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Pharmacovigilance

Dr Mary CouperQuality Assurance and Safety

of MedicinesWHO

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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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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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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

What IS this?

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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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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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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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• Pre-marketing safety data Animal Experiments: Relevant? Clinical Trials: Complete?

Why Pharmacovigilance?

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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? Factors influencing change

• Toxicity (adverse drug reactions)

• Lack of patient adherence

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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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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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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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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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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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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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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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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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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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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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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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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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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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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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National centres

• China• India• Indonesia• Philippines• Sri Lanka• Thailand• Vietnam

Associate members:• Nepal • Pakistan

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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.