Buprenorphine Products Research Articles

In Case You Haven't Heard…

Exhibit halls at conferences are interesting things. At the Cape Cod Symposium on Addictive Disorders, for example, the booth from Indivior was promoting only Sublocade, a long‐term version of buprenorphine. Nothing about OPVEE, the overdose reversal medication. In the next hallway over, the Hikma Pharmaceuticals booth was promoting only Kloxxado, the overdose reversal medication, but nothing about methadone. Indivior produced the first major buprenorphine product in the United States — Suboxone — and Hikma is one of the few major producers of methadone for opioid treatment programs. Hikma also makes buprenorphine.

Dosing and Misuse of Buprenorphine in the New Jersey Department of Corrections.

Opioid use disorder is common in incarcerated persons, and concern about the diversion of buprenorphine is a barrier to treatment. We conducted a retrospective chart review of incarcerated persons in the New Jersey Department of Corrections who received charges for misuse of medication, including buprenorphine, hypothesizing that the prescription of buprenorphine monoproduct, multiple tabs or films of buprenorphine, or higher doses of buprenorphine would be associated with more diversion incidents. Within the dosing range of 2 to 12 mg, there were more incidents of diversion of buprenorphine monoproduct (24.3%) compared with buprenorphine-naloxone (10.7%, p = .004). More incidents of diversion were seen when multiple films or tabs of buprenorphine product were prescribed (21.7%, comparison 12.7%, p = .01). This observation held when considering multiple buprenorphine-naloxone films, but not multiple buprenorphine tablets. No statistically significant association was found for institutional diversion charges related to higher doses of buprenorphine products. These results suggest that, within the dosing range of buprenorphine used in the New Jersey Department of Corrections, misuse charges were not associated with higher doses although were associated with prescribing buprenorphine monoproduct and multiple films of buprenorphine-naloxone.

Conversion of CII Opioid Medications to Buprenorphine in the Chronic Pain Population - Insights and Clinical Pearls.

There is a great deal of confusion associated with conversion from CII opioid to buprenorphine products. The data presented supports that patients can be converted from high dose opioid medication to buprenorphine products safely and effectively. This presentation will provide a road map to help guide practitioners who are interested in applying this to their clinical practice. Thepurposeoftheresearchwasnotonlytodiscoverifconversiontoapartialagonist CIII medication from full agonist CII medications would be achieveable without sacrificing analgesia, but also to provide guidance to providerswhoareinterestedinpursuingthisoptioninclinicalpractice. Procedures/data/observations: Patients who met inclusion criteria were stratified into subgroups on the basis of pre- conversion morphine milligram equivalents, whether they remained on opioids for breakthrough pain postconversion, and pre- and postconversion numerical rating scale pain scores. Outcomes of interest included the differences between pre- and postconversion numerical rating scale pain scores and daily morphine milligram equivalents for each sub-group. Of 157 patients reviewed, 87.9% were successfully converted to buprenor-phine buccal film. Overall, numericalrating scale pain scores were stable after conversion. Statistically significant reductions were demonstrated in the <90 daily morphine milligram equivalent subgroup. Postconversion daily morphine milligram equivalents decreased by 85.4% from baseline. Change in daily morphine milligram equivalents is representative of patients who remained on breakthrough pain medication. Results demonstrate continued analgesia after conversion to buprenorphine buccal film despite reductions in daily morphine milligram equivalents. Most patients were able to convert directly from their long-acting opioid to buprenorphine buccal film and stabilized without the use of concomitant opioids for breakthrough pain. Aggressive titration strategies were associated with greater success. This data proves that conversion from full agonist CII medications is possible without sacrificing analgesia while reducing the risk of adverse events associated with full agonist CII medications.

Partial Agonist, Full Barrier: A Case-Based Discussion on Challenges with Buprenorphine in Chronic Pain Management.

