At an Inquiry commenced on 4 August and concluded on 6 October 2004, the Pharmacy Board of Victoria found Mr Jason Chris Alexander Hosemans guilty of discreditable conduct having found two alleged charges to be proven. Mr Hosemans was alleged to have, at his pharmacy in Ararat, contrary to good pharmaceutical practice, supplied quantities of Nurofen Plus 48 tablets® to a consumer:
• when there was reason to believe that the consumer may have been misusing or abusing the Nurofen Plus®, without his taking all reasonable steps to ensure a therapeutic need existed for that poison, contrary to the provisions of regulation 61 of the Drugs Poisons and Controlled Substances Regulations 1995 (hereinafter called “the DPCS Regulations”); in that he:
• failed to make a record of such supply, similar to the records made for schedule 4 substances, so that he and other pharmacists employed in his pharmacy could monitor the consumer’s use;
• failed to ensure that a therapeutic need existed for the third party(s) for whom the consumer was also purporting to purchase the Nurofen Plus®;
• failed to refer the consumer to their medical practitioner regarding or to confirm their medical condition and or treatment;
• without providing directions for the use of that Schedule 3 Poison, contrary to the provisions of regulation 63(1)(b) of the DPCS Regulations.
The Board made the following statement on imposing the penalty:
“This inquiry involved the sale of excessive quantities of a Pharmacist Only Medicine (S3) namely Nurofen Plus 48 tablets® from your pharmacy in Ararat to one particular consumer over a prolonged period.
The active constituents of Nurofen Plus® are ibuprofen and codeine phosphate. Each Nurofen Plus® tablet contains 200 mg ibuprofen and 12.8 mg. codeine phosphate.
12.8 mg of codeine phosphate is equivalent to 9.42mg of anhydrous codeine, a drug which is known to be subject to abuse.
Nurofen Plus® is labelled with a maximum daily dose of 6 tablets per day, yet account records from your pharmacy showed that between:
(1) 30/10/02 – 28/11/02, a 30 day period, you supplied the consumer with Nurofen Plus® on 14 different occasions making a total of eleven packets of Nurofen Plus® 48 and nine packets of Nurofen Plus® 12 (S2)
(2) 31/12/02 – 2/1/03, a 3 day period – you supplied the same consumer with two packets of Nurofen Plus® 48. Then on 14/1/03 a further packet of 48 tablets was supplied
(3) 3/3/03-11/3/03, a 9 day period, you supplied this consumer with two packets of Nurofen Plus® 48 at the same time on 3 separate occasions, making a total of six packets in nine days.
Evidence was presented that additional purchases may have been obtained and paid for by cash.
The Drugs, Poisons and Controlled Substances Regulations 1995 (the Regulations) set out the legal requirements for pharmacists when supplying a Pharmacist Only Medicine and detailed guidance of how these requirements can be met in practice is provided in the Guide to the Regulations, and in the Pharmacy Board Guidelines for Good Pharmaceutical Practice which is provided to pharmacists annually.
Regulation 61 states, inter alia, that a pharmacist who supplies a Schedule 3 poison other than by wholesale or on prescription must do so only for the therapeutic use of a person after having taken all reasonable steps to ensure a therapeutic need exists for that poison.
Generally, for a pharmacist to “take all reasonable steps to ensure a therapeutic need exists” the following would need to be taken into account:
(a) with respect to the person who requests the supply of, or to whom it is proposed to prescribe or supply the substance -
(i) medical or medication history,
(ii) presenting symptoms or described condition
(iii) past or current drug therapy
(iv) signs of misuse or abuse of medicines/drugs
(b) with respect to the substance requested or proposed to be prescribed or supplied –
(i) its suitability for the treatment of the presenting symptoms or described condition
(ii) its potential for misuse or abuse
The Board Guidelines state that this means not merely agreeing to supply a product on request, but actually being aware of the symptoms of the patient; being satisfied that they are either severe enough to warrant treatment with the substance, or are not so severe as to warrant referral to a medical practitioner; and making a personal professional judgment that the substance is the treatment of choice for the condition of that patient. It is not sufficient merely to rely on the patient requesting the supply of a particular substance.
It means the pharmacist should inform himself/herself of:
• the history
• the range of symptoms
• whether there might be a more serious condition requiring referral
• past or current drug therapy
• contra-indications
• signs of misuse or abuse of medicines/drugs before making the rational selection of an appropriate medication for the condition.
On subsequent requests the emphasis will change more to:
• the duration of the condition and whether referral should now be made
• compliance with the recommended dose regimen of the medication
• the suitability of the medication for continued use.
Evidence was presented that non-pharmacist staff at your pharmacy would receive the request for Nurofen Plus®, obtain minimal information from the consumer, enter the dispensary, select the Nurofen Plus®, label it with the pharmacy identification, show it to the pharmacist who would nod acknowledgment, and then the non-pharmacist staff would supply the Nurofen Plus® to the consumer with minimal advice.
The pharmacist must personally be involved with each transaction, up to at least the point where the product is given to a staff member to complete the purchase. It can NEVER be taken to mean that a staff member can initiate and carry out a supply of a potent substance, with the pharmacist momentarily authorising the supply by a nod of the head or other such action.
Indeed, evidence was presented that requests purported to be on behalf of third parties were made by the consumer and Nurofen Plus® was provided without determination of a therapeutic need for the third parties. Supply was never refused for any request even though the situation was identified as a problem in November 2002.
The Board noted that the consumer was alleged to have used a convincing manner which is a well-recognised characteristic of people with drug seeking behaviour.
You relied on information gained from initial discussion with the consumer and assumed that the condition had remained unchanged for more than four months and your pharmacy continued to supply the Nurofen Plus® without review. The Board believes that over-the-counter medications of this nature are scheduled on the basis of providing short-term relief of minor symptoms and are not intended for chronic use.
Your personal intervention in these sales and referral to the consumer’s medical practitioner for confirmation of their condition and/or their treatment may have minimised the ultimate harm suffered by this particular consumer’s abuse of Nurofen Plus®.
Your failure to comply with the legislation and good pharmaceutical practice placed a member (or members) of the public at risk and fell well below the standard expected.
The Board noted the significant submissions made on your behalf regarding your previous good record and that you have implemented changes in procedures at your pharmacy. Nevertheless, the Board believes that your further study of the legal and professional obligations, staff training and implementation of professional practice standards is necessary.”
The Board imposed the following penalties:
• Reprimanded Mr Hosemans for his failure to comply with the legislation and good pharmaceutical practice in the supply of schedule 3 poisons;
• Fined him 25 penalty units with respect to the first charge; and
• Fined him 10 penalty units with respect to second charge being a total in fines of $3578.75
The Board also ordered him to pay the costs of and incidental to the Inquiry, being $14,138..