Updates to the Poisons Standard

A new Poisons Standard is due to come into effect on 1 February 2021. The Poisons Standard (also referred to as the Standard for Uniform Scheduling of Medicines and Poisons) is a legislative means of classifying medicines and poisons, with the following schedules relevant to clinical practice:

• Schedule 2 (Pharmacy Medicine) – substances that can be purchased from a pharmacy or licensed person without a prescription;
• Schedule 3 (Pharmacist Only Medicine) – substances that are available from a pharmacist without a prescription;
• Schedule 4 (Prescription Only Medicine or Prescription Animal Remedy) – substances that should only be used or supplied on the order of a permitted prescriber; and
• Schedule 8 (Controlled Drug) – substances that require additional restrictions to reduce abuse, misuse, or dependence.

Some of the major changes to the Poisons Standard February 2021 are summarised below.

Scheduling of triptans:

Eletriptan, rizatriptan, sumatriptan, and zolmitriptan each have a new entry in Schedule 3. This means that these agents can be provided to patients without a prescription if they have a stable, well-established pattern of symptoms. The Schedule 3 entry applies to oral preparations containing 40mg or less per dosage unit of eletriptan, 5mg or less of rizatriptan, 50mg or less of sumatriptan, or 2.5mg or less of zolmitriptan. Packs must not contain more than two dosage units. All other presentations of these medicines will remain prescription only.

Scheduling of higher strength ibuprofen preparations:

The Schedule 3 entry for ibuprofen has been amended to allow the over-the-counter supply of immediate-release preparations containing 400mg or less per dosage unit. The pack must contain no more than 12 dosage units and be labelled not for the treatment of children under 12 years of age.

Scheduling of low-dose cannabidiol:

Certain low dose cannabidiol (CBD) preparations will be down-scheduled from Schedule 4 to Schedule 3. To meet the criteria for inclusion in Schedule 3, the product must be included on the Australian Register of Therapeutic Goods (ARTG), be for use in adults, and have a maximum dose of 150mg per day. There are currently no CBD products approved in Australia that meet this criteria.

This down-scheduling follows a TGA safety review of low dose CBD. The review focused on safety rather than efficacy and did not make recommendations regarding possible indications. The review found that CBD offers a favourable safety and tolerability profile at low doses. Unlike tetrahydrocannabinol (THC), the other major cannabinoid found in cannabis, CBD does not cause psychomotor or cognitive impairment or strong psychoactive effects.

The dose cut off for inclusion in Schedule 3 is intended to prevent the use of over-the-counter CBD in conditions where medical supervision is required (e.g. epilepsy or schizophrenia), whilst also taking into account the safety of the CBD itself.

Updates to additional recommendations:

The Appendix D listing for acitretin has been updated to advise that female patients should avoid becoming pregnant in the 36 months after completing treatment.

This change from the previously recommended 24 months reflects the advice in the current acitretin product information. The update was made in response to published information indicating that the half-life of acitretin may be significantly longer than initially thought. Studies demonstrate that acitretin can be converted to etretinate in the presence of alcohol. Both acitretin and etretinate are teratogenic. However, etretinate remains in the body for longer and has a mean elimination half-life of 120 days.

Addition of new substances:

A number of new substances will be included in the Poisons Standard for the first time. This includes Schedule 4 entries for cariprazine (an antipsychotic), bilastine (an antihistamine), filgotinib (a janus kinase inhibitor), and trifarotene (a topical retinoid). A separate Schedule 4 entry has also been added for SARS-CoV-2 (COVID-19) vaccines. While any proposed vaccine for COVID-19 would be covered by the existing entry of ‘Vaccines for human therapeutic use’, a separate item has been created to maintain consistency with other vaccines specified in the Poisons Standard.

Summary:

The above scheduling changes come into effect on 1 February 2021. The current Poisons Standard can be found on the Federal Register of Legislation website.