This section provides information about reporting suspected adverse drug reactions (ADRs) for healthcare professionals. Information for patients is available in the 'Patient reporting of suspected adverse drug reactions' section (please see 'Related information on the right of this page').
1. Who can report?
2. How should patients reports ADRs?
3. With patients now reporting ADRs should healthcare professionals continue to report them?
4. Should I report reactions to unlicensed medicines?
5. Should I report reactions to medicines used 'off-label' (i.e. when the medicine is used for a purpose or indication for which it is not licensed)?
6. Do I have to be certain that the medicine caused the reaction - how do I judge causality?
7. Can I obtain data from the Yellow Card Scheme?
8. If I report ADRs, surely this will cause further work for me?
9. What happens to my Yellow Card?
10. How is Yellow Card data used to improve patient safety?
11. How will I find out if a new side effect has been identified?
1. Who can report?
The following sets of individuals can report suspected adverse reactions via the Yellow Card Scheme:
- doctors
- dentists
- coroners
- pharmacists
- nurses, including midwives and health visitors
- radiographers
- optometrists
- patients, parent or carers (since 2005).
2. How should patients reports ADRs?
Patients are now welcome to directly report suspected ADRs to us through the Yellow Card Scheme.
As healthcare professionals, you are well placed to inform patients of this scheme and we therefore ask you to encourage patients to report all possible side effects that were bad enough to interfere with everyday activities, and all possible reactions not listed in the patient information leaflet (PIL) included with their medicine.
Patients can report:
- online at www.mhra.gov.uk/yellowcard
- paper-based patient Yellow Card report form. These have been made available in 4000 GP surgeries in the UK and can be obtained by contacting the MHRA on 020 3080 6000
- alternatively they can call the Yellow Card hotline on 0808 100 3352.
More information on the development of patient reporting can be found in our Patient Reporting Working Group section:
Patient Reporting of Adverse Drug Reactions Working Group
3. With patients now reporting ADRs should healthcare professionals continue to report them?
Yes. Healthcare professionals have a professional responsibility to report suspected ADRs to the MHRA and continue to provide the vast majority of Yellow Card reports. We ask that you continue to send reports to the scheme as your reports are vital in gaining clinical information and perspective on possible side effects. We believe that this information can be complemented by patient reporting.
4. Should I report reactions to unlicensed medicines?
Yes, we would like to receive reports of suspected reactions to unlicensed herbal remedies and cosmetics.
5. Should I report reactions to medicines used 'off-label' (i.e. when the medicine is used for a purpose or indication for which it is not licensed)?
Yes. We are interested in any side effects of medicines used in clinical practice, regardless of whether or not they are being used according to the terms of the licence, as described in the product information. Our role is to ensure the safe use of medicines, not to comment on the way in which individual doctors use medicines.
It is important that we are aware of side effects which arise when medicines are used 'off-label', so that we can act to warn health professionals if necessary. However, the treatment of individual patients remains the responsibility of the doctor.
6. Do I have to be certain that the medicine caused the reaction - how do I judge causality?
It does not matter if you are uncertain whether a reaction is associated with the medicine being taken; even if you only have a suspicion that this is the case, then you should report. Please do not be put off from reporting simply because you are not certain about cause and effect.
For more information on how to assess causality please see our section on causality.
7. Can I obtain data from the Yellow Card Scheme?
Yes. Complete listings of suspected ADRs (Drug Analysis Prints) reported by healthcare professionals and patients are available online:
Drug Analysis Prints
In addition we are happy to provide information on the drug safety of any licensed medicine. Requests for information or any query about the Yellow Card Scheme or drug regulations should be addressed to:
Telephone: The National Yellow Card Information Service 0800 731 6789
(Manned during office hours only, answering machine at other times)
Write to: The Pharmacovigilance Group
Vigilance and Risk Management of Medicines
MHRA
151 Buckingham Palace Road
London
SW1W 9SZ
Email: pharmacovigilance@mhra.gsi.gov.uk
or write to one of the CHM Yellow Card Centres (listed under the 'Related information on the right of this page').
8. If I report ADRs, surely this will cause further work for me?
You may be asked to provide additional information to the reaction, so that we can evaluate the report fully. However, we do not routinely request follow-up for every report; this depends on the type of reaction being reported and how much information was included in the original report.
Follow-up information is only required where it is important e.g. we may ask specific questions about a particular reaction, or request important information that has been omitted from the report such as the outcome or dates of the reaction. If you do not know, or cannot obtain a particular piece of information, please say so on the initial report; this will help to ensure that we do not needlessly follow up for information that you do not have.
9. What happens to my Yellow Card?
Please see our 'What happens to a Yellow Card' section:
10. How is Yellow Card data used to improve patient safety?
Information gathered from Yellow Card reports is continually assessed by a team of safety experts comprising of doctors, pharmacists and scientists who study the benefits and risks of medicine. Possible risk factors which might increase the likelihood of a patient developing the reaction, such as age or underlying disease are also identified.
We consider the risk of a newly-identified adverse reaction to a particular medicine in the context of its overall side effect profile, and compare this profile with those of other medicines used to treat the same conditions. We also consider the benefit of the medicine in terms of its efficacy, the condition it is used to treat, and the target patient population.
In addition to data from the Yellow Card Scheme, we look at data from a variety of other sources when monitoring medicines. We evaluate epidemiological studies, published and unpublished data, including regular safety updates supplied by pharmaceutical companies, information from other regulatory authorities and a number of worldwide databases. We also have access to the General Practice Research Database which we use regularly when evaluating drug safety concerns.
We can seek advice on safety issues from the Commission on Human Medicines (CHM) as well as a variety of other committees consisting of representatives from all regulatory authorities across the European Community.
11. How will I find out if a new side effect has been identified?
All medicines have a Summary of Product Characteristics (SPC), which includes information on the indications for treatment, contra-indications to its use, dose and administration and its side effects. When new information becomes available on the safety of a medicine, the SPC will be updated to include this, as a matter of routine. SPC’s can be found in the ABPI Compendium of Data Sheets and Summaries of Product Characteristics' or the electronic Medicines Compendium website (external link).
All medicines are also accompanied by a patient information leaflet (PIL) which contains similar information to the SPC but is written specifically for the patient. The PIL will be updated at the same time as any changes are made to the SPC.
More serious safety issues are published in our regular monthly bulletin ‘Drug Safety Update’ intended for all healthcare professionals who work in the UK, and communicates important drug safety information. You can subscribe to be notified each month by email when it is published.
From time to time we may need to inform healthcare professionals more rapidly about a safety issue. This may be because of the seriousness of a newly identified adverse reaction, because a drug is being withdrawn from the market or because a quality defect has occurred. This information will be disseminated in a variety of ways depending on the nature of the problem.
For urgent safety issues, healthcare professionals may receive a letter from the Chairman of the CHM, outlining the issue, the action being taken, and advice on the implications for patient treatment; where relevant, information to help you discuss the issue with the patient may also be included. These letters are also published on this website in the section, 'Safety warnings and messages for medicines'. Alternatively, you may receive a letter from the pharmaceutical company responsible for the medicine.
The MHRA's drug alert fax cascade system, and the Chief Medical Officer's Public Health Link cascade system can also be used to send urgent safety or quality information.
