Complementary and alternative medicine is in need of stricter controls on practitioners, more research into safety and efficacy, and better public access to impartial advice, the Royal Pharmaceutical Society says in evidence to an inquiry by the House of Lords science and technology committee.
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Recommendations
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Answering the Lords committee's first question, about the role of patient satisfaction in evaluating the effectiveness of complementary treatments, and in determining availability, the Society says that the number of practitioners and the fact that they are paid directly by the patient suggests widespread patient satisfaction. However, although a patient may think a condition has improved following complementary therapy, the condition may be no better or may be masked, and the patient may delay seeking advice from a health care professional. Patients therefore need ready access to professional help (Recommendation 1).
On the question of whether all medical and health care interventions should be backed by evidence of efficacy, the Society points out that there are methodological difficulties in researching complementary medicine, although many of these problems can be solved with imaginative research design.
The Society says that generally the public does not demand objective, scientific evidence of efficacy, although it is critically important to protect the public from fraudulent claims (Recommendation 2).
Asked about the best sources of information on complementary medicine, the Society says that advice needs to be objective and impartial (Recommendation 3). It points out that pharmacists are particularly well placed to advise on complementary remedies and resolve any conflicts with orthodox medicines. The evidence refers to the Society's draft professional standard on complementary therapies and medicines, which states (among other things) that pharmacists should not recommend any remedy if they have any reason to doubt its safety or quality and should only offer advice in areas where they have undertaken approved training or have specialised knowledge.
On the question of controlling the quality of public information available on complementary treatments, the Society says that control is desirable but impracticable when so much information of uncertain quality is provided by press articles and on the internet. The Society suggests that, in view of the public's exposure to tabloid-quality information, reliable and easy-to-read texts should be provided for the layman. This would be easier if there were registered professional bodies that could commission suitable texts and also raise standards of practice (Recommendation 4).
On the question of whether research funding for evaluating complementary medicine should be increased, the Society says that there have been insufficient well-controlled clinical studies. It recognises the funding councils' difficulties and the impediments to research, but believes that directed research programmes should be established, using different assessment parameters from those currently employed (Recommendation 5).
On sources of funding, the Society says that one important source should be the complementary medicines industry, including manufacturers of herbal products, with additional funds from foundations and charities and from relevant professional groups. It suggests that there is a good case for Government funding to create a database for use in evaluating complementary medicines. Consideration should be given to establishing a programme to "kick-start" this research. There is a clear role for the NHS Executive and the Medical Research Council in the conduct of proper assessment procedures of research submissions, and the encouragement of improved quality of submissions, and the Society would support such initiatives.
In answer to a question about the types of additional research that would be useful, the Society suggests that three main areas of research need to be pursued - high-quality clinical trials (Recommendation 6), health services research (Recommendation 7) and health economics research (Recommendation 8).
It says that clinical trials are needed to inform any assessments that may be made by National Institute for Clinical Excellence, to assess interactions between herbal and orthodox medicines, and to identify clinical conditions in which specific herbal products are unsafe to use. Health services research should include practice research to assess the extent to which pharmacists advise on complementary remedies in an evidence-based manner, to identify the actions pharmacists take to resolve medication-related problems among users of complementary therapies, and to assess the impact of those actions on patient outcomes. Health economics research data are needed to make informed choices about NHS services and budgets.
On whether the increased interest in complementary medicine should be reflected in the training of health care professionals, the Society says that much advice currently given to the public is provided by lay persons with little or no training. Advice should be available from trained health professionals, with a system of referral to experts by those who are not adequately trained (Recommendation 9).
The evidence adds that the Council is to consider ways in which the undergraduate curriculum in Britain's schools of pharmacy can be strengthened in the areas of complementary therapies. The evidence also refers to a need for professionals trained in identifying and authenticating the raw materials used in herbal medicines, pointing out that centres of excellence in pharmacognosy within schools of pharmacy provide such training and undertake research.
