Alternative Medicine. Background alternative medicine (CAM). According to the ” alternative medicine, for the purposes of this document, the following …
Volume 6, Number 2
Senior Care
A Publication of Marshs Risk Consulting Practice
Complementary and Alternative Medicine
Background
Over the last decade, the publics increased desire for control over their own health care coupled with the ease of information access via the Internet, has led to an increased popularity in complementary and alternative medicine CAM According to the 2001 Berger Population Health Monitor survey, the proportion of Canadians consuming one or more natural health products NHPs, such as dietary supplements and herbs, in the previous six months grew from 70 percent in 1999 to 75 percent in 2001 and, an estimated 19 percent of Canadians used CAM practitioners such as massage therapists1,2 Not only are many Canadians using CAM, but they are also using these therapies as an adjunct to or replacement of therapies recommended/prescribed by conventional health care providers3 As complementary and alternative practices move into the mainstream, more health care
practitioners eg, nurses, physiotherapists are integrating or have integrated them into their conventional practice The resulting significant and growing trend in utilization has been associated with a steady increase in the number of residents seeking and expecting complementary therapies as part of their ongoing care in senior care settings Mainstream practitioners are increasingly encountering situations, questions, or concerns related to the provision of complementary/alternative therapy Considerable confusion exists among physicians and other health care professionals with regards to the appropriate response to this interest and how best to integrate CAM or NHPs into the overall plan of care for the resident
1 Hay Health Care Consulting Group, Berger Population Health Monitor Overview Report, March 2001 2 Health Canada, Complementary and Alternative Health Care: The Other Mainstream? Health Canada November 2003; Issue 7 3 See note 2 above
CAHC is the term used by Health Canada
to recognize the diversity of practice areas
Definitions
As there is no consensus about the definition of complementary and alternative medicine, for the purposes of this document, the following terms are defined as indicated: alternative therapies: therapies that are outside of mainstream traditional Western medicine and are used instead of conventional care complementary therapies: modalities or therapies eg yoga, massage, and acupuncture that are used in addition to or in conjunction with conventional care complementary and alternative medicine CAM: diagnosis, treatment and/or prevention that complements conventional care CAM is the term most often used internationally complementary and alternative health care CAHC: CAHC is the term used by Health Canada in a policy context to recognize the diversity of practice areas, including medicine, while CAM is a term used by Health Canada to recognize the diversity of practice areas, including medicine4 natural health products: a term used
by Health Canada5 for vitamins and minerals, herbal remedies, homeopathic medicines, traditional medicines such as traditional Chinese medicines, probiotics and others products like amino acids, or essential fatty acids CAM therapies are further classified into five major categories6,7: physical manipulative and body-based methods such as massage therapy; biological treatments such as herbal remedies; psychological mind-body interventions such as meditation or prayer; energy therapies such as Reiki; and alternative medicine systems such as Traditional Chinese Medicine The line between CAM therapies and conventional medicine can sometimes be blurred leading to further confusion in terminology
4 See note 2 on page 1 5 Health Canada, Drugs and Health Products, Natural Health Products Directorate, 2005: Main Page 6 Centre for Integrative Medicine, Overview of Complementary/Alternative Medicine, University of Saskatchewan, 2006 7 National Center for Complementary and Alternative Medicine,
What is Complementary and Alternative Medicine, NCCAM Publication, No D156, National Institutes of Health, May 2002
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The Risk
An individuals use of CAM may not be informed, whereby they are not based on considerations of safety and effectiveness or on the best reliable evidence Risk to an individual can be exacerbated both CAMs or intrinsic factors Many people take dietary supplements and herbs and/or other botanicals on a routine basis without seeking the advice of a physician, pharmacist, or other health care professional Research has also shown that many individuals do not inform their physician or other health care practitioner that they are using CAM therapies because they anticipate a negative response or feel it is not their business There is an assumption that natural products and other CAMs are safe and effective simply because they can be purchased without a prescription or physician referral8,9 While some CAMs are generally considered to be benign eg, relaxation and
visualization, others–either alone or interacting with other substances, treatments, or conditions–are more commonly assumed to have more of a potential for harm Not only may an individual take herbal or dietary supplements and prescription medications for the same condition without the knowledge of their physician, but the lack of regulation and the availability of these products for purchase over the Internet or abroad further complicates the potential for harm Individuals taking herbal preparations or dietary supplements may experience undesirable side effects, adverse herb-drug interactions, or have a severe or life-threatening reaction to the product The safety and quality of herbal and dietary products are also at issue There have been a number of instances where products contain prescription substances eg, sibutramine, a prescription medication that should only be taken under medical supervision10; are contaminated with bacteria; are not herbal preparations but standard
