Minutes of Medication Safety Expert Advisory Group MeetingThursday 10 November 2011 9.30am to 15.30pm

Karaka Room, Ministry of Health, Unisys House, 650 Great South Road, Penrose, Auckland

AttendeesDwayne Crombie (Chair) Steven Lillis (GP, NZCGP)Mary Seddon (CMDHB) David Woods (NZF)Nirasha Parsotam (HQSC) Alan Davis (NDHB)Janet Mackay (PHARMAC) Sandra Fielding (BoPDHB)Beryl Wilkinson (Consumer) Stacey Hurrell (Waitemata DHB) Avril Lee (Waitemata DHB) Mary-Anne O’Rourke (Kowhai Health)Rob Ticehurst (ADHB)

In Attendance: Gillian Bohm (HQSC), Beth Loe (HQSC), Carmela Petagna (HQSC)

Apologies : Chris Cameron (CCDHB)

MinutesItem Agenda Notes/comments Action Required 1. a. Member

introductions The chair welcomed people to the meeting

and attendees introduced themselves giving a brief resume

b. EAGdisclosure ofinterests

Members were asked to indicate any potential conflicts of interest that may arise for either themselves or through their immediate family

Members to send in conflict of interest register (All)

Update conflict of interest register (Beth)

c. EAG TOR The TOR for the governance group and the steering group were requested

The medication safety governance group, steering group, members and individual clinicians could suggest projects to the EAG

There is provision in the TOR for the chairs of the governance, expert advisory and steering group to attend meetings of each group

It was agreed that the strategic agenda items should come before the technical agenda items and that there did need to be a balance between the strategic and operational work

Prioritisation of the operational work would be necessary going forward

Circulate TOR (Beth)

d. EAG 2012meeting dates

Proposed meeting dates for 2012 had been circulated with the agenda: 9 Feb, 19 April, 14 June, 16 Aug, 11 Oct, 6 Dec

The dates will be confirmed when the draft minutes are circulated

Inform Beth if meeting dates all unsuitable (All)

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e. Medicationsafetygovernancestructure

Gillian gave a brief overview on the role of the HQSC and the history behind its genesis

The roles of the governance and steering groups and NICLG were highlighted

There was a clear need to integrate the work of the steering group, the EAG and NICLG

It was agreed that the structure diagram needed to more accurately reflect the two-way flow of information and work

Discussion between chairs of the 3 groups (EAG, Steering group & NICLG) (Dwayne)

Update flow diagram (Nirasha)

2. a, b & c.Medicationsafetyprogrammeupdate,balancedscorecard &status update

The medication safety programme update, scorecard and status update presented to the board were provided for information

There was discussion regarding possible prioritisation tools that could be used for medicines reconciliation

CMDHB have a tool based on the electronic information gathered from their PMS and automated dispensing cabinet information

This would not be transferable to all DHBs e.g. only 4 DHBs have automated dispensing cabinets and not all DHBs operate the same PMS

No evaluation has been carried out on the electronic tool yet but it is planned that NIHI will conduct an evaluation

The internationally agreed goal is that medicines reconciliation is carried out for all patients

Currently all DHBs are using different prioritisation methods

The Commission is reviewing the prioritisation tools being used currently and whether a simple tool that all DHBs could adopt can be developed and piloted

d. NationalMedicationChart

The paper on the NMC long stay version was discussed

There was discussion about evaluation and cost benefit analysis of the NMC

Australia had carried out an observational study and considered that there was a 17% error reduction since their NMC was introduced

The proof of the proposed long stay chart was circulated for comment

It was agreed that the current design with small corrections would be piloted

It was agreed that the risks identified at the design sub-committee meeting had been mitigated in the proposed design

It was agreed that the design would be piloted in the four volunteer DHBs

The proposal to include paediatric clinical requirements within the design of the NMC was discussed

It was agreed that paediatric clinicians would be consulted regarding the

Small corrections to the design to be communicated to the printer (Beth)

Consult with paediatric clinicians on design of paediatric friendly chart (Beth)

Feedback to informal change requests made by clinicians (Beth)

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proposed paediatric additions There was a proposal that a day stay chart

was required – this would include the current front page and once only page

Should the long stay pilot be successful and it is agreed that there should be one chart to cover acute and long stay then a proposal for a day stay chart would be considered

