Patient reporting of suspected adverse drug reactions

What is the MHRA?
The Medicines and Healthcare products Regulatory Agency (MHRA) is a UK government body whose principle aim is to protect the public’s health. It does this by making sure that medicines and medical devices work properly and are acceptably safe.

When any possible problem is found, the MHRA takes prompt action to protect the public.

Why report suspected side effects to the MHRA?
A side effect is a reaction to a drug that is not expected or wanted. All medicines can cause side effects, also known as adverse drug reactions, which can range in severity from mild to serious and even life-threatening. Occasionally, side effects can appear after a person has stopped taking the medicine, while some side effects might not be discovered until many people have been taking the medicine for a long time. That’s why it is important for people to report any suspected side effects to the MHRA, to enable us to make medicines safer for everyone.

If you are worried about a symptom that you think may be a side effect:

1. Check the patient information leaflet supplied with the medicine. This lists the known side effects and advises you what to do.

2. Talk to your doctor or pharmacist.

3. You can also get information from:

• NHS Direct in England and Wales on 0845 46 47 (textphone 0845 606 4647)
• NHS24 in Scotland on 08454 24 24 24 (textphone 18001 08454 24 24 24)
• The Yellow Card website at www.mhra.gov.uk/yellowcard

The MHRA advises that you consult your health professional about any suspected side effect or adverse reaction from a medicine that you are worried about. The MHRA cannot provide medical advice in individual cases.

If you think you have experienced a side effect from your medicine, you can report it to us through the Yellow Card Scheme.

You can make a Yellow Card report:

• using the online Yellow Card form - This is the easiest way to make a report, if you have access to the internet
• on a Yellow Card form, which can be found at pharmacies, GP surgeries or from the Yellow Card hotline by calling 0808 100 3352 (available weekdays 10:00 and 14:00)
• by downloading the Yellow Card form (1022Kb) to print (the form should be returned to the address on the bottom of the form - no stamp is needed)
• by calling the Yellow Card hotline on freephone 0808 100 3352 (available weekdays 10:00 - 14:00)

What to report?
You can report suspected side effects of any medicine or herbal remedy, whether it was prescribed by your doctor or bought without a prescription. It is especially useful for us to receive information about a suspected side effect that:

• is not mentioned in the patient information leaflet that came with the medicine
• causes problems bad enough to interfere with everyday activities
• happens when you're taking more than one medicine, and could be caused by interactions.

Sometimes it is difficult to tell whether a possible side effect is due to a medicine or something else; however, even if you are unsure whether a medicine or combination of medicines has caused a side effect, but suspect that it has, please complete a Yellow Card.

If you are worried about a suspected side effect, contact a doctor or pharmacist, or call NHS Direct in England and Wales on 0845 46 47 or NHS24 in Scotland on 08454 24 24 24.

Who can report?
You can report side effects that have happened to:

• you personally
• your child
• someone you are responsible for (such as your spouse or partner, or an adult child), or someone who asks you to make a report on their behalf with their agreement.

We also collect Yellow Card reports of suspected side effects from healthcare professionals such as doctors, pharmacists and nurses.

Completing the Yellow Card form
The form has five sections:

1. About the suspected side effect. The symptoms or a description of the side effect.
2. About the person who had the suspected side effect. Give as much information as you can, even if you prefer not to include a name.
3. About the medicine(s) which might have caused the side effect. As side effects can be caused by interactions between medicines, we need to know about any other medicines or herbal remedies being taken when the side effect happened.
4. About your doctor (optional). If you give permission for us to contact your doctor, please supply contact details.
5. About you – the person making the report. We need your name and contact details, so we can get in touch if we need more information. Please give a postal address even if you prefer not to give a phone number or email address.

If you need help…

• call the Yellow Card hotline on 0808 100 3352
• ask a healthcare professional (such as your doctor, nurse or pharmacist) for help.

We suggest that you have your medication and/or the leaflet that came with it in front of you while you fill out the report.

Please complete as much of the form as possible. It does not matter if you cannot complete all sections of the Yellow Card.

What happens next?
We will send an acknowledgement of your Yellow Card report along with a copy of the report for your records. If you give permission on the form, we will also send a copy to your doctor.

Protecting personal information
We ask for contact details so we can get in touch if more information on the Yellow Card is needed. The information you provide will be kept safe, secure and confidential, and will never be passed on to anyone outside the MHRA without your express permission.

If you wish to report a suspected side effect, but do not wish to tell us your name, please ask someone else to complete the form on your behalf. We may need to contact this person for further information about the report.

The MHRA regularly publishes data about information given on the Yellow Card reports, but this never includes names or other personal details of the people who made the report.

How is Yellow Card data used to improve patient safety?
Yellow Card reports are evaluated each week to find possible previously unidentified hazards and other new information on the side effects of medicines. We also evaluate information on medicines safety from other data sources within the United Kingdom and from around the world, including our General Practice Research Database (more information is available from the GPRD website) and from information collected by medicines safety organisations around the world.

When we identify a new possible side effect or learn more about a recognised one, we carefully consider this in the context of the overall side effect profile for the medicine. We also consider this information in comparison with the side effects of other medicines that can be used to treat the same condition, and re-evaluate the risk-benefit balance of the medicine.

If necessary, we will take action to ensure that the medicine is used in a way that minimises risk, and maximises benefits to the patient. Action might include requiring details of a new side effect to be included in the product information for a medicine, a reduction in the recommended dosage, or giving out warnings about groups of patients who should not be prescribed the medicine. Sometimes, we may need to withdraw a medicine from the market altogether, when we believe that the risks of a medicine are greater than its potential benefits.

Data collected through the Yellow Card Scheme on suspected side effects
Reports of suspected adverse drug reactions received by the MHRA through the Yellow Card Scheme are listed in our Drug Analysis Prints (DAPs) and can be accessed from the link below:

Drug Analysis Prints

As Yellow Card reports are made on the basis of suspected, rather than confirmed side effects to medicines, it is not possible to draw definite conclusions on the safety of a particular medicine from the information received on Yellow Card reports alone, without referring to other scientific research.

More information for patients on the Yellow Card Scheme

Evaluation of patient reporting to the Yellow Card Scheme - April 2006
The NHS Research and Development methodology Programme, in conjunction with the MHRA, has developed proposals for an evaluation of the patient reporting component of the Yellow Card Scheme, which is the UK’s national reporting system for adverse drug reactions.

Evaluation of patient reporting to the Yellow Card Scheme (53Kb)

The Methodology Programme is a Department of Health funded research programme managed by The National Co-ordinating Centre for the Methodology Programme.  The deadline for applications was 16 June 2006 and more information is available from the National Co-ordinating Centre for the Methodology Programme website (external link).