Prescription Safety Pilot Project
Report to the Health Quality and Safety Commission
13 July 2012
Authors: Dr Roshan Perera, Dr Helen Moriarty
Wellington School of Medicine and Health Sciences
University of Otago, Wellington
New Zealand
Disclaimer:
This project was sponsored with funding from the Health Quality & Safety Commission as part of the
Quality & Safety Challenge 2012. Publishing of project resources on the Commission’s website does
not necessarily constitute endorsement of the views or approach taken by the project, the Commission’s
intent in publishing is to showcase the achievements of the Challenge projects and share learnings
across the health sector.
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Contents
Acknowledgements .......................................................................................... 5
Executive summary.......................................................................................... 6
Chapter 1 ......................................................................................................... 8
Introduction................................................................................................... 9
Background ................................................................................................ 10
Methods ..................................................................................................... 12
Overview .................................................................................................... 12
Literature Search ........................................................................................ 12
Indicator Identification ................................................................................ 12
‘Sieve’ Indicator Appraisal Tool (SIAT) assessment of the indicators......... 13
Development of New Indicators.................................................................. 13
Test System for Classification of Indicators ................................................ 14
Policy Relevance ........................................................................................ 14
Chapter 2 ....................................................................................................... 16
Use of the Sieve Indicator Appraisal Tool (SIAT) for assessment of the
Veteran’s Administration Indicators ............................................................ 17
Overview .................................................................................................... 17
Indicator 1: Appropriate medical follow-up after opioid initiation ............ 18
Indicator 2: Serious adverse effects related to opioid therapy ................ 20
Indicator 3: Adjunctive pharmacotherapy............................................... 22
Indicator 4: Increased risk of adverse events due to co-prescription of
opioids with sedative medications........................................................... 24
Indicator 5: Acetaminophen (paracetamol) over-prescription ................ 26
3
Indicator 6: Rate of treatment and monitoring of patients with active
substance abuse disorder and outpatient opioid prescription. ................ 28
Indicator 7: Random urine drug screening on patients receiving opioid
prescriptions ........................................................................................... 32
Indicator 8: Bowel Regimen ................................................................... 34
Indicator 9: High dose prescriptions for opioid naïve patients ................. 36
Indicator 10: Initiating opioids for special populations ............................. 38
Indicator 11: Pharmacy reconciliation of opioid prescriptions ................. 40
Indicator 12: Psycho-social treatments for pain ..................................... 42
Indicator 13: Rehabilitation medicine ...................................................... 44
Indicator 14: Use of Complementary and Alternative Medicine treatments
for pain.................................................................................................... 46
Indicator 15: Use of other pain procedures ............................................. 48
Chapter 3 ....................................................................................................... 50
Overview .................................................................................................... 51
Indicator Suite (1) ................................................................................... 52
Indicator Suite (2): .................................................................................. 58
Indicator Suite (3): .................................................................................. 64
Indicator Suite (4): .................................................................................. 68
Indicator Suite (5): .................................................................................. 73
Indicator Suite (6): .................................................................................. 79
Indicator Suite (7): .................................................................................. 83
Chapter 4 ....................................................................................................... 89
Indicator Classification System: Selection of indicators on opiate prescribing
for chronic non-malignant pain ................................................................... 90
Indicator Classification System................................................................... 90
Chapter 5 ....................................................................................................... 91
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Discussion .................................................................................................. 92
Recommendations ..................................................................................... 93
Next steps .................................................................................................. 93
References .................................................................................................... 94
Appendices .................................................................................................... 97
Sieve Indicator Appraisal Tool
Result Tables ........................................ 98
Literature Search Results ......................................................................... 131
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Acknowledgements
The authors gratefully acknowledge the assistance of staff at the University of Otago,
Wellington medical library, in particular Donna Tietjens for her invaluable help in
literature searching and advice on the development of the classification system.
The authors also acknowledge the input of Professor Tony Dowell and Professor
Peter Crampton during the development of the Sieve Indicator Appraisal Tool.
We gratefully acknowledge Jodie Trafton and the Veterans Administration (VA) team
for providing us with the VA metrics as a basis for this work.
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Executive summary
This report was compiled to fulfil the requirements of the Health Quality and
Safety Commission contract undertaken as a result of the Quality and Safety
Challenge 2012.
A project was undertaken to 1) create a system for classifying quality and
performance indicators according to their suitability for purpose and caveats for
use; and 2) test the system, using indicators for one specific aspect of health care.
The chosen aspect of health care was safe prescribing, and in particular safe
community-based prescribing of controlled drugs (prescribing of opioids for
chronic non-malignant pain).
The project utilised a 4 step method. Firstly, a systematic search of the literature
was undertaken, to identify relevant indicators of opioid prescribing for chronic
non-malignant pain used locally and internationally. Next, a sample of the
identified indicators was assessed using the Sieve Indicator Appraisal Tool
(SIAT) to provide parameters for classifying indicators. A system for classifying
indicators was developed based on the results of the literature review and the
SIAT assessment of the indicator sample, and finally the assessed indictors were
categorised.
A significant issue encountered during the project was that few of the existing
international indicators related to opiate prescribing for chronic non-malignant
pain, identified through the review of the literature, were sufficiently well
developed to enable a full SIAT assessment to be conducted. The exception was
a set of metrics on opioid prescribing compiled by the Veterans’ Administration
(VA). The VA indicators were relevant to the project and a full assessment of
each of these 15 indicators was undertaken using The SIAT.
The SIAT assessments of the Veterans Administration indicators revealed that
some indicators were not sufficiently well defined to provide valid results.
Consequently, seven suites of additional indicators (comprising a total of 29 new
quality measures) were developed by the authors. The indicators were developed
in ‘suites’ to enable a comprehensive review of the aspect of care in question.
The new indicator suites were developed specifically for the New Zealand context.
An evidence-based Classification System was developed by the authors using
the insights gained through the development and use of the SIAT for assessment
of indicators. The Classification System was constructed to aid appropriate
selection and ultimately successful implementation of health system indicators.
The SIAT assessed VA indicators were classified according to the Classification
System, in preparation for potential implementation.
Field-based evaluation of the project completed to date is vital. This will enable
validation of the classification system, as well as determination of implementation
issues and feasibility of introducing selected VA indicators and the newly
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developed opioid prescribing indicators, within the New Zealand health care
environment.
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Quality improvement: the right
tool for the right task.
A prescription safety pilot project.
Chapter 1
Introduction
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Introduction
This report has been compiled to fulfil the requirements of the Health Quality and
Safety Commission contract undertaken as a result of the Quality and Safety
Challenge 2012.
Aims/Objectives:
The aims of the project are to: 1) create a system for classifying quality and
performance indicators according to their suitability for purpose and caveats for use;
and 2) test the system, using indicators for one specific aspect of health care. The
chosen aspect of health care is safe prescribing, and in particular safe communitybased prescribing of controlled drugs (prescribing of opioids for chronic nonmalignant pain).
Importance:
An indicator classification system is necessary for rational selection, utilisation and
interpretation of health quality indicators. The indicator classification system
produced for this project will help to rationalize and standardize health care indicator
use in the future. The specific example has been chosen as it is a prescription quality
and safety issue of increasing concern both in New Zealand and overseas.
Structure:
The report is structured in the following way.
Chapter 1 provides brief background information which sets out the underlying
rationale for undertaking the project. This is followed by a brief overview of the
methods used.
Chapter 2 of the report contains the assessments of the VA indicators using the
Sieve Indicator Appraisal Tool (SIAT).
Chapter 3 comprises the New Indicators created for the New Zealand context.
Chapter 4 describes the Outline of the Classification System, and provides the list of
the classified VA indicators.
Chapter 5 consists of the discussion and recommendations, and an outline of the
next steps required for continued progress with the work.
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Background
The safety and quality of health care provision is of major concern to consumers and
providers alike. Tools used for assessing the safety and quality of health care
provision can include indicators. Indicators provide a means for objective
measurement of the quality of care given to patients.
Indicators have been developed across New Zealand primary and secondary health
care. They are used at national, organizational and practice/practitioner levels for
external assurance purposes to ensure standards of quality are being met across the
health system, as well as for individual self determined quality improvement, and for
professional development and recertification by health professional colleges.
However not all indicators are ‘created equal’. Indicators developed for one purpose
may be inappropriate for a different application. Judgements made on the basis of
information from technically flawed indicators may be unreliable.(1) Inappropriate use
brings no guarantee of better health care provision, but may generate controversy,
misunderstanding and perverse application of performance incentives and
rewards.(1)
Practitioners and policy makers require access to reliable indicators suited for
specific purposes within specific settings.(2, 3) The literature identifies a need for and
lack of, a theoretically robust and standardized process nationally and internationally,
for classifying indicators according to their capability and caveats for use.(4-6) To
begin to address this deficit The Sieve Indicator Appraisal Tool (SIAT) was created
by one of us (RP).(1, 7) The SIAT provides a unique, transparent and evidence
based approach for indicator critique, and has been successfully used to develop and
select national, organisational and practice level indicators especially for use in
service monitoring, quality assurance and quality improvement activities.(8-10)
The literature identifies two issues which remain to be addressed with regard to
practical implementation of indicators in New Zealand and elsewhere:
1) Classifying indicators: ‘Best practice’ indicator use, requires provision of guidance
with regard to selection and utilisation. The literature, however, identifies a current
unmet need for a robust process for indicator classification to assist users to select
indicators according to suitability for purpose and caveats for use. This project is the
first to tackle the development of an indicator classification system.
2) Piloting indicator selection: a test case. This project has focussed on ways to
select indicators suitable for utilisation in the monitoring, and assessment of quality
assurance and quality improvement of appropriate prescribing of opioid medications
for chronic non-malignant pain. Improvement of controlled drug prescribing in the
community has become a concern on both national and international fronts. The
escalating use of prescription pharmaceutical opioids for this purpose and the burden
of related harm, especially when used in the long term for non-malignant pain, is a
significant patient safety issue. Improvement of patient safety requires prescribing in
accordance with guidelines, with assessment of the quality and safety of practice in
relation to: prescribing and dispensing; patient instruction and education; and patient
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monitoring. One organisation in the USA, the Veterans Association (VA), has
already taken the step of identifying prescribing indicators for this particular topic
area.(11) For this reason the project has used the VA metrics as a starting point from
which to create a selection of indicators suitable for this purpose in New Zealand.(12)
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Methods
Overview
The aims of this project were to:
Undertake a literature search focused on safe prescribing in the community
of opioids for chronic non-malignant pain (CNMP).
Identify relevant indicators of opioid prescribing for CNMP used locally and
internationally.
Assess a sample of the identified indicators using the SIAT to provide
parameters for classifying indicators.
Develop a test system for classifying indicators of quality and performance
based on the results of the literature review and the SIAT assessment of the
indicator sample.
Write a final report outlining key issues, approach taken, lessons learnt and
recommendations.
Literature Search
A systematic search of the literature was undertaken, facilitated by a specialist
librarian skilled in undertaking literature searches.
Initially a literature search using MEDLINE and EMBASE databases from 1946 to
present, using the keywords Analgesics, Opioid, (exploded) combined with subject
headings around primary health care and indicator* was performed. (see Appendix 2).
In addition free text searches of Scopus & Google Scholar were also undertaken.
A second search of the literature was subsequently also performed, using MEDLINE
and EMBASE databases from 1946 to present, and search of Scopus & Google
Scholar. The following keywords (opioid OR opioids) AND (benchmarking OR quality
assessment OR quality outcome OR target) AND prescribing were used. (see
Appendix 2) A search for grey literature was also undertaken by searching the Kings
College Fund databases and Google.
Indicator Identification
The results of the literature search were then sifted, and relevant articles identified
and abstracts obtained. All abstracts were then read by the research team, and full
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text articles obtained, if the abstract content was deemed pertinent to the project
aims. Articles were then read and a list of potential indicators was identified.
However, with the exception of metrics compiled by the Veterans’ Administration, few
of the indicators identified were sufficiently well developed to enable a full SIAT
assessment to be conducted. The authors contacted Trafton et al of the Veteran’s
Administration and obtained a list of the metrics compiled for monitoring the quality of
prescribing for chronic pain.(12) These indicators were relevant to the project and a
full assessment for each of these 15 indicators was undertaken using The SIAT
(Chapter 2). The SIAT was earlier developed by one of us (RP) in the course of a
doctoral thesis.(1)
‘Sieve’ Indicator Appraisal Tool (SIAT) assessment of the indicators
Utilisation of the Sieve Indicator Appraisal Tool (SIAT) for assessment of indicators
involved:
the retrieval, collation and analysis of international and local evidence
relevant to each indicator;
the application of the compiled evidence to each of the 30 criteria in the SIAT;
and
the evaluation of the strengths and weaknesses of each indicator on the basis
of the points described above.
The indicators were then assessed using the SIAT in a discussion between both
authors. A combination of the evidence from the literature, application of one of the
author’s (HM) knowledge of the New Zealand Medicines Control environment and
technical judgement was required to make an assessment on the various
components of the SIAT for each indicator. The indicators were assessed as
measures of performance in New Zealand according to the technical specifications of
the indicator.
Development of New Indicators
When undertaking the SIAT assessments of the Veterans Administration indicators, it
became apparent that in some cases indicators were not sufficiently well defined to
provide valid results. There were both content gaps and logic problems in some
aspects of the topic area that these indicators were covering. Consequently, seven
suites of additional indicators (comprising a total of 29 new quality measures) were
developed by the authors. These new indicators were constructed utilising an
evidence based process developed by one of us (RP).(13) The indicators were
developed in ‘suites’ to enable a comprehensive review of the aspect of care in
question. The new indicator suites were developed specifically for the New Zealand
context, and may be utilised within the New Zealand primary health care environment
or equally in a secondary care environment (e.g. hospital pain or addiction clinics,
emergency departments and other inpatient and outpatient settings).
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Test System for Classification of Indicators
An evidence-based Classification System was developed by the authors using the
insights gained through the development and use of the SIAT for assessment of
indicators. The Classification System was constructed to aid the implementation of
health system indicators. The Classification System will enable the categorisation of
existing and new indicators for purpose, i.e. measuring individual prescriber vs.
multidisciplinary health service performance or performance at an overall
administration, funding and planning level.
The SIAT assessed VA indicators were classified according to the Classification
System, in preparation for potential implementation.
Policy Relevance
This project is directly relevant and/or applicable to a number of New Zealand health
care policy implementation objectives contained within a variety of high level strategy
and policy documents. These include:
New Zealand Health Strategy(14)
The seven fundamental principles of the New Zealand Health Strategy include the
principles of “good health and wellbeing for all New Zealanders throughout their lives”,
and “a high-performing system in which people have confidence”. In addition The
Strategy identifies 13 population health objectives for action in the short to medium
term. One of the 13 priorities is directly applicable to this project i.e. “minimise harm
caused by alcohol and illicit and other drug use to both individuals and community”.
Primary Health Care Strategy(15)
One of the six key directions of the Strategy is to “continually improve quality using
good information”. The Strategy also requires a focus on early detection,
management and support of people with ongoing conditions. In addition, it requires
the best use of pharmaceuticals.
The New Zealand Triple Aim(16): “Improved quality, safety and experience of care;
improved health and equity for all populations; best value from public health system
resources”.
New Zealand Regulatory Guidelines for Medicines This can be accessed at:
http://www.medsafe.govt.nz/regulatory/guidelines.asp
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National Drug Policy 2007- 2012
This policy includes mention of pharmaceutical drug abuse. This can be accessed at:
www.ndp.govt.nz
The Royal Australasian College of Physicians, Prescription Opioid Policy(17)
A Prescription Opioid Policy released in April 2009 by The Royal Australasian
College of Physicians (and endorsed by three other specialist colleges), identified the
problem of an escalation in controlled drugs prescribing in Australia and New
Zealand. This is due primarily to repeat prescriptions issued by primary care
providers for chronic non-malignant pain indications, without reference to existing
indicators, clinical guidelines, or prescribing safeguards.
