -an instrument for recording the action of the heart 7. CARRIER -an individual who harbours in his body the specific organisms of a disease without manifesting its symptoms and thus act as a distributor or transmitter of the infection 8. CARTILAGE -the bristle or white elastic substance attached to the bone surfaces at the ts 9. CAST -an appliance to render immovable, displaced or injured parts 10. CATHARTIC -a drug that stimulates the evacuation of intestinal waste, a purgative 11. CAUSALGIA -burning pain that may accompany nerve injury 12. CAVITY -a hollow space within the body or within one of its organ 13. CELL -the minute protoplasmic building unit of living matter 14. CEPHALIC -pertaining to the head 15. CERUMEN -earwax 16. CERVICAL -pertaining to the neck or cervix of any structure 17. CHANCRE -the primary lesion of syphilis 18. CHEMOTHERAPY -the use of chemical agents to treat disease 19. CHOLESTASIS -stoppage of bile flow 20. CHOREA -“St. Vitus Dance” a nervous disease characterized by involuntary jerking muscle movements T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 48

21. CHYLE -a fluid consisting of lymph and emulsified fats as the result of digestion in the intestine CHYME -a thick greyish liquid that is a result of digestion on the intestine 22. CILIATED -provided with fringe or hair-like structures 23. CIRRHOSIS -chronic inflammation and degeneration of an organ especially the liver 24. CLAVICLE -the collar bone 25. COLIC -acute abdominal pain 26. COLITIS -inflammation of the colon.

D 1. DELIRIUM -a mental disturbance, usually temporary, marked by cerebral excitement, wandering speech, illusions and hallucinations 2. DEMENTIA -deterioration of mental capacity 3. DEMULCENT -a bland, soothing medication or application 4. DENDRON -a branch of nerve cell 5. DEPILATORY -a preparation for removing superfluous hair 6. DEPRESSION -lowered mental and physical activity 7. DERMATOLOGY -a branch of medicine dealing with disease of skin and skeletal muscles 8. DERMIS -the true skin DESQUAMATION -the shedding or scaling of the skin or cuticle 9. DIAGNOSIS -the recognition of a disease by its signs and symptoms 10. DIAPHORESIS -profuse perspiration 11. DIAPHRAGM -the muscular partition between the thoracic and abdominal cavities 12. DIARRHEA -abnormal frequency and fluidity of discharges from the intestines 13. DIATHERMY -the generation of heat in the body tissues due to resistance by the tissues to high frequency electric currents forced through them.

E 1. EMBOLUS -a clot or portion of a clot that has broken away from its site of origin and flows freely in the circulatory until it lodges in a narrow vessel 2. EMBOLISM -an obstruction of a blood vessel by a clot of blood


3. ELECTROCARDIOGRAM -a graphic tracing of an electric current produced by the contractions of the heart veins of anal region 4. EMBRYO -a term applied to the unborn child from conception to about the third month of pregnancy EMESIS -the act of vomiting 5. EMETIC -an agent that causes vomiting 6. EMPYEMA -collection of pus in the body cavity 7. ENCEPHALITIS -inflammation of the brain 8. ENDOCRINE GLANDS -ductless glands, glands of internal secretion 9. ENTERITIS -inflammation of the intestines 10. ENUCLEATION -the surgical removal of the eyeball 11. ENURESIS -involuntary discharge of urine, usually during sleep 12. EPIDEMIC -widespread disease in the certain geographic region 13. EPIDERMIS -outermost layer of the skin 14. EPIGLOTTIS -a thin plate of yellow elastic cartilage that closes to protect the larynx during swallowing EPILEPSY -a chronic disease marked by attacks of convulsions 15. EPINEPHRINE -the active principle of the medulla of the adrenal ***, it acts to slow heart and increase blood pressure 16. EPISTAXIS -nosebleed 17. EQUILIBRIUM -a state of balance 18. ERUCTATION -forceful expulsion of air from the stomach, known as belching 19. ERYTHEMA -redness of the skin due to congestion of the capillaries 20. ERYTHROCYTES -yellowish, circular, concave disks, found in the blood which contain haemoglobin and carry oxygen 21. ETHMOID -sieve-like 22. ETIOLOGY -the sum knowledge regarding the cause of the disease 23. EUPHORIA -a general feeling of comfort and well-being 24. EUSTACHIAN TUBE -the age from the throat to the middle ear 25. EUTHANASIA -an easy or painless death often referred to as “mercy killing” 26. EVISCERATION -the removal of abdominal organs, or the protrusion of the intestines through an abdominal wound 27. EXCORIATION -the removal of pieces of skin as a result of scratching or scraping 28. EXCRETED -thrown off, as waste matter, or by normal discharge 29. EXPECTORATION -spitting out mucus or other fluid from the lungs and the throat EXPIRATION -exhaling air from the lungs, a term sometimes used to refer to death T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 50

30. EXUDATE -material that has escaped from the blood vessels and is deposited in the tissues or on tissue surfaces.

F 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13.

14. 15. 16. 17. 18.

FAINT -loss of consciousness due to insufficient blood in the brain FATIGUE -weariness resulting from overexertion of the body or in the mind FEBRILE -pertaining to fever FECES -the residue from the digested food, which is discharged from the intestines FESTER -to suppurate superficially (as in a festering wound) FETIC -having disagreeable odour FETUS -a term applied to the unborn child after the third month of pregnancy FEVER -abnormally high body temperature FIBROUS -composed of oil or containing fibre FIMBRIATED -fringed FLACCID -weak, lax, or lacking muscle tone FLATUS -gas in the intestine or stomach FLEX -to bend FLUOROSCOPE -a device used for examining deep structures by means of the roentgen rays (x-ray) FOREIGN BODY -any substance lodged in a place where it does not belong FRACTURE -a break in the bone FRICTION –rubbing FUMIGATION -exposure to disinfecting fumes FUNCTION -a normal action of a part of an organ or body FUSION -the ing together of two adjacent parts or bodies.

G 1. 2. 3. 4. 5.

GAIT -a manner or style of walking GALL -the bile GANGRENE -the death of a part of a tissue GASTRIC -pertaining to the stomach GASTROENTOROLOGY -branch of medicine dealing with disease of the stomach or intestine GASTROINTESTINAL -pertaining to the stomach or intestines 6. GAVAGE -ing food into the stomach through a tube


7. GENES -factors in the chromosomes that determine the hereditary characteristics 8. GERIATRICS -the branch of medicine that deals with old age and its related disease, including the psychosocial problems of senility 9. GERMICIDES -agents that kills germs 10. GERMS -pathogenic microorganism 11. GESTATION -the period of development of the individual from fertilization to birth GLOMERULONEPHRITIS -renal disease with inflammation of the capillary loops in the glomeruli of the kidneys 12. GLOSSITIS -inflammation of the tongue 13. GLUTEAL -pertaining to the buttocks 14. GLYCOSURIA -presence of glucose or sugars in the urine 15. GOITER -an enlargement of the thyroid gland, causing a swelling in the front part of the neck GONORRHEA -a contagious inflammatory condition of the genital mucous membrane 16. GRAFT -a piece of skin or other tissue from one part of the body which is implanted on another part GRANULATION -the formation of fleshy tissue in the healing of wounds 17. GROIN -the lowest part of the abdominal wall where it s the thigh 18. GYNECOLOGY -the science that treats diseases of women, particularly of the genital organs .

H 1. HALLUCINATION -seeing, hearing, or feeling something when there is no objective stimulus HELIOTHERAPY -disease by composing the body to the sun rays, particularly in the morning (between 6- 7am) 2. HEMATEMESIS -vomiting of blood 3. HEMATOLOGY -the study of blood 4. HEMATOMA -a clot of extraverted blood 5. HEMATURIA -discharge of blood in the urine 6. HEMIPLEGIA -paralysis of side of the body 7. HEMACHROMATOSIS -a disorder of Iron metabolism with excessive deposits of iron in the body tissues, specially the liver, skin and pancreas (LSP*) 8. HEMOGLOBIN -the pigment of red blood cells that carries oxygen 9. HEMOPHILIA -a congenital condition characterized by delayed clotting of blood 10. HEMOPLYSIS -blood stained sputum or expectoration of blood T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 52

11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30. 31. 32. 33. 34. 35. 36. 37. 38. 39. 40.

HEMORRHAGE -bleeding, an escape of blood from the arteries HEMORRHOIDS -a distortion on the veins of the anal region HEMOTHORAX -presence of blood in the pleural cavity HEPATITIS -inflammation of the liver HEREDITY -the inheritance of physical or mental characteristics from ancestors HERNIA -the protrusion of a loop or knuckle of an organ or tissue through an abnormal opening HERPES -fever blisters, cold sores HICCUP -an involuntary spasmodic contraction of the diaphragm caused by the irritation of the phrenic nerve, which produced a sharp, respiratory cough HIRSUTISM -abnormal hairiness particularly in women (eg, Menoxidil, (Dilantin), Phenytoin for anticonvulsant) HORMONES -a chemical substance produced in an organ which is carried to an associated organ by the bloodstream, influencing its functional activity HYDRONEPHROSIS -distension of the pelvis and calyces of the kidney with urine, as a result of obstruction of the ureters HYDROTHERAPY -the use of water in the treatment of disease HYDROTHORAX -the collection of watery fluid in the pleural cavity HYPERALGESIA -increased sensitivity to pain HYPERCHOLESTEROLEMIA -excess cholesterol in the blood HYPEREMIA -excessive blood in the part of the body due to local or general relaxation of the arteries HYPERGLYCEMIA -excess of glucose in the blood HYPEROPIA -farsightedness HYPERTENSION -chronic elevation of the blood pressure HYPERTROPHY -a diseased enlargement of a part of the body or organ HYPNOSIS -an artificially induced ive state resembling the trance HYPNOTIC -an agent that produces sleep or drowsiness HYPOCHONDRIA -a morbid anxiety about health HYPODERMOCLYSIS -injection of fluids into the tissue under the skin HYPOGLYCEMIA -an abnormally low amount of sugar in the blood HYPOGONADISM -diminished activity of the testes and the ovaries HYPOKALEMIA -a deficiency of potassium in the blood HYPOMANIA -mania of the mild type HYPOTENSION -chronic depression of the blood pressure HYPOTHERMIA -a low body temperature which may be fatal HYSTERIA -lack of emotional control or actions HYSTERECTOMY -the surgical removal of the uterus


I 1. IDIOSYNCRACY -a personal peculiarity 2. ILEO-FEMORAL -pertaining to the ileum (last portion of the intestine) femur (thigh bone) 3. ILLUSION -a false impression or interpretation of sensory image 4. IMMOBILIZE -to prevent motion 5. IMMUNIZATION -protect against infection from any disease 6. IMPACTED -firmly wedged in place 7. INCISE -to cut 8. INCONTINENCE -the inability to control elimination of urine or feces 9. INCUBATION -the period of a disease between the implantation of pathogen and the manifestation of the symptoms of the disease 10. INDURATION -hardening of tissue 11. INFECTION -the invasion of the body by disease-producing agents with a resulting reaction to their presence and their toxins 12. INFLAMMATION -a condition resulting from the irritation in any part of the body, marked by pain, heat, redness and swelling 13. INHALATION -drawing air, vapours, fumes into the lungs 14. INHERENT -belonging to anything as a result of natural circumstance 15. INHIBITION -the partial or complete restraint of any process 16. INJECTION -forcing a liquid into a part of the body or into a body cavity 17. INOCULATION -introduction of virus or disease-producing microorganism into the body to give protection against certain disease 18. INSECTICIDE -an agent that is destructive to insects 19. INSIDIOUS -coming on in a stealthily manner 20. INSOMNIA -sleeplessness 21. INSULIN -substance produced by the pancreas which aids in the breakdown of carbohydrates INTELLECT -thinking ability or understanding 22. INTERMITTENT -occurring at intervals 23. INTRAVENOUS -situated within the vein 24. INTUBATION -the insertion of a tube, as into the larynx (in diphtheria) to introduce air INTUSSUSCEPTION -the telescoping or prolapsing of one part of the intestine into an adjacent part INUNCTION -application or rubbing of an ointment on the skin 25. IRRIGATION -washing out by a stream of water or a solution T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 54

26. IRRITANT -an agent that causes stimulation or undue sensitiveness to any part of the body ISCHEMIA -lack of blood flow to the part of the body 27. ISTHMUS -a narrow structure connecting two larger parts.

J 1. JAUNDICE -a yellowish discoloration of the skin due to bile 2. JURISPRUDENCE -the application of study of legal principles

K 1. KELOID -a scar on the skin consisting of dense tissues, found often in the Negro race 2. KERATITIS -inflammation of the cornea 3. KETONURIA -presence of ketone bodies in the urine 4. KETOSIS -increase of ketone bodies in the body tissue and fluid 5. KOPLIK’S SPOTS -bright red spots in the mouth and throat in the early stages of measles 6. KYPHOSIS -an abnormal increase in the thoracic curvature of the spine giving a “hunchback” appearance

L 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11.

LACTEALS -lymph vessels in the intestines LARYNGITIS -inflammation of the larynx LATENT -a condition that is concealed or not manifested LATERAL -pertaining to a side LAVAGE -washing out of an organ, such as the stomach or bowel LAXATIVE -mild cathartic that promotes evacuation of the intestines LENS -a transparent crystalline structure in the eye that converges or scatters light rays to focus images on the retina LENTIGO -small brownish pigmented areas on the skin due to an increase amount of melanin, commonly known as “freckles” LESION -a break in the body tissue such as a swore or wound LETHARGY -a state of stupor, dullness, indifference, lack of feeling LEUKEMIA -a disease of the blood-forming organs characterized by uncontrolled increase in the number of leukocytes


12. LEUKOCYTOSIS -increase in the number of leukocytes 13. LEUKORRHEA -a whitish or yellowish viscid discharge from the vagina 14. LIGAMENT -a tough, fibrous band binding together bones ing internal organs 15. LIGATE -to bind or tie with a ligature 16. LINIMENT -an oily preparation for rubbing on the skin 17. LIPOMA -a benign tumor composed of fatty tissues 18. LOCAL -limited to one part or place, not a general area 19. LOCHIA -vaginal discharge following childbirth 20. LORDOSIS -an abnormal increase in lumbar curvature of the spine, sometimes known as “swayback” 21. LUBRICANT -an oily substance that relieves irritation 22. LUMBAR REGION -that part of the back between the pelvis and the thorax 23. LUMEN -the cavity or channel within a tube or tubular region 24. LUPUS ERYTHOMATOSUS -a skin disease with inflammation and red scaly patches that induces atrophy, superficial scar formation and follicular plugging 25. LYMPH -clear, colorless fluid carried by vessels that return fluid from the body tissues of the heart LYMPHOCYTES -lymph cells, a variety of leukocytes 26. LYMPHOMA -any malignant condition of the lymphoid tissues.

M 1. MALAISE -a vague feeling of bodily discomfort 2. MALIGNANT -deadly, tending to go from bad to worse 3. MALINGERING -a deliberate feigning or exaggeration of the symptoms of illness or injury, usually to arouse sympathy 4. MALPRACTICE -injurious or faulty treatment that results in injury loss or damage 5. MANIA -a disordered mental state of extreme excitement 6. MASTICATE -to chew food. 7. MASTITIS -inflammation of the breast 8. MASTOIDITIS -inflammation of the mastoid bone 9. MATURATION -the process of ripening or becoming fully developed 10. MEATUS -an opening to some ageway in the body 11. MECONIUM -a dark green or black fecal substances in the intestine of the full green fetus or new born infant 12. MEDIAL -midline of the body or nearest to that midline 13. MEMBRANE -a thin layer of tissues covering a part or lining a body cavity T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 56

14. MENARCHE -the establishment of menstruation 15. MENINGES -the membranes that covers the brain and the spinal cord 16. MENINGITIS -inflammation of the meninges.

N 1. NECROSIS -mental or psychic disorder characterized by fears, anxiety and compulsion 2. NEVUS -a congenital circumscribed discolored area of the skin, either vascular or nonvascular NOCTURIA -excessive urination at night 3. NUTRITION -the process of using food for growth and development

O 1. OBESE -extremely fat 2. OBSTETRICS -branch of medicine dealing with pregnancy, labour and the puerperium 3. OINTMENT -a greasy semi-solid preparation for external use on the body 4. OLIGURIA -scanty secretion of urine 5. ONSET -the beginning of an illness when the first symptoms of disease appear 6. OOPHORECTOMY -the surgical removal an ovary or the ovaries 7. OPTHALMOLOGIST -a physician who specializes in the treatment of disorders of the eye 8. OPIATE -a drug containing or derived from opium 9. OPTICIAN -one who grinds lenses and fits eyeglasses 10. OPTOMETRIST -one who measures vision and prescribes glasses for visual defects ORAL -pertaining to the mouth 11. ORCHITIS -inflammation of the testicles 12. ORGAN -a group of body tissues having a particular function 13. ORIFICE -the entrance or outlet of any body cavity 14. ORTHOPEDICS -branch of surgery that deals with the correction of deformities and chronic diseases of the bones and ts 15. ORTHOPNEA -difficulty in breathing relieved only by sitting or standing erect 16. ORTHOSIS -straightening of a deformity 17. OSSEUS -bone-like structure; pertaining to the bone 18. OSTEOARTHRITIS -a degenerative t disease 19. OSTEOMALACIA -bone degradation due to lack of calcium T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 57

20. OSTEOPOROSIS -a bone disorder caused by loss of minerals 21. OSTEOSCLEROSIS -a spongy bone formation in the labyrinth of the ear .

P 1. PALLOR -paleness, absence of skin pigments 2. PALPITATION -unduly rapid or throbbing heartbeat that can be sensed by the patient 3. PALSY -loss of motion (paralysis) in a part of the body 4. PANCYTOPENIA -deficiency of all cell elements of the blood 5. PAPULE -a small, circumscribed elevation of the skin 6. PARACENTESIS -the surgical puncture of a body cavity for the aspiration of body fluids 7. PARALYSIS -loss of motion or impairment of sensation in a part of a body 8. PARAPLEGIA -paralysis of the lower part of the body 9. PARASITES -plants or animals that lives upon or within another organism 10. PARENTERAL -not through the alimentary canal i.e., by intravenous injection or IV route 11. PARESIS -slight or incomplete paralysis 12. PARIETAL -pertaining to the walls of a cavity 13. PAROXYSM -a sudden periodic attack or recurrence of symptoms of a diseases 14. PARTURITION -the act of giving birth to a child 15. IVE -submissive or not produced by active birth 16. PATELLA -the kneecap 17. PATENCY -the condition of being freely open 18. PEDIATRICS -the branch of medicine that is concerned with children’s diseases 19. PELLAGRA -a deficiency disease or syndrome caused by lack of Niacin 20. PERCUSSION -tapping a part of the body with short, sharp blows to elicit sounds or vibrations that aid in diagnosis 21. PERICARDIUM -the double membrane that envelops the heart 22. PERIOSTEUM -a tough, fibrous membrane surrounding the bone 23. PERIPHERAL -pertaining to the outward part of the bone 24. PHYSICAL -pertaining to the body 25. PLACEBO -an inactive or non-medicinal substance given in place of a medication to gratify a patient without his knowledge of its actual physiologic, therapeutic value T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 58

26. PLACENTA -organ developed in the uterus to which the embryo is attached via the umbilical cord and from which it receives its nourishment 27. PODIATRIST -one who diagnosis and treats foot disorders 28. POLIOMYELITIS -an acute viral disease involving the spinal cord, commonly known as “infantile paralysis” 29. POLLINOSIS -an allergic body reaction due to air-borne pollen 30. POLYCYTHEMIA -abnormal increase in the number of erythrocytes in the blood “Erythrocytosis” POLYDEPSIA -excessive thirst 31. POLYMENORRHEA -abnormally frequent menstruation 32. POLYP -a small protruding growth on a pedicle extending from a mucous membrane 33. POLYPHAGIA -an abnormal craving for all kinds of food 34. POLYURIA -excessive urination 35. POSTPARTUM -after childbirth or delivery 36. POULTICE -a soft, moist hot mass applied to the skin 37. PRESBYOPIA -farsightedness associated with the impairment of vision due to the aging process PRENATAL -existing or occurring before birth 38. PROCESS -a prominence or projection, as of the end of a bone 39. PROTOSCOPE -an instrument used for inspecting the rectum 40. PROGNOSIS -judging in advance the probable duration, course and termination of a disease PROPHYLAXIS -prevention of a disease 41. PROSTHESIS -the replacement of a missing part of a body by an artificial substitute 42. PROSTRATION -extreme exhaustion 43. PROTHROMBIN -a substance thought to exist in the blood, which can changed to thrombin 44. PRURITIS -intense itching 45. PSYCHIATRIST -a physician who specializes in the treatment of disorders of the psyche or mind PSYCHOLOGY -the science that deals with the mental process and their affects upon behaviour 46. PSYCHOSIS -a mental disturbance in which there is personality disintegration and an escape into reality 47. PLOSIS -a drooping or sagging of an organ or part from the normal position 48. PUNCTURE -a small elevation of the skin filled with pus or lymph 49. PURULENT -consisting of or secreting pus


50. PUS -a yellowish secretion formed in certain kinds of inflammation, consisting of albuminous substance, a thin fluid, and leukocytes or their remains 51. PUSTULE -a small elevation of the skin filled with pus or lymph 52. PYELITIS -inflammation of the pelvis of the kidney 53. PYEMIA -the presence of pus forming organisms in the blood 54. PYLORUS -the opening of the stomach into the duodenal portion of the intestines 55. PYOGENIC -producing pus 56. PYROSIS -a burning sensation in the stomach and the oesophagus commonly known as “heartburn” PYURIA -the presence of pus in the urine

Q 1. QUADRIPLEGIA -paralysis of all four extremities 2. QUARANTINE -a period of detention or isolation as a result of suspected contagion of a communicable disease 3. QUICKENING -the first movements of the foetus felt in pregnancy usually occurring from the 16th to the 16th week

R 1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

11. 12.

