Action 4.14

Identify and reduce risks

Review the effectiveness of the supply chain to deliver medicines in a way that is timely and secure, and that complies with manufacturer’s instructions, and legislative and state or territory requirements for medicines.

Establish appropriate governance and oversight to ensure that medicine storage systems are safe and inaccessible to the public, and the opportunity for diversion or theft is minimised (linked to Action 4.1).

Incorporate factors that reduce opportunity for ‘look-alike, sound-alike’ selection errors when considering (linked to Action 4.15):

• Product labelling, packaging and storage
• Listing of new medicines in the formulary
• Situations of temporary replacement of a formulary medicine (for example, when medicine shortages or supply chain interruptions occur)
• Contract specification and safe procurement (for example, anaesthetic medicines)
• Availability of medicines (review of ward stock or imprest lists)
• Design and layout (including workflow and safe access) of the dispensary and ward stock rooms or cupboards, their proximity (high- or low-traffic areas), and the labelling requirements in these areas.

Ensure that specific recommendations for the safe procurement and storage of anaesthetic medicines are included in any policies, procedures or protocols, to minimise risks from these medicines (linked to Action 4.15; also see Guidelines for the Safe Management and Use of Medications in Anaesthesia).

Evaluate the use and implementation of storage or delivery systems (including automated systems) for safety, quality and security risks, including:

• ‘End-to-end’ delivery of accountable medicines, such as Schedule 8 medicines
• Automated dispensing cabinets (check these against essential requirements, such as those of the Institute for Safe Medication Practices in Medication Safety Self Assessment® for Automated Dispensing Cabinets and Guidelines for Safe Use of Automated Dispensing Cabinets
• Limiting the range of medicines suitable for pneumatic tube delivery.

Ensure that policies, procedures and protocols for safe handling, storage and distribution of medicines are evidence based and comply with legislative requirements, state or territory directives and professional guidelines. See the Society of Hospital Pharmacists of Australia’s website for useful resources.

Perform a risk assessment of the processes in place for the handling, storage and distribution of medicines using validated or locally endorsed audit and risk tools (or relevant components), such as the Medication Safety Self Assessment® for Australian Hospitals.

Monitor and evaluate processes

Perform audits of compliance with policies, procedures and protocols for handling, storage and distribution of medicines. In particular, consider temperature-sensitive medicines and safety controls, such as separating look-alike packaging or electronic alerts.

Monitor usage patterns of medicines to identify unusual fluctuations.

Conduct observation audits and walk-arounds to review security, workflow, workforce access, and approval processes for access to medicine storage areas. Take corrective action when breaches, violations or practice variations are observed.

Review incident reports for incidents associated with handling (including procurement), storage and distribution of medicines.

Review the potential for increased risk of error when changes to product labelling, packaging or storage requirements are introduced as a result of changes to procurement arrangements and contracts, product shortages, recalls or substitution. Review and implement work practices that ensure safe and secure handling (including procurement), storage and distribution of medicines (including high-risk, investigational and clinical trial medicines) – for example (also see Action 4.15):

• Making opioids available only to clinicians with authorised access
• Providing clinicians with timely access to required medicines, given the casemix and acuity of the health service organisation.

Maintain the integrity of 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 prevent 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.

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
• Transportation or transfer of temperature-sensitive medicines between storage areas or facilities
• Workforce orientation and training on cold chain management
• Action required in the event of a cold chain breach or temperature excursion.

Review organisational policies, procedures and guidelines to ensure that the integrity of temperature-sensitive medicines is maintained.

Ensure that refrigerators (or coolrooms) of adequate size are available for the exclusive storage of vaccines or medicines that require storage between 2 °C and 8 °C.

Install alarms to monitor refrigerators and coolrooms, as well as medicine storage areas (including pharmacy departments), where temperatures would ideally be maintained below 25 °C (according to the manufacturer’s instructions).

Install audible temperature alarms on refrigerators (or coolrooms) within pharmacy departments, clinical areas or as a ‘back-to-base’ mechanism to provide an early warning in the event of a temperature excursion.

Maintain power to all refrigerators and coolrooms within the health service organisation at all times.

Implement policies, procedures and guidelines for disposal of unused, unwanted or expired medicines

Review and implement work practices and distribution systems that minimise wastage of medicines, such as by regular checking of stock expiry dates and stock rotation.

Set up inventory management practices to eliminate wastage of medicines. Take a proactive and planned approach to changes to formulary listing, and conduct routine reviews of medicines use.

Review and implement work practices (for example, compounding of high-risk medicines such as multiple doses of cytotoxic chemotherapy) that minimise waste, ensure safe handling and promote the efficient use of medicines.

