Questions and answers on Yellow Card data

What is the Yellow Card Scheme?
The Yellow Card Scheme provides a system for early detection of emerging drug safety hazards and routine monitoring for all medicines in clinical use. Suspected adverse reactions to marketed medicinal products are reported to the Commission on Human Medicines/Medicines and Healthcare products Regulatory Agency (MHRA), which are jointly responsible for running the Yellow Card Scheme. In the past, reports were primarily submitted voluntarily by GPs, hospital doctors, dentists, coroners, pharmacists and nurses. Reports are also received via the pharmaceutical industry, which has a statutory obligation to report suspected serious adverse drug reactions (ADRs). Since January 2005, patients have been able to submit adverse drug reaction reports through the Yellow Card Scheme, and these are now included in Drug Analysis Prints.

Why was there a Review of the Yellow Card Scheme?
The primary purpose of the Review was to consider whether, and if so under what conditions and for what purposes, the data should be made more widely available. The Review was stimulated in part by increasing numbers of requests by independent researchers in academia and clinical institutions, who wish to use the data for research and audit purposes and in part by the potential for new uses, for example, in researching the use of genetics to reduce the burden of adverse drug reactions.

What recommendations were made by the Review?
There were 24 main recommendations, including a recommendation to open access to the Yellow Card Scheme data, and to maximise the release of data from the Scheme for independent research. The MHRA has opened access to Yellow Card data and will now publish anonymised aggregated data on the MHRA website. More detailed data will be made available for research, proposals for which will undergo scientific and ethical review.

Who will make the decision to release more detailed data to researchers?
All research proposals will undergo scientific review by the Independent Scientific Advisory Committee for MHRA database research (ISAC), which is independent of the MHRA and the CHM.  The ISAC will advise the MHRA whether or not it is appropriate for the data to be released for the purposes stated in the application, and advise if ethical approval should be obtained from a NHS Research Ethics Committee.
› Further information on the Independent Scientific Advisory Committee for MHRA database research (ISAC)

What information is available on the website?
Yellow Card data is presented on the website in the form of a Drug Analysis Print (DAP) which gives a complete list of all suspected adverse drug reactions (ADRs) reported through the Yellow Card Scheme in association with a medicine. It is, however, important to remember that the inclusion of a particular reaction does not necessarily mean that it has been caused by the drug. 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 the patient may be taking and the underlying condition of the patient.

If a reaction is listed on a DAP for a particular drug does this mean that the drug has caused it?
The inclusion of a particular reaction on a DAP does not necessarily mean that it has been caused by the drug. 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 the 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.

Can I use the information in the DAP to determine the likelihood of me experiencing an ADR to a particular medicine?
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, for example, media references to it or a raised profile of a medical condition.
 
Will anyone be able to get this information?
DAPs are published on the MHRA’s website so that anyone who is interested can access the information easily.

Will the move not breech patient confidentiality?
Patient confidentiality is inherent to the Yellow Card Scheme and the data that will be published on the website will be suitably anonymised in order to fully protect patient confidentiality.

What about the recommendation to allow patients to report directly to the MHRA/CSM?
Recommendations for direct patient reporting of suspected side effects were immediately accepted on the publication of the Report of the Review on 4 May 2004. A nationwide pilot of patients directly reporting suspected side effects of drugs to the regulator was launched in October 2005. The pilot demonstrated that patient reporting provides valuable information and was established as a permanent part of the Scheme in February 2008 with new paper and online reporting forms.
› Reporting suspected adverse drug reactions