A national funding model for pharmacotherapy treatment for...

THE RESEARCH AND DEVELOPMENT PROGRAM IS FUNDED BY THE AUSTRALIAN GOVERNMENT DEPARTMENT OF HEALTH AND AGEING AS PART OF THE FOURTH COMMUNITY PHARMACY AGREEMENT

Appendices

A national funding model for pharmacotherapy treatment for opioid dependence in the community pharmacy

APPENDICES

2

Appendices

Contents

Appendix A – Participating pharmacies

Appendix B – Advisory Panel and Reference Group Members

Appendix C – Literature review

Appendix D – Pharmacy consent bundle

Appendix E – Client consent bundle

Appendix F – Randomisation protocol

Appendix G – BTOM-C and WHOQoL-8

Appendix H – Analysis report

3

AppendicesAppendix A – Participating pharmacies

Pharmacy State Pharmacy State Pharmacy State

Chemist Outlet PortKembla

NSWBushland BeachPharmacy

QLDDandenong PlazaPharmacy

VIC

Chullora Pharmacy NSW Coolangatta Pharamcy QLDEast BentleighPharmore Pharmacy

VIC

Flannerys Pharmacy NSW Cooloola Pharmacy QLDHealthwise PharmacyHorsham Plaza

VIC

Fresh TherapueticsPharmacy andCompounding Chemist

NSWGeorge FotinosPharmacy

QLD Immes Pharmacy VIC

Hamilton RoadDispensary

NSW J.P. Davies Pharmacy QLD Kent's Amcal Pharmacy VIC

Huskisson Pharmacy NSWKaralee ChemmartPharmacy

QLD Kofoed's Pharmacy VIC

Mahony's ManillaPharmacy

NSW Kenilworth Pharmacy QLDMartin & Diana NowakPharmacy

VIC

McCarthy's Pharmacy NSWLockyer ValleyPharmacy

QLDMcKenzie DaveyPharmacy

VIC

Miegel's Pharmacy NSWMalouf GroupPharmacies Cleaveland

QLDMurrumbeena RoadPharmacy

VIC

Moree Pharmacy NSW Moolooaba Amcal QLDMyrtleford CommunityPharmacy

VIC

Moss Vale SoulPattinson

NSW Moranbah Pharmacy QLD Nagels Pharmacy VIC

Mulhall and GrahamPharmacy

NSWNewmarket GuardianPharmacy

QLD Richmond Pharmacy VIC

Old Bar Pharmacy NSW Oakey Pharmacy QLDRob Foster Thuy TrinhPharmacy

VIC

Parkes Pharmacy NSW Petrie Village Pharmacy QLD S Schneier Pharmacy VIC

Portland Pharmacy NSWPriceline PharmacyMareeba

QLDSpringvale PlazaPharmacy

VIC

Rozelle Health BeautyPharmacy

NSW The Mitchell Pharmacy QLDEast FremantlePharmacy

WA

South hurstville marketpharmacy

NSWWynnum Day & NightAmcal Pharmacy

QLDFriendlies ChemistWanneroo

WA

The Chemist OutletLisarow

NSWYeppon ChemmartPharmacy

QLD Golden Bay Pharmacy WA

The Junction Pharmacy NSW Colin Johns Chemplus SAHigh WycombePharmacy

WA

Trafalger Pharmacy NSW Gordon Pharmacy SA Lynwood Pharmacy WA

Wentworth FallsChemmart Pharmacy

NSW Sparrow Pharmacies SAMt Lawley Pharmacy &Health Food

WA

Wilberforce everydaychemist

NSW Eastlands Pharmacy TAS Northam Pharmacy WA

Willoughby RoadPharmacy

NSW Scottsdale Pharmacy TASPharmacy 777Maylands

WA

Wollongbar Pharmacy NSW Black Rock Pharmacy VICSavings Plus ChemistNollamara

WA

Trower Road Night andDay Pharmacy

NTBruce CaldwellPharmacy

VIC

4

AppendicesAppendix B - Advisory Panel and Reference Group Members Advisory Panel Members

Chris Boag (Chair)

Robyn Davies

Kim Bessell

Chrysanthe Psychogios

Toni Riley

Jennie Shortt

Denis Leahy

Irvine Newton

Sarah Lord

Khin Win May

Reference Group Members

Bob Austic, NSW

Jerry Hampton, TAS

David Holmes, QLD

Bihn Luu, NSW

Perry Moshidis, VIC

Lenette Mullen, WA

Angelo Piccolo, VIC

Paul Simmons, SA

Paul Sinclair, NSW

Natalie Willis, WA

5

AppendicesAppendix C – Literature review

This project has been funded by the Department of Health and Ageing under the FourthCommunity Pharmacy Agreement Research and Development program.

i

Pharmacy Guild of Australia

Pharmacotherapy Funding Model

Literature Review

November 2008

This project has been funded by the Department of Health and Ageing under the FourthCommunity Pharmacy Agreement Research and Development program.

i

Pharmacy Guild of AustraliaPricewaterhouseCoopers

Professor Richard P. MattickDirector

National Drug and Alcohol Research CentreUniversity of New South Wales

Sydney NSW 2052

[email protected]


ContentsList of acronyms i

1. Introduction 1

2. Heroin/illicit opioid dependence: Prevalence and natural history 2

3. The innovation of methadone maintenance 3

4. Effects of opioid substitution therapy (OST) 5

5. International acceptance of OST 6

6. Barriers to treatment entry and retention 7

7. Treatment fees and ability to pay 9

8. The role of Community Pharmacists 11

9. The Australian situation 14

10. Summary 16

11. Appendix A: References 17

List of acronyms


i

List of acronymsHBV Hepatitis B Virus

HCV Hepatitis C Virus

HIV Human Immunodeficiency Virus

IDU Injecting Drug User

OST Opioid Substitution Therapy

PBS Pharmaceutical Benefits Scheme

WHO World Health Organisation


1

1. IntroductionSince methadone was introduced as a substitution treatment for opioid dependence just fourdecades ago, many studies have shown that opioid users reduce their illicit opioid use and improvetheir health and social well-being while maintained on methadone (Hall & Wodak, 1999; Mattick,Breen, Kimber, & Davoli, 2004, 2008; Mattick, Kimber, Breen, & Davoli, 2004; Ward, Hall, & Mattick,1999; Ward, Mattick, & Hall, 1992; Ward, Mattick, & Hall, 1998). When they leave treatment,however, most resume illicit opioid use (Ball & Ross, 1991; Dole & Joseph, 1978). Theeffectiveness of methadone seems to be reliant on continued treatment, just as its early proponentshad suggested when they argued that heroin dependence was a metabolic disease and then theynominated methadone as a suitable maintenance treatment (Dole & Nyswander, 1967, 1976), not atreatment to detoxify patients.

It is accepted that those who inject drugs and those who are drug dependent have the right to enjoythe highest standard of health attainable, in accordance with the United Nations General AssemblyUniversal Declaration of Human Rights (United Nations, 1948). Maximising the health benefits fromtreatment of heroin dependence is reliant on a number of factors to do with the effectiveness of thepharmacotherapy used, its accessibility and its attractiveness to the target group – dependent heroinusers. The personal and community impacts of pharmacotherapy for opioid dependence can bemarkedly enhanced by attending to each of these factors in turn. In that regard, users in developedcountries like Australia can now usually access effective pharmacotherapy treatment (in the form oforally administered methadone and buprenorphine), but the ability to retain these patients intreatment and thereby provide long-term care depends on a number of factors, including theaffordability of the treatment.

Heroin dependence prevalence, natural history, and aspects of effective treatment each need to beunderstood to allow a maximally effective public health response to the threats to the user andcommunity of heroin injection. As the provision of methadone treatment, like many other aspects ofmedical care, has undergone considerable privatisation in recent years (Bell et al., 1995) puttingcosts back onto patients, the impacts of this privatisation needs to be considered.


2

2. Heroin/illicit opioid dependence:Prevalence and natural history

2.1 Prevalence

Illicit opioid injection, typically through the use of heroin, is a significant health problem in manydeveloped countries, including Australia. Dependent users are responsible for the bulk of heroinuse by injection. Heroin dependence has become a prevalent problem in Australia over the pastfour decades (Degenhardt, Rendle, Hall, Gilmour, & Law, 2004), with approximately 74,000dependent users, and estimates of up to 0.7 percent of the adult population being currentlydependent.

Dependent heroin users have become daily, or near daily, injectors of heroin, and they will use otheropioid and sedating drugs if an easy supply of heroin is unavailable. These injectors use heroindespite the very large social and health problems that this use poses for them, such as sheerfinancial cost of supporting a heroin habit, the familial/social and community marginalisation theyexperience due to their drug use, the involvement in drug-related or property crimes leading to riskof being arrested and imprisoned, the likely exposure to blood-borne viruses causing seriousinfectious diseases (HBV, HCV, HIV), and the risk of opioid overdose requiring resuscitation andcausing death.

2.2 Natural history of a chronic relapsing disorder

In terms of natural history, the available studies come largely from the USA and indicate thatdependent heroin users usually will continue to use heroin for decades (Goldstein & Herrera, 1995;Y. I. Hser, Angkin, & Powers, 1993; Y.I. Hser, Hoffman, Grella, & Anglin, 2001). In this group, dailyheroin use is interrupted by periods of abstinence, or by entry into drug treatment or jail.

After leaving drug treatment, the majority of users will promptly relapse to heroin use (Gerstein &Harwood, 1990; Rosenbaum, Washburn, Knight, Kelley, & Irwin, 1996). Ignoring periods ofabstinence during treatment or imprisonment, it has been found that dependent heroin users will useheroin daily for half (40% to 60%) of the typical 20-year addiction period studied and engage insignificant levels of crime to fund their acquisition of heroin (Ball, Shaffer, & Nurco, 1983; Maddux &Desmond, 1992).

Heroin dependence (once established) is now understood to be an ongoing chronic and relapsingdisorder (American Psychiatric Association, 2000). This ongoing long-term dependence on heroinhas brought the attention of policy-makers, clinicians and researchers to address the best methodsof assisting these individuals to minimise the adverse social and health consequences that accruefrom such use. However, it was the clinicians (who were often opposed by policy-makers) that didthe early research and led the way forward to address the problem of heroin dependence. Thiswork first occurred in New York.


3

3. The innovation of methadonemaintenance

3.1 New York in the 1960s

It was in the 1960s that two clinicians, Dole and Nyswander (an endocrinologist and a psychiatrist,respectively), introduced what has probably been one of the most controversial treatments in all ofhealth care in the past half century. To reduce the use of illicit heroin among their patients in NewYork, they prescribed orally administered methadone (a synthetic opioid developed for analgesicpurposes in the first half of the twentieth century) to heroin dependent patients (Dole & Nyswander,1965, 1967). They assessed the impacts of giving prescribed opioids to the opioid dependent, andfound daily maintenance dosing led to significantly reduced heroin use and reduced rates ofreincarceration (Dole et al., 1969); there was a clear positive effect for methadone.

However, it was the controversial nature of the intervention that subsequently fuelled a verysubstantial research effort across time since the 1960s, as cautious and questioning governmentpolicy-makers demanded evidence on the effectiveness of this intervention. That research efforthas largely vindicated the percipient efforts of the early clinical researchers.

3.2 Non-pharmacological alternatives

Non-drug alternatives have been trialled in the form of therapeutic communities, residentialrehabilitation facilities, and abstinence-focused treatments such as naltrexone, and they do havesome success for opioid dependence. However, the evidence has best supported the substitution ofa licit prescribed opioid for illicit heroin in heroin dependent patients (Hall & Wodak, 1999; Ward etal., 1999; Ward et al., 1992; Ward et al., 1998).

Similarly, detoxification is not considered to be a treatment for heroin dependence (Mattick & Hall,1996), and attempts to withdraw patients usually meet with failure. Whether observed in the USA,or Australia, detoxification can be achieved over a five to 10 day period, but is followed by promptreturn to injecting drug use in the vast majority of cases.

3.3 Broadening of the pharmacotherapies

Methadone remained the monolithic pharmacotherapy response to opioid dependence for almosthalf a century, and it was effective (see below). More recently, methadone maintenance treatmenthas had some rival pharmacotherapies introduced. A number of alternative treatments includingheroin-prescribing in some European countries, and more recently the use of buprenorphine (apartial opioid agonist which has been an effective analgesic for decades marketed as Temgesic ®),have been introduced.

Buprenorphine comes as a mono-therapy preparation (currently marketed at Subutex ® inAustralia), and more recently a combination-therapy has been introduced in the form ofbuprenorphine-naloxone tablets (marketed at Suboxone ® in Australia). The rationale for thecombination therapy is that injection of Suboxone will be less attractive as injectors will fear awithdrawal reaction will occur. Intravenous naloxone will produce withdrawal, but the ability of thecombination therapy to markedly reduce inappropriate use and diversion has yet to be fully tested.Early work from Europe does suggest some decreased attractiveness of the combination-therapy(Alho, Sinclair, Vuori, & Holopainen, 2007), but the long-term market response in Australia is uncleardue to the recency of the introduction of this formulation.


4

Another relevant feature of buprenorphine is that it can be dosed every two days, or even thriceweekly, as its pharmacological properties allow for longer duration of action than methadone.Methadone is dosed daily.

3.4 Rationale for replacing heroin with a prescribed opioid

Together, the use of methadone and buprenorphine as a mono-therapy or as a combination–therapyin maintenance treatment to replace heroin use, have come to be termed opioid substitutiontherapies (OST), although some prefer the term opioid maintenance pharmacotherapy.

Fundamental to the use of these medications is the fact that all opioids show cross-tolerance foreach other (Jaffe & Martin, 1990), and from a public health perspective that an orally administeredpharmaceutical grade opioid is preferable to the use of an injected illicit drug such as heroin (whichis known by the correct chemical name as diacetylmorphine). Moving patents from injecting (threeto four injections per day) to oral administration of an opioid in deemed likely to better stabilise thepatient and reduce involvement in the illicit drug market.


5

4. Effects of opioid substitutiontherapy (OST)

Despite often quite ferocious opposition to these treatments, orally administered methadone andbuprenorphine maintenance treatments (or opioid substitution therapy (OST)) have becomeaccepted as effective and safe treatments for opioid dependence, supported by policy-makers,clinicians, and researchers. While controversial due to criticisms of these treatments, the evidencewhich has accumulated from randomised controlled trials shows that these interventions retainpatients in treatment and while in such treatment there is a marked and sustained reduction ininjecting opioid/heroin use (Mattick, Breen et al., 2004, 2008). Higher daily doses of methadone areassociated with better outcomes, and maintenance treatment approaches (rather than abstinence-oriented methadone-to-withdrawal) are likely to enhance patient well-being (Ball & Ross, 1991). It isnot feasible to address the extant literature in this review, and it is sufficient to state that thesynthetic reviews both qualitative (Ward et al., 1999; Ward et al., 1992; Ward et al., 1998) andquantitative (P.G. Barnett, Rodgers, & Bloch, 2001; Johansson, Berglund, & Lindgren, 2006; West,O'Neal, & Graham, 2000), all conclude the treatments are effective and that the CochraneCollaboration reviews show clear evidence of effectiveness (Mattick, Breen et al., 2008; Mattick,Kimber, Breen, & Davoli, 2008).

During such treatment, the physical health and well-being of patients improves, and there isevidence of markedly reduced mortality (Caplehorn, Dalton, Cluff, & Petrenas, 1994; Caplehorn,Dalton, Halder, Petrenas, & Nisbet, 1996; Darke, Degenhardt, & Mattick, 2007). Additionally, thereis very substantially reduced crime (Lind, Chen, Weatherburn, & Mattick, 2005), so that there is acost-benefit of being in treatment from reduced crime and because of other cost-offsets (P. G.Barnett & Hui, 2000; P.G. Barnett, Zaric, & Brandeau, 2001; Harwood et al., 2002; Shanahan,Hetherington, Mattick, & Weatherburn, 2007).

Retention in treatment is the major variable used by all commentators to assess the effects of OST,as it is the best single predictor of treatment success. Without retention in treatment, all of the othertreatment gains quickly evaporate. All major reviews rely on retention in treatment to assesstreatment-effectiveness (Amato et al., 2005).

Having said that, there is no doubt that these treatments are not without problems, includingdiversion of the pharmaceutical for resale, or injection, and community negative views that thetreatment with OST is less preferable than withdrawal. Death can occur during early phases ofinduction onto methadone (but this is less of a problem with buprenorphine) (Caplehorn, 1998;Caplehorn & Drummer, 1999; Caplehorn & Drummer, 2002). Congregation at large public clinicscreates opportunities for drug-dealing and concentrates patients in these locales, often to thedismay of residents. Establishment of new clinics is made difficult by the community concerns.These political and community misunderstanding of the treatment creates large problems for OST,problems which are magnified by the polarised debate over the value of abstinence-basedtherapies. The ability of community pharmacies to dilute the number of patients at any site, and todeal effectively with patients is a major benefit from the inclusion of the community pharmacy sectorin the delivery of this treatment.


6

5. International acceptance of OSTIt was a consequence of the international concerns about increasing rates of heroin dependenceinternationally, and the role of injecting heroin use in causing seroconversion to HIV, that led to theproposed listing of methadone and buprenorphine on the World Health Organization’s Model List ofEssential Medicines. Consequentially, the United Nations Office on Drugs and Crime (UNODC) andthe World Health Organization (WHO) have developed guidelines advocating OST in countrieswhere injecting opioid use is prevalent.

More countries in Europe that had rejected OST through the 1970s and the 1980s, have spent thepast decade developing the required infrastructure to implement this treatment. Similarly, inresource-poor and resource-constrained settings, there has been a steady expansion of OST overthe past decade (e.g., Indonesia, Vietnam, Thailand, China, and Iran). These often radical changesto government policy have been driven substantially by the population health concerns about HIV,concerns that are still relevant today for all countries including Australia (Mathers et al., 2008). OSTis recognised as an important method for reducing IDU-related HIV infection.


7

6. Barriers to treatment entry andretention

Reviews of the literature indicate that a number of factors influence retention in treatment andsatisfaction with treatment. These factors also can affect illicit drug use and patient wellbeing. Notbeing in treatment is associated with poor outcomes, and leaving treatment early without achievingsufficient stability is also associated with poor results. Based on a comprehensive review of theliterature, Ward et al. (1998) reported that the following factors were predictors of, or associatedwith, outcome in methadone treatment (Ward et al., 1998).

6.1 Higher daily doses enhance retention

Methadone dose level is positively associated with better outcomes and longer stays in treatment, ifthe doses are high (at least 60 mg and preferably 100 mg per day for most patients) and particularlyif there is not a low dose policy adopted by the clinic. Associated with that policy of low dose issometimes a policy towards abstinence. Patients who are in clinics which have a tolerance formaintenance, rather than the focus on abstinence, are more likely to be retained in treatment.Higher buprenorphine doses are also likely to enhance retention and compliance (Mattick, Kimber etal., 2008).

6.2 Ancillary services may help to increase retention

American research suggests that the provision of ancillary services of various kinds particularlymedical, psychological and financial services are associated with increased retention in treatmentand with better outcomes (Ball & Ross, 1991). Reviews of the value of these services, have reportedsome enhanced outcomes (Mattick, Ward, & Hall, 1998).

This information may be especially important in the clinic or community pharmacy setting, where thedispensing staff can take to opportunity to provide some counselling or management directingpatients to their prescriber or other services where such additional management is thought likely tobe relevant. Relevant to this issue is the recent systematic review of the evidence on the impacts offinancial facilitators on the provision of high quality pharmacy services via enhanced advice or“cognitive pharmaceutical services” (Albrecht et al., 2006; Roberts et al., 2005), a level of servicethat is especially relevant to the opioid dependent patient in a community pharmacy.

The role of the community pharmacist in provision of both clinical and professional assistance to thepatient (beyond dose administration) and to other health care providers (e.g., the patient’sprescriber) can potentially improve retention and health outcomes, and recent reviews of theliterature point to the role of community pharmacists in this context (Roughhead, Semple, & Vitry,2002). Work from the UK emphasises the potential role of community pharmacists in patienthealthcare (Noyce, 2007).

Notably, Australian research on the administration of OST showed that in community pharmacies,OST patients expressed dissatisfaction with the amount of time that prescribers made available forconsultations, and the “limited alternative supports for clients as part of treatment” (p.vi) (Lintzeris,Pritchard, & Sciacchitano, 2007). This research also indicated that “clients and prescribers notedthe value of support, especially counselling, for improving outcomes for OST clients” (p.iv).Additionally, overseas research has emphasised the role of community pharmacists in thesupervision of OST, and also in the provision of other medications for co-morbidity and promotion ofvaccination (e.g., for hepatitis B) (Sheridan, Manning, Ridge, Mayet, & Strang, 2007).

The broader literature does support the view that ancillary service provision, support, advice andsupportive assistance and counselling, as well as referral for further care are important determinants


8

of progress in this treatment (Ward et al., 1998). Patients in community pharmacy have regularcontact with the pharmacist, and often infrequent access to their prescriber, making the communitypharmacy an important potential venue for exchange of health information. Such an approach isconsistent with the new notion of cognitive pharmaceutical services (Albrecht et al., 2006; Roberts etal., 2005).

6.3 Accessibility enhances treatment entry and retention

Accessibility of treatment is also associated with better outcomes. Having a dosing point withinreasonable travelling time is important and is an important benefit of the community pharmacyinvolvement. Similarly, take-home (or takeaway) methadone doses have been associated withhigher retention rates, but can have negative consequences of diversion of methadone.

Related to geographic accessibility is the finding that the rapid assessment of patients for treatmentand hence rapid treatment commencement has been associated with better outcomes and withretention (Bell, Fernandes, & Batey, 1990). Quicker assessment gets ambivalent patients to accesstherapy when they are most motivated, and enhances their outcomes by reducing the time totreatment and the possibility of a change in motivation to cease injecting heroin use.

6.4 Treatment fees reduce retention

The variable of interest here is the introduction of co-payment, or treatment fees, to patients to havethem contribute to their treatment but also to allow them to transfer to a GP and pharmacydispensing model rather than a public clinic. In that regard, the provision of methadone treatment,like many other aspects of medicine, has undergone considerable privatisation in recent years.

The evidence is that the imposition of treatment fees decreases retention and worsens outcomes(Ward et al., 1998). The available evidence is set out below in review of the observational andrandomised trial research available to date. Additionally, some recent research relevant to theAustralian situation is set out.


9

7. Treatment fees and ability to pay

7.1 Rationale for fees

Treatment fees might be justified not only because they help to finance the OST programs, but itmay be that the payment of a fee helps to improve the effectiveness of treatment. Payment of a feehas been argued likely to improve the effectiveness of some forms of therapy (on the assumptionthat patients value their treatment more if they pay something for it), although there is little researchto support this notion. While payment of a fee could enhance OST outcomes, the possibility that itcan lead to a poorer outcome must be considered in the light of the limited ability of OST patients topay for treatment.

7.2 Ability to pay

Low rates of legitimate employment have repeatedly been observed among patients at the time ofentering treatment. For example, only 21% of clients at the Sydney medically supervised injectingcentre were in full-time employment at the time of registration at that service (MSIC EvaluationCommittee, 2003). Only 28% finished high school and 43% did not have the basic academicqualification (the School Certificate). Similarly, among heroin users entering treatment in Australia,only one in six patients (17%) listed a wage as their main source of income, most existing on socialsecurity payments (Ross et al., 2005). Patients in treatment have similarly high levels ofunemployment with up to 70% or more unemployed (Mattick et al., 2003). These data areconsistent with those reported elsewhere internationally (Hubbard et al., 1989), and the commentsfrom Rosenbaum that “very few clients appear to possess the financial resources to pay the $160 -$200 a month for treatment”. Taken together, the data on income indicate that most illicit opioidusers are poorly placed to pay any significant amounts towards the costs of their treatment.

7.3 Evidence on effects of fees on patient retention

If illicit heroin users are poorly prepared to pay for treatment, then imposing fees should see themleave therapy, an unfortunate outcome that is borne-out by the research on the effects of fees.

It was in the 1980s that early work from the USA, driven by concerns that fees were reducingretention, addressed the impact of fees. A review of retention in treatment in publicly-funded andthe privately-operated programs (Maddux, Prihoda, & Desmond, 1994) noted the work of Des Jarlaisin New York (Des Jarlais, 1982) showing that there was a substantial difference in retention betweenthe publicly-funded OST programs where no fee or a low fee was charged, and the privately-operated methadone programs wherein a fee was charged (and where the failure to pay the fee ledto discharge from the program). Des Jarlais (1982) reported that for two separate years analysed,the retention rates among those entering treatment were almost 60% in the publicly-fundedprograms compared with rates of almost 40% for the private-programs. The difference showed thatpatients were almost 60 percent more likely to be retained if they were not in the fee-for-serviceprograms. These results mirrored the relative retention rates in the Maddux randomised trial (seebelow) and provided real-life support for the notion that retention is worse in the fee-payingprograms.

Of course, it is not only those who are entering a new treatment episode that may be affected by theintroduction of fees for their OST. The patients who are in treatment have limited resources and themajority are not employed and remain on social security benefits. Rosenbaum and her colleaguesdescribed the negative effects of the introduction of a policy in California limiting access to publicly-funded OST to two years; after the two year period of free OST the patients were required to pay fortheir treatment ($160 - $200 per month) (Murphy & Rosenbaum, 1988; Rosenbaum, Irwin, &Murphy, 1988; Rosenbaum, UIrwin, & Murphy, 1987). The policy of fee payment essentiallydestabilised a large group of patients who were doing well on the OST program. A small number


10

detoxified (6% of 143 followed-up), while 25% managed to pay the fee; unfortunately, the majorityleft the OST program and eventually returned to heroin use. Notably, Australian experience intransferring stabilised OST patients off OST shows similarly dismal outcomes for them with relapseto heroin use or return to OST the usual outcome (Breen et al., 2003).

Other USA researchers confirmed the results of Rosenbaum and her colleagues. Anglin noted thatthe reduction or elimination of publicly-funded methadone treatment, which was replaced by fee-for-service methadone, resulted in only 40% of the patients transferring, the rest leaving OST. Thosewho left were worse off with more illicit narcotic use, more involvement in property crime and drugdealing, and higher levels of incarceration (Anglin, Speckart, Booth, & Ryan, 1989). Of course, oneis forced to conclude that these are exactly the outcomes that should be expected given theevidence from the randomised trials of OST effectiveness reviewed above.

Following these observations, a more recently reported randomised trial from North America wasconsistent and provided clear evidence on the impact of fees. Maddux and colleagues (1994)compared the fee-for-service methadone maintenance and free-treatment and found that patientsrandomised into the fee-for-service condition had poorer retention rates (34%) than those who didnot have to pay for their treatment (54%) at one year. Elimination of fees significantly increasedretention, with proportionally 60% more people retained in the no-fee group. That study showedclearly the potential for the introduction of a fee-for-service to reduce retention and potentiallyworsen outcomes for patients (Maddux et al., 1994). The researchers concluded that OSTprograms could “improve retention by reducing or eliminating fees” (p. 441).

7.4 Effects of fees on health-care provider and patient satisfaction

Obviously, reducing the fee for service to the patient should bring about better patient satisfactionand better retention. Additionally, it should allow for better staff satisfaction, as staff having to collectfees are likely to bear the brunt of the patient dissatisfaction.

Over and above any impact on retention and illicit drug use, there is an issue concerning theacceptance or patient satisfaction with a fee-for-service approach. The issue of patient acceptancehas not been well-studied, and as much of the research has occurred in the U.S.A., where the pooravailability of access to opioid replacement therapy arguably makes patients more compliant, localresearch is warranted.


11

8. The role of CommunityPharmacists

8.1 Community pharmacy involvement

The community pharmacy sector has taken on a large and central role in the administration of theOST program, and they do this for several reasons, including patient care and community service,and also for a fee-for-service. The inability of public clinic systems to provide the accessibility andhours of operation achieved by community pharmacies makes the involvement of this sector criticalto the effective reach of treatment in Australia. Such involvement occurs in other countries such asUSA, Spain, England and Switzerland, where the involvement of community pharmacies is central totreatment provision of OST (Fleming, McElnay, Hughes, Sheridan, & Strang, 2001; Gastelurrutia,Faus, & Fernandez-Llimos, 2005; Raisch et al., 2005; Samitca, Hiuissoud, Jeannin, & Dubois-Arber,2007; Sheridan et al., 2007).

In Australia, in terms of dosing opioid substitution therapy, the community pharmacy sector accountsfor the vast majority of the 38,498 patients in treatment in 2007, with 26,519 receiving their dose at apharmacy (68.9%). Another, 11 percent are dosed at public clinics, 9 percent at private clinics, and9 percent in correctional settings. Interestingly ninety three percent of buprenorphine/naloxoneclients are receiving their dose of opioid substitution at a community pharmacy, with 70 percent ofbuprenorphine clients being dosed at pharmacies and 67 percent of methadone clients being dosedat pharmacies.

There has been a long indication of the interest of community pharmacists in the provision of OST(Sheridan, Strang, Taylor, & Barber, 1997). As noted above, a literature has developed in this areainternationally (Fleming et al., 2001; Gastelurrutia et al., 2005; Raisch et al., 2005; Samitca et al.,2007; Sheridan et al., 2007; Sheridan, Wheeler, & Walters, 2005), and calls for communitypharmacy involvement over the past decade or more (Kalke, 1997; Sheridan, Strang, Barber, &Glanz, 1996; Strang, Sheridan, & Barber, 1996), as well as the development of guidelines fordispensing OST in community pharmacies (Greater Glasgow Area Pharmaceutical Committee,2000).

There is no evidence of any alteration in the safety or the effectiveness of community pharmacy-based OST dosing and administration, and the uptake by the community pharmacy sector has beenimpressive in Australia and internationally (Fleming et al., 2001; Matheson, Bond, & Tinelli, 2007;Sheridan et al., 2007).

8.2 Introduction of fees

Initially, in the USA and Australia (which largely adopted the USA model of a clinic-basedintervention), fees in OST were largely non-existent. Publically supported programs in the USA andin Australia provided treatment at no cost to patients (Maddux et al., 1994).

However, the development of private clinics in NSW, and the national move to a generalpractitioner model of care (rather than large specialised clinic-based care), brought fees to thepatients. In private clinics, patients had to pay a dispensing fee for their OST daily, while theAustralian Government paid for the prescriber costs of the general practitioners. In a generalpractitioner treatment approach, the patients were administered the OST dose at a communitypharmacy, and a daily fee was incurred, and again the Australian Government paid for theprescriber costs.


12

In an attempt to get more community pharmacy involvement in the OST program, somepayments from governments to community pharmacy have occurred. In one small jurisdiction,pharmacy fees are half paid by the government and the other half is a patient co-payment(ACT). In Victoria, the government pays dosing fees for patients under 19 years of age, andthose on Juvenile Justice orders, with pharmacies dosing these eligible clients charging $35 perweek (plus GST). In addition, dosing fees for post-release prisoners are paid for 4 weeks afterrelease. In NSW, there is a system of paying newly participating pharmacies a “once-only”practice incentive of $1000 per pharmacy, and all pharmacies are eligible for a dispensing feeof $200 per patient for a maximum of 20 patients (i.e., maximum of $4000 per year) (Morrison,2008). Otherwise, the dispensing fees are to be paid by the patients in community pharmacies.

8.3 Disincentives for community pharmacies to participate in the OSTprogram.

However, at the same time, there are significant disincentives for community pharmacies toparticipate in the OST program. For a decade, the disinclination of community pharmacists to beinvolved in OST has been noted (Matheson, Bond, & Mollison, 1999). The dislike of the clientele,associated with the whole notion of injecting drug use, plus the difficulties posed by some of thesepatients in terms of difficult interactions, make this a difficult group to manage.

Additionally, they are, on average, marginalised financially. More recently in Australia, research hasshown that there is a high rate of bad debt (A. Winstock, Lea, & Molan, 2008). Specifically, overseventy percent of pharmacies reported that they provide credit to clients, with one-quarter of the407 community pharmacies responding to the survey indicating that they had clients in debt.Additional problems associated with behavioural disinhibition and aggression among clients, shop-lifting, and general dislike of the clientele also reduce pharmacists’ enthusiasm for involvement inthe OST program. Recently concerns about diversion of buprenorphine have been reported bycommunity pharmacists in Australia (Neilsen et al., 2007), but there are reports that communitypharmacists are often positively disposed to the OST program and their involvement in it(Lawrinson, Roche, Terao, & Le, 2008).

