Medication Safety Standard 4
Part 2 – Governance and systems for
medication safety
Margaret Duguid, Pharmaceutical Advisor
Graham Bedford, Medication Safety Program Manager
Standard 4
Medication
Safety
Governance and systems for med safety
4.1 Developing and implementing governance arrangements and
organisational policies for medication safety
• Drug and Therapeutics Committee (DTC)
- Local, network
- Medication Safety Subcommittee
- Consumer representative
- Report to safety and quality governance, executive
- Arrangements for contracted services
• Small hospitals
• Link with LHN DTC
- Governance
- Resources, audit tools, indicators etc
Consumer
Governance and systems for med safety
4.1 Governance arrangements and organisation policies

Drug and Therapeutics Committee (DTC)
• Develop medication safety QI plan
- Actions to address gaps, poor
performance
- Indicators/audits for measuring,
monitoring improvements
- Responsibilities, timelines
Standard 4
Medication
Safety
Governance and systems for med safety

DTC role
• Advising on medication management
• Developing/approving medicines policies,
procedures
• Maintaining a risk register, quality improvement plan
• Monitoring the safety and quality of medicines use in
the facility
• Conducting and monitoring interventions to improve
the safety and quality
• Reviewing ADRs and medication incidents
• Informing staff about medicines use issues, policies
etc
Governance and systems for med safety

How? (Cont’d)
• Training programs for staff
• medication safety risks, strategies to reduce the
risks
• NIMC on line learning module
• NPS medication safety course
• Antimicrobial prescribing modules
• Medication reconciliation training resources
NPS medication
safety course
Medication safety training
Q. How can we increase uptake of the NPS medication
safety course e-learning modules?
A. Encourage staff to undertake as a continuing
professional development activity. Modules recognised
by Australian College of Nursing and Pharmacy Council
of Australia
Obtain feedback from NPS MedicineWise on completion
figures for the modules. This facility will be available in
2014.
Governance and systems for med safety
4.1:Developing and implementing governance arrangements and
organisation policies, procedures and/or protocols (cont’d)

What?
• 4.1.2 Develop and implement medication policies
and procedures across the organisation consistent
with legislative requirements
• Readily accessible, version control with review date
• Examples:
- prescribing policies and guidelines
- procedures for administering medicines, independent checking
- procedure for checking patient identification (Std 5)
- use of the NIMC and ancillary charts
- Mandatory alerts, recommendations
• Audits of compliance
Governance and systems for med safety

Q. Can you please clarify the hospital formulary. There appears to
be a misconception that a hospital formulary is a mandatory
requirement of Standard 4 (4.1.2). Most hospitals have a formulary
broken down into freely available and restricted items. They are not
always available to view throughout the hospital though and are
generally regulated through pharmacy staff (and iPharmacy).

A. Hospitals should have a list of the medicines (formulary) that
have been approved for use in the facility by the DTC (or equivalent
governance group). This should include restrictions placed by the
DTC on the prescribing of any of the medicines.

It is best practice that the list is readily available to staff throughout
the hospital.
Governance and systems for med safety - Policies
www.safetyandquality.gov.au/our-work/medication-safety/
Resources, list of jurisdictional contacts
NIMC

Q. We use an electronic medication management system so we
can’t comply with the use of the NIMC, do we have to change back.

A. The mandatory requirement for use of NIMC applies to those
health services using paper medication charts. It does not apply to
health services with Electronic Medication Management Systems
(EMMS).
As a minimum the EMMS should reflect the core functional and
technical features outlined in the Electronic Medication Management
Systems - A Guide to Safe Implementation Guide 2nd edition and be
working towards the desirable features. Guide available from
http://www.safetyandquality.gov.au/our-work/medicationsafety/electronic-medication-management-systems/


NIMC

Q. From 45 bed private hospital. We use a medication
chart that we modified from the National Inpatient
Medication Chart, some years ago. It is paper based.
Are we able to continue to use this chart or we need to
use the actual document to meet National Standards?

