‘Contumelious disregard’ for obligations

A pharmacist has been banned from working in any health service after he dispensed medicines to employees and repeatedly supplied off-label drugs

A pharmacist has had his registration cancelled and will not be able to seek a review of the cancellation for four years.

The man had been working as a registered pharmacist in Australia since the late 90s, having moved here from South Africa, where he also practised.

Once he began practising in Australia, at a pharmacy with a significant compounding business in a beachside Sydney suburb, his involvement with compounding pharmacies grew.

In around July 2000, he entered into a partnership with a pharmacist at the Sydney store where he had worked, though both the co-owners divested their ownership of this pharmacy in around May 2016.

In 2013, he and a doctor, identified in a NSW Civil and Administrative Tribunal transcript only as “Doctor A,” created an incorporated business offering patients the opportunity to request scripts for peptides and other compounded drugs.

In 2015, he established a compounding pharmacy which did not have a retail shopfront. Script requests would be reviewed and issued by a doctor, and then forwarded to this pharmacy for compounding and dispensing.

It was at this non-retail business that the Pharmaceutical Regulatory Unit conducted a stock check report in December 2015.

It found a number of drugs could not be accounted for.

These included:

  • 47 packs of 25 oxazepam 30mg tablets (Alepam and Serepax brands);
  • 92 packs of 25 temazepam 10mg tablets (Normison, Temaze and Temtabs brands);
  • 89 packs of 50 diazepam 5mg tablets (Valium and Valpam brands);
  • 25 packs of 30 anastrozole 1mg tablets (Anastrozole AN, Anastrozole RBX and Anastrozole SNZ brands);
  • Two packs of 30 tamoxifen 20mg tablets (Nolvadex-D brand);
  • Two packs of 10 clomiphene 50mg tablets (Clomid brand);
  • Three packs of 60 isotretinoin 10mg capsules (Oratane brand);
  • 48 packs of 60 modafinil 100mg tablets (Modafin and Modafinil SNZ brands);
  • 550 packs of 14 zolpidem 10mg tablets (Zolpidem Synthon and Zolpidem AN brands);
  • 112 packs of 20 paracetamol/codeine 500m0/30mg tablets (Prodeine Forte brand).

The Health Care Complaints Commission alleged that while working at the suburban Sydney pharmacy, he inappropriately dispensed, or permitted to be dispensed, a number of scripts.

The pharmacist admitted most of the particulars in the complaints, but not two.

These included an allegation that he dispensed an excessive quantity of Dehydroepiandrosterone to Patient A, where the script specified 50 15mg capsules but the patient was given 100; and dispensing DHEA to Patient B where the script was dated more than six months before the date on which the supply was requested, and had no specified interval for repeated supply.

An alternative to these particulars was given in the suggestion that the pharmacist allowed another to dispense under these circumstances.

Other particulars admitted by the pharmacist included that he inappropriate dispensed compounded phentermine despite an appropriate commercial product being available, and without confirming with the prescriber that there was a therapeutic purpose and no contraindications.

He also allowed other pharmacists to dispense the weight loss drug, including in excess of the quantity specified by the prescriber, and failing to maintain accurate dispensing records. He also allowed other pharmacists to compound it in excess of the amount on scripts.

He inappropriately dispensed the schedule 4D peptides Ipamorelin, CJC‑1295, CJC‑1295/GHRP‑2, CJC-1295/Ipamorelin, GHRP-6 and the Selective Androgen Modulator Receptor (‘SARM’) SARM S22, and allowed pharmacy employees to do so.

“The peptides were unregistered products and the prescribing was therefore off-label,” the Tribunal noted.

“He failed to verify that there was an individual therapeutic purpose for the dispensing to each patient.

“He failed to document any discussions with Doctor B about the intended use and evidence of efficacy and safety of the peptides.”

The same thing happened with off-label Oxytocin.

“Oxytocin is registered for use in managing labour in women and therefore the prescribing was off-label,” the Tribunal noted.

“He failed to verify that there was an individual therapeutic purpose for the dispensing to each patient.”

In relation to allowing his employees to dispense the drug, “the dispensing was the for purposes of enhancing social confidence and/or sexual function,” the Tribunal noted.

Two patients were given NutropinAq for the purpose of promoting injury repair, and there was no documentation of discussion with the prescriber regarding its intended off-label purpose.

Another patient obtained Testosterone 50mg/ DHEA 30mg/ Mesterelone 40mg without discussion with the prescriber, while yet another was given Sildenafil 100g/ Apomorphine 3mg and the schedule 4D drugs CJC-12951/Ipamorelin 200mcg/mL and SARMS S22.

In this case, the Sildenafil 100g/Apomorphine 3mg was for erectile dysfunction, while the CJC-1295/ Ipamorelin 200mcg/mL (not a registered product) was for stimulating growth hormone levels, muscle growth and fat/weight loss.

