Search the website

Reporting Adverse Drug Reactions: A guide for healthcare professionals

May 2006

The BMA has long been concerned with the health of the public and believes that effective reporting of adverse drug reactions (ADRs) is an important mechanism for post-marketing surveillance of medicines and is vital for maintaining drug safety. In 1996 the BMA’s Board of Science published Reporting adverse drug reactions- a policy document (see reference 1), which discussed the different structures in place within the UK for ADRs. The report focused on the Yellow Card Scheme through which suspected ADRs can be reported spontaneously, but also briefly discussed prescription-event monitoring as a means through which ADRs can be recorded.

Since the 1996 BMA report, there have been a number of significant changes to the Yellow Card Scheme. This report includes these changes and acts as a signposting resource for healthcare professionals. Recommendations about ways in which healthcare professionals can help improve reporting of ADRs are listed at the end of this report.

Compared to other countries the number of spontaneous reports submitted in the UK is relatively high and reporting rates in relation to prescription volumes are also among the best in Europe (see reference 2). There are also a number of structured databases which systematically monitor healthcare events, including ADRs, which can be useful tools for pharmacovigilance. Despite this good record, it is vital that healthcare professionals remain vigilant, are aware of the need to report and keep track of any changes to the systems in place.

The recent Board of Science report Over-the-counter medication (2005) (see reference 3) stated that the availability and use of non-prescription drugs that are bought over-the-counter (OTC) have increased in recent years. Increased private sector availability from sources such as newsagents, supermarkets and the internet can result in OTC medications, including herbal remedies, being purchased with little or no support or control from doctors or pharmacists. This trend towards greater self-care can make correct identification of ADRs more difficult if the right questions are not asked of a patient. Problems can also arise if communication breaks down between different healthcare settings. This resource aims to reinforce the importance of pharmacovigilance and the reporting of ADRs in particular.