8.4 What is the cost to patients?

Recent research in NSW shows that currently the community pharmacy sector has capacity toincrease patient numbers, but the factors that would encourage the pharmacists to take onadditional patients included stability of clients, ability to return unstable clients to a clinic for dosing,and “increased financial return per client” (A. Winstock et al., 2008).

It is generally accepted that the cost of treatment fees is $5 to $6 per day, or $30 to $40 per week.Victorian data show that the great majority of participants in the OST program pay $60 to $70 perfortnight (Rowe, 2008). Some pay more, but these are in the minority at seven percent.

The recent NSW community pharmacy survey of practices of 407 pharmacies also showed that formethadone, the majority of pharmacies (92%) charged a flat weekly dispensing fee (mean = $31.90)for methadone and 75% charged a flat weekly fee for buprenorphine dosing ($31.00) (A. Winstock etal., 2008). This result indicates that the level of payment is approximately $30 per week. There canalso be lower charges for buprenorphine where the medication is administered less than daily –every two days or thrice weekly - as little as $20 to $15 per week for second-daily or thrice weeklydosing of buprenorphine.

Interestingly, this same group has shown that the community pharmacy dispensing fees forbuprenorphine – naloxone, which can be given as a week or more take-away doses, wouldhave used a similar flat fee or a fee that was only marginally reduced (A. R. Winstock, Lea, &Ritter, 2007), further taxing patients. However, this approach may have difficulties. In theresearch which was conducted in the early introduction phase of suboxone the "What is the


13

cost to patients" question was posed as a hypothetical. The research findings therefore need tobe qualified in reporting this data to reflect the current market price of Suboxone for multipletakeaways per month.

Also there is the possibility of reduced fees for provision of buprenorphine to $20 or $15 weeklywhere clients receive doses twice weekly or thrice weekly. However, there are 2 problems withthis approach:

1. Where buprenorphine is provided in the form of Subutex, the possibility of reducing feeswhere the patient attends the pharmacy 2-3 times a week would seem to present anumber of difficulties to pharmacies. Most pharmacists agree to run a treatment"program" (i.e., a comprehensive pharmaceutical care model) where the delivery of adose is but a small part of the total package. In other words, clients are paying (weekly)for all that is involved in the service. In many cases, the pharmacist takes on the role ofcase manager and all that that entails. The fact that one client may attend less oftenthan daily attendees do, might have no influence on either the amount of workperformed or the complexity of what the pharmacist may be called on to provide.

2. Where buprenorphine is provided in the form of Suboxone with long term takeaways (7or more per month) the fee charged needs to be evaluated in terms of cost recoveryneeded for the pharmacy. The research may need to inform what is the optimumtreatment regime for people who are stable. The temptation to reduce pharmacy-administered doses and thereby reduce costs for clients is an irresistible one for manyclients, possibly to their personal detriment. Two or three day dosing is certainly notsuitable for all clients. Some are not sustained; others cope poorly with the loading dose.Others drift off into illicit drug use. The 2 day or 3 day regimen is simply too long formany. The interaction with the pharmacist is lost and for many, this is an essential partof what works for them. Therefore, such a reduced fee needs to be carefully considered.

8.5 A “raw deal”?

The situation confronting patients has been given additional attention by the recent publication of aVictorian study of the impacts of the fee-for-service model on OST patients in that state. ThisVictorian study on OST funding argued there are negative health impacts on patients in OST whohave to pay for their treatment (Rowe, 2008), and set out an equity basis for coverage of dispensingfees. Rowe writes persuasively, and the equity issue should not be overlooked in the co-paymentdebate.


14

9. The Australian situation

9.1 Number of patients in OST and in public/private settings

It is useful to take a view over the past two decades. The number of patients enrolled in methadoneand buprenorphine maintenance treatments in Australia has increased steadily over the past twodecades, most of the increase being in the private sector where patients pay for aspects of theirtreatment. There were approximately 4,446 patients in an opioid substitution therapy withmethadone in June 1987 and this increased to 14,996 by June 1994, and to a further estimated18,000 by June 1995 (Australian Institute of Health and Welfare, 2008; Commonwealth Departmentof Human Services and Health, 1995). The participation per hundred thousand of the populationaged 15 years to 54 years increased from 47 per 100,000 in June 1987 to 144 per 100,000 in June1984, to 328 per 100,000 in 2007. Based on these figures, almost exactly 0.33 percent of thepopulation aged 15-54 is in OST currently, a rate of treatment participation that is very substantial,and that probably represents 40% - 50% of all opioid-dependent persons in the country currently(Hall, Ross, Lynskey, Law, & Degenhardt, 2000). While this is an impressive participation rate, italso suggests that approximately half of the target population are not in care, and that they arecausing significant harms to themselves and the community.

Over that period from 1987 to 2007, the largest change in the supply of opioid substitution therapyhas come from the expansion of interventions provided through the private sector, rather than anexpansion of publicly-funded treatment programmes. That is, there has been a larger increase inpersons receiving methadone treatment from private medical practitioners than from publicly-fundedtreatment programmes. Nationally, the number of clients enrolled in public methadone increasedfrom 2,701 in June 1987 to 6,541 in June 1994 and to 10,695 by 2007. Over the same period thenumbers enrolled in private methadone increase from 1,745 to 8,449 in June 1994, and then to25,153 in 2007 (Australian Institute of Health and Welfare, 2008; Commonwealth Department ofHuman Services and Health, 1995). The participation rates have increased from 1987 to 2007 from28 to 116 per 100,000 for public settings, compared with 19 to 212 per 100,000 for private settings,most of the expansion being due to general practitioner and community pharmacy involvement.

9.2 The Australian Pharmaceutical Benefits Schedule

In Australia, in addition to the drugs and medicinal preparations available under normal PBSarrangements, a number of drugs are also available as pharmaceutical benefits but are distributedunder alternative arrangements where these are considered more appropriate. These alternativearrangements are provided for under section 100 of the National Health Act 1953.

Several programs exist for the provision of drugs as pharmaceutical benefits in this way and thissection lists those drugs which are available under the following programs: Highly Specialised DrugsProgram; Botulinum Toxin Program; Human Growth Hormone Program; IVF/Gift Program; OpiateDependence Treatment Program; and the Special Authority Program. The Australian Governmentfunds the cost of buprenorphine hydrochloride, buprenorphine hydrochloride with naloxonehydrochloride and methadone hydrochloride supplied as pharmaceutical benefits through clinics andpharmacies approved by State and Territory governments under Section 100.

There has been discussion of the role of the PBS to cover all of the costs of OST beyond any safetynet considerations, and the need to change from Section 100 to Section 85, but there is anargument that Section 100 can be used to unit dose, and that unit costs can be defined as suitablefor OST rather than a simple dispensing cost per day. A review of Section 100 may occur in thefuture, and it might then be determined whether it is appropriate mechanism for OST. At this time, itis beyond the scope of this document to comment on appropriate funding mechanisms, but it is clearthat a careful consideration of the pros and cons of Section 100 compared with other ways offunding OST would be helpful to guide the debate.


15

Of course, the two payment structures canvassed, s85 and s100, may not be the mostoptimum/appropriate funding models. Potentially there is a third alternative which would involveestablishing a separate funding model specifically targeted at the different areas if addiction care.

In the meantime, recent research has indicated that while government payment of all dispensingcosts would be relatively expensive for the government, making OST with methadone among the 20most costly funded by the Commonwealth under the PBS, substantial cost savings would ensue andwould provide a cost-saving of $12.8 million to $23.1 million per month (Chalmers, Ritter, Heffernan,& McDonnell, 2008).


16

10.SummaryIn summary, OST is effective in reducing illicit heroin use, and it is associated with health gains forthe user/patient, as well as significantly reduced crime in the community, and overall cost-benefitsfor society. The results from comprehensive reviews around the world are all convergent andconclusive about the benefits from OST. The consistency of the result has led the WHO to listmethadone and buprenorphine on the WHO Model List of Essential Medicines.

Retention in treatment is critical to achieving and maintaining these outcomes. Retention is affectedby a range of clinical and accessibility factors. Cost to the patient is an important factor in thisgroup. Having marginalised heroin users pay up to $1,600 to $2,000 of their government benefit forthis treatment is likely to be unattractive and render poorer retention rates than a system with eitherreduced costs or no costs.

The involvement of community pharmacies in OST is essential in Australia, and so is decreasingdisincentives to the community pharmacy sector to participate in the OST program, and increasingthe acceptability of the program to patients and thus their retention in treatment.

It is important to better understand the nature of the effect of fees on retention, and the best way forpatient payments to be made in community pharmacy delivered OST. Research addressing theissue has been lacking for the best part of 20 years, and it is timely that the issue be addressed inrandomised research as well as through other methodologies.

The ultimate mechanism for funding OST in Australia will require consideration of a number offactors associate with the benefits of such funding, the mechanisms in place already, and the bestway to support the OST program.


17

11.Appendix A: ReferencesAlbrecht, L. C., Roberts, A. S., Benrimoj, C. S. I., Williams, K. A., Chen, T. F., & Aslani, P. (2006).

Cognitive pharmaceutical services: Financial facilitators. Pharmacist, 25, 809-816.

Alho, H., Sinclair, D., Vuori, E., & Holopainen, A. (2007). Abuse liability of buprenorohine-naloxone

tablets in untreated IV drug users. Drug and Alcohol Dependence, 88, 75-78.

Amato, L., Davoli, M., Perucci, C. A., Ferri, M., Faggiano, F., & Mattick, R. P. (2005). An overview

of systematic reviews of the effectiveness of opiate maintenance therapies: Available evidence

to inform clinical practice and research. Journal of Substance Abuse Treatment, 28, 321-329.

American Psychiatric Association. (2000). Diagnostic and Statistical Manual of Mental Disorders

(Fourth Edition, Text Revision ed.). Washington, DC: American Psychiatric Association.

Anglin, M. D., Speckart, G. R., Booth, M. W., & Ryan, T. M. (1989). Consequences and costs of

shutting off methadone. Addictive Behaviors, 14, 307-326.

Australian Institute of Health and Welfare. (2008). National opioid pharmacotherapy statistics

annual data collection: 2007 report. Canberra: Author.

Ball, J. C., & Ross, A. (1991). The effectiveness of methadone maintenance treatment: Patients,

programs, services, and outcome. Vienna: Springer-Verlag.

Ball, J. C., Shaffer, J. W., & Nurco, D. N. (1983). The day-to-day criminality of heroin addicts in

Baltimore - a study in the continuity of offence rates. Drug and Alcohol Dependence, 12, 119-

142.

Barnett, P. G., & Hui, S. S. (2000). The cost-effectiveness of methadone maintenance. Mount Sinai

Journal of Medicine, 67, 365-374.

Barnett, P. G., Rodgers, J. H., & Bloch, D. A. (2001). A meta-analysis comparing buprenorphine to

methadone for treatment of opiate dependence. Addiction, 96, 683-690.

Barnett, P. G., Zaric, G. S., & Brandeau, M. L. (2001). The cost-effectiveness of buprenorphine

maintenance therapy for opiate addiction in the United States. Addiction, 96, 1267-1278.

Bell, J., Fernandes, D., & Batey, R. (1990). Heroin users seeking methadone treatment. Medical

Journal of Australia, 152, 361-364.

Bell, J., Ward, J., Mattick, R., Hay, A., Chan, J., & Hall, W. (1995). An evaluation of private

methadone clinics (No. No 4). Canberra: Commonwealth of Australia.

Breen, C., Harris, S., Hawken, L., Mattick, R., Lintzeris, N., Ritter, A., & Mendoza, E. (2003).

Cessation of methadone maintenance treatment using buprenorphine: Transfer from

methadone to buprenorphine and subsequent buprenorphine reductions. Drug and Alcohol

Dependence, 71(1), 49-55.

Caplehorn, J. R. M. (1998). Deaths in the first two weeks of maintenance treatment in NSW in

1994: Identifying cases of iatrogenic methadone toxicity. Drug and Alcohol Review, 17, 9-17.

Caplehorn, J. R. M., Dalton, M. S. Y. N., Cluff, M. C., & Petrenas, A. M. (1994). Retention in

methadone maintenance and heroin addicts' risk of death. Addiction, 89, 203-207.


18

Caplehorn, J. R. M., Dalton, M. S. Y. N., Halder, F., Petrenas, A. M., & Nisbet, J. G. (1996).

Methadone maintenance and addicts' risk of fatal heroin overdose. Substance Use and Misuse,

31, 177-196.

Caplehorn, J. R. M., & Drummer, O. H. (1999). Mortality associated with New South Wales

methadone programs in 1994: lives lost and saved. Medical Journal of Australia, 170, 104-109.

Caplehorn, J. R. M., & Drummer, O. H. (2002). Fatal methadone toxicity: signs and circumstances,

and the role of benzodiazepines. Australian and New Zealand Journal of Public Health, 26(4),

358-362.

Chalmers, J., Ritter, A., Heffernan, M., & McDonnell, G. (2008). Pharmacotherapy maintenance in

Australia: exploring affordability, availability, accessibility and quality using a systems dynamic

modelling approach. Sydney: National Drug and Alcohol Research Centre.

Commonwealth Department of Human Services and Health. (1995). Review of methadone

treatment in Australia. Canberra: Author.

Darke, S., Degenhardt, L., & Mattick, R. (2007). Mortality amongst illicit drug users. Melbourne:

Cambridge University Press.

Degenhardt, L., Rendle, V., Hall, W., Gilmour, S., & Law, M. (2004). Estimating the number of

current regular heroin users in NSW and Australia 1997-2002. Sydney: National Drug and

Alcohol Research Centre.

Des Jarlais, D. C. (1982). Retention rates among New York City methadone patients: A response

to Bayer and Koenigsberg [Letter to the editor]. International Journal of the Addictions, 17, 929-

930.

Dole, V. P., & Joseph, H. J. (1978). Long-term outcome of patients treated with methadone

maintenance. Annals of the New York Academy of Sciences, 311, 181-189.

Dole, V. P., & Nyswander, M. (1965). A medical treatment for diacetylmorphine (heroin) addiction:

A clinical trial with methadone hydrochloride. Journal of the American Medical Association,

193, 80-84.

Dole, V. P., & Nyswander, M. (1967). Heroin addiction : A metabolic disease. Archives of Internal

Medicine, 120, 19-24.

Dole, V. P., & Nyswander, M. (1976). Methadone maintenance treatment: A ten-year perspective.

Journal of the American Medical Association (JAMA), 235, 2117-2119.

Dole, V. P., Robinson, J. W., Orraca, J., Towns, E., Searcy, P., & Caine, E. (1969). Methadone

treatment of randomly selected criminal addicts. New England Journal of Medicine, 280,

1372 - 1375.

Fleming, G. F., McElnay, J. C., Hughes, C. M., Sheridan, J., & Strang, J. (2001). The role of

community pharmacist in drug abuse: A comparision of servce provision between Northern

Ireland and England/Wales. Pharmacy World and Science, 23, 13-16.

Gastelurrutia, M. A., Faus, M. J., & Fernandez-Llimos, F. (2005). Providing patient care in

community pharmacies in Spain. Annals of Pharmacotherapy, 39, 2105-2110.


19

Gerstein, D. R., & Harwood, H. J. (1990). Treating drug problems. Volume 1: A study of

effectiveness and financing of pubic and private drug treatment systems. Washington D.C.:

Institute of Medicine, National Academy Press.

Goldstein, A., & Herrera, J. (1995). Heroin addicts and methadone treatment in Albuquerque: a 22-

year follow-up. Drug and Alcohol Dependence, 40, 139-150.

Greater Glasgow Area Pharmaceutical Committee. (2000). Guidelines for supervision of

methadone consumption in pharmacies. Glasgow: Greater Glasgow Health Board.

Hall, W., Ross, J., Lynskey, M., Law, M., & Degenhardt, L. (2000). How many dependent opioid

users are there in Australia?, National Drug and Alcohol Research Centre Monograph Series

44. Sydney: National Drug and Alcohol Research Centre.

Hall, W., & Wodak, A. (1999). Is naltrexone a cure for heroin dependence? The evidence so far is

not promising. Medical Journal of Australia, 171, 9-10.

Harwood, H. J., Malhotra, D., Villarivera, C., Liu, C., Chong, U., & J., G. (2002). Cost effectiveness

and cost benefit analysis of substance abuse treatment: an annotated bibliography. Falls

Church Va.: Centre for Substance Abuse Treatment.

Hser, Y. I., Angkin, D. M., & Powers, K. (1993). A 24-year follow-up of California narcotics addicts.

Archives of General Psychiatry, 50, 577-584.

Hser, Y. I., Hoffman, V., Grella, C. E., & Anglin, D. (2001). A 33-year follow-up of narcotics addicts.

Archives of General Psychiatry, 58, 503-508.

Hubbard, R. L., Marsden, M. E., Rachal, J. V., Harwood, H. J., Cavanagh, E. R., & Ginzburg, H. M.

(1989). Drug abuse treatment: A national study of effectiveness. Chapel Hill, NC: University of

North Carolina Press.

Jaffe, J. H., & Martin, W. R. (1990). Opioid analgesics and antagonists. In A. G. Gilman, T. W. Rall,

A. S. Nies & P. Taylor (Eds.), The pharmacological basis of therapeutics (8th ed., pp. 485-521).

New York: Pergamon Press.

Johansson, B. A., Berglund, M., & Lindgren, A. (2006). Efficacy of maintenance treatment with

naltrexone for opioid dependence: a meta-analytical review. Addiction, 101, 491-503.

Kalke, J. (1997). Distribution of methadone by pharmacies - the Hamburg method

Gesundheitswesen, 59, 181-185.

Lawrinson, P., Roche, A., Terao, H., & Le, P. P. (2008). Dispensing opioid substitution treatment:

Practices, attitudes and intentions of community-based pharmacists. Drug and Alcohol Review,

27, 47-53.

Lind, B., Chen, S., Weatherburn, D., & Mattick, R. (2005). The effectiveness of methadone

maintenance treatment in controlling crime. British Journal of Criminology, 45, 201-211.

Lintzeris, N., Pritchard, E., & Sciacchitano, L. (2007). Investigation of methadone dosing in Victoria:

Factors influencing dosing levels. Melbourne: Turning Point Alcohol and Drug Centre.

Maddux, J. F., & Desmond, D. P. (1992). Methadone maintenance and recovery from opioid

dependence. American Journal of Drug and Alcohol Abuse, 18, 63-74.


20

Maddux, J. F., Prihoda, T. J., & Desmond, D. P. (1994). Treatment fees and retention on

methadone maintenance. Journal of Drug Issues, 24, 429-443.

Mathers, B., Degenhardt, L., Phillips, B., Wiessing, L., Hickman, M., Strathdee, S., Wodak, A.,

Panda, S., Tyndall, M., Toufik, A., & Mattick, R. P. (2008). The global epidemiology of injecting

drug use and HIV among people who inject drugs: A systematic review. Lancet, 372, in press.

Matheson, C., Bond, C. M., & Mollison, J. (1999). Attitudinal factors associated with community

pharmacists' involvement in services for drug misusers. Addiction, 94, 1349-1359.

Matheson, C., Bond, C. M., & Tinelli, M. (2007). Community pharmacy harm reduction services for

drug misusers: National service delivery and professional attitude development over a decade

in Scotland. Journal of Public Health, 29, 350-357.

Mattick, R. P., Ali, R., White, J. M., O'Brien, S., Wolk, S., & Danz, C. (2003). Buprenorphine versus

methadone maintenance therapy: a randomized double-blind trial with 405 opioid-dependent

patients. Addiction, 98, 441-452.

Mattick, R. P., Breen, C., Kimber, J., & Davoli, M. (2004). Methadone maintenance therapy versus

no opioid replacement therapy for opioid dependence (Cochrane Review). The Cochrane

Library Issue 3.

Mattick, R. P., Breen, C., Kimber, J., & Davoli, M. (2008). Methadone maintenance therapy versus

no opioid replacement therapy for opioid dependence. The Cochrane Database of Systematic

Reviews(Issue 2).

Mattick, R. P., & Hall, W. (1996). Are detoxification programmes effective? Lancet, 347, 97-100.

Mattick, R. P., Kimber, J., Breen, C., & Davoli, M. (2004). Buprenorphine maintenance versus

placebo or methadone maintenance for opioid dependence (Cochrane Review). The Cochrane

Library Issue 3.

Mattick, R. P., Kimber, J., Breen, C., & Davoli, M. (2008). Buprenorphine maintenance versus

placebo or methadone maintenance for opioid dependence. The Cochrane Database of

Systematic Reviews, Issue 2.

Mattick, R. P., Ward, J., & Hall, W. (1998). The role of counselling and psychological therapy. In J.

Ward, R. P. Mattick & W. Hall (Eds.), Methadone maintenance treatment and other opioid

replacement therapies. Australia: Harwood Academic Publishers.

Morrison, S. (2008). Pharmacy incentive scheme. Sydney.

MSIC Evaluation Committee. (2003). Final report on the evaluation of the Sydney medically

supervised injecting centre. Sydney: Authors.

Murphy, S., & Rosenbaum, M. (1988). Money for methadone: II. Unintended consequences of

limited-duration methadone maintenance. Journal of Psychoactive Drugs, 20, 397-402.

Neilsen, S., Deitze, P., Dunlop, A., Muhleisen, P., Lee, N., & Taylor, D. (2007). Buprenorphine

supply by community pharmacists in Victroia Australia: Perceptions, experiences and key

issues identified. Drug and Alcohol Review, 26, 143-151.


21

Noyce, P. R. (2007). Providing patient care through community pharmacies in the UK: Policy,

practice and research. Annals of Pharmacotherapy, 41, 861-868.

Raisch, D. W., Fudala, P. J., Saxon, A. J., Walsh, R., Casadnte, P., Ling, W., Johnson, B. A.,

Johnson, B. A., Malkerneker, U., Ordorica, P., Williford, W. O., & Sather, M. R. (2005).

Pharmacists' and technicians' perceptions and attitudes toward dispensing

buprenorphine/naloxone to patients with opioid dependence. Journal of the American

Pharmacists Association: JAPhA, 45, 23-32.

Roberts, A. S., Benrimoj, C. S. I., Chen, T. F., Williams, K. A., Hopp, T. R., & Aslani, P. (2005).

Understanding practice change in community pharmacy: A qualitative study in Australia.

Research in Social and Administrative Pharmacy, 1, 546-564.

Rosenbaum, M., Irwin, J., & Murphy, S. (1988). De facto destabilization as policy: The impact of

short-term methadone maintenance. Contemporary Drug Problems, 15, 491-517.

Rosenbaum, M., UIrwin, J., & Murphy, S. (1987). Money for methadone: Preliminary findings from

a study of Alameda County's new maintenance policy. Journal of Psychoactive Drugs, 19,

13-19.

Rosenbaum, M., Washburn, A., Knight, K., Kelley, M., & Irwin, J. (1996). Treatment as harm

reduction, defunding as harm maximisation: The case of methadone maintenance. Journal of

Psychoactive Drugs, 28, 241-249.

Ross, J., Teesson, M., Darke, S., Lynskey, M., Ali, R., Ritter, A., & Cooke, R. (2005). The

characteristics of heroin users entering treatment: Findings from the Australian Treatment

Outcome Study (ATOS). Drug and Alcohol Dependence, 24, 411-418.

Roughhead, L., Semple, S., & Vitry, A. (2002). The value of pharmacist professional services in the

community setting: A systematic review of the literature 1990-2002. Adelaide: University of

South Australia.

Rowe, J. (2008). A raw deal? Impact on the health of consumers relative to the cost of

pharmacotherapy. Melbourne: Centre for Applied Social Research (RMIT).

Samitca, S., Hiuissoud, T., Jeannin, A., & Dubois-Arber, F. (2007). The role of pharmacies in the

care of drug users: What has changed in ten years. The case of a Swiss region. European

Addiction Research, 13, 50-56.

Shanahan, M., Hetherington, K., Mattick, R. P., & Weatherburn, D. (2007). Estimating the cost-

savings of reduced crime while in methadone treatment. Sydney, NSW: National Drug and

Alcohol Research Centre, University of New South Wales.

Sheridan, J., Manning, V., Ridge, G., Mayet, S., & Strang, J. (2007). Community pharmacies and

the provision of opioid substitution services for drug misusers: Changes in activity and attitudes

of community pharmacists across England 1995-2005. Addiction, 102, 1824-1830.

Sheridan, J., Strang, J., Barber, N., & Glanz, A. (1996). Role of community pharmacies in relation

to HIV prevention and drug misuse: Findings from the 1995 national study of in England and

Wales. British Medical Journal, 313, 1480-1481.


22

Sheridan, J., Strang, J., Taylor, C., & Barber, N. (1997). HIV prevention and drug treatment

services for drug misusers: A national study of community pharmacists' attitudes and their

involvement in service specific training. Addiction, 92, 1737-1748.

Sheridan, J., Wheeler, A., & Walters, C. (2005). Health problems and health seeking activities at

Auckland methadone service: Potential for community pharmacy service expansion? Harm

Reduction Journal, 2, 25-29.

Strang, J., Sheridan, J., & Barber, N. (1996). Prescribing injectable and oral methadone to opiate

addicts: Results from the 1995 national postal study of community pharmacies in England and

Wales. British Medical Journal, 313, 245-246.

United Nations. (1948). Universal Declaration of Human Rights In United Nations General

Assembly Resolution 217 A (III) of 10 December 1948. New York: United Nations.

Ward, J., Hall, W., & Mattick, R. P. (1999). Role of maintenance treatment in opioid dependence.

Lancet, 353, 221-226.

Ward, J., Mattick, R. P., & Hall, W. (1992). Key issues in methadone maintenance treatment.

Sydney: New South Wales University Press.

Ward, J., Mattick, R. P., & Hall, W. (Eds.). (1998). Methadone maintenance treatment and other

opioid replacement therapies. London: Harwood Press.

West, S. L., O'Neal, K. K., & Graham, C. W. (2000). A meta-analysis comparing the effectiveness

of buprenorphine and methadone. Journal of Substance Abuse, 12, 405-414.

Winstock, A., Lea, T., & Molan, J. (2008). NSW community pharmacy survey: SWAT report 2 (Vol.

297). Sydney: National Drug and Alcohol Research Centre.

Winstock, A. R., Lea, T., & Ritter, A. (2007). The impact of community pharmacy dispensing fees

on the introduction of buprenorphine - naloxone in Australia. Drug & Alcohol Review, 26, 411-

416.


23

www.pwc.com/au

© 2008 PricewaterhouseCoopers. All rights reserved. “PricewaterhouseCoopers” refers to the networkof member firms of PricewaterhouseCoopers International Limited, each of which is a separate and independent legal entity.*connectedthinking is a trademark of PricewaterhouseCoopers LLP (US).

6

AppendicesAppendix D – Pharmacy consent bundle

Pharmacotherapy for Opiate Dependence Funding Trial

Invitation for Pharmacies to Participate

We are currently seeking community pharmacies to participate in a trial evaluating a national funding modelfor pharmacotherapy treatment for opioid dependence. This study is funded by the Pharmacy Guild ofAustralia (PGA) under the fourth Pharmacy Agreement with the Commonwealth Department of Health andAgeing. A potential outcome of this research will be an evidence-based business case for submission to theGovernment on options for a nationally consistent model for the pharmacotherapy program in communitypharmacies.

Background to the research

Sixty four percent of all patients on pharmacotherapytreatment attend Community pharmacies. Fewstudies have been completed on pharmacists’contribution to the treatment of opioid dependencyand there are a variety of different practices betweenstates and territories across Australia.

The PGA has engaged PricewaterhouseCoopers(PwC) and the National Drug and Alcohol ResearchCentre to develop, trial and evaluate a nationalfunding model for pharmacotherapy treatment foropioid dependence in community pharmacy.

Trial design

A nine month national, randomised trial willcommence in early 2009 and test the impact ofpayments to community pharmacies to reduce thecost to consumers receiving pharmacotherapytreatment at community pharmacies.

Community pharmacies assigned to the interventiongroup will receive payments in order to reduce thecost of the co-payment that the consumer pays.Consumers receiving treatment from the controlgroup pharmacies will continue to receive usual care.

The trial will recruit one hundred communitypharmacies and seven hundred consumers across allstates and territories.

All participating pharmacies will receive payment forproviding data.

All Australian pharmacies currently dispensingpharmacotherapy will be eligible to participate in thetrial.

Data will be collected from the pharmaciesparticipating in the trial and from consentingconsumers; at the beginning and the end of the trial.

What Participation involves

As part of the trial, participating pharmacies will beasked to invite their patients to participate in the trial.Following recruitment, the participating pharmacieswill be randomly allocated to the intervention orcontrol group. Eligible patients are those who areaged 18 years and over and receivingpharmacotherapy treatment for opioid dependence ina participating community pharmacy.

Participating pharmacies (in both the intervention andcontrol groups) will be asked to complete a survey atthe beginning and the end of the trial, Pharmacistswill be reimbursed $60 for the completion of each ofthe two surveys. These surveys will collectinformation on pharmacy characteristics and on theattendance and compliance rates of the individualparticipants that have been recruited into the study.

The following table outlines the types of paymentsthat will be made to both intervention and controlgroup pharmacists and to the intervention and controlgroup patients.

Page 2 of 2


Some participating pharmacies (up to 20) may alsobe asked to participate in an observational study toassess the time that pharmacy staff take to providepharmacotherapy services in order to betterunderstand the associated costs.

To register your interest for participation in the trial,please contact the PwC project team on1800 819 740 or via email to [email protected]

Intervention and controlgroup

Control groupIntervention groupIntervention groupIntervention and control

group

Interventionor control

group

$35 shopping voucher(twice)

The completion of atelephone interview byconsented patients at

baseline and end of trial

Patient interview

$50(monthly)

$15(weekly)

$15(weekly)

$60(twice)

Value ofpayment

Monthly payment topharmacies for

overhead costs andcontrol patient dosing

data

Payment made topharmacies per

intervention patient perweek for overhead costsand intervention patient

dosing data

Payment made topharmacies per patientper week for patient fee

subsidy

Completion of onlinesurvey at baseline and

end of trial byconsented pharmacies

Activity thatgenerates the

payment

Pharmacist incentivepayment


Subsidy paymentPharmacy survey

Type of payment

Intervention and controlgroup

Control groupIntervention groupIntervention groupIntervention and control

group

Interventionor control

group

$35 shopping voucher(twice)

The completion of atelephone interview byconsented patients at

baseline and end of trial

Patient interview

$50(monthly)

$15(weekly)

$15(weekly)

$60(twice)

Value ofpayment

Monthly payment topharmacies for

overhead costs andcontrol patient dosing

data

Payment made topharmacies per

intervention patient perweek for overhead costsand intervention patient

dosing data

Payment made topharmacies per patientper week for patient fee

subsidy

Completion of onlinesurvey at baseline and

end of trial byconsented pharmacies

Activity thatgenerates the

payment



Subsidy paymentPharmacy survey

Type of payment

Page 1 of 2

This project has been funded by the Department of Health and Ageing under the Fourth Community Pharmacy Agreement Researchand Development program


What do I need to do now?

If you decide you want to proceed with consenting to participate in the trial, the following table outlines theinitial actions that you need to undertake prior to the commencement of client recruitment.

Document Description Action RequiredAction

completed

PharmacyParticipantFrequentlyAsked Questions

This document contains thefrequently asked questions andprovides answers for theconvenience of the pharmacist

There is no action required from you regarding thisdocument; it is for your information only.

NA

PharmacyInformationStatement andConsent Form

The document containsbackground information on thetrial and two copies of theconsent form.

You are required to read the information in thisdocument.

Please sign both copies of the consent form in thepresence of a witness and send the ORIGINAL formback to PricewaterhouseCoopers in the prepaidenvelope provided. The other copy should be kept foryour records.

Please aim to have this returned to us within a week.

PharmacyInformation Form

This information is the coreinformation we would like to getfrom you regarding yourpharmacy details andcharacteristics.

Please fill in the information on the form and return itto us with the signed copy of your consent form in theprepaid envelope provided.


PharmacySatisfactionQuestionnaire

The satisfaction questionnairehas been designed to give usan understanding of the level ofsatisfaction you (as thepharmacist) have with thecurrent pharmacotherapyprogram.

Please tick your response to each question on theform and return it with the signed copy of yourconsent form in the prepaid envelope provided.


