When pharmacy reporting of adverse drug reactions via the yellow card system was introduced in 1997, hospital pharmacists were engaged on a nation-wide basis, but community pharmacists were only asked to participate in a trial covering four areas linked to Committee on Safety of Medicines regional monitoring centres, and, furthermore, to focus in their reporting on over-the-counter medicines and herbal products (PJ, March 8, 1997, p323).
It is with some pleasure that we record this week that those trials have been successful - although the reports sent in were not particularly numerous they were of good quality - and that ADR reporting by community pharmacists is now to be encouraged nation-wide (p776). Community pharmacists are to be on a par with their hospital colleagues.
As in the trial, community pharmacists are being particularly asked to report on suspected reactions to OTC medicines and herbal products, but they are not restricted to these. Nor should they be. They see in their daily practice all types of medicines being used for all types of patients. They have a potential contribution to make across the therapeutic board. Their potential is greater than the trial has indicated. Indeed, the emphasis on OTC and herbals may have contributed to the low rate of community pharmacist reporting (p786).
What are the implications for community pharmacists of the new policy? In our view they now have a real opportunity to become part of the primary care team and discuss patients' treatment with doctors. It is not a requirement that pharmacists talk to GPs before sending in an ADR report, but it would be good practice, particularly with prescribed medicines, and could open the door to further contact. In this connection it is worth noting that GPs surveyed by the CSM in Wales are for the most part (almost 90 per cent) in favour of community pharmacy reporting (p788), which amounts to a vote of confidence.
What needs to be done to encourage community pharmacists to report? A recent paper on their attitude to ADR reporting gives some clues (Green et al, Int J Pharm Pract 1999;7:92-9). Pharmacists need to be reassured that doctors and the CSM will value their reports. They need to know that they do not have to be 100 per cent certain of an ADR before reporting it. They need to be reassured about their legal liability if they report an ADR to a product they recommend. (GPs were worried about this initially.) Finally, there needs to be education for pharmacists from undergraduate level onwards to build confidence and knowledge. The universities and postgraduate training bodies should be helping with this.
One area where the CSM especially wants reporting is in relation to new drugs, which are marked with a black triangle in the British National Formulary, Mims and the ABPI Compendium of Data Sheets and Summaries of Product Characteristics.* Pharmacists could make a point of asking patients taking such medicines how they were getting on with them.
No pharmacist should now feel any inhibitions about reporting an ADR. They were inhibited in the past through lack of (or half-hearted) official encouragement. Those days are now past, thank goodness. Pharmacovigilance (and patients) should benefit.
*They are listed on the Medicines Control Agency website (www.open.gov.uk/mca/mcahome.htm). A list is also available from the yellow card information service (tel 0800 731 6789).