Detailed Drug Analysis Print interpretation guide

The DAPs provided on this website give complete listings of all UK spontaneous ADRs reported through the Yellow Card Scheme to the MHRA and the Government’s independent scientific committee on medicines safety, the Commission on Human Medicines (CHM).

Up until 2005, only healthcare professionals such as GPs, hospital doctors, pharmacists and nurses could submit Yellow Card reports. However, since January 2005, patients have also been able to submit ADR reports through the Yellow Card Scheme, and these are included in DAPs.

Each DAP lists the suspected reactions reported for a particular medicine, which are listed by the name of the active ingredient, not by the brand name. The name of the active substance(s) in your medicines can be found on the medicine pack or in the patient information leaflet (PIL) accompanying your medicine.

It is important to note that healthcare professionals and patients are asked to report an ADR even if they only have a suspicion that the medicine may have caused it. The fact that a report has been submitted does not necessarily mean that the medicine has been proven to cause a reaction.

Essential information about Drug Analysis Prints
The information contained in Drug Analysis Prints (DAPs) can be very useful in helping to identify possible safety issues with medicines. However, DAPs do not present a complete overview of the risks associated with specific medicines, and therefore cannot be used alone to base conclusions on the safety and risks of medicines.

For more comprehensive information about the risks of particular medicines, you should refer to the patient information leaflet for the medicine, or ask your doctor, nurse or pharmacist.

When using a DAP, you should remember that:

• The likelihood of experiencing an ADR when taking a medicine cannot be estimated from the information in DAPs as we have limited information about how many people have taken the medicine without experiencing a reaction.
• Both patient and healthcare professionals are asked to submit Yellow Card reports even if they only have a suspicion that the medicine may have caused the ADR; therefore the existence of an ADR report on a DAP does not necessarily mean that the medicine has caused the reaction.
• It may be difficult to tell the difference between something that has occurred naturally and an ADR. Sometimes reactions can be part of the condition being treated rather than being caused by a medicine.
• Many factors have to be considered when assessing whether a medicine has caused a reported ADR. When monitoring the safety of medicines, MHRA staff carry out careful analyses of these factors.
• It is not possible to compare the risks of different medicines by comparing the numbers presented in DAPs.
  

If you are concerned about the medicine you are taking, you should contact your GP, the health professional who prescribed the medicine, your pharmacist or NHS Direct on 0845 4647. You should not stop taking any prescribed medicine without first talking to a health professional.

Layout of Drug Analysis Prints
DAPs list all suspected reactions reported to have occurred in association with the use of a particular medicine through the Yellow Card Scheme. In addition, DAPs:

• list all individual suspected ADRs reported on Yellow Cards by active substance
• list medicines by active ingredient - the brand names included are shown at the beginning of the print if a Yellow Card report has specifically stated it
• include data for reports where the drug was given as a single active ingredient (known as a single-constituent drug) and where the drug was given in a product containing several other active ingredients (a multi-constituent drug)
• list the total number of reactions and reports on the first page of the print (each report relates to a single patient and may contain multiple reactions). On the last page of the print these are broken down into the number of reports for single constituent drugs, multi constituent drugs and a total
• group together suspected ADRs by medical terms, broken down by more specific conditions. A high level grouping method by System Organ Class (SOC - the highest level in MedDRA - Medical Dictionary for Regulatory Activities) which groups together reactions that affect similar systems/organs in the body) on page 2 of the print, followed by a more detailed breakdown on the following pages
• list the total number of reports received for a particular reaction (on the right-hand side of each reaction), and the number of reports where there was a fatal outcome by both single constituent and multi-constituent formulations. Totals of the data are displayed in the ‘Total unique reports’ columns.

Please note that many Yellow Card reports contain more than one suspected reaction and the total number of suspected reactions listed on the DAPs may be higher than the number of reports received for the drug.

Use of Yellow Card Data for publication
If you wish to copy or circulate either the Drug Analysis Print or the information contained within it to anyone else, please ensure that a copy of these guidelines is also provided.

The MHRA and CHM encourage the use of data from the Yellow Card Scheme in research and for publication, but wishes to ensure that the limitations to interpreting the data are made clear.

If you propose to publish information based on Yellow Card data or Drug Analysis Prints, the MHRA is most willing to provide advice on how the Yellow Card information is interpreted and might be best used and presented. The MHRA is also willing to provide feedback on manuscripts prior to publication. Please write to the Director, Vigilance and Risk Management of Medicines Division at the address below.

Further information
If you require further information, please contact the MHRA by:

Telephone: 020 3080 6000
Email: info@mhra.gsi.gov.uk

Write to us at:
Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
London
SW1W 9SZ

Please support the Yellow Card Reporting Scheme by reporting suspected adverse drug reactions (www.mhra.gov.uk/yellowcard).