• Appendix

What are the functions of a National Pharmacovigilance System?

The minimum functions of a national pharmacovigilance (PV) system have been defined to include the following:

  1. 1

    To promote PV in the country, collect and manage adverse drug reaction (ADR) reports as well as reports of medication errors and suspected counterfeit/substandard drugs

  2. 2

    To collaborate and harmonize with other ADR collection activities within the country (e.g. national disease control programmes, poison control centres, etc.) as well as international monitoring of ADRs in cohorts of defined patients

  3. 3

    To identify signals of drug safety, i.e. unknown or poorly characterized adverse events in relation to a drug or drug combination and/or its use

Minimum requirements for a functional PV System

Pharmacovigilance activities may be undertaken by several organisations, individuals and agencies. In most countries, the national system is organized and coordinated by the Ministry of Health or one of its agencies, typically the National Medicines Regulatory Authority. In some countries, it is undertaken by academic institutions, by hospitals or by independent legally-recognised organisations. The core minimum requirements that should be present in any funtional national pharmacovigilance system as follows:

01. A national PV center

A national pharmacovigilance center with designated staff (at least one full-time), stable basic funding, clear mandates, well defined structures and roles and collaborating with the WHO Programme for International Drug Monitoring

02. A national spontaneous reporting system

The existence of a national spontaneous reporting system with a national individual case safety report (ICSB) form i.e. an adverse drug reaction (ADR) reporting form

03. A national database

A national database or system for collating and managing ADR reports

04. PV Advisory Commitee

A national ADR or pharmacovigilance advisory commitee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where neccessary, crisis management including crisis communication

05. Communications strategy

A clear strategy for routine and crisis communications

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