importance of pharmcovigilance

presentation of importance of pharmcovigilance

1. IMPORTANCE OF PHARMACOVIGILANCE PRESENTED BY S.NIKHIL DEPARTMENT OF PHARMACEUTICS PE/2017/315

2. INTRODUCTION AIMS OF PHARMACOVIGILANCE NEED FOR PHARMACOVIGILANCE APPLICATION OF PHARMACOVIGILANCE REPORTING OF ADR 2

3. Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. 3 INTRODUCTION: Pharmacovigilance starts from clinical stage and continues throughout the product life cycle

4. Taste of Raspberries , Taste of Death The 1937 Elixir Sulphanilamide Incident LESSONS FROM HISTORY 4 Bristol company formulated Sulphanilamide elixir with diethylene glycol as solvent The elixir was tested for the flavor, appearance, fragrance but not for toxicity Solvent led to death of >100 people The drug and the deaths led to the passage of the 1938 Food, Drug , and Cosmetic Act, which increased FDA's authority to regulate drugs

5.   Use : Morning sickness Medical disaster ever, where over 10,000 children were born with malformations In 1961 5

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7. 7 Need NEED FOR PHARMACOVIGILANCE

8. POPULATIONS NOT STUDIED IN THE PRE-APPROVAL PHASE 8

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10. PARTNERS IN PHARMACOVIGILANCE 10

11. APPLICATION OF PHARMACOVIGILANCE PHARMACOVIGILANCE in drug regulation PHARMACOVIGILANCE in clinical practise PHARMACOVIGILANCE in international health 11

12. TERMINOLOGIES Absolute risk Risk in a population (e.g. 1 in 1,000). Adverse Event (AE) 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) A response which is noxious and unintended, and which occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function. (WHO, 1972). Causal relationship A relationship between one phenomenon or event (A) and another (B) in which A precedes and causes B. In pharmacovigilance; a medicine causing an adverse reaction. Causality assessment The evaluation of medicine was the causative agent of an observed adverse reaction. 12

13. Efficacy The ability of a drug to produce the intended effect as determined by scientific methods, for example in pre-clinical research conditions (opposite of hazard) Harm The nature and extent of actual damage that could be caused by a drug. Not to be confused with risk Periodic Safety Update Report (PSUR) A systematic review of the global safety data which became available to the manufacturer of a marketed drug during a specific time period Cohort Event Monitoring observational study of events that occur during the use of medicines 13

14. Relative risk Ratio of the risk in an exposed population ( absolute risk ) and the risk in an unexposed population ( reference risk ). Relative risk is the result of a relative comparison between outcome frequency measurements, e.g. incidences. Risk The probability of harm being caused; the probability (chance, odds) of an occurrence. Serious Adverse Event or Reaction A serious adverse event or reaction is any untoward medical occurrence that at any dose: results in death requires inpatient hospitalization or prolongation of existing hospitalization 14

15. Signal Reported information on a possible causal relationship between an adverse event and a drug, the relationship being unknown or incompletely documented previously Summary of Product Characteristics (SPC) A regulatory document attached to the marketing authorization which forms the basis of the product information made available to prescribers and patients Spontaneous reporting System whereby case reports of adverse drug events are voluntarily submitted from health professionals and pharmaceutical manufacturers to the national regulatory authority 15

16. SUSAR A suspected unexpected serious adverse reaction (SUSAR) is any UAR that at any dose: a. Results in death; b. Is life threatening (i.e. the subject was at risk of death at the time of the event) c. Refer to an event which hypothetically might have caused death if it were more severe d. Requires hospitalization or prolongation of existing hospitalization; e. Results in persistent or significant disability or incapacity; f. Is a congenital anomaly or birth defect. 16

17. Summary of identified risks of drugs and potential risks missing information Serves Basis for action plan for pharmacovigilance and risk management plan ACTION PLAN IN RMP RISK MANAGEMENT PLAN 17

18. 18 If the action plan specifies additional risk minimization activities, these could include

