Standard 4: Medication Safety

Adverse drug reactions

Action 4.7

The health service organisation has processes for documenting a patient’s history of medicine allergies and adverse drug reactions in the healthcare record on presentation

Intent

Medicine-related risks for patients are minimised by documenting and referring to the patient’s history of medicine allergies and adverse drug reactions (ADRs).

Reflective questions

How does the health service organisation ensure that a patient’s history of medicine allergies and ADRs is recorded when taking a best possible medication history (BPMH) on presentation?

How do clinicians who prescribe, dispense or administer medicines know that a patient has an existing medicine allergy or ADR?

Key task

Document known patient medicine allergies and ADRs on presentation, and make this information available when clinicians prescribe, dispense and administer medicines.

Strategies for improvement

Hospitals

As part of a BPMH, clinicians must elicit and document known medicine allergies and ADRs experienced by a patient before their current admission (see Actions 4.5 and 4.6).

Review organisational policies, procedures and guidelines on recording known medicine allergies and ADRs in the patient’s healthcare record. These should:

  • Identify the clinician responsible for recording information on known medicine allergies and ADRs
  • Outline what information to include (for example, type of reaction experienced, its severity, how it was managed)
  • Describe what action should be taken if the nature of the documented reaction needs to be challenged or verified (for example, as a result of immunologist consultation), including instances of allergy mismatch
  • Include criteria for the appropriate use of a coloured (red) patient allergy/ADR wristband
  • Describe where and when it is appropriate to record a known allergy or adverse reaction to substances other than medicines, such as food, in the patient’s medicine allergy and ADR history.

Ensure that known medicine allergies and ADRs are recorded:

  • In the medication history (paper or electronic)
  • On all forms on which medicines are ordered, such as national standard medication charts, ancillary charts and the anaesthesia record
  • In electronic medication management and dispensing systems
  • On ADR summary sheets or similar
  • By using an alert sticker on hard-copy healthcare records
  • By using electronic allergy/ADR alerts in digital healthcare records.

Provide orientation, training and education to clinicians, and review clinician work practices for:

  • Determining and documenting known medicine allergies and ADRs in the patient’s medicine allergy/ADR history, including the type of reaction, the severity and how it was managed
  • Referring to a patient’s medicine allergy/ADR history before, or at the point of, decision-making when prescribing, dispensing or administering medicines.

Conduct audits of documentation on medicine allergies and ADRs. These may focus on patients who have experienced previous medicine allergies or ADRs, the information that has been documented and where it has been documented (for example, in the medication chart, MMP or equivalent, discharge summary, medicines list, electronic medication management system). Data could be collected during an audit of the NIMC (linked to Action 4.8).

Collate and review audit trends, and provide information to clinicians through medication safety bulletins, in-service orientation sessions, case reports or grand rounds.

Day Procedure Services

As part of a BPMH, clinicians must elicit and document known medicine allergies and ADRs experienced by a patient before their admission (see Actions 4.5 and 4.6).

Review organisational policies, procedures and guidelines on recording known medicine allergies and ADRs in the patient healthcare record. These should:

  • Identify the clinician responsible for recording information on known medicine allergies and ADRs
  • Outline what information to include (for example, type of reaction experienced, its severity, how it was managed)
  • Describe what action should be taken if the nature of the documented reaction needs to be challenged or verified (for example, as a result of immunologist consultation), including instances of allergy mismatch
  • Include criteria for the appropriate use of a coloured (red) patient allergy/ADR wristband
  • Determine where and when it is appropriate to record a known allergy or adverse reaction to substances other than medicines, such as food, in the patient’s medicine allergy and ADR history.

Ensure that medicine allergies and ADRs are recorded:

  • In the medication history (paper or electronic)
  • On all forms on which medicines are ordered, such as national standard medication charts, ancillary charts and the anaesthesia record
  • In electronic medication management and dispensing systems
  • On ADR summary sheets or similar
  • By using an alert sticker on hard-copy healthcare records
  • By using electronic allergy/ADR alerts in digital healthcare records.

