Prescribed and Penalized: The Detrimental Impact of Mandated Reporting for Prenatal Utilization of Medication for Opioid Use Disorder.

OBJECTIVES: Some states, including Massachusetts, require automatic filing of child abuse and neglect for substance-exposed newborns, including infants exposed in-utero to clinician-prescribed medications to treat opioid use disorder (MOUD). The aim of this article is to explore effects of these mandated reporting policies on pregnant and postpartum people receiving MOUD. METHODS: We used modified grounded research theory, literature findings, and constant comparative methods to extract, analyze and contextualize perinatal experiences with child protection systems (CPS) and explore the impact of the Massachusetts mandated reporting policy on healthcare experiences and OUD treatment decisions. We drew from 26 semi-structured interviews originally conducted within a parent study of perinatal MOUD use in pregnancy and the postpartum period. RESULTS: Three themes unique to CPS reporting policies and involvement emerged. First, mothers who received MOUD during pregnancy identified mandated reporting for prenatally prescribed medication utilization as unjust and stigmatizing. Second, the stress caused by an impending CPS filing at delivery and the realities of CPS surveillance and involvement after filing were both perceived as harmful to family health and wellbeing. Finally, pregnant and postpartum individuals with OUD felt pressure to make medical decisions in a complex environment in which medical recommendations and the requirements of CPS agencies often compete. CONCLUSIONS FOR PRACTICE: Uncoupling of OUD treatment decisions in the perinatal period from mandated CPS reporting at time of delivery is essential. The primary focus for families affected by OUD must shift from surveillance and stigma to evidence-based treatment and access to supportive services and resources.

What is already known on this subject? Child protection systems (CPS) reporting is associated with barriers to prenatal care and family resources and services. Some state policies in the United States mandate reporting to CPS for prenatal substance exposure, including prescribed medications for opioid use disorder.What this study adds? This study centers the experiences of pregnant and postpartum people with opioid use disorder with mandated reporting policies for prenatal substance exposure, describes the harms to families associated with these policies, and makes recommendations for policy change. Findings emphasize the need to uncouple medical decisions from CPS reporting and involvement.

Fentanyl in the labor epidural impacts the results of intrapartum and postpartum maternal and neonatal toxicology tests.

BACKGROUND: A positive urine fentanyl toxicology test may have considerable consequences for peripartum individuals, yet the extent to which fentanyl administration in a labor epidural may lead to such a positive test is poorly characterized. OBJECTIVE: This study aimed to quantify the extent to which neuraxial fentanyl in labor neuraxial analgesia can lead to a positive peripartum maternal or neonatal urine toxicology test. STUDY DESIGN: We performed a prospective cohort study of pregnant participants planning a vaginal delivery with neuraxial analgesia. Participants with a history of substance use disorder, hypertension, or renal or liver disease were excluded. A urine sample was collected before initiation of neuraxial analgesia, each time the bladder was emptied during labor, and up to 4 times postpartum. Neonatal urine was collected once. Urine fentanyl testing was performed using 2 common toxicology testing methods, namely immunoassay and liquid chromatography with tandem mass spectrometric detection. RESULTS: A total of 33 maternal-infant dyads yielded a total of 178 urine specimens. All maternal specimens were negative for fentanyl using liquid chromatography with tandem mass spectrometric analysis and immunoassay before initiation of neuraxial analgesia. Intrapartum, 26 of 30 (76.7%) participants had positive liquid chromatography with tandem mass spectrometry results for fentanyl or its metabolites, and 12 of 30 (40%) participants had positive immunoassay results. Postpartum, 19 of 21 (90.5%) participants had positive liquid chromatograph with tandem mass spectrometric results, and 13 of 21 (61.9%) had a positive immunoassay result. Of the 13 neonatal specimens collected, 10 (76.9%) were positive on liquid chromatography with tandem mass spectrometry analysis, the last of which remained positive 29 hours and 50 minutes after delivery. CONCLUSION: Neuraxial fentanyl for labor analgesia may lead to positive maternal and neonatal toxicology tests at various times after epidural initiation and cessation and at different rates depending on the testing method used. Caution should be used in interpreting toxicology test results of individuals who received neuraxial analgesia to avoid false assumptions about nonprescribed use.

Subcutaneous Extended-release Buprenorphine Depot Misdiagnosed as an Abscess Resulting in Incision and Drainage and Disruption of Opioid Use Disorder Treatment.

Monthly extended-release buprenorphine subcutaneous injection (BUP-XR) is a newer treatment formulation for use in moderate to severe opioid use disorder. After injection into the subcutaneous tissue of the abdomen, the medication forms a depot to allow for slow release of buprenorphine. As such, a small yet visible and palpable nodule is normal and is expected to decrease in size over the following weeks to months. Given the newness of this medication, it is possible that not all healthcare providers are familiar with this formulation, nor will they interpret the BUP-XR depot as normal findings. Herein, we provide a case report where a patient's BUP-XR depot was misdiagnosed as an abscess, resulting in incision and drainage and disruption of life-saving opioid use disorder treatment. To prevent cases like this in the future, it is important that providers administering BUP-XR properly educate patients on what to expect during treatment with BUP-XR and when to seek care for potential abnormalities. In addition, it is critical that healthcare providers working in other treatment settings are aware of how to properly evaluate BUP-XR injection sites.

