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