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Development of guidelines for the use of complementary medicines in public hospitals. An ethical approach. ANNAK. DREW
Director, Hunter Drug Information Service, Department of Clinical Toxicology & Pharmacology, Newcastle Mater Misericordiae Hospital, NEWCASTLE NSW
ANDREWW. GILL
Director, Newborn Services, John Hunter Hospital, NEWCASTLE NSW
IAN KERRIDGE
Clinical Unit in Ethics and Health Law (University of Newcastle) John Hunter Hospital, NEWCASTLE NSW
JENNIFER MACDONALD
Deputy Director, Pharmacy Department, John Hunter Hospital, NEWCASTLE NSW
JOHN MCPHEE
Consultant, Clinical Unit in Ethics and Health Law (University of Newcastle) John Hunter Hospital, NEWCASTLE NSW
PETER SAUL
Senior Staff Specialist, Intensive Care Unit, John Hunter Hospital, NEWCASTLE NSW
ABSTRACT The extensive community use of complementary medicine (CM) can no longer be overlooked in the practice of hospital medicine. Protocols need to be developed and implemented so that health professionals can deal with the issues surrounding the use of CM. Policy development has generally focussed on the supply of CM in hospital but another approach, which is based on consideration of the ethical and legal context, is presented here. Such an approach demands clarification of institutional policy for individuals who are competent and those who are incapable of self-administration or non-competent.
INTRODUCTION
The term 'complementary medicine' (CM) encompasses many different practices ranging from acupuncture, herbal medicine, homoeopathy and dietary supplementation (with minerals and vitamins) to colour therapy and the use of electromagnetic fields. Some CM practices or therapies have been employed for over 2000 years but their availability is now commercialised. Increasing evidence has emerged for the popularity of complementary medicines. Community surveys in Australia indicate that half the population has used a CM in the preceding year. 1.2 In the USA 42% of those responding to a similar survey indicated that they had used at least one of a number of unconventional therapies in the
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previous year.s Expenditure on CM use (excluding CM practitioner visits) has been estimated to be almost twice the annual national prescription expenditure in Australia and total expenditure comparable to the amount spent out-of-pocket annually for all physician services in the US. 1. 3 The complementary medicines market was estimated to be £72 million in Britain in 1996 indicating a 36% growth over 5 years and the annual phytopharmaceutical market exceeds $2 billion (Canadian) in Germany.s-s Complementary medicines appear to be used because they enable individuals to maintain control over their own health decisions and because they provide health care alternatives that are more congruent with values and beliefs towards life and health rather than as a result of dissatisfaction with "conventional" medicine.s-? There is a strong belief that "all that is natural is safe". However the safety of CM alone or in combination with conventional treatments is not well understood. Efficacy of many CM treatments is not established but is starting to be examined with the scientific rigour applied to pharmaceuticals.s The quality of complementary medicines also cannot be guaranteed.s-w Sixty to seventy percent of patients do not inform their doctor they are taking alternative therapeutic agents.a-' Disclosure of eM use by patients creates difficulties for health professionals who lack a framework to deal with these therapies. The institutional response to CM use has generally centred on regulatory or supply issues. These range from disallowing all CM in hospital to treating CM as non-formulary items or as "patient's own" medication.t! We present an alternative approach that recognises the underlying ethical and legal principles as a basis for policy development regarding CM use in hospital. In this paper we do not consider the issues surrounding illicit drug use or other alternative therapies not involving the use of medicines/substances, for example manipulative modalities. In this paper a complementary medicine refers to any nonmedically prescribed substance containing active substances with a complementary or traditional use that a person uses with the belief that it will improve their health or wellbeing. 12 In general, the decision-making process regarding CM use in hospital is no different from that regarding any other medical intervention. Where patients are competent the main issue is of consent or informed decision-making, whereas where they are noncompetent, concerns relate primarily to the process of surrogate or substituted decision-making. There are also, as with decisions regarding the use of conventional medications in hospital, obligations to institute procedures that ensure the safety of other patients, visitors and staff.
