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Patient perspectives of methadone formulation change in British Columbia, Canada: outcomes of a provincial… Greer, Alissa M; Hu, Sherry; Amlani, Ashraf; Moreheart, Sarah; Sampson, Olivia; Buxton, Jane A Jan 14, 2016

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RESEARCH Open AccessPatient perspectives of methadoneformulation change in British Columbia,Canada: outcomes of a provincial surveyAlissa M. Greer1*, Sherry Hu1, Ashraf Amlani2, Sarah Moreheart3, Olivia Sampson1 and Jane A. Buxton2AbstractBackground: In British Columbia, Canada, methadone maintenance treatment formulation transitioned from theoral liquid compound Tang™-flavoured methadone to the ten-times more concentrated cherry-flavouredMethadose™ in February 2014. We quantitatively describe perceptions and reported consequences among a sampleof patients on methadone maintenance treatment following this transition.Methods: A province-wide survey was used. Bivariable analyses utilized independent samples t-tests, Phiassociations, and Chi-square tests. Multivariable logistic regression analyses evaluated factors related todependent variables – namely, increases in dose, pain, dope sickness, and the need to supplement withadditional opioids.Results: Four hundred five methadone maintenance treatment patients from fifty harm reduction sites across BritishColumbia reported transitioning to Methadose™ in February 2014. The majority (n = 258; 73.1 %) heard about theformulation change from their methadone provider or pharmacist. Adjusted models show worse taste was positivelyassociated with reporting an increasing dose (OR = 2.46; CI:1.31–4.61), feeling more dope sick (OR = 3.39; CI:1.88–6.12),and worsening pain (OR = 4.65; CI:2.45–8.80). Feeling more dope sick was positively associated with dose increase (OR= 2.24; CI:1.37–3.66), and supplementing with opioids (OR = 8.81; CI:5.16–15.05).Conclusions: Methadone maintenance treatment policy changes in British Columbia affect a structurally vulnerablepopulation who may be less able to cope with transitions and loss of autonomy. There may be a psychosocialcomponent contributing to the perception of Methadose™ tasting worse, and increased dope sickness, pain, and dose.Our study shows the pronounced negative impacts medication changes can have on patients without informed,coordinated efforts. We stress the need to engage all stakeholders allowing for communication about the reasons, risksand consequences of medication policy changes and provision of additional psychosocial support.Keywords: Methadone, Methadose, Opioid substitution therapy, Medication formulation change, People who usedrugs, Change intolerance, Policy changeBackgroundMethadone is a long-acting synthetic mu-opioid agonistwith unique dual opioid receptor agonist and non-selective N-methyl-D-aspartate (NMDA) receptor antag-onist abilities [1]. Methadone has been available formore than 50 years and is viewed as an efficacious andsafe agent for the treatment of chronic pain and opioidaddiction [1–3]. Taken orally once daily, methadone isused to initiate and maintain abstinence from illicit opi-oid use by relieving craving, suppressing opioid abstin-ence syndrome, and attenuating the euphoric effects ofillicit opioid use [4, 5]. Methadone maintenance treat-ment (MMT) is an evidence-based harm reduction inter-vention shown to decrease injection drug use, andthereby reduces the impact of blood-borne illnesses,such as HIV and hepatitis C [6, 7], and reduces morbid-ity, and mortality among people who use drugs (PWUD)[8]. When patients with opioid dependence initiate* Correspondence: a.greer@utoronto.ca1University of British Columbia, School of Population and Public Health, 2206East Mall, Vancouver, BC V6T 1Z3, CanadaFull list of author information is available at the end of the article© 2016 Greer et al. Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, andreproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link tothe Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver(http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.Greer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 DOI 10.1186/s13011-016-0048-3MMT, methadone is initially administered on a dailybasis under the supervision of a pharmacist. Doses aretitrated by the prescribing physician, and split doses areconsidered in symptomatic patients who demonstraterapid metabolism or who are pregnant [9]. Patients whodemonstrate biopsychosocial stability may be granted“carry” privileges and receive doses of methadone forhome administration [10].Periodic transitions in drug