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:

(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:

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:

(a) when separately specified in this Schedule;

(b) in hemp seed oil containing 50mg/kg or less of tetrahydrocannabinols, when labelled ‘Not for internal use’; or

The Act also provides for the making of regulations. The Poisons and Therapeutic Goods Regulation 2008 makes provision with respect to the following:

(a) packaging, labelling, storage, prescription and supply (including making records of supply) of poisons, restricted substances and drugs of addiction,

(b) supply of substances by wholesale, and the regulation of wholesale dealing,

(d) analysis and disposal of goods that have been seized under section 43 of the Poisons and Therapeutic Goods Act 1966,

(e) issue, suspension and cancellation of licences and authorities for the purposes of that Act,

(f) fees payable in respect of those licences and authorities,

(g) savings and formal matters.

Part 2 of the Regulations deals with poison Schedules 1, 2, 3, 5, 6, 7 and includes requirements for packaging and labelling, storage, prescribing, supply and recording of such substances. Clause 18 requires that a pharmacist must personally hand a Schedule 3 substance to a person and:

… gives the person an opportunity to seek advice as to the use of the substance including advice that the person may require in respect of the dosage, frequency of administration and general toxicity of any substance.

The clause goes on to identify exceptions to this requirement including those cases in which the supply is to other authorised persons and in some first aid or other emergency situations. Although there is no general requirement to record the supply of Schedule 3 substances, a pharmacist who supplies pseudoephedrine must record details of supply as if it were a Schedule 4 medicine.

Part 3 deals with restricted (Schedule 4) substances and includes requirements for packaging and labelling, storage, prescribing, supply and recording. Schedule 4 substances must be stored in a place where the public does not have access. Under clause 33 prescriptions may only be issued for certain purposes. For example, dentists must ‘… not issue a prescription for a restricted substance otherwise than for dental treatment and must endorse any such prescription with the words “FOR DENTAL TREATMENT ONLY” ’. Likewise, a medical practitioner must not issue a prescription for a restricted substance other than for medical treatment. Clause 35 describes those details that must be included on a prescription. Prescriptions must be in the handwriting of the prescriber or in such other way as may be approved by the Director-General. A pharmacist may receive an emergency prescription by telephone, electronic mail or facsimile. The prescriber is required to send the prescription within 24 hours. A pharmacist may also supply a person with a restricted substance otherwise than on the direction of a health practitioner (i.e. without a prescription) if the pharmacist is satisfied that the substance had been previously prescribed, the person is in immediate need of the substance, and it is not practicable for the person to obtain a prescription. A maximum of 3 days supply may be given or a standard pack in the case of liquids, ointments or anovulant tablets. A pharmacist must keep a record of all Schedule 4 substances supplied on prescription.

Part 4 deals with drugs of addiction (Schedule 8) detailing matters regarding packaging and labelling, storage, prescribing, supply, and recording. The major differences between Schedule 4 and Schedule 8 poisons insofar as pharmacists are concerned are in the storage and recording requirements. Schedule 8 substances are required to be stored apart from all other goods in a separate safe which is kept securely locked when not in immediate use. The specifications for such safes are included in clause 76 of the Regulation. Also, a pharmacist must verify any prescription for a Schedule 8 substance where he or she is not familiar with the handwriting of the prescriber or does not know the person presenting the prescription. Pursuant to Division 5 a pharmacist must keep a ‘drug register’ where Schedule 8 substances are recorded. A pharmacist dispensing Schedule 8 substances on prescription must record: the details of the prescription; its unique reference number; the date of supply; and the name of the person supplying the medicine.

Part 5 details requirements for supply by wholesale and by holders of wholesaler’s licences and authorities. Part 6 addresses issues regarding the preparation, handling, supply and labelling of therapeutic goods. Part 7 covers the analysis and disposal of seized goods. Finally, Part 8 addresses licences and authorities including the fact that licences and authorities may at any time be suspended by the Director-General. The grounds for such suspension include:

• the holder agrees to suspension or cancellation

• the holder is convicted of a serious offence under the Drugs Misuse and Trafficking Act 1985 (NSW)

• the holder is no longer a fit and proper person.

