15 August 2018

Fake medications and professional discipline

Last year I noted controversy over fake pharmaceuticals in Sydney. It is of interest regarding the identification of product authenticity and professional regulation.

In Attia v Health Care Complaints Commission [2018] NSWCATOD 131 the Tribunal yesterday stated
The applicant having graduated with a Bachelor of Pharmacy from the University of Sydney in 1998 was granted provisional registration as a pharmacist in New South Wales on 7 October, 1998 and full registration on 10 October, 1999. At the time of the occurrence of the events which led up to the cancellation of the applicant’s registration he owned a number of pharmacies. He also operated a pharmacy wholesale business under the trading name Hillmear Trading Pty Limited (“Hillmear”). Hillmear had a licence to wholesale pharmaceutical goods under the Poisons and Therapeutic Goods Regulation, being goods which in general terms were restricted substances and required a prescription from a medical practitioner before they could be sold to the public. One such restricted substance is Viagra, which is used to treat erectile dysfunction, and is also used in the treatment of pulmonary arterial hypertension. This latter use has application for paediatric patients. A condition of the wholesaler licence was that restricted substances could only be obtained from the holder of a licence or authority issued under a Commonwealth or State law. 
Hillmear acquired a quantity of Viagra from a Mr Sajay Rai in March 2010. At that time the applicant had had previous dealings with Mr Rai, in supplying by way of wholesale “general products” such as confectionery and coffee and over-the-counter medication such as Panadol. He thought that Mr Rai “dealt in sort of oversupply and end lines and that type of nature.” At that time the applicant was dealing with about half a dozen licensed wholesalers all of whom except for Mr Rai would send a product list from which purchases could be made. However, Mr Rai operated in a different manner. He did not send a product list, and he would call in from time to time offering product which he carried with him in a van. The applicant said that he assumed that Mr Rai was a TGA licensed wholesaler because he had offered to sell him a variety of products some of which were scheduled and some unscheduled. These included cold and flu products, Panadol, Nurofen and Nicabate. 
In late February 2010 Mr Rai came to the applicant and offered to sell him some Viagra at a price which was less than could be obtained directly from the manufacturer, Pfizer. Mr Rai left one or two samples with him. The applicant said he did not test the samples but did check their expiry date, batch number and other details. He could not recollect seeing anything different from the normal product. The applicant did not contact Pfizer to ascertain whether the product was genuine, and did not conduct any tests himself. He purchased 55 units of Viagra from Mr Rai on 3 March, 2010 and a further 1000 units on 9 March, 2010. His purchase price was $54.27 a unit, whereas the “normal” price was between $60 and $63. Those products were on-sold to other wholesalers. 
As it transpired, at least some of the Viagra which had been purchased from Mr Rai was counterfeit. A number of complaints had been made by customers of retail pharmacies that the product “did not work”, and a pharmacist at the Sydney Children’s Hospital had alerted Pfizer to the fact that these tablets were of a different consistency to the normal product when mixing them to be given to children. Pfizer immediately recalled its product and instituted an investigation, as did the TGA Regulatory Compliance Unit. Enquiries were later conducted of the applicant by the respondent. 
When initially questioned by TGA officers, the applicant informed them that he had purchased 55 units of Viagra on 3 March, 2010 at a cost of $2985.71 and 1000 units of Viagra together with a shipment of shampoo also in early March for a total cost of $83,583.50. He produced a copy of an invoice relating to the first purchase issued in the name of Tamer Distributors Pty Limited. At the bottom of that invoice there was handwritten the name “Michael”, a phone number and “cheque 1612”. It was later discovered that that company did not exist, the phone number was no longer current and that the cheque 1612 had been paid into the bank account of a pharmacist employee of the applicant. At a later time the applicant told investigators that he may have paid for the first invoice in cash but had written cheque number 1612 in order to reconcile his company’s books of account. His explanation given in evidence in the original proceedings before the Tribunal was that he had been untruthful in claiming that he had paid for the first purchase by cheque because he was concerned “about the transactional aspects of the deal.” 