Please endeavour to have the documents returned to us as soon as possible, preferably within a week ofreceiving them, so we can send you your client consent pack and you can begin to recruit your clients to thetrial.

If you have questions regarding any of the information in the documents or questions you may have about thetrial please do not hesitate to contact us on 1800 819 740 (Mon-Fri 9:00am-5:00pm EST) or email yourenquiry to [email protected] and we will get back to you as soon as possible.

Page 2 of 2


Next steps

Once we have received your signed consent form, completed pharmacy information form and your completedpharmacy satisfaction questionnaire we will send to you your client consent and invoicing pack.

This pack will contain the following documents:

How to Gain Client Consent

Client Participant Information Statement and Consent Form

Client Participant Frequently Asked Questions

Client Locator Form

Payment Information Sheet

Invoicing Templates

Drug Subsidiary Log

CD ROM (containing electronic versions of the data collection forms, templates and drug subsidiarylog).

Many thanks,

The Project Team.

Page 1 of 2



Pharmacy Participant - Frequently Asked Questions

Please find below some of the most frequently asked questions regarding the pharmacotherapytrial. If you need further information or would like to ask additional questions, please contactPricewaterhouseCoopers on 1800 819 740 (Mon-Fri 9:00am-5:00pm EST) or email your enquiryto [email protected]

Q What is the aim of the study?A The results of this study will be summarised into an

evidence-based business case for submission toGovernment and will outline options for thedevelopment of a nationally consistent model forfuture funding of the pharmacotherapy program incommunity pharmacies.

This trial tests whether a nationally funded programwill enable community pharmacies to reduce the costto clients receiving treatment at communitypharmacies, improve retention in treatment andincrease income to community pharmacists whodeliver the opioid pharmacotherapy service.

Q How long will the trial go for?A The trial will run over a nine-month period with a

staggered commencement date for individualpharmacies. The first pharmacies will commence inearly 2009. Each pharmacy will participate for sixmonths.

Q By when will the project be completed?A Data collection from the participating pharmacies and

the client participants will continue up until late 2009.The final report will be submitted to the PharmacyGuild of Australia (PGA) in April 2010.

Q When will you start recruiting pharmacies?A Pharmacy recruitment will begin the end of January

2009.

Q How much will I be compensated for participating?A All pharmacies selected for the trial will be

compensated for providing data. Pharmacists in boththe intervention group and the control group will

receive two $60 payments for providing data to thetrial via a survey at baseline and end of trial.

Pharmacies in the intervention group will receive $15payments per participating client per week for theclient fee subsidy and $15 per participating client perweek for overhead costs and supply of data on clientattendance. Pharmacies in the control group willreceive $50 for each monthly supply of data on clientattendance and overhead costs.

Q How will the control and intervention groups beallocated?

A Pharmacists who agree to participate will be randomlyallocated to either a control group or interventiongroup. The allocation will result in 66% of thepharmacies being in the intervention group. Both theintervention and control groups will be representativeof the distribution of community pharmacies acrossAustralia.

Q How will the subsidised payments work?A Pharmacies allocated into the control group will

continue to provide usual care and charge their clientparticipants the usual charge. Pharmacies allocatedinto the intervention group will receive $30/week/clientparticipant, and must reduce the cost ofpharmacotherapy medication to consumers by$15/week for each client participating in the trial. Theweekly benefit the pharmacy receives can be paid viaEFT either monthly during the duration of the trial oras a lump sum at the end of the trial.

Q Who will receive the payment?A The payment will be made to the pharmacy.

Page 2 of 2


Q How will you know how much to pay the interventiongroup pharmacies each month?

A Intervention group pharmacies will be asked to fill outa monthly form to indicate how many clients weredispensed pharmacotherapy during each week overthe month. We will provide intervention grouppharmacists with a form to track subsidiseddispensing fees. This form will be provided tointervention group pharmacists in the clientrecruitment pack.

Q What is required of pharmacies in the control group?A All participating pharmacies will be paid for time spent

providing data to the trial. Control group pharmacieswill be asked to fill out a monthly form to indicate howmany clients were dispensed pharmacotherapy inaddition to the pharmacy information sheet andsatisfaction questionnaire. The outcome of this studymay benefit all community pharmacies in the futurewho participate in the pharmacotherapy programs.

Q What benefit do the clients get?A The clients in the intervention groups will have the

dispensing fee charged to them reduced by $15 perweek. Control group clients will continue to receiveusual care and will be charged the usual fee. Bothgroups of clients will also receive two $35 Myer giftvouchers redeemable at any of the Myer group outletsincluding Coles, Myer, Target, K-Mart and Bi-Loamongst others. These gift cards are payable toclients who complete two surveys approximating onehour each, to compensate them for their out-of-pocketexpenses.

Q How will I know how many clients to recruit?A We encourage pharmacies to recruit all their clients

who are currently on the pharmacotherapy program.This will reduce any conflict that may arise if someclients are part of the trial and some are not.

Q What do I have to do to recruit the clients?A PwC will be providing a comprehensive “Client

Consent Bundle” which will provide each pharmacywith the information needed in regards to clientrecruitment. The pharmacy will be asked to providethe client with a consent form and inform them of thenature of the trial and the advantage anddisadvantage of their participation. A client participant– frequently asked questions form will also beavailable.

Q By when do I have to have all my current clientsrecruited?

A We have established a cut-off date a week after youhave received your “Client Consent Bundle” to recruityour clients who attend your pharmacy regularly. Ifyou have a client who does not attend your pharmacyregularly then you will need to contact us to discussan extended timeframe.

Q Can clients from pharmacies allocated to the controlgroup transfer to pharmacies allocated to theintervention group and vice a versa after the trial hasstarted?

A Clients who have consented to join the trial in apharmacy allocated to the control group cannotparticipate in the trial at an intervention grouppharmacy. Clients can continue in the trial if theytransfer from a control group pharmacy to anothercontrol group pharmacy or from an intervention grouppharmacy to another intervention group pharmacy.There is no restriction on clients transferring betweenpharmacies for continuing treatment but notcontinuing in the trial.

Q What happens after I sign the consent form?A After PwC receives the pharmacy consent to

participate in the trial, PwC will contact the pharmacyto complete the first survey and send a “ClientConsent Bundle” which will provide informationregarding consenting clients. One all baseline datahas been collected form the pharmacy and theirclients they will be notified if they have beenallocated to the intervention of control group.

Page 1 of 4



Pharmacy Information Statement and Consent Form

Please read through all the information in this document prior to signing the consent form. Signboth copies of the consent form and send the original of the copy marked ‘please return toPricewaterhouseCoopers’ in the provided prepaid envelope within a week of receipt. Pleasekeep the other copy for your records.

You (i.e. the research pharmacist participant)are invited to participate in a study that will trialco-payments to community pharmacies that willreduce the cost to clients receivingpharmacotherapy treatment at communitypharmacies and may increase income volumeand security to community pharmacists. We (i.e.the investigators) hope to identify and evaluatealternative funding models for pharmacotherapytreatment in community pharmacies. Yourpharmacy was selected as a possible participantin this study because as you are a communitypharmacy who is currently dispensingpharmacotherapy treatment for opioiddependence. Ethics approval has been obtainedfor this study.

If you decide to participate:

Your pharmacy will be allocated to one oftwo groups – a group that receives theintervention (new funding) or a group thatreceives no intervention (no changes tofunding) – this allocation is completelyrandomised. Client participants will beallocated to the intervention or control groupbased on the pharmacy that they attend.

We cannot and do not guarantee or promisethat you will receive benefits from this study.

To participate in this study, you will berequired to recruit and obtain informedconsent from your clients, who are currently

receiving pharmacotherapy treatment foropioid dependence.

The trial will run for a period of nine months.

As a pharmacy participant you will be askedto complete a pre-trial and a post-trial surveyand provide data on a monthly basis. Thesurvey will collect information on thecharacteristics of your pharmacy. Themonthly data will supply information on theattendance and compliance rates of theindividual client participants that have beenrecruited into the study.

Your interactions with the client participantmay be observed as part of an activity basedcosting study; however the identity of you,your pharmacy and the participants willremain anonymous.

Any information that is obtained in connectionwith this study and that can be identified withyou will remain confidential and will be disclosedonly with your permission, except as required bylaw. We plan to publish the results in a report tothe Pharmacy Guild of Australia. This report willoutline the findings of the research and will besummarised into an evidence based businesscase for submission to government. Thisbusiness case will outline options for futurefunding of the pharmacotherapy program incommunity pharmacies and present a nationallyconsistent model. In any publication, information

Page 2 of 4

Pharmacotherapy Funding Trial

will be provided in such a way that you and yourclients cannot be identified.

As compensation for your time spent completingboth the pre-trial and post-trial surveys, you willreceive reimbursement of $120 ($60 persurvey).

Complaints may be directed to the EthicsSecretariat:

The University of New South Wales, SYDNEY2052 AUSTRALIAPhone: (02) 9385 4234,Fax: (02) 9385 6648,Email: [email protected]

Any complaint you make will be investigatedpromptly and you will be informed of theoutcome.

Feedback will be made available to pharmaciesvia email and the Pharmacy Guild of Australiawebsite. Emails will provide an update on thecompletion of the study and a link to thePharmacy Guild of Australia website wherefurther information on the study can be found.

Participation in this study is voluntary. Yourdecision whether or not to participate will notprejudice your future relations with the Universityof New South Wales, PricewaterhouseCoopersor the Pharmacy Guild of Australia. If you decideto participate, you are free to withdraw yourconsent and to discontinue participation at anytime without prejudice.

If you have any questions, please feel free tocontact PricewaterhouseCoopers on1800 819 740 or [email protected]

Prof. Richard P Mattick can be contacted at theUniversity of New South Wales on (02) 93850331.

Please sign both copies of the accompanyingconsent form. Return the original of the copymarked ‘please return this copy toPricewaterhouseCoopers’ to us and keep theother copy for your records. Please aim to havethe consent form returned to us within a week ofreceipt; please notify us if you are unable to doso.

Page 3 of 4


Pharmacy Consent Form (please return this copy to PricewaterhouseCoopers)

You are making a decision whether or not to participate. Your signature indicates that, having read the informationprovided above, you have decided to participate.

Signature of Research Participant Signature of Witness

(Please PRINT name of Research Participant) (Please PRINT name of Witness)

Name of Pharmacy in which theresearch participant works

Date Nature of Witness

Revocation of Consent

I hereby wish to WITHDRAW my consent to participate in the research proposal described above and understandthat such withdrawal WILL NOT jeopardise any treatment or my relationship with The University of New SouthWales or PricewaterhouseCoopers.

Signature of research participant Date

(Please PRINT Name)

The section for Revocation of Consent should be forwarded to Ms Rebecca Jessop, PricewaterhouseCoopers,GPO 2650, Sydney NSW 1171 using the prepaid envelope provided.

Page 4 of 4


Pharmacy Consent Form (please keep this copy for your records)



(Please PRINT name of Research Participant) (Please PRINT name of Witness)

Name of Pharmacy in which theresearch participant works


Revocation of Consent

I hereby wish to WITHDRAW my consent to participate in the research proposal described above and understandthat such withdrawal WILL NOT jeopardise any treatment or my relationship with The University of New SouthWales or PricewaterhouseCoopers.

Signature of research participant Date

(Please PRINT Name)

The section for Revocation of Consent should be forwarded to Ms Rebecca Jessop, PricewaterhouseCoopers,GPO 2650, Sydney NSW 1171.

Page 1 of 2



Pharmacy Information Form

This form is for recording the required core data on participating pharmacies in the trial. Pleasereturn your completed information form with your signed consent and satisfaction survey in theprepaid envelope within a week of receipt.

Pharmacy name

Department of Health and Ageing approval number

State pharmacotherapy number_____________________________________________________________

Principal pharmacist

Name of preferred contact person at the pharmacy

Telephone number Mobile number

Fax number Preferred contact method (phone/mobile/fax/email)

Email address

Type of pharmacy (e.g. banner or independent)

Type of premises (e.g. shopping centre, street location etc)

Page 2 of 2


Number of clients on pharmacotherapy at this pharmacy taking:

Methadone/Biodone ________________ Subutex _______________ Suboxone _________________

Daily Dispensing Fee charged to the client for:

Methadone/Biodone $_______________ Subutex $_______________ Suboxone $________________

Is everyone charged the same rate in each of these medication groups (Yes/No)? ______________________

If No, what is the range ($XX - $YY) for:

Methadone/Biodone $_______________ Subutex $_______________ Suboxone $________________

Number of clients to which pharmacy is authorised to dispense____________________________________

Number of clients which the State subsidises (if any)__________________________________________

Once completed, please return this form along with one signed copy of the consent form and satisfactionsurvey in the prepaid envelope supplied within a week of receipt.

If you are unable to complete the form within the required timeframe, please notify us on 1800 819 740 (Mon-Fri 9:00am-5:00pm EST) or email us at [email protected]


Baseline Pharmacy Satisfaction Survey

This survey is designed to provide an indication of your overall satisfaction with the currentfunding arrangements for pharmacotherapy for opiate dependence. Please note that all theinformation provided will not be attributable to you and your responses will remain anonymousand be known only to research staff presiding over this project. Please return your completedsurvey with your signed consent and information form in the prepaid envelope within a week ofreceipt.

Pharmacy name

Completed by Date_______________________(Please print name)

For each question below, please tick the most appropriate box:

1. How satisfied are you with the current financial arrangements for the dispensing of pharmacotherapy?

1 Very satisfied 2 Satisfied 3 Neutral 4 Dissatisfied 5 Very dissatisfied

2. How satisfied are you with the current consumer contribution / co-payment for pharmacotherapy?


3. How satisfied are you with your current interactions and relationships with your clients on thepharmacotherapy program?


4. Overall, how satisfied are you with the pharmacotherapy program?


Once completed, please return this form along with one signed copy of the consent form and information form inthe prepaid envelope supplied within a week of receipt.

If you are unable to complete the form within the required timeframe, please notify us on 1800 819 740 (Mon-Fri9:00am-5:00pm EST) or email us at [email protected]


7

AppendicesAppendix E – Client consent bundle

Page 1 of 2



10/03/2009

Client Recruitment and Next Steps

We would like to thank you for the continued interest that you have expressed to participate in thepharmacotherapy for opiate dependence funding trial that PricewaterhouseCoopers is running inconjunction with the National Drug and Alcohol Research Centre for the Pharmacy Guild of Australia.

This folder contains all the documents you will need to participate in the trial over its duration. The folderis designed to help you recruit your clients to the trial in a quick and easy process which should not betoo time consuming. We encourage you to try and recruit ALL your current clients to the trial as this maysave problems down the track for your pharmacy as clients may get upset if they find out others in yourpharmacy are receiving their medication at a lower rate (that is, if you are randomly selected to theintervention group).

Following this letter you will find an outline on what is contained in the pack and exactly how to recruityour clients.

Please endeavour to recruit all of your clients as quickly as possible as this will ensure a timelycommencement of the trial. We envisage that the majority of pharmacies will have their clients recruitedwithin a week and then send in all client consent forms in the prepaid envelope/s provided. If this will beproblematic for you, please contact us to arrange an extended recruitment period.

The randomisation of the intervention and control groups will take place AFTER your recruited clientshave completed their baseline telephone survey.

After you have been assigned to either the control or intervention group, we will give you an OFFICIALSTART DATE for your commencement in the trial, this will be when you will begin to reduce your clientsco-payments (by $15 per week, client should pay a minimum of $5 per week after the subsidy) forintervention group pharmacies.

So please DO NOT reduce the cost of client medications (for intervention group pharmacies only) untilwe give you an official start date.

Control group pharmacies will also be given an official start date, but they will not be receiving anymonies to reduce the cost of medication, however they will receive a $50/month payment for their time tooffset overhead costs to provide data to the trial, clients will continue to receive their USUAL care.

The following table outlines the documents that you will find in this pack:

Page 2 of 2


Document Description Action RequiredAction

completed

Trial advertThis is a small advert that you can display inyour pharmacy to signal your participation inthe trial.

It is at your discretion if you choose to display theadvert in your pharmacy. You can find the adverton the inside cover of your folder.

NA

How to gainclientconsent

This document outlines the process you needto follow to gain “informed consent” (i.e. whenthe client understands the key facts about thetrial before deciding whether or not toparticipate) from your client.

Read through this document carefully to ensurethat you are familiar with the client recruitmentdocuments.

Clientfrequentlyaskedquestions

This document contains frequently askedquestions and provides answers in a clearand succinct way.

Read through this document carefully to ensurethat you are familiar with the types of questionsyou may be asked by your clients.

Clientinformationand consentform

This document contains backgroundinformation about the trial for the client andtheir consent form.

The client will need to sign the form in front ofyou. The signed section is to be mailed to us inthe prepaid envelope and the client is to take theremainder of the form home for their records.

Please aim to have your clients recruited within aweek.

Clientlocator form

The client locator form has been included toprovide us with the contact details of theclient and 3 other personal contacts of theclient participant. This will be used if they arenot contactable on their primary numberduring the trial, so that follow up may still bepossible.

Please fill this form out with your clients andensure that all information is captured. For yourconvenience this should be posted together withthe signed client consent.

Paymentinformationsheet

The business payment rules have beenprovided which outline the rules which governthe payment structure we have proposed.

Read through this document and ensure you arefamiliar with the payment rules for the trial.

Trialinvoices andinvoicingguide

This document provides you with the relevantinformation that you will need in order toproduce a valid invoice. We have providedinvoicing templates for your use; it is at yourdiscretion if you choose to use these.

If you prefer to use your own invoicing system,please ensure that the same information outlinedin our templates is included on your invoices toensure their validity and that there are no delaysin payment.

Subsidiarydrug log

The drug subsidiary register log contains theinformation we require on the dosing ofconsented clients throughout the trial.

We require this data to be submitted on a monthlybasis for both intervention and control grouppharmacies. This can be sent in conjunction withthe invoice assist with timely payments.

CD ROM The CD Rom has been included for yourconvenience; it has the some of the abovementioned forms on it so that you can providethese to us electronically.

The Drug Subsidiary Logs for Methadone,Biodone, Subutex and Suboxone, invoicingtemplates and the Client Locator Form are on theCD if you wish you use these.

If you have questions relating to the documents in this pack, client recruitment or the trial in generalplease do not hesitate to contact us on 1800 819 740 (Mon-Fri 9:00am-5:00pm EST) or email yourenquiry to and we will respond as soon as possible.

Kind regards,

The Project Team

Page 1 of 1



Guidelines for Gaining a Valid Client ConsentThis document outlines the key information that you will need to assist you in gaining informed and validclient consent. If you need further information or would like to ask additional questions, please contactPricewaterhouseCoopers on 1800 819 740 (Mon-Fri 9:00am-5:00pm EST) or email your enquiry [email protected]

We have included in our Client Consent Bundle anumber of items to allow you to gain informedconsent from a potential client participant. Included inthis bundle are the following documents:

Client Information and Consent Form

Is a required document, which will need to be signedby the client, to obtain a valid informed consent forparticipation in the trial. The ORIGINAL of the signedcopy must be sent back to PricewaterhouseCoopers,the client is to keep the second copy for their records.

The Client Information and Consent Form is the mostimportant form in the bundle. Once signed, the formprovides valid and informed consent for participation.Valid informed consent is required before a client isconsidered enrolled as a participant in the trial.

It is important that the pharmacist ensures it is“informed consent”; meaning the client understandsthe key facts about the trial before deciding whetheror not to participate. This includes the background,purpose, duration, required procedures and keycontacts; all of which will be in the information thatyou have received and is outlined in the clientfrequently asked questions.

We recommend that you familiarise yourself with thetrial information, expected outcomes and potentialbenefits to assist you with explaining the trial toenquiring clients.

Client Frequently Asked Questions

This document answers some of the anticipatedquestions that clients will have regarding the trial andtheir involvement. It will be helpful to familiariseyourself with the content of this document so that youcan confidently answer any of your clients questions.

If you encounter a question from a client and you areunsure of the answer, please contact us on 1800 819740 and we can assist you with the enquiry.

Client Locator Form

This form has been provided to obtain vital clientcontact information which will allow for interviews andfollow-up to occur.

The Client Locator Form requires the client to provideat least two phone numbers and preferably an emailaddress which will allow the interviewer (Roy MorganResearch) easier access to the participant to conductthe interview and subsequent follow up.

We require three other contact details of close friendsor relatives to the participant (for the above reasons)to allow for additional follow up if the client drops out,discontinues participation in the trial without reasonor we fail to make direct contact with the participant.

Payment Business Rules

This document outlines our business rules regardingpayment during the trial for both pharmacies andclient participants.

If you have any further questions after readingthrough the documents please do not hesitate tocontact us on 1800 819 740 (Mon-Fri 9:00am-5:00pmEST) or email your enquiry to [email protected]

Page 1 of 2



Client Participant - Frequently Asked Questions

Please find below some of the most frequently asked questions regarding the pharmacotherapyfor opiate dependence funding trial for clients. If you have any further questions please seeyour pharmacist.

Q What is the aim of the study?A The aim of the study is to trial a new funding model

for the delivery of the pharmacotherapy program.

The results of this study will be submitted toGovernment and will outline options for thedevelopment of a nationally consistent model forfuture funding of the pharmacotherapy program incommunity pharmacies.

We hope that this will enable communitypharmacies to reduce the cost to clients receivingtreatment at community pharmacies, improve theirretention in treatment and increase the support tothe community pharmacists who deliver the opioidpharmacotherapy service.

Q How long will the trial go for?A The trial will run over a nine-month period starting

in early 2009. Each pharmacy and their clients willparticipate for only six months.

Q Who can enrol in the trial?A Pharmacists who have volunteered to participate in

the trial will approach their clients to ask them toparticipate. A sample of pharmacies acrossAustralia are participating in this trial.

Q By when will the trial be completed?A Data collection from the pharmacies and from you

will continue up until late 2009.

Q When can clients join the trial?A We will begin to recruit clients in early 2009 and will

continue in some pharmacies until April/May 2009.

Q What benefit do the clients get?A All clients who consent to participate in the trial will

receive their usual care from their pharmacist and two$35 Myer gift vouchers redeemable at any of the Myergroup outlets including Coles, Myer, Target, K-Martand Bi-Lo amongst others. These gift cards are onlypayable to clients who complete two surveysapproximating 45 minutes each.

Pharmacies and their participating participants will beallocated to either a control or intervention group.

Those participants in the intervention group will havethe dispensing fee usually charged to them reducedby $15 per week, while those participants in thecontrol group clients will be charged the usual fee.

Participants in the trial will not be able to choosetheir allocated group and allocations will be madeafter all consenting to the trial and surveys havebeen completed. This is complete to preserve theintegrity of the trial.

Q How will clients be allocated to the control andintervention groups?

A Pharmacies who enrol in the trail will be randomlyallocated to either a control group or interventiongroup after they have recruited their all of theirclients who are interested in participating.

As a client, you will be allocated to the same groupas your pharmacy (i.e. if your pharmacy is allocatedinto the control group, you will also be part of thecontrol group). The allocation to the interventionand control groups is completely random will bedone by an independent researcher who is blind to

Page 2 of 2


the identity of the pharmacy. There will be a 66%chance that you will be allocated to an interventiongroup pharmacy. Changes to the allocation will notbe possible.

Q When will I be notified if I have been allocated tothe control or intervention group?

A Your pharmacist will notify you after the randomallocation has been made. The pharmacist will beallocated an official start date for the 6 month trial,it will be from this date that your dispensing fee willbe subsidised if your allocated to the interventiongroup.

Q Are there any other benefits for me to participate?A All clients will receive their usual care and will be

helping inform the government about how fundingimpacts the provision of pharmacotherapy services.The outcome of this study has a real chance ofbenefiting clients on pharmacotherapy in the futureby attracting government funding that will reduceyour costs.

Q What benefit(s) are there to participate if you fallinto the control group?

A If you are placed within the control group, you willbe paid for your time to participate in two telephonesurvey with two $35 Myer gift cards.

Q If I am allocated to the intervention group, when willmy medication dispensing fee be subsidised?

A If you are allocated to the intervention group, yourmedication dispensing fee will begin to besubsidised not long after you have completed yourtelephone survey.

Q What information will I be asked to provide?A You will be asked to provide general information

when you consent to be part of the trial. This willinclude contact details for yourself and others closeto you (note: we will not contact the people younominate unless we have failed on numerousoccasions to contact yourself with the detailsprovided).

Following this, we will ask you to complete twotelephone surveys approximating 45 minutes each.These surveys will ask questions about yourbackground details (age, gender, income, etc.),drug use, health, criminal offences, treatmenthistory and your satisfaction with the program. Youwill be provided with a $35 gift card following thecompletion of each of the telephone interviews.

Q What is the last date I can enrol into the trial?A You pharmacist has approximately one week to

enrol their clients who are interested in participatingin the study.

Q What happens after I sign the consent form?A After we receive your consent to participate in the

trial you will be contacted to complete the firstsurvey which will take approximately 45 minutes.You will then be contacted six months later tocomplete the second telephone survey.

Q Who will be ringing me to do my telephone survey?A An independent market research company, Roy

Morgan Research, will be conducting the telephoneinterview with you. Any information that you providein the survey will be kept strictly confidential andwill be de-identified so that it can not be linkeddirectly to you. The first telephone survey will takeplace after you have signed the consent form. RoyMorgan Research will contact you again six monthslater to complete the second telephone survey.

Q Is there anything else that I need to do during thetrial?

A No, other than completing the two telephonesurveys there is nothing else that will be required ofyou during the trial.

Q Can clients transfer to another pharmacy?A Clients are still free to transfer to another pharmacy

during the trial – subject to pharmacy and healthauthority agreement. As it is only a sample ofpharmacies across the country participating in thistrial, it is unlikely that clients will be able to transferpharmacies and still continue in the trial.

Clients who are in the control group who wish totransfer to a pharmacy in the intervention groupcannot continue in the trial. Clients in theintervention group who transfer to a pharmacy inthe control group cannot continue in the trial.

Clients can continue in the trial if they move fromone control group pharmacy to another controlgroup pharmacy or from one intervention grouppharmacy to another intervention group pharmacy.

Page 1 of 4



Client Participant Information Statement and Consent Form

Please read through all the information in this document prior to signing the consent form. Signboth copies of the consent form and send the original of the copy marked ‘please return toPricewaterhouseCoopers’ in the provided prepaid envelope within a week of receipt. Pleaseensure that the client keeps the other copy for their records.

You are invited to participate in a study to trialpayments to pharmacies which will be used toreduce the cost to clients receiving methadoneor buprenorphine. The purpose of this trial is toevaluate a funding model for the treatment ofopioid dependence in community pharmacies.Ethics approval has been obtained for this study.

You were selected as a possible participant inthis study because you are currently beingprescribed methadone (i.e. methadone syrup,Biodone syrup), buprenorphine (i.e. Subutex) orbuprenorphine-naloxone (i.e. Suboxone) in apharmacy that is participating in this research.

If you decide to participate:

You will be allocated to one of two groups.One group will receive a discount to the costof their medication and the other group willnot. This allocation is random and based onthe pharmacy that you attend. There is asample of pharmacies across Australiaparticipating in the trial.

You will be asked to complete a telephonesurvey at the beginning of the trial and againsix months later. The survey will askquestions about your background details(age, gender, income, etc.), drug use,health, criminal offences, treatment historyand your satisfaction with the program. Yourresponses to the survey at the start of the

study will be linked to your responses at theend of the study.

If you enrol in the trial we will contact you bytelephone after six months to complete thesurvey a second time, even if you changepharmacy.

Your interactions with the pharmacist maybe observed as part of the study; howeveryour identity will remain anonymous.

We will access your records of treatmentfrom your state/territory department ofhealth, to learn of your time in treatment andreasons for leaving treatment.

The study is funded by the Pharmacy Guild ofAustralia and is being conducted by theUniversity of New South Wales andPricewaterhouseCoopers.

As compensation for your time spent completingthe telephone surveys, you will receive a $35shopping voucher for each survey completed.Aside from this, we cannot and do not guaranteeor promise that you will receive any benefitsfrom this study.

Any information that is obtained in connectionwith this study and that can be identified withyou will remain strictly confidential to the projectteam and will be disclosed only with yourpermission or except as required by law.

Page 2 of 4


The information obtained about you inconnection with this study will be identified by astudy number only.

Only those persons directly involved in the studywill have access to the data, which will be storedin a locked storage area for a period of sevenyears, after which time it will be destroyed byshredding.

We plan to publish the results of the study in areport to the Pharmacy Guild of Australia, if yougive us your consent to participate in the trial bysigning this document, you may request to besent a copy. In any publication, information willbe provided in such a way that you cannot beidentified.

Complaints may be directed to:The Ethics Secretariat, The University of NewSouth Wales, SYDNEY 2052 AUSTRALIAPhone: (02) 9385 4234Fax: (02) 9385 6648Email: [email protected]

Any complaint you make will be investigatedpromptly and you will be informed of theoutcome.

Feedback will be made available to participantson request. Further information on the study andthe final report will be posted on the PharmacyGuild of Australia’s website:(http://www.guild.org.au/)

Your decision whether or not to participate willnot prejudice your future relations with theUniversity of New South Wales,PricewaterhouseCoopers or your pharmacist. Ifyou decide to participate, you are free towithdraw your consent and to discontinueparticipation at any time without prejudice.

You will be given a copy of this form to keep.

Page 3 of 4


Client Consent Form (please return this copy to PricewaterhouseCoopers)


Name of Pharmacy you Attend


(Please PRINT name) (Please PRINT name)


The section for consent to participate should be forwarded to Rebecca Jessop, PricewaterhouseCoopers, GPOBox 2650, Sydney 1171 or by fax to (02) 8286 5962.

Client Revocation of Consent

I hereby wish to WITHDRAW my consent to participate in the research proposal described above and understandthat such withdrawal WILL NOT jeopardise any treatment or my relationship with The University of New SouthWales, PricewaterhouseCoopers or my Pharmacist.

Signature Name of Pharmacy you Attend

(Please PRINT Name)

Date

The section for Revocation of Consent should be forwarded to Ms. Rebecca Jessop, PricewaterhouseCoopers,GPO Box 2650, Sydney 1171 or by fax to (02) 8286 5962.

Page 4 of 4


Client Consent Form (please keep this copy for your records)


Name of Pharmacy you Attend


(Please PRINT name) (Please PRINT name)


The section for consent to participate should be forwarded to Rebecca Jessop, PricewaterhouseCoopers, GPOBox 2650, Sydney 1171 or by fax to (02) 8286 5962.

Client Revocation of Consent

I hereby wish to WITHDRAW my consent to participate in the research proposal described above and understandthat such withdrawal WILL NOT jeopardise any treatment or my relationship with The University of New SouthWales, PricewaterhouseCoopers or my Pharmacist.

Signature Name of Pharmacy you Attend

(Please PRINT Name)

Date

The section for Revocation of Consent should be forwarded to Ms. Rebecca Jessop, PricewaterhouseCoopers,GPO Box 2650, Sydney 1171 or by fax to (02) 8286 5962.

Page 1 of 1



Client Participant Locator Form

The purpose of this form is to record your contact details as a participant of the trial. This form is to befilled out at the time of your consenting to the trial, which will be undertaken by the pharmacist.

Client family name: Client given name:

Home number: Work number:

Mobile number(s): Preferred time of contact:

Email address:

We would like to record a “secret question” (e.g. mothers maiden name, pets name etc) and your answer forway of verification when we contact you.

Secret question:

Answer:

We would like for you to give us 3 friends or relatives who we can contact if we can not get in touch with youwith the above details you have given. We will not under any circumstance contact them until we have noother means of contacting you.

