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Complementary medicines are a group of diverse products with varying levels of evidence to support their safety and efficacy. Pharmacists are committed to the principles of evidence-based medicine and play an important role in providing consumers with advice on complementary medicines in accordance with Quality Use of Medicines (QUM) principles. This document outlines the position of the Pharmaceutical Society of Australia (PSA) on complementary medicines. The use of complementary therapies, such as massage and meditation is outside the scope of this statement.
About PSAPSA is the peak national professional pharmacy organisation representing Australia’s approximately 29,000 pharmacists1 working in all sectors and locations.
PSA’s core functions relevant to pharmacists include:
• providing high quality continuing professional development, education and practice support to pharmacists
• developing and advocating standards and guidelines to inform and enhance pharmacists’ practice
• representing pharmacists’ role as frontline health professionals.
It should be noted that PSA is not a regulatory body.
SEPT 2015Complementary medicinesPosition statement
Summary of PSA’s positionComplementary medicines may have a role in the management or treatment of some conditions, and may be used as an adjunctive therapy with conventional medicines, provided that there is evidence to support their use.
PSA does not support the sale of homeopathy products in pharmacy.
PSA is committed to supporting pharmacists to assist consumers in making informed decisions regarding complementary medicines and continues to advocate strongly for a partnership approach to promote QUM and responsible self-medication.
When discussing the use of complementary medicines with consumers, pharmacists must ensure that
consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm.
In the event that a consumer chooses to use a product with limited evidence, the pharmacist must advise the consumer on the risks of rejecting or delaying treatments for which there is good evidence for safety and effectiveness.
PSA strongly encourages all consumers considering taking complementary medicines to first consult their pharmacist for sound, evidence-based advice.
Prevalence of complementary medicines use in australia Complementary medicines are used worldwide, and in developing countries, complementary medicines play a major role in health care. Evidence suggests that the use of complementary medicines in Australia is steadily increasing. A 2005 survey indicated that 68.9% of Australians used a complementary medicine at least once a year.3 In 2014, a survey of the complementary medicines industry stated that revenue in 2014 exceeded $3.5 billion, with a projection that in 2017-18 revenue would reach $4.6 billion.4
The role of complementary medicinesComplementary medicines may have a role in the management or treatment of some conditions, and may be used as an adjunctive therapy with conventional medicines, provided that there is evidence to support their use.
PSA recognises that while evidence for some complementary medicines is limited, they may potentially benefit some consumers.
Regulation of complementary medicinesMedicines in Australia must be listed or registered on the Australian Register of Therapeutic Goods (ARTG). The Therapeutic Goods Administration (TGA) oversees this classification and assesses medicines based on the claims associated with the medicine and the potential risks and benefits of use.5
Registered Medicines: Medicines that have been registered on the ARTG are identified by an “AUST R” number on their label.5 For registered medicines, the TGA assesses safety, quality and efficacy of the medicine.5 In Australia, all prescription medicines are registered on the ARTG. Most over the counter medicines (OTC) are also registered, with only some complementary medicines registered on the ARTG.
Listed Medicines: Medicines listed on the ARTG are identified by an “AUST L” number on their label and are assessed for safety and quality only – efficacy is not assessed.5 Listed medicines include: vitamin and mineral supplements and herbal medicines.
These medicines must only use low-risk, preapproved ingredients and not make claims or imply that they will be useful in the treatment of a serious illness or condition.5
PSA notes that while products sold in Australia are regulated through the TGA, products sold on international websites may not meet the standards of safety or quality enforced through the TGA – as such, by purchasing these products, consumers may be exposing themselves to risk.
Levels of evidenceThe strength of evidence for medicine efficacy varies. The following classification is used by the Australian National Health and Medical Research Council (NHMRC)6:
Level I - a systematic review of all relevant randomised controlled trials.
Level II - a randomised controlled trial.
Level III-1 - a pseudo-randomised controlled trial (ie. alternate allocation or some other method).
Level III-2 - a comparative study with concurrent controls (ie. cohort studies, case-control studies).
Level III-3 - a comparative study without concurrent controls (ie. historical control, two or more single-arm studies).
Level IV - a case series, either post-test, or pre-test and post-test.
In order for a medicine to be registered on the ARTG it must be supported by Level I evidence.7 The level of evidence required for medicines to be listed on the ATRG varies between medicines and associated claims; however the evidence base can range from Level III-1 to Level IV.7
It is important to acknowledge that lack of evidence is not analogous to evidence of no effect. Further, anecdotal reports are not considered as evidence.
In Australia, medicinal products containing herbs, vitamins, minerals, nutritional supplements, and homeopathic preparations may be referred to as complementary, natural or alternative medicines.2 Many of these products are available from pharmacies; however, evidence for these products varies greatly.
