Controlled Substances Advisory Council recommendations 2016-17
- proposed amendments to the Controlled Substances (Controlled Drugs, Precursors and Plants) Regulations 2014 to take account of new psychoactive substances
- amendments to the Controlled Substances (Poisons) Regulations 2011 to implement national uniform poisons controls for Schedule 5, 6 and 7 poisons
- remaking the Controlled Substances (Pesticides) Regulations 2003.
Forensic Science SA, South Australia Police and the Department for Health and Ageing proposed amendments to the Controlled Substances (Controlled Drugs, Precursors and Plants) Regulations 2014 to account of:
- inclusion of designer benzodiazepines in Schedule 9 (Prohibited Substance) of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP)
- the need to specify prescribed amounts for all drugs of dependence and take account of the forms these drugs are traded in
- the availability of new highly potent derivatives of fentanyl
- the availability of a highly potent opioid analgesic, 3,4-dichloro-N-[2‑(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700)
- changes to the national scheduling of cannabis and tetrahydrocannabinols as part of the implementation of a national framework for patient access to medicinal cannabis.
Designer benzodiazepines including those listed below have been identified as a growing class of drugs of abuse.
There is a risk of fatal overdose if these substances are ingested with other central nervous system depressants such as alcohol, opioid analgesics or 4-hydroxybutanoic acid (GHB). Flubromazolam was included in Schedule 9 of the SUSMP on 1 July 2016. The other designer benzodiazepines were included in Schedule 9 of the SUSMP on 1 October 2016.
The Council supported declaration of these substances as controlled drugs to take account of the potential for misuse and abuse, and the exceptional danger to humans associated with misuse of these substances. The Council recommended the prescribed amounts for these substances should be the same as those for the benzodiazepine, flunitrazepam, with the inclusion of discrete dosage units (DDUs).
Prescribed amounts for alprazolam, flunitrazepam, lisdexamfetamine, morphine, nabiximols (Sativex), oxycodone and tapentadol
The Council agreed the prescribed amounts for drugs of dependence (Schedule 8 poisons that have legitimate medical uses) that are traded in forms such as tablets or capsules should include DDUs. The number of DDUs for drugs of dependence should be higher than those for illegally supplied drugs such as LSD as the public health risk is lower with a pharmaceutical product. The number of DDUs for drugs of dependence should also take account of the quantity of tablets or capsules usually dispensed on a prescription.
The Council recommended:
- include DDUs in the prescribed quantities for flunitrazepam;
- the prescribed quantities for the benzodiazepine, alprazolam which is used in the treatment of anxiety and panic disorder, should be the same as for flunitrazepam, with the inclusion of DDUs;
- the prescribed quantities for lisdexamfetamine, which is used in the treatment of Attention Deficit Hyperactivity Disorder (ADHD), should be the same as those for dexamphetamine, except the Trafficable (mixed) weight should be increased to 10 grams as lisdexamfetamine is less potent than dexamphetamine;
- include DDUs in the prescribed quantities for the opioid analgesic, morphine;
- the prescribed quantities for the cannabis-derived medicine, nabiximols (Sativex) which is used in the treatment of moderate to severe spasticity in patients with Multiple Sclerosis, should be the same as those for cannabis;
- the Large Commercial (mixed) weight and Commercial (mixed) weight for the opioid analgesic, oxycodone, should be the same as those for morphine to better reflect the potency of oxycodone and include DDUs;
- the prescribed quantities for the opioid analgesic, tapentadol, should be the same as those for morphine and include DDUs.
Cannabis and tetrahydrocannabinols for human therapeutic use
The Council supported amendment to the entries for cannabis, cannabis - oil and tetrahydrocannabinol to include an exception for these substances when included in Schedule 8 (drugs of dependence) of the SUSMP. This would take account of the national scheduling of cannabis and tetrahydrocannabinols for human therapeutic use.
Fentanyl is a synthetic opioid analgesic. Several highly potent fentanyl derivatives had been seized in South Australia. These substances can cause severe respiratory depression, loss of consciousness and death in very small doses. The Council supported declaration of acetyl fentanyl, butyryl fentanyl, furanyl fentanyl, ocfentanil, para‑fluorobutyryl‑fentanyl and Fentanyls (not otherwise listed in this schedule) as controlled drugs. The Council recommended the prescribed amounts for these substances should be the same as for fentanyl.
The potent synthetic opioid analgesic, 3,4-dichloro-N-[2-(dimethylamino)cyclohexyl]-N-methylbenzamide (U-47700) had been seized in South Australia. Dangerous and life‑threatening effects including sedation, respiratory depression and loss of consciousness may occur if there is an overdose, or U-47700 is used in combination with other opioid analgesics or benzodiazepines. In November 2016 there had been at least 46 deaths in the USA associated with use of U-47700. The Council supported declaration of U-47700 as a controlled drug. This would take account of the risk of dependence and the exceptional danger U-47700 poses to humans. The Council recommended the prescribed quantities for U-47700 should be one-tenth of those for morphine as U-47700 is more potent than morphine.
Amendments to the Food Standards Code will come into operation on 12 November 2017 that will permit the sale of low tetrahydrocannabinol (THC) Cannabis sativa seeds and seed products as food. The Council was supportive of the general principle that use and sale of hemp food products should be allowed. The Council noted amendments to the Controlled Substances (Controlled Drugs, Precursors and Plants) Regulations 2014 would be needed to permit the use of low THC Cannabis sativa seeds and seed products as food.
Uniform Controls over Poisons
Harmonisation of poisons controls by states and territories was recommended by the Productivity Commission as a key reform in its Chemicals and Plastics Regulation review and was endorsed by the Council of Australian Governments to assist with achieving a seamless national economy. All jurisdictions were involved in preparing, and endorsed amendments to the SUSMP to implement national controls on Schedule 5, 6 and 7 poisons for:
- storage in retail premises
- labelling and packaging
- hawking or supply of product samples;
and the manufacture, sale, supply, purchase and use of specified paints and tinters (for example, those that contain heavy metals such as lead or cadmium).
The Council supported the amendments in the Controlled Substances (Poisons) Variation Regulations 2017 that achieve national consistency in the regulation of Schedule 5, 6 and 7 poisons and specified paints and tinters through adoption of the uniform controls published in Part 2 of the SUSMP.
The Controlled Substances (Poisons) Variation Regulations 2017 came into operation on 1 April 2017. The Controlled Substances (Miscellaneous) Amendment Act 2016 which includes an amendment that consolidated all the record-keeping requirements for retailers of Schedule 7 poisons in the Controlled Substances (Poisons) Regulations 2011 came into force on 1 April 2017.
The Controlled Substances (Pesticides) Regulations 2003 (the Pesticides Regulations) will expire on 1 September 2018. The Council of Australian Governments is undertaking reforms for consistent licensing and competency requirements for chemical users. Once this process is completed there will be consultation about implementation of the reforms at a local level. As this process is unlikely to be completed before 1 September 2018 the Council supported remaking the Pesticides Regulations with the addition of some minor and technical amendments.