statutory regulation of herbal medicine
The Department of Health's report The Regulation of the non-medical healthcare professions (July 2006) defines regulation as the set of systems and activities intended to ensure that healthcare practitioners have the necessary knowledge, skills, attitudes and behaviours to provide healthcare safely. This encompasses activity undertaken by individual professionals, teams, employers, regulatory bodies and other organisations.
The core activities of regulation are listed in the Health Act (1999) as:
1. Keeping the register of members admitted to practice
2. Determining standards of education and training for admission to practice
3. Giving advice about standards of conduct and performance
4. Administering procedures (including making rules) relating to misconduct, unfitness to practise and similar matters.
The prime purpose of professional regulation is public protection. Whilst there will also be considerable benefits for the professionals in the production of visible standards, the professionals themselves are not the main focus of regulation - the focus lies with the consumer.
Professional regulation becomes statutory regulation at the point where the State regards it as so important for public safety that it legislates for a ban on either using the professional title or doing certain things unless your name appears in the register. This protects patients from the harm caused by people practising a profession which they are not fit to. It engenders public confidence by allowing members of the public and the employers of professionals to check on a person's registration status, knowing that the information they find will be correct and up to date.
Statutory Regulation in the UK
The move towards statutory regulation of herbal practitioners originates from the House of Lords Select Committee on Science and Technology's Report on Complementary and Alternative Medicine (HMSO 2000) and the Government Response (Department of Health 2001) to it. The report recognised that complementary and alternative medicine (CAM) are both widespread and increasing across the developed world and that this has implications for patient safety. The Committee identified that there was considerable diversity of standards amongst the professions and that, for some therapies, the public was at risk from practitioners with inadequate or inappropriate training.
Herbal medicine was identified as posing particular challenges for public health. The statutory regulation of herbal medicine practitioners was supported because the profession meets agreed criteria that makes this appropriate. These criteria are risk to the public through poor practice, a voluntary regulatory system and a credible evidence base. Regulation would ensure that appropriate training was established. This would result in competent practitioners with an understanding of the evidence base for their therapy along with an appreciation of the limitations of the treatments they can provide. Safe practitioners would understand when to refer. Effective regulation would therefore seek to safeguard the public from incompetent practitioners. It would identify practitioners suitably qualified to use a range of potent herbal remedies that are not appropriate for over-the counter sale.
The House of Lords Select Committee on Science and Technology's Report on Complementary and Alternative Medicine (HMSO 2000) stated that CAM included a large range of therapies and that while some had well-developed regulatory structures, others were fragmented with no consensus about regulation. The evidence base for the various CAM therapies was also variable but the majority did not have one. It proposed that CAM therapies should be classified within 3 groups. Therapies assigned to Group 1 included the most organised CAM professions where NHS provision is increasing and where research into their effectiveness had either already commenced or was likely to be beneficial. The therapies assigned to Group 2 also have support from the NHS but are used in a complementary way alongside conventional medicine. Again they require further research and need to develop their regulatory structures. Those therapies assigned to Group 3 were considered to have no evidence base for clinical effectiveness.
Herbal medicine, or phytotherapy, was defined as, "a system of medicine which uses various remedies derived from plants and plant extracts to treat disorders and maintain good health". It was assigned to Group 1 along with acupuncture, chiropractic, homeopathy and osteopathy. Other therapies that also use herbal products, and in some cases acupuncture, in their practice were assigned to Groups 2 and 3. These include Maharishi Ayurvedic Medicine (Group 2), Ayurvedic Medicine (Group 3), Chinese Herbal Medicine (Group 3) and Traditional Chinese Medicine (Group 3). The proposals within this document take account of all traditions using herbal medicine as part of their practice in line with the Government's response to the House of Lords report.
The Government Response (Department of Health 2001) to the report from the House of Lords recommended that herbal medicine and acupuncture should work towards statutory regulation under the Health Act 1999 and that this was both in the interests of practitioners and patients. Taking account of the public health risks, statutory regulation should be implemented as soon as practicable.
In January 2002, the Department of Health, together with the Prince of Wales's Foundation for Integrated Health and the EHTPA established the Herbal Medicine Regulatory Working Group. The remit for the Group was to make recommendations on the regulation of herbal medicine practitioners and on the reform of S12(1) of Medicines Act 1968. In 2003, the HMRWG published its report Recommendations on the Regulation of Herbal Practitioners in the UK.
