Transcript The WHO Programme for International Drug Monitoring

Challenges for the WHO Programme
for International Drug Monitoring
Shanthi Pal
Quality Assurance and Safety of Medicines
Cecilia Biriell
Reports, Analysis and Country Support
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Technical Briefing Seminar, 1- 5 November 2010
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.
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Technical Briefing Seminar, 1- 5 November 2010
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
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Technical Briefing Seminar, 1- 5 November 2010
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
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Technical Briefing Seminar, 1- 5 November 2010
Why pharmacovigilance?
 Humanitarian concerns
– Hippocrates admonition
at least do not harm
 Economical concerns
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Technical Briefing Seminar, 1- 5 November 2010
Examples of product recalls due to toxicity
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Examples of serious and
unexpected adverse events
leading to withdrawal
Medicine
Year
Thalidomide
Practolol
Clioquinol
Benoxaprofen
1965
1975
1970
1982
Phocomelia
Sclerosing peritonitis
Subacute nephropathy
Nephrotoxicity, cholestatic
jaundice
Terfenadine
Rofecoxib
Sibutramine
1997
2004
2010
Torsade de pointes
Cardiovascular effects
Anxiety, depression, movement
disorders
Technical Briefing Seminar, 1- 5 November 2010
Studies of ADR related deaths
UK:
It has been suggested that ADRs may cause 5700 deaths
per year in UK
Pirmohamed et al, 2004
US:
ADRs were 4th-6th commonest cause of death in the US in
1994
Lazarou et al, 1998
Sweden:
ADRs were 7th commonest cause of death in Sweden in
2001
Jönsson et al, 2010
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Technical Briefing Seminar, 1- 5 November 2010
 125 Patients
 24 Patients experienced ADRs (19%)
59% were avoidable
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Technical Briefing Seminar, 1- 5 November 2010
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
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Technical Briefing Seminar, 1- 5 November 2010
Pharmacovigilance in WHO HQ
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
5. Fund raising
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Technical Briefing Seminar, 1- 5 November 2010
WHO HQ Pharmacovigilance staff
Dr Shanthi Pal, Acting Manager
Medicines Saftey, QSM
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Technical Briefing Seminar, 1- 5 November 2010
+ 3 support staff
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)
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Technical Briefing Seminar, 1- 5 November 2010
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)
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Technical Briefing Seminar, 1- 5 November 2010
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
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Technical Briefing Seminar, 1- 5 November 2010
4. Collaborations & Partnerships
within WHO
 Malaria
 HIV/AIDS
 Leprosy
Over a 100 million people targeted
for either diethylcarbamazine
citrate (DEC) plus albendazole or
ivermectin plus albendazole.
 Lymphatic Filariasis
 Leishmaniasis
 Chagas
 Patient Safety
 Poisons and Chemicals Safety
 Traditional Medicines
 Vaccines
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Technical Briefing Seminar, 1- 5 November 2010
5. Resource Mobilisation
 Gates foundation
 European Commission
 Global Fund
 Others
 Human resources:
WHO Consultants Network for Pharmacovigilance (PV)
in Africa (PvSF – Pharmacovigilance Sans Frontières)
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Technical Briefing Seminar, 1- 5 November 2010
WHO International Pharmcovigilance Programme
Full and Associate Members
November 2010, 102 member countries
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Technical Briefing Seminar, 1- 5 November 2010
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
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Technical Briefing Seminar, 1- 5 November 2010
UMC main tasks - summary
 Collect and analyse ICSRs worldwide
 Communicate potential drug safety issues
 Actively support and provide training
 Develop the science of pharmacovigilance
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Technical Briefing Seminar, 1- 5 November 2010
WHO Programme for International
Drug Monitoring
UMC-A
WHOCC
Accra
UMC
WHO-CC
Uppsala
WHO-HQ
Geneva
Medical
practices
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Technical Briefing Seminar, 1- 5 November 2010
National
Centres
Pharma
companies
Number of members of the
WHO International Drug Monitoring Programme
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Technical Briefing Seminar, 1- 5 November 2010
Strengths
 Global PV network
National
Centres Meetings
 Only available global
database of ADRs
 Over 40 years track record
in medicine safety
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Weaknesses
 Inadequate representation
in Africa
 Only Spontaneous
reporting
 no denominator data
 poor quality reports
 Public health approach
 Little or no budget
 No hidden agendas
 PHPs: Vertical approach
Technical Briefing Seminar, 1- 5 November 2010
Opportunities
Threats
 Donor interest in PV
 Lucrative business
 New partners
 Lack of harmonization
 Malaria, HIV AIDS,
neglected diseases
 Duplication of
efforts
•
•
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urgent PV needs
investing in new
methods
Technical Briefing Seminar, 1- 5 November 2010
Challenges 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)
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Technical Briefing Seminar, 1- 5 November 2010
Challenges to Pharmacovigilanc
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Technical Briefing Seminar, 1- 5 November 2010
Type of assistance needed
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Technical Briefing Seminar, 1- 5 November 2010
WHO - UMC relationships
WHO
Classifications
Vaccine
safety
Other
Tropical
Diseases
Malaria
Medicines
Policy and
Standards
UMC
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Technical Briefing Seminar, 1- 5 November 2010
HIV/AIDS
Patient
Safety
Alliance
3 tiers-approach for WHO
– Spontaneous reporting
Maintain as the
cheapest,
easiest, most
sustainable
method
Regional trainings –
Country support
–
WHO and UMC
WHO, UMC and UMC-A
1. As before


2. More than before
- Active surveillance
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
Tools


Handbooks
Nigeria, Tanzania, Ghana –
Cohort Event Monitoring in
Public Health Programmes
Technical Briefing Seminar, 1- 5 November 2010
CEMFlow for Cohort Event
Monitoring
Support, guidelines &
technical resources
Expecting the Worst - Crisis Management
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Technical Briefing Seminar, 1- 5 November 2010
3 tiers-approach for WHO
3. As never before




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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 2010
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:
–
–
–
–
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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 2010
Members of PV Consultants Network for
Africa
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Technical Briefing Seminar, 1- 5 November 2010
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
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Technical Briefing Seminar, 1- 5 November 2010
Thank you for your attention
www.who.int
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[email protected]
Technical Briefing Seminar, 1- 5 November 2010
www.who-umc.org