dispensing and prescribingpolicies are necessary due to developments in pharmaco-logical research or guideline shifts. In British Columbia(BC), Canada, several bodies regulate the dispensation ofmethadone and coordinate to implement policy or pre-scription changes: the BC Ministry of Health, a branchof the provincial government that leads policy changesregarding methadone; BC PharmaCare, a public entitycovers the cost of prescription drugs, including metha-done, for low-income individuals [11]; the College ofPhysicians and Surgeons of BC, which grants physiciansthe authority to prescribe methadone [12]; and theBC College of Pharmacists who standardize the train-ing of pharmacists and dispensation of methadone inthe province [13].In 2014, these regulatory bodies made the decision totransition from the previous Tang™-flavoured (orangetype flavor) 1 mg/mL pharmacist-compounded metha-done formulation to methadone hydrochloride 10 mg/mL cherry-flavoured oral liquid (Methadose™) [10]. BCwas the second province in Canada to implement thetransition to Methadose™; 14,662 patients were regis-tered in the methadone treatment program at the time[14]. The decision was based on several advantages ofMethadose™, including a longer shelf life (up to fouryears if unopened), elimination of the need for refriger-ation, improved quality control, and consistent dosing,which is possible mainly because Methadose™ is a solu-tion prepared by the manufacturer rather than mixed ordiluted by a pharmacist [10]. The new formulation iscited as hypertonic and painful to inject, a featurethat may deter opioid abuse and medication diversion[10, 15]. In addition to formulation changes, a newpolicy was introduced by the College of Physiciansand Surgeons of BC restricting pharmacies to providehome deliveries “under extraordinary circumstances,”requiring written authorization from the prescribingphysician [10].The transition to the methadone formulation Metha-dose™ posed several major public health concerns. First,methadone formulation changes may cause stress and in-stability in previously stable patients [16]. Such changesmay result in patients discontinuing MMT and/or supple-menting with other illegally obtained drugs [16, 17].People who are prescribed MMT often belong to a vulner-able population that may experience difficulties with drugpolicy transitions and consequently, are less tolerant tochanges in methadone prescribing or dispensing practices[16, 17]. Secondly, accidental overdoses during the transi-tion period were a concern. Methadose™ is ten times moreconcentrated by volume compared to the previously com-pounded methadone, and is dispensed undiluted. Hence,there is potential for prescribing and dispensing errorsduring the transition period, further increasing overdoserisk. As well, given that a smaller volume is dispensed, itmay make it more difficult to titrate doses to patients.During the methadone transition period in BC, phar-macists were asked to educate patients about safety con-cerns, including increased risk of overdose, education ontake-home naloxone (an opioid antagonist), and appro-priate security and storage [10]. The College of Physi-cians and Surgeons of BC in collaboration with theCollege of Pharmacist of BC provided information andtraining to physicians and pharmacists in the province;the colleges worked with people prescribed methadoneto produce patient information resources [12]. Publichealth campaigns, such as posters, were distributed toharm reduction sites and media releases were initiatedin BC to communicate the changes in appearance andconcentration of the new methadone formulation [15].PWUD who engaged with harm reduction sites andcommunity advocacy groups expressed concerns regard-ing the lack of awareness and involvement in the transi-tion process. Patients on MMT reported dissatisfactionwith Methadose™ and disruptions in treatment, whichinformed the intent and need to conduct a quantitativeprovince-wide survey. Our study seeks to understand ex-periences reported by MMT patients after the transitionto the new methadone formulation, Methadose™. Wecompare the perceptions of the new Methadose™ to theprevious compounded methadone formulation throughseveral variables, including satisfaction and efficacy mea-sures such as taste, pain, being dope sick, and dosechanges.MethodsSurvey tool developmentFour focus groups (n = 32) were undertaken with PWUDin Vancouver in the six weeks following the transition toMethadose™ to explore concerns about the methadoneformulation change and inform the quantitative surveyquestions. The results of this qualitative study have beenpresented