//Health Ombudsman releases report into medicine regulation in Queensland

Health Ombudsman releases report into medicine regulation in Queensland

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24 November 2016

A Health Ombudsman investigation has found deficiencies in the management and regulation of the most potent and addictive drugs used in the Queensland health system.

Health Ombudsman Leon Atkinson-MacEwen has released his findings following a comprehensive 18 month review into the regulatory system for scheduled medicines in Queensland. The Health Ombudsman has made 16 recommendations for how the system could be improved to better protect the health and safety of the public and health practitioners.

“My investigation focussed on schedule 8 medicines—such as opioid analgesics, benzodiazepines and psychostimulants—which are prescription drugs that have a recognised therapeutic need, but also have a higher potential for misuse, abuse and dependence,” Mr Atkinson-MacEwen said.

“During my investigation, I found a number of weaknesses in the system which posed an unacceptable risk that these potentially dangerous medicines could be subject to unauthorised access and misuse.”

Mr Atkinson-MacEwen said the system for regulating scheduled medicines in Queensland was complex and consisted of multiple agencies with overlapping policy and regulatory functions and responsibilities.

“Given the complexities of regulating scheduled medicines, there has been considerable interest from stakeholders in innovative strategies that either minimise these harms or enhance the potential monitoring and enforcement options,” he said.

“The current system used in Queensland by prescribers and dispensers is not able to alert them in real time of the potential misuse or inappropriate prescribing of schedule 8 medicines—such as prescription shopping—which can lead to delays in agencies like hospitals, the police or my office in taking action.

“In my report, I strongly recommend the Department of Health introduce a real time prescription monitoring system that will provide prescribers, dispensers, and regulators with immediate and up-to-date access to information on patients’ medication usage and doctors prescribing patterns.

“A real time system would immediately alert prescribers and dispensers to issues of misuse, oversupply, or prescription shopping and would allow them to engage with appropriate services to obtain advice or report potential misuse.

“It is evident to me that a real time monitoring system is both feasible and essential to assist in the effective and efficient management of the prescribing and dispensing of schedule 8 medicines in Queensland.”

Mr Atkinson-MacEwen said it was clear from his investigation that the regulation of scheduled medicines is an area which requires considerable development within Queensland and substantial interagency collaboration.

“One of my key recommendations is that the Department of Health establish a committee to review the roles and responsibilities of all of the agencies involved in the regulation of scheduled medicines and to develop a new framework for the regulation of medicines in Queensland.

“This review should include representatives from all key stakeholder groups including the Department of Health, Australian Health Practitioner Regulation Agency, Queensland Police Service, Office of the State Coroner, Queensland Health public health units and my office.

“There must be better alignment of policies and procedures to strengthen the regulatory environment, along with improved communication and cooperation between agencies, meaningful performance indicators, and the allocation of suitable resources to regulate scheduled medicines appropriately.”

The Health Ombudsman’s investigation also revealed that the current legislation was unsuitable for the implementation of a contemporary framework for regulating medicines, poisons and therapeutic goods in Queensland.

“The current laws are seen as ambiguous and ‘open to interpretation’ which makes it hard for healthcare providers to adapt the law into consistent policies and procedures,” he said.

“Conversely, the prescriptive wording of the Health Act 1937 and its associated Regulation was considered by healthcare providers to limit their capacity to adapt emerging technologies into their clinical practices.”

Mr Atkinson-MacEwen said the Queensland Police Service also identified current legislation as being a limiting factor in enforcement operations.

“For example, under the Health (Drugs and Poisons) Regulation 1996, it is a simple offence to possess, supply, manufacture, dispense, sell or otherwise deal with schedule 8 medicines, attracting maximum penalties of 80 penalty units. However, the Drugs Misuse Act 1986 provides for criminal penalties that include terms of imprisonment for the unlawful possession, supply, manufacture or trafficking of dangerous drugs,” he said.

“This can lead to situations where practitioners that have been charged or found guilty of offences related to the misuse of drugs are not required to disclose this status to employers or their national health practitioner registration board, allowing them to seek employment where they may come into contact with scheduled medicines.”

Mr Atkinson-MacEwen said the Department of Health had worked with his office throughout the investigation and had already commenced work to resolve some of the deficiencies of the system.

“My staff have met with the department to discuss the actions that have already been implemented, and that are planned to be implemented, as a result of my investigation,” he said.

“Based on these discussions, I am of the view that the department has a commitment to ensuring an effective and transparent regulatory framework is developed and I commend them on their willingness to work collaboratively with stakeholders to ensure the health and safety of the public is protected.”

The Health Ombudsman’s report into medicine regulation in Queensland is available from the Office of the Health Ombudsman website.

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