Action 4.15

Regularly assess use and misuse of high-risk medicines

Set up a structured framework for monitoring and review of high-risk medicines (and the frequency of these reviews) as part of routine governance of medication management (see Action 4.1). This could include:

• Monitoring and analysis of incident reports and logs
• Monitoring occurrence and reporting of ADRs (see Actions 4.7, 4.8 and 4.9)
• Monitoring of published literature, including websites and bulletins from medication safety and patient safety organisations such as the Institute for Safe Medication Practices (which offers subscriptions to a regular bulletin)
• Assessing local situations regarding alerts, advisories and reports
• Conducting risk assessments and audits
• Conducting a failure mode and effects analysis on, for example, a new high-risk medicine or a high-risk process associated with medicine use.

Use validated indicators, such as the National Quality Use of Medicines Indicators for Australian Hospitals (indicators 1.3, 1.4, 1.5, 2.3, 3.6, 4.1, 4.2, 5.4, 6.1, 7.1, 7.2 and 7.4) and local, or state or territory indicators.

Perform audit and risk assessment of high-risk medicines using validated or locally endorsed audit and risk tools (or relevant components), such as:

• Medication Safety Self Assessment® for Australian hospitals
• Medication Safety Self Assessment® for antithrombotic therapy in Australian hospitals
• International Medication Safety Self Assessment® for oncology.

Refer to and adapt existing international assessments, audit tools or indicators that might be suitable for the health service organisation, such as those from the Institute for Safe Medication Practices, the National Health Service (NHS) National Patient Safety Agency, NHS Trusts and the Institute for Healthcare Improvement.

Perform audits of compliance with:

• Policies, procedures and protocols for storing, prescribing, dispensing, administering and monitoring specific high-risk medicines such as anticoagulants, aminoglycosides, chemotherapy, opioids, concentrated electrolytes and insulin
• Recommendations from national alerts on high-risk medicines (for example, potassium chloride, vincristine)
• Specific storage requirements for high-risk medicines, such as safety controls or segregation of concentrated electrolytes (for example, injectable potassium chloride) and physical security restricting access to opioids
• Documentation and records retention requirements (for example, drugs and poisons legislation)
• Procedures for labelling injectable medicines, fluids and lines.

Review and implement work practices relating to high-risk medicines that ensure:

• Appropriate storage and safe delivery systems for medicines such as anaesthetics, neuromuscular blocking agents, anticoagulants, aminoglycosides, cytotoxic chemotherapy (for example, vincristine), opioids and insulin
• Storage of, and access to, high-risk medicines comply with legislative requirements (for example, opioids only available to clinicians with authorised access)
• Safe prescribing (for example, standardised or specialised charts, using protocols or standard sets, electronic prescribing, dose-calculating tools)
• Accuracy in medicine selection and dispensing (for example, using barcode or similar product scanning technology, using Tall Man lettering)
• Appropriate controls are in place for compounding high-risk medicines (for example, using commercially available products or ready-to-administer preloaded syringes, standardised single concentrations for infusions, adhering to good manufacturing practices, using National Association of Testing Authorities–certified cytotoxic containment cabinets or similar, spill containment procedures)
• Safe procurement practices (for example, avoiding look-alike packaging for high-risk medicines, especially those used in high-risk procedures such as sedation)
• Safe administration (for example, appropriate use of equipment such as infusion pump drug libraries, oral liquid dispensers, line labelling for routes of administration, epidural lines without injection ports, standardised premixed solutions, independent double checks, principles of ‘time out’).

Develop and implement evidence-based risk-reduction strategies

Use or adapt tools that have been developed to identify the organisation’s list of high-risk medicines, and make the list available to clinicians. Tools include the NSW Health High-risk Medicines Management Policy and the Institute for Safe Medication Practices List of High-Alert Medications in Acute Care Settings.

Determine which contributing factors (environmental, task, individual, team) underlie high-risk medicine-related incidents to assist the development of strategies and policies specific to the health service organisation that can be used to deal with these factors on several levels (see Action 4.2).

Implement a combination of risk reduction strategies that includes low-leverage (education) and high-leverage (NIMC, decision support software) standardisation processes¹, practices and products for medication management (for example, implementation of Tall Man lettering, use of smart infusion pumps).

