Reporting adverse drug reactions
By Dr Matt Piccaver, GPST3 and Trainee Doctor Advisory Board Member, MHRA
Following the problems with Thalidomide in the 1960s and 70s, increased scrutiny has been given to the regulation and monitoring of medicines through the MHRA.
GP trainees will be aware of the surveillance of adverse drug reactions (ADRs) – harmful or unwanted reactions that occur after administration of a drug or drugs. Such a reaction may be a known effect of the drug, or may have been previously unrecognised.
Adverse drug reactions can occur during initial drug trials, but some very rare ADRs may only become apparent when large numbers of patients take drugs for a prolonged period of time. This makes the reporting of suspected ADRs via the Yellow Card system all the more important.
A recent survey of GP trainees revealed that approximately 70% had heard of the MHRA, with as many having seen a patient with a suspected ADR. Around 67% knew how to report an ADR, but only 20% of respondents had actually reported an adverse drug reaction.1
Ideally, all ADRs should be considered for reporting, as this provides a body of data that may result in the discovery of potentially serious reactions. Even if there is uncertainty, the possibility of an adverse drug reaction should be reported. Reporting ADRs is easy, and takes a few minutes to complete. If done via www.yellowcard.gov.uk, an email acknowledging receipt of the ADR report is sent (something for the ePortfolio perhaps).
Once reported, ADR data is collated and any new and significant ADRs are identified and cascaded to healthcare professionals via the Drug Safety Update, “Dear Health Professional” letters or by new additions to the Summary of Product Characteristics.
Reporting of Adverse Drug Reactions plays a pivotal role in the post-marketing surveillance of medicines, helping to identify potential sources of harm and contribute to patient safety.
You should report:
- Serious adverse reactions to established medicines and vaccines (including herbal or over the counter medicines).
- All adverse reactions to new medicines (shown with a ▼ in the BNF).
- All adverse reactions in children to established medicines and vaccines.
References
1. Spooner C and Piccaver MT, Internal MHRA Survey.