Dr Mary Couper Quality Assurance and Safety of Medicines WHO
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Transcript of Dr Mary Couper Quality Assurance and Safety of Medicines WHO
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1World Health Organization
Pharmacovigilance
Dr Mary CouperQuality Assurance and Safety
of MedicinesWHO
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2World Health Organization
Procurement and Supply Management Plan
2.6 Ensuring rational use of medicinesIs 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.
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3World Health Organization
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
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4World Health Organization
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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5World Health Organization
Pharmacovigilance
What IS this?
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6World Health Organization
Vigilance
Vigilare = to watchalert watchfulness
forbearance of sleep; wakefulnesswatchfulness in respect of danger;
care; caution; circumspectionthe process of paying close and
continuous attention
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7World Health Organization
Pharmacovigilance
• The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems
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8World Health Organization
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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9World Health Organization
• Pre-marketing safety data Animal Experiments: Relevant? Clinical Trials: Complete?
Why Pharmacovigilance?
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10World Health Organization
Why Pharmacovigilance?• Post Marketing Topics Unexpected adverse reactions Interactions Risk factors Quality of life Long-term efficacy Cost assessment
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11World Health Organization
Why pharmacovigilance? Factors influencing change
• Toxicity (adverse drug reactions)
• Lack of patient adherence
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12World Health Organization
PrescriptionDr A. Who
31 December 2005Re: Mr Joseph Bloggs R/1) abacavir + lamivudine + zidovudine 1
BD2) atenolol 100 mg/d3) acetylsalicylic acid 150mg/d4) simvastatin 10 mg/d 5) bezafibrate 200 mg/d6) metformin 500 mg/d7) fluoxetine 50 mg/d8) sildenafil
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13World Health Organization
Why Pharmacovigilance for Procurement and Management Supply Plans?
• It is not always the product that determines drug safety but how it is used
• More than 50% of ADRs are preventable
• there is a high risk of misuse of drugs Disease Population Drug Health care system
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14World Health Organization
Populations
Mass treatment regimens, Low standard of living and education, Cultural specificities, not always suffering from the diseases unlabelled and off labelled indications (pregnant or breast feeding woman, small
children, elderly people), Drug and disease interactions.
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15World Health Organization
Urgent need for synergistic collaboration
PHPopportunity to
implement PV activities
Offer a cohort of patients under controlled conditions to be monitored for safety over a period of time
PVdetect, evaluate, and
prevent adverse eventspromote rational use of
drugs in mass treatment programmes
Evaluate the impact of the programmes
improve acceptability of the programme
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16World Health Organization
Expert Safety Review Panel
INTEGRATING P.H.P AND PVFUNCTIONAL AND STRUCTURAL RELATIONSHIP
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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17World Health Organization
WHO Programme for WHO Programme for International Drug MonitoringInternational Drug Monitoring
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres
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18World Health Organization
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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19World Health Organization
Exchange of Information
• WHO Pharmaceuticals Newsletter• WHO Drug Alerts• WHO Drug Information• WHO Restricted Pharmaceuticals
List• International Conference of Drug
Regulatory Authorities (ICDRA)
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20World Health Organization
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21World Health Organization
Policies, Guidelines and Normative Activities
• Guidelines– The Importance of Pharmacovigilance (2002)– Safety Reporting - A guide to detecting and
reporting adverse drug reactions (2002)– Pharmacovigilance in public health – Safety monitoring of herbal medicines– Advisory Committee on the Safety of
Medicines (ACSOMP)
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22World Health Organization
Country Support• 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)
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23World Health Organization
Technical support to countries
• Technical guidelines on all aspects of pharmacovigilance
(Several Publications and documents)• Training courses on pharmacovigilance (Regional Training Courses, biennial
course by UMC and HQ)
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24World Health Organization
WHO Programme for WHO Programme for International Drug MonitoringInternational Drug Monitoring
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres
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25World Health Organization
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26World Health Organization
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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27World Health Organization
WHO Collaborating Centre (Uppsala Monitoring Centre)
ADR Reports• Analysis• Output
– Feedback to National Centres– Signal documents
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28World Health Organization
WHO Programme for WHO Programme for International Drug MonitoringInternational Drug Monitoring
WHOWHOHQHQ
WHO WHO Collaborating Collaborating
Centre, UppsalaCentre, Uppsala
National National CentresCentres
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29World Health Organization
National centres
• China• India• Indonesia• Philippines• Sri Lanka• Thailand• Vietnam
Associate members:• Nepal • Pakistan
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30World Health Organization
Procurement and Supply Management Plan
2.6 Ensuring rational use of medicinesThere should be a system for monitoring adverse drug reactions and drug resistance. Describe briefly how the system works.