The National Health IT Plan(18)
The plan will include access to electronic prescriptions and other health records.
This has potential to assist in identification of patients on chronic opiate medication,
and offers opportunities to raise prescriber awareness and assist change in practice.
This can be accessed at: http://www.ithealthboard.health.nz.
New Zealand Law Commission review of Misuse of Drugs Act
The review identified prescription drug misuse as a problem area that needs to be
better addressed. http://www.lawcom.govt.nz/sites/default/files/publications/2011/05
/part_1_report_-_controlling_and_regulating_drugs.pdf
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Chapter 2
Prescription quality and safety:
Opiate prescribing for chronic
non-malignant pain
Use of the Sieve Indicator Appraisal
Tool for assessment of the
Veteran’s Administration Metrics
(indicators)
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Use of the Sieve Indicator Appraisal Tool (SIAT) for
assessment of the Veteran’s Administration Indicators
Overview
A summary of the assessment of each of the Veterans Administration indicators is
presented in this chapter. The summaries have been developed from SIAT data,
which is included in Appendix 1 of this report.
The assessment details for each indicator described comprises a summary
statement of the overall evaluation of the indicator, followed by the indicator
specifications and a statement regarding each of the assessment areas: purpose,
perspective, relevance and applicability to New Zealand, evidence base, technical
specifications in relation to the sensitivity and specificity of each indicator, and
potential implementation issues.
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Veterans Association Metrics(12)
Indicator 1: Appropriate medical follow-up after opioid initiation
Sieve Indicator Evaluation Summary
The purpose of this indicator is to ensure that there is medical follow up after a new
prescription of opiates is given. The given rationale however, discusses the need for
medical follow up after dose alterations, mentioning opioid naïve patients receiving
their first prescription defined as a high risk group. In addition, build up of methadone
levels is also mentioned with the need for follow-up in the first few days of initiation.
Thus there is some potential for confusion in the definition of the population group for
this indicator (i.e. is it only for naïve patients, is it for patients with new prescriptions
regardless of prior opiate use, or is it for patients getting dose adjustments?).
New Zealand guidelines for opioid substitution therapy (methadone) have
recommendations for review times. However, opioid substitution therapy is not the
same scenario as opioid prescribing for chronic pain.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the percent of new opioid prescriptions where
patients (opioid naïve patients receiving their initial prescription) have had a clinical
encounter with the organisation (Veterans Administration) within 4 weeks. This does
not cover the New Zealand situation where patients may have purchased opiates for
pain relief over the counter before seeking them on prescription.
Purpose and Perspective
The purpose of the indicator is to assess if patients have had any clinical encounters
to ensure appropriate assessment of initiated opiate treatment. Tolerance to opioid
develops slowly but unpredictably. Too rapid initiation may create risk of overdose.
Long half life for methadone and long acting morphine preparations especially result
in risk of unpredictable dose accumulations with continuous dosing or rapid dose
escalation.
The indicator addresses issues of importance for professional competence, personal
health and consumer perspectives.
Relevance
Opiate related deaths are highly newsworthy, e.g. coroners reports about
“methadone deaths” etc. These deaths are often multifactorial, however, care with
prescribing can reduce the aspect of risk arising from prescription opioids.
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Evidence Base
The underlying evidence base for this indicator is largely at the level of individual
case studies and from consensus guidelines.
The indicator is likely to be useful for service review of opioid initiation and rapid
escalation protocols. Feedback from indicator results may be used as part of inservice education.
Characteristics of the Indicator
Data on the validity and reliability of the indicator was not identified, but this is not
unexpected for an indicator derived from consensus practice. The indicator is
potentially sensitive to changes in the quality of prescribing of the initiating service or
prescriber.
Implementation requirements
Accuracy of data collection and analysis, and appropriate interpretation of indicator
results is dependant on greater clarity of the measure, in particular, appropriate
specification of the measure denominator (i.e. which category of opioid initiation
patients does this apply to, as explained above).
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Indicator 2: Serious adverse effects related to opioid therapy
Sieve Indicator Evaluation Summary
The VA indicator covers an important aspect of opiod therapy but as it stands (see
below) it makes no distinction between deliberate and accidental overdose. It is
entirely an administrative data-dredging indicator, without use of clinical data to assist
with interpretation. There are two main issues with the reliability of the indicator: 1)
the ability to identify all “serious” effects, and 2) in being certain that all events
reported are known to be caused by the opiate use. Consequently there is a risk of
both over, and under reporting on this indicator. Under-reporting relates to the risk
that some serious events are not reported or not attributed to opiod use. Overreporting relates to issues such as “methadone deaths” where the coroner lists
methadone as a cause of death even if it wasn’t necessarily the cause or a major
contributing factor.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as:
1) any serious adverse events in the fiscal year; and
2) rates of these adverse events within 180 days following opioid prescriptions filled
in the first 2 quarters of the 4 quarters assessed.
The VA indicator specifies that the adverse events to be examined include:
medication causing overdose in specific adverse events; injuries (falls/motor vehicle
accidents); and confirmed suicide attempts. Administration of Naloxone is considered
a proxy for opioid overdose.
Note: for New Zealand use, this description does not include the New Zealand
coroner reports e.g. methadone deaths as noted above. Work-related injuries (cf
motor vehicle accidents are also an important consideration but are omitted from the
criteria for this VA indicator. The administration of Naloxone alone may result in
under-reporting of opioid use.
Purpose and Perspective
The stated reason for inclusion of the indicator is to facilitate targeted efforts to
decrease opioid related risk.
The indicator addresses issues of importance for personal health and consumer
perspectives. It also addresses an important issue from a competency and cost
effectiveness perspective in relation to over prescribing. At an administrative level it
may also be used for assessing the efficiency of practice and organisational level
processes to address serious side effects, including accurate identification of opioid
related adverse events.
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Relevance
Opioids may be used in accidental or non accidental overdose. Opiates also
contribute to heightened injury risk, when taken either alone or in combination, due to
the sedation effects. Opioid use is not always the sole cause but may be a
contributing factor to suicide, overdose or other injuries.
Evidence Base
The underlying evidence base for this indicator relates to the risks of serious adverse
effects on persons taking opioid therapy. There is currently no evidence-base about
use of the indicator for making judgments of prescriber and health service quality.
However, with time there is an expectation that the VA will build up evidence about
its performance for these purposes.
The indicator is more likely to be useful for health professional education, for
example at the level of peer groups of clinicians, rather than useful for judging health
service quality. In New Zealand peer discussion of adverse events are encouraged
for continuing education purposes, and are likely to be subject to confidentiality
agreements, and not in the public arena.
Characteristics of Indicator
Availability of data on the potential validity of the indicator is better in relation to
overdose/suicide attempts, rather than for injuries. Until recently, road-side drugs
testing in New Zealand was not done, and drug testing was not considered early
enough in a work-place accident investigation for the evidence to be identified. The
validity of the indicator in relation to injuries would be reliant on verification that these
injuries were due to intoxication as a result of an over-prescription, or of being
impaired when in a withdrawal state, and not due primarily to other causes. The
sensitivity of the indicator to detect changes in the quality of prescribing is influenced
by the factors noted above.
Implementation requirements
Accuracy of data collection and analysis, and appropriate interpretation of indicator
results is dependant on interpretation of injury and caveats with respect to validity as
noted above.
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Indicator 3: Adjunctive pharmacotherapy
Sieve Indicator Evaluation Summary
This VA indicator is a safety and efficacy indicator. It is good practice to work from
the bottom of the analgesic ladder up for pain management, using the simpler and
milder analgesic alternatives first. Adjunctive alternatives could also reduce overall
opioid need and hence risks.
Indicator Evaluation Details
Indicator description
The measure is defined as the percent of patients with an opioid prescription who
also received any of the following: non opioid analgesics including NSAIDs and
acetaminophen; tricyclic antidepressants; SSRI’s and SNRI’s; anticonvulsants;
topical medications.
Purpose and Perspective
The purpose of the indicator is to assess if other prescription alternatives are made
available to the patient, to minimise daily opioid requirements. A longer term
objective could be to reduce risk of opioid dependence and other opiate-related
complications by keeping opiate dose, dose frequency and duration as low as
possible.
The indicator addresses both personal and population health perspectives. The
issue is significant from a cost effectiveness and professional competence
perspective with respect to use of adjunctive pharmacotherapy to facilitate minimising
the risk of long term iatrogenic dependence, and to give patients non-opiate
analgesic options.
Relevance
The use of this indicator is relevant to minimise overall dose and chronicity of opioid
use.
Evidence Base
The evidence base is mixed as the indicator includes multiple pharmacotherapeutic
products with differing levels of evidence of efficacy in chronic pain management.
The VA indicator draws on evidence included in the guideline from the American
Chronic Pain Association (ACPA) which specifies other medications which have been
shown to be effective for treatment of chronic pain.
The indicator is likely to be of utility at organisational, practice and individual levels.
VA is putting this indicator into practice and that will eventually generate data on its
usefulness as an indicator of health quality performance. However, the multiple
pharmacotherapeutic products included in the indicator makes it unlikely to obtain
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comparable data documenting use of this indicator for formal performance
assessment.
Characteristics of Indicator
There is no data on the reliability or validity of the indicator, as it is addressing
multiple pharmacotherapeutic products. The indicator is likely to be sensitive to
changes in the quality of prescribing.
Implementation requirements
Definition of appropriate exclusions is difficult as non responders, or patients with
side effects to other medications should be included. In New Zealand, the use of
opiates other than buprenorphine-naltrexone and over the counter codeine products
would require notes review. In New Zealand law, opiate prescriptions and
benzodiazepine prescriptions are treated separately. All Class B controlled drugs are
required to be prescribed by hand on an approved triplicate Controlled Drug (CD)
prescription form for a maximum of one month’s supply at a time, with 10 days
maximum dispensed at once, whereas prescriptions for Class C drugs (such as
benzodiazepines and buprenorphine-naltrexone) can be issued by regular practice
prescribing programmes, for monthly supply and no maximum dispensing period.
The records of class B CDs will be largely paper based (except in some large drug
clinics which use a special prescribing programme which has been pre-approved by
the Ministry of Health) Where such CD prescribing programmes exist the computer
systems are separate from regular practice prescribing programmes. Adjunctive
pharmacotherapy that is not a CD can be written using a regular practice prescribing
programme
Over the counter purchase of non-opiate analgesics may be missed if relying on
electronic health record sources unless cross-referenced with information from the
patient.
Defining a scoring system or target setting process may prove difficult as the
periodicity and mix of adjunct prescriptions may vary over time.
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Indicator 4: Increased risk of adverse events due to coprescription of opioids with sedative medications.
Sieve Indicator Evaluation Summary
While there is no doubt of the importance of the topic, this VA indicator as written is
an administrative data-dredging indicator. It does not address appropriateness of coprescribing, or the possibility that the nature or extent of co-prescribing may already
be moderated with clinical safety in mind. There is possible risk of inappropriate
judgments arising from use of this indicator, regarding professional competence of
the prescribing clinicians, including potential for utilization of the indicator to identify
‘bad’ doctors.
The indicator addresses multiple medications with sedating properties, including
some which are currently controlled drugs in New Zealand. There is a need to assess
each medication interaction separately. Potentially the interaction between
medications with sedating potential and alcohol and cannabis should also be
included; however, as these are not prescribed, accurate data collection of selfsourced sedatives such as cannabis, alcohol and over-the-counter sleep enhancing
products would prove problematic.
In addition, in New Zealand law, opiate prescriptions and benzodiazepine
prescriptions are treated separately. All Class B controlled drugs are required to be
prescribed by hand on an approved triplicate Controlled Drug (CD) prescription form
for a maximum of one months supply at a time, with 10 days maximum dispensed at
once, whereas prescriptions for Class C drugs (such as benzodiazepines and
buprenorphine-naltrexone) can be issued by regular practice prescribing
programmes, for monthly supply and no maximum dispensing period. The records of
class B CDs will be largely paper based (except in some large drug clinics which use
a special prescribing programme which has been pre-approved by the Ministry of
Health) Where such CD prescribing programmes exist the computer systems are
separate from regular practice prescribing programmes.
Indicator Evaluation Details
Indicator description
The VA indicator measure is defined as the percent of patients with overlapping
prescriptions for outpatient opioid and a barbiturate, benzodiazepine or SOMA
(Carisoprodol a sedating muscle relaxant used in USA for pain). Note that
barbiturates and Carisoprodol are not subsidized for use as medicines in New
Zealand).
Purpose and Perspective
The stated reason for inclusion of the indicator is to facilitate targeted efforts to
decrease opioid related risk.
25
The indicator addresses issues of importance for personal health, professional
competency and cost effectiveness perspectives in relation to sedative overprescribing. In addition, population health implications could include overdose
morbidity and mortality including injuries under the influence of excessive sedative
medication.
Relevance
Co-prescribing of sedatives increases the risk of overdose. This is of particular
concern among patients with existing respiratory problems, including sleep apnoea.
Note: As barbiturates and Carisoprodol are not subsidised on prescription in New
Zealand this aspect of the indicator does not apply in New Zealand.
Evidence Base
The underlying evidence base for this indicator exists largely at the level of individual
case studies and from consensus guidelines about co-prescribing. If the indicator has
been used to make judgments of prescriber and health service quality evidence this
is likely to lie in the medico-legal literature. However, as the VA group are now using
the indicator this will eventually build up an evidence-base about its utility.
The indicator is more likely to be useful for continuing education at the level of peer
groups of clinicians rather than for judging health service quality. A potential
exception may be in instances where there has been a critical event or a complaint.
Characteristics of Indicator
Each of the technical attributes of this indicator is dependant on whether the indicator
is assessing only benzodiazepines or considering other prescription medication with
sedating side-effects, and/or also considering concomitant alcohol use or cannabis
use or these substances in combination. Appropriate co-prescribing may be
inappropriately penalised if judged by this indicator alone. For example if the
benzodiazepine prescribing was declining with the aim of gradually stopping it, that
co-prescription would be identified by the indicator, although the prescription could
represent very appropriate co-prescribing.
Implementation requirements
For accuracy of data collection and analysis, and appropriate interpretation of results,
this indicator is reliant on greater clarity of the measure specifications. Accuracy of
data collection and analysis, and appropriate interpretation of indicator results would
be easier in relation to benzodiazepine co-prescribing, as long as only one prescriber
was involved.
Note: currently, it would be particularly hard to obtain useful information on
recreational vs. problematic use of cannabis and alcohol. In addition, it could be
difficult to measure/score/precisely or collect data on patient self-administered
alcohol and cannabis use data.
26
Indicator 5: Acetaminophen (paracetamol) over-prescription
Sieve Indicator Evaluation Summary
In New Zealand paracetamol is available in formulation alone and in a combination
formulation with opiates (codeine-paracetamol). Excessive use of combination
products risks accidental over dosage of either paracetamol or opiate. However, as
these can be obtained as over-the-counter products, the prescriber may not be
aware of their use.
This indicator is another data matching convenience indicator. The data matching
risks decision-making based on incomplete information, especially if the patient is
purchasing the medication, not getting it on a prescription. There is a biphasic impact
of this indicator in chronic pain management:
Paracetamol can be effective in pain management and if used correctly it can have
an opiate-sparing influence. Encouraging appropriate use of adjunct paracetamol
(not in a combination product) will allow dose titration up to an appropriate dose of
paracetamol, which as an adjunct to separately prescribed opiate medication, may
reduce the total daily opiate dose requirements. Limiting use of paracetamol-alone
formulations will have the effect of denying the patient any additional analgesic effect,
which can be opiate sparing, especially for increasing or escape pain. Paracetamol
can be the first analgesic used in chronic pain, as it lies at the lowest rung of the
analgesic ladder.
