Unlicensed Herbal Remedies

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Chapter: Pharmacovigilance: Spontaneous Reporting - UK

A survey of the use of unlicensed complementary and alternative medicines in the United Kingdom found that 20% of adults interviewed had used .


A survey of the use of unlicensed complementary and alternative medicines in the United Kingdom found that 20% of adults interviewed had used such treatments in the past year, and an estimate of the annual expenditure on these treatments in the United Kingdom suggested that it may exceed 1.5 billion (Ernst and White, 2000). Up to now alternative regulatory routes for herbal products existed in the United King-dom with only a minority of herbal products licensed for use based on evidence of safety, quality and safety, similar to those required for the licensing of a medicine. Traditionally herbal products have been exempt from licensing requirements by the conditions set out in Section 12 of the Medicines Act and for that reason 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 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 were 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 poten-tially serious adverse reactions associated with herbal remedies (Anon, 1996). Although levels of reporting remain low, there has been an almost twofold increase in the reporting of suspected ADRs to herbal reme-dies (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 informa-tion is important in monitoring the safety of herbal products, many of which are unlicensed and there-fore unregulated, and in evaluating how such products might interact with licensed medicinal products, for example the reported interactions between the herbal remedy St John’s Wort (Hypericum perforatum) and a number of medicines including the oral contraceptive pill (Anon, 2000d).

The safety of unlicensed herbal products was further emphasised when reports of serious hepatotoxicity, including fatal cases and cases resulting in liver trans-plants, were reported in association with the use of Kava-kava (Piper methysticum). As a result the CSM prohibited the use of Kava-kava in unlicensed medic-inal products in July 2002 and this was followed by a prohibition order in January 2003 (Anon, 2003). A year later, health professionals were asked to report cases of hepatic ADRs with the use of Black cohosh (Cimicifuga racemosa) via the Yellow Card Scheme following cases of hepatotoxicity in the United King-dom (Anon, 2004).

These safety issues highlighted the urgent need for regulatory standards for the safety and quality of herbal products and for more formal requirements to be made of the manufacturers for the provi-sion of information to consumers. In January 2002, the European Commission adopted formal propos-als for a Directive on Traditional Herbal Medicinal Products. Directive 2004/24/EC amending Directive 2001/83/EC, the Community code on medicinal prod-ucts for human use, was formally adopted and came into force on 30 April 2004 (Official Journal of the European Communities, 31 March 2004). This new Directive requires that all medicinal herbal products placed on the market in the United Kingdom will be required to be registered under the Traditional Herbal Medicines Registration Scheme (THMRS). The new Scheme requires traditional herbal medicines to meet specific and appropriate standards of safety, quality and traditional use and for the product to be accompa-nied by information for its safe use. The Directive was implemented in the United Kingdom on 30 October 2005, and a 7-year transitional period for unlicensed herbal medicines allow companies time to adjust to the new requirements. A new UK advisory committee on herbal medicines, the Herbal Medicines Advisory Committee (HMAC), has been established to advise the government on the THMRS, as well as on unli-censed herbal remedies supplied under Section 12 of the Medicines Act 1968. In the light of the large usage of unlicensed herbal remedies, it is important that efforts continue to be made to stimulate reporting in this area; with registration of these products under the new Directive, it is likely that further safety issues with herbal products will be unveiled.

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