Pharmaceutical Services comprises the Chief Pharmacist Unit and the Pharmaceutical Regulatory Unit. Both are units of the Legal and Regulatory Services Branch of the NSW Ministry of Health.
Collectively, the Chief Pharmacist Unit and the Pharmaceutical Regulatory Unit are responsible for the administration of the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). While the Chief Pharmacist Unit (CPU) has responsibility for the development of policies and guidelines to complement the legislation, the Pharmaceutical Regulatory Unit (PRU) is responsible for operational areas of regulatory compliance, including inspections, investigations and the issuance of a range of authorities in compliance with the legislation.
- To ensure that medicines are appropriately available to the public and are stored, distributed, prescribed and supplied in accordance with legislative requirements.
- To ensure that poisons (and other products that are potentially hazardous) are appropriately available to the public and are packed, labelled, stored, distributed and used in accordance with legislative requirements.
- To minimise harm from the use of medicines and poisons in the community through the development and implementation of appropriate policy, regulatory and educational initiatives.
- To promote the quality use of medicines in the community and health care facilities.
- To adopt best practice in regulation of medicines and poisons in NSW.
Functions of Pharmaceutical Regulatory Unit (PRU)
Administration of the NSW Opioid Treatment Program (OTP) for the treatment of opioid dependent persons, including the authorisation of medical practitioners to prescribe for individual patients.
Issuing authorities to medical practitioners to prescribe Schedule 8 opioids for chronic pain and Schedule 8 cannabis medicines.
Issuing authorities to prescribe psychostimulant drugs for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
Investigating the alleged diversion and illegal, inappropriate or unprofessional supply, administration or prescribing of medicines and poisons.
Investigating the alleged self-administration of drugs for non-medical reasons by health professionals (medical practitioners, dentists, nurses and pharmacists).
Inspecting to ensure compliance with Poisons and Therapeutic Goods legislation and for the purpose of assessing licence applications to supply poisons and/or restricted substances and licences to manufacture or supply drugs of addiction by wholesale.
Providing secretarial and administrative support for Statutory Committees (Medical Committee and the Stimulant Subcommittee of the Medical Committee).
Functions of the Chief Pharmacist Unit (CPU)
Providing expert advice on best practice medicines handling, and strategic management of emerging issues in pharmaceutical practice, policy and regulation.
Development of amendments to the Poisons and Therapeutic Goods legislation.
Development of policy and guidelines to complement Poisons and Therapeutic Goods legislation, including guidelines for handling medicines in hospitals.
Providing secretarial and administrative support for the statutory Poisons Advisory Committee.
Representation on national committees, including the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.
- The Pharmaceutical Regulatory Unit and Chief Pharmacist Unit will promote the safe use of medicines and poisons by publishing contemporary guidance materials.
- The Pharmaceutical Regulatory Unit will reduce the risk of harm from inappropriate prescribing and supply of medicines and poisons by providing advice and taking action against major breaches of legislation.
- The Pharmaceutical Regulatory Unit will reduce the diversion of medicines for unlawful purposes through targeted investigations.
Reporting on processing timeframes for authority applications
Please note that during the COVID-19 Pandemic the Pharmaceutical Regulatory Unit may not be able to meet processing timeframes as published on the website or relevant application forms.
During the reporting period 2018-2019 a total of 42,429 authority applications were processed by Pharmaceutical Regulatory Unit, including 13,317 applications and 15,644 exit notifications for the NSW Opioid Treatment Program (OTP) and 13,468 applications for an authority to prescribe other Schedule 8 drugs.
95% of applications to prescribe methadone or buprenorphine under the NSW OTP were finalised within targeted timeframes.
87% of applications to prescribe other Schedule 8 drugs were finalised within targeted timeframes.
During the reporting period 2018-2019 a total of 336 applications were received for:
- Possession and supply of Schedule 8 drugs or prohibited drugs for research and analysis purposes
- Wholesale supplies of veterinary medicines, including for use in feed mills
- Supply of medicines to masters of ships
- Privately operated paramedic services
- Use of Schedule 7 dangerous poisons
- Prescribing certain restricted substances
84% of the above authority applications were processed within targeted timeframes.
For information on applications to prescribe cannabis medicines see Approvals for authority to prescribe Schedule 8 cannabis medicines.
Regulatory compliance activity
During the reporting period 2018-2019 Pharmaceutical Regulatory Unit received 1,806 notifications or reports of potential regulatory breaches and lost or stolen accountable drugs. These ranged from minor non-compliance matters, to more substantive concerns that required further investigation or regulatory action.
In 2018-2019, 112 new investigations were initiated using a risk-based approach. During the year 2018-2019 action was taken to withdraw the authorities of 47 health practitioners to possess, supply or prescribe Schedule 4 or Schedule 8 drugs under the provisions of the Poisons and Therapeutic Goods legislation. During the period 10 health practitioners had their drug authorities restored.
In 2018-2019, Pharmaceutical Regulatory Unit Inspectors, using a risk-based approach visited:
- 8 cosmetic clinics
- 29 community pharmacies
- 15 wholesale medicine supply premises
for the purpose of auditng compliance with the Poisons and Therapeutic Goods legislation.
In response to investigations undertaken by the Pharmaceutical Regulatory Unit, 89 practitioners were referred for further action to the NSW Health Care Complaints Commission, the respective NSW Health Practitioner Council or the Veterinary Practitioners Board of NSW.