Who can submit a Yellow Card report and how?

Anyone can report using a Yellow Card, including:

• All HCPs (including pharmacists)
• People taking medicines or undergoing treatment 
• Parents
• Carers
• Members of the public

You can report a suspected ADR to the YCS through many ways:

• Online via the Yellow Card reporting website.
• On the app – search ‘Yellow Card’ on the Apple App Store or Google Play Store.
• Completing forms at the back of the British National Formulary (BNF), BNF for Children, The Monthly Index of Medical Specialities (MIMS), Association of the British Pharmaceutical Industry and sending them to ‘FREEPOST YELLOW CARD’.
• Via some clinical IT systems.
• By downloading and printing out a form from the Yellow Card website and sending it to ‘FREEPOST YELLOW CARD’.
• Freephone – 0800 731 6789 (9am to 5pm Monday to Friday).

There are different ways to report a problem with a medical device in Wales, Scotland or Northern Ireland. Further details can be found on the GOV.UK website.

How can pharmacists support Yellow Card reporting?

The reporting of suspected ADRs is voluntary. However, pharmacists have a professional responsibility to advise people and/or their carers on the reporting of any suspected side effects associated with their medicines. Reporting is supported within the codes of practice of all HCPs by their associations and their regulators. For further information, see the General Pharmaceutical Council website for the standards expected for registered pharmacies.

As best practice, we encourage the reporting of suspected ADRs under the YCS.

Following a discussion with the person, it may also be appropriate to make a record in the person’s notes and to notify the prescriber.

When and what should I report via the YCS?

Only a suspicion is needed to fill out a Yellow Card. If there’s any doubt about whether to report a suspected ADR, a Yellow Card should be completed.

All medicines and medical devices are covered by the YCS. This includes:

• Medicines (both prescribed and those available without a prescription).
• Suspected defective or counterfeit medical devices.
• Blood factors and immunoglobulins.
• Complementary products (e.g. herbal and homeopathic remedies).
• Unlicensed and off-label medicines. 
• Medical devices adverse incidents – devices used in healthcare for diagnosis, prevention, monitoring or treatment of illness or disability. For example, contact lenses, heart valves, blood glucose monitors, surgical instruments, wheelchairs, software, apps and AI. 
• E-cigarette products and their refills.
• Biological medicines (biosimilar medicines, blood products, antibodies, advanced therapies such as gene and tissue therapy) – ADR reports should clearly state the brand name and the batch number of the suspected medicine.

Suspected ADRs (often referred to as side effects) that are associated with the following are also reportable:

• Misuse.
• Abuse.
• Overdose.
• Medicine errors where harm occurs. 
• Defective medicines. 
• Suspected fake medicines. 
• Black triangle medicines (▼) – newer drugs and vaccines under additional monitoring.
• ADRs that are serious (serious events include those that are fatal, life-threatening, disabling or incapacitating, or resulting in hospitalisation), medically significant or that result in harm (for established medicines, even if the ADR is well-recognised).
• Children, young people and those over 65.
• Rare, long-term reactions and delayed drug effects; interactions with other medicines and food substances.
• Reactions not mentioned in the patient information leaflet (PIL) or summary of product characteristics (SPC).

What should my report include? 

You should include as much information as possible on the Yellow Card report to enable a full assessment by the MHRA. If all the information isn’t available at the time of reporting, you should still send in a Yellow Card report.

As a minimum, a Yellow Card report must include:

• Details about the person affected.
• Details about the drug(s)/vaccine(s) they were taking, including self-medication and complementary remedies.
• Details of the ADR they experienced.
• Details of the individual completing the report (i.e. their contact details).

Any information provided to the YCS is kept safe, secure and confidential. 

Anyone submitting a Yellow Card report will receive a confirmation of receipt of the report and may be contacted for additional information to help with the assessment of the report.

What happens to my Yellow Card report?

The report will be entered into the MHRA’s safety database. It’s then analysed alongside reports from the pharmaceutical company and additional sources of information, such as clinical and epidemiological studies, worldwide medical literature, data from other international medicines regulators and other databases.

Where appropriate, the MHRA acts and communicates any safety issues to minimise risk and maximise benefit to people. Examples of action include:

• Changes to or warnings in the product information or package label.
• Changing the information on how the medicine should be used.
• Changes in the specified dose of the medicine.
• Restricting the indications for use of a medicine (e.g. advising that it should not be used by particular groups).
• Changing the legal status of a medicine (e.g. from over the counter to prescription only).
• In rare circumstances, removal of the medicine from the market where the risks of the medicine are found to outweigh the benefits.

Veterinary medicines 

If a suspected ADR is related to a veterinary medicine affecting a human and/or an animal, refer to our pharmacy guide on veterinary medicines (link to be added soon) for further information.

Further information

RCPharm

• Pharmacovigilance guide (link to be added soon)
• Black Triangle Scheme guide

External

• National Institute for Health and Care Excellence – YCS
• MHRA – YCS
• GOV.UK – the YCS: guidance for healthcare professionals, patients and the public
• electronic medicines compendium and MHRA websites – SPCs and PILs
• MHRA – interactive Drug Analysis Profiles – suspected ADRs received 
• MHRA – Drug Safety Update – updated monthly

Online learning modules 

• MHRA – e-learning modules for HCPs
• Centre for Pharmacy Postgraduate Education
• NHS Education for Scotland – Turas Learn
• Health Education and Improvement Wales