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[2011] VCAT 2085
Victorian Civil and Administrative Tribunal
2011-11-03
Original judgment source is linked above.
The seriousness of the incident, which may involve the possession of commercial quantities of a Schedule 4 drug that is known to be abused and also the possession of unlicensed firearms, caused the incident to be referred for consideration that immediate action be taken to protect public health and safety.
The Board is proposing to take immediate action in relation to your registration as a registered pharmacist on the basis of the above concerns about your alleged conduct.
In circumstances where you are prepared to make the undertaking in the form attached you are invited to:
However, in circumstances where you are not prepared to make the undertaking, you are invited to:
The seriousness of the notification is the basis for the short timeframe provided for a response in circumstances where you are not prepared to provide an undertaking to the Board as proposed. Your written submission will be forwarded to the IAC for consideration.
The purpose of providing a written submission to the IAC and/or making verbal submissions in response to this show cause notice is to give you an opportunity to:
- address specifically any concerns raised in the notification (as described above) and provide the IAC with evidence, where it exists, to confirm your suitability to practise; and
- provide evidence to the IAC as to why you do not pose a serious risk to persons in your practice as a health practitioner and why immediate action is not necessary.
Evidence in possession of investigators including electronic and physical surveillance which links Oueida to the Farmacologica Compounding Pharmacy and Ali and Riza Kozanoglu. This evidence demonstrates a pattern of behaviour inconsistent with normal customer relationships and is heightened at the time of the various importations of DXM. Furthermore it can be reasonably inferred from other evidence of similar nature that Oueida was providing Weightman with DXM around the time of the Farmacologica importations.
13. A number of items were seized from Farmacologica Compounding Pharmacy including, but not limited to: 1 x sawn off shotgun with ammunition located in a rear storage area, 2 x handguns with ammunition located in a large safe which is used for storage of Schedule 8 poisons and Schedule 11 drugs of dependence, approximately 25 kilograms of DXM, numerous empty drums labelled as containing DXM, all computer storage equipment, a customer file relating to Mohammed Oueida, invoices relating to the purchase and receipt of DXM shipments, two flick knives, $16,900 cash secreted in silver bags in a box next to a large safe with documentation listing various figures of interest to investigators. A number of empty barrels labelled as containing DXM were located at the home address in Templestowe.
14. In total the packaging located accounted for all known DXM imports to the pharmacy apart from 3 x 25 kilogram blue drums imported on 3 August 2010. Of the 350.5 kilograms of DXM imported by Farmacologica Compounding Pharmacy in the past 12 months, approximately 25 kilograms of DXM is all that has been located.
15. Both Ali and Riza Kozanoglu were arrested and interviewed in relation to trafficking methorphan, the located firearms and cash. Ali made partial no comment to questions regarding DXM and supplying DXM to Oueida. Riza made a full no comment interview. Both have been released pending further investigation and evaluation of computer records. It is the belief of investigators that charges will be laid against both Ali and Riza Kozanoglu in this matter once the examination of the records is completed.
Specifically, the IAC determined to impose a condition on Mr Kozanoglu's registration that:
2. Mr Kozanoglu not hold the keys to any pharmacy; and
The IAC's decision was based on the information provided by Martin Robertson of Purana Task Force in his verbal notification and Dale Lapham of Purana Task Force in his written notification on 24 June 2011, and the information contained in your verbal submissions.
In particular, the IAC considered the evidence that:
(i) the importation of this quantity DXM alone is not a concern; and
(ii) your inability to properly account for the DXM is not a serious risk to the public.
(i) because of the registered health practitioner's conduct, performance or health, the practitioner poses a serious risk to persons; and
(ii) it is necessary to take immediate action to protect public health or safety.
Professional misconduct, of a registered health practitioner, includes -
(c) conduct of the practitioner, whether occurring in connection with the practise of the health practitioner's profession or not, that is inconsistent with the practitioner being a fit and proper person to hold registration in the profession.
The therapeutic purpose of DXM is for cough suppression. It has an antitussive effect similar to that of codeine and in this regard is considered to be stronger than an equivalent dose of codeine. It also has some use in pain relief in combination with opiod medication, in decreasing the amount of opiods needed. This indication is what is called 'off label use' and may be prescribed by a medical practitioner, on an individual basis.
If DXM is prescribed, for pain relief, a prescriber would try to establish a therapeutic dose that would be effective and also safe. This is because it would be an off label use of a medicine. Off label use refers to the prescribing of a registered (on the Australian Register of Therapeutic Goods (ARTG) register) for a use that is not included or is disclaimed in the product information. DXM has a low therapeutic index which means that the dosages used would not normally be much increased. Hence a dosage of no more than 120 milligrams a day for an adult would normally be considered.
Under the Drugs, Poisons and Controlled Substances Regulations 2006 there are provisions for the supply, storage and record-keeping. There is also a general requirement as to sale by wholesale that should prohibit resale in this matter.
The DXM used for pain relief, if this is the case, will have prescriptions that cover those dispensings. The guide to these regulations 2006, as issued September 2010, summarises these regulations. For this use of DXM, the appropriate sections include regulations 16 (pharmacist certification); regulation 29 (date of recording); division 4 (storage); division 5 records - regulations 38 and 39, which also includes destruction and disposal.
For the use DXM as a cough suppressant the onus would be on the pharmacist to prove that the product thus compounded would not be an S4. Hence the record-keeping, it may be posited, should be more stringent. The guide is attached.
If there was a mistake in the first large quantity received (150 kilograms) there would be an expectation that there would not be any re-ordering of that product.
For the prescription pain pathway, as noted previously, it could be expected that there would be a hesitancy by any medical practitioner to prescribe any unusual strength of this product. It is also only indicated for acute, most post-operative use. Here the quantity that may be used would be well below 100 grams a month.
Hence I cannot see any justification for importing or (sic) 350 kilograms in a 12 month period.
Just for clarity for the tribunal, what are the obligations of a pharmacist? What do they have to record regarding that schedule 4 drug when it's dispensed?When it's dispensed as a schedule 4, it needs the name and address of the patient. It needs the name of the practitioner that prescribed it. It needs the name of the chemical or the product, the dosing requirements, and the quantity.
And if it's dispensed as a schedule 2, that is, it has been - the DXM has been compounded with other medications or other substances - what are the recording requirements for the dispensing of that medication?Well, since it's - it can be compounded and - call it "dispensed". And it's then - the minute - the minute it's dispensed and the patient has it in their possession, it becomes an S2 at that stage. Therefore, the - it's the same obligations as to recording and - in fact, if not more.
But there wouldn't be a prescription in that case?Correct.
So is it right to say that for an S2 compounded medication, including DXM, the pharmacist is required to record the name of the customer or patient to whom it has been provided?Yes - on every occasion.
The address of the customer ?On every occasion - yes.
Unless permitted otherwise by the Board in writing or, until further order, the following conditions are imposed upon the applicant's registration as a pharmacist:
[12] The right of review is found in s 199 of the Act.
[13] See witness statement at Tribunal Book pages 101-115 and Transcript pages 19-50.
Kozanoglu
The Pharmacy Board of Australia