Healthcare professional reporting of adverse drug reactions: Frequently asked questions

Who can report?
The following can report suspected adverse reactions via the Yellow Card Scheme:

• doctors; 
• dentists; 
• coroners; 
• pharmacists; 
• nurses, including midwives and health visitors;
• radiographers; and 
• optometrists.

Can patients report?
A report of an Independent Review of Access to the Yellow Card scheme was published on 4 May 2004. One of the recommendations of the review was that the MHRA accept reports of adverse drug reactions from patients. This recommendation has been accepted.

Pilot schemes of direct patient reporting were launched in January 2005.  Patients can now submit reports on suspected adverse drug reactions to the MHRA directly through:

• the 'Patient reporting of suspected adverse drug reactions' section on this website; and
• paper-based Patient Yellow Card report forms. These have been made available in 4000 GP surgeries in the UK and can be obtained by contacting the MHRA on 020 7084 2000.

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

Should I report reactions to unlicensed medicines?
Yes, the MHRA would like to receive reports of suspected reactions to unlicensed herbal remedies.

Should I report reactions to medicines used 'off label' (used or a different indication or a different age group than the ones for which it was intended)?
Yes. We are interested in any side effects of medicines as used in clinical practice, regardless of whether 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.

Do I have to be certain that the medicine caused the reaction; how can I judge causality?
For more information please see section on causality

Can I get data from the Yellow Card Scheme?
Yes.  Complete listings of suspected adverse drug reactions (Drug Analysis Prints) received by the MHRA reported by healthcare professionals are available online: 

› Drug Analysis Prints

In addition staff at the MHRA are happy to provide information on the drug safety of any licensed medicine.  Requests for information or any query about the Scheme or drug regulation relating to such medicines 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
Market Towers
1 Nine Elms Lane
London
SW8 5NQ
E-mail: pharmacovigilance@mhra.gsi.gov.uk.

or write to one of the Commission on Human Medicine's (CHM) Regional Monitoring Centres (please see links under 'Related information' at the right of this page).

If I report, will I have to do more work?
Doctors, dentists, pharmacists, coroners, radiographers, optometrists and nurses who submit a Yellow Card may be asked to provide additional information, in order that we can evaluate the report fully. However, we do not routinely request follow up for every report; it will depend on the type of reaction being reported and how much information you have included on the original report.

We only request follow up information where it is important to do so. We may ask specific questions about a particular reaction, or request important information that has been omitted from the report e.g. 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 the report up for information you do not have.

What happens to my Yellow Card?
Please see our  'What happens to a Yellow Card' section:

› What happens to a Yellow Card

How are potential safety issues evaluated?
The staff of the Pharmacovigilance Group within the Post Licensing Division of the MHRA use data from Yellow Card reports to assess whether there is a causal relationship between the medicine and the reported reaction. We are also looking for possible risk factors which might increase the likelihood of a patient developing the reaction, such as age or underlying disease.

In addition to data from the Yellow Card Scheme, we look at data from a variety of other sources as part of our work to monitor 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 consider the risk of a newly identified adverse reaction in the context of the overall profile of side effects for the medicine, and compare it with other medicines which are 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.

We can seek advice on safety issues from the Commission on Human Medicine (CHM) (see definitions). In addition, issues may be considered in a variety of committees consisting of representatives from all regulatory authorities across the European Community.

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, as well as 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. SPCs can be found in the 'ABPI Compendium of Data Sheets and Summaries of Product Characteristics' or the electronic Medicines Compendium website.

All medicines also have a patient information leaflet (PIL); the PIL 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 made to the SPC.

For more serious safety issues we may wish to draw attention to the new safety information, in addition to updating the SPC and PIL. Three to four times each year we publish a bulletin, 'Current Problems in Pharmacovigilance' which is mailed to all doctors, dentists, pharmacists and coroners; it is also available on this website. We use this bulletin to communicate important drug safety information.

From time to time we may need to inform rapidly about a safety issue. This may be because of the seriousness of a newly identified adverse reaction, because a drug is being withdrawn or because a quality defect has occurred. How we disseminate such information will depend on the nature of the problem.

For urgent safety issues, health professionals may receive a letter from the Chairman of the CSM, outlining the issue, what action is being taken, and usually giving advice on the implications for patient treatment; where relevant, we may include information for patient to help you discuss the issue with the patient. 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.