The holder must be informed in writing and must be given reasonable opportunity to make representation with respect to the proposed suspension or cancellation.

The Regulation also includes the following appendices:

• A — Labelling of therapeutic substances

• B — Special restricted substances

• C — Persons authorised to possess and use substances

• D — Prescribed restricted substances.

Northern Territory

The Poisons and Dangerous Drugs Act (NT) regulates the ‘sale, supply, storage, possession and use of poisons and dangerous drugs and for related purposes’. It comprises 14 parts.

The application of the SUSDP to the poisons scheduling in the Northern Territory is dealt with in section 6A of the Poisons and Dangerous Drugs Act. A Schedule referred to by number in the Poisons and Dangerous Drugs Act is taken to be a reference to a Schedule of that number in Part 4 of the SUSDP. Similarly, an Appendix referred to by a letter of the alphabet is a reference to the corresponding Appendix in Part 5 of the SUSDP. The Health Minister has power to vary the scheduling of a poison or hazardous substance or impose such restrictions as the Health Minister believes appropriate. In addition, pursuant to section 90A, the Chief Health Officer may declare, by notice in the government gazette, a substance to be a restricted Schedule 4 substance.

Part 2, Manufacture of Poisons, and Part 3, Control of Wholesalers, does not impact directly on the practice of pharmacy. Part 4, Control of Retailers, covers the licensing and the terms and conditions of licence of retailers. At section 23 (1) ‘A person shall not supply a poison by retail unless he or she is licensed under the Part to supply that poisons by retail or is employed by a person who is licensed’. Section 23 (2) states that a pharmacist (and a medical practitioner, dentist or veterinarian) is taken to be licensed under this Part. Pursuant to section 24 other persons may be licensed by an application to the Chief Health Officer.

Section 28 deals with the supply of poisons by pharmacists from Schedule 1 through to Schedule 8. Section 30 states that the Chief Health Officer may direct a pharmacist:

[N]ot to hold on premises in which the pharmacist conducts business a Schedule 8 medicine specified in the notice except to the extent that is reasonably necessary to enable the pharmacist to fulfil a prescription after obtaining the substance from a place nominated by the Chief Health Officer.

The effect of this section is to prevent a pharmacist from holding stock of a Schedule 8 substance in the expectation of supplying it at some later date while giving him or her the ability to purchase the substance when in receipt of a prescription.

Part 5 deals with the supply of poisons (including substances for therapeutic use) by pharmacists, dentists, and veterinarians.

Prescriptions are dealt with in Part 6, which applies to all prescriptions issued by a medical practitioner, dentist, optometrist or veterinarian for the supply of a Schedule 1, 4, 7, or 8 substance. Prescriptions are valid for a period of 12 months, other than for Schedule 8 substances, which are valid for 2 months and must not provide for more than 2 months supply unless specific approval is obtained from the Chief Health Officer. Section 35 requires pharmacists to endorse prescriptions after dispensing while section 36 requires that the details of each prescription dispensed be recorded. Section 37 makes provision for the emergency supply of scheduled substances.

Pharmacists are required to keep delivery dockets and invoices relating to the receipt of Schedule 1, 4, 7, or 8 substances, and enter in a register the details of each supply by a pharmacist of Schedule 1, 4, 7, or 8 substances.

The Poisons and Dangerous Drugs Regulations at Part 2 addresses the supply of scheduled substances including time for notification by a nurse in charge and scheduled substance treatment protocols. Part 3 covers labels and containers through reference to Part 2 of the SUSDP, ‘Labels and containers’. Part 4 deals with storage, transport and disposal, including the disposal of Schedule 8 substances.

