Action 4.01

The Clinical Governance Standard has specific actions relating to health service organisations’ safety and quality systems.

• Action 1.07 – policies and procedures
• Action 1.10 – risk management systems
• Actions 1.19, 1.20 and 1.21 – education and training

Health service organisations should:

• Use these and other established safety and quality systems to support policies and procedures, risk management, and training for medication management
• Ensure that current versions of all relevant policies and procedures are readily available and accessible to clinicians.

Policies may be developed or adapted at different levels within the organisation. However, all policy documents should be incorporated into a single, coherent set to maximise the effectiveness of the policy development process.

Establish and implement medication management governance

Health service organisations are expected to have a governance group with responsibility for medication management, including formally reporting to the organisation’s clinical governance or managers. This is usually a drug and therapeutics committee, or a committee with a similar name and intent (for example, quality use of medicines committee, medication safety committee, medication advisory committee).

The drug and therapeutics committee should:

• Be multidisciplinary
• Have membership that reflects the size of the organisation and the services provided
• Have consumer representation or membership^1,2
• Be established at the level of the individual hospital, Local Hospital Network or hospital group (public or private).

Drug and therapeutics committees have an important role in:

• Developing, reviewing and overseeing medicine-related policy
• Developing the organisation’s medication safety and quality improvement strategies
• Monitoring quality improvement activities.

Drug and therapeutics committees (and their subcommittees) should work with the organisation’s safety and quality unit, clinical governance and executive to oversee organisation-wide safe and quality use of medicines, including:

• Monitoring occurrence of medicine-related incidents
• Implementing risk reduction strategies
• Implementing technology such as electronic medication management, ‘smart’ infusion pumps and drug libraries
• Managing contract arrangements, including those with external organisations that provide medication management services.

Resources such as Achieving Effective Medicines Governance: Guiding principles for the roles and responsibilities of drug and therapeutics committees in Australian public hospitals provide guidance for establishing and reviewing the structure, operation and processes (that is, the terms of reference); communications; and resources for an effective governance group responsible for medication management.

Review existing governance arrangements for medication management. Ensure that responsibility for implementing and monitoring the decisions of the drug and therapeutics committee and subcommittee is clearly defined (this is usually delegated to the pharmacy or organisation management).

High-risk medicines, and high-risk procedures involving medicines, pose considerable risk to patient safety. Consider designating a member of the workforce as the medication safety officer or ‘patient safety champion’ in high-risk procedural areas (for example, operating theatres, anaesthesia departments) to liaise with the pharmacy department on medicine-purchasing decisions and issues relating to presentation of anaesthetic products.

Implement policies and procedures

Policies, procedures and guidelines for medication management should be built on the National Medicines Policy and Guiding Principles to Achieve Continuity in Medication Management. Policies and procedures should be consistent with legislative and evidence-based documentation as it relates to safe medicine:

• Procurement, supply, storage and disposal
• Prescribing, dispensing and administration
• Reconciliation, review and monitoring of effects
• Compounding and manufacturing.

Other policies, procedures and guidelines may include:

• Medicine evaluation and list of approved medicines (formulary)
• Procedures for managing high-risk medicines (for example, administration of medicines in high-risk domains such as paediatrics, anaesthetics and chemotherapy)
• Recording of a best possible medication history (BPMH)
• Using standard forms such as the national inpatient medication chart (NIMC) or Pharmaceutical Benefits Scheme hospital medication chart (PBS HMC)
• Provision of information about medicines to patients
• Liaison with the pharmaceutical industry
• Use of oral dispensers for administering oral medicines
• User-applied labelling
• Avoiding use of abbreviations
• Safe implementation and use of electronic medication management
• Use of standardised electronic display of clinical medicines information
• Management and reporting of medication incidents and suspected adverse drug reactions (ADRs)
• Management of services contracted with external pharmacy providers.

Ensure that current versions of all medicine-related policies, procedures and protocols are readily available and accessible to clinicians.

Manage risks

Use established risk management systems (see Action 1.10) to identify, monitor, manage and review risks associated with medication management. Develop processes to manage clinical risks for different populations served by the organisation, clinical and workplace risks for the workforce, and organisational risks. Ensure that medication safety risks are recorded and can be identified in the organisation’s risk management system.

Use information from measurement and quality improvement systems, adverse events, clinical outcomes and patient experiences to inform and update risk assessments and the risk management system. Consider the training the workforce may need to effectively use incident management and investigation systems to inform risk management, and to plan and implement quality improvement processes to mitigate these risks.

The medication management pathway provides a framework for:

• Identifying where there is potential for errors or risk of harm
• Responding with strategies to reduce the opportunity for error.

