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Challenges for the WHO Programme for International Drug Monitoring Shanthi Pal Quality Assurance and Safety of Medicines Cecilia Biriell Reports, Analysis.

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Presentation on theme: "Challenges for the WHO Programme for International Drug Monitoring Shanthi Pal Quality Assurance and Safety of Medicines Cecilia Biriell Reports, Analysis."— Presentation transcript:

1 Challenges for the WHO Programme for International Drug Monitoring Shanthi Pal Quality Assurance and Safety of Medicines Cecilia Biriell Reports, Analysis and Country Support Challenges for the WHO Programme for International Drug Monitoring Shanthi Pal Quality Assurance and Safety of Medicines Cecilia Biriell Reports, Analysis and Country Support

2 Technical Briefing Seminar, 1- 5 November |2 |

3 3 |3 | Risk No medicinal product is entirely or absolutely safe for all people, in all places, at all times. We must always live with some measure of uncertainty.

4 Technical Briefing Seminar, 1- 5 November |4 | What is Pharmacovigilance? WHO definition: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. This applies throughout the life-cycle of a medicine equally to the pre-approval stage as to the post-approval. ADR monitoring – Medicines safety – Drug Monitoring

5 Technical Briefing Seminar, 1- 5 November |5 | What is the scope of pharmacovigilance? improve patient care and safety in relation to the use of medicines, and all medical and paramedical interventions, improve public health and safety in relation to the use of medicines, contribute to the assessment of benefit, harm, effectiveness and risk of medicines, encouraging their safe, rational and more effective (including cost-effective) use, and promote understanding, education and clinical training in pharmacovigilance and its effective communication to the public

6 Technical Briefing Seminar, 1- 5 November |6 | Why pharmacovigilance? Humanitarian concerns –Hippocrates admonition at least do not harm Economical concerns

7 Technical Briefing Seminar, 1- 5 November |7 | Examples of product recalls due to toxicity MedicineYear Examples of serious and unexpected adverse events leading to withdrawal Thalidomide1965Phocomelia Practolol1975Sclerosing peritonitis Clioquinol1970Subacute nephropathy Benoxaprofen1982Nephrotoxicity, cholestatic jaundice Terfenadine1997Torsade de pointes Rofecoxib2004Cardiovascular effects Sibutramine2010Anxiety, depression, movement disorders

8 Technical Briefing Seminar, 1- 5 November |8 | Studies of ADR related deaths ADRs were 4 th -6 th commonest cause of death in the US in 1994 Lazarou et al, 1998 It has been suggested that ADRs may cause 5700 deaths per year in UK Pirmohamed et al, 2004 ADRs were 7 th commonest cause of death in Sweden in 2001 Jönsson et al, 2010 UK: US: Sweden:

9 Technical Briefing Seminar, 1- 5 November |9 | 125 Patients 24 Patients experienced ADRs (19%) 59% were avoidable

10 Technical Briefing Seminar, 1- 5 November | Cost of ADRs in the US? 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

11 Technical Briefing Seminar, 1- 5 November | Pharmacovigilance in WHO HQ 1.Exchange of Information 2.Policies, guidelines, normative activities 3.Country support 4.Collaborations 5.Fund raising

12 Technical Briefing Seminar, 1- 5 November | WHO HQ Pharmacovigilance staff Dr Shanthi Pal, Acting Manager Medicines Saftey, QSM + 3 support staff

13 Technical Briefing Seminar, 1- 5 November | 1. Exchange of Information National Information Officers Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information) International Conference of Drug Regulatory Authorities (ICDRA)

14 Technical Briefing Seminar, 1- 5 November | 2. Policies, Guidelines and Normative Activities Guidelines –The Importance of Pharmacovigilance (2002) –Safety Reporting - A guide to detecting and reporting adverse drug reactions (2002) –Policy perspectives on medicines (Pharmacovigilance) 2004 –Safety monitoring of herbal medicines (2004) –Pharmacovigilance in Public Health –Advisory Committee for the Safe Use of Medicinal Products (ACSoMP)

15 Technical Briefing Seminar, 1- 5 November | 3. Country support Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ) Address specific / stated needs: kava, ARVs, antimalarials…. Annual Meeting of Pharmacovigilance Centres

16 Technical Briefing Seminar, 1- 5 November | 4. Collaborations & Partnerships within WHO Malaria HIV/AIDS Leprosy Lymphatic Filariasis Leishmaniasis Chagas Patient Safety Poisons and Chemicals Safety Traditional Medicines Vaccines Over a 100 million people targeted for either diethylcarbamazine citrate (DEC) plus albendazole or ivermectin plus albendazole.

