A prospective,multisite implementation-efficacy trial of a collaborative prescriber-pharmacist model of care for Medication Assisted Treatment for Opioid Dependence: Protocol for the EPIC-MATOD study

BackgroundMedication Assisted Treatment for Opioid Dependence (MATOD) is clinically effective and cost effective, yet a lack of MATOD prescribers in the community limits access to this treatment in Australia. These shortages are often greatest in regional and rural areas.Objective(s)The Enhancing Pharmacist Involvement in Care (EPIC)-MATOD study will evaluate clinical and implementation outcomes among people with opioid dependence receiving MATOD through a collaborative pharmacist-prescriber model of care across multiple sites in a regional location (encompassing a mix of metropolitan and non-metropolitan areas) of Victoria, Australia.Methods and analysisThe EPIC-MATOD study is a prospective, multisite, implementation trial of collaborative MATOD care. Pharmacists and prescribers will be recruited through the local network of opioid pharmacotherapy providers. Patients will be recruited through participating healthcare providers. After induction into the collaborative care model, patients and healthcare professionals will be followed up over 6- (patients) and 12-months (pharmacists and prescribers) in a hybrid implementation-efficacy study, with outcomes mapped to the RE-AIM framework. The primary clinical efficacy endpoint is patient retention in treatment at 26 weeks. The primary implementation outcome is treatment capacity, based on prescriber time required to provide treatment through collaborative care compared with traditional care. Secondary clinical endpoints include attendance for dosing and clinical reviews, substance use, mental and physical health and overall well-being. Implementation costs, acceptability, and provider engagement in collaborative care will be used as secondary implementation outcome indicators. Time and costs associated with collaborative care, and health service utilisation, will also be estimated.Project impactThe study will provide important information on outcomes and acceptability of collaborative care for MATOD, as well as the cost and key considerations in delivering a collaborative model of care in Australia and other countries where similar treatment barriers exist.     

Studying the impact of a medication use evaluation by the community pharmacist (Simenon): Drug-related problems and associated variables

BackgroundA medication use review (MUR) aims to optimize medication use, patient knowledge and can improve health outcomes. This pharmaceutical care service is not yet available in Belgium.ObjectivesTo describe drug-related problems (DRPs) detected during a MUR, subsequent interventions proposed by pharmacists and evolution of DRPs until follow-up and to identify patient-related variables associated with the number of reported DRPs.MethodsBelgian community pharmacists provided a MUR to older polymedicated ambulatory patients and registered DRPs, interventions and resolution at follow-up using the PharmDISC classification. The relationship between 14 patient-related variables and the number of reported DRPs was investigated with univariate analysis. A prediction model was developed with significant variables using negative binomial regression analysis.ResultsAcross 56 pharmacies, 453 patients received a MUR and 1196 DRPs were registered (median 3DRPs/patient, range 0–10). Only for 11.7% of patients no problems were identified. The top-3 causes were interaction (15.2%), inappropriate timing or frequency (13.5%) and adverse effect (11.9%). The top-3 recommended interventions by pharmacists were transmission of information (25.1%), in-depth patient counselling (15.0%) and therapy stop (8.2%). After six weeks, 42.6% of DRPs were resolved; data was missing for 33.3%. A higher number of chronic drugs, female gender and living alone were associated with more DRPs. The prediction model found that per additional chronic drug, the number of problems increases by 4.3% (95% CI: 2.0–6.6%). Male gender decreases DRPs by 22.1% (95% CI: 10.4–32.0%). Living alone provided no additional predictive value in the prediction model. Confounding process- and pharmacist-related variables also influenced the number of reported DRPs.ConclusionA MUR appears an effective strategy to detect and resolve DRPs. The number of chronic medications and female gender predict a higher number of DRPs. These findings are a starting point for evidence-based eligibility criteria for a MUR service in Belgium.     

Client and staff experiences of a co-located service for hepatitis C care in opioid substitution treatment settings in New South Wales,Australia

Background

Internationally, there are ongoing efforts to increase access to hepatitis C (HCV) assessment and treatment to counter a generally low uptake of treatment among people with a history of injecting drug use. The aim of this qualitative study was to examine client and staff attitudes towards and experience of co-location of HCV and opioid substitution treatment (OST) services.

