Harm Reduction In Substance Use Pharmaceutical Opioid Misuse Evaluation Report July 2014 Pharmaceutical Opioid Misuse – Evaluation Report July 2014 1 Document History This table is to record the document’s history, i.e., dates of proposed changes or revisions. Version No. Date 01 28 July 2014 Description of Revision Pharmaceutical Opioid Misuse – Evaluation Report July 2014 2 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 3 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 4 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 5 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 6 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. Pharmaceutical Opioid Misuse – Evaluation Report July 2014 7 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 Pharmaceutical Opioid Misuse – Evaluation Report July 2014 8 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 9 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 10 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) Pharmaceutical Opioid Misuse – Evaluation Report July 2014 11 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 12 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 13 (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 15 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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Appendices Appendix A Pharmaceutical Opioid Misuse – Evaluation Report July 2014 28 Appendix B Pharmaceutical Opioid Misuse – Evaluation Report July 2014 29 Appendix C Pharmaceutical Opioid Misuse – Evaluation Report July 2014 30 Appendix D Pharmaceutical Opioid Misuse – Evaluation Report July 2014 31 Appendix E Pharmaceutical Opioid Misuse – Evaluation Report July 2014 32 Pharmaceutical Opioid Misuse – Evaluation Report July 2014 33 Pharmaceutical Opioid Misuse – Evaluation Report July 2014 34 Appendix F Pharmaceutical Opioid Misuse – Evaluation Report July 2014 35 Pharmaceutical Opioid Misuse – Evaluation Report July 2014 36 Appendix G Pharmaceutical Opioid Misuse – Evaluation Report July 2014 37 Pharmaceutical Opioid Misuse – Evaluation Report July 2014 38 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
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