Healthcare professional reporting of adverse drug reactions: What information to include in a Yellow Card

There are four critical pieces of information which must be included on the report:

(i) Suspect drug(s)
Drug(s) suspected to have caused the reaction.

It is also helpful to have the following:

• route of administration;
• daily dose; and
• dates of administration. 

 (ii) Suspect reaction(s)

• Suspected drug reaction(s) including a diagnosis if relevant. 
• Tick boxes are provided for you to record whether you consider the reaction is serious and the reasons why.
• Any treatment given for the reaction, as well as the dates of the reaction and its outcome.

(iii) Patient details
Basic information about the patient is vital in assessing reports and obtaining further information. Please provide:

• patient sex;
• patient age at the time of the reaction;
• if known, please provide the patient’s weight
• to help you identify the patient in any future correspondence please include the patient's initials and a local identification number (hospital or practice reference number) which can identify the patient to you.

This does not breach confidentiality agreements between you and your patient.

What local patient identification number should I use?
You can use any number or code that will identify the patient to you, but not to the MHRA. For instance, you could use the patient's local practice or hospital number or you may wish to set up a file specifically for Yellow Cards.

We consider that it is vital that a copy of the Yellow Card report is included on the patient's notes for future reference.

(iv) Reporter details
This field must be completed in all cases. Please include your name and full address. This will enable us to acknowledge receipt of the report, and follow up for further information if necessary.

Any additional information
We would be grateful if any other information that you think might be relevant to the report could be provided in the other fields on the card.

• Other drugs: Please fill in as much information as known about drugs the patient was taking in the last three months prior to the reaction. If the patient was not taking any other drugs, or if no other information is available on the case, please indicate this.
• Any information on rechallenges'
• Relevant medical history, including allergies'
• Relevant test results'
• For congenital abnormalities please state all other drugs taken during the pregnancy and the date of the last menstrual period.
• Attach additional pages (including print-outs of test results) if necessary.

Any information you provide helps us to interpret the case and evaluate safety issues. Please provide as much relevant information as is readily available, but do not delay reporting just because some details are not known. We will contact you if we require additional information.