The Pharmaceutical Journal
Vol 280 No 7489 p174
16 February 2008

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Tell patients about yellow card reporting

The public has been reporting adverse drug reactions using the yellow card scheme under a nationwide pilot since 2005. Next week this arrangement becomes permanent — and the Medicines and Healthcare products Regulatory Agency wants pharmacists to spread the word, explains Matthew Wright (on the staff of The Journal)

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Yellow Card: Reporting suspected adverse drug reactions

This coming Monday marks the official expansion of the Medicines and Healthcare products Regulatory Agency’s yellow card scheme to include members of the public. The MHRA is counting on pharmacists to help boost people’s awareness of side effect reporting.

Although this allows pharmacists little time to prepare for a campaign — promotional materials are expected to be delivered to your pharmacy door over the next week — it is still worth finding the time to become involved.

According to the MHRA, members of the public are not generally aware that they can report their side effects using a yellow card.

Mick Foy, group manager, Pharmacovigilance Signal Management Group at the MHRA, says that taking the pilot scheme forward “provides an opportunity to ‘relaunch’ patient reporting, not only through the community pharmacy-based promotional campaign, but by the introduction of more user-friendly and simplified reporting systems, which are being launched at the same time”.

These updated reporting systems include a redesigned paper form for patients and a new electronic form (at www.yellowcard.gov.uk) for use by both healthcare professionals and patients.

Anyone in England, Scotland, Wales and Northern Ireland can make a yellow card report.

Professional responsibility

The Royal Pharmaceutical Society is supporting the campaign. In a letter from the Society to pharmacists, David Pruce, director of practice and quality improvement, explains: “It is the professional responsibility of pharmacists not only to report adverse reactions to the yellow card scheme where appropriate, but to inform patients that they may also independently send in a yellow card.”

He goes on: “The delivery of this current campaign through community pharmacies designates the pharmacy as a local focus for patient reporting and as such emphasises the role of the pharmacist in medicines management.”

By having pharmacists at the forefront of promoting the expanded scheme, the MHRA acknowledges pharmacy’s ability to reach patients. Mr Foy elaborates: “Patients need access to advice on medicines and their side effects, as well as information and advice on reporting to the yellow card scheme, and this is likely to be provided more effectively at a local level.”

He also highlights pharmacists’ professional obligation: “The current campaign, which aims to raise public awareness of patient reporting, builds on this professional responsibility to make community pharmacy the local home of patient reporting, alongside the continuing role of pharmacists as reporters to the scheme.”

So what resources will pharmacists receive from the MHRA? The British Association of Pharmaceutical Wholesalers is co-ordinating the delivery of resource packs to pharmacists — the packs will contain a poster, a supply of leaflets which contain patient reporting forms and some business card-sized reminders to be given to patients.

There will also be a leaflet for pharmacists that sets out what the MHRA intends for the scheme. Specifically it states:

• Patients do not have to be certain that a particular problem was caused by a medicine; they just need to suspect that this might be the case.

• You should 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 included with their medicine.

• It doesn’t matter if a healthcare professional may have reported a reaction; the patient should still report it if they wish to do so.

Taking part is simple

“In the first instance, we are simply asking you to display the poster provided in your pharmacy, to raise awareness of the yellow card scheme,” the pharmacist leaflet says.

“You could also think about mentioning the yellow card scheme to your customers when you talk to them about the side effects of medicines,” it goes on to suggest. “Any advice you can offer about whether a possible side effect could be caused by a medicine would also be useful.”

The MHRA is especially keen for patients to start using the online reporting system so it can receive and process reports quickly. A report can be sent in as long as it includes the following four pieces of information:

• Symptoms or description of the side effect

• The name of the medicine thought to have caused the side effect

• Basic information about the person who experienced the side effect

• Name and contact details of the reporter, so that the report can be acknowledged and followed up for further details as needed

“An investigation of reports received from members of the public during the early months of the pilot scheme suggested that their reports were similar to those received from healthcare professionals,” says Mr Foy.

“However, patients provided a different insight into suspected side effects than that obtained from healthcare professionals. In particular, members of the public provided richer descriptions of the symptoms experienced, including information about the impact on their life and lifestyle.”

Mr Pruce says that raising awareness of patient reporting, as well as continuing to identify and report adverse reactions to the yellow card scheme, is part of the expanding role of pharmacy in ensuring patients receive the safest, most appropriate medication.