Pharmaceutical Society of Australia. Complementary medicines position statement
https://my.psa.org.au/s/sfdcpage/%2Fapex%2FAsKnowledgeArticle%3FartType%3DStandard__kav%26artId%3Dka17F0000000zFwQAI[*quote*]
Complementary medicines
19/11/2018 | Position Statements, | Complementary medicinesThis is available for download as a PDF: Complementary Medicines Position.pdf
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PSA's Code of Ethics for Pharmacistshttps://www.psa.org.au/wp-content/uploads/2018/07/PSA-Code-of-Ethics-2017.pdf[*quote*]
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Complementary medicines
OCTOBER
2018
Position statementAbout 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.
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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
ingredients 7 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.
Homeopathy
PSA 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 medicines
Pharmacists, 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
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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 medicines
A 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.
References
1. Pharmacy Board of Australia. Registrant data. 30 Jun 2018.
At:
http://www.pharmacyboard.gov.au/About/Statistics.aspx2. Pharmacy Board of Australia. Code of conduct for
pharmacists. Mar 2014. At:
https://www.pharmacyboard.gov.au/codes-guidelines/code-of-conduct.aspx3. 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.pdf4. 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:
http://www.cmaustralia.org.au/resources/Documents/Australian%20Complementary%20Medicines%20Industry%20snapshot%202018_English.pdf7. Therapeutic Goods Administration. Registered and listed
medicines. At:
https://www.tga.gov.au/registered-and-listed-medicines8. Therapeutic Goods Administration. Permitted indications for
listed medicines. 7 Mar 2018. At:
https://www.tga.gov.au/permitted-indications-listed-medicines9. Therapeutic Goods Administration. Assessed listed
medicines pathway for complementary medicines. 27
Mar 2018. At:
http://www.tga.gov.au/assessed-listed-medicines-pathway-complementary-medicines10. Therapeutic Goods Administration. Buying medicines and
medical devices online. 27 Jun 2016. At:
http://www.tga.gov.au/community-qa/buying-medicines-and-medical-devices-online11. 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:
http://www.tga.gov.au/file/6086/download13. 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-conditions14. 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.pdfPHARMACEUTICAL 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: psa.nat@psa.org.au
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