Controlled Substances (Poisons) (Real Time Prescription Monitoring) Variation Regulations 2020

Consultation on the Controlled Substances (Poisons) (Real Time Prescription Monitoring) Variation Regulations 2020 is now open.

To implement a Real Time Prescription Monitoring (RTPM) system in South Australia, the RTPM Project Team in the Drugs of Dependence Unit (DDU) is seeking feedback on changes to the Controlled Substances (Poisons) Regulations 2011 by 10am Friday 14 August 2020.

Note: The RTPM Project Team specifically request submissions from prescribers who believe they should be considered for exemption from this new reporting requirement.

In addition, stakeholder feedback on the intention to mandate the use of ScriptCheckSA, and whether 12 months is an appropriate transitional period is sought.

Background

In 2018, the Government committed $7.5 million over three years to implement a Real Time Prescription Monitoring (RTPM) system in South Australia to reduce the risk of addiction, overdose and death associated with legitimate use of prescribed drugs of dependence (Schedule 8 drugs) in our community. This comes as the number of deaths and hospitalisations attributed to pharmaceutical opioid use now exceed that of illegal opioid use such as heroin. 

ScriptCheckSA is the name of South Australia’s real time prescription monitoring computer system. ScriptCheckSA is a secure system which will provide prescribers and pharmacists with real time information about a patient’s use of certain high-risk medicines when they are considering prescribing or dispensing these medicines. ScriptCheckSA will support more appropriate clinical decisions, and ensure that patients who genuinely need these medicines can still get them. ScriptCheckSA will not advise the health practitioner on whether or not to prescribe or dispense a monitored medicine; this decision will still remain with the health practitioner.

To enable the implementation of ScriptCheckSA, the Controlled Substances (Poisons) Regulations 2011 require amendment.

Proposed Legislative Change

The purpose of this consultation is to seek feedback on the five main amendments (summarised below) required to implement ScriptCheckSA, as presented in the Controlled Substances Poisons (Real Time Prescription Monitoring) Variation Regulations 2020 (PDF 35KB) (with further detail in the supporting Consultation Paper) (PDF 181KB).

  • Monitored Drugs
    ScriptCheckSA will monitor prescribing and dispensing history for all Schedule 8 drugs and selected Schedule 4 drugs which have an increased risk of harm when co-prescribed with S8s. This list is consistent with those monitored in Queensland and Victoria.
  • Information Recording
    Currently all prescribers and pharmacists are required to record defined information for Schedule 8 drugs prescribed or dispensed. This information will now be required to be recorded for all the ScriptCheckSA monitored drugs when prescribed or dispensed.
  • Information Reporting
    The reporting requirements for pharmacists will remain but will be extended to include all monitored drugs.

Prescribers will be required to report the information they record when prescribing monitored drugs to the regulator for the purposes of ScriptCheckSA.

For the majority of prescribers and pharmacists this will not change (but may reduce) existing workflows as the information on monitored drugs will be directly captured by their existing clinical software and sent to the ScriptCheckSA system. For prescribers that are not using integrated clinical software, exemptions to the data reporting requirement are being considered.

The RTPM Project Team specifically request submissions from prescribers who believe they should be considered for exemption from this new reporting requirement.

  • Information Sharing and Access
    The Variation Regulations specify who can share information, what can be shared, and when information can be shared. This will provide clarity for prescribers and pharmacists as well as build patient confidence that their data is not accessed nor shared for inappropriate uses.
  • Penalties
    A number of expiations have been included in the Variation Regulations and the maximum penalty for not recording and reporting information to the regulator has been increased to reflect the seriousness of the offences and also to align with other offences in the Controlled Substances Act 1984.

Submission Criteria

Written submissions, including your name, position and organisation (if relevant) should be emailed to health.rtpm@sa.gov.au or posted to RTPM, HPLS, PO Box 6, Rundle Mall, Adelaide, SA 5000.

Support for, comments, or proposed amendments to the variation regulations should be provided with supporting evidence where appropriate.

Comments are requested by 10am Friday 14 August 2020.