elsewhere [18]. Drug user organizations in-cluding the Vancouver Area Network of Drug Users andBC Association of People on Methadone were activelyengaged and provided input regarding content andwording of the draft questions which were incorporatedinto the final survey. The final survey consisted of twelvemethadone-specific questions, including: How do youfind the taste of the new cherry Methadose™ comparedGreer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 Page 2 of 8to the orange methadone? Did your dose change withthe new cherry Methadose™ compared to the orangemethadone? Do you feel you need to take additional opi-oids with the new cherry Methadose™ compared to theorange methadone? In general, do you wake up feelingdope sick on the new cherry Methadose™ compared tothe orange methadone? In general, how do you find thenew cherry Methadose™ addresses your pain needs com-pared to the orange methadone?The main variables of interest were subjective changesin dose, pain, taste, dope sickness, and the need to supple-ment with additional opioids. We also collected informa-tion on age, gender, ethnicity, housing status, geographiclocation, health authority, and how the participant heardabout the Methadose™ changes (i.e. methadone health careprovider or non-health care provider). Participants whoreported carries were also asked how they storedMethadose™.Recruitment and sampleAn annual survey was introduced in 2012 to obtain in-formation about drug use and related harms, and toevaluate the harm reduction supply distribution programthroughout BC [19]. A two-stage enrollment processwas used: harm reduction distribution sites with suffi-cient clients and resources were identified and invited toparticipate. In 2014, sites were requested to recruit amaximum of 40 PWUD aged 19 years and older overeight weeks in the summer (i.e. four to six months afterthe Methadose™ transition occurred); Vancouver CoastalHealth Authority was intentionally oversampled due tothe high density population of MMT patients in this re-gion. Sites were provided with $5 per survey to defraythe costs of administering the survey and/or for partici-pant incentives as the site determined most appropriate.Survey responses were entered into Fluid Surveys, anonline database. Details of these survey methods havebeen described previously [19].Statistical analysisStatistical analysis was performed with SPSS 21.0 and R2.3.1. Bivariable evaluations of the data were conductedthrough independent samples t tests for continuous vari-ables, and by Chi-square (x2) tests and calculating thePhi coefficient of association to determine the relation-ship between binary variables. Multivariable logistic re-gression analyses were performed to evaluate factorsrelated to dependent variables – namely: dose, pain,dope sickness, and the need to supplement with add-itional opioids. First, independent variables were consid-ered in a forward stepwise variable selection procedure.The criterion for entry in the stepwise procedure was asignificance level of P less than 0.05. Two explanatoryvariables, pain and dope sickness, were not included aspredictors in any same model. The rationale for this wasthreefold. First, the bivariable analysis revealed a rela-tively strong association (Phi = 0.46), indicating that theymay be describing the same effects, as pain may be asymptom of dope sickness. Second, the addition of painincreased the standard error of the beta coefficient fordope sick, indicative of a collinear variable. Finally, add-ing pain into the models in addition to dope sickness de-creased the overall predictive power of the model, asindicated in the Hosmer Lemeshow tests. Dope sicknesswas retained in the final model of supplement and doseincrease since the predictive power was higher thanthe model that included pain instead. The HosmerLemeshow chi-square tests (df = 8) for all models sug-gested they were a good fit to the data as p = 0.29–0.89 (>0.05). Nagelkerke R2 for models ranged from0.10 to 0.60 indicating models were able to explainbetween 10–60 % of variability in the data. Althoughage and gender did not have a significant effect onany dependent variable, both were force entered intothe models to account for any influence of demo-graphics. For responses where participants couldqualitatively enter an “other” description, items werecategorized and frequencies were calculated to de-scribe patterns.ResultsFifty harm reduction distribution sites across the prov-ince returned 1322 completed surveys. Of these, 405 re-spondents reported being on MMT at the time oftransition to Methadose™. The survey provided a sampleof