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Self-medication by a competent individual. Where a patient is competent the main issue is one of an individual's autonomy to take any legal substance. The therapeutic team has a responsibility to advise a patient on the likely effects of all medications and of possible interactions between substances. The final decisions, however, rest with the individual to adopt or disregard this advice. Given the importance of respect for patient autonomy within the context of hospital care, the responsibilities of the therapeutic team should include the following : (1)
(2)
(3)
(4)
To adequately obtain a history of all pharmacologically relevant substances, including prescription and non-prescription medicines. Failure to do so could be interpreted legally as a breach of the duty of care. Eliciting a full history of CM use is a skill that needs to be taught at both undergraduate and postgraduate levels and necessitates the use of a non-pejorative approach. Disclosure is unlikely if an individual perceives the therapeutic team disapproves of any CM hejshe may be takingw, or if there is an implicit norm of discourse between health professionals and patientsj clients that prevents open discussion of CM use. To ascertain, where possible, the risks and benefits of any CM. This is currently problematic as a full catalogue of CM does not exist, let alone full documentation of all pharmacological actions and interactions. To assist the clinical teams drug information services need to be readily available. On a broader scale the work of researchers in this field needs to be supported, there needs to be increased commitment to the clinical assessment of CM14 and the reporting of suspected adverse reactions to CM needs to be formalised. To adequately communicate the likely risks. In many cases there is insufficient knowledge to give clear advice and this uncertainty should also be honestly acknowledged. In instances where there are clearly documented adverse effects or interactions between the CM and a proposed course of treatment the advice may be to suspend or modify CM use. To adequately document the content and outcome of any discussion. In most cases a clinical case note documenting the substances an individual is using, evidence of knowledge of possible reactions and interactions and a record that this has been communicated to the patient will suffice. Where an individual chooses not to follow medical advice in the light of potentially serious adverse interactions it may be advisable to ask the patient to sign a written document outlining the risks and their decision, or to seek wider consultation e.g. with a local ethics committee.
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(5)
To ensure safe storage of CM brought on to hospital property in order to prevent harm to others. Promotion of complementary medicines is not the responsibility of the therapeutic team (except where evidence supports its use) and a neutral but scientific approach to CM use should be maintained. The intention of the steps outlined is to achieve optimal patient management and outcome. Likewise supply of CM may fall outside the realms of a health service because of statutory constraints, difficulties with acquisition, quality control and the financial burden that would be incurred. "Responsibilities" of the patient include: (1) To disclose CM use to the therapeutic team. This responsibility may be highlighted in published information provided to patients before or subsequent to their admission to hospital. (2) To comply with hospital policies and procedures with regard to the safe storage and handling of complementary medicine.
Administration of complementary medicines to noncompetent or incapable patients
At times individuals are unable to either make decisions for themselves because they are judged to be temporarily or permanently non-competent or through physical incapacity are unable to pursue autonomous decisions. The interests of a non-competent patient are safeguarded by a 'person responsible', usually the spouse or closest relative. (In our jurisdiction the Guardianship Act, 1987 (NSW) provides for the identification of a substitute decision-maker who is able to consent to treatment for the non-competent patient. In some other jurisdictions in Australia and the UK the next-of-kin are not able to make substitute decisions (Re T (Adult: Refusal of Treatment) [1993] Fam 95} although their knowledge of the patient's views will be valuable in ascertaining what course of action is in the patient's best interests.} The 'person responsible' has an obligation to represent the perceived wishes of the patient (often called "substituted judgement") and to act in the patient's best interests by promoting their health and wellbeing. This need to represent the wishes of the person for whom they are responsible and promote their health and wellbeing may place the 'person responsible' in a potential ethical conflict. Should they request the continued administration of medically questionable substances (representing the perceived wishes of the patient) or request that such substances be ceased (acting to promote the patient's best interests)? The duties and responsibilities of the therapeutic team are also far from clear. There is a conflict between respect for the individual's autonomy and a duty to act in the patient's best interests. Administration of CM by the team could be seen as an endorsement of the therapeutic efficacy and safety of the substance and renders the
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team accountable for any adverse outcomes. An alternative argument would be that failure to enable a non-competent patient or a patient who is incapable of self-administration to take his/her regular complementary medicines when competent, able-bodied patients are free to do so could amount to unjust discrimination because of their disability.