When interviewed on 16 June 2010 the applicant told the investigators that the paperwork for the second purchase was not on his premises and undertook to forward it to them. Upon receipt of a further request for that invoice the applicant informed the TGA officers on 21 June, 2010 that payment for the first invoice had been paid into an account belonging to CD3 Investments. On 24 June, 2010 the applicant informed the TGA investigators that he had located the invoice for the second purchase which had been issued by Tamer Distributors for 1000 units of Viagra at a cost of $57,000 and for shampoo at a cost of $26,538.66, being a total cost of $83,538.66. He said he had been instructed to pay the second purchase by money transfer to a nominated Commonwealth Bank account which he understood belonged to CD3 Investments. It was later ascertained that that entity did not exist. An investigator retained by Pfizer noted that the two invoices were “completely different”. The second invoice was computer-generated on A4 paper and the other was handwritten on a manual invoice. 
There were also discrepancies concerning payments made by the applicant’s company for the second invoice in the sum of $83,583.50 and an amount which had been deposited into Mr Rai’s account of $85,538. The applicant was not able to offer any explanation for this discrepancy. 
In addition to the above payments, investigators discovered that Hillmear had made a further payment to Mr Rai by bank transfer in June 2010 in the sum of $86,000. When asked why he had not disclosed this payment, the applicant replied that he had not been questioned about it. His explanation was that he had put in a further order for Viagra, but had cancelled that order when approached by TGA investigators. He said that Mr Rai had not repaid that amount. 
In the course of its decision, the Tribunal made the following factual findings;
(1) On two occasions in 2010 the applicant purchased a substance purporting to be Viagra tablets by wholesale from a person without a wholesaler licence, namely Mr Rai, in breach of a condition of his wholesale licence. So much was conceded by him for the purpose of those proceedings. 
(2) The Viagra was counterfeit, the applicant failed to ensure that it was genuine by contacting Pfizer to confirm the batch number and expiry date, the price offered by Mr Rai was significantly below the market rate, and this was the first occasion that Mr Rai had offered to supply a restricted substance 
(3) The applicant had given untruthful accounts to the investigators, particularly in describing the manner in which payment for the first delivery had been made. He had delayed informing the investigators of the identity of Mr Rai, and failed to refer to the last payment of $86,000 in June 2010 until he was confronted with Mr Rai’s bank records. 
(4) In his evidence before the Tribunal the applicant claimed that he had not looked inside the sample boxes of Viagra left by Mr Rai. This evidence was rejected because it was inconsistent with information given by him to the respondent’s investigators in February 2015 of having looked at the information leaflet and observing that the tablets were stamped. 
(5) In all the circumstances, the applicant should have known that the Viagra being supplied was not genuine. (It should be noted that the Tribunal specifically eschewed any finding that the applicant had actual knowledge that the product was not genuine). 
(6) The applicant provided false or misleading information to the TGA throughout the course of its investigation. He took 10 days to supply the TGA with the name and contact details of Mr Rai, he claimed the first payment was made by cheque and did not disclose the $86,000 bank transfer made in June 2010. 
(7) The invoice for the first payment was false because Tamer Distribution did not exist, no payment was made by cheque and cheque number 1612 was an incorrect number. A reference to a person named Michael and a telephone number were also incorrect. The applicant had sought to conceal “critical details and the true nature of the transaction” and thus mislead the investigators, as had been conceded by him in the course of giving evidence.
Based on the factual findings made and having regard to the totality of the circumstances, the Tribunal concluded that the conduct of the applicant fell significantly below the relevant standard being that of a pharmacist of an equivalent level of training or experience of the applicant. It concluded that he was guilty of professional misconduct.
In its latest decision the Tribunal considered the appeal by Mr Attia regarding his suspension as a health professional. After a discussion of community expectations, examination of references and assessment of Attia's acknowledgment of wrongdoing the Tribunal continued the suspension.