To ensure safe and effective use of medicines within the health service organisation, implement strategies to prevent medicine-related errors and the potential risk of patient harm. Steps taken early in the medication management pathway can prevent adverse events occurring later in the pathway.

Identify training requirements

Assess the competency and training needs of the workforce in line with the requirements of Actions 1.19, 1.20 and 1.21. Perform a risk assessment to inform the training schedule and to set priorities for the members of the workforce who require training. This will include clinicians and any other employed or contracted members of the workforce who are involved in medication management (for example, medicines procurement workforce). Develop or provide access to training and education resources to meet the needs of the workforce regarding medication management.

Training the workforce in risk identification, incident management and investigation systems, and quality improvement will support safe use of medicines.

Use ongoing education programs to supplement existing knowledge and skills to inform clinicians about:

• Medication safety risks identified from incident monitoring, risk assessments, or national, state or territory medication safety directives, alerts and information
• Strategies to reduce the risks.

Ongoing education could cover medication safety topics and known risk mitigation strategies, such as:

• Using national standard medication charts
• Taking a BPMH and reconciling medicines
• Managing high-risk medicines
• Checking procedures (for example, independent double-check)
• Documenting known and new allergies and ADRs
• Preventing medication errors or incidents
• Safely preparing and administering medicines, including labelling of injectable medicines, fluids and lines.

Review training programs for clinicians that relate to safe medication management practices. Ensure that training includes:

• Education on the common causes of medication incidents and how to make medicine use safer
• The different levels of knowledge and skills required by different clinicians
• How and where to access evidence-based medicine-related information and decision support tools
• Training on medication safety during orientation of new clinicians (for example, medical, nursing and pharmacy)
• Competency assessment.

The Clinical Governance Standard has specific actions relating to health service organisations’ safety and quality systems.

• Action 1.07 – policies and procedures
• Action 1.10 – risk management systems
• Actions 1.19, 1.20 and 1.21 – education and training

Health service organisations should:

• Use these and other established safety and quality systems to support policies and procedures, risk management, and training for medication management
• Ensure that current versions of all relevant policies and procedures are readily available and accessible to clinicians.

Policies may be developed or adapted at different levels within the organisation. However, all policy documents should be incorporated into a single, coherent set to maximise the effectiveness of the policy development process.

Review governance for medication management

Health service organisations are expected to have a governance group with responsibility for medication management, including formally reporting to the organisation’s clinical governance or managers. This is usually a drug and therapeutics committee, or a committee with a similar name and intent (for example, quality use of medicines committee, medication safety committee, medication advisory committee).

The governance arrangements for day procedure services may be less formal, but owners still have the responsibility to ensure that appropriate systems are in place, so that the service provides safe and high-quality care.

A suitable medication management governance group could comprise the service’s manager, specialist credentialed medical and other practitioners (including an anaesthetist in day surgeries), a nurse and a pharmacist (if available).

If possible, the medication management governance group should:

• Be multidisciplinary
• Have membership that reflects the size of the organisation and the services provided
• Have consumer representation or membership.^1,2

Medication management governance groups have an important role in:

• Developing, reviewing and overseeing medicine-related policy
• Developing the organisation’s medication safety and quality improvement strategies
• Monitoring quality improvement activities.

Medication management governance groups should work to ensure organisation-wide safe and quality use of medicines, including:

• Monitoring occurrence of medicine-related incidents
• Implementing risk reduction strategies
• Implementing technology such as electronic medication management, ‘smart’ infusion pumps and medicine libraries
• Overseeing the evaluation and selection of medicines that are suitable for use in the day procedure service (for example, anaesthetics)
• Managing contract arrangements, including those with external organisations that provide medication management services (for example, community pharmacies).

Resources such as Achieving Effective Medicines Governance: Guiding principles for the roles and responsibilities of drug and therapeutics committees in Australian public hospitals provide guidance for establishing and reviewing the structure, operation and processes (that is, the terms of reference); communications; and resources for an effective governance group responsible for medication management.

Review existing governance arrangements for medication management. Ensure that responsibility for implementing and monitoring the decisions of the medication management governance group is clearly defined.

High-risk medicines, and high-risk procedures involving medicines, pose considerable risk to patient safety and may require a specific resource that aims to minimise medicine-related risks. Consider designating a member of the workforce as the medication safety officer to liaise with external organisations contracted for medication management services to ensure safe procurement and supply of medicines (for example, anaesthetics).

In the absence of on-site pharmacy services, this responsibility would need to be assigned to a member of the governance group or the service’s manager. It may be useful to approach the local community pharmacist who might be involved in the supply of medicines or the local hospital (public or private) for pharmacist expertise or input on a sessional basis.