preparations of pharmaceuticals; contain undeclared medications, eg, corticosteroids, or could expose the individual to excessive amounts of heavy metals, eg, lead, when taken at the dosage recommended on the label As with any other treatment modality, complementary therapies are not free of risks For example, although incidence of adverse events from acupuncture is minimal, case reports have associated acupuncture with severe adverse events and fatalities11-13 Minor and/or transient event reports include bleeding and pain, while the most often reported rare but serious complications are pneumothorax, infection, spinal cord injury, or cardiac tamponade The most common clinical areas/procedures leading to a claim of chiropractic clinical negligence are: worsening of symptoms following back manipulation; injuries sustained during chiropractor treatment eg, fractures; stroke following neck manipulation; and delay in diagnosis of a more serious condition The training, skill, and experience
of the practitioner affect safety of the resident
8 See note 2 on page 1 9 National Center for Complementary and Alternative Medicine, Are You Considering Using Complementary and Alternative Medicine? Get the Facts, No D167 NCCAM Publication, August 2002 10 Health Canada, Advisory, 15 April 5, 2006 11 Chung A, L Bui, and E Mills, Adverse effects of acupuncture, Can Fam Physician 49 2003: 985-989 12 Peuker E, and D Grönemeyer, Rare but Serious Complications of Acupuncture, Acupunct Med, 19-2 2001: 103-108 13 White AR, S Hayhoe, A Hart, and E Ernst, Survey of Adverse Events Following Acupuncture: A Prospective Study of 32,000 Consultations, Acupunct Med, 19-2 2001: 84-92
Risk to an individual can be exacerbated both by CAMs or intrinsic factors
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CAM is considered mainstream by some members of the public and some health care professionals, and extremely controversial by others
Regulatory Framework
A core distinction between CAM and natural health products NHP is that CAM therapies
are generally provided by practitioners of that therapy while NHPs are more often initiated and self-administered by the consumer Although NHPs became regulated in Canada in 2004 placing requirements on those who manufacture, package, label, import or distribute natural health products, few complementary therapies are subject to statutory regulation Some operate under voluntary registering bodies and may become subject to statutory regulation in the future A critical differentiator between CAM and traditional medicine is that the knowledge required to provide CAM is not specific to any one discipline and CAM is often delivered by non-health care professionals CAM is considered mainstream by some members of the public and some health care professionals, and extremely controversial by others Licensed health care professionals providing care that involves complementary or alternative therapies and/or natural health products as an adjunct or option within their professional practice eg,
medicine, nursing, and physiotherapy are bound by standards of practice established by their professional body The professional college provides guidance to the regulated professional who is making decisions about incorporating CAM into his/her practice and may also provide guidance in those situations where the client initiates these therapies on their own In general, the colleges14,15 state that a professional must: have the necessary knowledge, skill, judgment, attitudes and competencies to provide the therapy in a safe, competent, and ethical manner; have the appropriate education eg, certificate, license to prepare him/herself to provide the therapy; have determined that the therapy is safe and effective including consultation with a pharmacist as appropriate, based on a clinical assessment of the client; have determined that the therapy is an appropriate intervention for that client; have knowledge of the risks and benefits of the therapy including and any expected or unexpected
effects; and obtain informed consent
14 College of Nurses of Ontario, Complementary Therapies, CNO, 2004 15 College of Physicians and Surgeons of Ontario, Complementary Medicine, Policy 1-00 CPSO, 2004
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Integrating CAM Therapies into the Overall Care for a Resident
Requests by admitted residents for complementary and/or alternative therapies can raise ethical, clinical, and risk management concerns, particularly if the facility lacks policies and procedures that can be used as guidance The practice of allowing CAM, including the use of NHPs, in a care setting has often grown without a policy to govern it and defined parameters for effective and safe practice Care settings need to formalize arrangements for the provision of all CAMs to strike a responsible balance between the residents right to autonomy and the facilitys responsibility to ensure that safe and appropriate care is provided A facility should have a policy that is enacted in situations where a resident requests a CAM
therapy or a health care practitioner wants to integrate a CAM therapy into a residents overall plan of care When introducing complementary therapies, it is vitally important that the use of any therapy is always in the best interests and safety of residents, and that informed consent is obtained The following outlines elements that should be included in a CAM policy 16-18: Policy Statement: A policy statement outlining the facilitys commitment to providing a range of therapeutic interventions which are evidence-based Definition of Terms: A definition of modalities eg, massage, acupuncture that are covered by the policy and the process for delivering therapies not included in the list eg, specifically negotiated with the physician/clinical nurse manager Service Provider: A statement outlining who eg, staff/independent contractor can deliver the interventions The framework for independent contractors eg, evidence of credentials, liability coverage, confidentiality and documentation
