Pharmaceutical Services Branch Newsletter - December 2020

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Electronically transmitted prescriptions

The advent of electronically transmitted prescriptions in Australia has the potential to improve the Quality Use of Medicines by prescribers, pharmacists and patients. Electronically transmitted prescriptions are an electronically transmitted and digitally signed legal order authorising the supply of a scheduled substance.

As awareness increases, members of the public will likely direct questions to prescribers and pharmacists about electronically transmitted prescriptions and how they work. Prescribers and pharmacists who wish to implement electronically transmitted prescriptions should contact their software vendor to confirm their software system has obtained approval from the Tasmanian Secretary for Health.

The Australian Digital Health Agency (ADHA) are working with professional organisations and software vendors on the adoption of electronically transmitted prescriptions into practice workflows. Prescribers and pharmacists with questions about system integration, practical implementation or technical support should contact their software vendors in the first instance, or the ADHA.

Information is available on the PSB website relating to the legal use of electronically transmitted prescriptions, including a list of software products currently approved by the Secretary for electronically transmitted prescriptions in Tasmania.

Emergency prescribing and dispensing of scheduled substances

Pharmaceutical Services Branch (PSB) have received increased reports of original hard copy prescriptions failing to be provided to dispensing pharmacists after a prescriber has issued emergency instructions (e.g. via fax or phone) to a pharmacist for dispensing under regulations 23 and 47 of the Poisons Regulations 2018.

Prescribers are reminded it is their legal obligation to send prescriptions to the dispensing pharmacist within five (5) days of issuing emergency instructions (regulations 23 and 47).

Regulations 23 and 47 are silent on the methods by which a prescriber may send a prescription to a prescribing pharmacist; however, all practitioners are expected to collaborate professionally in the provision of care to their patients.

Digital image prescriptions

Regulation 47 does not apply where digital images of prescriptions are issued by a prescriber to a dispensing pharmacist under certain conditions, as part of the interim COVID-19 Tasmanian approval to allow digital images of prescriptions.

This interim approval authorises a pharmacist to dispense from a digital image of a prescription as they would an original prescription from a prescriber, providing certain conditions are met by the prescriber. For more information, please refer to the fact sheets available on PSB’s website.

Please note, the interim approval does not apply to the prescribing of Schedule 4 declared restricted substances (S4Ds) to which Section 36 of the Poisons Act 1971 applies and does not apply to the prescribing of Schedule 8 narcotic substances (S8s).

The Tasmanian interim approval has been issued in response to the COVID-19 pandemic and complements the Commonwealth’s time-limited telehealth special arrangement. The approval commenced on 15 April 2020 and continues in force until midnight 31 March 2021 unless revoked earlier.

Continued dispensing arrangements during a public health emergency

The Commonwealth government has advised the National Health (Continued Dispensing – Emergency Measures) Determination 2020 is unchanged from the previous version has been extended until 31 March 2021. Therefore, consistent with all other Australian states and territories, regulation 53A which enables this determination will remain in place whilst a Public Health Emergency or State of Emergency is in place. Up to date information on current emergency orders can be located here

Pharmacists are reminded when supplying under this regulation they are required to label the scheduled substance in accordance with regulation 53(c) and must make an entry into in the patient record on their dispensing system in accordance with regulation 53(d).

Poisons Act 1971 compliance inspections

PSB is responsible for ensuring compliance with the Poisons Act 1971, including inspections, investigations, and issuing a range of authorities, permits and licenses in order to ensure the public is necessarily protected from harms related to medicines and poisons. Compliance inspections conducted by poisons inspectors form an important component of regulatory activity conducted by the Department.

Health practitioners will be aware that activities which are in breach of legal requirements may result in regulatory action being taken. These actions may range from improvement notices through to revocation of rights under Section 92 of the Act depending upon the extent of non-compliance.

In order to assist health practitioners managing scheduled substances in the course of their professional practice at their premises, and ensure relevant practices are safe and consistent with requirements, PSB will be producing Poisons Act 1971 Self-Inspection Checklists for various practice settings. A community pharmacy version is now available on PSB’s website.

Medical cannabis

In Tasmania, in order to allow treating practitioners the option of considering unapproved medical cannabis products as part of their treatment of patients, the Tasmanian Government developed the Controlled Access Scheme (CAS).

A central component of the CAS is that prescribing of these unapproved products in Tasmania will be restricted to medical specialists in the specific condition being treated (e.g. pain medicine specialists to treat pain). The relevant medical specialist must be present and practicing in Tasmania at the time of prescribing. As the CAS is not condition-specific, any relevant medical specialist present and practicing in Tasmania may make application to the CAS.

The CAS also requires all unapproved medical cannabis products to be dispensed from a Tasmanian Health Service pharmacy as the Tasmanian Government is the only jurisdiction in Australia subsidising the cost of these unproven medicines. Flowcharts which describe the pathway by which a patient may be assessed for treatment with these unproven products in Tasmania are available on PSB’s website.

Poisons List amendments

Several scheduling changes came into effect in Tasmania in recent months. The full version of The Poisons Standard is available on the TGA website while details regarding scheduling decisions are available on TGA Scheduling delegate's final decisions webpage.  Recent relevant changes to the SUSMP include:

Mometasone – new entry to Schedule 3, amended Schedule 4 entry

Effective 1 June 2020, the following additions and amendments were made to entries in The Poisons Standard for mometasone.

