This week, the Medicines and Healthcare products Regulatory Agency (MHRA) officially launched their nationwide pilot Yellow Card patient self-reporting scheme in the United Kingdom. Across the UK, anyone who experiences serious, unusual or unexpected side-effects from, or interactions between, any prescription or over-the-counter medicine, or nutritional or herbal supplement, can now to report it directly to the government agency responsible for ensuring that medicines and medical devices are both working and acceptably safe.
The Yellow Card scheme was set up in 1964 in the wake of the thalidomide tragedy for healthcare professionals to report side-effects not already included in the patient information leaflet. Since then, more then 500,000 reports have been received. A Blue Card scheme was established more recently to record specifically suspected side-effects in people with HIV, although, again, this was purely for doctors and pharmacists.
Last year, after an independent review of side-effect reporting, the UK Government accepted the review's recommendations to extend Yellow Card reporting to patients. This was strengthened last April, when the House of Commons Health Committee's Report on the influence of the pharmaceutical Industry also recommended that a “system of patient reporting to the Yellow Card Scheme...be put in place as soon as possible”.
A small-scale pilot scheme, which began in January this year, suggests that patient self-reporting of side-effects provides extremely valuable information over and above that provided by healthcare professionals. Of the 600 patient reports received between January and September this year, 71% were considered to be medically serious and 5.7% were associated with products under intensive monitoring.
At the official launch, held in central London this Tuesday, Dr Patricia Wilkie, Chairman of the Committee on Safety of Medicines Working Group on Patient Reporting, noted that "the reports received so far are of high quality, with patients giving detailed accounts of the severity of reactions experienced from the patient's own perspective."
Dr Wilkie added: "The incorporation of the patient experience in the Yellow Card Scheme is essential for medicines safety monitoring, and will be important for the development of information for patients about their medicines. The launch of the UK-wide pilot is a major step forward in achieving real patient involvement."
She told aidsmap that the MHRA are particularly interested in hearing from HIV-positive individuals on antiretroviral therapy, who are at high risk of experiencing side-effects. Earlier this month, a British HIV Association audit discovered that 51% of people switching from their first anti-HIV regimen did so due to side-effects. In addition, since HIV-positive individuals often take a variety of other prescribed and over-the-counter medicines alongside antiretroviral therapy, this is an opportunity to discover as-yet unknown interactions, including those between antiretrovirals and recreational drugs.
Patient Yellow Card reporting forms will be available in pharmacies, GP surgeries and other NHS outlets across the UK from next week. Reports on suspected side-effects can also be made on the Yellow Card website or by freephone to the Yellow Card hotline on 0808 100 3352.
More details on the specifics of how HIV-positive individuals can report side-effects and drug interactions to the MHRA, including issues around confidentiality, can be found in the June 2005 edition of AIDS Treatment Update.