What to Expect With Pregnant or Postpartum Prescribing of Extended-Release Buprenorphine (CAM2038).

Weekly and monthly CAM2038 (Brixadi®) extended-release subcutaneous buprenorphine (XR bup) has been available in Europe and Australia for several years and was approved by the Food and Drug Administration in May 2023. Little is known about the clinical experience of patients and providers using this new medication during prenatal care. Two cases of pregnant persons with opioid use disorder receiving weekly XR bup in an ongoing randomized multi-site outpatient clinical trial are presented along with a brief review of the pharmacology and literature on XR bup formulations. The cases in pregnancy illustrate how treatment with the weekly formulation is initiated including how to make dose adjustments, which may be necessary given the longer half-life; it takes 1 month to achieve steady state. Injection site pain with medication administration was time limited and managed readily. Other injection site reactions experienced included subcutaneous erythema and induration that was delayed in onset and typically mild, resolving with minimal intervention. Delivery management and breastfeeding recommendations while on weekly XR bup were not different compared to sublingual buprenorphine (SL bup). Weekly XR bup is a new treatment for opioid use disorder that may be used in the obstetric population. Obstetric and addiction medicine clinicians should be aware of this new formulation as its use is expected to increase.

"You have to take this medication, but then you get punished for taking it:" lack of agency, choice, and fear of medications to treat opioid use disorder across the perinatal period.

INTRODUCTION: Medications to treat opioid use disorder (MOUD) during pregnancy and in the postpartum period remain underutilized. A need exists to enhance our understanding of modifiable factors, facilitators, and barriers to MOUD utilization and adherence in the perinatal period to improve maternal and child outcomes. METHODS: The study conducted semi-structured qualitative interviews with recently pregnant people with opioid use disorder (OUD) to explore experiences as a pregnant and/or parenting person with OUD, perceptions of enabling factors and barriers to treatment utilization, incentivizing factors for maintaining adherence, and acceptability of ongoing supports to sustain treatment adherence. The study team used constant comparative methods to analyze transcripts and develop the codebook. The team double coded the transcripts, with an overall kappa coefficient of 0.88. RESULTS: The study team interviewed twenty-six women on average 10.1 months after delivery. All women had some prior experience using MOUD. Four unique themes emerged as barriers to medication utilization and adherence in the perinatal period: 1) Lack of agency and autonomy surrounding medication decisions because pregnancy or parenting status affected treatment adherence; 2) Hesitancy to use MOUD to minimize risk of newborn withdrawal; 3) Concern about increased scrutiny and potential loss of custody due to mandated child protective services reporting for opioid-exposure at delivery in Massachusetts; and 4) Perception that treatment environments, particularly methadone clinics, did not provide gender-responsive or equitable care, and standardized, inflexible visit regulations were particularly difficult to comply with in the early postpartum period. CONCLUSIONS: Women with OUD experienced a double bind when making perinatal treatment decisions, describing pressure to use MOUD with negative consequences after delivery. Key areas for possible intervention emerged from interviews. These areas include improving uptake of shared decision-making to increase patient autonomy and agency, particularly among those in the earliest stages of recovery during pregnancy; ongoing education around perinatal MOUD safety and efficacy; detangling MOUD and neonatal withdrawal signs from mandated child protective services reporting; and improving gender-responsive and equitable care in substance use disorder treatment programs, including incorporating the utilization of home visiting services for dosing assessments and administration in the early postpartum period.

Caring for Families Impacted by Opioid Use: A Qualitative Analysis of Integrated Program Designs.

OBJECTIVE: We sought to 1) identify models of integrated care that offer medical care and social services for children and families impacted by opioid use disorder (OUD) in the postpartum year; and 2) describe how each program was developed, designed, and sustained, and explore facilitators and barriers to implementation of a dyadic, two-generation approach to care. METHODS: In-depth semi-structured interviews (n = 23) were conducted with programs for women and children affected by OUD across North America. Using a phenomenologic approach, key program components and themes were identified. Following thematic saturation, these results were triangulated with experts in program implementation and with a subset of key informants to ensure data integrity. RESULTS: Five distinct types of programs were identified that varied in the degree of medical and behavioral care for families. Three themes emerged unique to the provision of dyadic care: 1) families require supportive, frequent visits with a range of providers, but constraints around billable services limit care integration across the perinatal continuum; 2) individual program champions are critical, but degree and reach of interdisciplinary care is limited by siloed systems for medical and behavioral care; and 3) addressing dual, sometimes competing, responsibilities for both parental and infant health following recurrence of parental substance use presents unique challenges. CONCLUSIONS: The key components of dyadic care models for families impacted by OUD included prioritizing care coordination, removing barriers to integrating medical and behavioral services, and ensuring the safety of children in homes with ongoing parental substance use while maintaining parental trust.

Integrating Harm Reduction into Outpatient Opioid Use Disorder Treatment Settings : Harm Reduction in Outpatient Addiction Treatment.

