MEDICATION
SAFETY
The Australian Commission on Safety and Quality in Health Care
Included in this issue:
ISSUE 7 • FEBRUARY 2012
will not need to complete an expression of interest
form to participate in phase 2.
•
NIMC VTE Pilot Phase 2 Now open
•
User-applied Labelling Recommendations
•
National Tall Man Lettering
•
New medication reconciliation resources
•
NIMC 2010 National Audit
prescribing section will be piloted. Currently there
•
NIMC in psychiatric facilities
are gaps between VTE prophylaxis evidence and
•
Dabigatran: Risk of bleeding
practice and evidence suggests that point of
About the NIMC VTE Pilot
A draft National Inpatient Medication Chart
(NIMC) with a pre-printed venous
thromboembolism (VTE) risk assessment and
prescribing prompts increase the rate of VTE risk
NIMC VTE Pilot Phase 2
assessment and prophylaxis prescribing.
The Australian Commission on Safety and Quality
The aim of the NIMC VTE Pilot is to evaluate the
in Health Care (ACSQHC) invited Australian
hospitals to participate in the NIMC VTE Pilot
efficacy and safety of a pre-printed VTE risk
assessment and prescribing section in the NIMC
Phase 2.
on VTE risk assessment documentation and
The NIMC VTE Pilot Phase 2 will pilot a draft NIMC
mechanical) in adult patients admitted to
with pre-printed VTE prophylaxis section and will
run from March to the end of November 2012.
Detailed information is provided in the expressions
of interest invitation document which is available
on the ACSQHC web site at
http://www.safetyandquality.gov.au/internet/saf
ety/publishing.nsf/Content/NIMC_006_NationalAu
prophylaxis prescribing (pharmacological and
hospital.
The first phase of piloting involved 19 hospitals in
three states and was conducted from August
2010 to February 2011. This pilot demonstrated a
significant increase in the documentation of VTE
risk assessment and prescribing of
dit
pharmacological prophylaxis. The rate of
Hospitals interested in participating should read
unchanged. The Phase 1 three month post-
the invitation to understand what is required and
whether they are eligible to participate.
Expressions of interest should be submitted on the
NIMC VTE Pilot Phase 2 Expression of Interest form
mechanical prophylaxis ordering was
implementation evaluation report is available on
the ACSQHC web site.
NIMC VTE Pilot Phase 2 will build on the results from
on the web site.
phase 1. Hospitals will use a draft version of the
Completed expression of interest forms can be
been modified to address issues identified in the
emailed to mail@safetyandquality.gov.au
Enquiries can be directed to Ms Helen Stark on 02
9126 3521. Closing date for expressions of interest
is 29 February 2012. NIMC VTE Pilot Phase 1 sites
NIMC with a VTE prophylaxis section that has
first phase of the pilot.
Pending the pilot final report, a revised version of
the NIMC with a VTE prophylaxis section is
expected to be available for introduction
nationally in mid-2013.
National Recommendations for Userapplied Labelling of Injectable Medicines
Implementation of the National
pre-printed sheet of sterile labels for use on the
perioperative sterile field and results are expected
to be reported in April 2012.
Recommendations for User-applied Labelling of
South Australia is developing an online e-learning
Injectable Medicines, Fluids and Lines (Labelling
tool for educating nursing staff about the
Recommendations) is progressing in hospitals and
Labelling Recommendations, available labels and
health services. Implementation resources for the
how to use them. This education tool will be
Labelling Recommendations are available at
available on the ACSQHC web site with a self-
http://www.safetyandquality.gov.au/internet/saf
assessment tool.
ety/publishing.nsf/Content/PriorityProgram-
ACSQHC recognises the importance of stability for
06_UaLIMFL
national standardisations within the context of a
In addition to the implementation guide, slide
quality assurance process. However, it has been
presentation and posters, implementation
necessary to make a single change to the
resources have been updated to include:
container labels effective from November 2011. A
•
third patient identifier (date of birth) has been
A set of frequently asked questions in which
implementation issues are addressed;
•
An issues register in which referred national
implementation issues are listed with decisions
and resulting actions;
•
A poster demonstrating application of the
Labelling Recommendations alongside
included on container labels to comply with the
National Safety and Quality Health Service
Standard: Patient Identification and Procedure
Matching. Container labels have been revised to
include date of birth as shown below.
Example of label including patient date of birth
labelling standard AS/NZS4375 in perioperative
areas; and
•
Gap analysis and audit tools from South
Australia and Victoria to assist with
implementation.
