Downloadable - Bayside Medicare Local

Harm Reduction In Substance Use
Pharmaceutical Opioid Misuse
Evaluation Report
July 2014
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Document History
This table is to record the document’s history, i.e., dates of proposed changes or revisions.
Version No.
Date
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28 July 2014
Description of Revision
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Harm reduction in Substance use
Pharmaceutical Opioid Misuse
Evaluation report
Report prepared by Laura Bennetto
Project Officer
July 2014
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Abstract
This paper describes the conduct of the Harm Reduction in Substance Use (HRSU) –
Pharmaceutical Opioid Misuse Project as well as outlines the design and methodology of its
evaluation. The Pharmaceutical Opioid Misuse Project was a community-based, harm reduction
project, funded by Bayside Medicare Local (BML) and located with Southcity Clinic.
The project sought, through practitioner participation, to provide unbiased information to
individuals accessing primary health services within the BML catchment who are misusing or at
risk or misusing opioid medication. The information was aimed to increase communication
between patients and primary health practitioners, increase patient health literacy and
ultimately decrease opioid medication misuse, as well as increase awareness of the issue of
pharmaceutical opioid misuse more generally.
The Pharmaceutical Opioid Misuse Project approached its overall goal from two angles.
1. Patient education covering the potential dangers of misusing opioid medication, as well
as the need to have a long term pain management plan.
2. Primary health clinician education covering best practice in prescribing of opioid
medication.
The evaluation's overall design focused on process using a combination of qualitative and
quantitative methods. The level and nature of practitioner participation in the Pharmaceutical
Opioid Misuse Project was assessed based on interviews of key informants, self administered
surveys and observational data.
The response of the local media was assessed using a log of related items in the local
newspapers across the project period.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Advisory Group
Sharon O’Reilly, Clinical Services Manager Southcity Clinic, Chair
Gabby Cohen, Project Officer Southcity Clinic
Laura Bennetto, Project Officer Southcity Clinic
Dr Benny Monheit, Medical Director SC; The Alfred Hospital, ReGen
Wendy Mence, Senior Clinician SC
Paul Dietze, Burnett Institute
Magali de Castro, BML
Marco Faccio
Nicole Lee, LeeJen Consulting, NCETA - Flinders University
Vanessa Anne Lontos, Clarendon Pharmacy
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Contents
Abstract ........................................................................................................................ 4
Advisory Group ............................................................................................................... 5
Contents ....................................................................................................................... 6
1. An examination of pharmaceutical opioid misuse ............................................................. 7
1.1.
Background and Rationale ...................................................................................... 7
1.2.
Pharmaceutical Opioid Misuse ................................................................................. 8
1.3.
Population Demographic ........................................................................................ 8
1.4.
Evidence of Harms .............................................................................................. 10
1.4.1.
Mortality............................................................................................................. 10
1.4.2.
1.4.3.
Health implications ................................................................................................ 11
Impact on broader community ................................................................................... 11
1.4.4.
Pharmaceutical opioid misuse and its relationship to crime ................................................ 11
1.5.
Pharmaceutical Opioids and General Practice ............................................................. 12
1.5.1.
Role of the General Practitioner (GP)........................................................................... 12
1.5.2.
1.5.3.
Chronic non-malignant pain ...................................................................................... 13
Drug seeking Behaviour ............................................................................................ 13
1.5.4.
1.5.5.
Doctor shopping .................................................................................................... 13
Intimidation ......................................................................................................... 14
1.6.
Pharmaceutical Opioids and the role of the Pharmacist ................................................. 14
1.7.
Conclusion ........................................................................................................ 15
2. Project ..................................................................................................................16
2.1.
Overview .......................................................................................................... 16
2.2.
Project goal ...................................................................................................... 16
2.3.
Target population ............................................................................................... 16
2.4.
Objectives ........................................................................................................ 16
2.5.
Project activity .................................................................................................. 16
2.6.
Reach .............................................................................................................. 18
2.7.
Process indicators ............................................................................................... 18
3. Evaluation ..............................................................................................................19
3.1.
Design.............................................................................................................. 19
3.2.
Results ............................................................................................................. 19
4.
5.
6.
7.
3.2.1.
Evaluation of the Pharmaceutical Opioids — Minimising the harms event (Appendix G) ................. 20
3.2.2.
Evaluation of the resources (Appendix H - I) ..................................................................... 20
Recommendations ....................................................................................................22
Discussion ..............................................................................................................23
References .............................................................................................................25
Appendices .............................................................................................................28
Appendix A ................................................................................................................. 28
Appendix B ................................................................................................................. 29
Appendix C ................................................................................................................. 30
Appendix D ................................................................................................................. 31
