Recent Initiatives To Enhance The Scheme

Although the importance of the Yellow Card Scheme in protecting public health, by monitoring the safety of medicines in routine practice, is not in dispute, there is a need to tackle continually the issue of under-reporting by addressing some of the factors highlighted in the section on weaknesses above. The environment in which the Scheme operates is very different now, compared with the 1960s. There is ever-increasing public and media interest in the availability of medicines and their safety, new medicines are delivered more rapidly to the market place than ever before, and more medicines are available without a doctor's prescription. Additionally, it is clear that the roles of pharmacists and nurses have evolved over recent years. For pharmacists, an increasing role in patient care is due at least in part to the increasing range of medicines being made available without prescription. Nurses are now able to prescribe some medicines, and have increasing involvement in the routine care of patients in the community, particularly in the management of chronic conditions. These changing roles now place pharmacists and nurses in a position in which they are increasingly likely to encounter suspected adverse reactions.

A number of initiatives have been undertaken recently in order to try to address a number of the issues raised in the section on weaknesses above. These initiatives fall into three main groups; initiatives aimed at increasing the general reporting base, those aimed at increasing reporting in particular areas where under-reporting is of particular concern, and those aimed at facilitation of reporting. Finally, recent developments in data protection legislation have resulted in the introduction of anonymised Yellow Card reporting. Initiatives in each of these areas are described below.

The potential impact of any change to the Scheme has been assessed in relation to its effectiveness in detecting previously unrecognised drug safety hazards. Simply increasing the number of reports is not alone of particular value; the objective is to receive Yellow Card information of suitable quality to enable detailed assessments of individual cases to be made as part of the investigation of potential safety hazards. Furthermore, although absolute numbers of reports are important for the identification of new hazards, it is paramount that reports of serious ADRs are collected, since these are more likely to impact on the balance of risks and benefits of the medicine than reports of more minor side effects. An increase in the number of reports received also has resource implications. Yellow Cards are processed rapidly, according to published targets, in order to ensure that data from the reports are available as quickly as possible for inclusion in the signal generation process. Any large increase in the volume of reports will slow down the time taken to process the reports and may increase the signal-to-noise ratio.

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