There is a different set of concerns for use of opiate- paracetamol combination
formulations. With these formulations it is not possible to separately titrate the
paracetamol and opiate doses. Limiting the use of the combination products by
patients who are also on prescribed opiates will reduce risk of accidental opiod
overdosing and may also reduce inadvertent paracetamol overdosing. However,
limitation of prescribed paracetamol-opiate combination products will not necessarily
mitigate the effects of unknown use of over-the-counter (OTC) preparations and selfsourced medication use.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the percent of patients with overlapping
prescriptions which total more than 1) 3g/day of acetaminophen and 2) more than
4g/day of acetaminophen.
This is a convenient prescription marker, of limited use due to the biphasic clinical
implications, as above. While the overall paracetamol dose should be kept within
limits, it can be useful additional analgesia for potential opiate-sparing purposes.
27
Purpose and Perspective
The purpose of the indicator is to reduce risk of paracetamol poisoning as a cause of
liver toxicity, which is not easily reversible, and is a cause of hospitalisation. The
indicator identifies patients who are prescribed at or over the daily maximum
recommended dose (4g) and also those patients who are prescribed doses close to
but under the daily maximum.
The indicator (as it stands) addresses issues of importance at an administrative,
cost-containment level only. The cost of care relates to cost of hospitalisations (for
liver failure), community care for lesser complications (liver enzyme disturbances)
and wasteful over-prescription of medications. It does not differentiate between what
is prescribed and what the patient actually consumes.
Evidence Base
The underlying evidence base for this indicator includes information from evidencebased guidelines (pharmacology-derived dose-setting) and toxicology case study
data.
There is no available data on documented use of this indicator for formal
performance assessment. However, paracetamol or paracetamol-combination
prescribing in patients with chronic opioid use may be the subject of practitioner
education for peer group audits or service reviews.
Potentially any over-prescribing of the combination product or paracetamol misuse
may be the subject of review by the Health and Disability Commissioner (HDC) or a
coronial investigation if there has been a serious adverse event or patient death.
Characteristics of Indicator
The reliability and validity of this indicator is dependant on the aspect of interest: i.e.
whether the indicator is for identifying use of combination products, avoiding use of
over-the-counter combination products, or use of over the counter paracetamol -only
medication, especially when opiates and/or paracetamol is already prescribed.
Alternately the interest may lie in encouraging appropriate use of paracetamol as the
first step in pain management before titrating in opiates as additional analgesia.
Patient use of over-the-counter combination products (paracetamol plus opioid) is not
actually a potential confounder for the indicator in this instance, as the VA indicator
stands, since it is concerned with prescribed paracetamol, not the amount ingested. It
is not within the control of the practitioner to prevent over-the-counter medication use,
but best practice would expect the practitioner to ask about use of over-the-counter
medications, check with local pharmacist, and advise the patient appropriately.
Implementation requirements
It would be possible to obtain accurate prescribing data for analysis. Appropriate
interpretation of indicator results would require consideration of the caveats
mentioned above.
28
Indicator 6: Rate of treatment and monitoring of patients with
active substance abuse disorder and outpatient opioid
prescription.
Sieve Indicator Evaluation Summary
This indicator is addressing 2 separate issues within one measure i.e. ensuring
specialist input into the treatment of patients with a substance abuse disorder; and
monitoring of drug use with a urine drug screen in these patients.
In New Zealand, part one of this measure is important as an indicator, because it is
illegal to prescribe for those with a known substance abuse disorder unless the
prescriber has Specialist Authority from a gazetted specialist or gazetted service
(Misuse of Drugs Act). With respect to part 2 of the measure, there are potentially
three reasons for monitoring urine: for other drug abuse; for compliance regardless of
whether or not they are abusing the prescribed drug; and monitoring progress in
treatment.
Additionally, the specific urine test required will differ according to the drug in
question. There are caveats with respect to the sensitivity and specificity of the urine
test with respect to the drug in question which need to be addressed in interpretation
of results. Quantified drug specific urine assays will be more sensitive/specific but
more expensive than routine drug screening tools, although their role is mainly to
monitor progress in treatment.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as at least one encounter in a specialty treatment
programme and at least one urine drug screen for every 90 days supply of Opioid.
These will be evaluated separately.
Part 1: Specialist Authority to prescribe with known dependency
Purpose and Perspective
In New Zealand the purpose of the indicator would be to ensure that prescribers are
compliant with the Misuse of Drugs Act. The stated reason for inclusion of the
indicator in the VA metrics is to address risk of misuse, and to assess those at risk of
substance use disorder. This is the rationale underpinning the relevant parts of the
Misuse of Drugs Act in New Zealand.
Indicator results can have professional competence implications, and in extreme
conditions may lead to a referral for disciplinary action. The indicator addresses
29
issues of important to personal and population health perspectives, and is significant
from a health policy and cost containment perspective. It is relevant from a
professional competence perspective with respect to ensuring compliance, and could
be considered to be of local importance in some regions, as drug seeking or
diversion is more prevalent in some regions. The population health implications
include prevention of diversion of prescription drugs to the illicit market, where they
may fuel the black market, supplying drugs of addiction to others, and could also be
injected drugs.
Relevance
It is a legal requirement in New Zealand: under section 24 of the Misuse of Drugs Act,
that patients with a known substance abuse disorder are seen by a gazetted
specialist or gazetted service, prior to receiving a prescription of opioids from their
general practitioner or any other prescriber. The prescriber must also have a
Specialist Authority to prescribe.
Evidence Base
The evidence is pragmatic –a legal requirement in New Zealand.
Characteristics of Indicator
There is no available data on use of this indicator for formal performance assessment,
and thus the validity and reliability of the indicator is unknown. However, the
indicator is likely to be sensitive to changes in the quality of the service or
prescriber’s administrative processes.
Implementation requirements
The issuing of a prescribing authority is a paper based system, and this might
influence the ease and accuracy of data collection. This factor will need to be
considered in interpretation of indicator results.
30
Part 2: Urine testing
Purpose and Perspective
The purpose of the indicator is to reduce risk of misuse in those with active
substance use disorder.
The indicator addresses both personal and population health perspectives in that
people who are receiving prescriptions and not using them, seek prescriptions for the
purpose of diverting the drugs, and the urinalysis will identify these individuals. The
issue is significant from a health policy and cost containment perspective, and also
from a professional competence perspective with respect to ensuring compliance. It
could be considered to be of local importance in some regions, as drug seeking or
diversion is more prevalent in some areas.
Relevance
The use of this indicator is relevant to both services and individuals. There is no
specified drug screening frequency in New Zealand, although this is a recommended
precautionary monitoring step in the guidelines for methadone maintenance for
addiction. However, chronic pain management is a different scenario to management
of addiction.
Evidence Base
The evidence base is mixed and varies depending on drug and type of urine test
used. Most of the urine tests applied in the community settings are commonly used to
test only for cannabis. It is necessary to specifically ask for other substances and
also to ask for drug quantification, if required. Urine testing should be done observed
to avoid cheating (i.e. provision of urine from someone who does comply with the
expectations). Compared with addiction monitoring experience in addiction services,
the need to observe urine and the confrontational nature of interpretation of results of
testing (the drug of interest is detected in the urine or not) is a relative barrier to
routine use.
Characteristics of Indicator
The validity and reliability of the indicator is dependant on drug and test used and
purpose for which it is to be used. Urine tests may be unreliable if the drug of interest
is mimicked by a cross-reacting substance in the urine. It is also subject to
interpretation based on test parameters, laboratory cut off for reporting a positive test,
timeframes for excretion and detection of various substances in the urine after
consumption etc. Some urine tests are sensitive to urine acidity and patients have
been known to take acidification or alkalinisaing substances to capitalise on this
effect. The indicator is potentially subject to confounding therefore, and caveats as
noted above will need to be accommodated in interpretation of results.
Implementation requirements
The accuracy of data may be influenced by the fact that urine tests done at the
laboratory will be in the electronic record but some urine tests are available as are kit
sets for point of care, sensitivity and specificity of these tests can vary (they are not
31
recommended as evidential tests) and results of such point-of-care tests may or may
not be entered manually into the clinical record.
32
Indicator 7: Random urine drug screening on patients receiving
opioid prescriptions
Sieve Indicator Evaluation Summary
This indicator is assuming the use of one urine test which has a multifunctionality in
detection of a range of drugs of interest. e.g. polychromatography. Therefore while it
is convenient, the results may be ambivalent and difficult to assess if used to
measure practitioner performance.
Many opioid substances are excreted in the urine, but not all in amounts that are
readily detected (for example, oxycodone). Some non-opioid substances of abuse
are stored and then secreted so that no clear dose relationship can be established
(for example, for cannabis urinalysis can be positive for weeks after a single
exposure). Urine screening for tobacco and cannabis may also be affected by
exposure to sideline smoke.
In New Zealand some non-opioid urine laboratory tests must be specifically
requested (for example, stimulants such as methylphenidate). Quantitative analysis
must also be specifically requested, as routine testing reports the presence or
absence of a particular substance.
Indicator Evaluation Details
Indicator description
The VA indicator measure is defined as the percent of patients receiving opioid
prescriptions who receive drug screening for: non-opioid substances of abuse;
heroin/morphine; non-morphine opioid compounds.
Purpose and Perspective
The purpose of the indicator is to assess rates of illicit drug use and adherence to
prescribed drug regime.
The indicator addresses issues from an organisational process review perspective,
and has significance from a population and individual health perspective.
Relevance
Clinical practice guidelines recommend drug screening for compliance with
medication, and checking for illicit drug use before and during the opioid prescription
regime.
Evidence Base
The evidence base is mixed and varies depending on drug and type of urine test
used. Most of the urine tests applied in the community settings are commonly to test
only for cannabis. Urine obtained for testing should be observed to avoid cheating
33
(provision of urine from someone who does comply with the expectations).
Compared with addiction monitoring experience in addiction services, where
observed urine, and the confrontational nature of interpretation of results of testing, is
expected (if the drug of interest is detected in the urine or not) this is a relative barrier
to routine use in pain management settings.
Characteristics of Indicator
There is no available data on use of this indicator for formal performance assessment,
and thus the validity and reliability of the indicator is unknown. However, the
indicator is predicted to be sensitive to changes in the prescriber’s practices or health
service administrative processes. It is necessary to specifically ask for other
substances of abuse and also to ask for drug quantification, if required.
Implementation requirements
The accuracy of data may be influenced by the fact that urine tests done at the
laboratory will be in the electronic record but some urine tests are available as kit
sets for point of care. The sensitivity and specificity of these test kits can vary (they
are not recommended as evidential tests) and the results of such point-of-care tests
may or may not be entered manually into the clinical record.
34
Indicator 8: Bowel Regimen
Sieve Indicator Evaluation Summary
This indicator is a measure of co-prescribing In relation to the management of bowel
related complications of opiate prescribing in primary health care. The indicator
makes no distinction as to whether the co-prescribing is relevant. It is an
administrative data-dredging indicator, and if used in isolation it would be an
incomplete indicator of bowel regime management, as there are also good nonpharmacological ways of addressing these issues. The indicator may be helpful for
cost containment, or for use within an audit prompted by a critical incident or adverse
event.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the percent of patients with an outpatient opioid
prescription who are prescribed a bowel regimen (i.e. laxatives) during the financial
year.
Purpose and Perspective
The stated purpose of the indicator is to assess the rate of bowel related
complications in patients prescribed an outpatient opioid.
This VA indicator has addressed issues of significance (management of bowel comorbidities) from an individual personal health perspective and a consumer
perspective. It may also be utilised from a cost containment perspective, aimed at
decreasing unnecessary medication use (i.e. reduction of the costs related to coprescriptions).
Relevance
The use of this indicator is relevant to: comparative prescription analysis, but it is
meaningless without measures of clinical appropriateness.
Evidence Base
The underlying evidence base for this indicator is derived largely from
epidemiological studies, and/or case control or case studies, as this is a prevalence
indicator. There is a related evidence base on the management of bowel related
adverse effects of opioid use.
Previous use of this indicator is likely to be limited to selected audit or educational
programmes at the level of peer groups of clinicians. Where these stem from a
discussion of patient adverse health events they are likely to be subject to
confidentiality agreements, and not in the public arena.
35
Characteristics of Indicator
Data on the validity and reliability of the indicator was not identified, and the
sensitivity of the indicator to enable assessment of change of quality of prescribing is
predicted to be low.
Implementation requirements
Medical records may need to be accessed in relation to appropriateness of
prescribing. Consideration of individual patient requirements is required for
appropriate analysis and interpretation of results.
36
Indicator 9: High dose prescriptions for opioid naïve patients
Sieve Indicator Evaluation Summary
This VA indicator is of limited utility in New Zealand. The New Zealand patients
attending for chronic pain management are highly likely to have sourced opiate
analgesic prior to presentation, and will not usually be opiate naïve. It is an
administrative data dredging-type indicator. At a first prescription New Zealand
patients may have been using over the counter, codeine or codeine-paracetamol
combinations, or using prescription opiates sourced from a relative or friend.
However the general principle of starting with lower strength opiates and low doses is
sound, and has safety implications. It can be difficult to ascertain commencement
tolerance of patients who are not opiate naïve.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the number of new opioid prescriptions that are
for a high dose formulation.
Purpose and Perspective
The stated purpose of the indicator is to identify all instances of high dose opioid
formulations prescribed to opioid naïve patients, as high dose opioids are dangerous
and can cause overdose or respiratory arrest in naïve patients. Note, as indicated
above, there is an intrinsic assumption that patients without a previous prescription
are indeed naïve and haven’t previously obtained opioids from other sources.
The indicator addresses issues from a cost effectiveness and professional
competence perspective with respect to appropriate initiation of opioid therapy in
opioid naïve patients. The issue is also important for personal and consumer
perspectives.
Relevance
The rationale for this indicator is that low dose formulations are appropriate when
commencing opioid analgesia. Physiological tolerance to opioids develops with time,
thus excessive dosing without tolerance can lead to overdosing or respiratory arrest.
Some opioid formulations are therefore inappropriate when starting opioids in
patients with chronic pain who are opioid naïve. These include fixed high dose tablet
formulations, high starting doses on opiates with long half-life, and trans-dermal
preparations.
Evidence Base
The underlying evidence base for this indicator is largely at the level of consensus
guidelines, anecdotal evidence and case studies.
37
There is a related body of literature on animal studies on toxicity, pharmacological
evidence of tolerance and epidemiology evidence of deaths during opioid initiation.
The use of the indicator could have potential medico-legal implications.
Characteristics of Indicator
The indictor is potentially valid, reliable and sensitive to changes in prescriber activity.
Implementation requirements
Data collection and analysis on this indicator is unlikely to be challenging.
It is important to note that in New Zealand the record of prescribing is in a triplicate
paper copy for opiates which require a controlled drug form and these prescription
records are not captured in practice prescribing programmes, except for codeine and
buprenorphine-naloxone (Suboxone).
Parameters for interpretation of the indicator would require consideration that the
commencing patients have not had opioids before and that the patient is truly opioid
naïve.
38
Indicator 10: Initiating opioids for special populations
Sieve Indicator Evaluation Summary
This is a best practice indicator. Issues include specific definition and ability to
identify ‘special’ or vulnerable populations.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the number of new opioid prescriptions for
elderly or frail patients in the last year that were above the recommended lower
starting dose range.
