Reporting systems

In many countries, adverse effects are required by law to be reported, researched in clinical trials and included into the patient information accompanying medical devices and drugs for sale to the public.

UK

The Yellow Card Scheme is a UK initiative run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM) to gather information on adverse effects to medicines. This includes all licensed medicines from medicines issued on prescription to medicines bought over the counter from a supermarket. The Scheme also includes all herbal preparations and unlicensed medicines found in cosmetic treatments. ADRs can be reported by a number of healthcare professionals including doctors, pharmacists and nurses, as well as patients.
For further information see the Yellow Card Scheme website, or find copies of the Yellow Card in the appedices of a BNF.
To read reports from the UK Yellow Card Scheme you can download here.

USA

In the USA several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse Event Monitoring System. MedWatch is the main reporting center, operated by the Food and Drug Administration.

Australia

In Australia, adverse effect reporting is administered by the Adverse Drug Reactions Advisory Committee (ADRAC), a subcommittee of the Australian Drug Evaluation Committee (ADEC). Reporting is voluntary, and ADRAC requests health professionals to report all adverse reactions to its current drugs of interest, and serious adverse reactions to any drug. ADRAC publishes the Australian Adverse Drug Reactions Bulletin every 2 months