Implement policies and procedures

Policies, procedures and guidelines for medication management should be built on the National Medicines Policy and Guiding Principles to Achieve Continuity in Medication Management. Policies and procedures should be consistent with legislative and evidence-based documentation as it relates to safe medicine:

• Procurement, supply, storage and disposal
• Prescribing, dispensing and administration
• Reconciliation, review and monitoring of effects, where required.

Other policies, procedures and guidelines may include:

• List of approved medicines (formulary)
• Procedures for managing high-risk medicines (for example, administration of medicines in high-risk domains such as paediatrics, anaesthetics and chemotherapy)
• Recording of a best possible medication history (BPMH)
• Use of standard forms such as national standard medication charts
• Provision of information about medicines to patients
• Liaison with the pharmaceutical industry
• Use of oral dispensers for administering oral medicines
• User-applied labelling
• Avoiding use of abbreviations
• Safe implementation and use of electronic medication management
• Use of standardised electronic display of clinical medicines information
• Management and reporting of medication incidents and suspected adverse drug reactions (ADRs)
• Management of services contracted with external pharmacy providers.

Ensure that current versions of all medicine-related policies, procedures and protocols are readily available and accessible to clinicians.

Manage risks

Use established risk management systems (Action 1.10) to identify, monitor, manage and review risks associated with medication management. Develop processes to manage clinical risks for different populations served by the organisation, clinical and workplace risks for the workforce, and organisational risks. Ensure that medication safety risks are recorded and can be identified in the organisation’s risk management system.

Use information from the measurement and quality improvement system, adverse events, clinical outcomes and patient experiences to inform and update risk assessments and the risk management system.

The medication management pathway provides a framework for identifying and managing risks of harm and medicine-related errors.

Identify training requirements

Assess the competency and training needs of the workforce in line with the requirements of Actions 1.19, 1.20 and 1.21. Perform a risk assessment to inform the training schedule and to set priorities for the members of the workforce who require training. This will include clinicians and any other employed or contracted members of the workforce who are involved in medication management (for example, medicines procurement workforce). Develop or provide access to training and education resources to meet the needs of the workforce regarding medication management.

Training the workforce in risk identification, incident management and investigation systems and quality improvement will support safe use of medicines.

Use ongoing education programs to supplement existing knowledge and skills to inform clinicians about:

• Medication safety risks identified from incident monitoring, risk assessments, or national, state or territory medication safety directives, alerts and information
• Strategies to reduce the risks.

Ongoing education could cover medication safety topics and known risk mitigation strategies, such as:

• Using national standard medication charts
• Taking a BPMH
• Managing high-risk medicines
• Checking procedures (for example, independent double-check)
• Documenting known and new allergies and ADRs
• Preventing medication errors or incidents
• Safely preparing and administering medicines, including labelling injectable medicines, fluids and lines.

The local community pharmacy or the local hospital (public or private) could be approached for pharmacist expertise to participate in educating and training clinicians, including their orientation.

Review training programs for clinicians that relate to safe medication management practices. Ensure that training includes:

• Education on the common causes of medication incidents and how to make medicine use safer
• The different levels of knowledge and skills required by different clinicians
• How and where to access evidence-based medicine-related information and decision support tools
• Training on medication safety during orientation of new clinicians (for example, medical and nursing)
• Competency assessment.

Examples of evidence

Select only examples currently in use:

• Policy documents about medication management that are accessible to the workforce
• Observation of clinicians’ practice that demonstrates use of the health service organisation’s processes for medication management
• Records of interviews with clinicians that show that they understand the health service organisation’s processes for medication management
• Committee and meeting records relating to medication safety
• Terms of reference and membership of the governance group or committee responsible for medication safety
• Documents that detail responsibilities for organisation-wide medication safety systems at all levels of the organisation
• Employment documents that outline the roles, responsibilities and accountabilities for clinical and organisational medication management activities
• Training documents about medication management and medication safety
• Reports from an incident management and investigation system, including analysis of incident data and trends relating to medication management
• Risk management system that includes actions to manage risks identified in medication management.

The Clinical Governance Standard has specific actions relating to health service organisations’ safety and quality systems.

• Action 1.07 – policies and procedures
• Action 1.10 – risk management systems
• Actions 1.19, 1.20 and 1.21 – education and training

Health service organisations should:

• Use these and other established safety and quality systems to support policies and procedures, risk management, and training for medication management
• Ensure that current versions of all relevant policies and procedures are readily available and accessible to clinicians.

Policies may be developed or adapted at different levels within the organisation. However, all policy documents should be incorporated into a single, coherent set to maximise the effectiveness of the policy development process.