Appendix F ................................................................................................................. 35
Appendix G................................................................................................................. 37
Appendix H ................................................................................................................. 39
Appendix I .................................................................................................................. 40
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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1.
An examination of pharmaceutical opioid misuse
1.1. Background and Rationale
Pharmaceutical opioid misuse has been recognized as a growing public health problem globally
(Kuehn, 2007). This has been evidenced in Australia in recent years as an increase in the
medical and non-medical use of pharmaceutical drugs, in particular, opioids. Currently
OxyContin and alprazolam are recognized as the most abused drugs in Australia (Monheit, 2010).
While pharmaceutical opioids have an important role in the treatment of a range of medical and
psychological conditions risks of extra-medical opioid use and diversion are widely
acknowledged. The problem is described as existing on a spectrum, ranging from inadvertent
misuse associated with inappropriate prescribing practices through to deliberate misuse with the
aim of experiencing non-therapeutic effects and/or on-selling the medicines for profit.
(Nicholas, et al., 2011, p. 20)
Numerous pharmaceutical drugs have the potential for misuse. These include benzodiazepines,
performance and image enhancing drugs, antidepressants and prescription stimulants. However,
because these substances also have medically beneficial effects, many issues pertinent to
understanding prescription drug misuse may differ from those associated with other misused
substances. The following literature review focuses on pharmaceutical opioid use for several
reasons:
1) Regular use of opioids (even in a therapeutic setting) can lead to dependence
(Jaffe & Martin, 2002);
2) Opioid dependence through use of prescription opioids has increased in low and middle
income countries as well as high income countries (Kuehn, 2007);
3) There is a growing trend of opioids specifically oxycodone being present in recorded
fatalities (though not necessarily a causal or contributory factor) (Rintoul, et al., 2011);
4) Clinicians have expressed concern over management of dependent patients and related
demand for treatment (Monheit, 2010); and
5) The potential for diversion of licit opioids is considerable (Fry, et al., 2007).
Australia is not alone in experiencing an increase in the prescribing of, and the harms associated
with, opioids. The United States and Canada in particular are also experiencing a range of
similar problems, albeit of greater severity. In the United States the number of unintentional
overdose deaths involving opioid analgesics now exceeds the sum of deaths involving cocaine or
heroin combined (Center for Disease Control and Pevention, 2011). With this knowledge
Australia is well placed to intervene at a relatively early stage of the trajectory of these issues
before they reach that being experienced in these countries (Nicholas, et al., 2011).
This paper will provide an overview of pharmaceutical opioid use, regulation of pharmaceutical
opioids and the manner in which they are made available in Australia.
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1.2. Pharmaceutical Opioid Misuse
There is no clear consensus about what constitutes prescription drug misuse.
Barrett, et al. (2008) stated that misuse is frequently defined on the basis of one or all of the
following:
1) User characteristics (i.e. any non-prescribed use);
2) The reason for use (i.e. use for recreational purposes); and
3) The presence of clinically significant symptoms (i.e. meeting diagnostic criteria for abuse
and dependence). Misuse is defined by the Alcohol and other Drugs Council of Australia
(ADCA) (2010) as ‘use by individuals that occurs without a prescription or other than
intended by the prescriber’. However this definition does not take into account misuse
due to inappropriate prescribing. The Diagnostic and Statistical Manual of Mental
Disorders, 4th revision (DSM-IV) definition of drug dependence relies heavily on the
concepts of loss of control over the drug and withdrawal symptoms. This definition is not
considered useful in the current context because these concepts are not the main driving
force in prescription drug abuse (Barrett, et al., 2008).
Due to a lack of definition of the term in research and the literature it is often difficult to
quantify and conceptualize the critical issues. For the purpose of the current paper a broad view
of opioid misuse is considered being:
1) Any use for non-medical purposes;
2) Overuse to manage a medical condition; or
3) Use to manage a medical condition for which the medication is not prescribed.
It is important to note that misuse can occur both inadvertently and consciously and misuse can
occur as a result of inappropriate prescribing.
1.3. Population Demographic
Daniulaityte, et al., (2006) argued that to develop appropriate treatment and prevention
programs, there must first be a comprehensive understanding of the population of people who
misuse pharmaceutical opioids. Who are the individuals that are misusing prescription opioids
and why? As indicated above this include those involved in illicit pharmaceutical use as well as
those who may unintentionally misuse these drugs in response to legitimate medical conditions
and including inappropriate prescribing. Wodak and Osborn (2007) supported this position in
their submission to the Drugs and Crime Prevention Committee (DCPC) (2007). It is important to
separate out the very different problems arising in different age groups and populations in order
to develop effective interventions. Very different issues and challenges arise in different quite
settings [such as] young polydrug users; middle aged people with severe chronic illnesses; and
the elderly.
Firstly, the populations who intentionally misuse medicines to experience non-therapeutic
benefits are a complex group. Research suggests that this group may use pharmaceuticals for
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recreational/social reasons, substitution of other illicit drugs, management of symptoms relating
to polydrug use, and importantly the relative cost, ease of availability and reduced risk of
supplying and possession of prescription drugs relative to illicit drugs (Fry, et al., 2007).
Daniulaityte, et al., (2009) suggested that individuals may also view pharmaceuticals to be less
‘dangerous’ or addictive that other illicit drugs. It is pertinent to note that many people who
use opioids problematically hold a concession card entitling them to a lower patient contribution
for PBS subsidized drug prescriptions. It is generally much less costly for people to obtain opioids
on prescription than on the black market (The Royal Australasian College of Physicians, 2009).
This disparity in price makes for an attractive and profitable venture further fueling the street
market.
Prescription drugs are reportedly relatively easy to obtain on the street and the supply is less
likely to be interrupted as opposed to illicit drugs. Fry, et al., (2007) suggested that prescription
drugs are available from a diffuse network of users, friends of users and dealers, some of who
also sell other illicit drugs (e.g. heroin, methamphetamine, cannabis).
Current research has shown that injection of particular benzodiazepines and pharmaceutical
opioids has become entrenched among some groups of people who inject drugs (PWID). Recent