Methods

In-depth interviews were conducted with 57 clients and 19 staff from four NSW clinics participating in the Australian ETHOS study.

Results

Client and staff participants typically welcomed integrated treatment, citing issues of convenience, reduced travel time and costs, persistent cues to engagement and immediacy of access to care. Positive attitudes towards the initiative were expressed even by clients who had not engaged with HCV care. Providing co-located care largely avoided the negative, stigmatising or discriminatory experiences that participants reported encountering in settings less familiar with people who use drugs. A minority of client participants expressed concerns about the lack of privacy and/or confidentiality available in the co-located model, preferring to seek HCV care elsewhere.

Conclusions

The co-location of HCV care in OST clinics was welcomed by the large majority of participants in this study. Besides issues of convenience, the appeal of the co-located service centred on the familiarity of existing relationships between clients and staff in the OST setting. While some clients remained distrustful of OST and chose not to take up HCV care in this setting, the co-located treatment model was overwhelmingly successful amongst both client and staff participants.     

An ethical analysis of medication treatment for opioid use disorder (MOUD) for persons who are incarcerated

Abstract

Opioid use disorder (OUD) is highly prevalent among persons who are incarcerated. Medication treatment for opioid use disorder (MOUD), methadone, buprenorphine, and naltrexone, is widely used to treat OUD in the community. Despite MOUD’s well-documented effectiveness in improving health and social outcomes, its use in American jails and prisons is limited.

Several factors are used to justify limited access to MOUD in jails and prisons including: “uncertainty” of MOUD’s effectiveness during incarceration, security concerns, risk of overdose from MOUD, lack of resources and institutional infrastructure, and the inability of people with OUD to provide informed consent. Stigma regarding MOUD also likely plays a role. While these factors are relevant to the creation and implementation of addiction treatment policies in incarcerated settings, their ethicality remains underexplored.

Using ethical principles of beneficence/non-maleficence, justice, and autonomy, in addition to public health ethics, we evaluate the ethicality of the above list of factors. There is a two-fold ethical imperative to provide MOUD in jails and prisons. Firstly, persons who are incarcerated have the right to evidence-based medical care for OUD. Secondly, because jails and prisons are government institutions, they have an obligation to provide that evidence-based treatment. Additionally, jails and prisons must address the systematic barriers that prevent them from fulfilling that responsibility. According to widely accepted ethical principles, strong evidence supporting the health benefits of MOUD cannot be subordinated to stigma or inaccurate assessments of security, cost, and feasibility. We conclude that making MOUD inaccessible in jails and prisons is ethically impermissible.     

The effect of telephonic patient support on treatment for opioid dependence: outcomes at one year follow-up

Objective

The present study examined the impact of a telephonic patient support program known as HereToHelp™ (HTH) on compliance and treatment outcomes among opioid dependent (OD) patients new to buprenorphine treatment (BUP).

Method

A total of 1426 OD patients new to BUP were randomized to receive BUP alone (standard care) or BUP plus the HTH patient support program. All patients completed the Addiction Severity Index (ASI) at the time of enrollment, and at 12 months post-enrollment.

Results

Subjects randomized to the HTH support program who accepted at least 3 care coach intervention calls were more compliant with BUP than the standard care group at month 12 (64.4% vs. 56.1%, χ² = 5.09, p < .025). Compared to patients who were non-compliant with BUP, compliant patients reported significantly lower scores on all 7 of the ASI composite scores, indicating lower severity on addiction-related problems.

Conclusions

The HTH intervention seemed to improve patient treatment outcomes indirectly by improving compliance with BUP. Supplementing BUP with a structured, telephonic compliance-enhancement program is an effective way to improve compliance with medication which then improves patient outcomes.     

