National Health (Medication chart prescription trial hospital) Amendment Declaration 2015 (PB 54 of 2015)

Overview

The National Health (Medication chart prescription trial hospital) Amendment Declaration 2015 amends the National Health (Pharmaceutical Benefits) Regulations 1960 to include additional public and private hospitals as part of a trial for paper-based medication chart prescriptions. This trial aims to streamline the prescribing process within hospitals under the Pharmaceutical Benefits Scheme (PBS) and the Repatriation PBS (RPBS), thereby reducing duplication and improving workflow for health professionals, which in turn can lead to better health outcomes for patients. The declaration is a legislative instrument under the Legislative Instruments Act 2003, and it is compatible with human rights as it supports the right to the highest attainable standard of physical and mental health by providing more efficient access to medicines through the PBS. The amendment follows consultation with the Australian Commission on Safety and Quality in Health Care and relevant stakeholders, ensuring that participating hospitals meet the necessary criteria, including IT system readiness.

Scope and Application

The National Health (Medication chart prescription trial hospital) Amendment Declaration 2015 amends the National Health (Pharmaceutical Benefits) Regulations 1960 to designate specific approved hospitals as 'listed approved hospitals' for the purpose of participating in a trial concerning the use of paper-based medication chart prescriptions within public and private hospitals. This trial is intended to facilitate the prescribing, dispensing, and claiming of pharmaceutical benefits through hospital medication charts, thereby eliminating the need for a separate prescription for PBS and RPBS purposes. The amendment includes the addition of certain hospitals to the trial list, as well as the removal of others, based on criteria such as IT system software readiness, ensuring trial safety and quality. This legislative instrument applies to approved hospitals participating in the trial and aims to enhance efficiency and health outcomes for patients by streamlining the prescription process for health professionals. The declaration is consistent with the human rights protections under the International Covenant on Economic, Social and Cultural Rights by supporting the right to the highest attainable standard of health through improved access to medications and streamlined healthcare processes. The amendments are made under the authority of the National Health (Pharmaceutical Benefits) Regulations 1960 and are effective from 1 July 2015.

Key Provisions

The primary operative sections of the National Health (Medication chart prescription trial hospital) Amendment Declaration 2015 (the Declaration) involve amendments to the list of hospitals participating in the PBS Hospital Medication Chart trial. Section 3 of the Declaration amends the list by adding certain approved public and private hospitals as listed approved hospitals for the purpose of the trial, while also removing some hospitals from the trial. The Regulations under which the Declaration operates, specifically subregulation 59(3) of the National Health (Pharmaceutical Benefits) Regulations 1960, allow the Minister to designate hospitals as listed approved hospitals for medication chart prescriptions. This permits the use of medication chart prescriptions for prescribing, dispensing, and claiming pharmaceutical benefits for patients in or at approved hospitals, thus avoiding the need for separate PBS prescriptions. The Declaration imposes specific obligations on the parties and entities it governs, primarily the hospitals participating in the trial. Each hospital must ensure that it meets the required criteria, including having the necessary IT system software upgrades, to participate in the trial safely and effectively. The Australian Commission on Safety and Quality in Health Care (ACSQHC) plays a critical role in selecting and consulting with hospital trial sites to ensure they meet all necessary criteria. Hospitals that are selected must comply with the clinical trial site selection criteria set by the ACSQHC. These obligations are intended to maintain the scope and purpose of the trial, ensuring that the use of medication charts leads to improved health outcomes and increased efficiencies for health professionals. The Declaration does not explicitly outline specific offences, penalties, or civil/criminal consequences for breaches. However, it is reasonable to infer that non-compliance with the trial requirements could result in the hospital being removed from the trial, potentially impacting their ability to participate in future trials or benefit from efficiencies gained through the trial. Additionally, any failure to adhere to the necessary IT system upgrades or clinical trial criteria could result in compromised patient safety and quality of care, leading to broader healthcare regulatory repercussions. The primary focus of the Declaration seems to be on ensuring that hospitals meet the necessary standards to participate in the trial, rather than detailing specific penalties for non-compliance.