History of the Yellow Card Scheme (YCS)

The Yellow Card Scheme (YCS) is run by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Commission on Human Medicines (CHM). The scheme is used to collect information from healthcare professionals and patients on suspected adverse drug reactions (ADRs). The MHRA and its predecessor organisations have collected reports of suspected ADRs through the YCS since its introduction in 1964. Since establishment of the YCS over 1,000,000 Yellow Card reports have been collected.

What is an adverse drug reaction (ADR)?

An adverse reaction is a response to a medicine that is noxious (harmful or very unpleasant) and unintended and is suspected to be related to the medicine.

How common are ADRs?

ADRs are common. A study of hospital admissions in the UK (1) found that:

  • 6.5% of admissions are related to ADRs

  • Projected annual cost to the NHS is £466 million

  • Over 2% patients admitted with an ADR die, suggesting an overall fatality rate from ADRs within the population of 0.15%

  • 72% of ADRs are definitely or possibly avoidable

    1. Pirmohamed M, et al. BMJ 2004; 329: 15–19

How does the Scheme work?

The Yellow Card scheme relies on healthcare professionals and patients/carers to voluntarily report ADRs. It acts as an early warning system for the identification of previously unrecognised reactions and enables the identification of risk factors, outcomes and other factors that may affect clinical management. Since late 2014, as well as reporting suspected adverse reactions to medicines, you can also report any suspected problems or incidents associated with medical devices, defective and fake healthcare products.

The value of the scheme has been demonstrated many times and it has helped to identify many safety issues. For example Yellow Cards about liver toxicity with black cohosh resulted in improved safety warnings. The continued success of the scheme depends on the vigilance of UK healthcare professionals and general public and their willingness to report suspect ADRs. Every report can make a difference.

What should you report?

Please report all suspected ADRs to black triangle drugs (i.e. drugs marked with an inverted black triangle▼). These drugs are under intensive surveillance because they meet one or more of the following criteria:

  • it contains a new active substance

  • it contains a biological

  • it contains a new biosimilar

  • the company is required to carry out additional studies

  • it has been given a conditional approval or approved under exceptional circumstances (where additional information is not yet available or cannot be provided)

  • after new safety signals are identified

The list of medicines under additional monitoring gives details of all black triangle drugs and is updated monthly.

Please report serious suspected reactions to established medicines including over-the-counter (OTC) and herbal medicines. Serious reactions are those which are:

  • Fatal

  • Life-threatening

  • Disabling or incapacitating

  • Medically significant

And those which:

  • Result in, or prolong, hospitalisation

  • Result in congenital abnormalities

Examples of serious reactions (see table on the last page of the document)

However, if you are unsure about the seriousness of a reaction please report it anyway.

Other areas of special interest

Although the MHRA monitor adverse drug reactions associated with all medicines on the market, there are a number of areas in which they are particularly interested in receiving reports:

Delayed drug effects

The MHRA are interested in reports of ADRs which may appear months or even years after drug exposure, e.g. cancers, retroperitoneal fibrosis. Please report any suspicion of such an association.

Congenital anomalies

If a baby is born with a congenital abnormality, or if a pregnancy results in a malformed aborted foetus, please consider whether this might have resulted from an adverse reaction to a medicine, and report it if appropriate. In the report, please give information about any medicine taken during the pregnancy, including self medication and the date of the last menstrual period.

Herbal remedies

There are many herbal remedies available over the-counter from outlets other than pharmacies, or supplied by herbal practitioners, and only some of these are actually licensed for use. It is important that both licensed and unlicensed herbal products are monitored to ensure their safety; therefore please report suspected adverse reactions to any herbal remedy. It is important that you provide as much information as possible about the remedy, including its ingredients, the source or supplier, if known, and the condition that the product was being used for. If the remedy was supplied by a herbal practitioner, it would be useful to receive their name and address. You should also retain a sample of the product if the reaction is severe, in case further investigations are required.

Causality does not need to be established - you only need to have a suspicion that a reaction is related to a drug.

How do I report?

The easiest way to report is using the electronic Yellow Card here. You can register on the site and the Yellow Card can be saved at any time. You can keep track of the Yellow Cards you send. The website gives full instructions on how to complete the Yellow Card.

Yellow Cards can be reported:

  • online at www.mhra.gov.uk/yellowcard

  • via the Yellow Card app available in the Apple App Store or Google Play Store. Learn more about the app here

  • through SystmOne, Vision, EMIS and MiDatabank clinical IT systems

  • by emailing yellowcard@mhra.gov.uk or by downloading printable forms from the Yellow Card website and sending them to
    FREEPOST YELLOW CARD (no other address details are needed)

  • by completing Yellow Card forms in the BNF, NPF, MIMS, or PAGB OTC directory

  • by calling the Yellow Card reporting line on 0800 731 6789 (9am to 5pm Monday to Friday) (patients only).

What information should I include?

There are four critical pieces of information that should be included on the report:

1 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

For the local 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.

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

2 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

3 Suspect reaction(s)

Describe the suspected reaction(s), including a diagnosis if relevant. Include the date when the reaction occurred, seriousness, any treatment given and outcome.

4 Reporter details

Please include your name and full address. This is so the MHRA we can acknowledge receipt of your report, and follow up your report for further information if necessary.

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 the Yellow Card database can detect duplicate reports and link the information.

Additional information

Please include any additional information that you think might be relevant to the reaction:

  • Other drugs taken in the last three months prior to the reaction, including OTC and herbal medicines

  • Any information on rechallenge with the suspect drug(s)

  • Relevant medical history, including allergies

  • Relevant test results e.g. liver, kidney or blood test results if these have been affected

  • For congenital abnormalities, please state all other drugs taken during pregnancy and the date of the last menstrual period

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

All the information you provide helps interpretation of the case and evaluation of safety issues. Please provide as much relevant information as is readily available because this will reduce the need for follow-up, but do not delay reporting just because some details are not known.

How is Yellow Card data used to improve patient safety?

Information gathered from Yellow Card reports made by patients and healthcare professionals is continually assessed by a team of safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines.

If a new side effect is identified, information is carefully considered in the context of the overall side effect profile for the medicine, and how the side effect profile compares with other medicines used to treat the same condition. Action is taken, whenever necessary, to ensure that medicines are used in a way that minimises risk while maximising patient benefit.

In assessing the safety of medicines, the MHRA receives advice from the CHM, which is the Government’s independent scientific advisory body on medicines safety. The CHM is made up of experts from a range of clinical and scientific specialities and includes lay representatives.

From the data collected on Yellow Card reports the following can result:

  • Changes to the medicine’s Summary of Product Characteristics (e.g. maximum doses, addition of contraindications or cautions in patient populations or concomitant disease)

  • Publication of safety information in Drug Safety Update. You can subscribe to have an e-mail notification sent to you when it is published each month (Get emails)

  • ‘Dear Healthcare professional’ letters from the chairman of the CHM

  • Listings of suspected ADRs to drugs, Interactive Drug Analysis Profiles (iDAPs).

  • Rarely, withdrawal of a medicine if there is a risk to public health