Reporting Adverse Effects From Medicines

Key Points

  • 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 (https://yellowcard.mhra.gov.uk), hardcopy form, smartphone app or using your clinical IT system where feasible).
  • Information that should be included in a Yellow Card report:

– Suspected drug(s)
– Suspected reaction(s)
– Patient details

  • 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 here.

 


Further Reading

  • Medicines and Healthcare Products Regulatory Agency.The Yellow Card Scheme: guidance for healthcare professionals. 2015