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Medication Safety version 3
Retrospective data in full
Australasian Clinical Indicator Report 2004–2011

About this report
These full data reports of the Australasian Clinical Indicator Report list collective performance
against each of the ACHS clinical indicators that were collected during 2011.
In this report, each of the indicators from the Medication Safety CI set has a table (shaded green)
that describes the indicator, its intent, numerator and denominator. Tables summarise the data
submitted in every year since 2004 that the indicator has been available.
For indicators of interest, this report will assist in better understanding the true granularity of the
data.
For indicators launched before 2009, trends in the rates over time are reported and the data are
displayed using a line graph. More than three years of data are needed to display a trend.
Outlier information is displayed using funnel plots.
Three measures of variation in rates between healthcare organisations (HCOs) are included; these
are quantified by the differences between the 20 th and 80 th centiles.
These green tables also include statistical estimates of the potential gains for all eligible indicators,
if changes in the distribution of data were achieved.
Centile gains show the number of units (for many CIs, patients) that would benefit if the
overall level of performance achieved by all organisations combined was the same as that of
the better performing 20% of organisations (as defined by the 20th or 80th centile rate).
Stratum gains show the number of units (for many CIs, patients) that would benefit if the
performance of organisations outside the better performing stratum was lifted to that level.
Strata can only be considered for these comparisons when there is sufficient data (at least
five organisations contributing to each stratum). Stratum differences may represent the
contrast between either metropolitan or non-metropolitan organisations, between any single
state / territory and the others, or between organisations belonging to the public and private
sectors. Where the differences between strata are statistically significant, further information
is provided within the report, and can be identified by the presence of a table shaded mauve
(public / private), pink (metro / non-metro) or apricot (states / territories / NZ). Multiple tables
are displayed when more than one stratum is statistically significant. Only the largest stratum
gain is recorded in the opening green table.
Outlier gains show the number of units (for many CIs, patients) that would benefit if those
organisations with results that are more than three standard deviations poorer than average
could achieve the average level of performance.
Medi Medication Safety, v3
Acknowledgements:
In 2011, there were changes to this indicator set.
The position of Chairperson for the Medication Safety Working Party is currently vacant. The working
party includes representation from the:
Therapeutic Goods Administration
NSW Therapeutic Advisory Group
The <strong>Australian</strong> <strong>Council</strong> on Healthcare Standards
Health Services Research Group, University of Newcastle
Published by ACHS, October 2012.
Telephone: +61 2 9281 9955
© The <strong>Australian</strong> <strong>Council</strong> on Healthcare Standards
This work is copyright. Apart from any use as permitted under the Copyright Act 1968,
no part may be reproduced by any process without prior written permission from the
<strong>Australian</strong> <strong>Council</strong> on Healthcare Standards.
Recommended citation
<strong>Australian</strong> <strong>Council</strong> on Healthcare Standards (ACHS). Medication Safety version 3.
Retrospective data in full. Australasian Clinical Indicator Report 2004–2011. Sydney NSW; ACHS; 2012.

Medi Medication Safety, v3
Contents
Reporting of adverse drug reactions to the Therapeutic Goods Administration (TGA)1
CI 1.1: Adverse drug reactions reported to OPC, TGA (N) 1
Medication errors resulting in an adverse event .............................................................. 3
CI 2.1: Medication errors – adverse event requiring intervention (L) 3
Documentation of a patient’s known adverse drug reactions (ADRs)........................... 5
CI 3.1: Known ADRs documented in current medication chart (H) 5
Error-prone abbreviations .................................................................................................. 7
CI 4.1: Medication orders with error-prone abbreviations (L) 7
Warfarin management ......................................................................................................... 9
CI 5.1: Warfarin – abnormal bleeding (L) 9
CI 5.2: Warfarin – INR / prothrombin reading >5 (L) 12
CI 5.3: Warfarin – written drug information upon discharge (H) 15
CI 5.4: Warfarin – dosage review following high INR result (H) 17
CI 5.5: Warfarin – starting doses consistent with hospital approved protocol (H) 18
Timely and appropriate monitoring of aminoglycoside antibiotics ............................. 19
CI 6.1: Aminoglycoside toxicity – dosage adjustment prior to next dose (H) 19
Clinical Significance of these results .............................................................................. 20
Therapeutic Goods Administration (TGA) 22
Australasian Clinical Indicator Report 2004–2011
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Medi Medication Safety, v3
Reporting of adverse drug reactions to the Therapeutic Goods Administration
(TGA)
CI 1.1: Adverse drug reactions reported to OPC, TGA (N)
Rationale
Reporting of adverse drug reactions to an external body may be beneficial for the future
management and safety of patients.
