Talking about Complementary and Alternative Medicine – a Resource for Clinicians JULY 2013 Many Australians report that they self-prescribe complementary and alternative medicine (CAM), but they do not disclose this information to their clinicians. 1 Without a full understanding of their patients’ health practices, it is difficult for clinicians to provide safe and holistic healthcare. This resource is intended to facilitate discussions about CAM use between clinicians and their patients. It provides clinicians with prompts for: • • • initiating a conversation about CAM use discussing evidence and the effectiveness of CAM discussing the potential risks of CAM use. The document also includes background information on the use and regulation of CAM in Australia, and provides sources of referral for clinicians and patients seeking further information on CAM. The information contained in this resource is targeted at medical practitioners, nurse practitioners, pharmacists and allied health professionals. Complementary and Alternative Medicine and its use in Australia The term CAM is used to describe a wide range of health care practices, therapies, and products that are not generally considered within the domain of conventional medicine.2 Defining CAM can be difficult, as new therapies are constantly emerging, and because the boundaries between CAM and conventional medicine are often blurred, with specific CAM practices becoming more widely accepted over time. Cultural or personal beliefs may also influence what a patient considers to be ‘CAM’. CAM products and therapies are considered to be ‘complementary medicine’ when used together with conventional medicine, or ‘alternative medicine’ when being used as an alternative to conventional medicine.2 In Australia, CAM is generally viewed by consumers as part of a holistic view of health and is often used in conjunction with, not in isolation from, other strategies for achieving and maintaining good health. It is estimated that more than two thirds of the Australian population use CAM products and services, and nationally, the annual 'out of pocket' expenditure on CAM is estimated to be around $4 billion. Information on CAM As the use of CAM continues to grow in Australia, there have been calls for improvements in the information available on CAM for Australian health consumers, to assist them in making better informed decisions. In 2009, an independent evaluation of CAM resources commissioned by NPS MedicineWise found that the sources of information available to consumers are of variable quality and reliability.4 As a consequence, some consumers may be relying on inaccurate or misleading statements when deciding whether a particular CAM is an appropriate healthcare option. The Consumers Health Forum of Australia have also raised awareness of information gaps faced by patients when considering CAM treatments – including information on regulation, consumer protection, efficacy and evidence.5 In addition to the lack of public consumer information on CAM, a national consumer survey conducted in 2008 by NPS MedicineWise found that only half of those reporting to use CAM mentioned or discussed their treatment with a doctor.1 There are a variety of reasons for patients not disclosing CAM use to their clinician, including: • a belief that CAM products and therapies are ‘natural’ and ‘safer’ than conventional medicines • a lack of awareness that CAM is medicine • a lack of awareness of the risk of unintended drug interactions • discomfort in raising the topic • fear of the practitioner’s response. However, one of the most common reasons given by patients about why they have not discussed their CAM use is that their clinician has failed to ask.3 This was confirmed by a survey of healthcare professionals conducted by NPS MedicineWise in 2008, which found that clinicians often did not initiate discussions about CAM with their patients and were often unaware of their patients’ CAM use.6 In response, NPS MedicineWise called for the promotion of active discussions about CAM between consumers and health care providers. talking about complementary and alternative medicine – a resource for clinicians • 2 of 8 Asking about CAM use It is important for clinicians to get a full picture of all conventional and CAM practices a patient is using to manage their healthcare. A first step in the process may be to include a question about the use of CAM on ‘personal details’ forms for new patients, and/or to request that patients bring a list of all therapies they use with them to consultations.7 Clinicians should consider initiating discussions with their patients about CAM, using questions that elicit the relevant information. Benefits of the CAM • What made you decide to try this medicine/therapy? • How long have you been using the medicine/therapy? Are you going to continue using it? • Do you feel you are benefiting from the medicine/therapy? Details of the CAM products • How often do you take the product? • What is the dosage, and how much of the active ingredient is in each dose? • Where are you getting this product from? • Are you using this treatment instead of, or in addition to, your regular medications? CAM use • What else have you tried for this problem? • Have you used any herbal or natural remedies, vitamins or supplements that you have bought from a supermarket, chemist or health food store, or that you have grown or prepared yourself? • Have you seen a complementary or alternative healthcare practitioner (naturopath, herbalist, chiropractor etc.)