1. Contact name: Relationship:

Contact number: Mobile number:





Page 1 of 2



Payment Information SheetThis document outlines the rules for receiving trial-related payments over the six months that your pharmacyand clients are participating in the trial. If you have any questions regarding the payment rules please feel freeto call us on 1800 819 740 (Mon-Fri 9:00am-5:00pm EST) or email your questions to [email protected]

Payment type:

PharmacySurveys

Subsidy payment Pharmacyincentivepayment

Pharmacistincentivepayment

Client interview

Who thepayment ismade to:

Intervention andcontrol grouppharmacies

Intervention grouppharmacies

Intervention grouppharmacies

Control grouppharmacies

Intervention andcontrol groupclients

Activity thatgeneratesthepayment:

Pharmacistscompletes surveyat baseline andend of trial

Payment perintervention client perweek for client feesubsidy – thepharmacist is expectedto reduce the clients co-payment by $15 perweek

Payment perintervention clientper week foroverhead costsand interventionclient dosing data

Payment foroverhead costsand the provisionof control clientdosing data

Consentedclients completetelephoneinterview atbaseline and endof trial

Value ofpayment:

$60 (ex. GST) $15 (ex. GST) perconsented client

$15 (ex. GST) perconsented client

$50 (ex. GST) $35

Frequencyand timingof payment:

Twice:

Baseline

End of trial

Six payments:

On a monthly basisfor the duration ofthe trial

Six payments:

On a monthlybasis for theduration of thetrial

Six payments:

On a monthlybasis for theduration of thetrial

Twice:

Baseline

End of trial

Proof ofservice togeneratepayment:

Completed paperbased survey

Client data to confirminvoiced amount forintervention grouppharmacies

Client data toconfirm invoicedamount forintervention grouppharmacies

Client data toconfirm invoicedamount for controlgroup pharmacies

Completedtelephoneinterview

Form ofpayment:

EFT EFT EFT EFT Shoppingvoucher

Page 2 of 2


Payment type:

PharmacySurveys

Subsidy payment Pharmacyincentivepayment

Pharmacistincentivepayment

Client interview

Businessrulesrelated topayment:

Both control groupand interventiongroup pharmacieswill receive thispayment once wehave received thecompleted surveyand an invoicehas sent by thepharmacy usingthe templateprovided

The intervention grouppharmacy is eligible fora payment for eachweek that the consentedclient attends for doses

Pharmacist agrees toreduce the weekly co-payment paid by theclients by $15 a week

Client payments arereduced by $15 a weekindependent of thenumber of attendances

Payment is not made forclients who haveconsented to participatein control group and whotransfer to anintervention grouppharmacy

Claims will be validatedby comparison with asample of client surveydata and, wherepossible, jurisdictionaldata

The pharmacy iseligible for apayment eachweek that aconsented client isin treatment withthe pharmacy

A pharmacy cannot enrol a controlgroup client whohas transferred toan interventionpharmacy

Payment will betriggered with thereceipt of aninvoicesubstantiated bythe monthly data.

Claims will bevalidated bycomparison with asample of clientsurvey data and,where possible,jurisdictional data

The control grouppharmacy iseligible for apayment eachmonth for supplydata to the trial.This is to offsetoverhead costsincurred forparticipating in thetrial

Payment will bemade topharmacists afterinvoice and datahas been received

$50 will be paid intotal each monthindependent ofthe number ofclients thepharmacy hasconsented to thetrial

Shopping voucherwill be provideddirectly to theclient forcompletedinterviews only

Voucher will bemailed out to theclient at theirpreferred mailingaddress

8

AppendicesAppendix F – Randomisation protocol

Random Allocation Methodology

1. KEEP IT CONFIDENTIAL: Do not show the randomisation list that I sent you fromBarbara Toson's work to you to anyone in the research team(Rebecca, Carrie, Anne-Marie,etc.) and do not keep a copy of the list (except in a sealed envelope inaccessible to you andthe research team).

2. CUSTODIAN MAKES UP THE ENVELOPES WITH THE A4 SHEETS WITH GROUPASSIGNMENT: Appoint a Custodian of the allocation list (independent of the research teamand of the project) to make up the required number of opaque (cannot see thru) A4 envelopesfor each of the three cells (51, 18, 36) numbered sequentially on the outside (1-51, 1-18, 1-36), with the cell label also on the outside (PhARIA1 <21, PhARIA1 >21, PhARIA2-6). Keepthe three cells' envelopes separate from each other (i.e., do not mix up).

3. Place an A4 sheet with the sequential number (1-51, 1-18, 1-36) the cell label (PhARIA1<21, PhARIA1 >21, PhARIA2-6) AND the group (usual care/intervention) into each envelope(following the schedule already sent). The sheet should also have space for the recording ofthe name of the pharmacy. These sheets should be carefully checked to ensure the persondid record the group allocation etc. accurately. (An error discovered later is horrid and maybe irretrievable). I am happy to do this task late next week.

4. GET THE COMPLETED PHARMACY DETAILS FROM ROYMORGAN: When RoyMorganP/L has completed the interviews with the all consented patients in a pharmacy, RoyMorganP/L will inform PWC of the number of completed interviews, and the number of patients whowithdrew consent. Your team should then record the pharmacy name(s) and details in turnon a hand-written running list, and ACCURATELY determine which cell the pharmacy belongsto, and then call the custodian of the allocation list. We need a backup person in case thecustodian is unavailable on a particular day (so two people need to be able to do theallocation). Alternatively, and probably better is that RoyMorgan calls the Custodian directly,and avoids involving the research team.

5. TELL THE CUSTODIAN THE PHARMACY NAME/PhARIA: Upon your team informing thecustodian of the pharmacy name (and the custodian must record the pharmacy namesequentially on a handwritten list for later auditing against your list), the custodian checks andconfirms the cell type (PhARIA1 <21, PhARIA1 >21, PhARIA2-6). (The custodian needs a listof the pharmacies and the cell to which each pharmacy belongs.)

6. CUSTODIAN ALLOCATES: The Custodian then pulls the first available envelope, recordsthe pharmacy name on the outside of the envelope, takes out the A4 sheet and records thepharmacy name on the A4 sheet, records the group allocation on the running list, and informsyou of the group allocation. You record the group allocation on your running list against thepharmacy name (also allows for auditing).

7. ENSURE THE CUSTODIAN IS DOING IT CORRECTLY: The second custodian shouldverify the correct allocation process has been followed every few days.

8. KEEP ALL RECORDS SAFE AND IN ORDER: That is the end of the allocation, exceptthe custodian keeps the records in absolute sequential order, and keeps them safe for laterauditing if necessary.

9. RESOURCES REQUIRED: one list of all pharmacies selected and consented with thePhARIA type for the team, and one for the custodian, a running list for the team and thecustodian, and three sets of envelopes.

Custodian Steps

Step 1: Setup Envelopes: Using a thick permanent black marker, write the numbers1-51 on one set of envelopes in sequential order, with PhARIA 1 <21 written belowthe number. Write the numbers 1-18 on another set of envelopes, sequentially withPhARIA 1>21 written below the number. Write the numbers 1-36 on another set ofenvelopes in sequential order with PhARIA 2-6 written below the number.

Step 2: Setup A4 Sheets of Paper: Repeat the steps above on A4 sheets of paper,but also include on the A4 sheet the group allocation obtainable from the excelspreadsheet. This step needs to be double checked by the custodian anddouble checked again by the second custodian.

Step 3: Recording Allocations: Roy Morgan will send in the details of whichpharmacy’s clients have been contacted. These details will be passed onto one ofthe custodians who will write the pharmacy name down (YES HAND WRITTEN) on arunning sheet along with the date. Pharmacy name is to be checked off the existingtotal list of pharmacies and their Cell Allocation (PhARIA 1 <21, PhARIA 1>21,PhARIA 2-6) needs to be determined. The custodian will take the first availableenvelope from the correct pile and record the name of the pharmacy on the front ofthe envelope. The custodian will then pull out the A4 sheet of paper and records thepharmacy name on the A4 sheet and record the group allocation (control orintervention) on the running sheet and also record the pharmacy name on the A4piece of paper and insert it back into the envelope. The envelope can be placed atthe bottom of its designated pile. The custodian should then inform the researchteam of the outcome so the research team can record it on their own running sheet.

Step 4: Double Checking: Every couple of days the second custodian shoulddouble check that the information has been recorded properly.

Step 5: Keep all records safe and envelopes in order: Keep all envelopes safeand in order and, ensure the process remains sequential and envelopes are notskipped.

Pharmacies should be randomly allocated on the day by alphabetical order firstbefore they are to be assigned into their respective groups.

9

AppendicesAppendix G – BTOM-C and WHOQoL-8

BTOM-C v1.0 Questionnaire

Methadone/Buprenorphinetreatment

NSW DEPARTMENT OF HEALTH

73 Miller Street

NORTH SYDNEY NSW 2060

Tel. (02) 9391 9000

Fax. (02) 9391 9101

TTY. (02) 9391 9900

www.health.nsw.gov.au

This work is copyright. It may be reproduced in whole or in part

for study training purposes subject to the inclusion of an acknowledgement

of the source. It may not be reproduced for commercial usage or sale.

Reproduction for purposes other than those indicated above,

requires written permission from the NSW Department of Health.

© NSW Department of Health 2004

SHPN (CDA) 040069

ISBN 0 7347 3664 9

For further copies of this document please contact:

Better Health Centre – Publications Warehouse

Locked Mail Bag 5003

Gladesville NSW 2111

Tel. (02) 9816 0452

Fax. (02) 9816 0492

Further copies of this document can be downloaded

from the NSW Health website: www.health.nsw.gov.au

June 2004

BTOM-C v1.0Methadone/Buprenorphine treatment questionnaire

NSW Health BTOM-C v1.0 Questionnaire – Methadone/Buprenorphine treatment 1

Agency code* __________________________________________________________________

Agency location* __________________________________________________________________

__________________________________________________________________

Client code* __________________________________________________________________

PSB code (optional) __________________________________________________________________

Date of interview ___________ / ___________ / ___________day month year

Interviewer name __________________________________________________________________

Date of commencement ___________ / ___________ / ___________day month year

(Note: Date of commencement of treatment refers to the date of first dose on current program.)

Has the client ever received methadone or buprenorphine treatment?

No (brand new) 1

Yes, but more than three months ago 2

Yes, currently in treatment 3

*Denotes data items required for NSW Minimum Data Set for Alcohol and Other Drug Treatment Services

For clients transferring between Methadone/Buprenorphine agencies:

Agency name __________________________________________________________________

Client code* __________________________________________________________________

Date of baseline interview ___________ / ___________ / ___________day month year

BTOM-C v1.0 Questionnaire – Methadone/Buprenorphine treatment NSW Health2

BTOM-C v1.0 – Methadone/Buprenorphine treatment questionnaire

Section A. Client details

The questions in this section provide us with some background information.

Tick only one box for each question, unless otherwise stated.

Note: Questions shaded in gray do not need to be completed at follow-up interview.

1 Sex*

Male 1

Female 2

Not stated/inadequately described 9

2a What is your date of birth?* ___________ / ___________ / ___________day month year

2b (Interviewer to answer)

Please indicate whether any component of the date of birth,

ie day, month and/or year was estimated?*

Estimated 1

Not estimated 2

3 Are you of Aboriginal or Torres Strait Islander origin?*

Yes, Aboriginal 1

Yes, Torres Strait Islander 2

Yes, Aboriginal & Torres Strait Islander 3

No 4

Not stated 9

4 In what country were you born?*

Australia 1101

Other

If other, please specify __________________________________________

______________________________________________________________

5 What language do you prefer to speak?*

English 19

Other


______________________________________________________________


6 What is your main source of income?*

Full-time employment 01

Part-time employment 02

Temporary benefit (eg sickness, unemployed) 03

Pension (eg aged, disability) 04

Student allowance 05

Dependant on others 06

Retirement fund 07

No income 08

Other 98

Not stated/not known/inadequately described 99

7 Who do you live with?*

Alone 01

Spouse/partner 02

Alone with child(ren) 03

Spouse/partner and child(ren) 04

Parent(s) 05

Other relative(s) 06

Friend(s) 07

Friend(s)/parent(s)/relative(s) and children 08

Other 98

Not stated/not known/inadequately described 99

8 Do you usually live in a:*

Rented house or flat (public or private) 01

Privately owned house or flat 02

Boarding house 03

Hostel/supported accommodation services 04

Psychiatric home/hospital 05

Alcohol/other drug treatment residence 06

Shelter/refuge 07

Prison/detention centre 08

Caravan on serviced site 09

No usual residence/homeless 10

Other 98

Not known 99


10 How do/did you usually take this drug?*

Ingest (eat, drink, swallow) 1

Smoke 2

Inject 3

Sniff (powder) 4

Inhale (vapour) 5

Other 8


11 What other drugs or alcohol have caused you concern?*

Please specify (one or more drugs – excluding the principal drug

of concern, up to a maximum of five)

1 ____________________________________________________________

2 ____________________________________________________________

3 ____________________________________________________________

4 ____________________________________________________________

5 ____________________________________________________________



Section B. Drug and alcohol use and related behaviours

In this section you will be asked about your use of drugs and alcohol in the last three months, unless

specified. Please refer to Chart 1 on page 12.

Note: This does not include methadone maintenance treatment, but may include ‘street methadone’ or

‘diverted doses’.


9 What drug has led you to seek treatment from this service?*

Heroin 1202

Methadone 1305

(street or diverted methadone)

Other




12 Did you last inject/hit up any drug?*

In the last three months 1

More than three but less than 2 (go to Q.15)

12 months ago

12 months ago or more 3 (go to Q.15)

Never injected 4 (go to Q.15)


13 How many times in the last three months did you use a needle and syringe after someone

else had already used it (including your sex partner and even if it was cleaned)?

Please specify __________________________ times

14 In the last three months, did you share any spoons, filters, water, tourniquets,

drug solution/mix, or swabs with anyone else?

No 0

Yes 1

15 How many times have you overdosed from any drug in the last three months?


The next nine questions are about the drugs and alcohol you have taken in the last month.

Please refer to Charts 2 and 3, page 24 of this BTOM-C questionnaire.

16a How many days in the last month did you use tobacco?


16b On average, how many cigarettes did you have on those days when you did use tobacco?

Please specify __________________________ cigarettes

17a How many days in the last month did you drink alcohol? (beer, wine, spirits)

Please specify __________________________ days

17b On average, how many standard drinks did you have on those days when you were

drinking? (please refer to standard drinks chart if required)

Please specify __________________________ drinks



18 How many days in the last month did you use heroin?


19 How many days in the last month did you use another opioid-based drug (excluding

heroin)? That is, morphine, pethidine, codeine or illegally obtained methadone?


20 How many days in the last month did you use cannabis?


21 How many days in the last month did you use cocaine?


22 How many days in the last month did you use amphetamines?


23 How many days in the last month did you use tranquilisers (benzos, valium, rohypnol)?


24 How many days in the last month did you use another drug(s) (please specify)?

No other drug used 0009

Other drug used (please specify) ____________________________________




25 How often in the last three months have you had any money problems, including

arguing about money or not having enough for food or housing?

Never or almost never 0

Sometimes 1

Often 2

Always or nearly always 3

26 How often in the last three months have you had conflict with your partner/spouse?

(By conflict, I mean verbal abuse, serious argument or violence, not a routine

difference of opinion.)

Not applicable (that is, no partner) 8


Sometimes 1

Often 2


27 How often in the last three months have you had conflict with your relatives?

No contact with relatives 8


Sometimes 1

Often 2


28 How often in the last three months have you had conflict with your employer/school?

Not employed/not at school 8


Sometimes 1

Often 2


29 How much of the time over the last 3 months have you lived with anyone

who uses heroin or other illicit drugs?

Do not live with a drug user 0

Some of the time 1

A lot of the time 2

All or nearly all of the time 3

Section C. Health and well-being

The questions in this section concern your general health and well-being.



30 How much of the time over the last three months have you spent with friends

who don’t use heroin or other illicit opioids?

Very often 0

Often 1

Sometimes 2

Never 3

31a How many times in the past three months have you been arrested?


31b How many of these arrests were for offences allegedly committed in

the past three months?

Please specify __________________________ arrests

32a Have you had any involvement with Child Protection Services,

(eg DOCS) in the past three months?

No 0 (go to Q.33)

Yes 1

32b If yes, did you receive supportive services? (eg housing assistance, food or other)

No 0

Yes 1

32c If yes, has a child been restored to your care?

No 0

Yes 1

32d If yes, has a child been removed from your care?

No 0

Yes 1

33 In the last three months would you say your health was:

Excellent 1

Very good 2

Good 3

Fair 4

Poor 5



Section D. Treatment specific section

The questions in this section concern your current and previous treatment.


34 Previous treatment*

(More than one box may be ticked)

Counselling 10

Inpatient/residential withdrawal management 21

Outpatient withdrawal management 22

Residential rehabilitation activities 31

Day program rehabilitation activities 32

Naltrexone 41

Buprenorphine 42

Slow release oral morphine 44

Methadone 45

Acamprosate 46

Disulfiram 47

Other maintenance pharmacotherapies 49

Inpatient consultation 51

Outpatient consultation (excluding detoxification) 52

Support and case management only 60

Assessment only 91

Information and education 92

Other 98

No previous treatment 99

35 Source of referral to treatment*

Self 01

Family member/friend 02

General practitioner 03

Medical officer/specialist 04

Psychiatric hospital 05

Other hospital 06

Residential community mental health care unit 07

Residential AOD treatment agency 08

Other residential community care unit 09

Education institution 10

Non-residential community mental health centre 11



35 Source of referral to treatment (continued...)*

Non-residential AOD treatment agency 12

Non-residential community health centre 13

Other non-health service agency 14

Police diversion 15

Court diversion 16

Other criminal justice setting 17

Workplace (EAP) 18

Family and child protection service 19

Needle and syringe program 20

Medically supervised injecting centre 21

Other 98


36 Other treatment types*

(More than one box may be ticked, do NOT include the ‘Main treatment type)

Counselling 10

Inpatient/residential withdrawal management 21

Outpatient withdrawal management 22

Residential rehabilitation activities 31

Day program rehabilitation activities 32

Naltrexone 41

Buprenorphine 42

Slow release oral morphine 44

Methadone 45

Acamprosate 46

Disulfiram 47

Other maintenance pharmacotherapies 49

Inpatient consultation 51

Outpatient consultation (excludes detoxification) 52

Support and case management only 60

Assessment only 91

Information and education 92

Other 98

No other services provided 99



37 Treatment delivery setting*

Non-residential/outpatient/

community setting 1

Residential/inpatient setting 2

Home 3

Outreach setting 4

Correctional setting 5

Therapeutic community 6

Other 8

38 Pharmacotherapy drug*

Buprenorphine 42

Methadone 45

39 Client’s current dose

____________. _____ mg (do not use ml)

(if dosing has not commenced, please complete later)

40 The client’s pharmacotherapy prescriber is a doctor in a:

Public clinic 1

Private clinic 2

General practice 3

Correctional centre 4

41 The client’s dosing point is a:

Public clinic/hospital 1

Private clinic 2

Doctors surgery 3

Pharmacy 4

Correctional setting 5

42 If a friend was in need of similar help, would you recommend our program to him/her?

Definitely 1

Probably 2

Unsure 3

Probably not 4

Definitely not 5


Chart 1. Three month chart:Days in the past three months


Every day 90

Six times a week 77

Five times a week 64

Four times a week 51

Three times a week 39

Twice a week 26

Once a week 13

Four times a month 12

Three times a month 9

Twice a month 6

Five days 5

Four days 4

Three days 3

Two days 2

One day only 1

Chart 2. One month chart:Days of estimated drug/alcohol use in the past one month

Every day 30

Six times a week 26

Five times a week 22

Four times a week 17

Three times a week 13

Twice a week 9

Once a week 4

Three days 3

Two days 2

One day only 1

spirits

1 nip

30 mL

40% alcohol/vol

ordinary beer

1 middy

285 mL

4.9% alcohol/vol

wine

1 glass

100 mL

12% alcohol/vol

fortified wine

1 glass

60 mL

18% alcohol/vol

light beer

1 schooner

425 mL

2.7%alcohol/vol

Chart 3. Standard drink chart



Baseline 3 Month 12 Months 2 Years 3 Years

Brief Treatment Outcome Measure-Concise (BTOM-C) v1.0Methadone/Buprenorphine treatment

Score summary sheet

Agency code* __________________________

Client code* __________________________

Commencement date*_____ / ______ / _____day month year

PSB code (optional) ________________________

BTOM-C Scores

Date of interview(day/month/year)

Drug using days(per month)

Heroin

Other opiates

Cannabis

Cocaine

Amphetamines

Tranquilisers

Other (please state)

Occasions of drug use scale (ODUS) [F=Frequency (a), Q = Quantity (b), T = Total]

BTOM-C Scores

Alcohol

Tobacco

BTOM-C Scores

Needle sharing frequency

Overdoses frequency

Polydrug use scale – Illicits only/7

Social functioning scale/18

Arrests frequency(committed last three months)

Health score



F Q T F Q T F Q T F Q T F Q T


Guide to scoringthe BTOM-C v1.0

Needle sharing frequency (Q.13)● Count the number of times the client has shared

a needle and syringe.

Overdoses frequency (Q.15)● Count the number of times the client has

experienced an overdose.

Occasions of drug use scale (Q.16-17)● Enter the frequency and quantity of alcohol

and tobacco use.

● Multiply them to get the total.

● If the client has not used a class of drugs in the last month, their total for that class is 0.

Drug using days (Q.18-24)● Count the number of days the client has used

a particular drug in the last month.

● If the client has not used a class of drugs inthe last month, their total for that class is 0.

Polydrug use scale – Illicits (Q.18-24)● If the client has taken the drug the question

refers to on one or more days in the last month,they score 1 point for that question.

● If the client has not taken the drug the questionrefers to in the last month, they score 0 points for that question.

● Add up the client’s points for questions 18-24 to get the polydrug score. The client receives a score out of 7.


Social functioning scale (Q. 25-30)● ‘Not applicable’ responses are possible for

questions 26-28. They are given the value ‘8’,to indicate they are missing.

● For the purposes of calculating this score, all responses to questions 25-30 that are notshown as being ‘not applicable’, are referred to as ‘valid responses’.

● The client receives a score out of 18.

a If the client has given no ‘Not applicable’responses:

SFS score = Q25 + Q26 + Q27 + Q28 + Q29 + Q30

b If the client has given one ‘Not applicable’response:

SFS score = (sum of valid responses) x 1.2

c If the client has given two ‘Not applicable’responses:

SFS score = (sum of valid responses) x 1.5

d If the client has given three ‘Not applicable’responses:

SFS score = (sum of valid responses) x 2

Arrests frequency (Q. 31b)● Count the number of times the client has

been arrested for offences committed in the past three months.

Health score (Q. 33)● This is simply the numbered code for the box

ticked in Question 33.


Agency code* ____________________________________________________________________

Commencement date* ____________ / ____________ / ____________day month year

Client code* ____________________________________________________________________

PSB code (optional) ____________________________________________________________________

Date of cessation of treatment episode* ____________ / ____________ / ____________day month year

Methadone/Buprenorphine treatment –Treatment cessation form

Reason for cessation of treatment episode*

Treatment completed 01

Transferred/referred to another service 02

Left without notice 03

Left against advice 04

Left Involuntary (non-compliance) 05

Moved out of area 06

Sanctioned by drug court/court diversion program 07

Imprisoned, other than through court sanction 08

Released from prison 09

Died 10

Ceased to participate upon expiation 11

Other 98


Referral to another service*

General practitioner 03

Medical officer/specialist 04

Psychiatric hospital 05

Other hospital 06

Residential community mental health care unit 07

Residential alcohol and other drug treatment agency 08

Other residential community care unit 09

Education institution 10

Non-residential community mental health centre 11

Non-residential alcohol and other drug treatment 12

Non-residential community health centre 13

Other non-health service agency 14

Workplace (EAP) 18

Family and child protection service 19

No referral 97

Other 98


SHPN (CDA) 040069

WHO-8: EUROHIS Quality of life scale1

Instructions: This set of questions asks how you feel about your quality of life, health or other areas of your life. We ask that you think about your life in the past two weeks.

1 © WHOQOL Group (2003). Reference: POWER M. (2003). Development of a common instrument for quality of life. A.

Nosikov and C. Gudex EUROHIS: Developing Common Instruments for Health Surveys. Amsterdam: IOS Press. 57: 145-163. This version prepared by A/Professor Graeme Hawthorne, Australian WHOQOL Field Centre, Centre for Posttraumatic Mental Health, Department of Psychiatry, University of Melbourne. The WHO-8 EUROHIS Quality of Life Scale may not be reproduced or used without the written consent of the WHOQOL Group.

1. How would you rate your quality of life? Very poor Poor Neither poor nor good Good Very good

2. How satisfied are you with your health?

Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied

3. Do you have enough energy for everyday life?

Not at all A little Moderately Mostly Completely

4. How satisfied are you with your ability to perform your daily living activities?


5. How satisfied are you with yourself? Very dissatisfied Dissatisfied Neither satisfied nor dissatisfied Satisfied Very satisfied

6. How satisfied are you with your personal relationships?


7. Have you enough money to meet your needs?

Not at all A little Moderately Mostly Completely

8. How satisfied are you with the conditions of your living place?


1

10

AppendicesAppendix H – Analysis report

Pharmacotherapy analysis report

Prepared:

25 February 2010

25 February 2010 PT analysis

CONFIDENTIAL Page 2

Contents

1 Introduction ....................................................................................................................................3

2 Summary .........................................................................................................................................3

3 Results.............................................................................................................................................3

3.1 Clients retention over the trial................................................................................................3

3.2 BTOM, Quality of Life and Patient satisfaction .......................................................................3

3.3 Cost/benefit analysis...............................................................................................................3

4 Appendices......................................................................................................................................3

4.1 Descriptive tables....................................................................................................................3

4.2 Effect of baseline characteristics on key outcomes................................................................3

4.2.1 Pharmacy satisfaction .....................................................................................................3

4.2.2 BTOM ..............................................................................................................................3

4.3 Association between cost and outcomes ...............................................................................3

4.4 Variable derivation and analyses details ................................................................................3

4.4.1 Client retention ...............................................................................................................3


CONFIDENTIAL Page 3

Tables

Table 1: Summary of survival analysis ....................................................................................................3

Table 2: Description of risk factors by treatment group.........................................................................3

Table 3: Cox model: analysis of time to drop‐out...................................................................................3

Table 4: Cox model: analysis of time to drop‐out (sensitivity analysis)..................................................3

Table 5: number of patients stay in the trial by month and treatment allocation.................................3

Table 6: Compliance of doses dispensed by month among all available patients .................................3

Table 7: BTOM – Drug using days: Heroin ..............................................................................................3

Table 8: BTOM – Drug using days: Other Opioid‐based drug (Morhpine, Pethidine, Codeine , etc) .....3

Table 9: BTOM – Drug using days: Cocaine ............................................................................................3

Table 10: Amphetamines ........................................................................................................................3

Table 11: Tranquilisers (Benzos, Valium, Rohypnol)...............................................................................3

Table 12: Marijuana or cannabis.............................................................................................................3

Table 13: BTOM – Alcohol and tobacco using ........................................................................................3

Table 14: BTOM – Needle sharing frequency .........................................................................................3

Table 15: BTOM – Overdose frequency ..................................................................................................3

Table 16: BTOM – Polydrug use scale .....................................................................................................3

Table 17: BTOM – Social functioning scale .............................................................................................3

Table 18: Distribution of social functioning scale items .........................................................................3

Table 19: BTOM – Arresting frequency in the last 3 months..................................................................3

Table 20: Quality of life scale ..................................................................................................................3

Table 21: Distribution of QoL items ........................................................................................................3


CONFIDENTIAL Page 4

Table 22: Patient satisfaction: Total satisfaction ....................................................................................3

Table 23: Distribution of patient satisfaction items ...............................................................................3

Table 24: Distribution of patient financial strain questions ...................................................................3

Table 25: Patient perceptions of subsidy................................................................................................3

Table 26: Pharmacy satisfaction .............................................................................................................3

Table 27: Cost estimated from observations..........................................................................................3

Table 28: Cost estimated from self‐reports ............................................. Error! Bookmark not defined.

Table 29: Investment costs per pharmacy..............................................................................................3

Table 30: Weekly income........................................................................................................................3

Table 31: ABC observed data ..................................................................................................................3

Table 32: The average daily dispensing fee charged to clients by state.................................................3

Table 33: Average cost of each type of consumable ..............................................................................3

Table 34: Description of all categorical variables ...................................................................................3

Table 35: Description of all continuous variables ...................................................................................3

Table 36: Overall satisfaction at start of trial..........................................................................................3

Table 37: Overall satisfaction at end of trial ...........................................................................................3

Table 38: Drug using days ‐ Heroin (DIF_Q22)........................................................................................3

Table 39: Drug using days ‐ Other Opioid‐based drug (DIF_Q23)...........................................................3

Table 40: Drug using days ‐ Cocaine (DIF_Q24) ......................................................................................3

Table 41: Drug using days ‐ Amphetamines (DIF_Q25) ..........................................................................3

Table 42: Drug using days ‐ Tranquilisers (DIF_Q26) ..............................................................................3

Table 43: Drug using days ‐ marijuana or cannabis (DIF_Q27) ...............................................................3

Table 44: Alcohol and tobacco using (DIF_Post_Pre_Q2829)................................................................3


CONFIDENTIAL Page 5

Table 45: Alcohol and tobacco using (DIF_Post_Pre_Q3031)................................................................3

Table 46: Polydrug use scale (DIF_polydrug) ..........................................................................................3

Table 47: Social functioning scale (DIF_sfs) ............................................................................................3

Table 48: BTOM: needle sharing, overdose, arrest, ...............................................................................3

Table 49: Quality of life (DIF_QoL)..........................................................................................................3

Table 50: Compliance with medication ..................................................................................................3

Table 51: Description of observed investment costs per pharmacy ......................................................3


CONFIDENTIAL Page 6

Figures

Figure 1: Survival curve of time to dropout ............................................................................................3

Figure 2: Retention rate per month........................................................................................................3


CONFIDENTIAL Page 7

1 Introduction The Pharmacotherapy study is intended to provide an evidence base for the development of

national policy on the subsidisation of pharmacotherapy services provided by community

pharmacies.

The hypotheses of the study were:

1. That the pharmacists will report greater satisfaction with the co‐payment then with

consumer full payments.

2. That there will be benefits to consumers including improved retention rates, client

compliance/adherence to treatment, health and social outcomes, and promotion of

abstinence from illicit opioids.

The study enrolled 748 clients from 74 pharmacies. This report is based on 712 clients with a valid

dropout date (240 in the control group and 472 in the intervention group). The results of the main

statistical analyses are presented in Section 3 and include the analysis of retention (primary outcome

– see Section 3.1), BTOM, quality of life and satisfaction (Section 3.2), and cost‐benefit analyses

(Section 3.3).

Appendices include a complete list of descriptive analysis for all the variables used and analysed

(Appendix 4.1), multivariate analyses investigating the relationship between baseline characteristics,

costs and key outcomes (Sections 4.2 and 4.3). The last section includes details on data derivation

and statistical methods.


CONFIDENTIAL Page 8

2 Summary The main analysis showed no significant difference in retention rates between the intervention and

control group. Similarly, the analysis of the BTOM and quality of life scales demonstrated no

significant improvement. The intervention significantly improved satisfaction, both from a

pharmacist and patient perspective.

Key outcome results are summarised below:

• No statistical significance was found for time to dropout (retention) between intervention

group and control group. (P‐value=0.1192 from Log‐Rank test, P‐value=0.0830 from GEE

model).

• There is a non‐significant 5% difference in retention rate at 6 months between intervention

group and control group. Assuming a constant linear trend in dropout rate, we would

achieve a 72% (95%CI=(65.5%, 78.6%)) retention rate in the intervention group and a 62%

(95%CI=(51.9%, 73.2%)) retention rate in the control group at 12 months of follow‐up (not

statistically different between the two groups).

• No significant differences in compliance, BTOM and QoL between intervention group and

control group.

• Statistically significant differences were found for patient satisfaction and pharmacy

satisfaction.


CONFIDENTIAL Page 9

3 Results

3.1 Clients retention over the trial

Figure 1: Survival curve of time to dropout

Kaplan-Meier Survival Estimate

Data cutoff: 18JAN2010 Last run: 28JAN2010 10:28T:\\Statistics\\Projects\\PWC\\PT\\Program\\a_retention.sas

controlintervention

Kap

lan-

Mei

er E

stim

ate

0.70

0.75

0.80

0.85

0.90

0.95

1.00

Retention Time in days0 20 40 60 80 100 120 140 160 180

Table 1: Summary of survival analysis

Stratum Treatment Total dropout Censored time (days) Mean(SE)

1 Control 240 44 196 156.3 (2.56) 2 Intervention 472 66 406 164.5 (1.60)

Total 712 110 602 162.8 (1.38)

Test of Equality over treatment groups Test Chi-Square DF Pr >

Chi-Square Log-Rank 2.4274 1 0.1192 Wilcoxon 2.5020 1 0.1137

The log‐rank test of a difference between the two survival curves was not significant (p=0.12)

indicating no difference in retention between the intervention and control groups.