Queensland

Medicines and poisons are regulated in Queensland by the Health (Drugs and Poisons) Regulation 1996, delegated legislation under the Health Act 1937. The Health (Drugs and Poisons) Regulation 1996 recognises the SUSDP. The legislation also regulates manufacturers and wholesalers as well as providing endorsements to various categories of health professionals in regard to scheduled medicines. In certain circumstances such endorsements may be revoked by the Chief Health Officer.

Endorsements generally cover the possession, prescribing, dispensing, issuing and selling of scheduled medicines and poisons and persons may not undertake any of those activities without specific endorsement. In regard to controlled (Schedule 8) medicines, a pharmacist may, to the extent necessary to practise pharmacy, obtain, dispense, sell (on a purchase order), possess (at a dispensary or institution), administer or supply a controlled drug. The endorsements for restricted (Schedule 4) medicines are similar in scope. While there are prescribing endorsements with varying limitations for dentists, doctors, optometrists, surgical podiatrists and nurse practitioners, there are no endorsements for pharmacists to prescribe either controlled or restricted medicines. It is noted that with a nurse practitioner it is an endorsement to give a pharmacist an oral or written instruction to supply.

In addition, recent amendments to the Regulation impose quality standards for dispensing certain drugs and selling certain poisons. These standards are recognised by the Pharmacists Board of Queensland and are available on the board’s website at www.pharmacyboard.qld.gov.au. Under section 4A(4) such standards must be consistent with the following principles:

(a) in selecting a way to manage a person’s condition, a pharmacist should consider appropriate options, including, for example, medicinal and non-medicinal options;

(b) for a medicinal option, the pharmacist should choose the medicine the pharmacist considers is the most appropriate having regard to relevant matters, including, for example, potential risks and benefits of using the medicine;

(i) maximises the efficacy of the medicine; and

(ii) minimises misuse of the medicine.

Chapter 2 of the Regulation deals with controlled (Schedule 8) drugs and includes sections on: licences; the issuing of particular endorsements; regulated controlled drugs; prescribing and dispensing; obtaining and selling; possession and storage; records; and treatment with, and dependence on, controlled drugs. The specific provisions relating to the labelling and recording are dealt with in Part 4 of this chapter. The section also deals with additional restrictions placed on the regulated controlled drugs dronabinol, amphetamine, dexamphetamine, methylamphetamine, methylphenidate and phenmetrazine. The chapter also covers the requirements regarding verbal prescriptions.

Chapter 3 covers prescription only (Schedule 4) medicines and is similar in structure to that pertaining to controlled drugs. It includes a section on the additional restrictions placed on regulated restricted drugs as included in Appendix D in the SUSDP. Also included are matters relating to the supply and recording of Prescription Only medicines as an emergency supply.

Chapter 4 addresses poisons including the endorsements needed to obtain, dispense, possess and sell Schedule 2, 3 and 7 poisons. Pharmacists, to the extent necessary to practise pharmacy, are endorsed to dispense, supply or sell S2, S3 or S7 poisons at a dispensary (s257) as long as they have prepared or adopted a relevant quality standard (s273A).

It has been recognised for a number of years that the sale of pseudoephedrine-containing products, predominantly Schedule 3, has presented particular problems because of the diversion of some of the purchased product to the illicit production of amphetamine-like substances. In an effort to minimise this diversion additional controls have been placed on the sale of pseudoephedrine-containing products through amendments to the Regulation. The subject of diversion has been discussed in a number of Pharmacist Board of Queensland Bulletins.^[7]

Section 277(1)(a) states a pharmacist can only sell pseudoephedrine to a purchaser who has a therapeutic need for the product and is able to provide an acceptable form of identification. In addition, a record of the sale of pseudoephedrine must be made at the time of the sale and include the date of the sale, the brand name and quantity sold, the purchaser’s name and address and the form of identification provided by the purchaser (s285A). Such a record, which may be in electronic form, must be kept for at least 2 years from the date of sale. In Queensland, pseudoephedrine is the only S3 medicine where the sale is required to be recorded.

