What happens to a Yellow Card

Acknowledgment and registration
When a Yellow Card is received you will receive an acknowledgement letter quoting the unique identification number assigned to your report. This number should be quoted in any future correspondence about the report. A copy of your report will also be provided, for inclusion in the patient's notes.

If you have ticked the box on the Yellow Card to request information about other reports associated with the suspect drug, you will also receive an anonymised cumulative listing of all suspected ADRs that have been reported by healthcare professionals.

Data entry
Cases are then entered onto the MHRA's Adverse Drug Reactions database together with their unique identification number. The database facilitates the monitoring of adverse drug reactions and allows rapid analysis of ADR reports.

Evaluation of reports
The physicians, pharmacists and scientists working in the Pharmacovigilance Group of the MHRA Post Licensing Division use data from Yellow Card reports to assess the causal relationship between the drugs and reported reactions, and to identify possible risk factors contributing to the occurrence of reactions, for example, age or underlying disease.

Assessment also includes analysis of relevant data from other sources, for example:

• case reports in the literature;
• pre- and post-marketing clinical trials;
• epidemiological studies;
• record-linkage databases; and
• data from other drug regulatory authorities.

The risk of a newly identified hazard is considered in the context of the overall adverse drug reaction profile for the drug in comparison with relevant therapeutic alternatives, and its benefits in terms of efficacy, the therapeutic indication and target patient population(s).

Regulatory action
Where necessary decisions are made on whether changes need to be made in the use of the medicine to minimise risks and maximise benefits. Such changes may include restrictions in use, reduction in dose, special warnings and precautions.

Rarely, a drug may be withdrawn from the market if the risks are considered to outweigh the benefits. The Commission on  Human Medicines and its Pharmacovigilance  Expert Advisory Group advises the MHRA on drug safety issues. Such issues are also considered in a variety of Committees including representatives from all EC Member States regulatory authorities.

Life cycle of a Yellow Card