Last year a review into pharmacy in Australia recommended homeopathic products be banned from sale in chemist shops across the country. This was a sensible recommendation, given pharmacists are trusted scientists in the community and science tells us homeopathic products simply don’t work.
In the government’s recent response to this review they “noted” the concerns of the reviewer, and have chosen not to adopt it. Here’s why that is a mistake.
What is homeopathy?
Homeopathy involves extreme dilution of a compound that is claimed to be therapeutically effective, and uses the concept of “like cures like”. For example a fever might be treated with a compound used to induce fevers, in the belief the diluted active ingredient will have the opposite effect and cure the fever.
Products tend to contain the equivalent active ingredient to a single molecule within an Olympic-size swimming pool. Practitioners of fact-based medicine have understandably indicated that any effect of the product could only be attributable to the placebo effect (it works because you believe it works) or because the product contains alcohol or a similar base.
Most pharmacists probably abhor such treatments lacking evidence, given they go through years of rigorous university training, are heavily regulated and have a strong professional ethic. But it makes the cash registers clang.
These days pharmacies also sell jelly beans, lipstick, energy bars, vitamins, teddy bears and sunglasses – as well as prescription medications. This, unfortunately, is business practice.
Pharmacies have a special status as businesses, along with many actors in the health system. Successive governments have grappled with tensions around service delivery, standards and competition.
They’ve also had to grapple with a very strong industry body, the Pharmacy Guild (stronger than the Pharmaceutical Society). Much of the review reflects agreement between them. In responding to the review the government has flicked the homeopathic hot potato to pharmacy owners:
Professional standards have been designed for use by individual pharmacists to assess their own professional practice. They are intended to serve as guidance for desired standards of practice. However, it is the sole responsibility of the individual pharmacist to determine, in all circumstances, whether a higher standard is required. It is equally their responsibility to meet that standard and ensure that consumers are provided with the best available information about the current evidence for, or lack-of efficacy in, offered treatments and therapies.
So given the government has not banned homeopathic products from pharmacies, we could hope for restriction under Australian Consumer Law. They can, for example, prohibit sale of products that lack the purported constituents or qualities. But this has yet to happen with homeopathy, as it’s considered misleading but harmless.
The government is putting the onus on consumers to ask the pharmacist “does this work?”, and only the exceptional customer will ask.
If consumers wish to purchase therapies without a proven effect, they should be able to do so from venues that sell incense sticks and similar “wellness” paraphernalia.
They should not be available for sale in an industry necessarily regulated by government and trusted by the community.
It’s time for the Guild and Society to take a stand and reject sale by their members of products that by definition do not work. If pharmacies want status, they have to skip the junk products dollar. The government should help.
When you enter a Chemmart pharmacy, it’s hard to miss the posters and brochures promoting its “revolutionary myDNA test”. The brochure states it’s “personalised medicine”, where “your DNA results … can help guide your future health and lifestyle choices”.
It’s an enticing promise. Knowing your genes unlocks a healthier future. Right?
The myDNA advertising, also on the Chemmart and mydna.life websites, claims that “70% of people who take a myDNA test have a finding that could affect current or future medications”.
Chemmart myDNA brochure front page. Freely available from Chemmart pharmacies
The promotional materials suggest taking the test if you’re using antidepressants, pain or reflux medication. The test also covers the common, but difficult to manage, blood thinner warfarin, which is prescribed to approximately 30% of patients over the age of 70 years.
Chemmart says it’s particularly relevant if you have a history of not responding to common drugs, you experience side-effects from your medication, you take multiple medications, you have children on prescribed medication, or you are pregnant or planning pregnancy.
But some of Chemmart’s claims may be misleading for consumers who lack detailed knowledge of DNA testing and may produce unrealistic expectations of the product’s effectiveness. In so doing, Chemmart appears to have breached a number of provisions of the Therapeutic Goods Advertising Code 2015.
The test costs A$149 and is not covered by Medicare or private health insurance rebates. It involves a cheek swab taken by a trained pharmacist, which is sent to Australian Clinical Labs (formerly Healthscope Pathology) for DNA analysis.
The results are delivered by personal consultation with the pharmacist and are also sent to your nominated doctor. If the pharmacist recommends changes to medication, you are referred to your doctor.
As part of their training, participating pharmacists are encouraged to explain the test to local doctors, both to educate them and prepare them for pharmacist referrals or enquiries from patients.
The test identifies common variations in four genes that are involved in processing a number of drugs. For example,
CYP2C9 and VKORC1 affect the metabolism of the blood-thinning drug warfarin
CYP2D6 is involved in the metabolism of the pain killers codeine and tramadole, as well as antidepressants
CYP2C19 affects the metabolism of antidepressants, the newer blood thinner clopidogrel and drugs taken for reflux, such as esomeprazole.
The term pharmacogenetics was first coined in 1959 but it is only recently that pharmacogenetic (PGx) tests have moved from the lab to the clinic.
Researchers have now identified inherited variation in approximately 20 genes affecting around 80 medications, which are potentially actionable in the clinic.
Genetic variations may predict, for example, that a patient is at increased risk of experiencing the side-effects of certain drugs because they metabolise it slowly and high concentrations can build up on a normal dose.
Other genetic variations may cause a particular drug to be metabolised too rapidly, so patients may need a higher dose of the drug to achieve a therapeutic effect.
