A pharmacist has been told not to compound or dispense drugs including peptides, HGH or Growth Hormone Secretagogues until his case is heard
The Health Care Complaints Commission had applied for the orders, which were considered at a hearing at the Civil and Administrative Tribunal NSW .
The Tribunal noted that a five-day hearing had been held in December 2020 regarding the matter, at which point the Health Care Complaints Commission asked for a condition be placed on the pharmacist’s registration.
This would prohibit him from supplying, dispensing or compounding any peptide, including BPC-157, CJC-1295, or Ipamorelin; Human Growth Hormone; or Growth Hormone Secretagogues, at any pharmacy in which he had a financial interest.
A further two days of hearing are listed for late March 2021, the Tribunal noted.
The pharmacist had owned a NSW pharmacy, offering compounding services, since 2001.
In February 2016, a patient attended the “Sydney Clinic” and received a vitamin infusion of “Myer’s Cocktail” as well as a Glutathione injection which had been compounded and dispensed by the pharmacist.
In a previous related article concerning a medical practitioner, a “Myer’s Cockail” was described as “a combination of magnesium, calcium, various B vitamins and vitamin C”.
The patient was later hospitalised with suspected endotoxaemia, though the Tribunal notes that there was no suggestion that the pharmacist was responsible for the condition which led to the patient’s admission.
Following the admission the Pharmaceutical Regulatory Unit investigated the Sydney Clinic, and in turn, several NSW-based compounding pharmacies, including that owned by the pharmacist in question.
In March 2017, PRU director Bruce Battye provided the Commission with a copy of its report into the pharmacist.
In a covering letter to the report, Mr Battye wrote that the pharmacy “dispensed at least 1,432 prescriptions for the following peptides, none being approved for human therapeutic use, either in isolation or in combination, during the period 1 June 2014 to 20 May 2016: SARM – S22; AOD9604; LGD-4033; CJC-1295; Ipamorelin; GHRP-6; GHRP-2; IGF-1 LR3”.
Mr Battye said it was “unclear what recognised science-based evidence” supported the pharmacist’s professional judgement to compound and dispense these peptides “in accord with recognised therapeutic standards of what is appropriate in the circumstances” contrary to regulations and guidelines.
The pharmacist prepared and dispensed compounded peptide preparations on “numerous” occasions, Mr Battye wrote, “when the safety and efficacy of such products for human therapeutic use has not been established, including the long-term safety of such substances”.
He said the pharmacist dispensed a large number of invalid prescriptions for human growth hormone, peptides, anabolic steroids and ketamine, and failed to ensure that a periodical inventory of Schedule 8 drugs was undertaken as required.
Mr Battye also wrote that the pharmacist had “obtained peptide raw materials, not approved for human therapeutic use, sourced from overseas, without the necessary evidence to demonstrate that the substances complied with the requirements of pharmacopeial standards”.
The pharmacist “Compounded human growth hormone and anabolic steroids when appropriate commercial products, registered on the Australian Register of Therapeutic Goods, where the quality, safety and efficacy of such products had been assessed by the Therapeutic Goods Administration and manufactured by licensed manufacturers to ensure quality standards of the commercial products were readily available,” he said.
Lastly, Mr Battye wrote that the pharmacist supplied “greatly excessive” quantities of peptide preparations to a doctor and clinic, excessive quantities of anabolic steroids and peptides to a person in Queensland and excessive quantities of compounded ketamine to another doctor, who has had his name removed from the AHPRA register of practitioners.
Mr Battye recommended immediate consideration and after the Council received the report, it imposed conditions on the pharmacist’s registration.
This included that he not dispense, supply or compound any products containing ketamine, and not allow the supply, dispensing or compounding of any products containing ketamine in any pharmacy in which he had a financial interest.
He had, in April 2016, had conditions imposed on his registration prohibiting him from allowing the compounding of products containing glutathione and nutrient “Myer’s Cocktail” mixtures at any pharmacy in which he had a pecuniary interest.
At the latest hearing, the Council alleged unsatisfactory professional conduct and professional misconduct.
The pharmacist admitted some particulars of the conduct, but denied that these constituted either unsatisfactory professional conduct or professional misconduct.
The College alleged that he had inappropriately compounded and dispensed the “Myer’s Cocktail” mixtures for another pharmacist, who was then provisionally registered and who operated two “wellness clinics”.
This pharmacist was also the subject of regulatory action over conduct relating to the Wellness Clinics, as well as other matters.
The Commission alleged that the pharmacist in question inappropriately compounded and dispensed 59 scripts for parenteral products to 17 patients in circumstances where he knew, or ought to have known, that they would then be administered to persons other than the person to whom they were prescribed.
It alleged that he also inappropriately compounded and dispensed 37 scripts based on orders from the other pharmacist when he had no contact with the prescribers or the patients, when the volume of the compounded products was inappropriate, and when the supply of glutathione was not in a quantity or for a purpose in line with therapeutic guidelines.
It alleged that he inappropriately compounded and dispensed medicines including HGH and peptides, including CJC-1296, knowing these were liable to be abused, not in line with therapeutic standards, having failed to check the patient’s history and failed to keep appropriate notes.
More complaints relate to inappropriate compounding and dispensing of peptides, CJC and Growth Hormone Releasing Peptides-6 (GHRP-6), ketamine and HGH.
The allegations have not been proven and are set to be examined at the upcoming March hearing.
The hearing considered issues including whether the safety, quality and efficacy of some of the drugs concerned has been properly established, and an endocrinologist provided evidence, saying that in his opinion they had not.
The pharmacist gave evidence that the drugs were only compounded and dispensed on prescription, and consistent with the pharmacy’s procedure since mid-2016, scripts would only be dispensed there if they had been issued by prescribers who signed a third-party agreement.
This agreement required prescribers to certify that they consider the prescribed medication to be “therapeutically advantageous for the patient following a risk/benefit analysis”.
The pharmacist said few medical practitioners now prescribe BPC-157, and the pharmacy dispenses only around six scripts a week for the medicine, mostly from one prescriber, and mostly for ligament tendon damage. He said that with no anabolic effect it is not open to abuse.
He also said most scripts for CJC-1295 and Ipamorelin are prescribed together and the pharmacy only dispenses the drugs if the prescribing practitioner indicates they have been prescribed for weight loss, lack of energy or injury repair.
The pharmacy had stopped dispensing HGH in 2016 and the pharmacist was unsure how often GHRP-2 and GHRP-6 are dispensed – perhaps twice a year, he said.
He said he was concerned that if the pharmacy could not dispense the medicines, some patients might attempt to access them elsewhere, including from overseas sources.
The Tribunal decided that at this time, “a cautious approach should be taken” given it was yet to decide whether the complaint against the pharmacist had been proven.
It said that if the pharmacist continued to dispense the medicines until the next hearing, there was risk to the health and safety of the public.
The Tribunal decided to make the order prohibiting the pharmacist from dispensing the drugs in question at any pharmacy in which he has a financial interest.