Discharge report for the community pharmacist: Development and validation of a prototype

BackgroundThe potential benefit of community pharmacist's involvement in continuity of care is well-known. However, it is not standard practice to exchange information with the community pharmacist (CP) after hospitalization.ObjectiveTo construct and validate an evidence-based prototype of a discharge report for the community pharmacist.MethodsFirst, a review of literature, guidelines and established initiatives was performed to construct a preliminary discharge report. Secondly, the content of the discharge report was reviewed and optimized using semi-structured individual interviews with CPs and general practitioners (GPs).ResultsThe review identified six guidelines for information exchange with the CP originating from three countries, 17 research papers and three local initiatives. Overall, 49 different elements for a discharge document were identified. Based on recurring elements, a preliminary discharge report was created. Interviews with ten CPs and nine GPs provided insights into which information is considered crucial for patient safety and why. This allowed an optimization of the document. The final discharge report consists of three categories: administrative, medication and medical data. The medication data includes medication registered at hospital admission as well as at hospital discharge, drug indications, reasons for initiating, adjusting or discontinuing therapies and start/stop dates. The medical data contains reasons for hospitalization, comorbidities and allergies.ConclusionsThe literature review and semi-structured interviews resulted in an evidence-based prototype of a discharge report for the community pharmacist. This document contains both administrative, medical and medication data.     

Coordination of medical care and opioid dependence treatment in primary care: A case report

ABSTRACT

This study was conducted to determine the psychometric properties of a measure of social support, the Community Assessment Inventory (CAI), and to examine the role of social support in recovery. The CAI and the Addiction Severity Index (ASI) were administered to 196 opioid-dependent adults in (n = 135) or out of (n = 61) methadone treatment in Baltimore, Maryland, between 2004 and 2006. Baseline CAI scale scores indicated a generally high level of internal consistency (α scores). Pearson correlations showed that the scales were stable and had good discriminant validity with the ASI composite scores. One-way analysis of variance indicated that in-treatment participants reported significantly more support at baseline than out-of-treatment participants. This study's findings indicate the CAI may be a useful measure of social support and that such support is an important factor in treatment entry.     

Process study within a pilot cluster randomised trial in community pharmacy: An exploration of pharmacist readiness for research

IntroductionCommunity pharmacies have an increasingly prominent public health function. This includes addressing alcohol, but guidance on delivery of alcohol interventions in this setting is lacking. We have developed an intervention that integrates attention to alcohol within existing community pharmacy medicine review services. This paper examines the experiences of community pharmacists (CPs) in conducting a pilot trial of the intervention, including the acceptability of the trial patient recruitment procedures and the training and support provided by the research team.MethodThe pilot trial was conducted in 10 community pharmacies in Yorkshire, England. One CP from each pharmacy was recruited via a multi-stage process to assess motivation, commitment and capacity to participate. Each CP attended a research training day and received on-going research support to conduct the trial. Semi-structured audio-recorded face-to-face interviews (lasting 40–105 min) were conducted with all the CPs at the end of the trial. Data were also available from three direct observations conducted during trial support visits. Data were analysed thematically.ResultsThe CPs were supportive of research in community pharmacy but had little direct experiences of research themselves. They valued the training and support provided, which had quickly identified areas where CPs were deviating from the study recruitment protocol. In some instances, the boundaries between research and practice became blurred with CPs making changes to their usual routines and interactions with patients to accommodate the research.ConclusionsThe trial procedures were acceptable to CPs, in part because of the training and support provided. There are also identifiable areas where CPs’ readiness for research could be enhanced to facilitate participation in future trials in this setting.     

Factors associated with dropout among patients in opioid maintenance treatment (OMT) and predictors of re-entry. A national registry-based study

Background

Retention in treatment is often highlighted as one of the key indicators of success in opioid maintenance treatment (OMT).

Aims

To identify factors associated with long-term retention in opioid maintenance treatment and to analyse predictors of subsequent treatment episodes.

Methods

Treatment retention and re-entry were examined for a national cohort of patients admitted to OMT in Norway in the period 1997–2003. Multivariate Cox regression models were used to investigate factors associated with treatment dropout 18 months after treatment entry.

Results

The 18 month retention rate among patients admitted to OMT in Norway (n = 2431) was 65.8% (n = 1599). Dropout from OMT within 18 months was associated with younger age (HR 0.97 [0.96–0.98]), high levels of general pre-treatment criminal offences (HR 1.66 [1.32–2.09]) and having drug-related offences during the 30 days prior to dropout (HR 1.80 [1.36–2.38]). Of the patients who dropped out (n = 832), 42.7% (n = 355) were re-engaged in subsequent treatment episodes. Pre-treatment criminal offences were associated with increased odds for treatment re-entry, whereas being younger and having drug-related offences during the first OMT episode were associated with lower odds for re-engagement in OMT. Gender was not associated with treatment dropout and re-entry.

