Implementing a pharmacist-integrated collaborative model of medication treatment for opioid use disorder in primary care: study design and methodological considerations.

BACKGROUND: Pharmacists remain an underutilized resource in the treatment of opioid use disorder (OUD). Although studies have engaged pharmacists in dispensing medications for OUD (MOUD), few studies have evaluated collaborative care models in which pharmacists are an active, integrated part of a primary care team offering OUD care. METHODS: This study seeks to implement a pharmacist integrated MOUD clinical model (called PrIMO) and evaluate its feasibility, acceptability, and impact across four diverse primary care sites. The Consolidated Framework for Implementation Research is used as an organizing framework for study development and interpretation of findings. Implementation Facilitation is used to support PrIMO adoption. We assess the primary outcome, the feasibility of implementing PrIMO, using the Stages of Implementation Completion (SIC). We evaluate the acceptability and impact of the PrIMO model at the sites using mixed-methods and combine survey and interview data from providers, pharmacists, pharmacy technicians, administrators, and patients receiving MOUD at the primary care sites with patient electronic health record data. We hypothesize that it is feasible to launch delivery of the PrIMO model (reach SIC Stage 6), and that it is acceptable, will positively impact patient outcomes 1 year post model launch (e.g., increased MOUD treatment retention, medication regimen adherence, service utilization for co-morbid conditions, and decreased substance use), and will increase each site's capacity to care for patients with MOUD (e.g., increased number of patients, number of prescribers, and rate of patients per prescriber). DISCUSSION: This study will provide data on a pharmacist-integrated collaborative model of care for the treatment of OUD that may be feasible, acceptable to both site staff and patients and may favorably impact patients' access to MOUD and treatment outcomes. TRIAL REGISTRATION: The study was registered on Clinicaltrials.gov (NCT05310786) on April 5, 2022, https://www. CLINICALTRIALS: gov/study/NCT05310786?id=NCT05310786&rank=1.

Engaging community pharmacies in practice-based research: Lessons from opioid-focused research.

There is an established need to translate evidence-based practices into real-world practice. Community pharmacists and their corresponding pharmacies are well-positioned to be effective partners as researchers seek to study and implement practice-based research. Challenges exist when partnering with community pharmacies which can vary based on the study type, the nature of the community pharmacy, and stakeholder groups (i.e., patients, staff, leadership, physicians). This commentary seeks to describe these challenges and provide recommendations that can help mitigate and/or overcome these challenges. Recommendations are provided for team structure, communication, research tools/technology, motivational factors, workflow, and sustainability. These recommendations are based on the authors' experience in partnering with community pharmacy for opioid-related research in a variety of study types, states, and pharmacy environments.

Patient navigation for pregnant individuals with opioid use disorder: Results of a randomized multi-site pilot trial.

BACKGROUND AND AIMS: Patient navigation (PN) may benefit pregnant individuals with opioid use disorder (OUD) by improving treatment adherence. We examined participant enrollment, session delivery and assessment feasibility for a PN intervention among pregnant participants and compared PN preliminary effectiveness for OUD treatment engagement with participants in usual care (UC). DESIGN: This study was a pilot single-blinded multi-site randomized trial. SETTING: Two academic medical centers in Pennsylvania (n = 57) and Utah (n = 45), United States participated. PARTICIPANTS: One hundred and two pregnant adult participants unestablished (fewer than 6 weeks) on medication for OUD (MOUD) were randomized to PN (n = 53) or UC (n = 49). INTERVENTION: PN was composed of 10 prenatal sessions (delivered after baseline but before the prenatal assessments) and four postnatal sessions (delivered before the 2- and 6-month postpartum assessments) focused upon OUD treatment and physical/mental health needs. UC involved brief case management. MEASUREMENTS: Feasibility assessments included consent, session delivery and assessment rates. Mixed-effect models for intent-to-treat (ITT) and per protocol (PP, received six or more sessions) populations were estimated to compare outcomes of MOUD use, secondary outcomes of substance use disorder (SUD) treatment attendance and non-prescribed opioid use, and exploratory outcome of overdose at baseline, predelivery and 2 and 6 months postpartum. FINDINGS: We consented 87% (106 of 122) of the proposed target, delivered ~60% of sessions delivered and completed ≥ 75% assessments. PN ITT and PP had better MOUD adherence, SUD treatment attendance, non-prescribed opioid use and overdose outcomes than UC. Notable changes included good evidence for greater percentage change in days for PN PP MOUD use from baseline to 2 months postpartum [PN = 28.0 versus UC = -10.9, 95% confidence interval (CI) = 9.7, 62.1] and some evidence for baseline to 6 months postpartum (PN = 45.4 versus UC = 23.4, 95% CI = -0.7, 48.2). PN PP percentage change in days for SUD treatment attendance also showed good evidence for improvements from baseline to prenatal assessment (PN = 7.4 versus UC = -21.3, 95% CI = 3.3, 53.5). PN compared to UC participants reported fewer overdoses at 2 months (PN = 11.9%/UC = 16.1%) and at 6 months postpartum (PN = 3.8%/UC = 6.2%). CONCLUSIONS: Patient navigation appears to be associated with improvements in opioid use disorder treatment engagement and overdoses during pregnancy. This pilot trial shows the feasibility of the intervention and a future large-scale trial.

