An adverse drug reaction (ADR) is an injury caused by taking a medication.
Early, routine reporting of ADRs, and medicine related incidents and near misses is encouraged to allow appropriate investigation, problems rectified and lessons learned.
For established medicines and vaccines all serious suspected ADRs, even if the effect is well recognised, should be reported.
New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristic (SPC). All suspected ADRs for these products should be reported.
Reports of suspected ADRs should be made through the Yellow Card website, hardcopy form, smartphone app or using your clinical IT system where feasible).
Information that should be included in a Yellow Card report:
More information on what to include may be found on the MHRA website.
Spontaneous reporting does not provide a reliable estimate of the incidence of ADRs but it gives some indication of trends regarding what is being reported.
Early phase 3 and phase 4 clinical studies are the best source of information on ADRs where comprehensive reporting and evaluating harms is included.
Summaries of spontaneous ADRs received by the MHRA regarding individual opioids may be found there.
Medicines and Healthcare Products Regulatory Agency.The Yellow Card Scheme: guidance for healthcare professionals. 2015