Recent Initiatives to Enhance the Scheme

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

The environment in which the Scheme operates is very different now, compared with the 1960s.


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 of Yellow Cards’ 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. Addi-tionally, it is clear that the roles of pharmacists and nurses have evolved over recent years. For pharma-cists, 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 a wide range of 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 some issues raised in the section on ‘Weaknesses of Yellow Cards’ above. These initiatives fall into three main groups: initia-tives 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. Developments in interpretation of data protection legislation resulted in the introduction of anonymised Yellow Card report-ing. Importantly in 2004, an independent review of the Yellow Card Scheme recommended greater access to data for research, and increased patient involve-ment. 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 signal detection and, where relevant, assessment of individual cases as part of the investigation of poten-tial safety hazards. Furthermore, although 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 minor side effects. An increase in the number of reports received also has resource impli-cations. Yellow Cards are processed rapidly, accord-ing to published targets, in order to ensure that data from the reports are available on the database as quickly as possible for inclusion in the signal gener-ation process. Any large increase in the volume of reports can slow down the time taken to make reports accessible for risk detection and may increase the signal-to-noise ratio.

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