Pharmaceutical Services Unit is part of the Legal and Regulatory Services Branch of the NSW Ministry of Health. The Unit is responsible for the administration of the Poisons and Therapeutic Goods Act 1966 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW), and the development of policies and guidelines to complement the legislation.

Objectives

• 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

• 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
• issuing authorities to prescribe stimulant drugs for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
• investigating the alleged 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 (Poisons Advisory Committee and the Medical Committee)
• development of amendments to the Poisons and Therapeutic Goods legislation
• development of policy and guidelines to complement Poisons and Therapeutic Goods legislation
• representation on national committees, including the Advisory Committee on Medicines Scheduling and the Advisory Committee on Chemicals Scheduling.

Regulatory outcomes

• the Pharmaceutical Services Unit will promote the safe use of medicines and poisons by publishing contemporary guidance materials
• the Pharmaceutical Services Unit will reduce the risk of harm from inappropriate prescribing and supply of medicines and poisons by taking action against major breaches of legislation
• the Pharmaceutical Services Unit will reduce the diversion of medicines for unlawful purposes through targeted investigations.

Reporting on processing timeframes for authority applications

During the reporting period 2015-2016 a total of 30,469 authority applications were processed by Pharmaceutical Regulatory Unit, including 11,034 applications and 10,911 exit notifications for the NSW Opioid Treatment Program (OTP) and 8,018 applications for an authority to prescribe other Schedule 8 drugs.

The percentage of applications for authority to prescribe other Schedule 8 drugs that were processed within the target timeframes was not available for 2015-2016 because of changes to a major information system used to manage applications.  For other types of applications/notifications, the percentage received that were processed within target timeframes varied from 90.0% to 100%.

Regulatory compliance activity

During the reporting period 2015-2016 Pharmaceutical Regulatory Unit received 902 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 2015-2016, 77 new investigations were initiated using a risk-based approach.  During the year 2015-2016 action was taken to withdraw the authorities of 44 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 11 health practitioners had their drug authorities restored.  In response to investigations undertaken by the Pharmaceutical Regulatory Unit, 37 health practitioners were referred for further action to the Health Care Complaints Commission or to the respective Health Practitioner Council.