The Yellow Card scheme

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In 2008, the Medicines and Healthcare products Regulatory Agency (MHRA) introduced the opportunity for patients to report side effects (adverse drug reactions - ADRs) from drugs directly to the agency via the previously established Yellow Card Scheme. It continues to be vitally important for patients to alert the agency about their suspicions or consequences of treatments.

Drug side effects The Yellow Card Scheme is run by the MHRA and the Commission on Human Medicines (CHM), and is used to collect information from both health professionals and the general public on suspected ADRs to a medicine. Its continued success depends on the willingness of people to report suspected ADRs. The agency collects Yellow Card reports from anyone from the UK on both licensed and unlicensed medicines, including:

  • prescription medicines
  • vaccines
  • over-the-counter (OTC) medicines
  • herbal remedies
  • swine flu antiviral medicines (Tamiflu or Relenza)
  • swine flu vaccines (Pandemrix, made by GSK, or Celvapan, made by Baxter).

All medicines can cause unwanted ADRs in some people. Many ADRs are mild, but some can be serious and even life-threatening. Occasionally ADRs can appear after a person has stopped taking a medicine.

You may ask “why are these ADRs not already known?” Some ADRs are not always seen in small clinical trials and it takes many people to have taken the medicine for a long time for these to become evident.
Sometimes, it can be difficult to tell whether a symptom is an ADR of your medicine, or something else. Even if you are not sure you can report the symptoms via a Yellow Card as it might not have been noted before.

The risk (potential of ADRs) versus the benefit (getting better) of any treatment are key considerations when embarking on a course of therapy. For some the list of ADRs contained within the in-pack patient information leaflet (PIL) will be of great concern, but improving symptoms and feeling better may outweigh such concerns. Remember that healthcare providers are there to help you understand the benefits of a course of treatment, but should always take into account your concerns regarding ADRs and any long-term risks.

If you are unsure or worried about ADRs talk to your doctor, even if the product you are taking has been bought without prescription or is a herbal remedy.

You can report ADRs by completing the Yellow Card form, which should be available at your doctor’s surgery or pharmacy.

Alternatively, you can report via the internet at www.yellowcard.gov.uk

First published in:
Skin ‘n’ Bones Connection – p13; Issue 35; 2012.