RADIALE -to diverge or spread from a common central point RADIUM -a metallic element that gives off rays used in treating malignancies RASH -a superficial eruption of the skin REACTION -action in response to some influence or force RECTUM -the distal portion of the large intestine between the sigmoid colon and the anal canal RECUMBENT -lying down RECUPERATE -to recover health or gain strength after an illness RECURRENCE -the return of symptoms after their remission REFLEX -an automatic response to a given stimulus REGURGITATION -the return of food from the stomach soon after eating, without ordinary efforts of vomiting REHABILITATION -the restoration of an ill or injures patient to self-sufficiency or to gainful employment at his highest attainable skill in the shortest possible time RELAPSE -recurrence of former symptoms during convalescence REMISSION -the lessening in severity or subsiding the symptoms of an illness


13. RESECTION -excision of a portion of an organ or structure such as bones 14. RESISTANCE -the power of the body to overcome the ill effects of injurious agents, such as pathogenic microorganisms, poisons, or irritants 15. RETENTION -the holding or keeping within the body matters that are usually expelled, such as urine, as in retention of urine 16. RHEUMATOLOGY -the study of diseases of muscle, tendon, t, bones or nerves (rheumatic disease) 17. RHINITIS -inflammation of the mucus membrane lining the nasal cavity 18. RICKETTS -a disease due to vitamin D deficiency in the diet 19. RIGOR MORTIS -the stiffening of the muscles after death 20. RUBEOLA –measles

S 1. SAC -a bag-like organ or structure; a pouch 2. SACRUM -triangular bone of the lower spine 3. SARCOMA -a type of tumour, often malignant, composed of a substance like embryonic connective tissues 4. SATURATED -pertaining to a solution in which no more of a substance can be dissolved 5. SCOLIOSIS -lateral curvature of the normally straight vertical line of the spine 6. SCURVY -a nutritional disease caused by an insufficient amount of fruits and vegetables in the diet SEBACEOUS -pertaining to sebum 7. SEBORRHEA -an increase in the secretion of the sebaceous glands 8. SEBUM -an oily, fatty secretion from the sebaceous glands 9. SEDATIVE -agent that allay activity and excitement 10. SEGMENTATION -the division into smaller parts, such as that which occurs in the zygote 11. SENILITY -a progressive feebleness of the body and mind generally associated with aging 12. SEPTICEMIA -a systemic disease produced by pathogenic bacteria in the blood 13. SEPTUM -a dividing wall between two cavities 14. SERA -the clear portion of the blood; the clear liquid that separates from the blood after clotting; serum (plural) 15. SHOCK -depression of the body functions due to the failure of the circulation 16. SINUS -a cavity T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 61

17. SMEAR -a specimen for microscopic study made by spreading infected material on the glass slide SOMATIC -pertaining to the body 18. SOMNABULISM -sleep-walking 19. SORDES -the foul, dark matter that collects around the teeth and lips in low fevers 20. SPASM -a sudden muscular contraction 21. SPECIMEN -a sample 22. SPHINCTER -a circular muscle that closes a natural entrance or outlet to a cavity 23. SPLINT -an appliance for fixation of displaced or movable parts 24. SPUTUM -matter ejected from the respiratory tract through the mouth 25. STASIS -a stoppage or stagnation of the flow of fluid in any art of the body 26. STERILE -the absence of microorganisms 27. STETHOSCOPE -an instrument used to listen to internal body sounds 28. STIMULANT -any agent that produces an increase in the activity in the body or one of its parts STOMA -small opening on a free surface, such as pore; an artificially created opening between a body cavity and the surface of the body 29. STOOL -feces; solid to semi-solid waste matter 30. STRABISMUS -a squint; cross-eyed 31. STRICTURE -an abnormal narrowing of a age 32. STROKE -a sudden paralysis of one or more parts of the body, also known as “apoplexy” or “cerebral vascular accident (CVA)” 33. STUPOR -reduced responsiveness or partial consciousness 34. SUB-ACUTE -between an acute or chronic state, with some acute features 35. SUBCUTANEOUS -beneath the skin 36. SUPPRESSION -a sudden stoppage of a secretion 37. SUPPURATION -the formation of pus 38. SUSCEPTIBLE -having little resistance 39. SUTURE -a surgical stitch or seam; also the line junction of the cranial bones 40. SYMPATHECTOMY -an excision of a portion of a sympathetic nerve 41. SYMPTOM -functional evidence of a disease or of the patient’s condition 42. SYNCOPE -a temporary state of unconscious, commonly known as “fainting” 43. SYNDROME -a group of symptoms that occur together 44. SYNTHESIS -an artificial production of a compound.

T T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 62

1. TABES DORSALIS -a progressive nervous disorder resulting from degeneration of the posterior spinal cord column 2. TACHYCARDIA -a rapid heartbeat 3. TACTILE -pertaining to touch 4. TAUT -tightly drawn 5. TENDON -fibrous tissue that attaches muscle of bone 6. TENSION -a stretch or strained condition 7. TEPID -moderately warm 8. TERMINAL -at the end 9. TETANUS -“lockjaw”; an acute infectious disease producing a toxin that causes persistent spasm due to disturbed calcium metabolism 10. TETANY -a condition of muscular spasm due to disturbed calcium metabolism 11. THERAPY -the treatment of disease 12. THORACOTOMY -a surgical incision of the wall of the thoracic cavity 13. THORAX -the chest 14. THROMBIN -the fibrin ferment of the blood; an enzyme present in shed blood but not circulating blood, which converts fibrinogen to fibrin 15. THROMBOEMBOLISM -obstruction of a blood vessel with a thrombus that has broken off from its site of origin 16. THROMBOLYTIC -pertaining to or responsible for the breaking up of a clot (thrombus) THROMBOPHLEBITIS -inflammation of a vein prior to development of a thrombus 17. THROMBUS -a clot in the blood vessel or in a cavity of the heart 18. TINNITUS -a ringing noise in the ear 19. TISSUE -a group of similar specialized cells united to perform a special function 20. TOLERANCE -the ability to endure the continued use of the drug 21. TONE -a normal vigor or lesion 22. TONUS -the slight, continuous contraction of muscle; in skeletal muscle, tonus aid in maintaining posture and returning blood to the heart 23. TOPICAL -pertaining to an external or local spot 24. TOURNIQUET -a device such as bandage, used to stop hemorrhage from an external wound by the compression of one or more blood vessels 25. TOXEMIA -general intoxication or poisoning due to absorption of bacterial products (toxins) formed by some local infection 26. TOXIC -pertaining to poison


27. TOXIN -any poisonous substance of microbe, vegetable, mineral, or animal origin 28. TRACHEOSTOMY -incision into the trachea, often for insertion of a tube to facilitate respiration TRANSECTION -a cross-section made by cutting across a long axis 29. TRANSFUSION -the introduction of whole blood, plasma substitute, or other injectable solutions directly into the bloodstream 30. TRANSMIT -to on 31. TRAUMA -a wound or injury 32. TUMOR -an abnormal new growth of tissue having no physiologic use which grows independently on its surrounding structures 33. TYMPANITIS -distension of the abdomen due to accumulation of gas

U 1. ULCER -an open sore on that external or internal surface of the body that causes the gradual disintegration of the tissue 2. UMBILICUS -a small soar on the abdomen that makes the former attachment of the umbilical cord to the foetus 3. UNCONSCIOUS -a lack of awareness of the environment with an incapability to react to sensory stimuli 4. UREA -the end product of protein metabolism on the body and the chief nitrogenous substance found in urine 5. UREMIA -an accumulation in the blood of substance that should have been eliminated in the urine URINALYSIS -analysis of urine 6. UROLOGY -the branch of medicine that deals with the urinary system in the female and genitourinary tract 7. URTICARIA -hives; an allergic reaction of the skin characterized by weal’s, which are often accompanied by severe itching

V 1. VACCINATION -the injection of killed or modified living organism for the purpose of treating or producing immunity to certain infectious disease 2. VALVE -a membranous structure in an orifice of age that allows age of contents on one direction only 3. VARICOSE VEIN -enlarge and twisted veins, usually occurring in the legs T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 64

4. 5. 6. 7. 8. 9. 10. 11.

VENIPUNCTURE -a puncture of the vein VENISECTION -an incision of a vein VERTIGO -a whirling sensation of oneself or of objects in the environment VISCERA -the internal body organs, particularly referring to those in the abdominal cavity VOID -to empty or cast out as waste matter VOLATILE -tending to vaporize easily VOLUNTARY -controlled by the will VOMITUS -matter forcible expelled from the stomach through the mouth

W 1. WON -a sebaceous cyst 2. WEAL -a smooth, slightly elevated area on the skin, usually pale with a maddened periphery, which is often attended by severe itching 3. WOUND -an injury to any body structure caused by physical means

X 1. XANTHOSIS -a yellowish pigmentation of the skin, often the result of the ingestion of excessive carotene rich foods such as carrots and egg yolks 2. XEROSIS -abnormal dryness of the skin, conjunctive or mucous membranes 3. X-RAY -a ray that is able to penetrate most substances, used to make photographic plates of parts of the body and to treat diseases as well.


CLINICAL LABORATORY TESTS USED IN THE EVALUATION OF DISEASE STATES, AND INTERPRETATION OF TEST RESULTS: A1) HEMATOLOGICAL TESTS:-

Blood contains three types of formed elements: 1) Red blood cells (RBCs), 2) White blood cells (WBCs), and 3) Platelets.


A CBC typically includes RBC count, total WBC count, hemoglobin (Hb), haematocrit (Hct), RBC indices (mean cell volume [MCV], mean cell Hb [MCH], mean cell Hb concentration [MCHC]), reticulocyte count, and platelet count.

A. RBCs (erythrocytes)

1. The RBC count, which reports the number of RBCs found in a given volume of blood, provides An indirect estimate of the blood’s Hb content. Values are oft en reported in cells/microliter (_L) or cells/litre and less commonly as cells/cubic millimetre (mm3). Normal values are a. 4.3 to 5.9 X 1012 cells/L of blood for men b. 3.5 to 5.0 X 1012 cells/L of blood for women

2. The Hct or packed cell volume (PCV) measures the percentage by volume of packed RBCs in A whole blood sample after centrifugation. The Hct value is usually three times the Hb value and is given as a percentage or fraction of 1 (42% to 52% or 0.42 to 0.52 for men; 37% to 47% or 0.37 to 0.47 for women). a. Low Hct values indicate such conditions as anaemia, over hydration, or blood loss. b. High Hct values indicate such conditions as polycythemia Vera or dehydration.

3. The Hb test measures the grams of Hb contained in 100 mL (1 dL) or 1 L of whole blood and provides an estimate of the oxygen-carrying capacity of the RBCs. The Hb value depends on the Number of RBCs and the amount of Hb in each RBC. a. Normal values are 14 to 18 g/dL for men and 12 to 16 g/dL for women. b. Low Hb values indicate anemia.

4. RBC indices provide important information regarding RBC size, Hb concentration, and Hb weight. They are used primarily to categorize anemias, although they may be affected by average


cell measurements. A peripheral blood smear can provide most of the information obtained through RBC indices. Observations of a smear may show variation in RBC shape (poikilo cytosis), as might occur in sickle-cell anemia, or it may show a variation in RBC size (anisocytosis), as might occur in a mixed anemia (folic acid and iron deficiency).

a. MCV is the ratio of the Hct to the RBC count. It essentially assesses average RBC size and reflects any anisocytosis.

(1) Low MCV indicates microcytic (undersize) RBCs, as occurs in iron deficiency. (2) High MCV indicates macrocytic (oversize) RBCs, as occurs in a vitamin B12 or folic acid deficiency. (3) Normal range for MCV is 90 ± 10.

b. Mean cell hemoglobin (MCH) assesses the amount of Hb in an average RBC. (1) MCH is defined as:

(2) Normal range for MCH is 30 ± 4.

c. Mean cell hemoglobin concentration (MCHC) represents the average concentration of Hb in an average RBC, defined as:


(1) Normal range for MCHC is 34 ± 3. (2) Low MCHC indicates hypochromia (pale RBCs resulting from decreased Hb content), as occurs in iron deficiency.

d. Red blood cell distribution width (RDW) is a relatively new index of RBCs. Normally; most RBCs are approximately equal in size, so that only one bell-shaped histogram peak is generated. Disease may change the size of some RBCs—for example, the gradual change in size of newly produced RBCs in folic acid or iron deficiency. The difference in size between the abnormal and the less abnormal RBCs produces either more than one histogram peak or a broadening of the normal peak. This value is used primarily with other tests to diagnose iron deficiency anemia. (1) An increased RDW is found in factor deficiency anemia (e.g., iron, folate, vitamin B 12). (2) A normal RDW is found in such conditions as anemia or chronic disease. (3) The RDW index is never decreased.

5. The reticulocyte count provides a measure of immature RBCs (reticulocytes), which contain Remnants of nuclear material (reticulum). Normal RBCs circulate in the blood for about 1 to 2 days in this form. Hence, this test provides an index of bone marrow production of mature RBCs. a. Reticulocytes normally make up 0.1% to 2.4% of the total RBC count. b. Increased reticulocyte count occurs with such conditions as haemolytic anemia, acute blood loss, and response to the treatment of a factor deficiency (e.g., an iron, vitamin B 12, or folate deficiency). Polychromasia (the tendency to stain with acidic or basic dyes) noted on a peripheral smear laboratory report usually indicates increased reticulocytes. c. Decreased reticulocyte count occurs with such conditions as drug-induced aplastic anemia.

6. The erythrocyte sedimentation rate (ESR) measures the rate of RBC settling of whole, uncoagulated blood over time, and it primarily reflects plasma composition. Most of the sedimentation effect results from alterations in plasma proteins.


a. Normal ESR rates range from 0 to 20 mm/hr for males and from 0 to 30 mm/hr for females. b. ESR values increase with acute or chronic infection, tissue necrosis or infarction, well established malignancy, and rheumatoid collagen diseases. c. ESR values are used to (1) Follow the clinical course of a disease (2) Demonstrate the presence of occult organic disease (3) Differentiate conditions with similar symptomatology—for example, angina pectoris (no change in ESR value) as opposed to a myocardial infarction (increase in ESR value)

B. WBCs (leukocytes)

1. The WBC count reports the number of leukocytes in a given volume of whole blood. a. Normal values range from 4,000 to 11,000 x103 cells/mm3 (or 109 cells/L) b. Increased WBC count (leukocytosis) usually signals infection; it may also result from leukaemia, tissue necrosis, or istration of corticosteroids. It is most oft en found with bacterial infection. c. Decreased WBC count (leukopenia) indicates bone marrow depression, which may result from metastatic carcinoma, lymphoma, or toxic reactions to substances such as antineoplastic agents.

2. The WBC differential evaluates the distribution and morphology of the five major types of WBCs: the granulocytes (neutrophils, basophils, eosinophils) and the non-granulocytes (Lymphocytes and Monocytes). A certain percentage of each type makes up the total WBC count. a. Neutrophils may be mature or immature. Mature neutrophils are polymorphonuclear leukocytes (PMNs), also referred to as polys; segmented neutrophils, or segs; immature neutrophils are referred to as bands or stabs.


(1) Chemotaxis. Neutrophils that phagocytize and degrade many types of particles serve as the body’s first line of defence when tissue is damaged or foreign material gains entry. They congregate at sites in response to a specific stimulus, through a process known as Chemotaxis.

(2) Neutrophilic leukocytosis. This describes a response to an appropriate stimulus in which the total neutrophil count increases, oft en with an increase in the percentage of immature cells (a shift to the left). This may represent a systemic bacterial infection, such as pneumonia (Table 302). (a) Certain viruses (e.g., chickenpox, herpes zoster), some rickettsial diseases (e.g., Rocky Mountain spotted fever), some fungi, and stress (e.g., physical exercise, acute hemorrhage or hemolysis, acute emotional stress) may also cause this response.



(b) Other causes include inflammatory diseases (e.g., acute rheumatic fever, rheumatoid arthritis, acute gout), hypersensitivity reactions to drugs, tissue necrosis (e.g., from myocardial infarction, burns, certain cancers), metabolic disorders (e.g., uraemia, diabetic ketoacidosis), myelogenous leukaemia, and use of certain drugs (e.g., epinephrine, lithium).

(3) Neutropenia, a decreased number of neutrophils, may occur with an overwhelming infection of any type (bone marrow is unable to keep up with the demand). It may also occur with certain viral infections (e.g., mumps, measles), with idiosyncratic drug reactions, and as a result of chemotherapy. Neutropenia is defined as an absolute neutrophil count (ANC) of <1000 cells/mm3. Some define absolute neutropenia as an ANC of <500 cells/mm3. The ANC is calculated by multiplying the percentage of neutrophils by the total WBC count:

b. Basophils stain deeply with blue basic dye. Their function in the circulation is not clearly understood; in the tissues, they are referred to as mast cells. (1) Basophilia, an increased number of basophils, may occur with chronic myelogenous leukaemia (CML) as well as other conditions. (2) A decrease in basophils is generally not apparent because of the small numbers of these cells in the blood.

c. Eosinophils stain deep red with acid dye and are classically associated with immune reactions. Eosinophilia, an increased number of eosinophils, may occur with such conditions as acute allergic reactions (e.g., asthma, hay fever, drug allergy) and parasitic infestations (e.g., trichinosis, amebiasis).

d. Lymphocytes play a dominant role in immunological activity and appear to produce antibodies. They are classified as B lymphocytes or T lymphocytes; T lymphocytes are further divided into helper-inducer cells (TH4 cells) and suppressor cells (TH8 cells).


(1) Lymphocytosis, an increased number of lymphocytes, usually accompanies a normal or decreased total WBC count and is most commonly caused by viral infection. (2) Lymphopenia, a decreased number of lymphocytes, may result from severe debilitating illness, immunodeficiency, or from AIDS, which has a propensity to attack TH4 cells. (3) Atypical lymphocytes (i.e., T lymphocytes in a state of immune activation) are classically associated with infectious mononucleosis.

e. Monocytes are phagocytic cells. Monocytosis, an increased number of monocytes, may occur with tuberculosis (TB), subacute bacterial endocarditis, and during the recovery phase of some acute infections. C. Platelets (thrombocytes). These are the smallest formed elements in the blood, and they are involved in blood clotting and vital to the formation of a hemostatic plug after vascular injury. 1. Normal values for a platelet count are 150,000 to 300,000/mm3 (1.5 to 3.0 x 1011/L). 2. Thrombocytopenia, a decreased platelet count, can occur with a variety of conditions, such as idiopathic thrombocytopenic purpura or, occasionally, from such drugs as quinidine and sulphonamides. a. Thrombocytopenia is moderate when the platelet count is <100,000/mm3. b. Thrombocytopenia is severe when the platelet count is <50,000/mm3.

A2) LIVER FUNCTION TESTS:A. Liver enzymes

1. Levels of certain enzymes (e.g., LDH, ALP, AST, and ALT) increase with liver dysfunction. 2. These enzyme tests indicate only that the liver has been damaged. They do not assess the liver’s ability to function. Other tests provide indications of liver dysfunction.

