Q&A 316.3
How do I complete a Yellow Card?
Prepared by UK Medicines Information (UKMi) pharmacists for NHS healthcare professionals
Before using this Q&A, read the disclaimer at www.ukmi.nhs.uk/activities/medicinesQAs/default.asp
Date Prepared: 21st February 2014
Background
The Yellow Card Scheme is the United Kingdom’s strategy for monitoring suspected Adverse Drug Reaction (ADRs). It was set up in 1964 in response to the thalidomide disaster. More than 20,000 reports of suspected ADRs are received by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the Scheme each year. The Scheme collects reports regarding all medicines, including prescription, over-the-counter or general sales list drugs. Reports are also received for herbal and other unlicensed medicines. The Yellow Card Scheme allows health professionals and patients to report suspected ADRs on a voluntary basis. In addition, there is a legal requirement for companies to report suspected ADRs to their drugs (1).
The Scheme primarily acts as an early warning system for the identification of previously unrecognised adverse reactions and also provides valuable information on recognised ADRs, allowing the CHM and MHRA to identify and refine the understanding of risk factors that may affect the clinical management of patients (1). The value of the Scheme has been demonstrated many times and it has helped to identify numerous important safety issues. The information from the Scheme may lead to changes in dose, special warnings or precautions being added to Summary of Product Characteristics (SPC) or even withdrawal of the drug from the market if the risks of receiving treatment are considered to outweigh the benefits.
Answer
An ADR is defined by the MHRA as ‘an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use, which is suspected to be related to the drug (1).’
Suspected ADR:
A Yellow Card should be completed whenever a drug is suspected to have caused an adverse reaction, regardless of whether causality can be ascertained – if in doubt please report (1).
Black Triangle Drugs:
All reactions (serious & non-serious) to black triangle drugs should be reported. A black triangle drug is one which is under additional monitoring by the MHRA. Black triangle status has recently been adopted by all EU member states and from Autumn 2013 all the drugs are denoted by a ▼symbol in the BNF, SPC, patient information leaflet (PILs) and any advertising material throughout Europe. There is relatively little safety information regarding a medicine when it comes to market due to small sample size of clinical trials that also use homogenous populations. Rare or delayed adverse effects may not be detected. Medicines are therefore allocated black triangle status in order to gain as much information about the associated risks of treatment and this is used ensure patient safety.
Black Triangle is always assigned to a medicine if:
¨ it contains a new active substance; new medicines or vaccines authorised on or after January 2011
¨ it is a biological medicine, such as a vaccine or a medicine derived from plasma (blood)
¨ it has been given a conditional approval (where the company that markets the medicine must provide more data about it) or approved under exceptional circumstances (where there are specific reasons why the company cannot provide a comprehensive set of data)
¨ the company that markets the medicine is required to carry out additional studies: for instance, to provide more data on long-term use of the medicine, or on a rare side effect seen during clinical trials.
A medicine will usually remain on the additional monitoring list for 5 years unless it is requested by the regulator that it remain black triangle in order to meet obligations on the marketing authorisation.
A list of medicines currently under additional monitoring is available from the MHRA (1).
Serious Reactions:
All serious reactions should also be reported regardless of whether it is a well established reaction or if the causal relationship is unconfirmed. A reaction is considered serious when it is:
¨ Fatal
¨ Life threatening
¨ Disabling
¨ Incapacitating
¨ Harmful enough to have led to, or prolonged hospitalisation
¨ Considered medically significant
¨ Implicated in a congenital malformation (1)
Child Reports:
All reactions that occur in children (under 18 years) should be reported regardless of whether they are considered serious or not (1,2).
How to Report:
An ADR can be reported electronically or on paper
¨ It is easiest to report online at www.mhra.gov.uk/yellowcard.
¨ Yellow Cards can be downloaded at http://yellowcard.mhra.gov.uk/downloadable-information/
¨ Yellow Cards are available in the BNF, BNF for Children, ABPI Medicines Compendium, MIMS Companion or by calling 0800 731 6789 (1)
¨ Healthcare professionals using the clinical system, SystmOne, can submit electronic Yellow Cards directly to the MHRA.
¨ Medicines Information pharmacists may submit electronic Yellow Cards through the MiDatabank 3 system.
Four essential pieces of information must be included on a Yellow Card:
¨ The suspect reaction(s)
¨ Patient details (at least one of Patient identifier (non-identifiable patient data e.g. initials, hospital number), sex, age, weight [if known]).
¨ The suspect drug(s)
¨ Reporter details so that the MHRA can acknowledge your report and contact you for further information if necessary (1)
Additional information is useful to include if available:
¨ Suspect drug(s)
o Dose, frequency, route and dates of administration
o For vaccines, quote the brand and batch number
¨ Suspect reaction(s)
o Describe the reaction and include any diagnosis
o Date reaction occurred
o Seriousness of reaction
o Details of any treatment given and outcome of reaction
¨ Any additional relevant information
o Other drugs taken in 3 months prior to reaction (including OTC medicines and herbal remedies)
o Test results
o Medical history
o Any details of rechallenge with suspect drug(s)
o In cases of teratogenicity, all drugs taken in pregnancy and date of last menstrual period (1)
All reports are entered onto the Sentinel database, which is analysed by the MHRA to look at the relationship between medicines and side effects.
¨ The risk is examined to see if it is common or serious, and then a decision taken on whether any action should be taken.
¨ Warnings may be added to the product information or patient information leaflet that comes with the medicine.
¨ Information on how the medicine should be used may be updated - for instance, limiting the dose, or advising that it should not be used by particular groups of patients.
¨ Information may be published on the MHRA website and in the monthly Drug Safety Update bulletin http://www.mhra.gov.uk/Publications/Safetyguidance/DrugSafetyUpdate/index.htm .
¨ Rarely, the medicine may be taken off the market, but only if the risks of the medicine are considered to outweigh its benefits (1).
Summary
The Yellow Card Scheme acts as an early warning system for the identification of previously unrecognised adverse reactions and also provides valuable information on recognised ADRs. It relies on voluntary reporting by health professionals and patients. The simplest way to submit a Yellow Card is online at www.mhra.gov.uk/yellowcard.
Limitations
The information is correct at the time of writing but may be affected by changes to the scheme by the MHRA and CHM.
Currently adverse reactions to medical devices or to blood and blood components are not covered by the Yellow Card Scheme, though this may change in the coming year.
References
1. Medicines and Healthcare Products Regulatory Agency. Accessed 21st February 2014 via http://www.mhra.gov.uk/Safetyinformation/Howwemonitorthesafetyofproducts/Medicines/TheYellowCardScheme/index.htm
2. Joint Formulary Committee. British National Formulary (online ed.) London: BMJ Group and Pharmaceutical Press <http://www.medicinescomplete.com> [Accessed on [21st February 2014]
Quality Assurance
Prepared by
Sarah Smith. Regional Drug and Therapeutics Centre
Update by Sarah Smith, Regional Drug and Therapeutics Centre
Date Prepared/Updated
5th March 2010.
Updated: 21st February 2014
Checked by
Hayley Johnson, Regional Drug and Therapeutics Centre
Date of check
18th March 2010
Updated version: 24th February 2014
Medicines Q&A Lead Check: 24th February 2014
Search strategy
MHRA searched on 21.02.14: ‘Yellow Card’
eBNF 62 searched on 21.02.14: ‘Yellow Card’
2
Available through NICE Evidence Search at www.evidence.nhs.uk