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All Yellow Card reports received either on paper or electronically are promptly entered onto the MHRA’s adverse drug reaction (ADR) database so that they are available for signal detection. Signal detection is the continual review of ADR reports to identify previously unrecognised concerns about medicines, vaccines or blood products, which may warrant further action. Sometimes a signal can comprise a change in the pattern or frequency of ADRs already associated with a medicine; this, too, may warrant further action.
The Yellow Card Scheme’s contribution to detecting these new concerns is immensely valuable. Analysis of data from the Yellow Card Scheme, alongside information from other sources to quantify the risk, leads to a decision on how best to act to protect public health.
Yellow Card Scheme procedures are specifically designed to ensure prompt availability of Yellow Card data for signal detection.
Data entry
Paper Yellow Cards require manual data entry, whereas electronic Yellow Cards are automatically loaded into the database then reviewed to ensure data has been entered correctly. Yellow Card Scheme staff ensure that the database accurately reflects Yellow Card reports and that the process fully supports prompt and effective action on emerging information on harms. Information from Yellow Card reports is entered onto a database and checked as follows:
- Minimum required details—such as patient details, reporter details, name of suspect drug/medicine, and reaction—are present. (For more information on confidentiality please see protecting patient confidentiality) All Yellow Card reports are acknowledged—either by email or electronic Yellow Card or by letter and are accompanied by a copy of the submitted Yellow Card report.
- All remaining information provided on the Yellow Card is then entered.
- A final quality audit step is carried out to ensure accuracy of the data.
Once all the information is on the database, a number of processes start.
Signal detection
Using specialised software, Yellow Card data are subjected to statistical analysis of all drug-reaction combinations on the database. This identifies ‘signals’—drug-reaction combinations that occur more frequently than would be expected when compared to the background frequency of other drug-reaction combinations in the database.
Signals that meet defined criteria are evaluated further by a team of safety experts to assess the likelihood of causal relationship between the drugs and reported reactions. (Please see the Looking for potential drug safety issues in Yellow Card data page for more information).
Assessment and follow-up for further information
After entry onto the database, Yellow Card reports are assessed by a team of physicians, pharmacists and scientists, with expertise in assessing the benefits and risks of medicines.
Importantly, at this stage we also use search other data sources to investigate the causal relationship between the medicines and reported reactions and to identify possible risk factors eg age, underlying disease and genetic predisposition. These sources include, for example, case reports in the literature, information from pharmaceutical companies, pre and post-marketing clinical trials, epidemiological studies and data from other medicine regulatory authorities and from global ADR databases.
Occasionally further information or clarification is requested from the reporter so that the report can be properly evaluated.
Regulatory action and communication
A number of options for action are available to minimise the risk from a newly confirmed adverse effect. In rare circumstances, a medicine may be withdrawn from the market if its risks are considered to outweigh its benefits. More usually, the risk of a side effect may be avoided or reduced by restricting its indications, reducing the recommended doses, changing the duration of treatment, or by adding special warnings and precautions.
The Commission on Human Medicines (CHM) and its Pharmacovigilance Expert Advisory Group (PEAG) advises the MHRA on medicine safety issues. Such issues are put to Committees which include representatives from all European Union regulatory authorities.
Changes as a result of new information on harm can by communicated in the product literature (summary of product characteristics and patient information leaflet); clinicians are also alerted of important changes by means of the monthly bulletin Drug Safety Update or by direct communication, usually from the pharmaceutical company. The MHRA also strives to alert secondary information providers (such as the British National Formulary and clinical software suppliers) of new information on adverse reactions.
Data provision
Another important function is the provision of anonymised data. The MHRA supplies anonymised case details (with reporter details removed and patient details anonymised) to pharmaceutical companies so they can perform safety analyses.
We also publish cumulative listings of all suspected ADRs received. The listings are called Drug Analysis Prints (DAPs) and are available on our website. These data are also used for answering enquiries on suspected adverse reactions from healthcare professionals and members of the public.
Patients and health professionals reporting suspected adverse drug reactions to the Yellow Card Scheme help contribute to these important processes. Suspected reactions can be reported online at www.mhra.gov.uk/yellowcard.
