Opinion: Why we need a National Poisons Law


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Prescribers and pharmacists have their time wasted trying to negotiate the red tape for their patients, writes Andrew Tooms

Introduction

We have in Australia six States that at federation in 1901 had separate and different legislation on almost every aspect of life, including therapeutic poisons[1]. The ACT and NT came into being later and then created their own poisons laws. On top of these eight, there is the Commonwealth. As a result there are now nine different varieties of poisons legislation.

This means that the nationally registered health practitioners who use poisons as everyday tools have to cope with the different rules in the various jurisdictions where they work. For some, who don’t change workplace often, it’s not a big problem. But for others who practise all over Australia, the differences can lead to a potentially career-ending legal error.

It’s not just health practitioners who suffer – even more importantly, patients can be detrimentally affected by the arcane differences between jurisdictions.

Why we don’t have a national poisons law

At federation, the States allowed the Commonwealth a list[2] of specific, limited powers – poisons were not in the list. What remained was the States’ responsibility. For twenty years it was thought that the States’ powers were reserved to them and difficult for the Commonwealth to impinge upon, but in 1920 the Commonwealth broke free[3] and ever since has gradually extended its legislative boundaries outwards at the expense of the States. However, the Commonwealth can only push so far: while it has constitutional power to create a system of paying for poisons[4] in the form of the Pharmaceutical Benefits Scheme, at present it has little power to control how poisons are stored, handled, used or disposed of. The main thrust of Commonwealth legislation in this area is to do with misuse,[5]  rather than therapeutic use and its power in this area is mainly derived from international treaties.

What has been done so far?

At the end of the last century, the Council of Australian Governments (COAG) commissioned a review, chaired by Rhonda Galbally, of the country’s many different poisons and therapeutics goods laws.[6] In 2000 the final report of this review was published[7] and in 2005 COAG accepted it. Many of the review’s recommendations have been acted upon, but recommendation 24 stands out as yet to be implemented – it is the call for a national poisons law to be adopted by reference by the States and Territories.

There has been some progress however. In a related recommendation, Galbally proposed that the Commonwealth’s Standard for the Uniform Scheduling of Medicines and Poisons[8] be adopted by the States and Territories – this has been done, with minor variations.[9]

Similarly,  the Review said that the Therapeutic Goods Act 1989 (Cth) should be adopted by all jurisdictions. This has been done except by Queensland and Western Australia. The former is considering it as part of the new legislation[10] currently before the Queensland parliament but the latter recently contemplated it as part of its recently commenced legislation,[11] then dropped it.[12]  It is to be hoped that Western Australia will eventually join its fellows.

What are poisons schedules?

Each poisons schedule from 1 to 10 applies a different degree of restriction upon use and possession. Schedule 2 medicines are available only from a pharmacy or in remote areas, a licensed retailer;  schedule 3 medicines are only available from a pharmacist or on prescription; schedule 4 contains medicines that are only available by prescription; schedule 8 substances are strictly controlled medicines such as morphine. Schedules 5, 6, and 7 contain things like weedkillers, insecticides and paints. Schedule 1 is empty; schedule 9 contains prohibited substances such as LSD that can be researched upon with a licence; schedule 10 contains poisons so dangerous that sale, supply, or use is prohibited.

The differences

Unfortunately, while the schedule a poison is in does not now vary from place to place, the same cannot be said of the restrictions attached to any particular poison. The Poisons Standard can be regarded as a base, from which no restrictions are taken away, but upon which States and Territories can build further constraints. It’s these differences which can cause problems.

The next few paragraphs illustrate some of the more common ones. Methylphenidate features a great deal as it has many extra restrictions placed on it and it is often prescribed for attention deficit hyperactivity disorder, a common condition of children in Australia. Methylphenidate is a schedule 8 medicine (controlled drug, controlled medicine).

It should be borne in mind that the main sufferer at the sharp end of the inefficiencies caused by the jurisdictional differences is the patient, with potential injuries to their health.