data from the Medically Supervised Injection Centre in Sydney (Holmes, Personal Communication
31 October 2011) indicates that opioids, other than heroin, are the drugs most commonly
injected at the facility. Much of the research suggests that for many this appears to be a
response to altered heroin supply, whereby certain pharmaceutical drugs are used as a
supplement/substitution to heroin. This could occur in markets where heroin may be less
available, of poorer quality, or more expensive relative to the various prescription
pharmaceuticals available (Fry, et al., 2007) (Gilson, et al., 2004) (Daniulaityte, et al., 2006)
(Dagenhardt, et al., 2007). More research is needed to better identify and quantify the
population of illicit users of pharmaceutical opioids (Zacny, et al., 2003). However, increasing
unsanctioned prescription drug use in this group may reflect a large and possibly growing unmet
demand for opioid substitution therapy (OST) (Black, et al., 2007) .
While there are Illicit Drug Reporting Systems that provide data about the diversion and
problematic use of prescription drugs there is little data about problematic use by those not
captured by these datasets. There appears to be a recent increase in the number of people
without a prior history of illicit drug use who are seeking treatment for opioid dependence
(Sigmon, 2006). Gilson, et al., (2004) and Daniulaityte, et al., (2006) indicated that increases in
pharmaceutical opioid misuse are linked to growing medical use of pharmaceutical opioids.
Experts have suggested that this small but problematic group of people are not well understood
(Monheit, 2010)
The second group, identified by Nielsen and Thompson (2008) as a “hidden” population are
individuals that develop dependence following medical use (known as “iatrogenic dependence”).
Included in this group are those that have unwittingly developed dependence using medication
for pain, anxiety or insomnia for longer than intended and at increasing doses as tolerance
develops so that the drugs become less effective at the recommended dose. Individuals who
misuse prescription pharmaceuticals often report reasons for non medical use that are consistent
with therapeutic indications of the abused drug (Daniulaityte, et al., 2006). This suggests that
use in this group may be in an attempt to self treat. Nicholas et al (2011) suggested that
currently the primary health care system is not equipped to respond to this population. In
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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addition services for people experiencing chronic non-malignant pain are not necessarily in
place. It can be reasonable concluded that General Practitioners are therefore required to fill
this gap.
1.4. Evidence of Harms
1.4.1.
Mortality
All opioid analgesics have a depressant effect on respiration and have been associated with some
overdose deaths and emergency department visits (Paulozzi, 2012). Further, the most recent
data indicates that oxycodone, methadone, and hydrocodone are most commonly associated
with these negative health outcomes (Paulozzi, 2012, Rintoul, et al., 2011). In 2010, nearly 60
percent of drug overdose deaths (22,134) in the United States involved pharmaceutical drugs.
Opioid analgesics, such as oxycodone, hydrocodone, and methadone, were involved in 3 of every
4 pharmaceutical overdose deaths (16,651), confirming the predominant role opioid analgesics
play in drug overdose deaths (U.S Department of Health and Human Services, 2013).
Methadone is both stronger than morphine and has a particularly long and variable half life. It
also has potentially dangerous interactions with benzodiazepines and is therefore considered
among the most risky of all opioid analgesics (Cicero, et al., 2007). However, increases in
oxycodone prescribing and use is seeing an increase in this drug being present in drug overdose
deaths (Rintoul, et al., 2011).
In light of the emerging epidemic identified in the United States and Canada Rintoul, et al.,
(2009) examined trends in fatal drug toxicity involving oxycodone in Australia from 2000-2009.
The study also identified the demographic characteristics and indicators of socioeconomic
disadvantage of the deceased. The study identified a growing trend of oxycodone being present
(but not necessarily a causal or contributory factor) in recorded fatalities. In 2000 four recorded
fatalities were linked to oxycodone use; this increased to 97 fatalities in 2009.
Research consistently highlights the emerging public health concern relating prescription drug
misuse and overdose deaths. Where the research diverges is on the issue of whether these
increases are occurring as a result of medical use or illicit use. Hall, et al., (2008) indicated that
the majority of overdose deaths were associated with nonmedical use and diversion of
pharmaceuticals, primarily opioid analgesics. In contrast, previous studies have indicated that
the increase in opioid-related overdoses is paralleled by increased prescription of opioids for
chronic non-cancer pain (Paulozzi & Ryan, 2006).
Dunn, et al., (2010) examined the extent to which overdose risks were elevated among patients
receiving medically prescribed long-term opioids. This study provided the first estimates that
directly link receipt of medically prescribed opioids to overdose risk. The results suggested that
overdose risk is elevated in patients receiving medically prescribed opioids, particularly in
patients receiving higher doses. It was however noted that patients receiving higher-dose
regimes may have been more likely to deviate from medically prescribed use.
It is evident is that patients require close supervision and careful instruction in appropriate use,
as recommended by expert guidelines (Monheit, 2010). Among patients with chronic nonmalignant pain (CNMP), requests for increasing opioid doses need careful assessment to
elucidate any nonmedical factors that may be at play (Zacny, et al., 2003) .
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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1.4.2.
Health implications
The health implications of chronic opioid treatment (COT) are of particular concern. Physical
implications include suppression of the immune response, dental problems, hyperalgesia and
escalating tolerance. In addition to the physical health risks is the impairment of mental
functioning including intoxication related harms (accidents, falls, and sedation). Further, illicit
use of pharmaceutical opioids entails risks of adverse events from injecting pharmaceutical
drugs (e.g. infections, respiratory fibrosis, and loss of limbs or digits) and blood borne virus
transmission (Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), Human Immunodeficiency Virus
(HIV) (The Royal Australasian College of Physicians, 2009).
Another less evident impact is on patients experiencing chronic non- malignant pain (CNMP).
Pharmaceutical opioid misuse may have negative implications for legitimate and appropriate use
of opioids, including stigmatization and under treatment of pain (Merrill, et al., 2002). This
stigmatization may not only affect individuals with no history of illicit drug use but may also
affect dependent illicit drug users. The data available on this population in Australia is limited.
However, dependent heroin users (or those on opioid substitution treatment) may have a higher
prevalence of CNMP than the general population. This problem may be under diagnosed, and the
treatment of pain is often difficult to measure and treat in this population.
1.4.3.
Impact on broader community
The misuse of opioids can and does impact on the broader community. Impacts include financial
costs, distress amongst family and friends, increase in crime and strain on the medical system.