Review organisational policies, procedures and protocols for disposal of unused, unwanted or expired medicines to ensure:

• Minimal risk to the workforce and the environment (for example, cytotoxic chemotherapy, vaccines, hazardous substances)
• Consistency with legislative, health and safety, and state or territory requirements (for example, secure disposal of recordable [Schedule 8] medicines only by those with the relevant authority)
• Assignment of responsibility and accountability
• Consideration of situations when only part of a tablet, capsule, ampoule or infusion is required
• Appropriate waste segregation (for example, use of purpose-designed disposal bins).

Obtain patient consent for disposal of patients’ own medicines brought into the health service organisation that are not prescribed, required, or returned to patients at transfer of care or on discharge.

Include specific requirements for waste segregation and disposal of medicines in the organisation’s waste management policies and contracts. For instance, special arrangements must be made for handling and disposal of cytotoxic chemotherapy and radiopharmaceuticals.

Action 4.14b is not applicable when evidence is provided that the day procedure service does not procure and store temperature-sensitive medicines. Refer to NSQHS Standards Guide for Hospitals for more detailed implementation strategies for this element of the action.

Identify and reduce risks

Review the effectiveness of the supply chain to deliver medicines in a way that is timely and secure, and that complies with manufacturers’ instructions, and legislative and state or territory requirements for medicines.

Establish appropriate governance and oversight to ensure that medicine storage systems are safe and inaccessible to the public, and the opportunity for diversion or theft is minimised (linked to Action 4.1).

Incorporate factors that reduce opportunity for ‘look-alike, sound-alike’ selection errors when considering (linked to Action 4.15):

• Product labelling, packaging and storage
• Listing of new medicines in the formulary
• Situations of temporary replacement of a formulary medicine (for example, when medicine shortages or supply chain interruptions occur)
• Contract specification and safe procurement (for example, anaesthetic medicines)
• Availability of medicines (review of ward stock or imprest lists)
• Design and layout (including workflow and safe access) of the dispensary and ward stock rooms or cupboards, their proximity (high- or low-traffic areas), and the labelling requirements in these areas.

Ensure that specific recommendations for the safe procurement and storage of anaesthetic medicines are included in any policies, procedures or protocols, to minimise risks from these medicines (linked to Action 4.15; also see Guidelines for the Safe Management and Use of Medications in Anaesthesia.

Evaluate the use and implementation of storage and delivery systems (including automated systems) for safety, quality and security risks, including:

• ‘End-to-end’ delivery of accountable medicines, such as Schedule 8 medicines
• Automated dispensing cabinets (check these against essential requirements, such as those of the Institute for Safe Medication Practices in Medication Safety Self Assessment® for Automated Dispensing Cabinets and Guidelines for Safe Use of Automated Dispensing Cabinets
• Limits on the range of medicines suitable for pneumatic tube delivery.

Day procedure services may choose to implement existing hospital policies, procedures or protocols for safe handling, storage and distribution of medicines through a day procedure network or group, rather than relying on internally developed documentation. It will be important to ensure that requirements developed via the network or group are tailored to the local environment. The procedures should be evidence based, and in accordance with legislative requirements, relevant directives and professional guidelines.

See the Society of Hospital Pharmacists of Australia website for standards of practice and related resources.

Perform a risk assessment of the processes in place for the handling, storage and distribution of medicines using validated or locally endorsed audit and risk tools (or relevant components), such as the Medication Safety Self Assessment® for Australian Hospitals.

Monitor and evaluate processes

Perform audits of compliance with policies, procedures and protocols for handling, storage and distribution of medicines. In particular, consider temperature-sensitive medicines and safety controls, such as separating look-alike packaging or using electronic alerts.

Monitor usage patterns of medicines to identify unusual fluctuations.

Conduct observation audits and walk-arounds to review security, workflow, workforce access, and approval processes for access to medicines storage areas. Take corrective action when breaches, violations or practice variations are observed.

Review incident reports for incidents associated with handling (including procurement), storage and distribution of medicines.

Review the potential for increased risk of error when changes to product labelling, packaging or storage requirements are introduced as a result of changes to procurement arrangements and contracts, product shortages, recalls or substitution. Review and implement work practices that ensure safe and secure handling (including procurement), storage and distribution of medicines (including high-risk, investigational and clinical trial medicines) – for example (also see Action 4.15):

• Making opioids available only to clinicians with authorised access
• Providing clinicians with timely access to required medicines, given the casemix and acuity of the health service organisation.

Implement policies, procedures and guidelines for disposal of unused, unwanted or expired medicines

Review and implement work practices and distribution systems that minimise wastage of medicines, such as by regular checking of stock expiry dates and stock rotation.

Set up inventory management practices to eliminate wastage of medicines. Take a proactive and planned approach to changes to formulary listing, and conduct routine reviews of medicines use.