? • Have you tried changing your diet because you thought it might help this problem, for example by adding or eliminating particular foods or food groups? Details of the CAM practitioners • What experience does your practitioner have in treating your condition? • Do you know if your practitioner has any relevant qualifications, professional registrations or memberships? • Are you comfortable with the costs per session, and are you aware of the likely total cost of treatment? • Would you feel comfortable for your CAM practitioner to let me know about your treatment and progress? talking about complementary and alternative medicine – a resource for clinicians • 3 of 8 Discussions about evidence Clinicians should encourage their patients to make well informed decisions about their healthcare and communicate to patients the importance of considering scientific evidence to make these decisions. It may be important to explain that most complementary medicines are classed as ‘listed’ medicines by the Therapeutic Goods Administration (TGA), which means that the TGA has not evaluated their effectiveness (see further discussion on regulation of CAM in Australia below).8 It is useful to know what emphasis the patient places on evidence. Some do not consider scientific evidence to be important. Others do not know how to consider evidence, choosing instead to rely on personal success stories of friends, family or colleagues. Some cultural practices can be closely linked with CAM use, which is important for clinicians to identify when discussing scientific evidence. You may like to consider information targeted at consumers about the strength of different types of evidence, including a summary of the ‘levels of evidence’ from the Cochrane Consumer Networka and information on ‘understanding clinical trials’ from NPS MedicineWise.b The NHMRC’s resource on ‘Decisions about Tests and Treatments: principles for better communication’c (targeted at both patients receiving treatment and clinicians delivering healthcare) may also be useful in facilitating discussions about evidence. a The Cochrane Consumer Network’s webpage on ‘levels of evidence’ is available at http://consumers.cochrane.org/levelsevidence b NPS MedicineWise’s information on ‘understanding clinician trials’ is available at http://www.nps.org.au/conditions-andtopics/topics/how-to-be-medicinewise/regulation-clinical-trials/ understanding-clinical-trials Discussing evidence • How do you know that the CAM treatment works? • Are you aware of any risks associated with the CAM treatment? • Is there scientific research evidence (not just personal stories) to back up statements about effectiveness and safety? — Has the research been published and peer reviewed? — Who paid for the research? Do they have a vested interest in the conclusions of the research – for example, will they benefit commercially or otherwise if the research is positive? Discussing reliability of information • Who is the author of the information and what is its purpose? • Where has the information come from? For example, is it based on research studies or personal stories? • What are the author’s qualifications? • Does the information explain how treatments work, and their benefits and risks? • Does the author or website owner have a commercial interest in promoting the treatment? • How is the treatment described by the manufacturer or provider? c NHMRC’s resource on Making Decisions about Tests & Treatments: principles for better communication is available at http://www.nhmrc.gov.au/_files_nhmrc/publications/ attachments/hpr25_0.pdf talking about complementary and alternative medicine – a resource for clinicians • 4 of 8 Discussing effectiveness Do your patients know whether their CAM is effective? You can help them identify any evidence of effectiveness for the CAM they use. They may need support and encouragement in thinking critically about the source and quality of information. Clinicians should encourage patients to make a decision based on evidence, such as evidence published in reputable peer-reviewed journals or by government, rather than using CAM simply because of something they have seen in an advertisement or on a website, or because of a personal success story. Clinicians may also encourage their patient to seek information from a source other than the CAM provider. Clinicians may need to advise their patients to be cautious where claims made for CAM products are not underpinned by quality evidence. This might include suggesting patients return for regular reviews to monitor progress if they choose to use a CAM. Patients should be encouraged to think twice about statements describing the therapy as a 'quick fix', 'scientific breakthrough', 'miracle cure', 'secret ingredient', or 'ancient remedy', or similar. It may help to suggest to patients that if it sounds too good to be true – such as a claims that a therapy can cure a disease or treat a variety of conditions – it usually is. Discussing potential risks Do your patients know whether their CAM is safe? As with all therapeutic goods, there