B. Serum bilirubin


1. Bilirubin, a breakdown product of Hb, is the predominant pigment in bile. Effective bilirubin conjugation and excretion depend on hepatobiliary function and on the rate of RBC turnover. 2. Serum bilirubin levels are reported as total bilirubin (conjugated and unconjugated) and as direct bilirubin (conjugated only). a. Bilirubin is released by Hb breakdown and is bound to albumin as water-insoluble indirect bilirubin (unconjugated bilirubin), which is not filtered by the glomerulus. b. Unconjugated bilirubin travels to the liver, where it is separated from albumin, conjugated with diglucuronide, and then actively secreted into the bile as conjugated bilirubin (direct bilirubin), which is filtered by the glomerulus. 3. Normal values of total serum bilirubin are 0.1 to 1.0 mg/dL (2 to 18 mmol/L); of direct bilirubin, 0.0 to 0.2 mg/dL (0 to 4 mmol/L)

BILIRUBIN METABOLISM:-


4. An increase in serum bilirubin results in jaundice from bilirubin deposition in the tissues. There are three major causes of increased serum bilirubin. a. Hemolysis increases total bilirubin; direct bilirubin (conjugated) is usually normal or slightly increased. Urine colour is normal, and no bilirubin is found in the urine. b. Biliary obstruction, which may be intrahepatic (as with a chlorpromazine reaction) or extra hepatic (as with a biliary stone), increases total bilirubin and direct bilirubin; intrahepatic cholestasis (e.g., from chlorpromazine) may increase direct bilirubin as well. Urine colour is dark, and bilirubin is present in the urine.


c. Liver cell necrosis, as occurs in viral hepatitis, may cause an increase in both direct bilirubin (because inflammation causes some bile sinusoid blockage) and indirect bilirubin (because the liver’s ability to conjugate is altered). Urine colour is dark, and bilirubin is present in the urine.

C. Serum proteins:

1. Primary serum proteins measured are albumin and the globulins (i.e.α, β, γ ) a. Albumin (4 to 6 g/dL) maintains serum oncotic pressure and serves as a transport agent. Because it is primarily manufactured by the liver, liver disease can decrease albumin levels. Albumin can also be used to assess nutritional status. b. Globulin (23 to 35 g/L) relates to the total measurement of immunoglobins (antibodies) found in the serum and function as transport agents and play a role in certain immunological mechanisms. A decrease in albumin levels usually results in a compensatory increase in globulin production. 2. Normal values for total serum protein levels are 6 to 8 g/dL (60 to 80 g/L).

A3) RENAL FUNCTION TESTS:A. Introduction 1. Renal function may be assessed by measuring blood urea nitrogen (BUN) and serum creatinine. Renal function decreases with age, which must be taken into when interpreting test values. a. These tests primarily evaluate glomerular function by assessing the glomerular filtration rate (GFR). b. In many renal diseases, urea and creatinine accumulate in the blood because they are not excreted properly. c. These tests also aid in determining drug dosage for drugs excreted through the kidneys.


2. Azotaemia describes excessive retention of nitrogenous waste products (BUN and creatinine) in the blood. The clinical syndrome resulting from decreased renal function and azotaemia is called uraemia. a. Renal azotaemia results from renal disease, such as glomerulonephritis and chronic pyelonephritis. b. Pre-renal azotemia results from such conditions as severe dehydration, hemorrhagic shock, and excessive protein intake. c. Post-renal azotemia results from such conditions as ureteral or urethral stones or tumours and prostatic obstructions.

3. Clearance—a theoretical concept defined as the volume of plasma from which a measured amount of substance can be completely eliminated, or cleared, into the urine per unit time—can be used to estimate glomerular function.

B. BUN 1. Urea, an end product of protein metabolism, is produced in the liver. From there, it travels through the blood and is excreted by the kidneys. Urea is filtered at the glomerulus, where the tubules reabsorb approximately 40%. Thus, under normal conditions, urea clearance is about 60% of the true GFR.

2. Normal values for BUN range from 8 mg/dL to 18 mg/dL (3.0 to 6.5 mmol/L). a. Decreased BUN levels occur with significant liver disease. b. Increased BUN levels may indicate renal disease. However, factors other than glomerular function (e.g., protein intake, reduced renal blood flow, blood in the gastrointestinal tract) readily affect BUN levels, sometimes making interpretation of results difficult.

C. Serum creatinine 1. Creatinine (CR), the metabolic breakdown product of muscle creatine phosphate, has a relatively constant level of daily production. Blood levels very little in a given individual.


2. Creatinine is excreted by glomerular filtration and tubular secretion. Creatinine clearance parallels the GFR within a range of < 10% and is a more sensitive indicator of renal damage than BUN levels because renal impairment is almost the only cause of an increase in the serum creatinine level. 3. Normal values for serum creatinine range from 0.6 to 1.2 mg/dL (50 to 110 mmol/L). a. Values vary with the amount of muscle mass—a value of 1.2 mg/dL in a muscular athlete may represent normal renal function, whereas the same value in a small, sedentary person with little muscle mass may indicate significant renal impairment. b. Generally, the serum creatinine value doubles with each 50% decrease in GFR. For example, if a patient’s normal serum creatinine is 1 mg/dL, 1 mg/dL represents 100% renal function, 2 mg/dL represents 50% function, and 4 mg/dL represents 25% function.

D. Creatinine clearance 1. Creatinine clearance, which represents the rate at which creatinine is removed from the blood by the kidneys, roughly approximates the GFR. a. The value is given in units of millilitres per minute, representing the volume of blood cleared of creatinine by the kidney per minute. b. Normal values for men range from 75 to 125 mL/min. 2. Calculation requires knowledge of urinary creatinine excretion (usually over 24hrs) and concurrent serum creatinine levels. Creatinine clearance is calculated as follows:

Where ClCR is the creatinine clearance in millilitres per minute, CU is the concentration of creatinine in the urine, V is the volume of urine (in millilitres per minute of urine formed over the collection period), and CCR is the serum creatinine concentration. 3. Suppose the serum creatinine concentration is 1 mg/dL, and 1440 mL of urine was collected in


24hrs (1440mins) for a urine volume of 1 mL/min. The urine contains 100 mg/dL of creatinine. Creatinine clearance is calculated as:

4. Incomplete bladder emptying and other problems may interfere with obtaining an accurate timed urine specimen. Thus, estimations of creatinine clearance may be necessary. These estimations require only a serum creatinine value. One estimation uses the method of Cockcroft and Gault, which is based on body weight, age, and gender. a. This formula provides an estimated value, calculated for males as:

b. For females, use 0.85 of the value calculated for males. c. Example: A 20-year-old man weighing 72 kg has a CCR of 1.0 mg/dL; thus

5. Determination of GFR. The modified diet in renal disease (MDRD) equation is considered a more accurate measurement of GFR than other equations used to estimate renal function (e.g., Cockcroft –Gault) in patients with reduced GFR and is used in staging renal disease. Patients must have a serum creatinine concentration. a. The MDRD equation for males is as follows:

Where, Pcr is serum creatinine. For females, multiply the result by 0.742; for African Americans, multiply by 1.210.


b. The MDRD has been validated in Caucasians, patients with diabetic kidney disease, kidney transplant recipients, and African Americans and Asians with non-diabetic kidney disease. c. The MDRD equation has not been validated in patients _ 18 years of age, pregnant women, patients _ 70 years of age, other ethnic groups, patients with normal kidney function who are at an increased risk for chronic kidney disease, and patients with normal renal function. d. Many institutions are routinely reporting MDRD-derived GFR estimation for patients as a routine component of a blood chemistry study. This value should be used to assist the clinician in staging a patient’s degree of renal dysfunction and is not a substitute for creatinine clearance as estimated by the Cockcroft and Gault equation, which should be used for drug dosing in renal impairment. The MDRD estimate has not been evaluated for the purpose of drug dosing.

A4) THYROID FUNCTION TESTS:INTRODUCTION: The butterfly-shaped thyroid gland is located just inferior to the larynx (voice box). It is composed of right and left lateral lobes, one on either side of the trachea, that are connected by an isthmus (IS-mus = a narrow age) anterior to the trachea A small, pyramidal-shaped lobe sometimes extends upward from the isthmus. The normal mass of the thyroid is about 30 g (1oz). It is highly vascularized and receives80 –120 mL of blood per minute.


ANATOMY OF THYROID GLAND:-


Thyroid disorders:1) Hypothyroidism • Primary • Secondary • Tertiary 2) Hyperthyroidism Thyroid function tests: Measure the concentration of products secreted by the thyroid gland 1. 2. 3. 4. 5. 6. 7. 8.

Free T4 test Total serum T4 test Serum T3 resin uptake test Free T4 index test Total serum T3 test TSH ( thyroid stimulating hormone ) TRH (thyroid regulating hormone) Radioactive iodine uptake test

1) Free T4 test: Reference range: 0.8 - 2.7 nanogram/dl Measures unbound fraction of T4 •

Decreased direct equilibrium dialysis (method) T4 and increase TSH is suggestive of primary hypothyroidism • Increased free T4 and TSH of less than 0.01 milliunits/L is suggestive of nonpituitary hyperthyroidism. 2) Total serum T4 test: Reference range: 4 - 12 microgram/dl. Measures both bound and free T4. •

Increased total serum T4 – hyperthyroidism/ increase concentration of thyroid binding proteins.


•

Decreased total serum T4 – hypothyroidism/decrease concentration of thyroid binding proteins/ non-thyroid illness [DM, liver disease, renal failure, prolonged infection and CV diseases]. 3) Serum T3 resin uptake test (thyroid hormone binding ratio): Reference range: 25 – 35%. •

Indirectly estimates the number of binding sites on thyroid binding proteins occupied by T3. • The T3 resin uptake is high when thyroid –binding protein is low and vice versa. • Increase in T3 resin uptake - consistent with hyperthyroidism. • Decrease in T3 resin uptake - consistent with hypothyroidism. This test is never used alone for diagnosis. In practice, the T3 resin uptake test is used only to calculate the free T4 index. 4) Free thyroxin (T4) index test: Reference range: 1.2 – 4.2 • Free T4 index = Total serum T4 (mg/dl) X T3 resin uptake (%) • The index is high in hyperthyroidism • The index is low in hypothyroidism. 5) Total serum T3: Reference range: 78 - 195 nanogram/dl. It is used to detect T3 toxicosis (increased T3 and normal T4). 6) TSH test: Ref range: 0.3 - 5 microunits /ml or milliunits /L • • •

Symptomatic primary hypothyroidism: >20 mu/L Mild symptomatic hypothyroidism: 10 to 20 mu/L Primary hyperthyroidism: <0.05 mu/L .

7) TRH test : • •

Regulates the TSH secretion from pituitary TRH test measure the ability of TRH to stimulate the pituitary to secrete TSH


• • •

TSH rise of 5 micro units/ml over baseline - euthyroid state A significant increase rules out – hyperthyroidism Is performed by drawing baseline serum TSH concentration and then ister approximately 200-400 microgram of TRH by iv over 30 – 60 seconds. Then TSH concentration drawn at 30 – 60 minutes. 8) Radioactive iodine uptake test: •

Radioactive iodine uptake test is used to assess intrinsic function of the thyroid gland • This test is not specific and the reference range should be adjusted based on local population • This test is indirect measure of thyroid activity. Subject with normal thyroid gland • 12 – 20% of radioactive iodine is absorbed after 6 hours. • 5 - 25% of radioactive iodine is absorbed after 24 hours. Increased radioactive iodine uptake noted in: • Thyrotoxicosis • Iodine deficiency • Post thyroiditis • Withdrawal rebound after thyroid hormone/ anti thyroid drug therapy Decreased radioactive iodine uptake noted in: • • • • •

Acute thyroiditis Euthyroid patients Patients on exogenous thyroid hormone therapy Patients taking anti-thyroid drugs Hypothyroidism.


B) TESTS ASSOCIATED WITH CARDIAC DISORDERS:

The heart is a muscular organ in most animals, which pumps blood through the blood vessels of the circulatory system. Blood provides the body with oxygen and nutrients, as well as assisting in the removal of metabolic wastes.] In humans, the heart is located between the lungs, in the middle compartment of the chest.

CARDIAC DISORDERS:• • • • • •

coronary heart disease stroke other cardiovascular diseases hypertensive heart disease inflammatory heart disease Rheumatic heart disease.


CARDIAC FUNCTION TESTS:There are 3 types of cardiac function tests. They are: 1. LABORATORY TESTS 2. CARDIAC BIOMARKERS 3. NON LABORATORY TESTS.

1) LABORATORY TESTS:

•

White blood cell count (WBC) is the number of white blood cells in a volume of blood. Normal range is generally between 4,300 and 10,800cells per cubic millimete (cmm).

•

White blood cell (WBC) differential count. White blood count is comprised of several different types that are differentiated, or distinguished, based on their size and shape. The cells in a differential count are lymphocytes, monocytes, eosinophils and basophils. Red cell count (RBC) signifies the number of red blood cells in a volume of blood. Normal range: 4.2 to 5.9 million cells/cmm.

•

This can also be referred to as the erythrocyte count and can be expressed in international units as 4.2 to 5.9 x 1012cells/liter. •

Hemoglobin (Hb). This is the amount of hemoglobin in a volume of blood. Hemoglobin is the protein molecule within red blood cells that carries oxygen and gives blood its red color. Normal ranges: 13 to 18 gm/dl for men. 12 to 16 gm/dl for women.

•

Haematocrit (Hct). This is the ratio of the volume of red cells to the volume of whole blood. Normal range: 42% to 52% for men.


37% to 47% for women. This is usually measured by spinning down a sample of blood in a test tube, which causes the red blood cells to pack at the bottom of the tube. •

Mean corpuscular volume (MCV) is the average volume of a red blood cell. This is a calculated value derived from the haematocrit and red cell count. Normal range may fall between 80 to 100 fentoliters (a fraction of one millionth of a liter).

•

Mean Corpuscular Hemoglobin (MCH) is the average amount of hemoglobin in the average RBC. This is a calculated value derived from the measurement of hemoglobin and the red cell count. Normal range: 27 to 32 pictograms.

•

Mean Corpuscular Hemoglobin Concentration (MCHC) is the average concentration of hemoglobin in a given volume of red cells. This is a calculated volume derived from the hemoglobin measurement and the haematocrit. Normal range: 32% to 36%.

•

Red Cell Distribution Width (RDW) is a measurement of the variability of red cell size and shape. Higher numbers indicate greater variation in size. Normal range: 11 to 15.

•

Platelet count. The number of platelets in a specified volume of blood. Platelets are not complete cells, but actually fragments of cytoplasm (part of a cell without its nucleus or the body of a cell) from a cell found in the bone marrow called a megakaryocyte. Platelets play a vital role in blood clotting. Normal range: 1, 50,000 to 4, 00,000 Cells/mm3.

2) CARDIAC BIOMARKERS:• • •

•

Cardiac biomarkers are substances that are released into the blood when the heart is damaged or stressed. Measurement of these biomarkers is used to diagnose, monitor. Cardiac biomarker tests are used to help and detect the presence of ACS and cardiac ischemia and to evaluate their severity as soon as possible so that appropriate therapy can be initiated. The current biomarker test of choice for detecting heart damage is troponin.


• •

Other cardiac biomarkers are less specific for the heart. Current cardiac biomarker tests used to help diagnose, evaluate, and monitor individuals suspected of having acute coronary syndrome (ACS) include: 1. Troponin I or T 2. CK 3. CK-MB. • Other biomarker tests that may be used: 1. Myoglobin 2. BNP (or NT-proBNP) — although usually used to recognize heart failure, an increased level in people with ACS indicates an increased risk of recurrent events. Troponin: Protein found in skeletal and contractual fibers of the heart (cardiac muscle) Troponin I and T are cardiac specific Normal: 0-0.3 ng/ml Timing Earliest rise: 3-4 hrs Peak:

10-24 hrs

Return to Normal: 1-3 wks. Elevated Troponin: Patients with elevated Troponin I levels, normal CK-MB and no ST elevation has an increased risk of death. • •

Useful marker for post-op cardiac surgery patient. Troponin has three subunits, TnC, TnT, and TnI • Troponin-C binds to calcium ions to produce a conformational change TnI. • Troponin-T binds to tropomyosin, interlocking them to form a troponintropomyosin complex • Troponin-I binds to actin in thin myofilaments to hold the troponintropomyosin complex.

Creatine Kinase: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 89

•

• • • •

Creatine kinase (CK/K) is an enzyme expressed in a number of tissues. Function: it catalysis the conversion of creatine to phosphocreatine degrading ATP to ADP. The CK enzyme consists of two subunits, B (brain type) or M (muscle type) Three different Isoenzymes: CK-MM, CK-BB and CK-MB. CK-BB occurs mainly in tissues, rarely of any significance in the bloodstream Skeletal muscle expresses CK-MM (98%) and low levels of CK-MB (1%) The myocardium has CK-MM at 70% and CK-MB at ~30%.

Myoglobin: •

Myoglobin may be ordered as a cardiac biomarker, along with troponin, to help diagnose or rule out a heart attack. • Levels of myoglobin start to rise within 2-3 hours of a heart attack or other muscle injury, reach their highest levels within 8-12 hours, and generally fall back to normal within one day. • An increase in myoglobin is detectable sooner than troponin, but it is not as specific for heart damage and it will not stay elevated as long as troponin. • Sometimes, a urine test is ordered to evaluate myoglobin concentrations in those who have had extensive damage to their skeletal muscles (rhabdomyolysis). 3) Non-laboratory Tests: These tests allows to look at the size, shape, and function of the heart as it is beating. They can be used to detect changes to the rhythm of the heart as well as to detect and evaluate damaged tissues and blocked arteries. • • • • • • • • • • •

EKG (ECG, electrocardiogram). Nuclear scan. Coronary angiography (or arteriography) Echocardiogram. Stress testing. Chest X-ray. Cardiac catheterization. Cardiac Stress Testing. Nuclear imaging. Myocardial perfusion imaging. Computed tomography.

1) Electrocardiography: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 90

Electrocardiography is a recording of electrical activity of the heart on an electrocardiogram.

•

Transmission, magnitude, and duration of the various electrical impulses of the heart. • Electrocardiograph – machine that measures and displays impulses of the heart. • Electrocardiogram (ECG) is a tool that is used to measure and record the electrical activity of the heart. An Electrocardiogram is necessary to establish many heart related defects like:• •

Atrial enlargement, Ventricular hypertrophy(enlargement of the ventricles),


•

Arrhythmias (abnormal electrical activity of the heart) and conditions that may lead to sudden death.

SIGNIFICANCE: • • • •

•

An electrocardiogram (EKG, ECG) translates the heart's electrical activity into line tracings on paper. The spikes and dips in the line tracings are called waves. The P wave is a record of the electrical activity through the upper heart chambers (atria). The QRS complex is a record of the movement of electrical impulses through the lower heart chambers (ventricles). The ST segment shows when the ventricle is contracting but no electricity is flowing through it. The ST segment usually appears as a straight, level line between the QRS complex and the T wave. The T wave shows when the lower heart chambers are resetting electrically and preparing for their next muscle contraction.

2) Exercise Electrocardiography:

• •

Stress tests - assesses the heart’s conduction system during exercise when the demand for oxygen increases. Measures the patient’s responses to work load.


3) CARDIAC CATHETERIZATION OR CORONARY ANGIOGRAM:• • •

Cardiac catheterization (or coronary angiogram) is an invasive imaging procedure that tests for heart disease. During the test, a long, narrow tube, called a catheter, is inserted into a blood vessel in the arm or leg and guided to the heart with the aid of a special X-ray machine. Contrast dye is injected through the catheter so that X-ray of the valves, coronary arteries, and heart chambers can be created.

4) CHEST X-RAY:• • • • •

The chest x-ray is the most commonly performed diagnostic x-ray examination. A chest x-ray makes images of the heart, lungs, airways, blood vessels and the bones of the spine and chest. An x-ray (radiograph) is a non-invasive medical test that helps physicians diagnose and treat medical conditions. Imaging with x-rays involves exposing a part of the body to a small dose of ionizing radiation to produce pictures of the inside of the body X-rays are the oldest and most frequently used form of medical imaging.


Two views are usually taken: • •

one in which the X-rays through the chest from the back (posterioranterior view), and One in which the X-rays through the chest from one side to the other (lateral view).


5) NUCLEAR IMAGING:• Nuclear imaging is a method of producing images by detecting radiation from different parts of the body after a radioactive tracer material is istered. • The images are recorded on computer. The nuclear imaging physician interprets the images to make a diagnosis. • The main difference between nuclear imaging and other radiologic tests is that nuclear imaging assesses how organs function, whereas other imaging methods assess anatomy, or how the organs look.

• • •

You will lie on a padded examination table under a gamma camera. You will be positioned under the camera for a variable amount of time while the camera takes a series of pictures. The average imaging time is less than one hour.


• •

A computer connected to the camera detects the radiation coming from the body organ being examined, and forms a series of images. These images are interpreted by nuclear medicine physicians who search for any abnormalities or disease and then make a diagnosis.

