1. 52
The Australian journal of Pharmacy vol.89 september 2008
T
he proposed overhaul of
Australian healthcare system,
including redefined doctors’
and pharmacists’ roles, and a
single national registration system of
providers, is reverberating through
Australia’s healthcare workforce;
the fastest growing group of which
is complementary medicine (CM)
therapists.1
Aimed at making the sector better
equipped to handle the imminent
chronic healthcare needs of an ageing
population, intergovernmental
health ministers are considering
expanding the national registration
and accreditation scheme from health
professions registered in all Australian
Calls for stronger regulation of
complementary practitioners echo
those about products—which will get
greater traction, asks Steven Chong.
complementary
medicine
Regulation, registration, revelationsSteven Chong, editor of the Journal of Complementary Medicine, steven.chong@appco.com.au
states and territories to those
registered only in some jurisdictions.
This would include traditional Chinese
medicine practitioners, at present
statutorily registered in Victoria.
Practitioners of other CM
therapies may follow, however
chiropractors and osteopaths will at
least join doctors and pharmacists
on 1 July 2010 as nationally
registered healthcare professionals
who can then practise in any
Australian state or territory.
The practitioner side
CM therapists are currently self-
regulated by professional associations,
of which there is a plethora and many
with state-based divisions. Some are
national and cover several therapies;
others are specific to a modality.
Herbal medicine and massage therapy
have national peak bodies but these
compete for members with large
umbrella natural-therapy associations,
such as the 11,000-strong Australian
Traditional-Medicine Society. A 2004
workforce survey found some 115 CM
practitioner associations2
, while the
total number is probably higher. The
survey called for statutory regulation
of CM practitioners, as have numerous
articles and reports before and since.
Into this confused and crowded
field has entered another report, by
a naturopath and PhD candidate at
the University of Queensland, Jon
Wardle.3
Prepared as a submission to
the Parliamentary Secretary for Health
& Ageing, Jan McLucas, the report
called for stronger regulation of both
practitioners and products, and found
that most CM therapists were in favour
of registration. The ensuing media
debate centred on the criteria for
regulation, namely the significance of
the risks of CM use.
No pharmacist would dispute
that there are risks associated with
CM product use, although they are
The extraordinary Federal Court
victory of Jim Selim, founder of Pan
Pharmaceuticals, over the TGA in
August has led the way for the CM
industry to take class actions against
the regulator.
The 2003 mass recall of all products
manufactured by Pan is now that much
more infamous, with the TGA settling
the case with Mr Selim for $55m.
Revelations about non-consensus
of expert opinion justifying the Class
1 recall, shredded documents, and
comments by TGA officers such
as ‘go for [Pan’s] jugular’ make
the saga of contaminated product,
hallucinating consumers, empty
shelves, stockmarket and job losses,
and upended companies all the more
lurid and dismaying.
Further, it undermines confidence
in the TGA, already bludgeoned
by a highly negative report by the
Australian National Audit Office in
2004, the failure of the long-heralded
trans-Tasman regulatory body,
and persistent Australian and New
Zealand CM industry complaints of
partisan persecution and reprisals. To
add to its woes, La Trobe University
public-health academic Dr Ken
Harvey has very publicly exposed
the TGA’s weaknesses in dealing
with complaints over advertising.
Moreover, only a handful of dozens of
recommendations made by an expert
committee on CMs formed after the
Pan recall have been implemented.
In response to the court order for a
record settlement––plus legal costs––to
an individual, the TGA issued a terse
defensive statement to the effect of
‘but he only got a fraction [ie. a quarter]
of what he originally wanted’. Such
a response is poor damage control,
especially when it is tax revenue––or,
ironically, industry fees as the TGA is
funded by those it regulates––that will
be paying for their mistakes.
The government has rejected Mr
Selim’s calls for a full enquiry but is
hastening to implement outstanding
expert recommendations, including
those to further the transparency of an
otherwise Kafka-like bureaucracy. But
this won’t include a recommendation
to shift its dependency on industry
funding, which was stoutly rejected by
the Howard government.
The TGA is one of the most
ambitious (or progressive, depending
on your perspective) in the world in
regulating CMs, and is justifiably proud
of some of its innovations. However,
this episode has shown that the best
intentions in the world, when mixed with
‘negligence and malfeasance’, have
shown it in need of cultural change.
When the regulator needs regulation

2. complementary
medicine
The AusTrAliAn journAl of PhArmAcy vol.89 sePTember 2008
53
OTHER FEATURES INCLUDE
• Compounding standards—
a valued key element of
a pharmacist’s skill is
extemporaneous preparation of
medicines. Recent discussion
papers on proposed regulatory
changes to compounding suggest
there may soon different classes,
based on volume of output. How do
leading compounders feel about this,
and what is likely to eventuate?