“The dispensing of SARMS S22 was for improved lean body mass and increased strength and bone density,” the Tribunal noted.

“He failed to document any discussions with the prescriber about the intended use and evidence of efficacy and safety of the off-label prescribing of those drugs. He failed to document any discussions with the prescriber about the evidence of efficacy and safety of using that combination of drugs.”

Between February 2014 and August 2015 he inappropriately dispensed S4 drugs on scripts from Doctor A to seven patients for various compounds made up of DHEA, Pregnenolone and Tadalafil, without the appropriate discussions with the prescriber, or discussion of the cardiovascular risks with the patients.

He also failed to talk to the patients about the fact that the frequency of dispensing exceeding the directions for use, or about how many capsules they took each day.

He had “maintained an inappropriate business relationship with Doctor C to dispense medicines on prescriptions for his patients in circumstances where the financial gain from that relationship caused a potential conflict of interest with obligations towards those patients”.

At the non-shopfront pharmacy, the pharmacist had engaged in bulk manufacturing and dispensing of drugs which were not for a particular person.

He supplied Prodeine Forte, Modafinil, Temazepam and Serepax to himself from the stocks of the non-shopfront compounding pharmacy, without a script or making records of the supply.

He supplied drugs to eight employee pharmacists, without valid scripts and failing to record supply.

These included variously S4 antibiotics, Zolpidem, Diazepam, Temazepam and Oxazepam, Prodeine Forte, Modafinil and Anastrozole.

He also supplied a drug-dependent patient with up to 450 boxes of Zolpidem without a valid script, or recording the supply.

The pharmacist admitted all this conduct, apart from the allegations around supply of DHEA to Patients A and B.

He said a “computer quirk” meant he might have dispensed a script before those particular dispensings, but his initials could remain if the next person to dispense did not change them.

The Tribunal decided that whether or not he had personally dispensed those drugs, he had failed in his obligations as the owner and proprietor of the pharmacy to ensure such a dispensing did not take place.

The Tribunal heard that the pharmacist’s wrongdoing took place over several years and involved different types of transgressions, while the failures as a proprietor took place over more than two years.

The HCCC submitted that the transgressions at the beachside suburb pharmacy on their own were “serious,” but that given he also ran the non-shopfront compounding pharmacy, there was “patent” risk to the community.

When the non-shopfront pharmacy was investigated, it said, the PRU found the pharmacist “supplied peptides, sometimes multiple different peptides, through a ‘closed loop’ arrangement between himself [the non-shopfront compounder], [the entity with Doctor A, of which he was a director], and a prescribing doctor, Doctor B.

“The advertising of peptides by [the incorporated entity] encouraged the purchasing of large and varied quantities of injectable peptides in order to receive financial discounts or rewards points as part of an apparent inventive scheme,” the PRU’s report stated.

“The online business model enabled individuals, from all parts of Australia and overseas, to purchase peptides where little, if any, clinical intervention by either the prescriber of the pharmacist occurred and where there is no face-to-face interaction between the patient, the prescriber or the pharmacist.”

The HCCC said the pharmacist’s evidence about whether he had considered the possibility of his employees abusing or diverting the medicines to be “nothing short of startling”.

It urged the Tribunal to reject his “attempt to dress up his actions as having some moral basis — protecting his employees from being “exploited” on the ‘dark web’.”

Regarding giving his employees drugs, the HCCC said that “over a period of more than two years the respondent demonstrated contumelious disregard for his obligations as a professional pharmacist by supplying schedule 4 and schedule 4D drugs to himself and to eight employees without a prescription; without recording the supply; and contrary to the Poisons and Therapeutic Goods Act (NSW) 1966, and the PTGR”.

It said that the pharmacist had shown little insight into his behaviour, including having described the Department of Health as undertaking a “witch hunt” against him.

In response to the allegations, the pharmacist said he knew the patients and doctors and released now that he should not have engaged in the off-label dispensing.

He said he recognised supplying his employees with drugs was a “grave error of judgement” which he would not make again.

“He was asked about bulk manufacturing and in response he stated that when manufacturing there has to be sufficient product for the weighing of the product and, therefore, it would not be possible to weigh two milligrams without consolidating it with other manufacturing to reach an acceptable level for weighing and sterilisation,” the Tribunal noted.

It said that each of the breaches was would have been enough on their own to see the pharmacist’s registration cancelled.

“The Tribunal is of the view that the breaches are extremely significant and that the only explanation for the conduct of the practitioner, a practitioner of some 30 years at the time of the breaches, constitutes a flagrant disregard for the obligations of the Respondent and a serious risk to the public,” it said.

It ordered that his registration be cancelled immediately.

The pharmacist will not be permitted to apply to be registered as a pharmacist again for four years.

He is now subject to a prohibition order that he not work in any health service, including online health services.

Previous Pharmacy's Rising Stars
Next Top 10 tips to avoid vaccination errors

NOTICE: It can sometimes take awhile for comment submissions to go through, please be patient.