Medicines Safety in WHO: promoting best practices in Pharmacovigilance


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IFPMA Geneva Pharma Forum on Pharmacovigilance: Partnering
for Patient Safety (Geneva, 20 November 2012)
Dr Shanthi Pal, Programme Manager for Pharmacovigilance
Quality Assurance and Safety of Medicines,
World Health Organization

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Medicines Safety in WHO: promoting best practices in Pharmacovigilance

  1. 1. Medicines Safety in WHO: promotingbest practices in Pharmacovigilance Dr Shanthi Pal Medicines Safety Programme Manager WHO (HQ) 1
  2. 2. Birth of modern pharmacovigilanceThalidomide – Phocomelia 1961 2
  3. 3. 16th World Health Assembly 1963 Assembly Resolution 16.36 - Clinical and Pharmacological Evaluation of Drugs INVITES Member States to arrange for a systematic collection of information on serious adverse drug reactions observed during the development of a drug and, in particular, after its release for general use. 3
  4. 4. WHO Programme for NationalInternationalPV Centres Drug Monitoring WHO WHO Collaborating Collaborating WHOCentre, Uppsala Centre, Ghana WHO Collaborating Centre, Morocco 4
  5. 5. Anatomical Therapeutic Chemical (ATC)ClassificationDefined Daily Dose (DDD) Another WHO Collaborating Centre Drug statistics methodology In Oslo, Norway International Working Group on Drug Statistics Methodology Meets twice a year Assigns codes and DDDs Integrated into the UMC database Need to use better in DUR 5
  6. 6. Roles and Responsibilities WHO WHO Collaborating Centres Policies and strategies for PV Tools and technologies Guidelines, norms and Research and Innovation standards Implementation / proof of Exchange of information concept Systems strengthening Everyday technical support Training and capacity Training and capacity building building Dialogue with donors & Exchange of information public health programmes 6
  7. 7. UMCTechnical supportNetwork operationsImplementationADR DatabaseSignalsCapacity buildingResearch and developmentCommunication 7
  8. 8. Collaborations & Partnerships within WHOMalariaHIV/AIDSTBNeglected tropical diseasesPatient SafetyTraditional MedicinesVaccinesClassifications 8
  9. 9. Advisory Committee on Safety of Medicinal Products (ACSoMP)The Advisory Committee on Safety of Medicinal Products shall provide advice on pharmacovigilance policy and issues related to the safety and effectiveness of medicinal products to the relevant Assistant Director-General in WHO and through him / her to the Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre), and to the Member States of WHO. 9
  10. 10. The WHO PV strategy What defines it 10
  11. 11. What is pharmacovigilance The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems.(The Importance of Pharmacovigilance, WHO 2002) A tool for generating evidence to inform policies 11 11
  12. 12. Putting the horse in front of the cart AFRICA If there are no systems, there will be no evidence 12
  13. 13. MemberCountries_1968_1990.mhtml 13
  14. 14. 14
  15. 15. …. or any other drug-related problems.Diethylene glycol tragedy in NigeriaNAFDAC Nigeria Paracetamol 1989 > 100 deaths (children) Paracetamol + Chlorpheniramine 2009 (teething mixture – ‘My Pikin’) ~100 deaths (children) ~110 Acute renal failure PV scope needs to be expanded to address quality issues 15
  16. 16. PV definition … understanding and prevention of adverse effects Up to 50% of ADRs are preventable 16
  17. 17. Pharmacovigilance system that Records errors Analyses Learns Implements checks Prevents errors WHO Guidance document on detecting Medication Errors from PV data 17
  18. 18. Spontaneous reporting: Bedrock of PV these forty years. But: Lack of denominator dataPublic health programmes need to address key safety questions, quickly provide rates of AEs monitor AEs in special populations (children..) 18
  19. 19. Addressing the PV needs of public healthprogrammes Dystonia with ACTs ? Result of malnutrition / repeated treatment with ACTs? Malaria HIV/AIDS Delete d4t?; NVP in women? Can we use TDF without renal monitoring? Risk of severe anaemia in children with AZT? Use NVP & rifampicin concomitantly in HIV/TB patients? 19
  20. 20. Methodological developmentAdditional data sources WHO has developed a protocol for cohort event monitoring (CEM) of antimalarials and ARVs WHO has developed a protocol for Targeted Spontaneous Reporting (TSR) TB medicines PV handbook 20
  21. 21. Understanding whats availableand whats needed in countries 21
  22. 22. Type of assistance needed 22
  23. 23. PV consultants forAFRICA: PVSF WHO CC for advocacy and training in PV, Accra, Ghana 23
  24. 24. Technical Solutions for AfricaVigiFlow: tool for national ICSRmanagement and submission toWHO/UMC Provides country with a national database E2b compliant Incorporates MedDRA Free software update and maintenance by UMC Challenge: access to broadband internet Solution: Silverlite 24
  25. 25. Joint WHO/Global Fundpharmacovigilance strategy Establish basic functions and minimum requirements of national pharmacovigilance system Min PV req pharmacovigilance toolkit to support training and development Slide 27 ( Strong wording in Round 10 requesting countries to include PV 25
  26. 26. 26
  27. 27. What gets measured, gets done Success indicators Outcomes Impact 27
  28. 28. “Weber effect” in postmarketing ADR reports Dear Healthcare Letter Drug Approval TimeWeber JCP. Advanced Inflammatory Res 1984; 6:1-7
  29. 29. Value of patient reports Less underreporting Patients report different ADRs Cover blindspots of pharmacovigilance systems OTC medication, herbal drugs Information about impact on daily life Use for signal detection
  30. 30. Background If patient reporting is to be recognized as beneficial for pharmacovigilance and further optimized, methodology and best practice must be internationally shared and promoted
  31. 31. Additional stakeholders: the fullpictureDirect patient reporting WHO guidelines Reporting tool patient organization input Being piloted in Croatia 31
  32. 32. Our strategy Understanding the local needs Engaging public health programmes Bringing in additional stakeholders More patient centred Expanding the scope of PV 32
  33. 33. Thank you The impossible: we are on it For miracles: expect some 33