Research Priorities for Expansion of Opioid Use Disorder Treatment in the Community Pharmacy.

In the last decade, the U.S. opioid overdose crisis has magnified, particularly since the introduction of synthetic opioids, including fentanyl. Despite the benefits of medications for opioid use disorder (MOUD), only about a fifth of people with opioid use disorder (OUD) in the U.S. receive MOUD. The ubiquity of pharmacists, along with their extensive education and training, represents great potential for expansion of MOUD services, particularly in community pharmacies. The National Institute on Drug Abuse's National Drug Abuse Treatment Clinical Trials Network (NIDA CTN) convened a working group to develop a research agenda to expand OUD treatment in the community pharmacy sector to support improved access to MOUD and patient outcomes. Identified settings for research include independent and chain pharmacies and co-located pharmacies within primary care settings. Specific topics for research included adaptation of pharmacy infrastructure for clinical service provision, strategies for interprofessional collaboration including health service models, drug policy and regulation, pharmacist education about OUD and OUD treatment, including didactic, experiential, and interprofessional curricula, and educational interventions to reduce stigma towards this patient population. Together, expanding these research areas can bring effective MOUD to where it is most needed.

Patient reported goals for medications for opioid use disorder: A theory of proximal goal attainment.

Background: There exist substantial patient barriers to accessing medications for opioid use disorder (MOUD), including travel distance, stigma, and availability of MOUD providers. Yet, despite these barriers, there exists a subset of patients who possess the requisite motivation to seek and remain adherent to treatment. Objective: To explore patient-derived goals in MOUD treatment-adherent patients. Methods: This study used in-depth interviews with patients receiving methadone who were enrolled in opioid treatment programs (OTPs) across Tennessee. Participants were recruited from 12 different OTPs to participate in telephonic semi-structured interviews to a point of saturation. Participants had to be adherent to treatment, in treatment for 6 months or greater, and English speaking. Analysis occurred inductively using a constructivist approach to Grounded Theory. Results: In total, 17 patient interviews were conducted in the spring of 2021. Participants described goal setting across three general stages of treatment: (1) addressing acute physical and emotional needs upon treatment entry, (2) development of supportive structure and routine to develop healthy skills facilitated by treatment team, and (3) identifying and pursuing future-focused goals not directly linked to treatment. A Proximal Goals in MOUD Framework is introduced. Conclusion: In this qualitative study on patient reported goals in MOUD it was found that goals are transitory and relative to the stage of treatment. Further research is needed to better understand goal evolution over the course of treatment and its impact on treatment retention.

Co-use of Opioid Medications and Alcohol Prevention Study (COAPS).