More patients are on chronic opioids, as patients who were initially started on full agonist opioids for cancer-related pain are living longer. Despite doing well from the cancer stand- point, some patients have difficulty tapering off their opioids because they have been taking them for years. Given the potential complications of chronic full agonist opioids, it is important to manage these patients in a safer way. However, there are various challenges including lack of education for patients and healthcare professionals and lack of product availability. Many healthcare providers do not have much formal training on initiating, maintaining, and tapering the various buprenorphine products. These providers may not be able to effectively educate patients given the lack of education. Also, patients research these products on their own and are hesitant to try them because of misinformation. Even if patients are informed thoroughly about buprenorphine, there are barriers to obtaining them including insurance denial and lack of product availability at pharmacies. Given the above challenges, easily accessible best practices as well as avenues for healthcare professionals to educate and guide each other are needed. Given the potential complications of chronic full agonist opioids, it is important to manage these patients in a safer way. However, there are various challenges including lack of education for patients and healthcare professionals and lack of product availability. Given the above challenges, easily accessible best practices as well as avenues for healthcare professionals to educate and guide each other are needed.

Clinical Pharmacist with DEA License: Efforts to Increase Access to Buprenorphine in a Veteran Population.

Opioid overdoses continue to rise in the United States. In 2021, a record 80,411 reported overdoses occurred in the US alone, nearly double that in 2017. Buprenorphine's pharmacology is ideal for management of patients with opioid use disorder (OUD) with or without chronic pain. Within the VA, clinical pharmacist practitioners (CPP) are uniquely equipped to operate with significant scope of practice to prescribe medications including controlled substances, an opportunity to vastly increase access to care for veterans suffering from OUD, complex opioid dependency or pain. The purpose of this case series is to describe how DEA licensed pain CPP safely and effectively manages 1) Suboxone home inductions to increase access for OUD 2) rotations from traditional full mu opioids to chronic pain buprenorphine products and 3) off label use of Suboxone for pain. Procedures/data/observations: Cases were collected in usual workload for clinical pharmacist. High rate of tolerability and efficacy noted with buprenorphine across all products. DEA licensed Pain CPPs can make an immediate positive impact for veterans with OUD and/or complex pain and may be more comfortable with buprenorphine than many other providers.

Protocol for the development of a consensus practice guideline To address clinical and regulatory barriers to buprenorphine dispensing in community pharmacy

BackgroundLess than half of community pharmacies in the United States stock buprenorphine products indicated for the treatment of opioid use disorder. This lack of access to buprenorphine in community pharmacies is a significant barrier to care. To address this issue, this protocol outlines a comprehensive approach to develop a practice guideline aimed at improving access to safe and effective opioid use disorder treatment in community pharmacies.MethodsThe guideline development process will proceed in three phases, following a technique closely aligned with the Institute of Medicine’s guidance on guideline development. The first phase will involve conducting qualitative interviews with pharmacists in three states to identify their beliefs toward buprenorphine dispensing. As limitations on buprenorphine supply are related to constraints at all levels of the drug supply and regulatory system, the second phase, we will recruit representatives from regulatory agencies, pharmacy organizations, the Drug Enforcement Administration, pharmaceutical wholesalers as well as addiction medicine physicians and psychiatric pharmacists to develop consensus recommendations through a modified Delphi design. This will be followed by a public comment period and external expert review of the recommendations led by the National Association of Boards of Pharmacy. Finally, in the third phase, a national, mixed media dissemination campaign will be led by the National Community Pharmacists Association (NCPA) to convey recommendations to practicing pharmacists.DiscussionThe guideline development process aims to incorporate the perspectives of multiple stakeholders and emphasize the importance of addressing the regulatory and pharmacy-specific aspects of care in addition to clinical evidence and guidance. The development of this guideline will provide targeted, multidisciplinary guidance for pharmacists, improving access to safe and effective opioid use disorder treatment in the community setting.PreregistrationThis protocol was registered with the Open Science Framework in March of 2023. Registration may be found at: https://doi.org/10.17605/OSF.IO/6S9DY.