Conclusion

High levels of pre-treatment criminal offences and drug offences during the 30 days prior to dropout were associated with treatment dropout. Efforts to increase support services to these patients may contribute to higher rates of retention in OMT.     

Pharmaceutical care model for patients with type 2 diabetes: integration of the community pharmacist into the diabetes team – a pilot study

OBJECTIVE: To evaluate the feasibility and impact of a structured approach for community pharmacist input as a member of the multidisciplinary team caring for patients with type-2 diabetes and health professional providing advice on medication. METHODS: Prospective pretest-posttest single group study. Sixty-two patients on oral hypoglycaemic therapy, identified as regular customers of four Scottish (UK) community pharmacies, were recruited. Each patient underwent an initial assessment: review of medical general practice notes/community pharmacy PMR (Patient medication record) system and structured interview. Standardised documentation was completed, a pharmaceutical care plan (PCP) prepared, peer-reviewed and then discussed face-to-face with patients' GPs (general practitioners). A second (final) assessment was conducted 24 to 28 weeks from the initial interview. MAIN OUTCOME MEASURES: Pharmaceutical care issues (PCIs) throughout study period; change in parameters from initial to final assessment: patient knowledge of oral hypoglycaemic and anti-hypertensive therapy; HbA1c; blood pressure; total cholesterol; medication compliance. RESULTS: A total of 178 PCIs were identified (mean [range] 2.9 [1-5] per patient) and categorised: drug therapy problems (n = 76); monitoring (n = 21); and patient knowledge (n = 81). Drug therapy problems discussed with the GPs were agreed for 74 (97%) and resolved for 55 (72%) at final assessment. Biological outcome measures were assessed for 59 patients (3 drop-outs). A reduction (P < 0.05) in HbA1 c, blood pressure and total cholesterol was observed over the study period. Patients knowledge was poor for oral hypoglycaemic therapy but improved (initial-51 %, final-72%, P < 0.05). CONCLUSION: This study demonstrated a feasible pharmaceutical care model for diabetes patients in an European country. The results have shown the pharmacist to be effective and well accepted by GPs and patients.     

Consideration of opioid agonist treatment in a pregnant adolescent: A case report and literature review

Abstract

Background: Opioid use greatly increases the risk of overdose death, as well as contracting human immunodeficiency virus (HIV) and hepatitis. Opioid agonist treatment is recommended for pregnant women who are dependent on opioids. However, there is a dearth of studies on the use of opioid agonist treatment in pregnant teenagers. Case: Ms. A, a 15?year-old G1PO in foster care, presented to our tertiary women’s hospital requesting opioid agonist treatment for use of pill opioids. She reported nasal inhalation of 5–6 opioid tablets daily, with recent attempts to self-taper using nonprescribed buprenorphine since learning of her pregnancy. Last reported opioid use was >24?hours prior to admission. Urine drug testing was positive only for opioids (negative for buprenorphine and methadone). She did not exhibit significant withdrawal symptoms while hospitalized. The psychiatric treatment team recommended deferring opioid agonist treatment and pursuing outpatient substance use treatment. Unfortunately, Ms. A did not attend outpatient treatment and was lost to follow up. Discussion: Based upon our experience and review of the studies regarding opioid use disorder (OUD) and perinatal and adolescent opioid use, we recommend that pregnant adolescents with OUD be referred to opioid agonist treatment with buprenorphine or methadone. Studies specifically addressing opioid agonist treatment in pregnant teenagers are needed.     

Evaluation of medication reviews conducted by community pharmacists: a quantitative analysis of documented issues and recommendations

Aims

To describe issues noted and recommendations made by community pharmacists during reviews of medicines and lifestyle relating to coronary heart disease (CHD), and to identify and quantify missed opportunities for making further recommendations and assess any relationships with demographic characteristics of the pharmacists providing the reviews.

Methods

All issues and recommendations noted by 60 community pharmacists during patient consultations were classified and quantified. Two independent reviewers studied a subsample of cases from every participating pharmacist and identified and classified potential issues from the available data. The findings of the pharmacists and the reviewers were compared. Relevant pharmacist characteristics were obtained from questionnaire data to determine relationships to the proportion of potential issues noted.

