Action 3.17 |
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The healthcare service that prescribes, supplies and/or administers medicines complies with manufacturer’s instructions, legislative and jurisdictional requirements for the:
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Note: This action is only applicable if your healthcare service prescribes, stores, supplies and/or administers medicines.
The prescribing, supply, storage and administration of medicines is regulated by legislation and jurisdictional requirements. These include:
- Therapeutic Goods Act 1989, Regulations and Orders set out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. This includes the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling and product appearance
- Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – commonly known as the Poisons Standard, collates decisions regarding the classification of drugs and poisons into different Schedules, and are included in relevant legislation of states and territories
- Poisons and controlled substances legislation in each state and territory. State and territory medicines and poisons regulation units – describe the legislative framework for who can prescribe, store, supply and administer medicines, based on the classification into different Schedules.
In addition, risks related to the prescribing, storage, supply and/or administration of medicines should be identified, recorded and mitigated where possible. For example, ‘look-alike, sound-alike’ (LASA) medicines are inherently at higher risk of errors in prescribing and supply. Strategies such as distinct signage, or separation of LASA medicines in storage areas may reduce the risks of these errors occurring. Guidance developed by the Commission outlines strategies and principles developed to address safe selection and storage of all medicines, including LASA medicines.
Temperature-sensitive medicines
Having effective processes in place will ensure that problems are detected early, responded to promptly, and managed before the integrity (safety, quality, potency and efficacy) of temperature-sensitive medicines is compromised.
Effective storage and response requirements will minimise the risk of ineffective vaccines or medicines being administered. Specific guidance is included in the latest edition of National Vaccine Storage Guidelines: Strive for 5.
Healthcare services should develop guidance on effective processes to ensure the integrity of the cold chain that includes:
- Audits of temperature control of storage facilities, including room temperature, refrigeration and frozen storage
- Regular testing and maintenance schedules for temperature alarms and temperature recording devices
- Safe transportation or transfer of temperature-sensitive medicines between storage areas or facilities (this could include receipt from manufacturers or wholesalers)
- Workforce orientation and training on cold chain management
- Action required in the event of a cold chain breach or temperature excursion.
Refrigerators (or cool rooms) of adequate size should be made available for the exclusive storage of vaccines or medicines that require storage between 2 °C and 8 °C, or lower temperatures where required. Alarms may need to be installed on refrigerators, cool rooms and medicine storage areas to alert of temperature changes. Systems and processes should be in place to maintain power to all refrigerators and cool rooms within the healthcare service at all times, with specific attention to active monitoring and contingency plans in instances of power outage, refrigeration failure or temperature changes that may compromise stored vaccines or medicines.
Implement policies, procedures and guidelines for disposal of unused, unwanted or expired medicines
Healthcare services that store medicines should review and implement work practices and distribution systems that minimise wastage, for example, by regular checking of stock expiry dates and stock rotation. Services should establish inventory management practices to eliminate wastage of medicines, such as minimising oversupply, and take a proactive and planned approach to changes to and routine review of the list of medicines held. The service should monitor usage patterns of medicines to identify unusual fluctuations and act based on this information.
The service should review and implement work practices that minimise waste, ensure safe handling and promote the efficient use of medicines. This includes consideration for the specific requirements for waste segregation and disposal of medicines.
- How does your healthcare service ensure that all medicines (including temperature-sensitive medicines) are stored and handled according to manufacturer’s’ directions?
- How does your healthcare service manage and report risks associated with the storage of medicines?
- How does your healthcare service ensure that processes for medicines disposal are consistent with state or territory requirements and the manufacturer’s instructions?
- Identify relevant legislative, regulatory and state or territory requirements and risks associated with medicines handling, storage and distribution across the organisation, and develop and implement evidence-based strategies to comply with requirements and reduce or mitigate these risks.
- Implement systems for storage and purpose-built equipment that continuously monitors and help to maintain the integrity of temperature-sensitive medicines.
- Implement policies, procedures and guidelines for the disposal of unused, unwanted or expired medicines.
The type and comprehensiveness of evidence used is dependent on each healthcare service context. The content and complexity of the policies and processes will likely depend on the size of the healthcare service, but could include:
- Access to relevant poisons legislation
- Evidence that medicines are stored and secured in accordance with legislation (for example, Schedule 4 medicines out of reach of public, Schedule 8 medicines in a lockable safe)
- Evidence of professional qualifications of workforce handling Schedule 8 medicines
- Process for the management and disposal of unused, unwanted or expired medicines
- Examples of risk management or incident records in which the storage, distribution and disposal of medicines were considered, and action taken to improve clinical safety
- Orientation or training documents about storage, distribution and disposal of medicines
- Examples of action taken to manage identified risks regarding the storage (including secure storage), distribution and disposal of medicines
- Observation of workforce access to infrastructure and equipment necessary to comply with legislative requirements, policy, procedures and/or protocols, or documented agreement (contract) with a facility that provides a compliant disposal service
- Record of routine temperature monitoring and scheduled maintenance of the refrigerators used to store medicines and vaccines
- Records of supply of medicines.
Commission resources
- National Tall Man Lettering List – a typographic technique that uses selective capitalisation to help make LASA medicine name pairs easier to differentiate. The Commission developed the List to help clinicians reduce the risk of medicine selection errors for medicines with LASA medicine names.
- Principles for the safe selection and storage of medicines: Guidance on the principles and survey tool – provides information on the strategies and principles to ensure safe storage and selection of medicines. The principles developed for health service organisations can be applied within community pharmacy or other settings where medicines are stored by healthcare service providers.
Other resources
- Australian Government Department of Health: Therapeutic Goods Act 1989, Regulations and Orders – set out the legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. This includes the requirements for inclusion of therapeutic goods in the Australian Register of Therapeutic Goods, including advertising, labelling and product appearance.
- Australian Government Department of Health: Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) – commonly known as the Poisons Standard, collates decisions regarding the classification of drugs and poisons into different Schedules, and are included in relevant legislation of states and territories.
- Australian Government Department of Health: Contacts for State/Territory medicines & poisons regulation units – details relevant poisons and controlled substances legislation in each state and territory, which describe the legislative framework for who can prescribe, store, supply and administer medicines, based on the classification into different Schedules.
- Australian Government Department of Health: National Vaccine Storage Guidelines: Strive for 5 – provides information and advice for vaccine storage management for Australian immunisation service providers.
- Australian Government Department of Health: The Return Unwanted Medicines (RUM) – a project funded by the Australian Government ensures that unwanted medicines are disposed of in accordance with regulatory and state or territory environment protection authority requirements.