The overall financial cost of pharmaceutical opioid misuse is difficult to predict. However the
healthcare costs alone of nonmedical use of prescription opioids in the U.S are estimated to
total $72.5 billion annually1. The costs involved can be broken down to five categories:
1) Cost of obtaining the drug (Pharmaceutical Benefits Scheme (PBS) and costs involved with
doctor shopping); (2) Preventative costs (programs such as doctor shopping program,
education campaigns);
2) Support costs (counseling, pharmacotherapy and opioid replacement therapy, housing
support and other specialist drug and alcohol services;
3) Costs of diversion (legal costs, cost of law enforcement, theft); and
4) Loss of productivity (sick days, unemployment).
1.4.4.
Pharmaceutical opioid misuse and its relationship to crime
Pharmaceutical opioid misuse and its relationship to crime were extensively examined in the
Australian national overview report (Fry, et al., 2007). The study reported that while the
acquisition of pharmaceutical drugs for illicit use is highly organised in the sense of being a
regular, planned behaviour involving networks of friends and other contacts, there was little
evidence of the involvement of organised criminal networks in the distribution of these drugs.
1
Centre for disease control and prevention (2011)
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The studies informants reported that supply to the illicit pharmaceutical markets in Australia
appeared to be driven mainly by small-scale diversion (from a number of sources, including
legitimate prescriptions, doctor- shopping, forged prescriptions) rather than through organised
burglary/thefts from pharmacies or point of wholesale/manufacture, or via other sources (e.g.
internet pharmacy, importation, trafficking). This small scale diversion is particularly difficult to
police. Police reported difficulties in distinguishing between illicitly and licitly held prescription
pharmaceuticals.
Although the study reported a low level of organized criminal activity related to the
procurement of prescription pharmaceuticals the findings suggest there may be some
relationship between the use of prescription drugs, dependence and some criminal activity.
Makki, (2002) suggested that the diversion of pharmaceutical drugs onto the black market may
have a direct effect on the criminal behaviour of individuals who use them illicitly. For
instance, shoplifting, property crime, drug dealing, violence, intoxicated driving, disinhibited
and aggressive behaviour, and spousal abuse were all attributable to the drugs.
Blank prescription paper theft and forged prescriptions are also on the rise, with the latter
spurred on by improved printing, and easier access to information on the web that help to
format a prescription correctly. Further to this although not commonplace in Australia at this
stage is pharmacy robbery including ‘ram raids’ which has caused a number pharmacies in the
U.S to cease dispensing certain medications.
1.5. Pharmaceutical Opioids and General Practice
There appears to be a significant evidence-practice gap in the prescribing of opioids in Australia.
The role of prescription opioids in opioid substitution treatment (OST) and the treatment of
serious acute pain and malignant pain is relatively uncontroversial. It appears, however, that
opioids are increasingly prescribed for less serious acute pain and for chronic non-malignant
pain, for which the evidence of efficacy has not been established (Nicholas, et al., 2011).
Availability plays an obvious role in pharmaceutical drug use. Prevalence of opioid misuse is
affected by the extent to which clinicians can and do prescribe different opioids, and how easy
they are to obtain from a health professional (Dagenhardt, et al., 2007).
1.5.1.
Role of the General Practitioner (GP)
Recent research in relation to illicit use, diversion and trafficking and harms has added another
complex dimension to an already difficult risk/benefit decision for GPs. General Practitioners
play a key role as gatekeepers to access pharmaceuticals. It is therefore critical to any effective
management initiative that they are provided with effective support to obtain better health
outcomes for Victorians (VAADA 2012, 2012). Murray (2002) stressed that clinicians need to be
aware of the monitoring systems (including limitations of monitoring systems) when providing
treatment for patients who misuse pharmaceuticals.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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1.5.2.
Chronic non-malignant pain
Treatment options for chronic pain include nonpharmacological and pharmacological modalities.
It is generally agreed that non- pharmacological therapies should be ruled out before
commencing opioid treatment (Passik, 2009). Blyth, et al., 2001 examined the prevelence of
pain in Australia and theresults showed that up to 20 per cent of the population suffers pain and
5-10 per cent of that pain is severe persistent pain. CNMP is associated with elderly populations,
retirement and inability to take part in the paid workforce and is strongly associated with
markers of social disadvantage. The effective management of CNMP is a challenge for clinicians
and the challenge is growing. In Australia and New Zealand the prevalence of chronic pain is
projected to increase as the population in these countries ages (James, et al., 1991) .
1.5.3.
Drug seeking Behaviour
Drug-seeking behavior (DSB) has been identified as a common problem both in General Practice
and in emergency departments (Grover, et al., 2012). There is no agreed definition of drug
seeking behaviour. In general, it seems that drug seeking is considered any one of a number of
seemingly inappropriate attempts to obtain pharmaceutical drugs. The term "drug seeking" is
defined by Compton (1999) as "a set of behaviours in which an individual makes a directed and
concerted effort to obtain a medication. Behaviours may include doctor shopping, feigned or
over reporting of symptoms, loss of medication, or hoarding. According to Compton drug-seeking
behaviour could be for legitimate or illegitimate purposes.
Sim, et al. (2004) found that in theory, people with non genuine pain demonstrate an
exaggeration of the pain response, are inconsistent with movement and behaviour (e.g. not
apparently in pain when feeling unobserved and inconsistent in showing signs of pain with
different movements), request specific drugs by name, and present at times when you are
unable to check their story. However, none of these are specifically distinctive. The Grover, et
al. (2012) study of drug seeking behaviour in an emergency department (ED) suggested that
reliance on historical features of a patient encounter may be inadequate when trying to assess
whether or not a patient is drug-seeking. In this study drug-seeking patients exhibited
“classically” described drug-seeking behaviors with only low to moderate frequency. Each of
the studied behaviors was recorded as present in less than one third of all ED visits. These
findings further highlight the difficulty and complexity of appropriate prescribing.
1.5.4.
Doctor shopping
Doctor-shopping has been reported as a means to obtain non therapeutic amounts of
pharmaceutical drugs, in particular benzodiazepines and opioids (Dobbin, 2011). The extent of
doctor/medication shopping in Australia is unclear however available evidence suggests that this
significant issue (Nicholas, et al., 2011). Relatively large numbers of people have been identified
as prescription shoppers by Medicare Australia. In 2005-2006, there were close to 55,000
individuals identified (Dobbin, 2011). Unfortunately this data is now more than 6 years old and
more recent data is not readily available. It may be reasonable to conclude that this
