Introduction to pharmacovigilance

8,549 views

Published on

Published in: Health & Medicine, Business
3 Comments
17 Likes
Statistics
Notes
No Downloads
Views
Total views
8,549
On SlideShare
0
From Embeds
0
Number of Embeds
16
Actions
Shares
0
Downloads
875
Comments
3
Likes
17
Embeds 0
No embeds

No notes for slide

Introduction to pharmacovigilance

  1. 1. Introduction to Pharmacovigilance Done By CID PV Team QPPV :- Dr. Rania Kamel Deputy :- Dr. Nahla Raafat
  2. 2. Outlines of the presentation Smooth orientation to pharmacovi gilance Why do we need pharmacovi gilance? WHO programme for drug monitoring Pharmacovi gilance in Egypt Important terminologie s in pharmacovi gilance Yellow Card & Blue Card Workshop
  3. 3. Smooth orientation to Pharmacovigilance concept.
  4. 4. Medicine Safety To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine Molière
  5. 5. Risk/Benefit Balance of medications Medicines are safe! (X) Approved medicines are safe! (X) No medicine is safe! (X) No medicine is without risk (√)
  6. 6. Risk/Benefit Balance of medications Acceptable Unacceptable
  7. 7. What is Pharmacovigilance?
  8. 8. 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
  9. 9. Pharmacovigilance prevention of adverse effects Assessment &Understand ing Detection
  10. 10. Learning from History 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Disaster: •Tranquilizer launched - 1957 • First reports of birth defects - 1959 • 13 reports of birth defects - 1961 •Withdrawn shortly afterward •10000 infants affected by Phocomelia.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.
  11. 11. Why do we need Pharmacovigilance?
  12. 12. Reason 1: Humanitarian concern Insufficient evidence of safety from clinical trials, Animal experiments & Phase 1 – 3 studies prior to marketing authorization
  13. 13. Limitations of clinical trials •Small number of patients studied •Restricted populations (age, sex, ethnicity) •Narrow indications •Short duration of drug exposure
  14. 14. Reason 2: Medicines are supposed to save lives Dying from a disease is sometimes unavoidable; dying from a medicine is unacceptable. Lepakhin V. Geneva 2005
  15. 15. • ADRs were 4th-6th commonest cause of death in the US in 1994 Lazarou et al, 1998 USA • It has been suggested that ADRs may cause 5700 deaths per year in UK. Pirmohamed et al, 2004 UK
  16. 16. 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.
  17. 17. 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
  18. 18. 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 )
  19. 19. Who program for international drug monitoring
  20. 20. Who program for international drug monitoring • Started 1968 • Located in Uppsala, Sweden • Collaborating centre for maintaining global ADR database - Vigibase
  21. 21. 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
  22. 22. Pharmacovigilance in Egypt
  23. 23. What is EPVC (Egyptian Pharmacovigilance centre ) In accordance with the legislation, EPVC has established a pharmacovigilance system for the collection and evaluation of information relevant to the risk-benefit balance of medicinal products, Medical devices & Biocides. (cosmetics, Vet. Products & Herbal products )
  24. 24. Implemented levels of regulatory actions in Egypt based on EPVC decisions • Asking for specific data from MAH • Modify the package insert • Black box warning in the insert • Boxed warning on the outer pack • Contraindication • Distribute “Dear Dr Letter” • Preventing importation of specific batches • Recall of certain batches from the market • Suspension of the marketing authorization • Withdrawal of the marketing authorization
  25. 25. Important Terminologies in Pharmacovigilance
  26. 26. 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.
  27. 27. Adverse Drug Reaction (ADR) Vs Adverse Event (AE)
  28. 28. 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.
  29. 29. Adverse Drug Reactions (ADR) vs Adverse Events (AE) vs Medication Errors (ME)
  30. 30. 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
  31. 31. 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
  32. 32. We are almost there
  33. 33. A VALID REPORT CONSISTS OF:- • Identifiable patient • Identifiable drug (pharmaceutical product) • Identifiable reaction • Identifiable reporter
  34. 34. Who should report? • Healthcare Professionals • Marketing authorization holder (MAH) • Patients & their relatives • Nurses • Pharmacists
  35. 35. Reports Journey Reporter QPPV Data entry RA
  36. 36. Workshop
  37. 37. Q1:- Define Pharmacovigilance: Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
  38. 38. Q2:-Why do we need Pharmacovigilance ? • Humanitarian concern • Medicines are supposed to save lives • ADRs are expensive !! • Promoting rational use of medicines and adherence • Ensuring public confidence • Ethics To know of something that is harmful to another person who does not know, and not telling, is unethical
  39. 39. Q3:- What are limitations to Clinical trials: 1. Small number of patients studied 2. Restricted populations (age, sex, ethnicity) 3. Narrow indications 4. Short duration of drug exposure
  40. 40. Q4:- Define ADRs : 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
  41. 41. Q5:- Mention four examples for serious ADR: 1. Life-Threatening 2. Death 3. Congenital Anomaly 4. Disability
  42. 42. Q6:- Mention four criteria for a valid report: 1.Identfiable patient 2.Identfiable Drug 3.Identfiable reaction 4.Identfiable reporter
  43. 43. Q7:- Who should report ? 1. Healthcare professional 2. Marketing Authorization Holder 3. Nurses 4. Pharmacist 5. Patient
  44. 44. Contact information Dr. Rania Kamel Rania.Kamel@hotmail.com Dr. Nahla Raafat nahlaraafat@gmail.com

×