In regard to storage, Schedule 2, 3 and 4 medicines must be stored ‘…in a place that is not accessible to the public’. Controlled drugs must be kept in a receptacle that complies with Appendix 6 of the Regulation. Appendix 6 details the minimum requirements for controlled drug receptacles.

South Australia

Poisons are regulated in South Australia through the Controlled Substances Act 1984 and the Controlled Substances (Poisons) Regulations 1996. The legislation regulates or prohibits the manufacture, production, sale, supply, possession, handling or use of certain poisons, drugs, therapeutic and other substances and certain therapeutic devices. For the purpose of poisons scheduling, the Controlled Substances (Poisons) Regulations 1996 have incorporated the ‘Uniform Poisons Standard’ at section 5. In the Interpretation to the Regulations the ‘Uniform Poisons Standard’ is defined as ‘… the Standard for the Uniform Scheduling of Drugs and Poisons published by the National Drugs and Poisons Schedule Committee’. The SUSDP may be modified by South Australian variations which can be found in Schedule A of the Regulations.

The Regulations declare that poisons listed in Schedule 4 and Schedule 8 are ‘prescription drugs’, and poisons listed in Schedule 8 are ‘drugs of dependence’. In addition, any substance either approved by the Therapeutic Goods Administration (TGA) for inclusion in the Australian Register of Therapeutic Goods or by the National Registration Authority of the Commonwealth for inclusion in the Australian Register of Agriculture and Veterinary Chemical Products will be taken to be a Schedule 4 poison unless otherwise scheduled or specifically exempt.

Part 2 of the Act covers matters relating to the Controlled Substances Advisory Council which functions to ‘keep under review substances and devices that are subject to [the] Act’ and to advise the Health Minister on matters relating to the Act including making recommendations for amendments to the Act or the making, varying or revoking Regulations under the Act. Although the membership of the Advisory Council does not specifically include a pharmacist the Act provides for ‘2 … persons who, in the opinion of the Minister, have qualifications and extensive experience in the field of chemistry, pharmacy or pharmacology’.

Part 3 (controlled substances) gives the government power by Regulation to schedule any substance under the Uniform Poisons Standard as: a poison; a prescription drug; a drug of dependence; a controlled drug; a controlled precursor; a controlled plant; a volatile solvent: or a therapeutic device. For the purposes of the Act a ‘controlled plant’ means ‘a growing cannabis plant or a cutting of a cannabis plant … or any other plant declared by the Regulations to be a controlled plant …’

Part 4 details general offences, while Part 5 details offences relating to controlled drugs, precursors and plants. Offences and penalties under the Act are dealt with in Part 6; search, seizure, forfeiture and analysis in Part 7; and miscellaneous provisions in Part 8.

The Controlled Substances (Poisons) Regulations 1996 (SA) (the Regulations) comprise the following parts:

• Part 2 Licences

• Part 3 Application of general offences (Part 4) of the Act

• Part 4 Prescriptions and dispensing

• Part 5 Special provisions relating to certain Schedule 4 drugs

• Part 5A Special provisions relating to drugs of dependence

• Part 6 Special provisions relating to certain poisons

• Part 7 Other offences

• Part 8 Miscellaneous.

The Regulations also include Appendices A–M.

While in South Australia the Regulations allow a prescription to be given to a pharmacist by a prescriber by facsimile transmission, this is not the case in all other states and territories. The only other state that specifically allows for the use of facsimile transmission is New South Wales, then only in relation to the emergency supply of prescription medicines. No other state or territory poisons legislation mentions facsimile transmission in relation to the prescribing of prescription medicines.

Tasmania

The Poisons Act 1971 (Tas) is an Act:

[T]o make provision with respect to the regulation, control, and prohibition of the importation, making, refining, preparation, sale, supply, use, possession, and prescription of certain substances and plants and matters incidental thereto.