Numerator
Denominator
Total number of adverse drug reactions, which were reported to ACSOM, OMSM
Total number of non same-day separations
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
*Centile
Gains
*Stratum
Gains
2004 117 1,301 765,708 0.17 0.011 0.16
2005 113 1,546 824,196 0.19 0.012 0.18
2006 120 919 818,559 0.11 0.011 0.14
2007 134 1,477 1,003,158 0.15 0.008 0.15
2008 140 1,036 1,061,923 0.098 0.012 0.090
2009 153 1,129 1,158,623 0.097 0.010 0.088
2010 136 1,194 1,159,509 0.10 0.006 0.070
2011 97 1,032 893,193 0.12 0.007 0.10
#per 100 separations *Gains are not calculated when the desirable level is not specified.
In 2011 there were 151 submissions from 97 HCOs. The annual rate was 0.12 per 100
separations.
*Outlier
Gains
Trends
The fitted rate decreased from 0.17 to 0.093, a change of 0.074 per 100 separations. This trend
was also significant after allowing for the changing composition of HCOs contributing over the
period. The rate change was 0.074 per 100 separations.
Australasian Clinical Indicator Report 2004–2011 Page 1
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Medication Safety, v3
Rates and centiles by year
Desirable rate unspecified
80 th centile rate
x
Aggregate rate
Period average rate
Fitted rate
20 th centile rate
Variation between strata
There were no significant stratum differences in 2010 and 2011.
Variation between HCOs
Outliers
Since it has not been specified whether high or low rates are desirable, outlier HCOs are not
reported.
Australasian Clinical Indicator Report 2004–2011 Page 2
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Medication Safety, v3
Medication errors resulting in an adverse event
CI 2.1: Medication errors – adverse event requiring intervention (L)
Rationale
The use of medication remains the most common intervention in health care. Medicine misuse,
underuse or over use and adverse reactions annually result in an estimated 140,000 annual
hospital admissions in Australia; most of these adverse drug events are preventable.
Numerator
Denominator
Total number of medication errors resulting in an adverse event requiring intervention
beyond routine observation and monitoring
Total number of occupied bed days
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
Outlier
Gains
2005 144 400 3,867,458 0.010 0.002 0.014 314 161
2006 203 1,394 6,392,952 0.022 0.002 0.016 1,239 497 758
2007 259 6,580 8,263,636 0.080 0.003 0.087 6,364 3,642 3,781
2008 267 5,185 9,484,850 0.055 0.002 0.039 4,955 3,246
2009 259 3,949 9,339,048 0.042 0.002 0.021 3,771 2,562
2010 262 2,211 9,425,487 0.023 0.001 0.015 2,082 1,328
2011 247 892 7,132,050 0.013 0.003 0.014 712 331
#per 100 bed days
In 2011 there were 420 submissions from 247 HCOs. The annual rate was 0.013 per 100 bed
days.
Trends
The fitted rate improved from 0.051 to 0.030, a change of 0.021 per 100 bed days. This trend
was also significant after allowing for the changing composition of HCOs contributing over the
period. The rate change was 0.020 per 100 bed days.
Rates and centiles by year
A Low rate is desirable
80 th centile rate
x
Aggregate rate
Period average rate
Fitted rate
20 th centile rate
Australasian Clinical Indicator Report 2004–2011 Page 3
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Medication Safety, v3
Variation between strata
There were no significant stratum differences in 2010 and 2011.
Variation between HCOs
In 2011 the potential gains totalled 712 fewer medication errors resulting in an adverse event
requiring intervention, corresponding to a reduction by approximately three quarters.
Outliers
In 2011 there were 21 outlier submissions from 17 HCOs whose combined excess was 330
more medication errors resulting in an adverse event requiring intervention. The outlier HCO
rate was 0.047 per 100 bed days.
