A compounding pharmacy has been criticised for dispensing a withdrawn substance… but is the reproval warranted?

The compounder, the doctor and the institute

In response to the defence offered in this AJP article by compounding pharmacist Daryll Knowles and MWI chief spruiker Geoff Jowett (and concerns expressed by Jarrod McMaugh and Jignesh Patel) I provide the following additional information.

The Pharmacy Board Guidelines on Compounding of Medicines state:

S2 “A compounded medicine should be prepared only in circumstances where an appropriate commercial product is unavailable…..The compounding of a medicine (whether prescribed or not) that would be a close formulation to an available and suitable commercial product, and would not be likely to produce a different therapeutic outcome to the commercial product, should not take place. In the case that such a medicine has been prescribed, the pharmacist should notify the prescriber that this medicine cannot be compounded under these circumstances.”

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Committee for Proprietary Medicinal Products (CPMP), the European Commission decided that the drugs’ licences should be withdrawn. Licences were withdrawn in the UK on April 9, 2000 and the drug was also withdrawn by the sponsor in Australia, Canada, and the majority of other countries of the world.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.

S15. “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:

  • an explanation of why a compounded product is being supplied, and how this differs to a commercially-available medicine which requires the manufacturer to meet the requirements of the TGA for addition of medicines to the Australian Register of Therapeutic Goods;
  • instructions on the correct use of the product;
  • the appropriate storage requirements and expiry date of the product;
  • the side-effect profile of the product, any contraindications and any other specific counselling points which would normally be contained in a written consumer medicines information leaflet, and
  • how to report adverse events”.

Patients have reported both to me and Prof Dixon that the medications arrived by mail from the compounding pharmacy and no written information was provided about the dot points above. Hence the AHPRA notification of compounding pharmacist Daryll Knowles.

In the AJP article Mr Knowles asserted that:

  • Diethylpropion was associated with less reported adverse reactions than celecoxib; however given the vast difference in prescribing rates that defence is meaningless.
  • The TGA had provided him with an permit to import diethylpropion. Given that the TGA have a track record of bizarre decision making that is also an unsatisfactory justification.
  • There have been no reported adverse reactions to diethylpropion dispensed by ACP. Given that ACP provides no information to patients about such matters and the doctors involved do not follow up the patients or adequately respond to their concerns that is hardly surprising.
  • He is considering legal avenues for his slanderous statements. As have others in the past.

With respect to the prescribers at the Medical WeightLoss Institute (MWI), Dr Thomas Goyer the initial doctor involved, has had unfavourable comments made about him by the Judge who heard the AMI case concerning the promotion and supply of medications for erectile dysfunction, with whom Dr Goyer was also involved. He has also had a number of conditions placed on his practice by the Medical Council of NSW &/or AHPRA.

The MWI modus operandi appears based on that of the AMI; MWI recruit vulnerable patients by placing prominent advertisements making extravagant claims; they order a large number of pathology tests of dubious relevance (at taxpayers’ expense) to give an appearance of authenticity; their doctors write ‘scripts for a cocktail of complementary and prescription drugs without seeing or examining the patients, and a closely related compounding pharmacy dispenses the drugs and fails to provide patients with the information expected by the Pharmacy Board’s Compounding Guidelines.

I suggest readers of AJP watch both Dr Goyer’s and Mr Geoff Jowett’s promotional videos, review the additional information below, and then make up their own mind about MWI and whether you, as a pharmacist, would dispenses their medication.

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About Dr Ken Harvey

Public Health Physician, Medical activitist
This entry was posted in Medicine policy, Pharmaceutical Promotion, Weight loss and tagged , , , , , , , , , , , , . Bookmark the permalink.

One Response to A compounding pharmacy has been criticised for dispensing a withdrawn substance… but is the reproval warranted?

  1. Jarrod McMaugh says:

    G’Day Dr Harvey

    I’m going to respond to a few of the points you have raised here. While doing so, let me just say thay I am commenting on the legal interpretation of the points you have raised, not the clinical appropriateness of the initial prescribing of the medication, nor the methods used by the Medical WeightLoss Institute in examining a patient or prescribing for them.

    For your comments on Section 2 – you are reading these too broadly. This section in fact justifies the compounding of a product that is scheduled in Australia.

    The regulation is to prevent a compounding pharmacy from formulating a strenght of medication that is commercially available. Compounded medications, but their nature, cannot have the same level of quality control as a commercially manufactured product. To duplicate one is inappropriate.

    That being said, doctors can prescribe a dose of an existing commercially available product in a strength that is not commercially available, and this can validly be compounded. For instance, ramipril 7.5mg could be compounded.

    This part of the regulation cannot be used to say that diethylpropion cannot be compounded since there is no commercial product that is the same.

    While diethylpropion is included in a schedule for human use in the SUSMP, there is no regulation that prevents it from being prescribed and imported for personal use. In addition, with the authority of the TGA (which the pharmacy in question has), this item can be imported and compounded for specific prescriptions.
    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
    The entry for Section 15 is valid. This information can be provided in a conversation with the patient, therefore written information may not be required, but since you are describing a patient you have spoken to, this would have been covered in your discussion with them. Not providing this information would be a breach of the regulation.
    ~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
    The rest of your article I don’t need to comment on as I don’t have any issue with, other than this point:

    “The TGA had provided him with an permit to import diethylpropion. Given that the TGA have a track record of bizarre decision making that is also an unsatisfactory justification.”

    We can’t pick and choose which decisions of the TGA we will respect or not respect. If the TGA has provided a permit to import and compound the item in question, that’s final… they are operating within the law and the regulations.

    Whether there is a clinical justification is still another question, and I doubt we’d disagree on this point. As far as the points I’ve made above, I think they provide an explanation of the legality (if not the appropriateness) of the compounding of diethylpropion.

    As a declaration of conflict – I own a compounding pharmacy. In the time since I have been here (and I believe, since Tenuate was withdrawn in Australia), we have not compounded diethylpropion, but the pharmacy has in the past.

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