Handling and Storage of Scheduled Substances Procedure
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Handling and Storage of Scheduled Substances Procedure Handling and Storage of Scheduled Substances Procedure UNDER REVIEW Related Policy Work Health and Safety Policy Responsible Officer Executive Director – Human Resources Approved by Executive Director – Human Resources Approved and commenced April, 2018 Review by April, 2021 Responsible Organisational Unit Work Health and Safety Unit – Human Resources CONTENTS 1 Objective ................................................................................................................... 2 2 Scope ........................................................................................................................ 2 3 Procedure .................................................................................................................. 2 3.1 Classification of Scheduled Poisons .......................................................................... 2 3.2 Table 1 List of Schedules .......................................................................................... 2 3.3 Risk Assessment ....................................................................................................... 4 3.4 Induction and Training ............................................................................................... 4 3.5 Authorisation for Use ................................................................................................. 5 3.6 Purchasing ................................................................................................................ 6 3.7 Storage ...................................................................................................................... 6 3.8 Handling .................................................................................................................... 7 3.8.1 Drug Register ............................................................................................................ 7 3.8.2 Note on Dilutions ....................................................................................................... 8 3.8.3 Drug Register Auditing ............................................................................................... 8 3.9 Reporting Theft and Loss .......................................................................................... 9 3.10 Disposal ..................................................................................................................... 9 4 Definitions and Acronyms ........................................................................................ 10 5 Responsibilities ........................................................................................................ 10 6 Supporting Documentation ...................................................................................... 11 7 Versioning ............................................................................................................... 11 1 Handling and Storage of Scheduled Substances Procedure (April, 2018) Handling and Storage of Scheduled Substances Procedure 1 Objective The objective of this Procedure is to provide information to ensure the safe and appropriate storage and use of scheduled substances according to the Commonwealth’s Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP). The SUSMP includes medicines, drugs, chemicals and poisons that have restrictions in relation to public use and access. This can include implications for their purchase and use within the University. The Tasmanian Poisons Act 1971 and subordinate Poisons Regulations 2008 adopts the SUSMP in Tasmania by reference. The relevant legislation in NSW adopts the SUSMP under the Poisons and Therapeutic Goods Act 1966 No. 31 (NSW) and the Poisons and Therapeutic Goods Regulation 2008 (NSW). The local poisons legislation describes the licence, permit or authorisation requirements of these substances and the legal provisions regarding their supply, labelling, storage, record keeping and disposal. 2 Scope This procedure has been developed for use by all University workgroups as a primary reference when developing local procedures for the management of scheduled substances. Note: this document does not detail the requirements of supply, prescription or administration of a scheduled substance by a practitioner in a clinical environment. 3 Procedure 3.1 Classification of Scheduled Poisons The Poisons Standard is the legal title of the Standard of the Uniform Scheduling of Medicines and Poisons (SUSMP), it is also referred to as the Poisons List. Medicines, chemicals (including industrial use) and poisons are classified into schedules (see Table 1) which determines public access and different levels of regulatory control. Different conditions apply to the purchase, storage, labelling and disposal of these substances depending on their schedule or classification in the Standard. The schedule and label description for each substance can be found in the Safety Data Sheet and on the label. 3.2 Table 1 List of Schedules 2 Handling and Storage of Scheduled Substances Procedure (April, 2018) Handling and Storage of Scheduled Substances Procedure Schedule 1. This Schedule is intentionally blank. Schedule 2. Pharmacy Medicine – Substances (medicinal poisons), the safe use of which may require advice from a pharmacist and which should be available from a pharmacy or, where a pharmacy service is not available, from a licensed person. Requires a permit for industrial, educational, advisory or research (laboratory) purposes under the Poisons Regulations 2008 An application for permit is available from Pharmaceutical Services Branch (DHHS). Schedule 3. Pharmacist Only Medicine – Substances (‘potent substances’), the safe use of which requires professional advice but which should be available to the public from a Pharmacist without a prescription. Requires a permit for industrial, educational, advisory or research (laboratory) purposes under the Poisons Regulations 2008 An application for permit is available from Pharmaceutical Services Branch (DHHS). Schedule 4. Prescription Only Medicine, or Prescription Animal Remedy – These are restricted substances, the use or supply of which should be by, or on the order of, persons permitted by State. Requires a permit for industrial, educational, advisory or research (laboratory) purposes under the Poisons Regulations 2008 An application for permit is available from Pharmaceutical Services Branch (DHHS). Certain Schedule 4 substances have more stringent restrictions on their storage and use. Schedule 5. Caution – Substances (domestic poisons) with a low potential for causing harm, the extent of which can be reduced through the use of appropriate packaging with simple warnings and safety directions on the label. Schedule 6. Poison – Substances (industrial or agricultural poisons) with a moderate potential for causing harm, the extent of which can be reduced through the use of distinctive packaging with strong warnings and safety directions on the label. Certain substances require an authority for buying, obtaining and using, see Poisons Regulations 2008, Reg. 66. Schedule 7. Dangerous Poison– Substances with a high potential for causing harm at low exposure and which require special precautions during manufacture, handling or use. These poisons should be available only to specialised or authorised users who have the skills necessary to handle them safely. Special regulations restricting their availability, possession, storage or use may apply. A University-wide permit covers most S7 substances (included in Appendix J of the SUSMP) but some may need a specific permit. Check with the WHS Unit or Pharmaceutical Services Branch (DHHS) for further advice. 3 Handling and Storage of Scheduled Substances Procedure (April, 2018) Handling and Storage of Scheduled Substances Procedure Schedule 8. Controlled Drug – Substances (narcotic substances) which should be available for use but require restriction of manufacture, supply, distribution, possession and use to reduce abuse, misuse and physical or psychological dependence. Requires a written direction from the Vice Chancellor of the University under Section 48 of the Poisons Act 1971. Schedule 9. Prohibited Substance – Substances which may be abused or misused, the manufacture, possession, sale or use of which should be prohibited by law except when required for medical or scientific research, or for analytical, teaching or training purposes with approval of Commonwealth and/or State Health Authorities. A licence is required under the Poisons Act 1971. Schedule 10 Substances of such danger to health as to warrant prohibition of (previously sale, supply and use - Substances which are prohibited for the purpose Appendix C). or purposes listed for each poison because of their known dangerous properties. 3.3 Risk Assessment In the first instance every effort should be made to eliminate the use of hazardous chemicals. Investigation of alternative methods or the use of an alternate chemical is recommended. If an alternative is not possible then a risk assessment must be completed in consultation with the workers who could be exposed. The possession and use of highly dangerous S7 poisons, S8 narcotics and S9 prohibited substances is prescribed through regulation. The risk assessment aims to identify the potential for exposure during the planned activity and detail the control measures proposed to manage the risk, including training and supervision requirements. Once agreed and approved, control measures must be