But a “normal” PGx test doesn’t mean you’re not at risk of drug-related side-effects or of not responding to a drug. Current tests only capture known variants of known genes.
And even if the test shows gene variants that impact on a certain drug’s metabolism, this is only one of many patient characteristics and factors that influence how they respond to drugs. Others include interactions with other drugs, allergies, and kidney and liver function.
As a result, the cost-effectiveness and clinical utility of PGx tests is still uncertain.
Case study: warfarin
Warfarin is a commonly prescribed blood-thinning drug that prevent strokes in patients who have an irregular heartbeat or whose heart valves have been replaced. However, it must be monitored closely with regular clotting tests to ensure it is at the right therapeutic level to prevent bleeding or stroke.
Variations in the genes VKORC1 and CYP2C9 can either slow warfarin metabolism, thereby increasing the risk of bleeding, or increase sensitivity, which may require a lower dose to produce the required effect.
However, in practice, the clinical implementation of genetic testing for warfarin dosing has been disappointing. The current consensus guidelines by the American College of Chest Physicians actually warn against the routine use of genetic data to guide dosing because of its poor predictive value for large populations.
In Australia, GPs manage warfarin dosage via regular monitoring of the clotting test. This allows GPs to adjust the patient’s dose, taking into account all important patient risk factors.
Chemmart claims “myDNA is a genetic test that identifies which medications will work best for you”. This overstates the role and value of this test.
It has limited applicability only to certain drugs in particular situations.
We do not believe the test is “particularly relevant” to those who “take multiple medications, have children on prescribed medication”, or “are pregnant or planning pregnancy” because of the extremely limited applicability of the test to these patient groups.
We also have problems with the claim that “the myDNA test covers 50% of the most commonly prescribed medications”. This is not in accord with data from the United States, which shows that just 7% of approved medications and 18% of outpatient prescriptions are affected by actionable pharmacogenes (genes you can test for and alter medication around). Nor is it in accord with Australian data on the top ten drugs prescribed.
We have submitted our concerns to the Therapeutic Goods Advertising Complaint Resolution Panel for an independent determination.
More research (and GP training) will be required to determine if PGX tests improve patient care and are cost-effective. In the meantime, marketing claims should reflect the current uncertain clinical role of these tests.
The role of test providers, pharmacists and doctors
Pharmacists play an important role in engaging with consumers and doctors to achieve better use of medication. But the current model of pharmacist “detailing” PGx tests has several problems. “Detailers” are not welcomed by all GPs. Some clinics have demanded the pharmacist bring a free lunch (often provided by drug reps) before they will schedule a visit.
Finally, the national prescribing service NPS Medicinewise has an important role to play in developing a pharmacogenetic education campaign. This could still involve trained pharmacists but NPS Medicinewise authority would provide greater access to GPs without the demand for lunch as the price of entry.
Pharmacists are consistently held up as among the most respected and trusted of professionals. They fulfil an important role within the health professions of being the gatekeepers of medication dispensing and the link between the community and their medication use. For more than one hundred years, there has been a very clear and ethical distinction between doctors (who prescribe medications) and pharmacists (who sell them). That way, the argument goes, doctors have no direct financial interest in drugs they prescribe, and pharmacists have no direct financial interest in recommending any of the drugs on their shelves directly to patients. So far, so good.
There has been a bit of role creep over the years, with calls from some doctors to be allowed to sell their own concoctions directly to their patients, as well as a much more concerted push by pharmacists to play a bigger role in health care, including providing immunisations and health checks direct to consumers. Naturally this is of concern to GPs as such proposals have the potential to fragment primary care even further. Not to mention taking the critical role of diagnosis and putting it into the hands of those who are underqualified, underinsured and undersupported to handle it.
What concerns me particularly is not so much that these health checks will take work away from GPs. If anything I suspect they will increase GPs workloads, sorting out the advice already given to patients by wannabe GP enthusiasts like pharmacists and their associated naturopaths. This month’s Skeptic magazine from Australian Skeptics highlights the problem quite well.
I think it’s time for pharmacists to decide if they want to keep the trust placed in them by the community to give sound advice. If they want to remain a trusted source of advice they need to lift their game and get all the ear candles, homeopathy, magnets, herbs and supplements out of their shops, along with the iridologists and other fairground ‘health professionals’. In short, they need to start acting like they deserve the trust and respect that is accorded them. We have heard nothing of the training and CPD requirements for pharmacists who want to diagnose and treat patients, let alone how they will be insured. I would want to see all this detail before I let my croupy baby or breathless grandmother within a bull’s roar of a pharmacist’s diagnostic skills.
The protectionism involved in the business of running pharmacies is breathtaking. Like dentists, only pharmacists are legally allowed to profit from running pharmacies, and they have defended this with all the bitterness and vitriol you might expect from a group who know they are onto a good thing. Health Minister Peter Dutton seems all for the pharmacists’ ambitions and has been on the media trail vowing not to wind back their protected status.
So it seems the pharmacists will have all they want. I wonder if they deserve it? I hope they take the opportunity to lift their game as a profession and use their protected status to raise standards, not profits. A good place to start would be to stop advertising and selling shonky devices and products that would be considered fraudulent in any other context. Too hard? Then get out of the expanded responsibility game for good.
Michael Vagg does not work for, consult to, own shares in or receive funding from any company or organisation that would benefit from this article, and has no relevant affiliations.