Introduction to Pharmacovigilance.pptx

Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem.

1. Introduction to PHARMACOVIGILANCE By: Mr. Mohammad Zishan Ibrahim Department of Pharmaceutics, Kandhar College of Pharmacy, Kandhar

2. Outlines of the presentation Smooth orientation to p h arma c ov i gilance Why do we need p h arma c ov i gilance? WHO progra m m e for drug monitoring Pharmac ovi gilance in Egypt Important ter m in olo g ie s in pharmacovi gilance Yellow Card & Blue Card Workshop

3. Medicine Safety To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine Molière

4. Risk/Benefit Balance of medications Medicines are safe! (X) Approved medicines are safe! ( X ) No medicine is safe! (X) No medicine is without risk ( √ )

5. Risk/Benefit Balance of medications Acceptable Unacce p t able

6. What is Pharmacovigilance?

7. WHO definition of pharmacovigilance Pharmacovigilance is the science and activities relating to the detection, assessment , understanding and prevention of adverse effects or any other medicine-related problem

8. Pharmacovigilance p r e v e n ti o n of adverse effects Assessment &Un der s ta n d ing Detection

9. Aims of Pharmacovigilance : Improve patient care and safety in relation to use of medicines Improve public health and safety Contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective use Promote understanding, education and clinical training in Pharmacovigilance and its effective communication to the public.

10. The history of Pharmacovigilance started 169 years ago, on Jan 29, 1848 when a young girl (Hannah Greener) from the north of England died after receiving chloroform anesthetic before removal of an infected toenail. Sir James Simpson had discovered that chloroform was a safer and powerful anesthetic, and he had introduced it in clinical practice.The causes of Hannah's death was investigated to understand what happened to Hannah, but it was impossible to identify what killed her.Probably she died of a lethal arrhythmia or pulmonary aspiration . Chloroform Anesthetic : Learning from History

11. Sulfanilamide Elixir In 1937, there were 107 deaths in the USA, because of the use of sulfanilamide elixir, containing diethyl glycol as the solvent. This solvent was considered the cause of deaths, but the manufacturing companies were not aware about its toxicity at that time.Consequently , the Federal Food, Drug and Cosmetic Act was established in 1938. Its aim was to renovate the public health system. It introduced a new system that the safety of drugs should be demonstrated before their market approval and introduced the possibility of conducting factory inspections. Sulfanilamide Elixir:

12. Thalidomide Disaster: Tranquilizer launched - 1957 First reports of birth defects - 1959 13 reports of birth defects - 1961 •Withdrawn shortly afterward 10000 infants affected by Phocomelia. No teratogenicity detected in testis during clinical trials and prior to launch.

13. Why do we need Pharmacovigilance?

14. Reason 1: Humanitarian concern Insufficient evidence of safety from clinical trials, Animal experiments & Phase 1 – 3 studies prior to marketing authorization

15. Limitations of clinical trials •Small number of patients studied •Restricted populations (age, sex, ethnicity) •Narrow indications •Short duration of drug exposure

16. Reason 2: Medicines are supposed to s ave lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005

17. ADRs were 4th-6th commonest cause of death in the US in 1994 Lazarou et al, 1998 U S A It has been suggested that ADRs may cause 5700 deaths per year in UK. Pirmohamed et al, 2004 UK

18. Reason 3: ADRs are expensive !! Cost of drug related morbidity and mortality exceeded $177.4 billion in 2000 (Ernst FR & Grizzle AJ, 2001: J American Pharm. Assoc). ADR related cost to the country exceeds the cost of the medications themselves.

19. Reason 4: Promoting rational use of medicines and adherence Reason 5: Ensuring public confidence Reason 6: Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical

20. Pharmacovigilance is needed in every country because of differences in: Drug production Distribution and use ( e.g. indications, dose, availability) Genetics, diet, traditions of the people (e.g. use of herbal remedies, etc.) Pharmaceutical quality and composition (active/inactive ingredients )

21. Who program for international drug monitoring

22. Who program for international drug monitoring Started 1968 Located in Uppsala, Sweden Collaborating centre for maintaining global ADR database - Vigibase

23. Roles of WHO Collaborating Centre Identify early warning signals of serious adverse reactions to medicines Evaluate the hazard Undertake research into the mechanisms of action to aid the development of safer and more effective medicines

24. Important Terminologies in Pharmacovigilance

25. Side Effect (SE) Vs Adverse Drug Reaction (ADR) Vs Adverse Event (AE) SE Response to a drug which is unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease. AE Any untoward medical occurrence in a patient or clinical investigation subject administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. ADR Response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis or therapy of disease A causal relationship between the drug and the occurrence is suspect.

26. Adverse Drug Reaction (ADR) Vs Adverse Event (AE)

27. Medication Errors (ME ) They could occur during prescribing, transcribing, dispensing, administering a drug. Examples of medication errors include, misreading or miswriting a prescription. Medication errors are more common than adverse events, but result in harm less than 1% of the time. About 25% of adverse events are due to medication errors . Not all medication errors lead to adverse outcomes .

28. Adverse Drug Reactions (ADR) vs Adverse Events (AE) vs Medication Errors (ME)

29. Seriousness of Adverse drug reactions Serious ADR Life-Threatening Hospitalization (initial or prolonged) Disability Death Congenital Anomaly Medically important event or reaction Cause Cancer OTHER WISE ADR IS NON-SERIOUS

30. Serious reports should be submitted in expedited manner i.e . as soon as possible & no later than 15 calendar days . Thus they best submitted Online Email or Fax

31. We are almost there

32. A VALID REPORT CONSISTS OF:- Identifiable patient Identifiable drug (pharmaceutical product) Identifiable reaction Identifiable reporter

33. Who should report? Healthcare Professionals Marketing authorization holder (MAH) Patients & their relatives Nurses Pharmacists

34. Reports Journey Reporter QP P V Data entry RA Qualified Person Responsible For Pharmacovigilance (QPPV)

35. Thank you