This section provides information about: completing a Yellow Card; feedback to reporters; medicines under intensive monitoring; and reactions regarded as “serious”.


Completing a Yellow Card

 How do I complete a Yellow Card?

If you are unsure about completing a Yellow Card and would like to discuss with a member of staff here, please Contact Us or telephone 0131 242 2919 during office hours.


Impact of Reporting

The video below shows Jazz, a pharmacist and Yellow Card reporter. She was concerned about a patient who almost choked after placing a medicine into the wrong part of their inhaler. Using the Yellow Card reporting scheme, she was able to make a big difference to patient safety.


Do I Need to be Certain Before Reporting?

All that is required is a reasonable suspicion that a health effect has been caused by a medicine in normal therapeutic use. It is important to remember that proof of association, for example, by a rechallenge, is NOT necessary.

In the case of serious reactions reporters are often uncertain as to whether to send in reports of reactions they regard as well known. For serious reactions it is still important to report these since this information is used to develop health policies, for example, on over the counter marketing, and to allow relative toxicity of drugs that are in the same class to be compared.

If you are concerned about the effects of drugs taken in overdose in Scotland, please contact Edinburgh Clinical Toxicology, part of the National Poisons Information Service, by telephone on 0844 892 0111, or visit the Edinburgh Clinical Toxicology website


Information to Include on a Yellow Card

Details of the patient

Please complete the patient’s local identifier number (e.g. hospital number) and initials, together with their age, gender, weight and ethnicity if known.

Suspect drug

Please complete the drug name, route, dose, dates of administration and, if known, the indication.

Suspect reaction

Please provide the clinical information available to you including date, outcomes, and treatment if known or relevant.

Other medicines

Please also include details of all additional other medicines prescribed for the patient or bought over the counter in the previous 3 months, including herbal remedies. This is necessary because the drug you suspect may in fact only have caused the reaction because of an interaction with one of the other medicines. Collecting data of this sort is extremely helpful in identifying ADRs.

Reporter details

Please complete all the details requested in the box, including a contact name, address and, ideally, telephone number. If you are not a physician please also include the relevant clinician’s name in the adjacent box. 


Confidentiality

Confidentiality of health details is important to patients and health professionals alike. Nevertheless, without a patient identifier on the Yellow Card it will not be possible for the MHRA to make full use of the report. This information is important in follow-up, and may also help to prevent duplicate reports on the database.

The reporter, however, must include all details of their name and address to ensure that appropriate follow-up can be carried out. If the reporter is anonymous it is unlikely the report will be entered into the database since this does not constitute a valid report.


Feedback to Reporters

All Yellow Card reports are dealt with by the MHRA, and YCC Scotland does not receive these directly. Yellow Card reports received by the MHRA are entered directly into their adverse drug reaction database. Where follow-up information is required, the MHRA may contact you to clarify details of the reaction or to obtain further information on the outcome of a reaction.

Information about other reports associated with a particular medicine can be found in the Interactive Drug Analysis Profiles (iDAPs) prepared by the MHRA. The way adverse drug reactions are reported in the United Kingdom, based upon suspicion rather than certainty that an adverse drug reaction (ADR) has occurred, means that such reports cannot be used as a method of assessing the likelihood of experiencing an ADR. The iDAP will, however, give you some information about the relative number of ADRs occurring in different body systems and the frequency of other reports which have been made that are similar to the report you submitted.