Healthcare professional reporting: How to report

Nurse reporting safety problem on a computer

 

How to report
There are three main methods for reporting a suspected adverse drug reactions (ADRs) to the Yellow Card Scheme.

Reporting online
It is easiest and quickest to report ADRs online at http://www.mhra.gov.uk/yellowcard Full instructions are given on the website. If you chose to register, you can also keep track of any Yellow Cards that you send.

Reporting directly from clinical systems
Electronic Yellow Card reporting is now available in the Medicines Information system MiDatabank (external link) (provided by CoAcS (external link)). For more information on this please visit the MiDatabank website (external link).

Health professionals using the clinical system SystmOne (external link) (provided by The Phoenix Partnership (external link)) can also transmit Yellow Cards to the MHRA directly from the software.

Reporting by post
Yellow Card forms are available:

Yellow Card forms are also available from our regional Yellow Card Centres:

These centres help to raising awareness of the Yellow Card Scheme and provide education and training in their region (including advice on what to report and help in completing the form). They also help provide information on drug safety matters at a regional level.


What to include
There are four critical pieces of information required for a Yellow Card report:

1. Suspect drug(s)
The name of the drug(s) suspected to have caused the reaction.
If known, it is helpful to have the following:

  • route of administration
  • daily dose, dose frequency and schedule
  • dates of administration
  • if it is a vaccine, please quote brand and batch number


2. Suspect reaction(s)
Describe the suspected reaction(s) including a diagnosis if relevant. Include:

  • when the reaction occurred
  • seriousness of the reaction
  • any treatment given
  • outcome of reaction

If the reaction has already been reported (e.g. by another healthcare professional or the patient) but you have additional information to report, please submit a Yellow Card as we can detect duplicate reports and link the information.

3. Patient details
Basic information about the patient is vital in assessing reports and obtaining further information. Please provide at least one of the following:

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

Providing this information does not breach confidentiality agreements between you and your patient.

For the identification number, 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.

4. Reporter details
This field must be completed in all cases. Please include your name and full address so that we can acknowledge receipt of the report and follow up for further information if necessary.


Any additional information
We would be grateful for any additional information in the report that you think might be relevant such as:

  • other drugs taken in the last three months prior to the reaction, including over-the-counter (OTC) and herbal medicines
  • Any information on re-challenge with the suspect drug(s)
  • 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

If the patient was not taking any other drugs, or if no other information is available, please indicate this.

All the information that you provide helps us to interpret the case and evaluate safety issues. Please provide as much relevant information as is readily available to reduce the need for follow-up. However, please do not delay reporting just because some details are not known. We will contact you if we require additional information.


Page last modified: 17 September 2005