Pharmacovigilance Shanthi Pal, M. Pharmacy, PhD

Pharmacovigilance

• Shanthi Pal, M.Pharmacy, PhD

• Quality Assurance and Safety of Medicines

• WHO

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

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?

Pharmacovigilance

• The science and activities relating to the detection, evaluation, understanding and prevention of adverse drug reactions or any other drug-related problems

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

Why Pharmacovigilance?

• Pre-marketing safety data

• Animal Experiments: Relevant?

• Clinical Trials: Complete?

Why Pharmacovigilance?

• Post Marketing Topics

• Unexpected adverse reactions

• Interactions

• Risk factors

• Quality of life

• Long-term efficacy

• Cost assessment

Why Pharmacovigilance?

• Adverse Drug Reactions are among the top ten causes of mortality

• (Lazarou J. et al., 1998)

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)

Why Pharmacovigilance?

• Economic impact

• Drug related morbidity and mortality expenses exceeded US$ 177.4 billion in the USA in 2000

• (Ernst & Grizzle, 2001)

WHO Programme for International Drug Monitoring

WHO Programme for International Drug Monitoring (HQ)

• Policy

• Exchange of Information

• Technical support to countries

• Advisory Committee on Safety of Medicinal Products

Technical support to countries

• Training courses on pharmacovigilance (Regional Training Courses, biennial course by UMC and HQ)

• Annual Meeting of Pharmacovigilance Centres

WHO Collaborating Centre (Uppsala Monitoring Centre)

• ADR database

• No of reports: more than 3.5 million

• Each year increase ~160,000 / year

WHO Collaborating Centre (Uppsala Monitoring Centre)

• ADR Reports

• Analysis

• Output

• Feedback to National Centres
• Signal documents

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

Public Health or community health

• Science and art of preventing disease, prolonging life and promoting health and efficiency through organized community efforts.

Public Health Programmes

• Specific to each country (developed or developing)

• Dependent on:

• The specific burden of illness

• The epidemiology of prevalent disease

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

PHP

• Education

• Environmental modifications

• Nutrition intervention

• Lifestyle and behavioural changes

• Mass free distribution of drugs

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?

PHP guidelines (WHO, National)

• Inadequate (no) reference to:

• ADRs

• Pharmacovigilance

• Reporting

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

Main reasons of discontinuation of first HAART regimen within 1st year: ICONA

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 and PHP Synergy

• Strengthen spontaneous reporting systems

• Establish active surveillance component in public health programmes

• HIV/AIDS

• Malaria

• Lymphatic filariasis

• Work with the WHO Collaborating Centre for International Drug Monitoring (the Uppsala Monitoring Centre)

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

Collaboration with HIV/AIDS

• Workshop in Pretoria 2004

• Action plan developed by ACSoMP 2005

• Joint training course planned for April 2006

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

• "Dying from a disease is sometimes unavoidable. But, dying from an adverse drug reaction is unacceptable".

• Dr Vladimir Lepakhin

• Geneva 2005

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.