Prescribers and pharmacists have their time wasted trying to negotiate the red tape for their patients: and just sometimes, the knots in the tape are a real source of danger to their careers.

Everyday cross border inefficiencies

Methylphenidate

Consider a paediatrician who practises on the Gold Coast in Queensland. If he writes a prescription for methylphenidate to treat attention deficit disorder then he must write “Specified Condition” on the prescription,[13] but he doesn’t need to apply to the Queensland government for authority to prescribe it – he has that automatically.[14]  A Queensland pharmacist will have no trouble dispensing it.[15]

However, if the patient is from somewhere in northern New South Wales – Ballina perhaps – and goes home before getting the prescription dispensed, then a NSW pharmacist cannot legally dispense it. The reason being that prescriptions for methylphenidate must have written on them the prescriber’s NSW authority number (which must be applied for) to write prescriptions for this drug.[16]

The problem is the same in reverse – a Queensland pharmacist will not be able to legally dispense a NSW prescription for methylphenidate because although it will have a NSW authority number on it, it is very unlikely to also bear the words ‘Specified Condition” because NSW law does not require it.

Repeat prescriptions

With some exceptions, a prescription for a controlled drug[17] may be written with repeats. But in NSW,[18] Tas[19] and WA[20] the pharmacy at which such a prescription is first dispensed must retain the repeat forms (in NSW anabolic steroid prescription repeats must also be retained[21] – the only jurisdiction this is a requirement). This can be a problem if a family with a child on methylphenidate wants to go on holiday for any length of time. The repeats will be at their usual pharmacy and may not be moved easily to another pharmacy.

In WA, transfer between pharmacies is allowed but only with the permission of the Dept of Health – a slow process.[22] New South Wales law allows exemption from the retention clause, but this is not publicised, and would again require some notice to put into effect as it must be in writing. In Tasmania there is legislative provision for verbal permission from the Dept of Health to transfer repeats to another pharmacy, which is more practical.

But why should repeats be retained? The ACT, NT, Qld, SA, and Vic don’t seem to have a problem with patients looking after their own repeats.

Destroying controlled drugs

In all States and Territories except Queensland, a health professional can destroy unwanted controlled drugs with another health professional as witness (NSW only allows this in certain circumstances though, and prefers a police officer or poisons inspector as a witness in a retail pharmacy). In Queensland, controlled drugs must be sent to a government facility for destruction. Why is Queensland different?

Dispensing prescriptions from interstate

This is one of the most tangled areas of poisons law.

On the whole, there is little difficulty with unrestricted schedule 4 substances. When it comes to restricted schedule 4 substances (however they are named), and controlled drugs, life can get more difficult.

In Western Australia, it is legal to dispense a prescription for a controlled drug written in another jurisdiction (provided that it is written correctly), except for cannabis-based products, dexamfetamine, lisdexamfetamine, methylphenidate, flunitrazepam, alprazolam, methadone, or for opioid replacement therapy.[23]

There is a problem with scripts for controlled drugs written in the ACT, Tasmania, and Western Australia in that these jurisdictions do not require that the total quantity prescribed be written in words and figures e.g. 20 (twenty) tablets. If a person wants to get such a prescription dispensed outside the state, the other jurisdictions[24] have this requirement.

The Northern Territory does not normally allow any interstate prescriptions for controlled drugs or restricted schedule 4 substances.[25]  Provision exists to allow them in certain limited circumstances in cross-border areas.[26]

Tasmania goes further and does not allow interstate controlled drug, specified psychotropic substances[27] or declared restricted substances[28] prescriptions. This includes benzodiazepines, anabolic steroids, epoetin, and other drugs that are subject to abuse. Incidentally, the lists of specified psychotropic substances and of declared restricted substances are almost identical.

NSW allows prescriptions from other jurisdictions for all medicines, but as described above for methylphenidate, certain medicines must be prescribed by a NSW authorised prescriber – whose NSW authorisation must be on the prescription.

