A most trusted profession ...?
Authors: Anthony J Smith and David A Newby
Published online: 7 November 2011
Pharmacists have an important role in protecting the public from regulatory loopholes
If the 2011 Readers Digest survey can itself be trusted, pharmacists are the sixth most trusted profession in Australia, coming in marginally behind nurses (fifth) and before medical specialists (eighth) and general practitioners (ninth), and well ahead of car salesmen (43rd) and politicians (44th).1
What qualities inspire trust? The Concise Oxford dictionary defines trust as “firm belief in reliability, honesty, veracity ...”, so presumably these are the characteristics recognised in pharmacists and applauded by the survey respondents. The advice of community pharmacists in response to customers’ enquiries is widely relied upon, but events in the past few months raise serious questions about the trustworthiness of some in the profession.
The first episode involved the marketing of SensaSlim (SensaSlim Australia, Sydney, NSW) a complementary medicine promoted as a new approach to achieving weight loss2 and sold largely through community pharmacies. In September 2010, the Therapeutic Goods Administration (TGA) included the medicine in the Australian Register of Therapeutic Goods (ARTG) as a listed product (labelled with an AUST L number). This means it had been evaluated for quality and safety but not efficacy. The product’s website claimed that a clinical trial involving more than 10 000 patients demonstrated its effectiveness, but requests from many health professionals to SensaSlim Australia failed to produce this evidence. Following complaints from doctors and pharmacists over the ensuing months, SensaSlim was discredited, although the associated legal battles are still unresolved.3 Despite widespread adverse publicity in the media, some community pharmacists continue to promote and sell the product, galvanised perhaps by the 65% profit margin on sales4 rather than the strength of the evidence for efficacy.
The second event was the much publicised intention of the Pharmacy Guild of Australia (“the leading advocate for community pharmacy and a vital contributor to improving health outcomes for all Australians”5) to add its “Gold Cross” endorsement to complementary medicines marketed by Blackmores (Sydney, NSW) as “companion products” to prescription medicines for common medical disorders. Justifications for this concept included that some antihypertensive medicines are associated with reduced plasma concentrations of zinc; coenzyme Q10 concentrations are lowered in patients taking statins; hypomagnesaemia has been reported in patients taking long-term proton pump inhibitors; and probiotics might prevent some cases of antibiotic-associated diarrhoea.6
It is a short jump from these observations to the idea that supplements of zinc, coenzyme Q10, magnesium or probiotics should be given routinely when using these medicines. If implemented, this would be a remarkable marketing coup for Blackmores and the community pharmacy. But is there any evidence of possible benefit? A team at the National Prescribing Service published an excellent summary of the available evidence on its website on 30 September.7 They found nothing to support the routine use of these companion products. Under pressure from many pharmacists (including the Pharmacist Coalition for Health Reform) and other health professionals, the Pharmacy Guild announced on 5 October that the plan to endorse the Blackmores products had been dropped.
These two disturbing events are symptoms of two underlying problems.
First, community pharmacies still rely significantly on product sales for income, rather than a fee-for-service model. This results in a tension between being a health care professional and being a retailer. While recent agreements between the Pharmacy Guild and the Australian Government are trying to address this issue by providing payments to pharmacists for cognitive services such as medication reviews, the uptake of this program has been variable.8
Second, there are regulatory issues around complementary medicines that are yet to be acted upon by the Australian Government and its regulators. For many years, Australia led the world in regulation of complementary medicines. However, the regulations have not kept pace with trends, especially in the case of listed products. In particular, the loophole that allows sponsors to have products such as SensaSlim included on the ARTG without any review of evidence to support their claims is an affront to any regulatory body.
When regulation of complementary medicines began in the 1990s, it was agreed that “low-risk” (AUST L) medicines would be allowed onto the market without independent review of efficacy, provided they were safe and of good quality. In 1999, it became a requirement that sponsors of listed products must “hold” the evidence to substantiate their claims. In 2003, a report on complementary medicines in the health system recommended that, as part of the listing process, sponsors should submit a summary of the evidence for efficacy to the TGA.9 The government accepted this recommendation,10 but no implementation has resulted. Enacting this recommendation may protect us from future SensaSlims, and would give a proper basis for the provision of sorely needed evidence-based consumer information about complementary medicines.
A positive aspect of the Pharmacy Guild’s forced U-turn is that it demonstrates there are sufficient numbers of alert and concerned people in this country, including many pharmacists, who are prepared to put pressure on the peddlers of untrustworthy proposals. It is presumably these pharmacists who have earned the accolades of trustworthiness for the profession as a whole.
Competing interests
References
- Reader’s Digest Australia. Australia’s most trusted professions 2011. http://www.readersdigest.com.au/australias-most-trusted-professions-2011 (accessed Oct 2011).
- SensaSlim [website]. http://www.sensaslim.com (accessed Oct 2011).
- Federal Court of Australia, New South Wales Registry. Australian Competition and Consumer Commission v Sensaslim Australia Pty Ltd (Administrator Appointed) ACN 140 333 133 & Ors. Federal Court of Australia File: NSD1163/2011. 15 Jul 2011. https://www.comcourts.gov.au/file/Federal/P/NSD1163/2011/actions (accessed Oct 2011).
- SensaSlim advertising. Pharmacy Daily 2011; 2 Feb: 3. http://archive. traveldaily.com.au/PD/2011/Feb11/pd020211.pdf (accessed Oct 2011).
- Pharmacy Guild of Australia [website]. http://www.guild.org.au (accessed Oct 2011).
- Harvey K. Pharmacies to push supplements as ‘fries and Coke’ to prescriptions. The Conversation 2011; 27 Sep. http://theconversation.edu.au/pharmacies-to-push-supplements-as-fries-and-coke-to-prescriptions-3578 (accessed Oct 2011).
- National Prescribing Service. Complementary medicines as companion products. http://www.nps.org.au/topics/companion_products (accessed Oct 2011).
- Lee CY, George J, Elliott RA, Stewart K. Prevalence of medication-related risk factors among retirement village residents: a cross-sectional survey. Age Ageing 2010; 39: 581-587. 0_CACFCJED
- Expert Committee on Complementary Medicines in the Health System. Complementary medicines in the Australian health system. Canberra: Commonwealth of Australia, 2003: 27. http://www.tga.gov.au/pdf/archive/committees-eccmhs-report-031031.pdf (accessed Oct 2011).
- Australian Government. Government response to the recommendations of the Expert Committee on Complementary Medicines in the Health System. Canberra: Commonwealth of Australia, 2005: 5. http://www.tga.gov.au/pdf/archive/committees-eccmhs-response-050309.pdf (accessed Oct 2011).