6) COMPUTED TOMOGRAPHY:

•

A CT scan is an x-ray procedure that combines many x-ray images with the aid of a computer to generate cross-sectional views of the body. • Cardiac CT uses the advanced CT technology with intravenous (IV) contrast (dye) to visual anatomy, coronary circulation. ➢ Cardiac CTs are used to evaluate: • • • • •

the heart muscle the coronary arteries the pulmonary veins the thoracic and abdominal aorta The sac around the heart (pericardium).


7) MRI SCAN:

• • • •

Magnetic Resonance Imaging (MRI) is a way of creating detailed images of internal organs. A cardiac MRI scan is used to view the heart’s structure and to assess how well it’s pumping. This is useful for detecting structural problems with heart such as congenital heart disease or age-related wear and tear of your heart valves. If for heart failure, the scan can help the doctor to determine the amount of healthy heart muscle.

C) FLUIDS AND ELECTROLYTES BALANCE:-


A. Sodium (Na) 1. Sodium is the major cation of the extracellular fluid. Sodium, along with chloride (Cl), potassium (K), and water, is important in the regulation of osmotic pressure and water balance between Intracellular and extracellular fluids. Normal values: 135 to 147 mEq/L or mmol/L. 2. The sodium concentration is defined as the ratio of sodium to water, not the absolute amounts of either. Laboratory tests for sodium are used mainly to detect disturbances in water balance and body osmolality. The kidneys are the major organs of sodium and water balance. 3. An increase in sodium concentration (hypernatremia) may indicate impaired sodium excretion or dehydration. A decrease in sodium concentration (hyponatremia) may reflect over hydration, abnormal sodium loss, or decreased sodium intake. 4. Patients with kidney, heart, or pulmonary disease may have difficulty with sodium and water balance. In adults, changes in sodium concentrations most oft en reflect changes in water balance, not salt imbalances. Therefore, sodium concentration is oft en used as an indicator of fluid status, rather than salt imbalance. 5. Control of sodium by the body is accomplished mainly through the hormones aldosterone and antidiuretic hormone (ADH). a. ADH is released from the pituitary gland in response to signals from the hypothalamus. ADH’s presence in the distal tubules and collecting ducts of the kidney causes them to become more permeable to the reabsorption of water; therefore, concentrating urine. b. Aldosterone affects the distal tubular reabsorption of sodium as opposed to water. Aldosterone is released from the adrenal cortex in response to low sodium, high potassium, low blood volume, and angiotensin II. Aldosterone causes the spilling of potassium from the distal tubules into the urine in exchange for sodium reabsorption. 6. Hyponatremia is usually related to total body depletion of sodium—as in mineralocorticoid deficiencies, sodium-wasting renal disease, replacement of fluid loss with non-saline solutions, gastrointestinal (GI) losses, renal losses, or loss of sodium through the skin—or to dilution of serum sodium—as in cirrhosis, CHF, nephrosis, renal failure, excess water intake, or syndrome of inappropriate antidiuretic hormone (SIADH) secretion. 7. Hypernatremia usually results from a loss of free water or hypotonic fluid or through excessive sodium intake. Free water loss is most oft en associated with diabetes insipidus, but fluid loss can


be via the GI tract, renal, skin, or respiratory systems. Excess sodium intake can occur through the istration of hypertonic intravenous (IV) solutions, mineralocorticoid excess, excessive sodium ingestion, or after istration of drugs high in sodium content (e.g., ticarcillin, sodium bicarbonate [HCO-3]).

B. Potassium (K)

1. Potassium is the most abundant intracellular cation (intracellular fluid potassium averages 141mEq/L). Approximately 3500 mEq of potassium is contained in the body of a 70-kg adult. Only 10% of the body’s potassium is extracellular. Normal values are 3.5 to 5.0 mEq/L or mmol/L. 2. The serum potassium concentration is not an adequate measure of the total body potassium because most of the body’s potassium is intracellular. Fortunately, the clinical signs and symptoms of potassium deficiency—malaise, confusion, dizziness, electrocardiogram (ECG) changes, muscle weakness, and pain—correlate well with serum concentrations. The serum potassium concentration is buffered by the body and may be “normal” despite total body potassium loss. Potassium depletion causes a shift of intracellular potassium to the extracellular fluid to maintain potassium concentrations. There is approximately a 100 mEq total body potassium deficit when the serum potassium concentration decreases by 0.3 mEq/L. This may result in misinterpretation of serum potassium concentrations as they relate to total body potassium. 3. The role or function of potassium is in the maintenance of proper electrical conduction in cardiac and skeletal muscles (muscle and nerve excitability); it exerts an influence on the body’s water balance (intracellular volume) and plays a role in acid–base equilibrium. 4. Potassium is regulated by • • • • • •

Kidneys (renal function) Aldosterone Arterial pH Insulin Potassium intake Sodium delivery to distal tubules.


5. Hypokalaemia can occur. The kidneys are responsible for approximately 90% of the daily potassium loss. Other losses occur mainly through the GI system. Even in states of no potassium intake, the kidneys still excrete up to 20 mEq of potassium daily. Therefore, prolonged periods of potassium deprivation can result in hypokalaemia. Hypokalaemia can also result from potassium loss through vomiting or diarrhoea, nasogastric suction, laxative abuse, and by diuretic use (mannitol, thiazides, or loop diuretics). Excessive mineralocorticoid activity and glucosuria can also result in hypokalemia. Potassium can be shifted into cells with alkalemia and after istration of glucose and insulin. 6. Hyperkalaemia most commonly results from decreased renal elimination, excessive intake, or from cellular breakdown (tissue damage, hemolysis, burns and infections). Metabolic acidosis may also result in a shift of potassium extracellularly as hydrogen ions move into cells and are exchanged for potassium and sodium ions. As a general guideline, for every 0.1 unit, pH change from 7.4, the potassium concentration will change by about 0.6mEq/L. If a patient has a pH of 7.1 and measured potassium of 4.5mEq/L, the actual potassium concentration would be

0.3 (units < 7.4) x 0.6 = 1.8 Potassium concentration = 4.5 - 1.8 = 2.7 mEq/L

Correction of the acidosis in this situation will result in a dramatic decrease in potassium unless supplementation is instituted.

C. Chloride (Cl):

1. Chloride is the major anion of the extracellular fluid and is important in the maintenance of acid–base balance. Alterations in the serum chloride concentration are rarely a primary indicator of major medical problems. Chloride itself is not of primary diagnostic significance. It is usually measured to confirm the serum sodium concentration. The relationship among sodium, chloride, and HCO_3 is described by the following:

+ Cl + HCO-3 + R = Na


Where, R is the anion gap. The normal value for Cl is 95 to 105 mEq/L or mmol/L. 2. Hypochloremia is a decreased chloride concentration, and it is oft en accompanied by metabolic alkalosis or acidosis caused by organic or other acids. Other causes include chronic renal failure, adrenal insufficiency, fasting, prolonged diarrhoea, severe vomiting, and diuretic therapy. 3. Hyperchloremia is an increased chloride concentration that may indicate hyperchloremic metabolic acidosis. Hyperchloremia in the absence of metabolic acidosis is unusual because chloride retention is oft en accompanied by sodium and water retention. Other causes include acute renal failure, dehydration, and excess chloride istration.

D. Bicarbonate (HCO-3)/carbon dioxide (CO2) content:

1. The carbon dioxide (CO2) content represents the sum of the bicarbonate (HCO-3) concentration and the concentration of CO2 dissolved in the serum. The HCO-3/CO2 system is the most important buffering system to maintain pH within physiological limits. Most disturbances of acid–base balance can be considered in of this system. Normal values are 22 to 28 mEq/L or mmol/L. 2. The relationship among this system is defined as follows:

HCO-3 + H+ x H2CO3 x H2O + CO2

(Bicarbonate ions bind hydrogen ions to form carbonic acid). Clinically, the serum HCO -3 concentration is measured because acid–base balance can be inferred if the patient has normal pulmonary function. 3. Hypobicarbonatemia is usually caused by metabolic acidosis, renal failure, hyperventilation, severe diarrhoea, drainage of intestinal fluid, and by drugs such as acetazolamide. Toxicity caused by salicylates, methanol, and ethylene glycol can also decrease the HCO-3 level.


4. Hyperbicarbonatemia is usually caused by alkalosis, hypoventilation, pulmonary disease, persistent vomiting, excess HCO-3 intake with poor renal function, and diuretics.

D) MICROBIOLOGICAL CULTURE SENSITIVITY TESTS: SENSITIVITY TESTING: It is the degree of activity of the selected antimicrobial agent against the infecting bacterial strains.

INTRODUCTION: • •

Usually almost all the bacteria in infectious disease are drug resistant. Hence sensitivity test is performed to select the correct antimicrobial drug of choice. • It may also help to identify the pathogen. LIMITATIONS: •

It helps us to measure only the antimicrobial activity against bacteria under laboratory conditions and not in the patients. • The patient’s clinical condition, type and site of infection, drug hypersensitivity, E, characters of the patients are not taken in to consideration in sensitivity testing techniques. Sensitivity testing can be performed by

1. Diffusion technique and 2. Dilution technique.

1) Diffusion technique:

1) Agar diffusion sensitivity test:


a) A disc of blotting paper is impregnated with a known volume and appropriate concentration of antimicrobial placed on a plate of sensitivity agar inoculated with test organism. b) The antimicrobial diffuses from the disc in to the medium. After 24 hours, the culture is examined for areas of growth around the disc. c) Growths of the sensitive strains are inhibited for a distance while for resistant strains it grows up to the edge of the disc. d) The zone of inhibition caused by the antimicrobial is compared with the control. e) The volume, moisture content, PH, constituent of agar medium, concentration, storage and application of dose influence the diffusion technique. f) Agar diffusion sensitivity tests are carried out either by Kirby-Bawer (KB) method, ICS method or by Stocks method. g) Modified KB method is recommended by the National Committee for clinical Laboratory Standards (NCCLS) and the WHO.

2) DILUTION SENSITIVITY TESTS: Dilution sensitivity tests usually measures the minimum inhibitory concentration (MIC) or minimum bactericidal concentration (MBC) required to kill the bacteria.

a) Here dilutions of antimicrobials are added to the broth or agar. b) A standardized inoculum of test organism is added. c) After overnight the lowest antimicrobial required to prevent visible growth is taken in to consideration. Dilution technique needs:• • • • •

Careful standardization Broth and agar medium Antimicrobial solution Incubation time and Dilution time.

General requirements for sensitivity testing: 1. Sensitivity testing agar. • Suitable media include Mueller Hinton agar, Iso sensitest agar and Gibco sensitivity testing agar no.2. • Mueller Hinton agar(MHA) Composition T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 103

• • • •

Meat infusion 2.0 g/l Casein hydrolysate 17.5 g/l Starch 1.5 g/l Agar-agar 13.0 g/l.

2. ANTIMICROBIAL DISC: • • •

This disc should be refrigerated at a temperature instructed by the manufacturer. This should not be used after expiry date. The working stock disc should be warmed to room temperature, avoid keeping in direct sunlight.

ANTIMICROBIAL RESISTANCE: ▪ Antimicrobial resistance can arise in bacteria in several ways. ▪ Microbes acquire resistance after a change in their DNA. Such changes may occur by :a. Genetic mutation i.e. by alteration in the structure of their own DNA. b. Genetic exchange i.e. by acquisition of extra- chromosomal DNA from other bacteria. DRUG RESISTANCE: ➢ It refers to unresponsiveness of a micro-organism to an antimicrobial agent. They are of 3 types: 1. Natural resistance 2. Acquired resistance 3. Cross resistance. NATURAL RESISTANCE: ✓ Some microbes have always been resistant to certain AMA. ✓ They lack the metabolic process or the target site which is affected by the particular drug. E.g.:a. gram negative bacilli are normally unaffected by Pencillin G b. M.tuberculosis is insensitive to tetracyclines.


ACQUIRED RESISTANCE: It is the development of resistance by an organism (which was sensitive before) due to the use of an AMA over a period of time.

CROSS RESISTANCE:

• •

Cross-resistance is the tolerance to a usually toxic substance as a result of exposure to a similarly acting substance. It is a phenomenon affecting e.g. pesticides and antibiotics as an example.

F) PULMONARY FUNCTION TESTS: Anatomy and Physiology of Lungs: • • • •

Left and right lungs are in the pleural cavity of the thorax. Right lung has three lobes, but the left has only two lobes; space is thus provided for the heart. Lungs are connected to pharynx by trachea. Trachea splits into left and right main stem bronchi that deliver inspired air to respective lungs.


PULMONARY FUNCTION TESTS: 

DEF: - Pulmonary function tests are a group of procedures that measure the function of the lungs, revealing problems in the way a patient breathes. The tests can determine the cause of shortness of breath and may help confirm lung diseases, such as asthma, bronchitis or emphysema. The tests also are performed before any major lung surgery to make sure the person won't be disabled by having a reduced lung capacity.

Contraindications 1. 2. 3. 4. 5.

Recent eye surgery Thoracic , abdominal and cerebral aneurysms Active haemoptysis Pneumothorax Unstable angina/ recent MI within 1 month.

Respiratory functions are assessed by: • •

lung volume tests Lung flow tests.

1) Lung volume tests:1. 2. 3. 4. 5. 6. 7. 8.

Expiratory reserve volume (ERV) Slow vital capacity (SVC) Residual volume (RV) Functional residual capacity (FRC) Inspiratory capacity (IC) Inspiratory reserve volume (IRV) Tidal volume (TV) Total lung capacity (TLC).

2) Lung flow tests:1. Forced expiratory volume (FEV) 2. Peak expiratory flow rate (PEFR) T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 106

3. Forced expiratory flow (FEF).

These can be measured by spirometry

Lung volume tests:•

Lung volume tests indicate the amount of gas contained in the lungs at various stages of inflation.

1) Tidal volume: • Amount of air inhaled or exhaled at rest • Reference range: 500 to 750 ml • It is infrequently used as a measure of respiratory disease. 2) Inspiratory capacity (IC): • •

The volume measured from the point of the TV where inhalation normally begins to maximal inspiration is known as IC. Reference range: 500 ml + 3.1 L = 3.6 L.


3) Inspiratory reserve volume: •

Amount of air that is inhaled with maximal inhalation after the normal inhalation. Or • The volume measured from the “top” of the TV, (i.e. the initial point of normal exhalation) to maximal inspiration is known as the IRV. • Reference range: 3.1 L. 4) Expiratory reserve volume: •

Amount of air that is exhaled with maximal expiration after the normal exhalation. Or • During exhalation, the volume from the “bottom” of the TV (ie. Initial point of normal inhalation) to maximal expiration is referred to as ERV. • Reference range: 1. 2 L. 5) Slow vital capacity: •

When the full inhalation-exhalation procedures is repeated slowly – instead of forcefully and rapidly – it is known as SVC • This value is the maximum amount of air exhaled after a full and complete inhalation • In patients with normal airway function, SVC and FVC are usually similar (hence shown as Vital Capacity). • In patients with diseases, such as COPD during the initial stages of disease, the FVC decreases before the SVC (because inter luminal thoracic pressures are not elevated during the forced manoeuvre). 6) Residual volume: • Amount of air that is left in the lungs after full exhalation • Reference range: 1. 2 litre • RV is immeasurable by spirometry but measurable by body plethysmography. • Without RV lungs would collapse like deflated balloons. • In asthma, RV increases due to obstruction. 7) Functional residual capacity: • • • •

It is the volume of the gas remaining in the lungs at the end of the TV It is the sum of the ERV and RV [2.4L] An increased FRC usually represents hyperinflation of the lungs and indicates airway obstruction. FRC decreases in diseases that affect many alveoli (pneumonia) and by restrictive changes (fibrotic pulmonary tissue changes)


Functional Residual Volume (2.4 L) + Tidal volume (0.5 L) + Inspiratory Reserve Volume (3.1L)

8) Vital Capacity (VC): •

TLC minus RV Or Maximum volume of air exhaled from maximal inspiratory level. (60‐70 ml/kg) 5000ml. VC ~3 TIMES TV FOR EFFECTIVE COUGH.

9) Total lung capacity: • • •

It is the total amount of gas contained in the lungs It is the sum of RV and vital capacity Reference range: 6 L.

2) Lung flow tests: - (obtained by spirometry)

Forced expiratory volume: • • •

Changes in FVC measurement from baseline reflect the degree of current airway obstruction. FEV0.5, FEV1, FEV3 are the amounts of air exhaled after 0.5 , 1 and 3 seconds respectively Of these, FEV1 has the most clinical relevance, primarily as an indicator of the large airway functions.


• •

• •

The normal value for FEV1 is 0.75 – 5.5 L & this wide variation is due to physical variables among patients. Usually, patient’s value is described either as a percentage of a predicted value or as a standard deviation (SD) from the mean of a physically matched population of the same age. A value of >80% of predicted value or within + 2 standard deviation (SD) is considered normal. In both obstructive and restrictive diseases, the FEV usually shows a reduction in flow The magnitude of change reflects the severity of disease as:


• • •

Mild: Moderate: Severe:

61 – 80% of predicted 41 – 60% of predicted < 40% of predicted

Peak expiratory flow rate: • It is the measure of maximum airflow rate • Occurs within the first millisecond of expiratory flow • Measured by using peak flow meter • Range is 400 – 800 L/minute and in women 200- 600L/minute. • Values of 50 – 100L / minute indicate severe acute obstruction. • PEFR reduced in obstructive disease but normal in restrictive diseases. • Commonly used as objective “at home” measurements of airway function. Forced expiratory flow: • • • • • •

FEF measures airflow rate during forced expiration. While FEV measures the volume of air during expiration, FEF measures the rate of air movement. The FEF from 25 to 75% of vital capacity is known as FEF 25-75. This test is specifically measure the flow rate of air in the medium and smaller airways (bronchioles and terminal bronchioles). Because asthma affects these airways the most, FEF 25-75 is a good indicator of obstruction. In obstructive disease FEF decreases but remain normal in restrictive disease.

SPIROMETER:


DRUG AND POISON INFORMATION A) INTRODUCTION TO DRUG INFORMATION RESOURCES AVAILABLE: Drug information resources Drug information is current, critically examined, relevant data about drugs and drug use in a given patient or situation. A. Current information uses the most recent, up- to-date sources possible. B. Critically examined information should meet the following criteria: 1. More than one source should be used when appropriate. 2. The extent of agreement of sources should be determined; 3. The plausibility of information, based on clinical circumstances,. C. Relevant information must be presented in a manner that applies directly to the circumstances under consideration. (e.g., patient parameters, therapeutic objectives, alternative approaches)

Primary Resources: Researcher’s and manufacturer’s information Patents containing original information regarding the discovery of drug Reports containing scientific data before product can be sold, supplied or represented • • • •

Scientific journals Provide original studies or reports E.g. Clinical trial, case series, case report Scope is narrow Good when topic is new or new data has been published


Advantages: • • •

1. 2. 3.

4. 5. 6. 7.

Most current evidence Provide data on new drugs Can personally assess validity of studies Journal articles provide the most current information about drugs and, ideally, should be the source for answering therapeutic questions. Journals enable pharmacists to: Keep up to date with professional news Learn how another clinician handled a particular problem Keep up with new developments in pathophysiology, diagnostic agents, and therapeutic regimens d. Distinguish useful from useless or even harmful therapy Enhance communication with other healthcare professionals and consumers Obtain continuing education credits Share opinions with other healthcare professionals through letters to the editor Prepare for the board certification examination in pharmacotherapy, nutrition , oncology, etc.

Disadvantages: • May not lead one to best decision because of limited scope • Data can be poor or controversial • Every study has limitations • Too complex for patients. Al though publication of an article in a well -known, respected journal enhances the credibility of information contained in an article, this does not guarantee that the article is accurate. Many articles possess inadequacies that become apparent as the ability to evaluate drug information improves.

Secondary Resources: • •

•

Abstract or index which summarizes the information arising in primary source Indexing and abstracting services are valuable tools for quick and selective screening of the primary literature for specific information, data, citation, and articles Three types of abstracts: 1. Telegraphic abstract (only string of words) 2. Indicative abstract (structured in sentence )


•

3. Informative abstract Bibliographic databases that provide abstracts or full-text of studies.

Advantages: •

Can construct searches to find specific information at high granularity

Disadvantages: • • • • •

Often require more expertise to use than primary or tertiary resources Retrieved references must be filtered for quality Must track down resources before looking for answers Too complex for patients Generally interpretations of a study and may be a misinterpretation of important information.

Pharmacists should obtain and evaluate the original article because abstracts may not include enough information to critically evaluate the study.

