Complementary medicines
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Complementary medicines Position statement This document outlines the position of the Pharmaceutical Society of Australia (PSA) on complementary medicines and the role of pharmacists. The use of complementary therapies, such as massage and meditation is outside the scope of this statement. About PSA PSA is the peak national professional pharmacy organisation representing Australia’s approximately 30,000 pharmacists 1 working in all sectors and locations. PSA’s core functions 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. PSA is also a registered training organisation and offers qualifications including certificate and diploma- level courses tailored for pharmacists, pharmacy assistants and interns. It should be noted that PSA is not a regulatory body. Summary of PSA’ s position Complementary medicines are a group of diverse products with varying levels of evidence to support their safety and efficacy. Complementary medicines may have a role in the management or treatment of some conditions, and may be used as an adjunctive therapy with conventional medicines. Pharmacists play an important role in providing consumers with evidence-based advice on complementary medicines in accordance with Quality Use of Medicines (QUM) principles. This is consistent with the Pharmacy Board of Australia’s advice2 that one aspect of good practice involves “facilitating the quality use of therapeutic products based on the best available evidence and the patient or client’s needs”. Pharmacists can assist consumers make informed decisions regarding complementary medicines to promote QUM and responsible self-medication. When discussing the use of complementary medicines, the pharmacist must ensure the consumer is 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. Pharmacists respect the autonomy and right of the consumer to take responsibility for their own treatment. When 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 consumers when considering taking a complementary medicine to consult with their pharmacist or general practitioner for evidence-based information about the product. Consumers taking complementary medicines should also raise this with their pharmacist and general practitioner to minimise the possibility of adverse effects such as interactions with another medicine. OCTOBER 2018
Transcript of Complementary medicines
Complementary medicinesPosition statement
This document outlines the position of the Pharmaceutical Society of Australia (PSA) on complementary medicines and the role of pharmacists. 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 30,000 pharmacists1 working in all sectors and locations.
PSA’s core functions 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.
PSA is also a registered training organisation and offers qualifications including certificate and diploma-level courses tailored for pharmacists, pharmacy assistants and interns.
It should be noted that PSA is not a regulatory body.
Summary of PSA’s positionComplementary medicines are a group of diverse products with varying levels of evidence to support their safety and efficacy. Complementary medicines may have a role in the management or treatment of some conditions, and may be used as an adjunctive therapy with conventional medicines.
Pharmacists play an important role in providing consumers with evidence-based advice on complementary medicines in accordance with Quality Use of Medicines (QUM) principles. This is consistent with the Pharmacy Board of Australia’s advice2 that one aspect of good practice involves “facilitating the quality use of therapeutic products based on the best available evidence and the patient or client’s needs”.
Pharmacists can assist consumers make informed decisions regarding complementary medicines to promote QUM and responsible self-medication. When discussing the use of complementary medicines, the pharmacist must ensure the
consumer is 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.
Pharmacists respect the autonomy and right of the consumer to take responsibility for their own treatment. When 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 consumers when considering taking a complementary medicine to consult with their pharmacist or general practitioner for evidence-based information about the product. Consumers taking complementary medicines should also raise this with their pharmacist and general practitioner to minimise the possibility of adverse effects such as interactions with another medicine.
OCTOBER
2018
PSA’s Code of Ethics for Pharmacists3 states that a pharmacist will only purchase, supply or promote any complementary medicine or herbal remedy where there is credible evidence of efficacy and the benefit of use outweighs the risk.
PSA does not support the provision or promotion of homeopathy products by pharmacists given the findings of the National Health and Medical Research Council (NHMRC) that there are no health conditions for which there is reliable evidence that homeopathy is effective.
Background
Use of complementary medicines in Australia
In Australia, medicinal products containing herbs (plants), vitamins, minerals, nutritional supplements, probiotics, or aromatherapy or homeopathic preparations are referred to as complementary, alternative, natural or traditional medicines.4
Reports suggest that the use of complementary medicines in Australia is continuing to increase. A 2005 survey indicated that 68.9% of Australians used a complementary medicine at least once a year.5 A survey of the complementary medicines industry stated that revenue in 2017 was $4.9 billion.6
Regulation of complementary medicines
Medicines in Australia are regulated by the Therapeutic Goods Administration (TGA) and must be listed or registered on the Australian Register of Therapeutic Goods (ARTG).7
Registered medicines have been assessed for safety, quality and efficacy and are identified by an “AUST R” number on their label.7 All prescription medicines and most over-the-counter medicines are registered on the ARTG, as well as some complementary medicines.
Listed medicines have been assessed for safety and quality only and are identified by an “AUST L” number on their label.7 They include vitamin and mineral supplements, and herbal medicines. These medicines must only use low-risk, pre-approved ingredients7 and indications drawn exclusively from a list of pre-approved ‘permitted indications’.8
In 2018, a new ‘assessed listed medicines’ pathway for complementary medicines was established to allow intermediate level indications subject to premarket TGA assessment of efficacy evidence.9
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.10
Levels of evidence
The strength of evidence for medicine efficacy varies and can be classified according to the hierarchy adopted by the NHMRC.11 For a medicine to be registered on the ARTG it must be supported by Level I evidence.12 Evidence required for medicines to be listed on the ARTG varies between medicines and associated claims; however the evidence base can range from Level III-1 to Level IV.12
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.