CONFIDENTIAL Page 10

Table 2: Description of risk factors by treatment group

Patient level characteristics

Treatment allocation Risk factors Control (n/%) Intervention (n/%) Gender Male 122(57.28) 235(60.57) Female 91(42.72) 153(39.43) Country of birth Australia 187(87.79) 330(84.83) Other 26(12.21) 59(15.17) Language English 212(99.53) 380(97.69) Other 1(0.47) 9(2.31) Employment status full/part time working 49(23.00) 81(20.82) Other 164(77.00) 308(79.18) Living arrangement Rented house/flat 154(72.3) 273(70.18) owned house/flat 45(21.13) 88(22.62) Other 14(6.57) 28(7.2) PhARIA Category1 190(79.17) 369(78.18) Category2-6 50(20.83) 103(21.82) State NSW 46(19.17) 176(37.29) NT 0(0.00) 17(3.60) QLD 66(27.50) 69(14.62) TAS 3(1.25) 12(2.54) VIC 85(35.42) 144(30.51) WA 19(7.92) 53(11.23) SA 21(8.75) 1(0.21)

Treatment allocation Risk factors Control (Mean/SD)

n=213 Intervention (Mean/SD)

n=389 Age 39.0(8.68) 40.0(8.82)

Pharmacy level characteristics:

Treatment allocation Risk factors Control (n/%)

n=25 Intervention (n/%)

n=49 PhARIA Category1 16(64.00) 32(65.31) Category2-6 9(36.00) 17(34.69) State NSW 5(20.00) 19(38.78) NT 0(0.00) 1(2.04) QLD 7(28.00) 11(22.45) TAS 1(4.00) 1(2.04) VIC 8(32.00) 9(18.37) WA 2(8.00) 7(14.29) SA 2(8.00) 1(2.04)

Baseline characteristics were well balanced between the two randomized treatments.



Table 3: Cox model: analysis of time to drop‐out

Variable Univariate analysis Multi-variable analysis HR 95% CI P-value HR 95% CI P-value

Treatment (con vs int) 1.352 0.923 1.980 0.1209 1.455 0.939 2.255 0.0932 Gender (female vs male) 1.097 0.728 1.654 0.6574 1.063 0.685 1.651 0.7843 Age 0.961 0.937 0.985 0.0015* 0.960 0.936 0.985 0.0020* Country (other vs Australia) 1.018 0.566 1.829 0.9531 1.059 0.570 1.968 0.8554 Language (other vs English) 1.423 0.350 5.777 0.6217 1.576 0.363 6.836 0.5434 Employment (other vs working) 1.068 0.645 1.768 0.7985 1.198 0.684 2.099 0.5276 Living arrangement Other vs owned home 1.476 0.672 3.242 0.3318 1.620 0.704 3.729 0.2568 Rented vs owned home 0.986 0.597 1.629 0.9562 0.885 0.525 1.491 0.6457 PhARIA (cat2-6 vs cat 1) 1.026 0.653 1.613 0.9118 0.738 0.426 1.279 0.2790 State NT vs NSW 1.020 0.242 4.308 0.9782 1.202 0.272 5.310 0.8080 QLD vs NSW 1.897 1.101 3.268 0.0211 1.498 0.807 2.781 0.2003 SA vs NSW 1.218 0.368 4.034 0.7471 0.614 0.138 2.737 0.5226 TAS vs NSW 1.793 0.541 5.940 0.3392 1.580 0.464 5.374 0.4642 VIC vs NSW 1.502 0.907 2.489 0.1140 1.157 0.650 2.057 0.6207 WA vs NSW 1.498 0.752 2.981 0.2502 1.323 0.627 2.794 0.4629 *P‐value<0.05. HR=Hazard Ratio

After adjusting the survival analysis for baseline covariates, only age was found to be significantly

associated with retention (time to dropout). With or without clustering adjustment, the intervention

did not significantly improve retention (p>0.09).

Table 4: Cox model: analysis of time to drop‐out (sensitivity analysis)

Variable Cox model Frailty model HR 95% CI P-value HR 95% CI P-value

Treatment (con vs int) 1.455 0.939 2.255 0.0932 1.459 0.809 2.631 0.210 Gender (female vs male) 1.063 0.685 1.651 0.7843 1.066 0.693 1.641 0.771 Age 0.960 0.936 0.985 0.0020* 0.960 0.928 0.993 0.019* Country (other vs Australia) 1.059 0.570 1.968 0.8554 1.058 0.653 1.715 0.818 Language (other vs English) 1.576 0.363 6.836 0.5434 1.580 0.508 4.919 0.430 Employment (other vs working) 1.198 0.684 2.099 0.5276 1.200 0.661 2.177 0.550 Living arrangement Other vs owned home 1.620 0.704 3.729 0.2568 1.628 0.645 4.109 0.302 Rented vs owned home 0.885 0.525 1.491 0.6457 0.883 0.475 1.641 0.695 PhARIA (cat2-6 vs cat 1) 0.738 0.426 1.279 0.2790 0.738 0.358 1.523 0.411 State NT vs NSW 1.202 0.272 5.310 0.8080 1.205 0.626 2.320 0.577 QLD vs NSW 1.498 0.807 2.781 0.2003 1.496 0.611 3.667 0.378 SA vs NSW 0.614 0.138 2.737 0.5226 0.612 0.193 1.942 0.405 TAS vs NSW 1.580 0.464 5.374 0.4642 1.580 0.762 3.276 0.219 VIC vs NSW 1.157 0.650 2.057 0.6207 1.156 0.484 2.761 0.744 WA vs NSW 1.323 0.627 2.794 0.4629 1.326 0.449 3.916 0.610 *P‐value<0.05

Comparison of Cox model and Shared Frailty models which obtain robust variance estimates taking

pharmacy (cluster) into account.



Table 5: number of patients stay in the trial by month and treatment allocation

Time Intervention group Control group P-value* P-value** N n (no-dropout) % N n (no-dropout) %

Month1 472 463 98.09 240 231 96.25 0.1386 0.1455 Month2 472 448 94.92 240 226 94.17 0.6744 0.6743 Month3 472 438 92.80 240 214 89.17 0.0993 0.1001 Month4 472 430 91.10 240 207 86.25 0.0462 0.0466 Month5 472 417 88.35 240 201 83.75 0.0867 0.0861 Month6 472 406 86.02 240 196 81.67 0.1290 0.1275

*P‐value from Chi‐square test **P‐value from GEE model

Patients with non‐missing data only were included in the analysis presented in the above table. In

those patients, the compliance rate appeared better in the intervention group; however the

difference was not statistically significant (Overall P‐value =0.0830 from GEE model).

Figure 2: Retention rate per month

Assuming a linear trend for time‐to‐dropout based on 6 months results (see Figure 2), the

percentage of retention after 12 months would be 72.03%, 95%CI=(65.5%, 78.6%) in the

Intervention group and 62.54%, 95%CI=(51.9%, 73.2%) in the Control group.

The equations for the fitted linear line in the graph above are (y=percentage of retention; x=time in

months):

• Intervention group: y=‐2.336x + 100.06

• Control group: y=‐3.0594x + 99.25



3.2 BTOM, Quality of Life and Patient satisfaction

Table 6: Compliance of doses dispensed by month among all available patients

Months Control Intervention Control vs Intervention n Mean SE n Mean SE Mean difference 95%CI P-value*

Compliance at month1(%) 219 94.3 1.0581 457 94.5 0.7852 -0.24 -2.89 2.41 0.8579 Compliance at month2(%) 215 94.2 1.0765 456 94.5 0.7868 -0.34 -3.01 2.34 0.8055 Compliance at month3(%) 211 94.5 1.0605 444 95.2 0.7354 -0.69 -3.23 1.85 0.5922 Compliance at month4(%) 203 96.0 0.8338 436 95.8 0.6772 0.16 -2.08 2.41 0.8784 Compliance at month5(%) 186 97.0 0.7603 430 96.4 0.5908 0.46 -1.55 2.48 0.6291 Compliance at month6(%) 167 97.6 0.6811 399 96.7 0.5691 0.85 -1.08 2.79 0.3370

*p‐value from t‐test

Table 7: BTOM – Drug using days: Heroin

Control Intervention Control vs Intervention

n Mean SE n Mean SE Mean difference 95%CI P-value*

Pre-trial 213 1.0845 0.2872 389 1.1697 0.2243 -0.085 -0.812 0.6419 0.8182

Post-trial 162 1.7593 0.4658 309 1.1683 0.2578 0.591 -0.373 1.5546 0.268

Difference

between Post and Pre trial

162 0.7407 0.387 309 0.1424 0.2513 0.5983 -0.278 1.4749 0.1805


Table 8: BTOM – Drug using days: Other Opioid‐based drug (Morhpine, Pethidine, Codeine

, etc)



Pre-trial 213 1.4131 0.3084 389 0.7969 0.1819 0.6162 -0.042 1.275 0.0861

Post-trial 162 0.7346 0.231 309 0.644 0.2023 0.0906 -0.549 0.7305 0.7682

Difference


162 -0.753 0.366 309 -0.084 0.2356 -0.669 -1.493 0.1556 0.1116




Table 9: BTOM – Drug using days: Cocaine



Pre-trial 213 0.0751 0.0491 389 0.1028 0.0565 -0.028 -0.194 0.1384 0.7113

Post-trial 162 0.0988 0.0562 309 0.0032 0.0032 0.0955 0.0151 0.1759 0.0917

Difference between Post and Pre trial

162 0.0123 0.0495 309 -0.1036 0.0668 0.1159 -0.0475 0.2793 0.1640


Table 10: Amphetamines

Control Intervention Control vs Intervention n Mean SE n Mean SE Mean difference 95%CI P-value*

Pre-trial 213 0.3005 0.1057 389 0.3676 0.0962 -0.067 -0.365 0.2308 0.6388

Post-trial 162 0.4074 0.2068 309 0.5113 0.161 -0.104 -0.631 0.4229 0.6985

Difference


162 0.1111 0.2393 309 0.1974 0.1178 -0.086 -0.553 0.3807 0.7466


Table 11: Tranquilisers (Benzos, Valium, Rohypnol)



Pre-trial 213 5.7183 0.7417 388 6.0928 0.5834 -0.374 -2.26 1.5113 0.6967

Post-trial 161 6.5776 0.933 309 6.4563 0.6602 0.1213 -2.111 2.3532 0.915

Difference


161 1.0621 0.824 308 0.5649 0.6592 0.4972 -1.643 2.6374 0.6483


Table 12: Marijuana or cannabis

Control Intervention Control vs Intervention n Mean SE n Mean SE Mean difference 95%CI P-value*

Pre-trial 213 8.4977 0.8344 389 8.0283 0.6046 0.4694 -1.542 2.4806 0.6469

Post-trial 162 6.784 0.8867 309 8.068 0.6819 -1.284 -3.524 0.9559 0.2606

Difference


162 -0.617 0.575 309 0.165 0.5073 -0.782 -2.384 0.8194 0.3082




Table 13: BTOM – Alcohol and tobacco using

Alcohol and Tobacco Control Intervention Control vs Intervention


Pre-trial

Days in tobacco use(Pre_Q28) 213 26.676 0.642 389 26.165 0.4999 0.5115 -1.11 2.1335 0.5359

Number of cigarettes per day(Pre_Q29) 192 16.703 0.6908 347 15.349 0.4238 1.3544 -0.153 2.8615 0.0956

Total number of cigarettes (Pre_Q28*29) 192 501.34 20.915 347 457.7 13.013 43.638 -2.347 89.623 0.0774

Days in drinking alcohol(Pre_Q30) 213 6.2488 0.687 389 5.2776 0.4737 0.9712 -0.634 2.5766 0.2353

Number of drinks per day(Pre_Q31) 105 6.181 0.562 169 6.3136 0.5212 -0.133 -1.7 1.4345 0.8678

Total number of drinks(Pre_Q30*31) 105 85.324 12.557 169 87.905 13.443 -2.582 -41.41 36.248 0.8885

Post-trial

Days in tobacco use(Post_Q28) 162 26.679 0.7508 307 26.205 0.5741 0.4738 -1.413 2.3609 0.622

Number of cigarettes per day(Post_Q29) 147 17.707 0.7425 274 15.131 0.5403 2.5761 0.7747 4.3775 0.0052

Total number of cigarettes(Post_Q28*29) 147 529.39 22.535 274 455.13 16.568 74.255 19.275 129.24 0.0082

Days in drinking alcohol(Post_Q30) 168 5.7654 0.773 308 5.6266 0.5667 0.1388 -1.751 2.0286 0.8853

Number of drinks per day(Post_Q31) 77 5.2857 0.5846 142 5.8028 0.3987 -0.517 -1.88 0.846 0.4555

Total number of drinks(Post_Q30*31) 77 82.623 18.364 142 70.092 7.9276 12.532 -21.51 46.573 0.5323

Difference between Post and Pre trial on total number of cigarettes 140 -15.53 17.627 262 -4.435 12.818 -11.09 -53.87 31.685 0.6105

Difference between Post and Pre trial on total number of drinks 62 7.7258 23.858 110 -28.89 17.461 36.617 -21.33 94.562 0.214


The total number of cigarettes was obtained by multiplying days in tobacco use to the number of cigarettes per day. The total number of drinks was obtained by multiplying days in drinking alcohol to the number of drinks per day.

Table 14: BTOM – Needle sharing frequency

Needle sharing Control Intervention Control vs Intervention n Mean SE n Mean SE Mean difference 95%CI P-value*

Pre-trial 9 7.1111 2.6164 13 4.1538 2.1834 2.9573 -4.155 10.07 0.3961

Post-trial 7 2.1429 0.5533 4 4.25 2.136 -2.107 -5.993 1.779 0.4023

Difference


3 -5 5.0332 1 0 . -5 -48.31 38.312 0.6686




Table 15: BTOM – Overdose frequency

Period/ Number of overdoses

Control

Intervention

P-value*

n (%) N (%) Pre-trial 0.5596 0 209 98.1 384 98.9 1 3 1.4 2 0.5 2 1 0.5 1 0.3 12 0 0.0 1 0.3 Post-trial 0.1752 0 160 98.8 304 98.4 1 2 1.2 1 0.3 2 0 0.0 4 1.3

*p‐value from Chi‐square test

Table 16: BTOM – Polydrug use scale

Polydrug scale Control Intervention Control vs Intervention

n Mean SE N Mean SE Mean difference 95%CI P-value*

Pre-trial 213 1.4366 0.0837 389 1.3213 0.0626 0.1153 -0.0901 0.3207 0.2718

Post-trial 162 1.2901 0.1001 309 1.2039 0.0666 0.0862 -0.1439 0.3163 0.4618

Difference


162 -0.025 0.0975 309 -0.117 0.068 0.0918 -0.139 0.3226 0.4348


Note: For each drug, if the client has taken the drug they score 1 and 0 if not. The polydrug score is

derived by adding the response from all 7 variables (maximum score = 7).



Table 17: BTOM – Social functioning scale

Social functioning scale Control Intervention Control vs Intervention


Pre-trial 213 16.345 0.2326 389 15.872 0.1787 0.4721 -0.11 1.0545 0.1119

Post-trial 162 15.619 0.2641 309 15.852 0.1972 -0.233 -0.887 0.4207 0.4837

Difference between Post and Pre trial 162 -0.53 0.2977 309 0.0016 0.2061 -0.531 -1.233 0.1703 0.1374

Difference between Post and Pre trial on

money problem (Q42) 161 -0.18 0.0867 307 -0.156 0.0626 -0.024 -0.234 0.1863 0.8241

partner conflict (Q43) 161 0.0497 0.0876 307 -0.036 0.0568 0.0855 -0.113 0.2836 0.3967

relatives conflict (Q44) 162 0.0556 0.0799 309 -0.032 0.0616 0.0879 -0.114 0.2902 0.3935

employer conflict (Q45) 162 0.1235 0.0586 308 0.1169 0.0486 0.0066 -0.149 0.1626 0.9341 live with drug user together (Q46) 161 -0.068 0.089 308 0.0682 0.0668 -0.137 -0.358 0.0847 0.2259

time with friends (Q47) 160 0.0188 0.1372 301 0.1163 0.096 -0.098 -0.423 0.2275 0.5557 *p‐value from t‐test



Table 18: Distribution of social functioning scale items

Control

Intervention

P-value*

n (%) n (%) PRE_Q42: money problem 0.1767 Never or almost never 60 28.3 112 29.0 Sometimes 70 33.0 108 28.0 Often 46 21.7 73 18.9 Always or nearly always 36 17.0 93 24.1 PRE_Q43: partner conflict 0.7191 Not applicable (that is, no partner) 92 43.2 165 42.6 Never or almost never 67 31.5 138 35.7 Sometimes 35 16.4 54 14.0 Often 10 4.7 19 4.9 Always or nearly always 9 4.2 11 2.8 PRE_Q44:relatives conflict 0.5366 No contact with relatives 27 12.7 45 11.6 Never or almost never 134 62.9 238 61.2 Sometimes 36 16.9 61 15.7 Often 9 4.2 20 5.1 Always or nearly always 7 3.3 25 6.4 PRE_Q45: employer conflict 0.9523 Not applicable 122 57.3 232 59.6 Never or almost never 83 39.0 143 36.8 Sometimes 5 2.3 8 2.1 Often 2 0.9 5 1.3 Always or nearly always 1 0.5 1 0.3 PRE_Q46: live with drug user together 0.4037 None of the time 164 77.0 322 83.0 Rarely 10 4.7 14 3.6 Sometimes 13 6.1 22 5.7 Most of the time 6 2.8 7 1.8 All of the time 20 9.4 23 5.9 PRE_Q47: time with friends 0.2370 None of the time 29 13.7 72 18.8 Rarely 22 10.4 44 11.5 Sometimes 39 18.5 85 22.1 Most of the time 54 25.6 83 21.6 All of the time 67 31.8 100 26.0 POST_Q42: money problem 0.7415 Never or almost never 64 39.5 107 34.6 Sometimes 48 29.6 94 30.4 Often 25 15.4 54 17.5 Always or nearly always 25 15.4 54 17.5 POST_Q43: partner conflict 0.0696 Not applicable (that is, no partner) 69 42.9 135 43.8 Never or almost never 66 41.0 106 34.4 Sometimes 13 8.1 48 15.6 Often 8 5.0 16 5.2 Always or nearly always 5 3.1 3 1.0 POST_Q44:relatives conflict 0.5394 No contact with relatives 20 12.3 36 11.7 Never or almost never 109 67.3 190 61.5 Sometimes 20 12.3 52 16.8 Often 8 4.9 23 7.4 Always or nearly always 5 3.1 8 2.6 POST_Q45: employer conflict 0.6132 Not applicable 80 49.4 172 55.8 Never or almost never 69 42.6 111 36.0 Sometimes 10 6.2 16 5.2 Often 2 1.2 6 1.9 Always or nearly always 1 0.6 3 1.0



POST_Q46: live with drug user together 0.4462 None of the time 130 80.7 265 85.8 Rarely 7 4.3 8 2.6 Sometimes 6 3.7 7 2.3 Most of the time 7 4.3 7 2.3 All of the time 11 6.8 22 7.1 POST_Q47: time with friends 0.8493 None of the time 24 14.9 45 14.8 Rarely 18 11.2 33 10.8 Sometimes 27 16.8 59 19.3 Most of the time 40 24.8 63 20.7 All of the time 52 32.3 105 34.4 *p‐value from Chi‐square test

Table 19: BTOM – Arresting frequency in the last 3 months

Control

Intervention

P-value*

n (%) n (%) Pre-trial 0.0685 1 196 92.0 359 92.3 2 12 5.6 21 5.4 3 1 0.5 7 1.8 4 4 1.9 0 0.0 5 0 0.0 1 0.3 6 0 0.0 1 0.3 Post-trial 0.0928 1 146 90.1 295 95.5 2 13 8.0 13 4.2 3 1 0.6 0 0.0 4 2 1.2 1 0.3




Table 20: Quality of life scale

QoL scale Control Intervention Control vs Intervention


Pre-trial 206 26.5 0.4211 378 26.138 0.3456 0.3624 -0.741 1.4662 0.5192

Post-trial 155 26.684 0.501 299 26.492 0.3991 0.1922 -1.107 1.4919 0.7714

Difference between Post and Pre trial 151 0.457 0.3945 292 0.1918 0.2772 0.2652 -0.675 1.2057 0.5798


rate of quality of life 162 0.0247 0.0706 308 0.0877 0.0571 -0.063 -0.248 0.1216 0.503

satisfaction of health 162 -0.031 0.0873 307 0.0391 0.0637 -0.07 -0.283 0.1428 0.5185

energy 161 -0.068 0.0886 304 -0.059 0.0653 -0.009 -0.226 0.2081 0.9343

daily living activity 159 -0.031 0.0929 309 -0.003 0.0624 -0.028 -0.244 0.1872 0.797

self satisfaction 160 0.0313 0.0871 307 0.1303 0.0623 -0.099 -0.309 0.1108 0.3541

relationship 157 0.1656 0.0997 301 0.0066 0.0721 0.159 -0.083 0.401 0.1975

living condition 160 0.0125 0.0873 309 -0.042 0.0688 0.0546 -0.17 0.2794 0.6336

money needs Q41 161 0.1988 0.0919 309 0.0227 0.0647 0.1761 -0.043 0.3953 0.1151




Table 21: Distribution of QoL items

Control

Intervention

P-value*

n (%) n (%) PRE_Q34:rate of quality of life 0.5860 Very poor 8 3.8 26 6.7 Poor 33 15.6 68 17.5 Neither poor nor good 48 22.6 86 22.1 Good 94 44.3 159 40.9 Very good 29 13.7 50 12.9 PRE_Q35:satisfaction of health 0.3602 Very dissatisfied 14 6.6 32 8.3 Dissatisfied 54 25.4 121 31.3 Neither satisfied nor dissatisfied 45 21.1 63 16.3 Satisfied 84 39.4 140 36.3 Very satisfied 16 7.5 30 7.8 PRE_Q36:energy 0.0483 Not at all 12 5.7 48 12.4 A little 48 22.6 65 16.8 Moderately 55 25.9 102 26.4 Mostly 64 30.2 104 26.9 Completely 33 15.6 68 17.6 PRE_Q37:daily living activity 0.5499 Very dissatisfied 15 7.1 30 7.7 Dissatisfied 39 18.5 82 21.1 Neither satisfied nor dissatisfied 41 19.4 55 14.2 Satisfied 91 43.1 171 44.1 Very satisfied 25 11.8 50 12.9 PRE_Q38: self satisfaction 0.1130 Very dissatisfied 13 6.2 39 10.1 Dissatisfied 47 22.3 95 24.5 Neither satisfied nor dissatisfied 48 22.7 59 15.2 Satisfied 87 41.2 159 41.0 Very satisfied 16 7.6 36 9.3 PRE_Q39: relationship 0.2338 Very dissatisfied 9 4.3 30 7.8 Dissatisfied 48 23.0 68 17.7 Neither satisfied nor dissatisfied 29 13.9 55 14.3 Satisfied 76 36.4 156 40.5 Very satisfied 47 22.5 76 19.7 PRE_Q40: living condition 0.3013 Very dissatisfied 16 7.5 33 8.5 Dissatisfied 18 8.5 32 8.2 Neither satisfied nor dissatisfied 23 10.8 25 6.4 Satisfied 78 36.8 166 42.7 Very satisfied 77 36.3 133 34.2 PRE_Q41: money needs 0.3095 Not at all 49 23.0 114 29.3 A little 48 22.5 68 17.5 Moderately 56 26.3 90 23.1 Mostly 40 18.8 82 21.1 Completely 20 9.4 35 9.0 POST_Q34: rate of quality of life 0.4764 Very poor 7 4.3 16 5.2 Poor 23 14.2 45 14.6 Neither poor nor good 32 19.8 71 23.1 Good 82 50.6 130 42.2 Very good 18 11.1 46 14.9 POST_Q35:satisfaction of health 0.6382 Very dissatisfied 13 8.0 24 7.8 Dissatisfied 41 25.3 91 29.4 Neither satisfied nor dissatisfied 37 22.8 53 17.2



Satisfied 58 35.8 115 37.2 Very satisfied 13 8.0 26 8.4 POST_Q36:energy 0.0282 Not at all 17 10.5 51 16.7 A little 30 18.5 39 12.7 Moderately 44 27.2 69 22.5 Mostly 58 35.8 100 32.7 Completely 13 8.0 47 15.4 POST_Q37:daily living activity 0.4918 Very dissatisfied 10 6.2 27 8.7 Dissatisfied 37 23.0 57 18.4 Neither satisfied nor dissatisfied 29 18.0 49 15.9 Satisfied 67 41.6 147 47.6 Very satisfied 18 11.2 29 9.4 POST_Q38: self satisfaction 0.6495 Very dissatisfied 14 8.6 24 7.8 Dissatisfied 37 22.8 72 23.4 Neither satisfied nor dissatisfied 30 18.5 46 14.9 Satisfied 67 41.4 127 41.2 Very satisfied 14 8.6 39 12.7 POST_Q39: relationship 0.3482 Very dissatisfied 9 5.7 30 9.9 Dissatisfied 23 14.6 39 12.9 Neither satisfied nor dissatisfied 24 15.2 38 12.5 Satisfied 63 39.9 135 44.6 Very satisfied 39 24.7 61 20.1 POST_Q40: living condition 0.1092 Very dissatisfied 12 7.5 18 5.8 Dissatisfied 10 6.2 36 11.7 Neither satisfied nor dissatisfied 13 8.1 27 8.7 Satisfied 61 37.9 134 43.4 Very satisfied 65 40.4 94 30.4 POST_Q41: money needs 0.5777 Not at all 34 21.1 77 24.9 A little 26 16.1 49 15.9 Moderately 42 26.1 92 29.8 Mostly 47 29.2 73 23.6 Completely 12 7.5 18 5.8




Table 22: Patient satisfaction: Total satisfaction

Pt satisfaction Control Intervention Control vs Intervention n Mean SE n Mean SE Mean difference 95%CI P-value*

Pre-trial 211 13.616 0.2207 386 13.889 0.1625 -0.272 -0.81 0.265 0.3198

Post-trial 160 13.775 0.2506 306 14.771 0.1891 -0.996 -1.621 -0.371 0.0018

Difference between Post and Pre trial 160 0.3938 0.1973 304 0.9671 0.1744 -0.573 -1.123 -0.023 0.0301


fee charge 162 0.2284 0.0886 308 0.7175 0.0847 -0.489 -0.751 -0.227 <.0001

time and process 161 0.1304 0.0877 308 0.0227 0.0758 0.1077 -0.133 0.3485 0.3534 progress on drug maintenance 161 -0.068 0.099 307 -0.052 0.0606 -0.016 -0.233 0.2003 0.889

aspects of program 162 0.0741 0.0912 307 0.228 0.0669 -0.154 -0.377 0.069 0.1754*p‐value from t‐test



Table 23: Distribution of patient satisfaction items

Control

Intervention

P-value*

n (%) n (%) Q59:fee charge 0.6359 Very dissatisfied 54 25.4 99 25.5 Dissatisfied 72 33.8 110 28.4 Neither dissatisfied nor satisfied 29 13.6 55 14.2 Satisfied 41 19.2 84 21.6 Very satisfied 17 8.0 40 10.3 Q62:time and process 0.0078 Very dissatisfied 14 6.6 30 7.7 Dissatisfied 44 20.8 46 11.9 Neither dissatisfied nor satisfied 30 14.2 44 11.3 Satisfied 80 37.7 197 50.8 Very satisfied 44 20.8 71 18.3 Q64:progress on drug maintenance 0.4629 Very dissatisfied 7 3.3 18 4.6 Dissatisfied 25 11.7 29 7.5 Neither dissatisfied nor satisfied 23 10.8 41 10.6 Satisfied 84 39.4 157 40.5 Very satisfied 74 34.7 143 36.9 Q66:aspects of program 0.3411 Very dissatisfied 6 2.8 19 4.9 Dissatisfied 27 12.7 50 12.9 Neither dissatisfied nor satisfied 38 17.9 53 13.6 Satisfied 88 41.5 182 46.8 Very satisfied 53 25.0 85 21.9 POST_Q59:fee charge <0.0001 Very dissatisfied 33 20.4 43 13.9 Dissatisfied 58 35.8 66 21.4 Neither dissatisfied nor satisfied 21 13.0 36 11.7 Satisfied 32 19.8 87 28.2 Very satisfied 18 11.1 77 24.9 POST_Q62:time and process 0.6629 Very dissatisfied 8 5.0 20 6.5 Dissatisfied 23 14.3 39 12.7 Neither dissatisfied nor satisfied 28 17.4 52 16.9 Satisfied 74 46.0 128 41.6 Very satisfied 28 17.4 69 22.4 POST_Q64:progress on drug maintenance 0.2740 Very dissatisfied 12 7.5 10 3.2 Dissatisfied 15 9.3 31 10.1 Neither dissatisfied nor satisfied 20 12.4 31 10.1 Satisfied 63 39.1 127 41.2 Very satisfied 51 31.7 109 35.4 POST_Q66:aspects of program 0.3659 Very dissatisfied 4 2.5 10 3.3 Dissatisfied 24 14.8 28 9.1 Neither dissatisfied nor satisfied 21 13.0 34 11.1 Satisfied 73 45.1 151 49.2 Very satisfied 40 24.7 84 27.4




Table 24: Distribution of patient financial strain questions

Control

Intervention P-value*

n (%) n (%) POST_QX13: cost impact1 0.0892 A large impact 55 36.7 131 44.3 Some impact 67 44.7 97 32.8 Very little impact 16 10.7 44 14.9 No impact 12 8.0 24 8.1 POST_QX14:cost impact2 0.1927 A large impact 2 16.7 5 41.7 Some impact 7 58.3 2 16.7 Very little impact 2 16.7 4 33.3 No impact 1 8.3 1 8.3 POST_QX15:without food 0.1998 YES 47 36.2 100 42.6 NO 83 63.8 135 57.5 POST_QX16:without meds 0.5092 YES 38 29.0 76 32.3 NO 93 71.0 159 67.7 POST_QX17:sleep outdoor 0.9650 YES 6 4.6 11 4.7 NO 125 95.4 224 95.3 POST_QX18:supports 0.4759 YES 45 34.4 69 29.5 NO 86 65.6 165 70.5 POST_QX19:argument 0.1502 YES 16 12.2 18 7.7 NO 115 87.8 217 92.3 POST_QX20:sources 0.6884 YES 7 5.3 15 6.4 NO 124 94.7 220 93.6 POST_QX21:debts 0.4988 YES 41 31.8 70 29.9 NO 88 68.2 164 70.1 POST_QX22:debts2 0.2659 Less than $500 20 48.8 30 42.9 $500-$999 13 31.7 15 21.4 $1000-$1999 4 9.8 9 12.9 $2000 or more 4 9.8 16 22.9 POST_QX23:freq food 0.4740 All the time 3 6.4 8 8.2 Frequently 6 12.8 21 21.4 Occasionally 26 55.3 52 53.1 Just once 12 25.5 17 17.3 POST_QX24:freq meds 0.9016 All the time 1 2.7 1 1.3 Frequently 4 10.8 11 14.7 Occasionally 26 70.3 52 69.3 Just once 6 16.2 11 14.7 POST_QX25:freq sleep outdoor 0.3935 All the time 1 16.7 0 0.0 Frequently 0 0.0 1 9.1 Occasionally 4 66.7 6 54.5 Just once 1 16.7 4 36.4 POST_QX26:freq supports 0.5365 All the time 6 13.3 4 5.9 Frequently 11 24.4 21 30.9 Occasionally 16 35.6 26 38.2 Just once 12 26.7 17 25.0 POST_QX27: freq argument 0.7520 All the time 2 12.5 2 11.8



Frequently 2 12.5 4 23.5 Occasionally 5 31.3 3 17.6 Just once 7 43.8 8 47.1 POST_QX28:freq sources 0.9213 All the time 1 14.3 2 13.3 Frequently 1 14.3 4 26.7 Occasionally 3 42.9 6 40.0 Just once 2 28.6 3 20.0 *p‐value from Chi‐square test

Table 25: Patient perceptions of subsidy

Control

Intervention

P-value*

n (%) n (%) POST_QX30I: $5 reduction 0.6711 YES 108 69.2 195 65.2 MAYBE 8 5.1 19 6.4 NO 40 25.6 85 28.4 POST_QX30II: $10 reduction 0.5820 YES 121 78.1 228 75.5 MAYBE 7 4.5 21 6.9 NO 27 17.4 53 17.5 POST_QX30III: $15 reduction 0.2284 YES 133 85.8 254 83.8 MAYBE 2 1.3 13 4.3 NO 20 12.9 36 11.9 POST_QX30IV: $20 reduction 0.9030 YES 136 87.2 260 85.1 MAYBE 4 2.6 7 2.3 NO 16 10.3 35 11.6 *p‐value from Chi‐square test



Table 26: Pharmacy satisfaction

Control (N=25)

Intervention (N=49)

P-value*

n (%) n (%) FIN_ARRANGEMNENTS 0.7283 Very Dissatisfied 4 17.4 5 10.2 Dissatisfied 9 39.1 19 38.8 Neutral 8 34.8 17 34.7 Satisfied 2 8.7 8 16.3 CONS_CONTRIBUTION 0.6752 Very Dissatisfied 2 8.3 3 6.1 Dissatisfied 11 45.8 21 42.9 Neutral 4 16.7 13 26.5 Satisfied 7 29.2 10 20.4 Very Satisfied 0 0.0 2 4.1 CURR_INTERACTIONS 0.3349 Dissatisfied 2 8.7 2 4.1 Neutral 2 8.7 13 26.5 Satisfied 16 69.6 28 57.1 Very Satisfied 3 13.0 6 12.2 SAT_OVERALL 0.2582 Very Dissatisfied 1 4.2 0 0.0 Dissatisfied 5 20.8 7 14.3 Neutral 10 41.7 21 42.9 Satisfied 7 29.2 21 42.9 Very Satisfied 1 4.2 0 0.0 FINARRANG_SAT 0.0001 Very Dissatisfied 2 10.0 0 0.0 Dissatisfied 3 15.0 1 2.4 Neutral 7 35.0 2 4.8 Satisfied 7 35.0 21 50.0 Very satisfied 1 5.0 18 42.9 CONSCONT_SAT 0.0026 Very Dissatisfied 2 10.0 0 0.0 Dissatisfied 1 5.0 3 7.1 Neutral 8 40.0 4 9.5 Satisfied 8 40.0 19 45.2 Very satisfied 1 5.0 16 38.1 INTREL_SAT 0.5446 Dissatisfied 1 5.0 2 4.9 Neutral 2 10.0 5 12.2 Satisfied 13 65.0 19 46.3 Very satisfied 4 20.0 15 36.6 CLIENTSUBFEE_SAT Intervention only Dissatisfied 3 7.7 Neutral 2 5.1 Satisfied 14 35.9 Very satisfied 20 51.3 OVERALL6MTH_SAT 0.0002 Dissatisfied 2 10.0 1 2.5 Neutral 7 35.0 2 5.0 Satisfied 11 55.0 17 42.5 Very satisfied 0 0.0 20 50.0 OVERALL_SAT 0.0009 Neutral 5 25.0 3 7.7 Satisfied 15 75.0 18 46.2 Very satisfied 0 0.0 18 46.2 *p‐value from Chi‐square test



3.3 Cost/benefit analysis

Table 27: Cost estimated from observations

Variable N Mean Std Dev Minimum Maximum

Total Dose Dispensing Cost 20 6.95 3.81 1.83 19.63

In-pharmacy Methodone not-prepared Cost 15 2.99 3.00 0.20 11.19 In-pharmacy&takeaway Methodone not-prepared Cost 10 3.76 5.12 0.06 16.65

In-pharmacy Methodone missing time Cost 1 0.08 . 0.08 0.08 In-pharmacy Suboxone/Subutex not-prepared Cost 12 2.09 2.80 0.09 8.74

In-pharmacy unspecified not-prepared Cost 1 0.04 . 0.04 0.04 In-pharmacy&takeaway Suboxone/Subutex not-prepared Cost 7 0.80 0.87 0.12 2.09

In-pharmacy Methodone prepared Cost 5 0.21 0.25 0.03 0.65 In-pharmacy&takeaway Methodone prepared Cost 6 3.38 3.75 0.06 9.16

Missing prepared Cost 0 . . . .

