Chapter 11 State and territory medicines legislation
THE GALBALLY REVIEW
In 2001 Ms Rhonda Galbally completed her review of the drugs and poisons legislation in Australia, titled Review of Drugs, Poisons & Controlled Substances Legislation.[1] The Galbally Review, as it is known, examined Australian state and territory legislation regulating medicines and poisons against national competition principles. The report made 22 recommendations aimed at achieving national uniformity of drugs and poisons legislation through legislative reform. In relation to scheduled medicines for human use, most of the recommendations were implemented by 2006–2007.
The Galbally Review was submitted to the Australian Health Ministers’ Advisory Council (AHMAC) which established a working party to assist in the preparation of a report. The working party recommended the adoption of all the recommendations (with some minor amendments) with the exception of Recommendation 7, which was concerned with administrative arrangements for scheduling.[2] At the time the report was written, discussions between Australia and New Zealand for a Trans-Tasman Joint Agency for the regulation of therapeutic goods had begun. It was felt that any changes to the scheduling arrangements in Australia should hinge on, and be harmonious with, arrangements for the joint agency. The discussions relating to the joint agency have been suspended.
Arguably the most contentious proposal in the Galbally Review was contained in Recommendation 5 which suggested if there was no evidence to support the retention of Schedules 2 and 3 as currently appearing in the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) then the schedules should be combined with new criteria to be developed. A report on Recommendation 5 was submitted to the AHMAC by the National Coordinating Committee on Therapeutic Goods (NCCTG).[3] The AHMAC endorsed the report and agreed to continue the scheduling arrangements for S2 (Pharmacy) and S3 (Pharmacist Only) medicines for an interim period of 5 years, subject to a further demonstration that the existing system delivered positive outcomes for health consumers.
The research for the NCCTG was undertaken by academics from the University of Sydney, the University of South Australia, and the University of Queensland together with external consultants.[4] The NCCTG report to AHMAC was based on the results of this research, stating that:[3]
The NCCTG report also expressed concern that there was a potential for ‘… the research methodology to skew the results of the epidemiology study as it relied on participants being self-selected rather than being selected at random …’.[3] It also noted that the results of the ‘Mystery Shopper Program’ showed there were a significant number of pharmacists who did not comply with provisions of the Standards for the Provision of Pharmacy Medicines and Pharmacist Only Medicines in Community Pharmacy.[3] The NCCTG report also stated there appeared to be ‘… considerable disparity in the level of counselling delivered and in some cases of supplying S3 medicines where no counselling had been delivered at all’.[3] This was identified with some level of concern as the lack of counselling not only did not comply with the S2/S3 Standards but was also in breach of state and territory drug legislation.
SCHEDULING
As discussed in Chapter 10, the SUSDP is defined pursuant to section 52A of the Therapeutic Goods Act 1987 (Cth) and gives effect to the decisions of the National Drugs and Poisons Scheduling Committee (NDPSC) regarding the classification of drugs and poisons into schedules for inclusion in the relevant state and territory legislation. The SUSDP also includes model provisions for containers and labels, a list of products recommended to be exempt from those provisions, and recommendations about other controls on drugs and poisons. It is presented with a view to promoting uniform scheduling of substances and uniform labelling and packaging requirements throughout Australia. The decisions of the NDPSC have no force in Commonwealth law but were recommended for incorporation into state and territory legislation by the Galbally Review. This has been achieved in all states and territories. However, as mentioned in the introduction, most state- and territory-based legislation has the power to vary a scheduling arrangement for any poison should the relevant Health Minister decide not to adopt a recommendation of the NDPSC.
The SUSDP defines a ‘poison’ as ‘… any substance or preparation included in a Schedule to the Standard’ while a ‘drug’ means ‘… a poison intended for human or animal therapeutic use’.[5] It is worthy to note that the term ‘drug’ is increasingly being replaced in many official documents — although not in the SUSDP — by the term ‘medicine’ or ‘substance’. One reason for this change could be the negative connotations associated with the term ‘drug’ as it is often used in association with illegal use and trafficking; for example, ‘drug abuse’, ‘drug baron’, ‘drug mule’, ‘drug bust’, ‘druggie’, and ‘to do drugs’.