Purpose and Perspective
The stated purpose for this indicator is to assess the number of patients who have
medical indications for cautious prescribing, but who have initial opioid doses above
the minimum recommended dose.
The indicator addresses an issue of importance from a clinical safety, and
professional competence/best practice perspective, given the need for understanding
caveats for people who can be identified as vulnerable for opiate prescribing,
especially when starting opioids. Increasingly with an aging population there is a risk
for elderly. Co morbidities in that population will often accompany chronic pain.
Relevance
This indicator is relevant for a number of vulnerable populations and specific medical
conditions where opioid treatment should be initiated with caution. Clinical practice
guidelines often specify these situations where initiation doses need to be particularly
low. Note that prescribing opiates for chronic pain in pregnancy is another special
situation.
Evidence Base
The underlying evidence base for this indicator is from case studies of adverse
effects of opiate prescribing for the elderly, and consensus guidelines.
The indictor may be used as an organisational or prescriber indicator of quality; and
for audit and feedback for educational purposes.
Characteristics of Indicator
There is little on the validity or reliability of the indicator. However this may be
rectified as VA implements the indicator in their services. The sensitivity of the
indicator is subject to precise definition or specification of parameters of the relevant
population i.e. frail or vulnerable.
39
Implementation requirements
The measure denominator requires greater clarification.
40
Indicator 11: Pharmacy reconciliation of opioid prescriptions
Sieve Indicator Evaluation Summary
The equivalent of this indicator in New Zealand is Medicines Use Review (MUR). In
New Zealand MUR is relatively new and not all pharmacists are accredited to
undertake it. There is also a low level of GP awareness of MUR and thus low
utilisation.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the percent of patients with an opioid
prescription with evidence of medicines management or prescription reconciliation.
Purpose and Perspective
The stated purpose of this indicator is to assess the rates at which patients with an
opioid prescription have an encounter with either a clinical pharmacist or an
encounter where they receive a medicines review/reconciliation.
Review of appropriate co-prescribing by pharmacist, together with patient education
is important for best practice. Review can lead to recommendations for appropriate
and alternative co-prescribing and improvement of patient compliance.
Relevance
This indicator is relevant with regard to the management of patients with chronic pain
who often have multiple co-morbidities and are more likely to be on multiple
medications, which increases the likelihood of interactions with opioid medications.
Evidence Base
The underlying evidence base for this indicator is from case studies of adverse
effects of polypharmacy for the elderly, and consensus guidelines.
In New Zealand and overseas MUR and pharmaceutical detailing is directed at
reducing polypharmacy.
Pharmaco-kinetic and pharmaco-dynamic evidence is available re interactions
especially with methadone via cytochrome p450 system. Interactions are also
possible between other medications and other opioids.
This is a very complex topic. It would be hard to specify the link to quality except that
rationalization of drug use, and use of fewer drugs is more likely to promote patient
safety.
41
Polypharmacy is often a topic for peer review group discussion, and in New Zealand
that peer education information is subject to confidentiality.
Characteristics of Indicator
There is no data on the reliability or validity of the indicator. While utilization of MUR
is attributable to the practitioner or service, their use is influenced by service
availability, particularly with respect to the availability of pharmacists accredited to do
MUR, and to DHB funding.
Implementation requirements
There are few issues of concern re data availability and precision with respect to this
indicator, other than the use of written paper reports due to pharmacist and medical
record systems not being compatible.
Interpretation of indicator results would need to take into account the caveats
previously mentioned, and the potential link between quality, patient safety and
polypharmacy.
42
Indicator 12: Psycho-social treatments for pain
Sieve Indicator Evaluation Summary
This is potentially a good indicator for the USA system but not in New Zealand due to
variation in service availability and funding requirements. Pain clinics may offer
psychologist assessment but this is usually an optional additional appointment. The
indicator is also reliant on paper records or patient self record.
Indicator Evaluation Details
Indicator description
The VA measure is defined as the percent of patients with an opioid prescription who
also received any of the following psycho-social treatments: Coping skills/stress
management training; or psychotherapy procedures.
Purpose and Perspective
The purpose for introduction of the indicator is stated to be to assess the availability
and use of these treatment modalities. It is based on a best practice rationale to
minimise reliance on medication, and as an adjunct to prescriptions. Undue reliance
on pharmacological management can be minimised by attention to psychological
drivers. Use of adjunctive non pharmacological treatment such as CBT and
biofeedback techniques can assist in pain management.
The indicator addresses both personal and population health perspectives. The
issue is significant from a health policy and cost effectiveness perspective, and also
from a professional competence perspective with respect to use of alternative
treatment modalities. In New Zealand it could be considered to be of local importance
in some regions, due to variation in service availability. For example, in some areas
there is limited access to coping skills courses, psychologists or counsellors.
Additionally if there is limited access to counselling services, if the cost of the
treatment is not covered by ACC, then New Zealand patients will have to bear the
cost as the GMS does not cover counselling.
Relevance
The use of this indicator is relevant to improvement of health outcomes and
functioning through minimising reliance on medication and promoting patient self
efficacy. It is also relevant to targeted health policy funding and planning in relation to
service availability.
43
Evidence Base
There is good evidence with respect to the importance of psycho-social interventions
in pain management. It is accepted best practice.
Previous use of this indicator is likely to be limited to selected audit or educational
programmes at the level of peer groups of clinicians. However, VA is now using the
indicator and this will lead to development of an evidence-base.
Characteristics of Indicator
There is no data on the reliability or validity of the indicator. The indicator is not likely
to be sensitive to changes in quality of health service provision, as it is subject to
service availability and cost; and would require patient ‘buy in’. Thus while referral
for psycho-social treatments would be attributable to the practitioner, it is dependant
on availability of treatment modalities, and funding in different localities.
Implementation requirements
The clarity of the measure is mixed. For example, a single psychologist clinic
attendance or one-off assessment by psychologist may not mean full compliance by
the patient with any recommended non-pharmacological pain management
programme.
Obtaining accurate data might prove problematic as some data might be paper
based e.g. referral letters or responses.
Ensuring data precision on psycho-social treatments received may require
verification/report data from patient.
44
Indicator 13: Rehabilitation medicine
Sieve Indicator Evaluation Summary
This indicator is to ensure that the rehabilitation effort is maximised and non
prescription options are utilised effectively to increase their rehabilitation effort.
Maintaining activity would be important to countermand the sedative effects of
opioids. Maintaining function and achievement of recovery is objective. Adjuct
therapies can reduce need/demand for prescriptions.
In New Zealand this indicator is subject to variation in service availability and funding
requirements.
Note: Pain clinic review would not be included as a non-prescription intervention in
New Zealand (a DHB Pain clinic doctor review appointment does not automatically
include physiotherapy or occupational therapy, which will be provided within the
community if pain is due to an injury and is ACC claimable).
Allied health funding and prescription funding come from different budgets in New
Zealand, therefore the indicator could not potentially be utilised from a cost-effective
perspective.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the percent of patients with an opioid
prescription who receive treatments to increase rehabilitation activities.
Purpose and Perspective
The stated purpose of the indicator is to assess use of treatments intended to
increase physical, social or occupational function by patients who receive an opioid
prescription.
The indicator addresses issues of significance from an individual personal health
perspective. It could be considered to be of local importance in some regions, due to
variation in service availability, and funding of occupational therapy, physiotherapy
etc.
Relevance
The use of this indicator is relevant to rehabilitation services
Evidence Base
The underlying evidence base for this indicator in relation to the effectiveness of
interventions is in the allied health literature. The level of evidence is not high due to
the subjective nature of assessing outcome measures.
45
Adjunct rehabilitation is funded in New Zealand by ACC, up to a ceiling. The
evidence for the total number of treatments is likely to be based on historical
utilisation data. ACC guidelines have been established for cost containment
purposes.
The indicator may be used as a quality and performance measure at an
organisational level, and for audit and feedback. In particular rehabilitation units and
pain clinics will monitor use of allied health appointments as adjunct therapy in pain
management.
Characteristics of Indicator
The indicator is influenced by service availability and funding.
Implementation requirements
Clarity of the measure requires specification of the rehabilitation modalities used
Obtaining accurate data may be problematic as information will need to be sourced
from individual providers in New Zealand or obtained directly from the patient with
regard to utilisation of allied health services due to incompatibility of IT systems
In order to ensure accuracy of the data and hence its analysis and interpretation, the
definition of attendance needs further clarification i.e. one off assessment or regular
visit, self-monitored programme at home etc.
46
Indicator 14: Use of Complementary and Alternative Medicine
treatments for pain
Sieve Indicator Evaluation Summary
This VA indicator is a prevalence indicator to assess the use of complementary
procedures as alternative treatments for pain. It may also potentially gauge
patient autonomy, as these are interventions are not often recommended by health
practitioners.
Indicator Evaluation Details
Indicator description
The indicator measure is defined as the percent of patients who receive an opioid
prescription who receive treatments considered complementary and alternative
therapies e.g. hypno-therapy, music therapy, bio feedback, acupuncture, Feldenkreis
or Alexander technique, yoga, relaxation therapies.
Purpose and Perspective
The stated purpose of the indicator is to assess the use of complementary and
alternative procedures commonly used to treat pain by patients who receive an
opioid prescription.
The indicator addresses issues of significance from an individual personal health and
consumer perspective. The issue is significant from a cost effectiveness perspective
in New Zealand, with respect to use of alternative treatment modalities, since many
of these therapies are user-pay options.
Relevance
Use of complementary self help procedures by patients could impact on demand for
opiates and other analgesics.
Evidence Base
There is minimal evidence for some of these therapies but a growing body of
literature. For example, there is some evidence available for the role of hypnotherapy, music therapy, bio feedback and acupuncture in pain management. Most
current evidence is focused on use of complementary and alternative medicine rather
than complementary procedures.
The underlying evidence base for this indicator in relation to the effectiveness of
interventions sits largely within the allied health literature. The level of evidence is
not high due to the subjective nature of assessing outcome measures.
47
Use of Complementary procedures is usually driven by patient choice and some
practitioners would not include these treatment options in their list of
recommendations.
Characteristics of Indicator
The indicator is subject to funding, service availability and patient motivation.
Therapies would be largely be self-funded by patients (except acupuncture which
may be funded by ACC if pain is the result of an injury).
Implementation requirements
Information would need to be obtained directly from the patient as most of these
complementary providers don’t share software and don’t report to a common funding
body.
48
Indicator 15: Use of other pain procedures
Sieve Indicator Evaluation Summary
“Other” pain procedures include, for example, use of a TENS machine; joint or nerve
blocks. Appropriateness of referral, patient outcomes or benefit are not addressed by
this indicator.
The indicator is an epidemiological indicator of provider/funder interest.
Indicator Evaluation Details
Indicator description
The VA indicator measure is defined as the percent of patients who receive an opioid
prescription who receive treatments considered other pain management analgesic
procedures (mechanical and pharmacological). These other procedures are those
likely to be offered in pain clinics (e.g. joint or nerve blocks) or specialized treatment
service (e.g. use of a TENS machine).
Purpose and Perspective
The stated purpose of the indicator is to measure use of pain management analgesic
procedures (mechanical and pharmacological), that are not counted in the other
rehabilitation indicator (Indicator 13).
The indicator addresses issues of significance from an individual personal health and
consumer perspective. The issue is significant from a professional competence
perspective; in as far as it demonstrates consideration and use of alternative
treatment modalities to give patients non-opiate analgesic options. It could be
considered to be of local importance in some regions, due to variation in service
availability,
Relevance
It is important to ensure that the practitioner has considered all other pain relief
alternatives, and to optimise use of non prescription analgesia procedures where
relevant. Some procedures could minimise use of opiates e.g. where a nerve block
procedure or TENS machine use was effective.
Evidence Base
The underlying evidence base for the indicator is mixed in relation to the specific
interventions used. There is a related evidence base regarding use of these
interventions in specific neurological problems and particular types of pain.
The indicator may be used for local audit and feedback, given the proviso that the
indicator is subject to service availability. It might help with service funding and
planning.
49
Characteristics of Indicator
There is no data on the reliability or validity of the indicator itself. While referral for
other pain procedures such as TENS machines, nerve block etc are attributable to
the practitioner, their use is influenced by funding and service availability. However,
VA will build up an evidence base as they implement the indicator.
Implementation requirements
The relevant population would be highly selective: those with specific conditions that
would be responsive to treatment with these modalities.
Data collection would require examination of clinical records. The opiate prescriber
will generally have a different computer system to the person performing nerve
blocks.
Interpretation would be limited to evidence of referral, rather than appropriateness or
benefit to the patient.
50
Chapter 3
Safe and appropriate Opiate
prescribing for chronic nonmalignant pain
New indicators for New Zealand
51
Overview
This chapter presents seven suites of new indicators developed for New Zealand use
by the authors of this report. The new indicators were created as a result of
perceived deficiencies of the VA indicators. The indicators were derived using an
evidence-based process and indicator development template developed by one of us
(RP).(13)
52
Indicator Suite 1
Topic Area: Clinical assessment and documentation
Aspect of care: Evidence of baseline assessment
Indicator Suite (1)
Indicator 1.1: A Clear initial documentation of the pain syndrome: cause, type
duration and pattern and intensity
Indicator 1.2: Clear initial documentation about pre-existing or co-existing mood or
addiction behaviours
Indicator 1.3: Clear initial documentation about co-existing use of sedating licit or
illicit substances
Indicator 1.4: Clear documentation of the indications for opiate prescribing
Indicator 1.5: Clear documentation of the contraindications and relative
contraindications to opiate prescribing
Delineation of intent
Paradigm: Quality Assurance based on a best practice rationale for appropriate
management of chronic non-malignant pain using opioid medication, including
indications, contraindications and relative contraindications
Stakeholder perspective and emphasis:
The indicator is derived from a clinical implementation perspective, for
• Improvement of individual health documentation;
• Quality of monitoring progress .
Purpose: establish the baseline (pre-opioid clinical status) for the purpose of
assessing response to changes in clinical management and also progress with the
rehabilitation.
Rationale for topic derivation and indicator selection
Clear documentation is required of the before and after clinical status, in order to
assess response to treatment.
Initial assessment should also clearly outline indications to support decision to use
opiate analgesia, and identify actual and potential risks.
53
Area for quality improvement
• Clear documentation of the pain syndrome: cause, type duration and pattern.
• Use of serial pain intensity measurement with comparisons to baseline ;
• Screening for pre-existing or co-existing mood disorder or substance disorder;
• Documentation of current use of cannabis, alcohol, benzodiazepines, other
(prescription or non-prescription) opiates and street drugs.
• Avoidance of unnecessary prescribing risk and pre-empting of possible
complications.
• Clear documentation of the indications for opiate prescribing
• Clear documentation of contraindications or relative contraindications.
Pre-assessment of patients considered for prescribed opioids for chronic non
malignant pain management
For optimal management the following pre-assessment steps should take place at
practitioner or practice level.
• Identification of the nature of the chronic pain condition to be treated, and
indications for commencing opiate treatment in particular
• Identification of patients likely to be at risk due to mood or substance disorders.
• Identification of patients likely to be at risk due to pre-existing sedative use (licit or
illicit)
• Clear initial documentation facilitates subsequent monitoring and follow up,
namely;
o Recording and coding of diagnosis
o Recording of risk assessment, relative contraindications to therapy,
goal setting and/or management and monitoring plan.
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practice.
Within their control:
Practice activity/systems for identification of high risk patients and those with
indicative symptoms; accurate record keeping
Incomplete information due to difficulties in obtaining relevant past records form other
services.
Outside their control:
Patient autonomy and preference, and compliance with advice and use of over-the
counter medicines, alcohol, and illicit substances with potential sedating properties.