MMT patients from all five geographic health regionsacross BC. The proportion of respondents from each re-gional health authority that were enrolled in an MMTprogram varied from 39.5 % in Vancouver CoastalHealth to 19.0 % in Fraser Health Authority. Eighty-ninepercent of participants in this sample reported polysub-stance use in the past 7 days. The socio-demographiccharacteristics of the 405 respondents in the MMT pro-gram at the time of transition are shown in Table 1.The majority (80.9 %) of participants reported a worsetaste with the new Methadose™ cherry-flavoured syrupcompared to the previous Tang™-flavoured methadone(Table 2). A third of respondents reported increasingtheir dose of Methadose™, while over half of respondentsreported having worse pain, feeling more dope sick, andsupplementing their methadone with other opioids.Table 3 describes variables assessing MMT outcomes.The majority (n = 258; 73.1 %) of participants heardabout the changes in their MMT from their healthcare provider or methadone pharmacist. Thirty-two(16.1 %) patients with methadone carries (n = 199)stored their methadone in a locked box. Of thosewho provided a reason for increasing their methadoneGreer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 Page 3 of 8dose (n = 76), three quarters reported it was to man-age symptoms; 46.1 % to avoid feeling dope sick and28.9 % to relieve pain.In the bivariable analyses, outcome and explanatoryvariables of interest were all significantly and stronglyassociated as indicated in the Chi-square tests and Phiassociation measure (Table 3). In the multivariable logis-tic regression analysis (Table 4), reporting worse tastewas independently associated with increased dose (OR =2.46; CI: 1.31–4.61), more dope sick (OR = 3.39; CI:1.88–6.12) and worse pain (OR = 4.65; CI: 2.45–8.80),while being more dope sick was found to be positivelyassociated with the odds of increasing dose (OR = 2.24;CI: 1.37–3.66), and supplementing with opioids (OR =8.81; 5.16–15.05).DiscussionThe goal of this study was to explore the perceptions ofhow persons enrolled in MMT in BC were affected bythe transition to Methadose™. Our findings revealedlarge proportions of participants reported worse taste,the need to increase methadone dose, and increasedwithdrawal and pain symptoms. Worse taste was signifi-cantly correlated with reported lack of effectiveness anddeterioration of symptoms across multiple parameters,as demonstrated by more withdrawal symptoms, painand need to increase dose. These associations were notsignificantly related to how patients heard about theformulation change, geographic region, or other sociode-mographic factors. Overall, our findings of increasedpain, withdrawal symptoms, and need to increase metha-done dose following the formulation change to Metha-dose™ have implications for the wellbeing of MMTpatients in BC that must be considered.Previous studies support our findings that medicationtransition periods can have pronounced bio-psychosocialimpacts on patients. In the United Kingdom, change inmethadone formulation in 1992 was correlated with anTable 1 Sociodemographics of a sample of methadonemaintenance treatment patients following a methadoneformulation change in British Columbia (n = 405)Number PercentRegion (n = 405)Fraser 40 9.9Interior 46 11.4Northern 20 4.9Vancouver Coastal 232 57.3Vancouver Island 67 16.5Ethnicity (n = 393)Aboriginal 114 29.0Non-Aboriginal 279 71.0Gender (n = 401)Female 161 40.2Male 237 59.1Transsexual 3 0.7Housing (n = 390)Stable (housed > =3 months) 305 78.2Unstable (<3 months or homeless) 85 21.8Age in years (n = 403) Mean (SD) Range42 (10.3) 19 – 71Table 2 Perceptions and outcomes of patients on methadonemaintenance treatment following a formulation changeN (%)How heard about the change (n = 353)Health care provider or methadone pharmacist 258 (73.1)Non methadone service provider 33 (9.3)Family or friend 26 (7.4)Newspaper or poster 36 (10.2)Of those with carries (n = 199)Does not store methadone in locked box 167 (83.9)Does store methadone in locked box 32 (16.1)Splitting doses (n = 293)No change 269 (91.8)Started splitting 21 (7.2)Stopped splitting 3 (1.0)Reason dose increased (n = 76)To avoid feeling dope sick 35 (46.1)To relieve pain 22 (28.9)To avoid using other opioids 19 (25.0)Reason for supplementing (n = 178)To avoid feeling dope sick 92 (51.7)To relieve pain 86 (48.3)Taste difference (n = 371)Same or better taste 71 (19.1)Worse taste 300 (80.9)Dose changes (n = 320)Lowered or same dose 213 (66.6)Increased dose 107 (33.4)Dope sick changes (n = 358)Same or less dope sick 156 (43.6)More dope sick 202 (56.4)Pain