Opioid use disorder (OUD) is increasingly recognized as a chronic, relapsing brain disease whose treatment should be integrated into primary care settings alongside other chronic conditions. However, abstinence from all non-prescribed substance use continues to be prioritized as the only desired goal in many outpatient, primary care-based treatment programs. This presents a barrier to engagement for patients who continue to use substances and who may be at high risk for complications of ongoing substance use such as human immunodeficiency virus (HIV), hepatitis C virus (HCV), superficial and deep tissue infections, and overdose. Harm reduction aims to reduce the negative consequences of substance use and offers an alternative to abstinence as a singular goal. Incorporating harm reduction principles into primary care treatment settings can support programs in engaging patients with ongoing substance use and facilitate the delivery of evidence-based screening and prevention services. The objective of this narrative review is to describe strategies for the integration of evidence-based harm reduction principles and interventions into outpatient, primary care-based OUD treatment settings. We will offer specific tools for providers and programs including strategies to support safer injection practices, assess the risks and benefits of continuing medications for opioid use disorder in the setting of ongoing substance use, promote a non-stigmatizing program culture, and address the needs of special populations with ongoing substance use including adolescents, parents, and families.

Real-world outcomes with extended-release buprenorphine (XR-BUP) in a low threshold bridge clinic: A retrospective case series.

BACKGROUND: In clinical trial settings, extended-release buprenorphine (XR-BUP) is noninferior to sublingual buprenorphine and may offer some advantages. However, real-world experiences of XR-BUP are limited and outcomes are unknown for low-threshold clinics with high-risk populations. Practical guidance is lacking on overcoming treatment challenges, such as inability for some to stabilize on sublingual (SL) BUP for seven days prior to XR-BUP and ongoing craving/withdrawal symptoms during treatment. METHODS: Retrospective case series of a convenience sample of 40 serial adults with opioid use disorder (OUD) treated with XR-BUP from Massachusetts General Hospital bridge clinic from February 1, 2019, to July 31, 2019. RESULTS: Patients were mostly male (67.5%), non-Hispanic white (97.5%), unstably housed (77.5%), and average age of 32.1 years old. The average SL BUP dose prior to XR-BUP was 18.6 mg (standard deviation [SD] = 5; range 8-32) for an average treatment duration of 105 days (SD = 191; range 1-810). Ten (25%) patients received SL BUP for fewer than the seven recommended days (mean = 3.7, SD = 1.4, range = 1-6). Standard induction dosing was administered to 30%, empiric high-dose XR-BUP (300 mg monthly) was administered to 25%, and 55% were treated with supplemental SL BUP ranging from 4 to24mg, daily or as needed, for varying time periods. At the end of data collection, 65% remained on XR-BUP, 30% discontinued XR-BUP, and one patient was lost to follow-up. Acute care utilization rates were similar between patients who continued XR-BUP versus discontinued at 18.5% and 16.6%, respectively (χ2 = 0.02, p-value = 0.89). Toxicology was negative for other opioids in 65% of patients throughout treatment. There were no reports of overdose, withdrawal after use of opioids, or precipitated withdrawal after subsequent XR-BUP. Patients' most cited reason for discontinuing XR-BUP was a preference for SL BUP. CONCLUSION: This real-world evaluation of XR-BUP in a low-threshold clinic found that treatment was feasible, well tolerated, and outcomes were good, with most individuals choosing to continue treatment and a majority with no evidence of ongoing opioid use or precipitated withdrawal.

A Retrospective Cohort Study Examining the Utility of Perinatal Urine Toxicology Testing to Guide Breastfeeding Initiation.

OBJECTIVE: National guidelines advise against breastfeeding for women who use nonprescribed substances in the third trimester. This reduces the number of women who are supported in breastfeeding initiation despite limited evidence on the prognostic value of third trimester substance use. We sought to examine the degree to which prenatal nonprescribed substance use is associated with non-prescribed use postpartum. METHODS: Retrospective cohort study of pregnant women with opioid use disorder on methadone or buprenorphine between 2006 and 2015. Nonprescribed use was defined by a positive urine drug testing (UDT). Sensitivity, specificity, positive predictive value, and negative predictive value were calculated comparing 3 prenatal periods with postpartum UDT results. Generalized estimating equations were used to examine the extent to which prenatal nonprescribed use was associated with postpartum use. RESULTS: Included were 545 deliveries by 503 women. Mean age was 28.3 years, 88% were White/non-Hispanic, 93% had public insurance, and 43% received adequate prenatal care. The predictive value of UDT's 90 to 31 days before delivery, 30 to 0 days before delivery, and at delivery showed low sensitivity (44, 26, 27%, respectively) and positive predictive value (36, 36, 56%, respectively), but higher negative predictive value (80, 85, and 78%, respectively), P-values all <0.05. In the final adjusted model, only nonprescribed use at delivery was significantly associated with postpartum nonprescribed use. CONCLUSIONS: Nonprescribed use at delivery was most strongly associated with postpartum use compared with earlier time periods currently prioritized in guidelines. In women with opioid use disorder prenatal UDT results alone are insufficient to guide breastfeeding decisions.