Implementation of the Labelling
Recommendations is an evolving process and
ACSQHC invites health services to contact us for
matters not addressed by the FAQs and the Issues
Register by email on
mail@safetyandquality.gov.au
Anaesthesia, intensive care, perioperative and
emergency services, in particular, continue to
raise important issues in relation to identification of
medicines and implementation of the Labelling
Recommendations. ACSQHC has established the
Labelling Recommendations Reference Group to
advise on maintenance of the Labelling
Recommendations and the group will hold an
initial meeting in March 2012. Decisions of the
group will be reported through the Issues Register.
Establishing a practical suite of sterile, durable,
pre-printed labels for the perioperative sterile field
has proven difficult. The Calvary Wakefield
Hospital, a major tertiary hospital with a strong
focus on neurosurgery, cardiac services and
orthopaedic surgery, is testing the suitability of a
The revision is valid immediately and will be
implemented as existing label stocks are
exhausted. Label manufacturers and suppliers
have been informed of the revision. The revised
print-ready labels are available on the ACSQHC
web site with updated posters for use by health
facilities.
Suppliers of custom procedure packs have been
asked to ensure that labels included in packs to
identify route of administration and medicines
used on the sterile field, e.g. operating rooms and
catheter labs, comply with the Labelling
Recommendations. Please contact
mail@safetyandquality.gov.au if you represent a
label manufacturer or supplier of custom packs
including labels and require further information on
the Labelling Recommendations.
National Tall Man Lettering
The Commission has developed a standard list of
Tall Man names to reduce the risk of drug
selection error by health professionals when
prescribing, dispensing and administering
medicines with look-alike sound-alike names. The
list and supporting documents are available at
http://www.safetyandquality.gov.au/internet/saf
ety/publishing.nsf/Content/PriorityProgram06_NTMS
Tall Man lettering is designed solely for use by
health professionals. For example, it should be
applied in electronic medication management
systems, on printed labels used for inpatient
dispensing, shelving in pharmacies, ward
medicines cupboards and in drug libraries for
smart pumps. It is NOT designed for handwriting or
for printed labels intended for consumers.
having a formal medication reconciliation
process.
The MMP form, the new training presentation and
other MMP implementation resources are
available from the ACSQHC web site at
http://www.safetyandquality.gov.au/internet/safet
y/publishing.nsf/Content/PriorityProgram06_MedRecon
Medicines list iPhone App
Patients and carers with iPhones can now keep
an up to date medicines list on their iPhone and
email and print the list. The new Medicines List
iPhone App, developed by NPS: Better Choices,
Better Health, also allows people to schedule
reminders which prompt them to take their
medicine. This is an exciting use of technology to
help patients maintain an accurate list of their
medicines and for the information to be available
when they present to hospital or visit their
Standards Australia’s Health Informatics (IT-014)
community health care provider. For more
Committee has been asked to consider
information on the NPS Medicines List iPhone App
developing National Tall Man Lettering into an
visit http://www.nps.org.au/iphonemedicineslist
Australian standard. The request will be
considered by the committee in the context of
NIMC 2010 National Audit
the large body of work it has been charged with
undertaking in the near to medium future.
No decision on incorporating Tall Man lettering
into the Australian Medicines Terminology (AMT)
has yet been made. However the National EHealth Transition Authority Ltd recently undertook
an AMT roadmap survey to understand what
additional information should be part of a
national medicines terminology. The issue of Tall
Man and AMT as a possible future development
was included in the survey. Details of the survey
are available from the NEHTA web site at
http://www.nehta.gov.au/media-centre/featurestory/945-australian-medicines-terminologyimplementation-plan-roadmap-survey
New medication reconciliation resources:
National MMP training presentation
A new online training presentation is available to
assist healthcare professionals use the National
Medication Management Plan form (MMP). The
presentation uses voice over to describe how to
obtain and document a complete and accurate
medication history. It provides an introduction to
the four steps of medication reconciliation and
highlights the evidence for, and the benefits of,
The National Inpatient Medication Chart (NIMC)
reduces the risk of prescribing and administration
errors in acute care
The NIMC standardises medication information
communication between doctors, nurses and
pharmacist with the aim of reducing harm to
patients from medication errors.
The NIMC 2010 National Audit of medication
charts was undertaken by nurses and pharmacists
in seven jurisdictions from August to December
2010. The audit included 2,591 patients with 3,720
medication charts and 30,005 medication orders
from 69 hospitals (including two private facilities).