Buprenorphine prescribing and treatment accessibility in response to regulation changes due to the COVID-19 public health emergency

BackgroundIn 2021, over 80,000 fatal overdoses occurred in the United States. Since 2020, the federal government has enacted multiple regulatory changes around buprenorphine prescribing for opioid use disorder (OUD) to increase access to buprenorphine. This study aims to explore trends in buprenorphine treatment initiation pre- and post-public health emergency to evaluate changes in the context of X-waiver relaxations and telehealth allowances. MethodsIn a cross-sectional study, all RI residents who filled a buprenorphine prescription at a pharmacy in Rhode Island (RI), Massachusetts, and Connecticut between January 2017 and December 2023 were obtained from the RI Prescription Drug Monitoring Program (PDMP). The study excluded buprenorphine products not approved for OUD treatment from the analysis. Identified individuals had initiated buprenorphine for OUD during the study period if they did not have a prior prescription or if they had >30 days without buprenorphine exposure between their prescriptions. Spearman's rank correlation tests were used to identify significant associations between outcomes and regulation changes. ResultsThe average number of patients dispensed buprenorphine did not significantly change over the study period, however the average number of initiates significantly decreased (ρ = −0.38255, p = .0003). The average number of providers prescribing CII-CV substances in RI has increased 3.4 % over the study period. The average percentage of prescribers in the PDMP prescribing buprenorphine for OUD doubled (ρ = 0.96075, p < .0001). ConclusionThough efforts have been made to increase buprenorphine initiation, buprenorphine initiates remain well below pre-PHE levels. Efforts must continue to eliminate existing barriers to treatment and improve access to individuals seeking treatment.

An Australian retrospective observational cohort comparison of the use of long-acting injectable buprenorphine products

IntroductionIn early 2019, Australia became the first jurisdiction to have two brands of long-acting injectable buprenorphine (LAI-B) products available. Previously published studies have mostly followed pre-planned dosing schedules and seldom compared use of both products. This study presents a retrospective analysis of the “real-world” dosing requirements of patients on LAI-B. MethodFive clinics provided data for patients commenced on LAI-B between 1 February 2019 and 30 June 2021 for buprenorphine doses and intervals between dosing. The study recorded basic demographic data including age, gender, and previous dose of transmucosal buprenorphine. The Local Institutional Ethics Committee provided approval. ResultsOver 3600 individual doses (59 % Buvidal® & 41 % Sublocade®) were administered to 340 individual patients (median age 40 years, 63 % male), with the longest duration in treatment of 856 days. Median estimated duration of a treatment episode was 16.5 months (95%CI: 14.3–19.1). Approximately 94 % transferred from transmucosal buprenorphine (median daily dose 16 mg, range 2-32 mg). Most common LAI-B doses were Sublocade® 100 mg (22.4 %) and Buvidal® Monthly 128 mg (21.5 %); Buvidal® Weekly 24 mg (0.8 %) was least used. 13 % transitioned between LAI-B products. Weekly dose intervals were a median 7 days and monthly doses were given a median of 28 days apart. Overall, 36 % discontinued LAI-B before the census date. Discussions and conclusionsMost patients who started LAI-B remained in treatment, with similar rates in both products. A small, but appreciable number of people switched brands, suggesting that it remains important to have treatment options available.

Frontline Perspectives on Buprenorphine for the Management of Chronic Pain.