Schedule 3 – New Entry

MOMETASONE is the only therapeutically active substances in preparations for dermal use containing 0.1 percent of less of mometasone in packs containing 15g or less.

Schedule 4 – Amend Entry

MOMETASONE except when included in Schedule 2 or 3.

Paracetamol (liquid formulations) – amended Schedule 3 and Schedule 2 entries

Effective 1 June 2020, the Schedule 3 and Schedule 2 entries of The Poisons Standard for paracetamol were amended. The sections amended are summarised below, please see The Poisons Standard for the full entries.

Schedule 3 – Amend Entry

PARACETAMOL:

  • (a) when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
  • (b) in modified release tablets or capsules containing 665 mg or less paracetamol; or
  • (c) in liquid preparations for oral use except when in Schedule 2.

Schedule 2 – Amend Entry

In addition to the circumstances previously described in the entry, the following amendment was made for paracetamol for therapeutic use:

  • (a) in liquid preparations for oral use containing a maximum of 10 g of paracetamol per container;

Paracetamol (modified-release) – amended Schedule 4 and Schedule 3 entries

Effective 1 June 2020, the Schedule 4 and Schedule 3 entries of The Poisons Standard for paracetamol were amended. The sections amended are summarised below, please see The Poisons Standard for the full entries.

Schedule 4 – Amend Entry

PARACETAMOL:

  • (f) in tablets or capsules enclosed in a primary pack containing more than 100 tablets or capsules except in Schedule 2 or 3;

Schedule 3 – Amend Entry

  • (a) when combined with ibuprofen in a primary pack containing 30 dosage units or less except when included in Schedule 2; or
  • (b) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing not more than 100 tablets or capsules; or
  • (c) in modified release tablets or capsules containing 665 mg or less paracetamol enclosed in a primary pack containing more than 100 tablets or capsules intended only as a bulk medicine and labelled ‘For dispensing only’ and ‘This pack is not to be supplied to a patient’.

Hyoscine butylbromide – new entries to Schedules 4, 3 and Appendix H, amended Schedule 2 entry

Effective 1 June 2020, the following additions and amendments were made to entries in The Poisons Standard for hyoscine butylbromide.

Schedule 4 – New Entry

HYOSCINE BUTYLBROMIDE except when included in Schedule 2 or 3.

Schedule 3 – New Entry

HYOSCINE BUTYLBROMIDE in undivided preparations for oral use with a recommended single dose not exceeding 20 mg of hyoscine butylbromide in a pack containing 100 mg or less of hyoscine butylbromide when labelled for adults and children 6 years and over.

Schedule 2

HYOSCINE BUTYLBROMIDE as the only therapeutically active substance, in divided preparations for oral use, containing 20 mg or less of hyoscine butylbromide per dosage unit in a pack containing 200 mg or less of hyoscine butylbromide.

Schedule 2 – Amend Entry

HYOSCINE (excluding hyoscine butylbromide):

  • (a) for transdermal use in preparations containing 2 mg or less of total solanaceous alkaloids per dosage unit; or
  • (b) for oral use:
    1. in undivided preparations containing 0.03 per cent or less of total solanaceous alkaloids, when labelled with a dose of 0.3 mg or less of total solanaceous alkaloids and a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids; or
    2. in divided preparations containing 0.3 mg or less of total solanaceous alkaloids per dosage unit when labelled with a recommended daily dose of 1.2 mg or less of total solanaceous alkaloids.

Appendix H – New Entry

HYOSCINE BUTYLBROMIDE

Salbutamol – amended entry to Schedule 3

Effective 1 October 2020, the Schedule 3 entry for salbutamol was amended as follows in the Poisons Standard.

Schedule 3 - Amend entry

SALBUTAMOL as the only therapeutically active substance:

  • (a) in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or
  • (b) in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose; and

where supply is limited:

  • (c) for the relief of bronchospasm in patients with asthma or chronic obstructive pulmonary disease, and for acute prophylaxis against exercise-induced asthma and other stimuli known to induce bronchospasm to persons with evidence of a medically diagnosed lung condition ; or
  • (d) for the treatment of a person with a record of previous supply from a pharmacy to persons with a record of previous supply from the pharmacist ; or
  • (e) to persons authorised under a law of a State or Territory to use or supply salbutamol in the practice of their profession; or
  • (f) for use in institutional first aid; and
    where paragraph (c) or (d) applies - supply is limited to one primary pack of salbutamol per person being treated.

Melatonin – new entries to Schedule 3 and Appendix H, amended Schedule 4 entry

Effective 1 October 2020, the following additions and amendments were made to entries in The Poisons Standard for melatonin.

Schedule 4 - Amend entry

MELATONIN for human use, except when included in Schedule 3.

Schedule 3 - New entry

MELATONIN in modified release tablets containing 2 mg or less of melatonin for monotherapy for the short-term treatment of primary insomnia characterised by poor quality of sleep for adults aged 55 or over, in packs containing not more than 30 tablets.

Appendix H - New entry

MELATONIN  

If you have questions regarding the content of this newsletter please contact PSB on (03) 6166 0400 or via pharmserv@health.tas.gov.au. This newsletter is available at www.health.tas.gov.au/psbtas/publications.

I would like to take this opportunity to wish everyone a merry Christmas, and a safe and happy new year.

Sam Halliday

Acting Chief Pharmacist

4 December 2020