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Letters to the Editor
Pharmacists’ ethical dilemma will soon be solved
From Mr T. B. Chapman, MRPharmS, and Mr C. Newbould
Alison Blenkinsopp’s article (PJ, 12 March, p296) warning of the ethical dilemma of recommending the use of St John’s wort also applies to many herbal medicines currently available.
Because of a historical loophole in the law it is possible to have unlicensed herbal medicines on display in the pharmacy alongside licensed ones.
Although there is no problem in recommending the licensed ones for their stated indications there could be problems with unlicensed ones because there is no requirement to manufacture them to good manufacturing practice (GMP) standards or to test the product for identification, assay, stability or contamination.
In addition it is prohibited to state any indications on the label of an unlicensed medicine or to use a data sheet so the pharmacist has no way of determining the product’s use in pregnancy, lactation, children or the elderly, or indeed its side effects or its drug-herb reactions. Nor is there a mechanism for the pharmacist to report any adverse events caused by the product to the authorities.
In the interest of public safety this is about to change when the UK implements the Traditional Herbal Medicinal Products Directive (THMPD) 2004/24/EC. From October 2005 all herbal medicines must have a product licence, which implies they must be manufactured to GMP by a manufacturer who holds a manufacturer’s licence.
The registration requirements will not be as onerous as a new chemical entity because as some evidence of safety and efficacy will be available based on traditional use in the EU. Additionally labels will state the medical indications, and information leaflets should provide valuable information such as dosages, contraindications and use with other medicines. It will be mandatory to report adverse reactions and to introduce a system of pharmacovigilance.
Products which were on the market before April 2004 will qualify for transitional protection under THMPD until April 2011 to enable manufacturers to comply with the regulations but if the product is not licensed by that date it will be removed from the market.
Professor Blenkinsopp’s ethical dilemma with St John’s wort could be resolved if the Medicines and Healthcare products Regulatory Agency decides to allow registration of St John’s wort but there is a possibility that this may not happen for other reasons, such as the fact that depression is not a self-diagnosable indication therefore this product would not fall within the scope of THMPD. The standardised extract also has some problems because it contains both hypericin and hyperforin and there is still debate about which one is the main active constituent.
Consequently other herbs currently in use may also fail to be registrable under the THMPD route because traditional medicines are intended to be used for ailments which the patient can self-diagnose.
If herbal medicines fail to be licensed by the THMPD route then they must be withdrawn from the market or use the normal drug route to obtain registration. The latter is expensive and protracted and may not be chosen by most of the “herbal” pharmaceutical companies because the individual market size would not support this expenditure, and consumer choice would be lost.
Chairman and EU Qualified Person
Chief Analyst and Laboratory Manager
Essential Nutrition Ltd