Take away Methodone not-prepared Cost 2 0.25 0.20 0.11 0.39 Take away Suboxone/Subutex not-prepared Cost 3 0.16 0.14 0.02 0.31

Missing Methodone not-prepared Cost 1 0.06 . 0.06 0.06 In-pharmacy Suboxone/Subutex prepared Cost 2 0.79 0.97 0.10 1.48

Take away missing not-prepared Cost 1 0.37 . 0.37 0.37 In-pharmacy&takeaway Suboxone/Subutex prepared Cost 1 1.33 . 1.33 1.33

Table 28: Investment costs per pharmacy

Investment costs are categorised in three groups:

1. Low cost (<$500): 10 pharmacies (50%)

2. Medium cost (between $500‐$2000): 5 pharmacies (25%)

3. High cost (>$2000): 5 pharmacies (25%)



By PhARIA:

Investment cost PhARIA(PhARIA category)

Low medium high

Total

6 4 5 Category 1

40% 26.67% 33.33% 15

1 1 0 Category 2

50% 50% 0% 2

3 0 0 Category 3

100% 0% 0% 3

Total 10 5 5 20

By State:

Investment cost State

Low medium high

Total

4 1 3 NSW

50% 12.5% 37.5% 8

5 0 1 QLD

83.33% 0% 16.67% 6

1 4 1 VIC

16.67% 66.67% 16.67% 6

Total 10 5 5 20



By number of scripts:

Investment cost PRESRIPTIONS

Low medium high

Total

1 2 2 <300

20% 40% 40% 5

3 2 1 301-800

50% 33.33% 16.67% 6

0 0 2 801-1200

0% 0% 100% 2

6 1 0 1201-2000

85.71% 14.29% 0% 7

Total 10 5 5 20



Table 29: Weekly income

Treatment APPROXIMATE WEEKLY INCOME (Post_QX29) Control Intervention

Total

$0 10.62%

20.65%

3

$1-$149 10.62%

82.59%

9

$150-$249 3119.14%

6621.36%

97

$250-$399 6439.51%

12640.78%

190

$400-$599 3119.14%

5016.18%

81

$600-$799 1911.73%

196.15%

38

$800-$999 42.47%

113.56%

15

$1,000-$1,299 42.47%

123.88%

16

$1,300-$1,599 21.23%

51.62%

7

$1,600-$1,999 10.62%

30.97%

4

$2,000 or more 31.85%

41.29%

7

CAN'T SAY 10.62%

10.32%

2

REFUSED 00.00%

20.65%

2

Total 162 309 471 Frequency Missing = 241



Table 30: ABC observed data

Mean time spent by the pharmacist on each of the observed activities

Time spent on observed activities (mins) N Mean Std Dev Minimum Maximum

In-pharmacy Methodone not-prepared Cost 15 11.37 7.32 2.25 26.5 In-pharmacy&takeaway Methodone not-prepared Cost

10 16.50 15.82 2.25 57.25

In-pharmacy Methodone missing time Cost 1 1.75 . 1.75 1.75 In-pharmacy Suboxone/Subutex not-prepared Cost

12 8.77 6.73 2 22.25

In-pharmacy unspecified not-prepared Cost 1 1.00 . 1 1 In-pharmacy&takeaway Suboxone/Subutex not-prepared Cost

7 7.64 2.33 5 12

In-pharmacy Methodone prepared Cost 5 2.38 1.51 1.25 5 In-pharmacy&takeaway Methodone prepared Cost

6 10.54 8.66 2.25 23.75

Missing prepared Cost 0 . . . .

Take away Methodone not-prepared Cost 2 5.13 3.71 2.5 7.75 Take away Suboxone/Subutex not-prepared Cost

3 3.67 2.75 1 6.5

Missing Methodone not-prepared Cost 1 2.50 . 2.5 2.5 In-pharmacy Suboxone/Subutex prepared Cost

2 10.00 7.78 4.5 15.5

Take away missing not-prepared Cost 1 7.75 . 7.75 7.75 In-pharmacy&takeaway Suboxone/Subutex prepared Cost

1 14.00 . 14 14



Table 31: Average daily dispensing fee charged to clients by state

Total daily dispensing fee by state:

Analysis Variable : dispensing cost

STATE N Mean Std Dev Minimum Maximum

NSW 23 10.34 6.78 1.43 30

NT 1 15.00 . 15 15

QLD 18 8.87 4.95 2.86 20

TAS 2 9.90 7.21 4.8 15

VIC 16 13.37 2.62 7.14 18

WA 9 12.75 5.12 4.5 19

SA 3 8.70 1.97 6.6 10.5

Total 72 10.93 5.36 1.43 30

Total daily dispensing fee on Methadone by state:

Analysis Variable : METHADONE dispensing cost weekly

State N Mean Std Dev Minimum Maximum

NSW 23 4.77 1.87 0 10

NT 1 5.00 . 5 5

QLD 18 3.40 1.58 0 6

TAS 2 4.90 0.14 4.8 5

VIC 16 4.66 0.79 3.57 6

WA 9 4.52 0.44 4 5

SA 3 2.90 0.66 2.2 3.5

total 72 4.30 1.50 0 10



Total daily dispensing fee on Subutex by state:

Analysis Variable : SUBUTEX dispensing cost weekly

State N Mean Std Dev Minimum Maximum

NSW 23 2.38 3.10 0 10

NT 1 5.00 . 5 5

QLD 18 2.00 2.45 0 7

TAS 2 2.50 3.54 0 5

VIC 16 4.06 1.71 0 6

WA 9 4.40 2.58 0 7

SA 3 2.90 0.66 2.2 3.5

total 72 2.97 2.63 0 10

Total daily dispensing fee on Suboxone by state:

Analysis Variable : SUBOXONE dispensing cost weekly

PH_STATE N Mean Std Dev Minimum Maximum

NSW 23 3.19 3.00 0 10

NT 1 5.00 . 5 5

QLD 18 3.47 1.95 0 7

TAS 2 2.50 3.54 0 5

VIC 16 4.66 0.79 3.57 6

WA 9 3.84 2.94 0 7

SA 3 2.90 0.66 2.2 3.5

total 72 3.66 2.32 0 10



Table 32: Average cost of each type of consumable

Variable N Mean Std Dev Minimum Maximum

Total consumable cost per week 20 44.92 51.62 4.62 228.46

Total BOTTLES COST per week 18 21.36 19.05 2.31 69.23

Total LABELS COST per week 20 7.65 15.41 0.06 57.69

Total MUGS COST per week 18 2.95 2.81 0.50 9.74

Total CORDIAL COST per week 8 2.71 3.04 0.23 10.00

Total OTHER1 COST per week 18 7.54 18.74 0.14 80.77





4 Appendices

4.1 Descriptive tables

Table 33: Description of all categorical variables

All patients

(N=712) Control (N=240)

Intervention (N=472)

n (%) n (%) n (%) Gender Male 357 59.3 122 57.3 235 60.4Female 244 40.5 91 42.7 153 39.3Unspecified 1 0.2 0 0.0 1 0.3Missing 110 27 83 Country Australia 517 85.9 187 87.8 330 84.8Asia 24 4.0 2 0.9 22 5.7Canada 1 0.2 1 0.5 0 0.0Greece 1 0.2 1 0.5 0 0.0Other europe 18 3.0 6 2.8 12 3.1New zealand 17 2.8 7 3.3 10 2.6Uk/ireland 19 3.2 7 3.3 12 3.1Other 5 0.8 2 0.9 3 0.8Missing 110 27 83 Language English 592 98.3 212 99.5 380 97.7Greek 1 0.2 1 0.5 0 0.0Cantonese 1 0.2 0 0.0 1 0.3Arabic 1 0.2 0 0.0 1 0.3Vietnamese 4 0.7 0 0.0 4 1.0Other 3 0.5 0 0.0 3 0.8Missing 110 27 83 Employment Full-time employment 91 15.1 34 16.0 57 14.7Part-time employment 39 6.5 15 7.0 24 6.2Temporary benefit (eg sickness, unemployed)

136 22.6 44 20.7 92 23.7

Pension (eg aged, disability) 316 52.5 115 54.0 201 51.7Student allowance 1 0.2 0 0.0 1 0.3Dependant on others 5 0.8 2 0.9 3 0.8Retirement fund 1 0.2 0 0.0 1 0.3No income 9 1.5 2 0.9 7 1.8Other 4 0.7 1 0.5 3 0.8Missing 110 27 83 Living arrangement Rented house or flat (public or private) 427 70.9 154 72.3 273 70.2Privately owned house or flat 133 22.1 45 21.1 88 22.6Boarding house 11 1.8 4 1.9 7 1.8Hostel/ supported accommodation services 14 2.3 5 2.3 9 2.3Psychiatric home/ hospital 1 0.2 1 0.5 0 0.0Shelter/ refuge 1 0.2 0 0.0 1 0.3Caravan on serviced site 2 0.3 0 0.0 2 0.5No usual residence/ homeless 8 1.3 3 1.4 5 1.3Other 5 0.8 1 0.5 4 1.0Missing 110 27 83 PhARIA PhARIA category 1 559 78.5 190 79.2 369 78.2PhARIA category 2 48 6.7 20 8.3 28 5.9PhARIA category 3 66 9.3 14 5.8 52 11.0PhARIA category 4 29 4.1 16 6.7 13 2.8PhARIA category 5 8 1.1 0 0.0 8 1.7PhARIA category 6 2 0.3 0 0.0 2 0.4Missing 0 0 0



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) State NSW 222 31.2 46 19.2 176 37.3NT 17 2.4 0 0.0 17 3.6QLD 135 19.0 66 27.5 69 14.6TAS 15 2.1 3 1.3 12 2.5VIC 229 32.2 85 35.4 144 30.5WA 72 10.1 19 7.9 53 11.2SA 22 3.1 21 8.8 1 0.2Missing 0 0 0 Patient dropout Reason Finished Program Successfully 15 12.9 7 14.3 8 11.9Transferred to another Pharmacy/ Treatment Program

49 42.2 21 42.9 28 41.8

Banned from Pharmacy 6 5.2 2 4.1 4 6.0Client incarcerated 11 9.5 1 2.0 10 14.9Died 2 1.7 2 4.1 0 0.0Unknown 18 15.5 6 12.2 12 17.9N/A 13 11.2 8 16.3 5 7.5Missing 2 1.7 2 4.1 0 0.0Missing 596 191 405 Patient age 18 to 25 years 14 2.3 7 3.3 7 1.825 to <30 years 73 12.1 28 13.1 45 11.630 to <40 years 236 39.2 86 40.4 150 38.640 to <50 years 193 32.1 65 30.5 128 32.950 to <60 years 82 13.6 27 12.7 55 14.160 to <70 years 4 0.7 0 0.0 4 1.0Missing 110 27 83 Main drug cause seek treatment Heroin 480 79.7 159 74.6 321 82.5Morphine 57 9.5 24 11.3 33 8.5Pethidine 5 0.8 3 1.4 2 0.5Codeine 14 2.3 8 3.8 6 1.5Methadone 11 1.8 2 0.9 9 2.3Buprenorphine (e.g. Subutex and suboxone) 1 0.2 1 0.5 0 0.0Oxycodone 16 2.7 6 2.8 10 2.6Opium 4 0.7 3 1.4 1 0.3Hydrocodone 1 0.2 0 0.0 1 0.3Hydromorphone 3 0.5 1 0.5 2 0.5Tramadol 1 0.2 1 0.5 0 0.0Endomorphins 1 0.2 0 0.0 1 0.3Other 8 1.3 5 2.3 3 0.8Missing 110 27 83 Pre_q11xc1:ingest No 545 90.5 192 90.1 353 90.7Yes 57 9.5 21 9.9 36 9.3Missing 110 27 83 Pre_q11xc2:smoke No 549 91.2 203 95.3 346 88.9Yes 53 8.8 10 4.7 43 11.1Missing 110 27 83 Pre_q11xc3:inject No 81 13.5 26 12.2 55 14.1Yes 521 86.5 187 87.8 334 85.9Missing 110 27 83 Pre_q11xc4:sniff No 594 98.7 210 98.6 384 98.7Yes 8 1.3 3 1.4 5 1.3Missing 110 27 83 Pre_q11xc5:inhale No 602 100.0 213 100.0 389 100.0Missing 110 27 83



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Pre_q11xc6:other No 602 100.0 213 100.0 389 100.0Missing 110 27 83 Pre_q11xc7:can't say No 599 99.5 211 99.1 388 99.7Yes 3 0.5 2 0.9 1 0.3Missing 110 27 83 Pre_q12:drug concern Yes 95 15.8 42 19.7 53 13.6No 505 83.9 171 80.3 334 85.9Can't say 2 0.3 0 0.0 2 0.5Missing 110 27 83 Pre_q13xc01:heroin No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc02:morphine No 88 92.6 39 92.9 49 92.5Yes 7 7.4 3 7.1 4 7.5Missing 617 198 419 Pre_q13xc03:pethidine No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc04:codeine No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc05:methadone No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc06:cannabis No 56 58.9 25 59.5 31 58.5Yes 39 41.1 17 40.5 22 41.5Missing 617 198 419 Pre_q13xc07:tobacco No 85 89.5 35 83.3 50 94.3Yes 10 10.5 7 16.7 3 5.7Missing 617 198 419 Pre_q13xc08:cocaine No 92 96.8 41 97.6 51 96.2Yes 3 3.2 1 2.4 2 3.8Missing 617 198 419 Pre_q13xc09:ecstasy No 94 98.9 42 100.0 52 98.1Yes 1 1.1 0 0.0 1 1.9Missing 617 198 419 Pre_q13xc10:ice No 90 94.7 42 100.0 48 90.6Yes 5 5.3 0 0.0 5 9.4Missing 617 198 419 Pre_q13xc11:speed No 69 72.6 33 78.6 36 67.9Yes 26 27.4 9 21.4 17 32.1Missing 617 198 419 Pre_q13xc12:sleeping pills No 81 85.3 39 92.9 42 79.2Yes 14 14.7 3 7.1 11 20.8Missing 617 198 419 Pre_q13xc13:ghb No 94 98.9 42 100.0 52 98.1Yes 1 1.1 0 0.0 1 1.9Missing 617 198 419 Pre_q13xc14:ketamine No 95 100.0 42 100.0 53 100.0



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Missing 617 198 419 Pre_q13xc15:lsd No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc16:psilocybin No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc17:inhalants No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc18:prescription drugs No 90 94.7 41 97.6 49 92.5Yes 5 5.3 1 2.4 4 7.5Missing 617 198 419 Pre_q13xc19:alcohol No 83 87.4 32 76.2 51 96.2Yes 12 12.6 10 23.8 2 3.8Missing 617 198 419 Pre_q13xc20:other No 89 93.7 39 92.9 50 94.3Yes 6 6.3 3 7.1 3 5.7Missing 617 198 419 Pre_q13xc21:can't say No 95 100.0 42 100.0 53 100.0Missing 617 198 419 Pre_q13xc22:other drugs No 93 97.9 40 95.2 53 100.0Yes 2 2.1 2 4.8 0 0.0Missing 617 198 419 Pre_q14:alcohol Yes 56 9.5 19 9.4 37 9.6No 533 90.3 183 90.1 350 90.4Can't say 1 0.2 1 0.5 0 0.0Missing 122 37 85 Pre_q15xc1:wine No 54 79.4 22 75.9 32 82.1Yes 14 20.6 7 24.1 7 17.9Missing 644 211 433 Pre_q15xc2:beer No 42 61.8 21 72.4 21 53.8Yes 26 38.2 8 27.6 18 46.2Missing 644 211 433 Pre_q15xc3:spirits No 26 38.2 10 34.5 16 41.0Yes 42 61.8 19 65.5 23 59.0Missing 644 211 433 Pre_q15xc4:liqueurs No 68 100.0 29 100.0 39 100.0Missing 644 211 433 Pre_q15xc5:all type No 68 100.0 29 100.0 39 100.0Missing 644 211 433 Pre_q15xc6:other No 66 97.1 29 100.0 37 94.9Yes 2 2.9 0 0.0 2 5.1Missing 644 211 433 Pre_q15xc7:can't say No 68 100.0 29 100.0 39 100.0Missing 644 211 433 Pre_q16:inject drug In the last month 130 21.6 50 23.5 80 20.6Between one to three months ago 58 9.6 20 9.4 38 9.8



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) More than three but less than 12 months ago

96 15.9 39 18.3 57 14.7

12 months ago or more 282 46.8 93 43.7 189 48.6Never 35 5.8 10 4.7 25 6.4Can't say 1 0.2 1 0.5 0 0.0Missing 110 27 83 Pre_q17:needle Yes 22 11.6 9 12.7 13 11.0No 167 88.4 62 87.3 105 89.0Missing 523 169 354 Pre_q19:spoons Yes 52 27.5 26 36.6 26 22.0No 137 72.5 45 63.4 92 78.0Missing 523 169 354 Pre_q32_1:other drug Yes, first mention 61 10.1 18 8.5 43 11.1No 541 89.9 195 91.5 346 88.9Missing 110 27 83 Pre_q32_2:other drug 2 Yes, second mention 22 36.1 6 33.3 16 37.2No others 39 63.9 12 66.7 27 62.8Missing 651 222 429 Pre_q32_3:other drug 3 Yes, third mention 11 50.0 4 66.7 7 43.8No others 11 50.0 2 33.3 9 56.3Missing 690 234 456 Qol pre_q34

Very poor 34 5.6 8 3.8 26 6.7Poor 101 16.8 33 15.5 68 17.5Neither poor nor good 134 22.3 48 22.5 86 22.1Good 253 42.0 94 44.1 159 40.9Very good 79 13.1 29 13.6 50 12.9Can't say 1 0.2 1 0.5 0 0.0Missing 110 27 83 Qol pre_q35

Very dissatisfied 46 7.6 14 6.6 32 8.2Dissatisfied 175 29.1 54 25.4 121 31.1Neither satisfied nor dissatisfied 108 17.9 45 21.1 63 16.2Satisfied 224 37.2 84 39.4 140 36.0Very satisfied 46 7.6 16 7.5 30 7.7Can't say 3 0.5 0 0.0 3 0.8Missing 110 27 83 Qol pre_q36

Not at all 60 10.0 12 5.6 48 12.3A little 113 18.8 48 22.5 65 16.7Moderately 157 26.1 55 25.8 102 26.2Mostly 168 27.9 64 30.0 104 26.7Completely 101 16.8 33 15.5 68 17.5Can't say 3 0.5 1 0.5 2 0.5Missing 110 27 83 Qol pre_q37

Very dissatisfied 45 7.5 15 7.0 30 7.7Dissatisfied 121 20.1 39 18.3 82 21.1Neither satisfied nor dissatisfied 96 15.9 41 19.2 55 14.1Satisfied 262 43.5 91 42.7 171 44.0Very satisfied 75 12.5 25 11.7 50 12.9Can't say 3 0.5 2 0.9 1 0.3Missing 110 27 83



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Qol pre_q38




Not at all 163 27.1 49 23.0 114 29.3A little 116 19.3 48 22.5 68 17.5Moderately 146 24.3 56 26.3 90 23.1Mostly 122 20.3 40 18.8 82 21.1Completely 55 9.1 20 9.4 35 9.0Missing 110 27 83 Social functioning pre_q42

Never or almost never 172 28.6 60 28.2 112 28.8Sometimes 178 29.6 70 32.9 108 27.8Often 119 19.8 46 21.6 73 18.8Always or nearly always 129 21.4 36 16.9 93 23.9Can't say/ (and pilot only: not applicable) 4 0.7 1 0.5 3 0.8Missing 110 27 83 Social functioning pre_q43

Not applicable (that is, no partner) 257 42.7 92 43.2 165 42.4Never or almost never 205 34.1 67 31.5 138 35.5Sometimes 89 14.8 35 16.4 54 13.9Often 29 4.8 10 4.7 19 4.9Always or nearly always 20 3.3 9 4.2 11 2.8Can't say 2 0.3 0 0.0 2 0.5Missing 110 27 83 Social functioning pre_q44

No contact with relatives 72 12.0 27 12.7 45 11.6Never or almost never 372 61.8 134 62.9 238 61.2Sometimes 97 16.1 36 16.9 61 15.7Often 29 4.8 9 4.2 20 5.1Always or nearly always 32 5.3 7 3.3 25 6.4Missing 110 27 83 Social functioning pre_q45



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) 1 354 58.8 122 57.3 232 59.6Never or almost never 226 37.5 83 39.0 143 36.8Sometimes 13 2.2 5 2.3 8 2.1Often 7 1.2 2 0.9 5 1.3Always or nearly always 2 0.3 1 0.5 1 0.3Missing 110 27 83 Social functioning pre_q46

None of the time 486 80.7 164 77.0 322 82.8Rarely 24 4.0 10 4.7 14 3.6Sometimes 35 5.8 13 6.1 22 5.7Most of the time 13 2.2 6 2.8 7 1.8All of the time 43 7.1 20 9.4 23 5.9Can't say 1 0.2 0 0.0 1 0.3Missing 110 27 83 Social functioning pre_q47

None of the time 101 16.8 29 13.6 72 18.5Rarely 66 11.0 22 10.3 44 11.3Sometimes 124 20.6 39 18.3 85 21.9Most of the time 137 22.8 54 25.4 83 21.3All of the time 167 27.7 67 31.5 100 25.7Can't say 7 1.2 2 0.9 5 1.3Missing 110 27 83 Arrest pre_q48

None 555 92.2 196 92.0 359 92.3One time 33 5.5 12 5.6 21 5.4Two times 8 1.3 1 0.5 7 1.83-4 times 4 0.7 4 1.9 0 0.05-6 times 1 0.2 0 0.0 1 0.37-10 times 1 0.2 0 0.0 1 0.3Missing 110 27 83 Patient satisfaction q59

Very dissatisfied 153 25.4 54 25.4 99 25.4Dissatisfied 182 30.2 72 33.8 110 28.3Neither dissatisfied nor satisfied 84 14.0 29 13.6 55 14.1Satisfied 125 20.8 41 19.2 84 21.6Very satisfied 57 9.5 17 8.0 40 10.3(Do not read) can't say 1 0.2 0 0.0 1 0.3Missing 110 27 83 Patient satisfaction q62

Very dissatisfied 44 7.3 14 6.6 30 7.7Dissatisfied 90 15.0 44 20.7 46 11.8Neither dissatisfied nor satisfied 74 12.3 30 14.1 44 11.3Satisfied 277 46.0 80 37.6 197 50.6Very satisfied 115 19.1 44 20.7 71 18.3Can't say 2 0.3 1 0.5 1 0.3Missing 110 27 83 Patient satisfaction q64

Very dissatisfied 25 4.2 7 3.3 18 4.6Dissatisfied 54 9.0 25 11.7 29 7.5Neither dissatisfied nor satisfied 64 10.6 23 10.8 41 10.5Satisfied 241 40.0 84 39.4 157 40.4Very satisfied 217 36.0 74 34.7 143 36.8Can't say 1 0.2 0 0.0 1 0.3Missing 110 27 83 Patient satisfaction q66



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Very dissatisfied 25 4.2 6 2.8 19 4.9Dissatisfied 77 12.8 27 12.7 50 12.9Neither dissatisfied nor satisfied 91 15.1 38 17.8 53 13.6Satisfied 270 44.9 88 41.3 182 46.8Very satisfied 138 22.9 53 24.9 85 21.9Can't say 1 0.2 1 0.5 0 0.0Missing 110 27 83 Post_q7:income Full-time employment 77 16.3 28 17.3 49 15.9Part-time employment 33 7.0 13 8.0 20 6.5Temporary benefit (eg sickness, unemployed)

114 24.2 34 21.0 80 25.9

Pension (eg aged, disability) 234 49.7 83 51.2 151 48.9Student allowance 2 0.4 0 0.0 2 0.6Dependant on others 7 1.5 2 1.2 5 1.6No income 2 0.4 1 0.6 1 0.3Other 2 0.4 1 0.6 1 0.3Missing 241 78 163 Post_q8:living Rented house or flat (public or private) 304 64.5 102 63.0 202 65.4Privately owned house or flat 123 26.1 43 26.5 80 25.9Boarding house 9 1.9 4 2.5 5 1.6Hostel/ supported accommodation services 22 4.7 10 6.2 12 3.9Psychiatric home/ hospital 1 0.2 1 0.6 0 0.0Shelter/ refuge 2 0.4 1 0.6 1 0.3Caravan on serviced site 5 1.1 0 0.0 5 1.6No usual residence/ homeless 3 0.6 1 0.6 2 0.6Other 2 0.4 0 0.0 2 0.6Missing 241 78 163 Post_q11_1:drug taken Yes 99 21.0 38 23.5 61 19.7No 370 78.6 124 76.5 246 79.6Can't say 2 0.4 0 0.0 2 0.6Missing 241 78 163 Post_q11c1:ingest No 87 87.9 32 84.2 55 90.2Yes 12 12.1 6 15.8 6 9.8Missing 613 202 411 Post_q11c2:smoke No 96 97.0 37 97.4 59 96.7Yes 3 3.0 1 2.6 2 3.3Missing 613 202 411 Post_q11c3:inject No 13 13.1 6 15.8 7 11.5Yes 86 86.9 32 84.2 54 88.5Missing 613 202 411 Post_q11c4:sniff No 99 100.0 38 100.0 61 100.0Missing 613 202 411 Post_q11c5:inhale No 99 100.0 38 100.0 61 100.0Missing 613 202 411 Post_q11c6:other No 99 100.0 38 100.0 61 100.0Missing 613 202 411 Post_q11c7:can't say No 99 100.0 38 100.0 61 100.0Missing 613 202 411 Post_q12:other drug Yes 70 14.9 25 15.4 45 14.6No 401 85.1 137 84.6 264 85.4Missing 241 78 163



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Post_q13c01:heroin No 67 95.7 24 96.0 43 95.6Yes 3 4.3 1 4.0 2 4.4Missing 642 215 427 Post_q13c02:morphine No 69 98.6 25 100.0 44 97.8Yes 1 1.4 0 0.0 1 2.2Missing 642 215 427 Post_q13c03:pethidine No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c04:codeine No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c05:methadone No 67 95.7 23 92.0 44 97.8Yes 3 4.3 2 8.0 1 2.2Missing 642 215 427 Post_q13c06:cannabis No 45 64.3 20 80.0 25 55.6Yes 25 35.7 5 20.0 20 44.4Missing 642 215 427 Post_q13c07:tobacco No 65 92.9 24 96.0 41 91.1Yes 5 7.1 1 4.0 4 8.9Missing 642 215 427 Post_q13c08:cocaine No 69 98.6 24 96.0 45 100.0Yes 1 1.4 1 4.0 0 0.0Missing 642 215 427 Post_q13c09:ecstasy No 69 98.6 25 100.0 44 97.8Yes 1 1.4 0 0.0 1 2.2Missing 642 215 427 Post_q13c10:ice No 68 97.1 25 100.0 43 95.6Yes 2 2.9 0 0.0 2 4.4Missing 642 215 427 Post_q13c11:speed No 58 82.9 21 84.0 37 82.2Yes 12 17.1 4 16.0 8 17.8Missing 642 215 427 Post_q13c12:sleeping pills No 52 74.3 17 68.0 35 77.8Yes 18 25.7 8 32.0 10 22.2Missing 642 215 427 Post_q13c13:ghb No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c14:ketamine No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c15:lsd No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c16:psilocybin No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c17:inhalants No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c18:prescription drugs