A. Check whether your changes comply with the Local
Management Guidelines produced by the Commission.
http://www.safetyandquality.gov.au/our-work/medicationsafety/medication-chart/quality-assurance-and-an-issuesregister/

If your chart does not comply you will need to transition
to the standard NIMC.
Patient Identification

25% of patient identification incidents are medicines administered to
the wrong patient 1

“Wrong patient” medication errors can occur at any point in the
patient’s journey

NSQHS Standard 5 –processes to correctly match patients with
their intended care using at least three approved patient identifiers.

Patient verification using three identifiers in all patient associated
tasks in the medication use process when:
• Medicines are prescribed
• Pharmacists and technicians enter/verify orders and dispense
medicines
• Medicines are administered
• Medicines are collected from the (outpatient) pharmacy by patients or
carers
• Diagnostic, pathology test results are received, given, and/or
documented. (results that may be relied upon when medicines are
prescribed).
1. Thomas MJW, Runciman WB. Mapping the limits of safety reporting systems in health care
— what lessons can we actually learn? Medical Journal of Australia 2011;194(12):635-39.
Patient Identification
Q. Are 3 identifiers required on dispensed medicines? Would
patient’s labels on medicines dispensed by the pharmacy
department require 3 identifiers?
A. No. Only 2 identifiers are required.
Given the process is in the context of other patient
identification requirements in the NSQHS Standards only 2
two identifiers are necessary.
Governance and systems for med safety
4.2 Assess medication use system
• How?
• Use a structured tool e.g. Medication Safety Self
Assessment
- Every three years
- Multidisciplinary team
• Identify what you are doing well, evidence actions met
• Identify areas for improvements
• Develop an action plan
• Implement and evaluate improvements
• Day procedure services
• Gap analysis using accreditation workbook and/or the
monitoring tool available from
http://www.safetyandquality.gov.au/publications/nsqhsstandards-monitoring-tool-for-hospitals-excel-2007/
Governance and systems for med safety
Q. Is review of medicines use system at facility
level sufficient. If no assessment, risk register,
planning at unit level is this a problem?
A. Assessment at facility level is appropriate as it
is the total medication management system that
should be assessed. It is not necessary to do
individual unit assessments.
NIMC national audit
Q. Hospitals uses non conforming chart.
Can we enter data into NIMC audit database?
A. No. But you can use the spreadsheet
Governance and systems for med safety
4.2.2 Assess medication use system
Q. Do we have to action all problems
identified?
A. Prioritise areas using risk matrix tool
• http://www.safetyandquality.gov.au/ourwork/accreditation/accreditation-newsroom/
Governance and systems for med safety
4.3: Authorising the relevant clinical workforce to prescribe, dispense and
administer medications

Why?
• To ensure that only staff with the competence and
authority to do so can prescribe, dispense and administer
medicines
• Staff work within their scope of practice
Governance and systems for med safety
4.3: Authorising the relevant clinical workforce to prescribe, dispense and
administer medications

What?
• Develop a system to:
• identify areas where specific authorisation is required to prescribe,
dispense or administer medicines; and
• verify and maintain register/log of individual clinicians with
qualifications and competencies(4.3.1)
• Review the use of the system. Identify if system breached
(4.3.2)
• Identify actions to strengthen the system, address any
breaches (4.3.3)
Governance and systems for med safety
4.3.1 : System in place to verify clinical workforce have medication authorities
appropriate to their scope of practice?
See also 1.10 – System for regular review of roles, responsibilities, accountabilities and
scope of practice for the clinical workforce.
Q. Is APHRA registration sufficient?
A. Institution may require additional training/quals/competency assessments for
high risk procedures e.g. chemotherapy prescribing, administration.
Q. How many medicines/specialty areas of practice require registers of qualified
practitioners?
A. This is a local and/or state decision. Areas/medicines where additional skills
are required would include administration of IV, intrathecal chemotherapy.
Health services need to have a process in place for checking specialist
practice qualifications or other professional recognition if is a requirement.
Governance and systems for med safety
4.3.1 : System in place to verify clinical workforce have medication
authorities appropriate to their scope of practice?
See also 1.10 – System for regular review of roles, responsibilities,
accountabilities and scope of practice for the clinical workforce.

