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Why and how to conduct and report drug safety surveillance.

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  1. 1. 1
  2. 2.  What is pharmacovigilance? Why is it necessary? When should to report? Who should do it? How it is conducted? CONCLUSION. 2
  3. 3.  WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects/ adverse drug reaction (ADR) or any other medicine-related problem. Is the study of safety of marketed drugs under the practical conditions of clinical use in large populations. 3
  4. 4.  To improve safety and rational use of medicine and devices thereby improving patient care and public health. When a medicine is released into the market , there is a lot to be learned about it’s safety and efficacy. 4
  5. 5.  Pharmacovigilance helps assess risk vs. benefits. This information will prevent unnecessary suffering. Decrease financial loss sustained by patients using inappropriate and unsafe drugs. 5
  6. 6.  Identify- unknown adverse reactions. Evaluate- the balance between benefit vs. risk. Provide- optimal information to the users. Take Action- to promote safe use. Monitor Impact of the action taken. 6
  7. 7. MAH ~ Data Source ~Clinical Trials/CRO Regulatory Body HCP Others (Lawyers) ~Patients ~Patients~Lit review ~Data Source 7
  8. 8.  Pharmacovigilance should be done during:  clinical trials.  post marketing surveillance (PMS). 8
  9. 9.  Report Severe Adverse Events (SAE) and unexpected adverse to the sponsor within 24hrs and to the ethics committee within 7 days. Safety Adverse Report should be received by the FDA within 14days. EU requirements for PMS; ~first 2 years after authorization report every 6months. ~next 2 years, report once a year. ~after that report every 3 year. 9
  10. 10.  FDA Center for Drug Evaluation and Research (CDER) IRB/ Ethics committee EU (EMEA, MHRA) MHLW ~ Japan CDSCO~ India WHO ~UPPSLA Others. 10
  11. 11.  A reaction or response to medicine which is noxious or unintended, including lack of efficacy. Can occur at any dosage resulting from overdose, misuse or abuse of medication. 11
  12. 12.  Name of drug/device. All suspected ADRs. Lack of efficacy and suspected defects on the device. Counterfeit medicines. Development of resistance e.g. antibiotics. Overdose, misuse. Medical error. 12
  13. 13.  Outcome of use during pregnancy. Adverse reaction during breastfeeding. Data on the pediatrics population. Concomitant drugs. Comorbidities. Age, gender. 13
  14. 14.  Reporting ofadverse events and medication errors is done voluntarily : healthcare professionals (such as physicians, physician assistants pharmacists, nurses) to the regulatory bodies and manufacturers. 14
  15. 15. Manufacturer report to the FDA in a timely manner. ADRs are entered into AERS (Adverse Event Reporting System) . 15
  16. 16. MonitorCollect Identify Evaluate Act on it impact Periodic Safety Data Update (PSUR) is a regulatory document prepared by the Marketing Authorization Holder (MAH) and submitted to the FDA. 16
  17. 17.  Passive surveillance. ~case series. ~spontaneous case reporting. Stimulated reporting. Active surveillance. ~ sentinel sites. ~drug event monitoring. ~registries. 17
  18. 18.  Comparative observational studies. ~cross sectional studies. ~case control study. ~cohort study. Targeted clinical investigations. Descriptive Studies. ~natural history of disease. ~drug utilization study 18
  19. 19. Identification Signal detection of new previously not known side effect.Evaluation Clinical assessment of ADR’s.Take Action Reporting. Creating awareness among. healthcare providers and the public. 19
  20. 20.  Fatal, death. Life threatening. Disability or incapacitation. Prolonged hospitalization. Congenital abnormality. 20
  21. 21.  Type A Pharmacological Mechanism Common > 1% Dose relationship Suggestive time relationship Reproducible 21
  22. 22.  Type B Specific characteristic reaction Immuno-allergic reactions Rare reaction <1% Susceptible to individuals Not reproducible 22
  23. 23.  Type C (Chronic) Due to repeat use of the drug. Time relationship variable. Difficult to reproduce. Mechanism unknown. 23
  24. 24.  Type D ( Delayed)  Takes time to develop  Carcinogenic, tetratogenesis Type E (Eliminated)  appears after termination of therapy  Rebound phenomena Type F ( Failure)  therapeutic failure  Inefficiencies (Vaccines, contraceptives) 24
  25. 25.  Case report describes suspected adverse reaction.  Certain ADR  Probable ADR  Possible ADR  Causality unlikely/ unclear ADR  No ADRs  Uncertain/unknown  Un-assessable De-challenge and re-challenge test. 25
  26. 26.  To establish causality or lack of the following is investigated:i. Association of time/place between drug use and event.ii. Pharmacology including current knowledge, nature and frequency of adverse reaction. 26
  27. 27. iii. Medical and pharmacological plausibility signs and symptoms, lab tests, pathological findings.iv. Likelihood of exclusion of other causes. 27
  28. 28.  Dechallenge test: when the drug is discontinued, the reaction resolves. ReChallenge test: when the drug is restarted, the reaction reappears. 28
  29. 29.  Adverse reaction case reports by MAH. PSUR (Periodic Safety Update Report). Spontaneous reporting system. ~national PV center/ Drug authorities. ~published scientific literature. Drug bulletins. 29
  30. 30.  Information should be communicated ethically and effectively to all involved parties. Education of proper drug use in crucial with dissemination of safety information to the public. All evidence needed to assess and understand risk and benefit should be readily available. 30
  31. 31. Pharmacovigilance reporting:I. Creates public awareness on drug use.II. Ensures that risks in drug use are anticipated and managed.III. Provides the information required by regulators to amend drug regimen.IV. Improves communication between the health industry and the public.V. Educates healthcare providers on the risk vs. benefit of prescriptions. 31
  32. 32.  Benefit vs. Risk assessment- is key in decision making. Public Health Safety- PMS is important to achieve safe and rational use of medicines and devices. Improvements and changes should be made in a timely manner. 32
  33. 33. WHO, Louise; Martinez, Carlos. The General Practice ResearchDatabase: Role in Pharmacovigilance. Drug Safety, Volume 27,Number 12, 2004 , pp. 871-881(11)Patrick C. Waller*, Stephen J. W. Evans. A model for the futureconduct of pharmacovigilance. Pharmacoepidemiology and DrugSafety Volume 12, Issue 1, pages 17–29, Jan/Feb 2003.Anne Trontell, M.D., M.P.H. Expecting the Unexpected — Drug Safety,Pharmacovigilance, and the Prepared Mind N Engl J Med 2004;351:1385-1387Sept 30, 2004 33