There needed to be some feedback to clinicians about the change requests already submitted for the NMC

There was discussion about submitting requests through the electronic change register

The Commission was scoping a piece of work to address the design and implementation of a medication chart appropriate for use in aged residential care. Once scoped this project would e tendered to the market.

e. Medicinereconciliation(MR)

The prioritisation tool for MR was discussed under 2a,b&c

MR health target (health target e.g. 6 hour wait in ED) was proposed to the Minister but is not proceeding in the 2012/2013 year but remains a possibility

f. eMedicinesprogramme -electronicprescribing andadministration(ePA) andelectronic MR(eMR)

There was a discussion around the cost benefit analysis. The associated business case had not been provided and was requested by members

The Commission is responsible for the paper based projects and in the transition phase of the Commission’s establishment had signalled a commitment to the next phase of the eMedicines programme.

It partners with the NHB and NHITB in the electronic projects and requested a business case be developed before the funding for the project could be released

The Commission has agreed a financial contribution for the next phase of the eMedicines Programme but requires some further enhancements to be made to the cost benefit analysis

The long term vision through “a Go For Gold” campaign is that by 2014 all DHBs will have introduced eMedicine Management solutions, specifically ePA and eMR

There was a discussion around vendor engagement and selection. The original intention under SMM was for multiple vendors but there is now a single vendor for each part of the programme. This does not limit a DHB from engaging with another vendor as long as inter-operability with other systems is maintained

The original SMM project called for e point

Distribute business case for e medicines programme after meeting on 18.11.11 (Beth)

Agenda item at the next meeting - review the “electronic direction” for medicines safety (Beth)

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of care i.e. prescription, medicine, patient linked electronically

The Commission is looking to appoint a dedicated clinical resource to manage the eMedicines implementation

A workshop is planned for 18.11.11 to further strengthen the cost benefit analysis

There was discussion about standards for vendors

3. Prioritisationof EAG work

A paper was circulated identifying seven possible long term goals and four defining categories (used by the VA in USA) that could be used as a basis for prioritisation

It was agreed that these were more principals rather than goals

Another possible framework was to use the organisationally based goals from “Building a Safer NHS”

There was a broad discussion about measuring and evaluation within the Commission but also the need to incorporate measuring and evaluation into EAG work

Each project should consider harm minimisation and a reduction in adverse effects. The ADE trigger tool is the only available measure of harm

Consider the medication journey and what can be done to reduce risk at points where harm can occur, look at both the SQM and the Australian journey (if one is available)

A simple cost benefit analysis that includes the opportunity costs, the proposed action and the proposed benefit could be used as the basis for agreeing priorities

Individual member priorities Situational awareness of where things are

at in terms of medication safety Identify strategic direction for medication

safety in New Zealand Unification and less duplication of effort Stop measuring and increase

implementation of effort Spreading knowledge and effort Empower patients to challenge Educate, inform and engage everyone with

patient safety Have the whole country on board A clear structure and very transparent at

the grass roots level as to what is happening

Prioritising patient and health professional safety

Consumer safety and the right of the consumer to refuse medication but when a consumer is unable to participate in that decision they will be safe. The need for health professionals to be given education whenever new medicines are marketed

Ensure the quality of prescribing and

Visualisation of the patient journey and possible harm points to be circulated (Beth)

Develop a potential prioritisation framework (Nirasha)

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empower the consumer4. National

MedicationSafetyStrategy

There was discussion about how the SQM strategy fits with “Actioning Medicines New Zealand”

There would need to be discussions with the MoH regarding how the two strategies could be joined

It was agreed that nothing should be done for a year while the direction and priorities are developed and set and then the situation would be reviewed

5. SaferPrescribing

The three papers included on the agenda were discussed

It was agreed that training on safer prescribing would be most appropriate as a core part of the curriculum at the intern level

The Medical Council and Health Workforce NZ should be made aware that there is a need for safer prescribing training and that training on the national Medication Chart should be introduced

A question was raised about the evidence available that training was needed and mention was made of the studies done on hospital discharge prescriptions and the spikes in medication errors when new graduates start

Papers on medication errors relating to hospital discharge prescriptions and spikes when new graduates start to be circulated (Beth)