phenomenon is increasing directly with the increased misuse of pharmaceuticals. Dunn, et al.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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(2010) indicated that multiple sources of prescribers and pharmacies are markers of increased
risk of adverse health outcomes including overdose death and ED presentations.
1.5.5.
Intimidation
General practitioners commonly experience intimidation and sometimes violence from their
patients. This intimidation is thought to be a contributing factor to inappropriate prescribing
(Nicholas, et al., 2011). It has been reported that 63.7% of GPs in New South Wales had
experienced violence in the previous year (Magin, et al., 2005). Violence included ‘low level’
violence such as verbal abuse (42.1%), property damage/theft (28.6%) and threats (23.1%). A
smaller proportion of GPs had experienced ‘high level’ violence, such as sexual harassment
(9.3%) and physical abuse (2.7%). Similar findings were identified in a study of Australian rural
GPs where 70% of GPs had been exposed to some type of violence from patients (Tolhurst, et
al., 2003). Verbal abuse in particular was commonly associated with drug-seeking behaviour. In a
survey of New South Wales health professionals, drug-seeking was amongst the most prominent
factors associated with violence against GPs (Alexander & Fraser, 2004).
Those who are most likely to be subject to violence include females, and younger/less
experienced GPs (Nicholas, et al., 2011). It may be possible to infer form this that these GPs are
potential targets for doctor shoppers and may therefore require further support and training to
minimize risk and increase confidence. The findings concerning violence perpetrated against
GPs is consistent with international literature (Koritsas, et al., 2007)
The extent to which violence, or the threat of it, impacts on prescribing practices is unclear.
However the Magin, et al., (2005) study highlighted the extent to which practitioners regard
drug-seeking patients as particularly dangerous and this can go some way to understanding the
many issues faced by prescribers. Nicholas, et al., (2011) emphasized the range of skills and
perhaps more importantly support methods required by practitioners to ensure the quality use of
medicines.
1.6. Pharmaceutical Opioids and the role of the Pharmacist
Pharmacists can play an important role in the management of opioid-dependence, as they are
one of the most easily accessible healthcare professionals that will interact frequently with
patients suffering from opioid-dependence. As medication experts, they can play an important
role in ensuring that patients use their medication correctly, monitor for drug-drug interactions,
counsel patients, and work with physicians to minimize the potential for abuse and misuse
(DiPaula, 2011).
The community pharmacist has a responsibility to assess for signs of drug diversion however
literature suggests that this is difficult to implement in practice (Carlson & Corsaro, 2012). A key
barrier to effective responses to this problem is the current inability of pharmacists to monitor
patient’s use of prescription medications. Patients looking to obtain medication for non
therapeutic purposes may fill scripts at numerous outlets. Further, prescription pad/paper theft
and forged or altered prescriptions is on the rise (Tung, 2012).
Although codeine is considered a relatively weak opioid analgesic, it is nevertheless addictive.
While evidence is accumulating about the non-medical use of prescription opioids and the
serious consequences of such use the literature on non-prescribed or over-the-counter (OTC)
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
14
opioids is mainly confined to case descriptions. Fry, et. al. (2010) investigated morbidity related
to misuse of over-the-counter (OTC) codeine–ibuprofen analgesics. The study included twentyseven cases collected from Victorian hospital-based addiction medicine specialists between May
2005 and December 2008. Significant morbidity and specific patient characteristics associated
with overuse of codeine–ibuprofen analgesics were identified and the study called for further
investigation and monitoring of OTC codeine–ibuprofen analgesic use. In many of these cases,
serious morbidity resulted from use initiated for therapeutic reasons, such as persistent pain.
The 2009 prescription Opioid Policy states that there should be more of an emphasis on
increasing pharmacists’ ownership of issues related to opioid control, and improving
pharmacists’ effectiveness in the screening of prescriptions and patients. Pharmacists should be
recognized as key stakeholders in a multidisciplinary group to implement and evaluate policy
(The Royal Australasian College of Physicians, 2009).
1.7. Conclusion
Drug overdoses have historically not been recognized as a public health issue. Instead, they have
been viewed as a substance abuse or law enforcement issue (Paulozzi, 2007). This has changed
in recent years as most drug overdoses have become associated with licit pharmaceuticals such
as opioid analgesics and psychotherapeutic drugs. Both chronic pain and prescription opioid
abuse are prevalent and exact a high toll on patients, physicians, and on society. Health care
professionals must balance aggressive treatment of chronic pain with the need to minimize the
risks of opioid abuse, misuse, and diversion.
People, who develop problems from their use of pharmaceutical opioids for pain relief, face a
number of obstacles when seeking help. Often healthcare services are not easily identified or
available for this group of people and long waiting lists exist for specialist pain management.
Individuals who misuse pharmaceutical medication for non- medical purposes do so for an array
of complex reasons. It is therefore important to acknowledge the biopsychosocial nature of
pharmaceutical opioid misuse. Health professionals are often not well trained or experienced to
prevent, manage and treat these complex problems and at times have to make difficult clinical
and ethical decisions.
Strategies for supporting individuals who misuse pharmaceutical opioids need to recognize the
essential role of GPs, and support the provision of multidisciplinary care at the primary care
level.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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2.
Project
2.1. Overview
The Pharmaceutical Opioid Misuse Project was primarily funded by Bayside Medicare Local (BML)
flexible funds to meet an identified need within the BML catchment. The project was located
with Southcity Clinic a Specialist Pharmacotherapy Clinic and clinical service of the BML.
Launched in January 2013 and funded as a 12 month seed project the project was extended for a
further six months in January 2014.
2.2. Project goal
To build capacity of general practice clinicians to respond to pharmaceutical opioid misuse.
2.3. Target population
General Practitioners and Pharmacist working within the BML catchment are the first line
beneficiaries of the project. In addition community members who use pharmaceutical opioids for
both medical and non medical reasons and the broader community will equally benefit from the
project. The activity is directed to educating, resourcing and supporting these practitioners to
obtain better health outcomes in relation to prescription of pharmaceutical opioids and
treatment options for opioid dependence. This will be achieved by delivering: a shared
understanding of current prescribing patterns and management of risks, a set of targeted
resources to inform GPs, pharmacists and consumers of the risks of Pharmaceutical Opioids to
assist future primary health practice to articulate approaches and respond to the needs of
individuals, families and their communities.
2.4. Objectives