The SUSDP is recognised in the Tasmanian legislation through the Poisons List. Amendments issued by the NDPSC are incorporated into the Poisons List through ‘orders’ made under section 14 of the Poisons Act 1971. The Poisons List defines the various schedules at section 14(2)(a)–(h). The Schedules in the Act mirror the schedules as they are found in the SUSDP. However, in common with most other states and territories, the Act also provides (s15) a power for the Health Minister to vary the scheduling arrangements for any substance.

The Act uses the term ‘pharmaceutical chemist’ to refer to a person registered as a pharmacist under the Pharmacists Registration Act 2001 (Tas). The legislation also authorises pharmacists to deal with scheduled poisons in certain ways. For example section 14(2)(c) permits a pharmacist to supply Schedule 3 substances ‘which are for therapeutic use and which are of a sufficiently dangerous nature to warrant their sale or supply only by … pharmaceutical chemists’.

Part 3, Poisons and Restricted Substances, covers restrictions on the sale, supply and possession of poisons and restricted substances. Pharmacists are authorised to have in their possession poisons and restricted substances ‘[I]n the lawful practice of his or her profession or business’, and to dispense prescriptions written by medical practitioners, dentists, veterinarians, and optometrists authorised to prescribe under Division 3A of Part 3 of the Optometrists Registration Act 1994 (Tas). Pharmacists are also authorised to compound extemporaneously.

Part 4 covers ‘new drugs’ which mean substances designed or intended for therapeutic use which is not included in the latest edition of the British Pharmacopoeia the British Pharmacopoeia Codex, or the United States Pharmacopoeia. Before such ‘new drugs’ are offered for sale an application shall be made to the Health Minister.

Part 5 includes special provisions relating to narcotics, prohibited plants and prohibited substances. Pharmacists are authorised to sell or supply, possess and dispense narcotic substances, if engaged in the lawful practice of their business.

The Poisons Regulations 2008 (the Regulation) prescribes particulars and information relating to the Poisons Act 1971. For the purposes of the Regulation, a pharmacist is classified as a ‘health professional’.

Part 3 of the Regulation addresses narcotic substances and prohibited plants. Pharmacists may only supply a narcotic substance on a prescription issued by a medical practitioner, veterinary surgeon or dentist. Pharmacists are also required to keep a narcotic substances register in compliance with section 13 of the Regulation. In addition, all records pertaining to the acquisition, sale or supply of narcotic substances must be kept for a period of not less than 2 years. Section 15(6) covers the prescribing and supply of narcotic substances including the requirement for a valid prescription. Pursuant to section 18, pharmacists are authorised to dispense a narcotic substance in an emergency situation on the instruction of a medical practitioner, veterinary surgeon or dentist without being in possession of a written prescription but one must be provided within 24 hours. Prescriptions for narcotic substances are valid for a period of 6 months.

Part 4, Poisons and Restricted Substances, describes advertising, prescribing, sale, supply and dispensing of restricted substances including emergency prescribing and dispensing.

Part 5, Packaging and Labelling of Therapeutic Substances, recognises the SUSDP and imposes its requirements.

Victoria

Drugs and Poisons are regulated in Victoria through the Drugs, Poisons and Controlled Substances Act 1981 and the Drugs, Poisons and Controlled Substances Regulations 2006. Section 12, Part 2, Poisons and Controlled Substances, of the Act empowers the Health Minister to prepare a Poisons Code. This code must contain a Poisons List which includes the ‘Commonwealth standard’ as defined in section 4.

Under section 13 a pharmacist is an authorised person and is authorised:

[T]o obtain and have in his possession and to sell or supply any poisons or controlled substance or drug of dependence in the exercise or performance of any power, function or duty conferred or imposed upon him by this Act …

The Act also provides for the establishment of a Poisons Advisory Committee made up of nine members appointed by the Health Minister; two members of the Committee are pharmacists with one having expertise in community pharmacy and one in hospital pharmacy.