Due to the prevalence of chronic pain and high-impact chronic pain in the US, a significant percentage of the population is prescribed opioids for pain management. However, opioid use disorder is associated with reduced quality of life, along with fatal opioid overdoses, and is a significant burden on the US economy. Considering the clinical needs of patients with intractable chronic pain and the potential harms associated with prescribed and illicit opioids in our communities, having a deep understanding of current treatment options, supporting evidence, and clinical practice guidelines is essential for optimizing treatment selections. Buprenorphine is a Schedule III opioid with a unique mechanism of action, allowing effective and long-lasting analgesia at microgram doses with fewer negative side effects and adverse events, including respiratory depression, when compared with other immediate-release, long-acting, and extended-release prescription opioids. Due to its relatively lower risk for overdose and misuse, buprenorphine was recently added to the Clinical Practice Guideline for the Use of Opioids in the Management of Chronic Pain as a first-line treatment for chronic pain managed by opioids by the US Departments of Defense and Veterans Affairs, and the Department of Health and Human Services recommends that buprenorphine be made available for the treatment of chronic pain. In this narrative review, we discuss the different buprenorphine formulations, clinical efficacy, advantages for older adults and other special populations, clinical practice guideline recommendations, and payer considerations of buprenorphine and suggest that buprenorphine products approved for chronic pain should be considered as a first-line treatment for this indication.

Characterizing acute and postsurgical pain management in patients receiving buprenorphine or buprenorphine/naloxone

BackgroundThere is currently a clinical dilemma in treating acute pain in patients receiving long-term buprenorphine products. MethodsThis is a retrospective cohort review involving patients receiving long-term buprenorphine therapy who either underwent a surgical procedure or presented to an emergency department (ED) for acute pain between January 1, 2012 and January 1, 2022. Patients were excluded if opioids were prescribed 30 days before the index date. Chart reviews were conducted to characterize buprenorphine treatment strategies and the addition of new pain medications. Chart review revealed (1) incidence of opioid use disorder (OUD) relapse, (2) hospital re-presentation for pain or OUD, (3) fatal and non-fatal overdose, and (4) all-cause mortality and suicidality. Descriptive statistics were used to analyze results. ResultsA total of 70 of 259 screened patients met inclusion criteria. The mean (±SD) age was 50.3 ± 13 years, 92.9% male, 64.3% White, and 78.6% had an OUD diagnosis. While 84.3% presented to the ED, 15.7% underwent surgical procedures. For the primary endpoint, the total daily dose of buprenorphine or buprenorphine/naloxone from index date to discharge was continued in 90.0%, increased in 2.9%, decreased in 1.4%, and discontinued in 5.7% of cases. At discharge, 46.2% were prescribed an additional pain medication. A total of 7.1% re-presented for pain or OUD relapse, 15.7% experienced an OUD relapse, 1.4% experienced new-onset suicidality, and 1.4% experience all-cause mortality within 90 days of the index date. No fatal or non-fatal opioid overdoses were observed. ConclusionThe most commonly observed practice was continuing buprenorphine doses in patients with acute or postsurgical pain, which was effective and safe. Although further data is necessary to fully elucidate these findings, the data herein may suggest that clinicians can safely continue buprenorphine doses in the acute pain setting in patients receiving these products chronically.

Legislative and regulatory barriers to pharmacies dispensing buprenorphine for OUD.

Buprenorphine (BUP) is increasingly recognized and utilized as a valuable medication for the treatment of opioid use disorder. This article focuses on the problem of regulatory restrictions on access to buprenorphine products without naloxone (mono-product), involving patients in one geographic area, but which may represent a more general access problem in the United States. In response to an audit by the Tennessee Board of Pharmacy, a pharmacy in northeast Tennessee designed a questionnaire to survey patient motivation for traveling long distances to fill their prescriptions for BUP, rather than buprenorphine/naloxone (BNx, combo-product), and to document their satisfaction with treatment with the mono-product. Questionnaires were submitted by 194 patients, living in northeast Tennessee, southwest Virginia, and southeast Kentucky. Significant, intolerable, side effects were reported by all patients in the survey prescribed BNx, but because of legislative and regulatory restrictions in their respective states, they were unable to obtain BUP closer to home. Consequently, they were required to drive significant distances from their homes to fill their prescriptions, a median distance of 52 miles, and in some cases as far as 216 miles round trip. Intolerable reactions included severe headaches, nausea and vomiting, allergies, and severe dysphoria. All patients tolerated BUP and were clinically well maintained on the mono-product. Severe, intolerable reactions/side effects from the naloxone component of BNx are not uncommon, but legislative and regulatory restrictions on the mono-product prohibit providers and pharmacies in some states from prescribing and dispensing BUP. The participants in this qualitative study found it necessary to travel significant distances to obtain their prescribed medication, thereby potentially limiting access to this life-saving therapy.

