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Challenges for the WHO Programme for International Drug Monitoring
Shanthi PalQuality Assurance and Safety of Medicines
Cecilia BiriellReports, Analysis and Country Support
Challenges for the WHO Programme for International Drug Monitoring
Shanthi PalQuality Assurance and Safety of Medicines
Cecilia BiriellReports, Analysis and Country Support
Technical Briefing Seminar, 1- 5 November 20102 |
Technical Briefing Seminar, 1- 5 November 20103 |
RiskRisk
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.
Technical Briefing Seminar, 1- 5 November 20104 |
What is Pharmacovigilance?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
Technical Briefing Seminar, 1- 5 November 20105 |
What is the scope of pharmacovigilance?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
Technical Briefing Seminar, 1- 5 November 20106 |
Why pharmacovigilance?Why pharmacovigilance?
Humanitarian concerns– Hippocrates admonition
at least do not harm
Economical concerns
Technical Briefing Seminar, 1- 5 November 20107 |
Examples of product recalls due to toxicityExamples of product recalls due to toxicity
MedicineYear
Examples of serious and unexpected adverse events leading to withdrawal
Thalidomide 1965Phocomelia
Practolol1975Sclerosing peritonitisClioquinol1970Subacute nephropathyBenoxaprofen1982Nephrotoxicity, cholestatic
jaundice
Terfenadine1997Torsade de pointesRofecoxib2004Cardiovascular effectsSibutramine2010Anxiety, depression, movement
disorders
Technical Briefing Seminar, 1- 5 November 20108 |
Studies of ADR related deathsStudies of ADR related deaths
ADRs were 4th-6th 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 7th commonest cause of death in Sweden in 2001
Jönsson et al, 2010
UK:
US:
Sweden:
Technical Briefing Seminar, 1- 5 November 20109 |
125 Patients
24 Patients experienced ADRs (19%)
59% were avoidable
Technical Briefing Seminar, 1- 5 November 201010 |
Cost of ADRs in the US?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
Technical Briefing Seminar, 1- 5 November 201011 |
Pharmacovigilance in WHO HQPharmacovigilance in WHO HQ
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Fund raising
Technical Briefing Seminar, 1- 5 November 201012 |
WHO HQ Pharmacovigilance staffWHO HQ Pharmacovigilance staff
Dr Shanthi Pal, Acting ManagerMedicines Saftey, QSM +3 support staff
Technical Briefing Seminar, 1- 5 November 201013 |
1. Exchange of Information 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)
Technical Briefing Seminar, 1- 5 November 201014 |
2. Policies, Guidelines and Normative Activities
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)
Technical Briefing Seminar, 1- 5 November 201015 |
3. Country support3. 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
Technical Briefing Seminar, 1- 5 November 201016 |
4. Collaborations & Partnerships within WHO
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.
Technical Briefing Seminar, 1- 5 November 201017 |
5. Resource Mobilisation5. Resource Mobilisation
Gates foundation
European Commission
Global Fund
Others
Human resources: WHO Consultants Network for Pharmacovigilance (PV) in Africa (PvSF – Pharmacovigilance Sans Frontières)
Technical Briefing Seminar, 1- 5 November 201018 |
WHO International Pharmcovigilance ProgrammeFull and Associate Members
WHO International Pharmcovigilance ProgrammeFull and Associate Members
November 2010, 102 member countries
Technical Briefing Seminar, 1- 5 November 201019 |
Uppsala Monitoring Centre (UMC)WHO Collaborating Centre for International Drug Monitoring
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
Technical Briefing Seminar, 1- 5 November 201020 |
UMC main tasks - summaryUMC main tasks - summary
Collect and analyse ICSRs worldwide
Communicate potential drug safety issues
Actively support and provide training
Develop the science of pharmacovigilance
Technical Briefing Seminar, 1- 5 November 201021 |
WHOWHO Programme for International Programme for International Drug MonitoringDrug Monitoring
WHOWHO Programme for International Programme for International Drug MonitoringDrug Monitoring
WHO-HQWHO-HQGenevaGeneva
UMCUMCWHO-CCWHO-CC UppsalaUppsala
NationalNational CentresCentres
UMC-A UMC-A WHO-WHO-
CCCCAccraAccra
MedicalMedical practicespractices
PharmaPharma companiescompanies
Technical Briefing Seminar, 1- 5 November 201022 |
Number of members of the WHO International Drug Monitoring Programme
Number of members of the WHO International Drug Monitoring Programme
Technical Briefing Seminar, 1- 5 November 201023 |
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
Technical Briefing Seminar, 1- 5 November 201024 |
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
Technical Briefing Seminar, 1- 5 November 201025 |
Challenges to PharmacovigilanceChallenges to Pharmacovigilance
An analysis of pharmacovigilance activities in 55 low- and middle-income countries
– Sten Olssona, Shanthi Palb, Andy Stergachisc, Mary Coupera
– Drug Safety 2009/2010
(a: WHO CC, Uppsala; b: WHO QSM; c: UWa)
Technical Briefing Seminar, 1- 5 November 201026 |
Challenges to PharmacovigilancChallenges to Pharmacovigilanc
Technical Briefing Seminar, 1- 5 November 201027 |
Type of assistance neededType of assistance needed
Technical Briefing Seminar, 1- 5 November 201028 |
WHO - UMC relationshipsWHO - UMC relationships
OtherTropicalDiseases
Malaria HIV/AIDSPatient Safety
Alliance
UMC
Vaccinesafety
WHOClassifi-cations
MedicinesPolicy andStandards
Technical Briefing Seminar, 1- 5 November 201029 |
3 tiers-approach for WHO3 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
Technical Briefing Seminar, 1- 5 November 201030 |
Expecting the Worst - Crisis Management
Support, guidelines & technical resourcesSupport, guidelines & technical resources
Technical Briefing Seminar, 1- 5 November 201031 |
3 tiers-approach for WHO3 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
Technical Briefing Seminar, 1- 5 November 201032 |
Activities the last few monthsActivities 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
Technical Briefing Seminar, 1- 5 November 201033 |
Members of PV Consultants Network for Africa
Members of PV Consultants Network for Africa
Technical Briefing Seminar, 1- 5 November 201034 |
Challenges for the futureChallenges 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
Technical Briefing Seminar, 1- 5 November 201035 |
Thank you for your attention Thank you for your attention
www.who.int info@who-umc.org www.who-umc.org
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