Write to Medical Council and Health Workforce New Zealand (Beth)

6. MedicineReconciliationin PrimaryCare

This was discussed under item 5 It was agreed that at the present time there

were many systems in place and not all hospitals or primary care services were at the same level of information provision

The principal feedback was that there were issues with the generalisability of the data because the work had been carried out in one region

Feedback to Patients First (Carmela)

7. HealthLiteracy andConsumerEngagement

The patient pamphlet wasn’t discussed The medicine reconciliation pamphlets that

had recently been published and were available to download off the Commission website were mentioned

The original scope given to NZ Guidelines Group for the Health Literacy report was unknown (unfortunately Gillian had to leave the meeting before this item)

Because the scope was unknown only the recommendation that requested information from the EAG was discussed

It was agreed, after some discussion, that the three classes of medicines for which significant safety issues arise that should be targeted for health literacy improvement are: over the counter analgesics (e.g. paracetamol, ibuprofen and other NSAIDs), anticoagulants, gout medication

There is a need for broader support on building the consumer voice

Communicate the three classes of medicines to health literacy staff (Beth)

Agenda patient pamphlet at next meeting (Beth)

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8. Labelling andpackaging

There was a discussion based on the request from the chair of the NZULM regarding the use of Tall Man lettering

The general consensus was that an agreed list of medicine names with tall Man lettering would be useful in electronic systems where picking from a drop down menu was a source of error

There had been a recent case where penicillamine had been chosen rather than penicillin from a drop down list

Both Australia and Spain had recently developed their own Tall Man lettering lists

Both countries based their lists on international lists, e.g. ISMP but had developed the country specific list in very different ways

The Australian evaluation work was discussed and it was agreed to contact the Australian Commission regarding any unpublished evaluation

Some of the papers regarding evaluation referenced in the Australian documents would be circulated

There was a discussion on the absence of a definite date for the introduction of barcoding in the recently published labelling guidelines and it was felt that this should be raised at a high level

The NZULM identified that there are issues with some manufacturers regarding standard wording particularly for concentrations and that non-standard wording increases the risk of medication error because the concentration can be misinterpreted and the wrong dose given

Recommended concentration wording for labelling standards (Rob)

Discuss labelling and packaging issues with Medsafe (to include barcoding, standardisation of displaying concentration) (Dwayne)

Circulate the papers referenced in the Australian guidelines that relate to evaluation (Nirasha)

Follow up any further evaluation undertaken by the Australian Commission (Beth)

9. Measuringand reporting

An evaluation frame work for the paper based chart and MR pilots and the ePA pilot had been developed based on the IHI principals and the PDSA cycle

This framework needed to be strengthened going forward and the Commission had asked for expressions of interest from providers to work with the Commission on measuring and evaluation for the medication safety programme

6 provider profiles have been submitted and a group will review the profiles and make a shortlist. Those groups will be asked to present before a final decision is made. This selection process is a joint decision between the Commission and the NHIT Board

There was a brief discussion on evaluation of the long stay chart in the forthcoming pilots and it was agreed that the prime evaluation was that it was fit for purpose and that it reduces harm

Evaluating a reduction in harm as discussed previously is hard to do with current available methodology

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Technical Agenda

10. Implementationprocess foralerts

The proposed process developed by SQM Group was discussed

It was agreed that this should be implemented

11. Heparin alert The alert had been issued with the accompanying action plan in September 2011

Three DHBs had returned interim action plans

Remind DHBs regarding action plans (Beth)

Review action plans in March 2012 (Beth)

12. Caffeine alert The alert was issued in October 201113. Dabigatran There was a discussion about comparing

the number of adverse drug reaction reports received by CARM to that anticipated from the clinical trial data

The data for the number of prescriptions as the denominator for the three month period July-October would be available from PHARMAC in January 2012

The CARM adverse reaction data for the same three month period was available

The latest alert issued by Boehringer Ingelheim through the European Medicines Agency and the UK Medicines and Healthcare products Regulatory Agency was shared, this was based on cases of fatal bleeding in Japan

The lessons that can be learned from what happened following the funding of dabigatran need to be identified to prevent a similar occurrence

One lesson is that there needs to be pro-active communication so that change management and education for both health professionals and consumers are available earlier than happened with dabigatran

