Pharmaceutical Services Branch Newsletter - December 2018

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This edition of the Pharmaceutical Services Branch (PSB) newsletter provides health practitioners information on PSB’s holiday season availability, poisons legislation amendments, fentanyl prescribing, the keeping of records for narcotic substances and recent scheduling changes.

Christmas and New Year

Prescribers and pharmacists are encouraged to use DORA as a clinical decision support tool to inform decisions regarding the safe supply of high-risk medicines subject to misuse. PSB will be closed from 5:00 pm 24 December 2018 through to 8:30 am 2 January 2019.

During this time if your enquiry is not urgent, please email pharmserv@health.tas.gov.au. If your call is not answered immediately, please leave a message. Messages will be checked throughout the day and your call will be responded to as soon as possible. A pharmacist will be on call at the Branch on Thursday 27 December, Friday 28 December and Monday 31 December 2018 from 8:30 am to 5:00 pm for urgent enquiries.

Legislation Amendments

In accordance with the provisions of Section 11(2) of the Subordinate Legislation Act 1992, the Poisons Regulations 2008 expire on 17 December 2018. These regulations were remade as the Poisons Regulations 2018 effective from 17 December 2018. This remake includes some changes to correct out of date references and minor changes to improve the administration of the Poisons Act 1971. These types of changes to the regulations occur on a regular basis throughout the year. The numbering of the Poisons Regulations 2018 will have differences when compared to the 2008 regulations, but the content of the regulations remain mostly unchanged.

The regulations will be available at the Tasmanian Legislation website Legislation on this site is usually updated within three working days after a change to the legislation.

Changes which prescribers and pharmacists should be aware of include:

  • The timeframe in which a prescriber is required to provide a written prescription in relation to emergency prescribing has been increased from 24 hours to five days.
  • A new sub-regulation has been included to permit the use of a medication chart as a prescription for a narcotic substance within medical institutions consistent with the adoption of Pharmaceutical Benefits Scheme approved hospital medication charts.
  • An amendment to allow for greater community availability of Schedule 3 adrenaline for treatment of anaphylaxis and Schedule 3 naloxone for the treatment of opioid toxicity
  • An amendment to require prescribers to include the date of birth of the patient when issuing prescriptions for schedule 4 substances. Including a patient’s date of birth on prescriptions assists pharmacists in accurately identifying the patient as well as providing an important clinical detail. This amendment received majority support from the relevant professional organisations. To facilitate this change, PSB has engaged the Medical Software Industry Association and understands there will be a lead in time for prescribing software to include this patient information on computer generated prescriptions. Please note that PSB will not be actively enforcing this amendment whilst the necessary software and practice changes take place over the coming twelve months.

Fentanyl prescribing

Fentanyl is a potent opioid with significant risks of dangerous sedation, respiratory depression, falls, accidental overdose and preventable death when prescribed inappropriately or in combination with other sedating medications. There is evidence that deaths in Australia caused by fentanyl are increasing.

Prescribers are reminded that fentanyl (except in the case of a patient with cancer) is included in Regulation 24 (previously Regulation 19) of the Poisons Regulations 2018. A prescriber must not issue a prescription for a substance listed in Regulation 24 without obtaining prior authorisation from the Secretary for Health for each patient under Section 59E of the Poisons Act 1971.

For a Section 59E application to be approved recent written support from a specialist medical practitioner in the relevant field of medicine is required. Prescribers should ensure they are familiar with the requirements of Regulation 24 and the substances listed in this regulation.

Records for narcotic substances

Regulation 18 of the Poisons Regulations 2018 details persons who must keep a narcotic substances register and how this register is to be used. Please ensure you are familiar with the requirements of this regulation.  Common discussion points raised during inspections of registers include:

  • Each entry in a narcotic substances register is to be made as soon as practicable after the occurrence of the event to which it relates and, in any event, not later than 48 hours after the occurrence of that event by the person responsible for the transaction.
  • A narcotic substances register must be in the form approved by the Secretary for Health and subject to the rules contained in the Regulations. The use of any other form of register must be approved by the Secretary for Health prior to use (including electronic registers).
  • Every record, prescription, invoice and other document relating to any transaction involving any narcotic substance must be kept for not less than two years from the latest date on which it was made or acted upon.
  • There is currently no national standard relating to scanning and electronic retention of these records.  As such, these records are required to be kept in the original form, and should not be scanned and destroyed prior to expiry of the two year period.

Poisons List amendments and labelling exemptions

Poisons List amendments

A number of scheduling changes came into effect in Tasmania over 2018. The full version of the SUSMP is available online on the Australian Government's Therapeutic Goods Administration (TGA) - SUSMP website while details regarding scheduling decisions are available on the TGA's Scheduling delegate's final decisions website.  Recent relevant changes to the SUSMP include:

  • BUDESONIDE (implementation date 1 February 2019)
    Schedule 2 – Amendment
    BUDESONIDE in aqueous nasal sprays delivering 64 micrograms or less of budesonide per actuation when the maximum recommended daily dose is no greater than 400 micrograms, for the prophylaxis or treatment of allergic rhinitis for up to 6 months in adults and children 12 years of age and over.
    Schedule 4 – No Change
    BUDESONIDE except when included in Schedule 2.

Labelling Exemptions

Voltaren Osteo® Gel 12 Hourly® topical gel (100g or 150g sizes) labelled as a Pharmacy Only Medicine may be supplied in Tasmanian pharmacies as an Unscheduled Medicine. This exemption applies until the stock of containers of the product that are incorrectly labelled are exhausted and, in any case, no later than 31  March  2020.

If you have any questions regarding the content of this newsletter please contact PSB on (03) 6166 0400 or via email at pharmserv@health.tas.gov.au.

PSB wishes all pharmacists and prescribers a happy and safe festive season.

Sam Halliday
Acting Chief Pharmacist
18 December 2018