Develop policies, procedures and guidelines

Implement high-risk medicine-related policies, procedures, guidelines and safe work practices that are evidence based, have been developed in collaboration with relevant clinicians, and include:

• Identifying and regularly reviewing a high-risk medicines list (which can be class or medicine specific) that reflects a subset of the organisation’s usual range of medicines
• Assessing and rating risks for individual high-risk medicines, their class and system risk(s), and how these risks are to be mitigated (for example, how to avoid medicine misuse for aminoglycosides or opioids, which is likely to be associated with devastating patient outcomes)
• Training requirements (for example, for the prescribing and administration of cytotoxic chemotherapy), including orientation and ongoing education on medication safety (for example, training and assessment of competence using simulation)
• Labelling and storage requirements (for example, implementing the National Standard for User-Applied Labelling of Injectable Medicines, Fluids and Lines, separate storage of highly concentrated electrolyte solutions such as injectable potassium chloride or magnesium)
• Patient-specific protocols for monitoring requirements that will ensure a prompt response to adverse events or side effects associated with treatment
• Availability of antidotes and reversal agents, and rescue protocols
• Work practice restrictions and access authorities, as necessary
• Incident reporting requirements
• Management of breaches, violations or practice variations.

Incorporate factors that contribute to safer use of high-risk medicines, or that reduce the opportunity for misuse or error, when considering:

• Medicines on the formulary (for example, listing a new medicine, contract specification and procurement, temporary replacement during a shortage)
• Availability of medicines (prescribing restrictions, review of ward stock or imprest lists and stock levels)
• Design and layout of the dispensary and ward stockrooms or cupboards, and labelling requirements in these areas, including selection of medicine distribution system (individual dispensing, bedside locked drawers, automated medicine cabinets)
• Alerts in electronic medication management systems.

Consider protocols for vulnerable populations, including patients who are older or obese, or children.

Analyse incidents

Investigate incidents involving high-risk medicines, analyse the frequency and causal factors, and implement strategies to mitigate risks associated with high-risk medicine-related incidents.

Use recommendations from high-risk medicine-related incident analysis to make relevant system-wide changes within the organisation.

Apply safe and robust design principles to processes. Ensure that recommendations from national, state or territory and local policies, alerts, incident reports and audits are actioned.

Communicate about high-risk medicines

Provide feedback for clinicians on high-risk medicine-related incidents and risk prevention strategies.

Promote medication safety awareness of high-risk medicines through regular communication to clinicians via memos, alerts, fact sheets, email broadcasts, newsletters, posters, presentations, in-house education sessions, awareness campaigns, lanyards or screensavers.

Tailor communications on high-risk medicines for patients and carers, which might include instructions on monitoring symptoms or side effects, and when to ask a clinician for assistance.

Monitor effectiveness and performance

Re-audit as necessary to show that recommended strategies for improvement have been implemented and outcomes sustained.

When assessing the effectiveness of strategies, establish both outcome and process measures, and routinely collect data to assess the effectiveness of risk reduction strategies for high-risk medicines. Share results as part of the governance of medication management (see Actions 4.1 and 4.2).

Action 4.15b will not be applicable for day procedure services that provide evidence as part of Action 4.15a that the service does not store, prescribe, dispense or administer high-risk medicines.

Day procedure services should use their incident reporting system to monitor and identify any medicines that have a high risk of causing significant patient harm if they are used in error.²

The Institute for Safe Medication Practices provides a number of examples of high-risk medicines outside the acute hospital setting.

Tools that have been developed to identify the organisation’s list of high-risk medicines are available on the Commission website – High-risk medicines

Regularly assess use and misuse of high-risk medicines

Set up a structured framework for monitoring and review of high-risk medicines (and the frequency of these reviews) as part of routine governance of medication management (see Action 4.1). This could include:

• Monitoring and analysing incident reports and logs
• Monitoring occurrence of, and reporting on, ADRs (see Actions 4.7, 4.8 and 4.9)
• Monitoring published literature, including websites and bulletins from medication safety and patient safety organisations, such as the Institute for Safe Medication Practices (which offers subscriptions to a regular bulletin)
• Assessing local situations in relation to alerts, advisories and reports
• Conducting risk assessments and audits
• Conducting a failure mode and effects analysis on, for example, a new high-risk medicine or a high-risk process associated with medicine use.

Refer to hospital tab for more detailed implementation strategies for this action.