Q. Is an annual check of registration adequate? We are told by
accreditors this is not adequate. Are other sites using the multiple
registration inquiry from AHPRA or is there another way that sites are
keeping track?

A. Annual check of registration is minimum requirement. APHRA are
required to notify employers of professionals with conditions on their
registration. Health services need to have a mechanism for informing
managing the communication of this information to the relevant
departments.
Governance and systems for med safety

4.3.2., 4.3.3 The use of medication authorisation system
is regularly monitored and action taken to increase it’s
effectiveness

Q. What the evidence is required for the above mentioned criteria. In
this organisation the List of Approved Medicines (LAM) and
Individual Patient Approvals mechanisms provide the authorisation
structures and the monitoring is done through the Drug Usage
Committee

A. Actions items 4.3.2., 4.3.3 do not relate to approvals to use drugs
such as Individual Patient Use/SAS items. They relate to health
practitioners managing medicines having the skills and competence
to prescribe/dispense or administer a medicine in accordance with
state or territory legislation. See page 20 of Safety and Quality
Improvement Guide for Standard 4.
Governance and systems for med safety
4.4: Using a robust organisation-wide system of reporting, investigating
and managing change to respond to medication incidents

What?

Implement a mechanism for staff to report medication incidents and for
incidents to be analysed, investigated and reported to the medication safety
governance group (4.4.1)

Review reports to identify trends, causes (4.4.1)
• Involve clinical staff, medication safety committee

Identify actions to reduce risk of recurrence (4.4.2)
• Medication safety risk register with actions
• Safety and/or quality improvement plan
• Report to quality/patient safety committee
• Feedback to staff e.g. alerts, bulletins
Governance and systems for med safety
4.4: Using a robust organisation-wide system of reporting, investigating
and managing change to respond to medication incidents
Q. How are sites approaching incident monitoring? Are they using
pharmacist intervention data ?
A. Some hospitals routinely report pharmacy intervention data to
Medication Safety or Drug and Therapeutics Committees.
Intervention data can provide information on important “near misses”.
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use

What?
• 4.5.1 The performance of the medication management
system is regularly assessed.
• Measuring the effect of quality improvement activities
outlined in the medication safety quality improvement
plan, risk register.
• Indicators e.g. Indicators for Quality Use of Medicines, state
performance measures
• IHI Global Trigger Tool (identify adverse medicines events and
areas for improvement in the medication management system)
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use

What?
• 4.5.1 The performance of the medication management
system is regularly assessed.
• Measuring the effect of quality improvement activities
outlined in the medication safety quality improvement
plan, risk register.
• Indicators e.g. Indicators for Quality Use of Medicines, state
performance measures
• IHI Global Trigger Tool (identify adverse medicines events and
areas for improvement in the medication management system)
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use

What?
• Assess the performance of the medication management
system and evaluate effectiveness of changes (4.5.1):
• Auditing implementation of recommendations, safety alerts
- Recommendations for labelling of injectable fluids, lines and
medicines
- National alerts
» Potassium storage - Indicator 6.1 QUM Indicators,
» Vincristine alert - % doses in minibags
- Error prone abbreviations – Indicator 3.3 QUM indicators
- NIMC audit
Governance and systems for med safety
Prescribing errors – unclear, incorrect orders
Administration documentation
Pharmacists’ documentation
Governance and systems for med safety
Q. Is it necessary to collect data routinely?
A. It is about a risk management, not auditing every item.
Focus on high risk medicines and areas initially – those
most likely to cause harm.
Once there is data to demonstrate process improvement
and process is stable then stop auditing and move to
next area identified as requiring improvement.
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use

