MHRA/CHM safety information

Drug Safety Update
A monthly newsletter from the MHRA and CHM, which 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.

Safety warnings
Monthly newsletter on safety information sent to healthcare professionals regarding any medicines including herbal preoarations

 
Product specific information and advice
The MHRA provides information on the following groups of drugs which are under close surveillance, due to serious or emerging safety concerns.

 
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 by healthcare professionals and patients. These can be accessed from the MHRA website, along with guidance for their interpretation

Questions and Answers on Interactive Drug Analysis Profiles
Q1. If a reaction is listed on a iDAP for a particular drug, does this mean that the drug has caused it?
A1. 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 have to be taken into account in assessing the likelihood that a drug has caused a reaction including the possible contribution of other medication that a patient may be taking and any underlying disease that the patient may have; the reaction may have happened in the first place or there may be reasons an individual or group of individuals might be at greater risk of a reaction.
   
Q2. Can the information in the iDAP be used to determine the likelihood of an ADR to a particular medicine occurring?
A2. No. 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 to it or a raised profile of a medical condition.