Feedback from the MHRA

Routine issues
The Summary of Product Characteristics (SPC) and patient information leaflets (PILs) are updated appropriately when there are new safety concerns. 

The Summary of Product Characteristics and patient information peaflets for a drug can be found in:

• The electronic Medicines Compendium website;
• The ABPI Compendium of Data Sheets and Summaries of Product Characteristics.

Patient information leaflets (PILs) are provided with all medicines.

Serious issues
Three to four times each year the MHRA publishes the bulletin, 'Current Problems in Pharmacovigilance', which is mailed to all doctors, dentists, pharmacists and coroners. This is used to communicate information about serious drug safety issues.

Urgent issues
Occasionally healthcare professionals must be immediately informed about a safety issue. This may be because of the seriousness of a newly identified ADR, because a drug is being withdrawn on safety grounds, or because a quality defect has occurred. How the information is disseminated will depend on the nature of the problem.

•  Urgent safety issues – health professionals may receive a letter from the Chairman of the Committee on Safety of Medicines which:
   
• • outlines the issue; 
  • outlines the action being taken; and
  • provides advice on the implications for patient treatment.
    

These letters are usually distributed via the MHRA's direct fax system for drug alerts or via the Chief Medical Officer's Public Health Link and are also published on the MHRA website. 

•  Alternatively, health professionals may receive a letter from the pharmaceutical company responsible for the medicine.