Other parts of the Act include:

• Part 3 The manufacture of heroin and other substances

• Part 4 Deleterious substances and search, seizure and detention powers relating to volatile substances; together with Part 4A which includes authorities for low-THC cannabis

• Part 5 Aspects of drugs of dependence including trafficking, possession and cultivation

• Part 6 Search and seizure powers and forfeiture.

Other parts cover evidentiary issues, drug rehabilitation, research funding, and the making of Regulations with respect to ‘regulating or controlling the manufacture, sale, possession, administration, use supply, distribution and storage’ of drugs, poisons and controlled substances.

Part 2 of the Drugs, Poisons and Controlled Substances Regulations 2006 covers possession, treatment, supply, storage, records, administration, destruction, and cultivation of narcotic plants.

In an emergency a pharmacist can supply, under certain criteria, 3 days supply of a Schedule 4 medicine or, if that is not practical, the smallest commercially available pack (s15(2)). Regulation 26 defines the requirements for a prescription for a Schedule 4 or Schedule 8 substance, and Regulation 27 states that where an emergency exists in the opinion of a medical practitioner, veterinary practitioner or dentist, an oral direction may be given to a pharmacist to supply a Schedule 4 or Schedule 8 substance. Section 29 deals with the information that must appear on a label for a Schedule 4, Schedule 8 or Schedule 9 substance. In Victoria prescriptions for Schedule 4 substances are valid for 12 months while prescriptions for Schedule 8 or Schedule 9 substances are valid for only 6 months.

Under Regulation 34, Schedule 4 substances are required to be stored in a secure area inaccessible to non-authorised persons. Schedule 8 and 9 substances are required to be stored in a safe that complies with section 35 of the Act.

Division 5 of Part 2 states that pharmacists must keep records that apply to Schedule 4, Schedule 8 and Schedule 9 substances for at least 3 years from the date of the transaction.

Part 4 covers the matter of Schedule 3 poisons. Under the legislation a pharmacist is required to supply a Schedule 3 poison only where he or she has taken all reasonable steps to ensure a therapeutic need exists for that substance (s61). In a pharmacy Schedule 3 poisons must not be stored in such a way that allows self-selection by the public (Regulation 62). The pharmacist is required to personally supervise the sale, provide directions for the use of the substance and place a label on the container that identifies the supplier (Regulation 63).

Part 5 covers Schedule 7 Poisons.

Western Australia

The Poisons Act 1964 (WA) regulates and controls the possession, sale and use of poisons and other substances allowed by the Act, and constitutes a Poisons Advisory Committee.

Part 2 covers the constitution and the administration of the Poisons Advisory Committee. The committee comprises 10 members. Two members are pharmacists and the Pharmaceutical Council of Western Australia and the Pharmacy Guild of Australia (WA Branch) may each nominate one member. The function of the committee is to advise the Health Minister and make recommendations regarding the scheduling of poisons, or the making, amending or revoking of any regulation under the Act.

Part 3 Poisons and Other Substances covers the classification, sale and general provisions of poisons. For the purposes of the Act, substances included in Schedules 1–9 of the SUSDP are poisons. Schedules 1–9 are incorporated into Appendix A of the Poisons Act 1964 and are the same as Schedules 1–9 of the SUSDP with some amendments to Schedules 4, 6, 7, 8 and 9.

Part 4, Drugs of addiction, deals with the general provisions that apply to Schedule 8 medicines.

Part 5, Miscellaneous provisions, include the general prohibitions against selling any poisons either by hawking or peddling, or by selling by automatic machines.

The Poisons Regulations 1965 prescribes particulars and information relating to the Poisons Act 1964.

