State and territory medicines legislation

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Chapter 11 State and territory medicines legislation

LEARNING OBJECTIVES

Upon completion of this chapter you should be able to:

• explain the structure of medicine scheduling
• describe how uniform medicine scheduling is achieved in Australian states and territories
• discuss the significance of the Galbally Review in regard to the scheduling of medicines
• explain the significance of drugs and poisons legislation to the practice of pharmacy
• discuss the issues of pseudoephedrine diversion in the context of contemporary pharmacy practice.

INTRODUCTION

In Australia there is no national medicines, poisons or controlled substances Act or regulation that deals with the manufacture, production, sale, supply, possession, handling or use of poisons (including drugs and other substances) and certain therapeutic devices in the states or territories. Neither is there national legislation that authorises certain health professionals to undertake certain specified actions in relation to poisons.

In regard to poisons, reference to the Standard for the Uniform Scheduling of Drugs and Poisons (SUSDP) by state and territory legislation affects a relatively uniform regulatory approach to the control of scheduled substances throughout Australia. However there are still variations — some not insignificant — in the schedules adopted by the states and territories through the use of powers under the individual Acts and regulations, to vary the SUSDP arrangements.

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 review considered the following questions within the framework of national competition principles:

• What were the objectives of the legislative controls? What were the nature and the magnitude of the health problems that the controls sought to address?
• Did the controls restrict competition? What was the likely effect of any restrictions on competition and on the economy in general?
• If yes, were there other non-regulatory ways to achieve the objectives of the legislation?
• What were, on balance, the costs and benefits and overall effects of drugs, poisons and controlled substances legislation and alternative, less restrictive approaches?
• Was it possible to reduce the level of controls, without compromising achievement of the objectives and, in doing so, increase competition?[1]

The Galbally Review also considered the efficacy of regulatory controls and noted that costs were increased and competitiveness undermined by: variations in legislation across jurisdictions; inefficiencies arising at the interface with related legislation; and, administrative inefficiencies. The Galbally Review then went on to consider whether changes in relation to regulatory requirements such as developing national uniformity in the legislation, or revising the number or range of schedules, or the manner of supply by professionals of drugs, poisons and controlled substances (the list is not exhaustive), would improve efficiency.

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 research demonstrated that there was likely to be a marginal benefit in retaining S2/S3 as a more flexible scheduling model … the evidence in the report was not compelling and NCCTG members were unable to conclude that the evidence clearly supported the benefit of retaining both schedules.

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.

Further research is ongoing in respect of improvements in health, and other outcomes for health consumers could be attributed to retention of the existing scheduling arrangements. A final decision in this matter is anticipated in 2010.

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 three amendments to the SUSDP issued each year include recent decisions of the NDPSC and must be read in conjunction with the SUSDP and not as stand-alone documents. The SUSDP is currently available in hard copy and electronically.

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]

Schedule 1 — Poisons of plant origin of such danger to health as to warrant their being available only from medical practitioners, nurse practitioners authorised under section 23(2)(e), pharmaceutical chemists or veterinary surgeons. (Note: no poisons are currently listed in this schedule in the SUSDP.)

Schedule 2 — Poisons for therapeutic use that should be available to the public only from pharmacies, or if there is no pharmacy service available, from persons licensed to sell Schedule 2 poisons.

Schedule 3 — Poisons for therapeutic use that are dangerous or are so liable to abuse as to warrant their availability to the public being restricted to supply by medical practitioners, pharmaceutical chemists, dentists or veterinary surgeons.

Schedule 4 — Poisons that should, in the public interest, be restricted to prescription or supply by a medical practitioner, dentist, veterinary surgeon, or nurse practitioner authorised under section 23(2)(e), together with substances or preparations intended for therapeutic use, the safety or efficacy of which requires further evaluation.

Schedule 5 — Poisons of a hazardous nature that must be readily available to the public but require caution in handling, storage and use.

Schedule 6 — Poisons that must be available to the public but are of a more hazardous or poisonous nature than those included in Schedule 5.

Schedule 7 — Poisons that require special precautions in manufacture, handling, storage or use, or special individual regulations regarding labelling or availability.

Schedule 8 — Poisons to which the restrictions recommended for drugs of dependence by the 1980 Australian Royal Commission of Inquiry into Drugs should apply.

Schedule 9 — Poisons that are drugs of abuse, where the manufacture, possession, sale or use should be prohibited by law except for amounts which may be necessary for educational, experimental or research purposes conducted with the approval of a designated authority.

There are 11 appendices to the SUSDP and these are listed in Chapter 10.

While a particular poison will usually appear in the same schedule in each jurisdiction, different requirements may be in force in the individual states or territories with regard to the prescribing, labelling, sale and recording of poisons.

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:

• any prescribing limits placed on doctors, dentists, veterinarians, nurse practitioners, optometrists and surgical podiatrists
• prescription requirements particularly for S4 and S8 medicines
• storage, dispensing and recording requirements for S8 medicines
• supplying, storage and labelling of S3 medicines
• storage of S2 medicines
• labelling requirements for the various scheduled medicines
• interstate prescriptions.