Australasian Clinical Indicator Report 2004–2011 Page 4
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Medication Safety, v3
Documentation of a patient’s known adverse drug reactions (ADRs)
CI 3.1: Known ADRs documented in current medication chart (H)
Rationale
The purpose of ADR documentation is to avoid further harm to patients who have previously
experienced an ADR to that (or similar) medication. Data from NSW audits of the National
Inpatient Medication Chart (NIMC) show that completion of ADR documentation occurs 49-85%
of the time. Incidents involving medication administration to patients with a known ADR to that
medication continue to occur. Prevention of such errors depends on current and complete
information being available at the time of prescribing, dispensing and administration.
Numerator
Denominator
Total number of patients whose known ADRs are documented on the current medication
chart
Total number of patients in the sample
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
Outlier
Gains
2009 49 6,877 9,526 72.2 63.5 95.4 2,208 2,033 1,425
2010 43 7,210 8,191 88.0 74.3 97.3 756 356 415
2011 57 14,572 15,674 93.0 83.7 99.0 950 612 570
#per 100 patients
In 2011 there were 91 submissions from 57 HCOs. The annual rate was 93.0 per 100 patients.
Variation between strata
Rates by Public / Private
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 Private 33 10,688 11,023 96.9 1.10
Public 24 3,884 4,651 83.7 1.70 612
#per 100 patients
Australasian Clinical Indicator Report 2004–2011 Page 5
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Medication Safety, v3
Rates by State
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 NSW 24 7,979 8,299 96.1 1.39
Qld 8 2,393 2,480 96.3 2.54
SA 7 904 1,113 81.7 3.78 160
Vic 13 2,650 3,009 88.1 2.30 242
Other 5 646 773 83.8 4.54 95
#per 100 patients
Variation between HCOs
In 2011 the potential gains totalled 950 more patients whose known ADRs are documented on
the current medication chart.
Outliers
In 2011 there were 21 outlier submissions from 17 HCOs whose combined excess was 569
fewer patients whose known ADRs are documented on the current medication chart. The outlier
HCO rate was 76.9 per 100 patients.
Australasian Clinical Indicator Report 2004–2011 Page 6
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Medication Safety, v3
Error-prone abbreviations
CI 4.1: Medication orders with error-prone abbreviations (L)
Rationale
This indicator addresses the effectiveness of processes that encourage clear and unambiguous
communication and medication orders. One of the major causes of medication errors is the use
of potentially dangerous abbreviations in prescribing.
Numerator
Denominator
Total number of medication orders that include error-prone abbreviations
Total number of medication orders in the sample
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
Outlier
Gains
2009 31 3,405 27,749 12.3 1.37 16.6 3,025 1,052
2010 29 2,577 44,483 5.79 0.33 9.31 2,430 1,772 1,185
2011 36 2,750 58,827 4.67 0.54 8.06 2,433 1,072
#per 100 medication orders
In 2011 there were 56 submissions from 36 HCOs. The annual rate was 4.7 per 100 medication
orders.
Variation between strata
There were no significant stratum differences in 2010 and 2011.
Variation between HCOs
In 2011 the potential gains totalled 2,433 fewer medication orders that include error-prone
abbreviations, corresponding to a reduction by approximately four fifths.
Outliers
In 2011 there were 12 outlier submissions from nine HCOs whose combined excess was 1,072
more medication orders that include error-prone abbreviations. The outlier HCO rate was 10.9
per 100 medication orders.
Australasian Clinical Indicator Report 2004–2011 Page 7
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Medication Safety, v3
Australasian Clinical Indicator Report 2004–2011 Page 8
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Medication Safety, v3
Warfarin management
CI 5.1: Warfarin – abnormal bleeding (L)
Rationale
Warfarin is a widely used drug with a narrow therapeutic index and with potentially serious
adverse reactions such as spontaneous bleeding.
Numerator
Denominator
Total number of non same-day separations receiving warfarin as an inpatient who
experience abnormal bleeding
Total number of non same-day separations receiving warfarin as an inpatient
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
Outlier
Gains
2004 28 13 2,313 0.56 0.47 0.99 2 3
2005 36 28 2,686 1.04 0.58 1.38 12 5
2006 31 16 2,530 0.63 0.33 0.63 8 3
2007 39 17 6,297 0.27 0.16 0.28 7 5 2
2008 31 12 4,790 0.25 0.23 0.31 1
2009 26 16 2,865 0.56 0.30 0.41 7 7
2010 22 27 2,856 0.95 0.39 0.62 16 15
2011 24 23 1,637 1.41 0.43 1.22 16 16 9
#per 100 separations
In 2011 there were 35 records from 24 HCOs. The annual rate was 1.4 per 100 separations.