Review and implement work practices (for example, compounding of high-risk medicines such as multiple doses of cytotoxic chemotherapy) that minimise waste, ensure safe handling and promote the efficient use of medicines.

Review organisational policies, procedures and protocols for disposal of unused, unwanted or expired medicines to ensure:

• Minimal risk to the workforce and the environment (for example, cytotoxic chemotherapy, vaccines, hazardous substances)
• Consistency with legislative, health and safety, and state or territory requirements (for example, secure disposal of recordable [Schedule 8] medicines only by those with the relevant authority)
• Assignment of responsibility and accountability
• Consideration of situations when only part of a tablet, capsule, ampoule or infusion is required
• Appropriate waste segregation (for example, use of purpose-designed disposal bins).

Obtain patient consent for disposal of patients’ own medicines brought into the health service organisation that are not prescribed, required, or returned to patients at transfer of care or on discharge.

Include specific requirements for waste segregation and disposal of medicines in the organisation’s waste management policies and contracts. For instance, special arrangements must be made for handling and disposal of cytotoxic chemotherapy. The community pharmacy servicing the day procedure service may be able to assist by disposing of medicines through its ‘return unwanted medicines’ bin.

Examples of evidence

Select only examples currently in use:

• Policy documents about the safe and secure distribution and storage of medicines (including Schedule 8 medicines, temperature-sensitive medicines and cold chain management)
• Policy documents about the disposal of unused, unwanted or expired medicines
• Audit results of compliance with the correct storage, distribution and disposal of medicines, including patients’ own medicines
• Reports on medicine use and review of usage patterns
• Committee and meeting records in which the storage, distribution and disposal of medicines were considered
• Orientation or training documents about storage, distribution and disposal of medicines
• Examples of action taken to manage identified risks regarding the storage, distribution and disposal of medicines
• Results of analyses of incident reports relating to medicine storage and disposal.

MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt and use the established policies and processes for safe and secure storage, distribution and disposal of medicines, and storage of temperature-sensitive medicines and cold chain management.

Small hospitals that are not part of a local health network or private hospital group should:

• Identify risks associated with medicines handling, storage and distribution across the organisation, and develop and implement evidence-based strategies aimed at reducing these risks
• Implement systems and equipment that continuously monitor, and maintain the integrity of, temperature-sensitive medicines
• Implement policies, procedures and guidelines for the disposal of unused, unwanted or expired medicines.

Identify and reduce risks

Review the effectiveness of the supply chain to deliver medicines in a way that is timely and secure, and that complies with manufacturers’ instructions, and legislative and state or territory requirements for medicines.

Incorporate factors that reduce opportunity for ‘look-alike, sound-alike’ selection errors when considering (linked to Action 4.15):

• Product labelling, packaging and storage
• Listing of new medicines in the formulary
• Situations of temporary replacement of a formulary medicine (for example, when medicine shortages or supply chain interruptions occur)
• Contract specification and safe procurement (for example, anaesthetic medicines)
• Availability of medicines (review of ward stock or imprest lists)
• Design and layout (including workflow and safe access) of storage rooms or cupboards, their proximity (high- or low-traffic areas), and the labelling requirements in these areas.

Ensure that policies, procedures and protocols for safe handling, storage and distribution of medicines are evidence based and comply with legislative requirements, state or territory directives and professional guidelines. See the Society of Hospital Pharmacists of Australia’s website for useful resources.

Perform a risk assessment of the processes in place for the handling, storage and distribution of medicines using validated or locally endorsed audit and risk tools (or relevant components), such as the Medication Safety Self Assessment® for Australian Hospitals.

Maintain the integrity of temperature-sensitive medicines

Refer to the latest edition of National Vaccine Storage Guidelines: Strive for 5 and 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
• Transportation or transfer of temperature-sensitive medicines between storage areas or facilities
• Workforce orientation and training on cold chain management
• Action required in the event of a cold chain breach or temperature excursion.

Ensure that refrigerators (or coolrooms) of adequate size are available for the exclusive storage of vaccines or medicines that require storage between 2 °C and 8 °C. Alarms may need to be installed on refrigerators, coolrooms and medicine storage areas.

Maintain power to all refrigerators and coolrooms within the health service organisation at all times.

Implement policies, procedures and guidelines for disposal of unused, unwanted or expired medicines

Review and implement work practices and distribution systems that minimise wastage of medicines, such as by regular checking of stock expiry dates and stock rotation.

Set up inventory management practices to eliminate wastage of medicines. Take a proactive and planned approach to changes to formulary listing, and conduct routine reviews of medicines use.

Review and implement work practices that minimise waste, ensure safe handling and promote the efficient use of medicines.

Include specific requirements for waste segregation and disposal of medicines in the organisation’s waste management policies and contracts.