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Notification of amendments to the Poisons Standard in relation to New Chemical Entities (NCEs) and Salbutamol

29 September 2020

1 Amendments to the Poison Standard in relation to New Chemical Entities (NCEs)

The NCEs listed below will be included in the new Poisons Standard that will come into effect on 1 October 2020.

Note

New text is shown as green, larger font, with a horizontal line above it.

Deleted text is shown as red, smaller font, with a strikethrough.

1.1.Elexacaftor

Schedule 4 - New Entry

ELEXACAFTOR.

Index - New Entry

ELEXACAFTOR

Schedule 4

Date of effect

1 October 2020.

1.2. Onasemnogene Abeparvovec

Schedule 4 - New Entry

ONASEMNOGENE ABEPARVOVEC.

Index - New Entry

ONASEMNOGENE ABEPARVOVEC

Schedule 4

Date of effect

1 October 2020.

1.3. Opicapone

Schedule 4 - New Entry

OPICAPONE.

Index - New Entry

OPICAPONE

Schedule 4

Date of effect

1 October 2020.

1.4. Trientine

Schedule 4 - New Entry

TRIENTINE.

Index - New Entry

TRIENTINE

Schedule 4

Date of effect

1 October 2020.

2 Amendments to the Poisons Standard in relation to salbutamol

Amendment

The Schedule 3 entry for salbutamol will be amended in the new Poisons Standard that will come into effect on 1 October 2020:

Schedule 3 - Amend entry

SALBUTAMOL as the only therapeutically active substance:

  1. in metered aerosols delivering 100 micrograms or less of salbutamol per metered dose; or
  2. in dry powders for inhalation delivering 200 micrograms or less of salbutamol per dose; and

    where supply is limited:

  3. 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
  4. for the treatment of a person with a record of previous supply from a pharmacyto persons with a record of previous supply from the pharmacist; or
  5. to persons authorised under a law of a State or Territory to use or supply salbutamol in the practice of their profession; or
  6. 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.

Date of effect

1 October 2020

Reasons for the amendment

It is proposed to amend the current Schedule 3 entry for salbutamol to ease and clarify the restrictions on dispensing that were implemented in response to excessive purchasing (stockpiling) arising from the COVID-19 pandemic.

Given the evolving situation with community spread of COVID-19 in some parts of Australia and the potential for future shortages should panic buying resume, restrictions on dispensing of salbutamol inhalers will remain inforce. However, the restrictions on supply will be broadened to allow pharmacists to dispense salbutamol inhalers to persons presenting with bronchospasm associated with asthma or chronic obstructive pulmonary disease, exercise-induced asthma and other stimuli known to induce bronchospasm. As well, there is a change to the wording re previous supply to clarify that previous supply can have been from any pharmacy.

In proposing this amendment, reports to the Therapeutic Goods Administration that the current restrictions are having an unintended consequence in that supply is being restricted to people with a legitimate need to access salbutamol inhalers without a prescription, have been taken into account.

While the limit on supply will remain at one primary pack of salbutamol, to facilitate access, the one pack restriction will now apply to per person being treated.

Salbutamol will continue to be allowed to be supplied by pharmacists for use in institutional first aid or to persons who are authorised under state or territory law to possess it or supply it under lawful practice of their profession without the limit of one pack per person.

The controls on salbutamol are necessary to protect public health to ensure continued access for all patients with a legitimate need. Shortages of these products would result in significant adverse health impacts for patients with chronic conditions.