Provide orientation, training and education to clinicians, and review clinician work practices for:

  • Determining and documenting known medicine allergies and ADRs in the patient’s medicine allergy/ADR history, including the type of reaction, the severity and how it was managed
  • Referring to a patient’s medicine allergy/ADR history before, or at the point of, decision-making when prescribing, dispensing or administering medicines.

Conduct audits of documentation on medicine allergies and ADRs. These may focus on patients who have experienced previous medicine allergies or ADRs, the information that has been documented and where it has been documented (for example, in the medication chart, MMP or equivalent, discharge summary, medicines list, electronic medication management system) (linked to Action 4.8).

Collate and review audit trends, and provide information to clinicians through medication safety bulletins, in-service orientation sessions or case reports.

Examples of evidence

Select only examples currently in use:

  • Policy documents about recording a patient’s known medicine allergies and ADRs on presentation
  • Audit results of healthcare records for documentation of known medicine allergies and ADRs on presentation
  • Feedback to the workforce about compliance with documenting known medicine allergies and ADRs on presentation
  • Training documents about taking and documenting a patient’s history of medicine allergies and ADRs on presentation.
MPS & Small Hospitals

MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt and use the established process for documenting a patient’s history of medicine allergies and ADRs, as a component of a BPMH (see Actions 4.5 and 4.6).

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

  • Develop or review policies, procedures and guidelines about recording known medicine allergies and ADRs in the patient healthcare record (paper or electronic) and on the MMP or equivalent
  • Ensure that known medicine allergies and ADRs are recorded on all forms on which medicines are ordered
  • Ensure that known medicine allergies and ADRs are recorded within electronic medication management systems and within dispensing systems
  • Provide orientation, training and education to clinicians
  • Review clinician work practices for determining and documenting known medicine allergies and ADRs, and referring to a patient’s medicine allergy and ADR history before and at the point of decision-making when prescribing, dispensing or administering medicines
  • Conduct audits of documentation of medicine allergies and ADRs
  • Collate and review audit trends, and provide information to clinicians through medication safety bulletins, in-service orientation sessions, case reports or grand rounds.

Action 4.8

The health service organisation has processes for documenting adverse drug reactions experienced by patients during an episode of care in the healthcare record and in the organisation-wide incident reporting system

Intent

Medicine allergies and ADRs experienced by patients while in the health service organisation are documented in the patient's medicine allergy/ADR history and in incident management and investigation systems.

Reflective questions

What processes are used to ensure that all medicine allergies and ADRs experienced by a patient during an episode of care are recorded in the patient’s healthcare record, and reported in the incident management and investigation system?

How do clinicians who prescribe, dispense or administer medicines know that a patient has experienced a new medicine allergy or ADR?

What processes are used to ensure that clinicians document a patient’s new medicine allergies or ADRs on their medicines list?

Key task

Document and report medicine allergies and ADRs experienced by patients during their episode of care (see Actions 4.1 and 4.2).

Strategies for improvement

Hospitals

Document all new medicine allergies and ADRs by including them in the patient’s existing history of medicine allergies and ADRs, to ensure that clinicians are alerted and can refer to this information when medicines are being prescribed, dispensed or administered.

Review organisational policies, procedures and guidelines on recording new medicine allergies and ADRs in the patient’s healthcare record. These should:

  • Identify the clinician responsible for managing and recording information on new medicine allergies and ADRs

  • Ensure that all new medicine allergies and ADRs are reported within the organisation’s incident management and investigation system

  • Include criteria for the appropriate use of a coloured (red) patient allergy/ADR wristband

  • Emphasise the importance of informing the patient about all new medicine allergies and ADRs, and informing other prescribers and members of their healthcare team

  • Incorporate information on new allergies and ADRs at care transfer and handover

  • Update the patient’s medicines list (linked to Action 4.12)

  • Inform the patient’s general practitioner and other members of the patient’s healthcare team (for example, community pharmacist) of all new medicine allergies and ADRs in the patient’s transfer or discharge summary.

