Medication safety

Note: This action is only applicable if your healthcare service prescribes, supplies and/or administers medicines.

Medicines are the most common treatment used in health care. Although the appropriate use of medicines contributes to significant improvements in health, medicines can also be associated with harm. Because they are so commonly used, medicines have the potential to be associated with a higher incidence of errors and adverse events when compared with other healthcare interventions.³⁹ Some of these adverse events are costly, and up to 50% are potentially avoidable.⁴⁰ Errors affect both health outcomes for consumers and healthcare costs. Strengthening the systems for reducing medication errors can improve medication safety.⁴¹

A best possible medication history (BPMH) is a list of all the medicines a patient is using at the time they receive care. The list includes the name, dose, route and frequency of the medicine, and is documented in a specific place (for example, template form or medicine record). All prescribed, over-the-counter and complementary medicines should be included.

The BPMH is generally obtained by a healthcare provider working within their scope of clinical practice who interviews the patient (and/or their carer); the information is confirmed, where appropriate, by using other sources of medicines information.

The patient is always the focus of the medication management pathway. Healthcare services should apply the principles of Partnering with Consumers, health literacy and shared decision making when developing, reviewing and implementing processes or practices within the medication management pathway.

Partnering with patients, carers and families in the management of their medicines occurs in order to support a patient’s understanding of what medicines are being proposed, or why a new medicine, or change in medicine/treatment (including a dose change or ceasing a medicine), is being recommended.

Patients should be involved in setting treatment goals and supported to understand the proposed outcomes of treatment. Discussion about medicines should include:

• Why the treatment is recommended or necessary
• If the medicine will cure their illness, or is required to control the symptoms of their chronic illness
• Duration of treatment and instructions for use
• Possible adverse effects that the medicine may have; their likelihood; and if experienced, what action should be taken.

• Develop and implement a process for healthcare providers to, within their own scope of clinical practice:
• take a BPMH as early as possible in the episode of care
• record this information in a patient’s healthcare record, including any adverse drug reactions
• use structures and systems established in the Partnering with Consumers Standard to partner with patients, carers and families in the management of medicines
• support patients, carers and families to keep an accurate medicines list
• encourage patients to share their medicines list with other healthcare providers
• share a patient’s medicines list with other healthcare providers with a patient’s consent
• use this information in the planning and delivery of health care
• Make template medicines lists available to patients, carers and families

• How do healthcare providers take a BPMH in your service?
• Where in a patient’s healthcare record is the BPMH recorded?
• How are patients encouraged to keep their own medicine list and to share this with other relevant healthcare providers?
• How is informed consent incorporated into your process for sharing the patient’s medicines list with other relevant healthcare providers on their behalf?

• Process for obtaining and documenting a BPMH
• Evidence that BPMHs are documented in a patient’s healthcare record
• Information available to patients about the need for maintaining a current list of their medicine

Australian Digital Health Agency: My Health Record. Information for healthcare providers on medication records in the My Health Record system. Patients can access their own record to view their own medicines list.

Australian Digital Health Agency: Keeping a medicines list is a useful resource which can be shared with consumers about keeping a current list of their medications.

World Health Organization: 5 Moments for Medication Safety resources. This tool can be applied at different levels of care and in different settings and contexts.

Partnering with patients, carers and families in the management of their medicines occurs to support a patient’s understanding on what medicines are being proposed; and why a new medicine, or change in medicine/treatment (including a dose change or ceasing a medicine) is being recommended. Information on medicines that is provided to patients in a way that meets their needs and preferences should include:

• A rationale for medicine use
• The risk to the patient of both taking and not taking the medicine
• Instructions for effective administration
• The expected outcome of use
• Action to take if a problem is identified or expected outcomes do not occur.

Information on medicines provided should be relevant, evidence-based and up to date.

When a suspected medicines-related problem is identified, healthcare providers must take action to minimise any risks of harms to patients. The specific action taken will be dependent on a healthcare provider’s scope of clinical practice. For example, a prescriber may take action by reviewing medication and potentially changing therapy, while a healthcare provider not involved in medication management may refer the patient to their prescriber or most appropriate healthcare provider, or may notify them directly. In some circumstances, emergency assistance may be sought.

Healthcare providers should ensure that the details of the occurrence and action taken are recorded in a patient’s healthcare record.

Any adverse event that may have been caused by a medicine is often referred to as a ‘suspected adverse reaction’ and can involve vaccines and prescription, over-the-counter and complementary medicines. Suspected adverse reactions (involving medicines) that people experience that have not been previously experienced or documented are considered to be new. The healthcare service is responsible for reporting new suspected adverse events involving medicines to the Therapeutic Goods Administration (TGA). Healthcare services may need to consider training for members of the workforce who are responsible for reporting adverse events (involving medicines) online to the TGA.

• Provide patients and carers with enough information about treatment options for them to make informed choices about their medicines, and to adhere to medicine-related treatment plans in the delivery of health care
• Support healthcare providers to provide medicine-related information when treatment options are discussed and when treatment decisions have been made
• Implement a process to report all new suspected adverse events involving medicines experienced by patients to the TGA and document these in the patient’s healthcare record

• How do healthcare providers provide information on medicines, tailored to patients’ needs and preferences?
• What strategies are in place to support patients and carers to raise concerns about medicine-related risks and clarify the information they are provided?
• What processes are used to identify patients at risk of medicine-related problems or adverse events?
• What action is taken when an adverse event involving medicines is suspected?
• How are suspected adverse events (involving medicines) that are experienced by patients reported to the TGA?