Trends
The fitted rate deteriorated from 0.45 to 0.77, a change of 0.32 per 100 separations.
Rates and centiles by year
A Low rate is desirable
80 th centile rate
x
Aggregate rate
Period average rate
Fitted rate
20 th centile rate
Australasian Clinical Indicator Report 2004–2011 Page 9
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Medication Safety, v3
Variation between strata
Rates by Public / Private
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 Private 10 1 755 0.41 0.57
Public 14 22 882 2.26 0.53 16
#per 100 separations
Rates by State
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 NSW 7 1 386 0.57 0.78
Vic 10 20 620 2.87 0.61 15
Other 7 2 631 0.47 0.61
#per 100 separations
Variation between HCOs
In 2011 the potential gains totalled 16 fewer separations receiving warfarin as an inpatient who
experience abnormal bleeding, corresponding to a reduction by approximately two thirds.
Australasian Clinical Indicator Report 2004–2011 Page 10
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Medication Safety, v3
Outliers
In 2011 there were three outlier submissions from two HCOs whose combined excess was nine
more separations receiving warfarin as an inpatient who experience abnormal bleeding. The
outlier HCO rate was 11.8 per 100 separations.
Australasian Clinical Indicator Report 2004–2011 Page 11
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Medication Safety, v3
CI 5.2: Warfarin – INR * / prothrombin reading >5 (L)
Rationale
Warfarin is a widely used drug with a narrow therapeutic index and with potentially serious
adverse reactions such as spontaneous bleeding.
Numerator
Denominator
Total number of non same-day separations receiving warfarin as an inpatient with an INR
reading greater than 5
Total number of non same-day separations receiving warfarin as an inpatient
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
Outlier
Gains
2004 36 282 7,472 3.77 2.85 7.70 69 78 55
2005 43 258 7,319 3.53 2.73 7.55 58 20
2006 35 289 5,598 5.16 3.04 8.11 119 83 4
2007 46 350 12,627 2.77 2.47 5.63 38 105 65
2008 35 305 8,221 3.71 1.53 7.10 179 75
2009 31 283 6,394 4.43 2.69 5.20 111 68
2010 29 233 8,343 2.79 2.40 6.56 33 45 13
2011 26 160 7,296 2.19 2.81 5.28 58 35
#per 100 separations
In 2011 there were 35 submissions from 26 HCOs. The annual rate was 2.2 per 100
separations.
Trends
The fitted rate improved from 4.2 to 2.8, a change of 1.3 per 100 separations. This trend was
also significant after allowing for the changing composition of HCOs contributing over the
period. The rate change was 1.4 per 100 separations.
Rates and centiles by year
A Low rate is desirable
80 th centile rate
x
Aggregate rate
Period average rate
Fitted rate
20 th centile rate
* The International Normalised Ratio is a test for blood clotting.
Australasian Clinical Indicator Report 2004–2011 Page 12
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Medication Safety, v3
Variation between strata
Rates by Metro / Non metro
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 Metropolitan 10 87 2,282 3.95 0.38 58
Non-Metro 16 73 5,014 1.39 0.25
#per 100 separations
Rates by Public / Private
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 Private 8 85 2,393 3.74 0.40 55
Public 18 75 4,903 1.44 0.28
#per 100 separations
Rates by State
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 NSW 7 11 367 3.32 1.21
Vic 10 31 661 4.25 0.90 15
Other 9 118 6,268 1.91 0.29
#per 100 separations
Australasian Clinical Indicator Report 2004–2011 Page 13
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Medication Safety, v3
Variation between HCOs
There were no potential gains in 2011.
Outliers
In 2011 there were two outlier submissions from one HCO whose combined excess was 35
more separations receiving warfarin as an inpatient with an INR reading greater than five. The
outlier HCO rate was 4.1 per 100 separations.
Australasian Clinical Indicator Report 2004–2011 Page 14
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Medication Safety, v3
CI 5.3: Warfarin – written drug information upon discharge (H)
Rationale
Warfarin is a widely used drug with a narrow therapeutic index and with potentially serious
adverse reactions such as spontaneous bleeding.