The HMRWG report includes a parallel report on the regulation of herbal remedies made up to meet individual needs and supplied to the public after a personal consultation under the provisions of Section 12(1) of the Medicines Act 1968. Proposals in this latter report aim to ensure that the herbal remedies supplied by practitioners are of the necessary quality to ensure public confidence in herbal treatment. In its response to the House of Lords Report, the Government agreed that future regulatory arrangements relating to the ingredients and products used by individual herbal practitioners should safeguard quality and safety standards while recognising the diversity of practice. The Government indicated an intention to hold discussions with herbal interest groups on this issue to consider the way forward and said that in the light of this they would consider whether any changes in legislation would be required in order to reach a satisfactory regulatory position. In effect, the work of the HMRWG on the issue of possible reforms to the regime of unlicensed herbal remedies supplied under Section 12(1) of the Medicines Act 1968 represents the first stage in the process of exploration and dialogue envisaged by the Government. It needs to be seen as distinct from, but complementary to, the wider European negotiations on the proposed Directive on Traditional Herbal Medicinal Products which relates to industrially produced traditional herbal remedies sold over-the-counter direct to the public.
Working in parallel to the HMRWG was the Acupuncture Regulatory Working Group which was set up to make recommendations on the regulation of acupuncturists. The ARWG published its report The Statutory Regulation of the Acupuncture Profession in September 2003.
The HMRWG, unlike the ARWG, concluded that the two professions should be regulated together, thereby addressing the high practitioner costs of running small regulatory bodies and resolving the need for Traditional Chinese Medicine practitioners, who practise both herbal medicine and acupuncture, to be registered twice and pay two sets of fees.
The Department of Health ran a consultation on the regulation of the two professions published as The Regulation of Herbal Medicine and Acupuncture: Proposals for Statutory Regulation in March 2004. The results of this consultation were published by the DH in February 2005 as Statutory Regulation of Herbal Medicine and Acupuncture: Report on the Consultation.
The MHRA ran a simulataneous consultation on S12.1 reform MLX299: Proposals for the Reform of the Regulation of Unlicensed Herbal Remedies in the United Kingdom made up to meet the Needs of Individual Patients and published the results in January 2005 as Summary of responses to consultation document MLX299.
Delays at the Department of Health due to the General Election in 2005 and pending developments in healthcare regulation as part of the Foster Review stalled further work for nearly a year. In early 2006, the Government set up the Steering Group for the regulation of Acupuncture, Herbal Medicine and Traditional Chinese Medicine to consider how to progress the regulation of these professions.
On the 12th June 2008 'The Steering Group Report for the regulation of acupuncture, herbal medicine and traditional Chinese medicine' was presented to the DH Minister Ben Bradshaw.
On the 16th June 2008 The Steering Group, chaired by Professor Pittilo, held a press conference at the Kings Fund to inform on this document.
Response to DOH Joint Consultation on the Report to Ministers from the DH Steering Group on the Statutory Regulation of Acupuncture, Herbal Medicine, Traditional Chinese Medicine and Other Traditional Medicine Systems Practised in the UK - click here to view (pdf)
Department of Health consultation
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General advice to consumers on the use of herbal remedies from the Medicines Healthcare products Regulatory Agency
From the website of the Medicines Healthcare products Regulatory Agency (www.mhra.gov.uk) Department of Health, UK
• Remember that herbal remedies are medicines. As with any other medicine they are likely to have an effect on the body and should be used with care. • Herbal remedies may sometimes interact with other medicines. This makes it particularly important to tell your doctor or pharmacist if you are taking a herbal remedy with other medicines such as prescribed medicines (those provided through your doctor or dentist). • Treat with caution any suggestion that a herbal remedy is '100% safe' or is 'safe because it is natural'. Many plants, trees, fungi and algae can be poisonous to humans. It is worth remembering that many pharmaceuticals have been developed or derived from these sources because of the powerful compounds they contain. Any medicine, including herbal remedies, which have an effect on the body should be used with care. • Treat with caution any herbalist or other person who supplies herbal remedies if they are unwilling or unable to provide written information, in English, listing the ingredients of the herbal remedy they are providing. • If you are due to have a surgical operation you should always remember to tell your doctor about any herbal remedy that you are taking. • Anyone who has previously experienced any liver complaint, or any other serious health complaint is advised not to take any herbal remedy without speaking to their doctor first.
