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Introduction

About the Malaysian Adverse Drug Reactions Advisory Committee

 

Overview

  • Malaysian Adverse Drug Reactions Advisory Committee (MADRAC) was established under Drug Control Authority (DCA) to perform the function of pharmacovigilance for drugs registered for use in Malaysia.
  • MADRAC provides DCA with important information pertaining to local and international drug safety issues, as well as advises DCA on risk management and risk communication following effective assessment of the benefit-risk profile of drugs.
  • The National Centre for Adverse Drug Reaction Monitoring acts as the secretariat to MADRAC. It is a WHO-approved pharmacovigilance centre, and was accepted as the 30th member of the World Health Organisation (WHO) Programme for International Drug Monitoring in 1990.
  • Under this programme, all adverse drug reaction reports received and assessed by MADRAC are forwarded to the central WHO Global ICSR (individual case safety report) database, which is maintained by the Uppsala Monitoring Centre (UMC), the WHO Collaborating Centre in Sweden.

 

Core Functions 

  • To promote ADR reporting in Malaysia.
  • To provide reliable information and advices to DCA on drug safety.
  • To disseminate drug safety information to doctors, pharmacists and other healthcare professionals.
  • To participate in global pharmacovigilance activities via the WHO Programme for International Drug Monitoring.

 

Objectives of ADR Monitoring 

  • To detect adverse reactions to drugs as early as possible, especially for serious, rare or unknown reactions.
  • To establish the frequency and incidence of adverse reactions for both well-recognised and newly discovered reactions.
  • To identify risk factors that may predispose / induce / influence the development, severity and incidence of adverse reactions.
  • To maintain a local database for sharing of information with regard to drug safety.
  • To implement preventive measures to reduce the risks associated with drug use.

 

Reporting Mechanism

madrac-reporting-mechanism

 

Impact of ADR Monitoring

Achievement of the primary objectives will empower the stakeholders to implement preventive activities to reduce the occurrence of future incidence.

  • Marketing authorisation holder can initiate steps to make changes to the product information.
  • Regulatory authority can take appropriate action in the interest of public health to minimise risk as a result of medicine use.
  • Healthcare professionals have better awareness on benefit and risk of medicines and thus practise rational prescription of drug.
  • Consumers are equipped with better knowledge of the consequences of drug use and thus use drugs more appropriately.

 

(Updated: 25 May 2012)

 

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