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) No 62 88.6 20 80.0 42 93.3Yes 8 11.4 5 20.0 3 6.7Missing 642 215 427 Post_q13c19:alcohol No 66 94.3 23 92.0 43 95.6Yes 4 5.7 2 8.0 2 4.4Missing 642 215 427 Post_q13c20:other No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c21:can't say No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q13c22:other drug No 70 100.0 25 100.0 45 100.0Missing 642 215 427 Post_q14:alcohol concern Yes 48 10.3 14 8.8 34 11.1No 418 89.5 146 91.3 272 88.6Can't say 1 0.2 0 0.0 1 0.3Missing 245 80 165 Post_q15c1:wine No 39 75.0 12 75.0 27 75.0Yes 13 25.0 4 25.0 9 25.0Missing 660 224 436 Post_q15c2:beer No 29 55.8 11 68.8 18 50.0Yes 23 44.2 5 31.3 18 50.0Missing 660 224 436 Post_q15c3:spirits No 29 55.8 8 50.0 21 58.3Yes 23 44.2 8 50.0 15 41.7Missing 660 224 436 Post_q15c4:liqueurs No 51 98.1 15 93.8 36 100.0Yes 1 1.9 1 6.3 0 0.0Missing 660 224 436 Post_q15c5:all type No 51 98.1 15 93.8 36 100.0Yes 1 1.9 1 6.3 0 0.0Missing 660 224 436 Post_q15c6:other No 52 100.0 16 100.0 36 100.0Missing 660 224 436 Post_q15c7:can't say No 52 100.0 16 100.0 36 100.0Missing 660 224 436 Post_q16:inject drug In the last month 91 19.3 32 19.8 59 19.1Between one to three months ago 41 8.7 15 9.3 26 8.4More than three but less than 6 months ago 27 5.7 14 8.6 13 4.2More than six months be less than 12 months ago

45 9.6 15 9.3 30 9.7

12 months ago or more 237 50.3 75 46.3 162 52.4Never 29 6.2 11 6.8 18 5.8Can't say 1 0.2 0 0.0 1 0.3Missing 241 78 163 Post_q17:needle Yes 11 8.3 7 14.9 4 4.7No 122 91.7 40 85.1 82 95.3Missing 579 193 386 Post_q19:spoons



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Yes 35 7.4 13 8.0 22 7.1No 435 92.4 149 92.0 286 92.6Can't say 1 0.2 0 0.0 1 0.3Missing 241 78 163 Post_q32_1:other drug1 Anti depressants/ anti anxiety medication (cypramil/ effexor

17 3.6 7 4.3 10 3.2

Sleeping pills (serapax/ valium/ imovan) 4 0.8 1 0.6 3 1.0Prescription pain relievers (tramadol/ oxycodone)

4 0.8 2 1.2 2 0.6

Prescription anti psychotic (zyprexa/ serequel)

3 0.6 2 1.2 1 0.3

Other prescription medication (antibiotics/ heart medication

5 1.1 3 1.9 2 0.6

Over the counter pain relievers (panadol/ ibuprophen/ panado

2 0.4 0 0.0 2 0.6

Ecstasy/ mdma 3 0.6 1 0.6 2 0.6Yes, first mention 3 0.6 0 0.0 3 1.0No 430 91.3 146 90.1 284 91.9Missing 241 78 163 Post_q32_2:other drug2 Anti depressants/ anti anxiety medication (cypramil/ effexor

1 2.4 0 0.0 1 4.0

Sleeping pills (serapax/ valium/ imovan) 1 2.4 0 0.0 1 4.0Prescription pain relievers (tramadol/ oxycodone)

1 2.4 1 6.3 0 0.0

Prescription anti psychotic (zyprexa/ serequel)

1 2.4 1 6.3 0 0.0


7 17.1 5 31.3 2 8.0

Over the counter pain relievers (panadol/ ibuprophen/ panado

3 7.3 1 6.3 2 8.0

Ventolin 2 4.9 1 6.3 1 4.0Yes, second mention 1 2.4 0 0.0 1 4.0No others 24 58.5 7 43.8 17 68.0Missing 671 224 447 Post_q32_3: other drug3 Anti depressants/ anti anxiety medication (cypramil/ effexor

2 11.8 1 11.1 1 12.5


2 11.8 1 11.1 1 12.5

Yes, third mention 2 11.8 1 11.1 1 12.5No others 11 64.7 6 66.7 5 62.5Missing 695 231 464 Qol post_q34

Very poor 23 4.9 7 4.3 16 5.2Poor 68 14.4 23 14.2 45 14.6Neither poor nor good 103 21.9 32 19.8 71 23.0Good 212 45.0 82 50.6 130 42.1Very good 64 13.6 18 11.1 46 14.9Can't say 1 0.2 0 0.0 1 0.3Missing 241 78 163 Qol post_q35

Very dissatisfied 37 7.9 13 8.0 24 7.8Dissatisfied 132 28.0 41 25.3 91 29.4Neither satisfied nor dissatisfied 90 19.1 37 22.8 53 17.2Satisfied 173 36.7 58 35.8 115 37.2Very satisfied 39 8.3 13 8.0 26 8.4Missing 241 78 163 Qol post_q36



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Not at all 68 14.4 17 10.5 51 16.5A little 69 14.6 30 18.5 39 12.6Moderately 113 24.0 44 27.2 69 22.3Mostly 158 33.5 58 35.8 100 32.4Completely 60 12.7 13 8.0 47 15.2Can't say 3 0.6 0 0.0 3 1.0Missing 241 78 163 Qol post_q37

Very dissatisfied 37 7.9 10 6.2 27 8.7Dissatisfied 94 20.0 37 22.8 57 18.4Neither satisfied nor dissatisfied 78 16.6 29 17.9 49 15.9Satisfied 214 45.4 67 41.4 147 47.6Very satisfied 47 10.0 18 11.1 29 9.4Can't say 1 0.2 1 0.6 0 0.0Missing 241 78 163 Qol post_q38




Not at all 111 23.6 34 21.0 77 24.9A little 75 15.9 26 16.0 49 15.9Moderately 134 28.5 42 25.9 92 29.8Mostly 120 25.5 47 29.0 73 23.6Completely 30 6.4 12 7.4 18 5.8Can't say 1 0.2 1 0.6 0 0.0Missing 241 78 163 Social functioning post_q42

Never or almost never 171 36.3 64 39.5 107 34.6Sometimes 142 30.1 48 29.6 94 30.4Often 79 16.8 25 15.4 54 17.5Always or nearly always 79 16.8 25 15.4 54 17.5Missing 241 78 163 Social functioning post_q43

Not applicable (that is, no partner) 204 43.3 69 42.6 135 43.7



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Never or almost never 172 36.5 66 40.7 106 34.3Sometimes 61 13.0 13 8.0 48 15.5Often 24 5.1 8 4.9 16 5.2Always or nearly always 8 1.7 5 3.1 3 1.0Can't say 2 0.4 1 0.6 1 0.3Missing 241 78 163 Social functioning post_q44

No contact with relatives 56 11.9 20 12.3 36 11.7Never or almost never 299 63.5 109 67.3 190 61.5Sometimes 72 15.3 20 12.3 52 16.8Often 31 6.6 8 4.9 23 7.4Always or nearly always 13 2.8 5 3.1 8 2.6Missing 241 78 163 Social functioning post_q45

1 252 53.5 80 49.4 172 55.7Never or almost never 180 38.2 69 42.6 111 35.9Sometimes 26 5.5 10 6.2 16 5.2Often 8 1.7 2 1.2 6 1.9Always or nearly always 4 0.8 1 0.6 3 1.0Can't say 1 0.2 0 0.0 1 0.3Missing 241 78 163 Social functioning post_q46

None of the time 395 83.9 130 80.2 265 85.8Rarely 15 3.2 7 4.3 8 2.6Sometimes 13 2.8 6 3.7 7 2.3Most of the time 14 3.0 7 4.3 7 2.3All of the time 33 7.0 11 6.8 22 7.1Can't say 1 0.2 1 0.6 0 0.0Missing 241 78 163 Social functioning post_q47

None of the time 69 14.6 24 14.8 45 14.6Rarely 51 10.8 18 11.1 33 10.7Sometimes 86 18.3 27 16.7 59 19.1Most of the time 103 21.9 40 24.7 63 20.4All of the time 157 33.3 52 32.1 105 34.0Can't say 5 1.1 1 0.6 4 1.3Missing 241 78 163 Arrest post_q48

None 441 93.6 146 90.1 295 95.5One time 26 5.5 13 8.0 13 4.2Two times 1 0.2 1 0.6 0 0.03-4 times 3 0.6 2 1.2 1 0.3Missing 241 78 163 Patient satisfaction post_q59

Very dissatisfied 76 16.1 33 20.4 43 13.9Dissatisfied 124 26.3 58 35.8 66 21.4Neither dissatisfied nor satisfied 57 12.1 21 13.0 36 11.7Satisfied 119 25.3 32 19.8 87 28.2Very satisfied 95 20.2 18 11.1 77 24.9Missing 241 78 163 Patient satisfaction post_q62

Very dissatisfied 28 5.9 8 4.9 20 6.5Dissatisfied 62 13.2 23 14.2 39 12.6Neither dissatisfied nor satisfied 80 17.0 28 17.3 52 16.8Satisfied 202 42.9 74 45.7 128 41.4



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Very satisfied 97 20.6 28 17.3 69 22.3Can't say 2 0.4 1 0.6 1 0.3Missing 241 78 163 Patient satisfaction post_q64

Very dissatisfied 22 4.7 12 7.4 10 3.2Dissatisfied 46 9.8 15 9.3 31 10.0Neither dissatisfied nor satisfied 51 10.8 20 12.3 31 10.0Satisfied 190 40.3 63 38.9 127 41.1Very satisfied 160 34.0 51 31.5 109 35.3Can't say 2 0.4 1 0.6 1 0.3Missing 241 78 163 Patient satisfaction post_q66

Very dissatisfied 14 3.0 4 2.5 10 3.2Dissatisfied 52 11.0 24 14.8 28 9.1Neither dissatisfied nor satisfied 55 11.7 21 13.0 34 11.0Satisfied 224 47.6 73 45.1 151 48.9Very satisfied 124 26.3 40 24.7 84 27.2Can't say 2 0.4 0 0.0 2 0.6Missing 241 78 163 Financial strain post_qx13

A large impact 186 41.6 55 36.7 131 44.1Some impact 164 36.7 67 44.7 97 32.7Very little impact 60 13.4 16 10.7 44 14.8No impact 36 8.1 12 8.0 24 8.1Don't know/ can't say 1 0.2 0 0.0 1 0.3Missing 265 90 175 Financial strain post_qx14

A large impact 7 29.2 2 16.7 5 41.7Some impact 9 37.5 7 58.3 2 16.7Very little impact 6 25.0 2 16.7 4 33.3No impact 2 8.3 1 8.3 1 8.3Missing 688 228 460 Financial strain post_qx15

Yes 147 40.2 47 35.9 100 42.6No 218 59.6 83 63.4 135 57.4Can't say 1 0.3 1 0.8 0 0.0Missing 346 109 237 Financial strain post_qx16

Yes 114 31.1 38 29.0 76 32.3No 252 68.9 93 71.0 159 67.7Missing 346 109 237 Financial strain post_qx17



Yes 34 9.3 16 12.2 18 7.7No 332 90.7 115 87.8 217 92.3Missing 346 109 237



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Financial strain post_qx20



Less than $500 50 45.0 20 48.8 30 42.9$500-$999 28 25.2 13 31.7 15 21.4$1000-$1999 13 11.7 4 9.8 9 12.9$2000 or more 20 18.0 4 9.8 16 22.9Missing 601 199 402 Financial strain post_qx23

All the time 11 7.5 3 6.4 8 8.0Frequently 27 18.4 6 12.8 21 21.0Occasionally 78 53.1 26 55.3 52 52.0Just once 29 19.7 12 25.5 17 17.0Don't know/ can't say 2 1.4 0 0.0 2 2.0Missing 565 193 372 Financial strain post_qx24


All the time 1 5.9 1 16.7 0 0.0Frequently 1 5.9 0 0.0 1 9.1Occasionally 10 58.8 4 66.7 6 54.5Just once 5 29.4 1 16.7 4 36.4Missing 695 234 461 Financial strain post_qx26



All the time 3 13.6 1 14.3 2 13.3Frequently 5 22.7 1 14.3 4 26.7Occasionally 9 40.9 3 42.9 6 40.0Just once 5 22.7 2 28.6 3 20.0



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Missing 690 233 457 Perception of subsidy post_qx30i

Yes 303 65.4 108 68.8 195 63.7Maybe 27 5.8 8 5.1 19 6.2No 125 27.0 40 25.5 85 27.8Can't say 8 1.7 1 0.6 7 2.3Missing 249 83 166 Perception of subsidy post_qx30ii

Yes 349 75.4 121 77.1 228 74.5Maybe 28 6.0 7 4.5 21 6.9No 80 17.3 27 17.2 53 17.3Can't say 6 1.3 2 1.3 4 1.3Missing 249 83 166 Perception of subsidy post_qx30iii

Yes 387 83.6 133 84.7 254 83.0Maybe 15 3.2 2 1.3 13 4.2No 56 12.1 20 12.7 36 11.8Can't say 5 1.1 2 1.3 3 1.0Missing 249 83 166 Perception of subsidy post_qx30iv

Yes 396 85.5 136 86.6 260 85.0Maybe 11 2.4 4 2.5 7 2.3No 51 11.0 16 10.2 35 11.4Can't say 5 1.1 1 0.6 4 1.3Missing 249 83 166 Pharmacy satisfaction fin_arrangemnents

Very dissatisfied 65 9.4 29 13.2 36 7.6Dissatisfied 325 47.1 107 48.9 218 46.3Neutral 197 28.6 76 34.7 121 25.7Satisfied 103 14.9 7 3.2 96 20.4Missing 22 21 1 Pharmacy satisfaction cons_contribution

Very dissatisfied 53 7.5 11 4.7 42 8.9Dissatisfied 351 49.8 116 49.6 235 49.9Neutral 103 14.6 36 15.4 67 14.2Satisfied 170 24.1 71 30.3 99 21.0Very satisfied 28 4.0 0 0.0 28 5.9Missing 7 6 1 Pharmacy satisfaction curr_interactions

Dissatisfied 23 3.3 13 5.9 10 2.1Neutral 162 23.5 32 14.6 130 27.6Satisfied 408 59.1 138 63.0 270 57.3Very satisfied 97 14.1 36 16.4 61 13.0Missing 22 21 1 Pharmacy satisfaction sat_overall

Very dissatisfied 6 0.9 6 2.6 0 0.0Dissatisfied 133 18.9 72 30.8 61 13.0Neutral 278 39.4 86 36.8 192 40.8Satisfied 272 38.6 54 23.1 218 46.3Very satisfied 16 2.3 16 6.8 0 0.0Missing 7 6 1 Pharmacy satisfaction finarrang_sat

Very dissatisfied 32 5.2 32 16.4 0 0.0Dissatisfied 48 7.8 38 19.5 10 2.4



All patients

(N=712) Control (N=240)


n (%) n (%) n (%) Neutral 75 12.2 55 28.2 20 4.8Satisfied 312 50.9 57 29.2 255 61.0Very satisfied 146 23.8 13 6.7 133 31.8Missing 99 45 54 Pharmacy satisfaction conscont_sat

Very dissatisfied 24 3.9 24 12.3 0 0.0Dissatisfied 42 6.9 5 2.6 37 8.9Neutral 125 20.4 92 47.2 33 7.9Satisfied 287 46.8 61 31.3 226 54.1Very satisfied 135 22.0 13 6.7 122 29.2Missing 99 45 54 Pharmacy satisfaction intrel_sat

Dissatisfied 21 3.5 8 4.1 13 3.2Neutral 62 10.3 21 10.8 41 10.0Satisfied 380 63.0 130 66.7 250 61.3Very satisfied 140 23.2 36 18.5 104 25.5Missing 109 45 64 Pharmacy satisfaction clientsubfee_sat

Dissatisfied 15 3.8 0 15 3.8Neutral 20 5.0 0 20 5.0Satisfied 185 46.3 0 185 46.3Very satisfied 180 45.0 0 180 45.0Missing 312 240 72 Pharmacy satisfaction overall6mth_sat

Dissatisfied 18 3.0 14 7.2 4 1.0Neutral 105 17.7 85 43.6 20 5.0Satisfied 286 48.1 96 49.2 190 47.6Very satisfied 185 31.1 0 0.0 185 46.4Missing 118 45 73 Pharmacy satisfaction overall_sat

Neutral 94 15.9 59 30.3 35 8.8Satisfied 317 53.5 136 69.7 181 45.5Very satisfied 182 30.7 0 0.0 182 45.7Missing 119 45 74

T:\\Statistics\\Projects\\PWC\\PT\\Program\\a_descriptive.sas

Data cutoff: 18JAN2010 Last run: 16FEB2010 16:45



Table 34: Description of all continuous variables

n mean (std) Q1 Q2 Q3 min max

nmiss All patients

(N=712) Control (N=240)


Age (years) 602 39.6 ( 8.8) 213 39.0 ( 8.7) 389 40.0 ( 8.8) 32 39 46 32 39 45 32 39 47 21 67 21 59 22 67 110 27 83 Drug use: MONTHDAYS_M1

696 24.4 ( 9.0) 227 24.9 ( 7.7) 469 24.1 ( 9.5)

21 28 28 27 28 29 14 28 28 0 99 0 35 0 99 16 13 3 Drug use: MONTHDAYS_M2

688 24.4 ( 8.4) 222 25.2 ( 7.4) 466 24.1 ( 8.8)


666 24.6 ( 8.0) 214 25.6 ( 6.5) 452 24.2 ( 8.6)


646 24.7 ( 7.2) 205 25.9 ( 6.1) 441 24.1 ( 7.7)


618 24.9 ( 6.9) 186 26.3 ( 5.1) 432 24.2 ( 7.4)


566 24.7 ( 6.7) 167 26.1 ( 4.9) 399 24.1 ( 7.2)

23 28 28 27 28 28 14 28 28 2 35 2 29 7 35 146 73 73 Needle sharing: PRE_Q18

22 5.4 ( 7.8) 9 7.1 ( 7.8) 13 4.2 ( 7.9)

1 2 4 2 3 10 1 2 4 0 30 0 20 0 30 690 231 459 Spoons sharing: PRE_Q20

52 10.4 ( 16.2) 26 10.3 ( 14.0) 26 10.5 ( 18.4)

2 3 11 1 4 20 2 3 10 1 90 1 50 1 90 660 214 446 Overdose frequency: PRE_Q21

602 0.2 ( 4.1) 213 0.0 ( 0.2) 389 0.3 ( 5.1)

0 0 0 0 0 0 0 0 0 0 99 0 2 0 99 110 27 83




nmiss All patients

(N=712) Control (N=240)


Polydrug use: PRE_Q22

602 1.1 ( 4.3) 213 1.1 ( 4.2) 389 1.2 ( 4.4)

0 0 0 0 0 0 0 0 0 0 30 0 30 0 30 110 27 83 Polydrug use: PRE_Q23

602 1.0 ( 3.9) 213 1.4 ( 4.5) 389 0.8 ( 3.6)


602 0.1 ( 1.0) 213 0.1 ( 0.7) 389 0.1 ( 1.1)


602 0.3 ( 1.8) 213 0.3 ( 1.5) 389 0.4 ( 1.9)


602 6.1 ( 11.9) 213 5.7 ( 10.8) 389 6.3 ( 12.4)


602 8.2 ( 12.0) 213 8.5 ( 12.2) 389 8.0 ( 11.9)

0 0 15 0 0 15 0 0 15 0 31 0 31 0 31 110 27 83 Alcohol and tobacco: PRE_Q28

602 26.3 ( 9.7) 213 26.7 ( 9.4) 389 26.2 ( 9.9)


539 15.8 ( 8.5) 192 16.7 ( 9.6) 347 15.3 ( 7.9)


602 5.6 ( 9.6) 213 6.2 ( 10.0) 389 5.3 ( 9.3)


274 6.3 ( 6.4) 105 6.2 ( 5.8) 169 6.3 ( 6.8)

3 4 7 3 4 7 3 4 7 1 60 1 30 1 60 438 135 303 Polydrug use: PRE_Q33_1

61 21.0 ( 12.3) 18 20.6 ( 13.1) 43 21.2 ( 12.1)




nmiss All patients

(N=712) Control (N=240)



22 24.0 ( 10.5) 6 26.0 ( 10.3) 16 23.3 ( 10.8)


11 24.5 ( 10.0) 4 24.0 ( 12.7) 7 24.7 ( 9.3)

15 30 30 18 30 31 15 30 30 5 31 5 31 8 30 701 236 465 Needle sharing: POST_Q18

11 2.9 ( 2.8) 7 2.1 ( 1.5) 4 4.3 ( 4.3)

1 2 5 1 2 3 1 3 8 1 10 1 5 1 10 701 233 468 Spoons sharing: POST_Q20

36 13.1 ( 23.5) 13 13.5 ( 26.0) 23 12.9 ( 22.5)

2 4 11 4 5 10 2 3 15 1 99 1 99 1 99 676 227 449 Overdose frequency: POST_Q21

471 0.0 ( 0.2) 162 0.0 ( 0.1) 309 0.0 ( 0.2)

0 0 0 0 0 0 0 0 0 0 2 0 1 0 2 241 78 163 Polydrug use: POST_Q22

471 1.4 ( 5.1) 162 1.8 ( 5.9) 309 1.2 ( 4.5)


471 0.7 ( 3.4) 162 0.7 ( 2.9) 309 0.6 ( 3.6)


471 0.0 ( 0.4) 162 0.1 ( 0.7) 309 0.0 ( 0.1)


471 0.5 ( 2.8) 162 0.4 ( 2.6) 309 0.5 ( 2.8)


471 6.6 ( 11.9) 162 6.9 ( 12.5) 309 6.5 ( 11.6)

0 0 5 0 0 5 0 0 5 0 60 0 60 0 31




nmiss All patients

(N=712) Control (N=240)


241 78 163 Polydrug use: POST_Q27

471 7.6 ( 11.8) 162 6.8 ( 11.3) 309 8.1 ( 12.0)

0 0 14 0 0 10 0 0 15 0 31 0 31 0 31 241 78 163 Alcohol and tobacco: POST_Q28

471 26.7 ( 10.9) 162 26.7 ( 9.6) 309 26.7 ( 11.6)


421 16.0 ( 9.0) 147 17.7 ( 9.0) 274 15.1 ( 8.9)


471 5.9 ( 10.8) 162 5.8 ( 9.8) 309 5.9 ( 11.3)


219 5.6 ( 4.9) 77 5.3 ( 5.1) 142 5.8 ( 4.8)

3 4 6 3 4 6 3 5 7 1 40 1 40 1 30 493 163 330 Polydrug use: POST_Q33_1

41 20.6 ( 12.7) 16 22.4 ( 12.5) 25 19.4 ( 13.0)


17 20.4 ( 12.8) 9 20.0 ( 13.1) 8 20.8 ( 13.3)


6 22.2 ( 12.6) 3 30.3 ( 0.6) 3 14.0 ( 14.0)

8 30 30 30 30 31 4 8 30 4 31 30 31 4 30 706 237 469 T:\\Statistics\\Projects\\PWC\\PT\\Program\\a_descriptive.sas




4.2 Effect of baseline characteristics on key outcomes

This section shows the result of linear regressions assessing the effect of baseline covariates on key

study outcomes. Each table is composed of two panels: univariate analyses using one simple linear

regression per variable (left panel) and multivariate analysis combining all variables in one multiple

regression (right panel). P‐values (right column) smaller than 0.05 flag variables significantly related

to the outcome after adjusting for other variables. Please note that due to the large number of tests,

significant tests should be interpreted with caution.

4.2.1 Pharmacy satisfaction

Table 35: Overall satisfaction at start of trial

Univariate analysis Multi-variable analysis

Variables Estimate 95% CI P-value Estimate 95% CI P-value

Treatment (con vs int) -0.32 -0.449 -0.201 <.0001 -0.46 -0.590 -0.336 <.0001

Gender (female vs male) -0.02 -0.147 0.115 0.8092 -0.04 -0.164 0.077 0.4830

Age 0.00 -0.007 0.008 0.8795 0.00 -0.006 0.007 0.8864

Country (other vs Australia) -0.00 -0.190 0.182 0.9650 -0.07 -0.244 0.097 0.3993

Language (other vs English) 0.50 0.001 0.999 0.0497 0.42 -0.041 0.873 0.0743

Employment (other vs

working)

0.13 -0.030 0.283 0.1138 0.03 -0.115 0.185 0.6487

Living arrangement

Other vs owned home -0.07 -0.354 0.204 0.5994 -0.01 -0.259 0.248 0.9664

Rented vs owned home 0.03 -0.130 0.186 0.7290 0.07 -0.075 0.213 0.3461

PhARIA (cat2-6 vs cat 1) -0.20 -0.340 -0.053 0.0073 -0.16 -0.301 -0.020 0.0252

State

NT vs NSW -1.24 -1.600 -0.872 <.0001 -1.35 -1.735 -0.957 <.0001

QLD vs NSW -0.17 -0.328 -0.011 0.0362 -0.05 -0.220 0.116 0.5440

SA vs NSW 1.26 0.940 1.587 <.0001 1.55 1.193 1.908 <.0001

TAS vs NSW 0.76 0.378 1.150 0.0001 0.78 0.386 1.182 0.0001

VIC vs NSW -0.01 -0.151 0.124 0.8480 0.04 -0.111 0.186 0.6170

WA vs NSW 0.00 -0.194 0.201 0.9737 0.04 -0.178 0.252 0.7334

T:\\Statistics\\Projects\\PWC\\PT\\Program\\a_impact.sas




Table 36: Overall satisfaction at end of trial



Treatment (con vs int) -0.67 -0.772 -0.571 <.0001 -0.62 -0.729 -0.502 <.0001


Age -0.00 -0.009 0.004 0.4259 -0.00 -0.008 0.004 0.4698


Language (other vs English) -0.24 -0.656 0.173 0.2531 -0.34 -0.707 0.025 0.0677


working)

0.01 -0.130 0.151 0.8803 -0.01 -0.135 0.125 0.9366

Living arrangement


Rented vs owned home -0.06 -0.200 0.088 0.4476 -0.02 -0.146 0.110 0.7810

PhARIA (cat2-6 vs cat 1) 0.06 -0.066 0.191 0.3415 0.05 -0.079 0.170 0.4766

State

NT vs NSW -0.33 -0.636 -0.023 0.0353 -0.37 -0.687 -0.052 0.0224

QLD vs NSW -0.27 -0.417 -0.129 0.0002 0.01 -0.142 0.161 0.9020

SA vs NSW -1.33 -1.644 -1.014 <.0001 -0.76 -1.101 -0.425 <.0001

TAS vs NSW 0.47 0.147 0.795 0.0044 0.51 0.187 0.832 0.0019

VIC vs NSW -0.28 -0.404 -0.152 <.0001 -0.07 -0.204 0.068 0.3249

WA vs NSW 0.12 -0.076 0.316 0.2314 0.06 -0.147 0.262 0.5818



4.2.2 BTOM

Table 37: Drug using days ‐ Heroin (DIF_Q22)



Treatment (con vs int) 0.60 -0.274 1.471 0.1789 0.37 -0.567 1.310 0.4380

Gender (female vs male) 0.12 -0.726 0.966 0.7809 -0.11 -0.991 0.773 0.8087

Age 0.00 -0.045 0.050 0.9167 0.00 -0.047 0.052 0.9133





Country (other vs Australia) 0.03 -1.181 1.243 0.9600 0.35 -0.907 1.609 0.5845


Employment (other vs working) 0.97 -0.034 1.974 0.0583 1.37 0.273 2.477 0.0145

Living arrangement



PhARIA (cat2-6 vs cat 1) 0.37 -0.639 1.376 0.4729 0.36 -0.661 1.382 0.4892

State

NT vs NSW 0.05 -2.738 2.841 0.9713 0.72 -2.119 3.555 0.6199

QLD vs NSW 1.15 -0.023 2.320 0.0548 1.21 -0.013 2.438 0.0525

SA vs NSW 1.62 -0.872 4.118 0.2024 1.38 -1.233 3.994 0.3006

TAS vs NSW 0.05 -2.738 2.841 0.9713 -0.04 -2.982 2.901 0.9787

VIC vs NSW 0.06 -0.955 1.084 0.9014 0.03 -1.031 1.094 0.9538

WA vs NSW 1.40 -0.288 3.097 0.1039 1.75 0.013 3.495 0.0483



Table 38: Drug using days ‐ Other Opioid‐based drug (DIF_Q23)



Treatment (con vs int) -0.67 -1.490 0.152 0.1101 -0.68 -1.564 0.204 0.1315

Gender (female vs male) 0.60 -0.190 1.399 0.1357 0.88 0.048 1.708 0.0382

Age 0.01 -0.036 0.054 0.6959 0.01 -0.037 0.056 0.6832


Language (other vs English) 0.99 -2.491 4.478 0.5762 0.86 -2.737 4.456 0.6395

Employment (other vs working) -0.38 -1.324 0.572 0.4371 -0.87 -1.905 0.171 0.1015

Living arrangement

Other vs owned home 0.89 -0.743 2.514 0.2868 1.05 -0.633 2.733 0.2213


PhARIA (cat2-6 vs cat 1) -0.01 -0.961 0.937 0.9804 0.24 -0.721 1.202 0.6241





State

NT vs NSW 0.91 -1.721 3.545 0.4972 0.49 -2.182 3.160 0.7197

QLD vs NSW -0.72 -1.830 0.381 0.1991 -0.59 -1.744 0.564 0.3160

SA vs NSW 0.42 -1.936 2.773 0.7276 1.04 -1.425 3.497 0.4093

TAS vs NSW -0.54 -3.175 2.090 0.6863 -0.47 -3.237 2.302 0.7407

VIC vs NSW 0.37 -0.594 1.330 0.4536 0.45 -0.552 1.449 0.3793

WA vs NSW -0.49 -2.086 1.108 0.5484 -0.56 -2.197 1.081 0.5046



Table 39: Drug using days ‐ Cocaine (DIF_Q24)




Gender (female vs male) 0.06 -0.123 0.252 0.5013 0.01 -0.183 0.208 0.9001

Age -0.00 -0.015 0.007 0.4729 -0.00 -0.016 0.006 0.4038


Language (other vs English) 0.06 -0.757 0.886 0.8777 -0.01 -0.860 0.838 0.9798

Employment (other vs working) 0.24 0.021 0.467 0.0316 0.30 0.057 0.547 0.0157

Living arrangement



PhARIA (cat2-6 vs cat 1) 0.08 -0.142 0.305 0.4759 0.10 -0.123 0.331 0.3705

State





NT vs NSW 0.13 -0.486 0.756 0.6709 0.26 -0.369 0.892 0.4157

QLD vs NSW 0.08 -0.180 0.342 0.5434 0.10 -0.177 0.367 0.4938

SA vs NSW 0.56 0.008 1.119 0.0468 0.52 -0.056 1.105 0.0768

TAS vs NSW 0.13 -0.486 0.756 0.6709 0.08 -0.574 0.733 0.8126

VIC vs NSW 0.08 -0.151 0.302 0.5147 0.06 -0.180 0.292 0.6407

WA vs NSW 0.11 -0.272 0.482 0.5842 0.15 -0.238 0.535 0.4518



Table 40: Drug using days ‐ Amphetamines (DIF_Q25)



Treatment (con vs int) -0.09 -0.551 0.378 0.7159 0.02 -0.474 0.515 0.9348


Age 0.01 -0.017 0.034 0.5016 0.01 -0.015 0.037 0.3920

Country (other vs Australia) 1.02 0.380 1.655 0.0018 0.98 0.318 1.642 0.0037



Living arrangement



PhARIA (cat2-6 vs cat 1) -0.01 -0.550 0.522 0.9596 0.15 -0.391 0.684 0.5927





State

NT vs NSW 2.64 1.162 4.111 0.0005 2.42 0.924 3.911 0.0015

QLD vs NSW 0.02 -0.598 0.641 0.9457 -0.05 -0.699 0.592 0.8707

SA vs NSW 0.07 -1.247 1.390 0.9155 0.02 -1.353 1.399 0.9739

TAS vs NSW -0.18 -1.656 1.293 0.8090 -0.19 -1.740 1.358 0.8091

VIC vs NSW 0.27 -0.269 0.808 0.3264 0.17 -0.392 0.727 0.5580

WA vs NSW 0.24 -0.659 1.130 0.6062 0.25 -0.664 1.169 0.5892



Table 41: Drug using days ‐ Tranquilisers (DIF_Q26)




