Return to home page
The Pharmaceutical Journal Vol 263 No 7071 p776
November 13, 1999 Clinical

"Yellow card" reporting now allowed for all community pharmacists

All community pharmacists in the United Kingdom can now report suspected adverse drug reactions via the "yellow card" scheme. This extension to the scheme follows positive results from the pilot scheme for community pharmacy reporting which has been running in selected areas since 1997 (see Panel).
Community pharmacists are now in the same position as their hospital colleagues, who have been allowed to report ADRs since 1997.
Announcing the extension of the scheme on November 10, Lord Hunt (Under-Secretary of State for Health) said: "The extension of the scheme to community pharmacists confirms their role as an essential part of the health care team. Community pharmacists will be able to play their part in detecting and reducing side effects to medicines. Patients will benefit as a result - they can access their pharmacist easily to discuss their medicines."
The President of the Royal Pharmaceutical Society (Mrs Christine Glover) welcomed the launch of nation-wide reporting, which she said was long overdue. She added: "Pharmacists are in an ideal position to report on adverse drug reactions; it is surprising that all community and hospital pharmacists have not been able to report ADRs until now. Pharmacists have more training and in-depth knowledge of medicines than any other health care professional and are more likely to recognise an ADR."
The "yellow card" scheme, which has been in existence for 35 years, is jointly run by the Medicines Control Agency and the Committee on Safety of Medicines.

The pilot scheme

In April 1997, "yellow card" reporting was introduced for community pharmacists in four areas linked to the CSM regional monitoring centres (Wales, West Midlands, Mersey and Northern). The pilot ("demonstration") scheme areas covered some 3,200 pharmacists.
This week's extension to the "yellow card" scheme is based on the results of an analysis of the first year of reporting from this pilot scheme (see p786). Reports from pharmacists were compared with those from GPs in the same areas. Pharmacists submitted a relatively small number of reports (96), but the reports were comparable to those from GPs in terms of the proportions of serious reports and reactions associated with "black triangle" drugs. Pharmacists submitted a significantly higher proportion of reports of suspected generic inequivalence and of reactions associated with herbal medicines compared with GPs.
The CSM and MCA planned to assess the value of patient medication records in pharmacy reporting - two of the regional sites restricted reporting to pharmacies with PMRs while the other two had no such restriction. In the event, however, there were not enough reports submitted to allow comparison between the two arms of the study.
In a second paper this week, from Wales, GPs and pharmacists who responded to a questionnaire indicated support for the idea of pharmacist ADR reporting (p778).

Report of suspected adverse drug reactions
Pharmacists will now be encouraged to join doctors and dentists in reporting suspected ADRs via the "yellow card" scheme

An information pack on ADR reporting is being sent with copies of this week's Pharmaceutical Journal mailed to addresses in Britain. It includes a letter from the CSM chairman (Professor Alasdair Breckenridge) and the director of the post-licensing division of the MCA (Dr June Raine), who comment: "We are always striving to maximise the effectiveness of the scheme, especially in areas where there is limited reporting. We believe that as a community pharmacist you have an important role to play, alongside your medical colleagues, in helping us to achieve this goal."
Professor Breckenridge said on November 10 at the launch of the new scheme that he had every expectation that community pharmacists would make an important contribution to the monitoring of drug safety.
From now on, all pharmacists, but not preregistration students, working in a community pharmacy can complete and sign a yellow card report. Pharmacists are encouraged to discuss the case with the patient's general practitioner before sending in a report.

Mrs Glover said that ADR reporting offered community pharmacists a unique opportunity to become more involved in patient care through discussions with the patients and their GPs. She emphasised that training would be important to ensure that pharmacists had the confidence to report.
Community pharmacists are asked to report in accordance with UK ADR guidelines, ie, all suspected reactions to new ("black triangle") drugs and serious or unusual suspected reactions to established drugs. However, they are being asked by the MCA and CSM to focus their reporting particularly in those areas in which they have specialist expertise and where there is limited reporting by doctors - OTC medicines and herbal medicinal products. "We consider that you are uniquely placed to report on suspected adverse reactions to over the counter (P and GSL) medicines and herbal products, both licensed and unlicensed," Professor Breckenridge and Dr Raine say in their letter to pharmacists.
Speaking at the launch meeting, Dr Raine said that reporting on OTCs and complementary medicines "will fill a significant gap that we have had up to now". But pharmacists were not only to report on such products. "We expect reporting over the whole range of medicines," she said.
She emphasised that the pilot study had shown that community pharmacists' reports were "just as good" as those from GPs.

Training

Training programmes to help pharmacists in the identification and reporting of ADRs will be available. In England, the Centre for Pharmacy Postgraduate Education is organising workshops, starting this week, and it also has a distance learning pack on ADRs. Details of courses are included in the pack sent out with The Journal. The distance learning pack will also be available to pharmacists in Wales, Scotland and Northern Ireland. Pharmacy postgraduate education centres in Scotland and Northern Ireland are also organising training. In Wales, where training was held in 1997 for the pilot study, no new courses are planned at present.