Tertiary Resources: Compilations of knowledge in the field E.g. Textbooks, handbooks, Online drug compendia Good for background questions Scope is broad.

Advantages: • • •

Provide comprehensive information Information reflects views of multiple experts in field Fast, easy to use, and may be good for patients.

Disadvantages • •

Usually at least 2 years out of date by publication High dependency on interpretation of authors** **Pharmacists can address this by consulting at least 2 tertiary resources.


General considerations when examining and using textbooks: 1. The author, publisher, or both: What are the author 's and publisher's areas of expertise? 2. The year of publication (copyright date) or last revision date? 3. The edition of the text: Is it the most current edition? 4. The presence of a bibliography: I f a bibliography is included, are important statements accurately referenced? When were the references published? 5. The scope of the textbook or database: How accessible is the information? 6. Alternative resources that are available (e.g. , primary and secondary sources, other relevant texts).

Other sources:1. 2. 3. 4. 5. 6.

Libraries Research associations Government bodies Information Centre in industries Analyst labs Poison centers.

Internet as drug information source Benefits: • Search for recently published or discussed in the media • Company specific information • Issues currently in the news • Government agencies news. Limitations: • Information may not be peer reviewed or edited before release • Information not reliable • Must have an address (URL) Selected websites • •

http://dda.gov.np/ http://www.nepalpharmacycouncil.org.np/


•

www.nhrc.org.np/

Available resources: 1. For drugs manufactured in the United States, the following resources are available: 1. The American Drug Index, updated annually 2. Drug Facts and Comparisons, updated monthly and bound annually/Facts and Comparison 4.0 (online) 3. Drug Topics Red Book, periodically supplemented and updated annually 4. Physician's Desk Reference (PDR) , updated annually 5. American Hospital Formulary Service (AHFS) Drug Information, supplemented quarterly and updated annually 6. Martindale: The Complete Drug Reference, updated every 3 years 7. Lexi-Drugs Online (Lexi -Comp Online) 8. Clinical Pharmacology 9. Thomson Healthcare Series (Micromedex).

2. For drugs manufactured in foreign countries, the following resources are available: 1. Martindale: The Complete Drug Reference 2. Index Nominum 3. USP Dictionary of United States Adopted Names (USAN) and International Drug Names 4. Lexi-Drugs International Online (Lexi -Comp Online).

3. For investigational drugs, the following resources are available:

1. 2. 3. 4.

Martindale: The Complete Drug Reference Drug Facts and Comparisons/Facts and Comparison 4.0 (online) The Pink Sheet published by FDC Reports The NDA Pipeline published by FDC Reports.

4. for orphan drugs:


that is, drugs that are used to prevent or treat a rare disease (affects < 200,000 people in the United States, so the cost of development is not likely to be offset by sales) and for which the U.S. Food and Drug istration (FDA) offers assistance and financial incentives to sponsors under taking the development of the drugs—the following resources are available: 1. 2. 3. 4.

Drug Facts and Comparisons/Facts and Comparison 4.0 (online) The FDA Office of Orphan Products Development (OOPD) The National Institutes of Health (NIH) Office of Rare Diseases National Organization for Rare Disorders e. Lexi -Drugs Online (Lexi -Comp Online).

B) SYSTEMIC APPROACH IN ANSWERING DRUG INFORMATION QUERIES: Whether you’re on a drug information, community, or hospital rotation, these 7 steps will help you provide the best possible answer to any medication question. 1. Secure requestor demographics. It’s important to know your audience, as your response technique may differ depending on whether the question comes from a health care professional or a patient. For example, you’d use the word “renal” with a pharmacist and “kidney” with a patient. It’s always best to inquire how the requestor would like the information delivered (e.g., phone or fax), as this will help ensure adequate follow-up. 2. Obtain background information. This is historically the most difficult step because you must act as a detective. Determine whether it’s a general or patient-specific question, and then identify resources the requestor has already consulted to help facilitate the process. For patient-specific questions, it’s important to inquire about pregnancy, weight, and renal function. 3. Determine and categorize the question. If a pharmacist requests information about whether a patient who’s breastfeeding can take amoxicillin, this would be classified as a lactation question. Various categories may include pregnancy, drug interaction, pharmacy law, or pill identification. 4. Develop a strategy and conduct a search. First, begin with tertiary literature, which is a compilation of primary literature. This may T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 117

include text books like Drugs in Pregnancy and Lactation or drug information databases like Clinical Pharmacology or Lexicomp. Next, consult your secondary literature resources, which is the path to primary literature. Secondary resources include PubMed and EMBASE, which will enable you to locate primary literature or original research. It’s important to use reputable resources when researching. When using websites, be sure to consult ones ending in .gov or .org.

5. Perform evaluation, analysis, and synthesis. Objectively critique all of the information you retrieve from your comprehensive literature search. Also, consider the background information of your question. Consult with pharmacists and other health care professionals with expertise in your specific drug information question. 6. Formulate and provide a response. Inform the requestor when one course of action is more desirable. Present competing viewpoints and considerations. Also, describe your evaluation of the research. Written responses should always be concise and fully referenced. 7. Conduct follow-up and documentation. Following up is important for ensuring the information was received. Always document your drug information questions so you can refer back to them. You’ll likely see the same question in the future, and this well help serve as a reference point.


MODEL OF DRUG INFORMATION REQUEST FORM:



C) CRITICAL EVALUATION OF DRUG INFORMATION AND LITERATURE: Need of the literature evaluation •

Increasing sophisticated patient population who educate themselves about drug therapy (from various sources such as healthcare professionals, purveyors of alternative meds, family and friends), internet and reading some medical literatures and lay press

•

The physicians and other health care often the pharmacist for opinion on various aspects of the therapy.

•

Addition and deletion of the drugs from the formulary.

These responses can only be made after careful analysis of the available studies by the pharmacist. Issues •

Many assume that only high quality information meets the qualifications for publication.

•

The reality is that much of the medical literature fails to meet standards for well conducted studies.

•

The poorly conducted research is hazardous because it may result in substantial harm to patients and wastes resources, time and money.

Reason of flaws and bias in the literatures published •

Quantity of publication to become tenured academicians may lead to an attempt to publish suboptimal quality publication or same study in more than one journal or portions of the same study in multiple journals.

•

Researchers may have lack of knowledge in study design and statistical analysis to perform well conducted study. Or maybe the reviewers of the journal may be deficient in such knowledge.


•

Even if the peer reviewers recognize the flaw they may consider it worthy of publication if the research is in an area of importance and its publication may stimulate further investigations.

Evaluating True Experiments •

Randomized Controlled Clinical Trials are considered as true experiment and are the gold standard for determining cause and effect relationships. Mostly they are put in the primary journals.

Literature Evaluation 1. Journal, Investigators, Research site and Funding •

Begin by briefly scanning the article.

•

Whether the study is published in a reputable article where manuscripts undergo peer review prior to publication.

In case of peer review rejection the study can be submitted to alternate journals for consideration. A. Clinical studies may also be published in other forms such as abstracts following presentation at scientific meetings which are rarely detailed enough to allow clinical decisions to be based on their results; B. Part of symposium or journal supplements which are focused on a specific topic; or C. Reports of experience with a single patient or a group of patients with regards to drug efficacy or toxicity may be presented as a letter to the editor. They do not meet the rigorous standards for the publications as journal article but are meant to stimulate interest and conversation among readers of the journal.

•

Throw away journal

•

Assess the investigators expertise and training in the area been studied preferably track record of previous research. Check the disclosures such as – affiliations of authors, the funding for the study.


•

Research site – to know whether they had appropriate resources and technology to effectively conduct the study.

•

Finally in of finance or the funding received for the study.

2. Title/ Abstract •

Title of the article should be brief and catch the attention of the readers interested in the topic. And it should not be biased or indicate the authors preference’s viz., “study on the superiority of drug A against drug B in xyz diseased patients.

•

Abstract is the road map of a study. It is less time consuming and by scanning the abstracts, readers should be able to determine whether the study is of interest and deserves further reading.

•

Some discrepancies regularly seen in the abstracts is that some data or numerical values mentioned in the abstract will not be discussed in the body of the article or will not be the same as the one given in the results of the study.

•

Structured abstracts for clinical studies include the following sections: objective, research design, clinical setting, participants, interventions, main outcome measurements, results, and discussion.

3. Introduction •

This will contain the background information for the study and states study objectives and hypotheses.

•

The background information states that the study is important and ethical. It familiarizes the readers with the research subject. Previous investigations and their limitations; need of the present study; and should clarify that the benefits of the study outweighs the risks tot eh patients entering the study. Superscriptions of references made for cross references.

•

Study objectives or goals should be precise and clearly stated that it will not confuse the readers and come to an erroneous conclusion regarding study results.

•

The ill stated objective shows that the study was not well planned.


•

Some studies state the null hypothesis and research hypothesis (researchers expect to find during the course of their study) in the introduction part.

•

Ethical issues are either addressed in the introduction part or in the methodology part. This is to ensure that the risks to subjects are minimal and they know about the possible benefits and hazards of the study. Also mention regarding the informed consent form if necessary

4. Methodology

•

The most important section of a clinical study.

•

Results of studies that show methodological flaws are unreliable.

•

The main contents of the methodology can include: the research site, study period, ethical committee approval statement, study design, study population, instrumentation, and statistics used for the investigation.

Study Design: •

Two major types of study design seen in the true experiments:

Parallel studies and Cross – Over studies •

In parallel study the patients/ subjects (either the control or the treatment group) receives only one treatment throughout the study. Whereas in case of cross-over study subjects receive all study drugs.

•

Parallel studies are appropriate in case when therapies are definitive or when disease states are self – limited (e.g., antimicrobials for infectious diseases).

•

Cross – over studies are appropriate in case diseases are chronic and/or variable (e.g., glaucoma, migraine headache). In this study the error caused by variability among subjects are minimized since the each subject serves as his or her own control .


Cross- Over Study Design:

A

B

C

D

Drug X

Drug X

Drug Y

Drug Y

Randomization

A

B

C

d

Parallel Study Design

Drug A Randomization Drug B Important considerations for cross- over studies: ❖ Wash- out period ❖ Multiple cross- over studies ❖ Randomization T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 125

❖ Double blinding in case of time when cross- over occurs ❖ Subject dropouts and deaths should be minimized (since each subject contributes at least two pieces of data for each measurement of outcome). Study Criteria:-

Inclusion criteria:

•

List the subject characteristics that must be present for enrolment into the study.

Exclusion criteria:

•

List the characteristics in the target population that should not be included in the study. / fine tuning of the subjects.

•

Subjects who are harmed by the therapy or who may confound the results of the study.

Diagnosis criteria for the disease state should be clearly defined. (Clinical, laboratory and demographic criteria that justifies the diagnosis). •

The reader should check whether the enrolled subjects represent the patients routinely encountered in the clinical practice.

Sample size •

A sample is a subgroup from the entire population of patients with a particular disease state.

•

Samples are used because of logistic, financial, and resource constraints that prohibit studying an entire population.

•

The study needs a relevant sample size. Depends on the study objectives and design.


•

Can be confident about the study in case the number of patients who completed the study equals the investigator’s initial sample size calculations presented n the methodology.

•

A discussion on the sample size calculation should be made by the investigator and whether the final number of subjects equals this calculation.

•

Many investigators add 10 – 20% of the sample size calculation keeping in mind about the drop outs or death of the subject that can happen during the study.

•

In case of multicentre study it should be mentioned and make sure that the all the centres understand the protocol and receives adequate training in the conduct of trial.

•

A minimum level of sample can be presented as pilot study that give rise to further research or hypotheses.

Controls

•

Two types of controls mainly used in the clinical trials: a) placebo control, and b) active control.

•

Historical controls ate used in case the use of the previously used drug is no longer ethical. The criteria’s and variables of the historical control should be similar to the current study. Time of data collection effects the patient response.

•

All the interventions and care should be similar in both the control and treatment group.

Outcome variables •

The variables to be measured and amount of difference between the treatment and control groups that the study is designed to detect should be clearly defined.

•

The clinical outcomes should be relevant, clearly defined, objective, and clinically and biologically significant.


•

Instruments used to measure outcome variables should be justified. E.g., questionnaires, sensitivity and specificity of the instruments or techniques used, etc.,

•

Follow up time and length of the study should be mentioned.

Randomization and Blinding •

By randomization the subjects have an equal and independent chance of receiving any of the treatment modalities.

•

Similar in regard to clinical and socioeconomic factors that may affect the treatment outcome. And diminishes the investigator and patient bias.

•

Blinding: Single, Double or Triple blinding. This improves the validity of the study.

Compliance

Influences the results and should be evaluated.

Statistical analysis

•

Errors in statistical analysis of data ate commonly encountered and invalidate the study.

Results Data •

Should be presented in a clear and understandable format.

•

Original data should be presented in case of request from the reader.

•

Data should present the actual numbers rather than percentage values since this can be use for the calculation purposes or the readers own analysis.


•

Reasons for termination of study or reason of drop outs can be mentioned.

•

Study validity – whether the result was actual treatment related consequence and can it be generalized.

Conclusions/ Discussions

•

Interpretation of data and how it relates to the clinical practice.

•

Consistent to the results and the initial study question.

•

Study limitations can be mentioned

References

•

Used by the authors for of the study.

•

Limit the citing of own research efforts and publications

Acknowledgments

•

Sources of funding and other .

•

Individuals who contributed to the research effort but do not qualify for authorship.

•

Multicentre trials the investigational sites participating in the study should be listed.


D) PREPARATION OF WRITTEN AND VERBAL RESPONSES: Goal:It is to prepare a document that is clear, concise, complete and correct.

General rules:• Organize the information before starting to write (what and how to write) • Use proper spelling and grammar • Preferably avoid ive voice throughout • Avoid writing in the first person and second person wherever possible • Prepare a document in a presentable manner (neat) • Keep things as simple and direct as possible • Consider whether tables or graph or figures would make the document simpler • Avoid using abbreviations or acronyms (or quote at first instance in parenthesis) • If the document is long, use sub headings • Present it in correct order as required • Write in your own words. At first make sure that all of the information is down on paper. Once that occurs, go back, revise and perhaps reorganize the document.

Specific document sections:It should contain:

• • •

Introduction Body Conclusion.

Introduction: Should inform what the remainder of the document is to cover.

Body: • • •

Should contain all the details of the document Do not include unnecessary information (even if it is interesting) Do not stray from the subject.


• •

Sub divide the document further in a logical order and as appropriate when necessary Always focus end point.

Conclusion: • •

Sub divide the document further in a logical order and as appropriate when necessary Always focus end point.

Preparation of verbal response: • • • • • • • • • • • •

Verbal communications are most frequently used in practice settings Need to use good verbal communications skills Deliver the information at an ideal place Deliver the content confidently Make analogous to the delivery of a presentation or lecture. Use appropriate language with good grammar Use correct pronunciation of all of the document Listen carefully when clarification is sought Don’t interrupt while clarification is sought Clarify all doubts confidently Must be prepared for additional questions Show evidence where necessary/ appropriate.

E) Establishing a Drug Information Centre:Definition: •

•

A “DRUG INFORMATION CENTRE” is an area where pharmacists (or other health professionals) specialize in providing information to health professionals or the public. The unique aspect of drug information Centre is that it draws together a range of information resources and makes them accessible to people who know how to make the best use of them.

INTRODUCTION:


1. WHO recognises independent drug information centres as a core component of national programs to promote the rational use of drugs. 2. DRUG INFORMATION is the process of providing information on the safe and effective use of therapeutic and diagnostic pharmaceuticals. 3. DRUG INFORMATION SERVICE can be applied to any activity where information about drug use is transferred and includes patient related aspects of pharmaceutical care. FUNCTIONS: • • •

The primary function of a drug information centre is to respond to enquiries on therapeutic drug use. Most centres provide services to health professionals and some also offer a service to the public. In some cases toxicology information is also provided .

The various functions of drug information centre are as follows:

DRUG EVALUATION: •

Assessment of therapeutic drugs is an important function of a drug information centre. The centre must have access to the principal medical and pharmaceutical journals.

THERAPEUTIC ADVICE: • •

Many centres offer patient-related drug information as their primary activity. This requires an adequate understanding of disease states and therapy. Therapeutic advice includes factors such as efficacy, optimum dosage, interactions, adverse effects, mode of istration, effects of other disease states, and strategies to promote adherence in chronic conditions.

PHARMACEUTICAL ADVICE: •

Most other enquiries will relate to pharmaceutical preparations generally and include issues of availability, formulation, cost, storage and stability.

EDUCATION AND TRAINING: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 132

Providing information to health professionals and the public is part of continuing health education. Training graduate and undergraduate students is an important aspect of overall clinical training. DISSEMINATION OF INFORMATION: •

Drug information centre scan disseminate information in the form of drug monographs, bulletins and websites. Editorial skills are important for these functions.

RESEARCH: •

Drug information centres should be involved in research activities including pharmacoepidemiology, e.g. drug utilisation studies and pharmacovigilance.

PHARMACOVIGILANCE: •

Drug information centres often have a role in programs which monitor adverse drug reactions. Enquiries about a potential adverse reaction can lead to reports of suspected reactions and research may be required to assess the likelihood that a drug has contributed to a reaction or for subsequent patient management.

TOXICOLOGY: •

Toxicology services provide information and advice on the diagnosis and treatment of poisonings. Toxicology services are best located within hospitals where there is liaison with clinicians who treat patients with poisoning.

RESOURCES: Drug information centres should have the following resources for effective functioning:-

PERSONNEL: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 133

•

The number of personnel required will depend on the range of activities offered and the hours of service. A centre should aim to provide a direct service during periods of major demand by its clients.

MANAGEMENT: •

Management is an important component of a successful drug information centre. a centre specialising in drug information requires coordination, monitoring and promotion. The manager’s responsibilities include:

• • • • • • •

•

Staff recruitment and coordination; Training; promoting the service; identifying and maintaining appropriate resources; Data management and reporting; Quality assurance and improvement; Liaison with colleagues, professional organisations (e.g. FIP Pharmacy Information Section), networks, university departments of pharmacy practice, and government agencies; Strategic development.

TEXTS AND DATABASES: •

•

The centre should maintain its own library of commonly used resources. Additional books and other publications should be accessible in hardcopy or electronically from external sources. An adequate literature search requires an understanding of available sources and their limitations, and training in the use of indexing and functions.

FACILITIES: Basic equipment required for a centre includes: • • •

furniture -desks, chairs, shelving; communications -telephones, facsimile, internet access; computers -including external data backup, printer;


• • •

software -for word processing, spread sheets, databases and presentations; photocopier; Textbooks and electronic information resources.

FINANCE:• • •

• •

A drug information centre should have an independent source of income and status guaranteeing its stability and objectivity. Funding from external organizations cannot be accepted unless the centre’s neutrality is guaranteed. Services should be provided free of charge to enquirers or through a contract arrangement which does not discourage appropriate use of the service to quality healthcare. Separate charges may be made for specific reports which do not directly relate to individual patient care. Sufficient expenditure to maintain up-to-date resources is essential for the longterm viability of the centre.

TRAINING:Specific training is required for drug information practice. In addition to clinical knowledge and experience, drug information practitioners require:

• • • • • •

communication skills to receive and comprehend enquiries; knowledge of all available resources; literature searching skills; capacity for critical analysis; writing skills; Ability to summarize complex or conflicting data.

QUALITY ASSURANCE:1. An effective retrieval system is essential to locate previous enquiries, monitor workload and categorise the types of enquiries received. 2. It can also facilitate quality assurance programs based on analysis of selected enquiries and failed deadlines. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 135

3. The recording process should provide secure, long-term storage and the confidentiality of enquirers should be respected. 4. Drug information centres have a responsibility to provide the highest possible standard of service. 5. This will include an assessment of staff, regular review of calls taken and answers provided, and periodic review of resources and procedures. 6. The process should continuously identify potential improvements and document progress towards implementation. 7. Direct output can be monitored through peer review of enquiries. 8. A random selection of enquiries can be regularly reviewed and sought from enquirers. 9. Where possible, the peer review process should include comments from one or more external experts, e.g. a drug information pharmacist or clinical pharmacologist.

NETWORKING:Cooperation between drug information centres can help to optimise limited resources and enhance overall service levels. Networking can involve two or more centres, and includes regional, national and international links. Networks provide opportunities for:

• • • • •

sharing resources and experience; establishing standard operating procedures; quality assurance programs with external review; inter-site training; Increased awareness of practice in different locations and cultures.

F) POISON INFORMATION – (ORGANIZATION AND INFORMATION RESOURCES):T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 136

Definition: •

The poison information Centre is a specialized unit providing information on poisoning to the whole community

Functions: • • • • • • •

Provision of toxicological information and advise Management of poisoning cases Provision of laboratory analytical services Toxicovigilance activities Research education and training in the prevention &treatment of poisoning. Patient management Drug information and pharmacovigilance.