In Queensland most interstate prescriptions are allowed as long as the script is written correctly. Exceptions are stimulants such as methylphenidate as described above, and certain specified medications including clozapine, isotretinoin, and pseudoephedrine.[29]

The ACT, South Australia, and Victoria allow any scripts from interstate to be dispensed.

For a patient with little technical knowledge, it’s a lottery as to whether or not they’ll succeed in getting an interstate prescription dispensed for a S4R or S8.

Risk to health practitioners

It would be fairly easy for a locum health practitioner to make a mistake when practising in several different jurisdictions. What’s legal in one place might be illegal in another. It is also true that all the time the laws of two different jurisdictions must be taken into account – the Commonwealth and the law of the State or Territory of practice.

To continue an example from above, if a visiting specialist from the ACT, Tasmania or Western Australia writes a script for a controlled drug in one of the other jurisdictions and fails to write the quantity in word and figures because that’s what they’re used to doing, the penalty for doing so ranges from $2,000 to $15,400 depending on the jurisdiction. The risk to any pharmacist who dispensed such a prescription includes jail.

Methylphenidate in the NT

Methylphenidate is a very good example yet again. It has a standard PBS quantity of 100 x 10mg tablets, and a PBS authority will usually be given to a medical specialist for this amount. But in the Northern Territory, methylphenidate can only be prescribed and dispensed in lots of one month’s supply.[30] Visiting specialists sometimes don’t realise this and write prescriptions for a box of 100 tablets even if the dose is, for example, two tablets daily. The maximum penalty for writing the script is 100 penalty units (currently[31] $15,400) and is an offence of strict liability[32] – this means that if you did it then you’re liable, there are no mitigating circumstances. Disciplinary action would undoubtedly follow. Taking a very legalistic view, a pharmacist who dispensed such a script could face four years’ imprisonment or a fine in excess of $60,000.[33]

Penalties for dispensing an out-of-date S4 script

A prescription for a unrestricted schedule 4 substance expires one year after it was written in all jurisdictions. It is illegal to dispense it after the year is up. But even when the rules are the same in all jurisdictions, the maximum penalty for breaking the law can be wildly different. The list that follows illustrates the point. As can be seen, the fine for dispensing an out of date script in WA is 30 times greater than in NSW. Why is this acceptable? It’s certainly not rational.

ACT                               50 penalty units           $7,500 [34]

NT                                  50 penalty units           $7,700 [35]

NSW                               15 penalty units           $1,500 [36]

Qld                                 60 penalty units           $7,314 [37]

SA                                                   Cash           $5,000 [38]

Tas                                 10 penalty units           $1,570 [39]

Vic                                 50 penalty units           $7,773 [40]

WA                                                  Cash           $45,000 [41]

 

An additional layer of confusion – nomenclature

In spite of the fact that there’s a nationally accepted list of poisons in the the Poisons Standard, the names given to the various categories of substances can be remarkably different around the country. An example will suffice: any drug in schedule 4 of the Poisons Standard, depending on context and jurisdiction, is a member of the following legal categories:

●        Medicine

●        Regulated substance

●        Poison

●        S4 drug

●        Poison or controlled substance

●        S4 poison

●        Prescription drug

●        S4 substance

●        Prescription only medicine

●        Schedule 4 poison

●        Regulated good

●        Schedule 4 substance

●        Restricted drug

●        Scheduled medicine

●        Restricted substance

●        Scheduled substance

It’s as if all the jurisdictions have set out deliberately to use different terminology to each other. Subcategories also exist, but they are not listed here.

National registration of health practitioners

A strong argument for a national poisons law is that from 1 July 2010 pursuant to a decision by the Council of Australian Governments (COAG) in 2008, the various jurisdictions abolished their own registers of doctors, nurses, pharmacists etc and established the Australian Health Practitioner Regulation Agency to administer a national set of registers. All health practitioners now pay one annual fee to AHPRA and are held to a national standard for their respective profession.