Administration by health professionals
Decisions concerning CM administration by health professionals to a non-competent patient should be made between the therapeutic team and the 'person responsible'. In the case of a competent but incapacitated patient any decision concerning CM should be made directly between the therapeutic team and the patient. Where a CM is to be administered it should be prescribed in the normal way and supplied by pharmacy; this should be limited to manufactured products that are recognised by a regulatory authority.
Administration by relatives
Should relatives be able to administer complementary medicines to non-competent or competent but incapacitated inpatients? This again presents an interesting ethical dichotomy. If one were to consider only those issues relating to autonomy then the answer should clearly be "yes". It is the patient's right to request a relative to administer any legal substance and the relative's right to choose whether or not they agree to do so . This argument is, however, tempered by the wider role of the hospital to act in the patient's best interests. The hospital has the responsibility to protect the patient from harmful substances even when administered by a relative. Pol's syndrome or Munchausens-by-proxy is a well-recognised paediatric situation in which parents administer harmful substances to their children (even in hospitals) for a perceived secondary gain. A second argument against administration by relatives is that relatives cannot usually be present at all times and requests for continuing medication may be made to the nursing staff. In this instance the nurse and hospital would carry the responsibility for any adverse events arising from the administration of a complementary medicine as argued above. On balance we conclude that the administration of complementary medicines by relatives should be discouraged. Such situations could be resolved through open discussion with the patient / carer and an agreement to prescribe and administer such substances in the normal way according to the following policy. Responsibilities of the therapeutic team include points (1)-(5) outlined earlier. Communication of the reasoning behind any decision to administer or withhold a Clvlwould be carried out with the 'person responsible'. If the team undertakes to dispense a CM the administration of the substance is 'legitimised' and supply should be arranged through the hospital pharmacy. Again this scenario could be
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limited to substances recognised by a regulatory authority and administration should be recorded on a medication chart as for pharmaceuticals.
Documentation of complementary medicine use
The optimal means of recording (charting) CM use is debatable. The alternatives are to simply record CM use in the patient's medical record, record it on a specific medication sheet or record it in the same manner as other prescribed medications. The benefits of using a separate CM administration chart are that it may act as a prompt for patients to disclose CM use that may have been omitted from the medication history, be a useful research tool, provide a clear record of dose change and make patients more aware of the pharmacological nature of CM by treating it/them in a similar manner to prescribed substances. However such charts may be burdensome on nursing time, add little to information that could be elicited in an adequate medication history, and be used inconsistently. Nevertheless a suitable form could be made available to be used at the discretion of the therapeutic team, for example for patients being stabilised on oral anticoagulants which are known to have significant interactions with CMs resulting in increased adverse events such as bleeding or thrombosis (clotting) .
Conclusion
The widespread use of complementary medicine raises unavoidable ethical, social and legal issues which hospitals can no longer avoid confronting. Policy based only on consideration of clinical efficacy, institutional supply or regulatory requirements only superficially address the issues raised. With current emphasis on "seamless care" (smooth transition for patients moving between hospital and community health care), hospital policy should reflect specific institutional requirements as well as the values, beliefs, attitudes and needs of the community. Institutional policies need to balance the sociocultural basis of health care choices and respect for patient autonomy with the obligation that the health care system has to provide optimal patient care and protect vulnerable individuals from harm. Summary of recommendations: • The health service should develop and implement policy on the attitudes to and use of CM. • Accompanying provision should be made for increased education of medical staff in documentation and management of CM. • Local information resources on CM should be developed and made accessible to health professionals. • Patient's responsibilities with regard to CM use should be incorporated in general patient information.
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Acknowledgements: The authors wish to acknowledge the Hunter Area Therapeutics Committee for their encouragement in writing this article and the Hunter Area Clinical Ethics Committee for their thoughtful consideration of the issues covered.
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