References1. Pharmacy Board of Australia. Pharmacy registrant data:
March 2015. PBA: 2015; May. At: www.pharmacyboard.gov.au/documents/default.aspx?record=WD15%2f16935&dbid=AP&chksum=bLY0lK9odtaeMo6vdAHZ9g%3d%3d
2. Sansom LN, ed. 2015. Australian Pharmaceutical Formulary and Handbook. 23rd Edition. Canberra, PSA. pp458-61
3. Xue C, Zhang A, et al. 2007. Complementary and alternative medicine use in Australia: a national population-based survey. Journal of Alternative and Complementary Medicine 2007;13(6):643-650
4. Complementary Medicines Australia. 2014. Complementary Medicines Australia Industry Survey. http://www.cmaustralia.org.au/resources/Documents/Reports/CMA%20Industry%20Audit%202014.pdf
5. Department of Health. 2015. Therapeutic Goods Administration – Registered and Listed Medicines. At: https://www.tga.gov.au/registered-and-listed-medicines
6. Sansom LN, ed. 2015. Australian Pharmaceutical Formulary and Handbook. 23rd Edition. Canberra PSA. pp616-17
7. Therapeutic Goods Administration. 2014. Evidence Guidelines. Guidelines on the evidence required to support indications for listed complementary medicines. Version 2.1 At: www.tga.gov.au/file/6086/download
8. National Health and Medical Research Council. 2015. NHMRC Statement on Homeopathy and NHMRC Information Paper - Evidence on the effectiveness of homeopathy for treating health conditions. At: http://www.nhmrc.gov.au/guidelines-publications/cam02
9. Pharmaceutical Society of Australia. 11 March 2015. Media Release: NHMRC report highlights lack of evidence for homeopathy. At: http://www.psa.org.au/media-releases/nhmrc-report-highlights-lack-of-evidence-for-homeopathy
10. Royal Australian College of General Practitioners. 2015. Position Statement: Homeopathy. At: http://www.racgp.org.au/download/Documents/Policies/Health%20systems/PPI-PositionStatement-Homeopathy-v1.pdf
11. Pharmaceutical Society of Australia. 2011. Code of Ethics for Pharmacists. At: http://www.psa.org.au/download/codes/code-of-ethics-2011.pdf
12. Morgan TK, Williamson M, et al. 2012. A national census of medicines use: a 24-hour snapshot of Australians aged 50 or older. MJA 2012;196(1):50-53
13. Williamson M, Tudball J, et al. 2008. Information Use and Needs of Complementary Medicines Users. National Prescribing Service. At: https://www.nps.org.au/__data/assets/pdf_file/0010/66619/Complementary_Medicines_Report_-_Consumers.pdf
PSA
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HomeopathyPSA endorses the NHMRC report, released in March 2015 which found that there are no health conditions for which there is reliable evidence that homeopathy is effective and that homeopathy should not be used to treat health conditions that are chronic, serious, or could become serious.8,9 The NHMRC further mentions that consumers may put their health at risk if they reject or delay treatments for which there is good evidence for safety and effectiveness.8
PSA does not support the sale of homeopathy products in pharmacy.
Pharmacists must use their professional judgement to prevent the supply of products with no reliable evidence or evidence of no effect.
PSA notes that other health organisations have taken similar positions on the issue of homeopathy.10
The pharmacist’s role in complementary medicinesPharmacists, as medicines and medication management experts, have a fundamental role in ensuring consumers have access to safe and effective medicines. When discussing the use of complementary medicines with consumers, pharmacists must ensure that consumers are provided with the best available information about the current evidence for efficacy, as well as information on any potential side effects, drug interactions and risks of harm.2
PSA is committed to supporting pharmacists to assist consumers in making informed decisions regarding complementary medicines and continues to advocate strongly for a partnership approach to promote QUM and responsible self-medication.
Pharmacists should be guided by the PSA Code of Ethics, which states that the pharmacist must respect the autonomy and rights of the consumer to actively participate in decision making, and must balance this with the health and wellbeing of the consumer – the pharmacist’s first priority.11
In the event that a consumer chooses to use a product with limited evidence, the pharmacist must advise the consumer on the risks of rejecting or delaying treatments for which there is good evidence for safety and effectiveness.
PSA encourages pharmacists to consider the available evidence for the use of complementary medicines when deciding to stock them in their pharmacy.
The responsibility of the consumer in complementary medicinesIn 2012, a survey conducted by the National Prescribing Service (NPS) found that 48% of respondents did not tell their pharmacist or doctor about other medicines they were taking.12 PSA encourages all consumers to notify their pharmacist and general practitioner if they are taking complementary medicines, as there is potential for interactions between conventional or prescribed medicines and complementary medicines.
Another survey conducted by the NPS showed that the three most common sources of information on complementary medicines, as reported by consumers were: family and friends, the internet and health food shop workers.13
To ensure best possible health outcomes, the PSA strongly encourages all consumers considering taking complementary medicines to first consult their pharmacist for sound, evidence-based advice.
PHARMACEUTICAL SoCIETy of AUSTRALIA
Level 1, 25 Geils Court Deakin ACT 2600
PO Box 42 Deakin West ACT 2600
P: 1300 369 772 f: 1300 369 771 E: [email protected]
www.psa.org.au
