Reporting suspected adverse drug reactions and suspected defects in medicinal products

The Yellow Card Scheme – collecting information on adverse drug reactions
The Yellow Card Scheme is run by the MHRA and the Commission on Human Medicines (CHM).  The Scheme is used to collect information from health professionals and patients on suspected adverse drug reactions (ADRs). 

The MHRA and its predecessor organisations have collected reports of suspected adverse drug reactions through the Yellow Card Scheme for over 40 years. Since the establishment of the Yellow Card Scheme over 500,000 UK reports have been collected.

We collect Yellow Card reports from both health professionals and members of the public on:

• prescription medicines;
• herbal remedies; and
• over-the-counter (OTC) medicines.

› Download information on medicines that has been collected through the Yellow Card Scheme (Drug Analysis Prints)

The MHRA and CHM also have five Yellow Card Centres whose role focuses on follow-up of reports in their areas as this has been shown to improve follow-up rates.  (Reporters may request follow up by MHRA if they would prefer this.)

• Yellow Card Centre Mersey, Freepost, Liverpool. L3 3AB.
• Yellow Card Centre  Wales, Freepost, Cardiff, CF4 1ZZ.
• Yellow Card Centre  Scotland, 51 Little France Crescent, Old Dalkeith Road, Edinburgh. EH16 4SA.
• Yellow Card Centre  Northern and Yorkshire, Freepost ,Newcastle-upon-Tyne. NE1 1BR.
• Yellow Card Centre  West Midlands, Freepost, Birmingham. B18 7BR.
  

Please select one of the following:

› A healthcare professional and wish to make a report on behalf of a patient?
› Patient, parent or carer and wish to make a report?
› Patient information on adverse drug reactions (ADRs)

The Defective Medicines Report Centre - collecting information on suspected defects in medicinal products
The Defective Medicines Report Centre (DMRC) receives and assesses complaints and reports of actual or suspected defects in medicinal products for human use and co-ordinates the necessary actions.

The Centre provides an assessment and communication system between suppliers (manufacturers and distributors), users of medicines and other regulatory authorities. 
  
Manufacturers and importers are obliged to report to the MHRA any quality defect in a medicinal product which could result in a recall or restriction on supply. Other users and distributors of medicinal products are encouraged to do this.

Where a defect is considered to be a risk to public health, the marketing authorisation holder withdraws the affected product from use and the MHRA issues a 'drug alert' letter. This alert is classified from 1 to 4 depending upon the risk presented to the public health by the defective product. Class 1 is the most critical, for example serious mislabelling, microbial contamination or incorrect ingredients, and requires immediate recall; Class 4 is the least critical and advises 'caution in use'.

The DMRC is also part of the European Rapid Alert System which disseminates information on drug quality issues within EU Member States.

Patients or members of the public who have concerns about the quality of a medicine should in the first instance refer the matter to their pharmacist or doctor, who may then decide to contact the MHRA. Should this not be possible, patients and members of the public may contact the DMRC directly. Telephone 020 7084 2574 (during office hours Monday to Friday 0900 -1700). Telephone 020 7210 3000 (urgent calls outside of normal working hours, at weekends or on public holidays).