Medicines, medical devices and blood regulation and safety – guidance

The Yellow Card Scheme: guidance for healthcare professionals

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

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

It is important that problems with medicines and medical devices 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 the patients.

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 complimentary 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.

The European Medicines Agency (EMA) 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 it should be quarantined if possible. Do not throw them away, repair them or return them to the manufacturer until MHRA has carried out its own investigation. Do not send medical devices to MHRA unless specifically requested.

Serious cases should be reported by the fastest means possible.

How to report

You can report through the Yellow Card website.

For medicines, in some cases you can report using your clinical IT systems, such as the MiDatabank system and SystmOne.

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

by downloading and printing out a form (PDF, 145KB, 2 pages) .
by writing to FREEPOST YELLOW CARD (no other address details necessary)
by emailing yellowcard@mhra.gsi.gov.uk

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.

Drug analysis prints (DAPs)

Complete listings of suspected ADRs reported by healthcare professionals and patients, which are called drug analysis prints, are available to view.

Further guidance and online learning

Guidance on adverse drug reactions (PDF, 78.9KB, 7 pages)

Contribution of Yellow Cards to identifying safety issues (PDF, 148KB, 8 pages)

Pharmacovigilance – how MHRA monitors the safety of medicines (PDF, 72.4KB, 5 pages)

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

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.