HomeopathyPSA endorses the NHMRC report 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.13 The NHMRC 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.13
Consistent with the above, PSA does not support the provision or promotion of homeopathy products by pharmacists.
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. Complementary medicines may have a role in the management or treatment of some conditions, and may be used as an adjunctive therapy with conventional medicines.
The pharmacist’s first priority is the health and wellbeing of the consumer.3 When discussing the use of complementary medicines, the pharmacist must ensure the consumer is 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, to assist in making informed decisions.4
References1. Pharmacy Board of Australia. Registrant data. 30 Jun 2018.
At: www.pharmacyboard.gov.au/About/Statistics.aspx
2. Pharmacy Board of Australia. Code of conduct for pharmacists. Mar 2014. At: https://www.pharmacyboard.gov.au/codes-guidelines/code-of-conduct.aspx
3. Pharmaceutical Society of Australia. Code of ethics for pharmacists. Feb 2017. At: https://svrweba.psa.org.au/wp-content/uploads/2018/07/PSA-Code-of-Ethics-2017.pdf
4. Sansom LN, ed. Australian pharmaceutical formulary and handbook. 24th ed. Canberra: Pharmaceutical Society of Australia; 2018. pp. 486-9.
5. Xue CC, Zhang AL, Lin V, et al. Complementary and alternative medicine use in Australia: a national population-based survey. J Altern Complement Med 2007;13(6):643-50.
6. Complementary Medicines Australia. Australia’s complementary medicines industry snapshot 2018. At: www.cmaustralia.org.au/resources/Documents/Australian%20Complementary%20Medicines%20Industry%20snapshot%202018_English.pdf
7. Therapeutic Goods Administration. Registered and listed medicines. At: https://www.tga.gov.au/registered-and-listed-medicines
8. Therapeutic Goods Administration. Permitted indications for listed medicines. 7 Mar 2018. At: https://www.tga.gov.au/permitted-indications-listed-medicines
9. Therapeutic Goods Administration. Assessed listed medicines pathway for complementary medicines. 27 Mar 2018. At: www.tga.gov.au/assessed-listed-medicines-pathway-complementary-medicines
10. Therapeutic Goods Administration. Buying medicines and medical devices online. 27 Jun 2016. At: www.tga.gov.au/community-qa/buying-medicines-and-medical-devices-online
11. Sansom op. cit. pp. 631-6.
12. Therapeutic Goods Administration. Evidence guidelines: Guidelines on the evidence required to support indications for listed complementary medicines. Version 2.1. Jul 2014. At: www.tga.gov.au/file/6086/download
13. National Health and Medical Research Council. NHMRC statement on homeopathy and NHMRC information paper – Evidence on the effectiveness of homeopathy for treating health conditions. 2015. At: https://nhmrc.gov.au/about-us/publications/evidence-effectiveness-homeopathy-treating-health-conditions
14. Morgan TK, Williamson M, Pirotta M, et al. A national census of medicines use: a 24-hour snapshot of Australians aged 50 years and older. Med J Aust 2012;196(1):50-3.
15. Williamson M, Tudball J, Toms M, et al. Information use and needs of complementary medicines users. Sydney: National Prescribing Service; 2008. At: https://westernsydney.edu.au/__data/assets/pdf_file/0007/537406/Information_Use_and_Needs_of_Complementary_Medicines_Users.pdf
PSA
5476
PHARMACEUTICAL SOCIETY OF AUSTRALIA
Level 1, 17 Denison Street 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
Pharmacists respect the autonomy and right of the consumer to actively participate in decision making.3 Pharmacists appreciate the consumer’s cultural and social beliefs regarding the use of complementary medicines, and respect their desire to take responsibility for their own treatment. PSA advocates strongly for a partnership approach to promote QUM and responsible self-medication.
A pharmacist respects the consumer’s choice.3 When a consumer chooses to use a product with limited evidence, the pharmacist must advise on the risks of rejecting or delaying treatments for which there is good evidence for safety and effectiveness.
Pharmacists should also support pharmacy assistants to understand the importance of evidence informing the use of complementary medicines.
The consumer’s role in complementary medicinesA study published in 2012 reported that 48% of respondents did not tell their pharmacist or doctor about other medicines they were taking.14 Another earlier report 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.15
To ensure best possible health outcomes, PSA strongly encourages all consumers considering taking a complementary medicine to first consult their pharmacist for evidence-based advice. Consumers are also encouraged to notify their pharmacist and general practitioner if they are taking a complementary medicine, as there is potential for interaction between conventional or prescribed medicines and complementary medicines.
