1500 words Complementary and Alternative Medicine Fitness to Practise essay

What is fitness to practise?

 

Introduction

 

People worldwide have relied on traditional medicine for treatment for the past 3000 years. Use of complementary and alternative medicine, CAM, has been increasing in recent years. There has been no new acts of parliament since Medicine Act of 1968 to regulate CAM practitioners and was widely believed that 1968 Act ensured all the rights to practise. At present there are regulatory proposals for CAM practitioners which are very likely to become law in 2011. New regulations are necessary due to high demand for herbal medicine, acupuncture and traditional Chinese medicine. Also there is a need to protect the public from bad practice, poorly and insufficient trained practitioners and people who call themselves herbalists without having been trained at all. It is also considered that Medicine legislation is out of date.

 

House of Lords Select Committee Report on CAM, Department of Health (2005),

That the inquiry was held to consider questions of significance for public health policy raised by the increased use of Complementary and Alternative Medicine (CAM) in the UK and the developed world. The report does not consider the clinical efficacy of particular products or therapies but covers questions relating to use, regulation, training, research and NHS provision. The main conclusions of the report are that: the evidence base for many of these therapies is weak and robust research into their efficacy is needed; the regulatory framework should be stronger to ensure that practitioners are properly trained and supervised; only well regulated therapies should be provided by the NHS and then only through a referral from a GP; there is a need for information and more effective guidance for the public. The Committee urges that legislative avenues be explored to better control the unregulated herbal sector.

 

The report also recommended that acupuncture and herbal medicine practitioners should be statutority regulated and herbal medicine must have assured quality and safety.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Discussion

 

The report is wellcomed by CAM practitioners due to its recognition for regulation. The General Medical Council keeps a register of qualified practitioners and controls medical education by the power given to GMC by the Medical Act 1983. Clients are best served by qualified CAM practitioners who are able to practice the skills of their particular therapy in a safe and competent manner. To achieve this, high standards of training is of importance. Therefore the best way will be through a system of licensing or registration.

 

Responsibilities and accountabilities

 

Duty of Care is one of the most improtant responsibilities that a practitioner should adhere to all the time. It involve duty to do best for the patient. To work through code of conduct. To treat patients within the law and do not cause any harm. To respect the privacy and confidentiality of the patient and be fair and non-discriminatory. To observ the statutory and voluntary regulations. Consent must be obtained from the patient before treatment. ‘A child of 16 or 17 (Dimond 1998, p135) has the right to give consent to treatment under the Family Law Reform Act 1969’.

 

Medical treatment requires the agreement of the patient therefore consent is mandatory. The consent is expressed in the form of writing. Before any treatment, physical examination or care, the practitioner must obtain consent. An adult mentally competent person has the right to refuse treatment. ‘Consent may be (Brazier 2003, p95) implied from the circumstances and need not be written.’ A written consent is not needed in case of accidents and emergecies. Medical law is governed by the Acts of Parliament. Complaint about Medical cases, in the first instance, are referred to Qeens Bench Division. If no result has been achieved, the case will go to Court of appeal then House of Lords and if there is still no outcome it goes to European Court.

 

Changes in medicine law in the U.K. and E.U. will result in providing better quality service to patients and stops bogus practitioners. EU Commission recognises need for Directive to regulate herbal products throughout EU. There is a major concern over herbal safety; misidentification, contamination of herbs e.g. heavy metals and irradiation. Adulteration is another concern, when cheaper substances are mixed for finantial gains. Also herb-drug interaction is of concern e.g. st john’s wort can interact with few conventional medicines. To stop fraud in preparation of herbal medicine and poor practice requires regulation. Corticosteroid has been found in creams intended for use in children with eczema, fenfluramine found in slimming products, presence of other conventional medicine like Warfarin found in herbal mix, illegal advertising, inability of talking to clients and no proper consultation.

 

Proposed solution

 

A)- New EU Directive on Traditional herbal medicine Producats (THMPD) sets new Over The Counter (OTC) standards adopted in April 2004 with requirements for full implementation by April 2011. In UK this will replace S12(2) of 1968 Medicine Act for OTC products..

B)- Aims to ensure correct idetification of medicinal plants and adoption of Good Manufacturing Practice by suppliers and manufacturers.

C)- Requires that OTC herbals demonstrate 30 years safe use for registration, 15 years of which within the EU.

D)- Monographing herbal safety and efficacy by the European Medicines Evaluation Agency Committee on herbals

E)- Permits limited medicinal claims on THMPD products.

