Yes. Data we gather from the Yellow Card Scheme are vital in our work to protect the public, by ensuring that drugs are used safely. We need the data in order to continue identifying new side effects and ways in which the risks of recognised side effects can be minimised. Every report we receive contains potentially useful information - without the reports, we simply would not be able to continue this important work.
The value of the scheme has been demonstrated many times and it has helped to identify numerous important safety issues. For example warnings were added to the product information for the smoking-cessation drug varenicline after we received Yellow Cards reporting suicidal ideation. Yellow Cards of adverse drug reactions to the former obesity drug rimonabant contributed to this drug being withdrawn - new evidence meant the risks were considered to outweigh any benefits
All medicines have a patient information leaflet (PIL), which gives instructions on how the medicine should be used, and information on its side effects. You can find information (including PILs) about most medicines available in the United Kingdom on the Electronic Medicines Compendium. Another useful publication is the British National Formulary, which is published twice yearly and provides health professionals with up-to-date information about the use of medicines. The British National Formulary can be accessed on the web, while hard copies should be available at your local public library or at a pharmacy.
You can talk to your doctor, pharmacist or nurse who should be able to tell you more about the known side effects of your medicine. You can also telephone NHS Direct on 0845 46 47 (in England and Wales) or NHS24 on 08454 24 24 24 (in Scotland) for medical advice regarding medicines.
The company that makes the medicine can also provide a full list of the known side effects of their medicines and products. The name of the company that made the medicine will be on the patient information leaflet, or on the medicine packaging.
A learning package on pharmacovigilance for clinical practitioners is available. This self-directed learning resource covers:
- How information on adverse effects of medicines is assembled
- How to find authoritative information on the risk of individual medicines, and
- How to fill a Yellow Card and contribute to our knowledge on possible harms.
The module concludes with exercises and a reading list for those wanting to learn more.
Doctors, nurses, and pharmacists all stand to benefit from the pharmacovigilance module - it will make them more aware of their role in protecting patients from preventable harm.
Drug Analysis Prints (DAPs) contain complete listings for all medicines of all UK spontaneous suspected adverse drug reactions received by the MHRA and are available to view on our website. 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. Further guidelines on how to interpret DAPs are available here.
I have submitted a Yellow Card and have not heard back from the MHRA, how do I know if my Yellow Card has been received?
The MHRA acknowledges every Yellow Card, either by letter or email to confirm receipt. If you have not received an acknowledgement to your submitted Yellow Card, please contact firstname.lastname@example.org and a replacement acknowledgement will be arranged.
The MHRA is responsible for ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely. We provide information to doctors and patients to help ensure medicines are used safely. However, the prescribing of any particular medicine and matters of clinical care of the patient remains the responsibility of the doctor. He or she is in the best position to decide on the type of treatment, which is most appropriate for an individual patient given their clinical expertise and their knowledge of the patients medical condition.
The MHRA does not regulate clinical practice or investigate allegations of medical malpractice. If you have concerns in this area or want to register a complaint about an individual doctor, you should contact your local Primary Care Trust (PCT) in the first instant or the General Medical Council (www.gmc-uk.org), who regulate standards of medical practice for doctors, can advise on how to proceed.
I don't want to submit a Yellow Card but have a question about side effects. How can I get my questions answered?
For answers to questions about specific products concerning side effects:
- Call 0808 100 3352 to speak to a MHRA representative who will be able to submit a request for information on your behalf
- Alternatively email us at email@example.com with your request.
Please allow 10 working days for us to respond to you.
Biological medicines are medicines derived or manufactured from a ‘living’ biological system. They encompass a broad range of therapeutic areas, including blood products, vaccines, antibodies and advanced therapies (such as gene and tissue therapy).
Biological medicines and vaccines are fundamentally different from standard chemical medicines in terms of their complexity. Unlike most small molecule drugs, their characteristics are determined as much by the specific manufacturing process as the active ingredient itself.
A wide variety of vaccines and biological medicines are available, and for many products a range of manufacturers produce the same ‘active ingredient’. These include a range of ‘biosimilar’ medicines, several vaccines which protect against a given infection, and products such as human immunoglobulin. Unlike most standard generic medicines, the characteristics of such products will not be identical. For this reason, it is very important that safety surveillance is carried out on a brand/product-specific basis. In addition, these products may vary from batch-to-batch and so it is important that we receive information on batch number.
As a specific example, there are more than ten different brands of influenza vaccines available in the UK each year. However, it is very often the case that suspected ADR reports refer only to ‘influenza vaccine’. Following the guidance below will allow us to accurately evaluate the safety profile of specific products.
Reporting suspected adverse drug reactions (ADRs) to biological medicines and vaccines
To allow us to perform product/brand-specific pharmacovigilance, when reporting a suspected ADR to a biological medicine (such as blood products, antibodies and advanced therapies [such as gene and tissue therapy]) or vaccine, in addition to the substance please ensure that you provide the brand name (or product licence number and manufacturer), and the specific batch-number, on the report. If you do not know this please indicate this using the displayed tick box.