Yellow Card in Medicines and Healthcare Products Regulatory Agency (MHRA) and its Reporting details at a Glance

What is Yellow Card Scheme in UK :

The Yellow Card Scheme is the UK system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The Yellow Card Scheme is essential in helping the MHRA to monitor the safety of all healthcare products in the UK to ensure they are acceptably safe for patients and those who use them.

The scheme includes all medicines including vaccines, blood factors and immunoglobulins, herbal medicines, homeopathic remedies, and all medical devices available on the UK market.

The Scheme collects information on suspected problems or incidents involving as follows

  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 then MHRA will review the product if necessary, and take action to minimize risk and maximize benefit to the patients.

The MHRA is also able to investigate counterfeit or fake medicines or devices and if necessary to take action to protect public health.

Background of Yellow card Scheme :

The Scheme was founded in 1964 after the thalidomide disaster, and was developed by Bill Inman.

It is run by the Medicines and Healthcare Products Regulatory Agency (MHRA) and the Commission on Human Medicines.

It was extended to hospital pharmacists in 1997, and to community pharmacists in 1999.

Suspected adverse reactions are collected on all licensed medicines and vaccines, from those issued on prescription to medicines bought over the counter from a pharmacist or supermarket.

What is Adverse Drug Reaction :

An unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use, which is suspected to be related to the drug or medicine

Serious adverse event or reaction as one when the patient outcome is one of the following.

  • Death
  • Life-threatening
  • Hospitalization (initial or prolonged)
  • Disability – significant, persistent, or permanent change, impairment, damage or disruption in the patient’s body function/structure, physical activities or quality of life.

How are Yellow Card reports used?

The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), runs the Yellow Card Scheme.

It collects reports of side effects from people taking medicines, as well as from healthcare professionals such as doctors, pharmacists and nurses also reporting suspected side effects experienced by a patient.

These reports are used to identify side effects and other safety information about medicines which might not have been known about before.

If a new side effect is found, the MHRA will review the way that the medicine can be used, and the warnings that are given to people taking it.

How to report a suspected side effect :

There are four main ways you can report :

  • complete the attached form, and send it back in the envelope provided (there’s no need for a stamp).
  • call the Yellow Card reporting line on freephone 0800 731 6789 (10am to 2pm Monday-Friday only)
  • using the free app – search ‘Yellow Card’.

What the Yellow card Form Contains : The form has five sections

  1. About the suspected side effect. Give as much information as you can. You can also tell us if the harm was because of a mistake in how you took the medicine or how it was given to you – this is called a medication error. For example: wrong drug, dose or route; and why (such as, too much medicine taken because of wrong instructions on the pharmacy label, or I accidentally took too much, or I was given the wrong medicine etc). All reports are kept in confidence.

2. About the person who had the suspected side effect. Give as much information as you can, such as age, sex, height and weight. This helps us differentiate between patients on our database. It also helps us understand if certain patients are more vulnerable to experiencing a side effect.

3. About the medicine(s) which might have caused the side effect. If you have it, provide the batch number which can be found on the medicines box. Sometimes side effects can also happen because of interactions, so we ask you to tell us about all medicines or herbal remedies being taken.

4. About your doctor (optional). If you give permission for us to contact your doctor, supply contact details.

5. About you – the person making the report. We need a name and contact details, it also helps us get in touch with you if we need more information.

Please sign and date the form before you post it in the attached envelope and if somebody need more space, write it on a separate sheet of paper and enclose it in the envelope with your form.

The MHRA will send an acknowledgement when Yellow Card report is received and if the patience have given permission on the form, MHRA will send a copy to patients doctor.

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