What?
• Use information from 4.5.1 to identify further improvement
activities required to increase the safety, quality and
effectiveness of medicines use (4.5.2)
• Implement recommendations/alerts
• Standardise work practices and products:
- Use pre-mixed solutions or preloaded syringes for injectable
high risk medicines
- Standardise dosing protocols, medication checking procedures
- Implement policies, procedures and workforce training to
support standardisation
• Use infusion pumps with IV safety software (“smart pump”
technology) and drug libraries
• Implement oral dispensers for oral liquid medicines
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use

Improvement activities to reduce gaps in practice
• VTE risk assessment and prophylaxis
• Antimicrobials stewardship program
• Safe management of high risk medicines e.g.
anticoagulants, insulin
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use
Q. We have no resources to routinely collect of indicator
data or use the Global Trigger Tool
A. Indicator data
• Collect as part of routine care
• Monitor 10 – 20 patients /month (5/week)
Global Trigger Tool
• Liaise with Safety and Quality staff who may collect the
information.
Q. How do we decrease burden of data collection
• Identify areas of highest risk, prioritise
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use
Issue: Lack of definitive, easily obtained, universal
indicators for Q & S of medicines use barrier to
systematic measurement of medicines use systems
A. Use Indicators for QUM in Australian Hospitals
Revised version will contain indicators for:
• Medication reconciliation on discharge
• Mental health
SA Health KPIs for continuity of care
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use
Q. Audit of compliance – what percentage of patients
should be audited, which clinical areas
Will surveyors require organisation wide audits or accept
small, more frequent audits targeted to high risk patients
or processes?
A. Audits are to measure/effect quality improvement
Not required to audit every area
Prioritise area – high risk patients, drugs, processes
Small regular audits (5 patients/week, 20/month) – time series/run
charts are appropriate
Dash boards for feedback to staff
Governance and systems for med safety
4.5: Undertaking quality improvement activities to enhance the safety of
medicines use
Q. To what extent will implementation of each criterion be
expected. e.g. ADR documentation in clinical record – to
what extent will this be assessed? Is 80% sufficient?
A. There are no targets. Health service should have:
•
Policy in place
•
Education provided to staff at orientation
•
NIMC audit for baseline
•
80% ADR documentation - trigger for QI activity – follow up
activity identified in Medication Safety QI Plan
Governance and systems for med safety
Q. Are the medication safety alerts, e.g. for potassium and vincristine,
mandated or recommended?
A. Mandated
Q. Is use of “related specialist and ancillary charts in hospitals”
mandatory or recommended?
A. Use of the NIMC or its specialist versions is mandatory. Includes:
• NIMC, NIMC long-stay
• paediatric NIMC, NIMC long-stay
• private hospital NIMC, NIMC long-stay
• private hospital day surgery NIMC
• four A4 page version of the NIMC (for use by GPs prescribing
for inpatients using GP prescribing software).
Use of ancillary charts is recommended e.g. Clozapine titration
chart.
Governance and systems for med safety

Q. There are issues in implementing barcode scanning in inpatient
and outpatient dispensing. Some hospitals do not use barcode
scanning.

A. Pharmacy Board of Australia intends to move toward a
mandatory requirement for use of barcode scanners during
dispensing by all pharmacists.
Health services not currently using barcode scanning in their
pharmacy dispensing processes should be actively planning to
introduce barcode scanners in both inpatient and outpatient
dispensing processes within the next 18 months.
In the interim, and if there are delays in implementation, health
services need to undertake a risk assessment of their dispensing
processes and put strategies in place to reduce the risk of
dispensing errors which would otherwise be mitigated by barcode
checking.
Australian Commission on Safety and Quality
in Health Care
Medication Safety Program
www.safetyandquality.gov.au
Email: mail@safetyandquality.gov.au
Margaret.duguid@safteyandquality.gov.au
Acknowledgement

Women’s and Children’s Health Network, South
Australia for use of clinical alert