Ensure that new medicine allergies and ADRs are recorded in the organisation's incident reporting system and:

  • In the medication history (paper or electronic)

  • On all forms on which medicines are ordered, such as national standard medication charts, ancillary charts and the anaesthesia record

  • In electronic medication management and dispensing systems

  • On ADR summary sheets or similar

  • By using an alert sticker on hard-copy healthcare records

  • By using electronic allergy/ADR alerts in digital healthcare records.

Provide orientation, training and education to clinicians, and review clinician work practices for:

  • Documenting and incorporating new medicine allergies and ADRs in the patient’s medicine allergy/ADR history, including the type of reaction, the severity and how it was managed

  • Referring to a patient’s medicine allergy/ADR history before, or at the point of, decision-making when prescribing, dispensing or administering medicines.

Audit documentation on medicine allergies and ADRs. These may include the medication chart, the MMP or equivalent, or the electronic medication management system. Data could be collected during an audit of the NIMC (linked to Action 4.7).

Collate and review trends in reported medicine allergies and audit results, and provide information to clinicians through medication safety bulletins, in-service orientation sessions, case reports or grand rounds.

Day Procedure Services

Document all new medicine allergies and ADRs by including them in the patient’s existing history of medicine allergies and ADRs, to ensure that clinicians are alerted and can refer to this information when medicines are being prescribed, dispensed or administered.

Review organisational policies, procedures and guidelines on recording new medicine allergies and ADRs in the patient’s healthcare record. These should:

  • Identify the clinician responsible for managing and recording information on new medicine allergies and ADRs
  • Ensure that all new medicine allergies and ADRs are reported within the organisation’s incident management and investigation system
  • Include criteria for the appropriate use of a coloured (red) patient allergy/ADR wristband
  • Emphasise the importance of informing the patient about all new medicine allergies and ADRs, and informing other prescribers and members of their healthcare team
  • Incorporate information on new allergies and ADRs at care transfer and handover
  • Update the patient’s medicines list (linked to Action 4.12)
  • Inform the patient’s general practitioner and other members of the patient’s healthcare team (for example, community pharmacist) of all new medicine allergies and ADRs in the patient’s transfer or discharge summary.

Ensure that new medicine allergies and ADRs are recorded in the organisation’s incident reporting system and:

  • In the medication history (paper or electronic)
  • On all forms on which medicines are ordered, such as national standard medication charts, ancillary charts and the anaesthesia record
  • In electronic medication management and dispensing systems
  • On ADR summary sheets or similar
  • By using an alert sticker on hard-copy healthcare records
  • By using electronic allergy/ADR alerts in digital healthcare records.

Provide orientation, training and education to clinicians, and review clinician work practices for:

  • Documenting new medicine allergies and ADRs in the patient’s medicine allergies/ADR history, including the type of reaction, the severity and how it was managed
  • Referring to a patient’s medicine allergy/ADR history before, or at the point of, decision-making when prescribing, dispensing or administering medicines.

Audit documentation on medicine allergies and ADRs. These may include the medication chart, the MMP or equivalent, or the electronic medication management system. Data could be collected during an audit of the NIMC (linked to Action 4.7).

Collate and review trends in reported medicine allergies and audit results, and provide information to clinicians through medication safety bulletins, in-service orientation sessions or case reports.

Examples of evidence

Select only examples currently in use:

  • Policy documents about recording new medicine allergies and ADRs experienced during an episode of care
  • Audit results of workforce compliance with policies, procedures, protocols and guidelines for documenting new medicine allergies and ADRs
  • Audit results of healthcare records for documentation of new medicine allergies and ADRs in places noted in policies, procedures, protocols and guidelines
  • Feedback to the workforce about compliance with policies, procedures, protocols and guidelines for documenting new medicine allergies and ADRs
  • Results of analysis of incident data relating to new medicine allergies and ADRs
  • Orientation or training documents about documenting patients’ new medicine allergies and ADRs.
MPS & Small Hospitals

MPSs and small hospitals should have policies and procedures about documenting and reporting medicine allergies and ADRs experienced by patients during their episode of care (see Action 4.1 and 4.2).

