1. 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

2. 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

3. 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

4. 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

5. 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

6. 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.

7. 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

8. 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.

9. Governance and systems for med safety - Policies www.safetyandquality.gov.au/our-work/medication-safety/ Resources, list of jurisdictional contacts

10. 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 2 nd edition and be working towards the desirable features. Guide available from  http://www.safetyandquality.gov.au/our-work/medication- safety/electronic-medication-management-systems/http://www.safetyandquality.gov.au/our-work/medication- safety/electronic-medication-management-systems/

11. 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/medication- safety/medication-chart/quality-assurance-and-an-issues- register/http://www.safetyandquality.gov.au/our-work/medication- safety/medication-chart/quality-assurance-and-an-issues- register/  If your chart does not comply you will need to transition to the standard NIMC.

12. 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.

13. 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.

14. 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/nsqhs- standards-monitoring-tool-for-hospitals-excel-2007/

15. 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

16. 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/our- work/accreditation/accreditation-newsroom/http://www.safetyandquality.gov.au/our- work/accreditation/accreditation-newsroom/

17. 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

18. 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)

19. 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.

20. 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.

21. 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.

22. 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

23. 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”.

24. 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)

25. 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)

26. 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

27. Prescribing errors – unclear, incorrect orders Administration documentation Pharmacists’ documentation Governance and systems for med safety

28. 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.

29. 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

30. 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

31. 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

32. 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

33. 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

34. 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

35. 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.

36. 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.

37. Australian Commission on Safety and Quality in Health Care Medication Safety Program www.safetyandquality.gov.au Email: mail@safetyandquality.gov.aumail@safetyandquality.gov.au Margaret.duguid@safteyandquality.gov.au

38. Acknowledgement  Women’s and Children’s Health Network, South Australia for use of clinical alert