19. TYPES OF ADR 19

20. REPORTING OF ADR 20

21. How to report? 21 Report serious adverse reactions. A reaction is serious when the patient outcome is life-threatening (real risk of dying) hospitalization (initial or prolonged) disability (significant, persistent or permanent congenital anomaly Who can report Any health care professional (Doctors including dentists, Nurses and Pharmacists)

22. Where to report? Adverse drug reaction Monitoring Centre (AMC) or to National Coordinating Centre 22 What happens to submitted form? Causality assessment of medicines done in AMC WHO-UMC scale Analyzed report are sent to NCC through ADR database Finally database analyzed and forwarded to global Pharmacovigilance database (WHO UPPSALA centre in Sweden)

23. REPORTING OF ADR INDIA UK(Y ellow card ) U S ( Medwatch ) AUSTRALIA (Blue card) 23

24. OUTCOMES OF PHARMACOVIGILANCE Reduces risk of ADR Rational use of medicines Assessing drug safety Label change(if necessary) 24

25. CASE STUDY 1980s pfizer developed drug for hypertension and angina efficacy was minimal Found erection in impotent male who are taking this treatment In jan 1997 they conducted study involving 3,000 subjects ages 19 to 87 In march 1998 they got approval for oral therapy by FDA Despite wide spreading adoption caused small no.ofdeaths in 6months in 6millions prescription dispensed FDA received deaths of 130 in that 77 are cardio related problems They found interaction with nitrates FDA ordered pfizer to amend label on this thing In july 2005 FDA received reported on small number men lost eye sight and label was changed 25

26. NEW DRUG ALERTS UK INDIA 26

27. OUTCOME OF PHARMACOVIGILANCE PROGRAMME OF INDIA SN.O DRUGS ADVERSE REACTION RECOMMENDATION OF PVPI TO CDSCO CDSCO INITIATIVE 1 Lamotrigine Steven johnson syndrome For label change In process 2 Ceftriaxone Steven johnson syndrome For label change In process 3 Betamethasone Photosensitivity reaction For label change In process 4 Surfactant Pulmonary hemorrhage For label change In process 5 Ranitidinde Cardiac arrest For label change In process REGULATORY ACTION ON BASIS OF ADR REPORT SN.O DRUG ADR CDSCO action 1 Carbmazepine Stevens johnson syndrome and toxic epidermal necrolysis CDSCO instructed marketing authorizing holder( mah ) to comply the same 2 Mannitol Hypokalaemia Approved in subject expert committee (SEC) of CDSCO 3 Rotavirus vaccine Intussusception Approved in SEC of CDSCO 4 Piperacillin & tazobactum Hypokalemia and bronchospasm CDSCO instructed to MAH comply with the same 5 Anti rabies vaccine Erythema multiforme CDSCO instructed to MAH to comply with the same On the basis of PVPI recommendations CDSCO has taken action 27

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29. CONCLUSION ; 29 Important for healthcare professional to know about each drug data documentation , drug benefit ratio profile Knowing about every step of pharmaceutical management cycle advantageous for health organization to educate patient clearly about every drug

30. REFERENCES Amery, W. K. (1999). Why there is a need for pharmacovigilance.  Pharmacoepidemiology and drug safety ,  8 (1), 61-64. World Health Organization. (2002). The importance of pharmacovigilance http://www.ipc.gov.in/PvPI/pv_home.html Biswas, P. (2013). Pharmacovigilance in Asia. Journal of Pharmacology & Pharmacotherapeutics , 4 (Suppl1), S7–S19 . Kumar, L. (2015). Lokesh ,.Pharmacovigilance/reporting adverse drug reactions: an approach to enhance health surveillance and extending market share by minimizing the chances of drug withdrawals. International Journal of Pharmacy and Pharmaceutical Sciences, 7 (9), 1-7. https://helix.northwestern.edu/.../thalidomide-tragedy-lessons-drug-safety-and- regulati .. 30

31. https://www.fda.gov/aboutfda/whatwedo/history/.../ sulfanilamidedisaster / www.fda.gov/safety/medwatch/howtoreport/downloadforms/default. uk.gov(drug safety updates) https://www.pfizer.com/files/health/.../22_What_is_a_Risk_Management_Plan.pdf 31