Incomplete information due to difficulties knowing about relevant records held with
other agencies.
TECHNICAL SPECIFICATIONS
Population of interest: All patients attending a medical practitioner who are being
considered for prescribed opiates for chronic non-malignant pain
Exclusions: None
54
Time period for analysis: monthly, or more depending on rate of new presentations
for this indication
Unit of analysis: Individual prescriber or by practice
Criteria:
All patients being considered for opioids should have clear initial documentation
about the pain syndrome
All patients being considered for opioids should have clear initial documentation
about pre-existing or co-existing mood or addiction behaviours
All patients being considered for opioids should have clear initial documentation
about co-existing use of sedating licit or illicit substances
All patients being considered for opioids should have clear initial documentation
about the indications, contraindications and relative contraindications for opiate use
Standard: 100% good record keeping and documentation
Good clinical assessment
Measure specifications:
Indicator 1.1: A Clear initial documentation of the pain syndrome: cause, type
duration and pattern and intensity
a)
Patients with documented pain causation
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
b)
Patients with documented pain type (neuropathic, nociceptive or mixture)
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
c)
Patients with documented pain duration
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
d)
Patients with documented initial pain pattern
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
e)
Patients with documented initial pain intensity
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
55
Indicator 1.2: Clear initial documentation about pre-existing or co-existing mood or
addiction behaviours
a)
Patients with documentation re pre-existing or co-existing mood disorder
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
b)
Patients with documentation re pre-existing or co-existing addiction behaviour
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
Indicator 1.3: Clear initial documentation about co-existing use of sedating licit or
illicit substances
a)
Patients with documentation re pre-existing alcohol abuse
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
b)
Patients with documentation of pre-existing cannabis use
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
c)
Patients with documentation of pre-existing benzodiazepine use
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
d)
Patients with documented pre-existing other opiate abuse (prescribed or OTC)
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
e)
Patients with documented pre-existing street (other illicit) drug abuse
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
56
Indicator 1.4: Clear documentation of the indications for opiate prescribing
Patients with indicator A1a satisfied, AND documentation that non-opiate
management has proven in-adequate for pain control
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
Indicator 1.5: Clear documentation of the contraindications and relative
contraindications to opiate prescribing
Absolute contraindications: documented allergy or previous serious side effect to the
specific opiate being considered; co-existing use of drugs with sedating side-effects.
a)
Clear initial documentation of screening for the above absolute contraindications
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
Relative indications include: conditions for which there is limited evidence of
analgesic efficacy (fibromyalgia, low back pain, osteoarthritis, headache, TMJ
dysfunction, chronic pelvic pain, irritable bowel); cognitive deficit; advanced age;
living alone.
b)
Clear initial documentation screening for the above relative contraindications
Patients undergoing consideration of new opioid treatment for chronic non-malignant
pain
Parameters for analysis and interpretation of indicator data:
Medical records may be incomplete as use of over-the-counter medications or street
medications are not recorded in the way that prescribed drugs are recorded. Rely on
appropriate questioning by clinician and patient self-report.
Potential perverse incentives or adverse consequences: prescriptions repeated
without re-assessment at appropriate interval (unclear how often monitoring of these
parameters should be undertaken).
Patients may be reluctant to self-report use of illicit or over- the –counter substances.
Additional comments:
57
IMPLEMENTATION REQUIREMENTS
The following implementation requirements are written in a generic format as many of
these aspects relate to all the new indicator suites.
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
Suggested Read code(s) for future use
Chronic opioid medication
58
Indicator Suite 2
Topic Area: Planned opioid initiation
Aspect of care: Clinical assessment and documentation when beginning
prescribed opioid treatment
Indicator Suite (2):
Indicator 2.1: Clear documentation of treatment initiation plan.
Indicator 2.2: Clear documentation that appropriate patient warnings have been
given.
Indicator 2.3: Clear documentation of dose adjustment regime and pain monitoring
that informs dose adjustment
Indicator 2.4: Clear documentation of treatment expectations
Delineation of intent
Paradigm:
Quality Assurance based on a best practice rationale for appropriate management of
chronic non-malignant pain using opioid medication, including careful dosing at
initiation with therapeutic trial and stepped care, warnings to patient and goal setting.
Stakeholder perspective and emphasis:
The indicator is derived from a clinical implementation perspective, for
•
Quality of initiation progress;
•
Agreement on realistic treatment expectations;
•
Monitoring for initial treatment response;
•
Improvement of individual health documentation.
Purpose: establish good prescription initiation processes, practitioner and patient
agreement on goals for clinical management, ensure appropriate early monitoring,
and documentation of all the above.
Rationale for topic derivation and indicator selection
•
Need for clear documentation of the steps to ensure safe opiate;
commencement and initial dose adjustment;
•
Importance of shared goal setting (between doctor/patient);
•
Evidence of monitoring during the initiation risk.
59
Area for quality improvement
• Clear documentation of the opiate initiation regime;
• Clear documentation of the dose adjustment plan;
• Use of serial pain intensity measurement with comparisons to baseline;
• Alignment of patient and practitioner expectations of treatment;
• Avoidance of unnecessarily prolonged prescribing or needless high dosing;
• Clear documentation of the above.
Treatment planning for initiating opioids for chronic non malignant pain
management
For optimal management the following initiation steps should take place at
practitioner or practice level.
• The opiate treatment commencement plan should be documented in particular:
starting dose, formulation (liquid/tablet etc), duration before dose adjustment;
• Appropriate warnings given to patient;
• Frequency of pain intensity measurement and comparisons to baseline;
• Identification of criteria for dose adjustment (symptoms that will prompt dose
increase or decrease);
• Regime for dose adjustment documented;
• Goals/Expectations of practitioner and patient documented;
• Clear documentation facilitates subsequent monitoring and follow up, namely;
o Recording of steps taken for safety during initiation processes.
o Documentation of clinical progress
o Recording of response to therapy, goal setting and/or management
and monitoring plan.
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practice.
Within their control:
Practice activity/systems for identification of patients on prescribed opiates,; accurate
record keeping; patient-held pain records need to be copied into clinical record.
Incomplete information due to difficulties in obtaining relevant past records form other
services.
Outside their control:
Patient autonomy and preference, and compliance with advice and use of additional
analgesia during initation including over-the counter medicines, alcohol, and illicit
substances with potential sedating properties.
Incomplete information due to heavy reliance on patient self-report and patient-held
pain records.
TECHNICAL SPECIFICATIONS
Population of interest: All patients attending a medical practitioner who are being
commenced on prescribed opiates for chronic non-malignant pain
Exclusions: None
60
Time period for analysis: Depending on rate of new presentations for this
indication.
Unit of analysis: Individual prescriber or by practice.
Criteria:
• All patients being commenced on opioid treatment for chronic non-malignant pain
should have clear documentation of treatment initiation plan and dose adjustment
regime including patient monitoring and warnings.
• All patients being commenced on opioid treatment for chronic non-malignant pain
should have clear documentation about initial treatment goals/expectations.
Standard: 100% good record keeping and documentation, including management
planning.
Good clinical assessment
Measure specifications:
Indicator 2.1: Clear documentation of treatment initiation plan.
a)
Patients with treatment initiation plan documented
patients being commenced on opioid treatment for chronic non-malignant pain
Initiation plan should include: starting dose, formulation (liquid/tablet etc), duration
before dose adjustment
b)
Initiation plan includes all above elements
Patients with a treatment initiation plan documented
Indicator 2.2: Clear documentation that appropriate patient warnings have been given.
a)
Documentation that patient has been given warning(s)/ advice on adverse effects
patients being commenced on opioid treatment for chronic non-malignant pain
Appropriate warnings (preferable in writing) include drowsiness, avoidance of other
substances with sedation effects, machinery and vehicle driving, regime for pain
monitoring, what to do in event of drowsiness or worsening pain.
61
b)
Documentation that warning(s)/advice was appropriate
Patients with documented warning(s)/advice
c)
Documentation of patient pain self-monitoring regime
Patients being commenced on opioid treatment for chronic non-malignant pain
Indicator 2.3: Clear documentation of dose adjustment regime and pain monitoring
that informs dose adjustment
a)
Intended dose adjustment regime documented
Patients recently commenced on opioid treatment for chronic non-malignant pain
b)
Records document results of patient pain self monitoring
Patients recently commenced on opioid treatment for chronic non-malignant pain
c)
Patients fulfilling indicator 2.3a and 2.3b
Patients recently commenced on opioid treatment for chronic non-malignant pain
Indicator 2.4: Clear documentation of treatment expectations
a)
Records document discussion about treatment goals
All patients on opioid treatment for chronic non-malignant pain
b)
Records document situations that will prompt dose increase or decrease.
All patients on opioid treatment for chronic non-malignant pain
Note: international guidelines recommend that patients not well known to practice or
patients at risk of opiate abuse should have a written opioid prescription agreement.
62
c)
Records include a written opioid prescription agreement
Patients who are not well known to practice OR at risk of opiate abuse AND on opioid
treatment for chronic non-malignant pain
Parameters for analysis and interpretation of indicator data:
Rely on appropriate questioning by clinician and patient self-report about the pain
monitoring.
Much of this data will require a detailed search of written medical records, not
automatically captured by data field headings
Potential perverse incentives or adverse consequences: Patients may be
incented to over report pain to obtain dose adjustment. Patients may be reluctant to
self-report adjunctive use of illicit or over-the-counter substances.
IMPLEMENTATION REQUIREMENTS
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
63
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
Suggested Read code(s) for future use
Chronic opioid medication
64
Indicator Suite 3
Topic Area: Clinical management of patients receiving their first prescription of
opioids for chronic non-malignant pain
Aspect of care: Short term review
Indicator Suite (3):
Indicator 3.1: Review after initiation (within 3 days)
Indicator 3.2: Review after dose adjustment
Delineation of intent
Paradigm: Quality Assurance based on a best practice rationale for appropriate
management of patients receiving their first prescription of opioids for chronic nonmalignant pain
Stakeholder perspective and emphasis:
The indicator is derived from a clinical safety perspective, for improvement of
individual health outcomes
Purpose: Optimised pain relief, ensuring no immediate toxicity or undue side effects
Compliance with non pharmacological interventions
Rationale for topic derivation and indicator selection
Part a: Opioid naïve patients are at high risk at initiation.
Part b: methadone etc can build up over days with risk of toxicity and overdose.
Patients need to be seen at initiation and at rapid dose adjustments.
Area for quality improvement
• Rapidly optimize pain relief;
• Assess for cumulative toxicity and overdose;
• Ensure compliance with non pharmacological measures.
Optimal management of patients initiated with opioids for chronic non
malignant pain in primary care
For optimal management in primary care the following steps should take place at
either practitioner or practice level. May be done in person or via telephone.
• Check for symptoms of cumulative toxicity and pending overdose;
• Check compliance and understanding of the prescription initiation or adjustment;
• Check for compliance with non pharmacological measures;
65
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practice.
Within their control:
How many days after dose initiation contact is made.
Outside their control:
Patient autonomy and preference (may not attend, and may not be contactable by
phone. Patients may under or over state the pain relief. Patients may under or over
state compliance with advice and prescription.
TECHNICAL SPECIFICATIONS
Population of interest: All patients with chronic non-malignant pain initiated on
opioids for management of that pain; or who are under going rapid dose escalation.
Exclusions: none
Time period for analysis: Within 4 weeks of initiation of the medication
Unit of analysis: Individual prescriber
Criteria:
• Opioid naïve patients receiving their first prescription of opioids should be
reviewed within 2 or 3 days
• Patients with frequent dose adjustments should be seen within a week of the
dose modification.
Standard: As set in the methadone guidelines for opioid substitution treatment.
Measure specifications:
Indicator 3.1: Review after initiation (within 3 days)
Review after initiation (within 3 days)
All patients with chronic non-malignant pain initiated on opioids for management of
that pain
Indicator 3.2: Review after dose adjustment
Patients seem within a week of dose adjustment
All patients with chronic non-malignant pain on opioids who are having rapid dose
adjustment
66
Parameters for analysis and interpretation of indicator data:
Telephone encounters might not be documented.
Potential perverse incentives or adverse consequences:
Patients may have to pay and so may not wish frequent appointments
IMPLEMENTATION REQUIREMENTS
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
67
Suggested Read code(s) for future use
Chronic opioid medication
68
Indicator Suite 4
Topic Area: Stepped care for chronic non-malignant pain management
Aspect of care: Stepped care in prescribing for chronic non-malignant pain.
Stepped care is making sure that lower rungs of analgesic ladder are tried first, along
with techniques that may reduce need for pharmacological management e.g. allied
health interventions such as physiotherapy and psychological therapies (stress
management, biofeedback techniques, cognitive behavioral therapy, and other pain
counseling) and other alternate techniques and self-help therapies (massage,
Alexander Techniques, etc).
Each aspect of steeped care could be developed in to a separate suite of indicators.
E.g.
1) Use of analgesic ladder when prescribing for chronic pain.
2) Use of adjunctive physiotherapy.
3) Use of adjuctive psychotherapy,
4) Use of adjunctive alternative techniques and self-help therapies.
As an example, the following is a suite of indicators, developed for the New Zealand
setting, to address stepwise use of analgesics when prescribing for chronic nonmalignant pan.
Indicator Suite (4):
1. Stepped care in prescribing for chronic non-malignant pain.
Indicator 4.1.1: Documented review of pain severity measurement
Indicator 4.1.2: Documented review of opiate need
Indicator 4.1.3: Patients began management with lower strength opiate options
Indicator 4.1.4: Documented advice on use of PRN doses
Delineation of intent
Paradigm: Quality Assurance based on a best practice rationale for appropriate
prescribing for patients with chronic non-malignant pain.
Stakeholder perspective and emphasis:
The indicator is derived from a strategic/ policy implementation perspective, for
• Improvement of individual health outcomes;
• Cost effective medication use.
69
Purpose: reduction of morbidity from the high strength or high dose opioid use;
appropriate use of milder analgesics where possible, and use of the analgesic ladder
to encourage use of milder opiates first, and stronger opiates of they fail to provide
adequate pain control.
Rationale for topic derivation and indicator selection
It is best practice to prescribe the lowest strength medication and lowest dose that
provides desired clinical effect.
Area for quality improvement
• Prescribing using the analgesic ladder to avoid unnecessary use of opiates;
• A stepped approach for avoidance of unnecessary prescribing of high potency
opiates;
• Optimal pharmacological treatment to manage chronic pain and escape pain.
Optimal approach to prescription opioids for chronic non malignant pain
For optimal prescription the following steps should take place at either practitioner or
practice level.
• Determining pain severity and ongoing need for pharmacological treatment;
• Use of simple analgesia in pain regime;
• Advice re PRN doses;
• Opiate regimes commence with low strength options;
• Documentation of management and monitoring plan.
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practices.
Within their control:
Practitioners and health care teams can be pro-active in the promotion of use of nonopiate analgesia for mild pain or escape pain as a fist step.
Where patients are demanding opiates for overlapping prescription periods or in
escalating daily doses the practices can introduce prescription dispensing frequency,
and if necessary restriction notices to ensure that one practitioner and one
pharmacist are involved in the dispensing and prescribing..
Outside their control:
Patient autonomy and preference, and compliance with advice and medicines.
Patients may not wish to ‘risk” takng lower strength or lower dose analgesia if they
fear recurrence of pain by doing so.
70
TECHNICAL SPECIFICATIONS
Population of interest: All patients who are prescribed opiates for chronic nonmalignant pain
Exclusions:
Patients who have been on continuous opioids prescriptions for less than 2 months
Patients who are resistant to advice or pharmacological treatment. (Requires
motivational advice)
Time period for analysis: This does depend somewhat on the number of patients
handled by the clinical service. Ideally each patient should individually have a 3monthly clinical review, at which time all these aspects should be reconsidered.