While there is limited research in the field regarding the various dimensions of co-use of alcohol and opioid medication, particularly related to co-use and levels of severity, our research has shown 20% to 30% of community pharmacy patients receiving opioid pain medications are engaged in co-use. Co-use of alcohol and opioid medications is a significant risk factor for opioid-related overdose. Community pharmacy is a valuable yet underutilized resource and setting for addressing the US opioid epidemic, with an untapped potential for identification of and intervention for risks associated with co-use of alcohol and opioids. This commentary describing the "Co-use of Opioid Medications and Alcohol Prevention Study (COAPS)" offers an innovative and promising approach to mitigating serious risks associated with co-use of alcohol (risk and non-risk use) and opioids in community pharmacy. COAPS aim 1involves adapting an existing opioid misuse intervention to target co-use of alcohol and opioid mediations. COAPS aim 2 involves testing the adapted intervention within a small-scale pilot randomized controlled trial (N = 40) to examine feasibility, acceptability and preliminary efficacy of the intervention versus standard care. COAPS aim 3 involves conducting key informant interviews related to future implementation of larger scale studies or service delivery in community pharmacy settings.

Medications for opioid use disorder in rural primary care practices: Patient and provider experiences.

INTRODUCTION: The opioid epidemic has exacted a significant toll in rural areas, yet adoption of medications for opioid use disorder (MOUD) lags. The Rural Access to Medication Assisted Treatment in Pennsylvania (RAMP) Project facilitated adoption of MOUD in rural primary care clinics. The purpose of this study was to gain a better understanding of the barriers and facilitators operating at multiple levels to access or provide MOUD in rural Pennsylvania. METHODS: In total, the study conducted 35 semi-structured interviews with MOUD patients and MOUD providers participating in RAMP. Qualitative analysis incorporated both deductive and inductive approaches. The study team coded interviews and performed thematic analysis. Using a modified social-ecological framework, themes from the qualitative interviews are organized in five nested levels: individual, interpersonal, health care setting, community, and public policy. RESULTS: Patients and providers agreed on many barriers (e.g., lack of providers, lack of transportation, insufficient rapport and trust in patient-provider relationship, and cost, etc.); however, their interpretation of the barrier, or indicated solution, diverged in meaningful ways. Patients described their experiences in broad terms pointing to the social determinants of health, as they highlighted their lives outside of the therapeutic encounter in the clinic. Providers focused on their professional roles, responsibilities, and operations within the primary care setting. CONCLUSIONS: Providers may want to discuss barriers to treatment related to social determinants of health with patients, and pursue partnerships with organizations that seek to address those barriers. The findings from these interviews point to potential opportunities to enhance patient experience, increase access to and optimize processes for MOUD in rural areas, and reduce stigma against people with opioid use disorder (OUD) in the wider community.

Patients' Perceptions of Physical Therapists Addressing Opioid Misuse.

INTRODUCTION: In the US, rising numbers of patients who misuse illicit or prescribed opioids provides opportunities for physical therapists (PTs) to be engaged in their care. Prior to this engagement, it is necessary to understand the perceptions of patients who access physical therapy services about their PTs playing such a role. This project examined patients' perceptions of PTs addressing opioid misuse. METHODS: We surveyed patients, newly encountering outpatient physical therapy services in a large University-based healthcare setting, via anonymous, web-based survey. Within the survey, questions were rated on a Likert scale (1 = completely disagree to 7 = completely agree) and we evaluated responses of patients who were prescribed opioids versus those who were not. RESULTS: Among 839 respondents, the highest mean score was 6.2 (SD = 1.5) for "It is OK for physical therapists to refer their patients with prescription opioid misuse to a specialist to address the opioid misuse." The lowest mean score was 5.6 (SD = 1.9) for "It is OK for physical therapists to ask their patient why they are misusing prescription opioids." Compared to those with no prescription opioid exposure while attending physical therapy, patients with prescription opioid exposure had lower agreement that it was OK for the physical therapist to refer their patients with opioid misuse to a specialist (ß = -.33, 95% CI = -0.63 to -0.03). CONCLUSIONS: Patients attending outpatient physical therapy seem to support PTs addressing opioid misuse and there are differences in support based on whether the patients had exposure to opioids.

Prospective acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder: A multisite qualitative study.