Examples of evidence

Select only examples currently in use:

• Policy documents about identifying, storing, prescribing, dispensing, administering and monitoring high-risk medicines
• List of high-risk medicines used in the health service organisation
• Audit results of compliance with policies, procedures, protocols and guidelines for documenting, storing, prescribing, dispensing, administering and monitoring high-risk medicines
• Results of audits or risk assessments of high-risk medicines
• Examples of implementation of alerts or advisories relating to high-risk medicines
• Committee and meeting records in which high-risk medicines were discussed
• Results of analysis of incidents involving high-risk medicines
• Orientation or training documents about high-risk medicines
• Feedback to the workforce about incidents associated with high-risk medicines and risk prevention strategies
• Examples of communication (including education) with patients and carers about high-risk medicines.

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 identifying high-risk medicines and managing the associated risks.

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

• Identify and regularly assess the use and misuse of high-risk medicines in relation to storage, prescribing, dispensing and administration
• Develop and implement evidence-based risk reduction strategies for high-risk medicines.

Regularly assess use and misuse of high-risk medicines

Set up a structured framework for monitoring and review of high-risk medicines (and the frequency of these reviews) as part of routine governance of medication management (see Action 4.1).

Review and implement work practices relating to high-risk medicines that ensure:

• Appropriate storage and safe delivery systems for medicines such as anaesthetics, neuromuscular blocking agents, anticoagulants, aminoglycosides, cytotoxic chemotherapy (for example, vincristine), opioids and insulin
• Storage of, and access to, high-risk medicines comply with legislative requirements (for example, opioids only available to clinicians with authorised access)
• Safe prescribing (for example, standardised or specialised charts, using protocols or standard sets, electronic prescribing, dose-calculating tools)
• Accuracy in medication selection and dispensing (for example, using barcode or similar product scanning technology, using Tall Man lettering)
• Appropriate controls are in place for compounding high-risk medicines (for example, using commercially available products or ready-to-administer preloaded syringes, standardised single concentrations for infusions, adhering to good manufacturing practices, using National Association of Testing Authorities–certified cytotoxic containment cabinets or similar, spill containment procedures)
• Safe procurement practices (for example, avoiding look-alike packaging for high-risk medicines, especially those used in high-risk procedures such as sedation)
• Safe administration (for example, appropriate use of equipment such as infusion pump drug libraries, oral liquid dispensers, line labelling for routes of administration, epidural lines without injection ports, standardised premixed solutions, independent double-checks, principles of ‘timeout’).

Develop and implement evidence-based risk-reduction strategies

Use or adapt tools that have been developed to identify the organisation’s list of high-risk medicines, and make the list available to clinicians. Tools include the NSW Health High-Risk Medicines Management Policy and the Institute for Safe Medication Practices List of High-Alert Medications in Acute Care Settings.

Determine which contributing factors (environmental, task, individual, team) underlie high-risk medicine-related incidents to assist the development of strategies and policies specific to the health service organisation that can be used to deal with these factors on several levels (see Action 4.2).

Implement a combination of risk reduction strategies that includes low-leverage (education) and high-leverage (NIMC, decision support software) standardisation processes, practices and products for medication management (for example, implementation of Tall Man lettering, use of smart infusion pumps).

Develop policies, procedures and guidelines

Implement high-risk medicine-related policies, procedures, guidelines and safe work practices that are evidence based and have been developed in collaboration with relevant clinicians.

Incorporate factors that contribute to safer use of high-risk medicines, or that reduce the opportunity for misuse or error, when considering:

• Medicines on the formulary (for example, listing a new medicine, contract specification and procurement, temporary replacement during a shortage)
• Availability of medicines (prescribing restrictions, review of ward stock or imprest lists and stock levels)
• Design and layout of storage rooms or cupboards, and labelling requirements in these areas, including selection of medication distribution system (individual dispensing, bedside locked drawers, automated medicine cabinets)
• Alerts in electronic medication management systems.

Consider protocols for vulnerable populations, including patients who are older or obese, or children.

Investigate incidents involving high-risk medicines, analyse the frequency and causal factors, and implement strategies to mitigate risks associated with high-risk medicine-related incidents.

When assessing the effectiveness of strategies, use both outcome and process measures, and routinely collect data to determine the effectiveness of risk reduction strategies for high-risk medicines. Share results as part of the governance of medication management (see Actions 4.1 and 4.2).