Processes for documenting medicine allergies and ADRs should:

  • Identify the clinician responsible for managing and recording information on new medicine allergies and ADRs
  • Describe how to report new medicine allergies and ADRs in the organisation’s incident management and investigation system
  • Include criteria for the appropriate use of a coloured (red) patient allergy/ADR wristband
  • Emphasise the importance of informing the patient about all new medicine allergies and ADRs, and informing other prescribers and members of their healthcare team
  • Incorporate information on new allergies and ADRs at care transfer and handover
  • Update the patient’s medicines list (see Action 4.12)
  • Inform the patient’s general practitioner and other members of the patient’s healthcare team (for example, community pharmacist) of all new medicine allergies and ADRs in the patient’s transfer or discharge summary.

Ensure that new medicine allergies and ADRs are recorded in the organisation’s incident reporting system and:

  • In the medication history (paper or electronic)
  • On all forms on which medicines are ordered, such as national standard medication charts and the anaesthesia record
  • In electronic medication management and dispensing systems
  • On ADR summary sheets or similar
  • By using an alert sticker on hard-copy healthcare records
  • By using electronic allergy/ADR alerts in digital healthcare records.

Provide orientation, training and education to clinicians, and review clinician work practices relating to documenting medicine allergies and ADRs.

Audit documentation on medicine allergies and ADRs. These may include the medication chart, the MMP or equivalent, or the electronic medication management system (see Action 4.7).

Collate and review trends in reported medicine allergies and audit results, and provide information to clinicians.

Action 4.9

The health service organisation has processes for reporting adverse drug reactions experienced by patients to the Therapeutic Goods Administration, in accordance with its requirements

Intent

All new suspected ADRs experienced by patients during their episode of care are reported to the Therapeutic Goods Administration (TGA).

Reflective questions

What processes are used to report all new suspected ADRs experienced by patients during their episode of care to the TGA?

What resources, tools or information are provided to clinicians to encourage the reporting of ADRs?

How does the health service organisation use the information and reports on suspected ADRs experienced by its patients?

Key task

Report all new suspected ADRs experienced by patients to the TGA.

Strategies for improvement

Hospitals

Any adverse event that may have been caused by a medicine is a suspected ADR. Suspected ADRs that patients experience during their episode of care that have not been previously experienced or documented are considered to be new. Report these new suspected ADRs to the TGA’s adverse event reporting system via the TGA website.

Assist communication and feedback about ADR reports by enrolling the health service organisation as a registered user when completing and submitting a report to the TGA’s adverse event reporting system.

Registered organisations have access to information about their own reports through the TGA website or by contacting the TGA directly. Reports sent by email will only be accessible if the organisation’s name and address are included in the report, and the reporter type is designated as ‘hospital’.

Review current information and training

Review current organisational policies, procedures and guidelines to ensure that all suspected ADRs that patients experience during their episode of care are reported to the TGA. Include or refer to specific TGA information about:

  • What to report
  • How to report suspected ADRs
  • How to maintain a record of the suspected ADR in the patient’s healthcare record
  • The process for a copy of the report to be sent to the organisation’s pharmacy department, drug committee or equivalent, or medication safety governance group.

The health service organisation can include the capability to report suspected ADRs online to the TGA as part of its strategy for electronic medication management.

Provide orientation, training and education to clinicians on reporting suspected ADRs to the TGA. This should include the importance of providing comprehensive information about the patient, the medicine that is suspected of causing the reaction, the patient’s concurrent medicines, the reaction they experienced and the organisation at which it was experienced.

Health service organisations can use online learning modules developed by the TGA for health professionals on reporting adverse events with medicines and vaccines.