To Engage with GPs and pharmacists to develop and trial a clinical resource.

To support GPs and pharmacists in their work with patients that use Pharmaceutical
opioids.

To disseminate resources to the community who misuse or are at risk of misusing
pharmaceutical opioids.

To build upon existing Special Interest Network (SpIN) to create a change agent in clinical
practice.
2.5. Project activity
A Project Advisory Group was set up to guide, review and provide professional expertise and
advice in relation to direction and implementation.
The project looked at three possible points of intervention being the GP, the pharmacist and the
patient who is either misusing opioid medication or at risk of misusing opioid medication.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
16
The approach focused on education through three mediums.
1. The development of patient focused resources to be distributed through General
Practices and Pharmacies.
2. A professional Development event titled Pharmaceutical Opioids – Minimising the
Harms.
3. The Special Interest Network (SpIN). A community of practice with a focus on
addiction issues.
The project activity focused on the engagement of primary health clinicians to develop a
resource grounded in evidence to support their work with patients that use or misuse
pharmaceutical opioids. The resources included:

Poster
For display in pharmacies and General Practices (Appendix A)

Patient brochure
Information for patients using pharmaceutical opioids (Appendix B)

Folding card
Encouraging patients to speak to their doctor or pharmacist if they have concerns or
questions about their pharmaceutical opioid use (Appendix C)

Sticker
Placed on bags and repeat scripts by pharmacists when dispensing opioid medication
(Appendix D)
The Harm Reduction in Substance Use, Expert Advisory Group (10 members), the overarching
advisory structure to the Pharmaceutical Opioid project meet monthly, providing the project
team with clear direction and advice. Individual members of the advisory group have provided
practical input and feedback specific to their discipline and area of work.
A Community of Practice model (CoP), building on the existing BML Special Interest Network
(SpIN) is another component of the Pharmaceutical Opioid project. This activity aims to bring
practitioners together over a common practice topic, to share information, address emerging
patterns and issues and develop a best practice response through incorporating collective
practice wisdom and evidence. Since January 2013, 244 practitioners have participated in the
SpIN meetings and shared resources relating to the issue.
In addition to the regular SpIN meetings the Pharmaceutical Opioids – Minimising the harms
event was developed in response to initial stakeholder interviews and recommendations
identified through the literature review. The event further built on knowledge and professional
competence and provided an up to date understanding of the trends in patterns of prescribing of
pharmaceutical opioids both globally and nationally as well as looked at best practice in
reducing the harms associated with long term use and misuse of pharmaceutical Opioids. The
event was used to launch the patient resources developed though the Pharmaceutical Opioids
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
17
Project. Participants at the event were the first to receive the resources with a second round of
distribution to follow after the event.
Stakeholder and consumer interviews have been completed. Interviews included GPs,
Pharmacists, Pain and addiction specialists as well as consumers with histories of long term
pharmaceutical opioid use. The meetings provided insight into the depth of the issue as well as
guidance and practical feedback into the patient resource and additional support requirements
and educational needs. The resources and the Pharmaceutical Opioid – Reducing the harms
event were developed in direct response to information garnered form these interviews.
2.6. Reach

Approximately 124 participants attended the Pharmaceutical Opioids – Minimising the
harms event. The participants were made up of General Practitioners, Addiction
Specialists, Practice Nurses and Pharmacists.

Eight SpIN meetings were held through the duration of the project with 244 participates
in attendance. The participants were made up of General Practitioners, Addiction
Specialists, and allied health.

The resources were distributed to 73 participating pharmacies and 123 participating
general practices as well as 4 community health centres via courier. In addition
Networking Health Victoria distributed the resources at NHV training events for GPs.

Downloadable copies of the resources were made available via the Bayside Medicare
Local website. It is unknown how much this service was utilised.

Ten thousand of each brochures, wallet cards and stickers were distributed as well as one
thousand posters.
2.7. Process indicators
All activities for the project are implemented as planned

The resources have been distributed. Participating services have been recorded.

SpIN meetings held – attendance and feedback recorded

Pharmaceutical Opioids – Reducing the harms event held - attendance and feedback
recorded

Program uptake recorded – GPs and pharmacists report that they are aware of the
resources and are using them in their practice.

Patient access – Patients have access to the STOP resources and the STOP message
through a variety of mediums.
The materials/components of the program are of good quality

Feedback on quality of information from patients, GPs and pharmacists.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
18
3.

GPs and Pharmacists report increased dialogue around opioid medication use with
patients.

GPs and Pharmacists report greater confidence in ability to identify and manage
Pharmaceutical Opioid misuse.
Evaluation
A process evaluation was used to review and detail interventions, impact indicators and project
reach.
A follow up survey was conducted with pharmacists and GPs who elected to participate in the
project and utilise the resources in their practice. The survey aimed to measure program
appropriateness and quality as well as narrative feedback around day to day use of the resources
and patient response.
Finally the evaluation measured whether all the activities of the project were implemented as
planned highlighting unexpected problems and adjustments as well as recommendations for
further roll out of the project.
3.1. Design
Evaluation of the Pharmaceutical Opioids – Minimising the harms event was conducted with
participants who attended the event via a hard survey distributed at the event. This survey was
completed by event attendees regardless of profession with an aim to measure learnings and
satisfaction.
Data were collected principally by email questionnaire sent to the 196 participating pharmacies
and GP clinics. The surveys related to the usability and quality of the resources as well as
uptake. Two versions of the surveys were distributed; a version for GPs and pharmacists
(Appendix E) and another for practice managers (Appendix F). The survey for practitioners was
sent to the practice managers with a request to forward it on to all GPs working within their
practice. All questions were checkbox and required an answer with space for further comment
provided for each question. The questionnaire was extensively piloted, particularly to test if it
was readily comprehended.
In addition to the email questionnaires a sample of 10 General Practices and 10 pharmacies were
randomly selected and visited to observe whether the resources were both visible and accessible
to patients.
Finally a small sample of 5 general practices and 5 pharmacies were interviewed using a semi
structured interview. Questions focused on observed changes in pharmaceutical opioid use over
the duration of the project (wether attributable to the project or not) as well as future
recommendations to build on the project.
3.2. Results
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
19
3.2.1. Evaluation of the Pharmaceutical Opioids — Minimising the harms event
(Appendix G)
Respondents: 43
17 pharmacists; 15 GPs; 6 practice managers; 5 psychologists
Participants we asked to rate their level of confidence and ability in a variety of areas before
and after the presentation.
Responses revealed the following.

