Li-Tzy Wu

Background: Pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) as part of a methadone medication unit (MU) of an opioid treatment program (OTP) can help address the opioid epidemic in the US. There are limited data to inform its implementation. Aims: We explored pharmacists’ knowledge and perceptions about PADMOUD and their intention to practice it. Design: An on-line survey of licensed pharmacists recruited from 50 states and District of Columbia (DC) was conducted. Findings: Of the 585 survey completers, 6.2% reported having ever worked at an OTP, 37.9% reported being aware of federal/state regulations allowing the methadone MU, and 39.2% perceived that most pharmacists would be interested in participating in a pharmacy methadone MU. The majority perceived confidence in their ability to develop a partnership with an OTP to establish/participate in a pharmacy methadone MU (57.2%). Being male, being in the other race category (vs. being White), practicing pharmacy services in the West region (vs. Northeast region), working at an independent pharmacy (vs. hospital/clinic pharmacy), and being an owner/partner/manager of a pharmacy (vs. staff pharmacist) were associated with increased odds of perceiving confidence in their ability to develop a partnership with an OTP to establish/participate in a pharmacy methadone MU. Additionally, 25.1% of pharmacists reported that they are likely to build a partnership with an OTP to participate in a pharmacy methadone MU. Being male, being in the other race category (vs. being White), and being Asian (vs. being White) were associated with increased odds of reporting an intention to build a partnership with an OTP to participate in a pharmacy methadone MU. Pharmacists identified barriers to implementing MUs (e.g., concerns about workload, regulations/liability, lack of training) and benefits (e.g., improved access to treatment, serving more patients, convenient locations, less stigma for patients). Conclusions: This nationwide survey of pharmacists suggests that while most pharmacists see benefits to support methadone MUs, they also cite significant barriers. Collective efforts among state pharmacy boards, pharmacist associations, and opioid treatment-related authorities could develop feasible program designs and help establish PADMOUD guidelines and training requirements for pharmacies/pharmacists to participate in methadone MUs. Clinical trial number: Not applicable.

Objectives: Injection drug use is a leading and growing risk factor for infective endocarditis (IE), as evidenced by a marked national increase in hospitalizations for drug use–associated infective endocarditis (DUA-IE). The typical treatment approach for persons with DUA-IE is a 6-week inpatient course of intravenous antimicrobials. This approach is resource-intensive, requiring substantial hospital resources and lengthy stays. Alternative methods of antibiotic delivery for DUA-IE treatment have been proposed and piloted, but their acceptance among people who inject drugs is unknown. Methods: Persons hospitalized with DUA-IE (N = 16) completed semi-structured interviews to identify facilitators and barriers to 3 proposed IE treatment options: (A) hospitalization for the entirety of antibiotic treatment, the current standard of care; (B) home-based outpatient parenteral antimicrobial therapy via indwelling catheter; or (C) weekly outpatient visits for long-acting antibiotic infusion. Interviews were transcribed and thematically coded to identify participant perspectives and preferences among these strategies. Results: Option A was ranked the most preferred treatment regimen (8 participants, 50%), followed by options C (5 participants, 31%) and B (3 participants, 19%). Participants felt option A provided the most effective treatment for their endocarditis, despite dissatisfaction with the hospitalization length. Options B and C appealed to participants given the convenience of outpatient care; however, inadequate transportation and housing instability were prominently cited as barriers. Conclusions: These diverse patient perspectives should inform trials to evaluate the effectiveness of alternative antibiotic delivery strategies, as well as interventions to improve patient-centered decision-making for DUA-IE treatment.