Gender (female vs male) 0.62 -1.435 2.681 0.5529 -0.32 -2.437 1.790 0.7644

Age -0.09 -0.208 0.025 0.1222 -0.06 -0.174 0.062 0.3553



Employment (other vs working) 1.98 -0.466 4.426 0.1126 2.47 -0.166 5.111 0.0663

Living arrangement






Rented vs owned home 2.76 0.356 5.163 0.0244 1.64 -0.829 4.118 0.1926

PhARIA (cat2-6 vs cat 1) 0.45 -2.001 2.903 0.7187 0.20 -2.249 2.641 0.8750

State

NT vs NSW 1.15 -5.565 7.857 0.7378 2.35 -4.436 9.137 0.4973

QLD vs NSW 2.84 0.021 5.658 0.0483 2.94 0.012 5.877 0.0490

SA vs NSW -4.05 -10.05 1.953 0.1861 -4.78 -11.03 1.476 0.1343

TAS vs NSW -1.67 -8.383 5.039 0.6254 -1.51 -8.544 5.530 0.6746

VIC vs NSW 4.18 1.724 6.644 0.0009 3.93 1.388 6.479 0.0025

WA vs NSW 2.83 -1.246 6.897 0.1738 3.42 -0.741 7.590 0.1071



Table 42: Drug using days ‐ marijuana or cannabis (DIF_Q27)





Age -0.03 -0.118 0.057 0.4904 -0.02 -0.105 0.075 0.7366




working)

0.86 -0.983 2.694 0.3616 1.16 -0.854 3.173 0.2589

Living arrangement







PhARIA (cat2-6 vs cat 1) -0.00 -1.845 1.835 0.9959 -0.07 -1.940 1.790 0.9373

State

NT vs NSW 2.82 -2.281 7.922 0.2785 2.92 -2.266 8.096 0.2701

QLD vs NSW 0.66 -1.483 2.801 0.5464 1.01 -1.228 3.249 0.3762

SA vs NSW -1.39 -5.956 3.168 0.5493 -0.87 -5.644 3.903 0.7209

TAS vs NSW 0.91 -4.190 6.013 0.7262 1.34 -4.035 6.709 0.6256

VIC vs NSW 0.98 -0.885 2.842 0.3035 0.80 -1.138 2.744 0.4173

WA vs NSW 3.11 0.020 6.210 0.0486 3.29 0.107 6.466 0.0428





Table 43: Alcohol and tobacco using (DIF_Post_Pre_Q2829)





Age 2.47 0.097 4.853 0.0413 1.67 -0.750 4.094 0.1761

Country (other vs Australia) -0.41 -58.53 57.713 0.9890 14.60 -44.80 73.995 0.6300



working)

50.98 0.910 101.05 0.0460 60.61 7.481 113.74 0.0254

Living arrangement


Rented vs owned home -41.9 -91.18 7.363 0.0955 -52.7 -103.3 -2.056 0.0414

PhARIA (cat2-6 vs cat 1) -0.49 -49.93 48.948 0.9844 -8.25 -57.78 41.281 0.7441

State

NT vs NSW -26.9 -165.4 111.56 0.7033 7.53 -132.5 147.58 0.9160

QLD vs NSW -9.58 -67.49 48.327 0.7457 1.08 -58.92 61.076 0.9720

SA vs NSW -116 -237.2 5.199 0.0607 -112 -237.7 14.205 0.0821

TAS vs NSW -113 -239.0 13.319 0.0796 -95.2 -227.1 36.664 0.1570

VIC vs NSW -26.0 -75.20 23.179 0.3000 -14.6 -65.06 35.873 0.5709

WA vs NSW -98.0 -184.4 -11.65 0.0261 -77.9 -165.2 9.395 0.0803





Table 44: Alcohol and tobacco using (DIF_Post_Pre_Q3031)





Age -0.33 -3.533 2.882 0.8424 -1.00 -4.355 2.352 0.5584




working)

30.51 -29.38 90.411 0.3180 33.26 -35.65 102.16 0.3442

Living arrangement

Other vs owned home 124.4 2.974 245.86 0.0446 106.3 -22.32 234.99 0.1052


PhARIA (cat2-6 vs cat 1) -5.92 -77.69 65.843 0.8715 -6.32 -79.06 66.418 0.8648

State

NT vs NSW -5.53 -174.1 163.03 0.9488 -8.22 -180.1 163.68 0.9253

QLD vs NSW 15.55 -59.44 90.536 0.6845 -4.63 -86.24 76.987 0.9116

SA vs NSW 12.81 -142.3 167.96 0.8715 -16.2 -180.3 147.81 0.8461

TAS vs NSW 40.47 -323.7 404.60 0.8275 50.25 -320.8 421.27 0.7907

VIC vs NSW 17.29 -53.22 87.806 0.6308 -9.93 -84.41 64.547 0.7939

WA vs NSW -27.3 -132.4 77.788 0.6104 -40.7 -152.9 71.388 0.4764





Table 45: Polydrug use scale (DIF_polydrug)





Age -0.00 -0.017 0.008 0.4783 -0.00 -0.014 0.011 0.8214




Living arrangement



PhARIA (cat2-6 vs cat 1) 0.12 -0.144 0.386 0.3709 0.14 -0.127 0.405 0.3049

State

NT vs NSW 0.48 -0.243 1.212 0.1922 0.61 -0.125 1.350 0.1037

QLD vs NSW 0.08 -0.223 0.388 0.5967 0.05 -0.265 0.372 0.7428

SA vs NSW -0.36 -1.011 0.291 0.2785 -0.47 -1.153 0.206 0.1723

TAS vs NSW -0.61 -1.334 0.121 0.1023 -0.56 -1.320 0.210 0.1547

VIC vs NSW 0.36 0.090 0.622 0.0086 0.33 0.052 0.605 0.0198

WA vs NSW 0.12 -0.318 0.565 0.5841 0.20 -0.257 0.648 0.3977





Table 46: Social functioning scale (DIF_sfs)





Age 0.02 -0.013 0.063 0.2039 0.03 -0.009 0.070 0.1304




Living arrangement



PhARIA (cat2-6 vs cat 1) -0.20 -1.008 0.606 0.6262 -0.23 -1.050 0.582 0.5740

State

NT vs NSW 0.80 -1.427 3.027 0.4815 0.98 -1.289 3.246 0.3975

QLD vs NSW -0.46 -1.400 0.471 0.3304 -0.28 -1.260 0.700 0.5752

SA vs NSW -1.24 -3.236 0.748 0.2210 -1.02 -3.113 1.066 0.3369

TAS vs NSW -0.44 -2.664 1.791 0.7009 0.09 -2.259 2.443 0.9387

VIC vs NSW -0.82 -1.632 -0.005 0.0486 -0.54 -1.385 0.314 0.2164

WA vs NSW 0.93 -0.426 2.276 0.1796 1.17 -0.221 2.562 0.0992



Table 47: BTOM: needle sharing, overdose, arrest,

Too few cases for these variables. No analysis done.



Table 48: Quality of life (DIF_QoL)



Treatment (con vs int) 0.27 -0.671 1.201 0.5787 -0.41 -1.413 0.588 0.4194


Age -0.01 -0.057 0.046 0.8383 -0.00 -0.057 0.048 0.8611




Living arrangement



PhARIA (cat2-6 vs cat 1) -0.03 -1.105 1.049 0.9597 0.17 -0.907 1.251 0.7543

State

NT vs NSW 0.68 -2.178 3.546 0.6394 0.71 -2.199 3.628 0.6306

QLD vs NSW 1.16 -0.071 2.381 0.0648 1.38 0.093 2.676 0.0357

SA vs NSW 3.81 1.247 6.368 0.0036 4.12 1.425 6.816 0.0027

TAS vs NSW 3.59 0.731 6.455 0.0139 3.77 0.753 6.791 0.0143

VIC vs NSW 1.35 0.266 2.428 0.0146 1.43 0.304 2.562 0.0129

WA vs NSW -0.04 -1.872 1.792 0.9659 0.02 -1.872 1.903 0.9870





Table 49: Compliance with medication




Gender (female vs male) -0.17 -1.195 0.845 0.7370 0.54 -0.504 1.587 0.3098

Age 0.23 0.176 0.290 <.0001 0.19 0.127 0.244 <.0001




working)

-1.39 -2.614 -0.157 0.0270 -1.78 -3.091 -0.471 0.0077

Living arrangement


Rented vs owned home -2.31 -3.548 -1.072 0.0003 -1.50 -2.767 -0.229 0.0207

PhARIA (cat2-6 vs cat 1) 1.32 0.221 2.423 0.0186 1.46 0.252 2.661 0.0178

State

NT vs NSW 1.14 -1.796 4.083 0.4458 1.11 -2.231 4.457 0.5142

QLD vs NSW -0.66 -1.978 0.658 0.3265 -0.57 -2.034 0.903 0.4502

SA vs NSW -1.47 -4.071 1.139 0.2700 -1.38 -4.407 1.653 0.3731

TAS vs NSW -1.48 -4.572 1.616 0.3492 0.56 -2.814 3.933 0.7450

VIC vs NSW -4.15 -5.273 -3.024 <.0001 -2.91 -4.208 -1.617 <.0001

WA vs NSW -7.29 -8.909 -5.666 <.0001 -8.42 -10.29 -6.551 <.0001





4.3 Association between cost and outcomes

This section analyses the relationship between costs and study outcomes. Outcomes analysed

include time to dropout, compliance of dose dispensed, BTOM, pharmacy satisfaction and QoL.

The models used are Cox models for time to dropout and GEE models for other outcomes. For

compliance of dose dispensed, patients repeated 6 times are taken into account in the model. For

other outcomes, clustering of pharmacy is taken into account. All models adjust for treatment

allocation.

The following predictors were considered:

1. Average cost of spending on medications in each pharmacy (Variable:

Total_average_cost) – Page 75

2. Costs of spending on medications in each pharmacy categorized into tertiles (low,

medium, high) – Pages 76‐ 78

For the first table, estimates represent the change in each outcome associated with an increase in

cost of $1. For example, a 1 dollar increase is associated with a decrease in compliance of 0.06%.

For the other 3 tables (Pages 76‐78), estimates represent the change in each outcome associated

with an increase from the lowest cost category to either the medium or high category. For example,

increasing the cost from the lowest category to the highest category is associated with a decrease in

compliance of 1.7%.

Note that because those analyses include both post‐baseline predictors and outcomes, significant

associations do not necessarily imply causal relationships.



Cost effect outcomes

Estimate LowerCL UpperCL

P‐value

Dropout (Hazard 95%CI) 1.0050 0.9929 1.0181 0.1015Compliance(%) ‐0.0614 ‐0.0942 ‐0.0285 0.0003*start of trial . . . .PRE_Q22, Heroin use ‐0.0038 ‐0.0286 0.021 0.7653PRE_Q23, Other opioid drug 0.0039 ‐0.0186 0.0263 0.7363PRE_Q24,Cocaine ‐0.0004 ‐0.0061 0.0052 0.8857PRE_Q25,Amphetamines ‐0.0058 ‐0.0159 0.0044 0.2659PRE_Q26, Tranquilisers ‐0.0202 ‐0.0845 0.0441 0.5385PRE_Q27,Cannabis ‐0.0130 ‐0.0816 0.0556 0.7107PRE_Q2829,total tobacco ‐1.3202 ‐2.9009 0.2605 0.1016PRE_Q3031,total alcohol 0.7128 ‐0.7645 2.1901 0.3443PRE_polydrug ‐0.0075 ‐0.0145 ‐0.0005 0.0357*PRE_sfs, social functioning ‐0.0005 ‐0.0204 0.0194 0.9601PRE_QoL 0.0263 ‐0.0111 0.0638 0.1683sat_overall ‐0.0082 ‐0.0123 ‐0.0042 <.0001*

end of trial . . . .POST_Q22, Heroin use 0.0024 ‐0.0311 0.0358 0.8888POST_Q23, Other opioid drug 0.0143 ‐0.0079 0.0364 0.2079POST_Q24,Cocaine 0.0007 ‐0.002 0.0033 0.6215POST_Q25,Amphetamines ‐0.0041 ‐0.0224 0.0142 0.6587POST_Q26, Tranquilisers ‐0.0236 ‐0.1009 0.0536 0.5489POST_Q27,Cannabis ‐0.0390 ‐0.1167 0.0386 0.3244POST_Q2829,total tobacco ‐0.7579 ‐2.6886 1.1729 0.4417POST_Q3031,total alcohol 1.3611 0.1335 2.5886 0.0298POST_polydrug ‐0.0025 ‐0.0105 0.0054 0.5308POST_sfs, social functioning 0.0032 ‐0.0194 0.0259 0.78POST_QoL ‐0.0240 ‐0.0687 0.0207 0.2932overall_sat 0.0042 0.001 0.0075 0.0101

difference between Post and Pre trial

. . . .

DIF_Q22, Heroin use 0.00544 ‐0.025 0.0359 0.7259

DIF_Q23, Other opioid drug 0.00788 ‐0.0207 0.0365 0.5891

DIF_Q24,Cocaine ‐0.00032 ‐0.0071 0.0064 0.9268

DIF_Q25,Amphetamines 0.00477 ‐0.0114 0.021 0.5639

DIF_Q26, Tranquilisers 0.02245 ‐0.0515 0.0964 0.5519

DIF_Q27,Cannabis ‐0.03179 ‐0.0873 0.0237 0.2616

DIF_Q2829,total tobacco 0.31265 ‐1.1934 1.8187 0.6841

DIF_Q3031,total alcohol 0.6606 ‐1.5932 2.9144 0.5656

DIF_polydrug 0.00822 0.0002 0.0162 0.0433

DIF_sfs, social functioning 0.00756 ‐0.0168 0.0319 0.5424

DIF_QoL ‐0.03964 ‐0.0714 ‐0.0079 0.0145

DIF_sat_overall 0.01559 0.0102 0.021 <.0001





P‐value

Dropout (Hazard 95%CI) . . . . medium cost group vs low group 1.08734 0.6993 1.6908 0.7101high cost group vs low group 1.09004 0.6641 1.7891 0.7331

Compliance(%) . . . . medium cost group vs low group 0.66462 ‐0.3967 1.726 0.2197high cost group vs low group ‐1.74434 ‐2.9628 ‐0.5259 0.005

start of trial . . . . PRE_Q22, Heroin use . . . .

medium cost group vs low group 0.23415 ‐0.595 1.0633 0.5799high cost group vs low group ‐0.10462 ‐1.0225 0.8133 0.8232

PRE_Q23, Other opioid drug . . . . medium cost group vs low group ‐0.38635 ‐1.1366 0.3639 0.3128high cost group vs low group ‐0.58545 ‐1.4161 0.2452 0.1671

PRE_Q24,Cocaine . . . . medium cost group vs low group 0.04226 ‐0.1466 0.2311 0.661high cost group vs low group 0.02759 ‐0.1815 0.2367 0.7959

PRE_Q25,Amphetamines . . . . medium cost group vs low group ‐0.27369 ‐0.6125 0.0651 0.1134high cost group vs low group ‐0.36417 ‐0.7393 0.011 0.0571

PRE_Q26, Tranquilisers . . . . medium cost group vs low group ‐1.70626 ‐3.8515 0.439 0.119high cost group vs low group ‐1.85901 ‐4.2324 0.5144 0.1247

PRE_Q27,Cannabis . . . . medium cost group vs low group ‐0.93947 ‐3.2308 1.3518 0.4216high cost group vs low group 0.38527 ‐2.1514 2.922 0.7659

PRE_Q2829,total tobacco . . . . medium cost group vs low group ‐54.5584 ‐106.727 ‐2.3896 0.0404high cost group vs low group ‐55.0414 ‐112.659 2.5759 0.0612

PRE_Q3031,total alcohol . . . . medium cost group vs low group 35.31818 ‐10.3402 80.9765 0.1295high cost group vs low group 13.71881 ‐36.5408 63.9785 0.5927

PRE_polydrug . . . . medium cost group vs low group ‐0.29012 ‐0.5233 ‐0.0569 0.0147high cost group vs low group ‐0.28744 ‐0.5456 ‐0.0293 0.0291

PRE_sfs, social functioning . . . . medium cost group vs low group 0.24234 ‐0.4217 0.9064 0.4744high cost group vs low group 0.21146 ‐0.5237 0.9466 0.5729

PRE_QoL . . . . medium cost group vs low group ‐0.44553 ‐1.7013 0.8102 0.4868high cost group vs low group 1.06393 ‐0.3177 2.4456 0.1312

sat_overall . . . . medium cost group vs low group ‐0.12994 ‐0.2667 0.0068 0.0626high cost group vs low group ‐0.24418 ‐0.3971 ‐0.0913 0.0017





P‐value

end of trial . . . . POST _Q22, Heroin use . . . .

medium cost group vs low group 0.72807 ‐0.3513 1.8075 0.1862high cost group vs low group 0.33279 ‐0.8835 1.5491 0.5918

POST _Q23, Other opioid drug . . . .medium cost group vs low group 0.37792 ‐0.339 1.0949 0.3015high cost group vs low group ‐0.03707 ‐0.845 0.7708 0.9283

POST _Q24,Cocaine . . . .medium cost group vs low group ‐0.02619 ‐0.1116 0.0592 0.5478high cost group vs low group 0.0185 ‐0.0778 0.1148 0.7064

POST _Q25,Amphetamines . . . .medium cost group vs low group ‐0.00389 ‐0.5945 0.5868 0.9897high cost group vs low group ‐0.27125 ‐0.9368 0.3943 0.4244

POST _Q26, Tranquilisers . . . .medium cost group vs low group 0.02015 ‐2.4751 2.5154 0.9874high cost group vs low group ‐2.18183 ‐4.9889 0.6253 0.1277

POST _Q27,Cannabis . . . .medium cost group vs low group ‐1.05753 ‐3.5644 1.4493 0.4083high cost group vs low group ‐2.24215 ‐5.0671 0.5828 0.1198

POST _Q2829,total tobacco . . . .medium cost group vs low group ‐47.2541 ‐108.933 14.4243 0.1332high cost group vs low group ‐45.4758 ‐114.766 23.8148 0.1983

POST _Q3031,total alcohol . . . .medium cost group vs low group 11.4079 ‐27.2636 50.0794 0.5631high cost group vs low group 24.0264 ‐19.0772 67.13 0.2746

POST _polydrug . . . .medium cost group vs low group ‐0.16341 ‐0.4194 0.0926 0.2109high cost group vs low group ‐0.24905 ‐0.5375 0.0394 0.0906

POST _sfs, social functioning . . . .medium cost group vs low group ‐0.07485 ‐0.8068 0.6571 0.8411high cost group vs low group ‐0.16009 ‐0.9849 0.6647 0.7036

POST _QoL . . . .medium cost group vs low group ‐0.33649 ‐1.8 1.127 0.6523high cost group vs low group ‐0.86381 ‐2.514 0.7864 0.3049

overall_sat . . . .medium cost group vs low group 0.16225 0.0518 0.2727 0.004high cost group vs low group ‐0.03891 ‐0.1636 0.0857 0.5406





P‐value

difference between Post and Pre trial . . . .DIF _Q22, Heroin use . . . .

medium cost group vs low group 0.32398 ‐0.6591 1.307 0.5183high cost group vs low group 0.33389 ‐0.7739 1.4417 0.5547

DIF _Q23, Other opioid drug . . . .medium cost group vs low group 0.68184 ‐0.2414 1.605 0.1477high cost group vs low group 0.48014 ‐0.5602 1.5205 0.3657

DIF _Q24,Cocaine . . . .medium cost group vs low group ‐0.14222 ‐0.36 0.0755 0.2005high cost group vs low group ‐0.08481 ‐0.3302 0.1606 0.4982

DIF _Q25,Amphetamines . . . .medium cost group vs low group 0.3632 ‐0.1598 0.8862 0.1735high cost group vs low group 0.17655 ‐0.4128 0.7659 0.5571

DIF _Q26, Tranquilisers . . . .medium cost group vs low group 2.74544 0.361 5.1299 0.024high cost group vs low group 1.04934 ‐1.6308 3.7295 0.4429

DIF_Q27,Cannabis . . . .medium cost group vs low group 0.17617 ‐1.6079 1.9602 0.8465high cost group vs low group ‐2.23542 ‐4.2458 ‐0.225 0.0293

DIF _Q2829,total tobacco . . . .medium cost group vs low group 34.31673 ‐13.4641 82.0975 0.1592high cost group vs low group 18.29319 ‐35.5174 72.1038 0.5052

DIF _Q3031,total alcohol . . . .medium cost group vs low group ‐13.7011 ‐80.6659 53.2637 0.6884high cost group vs low group 10.12942 ‐64.1031 84.3619 0.7891

DIF _polydrug . . . .medium cost group vs low group 0.13861 ‐0.1198 0.3971 0.2932high cost group vs low group 0.14766 ‐0.1436 0.4389 0.3204

DIF _sfs, social functioning . . . .medium cost group vs low group ‐0.39679 ‐1.1825 0.3889 0.3223high cost group vs low group ‐0.18863 ‐1.0741 0.6968 0.6763

DIF _QoL . . . .medium cost group vs low group 0.10485 ‐0.939 1.1487 0.8439high cost group vs low group ‐1.73627 ‐2.905 ‐0.5675 0.0036

DIF_sat_overall . . . .medium cost group vs low group 0.35431 0.166 0.5426 0.0002high cost group vs low group 0.4257 0.2132 0.6382 <.0001



Table 50: Description of observed investment costs per pharmacy

PHARM_ID INVESTMET 1 INVESTMET 2 INVESTMET 3 INVESTMET 4 INVESTMET 5 INVESTMET 6 SUM OF COST

10639Y 750 2500 50 60 150 . 351010661D . 1820 6000 600 . . 842011698Q . . . . . . 012715F . . . . . . 013120N 500 19 6 . . . 52513420H . . . . . . 013767N 30 . . . . . 3021770T 750 500 . . . . 125022493W . . . . . . 022844H 75 1000 75 250 120 300 182022845J 1000 3000 . . . . 400031150L 400 . . . . . 40032257R 320 . . . . . 32032419G 40 . . . . . 4032442L . . . . . . 032537L 10 25 . . . . 3532766M 4000 3000 3900 5500 500 1600 185004130J 500 200 . . . . 7004479R 20 3 320 20 88 88 5399747B 7000 600 1000 . . . 8600

Average cost per pharm: $2434.45 per year; Median cost =$462.5; Standard deviation: $4606 which is very large.



4.4 Variable derivation and analyses details

4.4.1 Client retention

Survival analysis for time to dropout

Variable Value Coding/calculation

Time_to_dropout Time from start of trial to dropout or the end of trial in days 1=dropout; 0=censoring

PHARM_END_DATE - HARM_START_DATE PAT_DOUTDATE - HARM_START_DATE

Age Client age in years PHARM_START_DATE - PRE_Q2V Treatment 1=control; 2=intervention PH_ALLOCATION Gender 1=Male; 2=Female QSEX Country of birth See data dictionary PRE_Q4 Language See data dictionary PRE_Q5 Employment status See data dictionary PRE_Q7 Living arrangement See data dictionary PRE_Q8 PhARIA See data dictionary PHARIA State See data dictionary PH_STATE Method: Analysed time to dropout by Kaplan‐Meier Survival curve with Log‐Rand test. Analysed the association between time to dropout and risk factors by using Cox proportional hazard regression model.

43 of the original 748 patients had a dropout date earlier than Pharmacy start date in trial (see table below):

PAT_DOUTDATE Frequency 01JAN2001:00:00:00 3 01MAY2009:00:00:00 1 02FEB2002:00:00:00 7 03MAR2003:00:00:00 27 13APR2009:00:00:00 1 14APR2009:00:00:00 1 20MAY2009:00:00:00 1 24MAR2009:00:00:00 1 31MAR2009:00:00:00 1

According to the data dictionary, 01Jan2001 is missing, 02Feb2002 is NA, 03Mar2003 is dropped out

before start of trial. However, after checking the dropout reason and dropout status in each month,

6 patients out of 43 patients above are recoded as stay in the trial from start to the end. Their id are

"22845J0014", "22845J0728","22864J0871","32766M0913","40388Q1000","51193J0030". (Need

confirmation).

After recoding, 712 patients remained in the trial.



Generalised Estimating Equation (GEE) model for dropout by month

Variable Value Coding/compute

Dropout Drop out by months from month 1 to month 6. 1=dropout; 0=no dropout

Categorise the Time_to_dropout into months and locate patients who dropped out in corresponding month.

Methods: Analysed dropouts by month using GEE model taking into account repeated measure of client dropout status.



Impact of group on BTOM, QoL, Patient satisfaction


Compliance_pct_m1 Compliance_pct_m2 Compliance_pct_m3 Compliance_pct_m4 Compliance_pct_m5 Compliance_pct_m6

Compliance of dose dispensing by months in percentage

Compliance_pct_m1= Dosesdispmth_M1/ MONTHDAYS_M1 *100 Compliance_pct_m2= Dosesdispmth_M2/ MONTHDAYS_M2 *100 Compliance_pct_m3= Dosesdispmth_M3/ MONTHDAYS_M3 *100 Compliance_pct_m4= Dosesdispmth_M4/ MONTHDAYS_M4 *100 Compliance_pct_m5= Dosesdispmth_M5/ MONTHDAYS_M5 *100 Compliance_pct_m6= Dosesdispmth_M6/ MONTHDAYS_M6 *100

BTOM – drug using days:

DIF_Q22 Difference in Heroin using days between Post and Pre visit. DIF_Q22= Post_Q22 - Pre_Q22

DIF_Q23 Difference in Other opioid-based drug using days between Post and Pre visit. DIF_Q23= Post_Q23 - Pre_Q23

DIF_Q24 Difference in Cocaine using days between Post and Pre visit. DIF_Q24= Post_Q24 - Pre_Q24

DIF_Q25 Difference in Amphetamines using days between Post and Pre visit. DIF_Q25= Post_Q25 - Pre_Q25

DIF_Q26 Difference in Tranquilisers using days between Post and Pre visit. DIF_Q26= Post_Q26 - Pre_Q26

DIF_Q27 Difference in Marijuana or cannabis using days between Post and Pre visit. DIF_Q27= Post_Q27 - Pre_Q27

BTOM – Needle sharing

DIF_Q18 Difference in Needle sharing frequency in days between Post and Pre visit.

DIF_Q18= Post_Q18 - Pre_Q18

BTOM – Overdoses frequency

Count the number of times the client has experience overdose

BTOM – Polydrug scale

See document: Guide to scoring to BTOM-C V1.0 dif_Polydrug=Post_Polydrug - Pre_Polydrug

BTOM – Social Functioning scale

See document: Guide to scoring to BTOM-C V1.0 dif_SFS=POST_SFS - Pre_SFS

QoL Quality of Life scale dif_QoL=Post_QoL - Pre_QoL



Cost/benefit analysis


Num_client_ABC

Number of cases observed

Num_client_ABC=sum( INPHARM_METH_NPP_NUM , INPHARMTA_METH_NPP_NUM , INPHARM_METH_MISSING_NUM , INPHARM_SS_NPP_NUM , INPHARM_MISSING_NPP_NUM , INPHARMTA_SS_NPP_NUM , INPHARM_METH_PP_NUM , INPHARMTA_METH_PP_NUM , MISSING_MISSING_PP_NUM , TA_METH_NPP_NUM , TA_SS_NPP_NUM , MISSING_METH_NPP_NUM , INPHARM_SS_PP_NUM , TA_MISSING_NPP_NUM , INPHARMTA_SS_PP_NUM );

Num_client_All Number of clients on pharmacotherapy at the pharmacy taking medications

Num_client_All=sum( METH_HEADCOUNT, SUBUTEX_HEADCOUNT, SUBOXONE_HEADCOUNT);

Observed activity: DOSE_DISPENSING_COST

INPHARM_METH_NPP_COST

Average cost for cases dosed in pharmacy, for methodone, not prepared

(INPHARM_METH_NPP_TT * INPHARM_METH_NPP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARMTA_METH_NPP_COST

Average cost for cases both dosed in pharmacy and takeaway, for methodone, not prepared

(INPHARMTA_METH_NPP_TT * INPHARMTA_METH_NPP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARM_METH_MISSING_COST

Average cost for cases dosed in pharmacy, for methodone, with no information as to whether the dose was prepared.

(INPHARM_METH_MISSING_TT* INPHARM_METH_MISSING_NUM )* (892/(60*38)) /Num_client_ABC

INPHARM_SS_NPP_COST

Average cost for cases dosed in pharmacy, for suboxone/subutex, not prepared.

(INPHARM_SS_NPP_TT * INPHARM_SS_NPP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARM_MISSING_NPP_COST

Average cost for cases dosed in pharmacy, for unspecified drug type, not prepared.

(INPHARM_MISSING_NPP_TT * INPHARM_MISSING_NPP_NUM)* (892/(60*38)) /Num_client_ABC

INPHARMTA_SS_NPP_COST

Average cost for case dosed by inpharmacy and takeaway, for suboxone/subutex, not prepared.

(INPHARMTA_SS_NPP_TT * INPHARMTA_SS_NPP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARM_METH_PP_COST

Average cost for cases dosed inpharmacy, for methodone, pre-prepared.

(INPHARM_METH_PP_TT * INPHARM_METH_PP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARMTA_METH_PP_COST

Average cost for cases both in pharmacy and takeaway, for methodone, pre-prepared.

(INPHARMTA_METH_PP_TT * INPHARMTA_METH_PP_NUM )* (892/(60*38)) /Num_client_ABC

MISSING_MISSING_PP_COST

Average cost for cases with missing dispensing type, missing drug type, pre-prepared

(MISSING_MISSING_PP_TT * MISSING_MISSING_PP_NUM )* (892/(60*38)) /Num_client_ABC

TA_METH_NPP_COST Average cost for cases with Takeaway doses, for methodone, not pre-prepared

(TA_METH_NPP_TT * TA_METH_NPP_NUM )* (892/(60*38)) /Num_client_ABC

TA_SS_NPP_COST Average cost for cases with takeaway doses for subutex/suboxone, not pre-

(TA_SS_NPP_TT * TA_SS_NPP_NUM )* (892/(60*38)) /Num_client_ABC



prepared MISSING_METH_NPP_COST

Average cost for cases with missing dispensing type, methodone, not pre-prepared

(MISSING_METH_NPP_TT * MISSING_METH_NPP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARM_SS_PP_COST

Average cost for cases with inpharmacy, suboxone/subutex, pre=prepared.

(INPHARM_SS_PP_TT * INPHARM_SS_PP_NUM )* (892/(60*38)) /Num_client_ABC

TA_MISSING_NPP_COST

Average cost for cases with Takeaway doses, for cases with missing drug type, not pre-prepared.

(TA_MISSING_NPP_TT * TA_MISSING_NPP_NUM )* (892/(60*38)) /Num_client_ABC

INPHARMTA_SS_PP_COST

Average cost for cases with Inpharmacy and takeaway, for suboxone/subutex, pre-prepared.

(INPHARMTA_SS_PP_TT * INPHARMTA_SS_PP_NUM )* (892/(60*38)) /Num_client_ABC

Consumable_cost Consumable cost per client per week

consumable_cost=sum(OBS_BOTTLES_COST, OBS_LABELS_COST, OBS_MUGS_COST, OBS_CORDIAL_COST, OBS_OTHER1_COST, OBS_OTHER2_COSTn, OBS_OTHER3_COSTn)*(12/52)/Num_client_All

Investment_cost Investment cost per client per week

investment_cost=sum( OBS_INVVALUE1, OBS_INVVALUE2n, OBS_INVVALUE3n, OBS_INVVALUE4, OBS_INVVALUE5, OBS_INVVALUE6n)/(52*Num_client_All)

Observe_total_cost Observe_total_cost=sum( TIME_RELATE_COST, consumable_cost, investment_cost)

dispensing_cost Dispensing cost per client per day

Sum(METH_DDF SUBUTEX_DDF SUBOXONE_DDF), if charge_same=yes Average(METH_DDF_min SUBUTEX_DDF_min SUBOXONE_DDF_min METH_DDF_max SUBUTEX_DDF_max SUBOXONE_DDF_max), if charge_same=no

The following paragraph describes the steps taken to calculate each cost component.

1. Time related dispensing cost

a. obtain total number of observed cases

b. obtain total time taken for cases dispensing

c. divide total dispensing time by number of observed cases to get time on

dispensing activity per client

d. multiply the spending time and rate ($1193.75/per week (38hours)) to get cost

per client



2. Investment/consumable cost:

a. obtain total cost of all type of investment per week

b. obtain number of patients on pharmacotherapy at the pharmacy taking

medications.

c. divide total cost by number of patients on pharmacotherapy to get cost per

client per week

Date post:	13-Aug-2020
Category:	Documents
Upload:	others
View:	11 times
Download:	0 times

A national funding model for pharmacotherapy treatment for...

Documents