The compounder, the doctor and the institute

A compounding pharmacy has been criticised for dispensing a withdrawn substance… but is the reproval warranted?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He mentions a patient that came forward having been prescribed a “cocktail of drugs including diethylpropion; a drug withdrawn from the Australian market by the TGA because of serious adverse effects, including irregular heartbeat, high blood pressure, seizures, nervousness, and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.”

Knowles disagrees.

“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.

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  1. Jarrod McMaugh

    I’m always very interested in Dr Harvey’s process and so far I’ve always supported the actions he has taken.

    In this case, though, I’m not sure that the complaint is correct.

    There is a difference between the approval of a product with TGA, and an ingredient in the SUSMP.

    In addition, the pharmacy in question has an import licence approved by TGA for this product the be compounded and dispensed for exactly the purpose for which it is being used.

    So long as there are not state laws that are being breached (and there are none I can find that would be the case) then I don’t think the complaint is valid.

    That being said, there are two comments by Mr Knowles has made that I would contest:

    1) Dr Harvey isn’t a serial complainant, in that this description would imply vexatious complaints. I value that there is someone willing to hold TGA and similar bodies to their mandates…. If only there were more

    2) the assertion that all schedule 4 medications have good evidence is a little naive – assuming positive evidence for a scheduled product is as bad as assuming that CAM has no evidence by virtue of that label.

    Scheduling (or lack of scheduling) is not a surrogate to knowing the facts about a medication.

  2. Jignesh Patel

    it’s too much Dr.Harvey this time.

  3. Professor John B Dixon

    Dr Harvey is spot on. Managing weight over the phone, not examining the patient, neither the doctor nor the pharmacist talking to the patient about side-effects. No follow-up arrangements with the doctor.

    There is also no hint that the MWI provides individualised care for behavioural programs, and does not use TGA approved and available weight loss medications. There is no evidence that the average patient can lose 30 kg on any behavioural of drug program. IT IS A SCAM and totally inappropriate practice of medicine.

    Poor medicine, ripping off vulnerable Australians, cosy relationships between doctor managing patients from anywhere in Australia over the phone and compounding pharmacists providing potentially dangerous medications to patients with contraindications is inappropriate and must be stopped.

    AJP should support highest standards of ethical and quality care. Not attack messengers uncovering health scams and poor health care.

    • Jarrod McMaugh

      G’Day Professor Dixon

      That’s different from what was covered in this article

      Dr Harvey’s complaint (at least as reported here) is regarding the TGA regulations on the supply of this medication in a compounded form after importation.

      Yet it would seem that the compounder has the appropriate approvals to do this.

      If there is a CLINICAL issue, then that’s different from the issue as presented here, which seems to be a REGULATORY issue.

  4. Trish

    If the complaint is found to be unwarranted, can the pharmacy and prescribing doctor sue Dr Harvey for defamation?

  5. Ron Batagol

    Obviously I’m not in a positon to comment on the facts surrounding the allegation and the reported comments of the compounder.

    However, I agree with Jarrod’s comments about Dr. Harvey and I also I value that through his work, Ken Harvey has been able to hold TGA and similar bodies to their mandates, and, indeed, he has
    had a proven track record over the years of positive outcomes in his challenges to what
    he has seen as various claims made for a wide range of marketed medications,
    including various complementary medicines.

    Oh, and by the way, just this year,for his efforts, Ken Harvey was awarded the Australian and New Zealand Association 2016 ANZAAS Medal for the Advancement of Science!

    As to the facts, claims and counter-claims, I’m sure that will all play out over time
    through the usual processes. Like most pharmacists, I will be most interested to read, in due course, of the outcome.

    Ron Batagol

  6. Beverley F Snell

    Diethylpropion is an S4 medication which may be prescribed for specified indications. S4 medicines may only be obtained by prescription from an authorised medical practitioner and dispensed by an authorised pharmacist on receipt of a genuine prescription.
    Prescribing any S4 medication over the phone, for a patient not known by the prescriber and without even seeing (or examining) the patient should be absolutely unacceptable. In addition, provision to a patient by a pharmacist who also has no contact with the patient, provides no written information nor possibility for follow-up must be outside the legal requirements for prescribing and for dispensing S4 medications. 

    Managing weight loss involves individual ongoing care and support for life-style modifications as well as for monitoring the effects of medication. I believe this ‘long distance medical practice’ needs serious investigation. When the legal requirements for prescribing and dispensing medicines were enActed this sort of practice did not exist. The legislation needs to be brought up to date to cover and control practices adequately. Dr Harvey must be applauded for bringing this need to notice.

  7. Jarrod McMaugh

    Thanks Ken, I’m going to make a response on there.

    To reiterate, my comments are based around the legalities, not the clinical appropriateness.

    I have made my fare share of complaints about inappropriate supply (including from compounding pharmacies), and I understand the difficulties in finding the appropriate legal avenue for making such a complaint.

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