Few conventional medicines have been established as safe to take during pregnancy and it is generally recognised that no medicine should be taken unless the benefit to the mother outweighs any possible risk to the foetus. This rule should also be applied to herbal medicinal products. However, herbal products are often promoted to the public as being “natural” and completely “safe” alternatives to conventional medicines. Some herbal ingredients that specifically should be avoided or used with caution during pregnancy. As with conventional medicines, no herbal products should be taken during pregnancy unless the benefit outweighs the potential risk.
Many herbs are traditionally reputed to be abortifacient and for some this reputation can be attributed to their volatile oil component.(6) A number of volatile oils are irritant to the genito-urinary tract if ingested and may induce uterine contractions. Herbs that contain irritant volatile oils include ground ivy, juniper, parsley, pennyroyal, sage, tansy and yarrow. Some of these oils contain the terpenoid constituent, thujone, which is known to be abortifacient. Pennyroyal oil also contains the hepatotoxic terpenoid constituent, pulegone. A case of liver failure in a woman who ingested pennyroyal oil as an abortifacient has been documented.
A stimulant or spasmolytic action on uterine muscle has been documented for some herbal ingredients including blue cohosh, burdock, fenugreek, golden seal, hawthorn, jamaica dogwood, motherwort, nettle, raspberry, and vervain. Herbal Teas Increased awareness of the harmful effects associated with excessive tea and coffee consumption has prompted many individuals to switch to herbal teas. Whilst some herbal teas may offer pleasant alternatives to tea and coffee, some contain pharmacologically active herbal ingredients, which may have unpredictable effects depending on the quantity of tea consumed and strength of the brew. Some herbal teas contain laxative herbal ingredients such as senna, frangula, and cascara. In general stimulant laxative preparations are not recommended during pregnancy and the use of unstandardised laxative preparations is particularly unsuitable. A case of hepatotoxicity in a newborn baby has been documented in which the mother consumed a herbal tea during pregnancy as an expectorant. Following analysis the herbal tea was reported to contain pyrrolizidine alkaloids which are known to be hepatotoxic.
A drug substance taken by a breast-feeding mother presents a hazard if it is transferred to the breast milk in pharmacologically or toxicologically significant amounts. Limited information is available regarding the safety of conventional medicines taken during breast-feeding. Much less information exists for herbal ingredients, and generally the use of herbal remedies is not recommended during lactation.
Herbal remedies have traditionally been used to treat both adults and children. Herbal remedies may offer a milder alternative to some conventional medicines, although the suitability of a herbal remedy needs to be considered with respect to quality, safety and efficacy. Herbal remedies should be used with caution in children and medical advice should be sought if in doubt. Chamomile is a popular remedy used to treat teething pains in babies. However, chamomile is known to contain allergenic sesquiterpene lactones and should therefore be used with caution. The administration of herbal teas to children needs to be considered carefully and professional advice may be needed.
The need for patients to discontinue herbal medicinal products prior to surgery has recently been proposed. The authors considered eight commonly used herbal medicinal products (echinacea, ephedra, garlic, ginkgo, ginseng, kava, St John’s Wort, valerian). On the evidence available they concluded that the potential existed for direct pharmacological effects, pharmacodynamic interactions and pharmacokinetic interactions. The need for physicians to have a clear understanding of the herbal medicinal products being used by patients and to take a detailed history was highlighted. The American Society of Anaesthesiologists (ASA) has advised patients to tell their doctor if they are taking herbal products before surgery and has reported that a number of anaesthesiologists have reported significant changes in heart rate or blood pressure in some patients who have been taking herbal medicinal products including St John’s Wort, ginkgo and ginseng. MCA is currently investigating a serious adverse reaction associated with the use of ginkgo prior to surgery. In this case, the patient who was undergoing hip replacement experienced uncontrolled bleeding thought to be related to the use of ginkgo.
From the website of the Medicines Healthcare products Regulatory Agency (www.mhra.gov.uk) Department of Health, UK
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