Given that health practitioners now have national registration, it’s absurd that poisons used as tools every day by a whole range of health practitioners are still regulated differently in different parts of the country.

Calls for change

This article is by no means the first to make the point. In 2015 an article in the Medical Journal of Australia[42] highlighted the difficulties caused by differences in schedule 8 medicines regulations around the country; in 2016 a similar piece was published in the Journal of Pharmacy Practice and Research.[43]

COAG and poisons reform

The COAG commissioned Galbally Review does seem to have run out of steam in this area, but the Intergovernmental Agreement on Competition and Productivity-Enhancing Reforms[44] has some elements that could be used to push change (and resurrect Galbally’s recommendation 24), even if only five jurisdictions have signed up so far. Its objectives of improving standards of access, equity and quality, and and promoting efficient use of resources are particularly relevant. The resources in question are medicines for the community, which the Commonwealth pays a great deal of money for directly, and indirectly through the time taken to prescribe and dispense them. If patients can’t easily access their legitimately prescribed medicines because of State and Territory legal barriers, then the principles of equity and efficiency are not operating properly. 

Also very much to the point: the first guiding principle for human services reform is ‘A better outcome for individuals who use human services should be at the heart of service delivery.’[45]

Misuse of drugs

A secondary point that needs to be addressed is that some jurisdictions have separate legislation for poisons misuse and therapeutic use:[46] others have the two mixed together.[47]

Misuse and therapeutic use of poisons deal with some of the same substances, but do not sit comfortably together. The two subjects should be dealt with separately as is the case in the Northern Territory. Not all poisons are subject to misuse, and not all misused substances are therapeutically used. Legislation gets somewhat byzantine when misuse and therapeutic use are regulated in the same Act.

Constitutional issue

Constitution s 117 Rights of residents in States

A subject of the Queen, resident in any State, shall not be subject in any other State to any disability or discrimination which would not be equally applicable to him if he were a subject of the Queen resident in such other State.

Does this make any difference? If as discussed above, a Queensland resident tries to get a Queensland paediatrician’s methylphenidate prescription dispensed in NSW and can’t, is that unconstitutional either from the paediatrician’s point of view or the patient’s?

Change the Queensland resident to a NSW resident – is that unconstitutional?

If the prescription is a PBS prescription (which most are), paid for by the Commonwealth, does that make any difference in either case?

These are interesting questions, to which currently there are no answers. S 117 was thought to be a dead letter since one of the earliest decisions of the High Court,[48] affirmed decades later by Henry v Boehm.[49] However, two more recent cases, Street v Queensland Bar Association [50] and Goryl v Greyhound Australia Pty Ltd [51]  have breathed a little life into it.

The most recent High Court case considering s 117 is Sweedman v Transport Accident Commission,[52] but nothing new was added to the law in this respect.

S 117 and the Commonwealth

In 1992 Leeth v Commonwealth [53] looked at s 117 with regard to Commonwealth law: the majority judgment stated that the question of whether or not s 117 applies to the Commonwealth has not been decided.[54] Further,

there can be no question, specific restrictions and implications arising from the federal structure apart, that the Commonwealth may give a varying application to its laws by reference to the laws of the States.[55]

This does seem to lend legitimacy to the differing treatment of PBS scripts in different jurisdictions.  However, against this obiter is:

While it has never been decided, there is no reason to doubt that s 117 of the Constitution applies to the Commonwealth as well as to the States.[56]

The point is that the Pharmaceutical Benefits Scheme is a universal system for all Australians – is it constitutional for a State law to impinge upon a person’s ability to access that system? The National Medicines Policy[57] states as one of its objectives

  • timely access to the medicines that Australians need, at a cost individuals and the community can afford;

It is arguable that in some circumstances, State and Territory law get in the way of this objective. While policy is not law, it can inform High Court judges in their decision-making.

