1 WHO Programme for International Drug Monitoring : ensuring the safety of medicines Dr Mary Couper & Dr Shanthi Pal Quality Assurance and Safety: Medicines Department of Medicines Policy and Standards
Mar 27, 2015
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WHO Programme for International Drug Monitoring : ensuring the safety of medicines
Dr Mary Couper & Dr Shanthi Pal
Quality Assurance and Safety: Medicines
Department of Medicines Policy and Standards
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Medicine Safety
To undergo treatment you have to be very healthy, because, apart from your sickness you have to withstand the medicine
Molière
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Pharmacovigilance (PV)
WHO definition
The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem
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Why PV (1)
How pre-marketing knowledge about safety problems is created
Animal experiments (Incomplete picture) (ED50, LD50, kinetics, carcinogenicity, teratogenicity…)
Clinical trials (Incomplete information)
limited size
narrow population
narrow indications
short duration
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Why PV (2)
Topics to be studied after approval
reappraisal of indications extension or restriction
characteristics of users (risk factors, elderly/children)
inappropriate use e.g. addiction, off-label
rare adverse effects (ADR 1 in 1000 = 18 200 patients needed)
long-term toxicity
cost assessment
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Why PV (3)
Impact of ADRs
The cost factor
588 million $ / year in Germany (1997), > $ 177.4 billion in the US in 2000,
$847m / year in the UK (2006, BMJ)
Humanitarian reasons:
4-6th leading cause of death (Lazarou et al, JAMA; 1998)
Upto 19 % of in-patients will have an ADR (Davies et al, J Clin
Pharm & Ther; 2006);
up to 70 % ADRs are preventable (Pirmohamed et al, BMJ; 2006
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Why PV (4)
Newer reasons
Access driven (HIV AIDS, Malaria, TB)If access to medicines is a human right, then preventingavoidable harm from medicines is a professional and a moral obligation (Couper et al. BMJ ; 2006).
Public health approach to HIV-AIDS treatment (Gilks et al. Lancet ; 2006)
Fast track medicines in resource poor settings
Counterfeit medicines
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Why PV (5) : To be on top of things
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Pharmacovigilance : Major Aims
early detection of unknown safety problems detection of increases in frequency identification of risk factors quantifying risks preventing patients from being affected unnecessarily
Rational and Safe use of Medicines
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WHO Programme for WHO Programme for International Drug International Drug
MonitoringMonitoring
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WHO Programme for International WHO Programme for International
Drug MonitoringDrug Monitoring
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres
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History
16th WHA (1963) Pilot project of 10 countries (Australia, Canada,
Denmark, Germany, Ireland, Netherlands, New Zealand, Sweden, United Kingdom, USA)
23rd WHA (1970) 1978 WHO-Swedish agreement
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Pharmacovigilance in HQ
1. Exchange of Information
2. Policies, guidelines, normative activities
3. Country support
4. Collaborations
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1. Exchange of Information National Information Officers
(WHO Liaison Officers)
Publications (WHO Pharm Newsletter, Restricted Pharm List, Drug Alerts, WHO Drug Information)
International Conference of Drug Regulatory Authorities (ICDRA)
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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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3. Country Support
Strengthen spontaneous reporting systems
Establish active surveillance component in public health programmes
Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)
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4. Collaborations & Partnerships within WHO
Malaria HIV/AIDS Patient Safety Leprosy Lymphatic Filariasis and Helminths Poisons and Chemicals Safety Traditional Medicines
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WHO Collaborating Centrethe Uppsala Monitoring Centre
established as a foundation 1978 based on agreement Sweden - WHO international administrative board WHO Headquarters responsible for policy self financing
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WHO CC Functions
ADR data base & management Identification of previously unknown drug reactions (Signal detection) Data management and signal detection tools (WHO-ART, WHO Drug
dictionary, ATC/DDD, Vigiflow-online, Vigisearch) ADR queries/searches PV training and country support Publications (Uppsala Reports, View Point, Signals document…) Net working (Vigimed)
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Examples of WHO signals generated by data mining
Topiramate and glaucoma Spring 2001
Antipsychotics and myocarditis Spring 2001
Olanzapine and granulocytopenia Spring 1998
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Vigisearch
adverse reaction profiles
IBUPROFEN - ADR profile
0 1000 2000 3000 4000 5000 6000 7000 8000
Appl site
Cardiovasc
Foetal
Liver-bil
Neoplasms
Repro
Skin
Vision
Sys
tem
Org
an C
lass
No of reports
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Countries in the Programme
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No of Countries
Members of WHO Drug Monitoring Programme
020406080
100
1969 1979 1989 1999
Year
No
of c
ount
ries
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Performance indicator (2005)
Frequency of reporting At least 4 submissions/12 months –
performing well
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Western Pacific Region
Performing well Australia (+) New Zealand (+)
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South East Asian Region
Performing well Malaysia Singapore (+) Thailand
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Eastern Mediterranean Region
Performing well Iran Jordan (+) Morocco Oman
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African Region
Performing well South Africa Ghana
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European Region
Performing well Moldova Russia Sweden Switzerland Turkey United Kingdom
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American Region
Performing well Argentina (+) Brazil (+) Canada (+) USA (+) Venezuela
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Equal partnership for effective Equal partnership for effective
pharmacovigilancepharmacovigilance
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres