Guidance

The Yellow Card scheme: guidance for healthcare professionals, patients and the public

Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.

From:
Medicines and Healthcare products Regulatory Agency
Published
23 January 2015
Last updated
1 January 2021 — See all updates

Reporting during the Coronavirus (COVID-19) outbreak

You should use our new dedicated reporting website to report any suspected side effects from medicines, future vaccines or medical devices relating to COVID-19 treatment.

However, sponsors should continue to report via the established routes for clinical trials.

Suspected side effects to a medicine, device, vaccine herbal or homeopathic remedy

Patients, care givers and healthcare professionals are asked to submit all suspected side effect reports using the Yellow Card scheme electronically instead of paper. This is because all MHRA staff are working remotely and no longer have access to the MHRA building since 23 March 2020 due to the pandemic.

Please note that once the MHRA regains access to its building, we will process any paper suspected side effects reported to the Yellow Card scheme. If you have sent a side effect Yellow Card after 17 March 2020, and you haven’t received an acknowledgement of your report, you may wish to resubmit your suspected side effect electronically.

You can report suspected side effects electronically via:

For any patients who do not have online access to report a suspected side effect to the Yellow Card scheme, call 0800 731 6789 for free, Monday to Friday between 10am and 2pm.

You can leave a message outside of these hours and one of our team will get back to you.

Medical Devices adverse incidents

There are different ways for healthcare professionals to report a problem with a medical device if you’re in Scotland or Northern Ireland.

If you are in England or Wales, please report any problems with medical devices online using the Yellow Card website.

Defective, fake medicines and medical devices, and e-cigarettes

Please use the Yellow Card website to report information on suspected problems or incidents involving:

Overview

The Yellow Card scheme is vital in helping the Medicines and Healthcare products Regulatory Agency (MHRA) monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and users.

Reports can be made for:

  • suspected adverse drug reactions (ADRs) to all medicines including:
    • vaccines
    • blood factors and immunoglobulins
    • herbal medicines
    • homeopathic remedies
  • all medical devices available on the UK market
  • defective medicines (those that are not of an acceptable quality)
  • fake or counterfeit medicines or medical devices
  • nicotine-containing electronic cigarettes and refill containers (e-liquids)

It is important that problems with medicines and medical devices and other nicotine e-cigarette products are reported, as the reports help identify new problems with these products.

MHRA will review the product and if necessary and take action to minimise risk and maximise benefit to patients and the public.

MHRA is also able to investigate counterfeit medicines or devices and if necessary take action.

What to report

Medicines

For established medicines and vaccines you should report all serious suspected ADRs, even if the effect is well recognised.

We are particularly interested in receiving Yellow Card reports of suspected ADRs:

  • in children
  • in patients that are over 65
  • to biological medicines and vaccines
  • associated with delayed drug effects and interactions
  • to complementary remedies such as homeopathic and herbal products

See what to include in your Yellow Card of an adverse drug reaction (PDF, 74.2KB, 3 pages).

See specific areas of interest for adverse drug reactions reporting (PDF, 79.5KB, 3 pages).

You do not have to prove causality to report a suspected ADR, only a suspicion is needed.

Black triangle scheme

New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristic, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected ADRs for these products.

For products with regards to Northern Ireland, the European Medicines Agency (EMA) is responsible for maintaining the list of black triangle products. For products with regards to the United Kingdom the MHRA is responsible for maintaining the list of black triangle products.

This symbol appears next to the name of a relevant product:

  • in the British National Formulary (BNF)
  • in the British National Formulary for Children (BNFC)
  • in Monthly Index of Medical Specialties (MIMS)
  • in the Association of the British Pharmaceutical Industry (ABPI) Medicines Compendium
  • on advertising material
  • in Drug Safety Update
  • in summaries of product characteristics and patient information leaflets

See the Black Triangle scheme - new medicines and vaccines subject to EU-wide additional monitoring (PDF, 139KB, 4 pages).

Medical devices

Any adverse incident involving a medical device should be reported.

If a device has been involved in an incident, do not throw it away or repair it if possible. If the police or coroner is involved in the investigation hold onto the device until MHRA contacts you. Otherwise you can make the device available to the manufacturer for analysis.

Do not send medical devices to MHRA unless we specifically ask you.

E-cigarettes and e-liquids

Any adverse incident involving a nicotine e-cigarette or refill container (e-liquid) should be reported. MHRA works with local Trading Standards bodies to ensure the safety of these products.