S 117 as it stands is a weak section of the Constitution, but with the potential to be greater than it is at present. Time will tell if, in the absence of a national law, it can be used to improve access to the PBS.

For a discussion of s 117 see Section 117 Of The Constitution: The Unfinished Rehabilitation, by Michael Mathieson.[58] A later discussion, which includes consideration of Sweedman, can be found in the Melbourne University Law Review.[59]

Uniform laws already created

The States and Territories have already created national laws for subjects as diverse as electronic transactions, children’s education and care, business names, and evidence – to name but a few. Why not poisons?

Conclusion

It is clear that a national approach to poisons regulation is needed. COAG should begin work on a national poisons law and fulfill its commitment to the Galbally Review. The new law could be issued under the Therapeutic Goods Act 1989 (Cth), in a similar fashion to the current Poisons Standard. States and Territories could then adopt it, with those that need to do so moving their misuse of drugs provisions to separate legislation.

 

Andrew Tooms BSc(Hons) LLB AACPA AFCHSM FACP is a pharmacist with a strong interest in the law. He’s worked in community, hospital and military pharmacy over many years in Victoria, the Northern Territory, NSW and now in Western Australia.

 

[1] From now on, unless otherwise stated, ‘poisons’ refers to therapeutic poisons.

[2] Constitution s 51.

[3] Amalgamated Society of Engineers v Adelaide Steamship Co Ltd [1920] HCA 54 (The Engineers Case).

[4] Constitution s 51(xxiiiA).

[5] Narcotic Drugs Act 1967 (Cth).

[6] https://www.tga.gov.au/review-drugs-poisons-and-controlled-substances-legislation-galbally-review .

[7] Rhonda Galbally, ‘National Competition Review of Drugs, Poisons and Controlled

Substances Legislation’ (Final Report, Council of Australian Governments, December 2000). 

[8] Poisons Standard 2017 (Cth) – updated frequently – issued pursuant to Therapeutic Goods Act 1989 (Cth).

[9] For instance, Western Australia has added one thing – a local medicinal plant – to schedule 4, which seems a reasonable thing to do, but it would be better if it could have been done nationally.

[10] Medicines, Poisons and Therapeutic Goods Bill 2015 (Qld).

[11] Medicines, Poisons and Therapeutics Bill 2013 (WA).

[12] Medicines and Poisons Act 2014 (WA).

[13] Health (Drugs and Poisons) Regulation 1996 (Qld) s 79(4)(k).

[14] Health (Drugs and Poisons) Regulation 1996 (Qld) s 78(1)(ba).

[15] Health (Drugs and Poisons) Regulation 1996 (Qld) s 82(2)(h).

[16] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 90.

[17] A schedule 8 substance.

[18] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 89.

[19] Poisons Regulations 2008 (Tas) r 23.

[20] Medicines and Poisons Regulations 2016 (WA) rr 23(1)(e)(i), 24(2).

[21] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 42.

[22] Medicines and Poisons Regulations 2016 (WA) r 23(1)(e)(ii).

[23] Schedule 8 medicines prescribing code 2017 (WA).

[24] Medicines Poisons and Therapeutic Goods Regulations 2014 (NT) r 10(1)(b); Poisons and Therapeutic Goods Regulation 2008 (NSW) 80(1)(c); Health (Drugs and Poisons) Regulation 1996 (Qld) 79(4)(e); Controlled Substances (Poisons) Regulations 2011 (SA) r 34(1)(d)(ii); Drugs Poisons and Controlled Substances Regulations 2017 (Vic) r 24(3)(g)(iii).

[25] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) ss 24, 57, 58 (there no restricted S4 meds at present in the NT, but provision exists for them to be declared).

[26] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 253.

[27] Poisons Regulations 2008 (Tas) sch 4.

[28] Poisons (Declared Restricted Substances) Order 1990 (Tas).

[29] Health (Drugs and Poisons) Regulation 1996 (Qld) s 193A.