On safety of complementary medicine, the Society says that there are definitely areas where lack of regulation causes unacceptable risk. Complementary therapies may be unsafe in a number of ways: products may be unsafe because they are impure, contaminated, adulterated or non-authentic; products may be unsafe if they are used by certain patients (eg, pregnant women or patients with renal and hepatic diseases); and complementary medicines may be used in conjunction with orthodox medicines, with the potential for interactions (Recommendation 10).
The Society gives examples of products that have put the safety of the public at risk, including some demonstrating a need for a registration system for suppliers of traditional Chinese medicines (Recommendation 11).
The evidence goes on to consider the specific areas of herbal medicines, homoeopathic preparations and aromatherapy oils. On herbal medicines, it says that all herbal remedies should be regulated through a new category of licensed herbal medicines (Recommendation 12). The licensing requirements in this category might not be as demanding as those currently applied to licensed medicines, particularly in regard to the "level of proof" of activity. However, these products ought to be required to substantiate a history of safe use for the dosage and indications to be approved, and the licence should clearly indicate the inappropriate conditions of use. Quality issues would have to include an adequate specification, with proof of the authenticity of the product or its ingredients, and proof of its freedom from substitution or adulteration, compliance with certain chemical tests and manufacture in accordance with good manufacturing procedures.
The evidence adds that existing compendial requirements for herbal products include a European Pharmacopoeia monograph for "herbal drugs", and World Health Organisation guidelines for assessing herbal medicines for quality, safety and efficacy.
In addition to the potential for contamination or adulteration of raw plant materials, there is a concern about the substitution of one product for another and about medicinal herbs used in Eastern herbal traditions that may be largely unknown to scientists in the West. There is a need to balance the freedom of choice for consumers, together with a respect for their cultures, against the responsibility of the medicines regulatory authorities to protect public health.
On homoeopathic preparations, the Society supports the use of compendial monographs in establishing the required standards for safety and quality of homoeopathic medicines, pointing out that the European Pharmacopoeia contains monographs that define what a homoeopathic preparation is and sets out standards for some 52 raw materials used as homoeopathic stock.
The European Pharmacopoeia also contains a number of monographs for essential oils, some of which may be used topically in aromatherapy. The Society supports the development of compendial specifications for all aromatherapy oils. Since some such oils are hazardous when used in pregnancy, this should be clearly indicated on product labels.
The Society adds that, as well as regulation of complementary medicine products, there should be proper regulation of practitioners. It suggest that the model of osteopathy and chiropractic should be extended to other complementary therapies, with registration of practitioners (Recommendation 13). The need for insurance indemnity against claims of malpractice could be a driver towards the registration of practitioners.
Answering a question about the integration of elements of complementary medicine into mainstream health care, the Society says that it supports such a move. It points out that osteopathy and chiropractic are already accepted within the mainstream of practice and that homoeopathy is allowable under the NHS although, depending on the attitude, training and experience of the patient's general medical practitioner, it is not always available.
The Society suggests that pharmacists can be instrumental in integrating orthodox and complementary medicine for individual patients, and between practitioners of the two types of medicine.
Practitioners of orthodox and complementary medicine need to be encouraged to work together in all areas of practice, including the management of research at the interface (Recommendation 14). The Society welcomes the work of the Foundation for Integrated Medicine which is attempting to achieve closer integration.
On the question of which complementary therapies should be available through the NHS, the Society says that NHS availability should be limited to therapies that are subject to formal, regulatory approval (Recommendation 15). Before access to other types of complementary medicines could be considered, they should have to meet objective and enforceable standards of quality. British Pharmacopoeia and European Pharmacopoeia mechanisms could be extended to these products to provide publicly available standards of quality. Compliance with these standards could then form the basis of NHS acceptance and reimbursement.
With regard to a suggestion that NHS treatments should be limited to those that have an evidence base, the Society says that there should be a long-term objective that such treatments should be assessed by the NICE, although this should not preclude the use of treatments in the short term where good evidence of efficacy exists.