changes (n = 358)Same or better pain 165 (46.1)Worse pain 193 (53.9)Supplements with opioids (n = 360)No supplementing with opioids 179 (49.7)Yes supplementing with opioids 181 (50.3)Greer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 Page 4 of 8increase use of non-prescription opioids, decline in so-cial stability, and an increase in pharmacy break-ins [20].A clinical study conducted by Soyka and Zingg in 2009found the transfer from racemic methadone to (R)-methadone decreased withdrawal symptoms, cravings,and supplementing with additional drugs [21]. In ourstudy, over half of participants reported supplementingwith other drugs following the transition to Methadose™.Methadone diversion and its illicit use are not uncom-mon; the 2014 survey of clients at harm reductionsupply distribution sites in BC found that 8 % of re-spondents accessed methadone without a prescription(unpublished BCCDC data). Diversion in medicationcompliance has been critical in subsequent injectiondrug use, crime, and morbidity and mortality rates[22, 23]; hence, any instability in MMT leading to arebound in illicit drug use may result in possible declinein social function and worse health outcomes in BC.Silver and Shaffer (1997) found patients could be moreintolerant to methadone formulation changes thanothers (coined ‘change intolerance’) [24]. In their studyof 177 MMT patients, researchers found gender, treat-ment history, and previous methadone abuse predictedchange intolerance. Gourevitch et al. provides furtherevidence demonstrating that change intolerance to dif-ferent methadone formulations is related to psychosocialstressors rather than having a pharmacodynamic basis[17]. In a small double-blind crossover trial of threemethadone formulations they demonstrated self-reported withdrawal symptoms did not correlate withplasma methadone levels [17]. The effect of taste on pa-tients’ perception of pharmacological efficacy and sideeffects is not well studied. A randomized control trialconducted by Farr (1986) showed that medication tasteaffected participants’ perceptions [25]. In this study, bit-ter tasting zinc gluconate lozenges were perceived tohave more negative side effects than the tasteless pla-cebo tablets. This effect diminished when taste-matchingplacebos were used [25]. In France, where the capsuleformulation of MMT recently became available inaddition to the syrup formulation, two recent studiesshowed the potential superiority of the dry (capsule)MMT formulation [18, 26]. Boucherie et al. (2015) dem-onstrated that there was a rise in capsule MMT users ina five year period with a corresponding drop in preva-lence of individuals using the syrup formulation [26],and Eiden et al. (2013) described 80 % of patients experi-enced negative side effects from use of the syrup MMTformulation [18]. In light of the large proportion ofMMT patients in our study who reported worse tasteand its relation to negative outcomes, consideration ofother formulations of methadone including the capsuleTable 3 Bivariable associations between taste, dose increased, supplements, pain, and dope sickness following a methadoneformulation changeTaste worsened Dose increased Began supplementing with opioids More dope sickX2 Phi X2 Phi X2 Phi X2 PhiDose increased 9.93** 0.20**Began supplementing with opioids 3.99* 0.11* 21.50** 0.27**More dope sick 22.52** 0.25** 13.70** 0.20** 70.63** 0.46**More pain 22.23** 0.27** 13.06** 0.21** 29.43** 0.30** 77.28** 0.46***p < 0.05, **p < 0.01degrees of freedom for Chi-square (X2) tests = 1Table 4 Adjusted odds ratios (OR) with 95 % confidence intervals (CI) and goodness of fit for taste and more dope sick related to oddsof dose increase, supplements with additional opioids, more dope sick, and more pain following methadone formulation changeWald OR* 95 % CI** Hosmer Lemeshow Test Nagelkerke R2Dose IncreasedTaste 7.79 2.46 1.31–4.61 0.89 0.37More dope sick 10.28 2.24 1.37–3.66SupplementsMore dope sick 63.89 8.81 5.16–15.05 0.29 0.60More dope sickTaste 11.91 3.39 1.88–6.12 0.30 0.11More painTaste 22.06 4.65 2.45–8.80 0.83 0.10*OR adjusted for age, gender, and indicated covariates**95 % CI based on Wald chi-square tests with df = 1Greer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 Page 5 of 8form, may be warranted. However, some literature hashighlighted that non-syrup forms of MMT may increasediversion and misuse liability [18].These findings are corroborated by a recent qualitativestudy conducted by McNeil et al. (2015) who inter-viewed 34 MMT patients in the Vancouver region; 31who had transitioned to MethadoseTM at the time ofinterview [16]. This study