65% increase in ability to identify problematic opioid use

65% increase in ability to council clients about their PO misuse

67.5% increase in ability to manage clients regarding their PO misuse

60.5% increase in reported comfort level in providing services to clients who may be
misusing POs

67.5% increase in reported overall knowledge of the topics covered in the presentation
3.2.2.
Evaluation of the resources (Appendix H - I)
Respondents: 40
15 pharmacists; 9 GPs; 16 practice managers
Clinician awareness:
81% (n=13) of practice managers indicated that they were aware of the STOP resources. Of those
84% (n=11) indicated that they had made the clinicians in the practice aware of the resources.
50% (n=1) of the respondents that did not forward the information indicated that the clinicians
have too many resources and that they do not use this sort or resources. 50% (n=1) indicated
that they intended to pass on the resources but had not yet done so.
70% (n=16) of GPs and pharmacists indicated that they were aware of the STOP resources.
Resource utilisation:
69% (n=9) of practice managers indicated that the resources had been left in a visible place for
patients to take passively with 30% (n=4) of clinics having passed on the resources to the GPs for
more active distribution. 15% (n=2) of respondents indicated that the resources are not being
used. When prompted as to why this was the case, half indicated that they intend to use the
resources in the future with one participant indicating that upon discussion with the GPs they
decided they did not want to use the resources.
81% (n=13) of GP and pharmacist respondents indicated that they use the resources in their
practice. Pharmacists and GPs were asked to indicate how they used the STOP resources in their
practice. 16 responses were recorded.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
20
Table 1: How have you used the STOP resources in your practice?
How have you used the STOP resources in your practice?
(check all that apply)
Other (please specify)
3
I do not use them
3
I use them when explaining how to use medecins…
I leave them in a visable place
I hand them out to patients
5
5
7
Other responses included

Verbal communication

“I put them selectively in the bags of the appropriate patients”

“I stick the STOP sticker onto the Panadeine Extra 24 and Nurofen Plus 30 packs”
(not 12 tablets pack)
The respondents whom indicated that they did not use the resources (n=2) indicated that the resources
were not patient friendly or that they had alternative information that they handed out to patients.
The random sample of general practices (n=10) and pharmacies (n=10) that were visited yielded
a positive result in 13 cases. 80% (n=8) of general practices had the resources displayed. In
pharmacies only 40% (n=4) had the resources displayed.
Resource Quality:
Pharmacists and GPs were asked to comment on the quality of the resources including look and
feel, content, layout and suitability. 15 responses were recorded.
Table 2: Quality of the resources.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
21
Resource Quality
The material is suitable for handing out
to patients to read on their own
My patients can easily understand the
material
strongly agree
agree
The layout is easy to follow
disagree
strongly disagree
The content is useful
The look and feel of the resources is
high quality
0
2
4
6
8
10
12
14
Pharmacists and GPs were asked to indicate patient feedback. 13 responses were recorded.
53.85% (n=7) indicated that they had not received any patient feedback; 38.46% (n=5) indicated
that the feedback received was generally positive and 7.69% (n=1) indicated that feedback was
generally negative. Comments noted that conversations with patients had not been very
committal and that they had not actively asked patients for feedback.
4.
Recommendations
Looking at sustainability beyond the funding timeframe has identified a number of opportunities
to allow for lasting project impact. Although additional resources will be required for the
project to be continued and developed further, some of the project impacts may be sustained
through Bayside Medicare Local (BML) continuing to support distribution of the resources. This
can be done with minimal staff support as well as seeking distribution opportunities through
partnering with GP and pharmacy training events. There will however be extra costs associated
with subsequent reprints of the materials.
It is recommended that participating pharmacies and GP clinics be contacted at six months and
again at 12 months to prompt reordering of the resources. Further resources could be
distributed to pharmacies and general practice clinics not included in the first round of the
project.
The Southcity Clinic Special Interest Network has been well established and participation levels
continue to increase. It is imperative that this community of practice continues to be supported
by the BML and adequate resources be allocated to this activity as well as sufficient staff
support.
The following recommendations are tabled should the project be able to attract additional
funding for a second phase. The recommendations are drawn from stakeholder interviews as
well as learnings from stage one of the project.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
22
5.

Public education campaign on the harmful effects of long term opioid use.

Public education campaign on safe return of unused medicines.

Further education with GPs to reduce the stigma associated with the pharmaceutical
opioid misuse.

Promotion of naloxone co-prescribing.

Publication of resources in different languages to increase accessibility of resources to a
broader demographic.