are potential risks associated with CAM use. It is often difficult for consumers to know if an individual CAM is safe or potentially harmful, and this may differ from patient to patient. Clinicians should explain to their patients that all health and treatment decisions involve weighing up potential benefits and potentials risks to decide whether the treatment is appropriate for them. NPS MedicineWise have found that many consumers are not aware of the side effects of some complementary medicines and their potential interactions with conventional medicines, which may put some users at unnecessary risk of harm.1 Clinicians may need to consider and explain to their patients the risk of adverse reactions (including unintended medicine interactions). If considered clinically necessary, general practitioners may refer their patient to a pharmacist for a Medicare- supported Home Medicine Review to prevent medication-related problems. Some complementary medicines contain ingredients that are contraindicated in individuals that suffer from certain conditions or have allergies. For example, the National Asthma Council Australia warns that Echinacea, which is sometimes used as a CAM treatment for the common cold, may trigger an allergic response or exacerbate symptoms when used by asthma patients.9 Similarly, complementary medicines containing St John’s Wort can reduce the therapeutic effects of many pharmaceutical medicines including anti-depressants, epilepsy and HIV medications, and the oral contraceptive pill, leading to potentially significant consequences for the patient.10 Where CAM is used in place of conventional medicine, clinicians should discuss with their patient the health and financial consequences of a delay in accessing conventional treatment which may (potentially) be more effective. Clinicians should especially advise caution in cases where CAM of uncertain effectiveness is used as a replacement for conventional medicine of known effectiveness. talking about complementary and alternative medicine – a resource for clinicians • 5 of 8 Regulation of Complementary and Alternative Medicine in Australia Based on these risks, the appropriate evaluation process is applied based on a two-tiered classification system: In Australia, CAMs containing herbs, vitamins, minerals and nutritional supplements, homeopathic medicines and some aromatherapy products are regulated as complementary medicines under the Therapeutic Goods Act 1989 by the TGA. Therapeutic goods must be entered on the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia. There are about 10,000 complementary medicines on the ARTG.11 • Registered medicines (labelled as Aust R), which include all prescription and some nonprescription medications, are considered to be of relatively higher risk and are individually evaluated by the TGA for quality, safety and efficacy prior to market entry. The TGA uses a ‘risk-management’ approach to regulate medicines supplied in Australia. A number of factors are used to determine the risks associated with a particular medicine, including: • the toxicity of the ingredients • the dosage form of the medicine • whether the medicine is indicated for a serious form of a disease, condition or disorder, or for the treatment, cure, management or prevention of a disease, condition or disorder • any possible side effects and interaction with other medicines • whether there may be adverse effects from prolonged use or inappropriate selfmedication. • Listed medicines (labelled as Aust L) are considered to be of lower risk and are required to meet certain criteria in relation to safety and quality of manufacture, but the TGA does not evaluate their effectiveness prior to market approval or review sponsor- held evidence prior to listing on the ARTG. Most, but not all, complementary medicines are classed as listed medicines, where they only contain ingredients that have been determined as being of low risk and only make limited therapeutic claims.9 There is no assurance that CAM products purchased in other countries or on the internet have been manufactured to Australian standards of quality and safety.12 In Australia, the regulation of CAM therapists varies across modalities. Some specific CAM modalities (including Chinese medicine, chiropractic and osteopathy) are now regulated by a National Board established under the Australian Health Practitioner Regulation Agency,13 but the majority of other CAM modalities are largely self-regulated, and this regulation often differs between each State and Territory. Most CAM therapists are affiliated with a professional association, but membership is usually voluntary and any agreed standards of care do not have legal obligations.14 talking about complementary and alternative medicine – a resource for clinicians • 6 of 8 Further information For clinicians Systematic reviews on CAM by the Cochrane Collaboration (http://www.thecochranelibrary.com/view/0/browse.html?cat=ccochcomplementaryalternativemedicine) US Government’s National Center for Complementary and Alternative Medicine website, Time to Talk: Resources for Health Care Providers (http://nccam.nih.gov/health/providers) Australian Medical Association Position Statement Complementary Medicine – 2012 (https://ama.com.au/positionstatement/complementary-medicine-2012) NPS