Background: While medications for opioid use disorder (MOUD) effectively treat OUD during pregnancy and the postpartum period, poor treatment retention is common. Digital phenotyping, or passive sensing data captured from personal mobile devices, namely smartphones, provides an opportunity to understand behaviors, psychological states, and social influences contributing to perinatal MOUD non-retention. Given this novel area of investigation, we conducted a qualitative study to determine the acceptability of digital phenotyping among pregnant and parenting people with opioid use disorder (PPP-OUD). Methods: This study was guided by the Theoretical Framework of Acceptability (TFA). Within a clinical trial testing a behavioral health intervention for PPP-OUD, we used purposeful criterion sampling to recruit 11 participants who delivered a child in the past 12 months and received OUD treatment during pregnancy or the postpartum period. Data were collected through phone interviews using a structured interview guide based on four TFA constructs (affective attitude, burden, ethicality, self-efficacy). We used framework analysis to code, chart, and identify key patterns within the data. Results: Participants generally expressed positive attitudes about digital phenotyping and high self-efficacy and low anticipated burden to participate in studies that collect smartphone-based passive sensing data. Nonetheless, concerns were noted related to data privacy/security and sharing location information. Differences in participant assessments of burden were related to length of time required and level of remuneration to participate in a study. Interviewees voiced broad support for participating in a digital phenotyping study with known/trusted individuals but expressed concerns about third-party data sharing and government monitoring. Conclusion: Digital phenotyping methods were acceptable to PPP-OUD. Enhancements in acceptability include allowing participants to maintain control over which data are shared, limiting frequency of research contacts, aligning compensation with participant burden, and outlining data privacy/security protections on study materials.

Mapping prescription drug monitoring program data to self-report measures of non-medical prescription opioid use in community pharmacy settings.

BACKGROUND: Community pharmacists are well-positioned to identify patients engaged in non-medical prescription opioid use (NMPOU) through Prescription Drug Monitoring Program (PDMP) databases. Integrating patient-reported outcomes with PDMP data may improve the interpretability of PDMP information to support clinical decision-making. OBJECTIVE: This study linked patient-reported clinical measures of substance use with PDMP data to examine relationships between average daily opioid dose in morphine milligram equivalents (MME) and visits to multiple pharmacies/prescribers with self-reported NMPOU. METHODS: Data from a cross-sectional health assessment given to patients aged ≥18 years filling opioid prescriptions were linked to PDMP records. NMPOU in the past three months was assessed on a continuous scale (range 0-39) using an adapted version of the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST). PDMP measures included average daily MME and number of distinct pharmacies/prescribers visited in the past 180 days. Univariable and multivariable zero-inflated negative binomial models estimated associations between PDMP measures and any NMPOU and severity of use. RESULTS: The sample included 1421 participants. In multivariable models adjusted for sociodemographic, mental health, and physical health characteristics, any NMPOU was associated with higher average daily MME (adjusted OR = 1.22, 95% CI = 1.05-1.39) and number of distinct prescribers visited (adjusted OR = 1.15, 95% CI = 1.01-1.30). Higher average daily MME (adjusted mean ratio (MR) = 1.12, 95% CI = 1.08-1.15), number of distinct pharmacies visited (adjusted MR = 1.11, 95% CI = 1.04-1.18), and number of distinct prescribers visited (adjusted MR = 1.07, 95% CI = 1.02-1.11) were associated with increased NMPOU severity. CONCLUSIONS: We observed significant, positive associations between average daily MME and visits to multiple pharmacies/prescribers with any NMPOU and severity of use. This study demonstrates self-report clinical measures of substance use can be cross-walked to PDMP data and translated into clinically interpretable information.

Strategies to recruit rural primary care providers to implement a medication for opioid use disorder (MOUD) focused integrated care model.