Part 2, Licences and permits, addresses licences and permits able to be effected under the Regulations. Pharmacists (pharmaceutical chemists) are only authorised to sell or supply a poison from a pharmacist registered under the Pharmacy Act 1964 (WA).

Part 3, Containers and Labels, adopts the provisions of Part 2 of the SUSDP. In addition, section 21 details the requirements for labelling a poison supplied in the course of professional practice by a pharmacist, medical practitioner, registered nurse at a remote area, or a dentist.

Part 4, Storage, Disposal and Loss or Theft of Poisons, includes the requirements for disposal of poisons and the procedures to adopt in the case of loss or theft of a poison. Poisons, other than drugs of addiction, shall be kept ‘… in such a manner as to preclude contamination of an food, drink, or condiment by the poison; and to preclude access to the poison by children’.

Part 5, Sale, Supply and Use, includes general restrictions and sections relating to Schedule 3 and 4 poisons. Schedule 3 substances can only be sold under the direct personal supervision of a pharmacist and only after all reasonable steps have been taken to ensure there is a therapeutic need for the substance (s38A). The sale of Schedule 3 poisons must be recorded and the product labelled with the name and address of the pharmacy and a unique sale identification number. In the case of pseudoephedrine, the purchaser must give photographic evidence of his or her identity unless personally known to the pharmacist. Records of the sale of Schedule 3 poisons must be kept for a minimum period of 2 years and Schedule 3 substances must be stored in such a manner inaccessible to the general public. The Regulations also preclude the advertising of Schedule 3 and Schedule 4 substances other than that which is permitted by the SUSDP. The one exception are substances contained in a pregnancy testing kit which may be advertised.

The requirements for a prescription for Schedule 4 poisons are detailed in section 37. Where an emergency exists a pharmacist can dispense a prescription received orally or by telephone or telegram with a written copy being sent to the pharmacist within 24 hours.

Part 6, Drugs of addiction, includes sections on prescribing and supply, dispensing and delivery, safe custody and labelling. Schedule 8 substances must be stored by a pharmacist in a safe that complies with clause 1 of Appendix M of the Regulations. If a pharmacist is storing Schedule 8 poisons in quantities greater than prescribed in section 56A of the Regulations additional security arrangements as prescribed in clause 2 of Appendix are required.

A number of appendices and schedules are attached to the Regulations including Form 3, A Pharmaceutical Chemist’s Licence to Sell Poisons, Appendix H, Schedule 4 Substances Referred to in Regulation 39(1), and Appendix L, Specific Criteria for the Generation of Prescriptions by Computer.

PSEUDOEPHEDRINE

Pseudoephedrine is an oral sympathomimetic decongestant that acts on alpha- adrenoreceptors and vascular smooth muscles in the respiratory tract producing vasoconstriction of dilated nasal vessels reducing tissue swelling and nasal congestion.^[8] However, it was not its pharmacological activity that thrust it into the scheduling spotlight from the late 1990s onward, but rather the fact that it was a precursor to methylamphetamine, also known as ‘speed’ or ‘ice’. There has been a marked increase in the use of methylamphetamine, a stimulant that can be snorted, swallowed, injected or smoked, with 9.1% of Australians reporting having used the drug.^[9] It has been estimated that there are approximately 76 000 dependent methylamphetamine users in Australia — almost double the estimated number of heroin users.

It was the diversion of significant quantities of pseudoephedrine purchased through community pharmacies into the area of illicit drug manufacture that was a major stimulus to the up-scheduling of pseudoephedrine, from Schedule 2 (Pharmacy medicine) in the 1990s, to Schedule 3 (Pharmacist Only medicine) and Schedule 4 (Prescription Only medicine) in 2006. Prior to the inclusion of pseudoephedrine products in Schedule 3 in 2006 the larger packs of the single product (pseudoephedrine 60mg tablets) were moved from Schedule 2 to Schedule 4. This move could be seen as a failure of the profession to follow good practice standards and guidelines. In 1998 seminal work undertaken by the Department of Pharmacy, University of Sydney and the School of Pharmacy and Medical Sciences, University of South Australia, supported by funding from the then Commonwealth Department of Health and Family Services, resulted in the development of Standards for the provision of Pharmacy medicines and Pharmacist Only medicine in community pharmacy. However, despite the wide dissemination and support for the standards together with advice and warnings from regulatory authorities, a significant number of pharmacists continued to supply pseudoephedrine in larger sizes (60s and 100s) with little regard for their professional responsibilities or duty of care.