How to report

You can report through the Yellow Card website.

Video guides

We have produced short videos on how to report online through the Yellow Card website. Please note there is no audio in these videos.

How to report a side effect from a medicine

How to report a problem with a medical device

For medicines, in some cases you can report using your clinical IT systems, such as the MiDatabank system, SystmOne and Vision.You can also use the free Yellow Card app available to download from Apple App Store or Google Play Store – just search ‘Yellow Card’.

You can send medicines Yellow Card reports by post. Forms are available:

If you want to report an incident with a medical device in Northern Ireland you should report it to the Northern Ireland Adverse Incident Centre (NIAIC).

If you want to report an incident with a medical device in Scotland you should report it to Health Facilities Scotland unless you are a private facility providing care to private clients, in which case you should report to MHRA and the Care Inspectorate.

Interactive Drug Analysis Profiles (iDAPs)

Interactive listings of all suspected ADRs reported by healthcare professionals and members of the public for a particular drug substance (formally called drug analysis prints) are available to view.

Further guidance and online learning

Guidance on adverse drug reactions (PDF, 135KB, 5 pages)

Contribution of Yellow Cards to identifying safety issues (PDF, 226KB, 28 pages)

Pharmacovigilance – how MHRA monitors the safety of medicines (PDF, 112KB, 5 pages)

E-learning module: pharmacovigilance – identifying and reporting adverse drug reactions: in association with MHRA

New e-learning module for doctors

We have created a new free e-learning module for doctors to learn about the importance of reporting suspected adverse drug reactions (ADRs).

The European Accreditation Council for Continuing Medical Education (EACCME), part of the European Union of Medical Specialists (UEMS), has given the module the highest order of accreditation. Doctors are awarded 1 EACCME credit (1 hour CPD) on completion of the 45 minute ADR e-learning module.

Adverse Drug Reactions: reporting makes medicines safer

The module was developed as part of the SCOPE Joint Action project to raise awareness levels of ADR reporting.

Please complete this short survey upon completion of the free e-learning.

E-learning modules for pharmacists

The Centre for Postgraduate Pharmacy Education (CPPE) has developed a series of 3 e-learning programmes with the Wales Centre for Pharmacy Professional Education and MHRA. The programme has been endorsed by the Drug Safety Research Unit.

The e-learning modules should help pharmacists understand how to identify, report and prevent ADRS.

Adverse drug reactions and medicines safety

Reporting adverse drug reactions

Patients and adverse drug reactions

E-learning module for nurses

The Nursing Times, in close collaboration with MHRA, have developed an e-learning module for nurses.

The module is free once you have registered and counts for 2 hours continuing professional development (CPD) credits.

Information material for patients and public

These resources have been produced to give patients and the public more information about the Yellow Card scheme, including awareness raising material and how to make a report.

They can be downloaded, printed and used as required by healthcare professionals and patient representative groups to encourage the reporting of suspected side-effects.

Reporting forms

Leaflets, information cards and presentations

Information in other languages

Published 23 January 2015
Last updated 1 January 2021 + show all updates

  1. Following the end of the transition period, updated references to EMA/EU systems.

  2. Updated PDF: Contribution of Yellow Cards to identifying safety issues

  3. Added a link to our new dedicated website to report any suspected side effects from medicines, future vaccines and incidents involving medical equipment relating to COVID-19 treatment.

  4. We have updated the information about reporting suspected side effects to a medicine, device, vaccine herbal or homeopathic remedy via electronic methods instead of paper.

  5. We have updated the messaging about reporting during the COVID-19 outbreak to include information on medical devices, defective or fake medicines/devices and e-cigarettes.

  6. During the Coronavirus (COVID-19) outbreak we are encouraging Yellow Card reporting to take place online, rather than paper.

  7. Added 2 video guides to assist with completing reports on the Yellow Card website.

  8. Uploaded an amended version of the Guidance on adverse drug reactions document.

  9. Added links to materials for patients and public groups about the Yellow Card Scheme.

  10. Updated the document Contribution of Yellow Cards to identifying safety issues.

  11. Updated survey link

  12. Information about new e-learning modules for doctors.

  13. New .pdf attachment for 'Contribution of Yellow Cards to identifying safety issues'.

  14. Updated Medical devices information.

  15. Updated to include reference to reporting issues with nicotine-containing electronic cigarettes and refill containers (e-liquids).

  16. Drug analysis prints renamed to Interactive Drug Analysis Profiles.

  17. First published.

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