Background: Access to providers and programs that provide medications for opioid use disorder (MOUD) remains a systemic barrier for patients with opioid use disorder (OUD), particularly if they live in rural areas. The Rural Access to Medication Assisted Treatment (MAT) in Pennsylvania Project (Project RAMP) addressed this problem with a multisystem partnership that recruited, trained, and supported rural primary care providers to provide MOUD and implement an integrated care model (ICM) for patients with OUD. Given the demonstrated efficacy of Project RAMP, this article summarizes our recruitment strategies, including feasibility concerns for further expansion into other regions. Methods: The approach for recruiting implementation sites included two phases: partner outreach and site identification. Once recruited, the Systems Transformation Framework guided planning and implementation activities. Recruitment and implementation activities were assessed with implementation trackers and evaluated by providers via key informant interviews (KIIs). Results: Project RAMP recruited 26 primary care practices from 13 counties, including nine health systems and two private practice groups-exceeding the original target of 24 sites. There was a median of 49 days from first contact to project onboarding. A total of 108 primary care practices spanning 22 health systems declined participation. Findings from the KIIs highlighted the value of engaging PCPs by connecting to a shared vision (i.e., improving the quality of patient care) as well as addressing perceived participation barriers (e.g., offering concierge technical assistance to address lack of training or resources). Conclusion: Findings highlight how successful recruitment activities should leverage the support of health system leadership. Findings also emphasize that aiding recruitment and engagement efforts successfully addressed prescribers' perceived barriers to providing MOUD as well as facilitating better communication among administrators, PCPs, behavioral health professionals, care managers, and patients.Plain Language Summary: Opioid use disorder (OUD) is one of the leading causes of preventable illness and death. The standard of care for OUD is the provision of medications for opioid use disorder (MOUD) and the application of an integrative integrated care model (ICM) where behavioral health is blended with specialized medical services. Unfortunately, access to providers and healthcare facilities that provide MOUD or apply an ICM remains a systemic barrier for patients with OUD, particularly if they live in rural areas. Although there is no one-size-fits-all approach to implementing MOUD in primary care, findings from Project The Rural Access to Medication Assisted Treatment (MAT) in Pennsylvania Project (Project RAMP) highlight strategies that may improve future MOUD and ICM implementation efforts in similar rural contexts. Specifically, future efforts to increase MOUD capacity by recruiting new providers should be prepared to leverage health system leadership, address provider barriers via training and expert consultation, and facilitate connections to local behavioral health providers. This approach may be helpful to others recruiting health systems and primary care practices to implement new care models to use MOUD in treating patients with OUD.

Nonfatal Overdoses Among Pregnant Individuals With Opioid Use Disorder.

Little is understood about overdose history among pregnant individuals with opioid use disorder (OUD). We performed a cross-sectional secondary analysis of data from the OPTI-Mom 2.0 (Optimizing Pregnancy and Treatment Interventions for Moms 2.0) study (NCT03833245), a multi-site randomized controlled trial of patient navigation and usual care. We summarized participant demographics, overdose history, and substances involved in most recent overdose. Of the 102 participants with severe OUD included, 64.7% (95% CI 54.8-73.4%) had a reported a history of an overdose event and 41.2% (95% CI 31-52%) reported at least one overdose within the past year. In the most recent overdose, 81.8% (95% CI 70.4-89.5%) reported using opioids and 30.3% (95% CI 20.3-42.6%) reported using sedatives. These findings suggest need for heightened awareness of overdose-reduction and harm-reduction strategies in this population.

Community-Centered Patient Journey Map in Opioid Use Disorder: A Tool to Address Compassion Fatigue among Community Pharmacists.

Community pharmacists have become increasingly exposed to opioid use disorders in recent decades. However, both pharmacist training and traditional practice environments have not been adequate to prepare the pharmacist for both the patient care needs and regulatory barriers of patients experiencing opioid use disorders (OUD). As a result, there is a need to increase pharmacists' awareness of both the overall patient experience as they navigate their OUD and the role of the community pharmacy as a touchpoint within that experience. To this end, a Community-Centered Patient Journey in Drug Addiction Treatment journey map was developed with expert insights, clinical experience, and in-depth interviews (conducted in spring of 2021) with 16 participants enrolled in licensed opioid treatment programs in Tennessee. Patients, policymakers, clinicians, and academic researchers were involved in the map development. Lived experiences of key informants were captured via in-depth interviews. A consensus decision-making approach was used throughout the patient journey map development process. The final patient journey map illustrates a non-linear pathway, describes the central role of the patient's community, and emphasizes three major "pain points" within the system (access, adherence, and affordability). Future research should investigate the impact of such a journey map on pharmacy personnel's knowledge, attitudes, and behaviors.

Cluster analysis to identify patient profiles and substance use patterns among pregnant persons with opioid use disorder.

