Pharmacovigilance Shanthi Pal, M.Pharmacy, PhD Quality Assurance and Safety of Medicines WHO.
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Transcript of Pharmacovigilance Shanthi Pal, M.Pharmacy, PhD Quality Assurance and Safety of Medicines WHO.
Pharmacovigilance
Shanthi Pal, M.Pharmacy, PhD
Quality Assurance and Safety of Medicines
WHO
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Learning objectives
Participants will be aware of what pharmacovigilance is
Participants will learn why safety monitoring is important
Participants will learn what WHO is doing in pharmacovigilance
Participants will learn what they could do in pharmacovigilance
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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
Pharmacovigilance
What IS this?
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The science and activities relating to the detection, evaluation, understanding and
prevention of adverse drug reactions or any other drug-related problems
Pharmacovigilance
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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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Why Pharmacovigilance?
Pre-marketing safety data Animal Experiments: Relevant? Clinical Trials: Complete?
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Why Pharmacovigilance?
Post Marketing Topics Unexpected adverse reactions Interactions Risk factors Quality of life Long-term efficacy Cost assessment
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Why Pharmacovigilance?
Adverse Drug Reactions are among the top ten causes of mortality
(Lazarou J. et al., 1998)
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Why Pharmacovigilance?
The percentage of hospital admissions due to drug related events in some countries is
about or more than 10%.
(Bhalla et al, 2003; Imbs et al, 1999)
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Why Pharmacovigilance?
Economic impact
Drug related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in
2000
(Ernst & Grizzle, 2001)
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WHO Programme for International Drug WHO Programme for International Drug MonitoringMonitoring
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres
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WHO Programme for International Drug Monitoring (HQ)
Policy Exchange of Information Technical support to countries Advisory Committee on Safety of Medicinal
Products
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Technical support to countries
Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)
Annual Meeting of Pharmacovigilance Centres
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WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR database No of reports: more than 3.5 million Each year increase ~160,000 / year
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WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR Reports Analysis Output
Feedback to National Centres Signal documents
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Why Pharmacovigilance for Procurement and Management Supply Plans?
It is not always the product that determines drug safety but how it is used
There is a high risk of misuse of drugs
Disease
Population
Drug
Health care system More than 50% of ADRs are preventable
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Public Health or community health
Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.
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Public Health Programmes
Specific to each country (developed or developing)
Dependent on:
The specific burden of illness
The epidemiology of prevalent disease
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DEVELOPING COUNTRIES
Endemic and/or epidemic diseases Tuberculosis, Leprosy, HIV/AIDS, STD
Malaria, Schistosomiasis, Amoebiasis, Leishmaniasis, Trachoma, Lymphatic filariasis, Onchocerciasis,
High morbidity and mortality rates
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PHP
Education Environmental modifications Nutrition intervention Lifestyle and behavioural changes Mass free distribution of drugs
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PHP ORGANIZATION
LEVEL
INTERNATIONAL
NATIONAL
LOCAL
SPONSORSWHO
OTHERS
MALARIA
PROGRAMME MANAGERS
HEALTH WORKERS
PATIENTS
V a c c i n e sMalaria
Tuberculosis HIV/AIDSFilariasis
MALARIA
PUBLIC HEALTH
PROGRAMMES
LOCAL COORDINATOR FOR HEALTH PROGRAMMES
Others
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PHP monitoring
Incidence and prevalence of the disease Morbidity and mortality rates Number of patients treated Number of drug units delivered
What about the risk / effectiveness of drugs used?
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PHP guidelines (WHO, National)
Inadequate (no) reference to: ADRs Pharmacovigilance Reporting
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New Challenges in PHPs
Mass treatment regimens Nutritional aspects Unlabelled and off-labelled indications (pregnant or breast feeding woman, small children, elderly
people) Drug resistances New drugs Co-morbidities Adherence
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Eroding confidence in the malaria programme
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Main reasons of discontinuation of first HAART regimen within 1st year: ICONA
I C ON A
ItalianCohort
NaiveAntiretroviral
Monforte et al. AIDS 1999
Toxicity
Failure
Non-adherence
Other
Continued
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EXISTING SYSTEMS
WHOPROGRAMME
S
WHOPROGRAMME
S
V a c c i n e sMalaria
TuberculosisFilariasis
HIV / AIDS
WHO-PV(UMC)
PV CoordinatorNational PV centre
PATIENTS
NATIONAL PUBLIC HEALTH PROGRAMMES
VaccinesMalaria
Tuberculosis Filariasis
HIV/AIDS
Health workers
Health workers
PATIENTS
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Urgent need for synergistic collaboration
PHP opportunity to implement PV
activities Offer a cohort of patients under
controlled conditions to be monitored for safety over a period of time
PV detect, evaluate, and prevent
adverse events promote rational use of drugs in
mass treatment programmes Evaluate the impact of the
programmes improve acceptability of the
programme
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Expert Safety Review Panel
INTEGRATING P.H.P AND PVFUNCTIONAL AND STRUCTURAL RELATIONSHIP
W.H.OPROGRAMME
S
W.H.OPROGRAMME
S
V a c c i n e sM a l a r i a
T u b e r c u l o s i sF i l a r i a s i s
T r a c h o m a t i s
WHO ADVISORYCOMMITTEE
WHO-PV(UMC)
PV CoordinatorNational PV centre
Health workers
NATIONAL PUBLIC HEALTH PROGRAMMES
V a c c i n e sM a l a r i a
T u b e r c u l o s i sF i l a r i a s i s
T r a c h o m a t i s
DISTRICT INVESTIGATION
TEAM
DRUG REGULATORY AUTHORITY
PATIENTS
PATIENTS
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Strengthen spontaneous reporting systems Establish active surveillance component in public
health programmesHIV/AIDSMalariaLymphatic filariasis
Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)
PV and PHP Synergy
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Malaria Collaboration
Joint training course Joint reviews of specific antimalarials
Artemesinin derivatives Chlorproguanil-dapsone Amodiaquine-artesunate
Joint initiatives for collaboration with pharmaceutical industry – Novartis Agreement
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Collaboration with HIV/AIDS
Workshop in Pretoria 2004 Action plan developed by ACSoMP 2005 Joint training course planned for April 2006
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Collaboration with TDR
Chlorproguanil-dapsone example Joint initiatives on post-marketing
surveillance studies (Phase 4 clinical trials) Joint initiatives on development of pregnancy
registers for antimalarials and antrietrovirals
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"Dying from a disease is sometimes unavoidable. But, dying from an adverse
drug reaction is unacceptable".
- Dr Vladimir Lepakhin
Geneva 2005
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Procurement and Supply Management Plan
2.6 Ensuring rational use of medicines
Is there a system for monitoring adverse drug reactions and drug resistance? If yes, describe briefly how the system works. If no, describe plans to establish a system.
Thank YouThank You
Merci beaucoup !Merci beaucoup !