Background: The Tobacco, Alcohol, Prescription Medication, and Other Substance (TAPS) tool is a screening and brief assessment instrument to identify unhealthy tobacco, alcohol, drug use, and prescription medication use in primary care patients. This secondary analysis compares the TAPS tool to the Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) for alcohol screening. Methods: Adult primary care patients (1124 female, 874 male) completed the TAPS tool followed by AUDIT-C. Performance of each instrument was evaluated against a reference standard measure, the modified World Mental Health Composite International Diagnostic Interview, to identify problem use and alcohol use disorder (AUD). Area under the curve (AUC) appraised discrimination, and sensitivity and specificity were calculated for Youden optimal score thresholds. Results: For identifying problem use: On the AUDIT-C, AUC was 0.90 (95% Confidence Interval: 0.86-0.92) for females and 0.91 (0.89-0.93) for males. Sensitivity and specificity for females were 0.89 (0.83-0.93) and 0.78 (0.75-0.80), respectively, and for males were 0.84 (0.79-0.88) and 0.82 (0.79-0.85). On the TAPS tool, AUC was 0.82 (0.79-0.86) for females and 0.81 (0.78-0.84) for males. Sensitivity and specificity for females were 0.78 (0.72-0.84) and 0.78 (0.75-0.81), respectively, and for males were 0.76 (0.71-0.81) and 0.76 (0.72-0.79). For AUD: On the AUDIT-C, AUC was 0.90 (0.88-0.93) for both females and males. Sensitivity and specificity for females were 0.83 (0.74-0.90) and 0.83 (0.80-0.85), respectively, while for males, they were 0.81 (0.74-0.87) and 0.84 (0.81-0.87). On the TAPS tool, AUC was 0.84 (0.80-0.89) for females and 0.82 (0.78-0.86) for males. Sensitivity and specificity for females were 0.73 (0.63-0.81) and 0.85 (0.83-0.88), respectively, while for males, they were 0.75 (0.68-0.81) and 0.84 (0.81-0.86). Conclusion: The AUDIT-C performed somewhat better than the TAPS tool for alcohol screening. However, the TAPS tool had an acceptable level of performance for alcohol screening and may be advantageous in practice settings seeking to identify alcohol and other substance use with a single instrument.

Background: Pharmacists play a key role in combating the opioid-related overdose epidemic in the United States (US), but little is known about their experience and willingness to deliver preventive services for opioid use disorder (OUD). Aims: This study seeks to identify correlates of pharmacists’ concerns about drug use problems (prescription drug misuse/use disorder and illicit drug use/use disorder) as well as their practice experience delivering preventive services for OUD (e.g., asked about opioid use, provided advice, made a referral) and willingness to provide services to patients with drug use problems. Design: An online survey of licensed US pharmacists was conducted. Participants were recruited from Community Pharmacy Enhanced Services Networks (CPESN) and state pharmacist associations (N = 1146). Findings: Overall, 75% of surveyed pharmacists indicated having concerns about opioid use problems, and 62% had concerns about non-opioid drug use problems at their pharmacies. Pharmacists who were White, practiced at a rural location, worked at a chain pharmacy, had not received opioid-related training in the past year, or practiced screening patients for opioid use had elevated odds of perceiving concerns about opioid use problems in their practice settings. Pharmacists who were White, practiced at a rural location, or had not received opioid-related training in the past year had elevated odds of perceiving concerns about non-opioid (illicit) drug use problems. Being male, being White, or having received opioid-related training were associated with increased odds of screening patients for opioid use problems. Being White, having practiced at a rural location (vs. an urban location), being a pharmacy owner/manager, or having received opioid-related training were associated with increased odds of delivering opioid-related advice/intervention. Being male or having received opioid-related training were associated with increased odds of making a referral to OUD treatment. Finally, being male, being White, having practiced pharmacy services for under 6 years, having received opioid-related training for 2 h in the past year, or having performed OUD-related preventive services (asked about opioid use, provided advice, or made a referral) were associated with increased levels of commitment/readiness for providing care to patients with drug use problems. Conclusions: The overall findings highlight pharmacists’ involvement with OUD preventive services. It is critical to promote opioid-related preventive service training for pharmacists and provide incentives/tools to help initiate a structured practice of delivering such preventive services.