The study objective was to identify distinct profiles of pregnant persons with opioid use disorder (PP-OUD) using cluster analysis and examine difference in substance use patterns between profiles. We examined data from 104 PP-OUD ≤ 32 weeks of gestation who were recruited into a behavioral health clinical trial at two academic medical centers. We used Partitioning Around Medoids analysis to identify clusters and explored patterns of substance use and substance use treatment between clusters using bivariate statistical tests and regression methods. We identified two distinct clusters of participants, including 'Group A' (n = 68; 65.4 %) and 'Group B' (n = 36; 34.6 %). Group A had fewer members who were not employed (38 % vs 58 %) and incarcerated (3 % vs 8 %) compared to Group B. Group A compared with Group B included more members with: a history of overdose (72 % vs 50 %); anxiety (85 % vs 25 %); ≥moderate pain (76 % vs 22 %); ≥moderate depression (75 % vs 36 %); ≥moderate drug use severity (94 % vs 78 %); and, more days of cannabis (mean: 6.2 vs 2.3 days), stimulant (mean: 4.5 vs 1.3 days), and injection heroin (mean: 1.3 vs 0 days) use in the past 30 days (P < 0.05 for all comparisons). Clusters of PP-OUD differed with respect to sociodemographic characteristics, mental health conditions, and substance use patterns. More research is needed to confirm identified profiles and assess treatment outcomes associated with cluster membership.

Effect of Different Interventions to Help Primary Care Clinicians Avoid Unsafe Opioid Prescribing in Opioid-Naive Patients With Acute Noncancer Pain: A Cluster Randomized Clinical Trial.

Importance: Prescription opioids can treat acute pain in primary care but have potential for unsafe use and progression to prolonged opioid prescribing. Objective: To compare clinician-facing interventions to prevent unsafe opioid prescribing in opioid-naive primary care patients with acute noncancer pain. Design Setting and Participants: We conducted a multisite, cluster-randomized, 2 × 2 factorial, clinical trial in 3 health care systems that comprised 48 primary care practices and 525 participating clinicians from September 2018 through January 2021. Patient participants were opioid-naive outpatients, 18 years or older, who presented for a qualifying clinic visit with acute noncancer musculoskeletal pain or nonmigraine headache. Interventions: Practices randomized to: (1) control; (2) opioid justification; (3) monthly clinician comparison emails; or (4) opioid justification and clinician comparison. All groups received opioid prescribing guidelines via the electronic health record at the time of a new opioid prescription. Main Outcomes and Measures: Primary outcome measures were receipt of an initial opioid prescription at the qualifying clinic visit. Other outcomes were opioid prescribing for more than 3 months and a concurrent opioid/benzodiazepine prescription over 12-month follow-up. Results: Among 22 616 enrolled patient participants (9740 women [43.1%]; 64 American Indian/Alaska Native [0.3%]; 590 Asian [2.6%], 1120 Black/African American [5.0%], 1777 Hispanic [7.9%], 225 Native Hawaiian/Pacific Islander [1.0%], and 18 981 White [83.9%] individuals), the initial opioid prescribing rates at the qualifying clinic visit were 3.1% in the total sample, 4.2% in control, 3.6% in opioid justification, 2.6% in clinician comparison, and 1.9% in opioid justification and clinician comparison. Compared with control, the adjusted odds ratio (aOR) for a new opioid prescription was 0.74 (95% CI, 0.46-1.18; P = .20) for opioid justification and 0.60 (95% CI, 0.38-0.96; P = .03) for clinician comparison. Compared with control, clinician comparison was associated with decreased odds of opioid therapy of more than 3 months (aOR, 0.79; 95% CI, 0.69-0.91; P = .001) and concurrent opioid/benzodiazepine prescription (aOR, 0.85; 95% CI, 0.72-1.00; P = .04), whereas opioid justification did not have a significant effect. Conclusions and Relevance: In this cluster randomized clinical trial, comparison emails decreased the proportion of opioid-naive patients with acute noncancer pain who received an opioid prescription, progressed to treatment with long-term opioid therapy, or were exposed to concurrent opioid and benzodiazepine therapy. Health care systems can consider adding clinician-targeted nudges to other initiatives as an efficient, scalable approach to further decrease potentially unsafe opioid prescribing. Trial Registration: ClinicalTrials.gov Identifier: NCT03537573.

Umbilical Cord Collection and Drug Testing to Estimate Prenatal Substance Exposure in Utah.