MedicineWise Review of the Quality of Complementary Medicines Information Resources: Summary Report, March 2009 (http://www.nps.org.au/__data/assets/pdf_file/0005/69656/CMsInfoSummary.pdf) TGA Webpage The regulation of complementary medicines in Australia – an overview (http://www.tga.gov.au/industry/cm-basics-regulation-overview.htm) TGA Adverse Events Database (http://www.tga.gov.au/daen/daen-entry.aspx) Izzo A. and Ernst. E. Interactions between herbal medicines and prescribed drugs: An updated systematic review. Drugs 2009:69(13): 1777-1798 (http://www.cenegenicsfoundation.org/library/library_files/Interactions_between_herbal_medicines_ and_prescribed_drugs_An_updated_systematic_review.pdf) Medicare Australia’s Home Medicines Review program (http://www.medicareaustralia.gov.au/provider/pbs/fourthagreement/hmr.jsp) For patients Cochrane Summaries – independent high-quality evidence summaries for health care decision making (http://summaries.cochrane.org/) Australian Government’s HealthInsite web portal (http://www.healthinsite.gov.au/topics/Complementary_and_Alternative_Therapies) NPS MedicineWise Topic, Using Complementary Medicines (http://www.nps.org.au/conditions-andtopics/topics/how-to-be-medicinewise/using- complementary-medicines) Victorian Government’s Better Health Channel website, Complementary and alternative medicine (http://www.betterhealth.vic.gov.au/bhcv2/bhcarticles.nsf/pages/ct_alternative)= Health Voices Journal of the Consumers Health Forum of Australia, Complementary Medicines: How well do consumers know their product, Issue 11, November 2012 (https://www.chf.org.au/pdfs/chf/HealthVoices_NOV12_ComplementaryMedicine.pdf) US Government’s National Center for Complementary and Alternative Medicine website, Time to Talk: Be an informed consumer (http://nccam.nih.gov/health/decisions) talking about complementary and alternative medicine – a resource for clinicians • 7 of 8 References 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. Williamson M, Tudball J, Toms M, Garden F, and Grunseit A. Information Use and Needs of Complementary Medicines Users. Sydney: National Prescribing Service, 2008. National Center for Complementary and Alternative Medicine. What is CAM? [Internet]. 2008 [updated May 2012; cited 2013 Feb 18]. Available from: http://nccam.nih.gov/sites/nccam.nih.gov/files/D347_05-25-2012.pdf Xue CL, Zhang AL, Lin V, Costa CD, Story DF. Complementary and alternative medicine use in Australia: A national population-based survey. Journal of Alternative and Complementary Medicine. 2007; 13(6):643-650. McGuire TM, Walters JA, Dean AJ, Van Driel M, Del Mar C, Kotsirilos V et al. Review of the Quality of Complementary Medicines Information Resources: Summary Report. Sydney: National Prescribing Service, 2009. Consumer Health Forum of Australia. Complementary Medicines: How well do consumers know their product [Internet]. 2012 Nov [cited 2012 Nov 20]. Available from: https://www.chf.org.au/pdfs/chf/Health-Voices_NOV12_ComplementaryMedicine.pdf Brown J, Morgan T, Adams J, Grunseit A, Toms M, Roufogalis B et al. Complementary Medicines Information Use and Needs of Health Professionals: General Practitioners and Pharmacists. Sydney: National Prescribing Service, 2008. National Center for Complementary and Alternative Medicine. Time to Talk: Ask Your Patients about Their Use of Complementary Health Practices [Internet]. 2012 [updated 2012 Jun 4; cited 2013 Feb 18]. Available from: http://nccam.nih.gov/timetotalk/forphysicians.htm Therapeutic Goods Administration. The regulation of complementary medicines in Australia – an overview [Internet]. 2012 [updated 2012 Mar 16; cited 2013 Jan 16] Available from: http://www.tga.gov.au/industry/cm-basics-regulationoverview.htm National Asthma Council Australia. Asthma and Complementary Therapies [Internet]. 2012. [cited 2013 Feb 18]. Available from: http://www.nationalasthma.org.au/uploads/content/652-Asthma-Complementary-Therapies-Health- Professionals.pdf Therapeutic Goods Administration Safety Information Alert - Important interactions between St John's Wort (Hypericum perforatum) preparations and prescription medicines [Internet]. 2001 [updated 2012 Aug 13; cited 2013 May 8] Available from: http://www.tga.gov.au/safety/alerts-medicine-stjwort-000313.htm Australian National Audit Office. Audit Report No.3 2011–12 Therapeutic Goods Regulation: Complementary Medicines [Internet]., 2011 [cited 2013 Feb 14]. Available from: http://www.anao.gov.au/~/media/Uploads/Audit%20Reports/2011%2012/201112%20Audit%20 Report%20No%203.pdf Better Health Channel. Complementary medicines – tell your doctor [Internet]. 2012 [cited 2013 Feb 18]. Available from: http://www.betterhealth.vic.gov.au/bhcv2/bhcpdf.nsf/ByPDF/Complementary_medicines_ tell_your_doctor/$File/Complementary_medicines_tell_your_doctor.pdf Australian Health Practitioner Agency. Homepage [Internet]. 2013 [cited 2013 Feb 18]. Available from: http://www.ahpra.gov.au Better Health Channel. Complementary therapies - safety and legal Issues [Internet]. 2012 [cited 2013 Feb 18]. Available from: http://www.betterhealth.vic.gov.au/bhcv2/bhcpdf.nsf/ByPDF/Complementary_therapies_ safety_and_legal_issues/$File/Complementary_therapies_safety_and_legal_issues.pdf talking about complementary and alternative medicine – a resource for clinicians • 8 of 8