Background: The US federal regulations allow pharmacy administration and dispensing of methadone for opioid use disorder (PADMOUD) to increase the capability of opioid treatment programs (OTPs) in providing methadone maintenance treatment (MMT) for opioid use disorder (OUD) as part of a medication unit. However, there is a lack of research data from both pharmacy and OTP staff to inform the implementation of PADMOUD. Methods: Staff of a pharmacy (n = 8) and an OTP (n = 9) that participated in the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were recruited to participate in this qualitative interview study to explore implementation-related factors for PADMOUD. Each interview was recorded and transcribed verbatim. NVivo was used to help identify themes of qualitative interview data. The Promoting Action on Research Implementation in Health Services (PARIHS) framework was used to guide the coding and interpretation of data. Results: Six pharmacy staff and eight OTP staff (n = 14) completed the interview. Results based on PARIHS domains were summarized, including evidence, context, and facilitation domains. Participants perceived benefits of PADMOUD for patients, pharmacies, OTPs, and payers. PADMOUD was considered to increase access for stable patients, provide additional patient service opportunities and revenues for pharmacies/pharmacists, enhance the capability of OTPs to treat more new patients, and reduce patients’ cost when receiving medication at a pharmacy relative to an OTP. Both pharmacy and OTP staff were perceived to be supportive of the implementation of PADMOUD. Pharmacy staff/pharmacists were perceived to need proper training on addiction and methadone as well as a protocol of PADMOUD to conduct PADMOUD. Facilitators include having thought leaders to guide the operation, a certification program to ensure proper training of pharmacy staff/pharmacist, having updated pharmacy service software or technology to streamline the workflow of delivering PADMOUD and inventory management, and reimbursement for pharmacists. Conclusion: This study presents the first findings on perspectives of PADMOUD from both staff of a community pharmacy and an OTP in the US. Finding on barriers and facilitators are useful data to guide the development of strategies to implement PADMOUD to help address the US opioid crisis.

Background: Pharmacy administration and dispensing of methadone treatment for opioid use disorder (PADMOUD) may address inadequate capability of opioid treatment programs (OTPs) in the US by expanding access to methadone at community pharmacies nationally. PADMOUD is vastly underutilized in the US. There is no published US study on OUD patients’ perspectives on PADMOUD. Data are timely and needed to inform the implementation of PADMOUD in the US to address its serious opioid overdose crisis. Methods: Patient participants of the first completed US trial on PADMOUD through electronic prescribing for methadone (parent study) were interviewed to explore implementation-related factors for PADMOUD. All 20 participants of the parent study were invited to participate in this interview study. Each interview was recorded and transcribed verbatim. Thematic analysis was conducted to identify emergent themes. Results: Seventeen participants completed the interview. Patients’ perspectives on PADMOUD were grouped into five areas. Participants reported feasibility of taking the tablet formulation of methadone at the pharmacy and identified benefits from PADMOUD (e.g., better access, efficiency, convenience) compared with usual care at the OTP. Participants perceived support for PADMOUD from their family/friends, OTP staff, and pharmacy staff. PADMOUD was perceived to be a great option for stable patients with take-home doses and those with transportation barriers. The distance (convenience), office hours, and the cost were considered factors most influencing their decision to receive methadone from a pharmacy. Nonjudgmental communication, pharmacists’ training on methadone treatment, selection of patients (stable status), workflow of PADMOUD, and protection of privacy were considered key factors for improving operations of PADMOUD. Conclusion: This study presents the first findings on patient perspectives on PADMOUD. Participants considered pharmacies more accessible than OTPs, which could encourage more people to receive methadone treatment earlier and help transition stable patients from an OTP into a local pharmacy. The findings have timely implications for informing implementation strategies of PADMOUD that consider patients’ views and needs.