 

 

Problems with the THMPD

 

If the present proposals go through and become law, the cost of licensing will be high, also the cost of quality assureance will be high. As the proposals stand now, quality control guidelines are not workable for multi-herb complexes. There is a need for new quality guidelines. The time for all this is running out as Section 12(2) of 1968 Act, the products should be withdrawn from market from April 2011 when the THMPD is fully implemented. The new regulations and guidelines have an impact on UK herb sector and it is likely to be severe. The range of herbal OTC products under THMPD is limited therefore can manifacturing companies profit from the new regulations and stay in business?

 

According to the proposals, multi-herb complexes and products should be manufactured in the UK. This is not workable due to some products used by medical herbalists come from abroad, e.g. Mediherb products are of high stndard and if it is manufactured in the UK, it will certainly increases the cost. Safety should be linked to the ability to use more potent remedies e.g.Belladanna nd Ma Huang, to membership of herbalist register. Also the ability for a registered herbalist to delegate some tasks to staff working under supervision should be considered. Medical Health and Regulation Authority (MHRA) has proposed that registered herbalists, Department of Health (2004), may be considered “authorised health professionals”. This allows them to order industrially produced herbal remedies for specific needs without need for full medicines licence. These remedies would be manufactured under special licence from the MHRA and the initiative to make them must come from the practitioner. Companies will not be permitted to advertise these products. It is of benefit to include some non-plant traditional medicines in the proposal.

 

Complementary medicine (Stone and Matthews 1996, p79) ‘has none of the organizational infrastructures that have been set up to support and organize orthodox medicine. In addition, complementary medicine, which generally eschews pharmaceutical drugs, has never had the financial backing of drug companies for research and publishing purposes that orthodox medicine receives’.

 

 

 

 

Conclusion

 

CAM practitioners as health care professionals, have ethical as well as legal duties. They have different therapeutic approaches but perform their duties within the same ethical parameters as all other health professionals with the purpose and desire to benefit and not to cause patients harm.

 

New proposed reforms enable the public to identify qualified and competent practitioners who abide by a professional code of conduct. Give legislators the opportunity to recognise and take avantage of the skill and competence of statutory regulated herbalists and traditional medicine practitioners when diciding on the safety of individual herbal medicines. Offer a secure legislative home for remedies considered too potent for general sale. Since effectively at present anyone can be a herbalist, there is currently no inbuilt safety. Ability of herbalists legally recognised means easier to keep potent remedies e.g. ephedra. It is included in the new proposals that herbal and traditional practitioners on the register will be considered authorised health professionals. This permits authorised health professionals on the statutory register to initiate manufacture by a third party of unlicensed herbal medicines to meet the needs of individual patients. This is important for any complex formulation that may reqire industrial processing. This is particularly important for new practitioners who do not have the room to do their own dispensing.

 

There is scope of possible extension to non-herbal ingredients. This would potentially allow the compounding of some non-herbal active ingredients in external remedies such as clays, zinc oxside,etc. It potentially allows the internal use of some non-herbal medicines such as propolis and authorised TCM and Ayurvedic minerals such as gypsum.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reference List

 

 

Brazier, M.  (2003).  Medicine, patient and the law.  (3rd ed).  London: Penguin.

 

Department of Health.  (2000).  Complementary and alternative medicine: House of Lords Select Committee on Science And Technology.  [online}.  London: Stationery Office. (SN; HL paper, session 1999-2000 12). Available from: http://www.doh.gov.uk  [accessed 21st February, 2008].

 

Dimond, B.  (1998).  The legal aspects of complementary therapy practice: a guide for health care professionals.  London: Churchill Livingstone.

 

Stone, J. and Matthews, J.  (1996).  Complementary medicine and the law.  Oxford: Oxford University Press.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Bibliography

 

 

Department of Health.  (2006).  The regulation of the non-medical healthcare profession: review led by Andrew Foster.  [online].  London: Stationery Office.  Available from:  http://www.doh.gov.uk  [accessed 23rd February, 2008].

 

Gillon, R. & Lloyd, A.  (1994).  Principles of health care ethics.  Chichester: John Wiley & sons.

 

Mason, K. & McCall Smith, A.  & Laurie, G.  (2002).  Law and medical ethics.  (Sixth ed).  London: Butterworths.

 

Stone, J.  (2002).  An ethical framework for complementary and alternative therapists.  London: Routledge.