Pharmacovigilance pv role of pharmacy.pptx

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1. DEPARTMENT OF PHARMACY PRACTICE H.K.E.S MATOSHREE TARADEVI RAMPURE INSTITUTE OF PHARMACEUTICAL SCIENCES GULBARGA -585 105 SUBHAN GANI Pharmacovigilance

2. Definition : The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.

3. Aims of Pharmacovigilance: To improve patient care and safety. To improve public health and safety. To contribute to the assessment of benefit, harm, effectiveness and risks of medicines. To promote understanding, education and clinical training. To improve public health and safety in relation to medicines, cosmetics, herbal products etc. Early detection of unknown adverse reactions and interactions. Identification of risk, factors and possible mechanisms undelaying adverse reactions. Estimation of quantitative aspects of benefits/risk analysis of information needed to improve drug prescribing and regulations

4. Need of pharmacovigilance Safe use of medicines. Humanitarian concern. ADRs are expensive. Promoting rational use of medicines. Ilegal sale of medicines and drugs of abuse. Increasing self−medication practices or OTC drugs. Widespread manufacture and sale of counterfeited substandard medicines. Increasing use of traditional medicines and herbal medicines with other medicines with potential for adverse interactions.

5. ADVERSE DRUG REACTIONS: Definition : Any untoward medical occurrence that may present during treatment with a pharmaceutical product but which does not necessarily have a causal relationship with this treatment. Adverse Drug Reaction (ADR): Any noxious change which is suspected to be due to a drug, occurs at doses normally used in man, requires treatment or decrease in dose or indicates caution in future use of the same drug. Therefore, an adverse drug reaction is an adverse event with a causal link to a drug.

6. Classification of ADRs

7. PREDISPOSING FACTORS factors that affect medication response : Polypharmacy increases the risk of drug interactions and side effects. Taking multiple medications can lead to complex interactions and errors. Multiple diseases or health conditions require adjusted medication plans. Certain medications may need to be avoided or used with caution. Age affects medication metabolism. Older adults may be more sensitive, while children and adolescents may metabolize medications faster. Medication characteristics influence absorption, distribution, and elimination. Half-life, toxicity, and accumulation vary between medications. Gender differences: in medication response exist due to hormonal and body composition variations. Genetic variations :and race affect medication metabolism and response. Understanding these factors helps personalize medication plans.

8. MECHANISM OF ADR Mechanism of Type A Reactions: Any Type A reaction which occurs in an individual may be due to one of the following reasons: Pharmaceutical causes Pharmacokinetic causes Pharmacodynamic causes Mechanism of Type B Reactions: Any Type B reaction which occurs in an individual may be due to one of the following reasons Pharmaceutical causes Pharmacokinetic causes Pharmacodynamic causes

9. Mechanism of type A reaction : Pharmaceutical causes: Changes in the drug quantity present in a particular product .Changes in drug releasing properties Eg: Griseofulvin having different particle size in final dosage form. Switching its larger particle size product with smaller one leads to toxicity by increasing peak concentration Pharmacokinetic causes: Alteration in the ADME of drugs ˘ changing concentration of drug at site of action . Absorption: changes in rate and extent of drug absorption Distribution: changes in blood flow and protein or tissue binding  Metabolism: Reduced metabolism lead to higher rate of type A ADRs whereas therapeutic failure occurs as metabolism increases Excretion: changes in drug excretion rate

10. Pharmacodynamic causes: Increased sensitivity of target tissues or organs. Drug receptors: inter−individual variation in drug receptor Homeostatic mechanism: changes in physiological factors determine the extent of a drugs effect Disease: Eg : asthmatic patient developing bronchoconstriction after taking non−selective beta blockers (Propranolol)