requirements where used must be specified Competency to Practice: An outline of the requirements for competency such as demonstrated education eg, certification in the modality, completion of recognized training program, knowledge, skills, and currency in their area of practice The process for maintaining ongoing competency eg, re-certification, CME should be set out Assessments: A specified process for assessing residents is specified eg assessments must be undertaken by a member of staff who holds a recognized qualification in complementary therapy and/or attended appropriate course agreed by the manager All assessments must be carried out by a qualified therapist and contraindications/side effects noted in the care plan
16 ECRI, Assessing Alternative Medicine Risks, HRC, Special Clinical Services 10 2000 17 Guild Community Healthcare NHS, Policy on Complimentary Therapy, September GCH, 2001 18 McNeil, T, Complementary and alternative therapies: New HSC policy addresses their
possible use, HSC Journal, 3-4 2002
There should be a reasonable basis in evidence to support the efficacy of the CAM or its documented lack of harm
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The use of a substance must be documented in the residents medical record in accordance with the established procedures for medication administration
Standards of Practice: All service areas providing complementary therapies must have standards of practice that are evidence-based to ensure safety and protection of both the resident and staff There should be a reasonable basis in evidence to support the efficacy of the CAM or its documented lack of harm The therapy should not replace or reduce medical care as set out by the physician Access: The policy should set out guidance on what a staff provider should do if a resident requests a CAM referral or is using CAM simultaneously with recommended traditional treatment Consent: The requirement is that each resident must be able to give informed consent in order for complementary therapy
to be practiced The informed consent process must include explanation of the treatment/care plan including any benefits, risks, possible side effects and/or interactions with other remedies, medications or treatments the individual is currently undergoing Documentation: As with any other intervention, documentation on the residents chart by the CAM provider should include: the request for the CAM, the specific CAM practiced, and an evaluation of the outcome Where independent contractors are used, these interventions should be similarly documented on the clinical record Evaluation: The use of CAM should be evaluated to ensure acceptable outcomes are being achieved The following outlines the additional administration and use of botanicals and herbal products with pharmacologic actions and used for therapeutic purposes19: Admission Assessment: All residents should be asked about their use of over-the-counter substances eg, botanicals, vitamins, etc upon admission The admission assessment
form should include a section for documenting these substances as part of the medication profile Risk Assessment: A risk assessment must be done to determine whether the substance presents any known significant material risks If the physicians opinion is that the substance presents known significant material risks eg, alters the heart rate, inhibits blood clotting, alters the immune system, or changes the effects and duration of anaesthesia, the substance should not be administered, even if the resident wants to accept the risks as this would likely violate the standard of care If the physician determines that the substance presents no known significant material risks, the residents desire to receive the substance and information used to make the risk determinations should be documented in the clinical record The resident should sign an assumption of risk form Medication Order: A physician must write an order for the substance which contains all elements required of standard medication
orders ie, the name of the substance dosage, route, and frequency
19 Johns Hopkins University and Health System, Complementary and Alternative Medicine Use Policy, JHUHS, 2001
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Product Supply: A resident should use their own supply of the substance only if they are in the manufacturers labelled original container or in a labelled pharmacy prescription container The pharmacy should supply substances only if they have been added to the facilitys drug formulary or when the substances are part of an approved research protocol Documentation: The use of a substance must be documented in the residents medical record in accordance with the established procedures for medication administration Adverse reactions must be documented and reported using standard procedures Staff should be fully educated in the role of CAM sanctioned by the facility and offered to residents
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Senior Care is a publication of Marsh Canada Limited Copyright 2006 by Marsh Canada Limited Reproduction, distribution or translation without permission is prohibited This newsletter is intended only as an information service Recommendations and commentaries appearing within this newsletter are not to be construed as health or legal advice Implementation of any risk assessment and loss prevention measures should be taken only in consultation with all required experts and professionals, including legal counsel Marsh Canada Limited accepts no responsibility for loss or damage sustained in reliance on this newsletter For further information please contact: Ruth Stewart,
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B060912-SC C061006TE: 2006/10/19
Source:nsvrc.org