Numerator
Denominator
Total number of patients discharged on warfarin who receive written drug information prior
to discharge
Total number of non same-day separations receiving warfarin as an inpatient
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
Outlier
Gains
2004 18 385 420 91.7 85.1 99.2 31 17 17
2005 29 665 779 85.4 86.9 99.5 110 70 72
2006 24 483 509 94.9 96.2 99.3 22 16
2007 30 542 734 73.8 78.1 98.8 183 89 116
2008 27 619 807 76.7 61.0 96.9 163 74
2009 23 549 689 79.7 88.6 96.6 116 105 26
2010 25 577 652 88.5 82.1 97.6 60 7
2011 20 2,296 2,728 84.2 27.9 99.0 404 87 129
#per 100 patients
In 2011 there were 25 submissions from 20 HCOs. The annual rate was 84.2 per 100 patients.
Trends
The fitted rate deteriorated from 86.0 to 82.6, a change of 3.4 per 100 patients.
Rates and centiles by year
A High rate is desirable
80 th centile rate
x
Aggregate rate
Period average rate
Fitted rate
20 th centile rate
Australasian Clinical Indicator Report 2004–2011 Page 15
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Medication Safety, v3
Variation between strata
Rates by Public / Private
Year
Stratum
No.
HCOs
Total
numerator
Total
denominator
Stratum
rate #
Standard
error
Stratum
gains
2011 Private 8 2,072 2,370 87.4 3.86
Public 12 224 358 63.1 9.94 87
#per 100 patients
Variation between HCOs
In 2011 the potential gains totalled 404 more patients discharged on warfarin who receive
written drug information prior to discharge.
Outliers
In 2011 there were seven outlier submissions from seven HCOs whose combined excess was
128 fewer patients discharged on warfarin who receive written drug information prior to
discharge. The outlier HCO rate was 22.4 per 100 patients.
Australasian Clinical Indicator Report 2004–2011 Page 16
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Medication Safety, v3
CI 5.4: Warfarin – dosage review following high INR result (H)
Rationale
Warfarin is a widely used drug with a narrow therapeutic index and with potentially serious
adverse reactions such as spontaneous bleeding.
Numerator
Denominator
Total number of patients on warfarin with an INR of 4 or above whose dosage has been
adjusted or reviewed prior to the next warfarin dose
Total number of patients on warfarin with an INR result of 4 or above
Year
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
Stratum
Gains
2011 23 271 280 96.8 97.6 99.4 7 6
#per 100 patients
In 2011 there were 30 submissions from 23 HCOs. The annual rate was 96.8 per 100 patients.
Outlier
Gains
Variation between strata
There were no significant stratum differences in 2011.
Variation between HCOs
There was relatively little variation between HCOs and so the potential gains were small in
2011.
Outliers
In 2011 there were two outlier submissions from two HCOs whose combined excess was six
fewer patients whose dosage has been adjusted or reviewed prior to the next warfarin dose.
The outlier HCO rate was 50.0 per 100 patients.
Australasian Clinical Indicator Report 2004–2011 Page 17
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Medication Safety, v3
CI 5.5: Warfarin – starting doses consistent with hospital approved protocol (H)
Rationale
Warfarin is a widely used drug with a narrow therapeutic index and with potentially serious
adverse reactions such as spontaneous bleeding.
Numerator
Denominator
Total number of patients prescribed hospital initiated warfarin whose starting doses are
consistent with a hospital approved protocol
Total number of patients initiated on warfarin
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
Year
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
Centile
Gains
2011 7 57 85 67.1 52.0 98.1 26
#per 100 patients
Stratum
Gains
Outlier
Gains
In 2011 there were eight submissions from seven HCOs. The annual rate was 67.1 per 100
patients.
Variation between strata
There were no significant stratum differences in 2011.
Variation between HCOs
In 2011 the potential gains totalled 26 more patients whose starting doses of warfarin are
consistent with a hospital approved protocol.
Outliers
There were no outlier HCOs in 2011.
Australasian Clinical Indicator Report 2004–2011 Page 18
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Medication Safety, v3
Timely and appropriate monitoring of aminoglycoside antibiotics
CI 6.1: Aminoglycoside toxicity – dosage adjustment prior to next dose (H)
Rationale
Aminoglycosides are useful but toxic medicines with a narrow therapeutic index. In patients
treated with aminoglycosides for more than 48 hours, dosage should be adjusted according to
plasma drug concentrations and renal function. Failure to act on a toxic concentration result
could lead to renal impairment and ototoxicity.