supports the notion that themethadone formulation transition in BC produced con-siderable negative health and social impacts on patientsand demonstrated that these effects were exacerbated bythe structural vulnerability that patients on MMT aresubjected to [16]. They also suggest real or perceivedwithdrawal symptoms might have a psychological com-ponent, as in our study, which strongly suggests percep-tions of changes in taste contribute to withdrawalsymptoms, pain, and need to increase dose. Although weanticipated similar findings, our study had a number ofstrengths and adds to the literature. We had quantitativeresponses from over 400 people throughout the provinceand, thus, our results were not limited to the Vancouverarea. While methadone formulation changes have oc-curred in other provinces in Canada (i.e. Alberta,Ontario), there remains a lack of evaluation data of theimpact and differences of the implementation of thesepolicies.These studies and ours underscore the importance ofrecognizing that many persons participating in MMTbelong to a particularly vulnerable population who areoften victim to structural discrimination, which maymake them less able to cope with imposed medicationchanges and loss of autonomy [25]. Trujols et al. (2011)argue much of the satisfaction with MMT comes frompatients who perceive themselves as participating tosome extent in treatment decisions [27]. The impact ofthe transition to Methadose™ in BC among MMT pa-tients may be further exacerbated by the change in homedelivery policy further adding to the instability and dis-satisfaction to the program. The capacity for agency anda flexible interim period appear to be important factorsin the stability of medication transitions. There is evi-dence that patients are more satisfied with their MMTprograms when they perceive themselves as participatingin treatment decision-making [27]. Another study sug-gested that although there may be some transitional in-stabilities encountered after methadone formulationchanges, they could be further mitigated by providingpatients with a longer transition period as well as achoice of the transitional process [28].One strategy to mitigate this impact that could be in-corporated during medication formulation changes, isinvolving and consulting the community affected in thedevelopment and implementation of new regulatory pol-icies. El Ansari and Phillips (2004) found that a lowamount of involvement with the community is associ-ated with decreased costs and increased satisfaction withpolicies [29]. In BC, the College of Pharmacists, Collegeof Physicians and Surgeons and Ministry of Health metwith representatives from the Vancouver Area Networkof Drug Users and BC Association of People on Metha-done on three occasions over ten months prior to thechange to Methadose™ (Personal communication SolvenS., 2015). During this time patient groups provided feed-back regarding the dispensing standards for MMT thatresulted in several changes and helped to produce com-munication materials (i.e. “Think before you drink” cam-paign) [30].Despite a concerted effort by the College of Pharmacistsof BC to engage with people on methadone, our studyfound significant negative perceptions of the methadoneformulation change in the province. It is interesting tonote that our results showed nearly three-quarters heardabout the methadone formulation transition from theirmethadone-prescribing physician or pharmacist, whocould be a useful avenue for the dissemination of educa-tional resources. However, the remaining one-quarter ofparticipants could have benefited from greater awarenessand public education campaigns during the transitionperiod. Patients may benefit from longer and more flexibletransitional timeline of several months, rather than weeks,when the old formulation may be accessible during theintroduction of the new formulation. During this time, pa-tients could be monitored closely for changes in pain anddope sickness. Although patients may be more acceptingwith a longer and more flexible transition period, the Col-lege of Pharmacists of BC believed a shorter transitionperiod would minimize the chance of error with the twodifferent strengths, and therefore decided against an in-creased transition period(Personal communication SolvenS., 2015). Lastly, it may have been helpful to introducedifferent formulation options for patients; similar toAlberta and Ontario, Methadose™ may be better tolerated(particularly taste) if MMT patients were given the optionto have unflavored Methadose™ or be able to dilute in aTang™-flavored drink which would maintain consistencywith previous