The diversion of the substance resulted in major scheduling difficulties for manufacturers, pharmacists and authorities. On the one hand, the general public had access to products containing pseudoephedrine, either on its own or in combination with other compounds such as analgesics, anti-inflammatories or antihistamines, which enabled persons to treat the symptoms of minor self-limiting diseases such as the ‘flu’ and common cold. On the other hand, pseudoephedrine was a product available to the general public with relatively little restriction which could be used to produce methylamphetamine through a series of relatively simple steps in clandestine laboratories.

When it became apparent that large-scale diversion of pseudoephedrine into the area of illicit drug manufacture was taking place, there were suggestions from regulatory authorities that one way to minimise the problem would be to reschedule pseudoephedrine to a Schedule 4 Prescription Only medicine. This suggested solution was vigorously opposed by industry and to a lesser extent the pharmacy profession on the basis that any such re-scheduling would seriously disadvantage thousands of Australian who had a therapeutic need for pseudoephedrine. There was also no compelling evidence that such a move would curtail the spread of illegal drugs.^[10]

However, the growing problem posed by the availability of methylamphetamine required that some action be taken. The NDPSC decided, in 2005, that all pseudoephedrine-containing products would be re-scheduled to Schedule 3 or Schedule 4, depending on the strength of the product, the total amount of pseudoephedrine in the pack and whether or not it was in combination with other compounds. In line with this change, a number of state and territory authorities amended poisons Acts and regulations to further regulate the sale of pseudoephedrine.

Another suggestion put forward during the discussions on the re-scheduling of pseudoephedrine was for it to be replaced by phenylephrine, another sympathomimetic substance that had the advantage of not being able to be converted to methylamphetamine. To that end the TGA adopted a modified approach to the registration of products that contain phenylephrine in place of pseudoephedrine. This process only applied to products that were intended for marketing instead of, or parallel to, equivalent registered products of the same sponsor containing pseudoephedrine.

A number of Pharmacy Boards offered advice to members of the profession on strategies to minimise the risk of diversion of pseudoephedrine-containing products, including: only holding minimum stock levels and having minimum stock visible on the shelves; ensuring that a therapeutic need existed before completing a sale; and not using in-store displays to promote the sales of such product.

In addition, the Pharmacy Guild of Australia developed ‘Project STOP’.^[11] This is a decision-making tool for pharmacists aimed at minimising the use of pseudoephedrine-based products for methylamphetamine manufacture by recording sales of pseudoephedrine-containing products to allow tracking, identification and blocking of ‘pseudoephedrine runners’. These runners visit multiple pharmacies over a short period of time. Project STOP is based on an online tool that provides decision-making support to pharmacists who need to establish whether a request for pseudoephedrine-based product is legitimate. The database allows the recording of the identification card number provided by the potential purchaser and the product and the quantity requested. The database provides the pharmacist with information regarding the purchase history associated with the identification card number and a decision can then be made whether or not to conclude the sale. The database then records whether or not the sale was made. The database was originally developed in Queensland and rolled-out nationally in 2007.

At the time of writing the uptake of Project STOP Australia-wide stood at 67.13%, ranging from New South Wales at 49.71% to the ACT and Northern Territory at 100%.^[12] Refer to Table 11.2 for a summary of controls on pseudoephedrine sales.

Table 11.2 Summary of controls on pseudoephedrine sales