Disparities in Emergency Department Naloxone and Buprenorphine Initiation.

Prescribing of buprenorphine and naloxone in the emergency department (ED) has been shown to be an effective intervention. The purpose of this study was to determine the frequency of prescribing of naloxone and buprenorphine and the sub-groups that may be more or less likely to receive treatment. We used a national electronic health record database to identify patients with opioid poisoning or overdose presenting between January 2019-December 2021. Patients who were prescribed naloxone or buprenorphine were identified in this dataset and then further segmented based on self-identified gender, age, racial and ethnic identity, income categories, and social vulnerability index in order to identify sub-groups that may be less likely to be prescribed treatment. We found 74,004 patients in the database whom we identified as presenting to the ED with an opioid poisoning or overdose. Overall, 22.8% were discharged with a prescription for naloxone, while 0.9% of patients were discharged with buprenorphine products. Patients were less likely to receive naloxone prescriptions if they were female, White or Pacific Islander, non-Hispanic, not between the ages of 18-65, and non-English speaking. We found the same pattern for buprenorphine prescriptions except that the results were not significant for ethnicity and English-speaking. Despite evidence supporting its use, buprenorphine is not prescribed from the ED in a substantial proportion of patients. Naloxone is prescribed to a higher percentage, although still a minority of patients receive it. Some sub-groups are disadvantaged in the prescribing of these products. Further study may assist in improving the prescribing of these therapies.

The association between longitudinal trends in receipt of buprenorphine for opioid use disorder and buprenorphine-waivered providers in the United States.

We sought to describe longitudinal trends in buprenorphine receipt and buprenorphine-waivered providers in the United States from 2003 to 2021 and measure whether the relationship between the two differed after capacity-building strategies were enacted nationally in 2017. This was a retrospective study of two separate cohorts covering the years 2003-21, testing whether the association between two trends in these cohorts changed comparing 2003 to 2016 and from 2017 to 2021, among buprenorphine providers in the United States, regardless of treatment setting. Patients receiving dispensed buprenorphine at retail pharmacies. All providers who have obtained a waiver to prescribe buprenorphine in the United States, and an estimate of the annual number of patients who had buprenorphine for opioid use disorder (OUD) dispensed to them at a retail pharmacy. We synthesized and summarized data from multiple sources to assess the cumulative number of buprenorphine-waivered providers over time. We used national-level prescription data from IQVIA to estimate annual buprenorphine receipt for OUD. From 2003 to 2021, the number of buprenorphine-waivered providers in the United States increased from fewer than 5000 in the first 2 years of Food and Drug Administration (FDA) approval to more than 114 000 in 2021, while patients receiving buprenorphine products for OUD increased from approximately 19 000 to more than 1.4 million. The strength of association between waivered providers and patients is significantly different before and after 2017 (P < 0.001). From 2003 to 2016, for each additional provider, there was an average increase of 32.1 [95% confidence interval (CI) = 28.7-35.6] patients, but an increase of only 4.6 (95% CI= 3.5-5.7) patients for each additional provider, beginning in 2017. In the United States, the relationship between the rates of growth in buprenorphine providers and patients became weaker after 2017. While efforts to increase buprenorphine-waivered providers were successful, there was less success in translating that into significant increases in buprenorphine receipt.

FDA approves new buprenorphine treatment option for opioid use disorder

In May, the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended‐release injection for subcutaneous use (under the skin) to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations, a weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine.

Long‐running patent‐switch lawsuit resolved between Indivior and state AGs

On June 2, Indivior, which makes the buprenorphine product Suboxone, resolved a lawsuit by 42 attorneys general (AGs)who had claimed that the Virginia‐based pharmaceutical company fraudulently removed its tablets from the market in order to prevent generics from entering. In the agreement, announced June 2, Indivior will pay the states a total of $102.5 million.

