52The AusTrAliAn journAl of PhArmAcy vol.89 sePTember 2008

The 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 sideCM 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

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––choicedeliberates 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 pharmacyAll 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 standardsUrinary incontinence

ADHD and cold/flu holistic case studiesDiagnosis through breath testing

Silicon’s indications and supplementationIntegration with GP team-care arrangementsChildhood obesity

THE JOURN

AL OF Vol 7 N

o 5

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