PHARMAC pointed out that funding decisions for medicines often happen very quickly

It was agreed that a process for managing the approval and funding for high risk medicines onto the market is needed

It was agreed that a proposal be made to PHARMAC that identifying possible safety issues that may result from any internationally recognised high risk medicine implementation should be included in PTAC considerations

There was a discussion about the information that had been available to consumers on dabigatran when it was funded: the package information leaflet and the information in any direct to consumer advertising

It was agreed that a consumer friendly patient information leaflet would have been helpful and one would be developed in conjunction with the health literacy team

It was agreed that there would be no

Review of adverse drug reaction reports against prescription numbers for the first three months of dabigatran usage

Send proposal to PHARMAC that safety considerations be taken into account when proposals to fund high risk medicines are considered by PTAC (Beth)

Develop PIL for dabigatran (Medication Safety team)

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benefit in developing a second dabigtatran alert at this time

14. Oralmethotrexate

This was not discussed

15. Renal Drug Dosing

This was not discussed Individual members gave some written

feedback

Update alert appropriately (Beth)

16. Paediatricweight baseddosing

This was not discussed

17. Transdermalpatch alert

This was not discussed Members provided written feedback

18. Hearing lossassociated withcisplatin andgentamicin

The paediatric oncology centres in Auckland and Christchurch both follow the guidelines in the paediatric protocols regarding audiology testing and the testing is carried out by the audiology service at the two centres

A degree of hearing loss is expected but all possible precautions are taken to prevent it e.g. dose modification, no treatment with other ototoxic agents

It has been identified that the normal ototoxicity of aging is accelerated by cisplatin treatment

It was agreed that no further action was required and that the proposed gentamicin alert would not to be developed

19. Clozapinerelatedcardiomyopathyand actionsarising fromcoroner’s report

The coroner’s report was discussed The comments raised by CCDHB

regarding the recommended Waitemata DHB guidelines were discussed

It was agreed that national clozapine best practice guidelines should be agreed between the DHB mental health services

It was agreed that the Chief Coroner should be notified that where the development of national guidelines was felt to be appropriate the Commission was not always the appropriate body to oversee their development

Reply to CCDHB regarding development of national best practice guidelines (Beth)

Write to Chief Coroner regarding the development of national guidelines (Beth)

20. Methoxyfluraneuse in NZambulanceservice

This had been added to the agenda through the Commission chair and had been raised by the ANZCA

It was unclear exactly what was expected of the EAG

Many of the references in the supplied background document related to malignant hypothermia which is a recognised adverse reaction when methoxyflurane is used as a general anaesthetic but does not occur when it is used as an analgesic (ambulance use is as an analgesic)

There are some references on trials carried out in the Australian ambulance service that are not included in the information from the ANZCA

It was agreed that the Chief Medical Officer for the ambulance service would be contacted as to whether a protocol for the

Contact ambulance service Chief Medical Officer regarding the protocol that is used for methoxyflurane (Beth)

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use of methoxyflurane existed and if any issues had been identified

21. Paracetamolinduced liverdamagerequiring livertransplants inchildren

The articles for Kaitiaki and the Best Practice needed modification and would be discussed at the next meeting

Update both articles (Beth)

22. Look alikesound alikeissues

These would be highlighted when necessary going forward

23. Allergy alertsystem andeducation

This was an ongoing issue and the MoH was working on a new NHI platform

It was important to ensure the functionality could be seen in both primary and secondary care

High riskmedicines forwhich no alerthad beendeveloped

Of the internationally recognised high risk medicines no alert had been developed for insulin

Two possible education modules for health professionals were available

Include insulin for discussion on the next agenda (Beth)

Relationshipwith NZPhVCand ACC

It was commented that it was important to maintain the links SQM Group had with both these organisations and in particular NZPhVC because of their current project looking at medication error reports from primary care

It was agreed that the relationship between the EAG and both organisations would be maintained

Invite both the NZPhVC and ACC to the February meeting (Beth)

Standards forprimary carepracticemanagement(PM) systems

It was commented that the proposal to develop standards for practice management systems made by Patients First should be investigated further as this may add value

It was felt that other organisations may already be working on this

Who, if anyone, is considering standards for PM systems (Nirasha)

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