Benefits: • • • •

•

It offers considerable direct health benefits by reducing morbidity & mortality from poisoning Specific antidotes, therapeutic agents and medical equipment can be made more easily available through coordination of stocks. Also help to prevent the unnecessary use of special antidotes and of sophisticated and expensive treatments. Access to information and advice at poison information centers stimulates the interest of local communities and makes them more committed to the prevention of poisoning. Help in promoting the awareness of special requirements concerning the control and regulation of chemicals.

Establishing a poison information center:•

A poison information Centre should be available in every country irrespective of its size or population.

Location: •

The Centre should be located at a leading hospital with emergency & intensive care services as well as the medical library and lab.


• • •

It should be linked directly with the hospital department where poison patients are treated. The lab facilities of such hospitals should allow toxicological analysis It should operate 24hrs a day all year round.

Staff: • •

• • •

PIC needs a multidisciplinary team of poison information specialist lead by physicians with toxicological experience. The team may include physicians, nurses, analysts, pharmacists’ veterinarians and other scientists from various fields including biology, chemistry, medicine and pharmacology. A poison information specialist helps to prepare & provide information & advise on preventing and dealing with poisoning. A poison information specialist should work under the supervision of medical toxicologist. Minimum of 2 poison information specialists should be on duty to answer calls.

Equipment & facilities: • •

• • •

Suitable office furniture & facilities for the storage of confidential data. Specific areas should arrange for answering telephone enquiries, consultation with patients, and preparation of documents, staff meetings and secretarial and istrative work. Additional desk space is needed at centers using computer equipment and online databases, air conditioning and humidity control may also be necessary. PIC’s should their own libraries & facilities for handling and reproducing documents. A fax machine is necessary for communicating the information rapidly among centers and hospitals during emergency.

ORGANIZATION & OPERATION: •

•

The effective function of a poison information Centre depends on the availability of an adequate volume of evaluated data to furnish a basis for the advice given. PIC’s should establish a mechanism for obtaining access to adequate data on commercial products from manufacturers and should be regularly updated &its confidentiality protected.


• • •

Once a PIC becomes operational, i.e. able to offer an emergency response service, it should function around the clock. The information handled by PIC relating to manufactured products and patients, must be considered as confidential. Rapid identification of poisons or type of poison involved in an emergency is one of the center’s main tasks.

PHARMACOVIGILANCE: The word "pharmacovigilance" are: pharmakon (Greek for drug) and vigilare (Latin for to keep watch). As such, pharmacovigilance heavily focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. DEFINITION: Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effects with pharmaceutical products SCOPE: Pharmacovigilance conducting advanced drug monitoring study based Adverse drug reactions, adverse events report of new drugs include: 1. 2. 3. 4.

Medication errors and irrational use of medicines. Herbal, traditional and complimentary medicines Substandard medicines and counterfeit medicines Blood products, biologicals, medical devices and vaccines ADR Pharmacovigilance main aim is to give clear information regarding drug safety and its Risk or benefits of drugs to the patients.

Patients are main end s of medicine. Patient information leaflet relating to medicine to be provided to the patient to increase the advantages of the medication and to reduce the risk associated with them. It is essential for Risk T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 139

Minimization by making an early detection and preventing the progression of the adverse effects. AIMS OF PHARMACOVIGILANCE: Events such as the thalidomide tragedy highlight the extreme importance of effective drug monitoring systems for all medicines. The principal aims of pharmacovigilance programmes are: 1. To improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions; 2. To improve public health and safety in relation to the use of medicines; 3. To contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use; 4. To promote understanding, education and clinical training in pharmacovigilance and its effective communication to health professionals and the public. Over the last decade, it has been increasingly recognized that the scope of pharmacovigilance needs to be extended beyond the strict confines of detecting new signals of safety concerns. Globalization, consumerism, the resulting explosion in free trade and communication across borders, and increasing use of the Internet have all contributed to a change in the way people access medicinal products and information about them. These changing patterns in drug use require a shift in the approach to pharmacovigilance, more specifically, towards one that is more closely linked, and thus better able to respond, to the prevailing patterns of drug use within society.

B) ADVERSE DRUG REACTIONS: DEFINITION: “Any harmful or seriously unpleasant effects occurring at doses intended for therapeutic (incl. prophylactic/ diagnostic) effect and which requires reduction of dose or withdrawal of drug & /or forecasts hazard from future istration.” T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 140

CLASSIFICATION: 1) Type-A reactions: - (predictable) pharmacological action.

An exaggerated, but otherwise normal

Type A. Reactions have the following characteristics: • • • •

Largely predictable Usually dose-dependent Incidence and morbidity high Mortality low.

Examples of type-A reactions include respiratory depression with opioid Analgesia, cough with angiotensin-converting enzyme (ACE) inhibitors, and Withdrawal effects with benzodiazepines or alcohol. 2) Type-B reactions:- (unpredictable) Idiosyncratic, aberrant, or bizarre drug effects

that are unrelated to the pharmacology of the drug. Type B reactions have the following characteristics: • • • • •

Usually unpredictable Might not be picked up by toxicological screening Not necessarily dose-related Incidence and morbidity low Mortality high.

EXAMPLE: Type B reactions are most commonly immunological (e.g. penicillin allergy). 3) TYPE – C REACTIONS: - (CHRONIC) These ADRs persists for a relatively long time after the drug has been stopped. EXAMPLE: Bisphosphonate induced osteonecrosis of the jaw. 4) TYPE –D REACTIONS: - (DELAYED) The ADRs can become apparent sometime after the drug has been used. This can make it difficult to determine whether or not the drug caused the reaction. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 141

5) TYPE – E REACTIONS : - (END – OF –USE) This might include withdrawal effects on stopping benzodiazepines or reflex hyperacidity after stopping PPIs.

MECHANISMS: 1) Pharmaceutical causes 2) Pharmacokinetic causes: a) Absorption b) Distribution c) Metabolism d) excretion 3) Pharmacodynamics causes a) Drug receptor b) Homeostatic mechanism c) Disease.

1) PHARMACEUTICAL CAUSES: The possible pharmaceutical causes includes changes in drug quantity present in a particular product and changes in its drug release properties EXAMPLES:


2 brands of the poorly soluble anti-fungal agent ( griseofulvin) having widely different particle size in the dosage forms.

by switching patient on the brand with bigger particle to smaller particle.

the peake concentration of griseofulvin increasd.

TOXICITY.

2) PHARMACOKINETIC CAUSES: . ADRs may be caused due to the alteration in absorption, metabolism, distribution and elimination.

causes alter in drug concentration of site of action.

ABSORPTION: • •

Any alter in bioavailability May results in either therapeutic failure or toxicity The plasma concentration of the drug taken orally greatly depends on gastric emptying time.


•

It may also be depends on drug formulation gastro intestinal motility and 1st mass metabolism.

DISTRIBUTION: •

Several factors determine the extent of drug distribution of a drug including regional blood flow tissues / protein binding and membrane permeability.

METABOLISM: • •

It depends on individual metabolic rate. The individual with low metabolic rate accumulation of the drug is body may be leading to increased risk of ADRs.

EXAMPLES: OXIDASING ENZYME CYP3A4 is responsible for metabolism.

grape juice increasibily inhibits the CYP3A4 ENZYMES that leads to retain of the drugs in the body. EXCRETION: • • •

Most of the drugs are excreted by kidney and liver. Change in the drug elimination rate decreases excretion. Decreased elimination causes the increased bioavailability of drugs and then increased toxicity.

3) PHARMACODYNAMIC CAUSES:DRUG RECEPTOR: The drug elicits their response by combining with receptors, the amount and sensitivity of receptors may leads to ADRs. HOMEOSTATIC MECHANISM: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 144

Many physiological factors may determines the extent of drug effects in an individual as drug effects occurs within the environment of the body, EXAMPLE: atropine produce increased heart rate and produce tachycardia in some people whereas same dose in in affective in some other individuals. DISEASE: the pharmacological effect may be not apparent in healthy individual may be unmasked by undercurrent disease. Example: arithmetic patient develop brancho constriction while taking propranolol.

FACTORS PREDISPOSING TO ADRS: Factors that predispose to ADRs are many and varied, and some are related only to specific disease–drug interactions, such as EXAMPLES: A rash with amoxicillin, In patients with glandular fever. However, the following factors are generally considered to i patient risk: 1. 2. 3. 4. 5. 6. 7.

Age Renal impairment Hepatic impairment ‘frailty’ Polypharmacy Previous history of ADRs Genetics.

The first four factors predispose to type A reactions because they are determinants of drug toxicity, but the remaining factors predispose to type A or type B reactions.

CASUALITY ASSESSMENT (DIFFERENT SCALES USED): Why causality assessment? 1) An inherent problem in pharmacovigilance is that most case reports concern suspected adverse drug reactions. Adverse reactions are rarely specific for the drug, diagnostic tests are usually absent and a re-challenge is rarely ethically justified. In practice few adverse reactions are ‘certain’ or ‘unlikely’; T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 145

most are somewhere in between these extremes, i.e. ‘possible’ or ‘probable’. In an attempt to solve 2) This problem many systems have been developed for a structured and harmonised assessment of causality. None of these systems, however, have been shown to produce a precise and reliable 3) Quantitative estimation of relationship likelihood. Nevertheless, causality assessment has become a common routine procedure in pharmacovigilance. The advances and limitations of causality assessment are reviewed in Table:-

-: Advances and limitations of standardised case causality assessment:DIFFERENT SCALES USED IN CASUALITY ASSESSMENT:

1) The WHO-UMC causality assessment system (the UPPSALA MONITORING SYSTEM): The WHO-UMC system has been developed in consultation with the National Centres participating in the Programme for International Drug Monitoring and is meant as a practical tool for the assessment of case reports.


The use of the WHO-UMC system: • •

To illustrate how the system works, we suggest to first making a comparison of the criteria and wording of ‘Probable’ and certain’. First of all there is one more criterion in the category ‘Certain’, the fourth: ‘Event definitive pharmacologically or phenomenologically, i.e. an objective and specific medical disorder or a recognised pharmacological phenomenon (for instance ‘grey baby syndrome’ and chloramphenicol, or


•

•

•

•

• •

•

•

anaphylaxis immediately after the istration of a drug that had been given previously). This means that any other event is automatically excluded and can never qualify for ‘Certain’ (even in the case of a positive rechallenge observation). For ‘Certain’, rechallenge information with a satisfactory outcome is requested (i.e. what has happened when the drug was first stopped and later on resumed), unless the evidence in the report is already convincing without a re-exposure. For ‘Probable’, on the other hand, a rechallenge is not required. To qualify as ‘Certain’ the interval between the start of the drug and the onset of the event must be ‘plausible’; this means that there is in sufficient detail a positive argument in of the view that the drug is causally involved, pharmacologically or pathologically. For ‘Probable’ the time relationship should be ‘reasonable’; this is a more neutral term covering everything that is not unreasonable. Also, with regard to the second criterion, ‘alternative causes’, the wording is different in ‘Probable’. For ‘Certain’ the occurrence of the event cannot be explained by any disease the patient is known to have or any other drug taken. For ‘Probable’, on the other hand, the event is ‘unlikely’ to be attributable to another cause. Also the dechallenge situations (i.e. what happened after stopping) are different. In a ‘Certain’ case report, the course of events constitutes a positive argument in favour of holding the suspected drug responsible, in pharmacological or pathological respects, whereas in a ‘Probable’ case it is sufficient if it is ‘clinically reasonable’ (i.e. not unreasonable). The essential distinctions between ‘Probable’ and ‘Possible’ are that in the latter case there may be another equally likely explanation for the event and/or there is no information or uncertainty with regard to what has happened after stopping.


•

•

• •

•

•

The criteria that may render the connection ‘Unlikely’ are firstly the time relationship is improbable (with the knowledge at the time), and/or another explanation is more likely. The term ‘Unclassified/ Conditional’ is of a preliminary nature and is appropriate when, for a proper assessment, there is more data needed and such data are being sought, or are already under examination. Finally when the information in a report is incomplete or contradictory and cannot be complemented or verified, the verdict is ‘Unclassifiable’. Since by far the most frequent categories in case reports are ‘Possible’ and ‘Probable’, the usual approach to using the system is to choose one of these categories (depending on the impression of the assessor) and to test if the various criteria fit with the content of the case report. If the report seems stronger one can go one step ‘higher’ (e.g. from ‘Possible’ to ‘Probable’), if the evidence seems weaker one should try a ‘lower’ category. To see if that category is the right one or if it does again not seem to fit, the next adjacent term is tried. For drug-drug interactions the WHO-UMC system can be used by assessing the actor drug, which influences the kinetics or dynamics of the other drug (which has usually been taken over a longer period), in the medical context of the patient.





REPORTING OF ADRs: Most ADRs are not reported and this can lead to delays in identifying important reactions. The reasons for failure to report ADRs have been called the ‘seven deadly sins’. Pharmacists should attempt to address these and encourage their medical and nursing colleagues to report ADRs, in addition to sending in their own reports. The regulatory authorities in many countries have systems for reporting


ADRs and it is important to find out how ADRs are reported and whether pharmacists can submit reports. In the UK, doctors, dentists, pharmacists, nurses, and patients can report ADRs to the Medicines and Healthcare products Regulatory Agency (MHRA) through the yellow card scheme. New drugs are labelled with a black inverted triangle in the British National Formulary (BNF), and the MHRA requests that all ADRs to these drugs are reported. For established drugs, unusual or significant reactions should be reported. Yellow card data can be accessed online. Failure to report ADRs: (THE ‘SEVEN DEADLY SINS’): 1. Complacency — a mistaken belief that only safe drugs are allowed onto the market and that these will not cause serious ADRs 2. Fear of involvement in litigation, or of a loss of patient confidence 3. Guilt that a patient has been harmed by a prescribed treatment 4. Ambition — to collect and publish a personal series of cases 5. Ignorance of what should be reported or how to make a report 6. Diffidence — a reluctance to report an effect for which there is only a suspicion that it is drug-related 7. Lethargy — this may include a lack of time or interest, inability to find a report card, etc.

EVALUATION OF ADRs The cause(s) of each suspected ADR should be evaluated on the basis of the: • • • •

Patient’s medical and medication history The circumstances of the adverse event, The results of dechallenge and rechallenge (if any), Alternative aetiologies and a literature review.

Questions used in the Evaluation of ADR: 1. Was there a temporal relationship between the onset of drug therapy and the adverse reaction? 2. Was there is dechallenge; i.e., did the signs and symptoms of the adverse reaction subside when the drug was withdrawn? T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 154

3. Can signs and symptoms of the adverse reaction be explained by the patient’s disease state? 4. Were there any laboratory tests that provide evidence for the reaction being an ADR?

5. What was the patient’s previous general experience with the drug 6. Did symptoms return when the agent was re-istered?

Drug monitoring: 1. To assess the reaction: Emergency care/ission if ADR is Serious or life threatening; primary care; or seeks specialist advice. 2. To review the treatment: Either withdraw the suspected drug or reduce the dose. 3. To manage the symptoms of ADR and provide ive therapy. 4. To record the ADR in the individual’s health record. Consider the submission of an ADR report (Yellow Card) if appropriate documentation for the future purpose.

Detection and Monitoring of ADR: 1. Premarketing Studies: Preclinical studies done in animals (cannot extrapolate data with the human)Clinical trials prior marketing done in small number of patients, long duration effects not in study, special populations not considered, co morbidities not considered and polypharmacy not considered. Type-A reactions are mostly the known ones. Infrequent ADRs are not known. 2. Post Marketing Surveillance: The Information from the healthcare system is spontaneous forwarded to adverse reaction reporting.


Prevention of ADRs: ADRs are cannot be totally avoided. It can only be minimized. Steps taken include: 1. Avoid inappropriate drugs in the context of clinical condition. 2. Use appropriate dose, route, frequency based on the patient variables (age, sex, other drugs, other disease conditions, etc.,) 3. Elicit medication history; 4. considered untoward incidents; 5. Rule out drug interactions. 6. Elicit history of allergies. 7. Carryout appropriate monitoring.

Adverse drug reaction management: The ADRs are can be managed by following methods: 1. Assess the nature and severity of the reaction: Whether an urgent action is required or can be managed by primary care. E.g.: whether a anaphylactic shock or something minor. 2. Review on the presenting symptoms: Timing: Time of start of the reaction after giving the drug; Time taken to abate after the stopping of drug or reducing the dose. Relationship to dose: Whether reaction minimized with reducing the dose; symptoms resolve when the medicine withdrawn and recur when reintroduced. Other possible causes: Possibility of underlying illness or other disease; other medications (including OTC and Herbals); drug interactions (including diet).

3. Take complete drug history - Review any History of Allergy or previous ADR:


When the drug was started, dose, other drugs, OTC and herbal. Past ADRs Long duration of action or long term use effect can be expected for some drugs. Review the adverse effect profile of the drugs, and check how common it is. 4. Further Examination and Investigations if required: Specific investigations and laboratory tests required. E.g.: Liver and Renal Function Tests.

Role of the Pharmacist in the management OF ADRs: 1. Pharmacists should exert leadership in the development, maintenance, and on-going evaluation of ADR programs. 2. They should obtain formal endorsement or approval of such programs through appropriate committees (e.g., a pharmacy and therapeutics committee and the executive committee of the medical staff) and the organization’s istration. 3. In settings where applicable, input into the design of the pro‐gram should be obtained from the medical staff, nursing staff, quality improvement staff, medical records department, and risk managers. 4. The pharmacist should facilitate: a) Analysis of each reported ADR, b) Identification of drugs and patients at high risk for being involved in ADRs, c) The development of policies and procedures for the ADR‐monitoring and reporting program, d) A description of the responsibilities and interactions of pharmacists, physicians, nurses, risk managers, and other health professionals in the ADR program, e) Use of the ADR program for educational purposes, f) Development, maintenance, and evaluation of ADR records within the organization, g) The organizational dissemination and use of information obtained through the ADR program, h) Reporting of serious ADRs to the FDA or the manufacturer (or both), and T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 157

i) Publication and presentation of important ADRs to the medical community.

Direct patient care roles for pharmacists should include patient counselling on ADRs, identification and documentation in the patient’s medical record of high‐risk patients, monitoring to ensure that serum drug concentrations remain within acceptable therapeutic ranges, and adjusting doses in appropriate patients (e.g., patients with impaired renal or hepatic function).

PATIENT COUNSELLING AND COMMUNICATION SKILLS: DEFINITION: Patient counselling is abroad term which describes the process

through which healthcare professionals attempt to increase patient knowledge of health care issues. • • •

Patient counselling may be verbal or written performed on an individual basis or in groups, & provide directly to the patient or care giver. The process provides for the exchange of information between the patient & health practitioner. The information gathered is needed to assess the patient’s medical condition to further design, select, implement, evaluate & modify health interventions.

OUTCOMES OF THE PATIENT COUNSELLING: • • •

Patient recognizes the importance of their wellbeing. It encourages the patient to establish a working relationship with a pharmacist & foundation for continual interaction and consultation. It improves the coping strategies to deal with medication side effects and drug interactions.


• • •

To motivates the patient to take medicine for improvement of his/her health status. The patient becomes an informed, efficient and active participant in disease treatment and self-care management. Develops the ability in patient to take appropriate medicationrelateddecision concerning thecomplianceor adherence to their medication regimen.

Patient counsellingmethods: The structure of the counselling session is divided into fourgroups: a) b) c) d)

Introduction of the session. Contentof the session. Process followed. Conclusionof thesession.

Counselling content items:

1. Discuss the name and indication of the medication. 2. Explain the dosage regimen including duration of therapy when appropriate. 3. Assist the patient in developing a plan to incorporate the medication regimen into his/her dailyroutine. 4. Explain how long it will take for the drug to show its effect. 5. Discuss storage and refilling information. 6. Emphasize the benefits of completing the medication as prescribed. 7. Discuss the potential side effect. 8. Discuss how to prevent or manage the side effects of the drug. 9. Discuss theprecautions. 10. Discuss the significant drug‐drug, drug‐food, and drug‐disease interaction. 11. Explain precisely what to do if the patient misses the dose. 12. Explore the potential problems of the patient. 13. Provides accurate information. T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 159

14. Uselanguagethatthepatientislikelytounderstand. 15. Use the appropriate counselling aids to counselling. 16. Present the factand orderina logical order. 17. Maintaincontrol & directionof thecounselling session. 18. Probes foradditional information. 19. Use open‐endedquestion. 20. Displayeffective non‐verbal behaviours.