11. Mechanism of type B reaction Pharmaceutical causes: Decomposition of the active ingredients. Effects of drug excipients ( Eg : propylene glycol and carboxymethylcellulose causes hypersensitivity) Synthetic by product of active constituents ’ Death have been reported due to decomposition of paraldehyde to acetaldehyde and its Pharmacokinetic causes: Although pharmacokinetic changes lead to type B ADRs but there are no documented type B ADRs due to absorption and distribution. Metabolism unusual reactive drug metabolite leads to type B ADRs. Eg : Carbamazepine induced hypersensitivity reactions. Pharmacodynamic causes: Age, sex, body weight, medical condition and drug therapy influence the end response of a patient to an administered drugs Genetic causes for abnormal responses: Eg G6PD deficiency results in hemolysis Immunological reasons for abnormal response Teratological and neoplastic reasons for abnormal response

12. REPORTING OF ADR What to report : 1. All ADRs as a result of Prescription and Non−Prescription medicinal products. 2. All suspected ADRs regardless of product information provided by the company. 3. Unexpected reaction with the product regardless of their nature or severity. 4. A serious reaction, whether expected or not. 5. All suspected ADRs associated with drug−drug, drug− food or drug−food supplements interactions. 6. ADRs occurring from overdose or medication error Unusual lack of efficacy or when pharmaceutical defects are observed. Who should report : 1. Health care Professionals and Providers 2. Manufacturers of Product 3. Health care centers

13. When to Report 1. ADR should be reported as soon 2. Delay in reporting make the report and unreliable. How to report 1. Report should be on a standardized ADR reporting form. 2. Dully filled the ADRs in the reporting from when an ADR is encountered Use a separate from for each patient and filled with the complete information. 3. The completed ADR form is then returned to the nearest adverse drug reaction monitoring Centre (AMC) or to National Coordinating Centre.

14. CAUSALITY ASSESSMENT OF ADR

15. I . Expert Judgment /Global Introspection Expert judgments are individual evaluation on the basis of previous knowledge and experience in the field. These judgments are made without using any standardized tool for getting the conclusions regarding causality. There are two methods based on expert opinion or global introspection: 1. Swedish method by Wilholm et al. 2. World Health Organization (WHO)

16. II. Algorithms Algorithmic Methods are: 1. Dangaumous french method 2. Kramer et al. Method 3. Naranjo et al. Method (Naranjo scale) 4. Balanced assessment method (Lagier et al.) 5. Summary time plot (Castle et al.) 6. Ciba geigy method (Venulet et al.) 7. Roussel Uclaf causality assessment method (RUCAM)

17. Widely and globally accepted method. WHO-UMC system provides practical tool for assessment of case reports for International drug monitoring. System is used to detect unknown and unexpected adverse drug reaction. Assessment is based on following four criteria-: a) Time relationships between the drug use and the adverse event. b) Absence of other competing causes (medications, disease process itself). c) Response to drug withdrawal or dose reduction (de-challenge). d) Response to drug re-administration (re-challenge). The level of causal association is grouped into four categories which are based on a number of the above criteria being met .   World Health Organization (WHO) - Uppsala Monitoring Centre (UMC) causality assessment criteria

18. Naranjo et al. Method (Naranjo scale) 1) This method is widely accepted 2) This method facilitates in determining the likelihood of whether an adverse drug reaction (ADR) is actually due to the therapeutic drug rather than the other factors result. 3) It consists of ten questions that are answered as “yes", “no", and “unknown”(don"t know) 4) These answers are assigned by a score termed as: Definite, Probable, Possible Or Doubtful. i) Definite- when a total score of > 9. ii) Probable- when a total score of 5-8. iii) Possible- when a total score of 1-4. iv) Doubtful- when a total score of < 0.

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20. ROLE OF PHARMACIST IN PHARMACOVIGILANCE Monitoring patient who are at greater risk of developing ADRs Monitoring patients who are prescribed with drugs likely to cause ADRs. Assessing patient previous allergic status, patient’s drug therapy, possible drug interactions. Assisting health care professionals in the detection and assessment of ADRs. Documentation of all suspected reported reactions Follow up patient to assess the outcome of the reaction and management. Educating the health care professionals about the importance of reporting an ADR Creating awareness about ADRs amongst healthcare professionals, patients and the public. Collaboration with health care professionals. Participation in health care programmes .

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