OBJECTIVE: Our primary objective was to estimate statewide prenatal substance exposure based on umbilical cord sampling. Our secondary objectives were to compare prevalence of prenatal substance exposure across urban, rural, and frontier regions, and to compare contemporary findings to those previously reported. METHODS: We performed a cross-sectional prevalence study of prenatal substance exposure, as determined by umbilical cord positivity for 49 drugs and drug metabolites, through the use of qualitative liquid chromatography-tandem mass spectrometry. All labor and delivery units in Utah (N=45) were invited to participate. Based on a 2010 study using similar methodology, we calculated that a sample size of at least 1,600 cords would have 90% power to detect 33% higher rate of umbilical cords testing positive for any substance. Deidentified umbilical cords were collected from consecutive deliveries at participating hospitals. Prevalence of prenatal substance exposure was estimated statewide and by rurality using weighted analysis. RESULTS: From November 2020 to November 2021, 1,748 cords (urban n=988, rural n=384, frontier n=376) were collected from 37 hospitals, representing 92% of hospitals that conduct 91% of births in the state. More than 99% of cords (n=1,739) yielded results. Statewide, 9.9% (95% CI 8.1-11.7%) were positive for at least one substance, most commonly opioids (7.0%, 95% CI 5.5-8.5%), followed by cannabinoid (11-nor-9-carboxy-delta-9-tetrahydrocannabinol [THC-COOH]) (2.5%, 95% CI 1.6-3.4%), amphetamines (0.9%, 95% CI 0.4-1.5), benzodiazepines (0.5%, 95% CI 0.1-0.9%), alcohol (0.4%, 95% CI 0.1-0.7%), and cocaine (0.1%, 95% CI 0-0.3%). Cord positivity was similar by rurality (urban=10.3%, 95% CI 8.3-12.3%, rural=7.1%, 95% CI 3.5-10.7%, frontier=9.2%, 95% CI 6.2-12.2%, P=.31) and did not differ by substance type. Compared with a previous study, prenatal exposure to any substance (6.8 vs 9.9%, P=.01), opioids (4.7 vs 7.0% vs 4.7%, P=.03), amphetamines (0.1 vs 0.9%, P=.01) and THC-COOH (0.5 vs 2.5%, P<.001) increased. CONCLUSION: Prenatal substance exposure was detected in nearly 1 in 10 births statewide.

Associations between elevated depressive symptoms and substance use, prescription opioid misuse, overdose history, pain, and general health among community pharmacy patients prescribed opioids.

Background: Individuals with pain prescribed opioids experience high rates of comorbid depression. The aim of this study was to characterize pain, substance use, and health status as a function of depressive symptom level in individuals filling an opioid prescription at a community pharmacy. Methods: Participants (N = 1268) filling an opioid prescription enrolled in a study validating a prescription drug monitoring metric completed an online survey assessing sociodemographics, depressive symptoms, substance use, prescription opioid misuse, overdose history, general health, and pain severity and interference. Results: Approximately one-fifth (19.3%) had a positive depression screen result. In covariate-adjusted logistic regression analyses, individuals with a positive depression screen result were more likely to have moderate/high substance use risk scores for prescription opioids (adjusted odds ratio [AOR] = 2.06; 95% confidence interval [CI], 1.51-2.79); street opioids (AOR = 7.18; 95% CI, 2.57-20.01); cannabis (AOR = 2.00; 95% CI, 1.34-3.00); cocaine (AOR = 3.46; 95% CI, 1.46-8.22); tobacco (AOR = 1.59; 95% CI, 1.18-2.15); methamphetamine (AOR = 7.59; 95% CI, 2.58-22.35); prescription stimulants (AOR = 2.95; 95% CI, 1.59-5.49); and sedatives (AOR = 3.41; 95% CI, 2.43-4.79). Individuals with a positive depression screen were more likely to misuse prescription opioids (AOR = 3.46; 95% CI, 2.33-5.15), experience a prior overdose (AOR = 2.69; 95% CI, 1.76-4.11), report poorer general health (AOR = 0.25, 95% CI, 0.18-0.35), and report moderate/severe pain severity (AOR = 4.36, 95% CI, 2.80-6.77) and interference (AOR = 6.47, 95% CI, 4.08-10.26). Conclusions: Individuals prescribed opioids with heightened depression were more likely to report other substance use, prescription opioid misuse, prior overdose, greater pain, and poorer health.