Counsellingconclusionsteps: 1. 2. 3. 4.

the patient understanding via . Summaries by acknowledging or emphasizing key points of information. Provide an opportunity for final concerns or questions Help the patient to plan, follow up and next consecutive steps.

Interactive communication skills requires: -(five key elements) 1. 2. 3. 4. 5.

open‐ended questions; awareness of nonverbal cues; active listening; reflective responses;and Verification of understanding.

Open ended questions: • •

•

A key component of interactive communication is using open‐ended questions. Open‐ended questions are questions that start with who, what, where, when, how and why and require more than a yes/no response to these questions encourage disclosure of information. Closed‐ended questions and leading/restrictive questions elicit yes/no responses and limit the information sought from the receiver. These types of questions should be avoided.

Example: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 160

1. Closed‐ended: "Do you know how to take your medication?" "Yes" 2. Leading/restrictive: "You'refamiliarwithyourmedications, aren'tyou? “Yes” 3. Open‐ended: "What did the doctor tell you about taking the medications?

Nonverbal cues: Appropriate nonverbal cues are also critical for effective communication. • • • •

Facial expressions, bodyposture, tone of voice and The use of eye .

All are the forms of nonverbal clues Skilled use of our nonverbal communication can make the difference between successful interactive dialogues and frustrating non-productive encounters. What we say and how we say it must have the same meaning. When nonverbal cues are inconsistent with the words spoken, people tend to believe the nonverbal message.

Appropriate non‐verbal clues: 1. 2. 3. 4. 5. 6. 7.

Friendly and smiling facial expressions. Varied eye (consistent, but not startling.) Professional appearance Relaxed, warm and comfortable gestures. Attentive body posture(slightly leaning forward) Appropriate personal space(18‐48 inches) Varied voice rate and volume to keep the individual interested. However, a high pitched voice should be avoided.


Distracting non‐verbal clues: 1. Lack of eye may indicate little confidence or interest. 2. Insufficient spatial discomfort (causing discomfort) 3. Unfavourabletoneof voice(can upset the people and create an unintended meaning) 4. Slouching or weight shifted to one side (may indicate lack of interest) 5. Messy work environment.


Active listening: •

•

When we think of communication skills, we usually think of skills relating to the manner in which we speak. However, equally important, and perhaps more difficult to learn, is the ability to listen well. Studies show that most people are not good listeners. In pharmacy practice environments, listening skill may be further challenged by the perception or reality of little time and by the attitudes of the listener and/or the speaker.

The following are specific habits that may interfere with an individual's ability to listen. Also listed are recommendations for improving one's listening ability. 1. Trying to do two or more things at once. This lack of attention comes across as a lack of interest in the other person and what they are saying to you. Solution: Get rid of distractions. 2. Jumping to conclusions before a person has completed his or her message: The result is you only hear part of what was said. Solution: Stop talking, you can't listen if you are talking. 3. Communicating stereo types that you have to internalized. Solution: React to the information, not the person. 4. Faking interest in what is being discussed. Solution: Use good eye , this will help you concentrate. 5. Judging the individual based upon his or her appearance or condition. Solution: Focus on content, nonverbal cues and the manner in which something is said. There are additional skills that can be used to enhance listening. These include • • • •

paraphrasing, clarifying, summarizing and .

Paraphrasing allows you (the listener) to convey back to the sender the message, and allows the sender to know that the receiver is listening. This technique encourages a dialogue. Clarifying provides opportunities to comprehend what is being said by helping the listener or receiver to understand the message. Summarizing assesses whether you accurately understand the information that you heard and enables you to that you process the information from the sender correctly.

Phrases and questions that facilitate listening: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 163

Paraphrasing: • • • • •

Are you saying that…? Do I understand you to mean…? What I’ve heard so far…? Let me tell you what I understand….. What I hear you say is…..

Clarifying: • • • •

What do you mean by….? How doyou know….? What do you mean….? I don’t understand what do you mean….?

Summarizing: • • •

Would an example of that be…? Is that like when….? As you’ve described it…?

Active feed-back: • • • •

I see… Uh huh… No, I don’t feel that way, but tell me why you do… Yes, that’s how I’ve found it to be...

Paraphrasing: • • • • •

Are yousaying that…..? Do I understand you to mean…? What I’ve heard so far…? Let me tell you what I understand….. What I hear you say is…..

Clarifying: • • • •

What do you mean by….? How doyou know….? What do you mean….? I don’t understand what do you mean….?

Summarizing: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 164

• • •

Would an example of that be…? Is that like when….? As you’ve described it…?

Active : • • • •

I see… Uh huh… No, I don’t feel that way, but tell me why you do… Yes, that’s how I’ve found it to be...

Reflective (empathic) responses: • • • • • •

I gather that Sounds like you’re…. You seem to be saying…. So you believe…. It seems like you…. You appear to be feeling….

Verification of understanding: •

ing understanding prevents misunderstandings.

• It is an important skill in the communication process because it is a checkpoint for communication.

• This process involves asking the receiver to state back the message that was sent by the sender

• •

and enables confirmation of what a person knows ... not what we think they know. This tool confirms that the sender's message was translated as intended. In a pharmacist‐patient interaction, ing understanding confirms that the patient has received the information necessary to take his or her medication(s) properly. ing understanding can be achieved as discussed earlier by asking open‐ended questions.

For example, "Just to make sure I've discussed everything, can you tell me how you are going to take your medication?"

• Themannerinwhich thequestionsarephrased is important. ,activecommunication skills foster a discussion in which both parties participate.

• Asking a question using phases such as, "Now tell me how you are going to take your medication." are likely to be perceived more as a pop quiz than as part of a discussion and may make the patient feel uncomfortable or angry.

• Effective communication is a dynamic process that requires using a wide variety of skills.


Medication History Interview:Introduction Patient Medication history interviews help the pharmacist to establish rapport with the patient, commence preliminary counselling and help to devise an on-going pharmaceutical care plan Sources: Patient, medication records from the hospital and other sources. Goals • • • • • • • • • •

To gather information to be utilised to Compare medication profiles with the medication istration record and investigate discrepancies medication histories taken by other staff and provide additional information where appropriate Document allergies and adverse reactions Screen for drug interactions assess patient medication compliance Assess the rationale for drugs prescribed Assess for evidence of drug abuse Appraise drug istration techniques Examine the need for medication aids Document patient-initiated medication istration

Documentation: Documentation of medication history include • • • • •

Current medication istration record Previous prescriptions Current ission details Referral letter from local doctor or other sources The patient’s own medication list

Preparing for the Interview: • • • • • • •

Determine specific goals of the interview Establish the identity of the patient Introduce yourself Explain the purpose of the interview Respect the patient’s right to decline an interview Adopt a suitable physical position to enable the interview to take place comfortably and effectively If the patient is not in a position to manage the care, the interview should be done with the relevant person


Information to be obtained in the Interview: • • • • • • • •

Prescription medication use Non-prescription medication use Allergies, previous adverse drug reactions and their manifestations Use of alternative therapies Social drug use (e.g. Alcohol, smoking) Illicit drug use Immunisation status Community pharmacies and general practice surgeries visited

Seeking Specific Information: • • • • • • • •

The patient’s perception of the purpose and effectiveness of the medication(s) The dose and dosage schedule used The duration of the therapies used The perceived effectiveness of the medication(s) A general impression of the likelihood that the patient has the medication(s) as prescribed The reasons for discontinuation or alteration of medications The storage of medications Any problems with the medication therapy

Conclusion: • • •

Summarise the important information Answer patient’s questions regarding therapy Encourage the patient for further information

Follow-up • • •

Comparison of medication profile with medication istration record Identify and resolve drug related problems Counsel the patients about alterations to their medications.

PRESENTATION OF CASES 1. General Description:•

Giving an oral presentation on ward rounds is an important skill for medical student to learn. It is medical reporting which is terse and rapidly moving. After collecting the data, you must then be able both to document it in a written format and transmit it clearly to other health care providers.


•

•

•

•

•

•

In order to do this successfully, you need to understand the patient’s medical illnesses, the psychosocial contributions to their HPI and their physical diagnosis findings. You then need to compress them into a concise, organized recitation of the most essential facts. The listener needs to be given all of the relevant information without the extraneous details and should be able to construct his/her own differential diagnosis as the story unfolds. Consider yourself an advocate who is attempting to persuade an informed, interested judge the merits of your argument, without distorting any of the facts. Depending on the purpose of the presentation, different parts of the database are included. The same patient will be presented very differently to the cardiology consultant who is asked to give advice on the optimal treatment for their CHF, the surgeon who is considering aortic valve replacement, the social worker who is helping obtain disability funding and the attending who needs to know who was itted last night. As you progress in your training, you will become expert at adapting and editing the story to serve its various purposes. Last year you learned to collect and organize the complete database and do a complete write-up. In taking your history you have gathered more information than you will include in your write-up and likewise, your write-up contains more information than you will include in an oral presentation.

2. Basic principles: • • •

An oral case presentation is NOT a simple recitation of your write-up. It is a concise, edited presentation of the most essential information. A case presentation should be memorized as much as possible by your 3rd year rotations. You can refer to notes, but should not read your presentation. Length – this will vary depending on your service. A full medicine presentation in attending rounds should be under 5 minutes. A presentation in the hallway on walk rounds on medicine should take no more than 3 minutes.

3. Similarities and differences between written and oral presentations: • • •

Both are an organized reconstruction of the patient’s narrative into a coherent HPI, not a random assortment of facts. Both follow the same organizational format (see #4 below) Separation of subjective data – derived from the patient, family and medical record and objective data which include your physical exam and today’s lab/radiographic data.

4. Basic structure for oral case presentations – the order parallels that of the write-up: 1) Identifying information/chief complaint (ID/CC) T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 168

2) 3) 4) 5) 6) 7) 8) 9)

History of present illness (HPI) including relevant ROS only Other active medical problems Medications/allergies/substance use (note: The complete ROS should not be presented in oral presentations Brief social history (current situation and major issues only) Physical examination (pertinent findings only) One line summary Assessment and plan

6. Organization and Content of Case Presentation. 1. Identifying Information/Chief Complaint (II/CC) – you want flesh out the bare bones enough to make your presentation engage the listener and give them a feel for the patient as a person. a. Structure: “Mr/Mrs/Ms ___ is a ___year-old man/woman who presents with a chief complaint of ___ (or who was electively itted for evaluation of ___, or who comes in to clinic for follow up of_____)”. b. Only include the race or ethnicity of the patient if it is relevant and will make your listener weigh diagnostic possibilities differently. c. To orient your listener, the identifying information should include the patient’s relevant active medical problems, of which there are usually no more than four. You will list these problems here by diagnosis only, and will elaborate on them later in the “HPI” or “other medical problems.” Your small group facilitator should help you identify which problems are relevant when this is not obvious.

Good Examples: Mr Smith is a 55 year-old man with a long history of diabetes mellitus, cirrhosis, and chronic obstructive lung disease, who presents with a chief complaint of fever and productive cough… Mrs Jones is a 39 year-old woman who was electively itted for evaluation of exertional dyspnoea. Her active problems include rheumatoid arthritis and hypertension. She was in her normal state of health until…

Avoid presentation of distracting information, such as an overly detailed discussion of the patient’s medical problems in your introductory remarks: Examples:


BAD # 1: …his problem list includes coronary artery disease – myocardial infarction x 2, the last in 1996, multiple negative rule-outs since, ejection fraction equalled 35% in 1994; diabetes mellitus x 10 years, insulin requiring for five years, complicated by retinopathy; chronic obstructive lung disease – with a FEV1* of 1.2 litres and steroid Dependence… GOOD #2: …his active problems include coronary artery disease, diabetes mellitus, and chronic obstructive lung disease….

In example 1 the listener will forget the chief complaint by the time you reach the history of present illness. Example2 is concise and does not interrupt the listener’s train of thought between the chief complaint and the history of present illness; relevant information about each of these problems should be introduced when appropriate in the “HPI” or “other medical problems.” 2. History of Present Illness (HPI) a. Introductory sentence: Mr/Mrs/Ms____ was in his/her usual state of ____ (e.g., excellent health/poor health) until ____ (e.g., three days prior to ission) when he/she developed the ___ (acute/gradual) onset of _____. The introductory sentence may include details of past medical history if the patient’s illness directly relates to an On-going chronic disease. b. Don’t mention that an event occurred “on Saturday”, rather refer to the time relative to the day of ission, e.g. 3. Days prior to ission. Examples: 1) Mr Smith has a long history of chronic obstructive lung disease characterized by two block dyspnoea on exertion, FEV1 of 1.0 litre, and home oxygen therapy. He was in this usual state of health until three days prior to ission when he developed the gradual worsening of his shortness of breath, associated with a cough productive of yellow sputum and a fever of 102_….. 2) Mr White has a long history of coronary artery disease characterized by three myocardial infarctions, the most recent in 1995, ventricular tachycardia treated with amiodarone, and congestive heart failure. He was in his usual state of health, with angina occurring once per week, until the night of ission when, while watching a football game, he developed the acute onset of severe sub sternal chest heaviness… 3) Content of history of present illness – specifically characterize the major presenting symptoms including patient attributions (what the patient thinks is causing the T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 170

symptoms), any prior episodes, and complications and the relevant ROS questions (these includes x related to the major and adjacent organ systems, constitutional complaints such as fever and weight loss and epidemiological risk factors or exposures. If there was any evaluation of the chief complaint prior to hospital ission, this should be included. The following is a useful mnemonic to make sure all those bases are covered: 1) 2) 3) 4) 5) 6) 7) 8)

C- Character, circumstances L -location – deep or superficial, well or poorly localized E -exacerbating factors A -alleviating factors R -radiation of pain A -associated sx S -severity on a 1-10 scale T -temporal features - timing (intermittent/constant), duration, frequency, changes over time (progressive, stable or improving)

Examples: A poorly characterized and too brief history of present illness:…itted for evaluation of chest pain. He was well until three weeks prior to ission when he began to feel chest heaviness whenever he exerted himself. He saw his local doctor who prescribed antacids with little benefit. The pain woke him last night so he came into the emergency room for evaluation. His other problems include… A complete example: ……….itted for evaluation of chest pain. He was in his usual state of excellent health until three weeks prior to ission when he developed the gradual onset of intermittent chest pain, characterized as poorly localized deep sub sternal heaviness which radiated to his left shoulder, lasting about five minutes per episode, occurring several times a day, aggravated by exertion and relieved by rest. Associated with the pain were shortness of breath and nausea. One week prior to ission he was seen by a local doctor who, without other testing, diagnosed gastritis and prescribed antacids without benefit. The chest pain was stable until two hours prior to ission, when the patient awoke with a more severe version of the same pain that lasted until he came to the emergency room. He was quickly transferred to the coronary care unit. There was no history of cough, heartburn, weight loss, or fever, chills or sweats. The patient’s risk factors for coronary artery disease include a positive family history and cholesterol of 310 in 1998. He has no history of high blood pressure or diabetes and has never smoked cigarettes. 3. Other Medical Problems:


a. Include here details of those problems that are active and you feel are relevant to the present illness. These are usually the same problems you mentioned in “identifying information”. For example: a. Diabetes mellitus is relevant to a patient itted with angina. Consider each condition separately, recounting the details in a chronological fashion. In other words, first explain the patient’s h/o coronary disease, telling the story from the beginning to the present. Then discuss their peptic ulcer, and then his/her COPD. In general, discuss the most important problem first, and then present the others from next most important to least important…….…his other medical problems include insulin-requiring diabetes for 12 years, complicated by retinopathy, polyneuropathy, and nephropathy. His recent creatinine was 1.7….. b. Key words and phrases summarize an on-going chronic illness and are discussed in this section (or may be included with the HPI if they are related to the current problem as discussed above). The key words vary with the nature of the problem. You will learn these as you gain clinical experience and by listening to others summarize and present cases. In general, key words emphasize date of diagnosis, its treatment, current symptoms, complications, and any recent objective tests. ….long history of chronic obstructive lung disease with steroid dependence and the requirement for home oxygen therapy, a 1994 FEV1 of 0.8L, and three hospital issions for exacerbations in the last year. He has never been intubated……two year history of congestive heart failure, felt to be secondary to alcoholic cardiomyopathy, characterized by chronic two block dyspnoea on exertion, three pillow orthopnoea, and ankle oedema. In addition to his long term therapy with furosemide and enalapril, digoxin was added six months ago. An echocardiogram four months prior to ission showed four chamber enlargement and global hypo kinesis…… c. In the case presentation you avoid presentation of irrelevant diagnoses. What is irrelevant is not always obvious to you at your level of training and also improves with your clinical experience. Consultation with your facilitator and preceptor will help you make this determination. “gonorrhoea in 1945, malaria in 1940, cataract extraction in 1972, and tinea pedis” are probably not relevant during presentation of the diabetic with crescendo angina. You must know all of the patient’s problems and include them in your write-up, but presentation of problems which are not relevant to the current active problems only distracts your listener. 4. Medications, Allergies, Substance Use: 1) Provide a list of all prescribed medications and a list of any relevant non-prescription medications.


2) Unless you have the chance to review the patient’s chart, you will only be able to give as much detail about medications as the patient can give you. 3) Report any relevant drug allergies and the type of reaction (for example, “the patient developed a skin rash approximately 20 years ago after receiving penicillin and carries the diagnosis of penicillin allergy”). 4) Summarize substance use not already mentioned in HPI. However, f it has been mentioned in the HPI, do not repeat it.

5. Social History (brief) – We are more than our habits and marital status. Please don’t try and reduce patients to these facts alone. Summarize their social history into a brief (2-3 sentences) paragraph commenting on their current life situation including work, living situation, and systems, and any on-going social issues of note. It is often the social history that explains why the patient has fallen ill now, as opposed to some other time or not at all: patients may have chaotic lives and little social so don’t have the help they need to follow therapeutic recommendations, few financial resources and can’t afford their meds, depression and feelings of hopelessness about their conditions, etc. These factors, if not addressed, will tend to lead to re-hospitalizations. If appropriate, include information about the patient’s personal wishes for health such as advance directives (their living will and durable power of attorney) including discussion concerning these issues. 6. Physical Examination: a) General description – be colourful, allow the listener to visualize the patient. “The patient was short of breath” is inferior to “the patient was sitting on the edge of the bed, leaning forward and gasping for breath.” b) Vital signs should always be mentioned, including postural changes if relevant. c) Mention only the relevant positive findings and relevant negative findings. An example of the latter includes (in the dyspnoeic patient) “the exam is remarkable for clear lungs bilaterally.” Use concise but complete descriptions of positive findings.

7. Summary and Assessment (brief): a. This takes the following form: “…the patient’s major presenting problem is ____ (best positive statement you can make; say “chest pain” and avoid statements like “rule-out myocardial infarction”). The differential diagnosis includes ____, ______, and _____. The diagnosis of _____ appears to be the most likely of these because ______.. Example: …..the patient’s main problem is chest pain, which could be due to a myocardial infarction, a dissecting aortic aneurysm, pericarditis, and a variety of other diagnoses such as pneumonia, pulmonary embolus, or oesophageal disease. MI seems most likely, because T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 173

his description of chest pain is classic for angina and because his ECG reveals a new injury current in the inferior leads. Common Mistakes in Oral Presentation 1. Slow laboured rhythm – A wandering, disorganized and desultory presentation is the most common problem encountered in early students. The ability to convert a written history and physical examination into a compressed presentation requires careful thought and practice. Ask your attending or facilitator how long a presentation they would like. You should maintain eye with your listener during the presentation, which means that you should refer to notes and not read your write-up. In order to keep it under 5 minutes, you will need to PRACTICE it two or three times in advance. This is helpful to do with a classmate who can give you and then let you try again. It is also worth taping yourself and listening to the tape – you would often give yourself . 2. History of present illness too brief – 90% of correct diagnoses come from the history alone; do not sabotage your listener’s understanding of the case by omitting important information. The HPI portion of the oral presentation, as a general rule, should take 1/3 to 1/2 of the presentation time. Common pitfalls include incomplete characterization of the major symptoms, omitting pertinent negatives or positive ROS questions, and omitting specific information about past history that relates to the present problem. 3. Failure to use parallel reference points – in both write-ups and oral presentation, relate time in “hours/days/weeks prior to ission”. Avoid “at 2:00 in the morning of last Wednesday” or “on May 25th; instead, say “three hours prior to ission”, or “at 2:00 am, three days prior to ission”. 4. Editorializing in the middle of the presentation - avoid comments like “do you even want to hear this?” or “cardiac examination revealed a systolic murmur….well, I thought heard it, but the resident didn’t…so maybe it isn’t there….I don’t really know….” 5. Use of negative statements instead of positive statements. Positive statements add colour and accuracy to your presentation. “Chest X-ray shows normal heart size” is better than “chest X-ray shows no cardiomegaly”. “In summary, this patient’s problem is acute dyspnoea” is better than “the patient’s problem is rule-out pneumonia”. 6. Repetition- varies your sentence structure. An overly repetitious presentation is monotonous for the listener. “On pulmonary exam, the lungs were normal…on cardiac exam, the heart sounds were…, on lymph node exam, there were no cervical nodes…etc” is difficult to listen to and unnecessary – your listener knows that S1 and S2 are part of the cardiac exam! Use brief descriptive sentences: “an S3 gallop was heard at the left lower sternal border.”


