A compounding pharmacy has been criticised for dispensing a withdrawn substance… but is the reproval warranted?
Dr Ken Harvey, from Monash University’s School of Public Health, has notified the AJP that he has submitted a complaint to AHPRA and the ACCC regarding a compounding pharmacy and its dispensing of the appetite suppressant, diethylpropion.
He mentions a patient that came forward having been prescribed a “cocktail of drugs including diethylpropion; a drug withdrawn from the Australian market by the TGA because of serious adverse effects, including irregular heartbeat, high blood pressure, seizures, nervousness, and reports of people become psychologically dependent on this medicine”.
The capsules that included 30 units of diethylpropion were prescribed by a medical practitioner working for the Medical WeightLoss Institute, and dispensed by the compounding pharmacy Australian Custom Pharmaceuticals.
Dr Harvey claims that through the prescription of such drugs, MWI, the prescribing doctor and the compounding pharmacist are “putting patients at serious risk of adverse effects, as is the failure of the regulators to curtail these activities to-date.”
ACP hits back
Australian Custom Pharmaceuticals (ACP) has responded with indignation to Dr Harvey’s claims.
Owner and pharmacist Daryll Knowles told AJP that ACP is completely within its right – and the law – to dispense diethylpropion to patients who present with a script.
“ACP imports diethylpropion through its agent under the strict requirements of a TGA Import Permit,” says Knowles.
“Part of this permit requires ACP to state exactly the purpose of the diethylpropion and what is it being used for. ACP filled out an end user statement which forms part of the Permit procedure which states that ACP will be using the diethylpropion for compounding of prescriptions for patients whose doctors have prescribed it.
“This process was completed and a permit obtained from TGA for its import and intended use.”
Knowles argues that diethylpropion is not as dangerous as Dr Harvey makes it out to be.
“It is true that diethylpropion is no longer on the ARTG but it does appear under Schedule 4 on the TGA SUSMP. It is not a banned substance. It is however still an FDA-approved medicine and has marketing approval in the UK from the MHRA.
“Since its introduction in 1958, nearly 60 years ago nearly 30,000,000 patients worldwide had used it in its first 30 years. In its time in Australia the TGA database of adverse events has recorded only 36 adverse events where diethylpropion has only been suspected – not proven – to be responsible, with no deaths reported.
“For perspective, Celecoxib has 3481 reported adverse reactions for a single suspected medicine and 57 deaths. It is still currently listed on the ARTG as an approved TGA medicine,” says Knowles.
“Diethylpropion has been on the market for over 50 years and like all S4 medications has a well-documented safety and adverse reaction profile.
“It is prescribed for an on-label indication of short term (maximum three months) weight loss treatment in conjunction with lifestyle considerations after a thorough medical check-up.
“There have been no reported adverse reactions to diethylpropion dispensed by ACP,” he says.
Dr Harvey’s position
However, Dr Harvey is adamant about the danger of the drug, calling for the Pharmacy Board of NSW to discipline Daryll Knowles for breaching the Pharmacy Board of Australia’s Guidelines on compounding of medicines.
He says the Pharmacy Board Guidelines on Compounding of Medicines state:
“A compounded medicine should be prepared only in circumstances where an appropriate commercial product is unavailable” (section 2).
“First of all, following a review of the risks and benefits of diethylpropion and related anorectic drugs by the European Committee for Proprietary Medicinal Products (CPMP), the European Commission decided that the drugs’ licences should be withdrawn. Licences were withdrawn in the UK on April 9, 2000 and the drug was also withdrawn by the sponsor in Australia, Canada, and the majority of other countries of the world.
“Second, a related weight loss medication, phentermine (Duromine modified release) is registered by the TGA for the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction,” explains Dr Harvey.
He also says patients have reported that medications have arrived by mail from the compounding pharmacy, even though section 15 of the compounding guidelines states that:
“Pharmacists should ensure that every patient or their agent are offered counselling and relevant consumer medicine information on each occasion a compounded medicine is supplied. Written consumer medicines information leaflets are not usually available for compounded medicines.
“However, alternative written information should be provided by the pharmacist to assist in the communication of the following counselling points to facilitate the safe and effective use of the compounded product.”
“ACP has not contravened any Pharmacy Board guidelines as alleged by Ken Harvey and are currently considering legal avenues for his slanderous statements,” he says.
Connection to MWI
In addition to pursuing ACP, Dr Harvey has submitted a complaint to both AHPRA and the ACCC about the Medical Weightloss Institute – the medical centre behind the diethylpropion prescription – and its owner Geoff Jowett.
He alleges the institute is “misleading, deceptive and exploitative, lacks an evidence base and preys on a vulnerable population, the overweight and obese,” and calls for the NSW HCCC to permanently prohibit Jowett from providing health services.
Geoff Jowett has responded to criticism of his weight loss clinic with shock.
“It surprises me that we still often get asked, ‘Is this a scam?’
“I’ve been helping people lose weight for 20 years. And I’m very proud to say that everything I’ve done in the fitness and weight loss space has been a success and has helped a lot of people.
“But nothing is as good as [the Medical Weightloss Institute]. Nothing as good as these treatments, these eating plans, the coaches, the motivational people in the office… this is anything but a scam,” says Jowett, who has a background in sports science.
“And the great thing is, it’s medical,” he continues. “Medical doctors are involved here – not just me, not just nutritionists. Medical doctors and quite a few of them, who are proud to be associated with the Medical Weightloss Institute.”
Dr Harvey is calling for all doctors associated with the institute to be deregistered by AHPRA, for “writing scripts for a cocktail of complementary and prescription drugs without seeing or examining the patient”.
In addition, he points out that one of the main doctors at the institute has had a number of conditions placed on his practice by the Medical Council of NSW and AHPRA.
This article has been edited to add further comment from Dr Harvey.