20. Dr. Shanthi Pal - World Health Organization


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“WHO Medicines Safety Programme: Pharmacovigilance and risk minimization programs for biological products”

Illustrates the WHO work program on pharmacovigilance, with a focus on both small molecule chemically-synthesized medicines and biotherapeutics

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  • Article published 1961 in The Lancet. Resulted in the birth of pharmacovigilance. Before this catastrophy the general opinion about drug use was only positive. No negative effects were expected. Phocomelia means ’limbs like a seal’.
  • National Information officers, WHO Pharmaceuticals Newsletter, ICDRA conference The Importance of pharmacovigilance, PV Toolkit, Public reporting of ADRs Training courses – in cooperation with others Collaboration with public health programmes to make PV a part of them e.g. Malaria, Chagas disease, Vaccines Make them interested in PV e.g Global Fund (sponsored the PV Toolkit), Gates foundation etc
  • Update every 6-12 months
  • 20. Dr. Shanthi Pal - World Health Organization

    1. 1. WHO Medicines Safety Programme:Pharmacovigilance and risk minimization programsfor biological productsDr Shanthi PalMedicines Safety Programme ManagerEssential Medicines and Health Products, WHOpals@who.intpvsupport@who.int
    2. 2. Birth of modern pharmacovigilanceThalidomide – Phocomelia 1961
    3. 3. 16th World Health Assembly 1963Assembly Resolution 16.36 - Clinical andPharmacological Evaluation of DrugsINVITES Member States to arrange for a systematiccollection of information on serious adverse drugreactions observed during the development of a drugand, in particular, after its release for general use.
    4. 4. WHO Programme for InternationalDrug MonitoringWHO-HQGenevaWHO-HQGenevaUMCWHO-CCUppsalaUMCWHO-CCUppsalaNationalCentresUMC-AWHO-CCAccraUMC-AWHO-CCAccraWHO-CCRabatWHO-CCRabatWHO-CCOsloATC DDDWHO-CCOsloATC DDD
    5. 5. Pharmacovigilance in WHO1. Exchange of Information2. Policies, guidelines, normative activities3. Country support4. Collaborations5. Resource mobilisation
    6. 6. Advisory Committee on Safety of MedicinalProducts (ACSoMP)The Advisory Committee on Safety of Medicinal Products shallprovide advice on pharmacovigilance policy and issuesrelated to the safety and effectiveness of medicinal productsto the relevant Assistant Director-General in WHO andthrough him / herto the Collaborating Centres for the Medicines SafetyProgramme, andto the Member States of WHO
    7. 7. What defines itThe WHO PV strategy
    8. 8. Understanding whats available andwhats needed in countries
    9. 9. Challenges to Pharmacovigilance
    10. 10. Type of assistance needed
    11. 11. WHO International Drug Monitoring ProgrammeSituation 1990
    12. 12. WHO International Drug Monitoring ProgrammeSituation 2012
    13. 13. WHO strategy
    14. 14. Concept of genericsPatent expiry of medicines enablesGenericsCost savings because no need to invest in furtherhuman trials for safety and efficacyCan use data from investigations with innovatorproductsMore patients receive treatmentFurther investment in new medicines
    15. 15. Global Fund HIV/AIDS CoverageAfter 9 Rounds of proposals0 5,0002,500Kilometers´
    16. 16. Traditional chemical medicinesrelatively smallStable moleculesNo need to repeat large-scale human trialsSafety monitoring is needed neverthelessUsed in other environments & populations: LMIC Comorbidities, nutritional effects, genetic differencesLong-term effects
    17. 17. Pharmacovigilance in Global Fund grantsA 2010 analysis of Grant applications in the Global FundA 2010 analysis of Grant applications in the Global Funddatabase (R4 to R9)database (R4 to R9)Is PV mentioned?Does it set out to establish min PV requirements? 431 individual Global Fund Proposals31% had “acceptable reference to PVInterviews: even if mentioned, PV not implemented inpractice(Ref: Unpublished data, Pal, Xueref et al; 2010)
    18. 18. Joint WHO/Global Fundpharmacovigilance strategyEstablish basic functions and minimum requirements ofnational pharmacovigilance systemMinimum PV requirementspharmacovigilance toolkit to support training anddevelopmentwww.PVToolkit.orgStrong wording in Round 10 requesting countries to includePV
    19. 19. BiotherapeuticsGenerally large, complex moleculesproduced from living cells using biotechnologycan pose rare but serious risks of unwanted immuneresponsesRequire extensive testing and risk managementplanning
    20. 20. Similar biotherapeutic products (SBPs)Copies or generic versions of biotherapeuticproducts (SBP)Are not exact copies of innovator productsDue to manufacturing processUnlike other generics, cant rely on data for / frominnovator productsNeed sufficient proof of similarity to innovatorproduct (both preclinical laboratory testing andclinical trialsRisk management plans are also essential
    21. 21. Guidance from WHODeveloped in 2009Published in 2010Based on EMA guidelines of 2006
    22. 22. Pharmacovigilance of SBPsManufacturer required to submitSafety specification and PV plan at the time ofsubmission for approvalSafety specification should describe importantidentified or potential safety risks for RBP, thesubstance class and / or any that are specifc for the SBP Risk minimization activities may be needed : educationmaterial for patients / HCP etc
    23. 23. Post approval activities for SBPsDue to potential of SBPs to provoke immunereactionsmanufacturers to undertake post marketingsurveillance to the same standards as RBP MAHPharmacovigilance plan should includeSafety monitoring as required of corresponding RBPSafety monitoring for additional risks identifiedSBP manufacturers required to havePV systems in place at approvalQualified PV personnelmeans to report to NRAs where the reactions occur
    24. 24. Traceability of Adverse eventsAEs may be product specificCritical information to assign AEs with specific BPsADR report for any BP to includeINNProprietary or brand nameManufacturers nameLot numberCountry of origin
    25. 25. Number of reports/million inhabitants/yearReporting last 5 years
    26. 26. Reports on Monoclonal antibodies (MABs) inWHO database (out of 8 million Individual CaseSafety Reports, ICSRs)TotalICSR 356787ICSRs with INN, tradenames, indications285327
    27. 27. Reports by country (top 10)
    28. 28. Top 5 ADRs with MAB in WHOdatabaseMedDRA_PT_name Number_of_ReportsFatigue 18208Drug ineffective 15879Headache 13543Dyspnoea 13100Pyrexia 13031
    29. 29. CountryMABreportsUkraine1Latvia9Estonia21Russian Federation23Lithuania55Serbia73Slovenia
    30. 30. SBPs provideAn opportunity to engage in PPP for PV in LMICMAH of generic and innovator biotherapeutics areobliged to invest in PVGenerics are often used in LMICThrough PV of SBPs, possible to create PV systems inLMICThat will be used also for other medicines (not only SBP)Governments and Pvt industry should work out amodelData on products (MAH & Regulator)PV System and PV capacity in country
    31. 31. www.who.int/medicines/areas/quality_safety/safety_efficacy/en
    32. 32. But we do need to build structures and bestpractices because…Dying from a disease is sometimes unavoidable. Butdying from an adverse drug event is unacceptableDr Vladimir Lepakhin, ex Assistant Director General, WorldHealth Organization