Numerator
Denominator
Total number of patients with a toxic aminoglycoside concentration whose dosage has
been adjusted prior to the next aminoglycoside dose
Total number of patients with a toxic aminoglycoside concentration in the sample
Dimensions of care: Accessibility Appropriateness Continuity
Effectiveness Quality Improvement and Risk Safety
Desirable level: Low High Not specified
Type of Indicator: Process Outcome Structure
Year
No.
HCOs
Total
numerator
Total
denominator
Rate #
Rate#
(20)
Rate #
(80)
2011 3 45 46 97.8 97.8 97.8
#per 100 patients
Centile
Gains
Stratum
Gains
Outlier
Gains
In 2011 there were three submissions from three HCOs. The annual rate was 97.8 per 100
patients.
Variation between strata
There were no significant stratum differences in 2011.
Variation between HCOs
There were no potential gains in 2011.
Outliers
There were no outlier HCOs in 2011.
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Clinical Significance of these results
Of the six indicators that were suitable for trending, two improved and two deteriorated. There was a
significant contribution from private HCOs to these indicators, in excess of 50% of patients covered in
several indicators.
Reporting of adverse drug reactions to the TGA
CI 1.1: Adverse drug reactions reported to OPC, TGA (N)
In 2011, there were 893,193 separations reported to the Therapeutic Goods Administration (TGA) from 97
HCOs. The annual rate was 0.12 per 100 separations. The fitted rate decreased from 0.17 to 0.093, a
change of 0.074 per 100 separations. This trend was also significant after allowing for the changing
composition of HCOs contributing over the period.
Medication errors resulting in an adverse event
CI 2.1: Medication errors – adverse event requiring intervention (L)
In 2011, there were 7,132,050 bed days reported from 247 HCOs. The annual rate was 0.013 per 100 bed
days. The fitted rate improved from 0.051 to 0.030, a change of 0.021 per 100 bed days. This trend was
also significant after allowing for the changing composition of HCOs contributing over the period. The rate
change was 0.020 per 100 bed days. In 2011, there were 21 outlier submissions from 17 HCOs whose
combined excess was 330 more medication errors resulting in an adverse event requiring intervention.
Documentation of adverse drug reactions (ADRs)
CI 3.1: Known ADRs documented in current medication chart (H)
In 2011, there were 15,674 patients reported from 57 HCOs. The annual rate was 93.0 per 100 patients. In
2011, there were 21 outlier submissions from 17 HCOs whose combined excess was 569 fewer patients
whose known ADRs are documented on the current medication chart.
Error-prone abbreviations
CI 4.1: Medication orders with error-prone abbreviations (L)
In 2011, 58,827 medication orders were reported from 36 HCOs. The annual rate was 4.7 per 100
medication orders. There were 12 outlier submissions from nine HCOs whose combined excess was 1,072
more medication orders that include error-prone abbreviations.
Warfarin management
CI 5.1: Warfarin – abnormal bleeding (L)
In 2011, there were 35 submissions reported from 24 HCOs. The annual rate was 1.4 per 100 separations.
The fitted rate deteriorated from 0.45 to 0.77, a change of 0.32 per 100 separations. In 2011, there were
three outlier submissions from two HCOs whose combined excess was nine more separations of inpatients
receiving warfarin who experience abnormal bleeding. The outlier HCO rate was 11.8 per 100 separations.
CI 5.2: Warfarin – INR * / prothrombin reading >5 (L)
In 2011, there were 7,296 separations reported from 26 HCOs. The annual rate was 2.2 per 100
separations. The fitted rate improved from 4.2 to 2.8, a change of 1.3 per 100 separations. This trend was
also significant after allowing for the changing composition of HCOs contributing over the period. The rate
change was 1.4 per 100 separations. In 2011, there were two outlier submissions from a single HCO
whose combined excess was 35 more separations receiving warfarin as an inpatient with an INR* reading
greater than 5.
* The International Normalised Ratio is a test for blood clotting.
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CI 5.3: Warfarin – written drug information upon discharge (H)
In 2011, there were 2,728 patients reported from 20 HCOs. The annual rate was 84.2 per 100 patients.