As in the 2009 audit, the 2010 audit found that
some aspects of prescribing practices have
improved since the introduction of the NIMC in
2006 and 2007, with a corresponding potential to
Table 2: Examples of prescribing error rates
reduce medication errors and possible adverse
drug events. However in some areas there has
Audit results (%)
Criteria for missing,
been little change and even a decline in the
incorrect
2006 post
2009
2010
NIMC pilot
audit
audit
N=
N = 30,005
9,047
orders
safety of prescribing, particularly in the use of
or unclear medication
audit
error-prone abbreviations. Overall 11% of doses
orders
N= 15,416
were omitted or their administration not signed
for.
orders
orders
Unclear medication
The 2010 audit report will be available shortly on
names
3.0
7.6
4.0
the ACSQHC web site.
Route errors (missing,
6.5
13.3
10.3
4.3
18.4
14.2
15.5
20.0
19.6
32.2
35.6
46.2
N/A
22.6
24.6
unclear, incorrect)
Table 1: Rate of compliance in selected NIMC safety
features
Dose errors missing,
unclear, incorrect
Criteria for safe prescribing
Rate of compliance (%)
2006 post
2009
2010
NIMC
audit
audit
pilot
N=864
N=2,591
audit
19.8
frequency errors (missing,
unclear, incorrect)
- PRN frequency
errors
Error prone abbreviations
N=1,234 *
Patient identification
Regular, PRN, Variable
31.3
32.8
used
completed (all patients)
Indication documented
22.8
14.5
20.2
Patients’ weight
Orders ceased correctly
N/A
24.1
49.5
documented
•
all patients
•
paediatric
patients
Complete details of
19.1
29.4
23.1
24.4
75.7
N/A
NIMC National Audit 2012
62.7
77.3
Nationally coordinated NIMC auditing will begin
previous ADR documented
in 2012 and take place from 1 August to 30
(drug name and reaction
September. National auditing will occur every two
or nil known)
Warfarin orders with target
70
69.6
95.7
34.3
62.1
70
11.0
10.0
12.6
INR documented
Indication for warfarin
documented
Warfarin education for
patients documented
Patients with drugs
years thereafter at the same time of year.
Hospitals using the NIMC are invited to participate
in the audit to identify areas of practice requiring
improvement, to compare with peer hospitals
and to track practice over time.
Hospitals can collect audit data using the paper-
0.9
1.6
0.9
based NIMC Audit Form, the NIMC Audit
prescribed of a similar class
Spreadsheet or enter directly into the NIMC Audit
(duplication)
System at
Medicines prescribed by
73.0
80.2
78.8
generic name
Sustained release forms of
www.safetyandquality.gov.au/nimcaudit.
For more information on the NIMC 2012 National
37.7
46.4
61.3
drugs identified
Audit, visit the ACSQHC web site at
http://www.safetyandquality.gov.au/internet/saf
ety/publishing.nsf/Content/NIMC_2012-
* N = number of patients
Table 2 shows prescribing error rates compared to
previous audits. Areas where there is significant
room for improvement include use of approved
abbreviations and the frequency of PRN orders.
NationalAudit or email Ms Angela Wai at the
ACSQHC on nimc.audit@safetyandquality.gov.au
You can also contact your local State or Territory
representative, or quality coordinator, for further
information on participating in the NIMC 2012
National Audit.
NIMC in psychiatric facilities
The Commission is researching NIMC use in
psychiatric acute care facilities. The research is
looking at NIMC issues raised by a number of
health professionals working in psychiatric acute
services and to assess if any additional
implementation resources are required to assist
safe and standard use of the NIMC in that setting.
Dabigatran (Pradaxa) is one of three new oral
anticoagulants approved for the prevention of
venous thromboembolism after major
orthopaedic surgery of the lower limb (elective
total hip or knee replacement). The other agents
are rivaroxaban (Xarelto) and apixaban (Eliquis).
Dabigatran is also approved for prevention of
stroke and systemic embolism in patients with
atrial fibrillation. Incidents have been reported
An ACSQHC survey of health professionals
where patients admitted to hospital taking
working in psychiatric acute services was held
dabigatran have been commenced on other
from July to November 2011. Preliminary results
anticoagulants on admission to hospital as
indicate that there are some specific practice
prescribers were not aware that the drug was an
issues in psychiatric acute services which affect
anticoagulant.
NIMC use and that standardised ordering of
certain medicines, particularly clozapine, present
difficulties.