Objectives: Minimal research has assessed COVID-19’s unique impact on the Native Hawaiian/Pacific Islander (NH/PI) population—an Indigenous-colonized racial group with social and health disparities that increase their risk for COVID-19 morbidity and mortality. To address this gap, we explored the scope of COVID-19 outcomes, vaccination status, and health in diverse NH/PI communities. Methods: NH/PI staff at partner organizations collected survey data from April through November 2021 from 319 community-dwelling NH/PI adults in 5 states with large NH/PI populations: Arkansas, California, Oregon, Utah, and Washington. Data were analyzed with descriptive statistics, Pearson χ² tests, independent and paired t tests, and linear and logistic regression analyses. Results: During the COVID-19 pandemic, 30% of survey participants had contracted COVID-19, 16% had a close family member who died of the disease, and 64% reported COVID-19 vaccine uptake. Thirty percent reported fair/poor health, 21% currently smoked cigarettes, and 58% reported obesity. Survey participants reported heightened COVID-19–related psychosocial distress (mean score = 4.9 on 10-point scale), which was more likely when health outcomes (general health, sleep, obesity) were poor or a family member had died of COVID-19. Logistic regression indicated that age, experiencing COVID-19 distress, and past-year use of influenza vaccines were associated with higher odds of COVID-19 vaccine uptake (1.06, 1.18, and 7.58 times, respectively). Conclusions: Our empirical findings highlight the acute and understudied negative impact of COVID-19 on NH/PI communities in the United States and suggest new avenues for improving NH/PI community health, vaccination, and recovery from COVID-19.

Background: Mifepristone (RU-486) has been approved for abortion in Taiwan since 2000. Mifepristone was the first non-addictive medicine to be classified as a schedule IV controlled drug. As a case of the “misuse” of “misuse of drugs laws,” the policy and consequences of mifepristone-assisted abortion for pregnant women could be compared with those of illicit drug use for drug addicts. Methods: The rule-making process of mifepristone regulation was analyzed from various aspects of legitimacy, social stigma, women’s human rights, and access to health care. Results and Discussion: The restriction policy on mifepristone regulation in Taiwan has raised concerns over the legitimacy of listing a non-addictive substance as a controlled drug, which may produce stigma and negatively affect women’s reproductive and privacy rights. Such a restriction policy and social stigma may lead to the unwillingness of pregnant women to utilize safe abortion services. Under the threat of the COVID-19 pandemic, the US FDA’s action on mifepristone prescription and dispensing reminds us it is time to consider a change of policy. Conclusions: Listing mifepristone as a controlled drug could impede the acceptability and accessibility of safe mifepristone use and violates women’s right to health care.

Background and Aim: There is no gold‐standard and considerable heterogeneity in outcome measures used to evaluate treatments for opioid use disorder (OUD) along the opioid treatment cascade. The aim of this study was to develop the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network (CTN) opioid use disorder core outcomes set (OUD–COS).Design: Four‐round, e‐Delphi expert panel consensus study and plenary research group discussion and targeted consultation.Setting: United States.Participants: A panel of 25 members including clinical practitioners, clinical researchers and administrative staff from the CTN, the network's affiliated clinical and community sites and the NIDA Centre for the CTN.Measurements: From a pool of 24 candidate items in four domains (biomedical/disease status; behaviors, symptoms and functioning; opioid treatment cascade; and morbidity and mortality), the panel completed an on‐line questionnaire to rank items with defined specification on a 9‐point scale for importance, with a standard 70% consensus criterion.Findings: After the fourth round of the questionnaire and subsequent discussion, consensus was reached for five outcomes: two patient‐reported (global impression of improvement and incident non‐fatal overdose); one clinician‐reported (illicit/non‐medical drug toxicology); and two from administrative records (duration of treatment and fatal opioid poisoning).Conclusions: An e‐Delphi consensus study has produced the US National Institute on Drug Abuse (NIDA) National Drug Abuse Treatment Clinical Trials Network opioid use disorder core outcomes set (version 1) for opioid use disorder treatment efficacy and effectiveness research.