About Yellow Card

The Yellow Card Scheme is vital in helping the MHRA monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those that use them. Reports can be made for all medicines including vaccines, blood factors and immunoglobulins, herbal medicines and homeopathic remedies, and all medical devices available on the UK market. From the 20th of May 2016, the MHRA is also collecting reports of safety concerns associated with e-cigarette products through the Yellow Card Scheme.

The Scheme collects information on suspected problems or incidents involving

  1. side effects (also known as adverse drug reactions or ADRs)
  2. medical device adverse incidents
  3. defective medicines (those that are not of an acceptable quality)
  4. counterfeit or fake medicines or medical devices
  5. safety concerns for e-cigarettes or their refill containers (e-liquids)

It is important for people to report problems experienced with medicines or medical devices as these are used to identify issues which might not have been previously known about. The MHRA will review the product if necessary, and take action to minimise risk and maximise benefit to the patients. The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary take action to protect public health.

Side effects to a medicine, vaccine, herbal or complementary remedy

All medicines can cause side effects (commonly referred to as adverse drug reactions or ADRs by healthcare professionals).

Side effects reported on Yellow Card are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, to identify previously unknown safety issues. These reports are assessed by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines. If a new side effect is identified, the safety profile of the medicine in question is carefully looked at, as well as the side effects of other medicines used to treat the same condition. The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.

See our animation below, developed as part of an EU wide social media campaign from the Strengthening Collaborations to Operate Pharmacovigilance in Europe (SCOPE) Joint Action project. It can also be viewed on MHRA's YouTube channel here: https://youtu.be/3et5LdYLc8M.

Help raise awareness about reporting suspected side effects to the MHRA by sharing the animation on social media:

More information about the reporting of suspected side effects or adverse drug reactions are available on the MHRA website:

Yellow Card Mobile App: You can now receive news updates from the MHRA and report side effects to medicines via the Yellow Card app. Please download it from the Apple App Store or Google Play Store. Key features of the app include the ability to create a ‘watch list’ of medications for which you can receive news and alerts from the MHRA. You can view numbers of Yellow Cards reported to the MHRA for medicines of interest and see previous Yellow Cards you have submitted through the app.  At the moment account details are not syncronised between this website and the app, so you need to create separate accounts. We are also considering ways to report medical device adverse incidents, defective medicines and counterfeit products through the app.  

 

Medical device adverse incidents

The term 'medical device' covers almost all products, except medicines, that are used in healthcare. They can be used for the diagnosis, prevention, monitoring or treatment of illness or disability.

The range of products is very wide: it includes contact lenses and condoms; heart valves and hospital beds; resuscitators and radiotherapy machines; surgical instruments and syringes; wheelchairs and walking frames.

An adverse incident is an event that caused, or almost caused, an injury to a patient or other person or a wrong or delayed diagnosis and treatment of a patient.

Examples of problems:

  • faulty brakes on a wheelchair
  • a faulty ear thermometer giving a low reading
  • a faulty batch of test strips for a blood glucose meter giving wrong readings.
  • labelling or instructions on the device aren’t clear

If your equipment has a fault you should let us know as soon as you can. If possible, keep the faulty equipment until you have contacted us.

Defective medicines (those that are not of an acceptable quality)

Defects in medicines may relate to quality issues with the product itself, the packaging, e.g. carton and blister or other packaging components such as the patient information leaflet. Yellow Card reports of defective medicines are submitted to the defective medicines report centre (DMRC).  The role of the DMRC is to minimise the hazard to patients arising from the distribution of defective medicines by providing an emergency assessment and communication system between manufacturers, distributors, regulatory authorities and users.

Where a defective medicine is considered to present a risk to public health, the company or manufacturer as appropriate, is responsible for recalling any affected batch(es) or, in extreme cases, removing all batches of the product from the market.  DMRC normally supports this action by issuing a drug alert notification to healthcare professionals. Other regulators and countries may be notified of a recall by the issue of a Rapid Alert notification.

If a member of the public has reason to believe that their medicine is not of an acceptable quality they should, in the first instance, consult with their doctor or a pharmacist who may then decide to refer the matter to the MHRA.

Further information about defective medicines can be found within the guide to defective medicinal products

 

Counterfeit healthcare products

The MHRA makes sure that the UK has systems in place to prevent counterfeit or fake healthcare products entering the supply chain.  If counterfeit products become available, we make sure we detect counterfeits early and take action to protect the public.

When medicines and medical devices are bought on the internet the source of these products is sometimes difficult to trace and it is highly unlikely that the manufacturers of these products conform to European standards of safety and effectiveness. This means there can be a significant risk of harm to the patient or person using the product.

Yellow Card counterfeit reports are investigated in accordance with the terms of the Human Medicines Regulations 2012 and Consumer Protection Act 1987, and associated legislation.

The MHRA has statutory powers to enter business and private property to seize products suspected of being in breach of the Human Medicines Regulations. Investigations concerning counterfeits can be complex, involving networks of companies and countries, banks, international law enforcement agencies, solicitors, financial investigators, crime analysts, internet investigators, disclosure officers, test purchasers, and specialists in the use of the Regulation of Investigatory Powers Act 2000.

The MHRA can work with manufacturers to resolve any potential issues and problems. However, where necessary, the MHRA has the powers to take formal enforcement action against individuals and organisations. Offenders can be prosecuted under various regulations and Acts which can result in fines and often imprisonment. Civil injunctions are also given, where appropriate.

Further information about counterfeits can be found on the counterfeit medicines and devices pages on the MHRA website.

 

Blood factors and immunoglobulin products

Blood factor and immunoglobulin products, such as factors I to XIII or Anti-D (RHO) immunoglobulin, are considered medicines.  Suspected side effects to these products should be reported using the Yellow Card side effect form.

E-cigarette products

The Tobacco Products Directive came into effect in the UK on the 20th of May 2016 and introduces new rules for e-cigarettes and their refill containers. These rules ensure that there are minimum standards for the safety and quality of all e-cigarettes and refill containers. The MHRA is the competent authority for enforcing these rules and as part of this safety concerns for these products from healthcare professionals and members of the public are now being collected by the MHRA through the Yellow Card Scheme. For further information please visit the MHRA webpage