Drug Safety Update

Drug Safety Update is a monthly newsletter from the MHRA and CHM, and aims to provide information and advice about the safe use of medicines. It is intended for all healthcare professionals who work in the UK – doctors, pharmacists, nurses, non-medical prescribers, dentists, allied health professionals and coroners. View the latest edition or sign up to receive Drug Safety Update by email by visiting the Drug Safety Update website.

Product specific information and advice

The MHRA provides information on managing specific medicines and medical devices and using them safely. Visit the MHRA’s product-specific information for more details.

Interactive Drug Analysis Profiles

Interactive Drug Analysis Profies (iDAPs) are complete listings of all suspected adverse drug reactions reported to the MHRA via the Yellow Card Scheme. These can be accessed from the iDAP section of the MHRA website, along with guidance for their interpretation

The inclusion of a particular reaction on a iDAP does not necessarily mean that it has been caused by the drug. Reporters are asked to submit Yellow Cards even if they only have a suspicion that a medicine may have caused the adverse reaction. Many factors must be taken into account in assessing the likelihood that a drug has caused a reaction, iluding the possible contribution of other medication that a patient may be taking and any underlying disease that the patient may have. There may be reasons an individual or group of individuals might be at greater risk of a reaction.

The number of reports for a particular medicine cannot be used to determine the commonness of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug is known. It is also known that many factors can influence reporting on a particular medicine, e.g. media references or a raised profile of a medical condition.

Regulatory Agencies

Pharmacovigilance

  • Yellow Card Scheme (MHRA)
  • YCC North West
  • YCC Scotland
  • YCC Wales
  • YCC West Midlands
  • Clinical Practice Research Datalink
  • Drug Safety Research Unit
  • Dutch Pharmacovigilance Centre (Lareb)
  • MedWatch: The FDA Safety Information and Adverse Event Reporting Program
  • Australian Advisory Committee on Medicines (ACM)
  • WHO Uppsala Monitoring Centre
  • MedEffect Health Canada
  • European Database of Suspected Adverse Drug Reaction Reports
  • Pharmacovigilance Risk Assessment Committee (PRAC)

Reporting Adverse Drug Reactions

  • Healthcare professional/ Patient
  • Black triangle information and list of current black triangle products
  • Drug Safety Update

Australian Adverse Drug Reactions

  • Database of Adverse Event Notifications (DAEN) – medicines
  • Medicines Safety

Medicines Information

  • Specialist Pharmacy Service (SPS)
  • United Kingdom Medicines Information (UKMi)
  • NICE Evidence Search
  • BNF (via NICE website)
  • Electronic Medicines Compendium (eMC)

Patient Information

  • NHS 111
  • NHS
  • Patient ADR reporting
  • Patient UK

Other

  • Department of Health
  • Commission on Human Medicines (CHM) of the MHRA
  • National Institute for Health and Care Excellence (NICE)
  • Toxbase
  • World Health Organization (WHO)