The Introduction to the SUSDP and the first three Parts are discussed in Chapter 10. Part 4, The Schedules, are as follows:[5]
There are 11 appendices to the SUSDP and these are listed in Chapter 10.
Generally speaking, drugs and poisons legislation regulates the manufacture, production, sale, supply, possession, handling or use of poisons (including drugs and therapeutic and other substances) and certain therapeutic devices. The legislation also authorises some health professionals to undertake certain dealings in relation to poisons. Table 11.1 lists the main legislation in each of the states and territories relating to the control of drugs and poisons.
Table 11.1 Drugs and poisons legislation
State | Act | Regulation |
---|---|---|
Australian Capital Territory | Medicines, Poisons and Therapeutic Goods Act 2008 | Medicines, Poisons and Therapeutic Goods Regulation 2008 |
New South Wales | Poisons and Therapeutic Goods Act 1996 | Poisons and Therapeutic Goods Regulation 2008 |
Northern Territory | Poisons and Dangerous Drugs Act | Poisons and Dangerous Drugs Regulations |
Queensland | Health Act 1937 | Health (Drugs and Poisons) Regulation 1996 |
South Australia | Controlled Substances Act 1984 | Controlled Substances (Poisons) Regulations 1996 |
Tasmania | Poisons Act 1971 | Poisons Regulations 2002 |
Victoria | Drugs, Poisons and Controlled Substances Act 1981 | Drugs, Poisons and Controlled Substances Regulations 2006 |
Western Australia | Poisons Act 1964 | Poisons Regulations 1965 |
Note: The Northern Territory does not include the date in the title of this legislation.
The following is a general overview of the relevant legislation enacted in the states and territories in regard to the practice of pharmacy. In familiarising themselves with drugs and poisons legislation in the various jurisdictions pharmacists should pay particular attention to:
Australian Capital Territory
The medicines and poisons standard refers to the Poisons Standard in the Therapeutic Goods Act 1989 (Cth) which references the latest edition of the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) — as defined in section 52A. The Poisons Standard is prepared or amended by the National Drugs and Poisons Schedule Committee pursuant to section 52D (2) of the Therapeutic Goods Act 1989 (Cth).
New South Wales
Part 2 of the Act addresses the Poisons Advisory Committee and the Poisons List. The membership of the committee and its procedures are identified in this Part of the Act. There are 16 members of the committee. Six members are nominated (one being the Head of the Department of Pharmacy, University of Sydney, or a delegate) while the remaining 10 members are appointed by the Governor. Of these, one is a representative of the Pharmacy Guild of Australia (NSW branch) and one is a representative of the Pharmaceutical Society of Australia (NSW branch). The two functions of the committee are, firstly, to make recommendations regarding the making, altering or repealing of any regulation under the Act and, secondly, make recommendations for amending the Poisons List.
For the purposes of the scheduling of poisons, New South Wales has adopted the New South Wales Poisons List which is a list proclaimed under section 8 of the Act.[6] The Poisons List may be amended by applying, adopting or incorporating, with or without modification, the current Poisons Standard within the meaning of Part 5B of the Therapeutic Goods Act 1989 (Cth). The effect is to adopt the SUSDP as amended (with any New South Wales variations) as the Poisons List. In the current Poisons List, Schedule 2 has a variation to the entry for codeine when compounded in preparations containing 10mg or less of codeine, where the restriction on a primary pack containing 25 dosage units or less in the SUSDP has been removed.[4] Likewise, Schedule 3 also includes a variation to the entry to codeine. There are also two additions to Schedule 8 poisons listed in the SUSDP, etorphine and tetrahydrocannabinol and its alkyl homologues, except:
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