Review governance for medication management

Health service organisations are expected to have a governance group with responsibility for medication management, including formally reporting to the organisation’s clinical governance or managers. This is usually a drug and therapeutics committee, or a committee with a similar name and intent (for example, quality use of medicines committee, medication safety committee, medication advisory committee).

The drug and therapeutics committee should:

• Be multidisciplinary
• Have membership that reflects the size of the organisation and the services provided
• Have consumer representation or membership^1,2
• Be established at the level of the individual health service organisation, Local Hospital Network or hospital group (public or private).

Drug and therapeutics committees (and their subcommittees) should work with the organisation’s safety and quality unit, clinical governance and executive to oversee organisation-wide safe and quality use of medicines, including:

• Monitoring occurrence of medicine-related incidents
• Implementing risk reduction strategies
• Implementing technology such as electronic medication management, ‘smart’ infusion pumps and drug libraries
• Managing contract arrangements, including those with external organisations that provide medication management services.

Review existing governance arrangements for medication management. Ensure that responsibility for implementing and monitoring drug and therapeutics committee and subcommittee decisions is clearly defined (this is usually delegated to the pharmacy or organisation management). High-risk medicines and high-risk procedures involving medicines pose considerable risk to patient safety. Consider designating a member of the workforce as the medication safety officer or ‘patient safety champion’ in high-risk procedural areas (for example, operating theatres, anaesthesia departments) to liaise with the pharmacy department on medicine-purchasing decisions and issues relating to presentation of anaesthetic products.

In the absence of on-site pharmacy services, this responsibility would need to be assigned to a member of the governance group or the facility manager. It may be useful to approach the local community pharmacist who might be involved in the supply of medicines or the local hospital (public or private) for pharmacist expertise or input on a sessional basis.

Implement policies and procedures

Policies, procedures and guidelines for medication management should be built on the National Medicines Policy and Guiding Principles to Achieve Continuity in Medication Management. Policies and procedures should be consistent with legislative and evidence-based documentation as it relates to safe medicine:

• Procurement, supply, storage and disposal
• Prescribing, dispensing and administration
• Reconciliation, review and monitoring of effects, where required
• Compounding and manufacturing.

Other policies, procedures and guidelines may include:

• Medicine evaluation and list of approved medicines (formulary)
• Procedures for managing high-risk medicines (for example, administration of medicines in high-risk domains such as paediatrics, anaesthetics and chemotherapy)
• Recording of a best possible medication history (BPMH)
• Use of standard forms such as national standard medication charts
• Provision of information about medicines to patients
• Use of oral dispensers for administering oral medicines
• User-applied labelling
• Avoiding use of abbreviations
• Safe implementation and use of electronic medication management
• Use of standardised electronic display of clinical medicines information
• Management and reporting of medication incidents and suspected adverse drug reactions (ADRs)
• Management of services contracted with external pharmacy providers.

Manage risks

Use established risk management systems (Action 1.10) to identify, monitor, manage and review risks associated with medication management. Develop processes to manage clinical risks for different populations served by the organisation, clinical and workplace risks for the workforce, and organisational risks. Ensure that medication safety risks are recorded and can be identified in the organisation’s risk management system register.

Use information from the measurement and quality improvement system, adverse events, clinical outcomes and patient experiences to inform and update risk assessments and the risk management system.

Identify training requirements

Assess the competency and training needs of the workforce in line with the requirements of Actions 1.19, 1.20 and 1.21. Perform a risk assessment to inform the training schedule and to set priorities for the members of the workforce who require training. This will include clinicians and any other employed or contracted members of the workforce who are involved in medication management (for example, medicines procurement workforce). Develop or provide access to training and education resources to meet the needs of the workforce regarding medication management.

Training the workforce in risk identification, incident management and investigation systems, and quality improvement will support safe use of medicines.

Use ongoing education programs to supplement existing knowledge and skills to inform clinicians about:

• Medication safety risks identified from incident monitoring, risk assessments, or national, state or territory medication safety directives, alerts and information
• Strategies to reduce the risks.

Ongoing education could cover medication safety topics and known risk mitigation strategies, such as:

• Using national standard medication charts
• Taking a BPMH and reconciling medicines
• Managing high-risk medicines
• Checking procedures (for example, independent double-check)
• Documenting known and new allergies and ADRs
• Preventing medication errors or incidents
• Safely preparing and administering medicines, including labelling of injectable medicines, fluids and lines.

The local community pharmacy or the local hospital (public or private) could be contacted for pharmacist expertise to be involved in educating and training clinicians, including their orientation.