• Observation of the healthcare provider accessing medicines information, or communicating with patients about medicines information in way that is tailored to their needs and preferences
• Samples of medicine-related information resources (for example, Consumer Medicines Information, newsletters or other communication material) for the workforce, patients, carers and families that are tailored to their specific needs and meet the health literacy actions of the Partnering with Consumers Standard (for example, appropriate print size and font of the resource in the patient’s preferred language)
• Examples of medicines lists including where medicines lists have been tailored to the specific needs of recipients (for example, the patient, community pharmacist, general practitioner, nurse practitioner, allied healthcare provider or school nurse)
• Communication to the workforce explaining the process for reporting suspected adverse events involving medicines to the TGA
• Record of suspected adverse drug reaction reports submitted to the TGA
• Register of adverse events involving medicines that includes actions to address the identified risks
• Access to tools for reporting adverse events involving medicines, for example via the TGA website or using clinical software
• Examples of incident records identifying potential medicine-related risks and associated actions to reduce risk or improve clinical safety outcomes
• Records of patient or carer feedback on medicine-related information provided during care 

Therapeutic Goods Administration: Reporting adverse events information on the website. Everyone can play an important role in monitoring the safety of therapeutic goods in Australia.

Medicines information for healthcare providers can be accessed via clinical software, medicines references.

Healthdirect website. Provides Health and medicines information for consumers

Department of Veteran’s Affairs: Veterans’ Medicines Advice and Therapeutics Education Services (Veterans’ MATES). Aims to improve the use of medicines and related health services in the veteran community.

Better Health Channel: Medicines information leaflets for consumers. Leaflets provide important information for consumers.

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, and Regulations and Orders, which 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, this 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. These 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 ‘look alike, sound alike’ 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 ‘look-alike, sound-alike’ 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.

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 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.

Healthcare services that store medicines should 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. Services should establish inventory management practices to eliminate wastage of medicines, such as minimising oversupply of medicines, 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.

• 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

• How does your healthcare service ensure that all medicines (including temperature-sensitive medicines) are stored and handled according to manufacturers’ 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?

• 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

Australian Commission on Safety and Quality in Health Care: National Tall Man Lettering List. A typographic technique that uses selective capitalisation to help make look-alike, sound-alike (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.

Australian Commission on Safety and Quality in Health Care: 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.

Australian Government Department of Health: Therapeutic Goods Act 1989, and Regulations and Orders, which 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, which 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 and 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) 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.

Note: This action is only applicable if your healthcare service prescribes, stores, supplies and/or administers medicines.

High-risk medicines have an increased risk of causing significant patient harm or death if they are misused or used in error. Errors with these medicines are not necessarily more common than with other medicines. Because they have a low margin of safety, the consequences of errors with high-risk medicines can be more devastating.

Healthcare services should implement high-risk medicine-related policies, procedures, guidelines and safe work practices about identifying, storing, prescribing, dispensing, administering and monitoring high-risk medicines.

The healthcare service should incorporate factors that contribute to safer use of high-risk medicines, or that reduce the opportunity for misuse or error, when considering:

• Storage of, access to, and disposal of high-risk medicines that comply with legislative requirements
• Safe prescribing (for example, active ingredient prescribing, prescribing restricted substances, electronic prescribing, dose-calculation tools)
• Safe selection, labelling and storage of all medicines (for example, look-alike, sound-alike [LASA] medicines)
• Design and layout of storage rooms or cupboards, and labelling requirements in these areas
• Alerts and safety checks in healthcare service’s clinical software.

Consider how the use of high-risk medicines will be managed for specific population groups. The healthcare service should 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.

• Identify high-risk medicines prescribed, dispensed, stored or administered in the healthcare service
• Regularly assess the use and misuse of high-risk medicines, relating to storage, prescribing, dispensing and administration
• Develop and implement risk reduction strategies for the storage, prescribing, dispensing, administration and disposal of high-risk medicines relevant to your health service

• What processes are in place to identify medicines that are considered to be high risk?
• How does your healthcare service ensure safe and appropriate storage, prescribing, administration, distribution and disposal practices for high-risk medicines?

• Processes for identifying, storing, prescribing, dispensing, administering, monitoring and disposing of high-risk medicines, where applicable
• List of high-risk medicines used in the healthcare service
• Orientation or training documents about high-risk medicines
• Results of analysis of incidents involving 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
• Examples of improvement activities that have been implemented and evaluated to reduce the risks of storing, prescribing, dispensing and administering high-risk medicines

Australian Commission on Safety and Quality in Health Care: APINCHS classification of high risk medicines . The ‘APINCHS’ acronym and classification assist healthcare providers to focus on a group of medicines known to be associated with high potential for medication-related harm.

Australian Commission on Safety and Quality in Health Care: Active ingredient prescribing. An initiative to support the uptake of generic and biosimilar medicines and improve the health literacy of consumers and prescribers around the active ingredient in medicines. 

Australian Commission on Safety and Quality in Health Care: Safer naming and labelling of medicines. The Commission works with national and international partners to improve the safety of medicines naming and labelling.