Post-marketing surveillance of drugs. The spontaneous reporting scheme: role of the Adverse Drug Reactions Advisory Committee.

Post-marketing surveillance of drugs in Australia operates predominantly through the spontaneous reporting of suspected adverse drug reactions (ADRs). Approximately 50% of reports are submitted by hospitals and the rest by individual doctors, pharmacists and dentists. Some 4500 reports ("blue cards") are now reviewed annually by the Adverse Drug Reactions Advisory Committee (ADRAC) and its Secretariat. The register of ADRs has now accumulated more than 65,000 reports. Collations and analyses of data derived from the review process are published to increase awareness by health professionals of drug associated morbidity. Continued educational efforts by professional bodies and regulatory agencies will play a key role in rationalising drug use and reducing drug induced disease.