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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

As mentioned above, there is some evidence to suggest that hospital doctors report less frequently than GPs (Bateman, Sanders and Rawlins, 1992; Eland et al., 1999).


As mentioned above, there is some evidence to suggest that hospital doctors report less frequently than GPs (Bateman, Sanders and Rawlins, 1992; Eland et al., 1999). This may result in under-reporting being a particular problem for medicines where treat-ment is initiated and monitored by hospital specialists. In addition, in certain situations or patient groups, data to support the safe and effective use of medicines is particularly limited. For such areas of particular concern, an increase in the number of relevant reports may not be achieved simply by increasing the over-all reporting base. Rather, in such areas, an approach has been taken to target existing reporting groups to improve the reporting of reactions relevant to these areas. Described here are recent initiatives aimed at improving reporting of ADRs in three areas of partic-ular interest: drugs used in the treatment of human immunodeficiency virus (HIV)/Acquired Immunode-ficiency Syndrome (AIDS), ADRs in children, and those associated with herbal products, including unli-censed remedies.

The HIV Reporting Scheme

Since the mid-1990s a number of important new drugs have become available for the treatment of individuals infected with HIV. Some of these drugs have been licensed on the basis of clinical trials that involved small numbers of patients and were designed to show changes in surrogate markers of HIV disease. This meant that at the time of licensing there was very limited safety data available for these drugs.

Following their introduction onto the UK market, it was noted that relatively few suspected ADRs were being reported in the United Kingdom for these anti-retroviral treatments, despite the fact that new safety issues were being identified from worldwide safety data.

In order to address this, the HIV reporting Scheme, an extension of the Yellow Card Scheme, was launched in November 1997 by the MHRA and CSM in collaboration with the Medical Research Council HIV Clinical Trials Centre (Anon, 1998a). The Scheme targeted specialist health professionals (doctors, nurses and pharmacists) working with people infected with HIV; these health professionals were asked to report suspected ADRs on specific reporting forms which did not request the name of the patient, in order to allay concerns over patient confidentiality which might be a serious deterrent to reporting for this particular patient group.

The introduction of this Scheme resulted in a significant increase in the number of UK reports of suspected ADRs associated with anti-retroviral drugs: for instance, during the seven months prior to the launch of the Scheme, 112 reports were received, compared with 207 during the seven months following the launch (Anon, 1998b). Promotion of the Scheme, including the production of a regular newsletter HIV ADR Reporting Scheme News, was aimed at maintain-ing the effectiveness of this initiative.

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