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The Pharmaceutical Journal
Embracing ADR reporting could improve pharmacists' standing
By Anthony Cox
We are told that pharmacists are the "experts in medicines". Where might we look for evidence this expertise is being put into practice? The many valuable interventions made by pharmacists to ensure the safe and effective use of medicines largely remain unrecorded and unreported. However, there is one national scheme that can be used as an indirect measure of the clinical involvement of pharmacists and as a direct marker of their involvement in the safety of medicines. The scheme is the yellow card scheme for adverse drug reaction (ADR) reporting.
As the "experts in medicines" pharmacists for many years argued their case for admission as valid reporters to the yellow card scheme. The Royal Pharmaceutical Society proposed its own "pink card" ADR reporting scheme to the Committee on Safety of Medicines (CSM) in 1983. However in 1985, a CSM working party rejected pharmacists as reporters, although the chairman of the CSM believed pharmacists had a role in "cajoling and reminding" doctors to report. Despite this setback, pharmacists continued to fill in yellow cards informally and set up local schemes for ADR reporting in hospitals throughout the 1980s.
Pharmacists are now able to report, following successful trials and a desire to increase the size of the reporter population. It is, therefore, important that pharmacists live up to the expectations that they were, in part, responsible for raising. So how are we doing?
Pharmacists not performing fully
Dr Edmund Major's article (PDF* 50K) this week (p25) gives some encouragement about pharmacist reporting. We are contributing valued reports and reports are still increasing in numbers. However, as Dr Major notes, pharmacists are clearly not performing to their full potential in terms of the potential number of reports they could contribute. The trend of increasing hospital pharmacy reports in previous years appears to have come to a halt in 2001, levelling out at around 1,800 reports per year. Although community pharmacy reports increased this year, the absolute number is small given the larger number of potential reporters in that branch of the profession.
Of course, under-reporting is not confined to pharmacists; medical staff do not perform to their full potential either. Changes in professional culture can take years to become embedded. Pharmacy is also in the throes of a workforce crisis, with up to 60 per cent of hospital pharmacies not being able to provide the services they wish to. Community pharmacists face similar pressures.
It should also be remembered that medical reporting took several years to reach even its current levels. In Canada, where pharmacists were permitted reporters from the inception of its ADR reporting scheme, they provide the highest proportion of reports. There is no reason why pharmacists in the UK should not have this as a long-term objective.
Research into pharmacist ADR reporting1,2 has shown that those who undergo training are more likely to report. High workload, a lack of time in clinical practice and the time taken to report are cited as deterrents to reporting. At a more fundamental level, pharmacists may not have the time to find ADRs while practising. Although most pharmacists are aware of the scheme, a sizeable number still appear unclear about what should be reported. Pharmacists are more likely to report an ADR when they are confident that the drug caused the ADR, yet, in fact, only a suspicion is required to make a report.
Some pharmacists are keen reporters. For instance, no less than 2.5 per cent of all hospital pharmacist reports submitted nationally since 1997 are from just five reporters in the West Midlands. Although this shows what can be done, it is perhaps too much to expect all pharmacists to perform at this level. However, if each practising pharmacist in the UK submitted just one card a year, the total number of reports to the CSM would be doubled.
ADRs are not hard to find. In the community around 2 per cent of GP consultations are due to ADRs, and a sizeable proportion of drug returns to pharmacy are from patients who have suffered an ADR. Five per cent of admissions to hospital involve an ADR and a similar percentage of patients suffer one within the hospital.
A developing culture needs nurturing. Pharmacy's professional bodies, schools of pharmacy and leaders of the profession all have their part to play in fostering and encouraging the habit. A recent, unpublished, survey of pharmacy schools in the UK has showed that the yellow card scheme is part of the syllabus in 12 schools (86 per cent) and in the course assessments of 11 schools (80 per cent); this latter percentage, in particular, is higher than occurs in medical schools. The Royal Pharmaceutical Society's Code of Ethics asks pharmacists to assume as a personal responsibility that they ensure "they take action to report to the prescriber and relevant authorities, suspected adverse drug reactions", although the yellow card scheme is not explicitly mentioned.
Although it is to be welcomed, the heightened interest in measuring and tackling the problem of medication errors could potentially lead to ADR reporting being perceived as less of a priority, particularly in already over-stretched pharmacy services. The Audit Commission suggested that hospital pharmacists are the group which will be crucial in reducing medicine-related problems in our hospitals, and ADR reporting is part of this role. A desire for more information about medication errors should not lead to a failure to deliver on ADR reporting. Many ADRs have an element of error in prescribing and the CSM has previously warned of potential medication errors based on reports to the yellow card scheme.
The recent consultation on supplementary prescribing for pharmacists and nurses clearly indicates that ADR reporting will be an integral part of the responsibilities of supplementary prescribers and will be included in the associated clinical management plans. Why not demonstrate one of the abilities required for these future roles by developing a reporting habit now? More potent therapeutic agents are also being considered for a POM-to-P move. A high level of community pharmacy reporting would help increase the confidence that a safety net existed to allow such changes to occur.
The admission of pharmacists to the yellow card scheme was a breakthrough, but being accepted as valid reporters was not an end in itself. Pharmacists have to deliver. Improving on our current reporting rates will be a clear indication that we can become the experts in the clinical use of medicines. If pharmacists want to help the profession improve its standing, then making use of the yellow pages at the back of the British National Formulary would be a small, but vital contribution.
Tips on reporting adverse drug reactions are at www.csmwm.org.
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Citation: The Pharmaceutical Journal URI: 20007177
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