volume and flavor [31, 32].While our study highlights some important findingsthat may have policy implications, several limitationsmust be considered. First, we recruited and sampledpeople who access harm reduction sites for suppliesacross BC, signifying that many of our survey partici-pants may use illicit drugs in addition to their MMT.These patients may represent a structurally vulnerablepopulation [16]; as such, these findings may not begeneralizable to all MMT patients. However, it is im-portant to understand the challenges of MMT for theseindividuals and reduce their heightened barriers for ac-cess [33]. Although our study was administered in allGreer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 Page 6 of 8five regional health authorities at 50 harm reductionsites across BC, access to MMT varies across regions.Regions where patients have one source of MMT maybe more accepting of changes as they are not accus-tomed to having a choice of MMT; however, our find-ings were not significantly different across regions. Asthis study was a cross-sectional design after the changeoccurred, satisfaction with MMT was not assessed priorto the change. Future research may benefit from measur-ing dose and satisfaction with MMT longitudinally, cap-turing both before and after measures. This study didnot examine whether negative experiences following theformulation change impacted continuation on MMT,which could be an area for future research. Finally,multiple bivariate analyses were conducted with manyvariables serving as both explanatory and outcomevariables. With multiple analyses, we acknowledge theconsequent risk of Type I error that may be inflatedwith this type of analysis.ConclusionIn conclusion, we characterized several negative percep-tions and outcomes among a sample of MMT patients fol-lowing a province-wide methadone formulation change toMethadose™ in BC, Canada. These findings highlight thestructural vulnerability PWUD and MMT patients face,and point to the importance of involving all stakeholderspolicy decision-making. We urge policy makers to con-sider a more engaging and transparent approach whenworking with structurally vulnerable populations, includ-ing people with a history of substance misuse, incarcer-ation and mental health illness, and homelessness.Ethics, consent and permissionsThis study was approved by the University of BritishColumbia Research Ethics Board prior to collectingdata, and for the duration of this research. Informedconsent was obtained from all participants, includingconsent to publish.AbbreviationsBC: British Columbia; CI: Confidence interval; MMT: Methadone maintenancetreatment; OR: Odds ratio; PWUD: People who use drugs.Competing interestsThe author(s) declare that they have no competing interests.Authors’ contributionsJAB and AA were responsible for study design. AMG, SH, and JAB wasresponsible for analysis and interpretation. AMG and SH were responsiblefor collection of the literature and first draft. SM and OS were responsiblefor data collection and AA coordinated the study. All authors providedcritical comments on the first draft of the manuscript. All authors read andapproved the final manuscript.AcknowledgementsThe authors would like to thank S. Solven, Deputy Registrar of the Collegeof Pharmacists of BC and Drs A. McNestry and J. Agnew of the College ofPhysicians and Surgeons of BC for their input and support.Author details1University of British Columbia, School of Population and Public Health, 2206East Mall, Vancouver, BC V6T 1Z3, Canada. 2BC Centre for Disease Control,655 West 12th Avenue, Vancouver, BC V5Z 4R4, Canada. 3Simon FraserUniversity, 8888 University Drive, Burnaby, BC V5A 1S6, Canada.Received: 1 October 2015 Accepted: 10 January 2016References1. Layson-Wolf C, Goode J-V, Small RE. Clinical use of methadone. 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Strike CJ, Gnam W, Urbanoski K, Fischer B, Marsh DC, Millson M. Factorspredicting 2-year retention in methadone maintenance treatment foropioid dependence. Addict Behav. 2005;30:1025–8.•  We accept pre-submission inquiries •  Our selector tool helps you to find the most relevant journal•  We provide round the clock customer support •  Convenient online submission•  Thorough peer review•  Inclusion in PubMed and all major indexing services •  Maximum visibility for your researchSubmit your manuscript atwww.biomedcentral.com/submitSubmit your next manuscript to BioMed Central and we will help you at every step:Greer et al. Substance Abuse Treatment, Prevention, and Policy  (2016) 11:3 Page 8 of 8


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