Australian Capital Territory

Drugs and poisons were regulated in the ACT under the Poisons Act 1933, the Poisons and Drugs Act 1978 and the Public Health (Prohibited Drugs) Act 1957 — together with subordinate legislation. These Acts and regulations were repealed in 2008 with the commencement of the Medicines, Poisons and Therapeutic Goods Act 2008 which was an Act to consolidate and reform the law relating to regulated substances and regulated therapeutic goods, to give effect to the medicines and poisons standard, and for other purposes. The Act aims to promote and protect public health and safety and to ensure the consumers of prescription and non-prescription medicines have adequate information and understanding necessary to allow them to use the medicines safely and effectively.

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).

It should be noted that pharmacists practising in the ACT are required, pursuant to section 7 of the Medicines, Poisons and Therapeutic Goods Act 2008, to ensure ‘that the prescription or supply of the medicine is for a quantity and purpose that is consistent with the recognised therapeutic standard …’. This is consistent with Principle one of the Code of Professional Conduct that states, ‘The primary concern of the pharmacist must be the health and wellbeing of both clients and the community’; which is further expanded in Principle one, Obligation three, which states:

A pharmacist must exercise professional judgment to prevent the supply of products likely to constitute an unacceptable hazard to health or the supply of unnecessary and/or excessive quantities of medicines and other products, particularly those which have a potential for abuse or dependency.

It is an offence for a person without an authority to deal with a regulated substance. Section 19 of the Act, Meaning of deals with a regulated substance, states:

(1) For this Act, a person deals with a regulated substance if the person does 1 or more of the following:

(a) manufactures the substance;
(b) obtains the substance;
(c) possesses the substance;
(d) supplies the substance;
(e) administers the substance;
(f) discards the substance;
(g) issues a purchase order for the substance;
(h) if the substance is a medicine—

(i) prescribes the medicine; or
(ii) issues a requisition or standing order for the medicine;

(i) if the substance is a dangerous poison, prohibited substance or appendix C substance—gives a written or oral direction to—

(i) supply the poison or substance for administration to a person; or
(ii) administer the poison or substance to a person.

(2) For this Act, a person also deals with a regulated substance if the regulated substance otherwise comes into, or goes out of, the person’s possession, including, for example, if the person loses or finds the regulated substance or the substance is stolen from the person.’

The various chapters of the Medicines, Poisons and Therapeutic Goods Regulation 2008 (ACT), under the Medicines, Poisons and Therapeutic Goods Act 2008, contains matters of particular interest to the practice of pharmacy including:

• medicines — supply authorities (Chapter 3)
• supplying medicines, including dispensing and supplying without prescription in emergencies (Chapter 4)
• obtaining and possessing (Chapter 6)
• packaging and labelling (Chapter 10)
• storage including storage of controlled medicines (Chapter 11)
• controlled medicines registers (Chapter 12)
• controlled medicines and appendix D, medicines for human use (Chapter13)
• opioid dependency treatment guidelines (Chapter 15)
• advertising provisions (Chapter 15), and
• low and moderate harm poisons.

While the Act requires that a person must not deal with a medicine in a particular way unless the person is authorised to, the Regulation authorises certain dealings with medicines. Schedule 1 (Medicines — health-related occupations authorisations) at Part 1.9 authorises a pharmacist:

… to the extent necessary to practice pharmacy and, if employed with the scope of employment do any of the following:

(a) issue purchase orders and requisitions for medicines;
(b) obtain medicines;
(c) possess medicines;
(d) dispense medicines;
(e) administer medicines;
(f) manufacture medicines to dispense or supply them on requisition;
(g) supply pharmacy medicines;
(h) if a pharmacist at institution — supply pharmacist only medicines without prescription;
(i) if pharmacist at community pharmacy — supply pharmacist only medicines without prescription but in accordance with the Act s7;
(j) supply medicines on purchase order, requisition or standing order.

Within the same schedule there are authorities for intern pharmacists, employees assisting pharmacists at a hospital and employees at a community pharmacy. It should be noted that the authority does not authorise a pharmacist to prescribe medicines (just as in Part 1.3, doctors are not authorised to dispense medicines).

New South Wales

The Poisons and Therapeutic Goods Act 1966 (NSW) is an Act relating to the regulation, control and prohibition of the supply and use of poisons, restricted substances, drugs of addiction, certain dangerous drugs and certain therapeutic goods. The Act establishes a Poisons Advisory Committee and defines its powers, authorities, duties and functions. For the purposes of the Act a pharmacist means a person so registered under the Pharmacy Practice Act 2006 (NSW).

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.

Poisons and restricted substances are dealt with in Part 3 of the Act, which includes divisions on supply and possession of poisons and certain authorisations. For example pursuant to section 16 a person shall not have in his or her possession a prescribed restricted substance unless:

… the person is a … pharmacist … and the person obtains possession or attempts to obtain possession of it in the lawful practice or the person’s profession as such …

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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