Specialist Therapeutic Areas

As mentioned above, there is some evidence to suggest that hospital doctors report less frequently than GPs (Bateman et al., 1992; Eland et al., 1999). This may result in under-reporting being a particular problem for medicines where treatment 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 overall 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 particular interest: drugs used in the treatment of HIV/AIDS, ADRs in children, and those associated with herbal products, including unlicensed 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 world-wide 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 MCA 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). Ongoing promotion of the scheme, including the production of a regular newsletter, is aimed at maintaining the effectiveness of this initiative.

Suspected ADRs in Children

There has been significant public interest expressed in the safety of medicines used in children; particular concern surrounds the safety of medicines which are not specifically licensed for use, or are used ''off label'' (i.e. for unlicensed indications) in this patient group (Wells, 1996). Despite the lack of firm evidence of safety and efficacy in children of medicines licensed for use in adults, such medicines may well be used when treating children, especially where no licensed alternatives exist. Safety and efficacy in children cannot be assumed simply based on data from studies in adults; for instance, children differ from adults in terms of their pharmacokinetics (Reed, 1996; Leeder, 1996). It is possible that the adverse reaction profile of a medicine in children may differ from that in adults, and it is therefore particularly important to collect suspected ADR reports in this area. However, it is notable that under-18-year-olds make up around 20% of the population, but that the proportion of Yellow Card reports received for this age group is somewhat lower (approximately 8% in 1997 and 1998).

To investigate whether unlicensed or ''off label'' use of medicines in children was leading to adverse reactions, and whether such reactions were being reported, a pilot scheme to stimulate reporting of suspected ADRs in children was set up in the Trent NHS region in September 1998; this scheme targeted paediatricians and hospital pharmacists.

An analysis by the MCA of this pilot scheme, two years following its introduction, showed that there was an increase in the absolute numbers of hospital reports of suspected ADRs in children received from the Trent region. Since the time covered by this analysis overlapped significantly with the nation-wide meningitis C vaccination campaign, it was perhaps not surprising that the majority of reports received were of suspected ADRs associated with this vaccine. However, when reports for meningitis C vaccine were excluded, it was notable that the underlying rate of paediatric reporting in the Trent region had remained relatively static between 1994 and 2000, and was comparable with national reporting rates for suspected ADRs in children; additionally a relatively low proportion (less than 30%) of reports related to serious reactions. Broader initiatives are being planned, building on the experience gained in the pilot scheme.

by the general public; many products are available on general sale in pharmacies and health food shops and are likely to be used by patients to self medicate without prior consultation with their health professional.

Until 1996, the Yellow Card Scheme collected reports of suspected ADRs to licensed herbal products only; in 1995, less than 0.2% of Yellow Cards received related to such products. In October 1996, the Yellow Card Scheme was extended to include reporting for unlicensed herbal remedies, following a report from Guy's Hospital Toxicology Unit on potentially serious adverse reactions associated with herbal remedies (Anon, 1996). Although levels of reporting remain low, there has been an almost two-fold increase in the reporting of suspected ADRs to herbal remedies (around 40 reports per year until 1998; more than 70 reports in 2001), with such reports accounting for 0.4% of reports received in 2001. This information is important in monitoring the safety of herbal products, many of which are unlicensed and therefore unregulated, and in evaluating how such products might interact with licensed medicinal products, e.g. the recently reported interactions between the herbal remedy St John's Wort and a number of medicines including the oral contraceptive pill (Anon, 2000d). It is important that efforts continue to be made to stimulate reporting in this area, in light of the large usage of unlicensed herbal remedies; it is likely that community pharmacists may play an important role in reporting in this area (Davis and Coulson, 1999).

Unlicensed Herbal Remedies

A survey of the use of complementary and alternative medicine in the United Kingdom found that 20% of adults interviewed had used such treatments in the past year, and it was estimated that the annual expenditure on these treatments in the United Kingdom may exceed £1.5 billion (Ernst and White, 2000). Although some herbal products are licensed for use, there is a large variety of unlicensed herbal preparations, including traditional Chinese and Ayurvedic remedies, which are increasingly available. Herbal products may be perceived as ''natural'' and therefore safe

FACILITATION OF REPORTING—NEW TECHNOLOGY AND MEDIA

It seems self-evident that making reporting easier may increase levels of reporting; this is demonstrated by the rise in reporting in the mid 1980s following the move to make Yellow Cards readily available by including them in the BNF and in GP's prescription pads. This is supported by the fact that lack of time has been found to be one of the main factors in deterring ADR reporting in various studies (Bateman et al., 1992; Belton et al., 1995; Sweis and Wong, 2000), including the MCA's work with GP focus groups.

In addition to increasing time pressures on health professionals, the recent expansion in the use of information technology means that the majority of GP practices, hospitals and pharmacies are now using computers as a routine tool in their daily work. In light of this, it is recognised that the paper Yellow Card may no longer be the most convenient method of reporting. Electronic reporting of suspected ADRs to the MCA is now routine for a small number of pharmaceutical companies who have been submitting reports via the MCA's ADROIT Electronically Generated Information Service (AEGIS) since 1995. Following on from this initiative, the MCA is currently piloting the use of electronic reporting for health professionals. Working with the GP practice software companies EMIS and Meditel, electronic reporting has now been made available to all users of these systems, either by the electronic submission of reports via a modem, or semi-automated completion of an electronic Yellow Card which is printed out and posted to the MCA. This pilot scheme was introduced in mid-1998 (Anon, 1997b); to date almost 1800 GP electronic reports have been received, and these reports comprised approximately 2.5% of UK reports received in 2001.

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