17 Technical Briefing Seminar, 1- 5 November | 5. Resource Mobilisation Gates foundation European Commission Global Fund Others Human resources: WHO Consultants Network for Pharmacovigilance (PV) in Africa (PvSF – Pharmacovigilance Sans Frontières)

18 Technical Briefing Seminar, 1- 5 November | WHO International Pharmcovigilance Programme Full and Associate Members November 2010, 102 member countries

19 Technical Briefing Seminar, 1- 5 November | Uppsala Monitoring Centre (UMC) WHO Collaborating Centre for International Drug Monitoring the operational centre of the WHO PV Programme established as a foundation 1978 based on agreement Sweden - WHO international administrative board WHO Headquarters responsible for policy self financed

20 Technical Briefing Seminar, 1- 5 November | UMC main tasks - summary Collect and analyse ICSRs worldwide Communicate potential drug safety issues Actively support and provide training Develop the science of pharmacovigilance

21 Technical Briefing Seminar, 1- 5 November | WHO Programme for International Drug Monitoring WHO-HQGeneva UMCWHO-CCUppsala NationalCentres UMC-A WHO- CC Accra MedicalpracticesPharmacompanies

22 Technical Briefing Seminar, 1- 5 November | Number of members of the WHO International Drug Monitoring Programme

23 Technical Briefing Seminar, 1- 5 November | Strengths Global PV network National Centres Meetings Only available global database of ADRs Over 40 years track record in medicine safety Public health approach No hidden agendas Weaknesses Inadequate representation in Africa Only Spontaneous reporting no denominator data poor quality reports Little or no budget PHPs: Vertical approach

24 Technical Briefing Seminar, 1- 5 November | Opportunities Donor interest in PV New partners Malaria, HIV AIDS, neglected diseases urgent PV needs investing in new methods Threats Lucrative business Lack of harmonization Duplication of efforts

25 Technical Briefing Seminar, 1- 5 November | Challenges to Pharmacovigilance An analysis of pharmacovigilance activities in 55 low- and middle-income countries –Sten Olsson a, Shanthi Pal b, Andy Stergachis c, Mary Couper a –Drug Safety 2009/2010 (a: WHO CC, Uppsala; b: WHO QSM; c: UWa)

26 Technical Briefing Seminar, 1- 5 November | Challenges to Pharmacovigilanc

27 Technical Briefing Seminar, 1- 5 November | Type of assistance needed

28 Technical Briefing Seminar, 1- 5 November | WHO - UMC relationships Other Tropical Diseases Malaria HIV/AIDS Patient Safety Alliance UMC Vaccine safety WHO Classifi- cations Medicines Policy and Standards

29 Technical Briefing Seminar, 1- 5 November | 3 tiers-approach for WHO 1.As before – Spontaneous reporting Regional trainings – WHO and UMC Country support – WHO, UMC and UMC-A 2.More than before - Active surveillance Tools -CEMFlow for Cohort Event Monitoring Handbooks Nigeria, Tanzania, Ghana – Cohort Event Monitoring in Public Health Programmes Maintain as the cheapest, easiest, most sustainable method

30 Technical Briefing Seminar, 1- 5 November | Expecting the Worst - Crisis Management Support, guidelines & technical resources

31 Technical Briefing Seminar, 1- 5 November | 3 tiers-approach for WHO 3.As never before Indicators Minimum requirements for a Functional National PV System Fundraising EuropeAid; UNITAID, GFATM, PEPFAR; FP7 etc Centres of excellence Ghana – WHO Collaborating Centre for Advocacy and training in PV Morocco – training for francophone countries Developing networks PV Consultants Network for Africa Global Network for ADR reporting in prequalified vaccines National Centres meeting in Ghana

32 Technical Briefing Seminar, 1- 5 November | Activities the last few months Ghana, May –PV conference arranged by West African Health Organization Morocco, June –Training course for francophone countries Togo, October – PV Consultants Network for Africa Ghana, November – Stakeholders meeting, Donors and WHO Activities in other parts of the world: – Training course in Singapore for Asian countries – UMC country visits in eastern European countries – Restart of PV in India – Coming – training course in Mexico

33 Technical Briefing Seminar, 1- 5 November | Members of PV Consultants Network for Africa

34 Technical Briefing Seminar, 1- 5 November | Challenges for the future To make PV systems sustainable through: –stable financing –trained and dedicated staff Create a culture of reporting –from health professionals –the public

35 Technical Briefing Seminar, 1- 5 November | Thank you for your attention


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