Project to tighten up regulations on dispensing pain medication via hospitals and
emergency departments and to improve patient follow up on discharge from hospital.
Discussion
All the activities of the project can be recorded as implemented as intended.
The quality of materials/components of the program was consistently rated has high. The
resources were well received and knowledge of and use of the resources as intended, was high.
It is possible however that the high rating of resource awareness was skewed as those who
responded to the questionnaire are more likely have knowledge of the resources. GPs and
Pharmacists reported an increase in dialogue around opioid medication use with patients as well
as increased confidence in their ability to identify and manage Pharmaceutical Opioid misuse.
The results from the random visits to pharmacist and GP clinics to observe resource utilisation
was positive in general practices. The lower result in pharmacies was due in some cases to a
more active approach to distribution of resources. On questioning pharmacists about the
visibility of the resources all but one indicated that the resources were kept behind the counter
and handed out selectively. General practices indicated a more passive approach where patients
could take the resources on their own accord as well as being exposed to the poster while in the
waiting room. This result was expected.
Although the project was designed specifically to curtail the difficulty in engaging GPs and
affecting practice change, lack of GP input, a key stakeholder group, was a shortfall to the
project design. GPs were consulted through the design phase of the project however input was
limited and GPs were hesitant to speak freely and openly. This was due in part to time
constraints, an expectation to be paid for participation in research and in some cases a lack of
conviction that pharmaceutical opioid misuse is an issue or that it is an issue affecting their
patients. Further there was no GP representation on the advisory group despite approaching a
number of GPs. This was due largely to work time constraints and an inability to commit to
regular meetings.
Regular contact and follow up with project participants was an essential component to the
project. Without this, motivation from participants waned. On discussion with participants it
was identified that this was due to day to day time pressures and requirements of running a busy
practice or business. Most participants, on prompting, were eager to actively participate and
give feedback.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
23
The STOP resources, community of practice and clinician education are a small part of a much
larger response to the issue of pharmaceutical opioid misuse. Reduction in pharmaceutical
opioid misuse will require a multifaceted approach targeting policy, practice change, patient
education, treatment and support as well as public education. For this reason it is difficult to
attribute change to any one intervention. What can be ascertained is that over the 18 months of
the project the landscape has shifted and the issue of pharmaceutical opioid misuse and its
associated dangers has been bought to the forefront. More and more people are recognising this
as a substantial problem affecting multiple communities and a variety of individuals. As a result
willingness to participate in and contribute to project and education opportunities are likely to
increase.
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
24
6.
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7.
Appendices
Appendix A
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix B
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix C
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix D
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix E
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix F
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix G
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Pharmaceutical Opioid Misuse – Evaluation Report July 2014
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Appendix H
Pharmaceutical Opioid STOP Resources - GP and Pharmacist
Q1. Please indicate your profession
Answer Options
Pharmacist
General Practitioner
Response Percent Response Count
62.5 %
15
37.5 %
9
answered question
24
skipped question
0
Q2. Are you aware of the Pharmaceutical Opioid STOP resources?
Answer Options
Yes
No
Response Percent Response Count
69.6 %
16
30.4 %
7
answered question
23
skipped question
1
Q3. How have you used the STOP resources in your practice? (Check all that apply)
Answer Options
I hand them out to patients
I leave them in a visible place
I use them when explaining how to use medicines to patients
I do not use them
Other (please specify)
Response Percent Response Count
43.8 %
7
31.3 %
5
31.3 %
5
18.8 %
3
18.8 %
3
answered question
16
skipped question
8
Q4. Why do you not use the resources in your practice?
Answer Options
The resources do not provide appropriate information
The resources are not patient friendly
I am time poor
I intend to use the resources in future
other (please specify)
Response Percent Response Count
0.0 %
0
50.0 %
1
0.0 %
0
0.0 %
0
50.0 %
1
answered question
2
skipped question
22
Q5. Have the resources led to dialogue around opioid use and concerns?
Answer Options
Yes
No
Comments
Response Percent Response Count
53.8 %
7
46.2 %
6
1
answered question
13
skipped question
11
Q6. What has the feedback been from patients?
Answer Options
I haven’t had any patient feedback
Generally positive
Very positive
Generally negative
Very negative
Comments
Response Percent Response Count
53.8 %
7
38.5 %
5
0.0 %
0
7.7 %
1
0.0 %
0
2
answered question
13
skipped question
11
Q7. Please comment on the following
Answer Options
The look and feel of the resources is high quality
The content is useful
The layout is easy to follow
My patients can easily understand the material
The material is suitable for handing out to patients to read on their own
Comments
strongly disagree
disagree
1
1
1
1
1
1
1
1
1
0
agree strongly agree
11
11
11
12
12
Response Count
15
15
15
15
15
0
answered question
15
skipped question
9
2
2
2
1
2
Q8. Do you see pharmaceutical opioid misuse in your practice?
Answer Options
never
occasionally
often
Comments
Response Percent Response Count
4.5 %
1
90.9 %
20
4.5 %
1
1
answered question
22
skipped question
2
Q9. Do you require further support/education in relation to working with patients who have been prescribed pharmaceutical opioids? (Check all that apply)
Answer Options
Complementary written resources
Training / education sessions
Community of practice/special interest network
I don't need any support
Comments
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
Response Percent Response Count
42.9 %
9
19.0 %
4
14.3 %
3
47.6 %
10
0
answered question
21
skipped question
3
39
Appendix I
Pharmaceutical Opioid STOP Resources PM
1. Please indicate your profession
Answer Options
Practice Manager
Other (please specify)
Response Percent
Response Count
100.0%
16
2
answered question
skipped question
16
0
2. Are you aware of the Pharmaceutical Opioid STOP resources?
Answer Options
Yes
No
Response Percent
Response Count
81.3%
18.8%
answered question
skipped question
13
3
16
0
3. Have the clinicians in the clinic been made aware of the STOP resources?
Answer Options
Yes
No
Response Percent
84.6%
15.4%
answered question
skipped question
Response Count
11
2
13
3
4. How have you used the STOP resources in your practice? (Check all that apply)
Answer Options
They are handed out
to patients
They are left in a
visible place
They have been
passed onto the
General Practitioners
They are not being
used
Other (please
specify)
Response Percent
Response Count
0.0%
0
69.2%
9
30.8%
4
15.4%
2
0.0%
0
answered question
skipped question
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
13
3
40
5. Why were the Clinicians not made aware of the STOP resources?
Answer Options
The resources are
poor quality
The resources are
not relevant
The clinicians don't
use this sort of
resource
The clinicians have
too many resources
I intend to pass the
resources on in the
future
Percent
Count
0.0%
0
0.0%
0
50.0%
1
50.0%
1
100.0%
2
answered question
skipped question
2
14
6. Why do you not use the resources in your practice?
Answer Options
The resources do not
provide appropriate
information
The resources are
not patient friendly
I intend to use the
resources in future
other (please specify)
Percent
Count
0.0%
0
0.0%
0
50.0%
1
50.0%
answered question
skipped question
1
2
14
7. Do the practitioners in your clinic require further support/education in relation to working with
patients who have been prescribed pharmaceutical opioids? (Check all that apply)
Answer Options
Percent
Count
Complementary
33.3%
5
written resources
Training / education
13.3%
2
sessions
Community of
practice/special
0.0%
0
interest network
No support needed
53.3%
8
Other (please specify)
2
answered question
15
skipped question
1
Pharmaceutical Opioid Misuse – Evaluation Report July 2014
41