7. Disorganization – this problem is a result of lack of rehearsal. Stopping at the end of the HPI to say “Oh, I can’t believe I forgot to tell you this” will kill a presentation. Or “…in summary, this patient…wait, I forgot to tell you the most important thing…” You need to be aware that this can happens even with careful preparation. The best advice when you forget something crucial to your presentation, is to work it in as soon as possible and don’t make a big deal about it. 8. Physical findings presented without proper terminology - for example, “lymph node exam shows some small cervical nodes” is not as descriptive as “…there were three soft tender mobile nodes in the left anterior cervical chain which measure 1 x 1 x 2 cm each… “Commitment to accuracy will improve your physical examination skills. 9. Diagnoses used instead of descriptions in the physical examination - diagnoses belong in the assessment, descriptions in the physical examination. For example, avoid “exam showed the murmur of mitral regurgitation” …instead say “a 2/6 holosystolic murmur was heard at the apex when radiated to the axilla”. Avoid “skin exam showed psoriatic lesions on the elbows…”: instead, say “there were several 2cm diameter round plaques with silver scale distributed on the extensor surface of the elbows…”.

PHARMACEUTICAL CARE: Definition: It is defined as the responsible provision of drug therapy for the purpose of achieving definite therapeutic outcomes that improve the patient’s quality of life. These outcomes are: • • • •

Cure of the disease Elimination or reduction of patient’s symptomology Arresting or slowing of a disease process Preventing a disease or symptoms.

Functions: 1. 2. 3. 4. 5. 6.

Collection Of Patient Data Identification Of Problems Establishing Outcome Goals Through A Good Therapeutic Plan Evaluating Treatment Alternatives, By Monitoring And Modifying Therapeutic Plan Individualizing Drug Regimens Monitoring Outcomes.

1) COLLECTION OF PATIENT DATA T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 175

• • • • • •

Demographics Current problems Past medical history Current medication Social habits Relevant laboratory data.

2) IDENTIFICATION OF PROBLEMS: The data collected can be used to identify actual or potential drug related problems. • •

ACTUAL: A condition that requires the initiation of a new or additional drug. POTENTIAL: The patient may be at risk to develop a new medical problem.

These problems may be related to the patient’s current drug therapy, drug istration, drug compliance, drug toxicity, ADR’s and a failure to achieve desired outcomes by the treatment. 3) ESTABLISHING OUTCOME GOALS Drug therapy can produce positive outcome: 1. 2. 3. 4. 5.

Cure of the disease Elimination or reduction of patient’s symptomology Arresting or slowing of a disease process Preventing a disease or symptoms It may also produce negative result, i.e. resulting in disease morbidity and sometimes mortality.

4) EVALUATING TREATMENT ALTERNATIVES BY MONITORING AND MODIFYING THERAPEUTIC PLAN • •

Efficacy, safety, availability and cost of treatment and suitability of the treatment to the patient should be considered while evaluating. The risk-benefit ratio factors should also be considered: seriousness of the disease, complications if untreated, efficacy of drug, ADR’s.

5) INDIVIDUALISING DRUG REGIMENS: When more than one therapeutic alternative exist, the following factors to be considered: • •

Patient factors:- diagnosis, treatment goals, past medical and medication history, contraindication, allergies, compliance Drug factors: - efficacy, adverse effects, dosage form, cost, drug-drug interactions.

6) MONITORING OUTCOMES: The goals are:


• • • •

Cure of the disease, elimination or reduction of patient’s symptomology, arresting or slowing of a disease process, Preventing a disease or symptoms.

But often leads to suboptimal outcomes due to: • • • •

inappropriate or unnecessary prescribing or drug regimen, dispensing error, non-compliance, Inappropriate monitoring.

To ensure good monitoring outcomes:• • • •

Regularly should review whether satisfactory progression is made or not according to the therapeutic plan. To determine whether original plan should continue or any treatment modifications to be made or not. Reviews ongoing progress and provides report to patient’s other healthcare providers. Should regularly update patient’s medical/pharmacy records with information concerning patient’s progress.

7) PHARMACEUTICAL CARE IN HOSPITALS • • • • • • •

Prescription monitoring Prescribing advice to medical and nursing staff Medication errors and adverse reaction monitoring Medication history interview Patient education and counseling Pharmacokinetics and therapeutic drug monitoring Hospital formulary.

8) PHARMACEUTICAL CARE FOR THE COMMUNITY • • • • •

Participate in health screening Participate in health promotion and education Serve as a source of drug and poison information Collaborate with other health care professionals to develop treatment guidelines Design and monitor procurement and drug distribution system including storage and disposal.


9) BARRIERS TO PHARMACEUTICAL CARE • • • •

Pharmacist barrier Practice setting constraints System impediments Intra professional barrier.

Critical Evaluation of Biomedical Literature: Introduction: There are more than 20,000 biomedical journals available worldwide, approximately 9000 articles are being published every day, and Updating scientific knowledge is a Herculean task for the healthcare professionals. The Vancouver guidelines format include 1. 2. 3. 4. 5. 6. 7.

Format of abstract Text Tables/graphs Reference Permissible abbreviations and symbols Authorship recommendation Acknowledgements.

The Journal: Reputed journal usually demonstrate: • • • •

The editorial policy specifying types and format of articles Publishes results of well-conducted research Articles undergo peer review Texts exceed pages of advertising /promotional material.

Selecting the Article: Primary step in evaluation of a literature is to select an article which has a greater impact in clinical practice. Initially, read the title, authors and abstract. The title should be comprehensive that the reader can efficiently analyse the article’s potential and its importance in current clinical practice. If not, reader can reject it and move on to the next article.

Reading the Literature: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 178

Reviewing begins with reading and understanding the abstract or short summary that gives a brief background about the research. Initial reading gives the concept of objectives, methodology, results and proposed significance of the study. A proper understanding of research study’s nature is must for a reader.

Title: ‘Title’ describes the breadth and depth of the current study and indicates the methodology used. It is the limited possible words that adequately describe contents of the study. The title of an article should be brief, definite and concise and should catch the attention of the readers interested in the study.

Evaluation of Title: 1. 2. 3. 4.

Based on the title itself reader cannot review or discard the study. Title should not contain abbreviations, proprietary names, chemical formulae, and jargons. The title should inform the real subject of the article. Title should not reflect its content. First impression is the best impression; the title should be specific and studied well. 5. Title should not indicate author’s preference for any specific subject.

Abstract: An abbreviated accurate representing the contents of a document, mainly prepared by its author(s) for publication in it. Abstract can be defined as a summary of the information in a document. A synopsis (not more than 250 words) should be mentioned before introduction in the article.

Evaluation of Abstract: “Abstract” should outline a brief Summary of each section; Introduction, objectives, scope of investigation, materials and brief Methodology, results, and conclusion which indicate study findings. Abstract does not provide Complete information about the study and should not be used alone to evaluate the study.

Introduction: It serves two purposes in the study, creating readers interest in subject and providing them with enough information to understand the study.

Evaluation of Introduction: • • •

Introduction should be presented, with all possible clarity, the nature and scope of the problem investigated. It should provide pertinent literature to orient the reader. It should explain the reason why the current research is needed?

Objective: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 179

‘Objective’ of a study is what the author is trying to achieve. It is a specific, clear and succinct statement of intended outcomes from research. Objective should be stated in a clear and concise manner. Evaluation of Objective: 1) 2) 3) 4) 5)

Establishing new health programs Implementing new policies Trying to settle a controversy Showing the validity of a new technique Opening up a new field of inquiry.

Study Designs: The first part of this section is generally an overview of the type of study design that is utilized in doing research. A sound study design s study conclusion and result. Study design should be clear and provide enough details so that potential reader can repeat the research.

Various types of Study design: 1) Observational studies: Data collected from one or more group of subjects, Observational studies may be prospective or retrospective. 2) Single blind: Either subjects or investigators are unaware of treatment allocation. 3) Double blind: Neither subjects nor investigators are aware of treatment allocation. 4) Triple blind: Subjects and investigators are unaware of treatment allocation; another group involved with interpretation of data is also unaware of treatment allocation. 5) Parallel study: All subjects receive only one treatment. 6) Prospective: Data is collected forward in time from the start of the study. 7) Retrospective: Historical data (i.e., data referring to past events) is collected. 8) Cohort studies: Cohort studies consist of prospective observation of one or more groups with certain characteristics. 9) Randomized control trial: Subjects are randomly allocated to either an intervention group or control group. Randomized controlled trials are described as the “gold standard” in clinical research.

Evaluation of Study Designs: The study design selected by an investigator should be sound and likely to answer the research questions. Author(s) must describe study population well enough so that the reader is able to visualize the sample population precisely under investigation.

Bias: It is a systemic variation in which treatment groups under study are treated or measured differently on a consistent basis. Bias can mislead one to get into an erroneous outcome. The reader should be able to find out the source of bias and its influence on the final outcome of study.

Types of bias: T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 180

1) Missing clinical data bias: Certain clinical data may be missing because they were normal, negative or never measured. 2) Withdrawal bias: Patients who withdraw from a study may differ from those who remain. 3) Sample size bias: Too small Samples are insignificant; samples which are too large are proved to be helpful. 4) Instrument bias: Defects in the calibration or maintenance of instruments may lead to systematic deviations in results.

Statistics: Knowledge of ‘Statistics’ can help an individual to evaluate whether the statistical tests used in a study are appropriate or not. Different types of data (or variables) are encountered in statistics. Errors in statistical analysis of data lead to invalid result/conclusion.

Evaluation of Statistics: • • •

Readers should determine whether appropriate statistical methods were used for data analysis. Use of inappropriate methods will results in misleading conclusion. Method section of any scientific literature should include a summary description of the statistical tests that were used to evaluate data. Qualitative and quantitative data are examined differently

.

Study Results and Analysis: Results’ should be described and presented in figures, tables, and charts, as they are the heart of the scientific literature. Figures, tables, and charts will assist the reader in deciding whether it is worth to read the rest of the article or to discard it. A properly


conducted study should present data on subjects involved in the study. All the data collected in the method section should also be presented.

Evaluation of Study Results and Analysis: • • •

Reader should have a proper understanding of study and should evaluate clinical and statistical reliability of the study Sometimes authors try to present results in a confusing way, which most likely reflects hap hazardous data collection and lack of clearly defined study objectives. Are the negative results been quoted? In case of any negative results those should be quoted and the limitations have to be specified.

Discussion and Conclusion: 1) ‘Discussion Section’ of a study provides an opportunity for the author to interpret results and explain their clinical importance by relating or comparing with previous work or practice. 2) ‘Conclusion’ is the author’s generated inferences, opinions and hypotheses about results. This section should contain views that the author draws from data obtained by the study.

Evaluation of Discussion and Conclusion: • • • •

Is the conclusion over-generalized? The ‘Conclusion’ must be clear and understandable to the reader. Conclusion must be consistent with study objectives and justified by results. Conclusion should not be a matter of dispute. How does the research fit into the context of its conclusion? It should give the answer of the study objective for which claim was made prior to study. Readers must understand the relationship between the data and the conclusions.

References: • •

While writing article, authors always refer to some information from other sources. All these sources are listed in ‘Reference Section’, sometimes referred to as ‘Bibliography’.

Evaluation of References: 1) Are the references given? Whether appropriate and adequate references are used in the study? 2) Are the references quoted appropriately in the research article? 3) Are the references given recent and important? 4) What is the size of ‘Reference Section’? 5) How the references are used for , rebuttal etc.? 6) Do the references match citations in the text? 7) Authors should avoid citing their own research efforts and publication.


MEDICATION ERRORS: CAUSES & PREVENTION Introduction: • •

• • • •

Drug use is a complex process and there are many drug related challenges at various levels, involving prescriber, pharmacists and patients. While medication can occur anywhere in the health care system from prescriber to dispenser to istration and finally to patient use, the simple truth is that many errors are preventable, and pharmacists assume active role in appropriate use of drugs. Pharmacy entails a health science specialty which embodies the Knowledge of pharmacology, toxicology, pharmacokinetics and therapeutics for the care of patients. Health care is nearly 10 years behind other industries in its efforts to reduce the errors. According to studies cited in the institute of Medicine report, “to Err is Human; Building a Safer Health System” 44,000 to 98,000 Americans die each year as a result of medical errors. Medication error may be nobody’s baby, but when it happens, it could well turn out to be everyone’s worry and the reasons given for medication error range from silly to the downright serious.

Medication errors: “A medication error is an preventable event that may cause or lead to inappropriate medication use or patient while the medication is in the control of the health care professional, patient, or consumer. Such events may be related to professional practice, health care products, producers and systems, including prescribing; order communication; product labelling packaging and nomenclature; compounding ;dispensing; distribution; istration; education; monitoring; and use”3 Most medication errors are considered latent. For example: When a pharmacist fills a prescription with the incorrect medication, patients typically realize this mistake once they have returned home and have taken the first dose. Latent errors can be described as “accidents waiting to happen “The causes of these types of errors are usually identifiable and can be corrected before the error reoccurs. 1. Incomplete patient information (not knowing about patients’ allergies, other medicines they are taking, previous diagnoses, and lab results for example) 2. Unavailable drug information (such as lack of up-to date warnings) 3. Miscommunication of drugs orders, which can involve poor handwriting, confusion between drugs with similar names, misuse of zeroes and decimal points, confusion of metric and other dosing units, and inappropriate abbreviations. 4. Lack of appropriate labelling as a drug is prepared and repackaged into smaller units and Environmental factors, such as lighting, heat, noise, and interruptions that can distract health professionals from their medical tasks.


Dispensing errors: “The Error of wrong interpretation of doctor’s prescription and inaccurate calculation of doses especially in children”. Dispensing error refers to medication errors linked to the pharmacy and includes: 1. Error of commission (dispensing the wrong drug or dose) and 2. Those of omission (failure to counsel on safe use of medicine). 3. Most dispensing errors involve the dispensing of an incorrect Medication, dosage strength or dosage form. 4. Lookalike and sound alike drug often causes confusion with ineligible prescriptions or verbal medication orders and errors are likely. Causes for errors: In a data report indicates that pharmacists perceived the following as causative factors for medication errors:1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

Too many telephone calls (62%) Overload/ unusually busy day (59%) Too many customers (53%) Lack of concentration (41%) No one available to double check (41%) Staff shortage (32%) Similar drug names (29%) No time to counsel (29%) Illegible prescription (26%) Misinterpreted prescription (24%)

Common types of medication errors: The Institute for Safe Medication Practices (ISMP) identifies the following areas as potential causes of medication errors. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Failed communication: handwriting and oral communications, especially over the telephone, drugs with similar names, missing or misplaced zeroes and decimal points, confusion between metric and apothecary systems of measure, Use of nonstandard abbreviations ambiguous or incomplete orders Poor drug distribution practices. Workplace environmental problems increasing the job stress. Complex or poorly designed technology. Access to drugs by non-pharmacy personnel Dose miscalculations Lack of information to prescribers Lack of patient information Lack of patient understanding about his therapy.

Medication error rate: “Medication error rate” is determined by calculating the percentage of errors. The numerator in the ratio is the total number of errors. The numerator in the ratio is the total number of errors that they observe, the denominator is called T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 184

“opportunities for errors” and includes all the doses observed being istered plus the doses ordered but not istered. The equation for calculating a medication error rate is as follows:

Medication Error Rate =

Number of Errors Observed x 100 Opportunities for Errors

Medication error rate (MER) A-medication error rate of 5% or above indicates that the facility has systemic problems with its drug distribution system and a deficiency should be written. Medication errors due to failure to follow label instruction: 1) Failure to “shake well”: The failure to “shake” a drug product that is labelled “shake well “. This will almost always lead to an under dose or over dose depending on the suspending abilities of the diluent’s and the elapsed time since the last “shake “. Also included under this category is the failure to “roll” insulin suspensions. Insulin suspensions should not be shaken, they should be “rolled” in order to mix the insulin particles with the diluents without creating air bubbles. 2) Crushing medications: Crushing tablets or capsules that the label states “do not crush”. For example: sustained or extended release dosage form, coated tablets. 3) Medications taken with food or antacids: The istration of medications without food or antacids when the instruction specifies that food or antacids is taken with or before the medication in order to prevent GI irritation. For example: Non-steroidal Anti-Inflammatory Drugs (NSAID’s) taken with food or antacids and whereas, some of the medication is istered in empty stomach or before taking food for better pharmacological & therapeutically action. 4) Sublingual tablets which should not be swallowed: Swallowing a sublingual tablet (e.g. nitroglycerin, isosorbide dinitrade).If it is swallowed; its absorption is greatly reduced. This will result in less symptom relief. 5) Use of inappropriate solvents: Some of the drugs (e.g. anticancer drugs) which require reconstitution before istration. Use of inappropriate solvent may reduce the efficacy and potency of the main drug. For example: Oxaliplatin must be reconstituted with 5%dextrose only.

Medication error prevention: The National Coordinating Council for Medication Error Reporting and Prevention and Institute for Safe Medication Practices emphasize that T.J.MOHAN RAO (Ph-D), NALANDA INSTITUTE OF PHARMACEUTICAL SCIENCES, KANTEPUDI (V), GUNTUR, AP. Page 185

illegibility of prescriptions and medication orders has resulted in injuries to, or deaths of patients. The following recommendations to help minimize errors: 1. The Institute for Safe Medication Practices suggests a number of error prevention tools ranging from forcing functions to independent double-check systems. Prescription orders should include a brief notation of purpose (e.g. for cough), unless considered inappropriate by the prescriber. Notation of purpose can help further assure that the proper medication is dispensed and creates an extra safety check in the process of prescribing and dispensing a medication Independent double-check systems can reduce the risk of error by way of having one person independently check another’s work. When this procedure is properly carried out, the likelihood that two individuals would make the same error with the same medication for the same patient is quite low. 2. Forcing functions and constraints they allow for deg processes to ensure that errors are virtually impossible or at least difficult to make. Examples include: software programs with “forcing functions “that require the entry of additional pertinent patient information before the order is completed and the medication is dispensed. Automation and computerization of medication use processes and tasks can lessen human fallibility by limiting reliance on memory. Examples include use of technologically and clinically sound computerized drug information system. 3. All prescription orders should be written in the metric system except for therapies that use standard units such as insulin, vitamins, etc. Units should be spelled out rather than writing “U”. The change to the use of the metric systems from the archaic apothecary and avoirdupois systems will help avoid misinterpretations of these abbreviations and symbols, and miscalculations when converting to metric, which is used in product labelling and package inserts. 4. Prescribers should include age, and when appropriate, weight of the patient on the prescription or medication order. The most common errors in dosage result in paediatric and geriatric populations in which low body weight is common. The age (and weight ) of a patient can help dispensing health care professionals in their double check of the appropriate drug and dose 5. The medication order should include drug name, exact metric weight or concentration, and dosage form. Strength should be expressed in metric amounts and concentration should be specified. Each order for a medication should be complete. The pharmacist should check with the prescriber if any information is missing or questionable. 6. A leading zero should always precede a decimal expression of less than one. A terminal or trailing zero should never be used after a decimal. Ten-fold errors in drug strength and dosage have occurred with decimals due to the use of a trailing zero or the absence of a leading zero. 7. Prescribers should avoid use of abbreviations including those for drug names (e.g., MOM, HCTZ) and Latin directions for use. The abbreviations in (table-1) are found to be particularly dangerous because they have been consistently misunderstood and therefore, should never be used.


Clinical Pharmacy- Simple Notes.pdf s5z18

Overview 3e4r5l

More details w3441

Related Documents 3m3m1z

Clinical Pharmacy- Simple Notes.pdf s5z18

Hospital And Clinical Pharmacy 10243c

1-introduction To Clinical Pharmacy 1d1m3o

A Textbook Of Clinical Pharmacy Practice 5n6to

Pharmacy 1v6z3e

Vtu Dsp Notespdf v21k

More Documents from "smart hussain" 4f3p46

Clinical Pharmacy- Simple Notes.pdf s5z18

Lal Kitab And Remedies t1f4o

Democratic Rights-india 5d4x6i

18055318 100s Of Telugu Film Torrents 361536

Empires-across Three Continents 5c6bn

Ch-1-democracy In The Contemporary World 69p6i