The fitted rate deteriorated from 86.0 to 82.6, a change of 3.4 per 100 patients. In 2011, there were seven
outlier submissions from seven HCOs whose combined excess was 128 fewer patients discharged on
warfarin who received written drug information upon discharge.
CI 5.4: Warfarin – dosage review following high INR result (H)
In 2011, there were 280 patients reported from 23 HCOs. The annual rate was 96.8 per 100 patients. In
2011, there were two outlier submissions from two HCOs whose combined excess was six fewer patients
whose dosage has been adjusted or reviewed prior to the next warfarin dose.
CI 5.5: Warfarin – starting doses consistent with hospital approved protocol (H)
In 2011, there were 85 patients reported from seven HCOs. The annual rate was 67.1 per 100 patients.
Timely and appropriate monitoring of aminoglycoside antibiotics
CI 6.1: Aminoglycoside toxicity – dosage adjustment prior to next dose (H)
In 2011, there were 46 patients reported from three HCOs. The annual rate was 97.8 per 100 patients. *
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Medication Safety, v3
Expert commentary
Therapeutic Goods Administration (TGA)
Reporting of adverse drug reactions to the TGA
Although the number of adverse drug reaction (ADR) reports submitted to the TGA increased
from almost 11,000 in 2004 to 14,500 in 2011, there has been a drop in reporting of CI 1.1 by
HCOs from a peak of 3,010 in 2004 to 1,660 in 2011. This is contrary to international trends,
where the number of hospital admissions, and hospital admissions extended by adverse drug
reactions, is increasing. 1,2 Australia shares an ageing population and the tendency to increasing
polypharmacy, suggesting a likely increase in the total number of adverse drug reactions
(ADRs) experienced by consumers. 3,4
While the rate of reporting increased in 2011 to a rate of 0.12 reports per 100 separations, it is
not clear why the number of reports and the number of reporting HCOs has dropped,
particularly since there is a requirement for the clinical workforce in public hospitals to document
patients’ previously known ADRs and report them to the TGA.
The TGA seeks information from a variety of sources when monitoring the safety of medicines
and vaccines on the market. One source of information is spontaneous adverse event reporting.
The TGA encourages all hospitals to ensure that they have systems in place for reporting
adverse events related to medicines.
Adverse event reports from hospitals are particularly important to the TGA for a number of
reasons:
hospitals have early experience with new medicines and/or their use in people with comorbidities
who would be excluded from clinical trials, and therefore may detect new
signals;
hospitals are encouraged to have in place systems to ensure that ADRs are identified
and reported internally and to the TGA and
patients may present to a hospital following a serious ADR.
The TGA encourages all health professionals to report adverse events associated with
medicines and thus contribute to the post-market detection and understanding of adverse drug
reactions. The TGA supports the use of e-prescription forms to increase ADR reporting, and
looks forward to the update of the software functionality.
Medicines are just one clinical indicator data set. Equal consideration should be given to
collecting CIs on medical device incident reports. The TGA also analyses reports of adverse
reactions to medical devices to detect and investigate safety signals, and can provide
comments on these.
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Warfarin management
The TGA encourages the collection of data on reporting rates of warfarin, however has no
specific comment on these indicators (CIs 5.1–5.5). As other anticoagulants gain market
prominence, their potential for exacerbating morbidity and mortality may need to be monitored.
The TGA suggests that consideration be given to collecting data on the use of other
anticoagulants as they become available.
References
1 Wu TY, Jen MH, Bottle A et al. Ten year trends in hospital admissions for adverse drug reactions in
England 1999–2009. J R Soc Med 2010; 103(6): 239–250.
2 Hartholt KA, van der Velde N, Looman CWN et al. Adverse drug reactions related hospital admissions in
persons aged 60 years and over, The Netherlands, 1981–2007: less rapid increase, different drugs. PLoS
One 2010; 5(11): e13977.
3 Hovstadius B, Hovstadius K, Astrand B and Petersson G. Increasing polypharmacy – an individualbased
study of the Swedish population 2005–2008. NCHS Data Brief 2010; 42(Sep): 1–8.
4 Jyrkkä J, Vartiainen L, Hartikainen S et al. Increasing use of medicines in elderly persons: a five year
follow-up of the Kuopio 75+ study. Eur J Clin Pharmacol 2006; 62(2): 151–158.
Australasian Clinical Indicator Report 2004–2011 Page 23
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