Unit of analysis: Individual prescriber or service
Criteria:
• Patients on opioids for chronic non-malignant pain should have pain severity
measurement reviewed;
• All patients should have review of ongoing need for an opiate-based analgesia
regime;
• Opiate analgesia regimes begin with lower strength opiates;
• Patients prescribed PRN analgesia doses should receive appropriate advice;
• Documentation supporting the decision should be completed for all patients.
Standard: 100% of patients receiving opioids should have appropriate review, advice
and supporting documentation, and begin with lower strength opioids.
Measure specifications:
Indicator 4.1.1: Documented review of pain severity measurement
Documented review of pain severity measurement
Patients on opioids for chronic non-malignant pain for 2 months or longer
Indicator 4.1.2: Documented review of opiate need
Documented review of opiate need
Patients on opioids for chronic non-malignant pain for 2 months or longer
Indicator 4.1.3: Patients began management with lower strength opiate options
Patients began management with lower strength opiate options
Patients on opioids for chronic non-malignant pain for 2 months or longer
71
Indicator 4.1.4: Documented advice on use of PRN doses
Documented advice on use of PRN doses
Patients on opioids for chronic non-malignant pain for 2 months or longer
Parameters for analysis and interpretation of indicator data:
Prescribing records may be incomplete as prescriptions for opiates need to be hand
written on triplicate Controlled Drug forms and this may result in paper copies at
various treatment sites. It will require a manual search of paper records to identify
people who have opioid prescriptions over a prolonged period, evidence of the
triplicate prescription copy in records, electronic record search for words such as
chronic pain, dependency.
Potential perverse incentives or adverse consequences: There is always a risk,
with long term medication prescribing, that prescriptions may be repeated on patient
request without assessment of need. Patients on long term opiates can develop
iatrogenic opioid dependency and the patient behavior may then charge with drugseeking and other demands, resistance to clinical review and resistance to
moderating advice.
Additional comments:
Certain indicators within this suite of indicators require investigation of clinical notes
which would be time intensive. Prescription data in electronic records at practices will
not be complete for most opiates; they will be detected by comments on medical
records or by location of paper forms. Some opiates (Class C controlled drugs such
as buprenorphine-naltrexone and codeine) are not required to be written on triplicate
forms. Electronic record of dispensing of Class B drug prescribing data (includes
most other opioids) is separately recorded with strictly limited access. Class B
prescription reporting is available per doctor not patient, for confidentiality reasons.
IMPLEMENTATION REQUIREMENTS
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
72
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
Suggested Read code(s) for future use
Chronic opioid medication
73
Indicator Suite 5
Topic Area: Appropriate monitoring of opioid prescribing
Aspect of care: Clinical assessment and documentation of on-going prescribed
opioid treatment
Indicator Suite (5):
1. Clinical assessment and documentation of on-going prescribed
opioid treatment
Indicator 5.1.1: A clear documentation of the pain management plan
Indicator 5.1.2: Documentation of pain monitoring and progress toward/revision of
treatment goals
Indicator 5.1.3: Documentation of risk of adverse effects
Indicator 5.1.4: Documentation of care and attention in repeat prescribing of opiates
Delineation of intent
Paradigm: Quality Assurance based on a best practice rationale for appropriate
management of chronic non-malignant pain using opioid medication, including
continued clinical assessment and appropriate dose adjustment, watchful monitoring
on higher doses, and on PRN doses. Continual alert to risk of diversion and
iatrogenic dependence.
Stakeholder perspective and emphasis:
The indicator is derived from a clinical implementation perspective, for
• Quality of continuity of care;
• Monitoring for adverse effects including diversion and dependency;
• Improvement of individual health documentation.
Purpose: establish good continuing care processes, ensure adverse events are
detected promptly, and documentation of all the above.
Rationale for topic derivation and indicator selection
• Need for clear documentation of the steps to ensure safe opiate medication
monitoring;
• Early detection of adverse events
74
Area for quality improvement
• Clear documentation of the opiate maintenance regime;
• Clear documentation of the dose adjustment plan;
• Use of serial pain intensity measurement with comparisons to baseline;
• Assessment of development of dependency and risk of diversion;
• Avoidance of unnecessarily prolonged prescribing or needless high dosing;
• Clear documentation of the above.
Monitoring of patients on opioids for chronic non malignant pain management
For optimal management the following initiation steps should take place at
practitioner or practice level.
• The opiate treatment plan should be documented;
• Frequency of pain intensity measurement and comparisons to baseline;
• Identification of criteria for dose adjustment (situations that will prompt dose
increase or decrease);
• Periodic assessment of opiate adverse events;
• Care and attention in opiate repeat prescribing;
• Clear documentation facilitates monitoring and follow up, namely:
o Recording of regular regime.
o Documentation of clinical progress and adverse events.
o Recording of response to therapy, progress toward treatment goals.
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practice.
Within their control:
Practice activity/systems for identification of patients on prescribed opiates,; accurate
record keeping; patient-held pain records need to be copied into clinical record.
Where a relevant referral is ought the clinical reports should be obtained.
Outside their control:
Patient autonomy and preference, and compliance with advice and use of additional
analgesia including over-the counter medicines, alcohol, and illicit substances with
potential sedating properties.
Incomplete information due to heavy reliance on patient self-report and patient-held
pain monitoring records.
TECHNICAL SPECIFICATIONS
Population of interest: All patients attending a medical practitioner who are being
prescribed opiates for chronic non-malignant pain
Exclusions: None
Time period for analysis: 3-monthly,
75
Unit of analysis: Individual prescriber or by practice
Criteria:
• Patients being considered for opioids should have clear initial documentation
about the opiate treatment plan including frequency of clinical review, and use of
adjuctive treatments
• Patients being considered for opioids should have clear initial documentation
about pain monitoring and progress toward treatment goal
• Patients being considered for opioids should have clear initial documentation
about monitoring for adverse effects
• Due care and attention is taken with repeat prescribing of opiates
Standard: 100% of patients should have complete records and documentation of
opiate treatment plan, progress and monitoring frequency.
Measure specifications:
Indicator 5.1.1: A clear documentation of the pain management plan
a)
Patients with documented prescribing regime
Patients on opioid treatment for chronic non-malignant pain
b)
Patients with documented frequent review by prescriber
Patients on opioid treatment for chronic non-malignant pain
Note: clinical review may be with both opiate prescriber and with pain
specialists/surgeons and with other therapists providing adjuctive therapy.
c)
Patients with documented adjuctive therapy regime
Patients on opioid treatment for chronic non-malignant pain
Indicator 5.1.2: Documentation of pain monitoring and progress toward/revision of
treatment goals
a)
Records document results of patient pain self monitoring
patients maintained on opioid treatment for chronic non-malignant pain
b)
Records document progress toward/revision of treatment goals
76
Patients maintained on opioid treatment for chronic non-malignant pain
Indicator 5.1.3: Documentation of risk of adverse effects
a)
Records document screening for opiate side effects
Patients maintained on opioid treatment for chronic non-malignant pain
b)
Records document screening for opiate dependency
Patients maintained on opioid treatment for chronic non-malignant pain
c)
Records document screening for opiate diversion
Patients maintained on opioid treatment for chronic non-malignant pain
Note: 5.1.3c could include unannounced urinalysis- see additional indicator on use of
urinalysis.
d)
Records document safe home storage of medication
Patients maintained on opioid treatment for chronic non-malignant pain
Note: especially important where children also live/visit the home and where risk of
home invasion is higher (elderly living alone)
Indicator 5.1.4: Documentation of care and attention in repeat prescribing of opiates
a)
Notes include evidence of stepped prescribing approach
Patients maintained on opioid treatment for chronic non-malignant pain
Note: stepped approach includes use of weaker opioids (codeine, tramadol) before
prescribing stronger opioids (morphine, oxycodone, methadone)
b)
Usual prescription renewal frequency and amount is not exceeded
Patients maintained on opioid treatment for chronic non-malignant pain
77
c)
Records contain documentation of indication for PRN doses
Patients who have opiates prescribed on PRN basis
d)
Records include verification of opioid prescription
Casual patients/patients not registered at practice requesting opiate prescription
e)
Identification of patients on high dose (over 200mg morphine dose equivalent)
Patients maintained on opioid treatment for chronic non-malignant pain
Parameters for analysis and interpretation of indicator data:
Much of this data will require a detailed search of written medical records, as it is not
automatically captured by data field headings.
Information about diversion may come from other sources e.g. suspicions of
dispensing pharmacist, which needs to be appropriately documented, but may not be
captured in the specification of the measures.
Potential perverse incentives or adverse consequences: Patients may over-report
pain to obtain dose adjustment, deny abuse, dependence or diversion. Patients may
be reluctant to self-report adjunctive use of illicit or over- the –counter substances,
which could drive dependence.
Additional comments:
The indicator suites alter clinicians to the need for appropriate questioning by
clinician and patient self-report about the pain monitoring, compliance and diversion
Prescribers should be always alert to behaviours that could indicate development of
dependence.
IMPLEMENTATION REQUIREMENTS
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
78
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
Suggested Read code(s) for future use
Chronic opioid medication
79
Indicator Suite 6
Topic Area: Misuse of prescription controlled drugs
Aspect of care: Avoiding controlled drug misuse
Rationale for topic derivation and indicator selection:
Relevance to NZ policy; Significant cost, morbidity and mortality burden
Indicator Suite (6):
1. Avoiding controlled drug misuse
Indicator 6.1.1: Alcohol and Drug clinic assessment
Indicator 6.1.2: Documented baseline urine monitoring on first presentation
Indicator 6.1.3: Additional urine test within 3 months of first presentation
Delineation of intent
Paradigm: Quality Assurance based on a best practice rationale.
Stakeholder perspective and emphasis:
The indicator is derived from a strategic/ policy implementation perspective, for
• Improvement of population and individual health outcomes at a national level;
• Cost effective intervention.
Purpose: reduction of morbidity and mortality
Area for quality improvement
• Monitoring of compliance with opioids, and identification of possible diversion;
• Identification of potential abuse;
• Optimal management of high risk patients;
• Appropriate use and interpretation of urine tests;
• Availability of tests/assays that are quantifiable, and have a high sensitivity and
specificity.
Optimal drug monitoring for abuse or non compliance
For optimal management in primary care the following steps should take place at
either practitioner or practice level.
80
•
•
•
•
Appropriate monitoring and follow up of high risk patients;
Diagnosis of worsening condition;
Recording and coding of diagnosis;
Recording of risk assessment, contraindications to therapy, management and
monitoring plan.
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practice.
Within their control:
Practice activity/systems for identification of high risk patients and those with
indicative symptoms
Outside their control:
Patient autonomy and preference, and compliance with advice and medicines.
TECHNICAL SPECIFICATIONS
Population of interest: All registered patients at a general practice who are
prescribed opiates for chronic non-malignant pain, and known to have a substance
abuse disorder
Exclusions: If doses are not escalating, tests may not be required every 3 months
Time period for analysis: Quarterly
Unit of analysis: Individual prescriber
Criterion: Patients with a substance abuse disorder should be assessed at an
Alcohol and Drug Clinic in accordance with Section 24 of the Misuse of Drugs Act
Standard: 100% of patients registered at the practice with a substance abuse
disorder should be assessed at an Alcohol and Drug Clinic.
Measure specifications:
Indicator 6.1.1: Alcohol and Drug (A & D ) clinic assessment
Patients on opioids with an A & D clinic assessment in the past 3 months
Patients on opioids for chronic non-malignant pain with A & D
Indicator 6.1.2: Documented baseline urine monitoring on first presentation
Patients on opioids with documented baseline urine monitoring on first presentation
Patients on opioids for chronic non-malignant pain with A & D
81
Indicator 6.1.3: Additional urine test within 3 months of first presentation
Patients on opioids who have had at least one additional urine test within 3 months of
first presentation
Patients on opioids for chronic non-malignant pain with A & D
Parameters for analysis and interpretation of indicator data: The urine test
needs to be specified and appropriate for the particular opiate taken.
Potential perverse incentives or adverse consequences:
Funding of medications (some are subsidized, others not)
Additional comments:
Clinical circumstances e.g. escalating doses may require additional tests; or if doses
are not escalating, tests may not be required every 3 months
Tests need to be taken under observation as it is possible to ‘fudge’ results
Caveats need to be accounted in use of certain tests e.g. may be confounded by
cough medicine etc.
IMPLEMENTATION REQUIREMENTS
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
82
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
Suggested Read code(s) for future use
Chronic opioid medication
83
Indicator Suite 7
Topic Area: Management of complications of opiate treatment in chronic nonmalignant pain
Aspect of care: Proactive monitoring for complications of prescribing for chronic
pain
Complications can include:
1) Bowel problems ranging from opiate-induced constipation and, opiate
exacerbation of pre-existing chronic bowel conditions, to opiate bowel syndrome
(painful bowel syndrome that responds to cessation of opiates);
2) Opiate induced hyperalgesia,
3) Opiate-induced hypogonadism;
4) Osteoporosis and resulting risk of low impact fracture.
5) Premature dental decay
Each of these (1-5) can be developed in to a separate suite of indicators for
appropriate prescribing in chronic pain management. The indicator suite below is an
example using just opiate-related bowel complications (number 1 above). This new
suite of indicators was developed especially for the New Zealand setting. The
interested reader may wish to compare the paradigm, perspective, purpose and
content with the VA indicator (indicator 3) which also addresses opiate-related bowel
complications.
Indicator Suite (7):
1. Proactive management of opiate-induced constipation and
opiate exacerbation of pre-existing chronic bowel conditions
Indicator 7.1.1: Assessment of risk of bowel related complications
Indicator 7.1.2: Documented advice given regarding bowel management
Indicator 7.1.3: Patients at risk with a bowel management prescription
Indicator 7.1.4: Documented justification for bowel management
Indicator 7.1.5: Documented bowel monitoring
84
Delineation of intent
Paradigm:
Quality Assurance based on a best practice rationale for appropriate management of
constipation in patients prescribed opioids for chronic non-malignant pain.
Stakeholder perspective and emphasis:
The indicator is derived from a strategic/ policy implementation perspective, for
• Improvement of individual health outcomes;
• Cost effective medication use;
• Audit and peer review feedback for individual prescribers.
Purpose:
Reduction of morbidity from the constipating effects of opioid use; appropriate use of
emetic medications; cost effective laxative medication use.
Rationale for topic derivation and indicator selection
“Opioid medication causes slowing of intestinal motility. Untreated constipation is a
significant contributor to opioid non-adherence and patient dissatisfaction with opioid
therapy”.(12) Due to the effects on intestinal mobility, opiates can also contribute to
exacerbation of pre-existing bowel disease and also are responsible for a recognized
Opiate Bowel Syndrome.
Area for quality improvement
• Rationalisation of the management of constipation;
• Avoidance of increasing reliance on constipation medication;
• Avoidance of unnecessary prescribing;
• Provision of lifestyle bowel management information to all patients on opioid
therapy;
• Pro-active pharmacological treatment to manage constipation in patients at risk of
bowel related complications.
Optimal management of constipation in patients prescribed opioids for chronic
non malignant pain in primary care
For optimal management in primary care the following steps should take place at
either practitioner or practice level.
• Identification of patients at increased risk of constipation as a result of chronic
opioid use – this includes patients with a past history of bowel problems, and
patients on high dose opioids, and those with indicative symptoms;
• Provision of lifestyle advice for optimal bowel management;
• Determining severity and need for pharmacological treatment;
• Shared decision making;
• Monitoring and follow up;
• Recognition of worsening condition and appropriate diagnosis;
• Recording and coding of diagnosis;
• Recording of risk assessment, contraindications to therapy, management and
monitoring plan.