[30] Code of Practice Schedule 8 Substances Vol 1 2014 (NT) pt 3.8.

[31] Penalty Units Regulations 2010 (NT).

[32] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 87.

[33] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 50.

[34] Medicines, Poisons and Therapeutic Goods Act 2008 (ACT) s 27(1)(c)(v); Legislation Act 2001 (ACT)  s 133.

[35] Medicines, Poisons and Therapeutic Goods Act 2012 (NT) s 93; Penalty Units Regulations 2010 (NT).

[36] Poisons and Therapeutic Goods Regulation 2008 (NSW) cl 40(1)(g)(iii); Crimes (Sentencing Procedure) Act 1999 (NSW) s 17.

[37] Health (Drugs and Poisons) Regulation 1996 (Qld) s 193(2)(f); Penalties and Sentences Regulation 2015 (Qld).

[38] Controlled Substances (Poisons) Regulations 2011 (SA) r 35(7)(a)(i)(B).

[39] Poisons Regulations 2008 (Tas) r 17; Penalty Units and Other Penalties Act 1987 (Tas) ss 4, 4A.

[40] Drugs, Poisons and Controlled Substances Regulations 2006 (Vic) r 30(2)(a); Sentencing Act 1991 (Vic) s 110(1); Monetary Units Act 2004 (Vic) s 5(2).

[41] Medicines and Poisons Regulations 2016 (WA) r 23(3); Medicines and Poisons Act 2016 (WA) ss 14(1), 115.

[42] Andy Hua, Finna Shen, Xiaoting Ge, ‘State-based legal requirements for Schedule 8 prescriptions: why so complicated?’ (2015) 203(2) Medical Journal of Australia 64.

[43] Denise Hope et al, ‘Borderline health: jurisdictional variation in Australian medicines legislation poses potential risks to patients and healthcare practitioners’ (2016) 46 Journal of Pharmacy Practice and Research 201.

[44] Council of Australian Governments Intergovernmental Agreement on Competition and Productivity-Enhancing Reforms 9 Dec 2016.

[45] Council of Australian Governments Intergovernmental Agreement on Competition and Productivity-Enhancing Reforms 9 Dec 2016, app B s 2(a).

[46] E.g. Medicines, Poisons and Therapeutic Goods Act 2012 (NT); Misuse of Drugs Act 1990 (NT).

[47] E.g. Drugs, Poisons and Controlled Substances Act 1981 (Vic).

[48] Davies and Jones v Western Australia (1904) 2 CLR 29.

[49] (1973) 128 CLR 482.

[50] (1989) 168 CLR 461.

[51] (1994) 179 CLR 463.

[52] (2006) 226 CLR 362.

[53](1992) 174 CLR 455.

[54] Leeth v Commonwealth (1992) 174 CLR 455, 468.

[55] Leeth v Commonwealth (1992) 174 CLR 455, 468.

[56] Westlaw, The Laws of Australia (at 11 June 2017) 19 Government, ‘5 Federal Constitutional System’ [19.5.2870].

[57] Australian Government, Department of Health and Ageing, ‘National Medicines Policy’ (2000).

[58] Michael Mathieson, ‘Section 117 Of The Constitution: The Unfinished Rehabilitation’ (1999) 27(3) Federal Law Review. http://pandora.nla.gov.au/nph-wb/20001025130000/http://law.anu.edu.au/publications/flr/Vol27no3/MATHIESON.htm

[59] Amelia Simpson, ‘The (Limited) Significance of the Individual in Section 117 State Residence Discrimination’ (2008) 32(2) Melbourne University Law Review 639. http://www.austlii.edu.au/cgi-bin/sinodisp/au/journals/MelbULawRw/2008/19.html

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2 Comments

  1. Tom Simpson
    01/11/2017

    Thanks for a really well-written article Andrew.

  2. Notachemist
    02/11/2017

    Great article Andrew.

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