There is no antidote or specific reversal agent for
these agents.
Health services should ensure prescribers are
aware of:
•
New anticoagulants;
•
Risks associated with their use;
•
Monitoring requirements;
•
Management in the peri-operative period;
and
•
Management of bleeding.
Links to state safety notices on the new oral
A report on the ACSQHC survey, and other
anticoagulants have been posted on the
research, will be considered by the Health
ACSQHC web site at
Services Medication Expert Advisory Group in
http://www.safetyandquality.gov.au/internet/saf
February along with recommendations. The
ety/publishing.nsf/Content/NIMC_005_Medicatio
report, and meeting outcomes, will be available
n-Safety-Alerts
on the ACSQHC web site shortly after.
Adverse events associated with the new oral
anticoagulants should be reported to the TGA at
Safety advisory on dabigatran (Pradaxa):
Risk of bleeding
http://www.tga.gov.au/safety/problemmedicine-report-adr.htm
On 3 November 2011 the Therapeutic Goods
Administration (TGA) updated the safety advisory
on the risk of bleeding relating to the use of the
oral anticoagulant dabigatran. The update,
available at http://www.tga.gov.au/safety/alertsmedicine-dabigatran-111005.htm includes new
recommendations for monitoring kidney function
when prescribing the drug.
From June 2009 to 0ctober 2011, TGA received
297 reports of adverse events with dabigatran;
196 of them serious of which 70 were bleeding
events.
National Safety and Quality Health Service
Standards
ACSQHC has developed ten National Safety and
Quality Health Service (NSQHS) Standards to drive
the implementation and use of safety and quality
systems and improve the quality of health service
provision in Australia. The NSQHS Standards were
selected because they address areas where:
•
The effect is on a large number of patients;
•
There is a known gap between the current
situation and best practice outcomes; and
•
Improvement strategies exist that are
A number of other standards contain criteria that
evidence-based and achievable.
are relevant to medication safety including
From early 2013 hospitals and day procedure
services will be assessed against the NSQHS
Standards as part of their accreditation processes.
Medication Safety is standard 4. The aim of the
medication safety standard is to ensure
competent clinicians safely prescribe appropriate
medicines to informed patients and carers.
Patient Identification and Procedure Matching,
Clinical Handover and the two overarching
standards; Governance for Safety and Quality in
Health Service Organisations and Partnering with
Consumers.
The NSQHS Standards, fact sheets and other
information to support health services implement
the NSQHS are available from the ACSQHC web
site. Guides to implementation are in
development and will be available shortly.
http://www.safetyandquality.gov.au/internet/saf
ety/publishing.nsf/Content/PriorityProgram-07
Safer Naming, Labelling and Packaging of
Medicines Round Table
A report on the National Round Table on Safer
Naming, Labelling and Packaging of Medicines is
available on the Commission web site at
The standard includes 5 criteria:
•
Governance for medication safety;
•
Documentation of patient information;
•
Medication management processes;
•
Continuity of medication management; and
•
Communicating with patients and carers.
A full copy of the Medication Safety Standard is
contained in the NSQHS Standards. It includes the
criteria, items and actions required for health
services to meet the Standard.
ACSQHC tools and resources to assist health
services implement the Medication Safety
Standard include:
http://www.safetyandquality.gov.au/internet/saf
ety/publishing.nsf/Content/PriorityProgram06_SaferNaming The report contains
recommendations for future activity and will
guide national activity.
The round table was held in Sydney on 24 May
2011. Co-hosted by ACSQHC and the Therapeutic
Goods Administration (TGA), the round table
brought together the pharmaceutical industry,
regulators, policy-makers and consumers. The aim
of the round table was to improve patient safety
in relation to medicines naming, labelling and
packaging through agreement and coordination
amongst key stakeholders.
Review of labelling and packaging
•
NIMC and support materials;
•
National Terminology, Abbreviations and
packaging regulatory framework for prescription
Symbols to be used in the Prescribing and
medicines, over the counter medicines and
Administering of Medicines in Hospitals;
complementary medicines. A public consultation
National Medication Management Plan form
paper is expected to be released in early 2012.
•
•
The TGA has initiated a review of the labelling and
and support materials;
Information on the review is available from
National Recommendations for User-applied
review.htm
Labelling of Injectable Medicines, Fluids and
Lines;
•
National Tallman Lettering List; and
•
Medication safety alerts.
http://www.tga.gov.au/industry/labelling-