Results

A total of 2228 issues and 2337 recommendations were noted by the pharmacists in the 738 patients seen, a median of three per patient (interquartile range 2–4). The majority of the recommendations made (1719; 74%) related to CHD. In the subsample of 169 patients (23% of the total), the reviewers identified 1539 potential issues, of which pharmacists identified an average of 33.8% (95% confidence interval 30.1, 36.4). No relationship was found between the proportion of issues noted and potentially relevant factors such as pharmacists'' characteristics and their experience of doing reviews.

Conclusions

The majority of issues and recommendations noted by pharmacists related to CHD, although pharmacists recorded only a minority of the issues identified by reviewers. Variation between pharmacists in the completeness of reviews was not explained by review or other relevant experience.

What is already known about this subject?

• There is conflicting evidence concerning the potential benefits of pharmacist-led medication review.
• Little work has been published on the completeness of medication reviews provided by community pharmacists.

What this study adds

• The 60 community pharmacists taking part in a large randomized controlled trial showed considerable variation in the completeness of the reviews they recorded for intervention patients.
• Overall, pharmacists recorded only a minority of the potential issues present in these patients.
• The frequency with which pharmacists recorded issues was not related to key characteristics or to the number of reviews completed.

     

Unintended impacts of regulatory changes to British Columbia Methadone Maintenance Program on addiction and HIV-related outcomes: An interrupted time series analysis

BackgroundIn February 2014, several regulatory reforms were introduced to the methadone maintenance treatment (MMT) program in British Columbia, Canada, including a switch to a ten-times more concentrated methadone formulation and restrictions in pharmacy delivery services. We evaluated possible unintended effects of these changes on illicit drug use patterns and HIV treatment outcomes among HIV-positive opioid users.MethodsData was drawn from ACCESS, a prospective community-recruited cohort of HIV-positive people who use illicit drugs in Vancouver, Canada. Interrupted Time Series Analyses were used to evaluate impacts of the policy change on monthly rates of MMT enrolment, illicit heroin injection, antiretroviral therapy (ART) adherence, and HIV viral suppression among HIV-positive opioid users between November 2012 and May 2015.ResultsA total of 331 HIV-positive opioid users were included. The MMT policy change led to a significant immediate 11.5% increase in heroin injection, and 15.9% drop in optimal ART adherence. A gradual increase in the prevalence of MMT enrolment after the policy change was also documented (0.9% per month). No changes in viral suppression rates were observed.ConclusionWe observed immediate increases in illicit heroin injection and decreases in ART adherence in the wake of regulatory changes to the local MMT program. These findings underscore the need to consider potential unintended effects of altering health programmes for vulnerable populations, the need to develop appropriate mitigation strategies, as well as to involve all relevant stakeholders in the planning and implementations of new policies.     

Dispensing opioid substitution treatment: practices, attitudes and intentions of community-based pharmacists

INTRODUCTION AND AIMS: Community-based pharmacists (CPs) play a pivotal role in the provision of opioid substitution treatment (OST). This study examined practices, experiences, attitudes and intentions of a sample of South Australian pharmacists involved with the provision of OST. DESIGN AND METHODS: A random sample, stratified by geographic location, of 50 SA CPs were administered a telephone survey. The survey included pharmacist and pharmacy details, current practices, problems experienced, attitudes towards and future intentions in relation to the provision of OST. RESULTS: Pharmacists indicated high levels of support for the OST programme and most (98%) intended to continue providing OST. Sixty-four per cent of all pharmacists, and significantly more rural pharmacists (90%), indicated that they were willing to take on additional clients. Metropolitan pharmacists dosed greater numbers of OST clients (median = 7) than rural pharmacists (median = 4). There was a strong positive correlation between number of regular clients seen and problems experienced by pharmacists. Seventy per cent of pharmacists reported detecting no diversion of pharmacotherapy medication. DISCUSSION AND CONCLUSIONS: Despite reports to the contrary, pharmacists appear to be generally positively predisposed to providing OST. Policies aimed at retaining pharmacists, particularly in resource poor rural areas, could consider embracing a shared-care approach between general practitioners and pharmacists.     