• ADHD and paediatric obesity––
a case study of successful holistic
treatment of a child where Ritalin
wasn’t wanted; plus the debate on the
‘epidemic’ of childhood obesity: what
are health professionals to advise do in
the face of conflicting views on causes
and prevalence?
• Urinary incontinence––magnetic,
electronic and biofeedback devices
are now employed in managing this
condition, some with surprisingly good
results. This review also looks at why
pelvic-floor muscle training is a natural
therapy of choice, the influence of
hormones and particular foods and
beverages, as well as how weight loss,
potassium and magnesium may also
play a role.
one may expect ginkgo is another
substance with which warfarin
interacts, despite theoretical concerns
the clinical evidence to date suggests
that it does not. Dr Lesley Braun
explodes another myth around
complementary medicine.
• Silicon––it isn’t considered essential
but it’s abundant in our hair, nails and
skin and is marketed as a supplement
for healthy maintenance of the same. We
look at why it may be helpful and factors
in its bioavailability and metabolism.
• Ongoing controversies––choice
deliberates on the cognitive
supplements category; the march
of evidence for omega–3s and
whether its better from marine or plant
sources; why pharmacists must adapt
to the ‘new consumer’ armed with
health information; interactions and
integration; a couple of vitamin B6
adverse events.
FeAtUrinG in tHe
Journal of Complementary Medicine...
Pregnant and breastfeeding
women and children frequently take
complementary medicines (CMs),
or are interested in doing so, but
are confused about what is safe.
Pharmacists fielding questions
about safety of CM products
during these critical life stages will
find invaluable a four-page guide
that answers these questions for
commonly used CMs.
To subscribe to The Journal of Complementary Medicine, contact www.jnlcompmed.com.au
relatively low compared to other
medicines or treatments. Concerning
CM therapies, the risks are more
financial and indirect (eg. denial
or delay of proven conventional
treatment) than direct (the supposed
risks of spinal manipulation, such
as practised in chiropractic, have
been found to be wildly inflated4
);4
);4
the therapies reliant on ingestible
treatments (herbal medicine and
naturopathy but not homeopathy)
have been assessed by various states
and found to be wanting registration.5
Why it matters to pharmacy
All clinical pharmacists will indirectly
encounter the CM professions when
engaging with consumers.
With CM use so prevalent, it is
inevitable to find a customer or
patient who is taking something
recommended by a naturopath, or
is consulting a herbalist or masseur.
Retail pharmacists in particular are
hiring naturopaths to work in their
premises as assistants, vitamins
consultants or de-facto nutritionists/
health coaches for customers; at the
very least pharmacies often receive
visits from naturopathically trained
reps for their CM product lines.
However, with no protection of
title and no minimum standards of
training or qualifications, anyone can
represent themselves as a naturopath.
Membership of professional
association(s), and thus accreditation
from private health-insurance funds
to provide rebateable services to
patients, is no real indication of their
skills and expertise.
Where does this leave a
pharmacist who wants a good CM
therapist, whether for themselves,
their front-of-shop or to whom they
can refer a customer?
Wardle’s report, and another
new survey of Australian CM
education providers6
, both state
that the minimum education
benchmark is that of a Bachelor’s
degree because of the risk involved
in ingestible therapies, and the
need for better integration with
mainstream healthcare.
There are at least a dozen
courses that provide this in
naturopathy and Western herbal
medicine, however, diploma
and advanced diploma courses
still predominate. Many of these
are offered by private colleges
and institutions, the owners or
associates of which sit on the
boards of the professional bodies,
leading to clear conflicts of interest.
Naturally, it is these professional
bodies that are campaigning
to maintain self-regulation, or
augment it to ‘government
monitored self-regulation’.7
Needless to say, finding a good
CM therapist involves more than
assessing their education. How they
interact with your and their clients
and customers, their continuing
professional development activities
and indemnity, financial conflicts,
fee structure, limitations, ethical
affiliations, therapeutic preferences
and protocols, organisational skills
and integration with the rest of your
pharmacy team all indicate their
overall suitability. These impressions
can be gained from talking with the
patients and of the therapist, as well
as other health practitioners. n
References available on request
complementary
medicine
changes to compounding suggest • Ginkgo and warfarin––although
Journal of Complementary Medicine
women and children frequently take
complementary medicines (CMs),
or are interested in doing so, but
are confused about what is safe.
during these critical life stages will
find invaluable a four-page guide
that answers these questions for
Compounding standards
Urinary incontinence
ADHD and cold/flu holistic
case studies
Diagnosis through
breath testing
Silicon’s indications and
supplementation
Integration with GPteam-care arrangements
Childhood obesity
THEJOURNALOF
Vol7No5
PP255003/09005
The Independent Peer-Reviewed Journal for Healthcare Professionals
SEPTEMBER / OCTOBER 2008 Vol 7 No 5
Paediatrics
and CMA guide to safety in pregnancy,breastfeeding and infants