85
Variables that affect optimal management
These may be either within or outside of the control of the practitioners / practice.
Within their control:
Practice activity/systems for identification of high risk patients and those with
indicative symptoms; accurate record keeping
Outside their control:
Patient autonomy and preference, and compliance with advice and medicines.
TECHNICAL SPECIFICATIONS
Population of interest: All registered patients at a general practice who are
prescribed opiates for chronic non-malignant pain
Exclusions:
Patients who have been on continuous opioids prescriptions for less than 2 months
Patients who are resistant to advice or pharmacological treatment. (Requires
motivational advice)
Time period for analysis: 3 – 6 months (driven by the maximum time period for
repeat prescriptions for non-controlled drugs such as laxatives). 6 months would
usually cover two 3-month serial repeat prescriptions.
Unit of analysis: Individual prescriber
Criteria:
• Patients receiving opioids should have advice about complicating effects on
bowel function;
• Patients who do have symptoms should have lifestyle advice
• Prescriptions should be issued for patients whom lifestyle modification is not
sufficient
• All patients who received advice should receive monitoring advice
• Documentation supporting the decision should be completed
Standards:
100% of patients receiving opioids should receive advice about complicating effects
on bowel function, and 100% of those with symptoms should receive lifestyle advice.
All those who receive a prescription should receive monitoring advice.
Supporting documentation for decision making should also be completed for 100% of
patients.
A standard for issuing prescriptions is difficult to set as it is based on clinical
reasoning. Information about each individual patient is necessary to ascertain if the
practitioner is correct in determination of risk of bowel complications and of
86
advisability of prescribing adjunct laxatives to manage bowel complications. Baseline
information of the range is required prior to setting a standard.
Measure specifications:
Indicator 7.1.1: Assessment of risk of bowel related complications
Patients with documented bowel history
Patients on opioids for chronic non-malignant pain for 2 months or longer
Indicator 7.1.2: Documented advice given regarding bowel management
Patients with documented bowel history who have received any management advice
Patients on opioids for chronic non-malignant pain for 2 months or longer
Indicator 7.1.3: Patients at risk with a bowel management prescription
Patients with a prescription for pharmacological treatment
Patients on opioids for chronic non-malignant pain for 2 months or longer
Indicator 7.1.4: Documented justification for bowel management
Patients with whose documentation supports the decision for pharmacological
treatment
Patients on opioids for chronic non-malignant pain for 2 months or longer
Indictor 7.1.5: Documented bowel monitoring
Patients with documentation of monitoring treatment response
Patients with documented bowel history who have received any management advice
Parameters for analysis and interpretation of indicator data:
GP practice records may be incomplete as prescriptions for opiates need to be hand
written in triplicate.
Identification of people who have opioid prescriptions will need evidence of triplicate
records.
Potential perverse incentives or adverse consequences:
Potentially prescriptions could be repeated without assessment of need.
1) Funding of opioids and laxative medication is different i.e. there is no funding for
repeat of medication other than opioid. Therefore constipation medication may be
automatically repeated at the time of the opiod repeat. 2) Timing of funding of
prescriptions is also not the same – opioids are reviewed monthly, laxitives 3 monthly.
87
3) Some constipation medications are subsidised, while others are not subsidized.
Additional comments:
Certain indicators within this suite of indicators require investigation of clinical notes
which would be time intensive. Prescription data in electronic records at practices will
be complete for constipation medications, but triplicate nature of opioid prescribing
means they will have to look for paper forms or electronic entry that is separately
generated for the opioid at the practice. EPM access is only to Class B drugs
(includes opioids). Access is limited to the Ministry of Health only. Reports come out
per doctor not per patient for confidential reasons. Other prescribing records are not
accessible. This means that prescription data for controlled and non controlled drugs
information will be held in two different places.
IMPLEMENTATION REQUIREMENTS
Data sources
Implementation requirements for all of the prescribing indicators are:
1) Access to the GP medical notes or primary care electronic health record to find the
paper triplicate CD copy or find written mention of prescribing opiates in the notes.
Some practices keep triplicate copy in paper notes. These may be archived. Some
practices may scan in the triplicate copy, or have a nurse or administrator make a
written entry in the notes. It would be possible to request the MOH to provide a list of
patients to whom a doctor was prescribing opiates, but this would require special
permission, and is not done routinely.
Note: Electronic Prescription Monitoring (EPM), is a programme that allows the electronic equivalent of
the triplicate copy of the Controlled Drug prescription form (copy for Ministry) to be accessed by Ministry
officials with specified role delegation to monitor the prescriptions of Class B controlled drugs at the
point where they are dispensed to patients at community pharmacies. In theory EPM does identify class
B controlled drugs prescribed but this has restricted access so isn’t available for external (non-Ministry)
QA or QI activities.
2) Access to the practice or service electronic prescribing programme for record of
prescription of other opiates (codeine and buprenorphine-suboxone) other controlled
drugs drugs (eg benzodiazepines) , other sedating drugs (antidepressants) ,
and adjunct prescribing (paracetamol etc).
3) Access to the GP medical notes or primary care electronic daily health record to
source adjunctive prescriptions, identify if risk of complications assessed, whether
lifestyle management advice was given, and if the patient was reviewed.
Implementation for indicators that include non-prescription elements e.g. adjunct
therapies require notes search for referral information/letters. For non-prescribed
88
adjunct pain remedies patient self report or (in some instances) pharmacy records
may be required for implementation (e.g. pharmacies record codeine purchase).
Possible Read codes
Chronic Pain; Chronic injury
Malignancy – to ensure independency
Constipation
Suggested Read code(s) for future use
Chronic opioid medication
89
Chapter 4
Indicator Classification System:
Selection of indicators on opiate
prescribing for chronic nonmalignant pain
90
Indicator Classification System: Selection of indicators on
opiate prescribing for chronic non-malignant pain
Indicator Classification System
The Indicator Classification System is awaiting publication and is not currently
available for general release. However, it has been used to develop this project.
91
Chapter 5
Discussion and
Recommendations
92
Discussion
The report has explained why prescribing of chronic non-malignant pain is an
important quality and safety issue for New Zealand and elsewhere. Opiate use for
this indication has escalated, in part due to increased availability of prescription
opiates (recent subsidisation in New Zealand of oxycodone, fentanyl patches and a
brand named buprenorphine-naloxone combination). It is difficult to envisage that
the patient pain case-load could have increased at a corresponding rate to the
demand for prescription opiates. Undoubtedly pharmaceutical company marketing
activity as well as publicity about the subsidisation has contributed to heightened
public awareness, patient interest and increasing demand, as has been seen with
other “new” medicines introduced to the market.
Aside from the increasing prescribing cost to Vote Health, this phenomenon also
increases cost by placing more patients at risk of potentially preventable opioid
induced health complications, and drug interactions. In 2008 the combined
Australasian Colleges strategy document (17) called for guidelines to be developed
to facilitate improvements in current opiate prescribing for chronic non-malignant pain.
There has been to date no action following up on from that recommendation.
Indicator use for quality assurance and quality improvement is not novel to the New
Zealand health care system. This project has explored existing indicators and
proposed new indicators that lend themselves to this particular application, and which
could be included in development of a guideline for opiate use in chronic nonmalignant pain. Indicator use has often received less than enthusiastic adoption in
health practitioner circles, in part driven by the link to target-setting by service
funders and planners, raising a corresponding scepticism from health practitioners
about indicator applicability and interpretation.
Use of the Sieve Indicator Appraisal Tool has drawn attention to inherent
weaknesses in some aspect or aspects of each of the indicators, which has guided
the recommendations for classification, and resulted in a list of indicators rated
according to their suitability to the New Zealand setting. The process of classifying
indicators in this way is logical, evidence-based and transparent. It is a process that
lends itself to measurement of quality and safety of any other prescribing, or indeed
any other aspect of health care provision.
Piloting in health care settings of these recommended indicators of safe and
appropriate prescribing for chronic non-malignant pain is the next step toward
development of evidence-based guideline to improve prescription safety and quality.
The authors will seek further funding to build upon the work outlined in this report and
to continue development of this important health quality and safety initiative.
93
Recommendations
1) The wise application of health care quality indicators
Indicators have an important role in objective measurement of health quality and
safety. Convenience indicators i.e. those created by matching data sets, may be
subject to error, and quality judgements based on them may be erroneous and even
unsafe.
2) Appropriate indicator selection
Indicators need to be chosen and assessed with care to determine caveats for use.
Enabling providers to be able to choose indicators appropriate for their setting and
needs is necessary. The classification system allows, for the first time, the selection
of indicators assessed and graded according to intent and suitability for purpose.
3) Indicators of quality opioid prescribing in chronic non-malignant pain
Indicators and prescribing guidelines are necessary to address the quality and safety
of prescribing for chronic non-malignant pain. Existing indicators in use in this area
are not sufficiently well developed to make appropriate judgements of the quality and
safety of prescribing for chronic non-malignant pain. International indicators may not
be appropriate for the New Zealand context, as legal requirements may differ for
example, thus indicator customisation or de novo development of New Zealand
specific indicators is important. The new indicators developed for this project should
be considered for feasibility testing with regard to implementation within the New
Zealand health care environment.
4) Assessment of quality in opioid prescribing in chronic non-malignant pain
Prescribers of opiates for chronic non-malignant pain should be subject to quality
assurance assessment. This could include use of the new indicators generated for
this project. Better systems for centralised monitoring of opioid prescribing in New
Zealand are also required.
5) Other considerations
Opioid prescribers should consider patient self-administration of non-prescribed
sedating substances (alcohol, cannabis, over-the-counter opiate combinations and
other sources of sedatives). Guidelines for detection of substance abuse could be
upgraded for this purpose.
Next steps
The next step toward prescription quality improvement in this area is a pilot of the
indicators in clinical practice. Field-based evaluation of the project completed to date
is now necessary. This includes validation of the classification system, as well as
determination of implementation issues and feasibility within the New Zealand health
care environment of the new opioid prescribing indicators developed for New
Zealand. Further funding will be sought in the 2012/13 year to undertake a pilot for
this work in selected general practices.
94
References
95
References
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Perera GAR. Panning for Gold. The Assessment of Performance Indicators
in Primary Health Care [PhD thesis]. Wellington: University of Otago; 2009.
2.
Ibrahim JE. Performance indicators from all perspectives. International
Journal for Quality in Health Care. 2001;13(6):431-2.
3.
Baker R. Managing quality in primary health care: the need for valid
information about performance. Quality in Health Care. 2000;9:83.
4.
Downing A, Rudge G, Cheng Y, Tu Y, Keen J, Gilthorpe M. Do the UK
govenment's new Quality and Outcomes Framework (QOF) scores adequately
measure primary care performance? A cross-sectional survey of routine healthcare
data. BMC Health Serv Res. 2007;7(166).
5.
Maxwell RJ. Dimensions of quality revisited: from thought to action. Quality in
Health Care. 1992;1:171-7.
6.
Reeves D, Doran T, Valderas JM, Kontopantelis E, Trueman P, Sutton M.
How to identify when a performance indicator has run its course. British Medical
Journal. 2010;340(24 April ):899-901.
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Perera R, Dowell T, Crampton P, Kearns R. Panning for gold: An evidence -
based tool for assessment of performance indicators in primary health care. Health
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Perera R, Dowell A, Crampton P. Review of Ministry of Health proposed
performance indicators for PHOs. Report prepared for the Ministry of Health.
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Perera R, Dowell A, Crampton P. Clinical indicators for PHOs:
Recommendations for target setting. Report prepared for the Ministry of
Health/DHBNZ. Wellington: Wellington School of Medicine and Health Sciences,
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10.
Perera R, Morris C, Dowell AC. Voyage to Quality: Clinical Indicator Report.
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Trafton et al. Evaluation of the Acceptability and Usability of a DSS to
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primary care providers. Pain Medicine 2010;epub 3/1/10.
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Trafton JA, Lewis ET, Midboe AM, The PERC Data Analysis Group. Status
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Ministry of Health. The Primary Health Care Strategy. Wellington: Ministry of
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97
Appendices
Appendix 1: Sieve Indicator Appraisal Tool Result Tables
Appendix 2: Literature Search Results
98
Appendix 1
Sieve Indicator Appraisal Tool
Result Tables
99
Indicator 1: Appropriate medical follow-up after opioid initiation
Table 1.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 1.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
Table 1.3
There is evidence (positive or negative) for use of this indicator in :
Yes
None
identified
Performance measurement of an organisation
*
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
* Possible use for service review of initiation and of rapid escalation protocols. Part of in service education.
100
Table 1.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
*Attributable to the initiating service and prescriber
^ Dependant on appropriate specification of the measure denominator
Yes
No
No data
identified
*
^
NA
^
Table 1.5
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
* Dependant on appropriate specification of the measure denominator
Yes
No
Influenced
by systems
level factors
*
Table 1.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
* Dependant on appropriate specification of the measure denominator
Yes
No
*
*
*
Influenced
by systems
level factors
101
Indicator 2: Serious adverse effects related to opioid therapy
Table 2.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 2.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
Table 2.3
There is evidence (positive or negative) for use of this indicator in :
Yes
None
identified
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
*
Educational programme without local audit data (e.g. impact of guidelines)
*
*This indicator is more likely to be useful for education at the level of peer groups of clinicians rather than for
judging health service quality. Where these stem from adverse events they are likely to be subject to confidentiality
agreements, and not in the public arena.
102
Table 2.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Yes
No
No data
identified
*
^
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
*validity of the indicator in relation to overdose/suicide attempt
^validity of the indicator in relation to injuries would be reliant on verification that these were as a result of an
overdose, or of being impaired when in a withdrawal state
Table 2.5
Data Collection
Yes
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Influenced
by systems
level factors
Exclusions are well defined
Data collection specifications are well defined
No
*
^
*
^
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
* in relation to overdose/suicide attempt ^ in relation to injuries
Table 2.6
Data Analysis and Use
Yes
No
Precision/accuracy of data collection can be verified
*
^
Reports can be easily generated from the collated data for feedback
*
^
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
* in relation to overdose/suicide attempt ^ in relation to injuries
Influenced
by systems
level factors
103
Indicator 3: Adjunctive pharmacotherapy
Table 3.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 3.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
*
*American Chronic Pain Association (ACPA)
Table 3.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
104
Table 3.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
Yes
No
No data
identified
NA
Table 3.5
Data Collection
Yes
No
Influenced
by systems
level factors
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
*
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
^
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
* Difficulty would be that non responders, or patients with side effects to other medications should be included
^ in New Zealand, the use of opiates other than buprenorphine-naltrexone and over the counter codeine products,
would require notes review (cf all the other indicators)
Table 3.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
Yes
No
Influenced
by systems
level factors
*
^
The indicator lends itself to a target setting process
* ^
*Opiate prescribing RX must be on a triplicate CD form and cannot be done through a prescribing programme.
OTC purchase of non-opiate analgesics may be missed if relying on electronic health record sources unless verified
by the patient.
^Periodicity of adjunct prescriptions may vary.
105
Indicator 4: Increased risk of adverse events due to co-prescription of
opioids with sedative medications.