Perspectives on privacy in the pharmacy: The views of opioid substitution treatment clients

BackgroundMany pharmacists practise in settings in which protecting privacy can be difficult. To address this, some community pharmacies are rearranging their retail space to provide private areas for clinical consultations. Such facilities are deemed particularly important when dealing with clients who have sensitive medical conditions, such as opioid dependence.ObjectiveTo explore Opioid Substitution Treatment (OST) patients’ perceptions of privacy in a community pharmacy setting, with a particular focus on the layout of the community pharmacy.MethodsWe conducted semi-structured interviews with OST clients. Recruitment and the interviews were conducted at state government drug and alcohol clinic. The interviews were audio recorded and transcribed verbatim. The data were analysed in NVivo using the framework approach.ResultsWe interviewed fourteen OST clients. Most participants were concerned about privacy and considered that the pharmacy layout could enhance or hinder privacy. However, they disagreed about exactly which pharmacy layout was most privacy-protecting. In addition, a small group of clients interviewed who had a very positive relationship with pharmacists believed that the relationship contributed to their confidence that their privacy was protected.ConclusionsThere is little consensus amongst consumers about how to protect privacy in the community pharmacy. The range of views expressed by clients in this study may reflect the lack of consensus about the nature of privacy in health ethics. Attention to the meaning of and rationales for privacy protections may be helpful when designing pharmacy layouts to meet the needs of a broad range of consumers. An enclosed or screened private area which can be used as a consultation area for all private pharmacy discussions, including for OST dosing, could be a solution to addressing these varying views on privacy in the pharmacy. Further attention to enhancing the pharmacist and client relationship may assist in reducing sensitivity about privacy.     

Assessing the reporting quality of simulated patient studies in pharmacy research using a novel checklist (CRiSP)

BackgroundUse of simulated patients (SP) to assess the quality of pharmacy services and impact of interventions is increasing. The CRiSP (Checklist for Reporting research using Simulated Patient methodology) checklist was recently developed, assisting researchers to report items necessary to meet a minimum agreed standard.Objective(s)To identify which CRiSP items were reported in SP studies for community pharmacy research, identify any gaps in reporting and describe the overall quality of reporting for the SP studies identified.MethodsPapers published during 2018–2020 using SP methodology in community pharmacy settings were identified from MEDLINE and Embase. The 50 most recent ones were selected. Data were extracted independently and in duplicate. Each paper received a coded numerical value denoting compliance with each item of CRiSP (1 = yes, 2 = no, 3 = unclear, 4 = not applicable, 5 = partially complete). Data were analysed using Microsoft Excel and reported as frequencies and percentages of each code for the checklist items, across the 50 papers.ResultsNo paper fulfilled all items in the CRiSP checklist. The mode(s) of delivery of SP assessments (item 17) was reported in all papers, while use of the term SP (item 1); number of SPs (4a); scenario details (9a); describing procedures¹²; data collection procedure (18); and ethics approval (23a) were reported in at least 80% of papers. Items not reported in over 50% of papers were: scenario development (8a), validation (8b) and flexibility (9b); materials used (10a) and copies of materials (10b); and procedures for SP identification (15). Researchers found interpretation of the checklist unclear and utilised working definitions to ensure consistency in coding.ConclusionsThis review identified that pharmacy research involving SP methodology is often inadequately reported by researchers. The CRiSP checklist is a comprehensive tool to assess the quality of SP methodology reporting but may require some refinement to ensure consistency in use.     

Predictors of methadone maintenance treatment utilization in a multisite cohort of illicit opioid users (OPICAN)

Although methadone maintenance treatment (MMT) has been a primary treatment response to illicit opioid use in Canada for decades, analytical treatment data are scarce. Using data from the multisite OPICAN cohort of illicit opioid and other drug users repeatedly assessed between 2002 (baseline) and 2005 (last follow-up [FU]), we (1) longitudinally examined characteristics associated with MMT uptake between baseline and FU and (2) cross-sectionally compared drug use patterns between cohort participants in MMT (n = 133) and those not in MMT (n = 400) at the last FU through bivariate and multivariate analyses (stepwise logistic regression). Significant baseline predictors of MMT uptake emerging in the logistic regression model included injection drug, heroin, as well as alcohol use, housing status, and Quebec City as a site. Furthermore, lower prevalence levels of opioid (e.g., morphine and OxyContin) and nonopioid (e.g., cocaine and crack) drug use as well as lower frequency of heroin use days were observed among MMT users. This study highlights potential factors relevant for improved MMT uptake and illustrates possible reductions of drug use related to MMT.