Description

This register is an essential tool for healthcare and pharmaceutical professionals in New South Wales, designed to ensure compliance with regulatory requirements for managing Schedule 8 drugs. Whether in a physical bound book form or an approved electronic format, it serves as an official record for transactions involving these controlled substances.

Key Functions

• Transaction Recording: Each entry must be made on the day of the transaction, ensuring records are kept up-to-date and accurate. Transactions include the receipt, supply, administration, destruction, and disposal of Schedule 8 drugs.
• Entry Requirements: All entries must be completed in English, legibly, and indelibly, with each entry dated and signed by the person responsible.

Management and Compliance

• Correction Protocol: Corrections are handled through marginal notes or footnotes, with no alterations or cancellations allowed, maintaining the integrity of the records.
• Page Allocation: A separate page is dedicated to each drug, form, and strength, providing clear and organized documentation.
• Location and Retention: The register must be kept at the location where the drugs are stored or used and retained for at least two years from the date of the last entry.

Security and Reporting

• Loss or Theft Reporting: Any loss, theft, or destruction of the register must be reported to the appropriate authorities promptly.
• Electronic System Standards: If used in electronic form, the system must meet standards for security, access control, audit logging, and data retention. During any electronic downtime, a compliant physical book should be used.

Common Use Cases

This register is widely used across various settings, including:

• Hospitals and licensed health facilities
• Community pharmacies
• Residential aged care facilities
• Medical, dental, and veterinary practices
• Research organisations
• Licensed pharmaceutical wholesalers

Maintenance Guidelines

• Secure Storage: Ensure the register is stored securely to prevent unauthorized access.
• Inventory Checks: Conduct regular inventory checks and reconcile stock balances.
• Retention Period: Adhere to the required retention period and report any issues as mandated by law.

Materials

For the physical version, the register comprises a bound paper book with consecutively numbered pages, providing a durable and reliable means of record-keeping. The electronic version, when used, must be a secure and compliant software system, equipped with necessary audit logging and access controls.