Table 4.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
*
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
*Population health implications could include overdose/accidents under the influence of excessive sedative
medication
Table 4.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
* largely from pharmaceutical ‘detailing’ data
Yes
None
identified
*
Table 4.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
106
Table 4.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
Yes
No
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
No data
identified
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
*
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
*each of the technical factors depend whether the indicator is assessing only benzodiazepines or other prescription,
or concomitant alcohol use or cannabis use or any of these substances in combination
Table 4.5
Data Collection
Yes
No
Influenced
by systems
level factors
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
*
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
* Particularly hard to decide on recreational vs problematic use of cannabis and alcohol. Appropriate co-prescribing
also a factor
Table 4.6
Data Analysis and Use
Yes
No
Precision/accuracy of data collection can be verified
*
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Influenced
by systems
level factors
* *It could be difficult to measure/score/precisely or collect data on patient self-administered alcohol and cannabis
use data.
107
Indicator 5: Acetaminophen (paracetamol) over-prescription
Table 5.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 5.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Yes
None
identified
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
*
* Cost of care relates to both cost of hospitalisations (for liver failure), community care for lesser complications
(liver enzyme disturbances) and wasteful over use of medications
Table 5.3
There is evidence (positive or negative) for use of this indicator in :
Yes
None
identified
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Other
There is no available data on documented use of this indicator for formal performance assessment. However,
paracetamol-combination product or just co-exiting paracetamol prescribing in patients with chronic opioid use may
be the subject of general practice or emergency department peer group or service reviews.
Potentially this combination product misuse or over the counter paracetamol overdose may be the subject of
review by the HDC or a coronial investigation if there has been a serious adverse event or patient death.
108
Table 5.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
Yes
No
No data
identified
*
*
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
^
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
* The reliability and validity of this indicator is dependant on the aspect of interest: i.e. avoiding use of combination
products, avoiding use of over the counter combination or over the counter paracetamol-only medication when
paracetamol is already prescribed, or encouraging use of appropriate paracetamol dose as the first step in pain
management then titrating (hopefully less) opiates in addition.
^ The use by the patient of over the counter combination products (paracetamol plus opiod) is not actually a potential
confounder for the indicator in this instance, as the indicator concerns limiting the amount of paracetamol
prescribed, not the amount ingested. Also while it is not within the control of the practitioner as to whether or not
the patient uses over the counter medications, best practice would suggest that the practitioner should ask about
use of over the counter medications, and could check with local pharmacist.
Table 5.5
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
Yes
No
Influenced
by systems
level factors
Table 5.6
Data Analysis and Use
Yes
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
No
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Influenced
by systems
level factors
109
Indicator 6: Rate of treatment and monitoring of patients with active
substance abuse disorder and outpatient opioid prescription.
Part 1: Specialist Authority to prescribe with known dependency
Table 6.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
*
*Legal requirement in New Zealand
Table 6.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Other
Available evidence relates to:
Morbidity
Mortality
Cost of care
Legal requirement
Yes
None
identified
Table 6.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
110
Table 6.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
Yes
No
No data
identified
NA
Table 6.5
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
Yes
No
Influenced
by systems
level factors
Table 6.6
Data Analysis and Use
Yes
Precision/accuracy of data collection can be verified
*
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
*the issuing of prescribing authority is a paper based system,
No
Influenced
by systems
level factors
111
Part 2: Urine testing
Table 6.7
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 6.8
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
*
*
*
*The evidence varies depending on drug and type of urine test
Table 6.9
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
112
Table 6.10
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
* depends on drug and test used and purpose for which it is to be used
^ Interpretation with respect to caveats will need to be accommodated
Yes
No
No data
identified
*
*
^
NA
*
*
Table 6.11
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
Yes
No
Influenced
by systems
level factors
Table 6.12
Data Analysis and Use
Yes
Precision/accuracy of data collection can be verified
*
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
No
Influenced
by systems
level factors
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
*urine tests done at the laboratory will be in electronic record but some urine tests are kit sets for point of care and
results of that may or may not be entered manually into clinical record.
113
Indicator 7: Random urine drug screening on patients receiving opioid
prescriptions
Table 7.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 7.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
Table 7.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
114
Table 7.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
Yes
No
No data
identified
Table 7.5
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
Yes
No
Influenced
by systems
level factors
Table 7.6
Data Analysis and Use
Yes
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
No
Influenced
by systems
level factors
115
Indicator 8: Bowel Regimen
Table 8.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 8.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Yes
None
identified
Highest level of evidence:
*
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
^
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
*In relation to the management of adverse effects of opioid use
^As this is a prevalence indicator, the underlying evidence is derived largely from epidemiological studies, and/or
case control or case studies.
Table 8.3
There is evidence (positive or negative) for use of this indicator in :
Yes
None
identified
Performance measurement of an organisation
*
Audit and feedback at the level of the individual clinician
*
Educational programme without local audit data (e.g. impact of guidelines)
*Previous use of this indicator is likely to be limited to selected audit or educational programmes at the level of
peer groups of clinicians. Where these stem from adverse events they are likely to be subject to confidentiality
agreements, and not in the public arena.
116
Table 8.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
Yes
No
No data
identified
Table 8.5
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
Yes
No
Influenced
by systems
level factors
Table 8.6
Data Analysis and Use
Yes
No
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Influenced
by systems
level factors
117
Indicator 9: High dose prescriptions for opioid naïve patients
Table 9.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 9.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
^animal studies
Yes
None
identified
^
*
*
* Pharmacology evidence of tolerance and epidemiology evidence of deaths during opioid initiation.
Table 9.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
118
Table 9.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
Yes
No
No data
identified
NA
Table 9.5
Data Collection
Yes
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
No
Influenced
by systems
level factors
*
Existing IT software is sufficient for data collection
*
Existing IT software is sufficient for data collation
*
*Paper record of prescribing is in triplicate controlled drug form and the prescription record is not in MedTech, except
for buprenorphine-naloxone (Suboxone)
Table 9.6
Data Analysis and Use
Yes
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
No
Influenced
by systems
level factors
119
Indicator 10: Initiating opioids for special populations
Table 10.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 10.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
Table 10.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
120
Table 10.4
Technical characteristics of indicator
Yes
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
*
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
*subject to ability to precisely define/specify parameters for frail or vulnerable
No
No data
identified
*
Table 10.5
Data Collection
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
*subject to ability to precisely define/specify parameters for frail or vulnerable
Yes
No
Influenced
by systems
level factors
*
Table 10.6
Data Analysis and Use
Yes
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
*
*subject to ability to precisely define/specify parameters for frail or vulnerable
No
Influenced
by systems
level factors
121
Indicator 11: Pharmacy reconciliation of opioid prescriptions
Table 11.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 11.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Yes
None
identified
*
Available evidence relates to:
Morbidity
Mortality
Cost of care
Pharmaco-kinetic and pharmaco-dynamic evidence is available re interactions especially with methadone via
cytochrome p450 system. Interactions are also possible between other medications and other opioids.
Table 11.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
* Polypharmacy is a topic for peer review groups
Yes
None
identified
*
122
Table 11.4
Technical characteristics of indicator
Yes
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
*
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
*
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
* subject to availability of pharmacists accredited to do MUR and to DHB funding.
No
No data
identified
*
*
Table 11.5
Data Collection
Yes
No
Influenced
by systems
level factors
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
*
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
*May be written paper report as pharmacist and medical record systems may not be compatible
Table 11.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Yes
No
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Influenced
by systems
level factors
123
Indicator 12: Psycho-social treatments for pain
Table 12.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
*
Practice and organisation level processes
*
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
*
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
* Referral would be attributable to the practitioner; however, it is dependant on availability of treatment modalities.
In some areas there is limited access to coping skills courses, psychologist or counsellors. Additionally if there is
limited access to counselling services, if the cost of the treatment is not covered by ACC, patients will have to bear
the cost as the GMS does not cover counselling.
Table 12.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
Yes
None
identified
Table 12.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
124
Table 12.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
*subject to service availability and cost; requires patient buy in
Yes
No
No data
identified
*
Table 12.5
Data Collection
Yes
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
^
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
*subject to funding and availability of psycho-social treatments in New Zealand localities
^some data might be paper based – referral letters or responses
No
Influenced
by systems
level factors
*
^
^
^
Table 12.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
Yes
No
Influenced
by systems
level factors
€
The indicator lends itself to a target setting process
€Data on psycho-social treatments may require verification/report data from patient.
A psychologist clinic attendance or one-off assessment by psychologist may not mean compliance with
recommended non-pharmacological pain management programme.
125
Indicator 13: Rehabilitation medicine
Table 13.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
*Dependant on local availability and funding of occupational therapy, physiotherapy etc
*
Table 13.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Yes
None
identified
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
*
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
^
Cost of care
*evidence of effectiveness of the intervention is in allied health literature
^ACC funds adjunctive rehabilitation up to a ceiling. Evidence for total number of treatments probably based on
historical utilisation data. ACC guidelines established for cost containment purposes
Table 13.3
There is evidence (positive or negative) for use of this indicator in :
Yes
None
identified
*
Performance measurement of an organisation
*
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
* Mainly the rehabilitation units and pain clinics will monitor use of allied health appointments as adjunct therapy in
pain management
126
Table 13.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
* subject to fundng and service availability
^ for one or more rehabilitation modalities used
Yes
No
No data
identified
*
*
*
^
Table 13.5
Data Collection
Yes
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
^
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
*
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
routine practice activities
No
Influenced
by systems
level factors
#
#
Existing IT software is sufficient for data collection
Existing IT software is sufficient for data collation
^ for one or more rehabilitation modalities used
* subject to funding availability and service availability
# Information will need to be obtained from individual providers in New Zealand or from the patient about utilisation of
allied health services due to incompatibility of IT systems
Table 13.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Yes
No
Influenced
by systems
level factors
*
*The definition of attendance needs further clarification i.e. one off assessment or regular visit, self-monitored
programme at home etc
127
Indicator 14: Use of Complementary and Alternative Medicine treatments
for pain
Table 14.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 14.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Yes
None
identified
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
*
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
* Minimal evidence but growing body of literature. There is some evidence available for hypno-therapy, music
therapy bio feedback and acupuncture in pain management. Most current evidence is focused on alternative
medicine rather than complementary procedures.
Table 14.3
There is evidence (positive or negative) for use of this indicator in :
Yes
None
identified
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
*
Other
* Use of Complementary procedures is usually driven by patient choice and some practitioners would not include
these treatment options in their list of recommendations
128
Table 14.4
Technical characteristics of indicator
Yes
No
No data
identified
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
*
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
*The indicator is subject to funding, service availability and patient motivation. Therapies would be largely selffunded for patients (except acupuncture which may be funded by ACC if pain is the result of an injury).
Table 14.5
Data Collection
Yes
No
Influenced
by systems
level factors
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
*
routine practice activities
*
Existing IT software is sufficient for data collection
*
Existing IT software is sufficient for data collation
*Information would need to be obtained directly from the patient as providers don’t share software and don’t report to
a common funding body. Largely self funded by user pays.
Table 14.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Yes
No
Influenced
by systems
level factors
129
Indicator 15: Use of other pain procedures
Table 15.1
Perspective from which the indicator is derived
Yes
Cost effectiveness/cost containment
Professional competence/accreditation
Practice and organisation level processes
Population health (i.e. is meaningful in terms of
population health outcomes e.g. immunisation)
Personal health
Patient/Consumer (e.g. waiting times)
Only of local importance (country / regional specific)
Health inequalities
Treaty of Waitangi (e.g. Te reo Maori)
Table 15.2
There is evidence (positive or negative) related to the clinical validity /
health outcomes of this indicator from:
Yes
None
identified
Highest level of evidence:
Meta analyses/systematic reviews
Evidence based guideline
Individual intervention studies
Individual descriptive studies
Consensus guideline
Available evidence relates to:
Morbidity
Mortality
Cost of care
* Evidence for specific neurological problems and particular types of pain in particular localities some of these
should be considered.
Table 15.3
There is evidence (positive or negative) for use of this indicator in :
Performance measurement of an organisation
Audit and feedback at the level of the individual clinician
Educational programme without local audit data (e.g. impact of guidelines)
Yes
None
identified
130
Table 15.4
Technical characteristics of indicator
The primary focus of this indicator within the health organisation
relates to :
Structure
Process
Outcome
The indicator has been demonstrated to be a valid measure of
performance
The indicator has been demonstrated to be a reliable measure of
performance
Change in the indicator is linked to health outcomes
Change in the indicator is attributable to primary care intervention
The indicator allows clear assessment of change in performance
(better or worse)
The indicator is not subject to confounding by factors outside the
control of those whose performance is being measured
Adjustment for the influence of external factors on indicator data is
possible to enable comparisons between providers or organisations
The indicator is able to detect differences between primary care
providers or organisations
Appropriate interpretation of results does not require local
knowledge and experience
It is a “stand-alone” indicator (can be analysed in isolation from other
indicators)
* Subject to funding and service availability
Yes
No
No data
identified
*
Table 15.5
Data Collection
Yes
No
Influenced
by systems
level factors
There is clarity about the unit of analysis ( e.g. relates to individual
clinician, aggregates of clinician, nurse, doctor, team, or organisation
*
The sample/population is well defined. e.g. women, men etc
Exclusions are well defined
Data collection specifications are well defined
Required data elements for the indicator can be obtained from
existing data sources
Required data elements for the indicator can be gathered during
#
routine practice activities
#
Existing IT software is sufficient for data collection
#
Existing IT software is sufficient for data collation
* Highly selective, need to have specific conditions that would be responsive to consider treatment with these
modalities.
#
Requires examination of clinical records
Table 15.6
Data Analysis and Use
Precision/accuracy of data collection can be verified
Reports can be easily generated from the collated data for feedback
Criteria and standards for the indicator have been defined
Parameters for the interpretation of results have been defined
There is a scoring system for indicator results
The indicator lends itself to a target setting process
Yes
No
Influenced
by systems
level factors
131
Appendix 2
Literature Search Results
132
Search 1
Database: Ovid MEDLINE(R) 1946 to Present with Daily Update Search Strategy:
-------------------------------------------------------------------------------1 exp Analgesics, Opioid/ (84973)
2 general practitioners/ or physicians, family/ or physicians, primary care/ (15493)
3 general practice/ or family practice/ (60646)
4 Primary Health Care/ (47223)
5 2 or 3 or 4 (113918)
6 1 and 5 (470)
7 from 6 keep 4-6,10,20,25,27,50,58,75,95,97,118,135,143,146 (16)
8 indicator*.mp. [mp=title, abstract, original title, name of substance word, subject
heading word, protocol
supplementary concept, rare disease supplementary concept, unique identifier]
(212250)
9 1 and 8 (788)
10 5 and 9 (6)
Search Results
Brown, J., B. Setnik, et al. (2011). "Assessment, stratification, and monitoring of the
risk for prescription opioid misuse and abuse in the primary care setting." Journal of
Opioid Management 7(6): 467-483.
Cheatle, M. D., J. W. Klocek, et al. (2012). "Managing pain in high-risk patients within
a patient-centered medical home." Translational Behavioral Medicine 2(1): 47-56.
Cohen, M. L. and A. D. Wodak (2012). "Opoid prescribing in general practice: A
proposed approach." Medicine Today 13(1): 24-32.
Cornish, R., J. Macleod, et al. (2010). "Risk of death during and after opiate
substitution treatment in primary care: Prospective observational study in UK General
Practice Research Database." BMJ (Online) 341(7779): 928.
Dillie, K. S., M. F. Fleming, et al. (2008). "Quality of life associated with daily opioid
therapy in a primary care chronic pain sample." Journal of the American Board of
Family Medicine: JABFM 21(2): 108-117.
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135
Search 2
Search parameters: MEDLINE and EMBASE databases from 1946 to present, and
search of Scopus & Google Scholar.
The following keywords were used (opioid OR opioids) AND (benchmarking OR
quality assessment OR quality outcome OR target) AND prescribing.
A search for grey literature was also undertaken by searching the Kings College
Fund databases and Google.
Search results
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136
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