Conditions to stay on compounder’s registration


A NSW pharmacist who shot into the media spotlight for his connection to the Medical WeightLoss Institute has had his dispensing abilities restricted

CORRECTION: This article was originally published under the headline “Compounder loses appeal against registration conditions”, which contained a factual error.

The article has now been corrected to reflect the fact that the Tribunal refused the application of Mr Knowles for a stay on the conditions imposed pending the outcome of Mr Knowles’ appeal. The appeal remains on foot, and Mr Knowles says he will continue to prosecute his appeal on the grounds that his actions are for the benefit of the public.

The remainder of the article text has not been altered. AJP apologises for the error.

Mr Darryl Knowles, pharmacist and owner of Australian Custom Pharmaceuticals (ACP), has had an application to stay conditions imposed on his registration refused.

In January, a decision was made by the Pharmacy Council of NSW to impose conditions on his practice. Mr Knowles had requested that the conditions be stayed pending the outcome of his appeal against the decision.

At the time of the decision, the council had ruled that Mr Knowles’ practice in relation to the dispensing of peptides was “not within accepted standards nor compliant with the Pharmacy Board of Australia’s Guidelines on Compounding Medicines”.

As a result of the findings, Mr Knowles – who has been a registered pharmacist since 1982 – had the following conditions imposed on his registration:

  1. Not to allow the compounding, in any pharmacy business in which you have a financial interest, of peptides, proteins or Selective Androgen Receptor Modulators (SARMS) for human use, except in circumstances where they are dispense in accordance with the agreed protocol of a registered clinical trial which has ethics approval.
  2. Within four weeks of receiving written ethics approval to participate in a registered clinical trial before compounding the above drugs, to provide the Pharmacy Council with a copy of the ethics approval.
  3. By the second of each calendar month to provide the Pharmacy Council with a copy of all invoices relating to the purchase of peptides, proteins or SARMS materials in the previous month.
  4. By the second of each calendar month to provide the Pharmacy Council with a copy of the dispensing history relating to the supply of peptides, proteins and SARMs in the previous calendar month, which have been compounded in accordance with condition one.

At the August hearing, Mr Knowles sought a stay on the conditions placed on his registration, arguing that they were of an “oppressive and wide-ranging nature”, and that his customers were suffering “severe difficulties” in having their prescriptions filled.

He stated that due to the conditions, he is unable to fill prescriptions for a number of items that are not the subject of any inquiry leading to the imposition of conditions by the Council, and listed prescription items including rice protein powder, melatonin, oxytocin, follistatin and ACE inhibitors.

However the council found that “the interests of justice require that the conditions remain in place and that the applicant’s request for a stay of the decision be refused”.

“In my view, the protection of the health and safety of the public must be the paramount consideration,” said a principal member of the council who handed down the decision on Monday.

A representative for Mr Knowles says his client will continue to prosecute his appeal on the grounds that his actions are for the benefit of the public.

Mr Knowles had been in the news last year when Dr Ken Harvey, from Monash University’s School of Public Health, had notified the AJP that he has submitted a complaint to AHPRA and the HCCC regarding ACP and its dispensing of the appetite suppressant, diethylpropion.

Diethylpropion had been prescribed by a medical practitioner working for the Medical WeightLoss Institute (MWI), and dispensed by Mr Knowles’ company ACP.

Dr Harvey noted that diethylpropion had been 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”.

At the time, Mr Knowles told AJP that he that ACP was 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,” said Knowles.

“So far Ken Harvey’s allegations are false and have no evidence of patient harm to back them up. Diethylpropion was not taken off the market by the TGA for side effect related issues. It was withdrawn voluntarily by its sponsor Sanofi Aventis for economic reasons.”

However Dr Harvey claimed that through the prescription of such drugs, MWI, the prescribing doctor and the compounding pharmacist were “putting patients at serious risk of adverse effects, as is the failure of the regulators to curtail these activities to-date.”

He had followed this up with a call for the Pharmacy Board of NSW to discipline Mr Knowles for breaching the Pharmacy Board of Australia’s Guidelines on compounding of medicines.

Earlier this year, the MWI ceased trading on 9 February 2017 and about the same time, the Health Care Complaints Commission (HCCC) had issued a public warning about the institute.

The HCCC investigation found that the medication prescribed by MWI doctors was sent to clients in the mail by a compounding pharmacy without the provision of counselling and other relevant medicine information required to facilitate the safe and effective use of the compounded product.

“A particularly vulnerable cohort of health consumers was convinced to part with large sums of money for pharmaceutical preparations that may have serious contraindications and side effects and for which there is no credible evidence of efficacy for weight loss,” said the HCCC in its warning.

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5 Comments

  1. karina
    28/09/2017

    Should Dr Harvey really be discussing the contents of a notification with anyone from the media?

    • It takes the regulators a long time to make public warnings &/or institute legal action about such matters. Meanwhile consumer detriment continues. The media (and whistleblowers) play a crucial role in warning the public about such scams, see: Case study (Sept 8, 2018 Seminar): AMI begat MWI begat AMHC…http://www.medreach.com.au/?p=2160

      • karina
        03/10/2017

        I dont disagree with that and I would go further and say people going public is what makes a regulator act in some instances. HOWEVER, I would be at least consulting a lawyer in regards to my own boundaries if it was something I was considering to do on a regular basis. There would be case law on how good faith sits with notifiers that decide to go public before a case is finalised. A good lawyer can provide guidance on where the limitations are and how to achieve the aim without destroying yourself in the process.

        • Indeed, Maurice Blackburn Lawyers (their Social Justice Practice) have kindly given advice and represented me pro bono when legal action has eventuated (SensaSlim) and been threatened (Undoit & Medical Weight Loss Institute).

          • karina
            03/10/2017

            That certainly sounds as if you have defamation covered (an area that is notoriously difficult to win in according to lawyers I have spoken to). In your situation I would be more concerned about the regulator teaming up with the subject of the notification so subsequent legal action can then be taken against you. Something along the lines of this attachment is what I am thinking may be the next move. (If the attachment doesnt go through I am referring to regulators labelling people as unreasonable complainants) http://www.ombudsman.gov.au/__data/assets/pdf_file/0022/35617/GL_Unreasonable-Complainant-Conduct-Manual-2012_LR.pdf

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