Assess the quality, content and timeliness of ADR reports. Reports are most useful for detecting new safety issues if they are made soon after the reaction has occurred. Encourage clinicians to report ADRs by using awareness campaigns.

Access information on ADRs and medication safety issues by:

Communicate about ADRs

Collate and review ADRs that have been experienced and reported, and circulate information to clinicians through medication safety bulletins, in-service orientation sessions, case reports or grand rounds.

Include ADR reports for the relevant governance committee to consider as part of the review of the safety of the medication management pathway.

Provide patients with information about ADRs, how to recognise symptoms and how to self-report to the TGA. Both the TGA and NPS MedicineWise have information on their websites that is suitable for consumers.

Day Procedure Services

Any adverse event that may have been caused by a medicine is a suspected ADR. Suspected ADRs that patients experience during their episode of care that have not been previously experienced or documented are considered to be new. Report these new suspected ADRs to the TGA’s adverse event reporting system via the TGA website.

Assist communication and feedback about ADR reports by enrolling the health service organisation as a registered user when completing and submitting a report to the TGA’s adverse event reporting system.

Registered organisations have access to information about their own reports on the TGA website or by contacting the TGA directly. Reports sent by email will only be accessible if the organisation’s name and address are included in the report, and the reporter type is designated as ‘hospital’. This applies to day procedure services.

Review current information and training

Review current organisational policies, procedures and guidelines to ensure that all suspected ADRs that patients experience during their episode of care are reported to the TGA. Include or refer to specific TGA information about:

  • What to report
  • How to report suspected ADRs
  • How to maintain a record of the suspected ADR in the patient’s healthcare record
  • The process for a copy of the report to be sent to the organisation’s medication safety governance group.

The health service organisation can include the capability to report ADRs online to the TGA as part of its strategy for electronic medication management.

Provide orientation, training and education to clinicians on reporting suspected ADRs to the TGA. This should include the importance of providing comprehensive information about the patient, the medicine that is suspected of causing the reaction, the patient’s concurrent medicines, the reaction they experienced and the organisation at which it was experienced.

Health service organisations can access online learning modules developed by the TGA for health professionals on reporting adverse events with medicines and vaccines.

Assess the quality, content and timeliness of ADR reports. Reports are most useful for detecting new safety issues if they are made soon after the reaction has occurred. Encourage clinicians to report ADRs by using awareness campaigns.

Access information on ADRs and medicine safety issues by:

Communicate about ADRs

Collate and review ADRs that have been experienced and reported, and circulate information to clinicians through medication safety bulletins, in-service orientation sessions or case reports.

Include ADR reports for the relevant governance committee to consider as part of the review of the safety of the medication management pathway.

Provide patients with information about ADRs, how to recognise symptoms and how to self-report to the TGA. Both the TGA and NPS MedicineWise have information on their websites that is suitable for consumers.

Examples of evidence

Select only examples currently in use:

  • Policy documents on recording and reporting suspected ADRs to the TGA
  • Record of suspected ADR reports submitted to the TGA
  • Communication to the workforce explaining the process for reporting suspected ADRs to the TGA
  • Reports from audits of workforce compliance in using the process for reporting ADRs to the TGA
  • Communication with the workforce and the highest level of governance summarising TGA reports of suspected ADRs experienced within the health service organisation
  • Consumer resources outlining how they can self-report ADRs to the TGA
  • Orientation or training documents about identifying and reporting suspected ADRs to the TGA.
MPS & Small Hospitals

Any adverse event that may have been caused by a medicine is a suspected ADR. Suspected ADRs that patients experience during their episode of care that have not been previously experienced or documented are considered to be new.

MPSs or small hospitals that are part of a local health network or private hospital group should adopt or adapt and use the established process for recording and reporting new suspected ADRs.

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

MPSs or small hospitals may need to consider training for members of the workforce who are responsible for reporting ADRs online to the TGA.

Last updated 19th July, 2018 at 10:39pm
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