FDA approves Brixadi, new buprenorphine treatment option

Last month the U.S. Food and Drug Administration approved Brixadi (buprenorphine) extended‐release injection for subcutaneous use to treat moderate to severe opioid use disorder (OUD). Brixadi is available in two formulations: A weekly injection that can be used in patients who have started treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine, and a monthly version for patients already being treated with buprenorphine. It is not for induction or new treatment. The weekly doses are 8 milligrams (mg), 16 mg, 24 mg, 32 mg; and the monthly doses are 64 mg, 96 mg, and 128 mg. The approved weekly formulation in various lower strengths offers a new option for people in recovery who may benefit from a weekly injection to maintain treatment adherence. Brixadi will be available through a risk evaluation and mitigation strategy program and administered only by health care providers in a health care setting. The FDA granted approval of Brixadi to Braeburn Inc.

Buprenorphine use and setting type among reproductive-aged women self-reporting nonmedical prescription opioid use

IntroductionScreening for opioid misuse and treatment for opioid use disorder are critical for reducing morbidity and mortality. We sought to understand the extent of self-reported past 30-day buprenorphine use in various settings among women of reproductive age with self-reported nonmedical prescription opioid use being assessed for substance use problems. MethodsThe study collected data from individuals being assessed for substance use problems using the Addiction Severity Index–Multimedia Version in 2018–2020. We stratified the sample of 10,196 women ages 12–55 self-reporting past 30-day nonmedical prescription opioid use by buprenorphine use and setting type. We categorized setting types as: buprenorphine in specialty addiction treatment, buprenorphine in office-based opioid treatment, and diverted buprenorphine. We included each woman's first intake assessment during the study period. The study assessed number of buprenorphine products, reasons for using buprenorphine, and sources of buprenorphine procurement. The study calculated frequency of reasons for using buprenorphine to treat opioid use disorder outside of a doctor-managed treatment, overall and by race/ethnicity. ResultsOverall, 25.5 % of the sample used buprenorphine in specialty addiction treatment, 6.1 % used buprenorphine prescribed in office-based treatment, 21.7 % used diverted buprenorphine, and 46.7 % reported no buprenorphine use during the past 30 days. Among women who reported using buprenorphine to treat opioid use disorder, but not as part of a doctor-managed treatment, 72.3 % could not find a provider or get into a treatment program, 21.8 % did not want to be part of a program or see a provider, and 6.0 % reported both; a higher proportion of American Indian/Alaska Native women (92.1 %) reported that they could not find a provider or get into a treatment program versus non-Hispanic White (78.0 %), non-Hispanic Black (76.0 %), and Hispanic (75.0 %) women. ConclusionsAppropriate screening for nonmedical prescription opioid use to assess need for treatment with medication for opioid use disorder is important for all women of reproductive age. Our data highlight opportunities to improve treatment program accessibility and availability and support the need to increase equitable access for all women.

Retrospective Cohort Study of Safety Outcomes Associated with Opioid Rotations to Buprenorphine

The objective of this study was to understand the effect buprenorphine rotations have on respiratory risk and other safety outcomes. This was a retrospective observational study evaluating Veterans who underwent an opioid rotation from full-agonist opioids to buprenorphine products or to alternative opioids. The primary endpoint was change in the Risk Index for Overdose or Serious Opioid-induced Respiratory Depression (RIOSORD) score from baseline to six months post-rotation. Median baseline RIOSORD scores were 26.0 and 18.0 in the Buprenorphine Group and the Alternative Opioid Group, respectively. There was no statistically significant difference between groups in baseline RIOSORD score. At six months post-rotation, median RIOSORD scores were 23.5 and 23.0 in the Buprenorphine Group and Alternative Opioid Group, respectively. The difference in change in RIOSORD scores between groups was not statistically significant (p = 0.23). However, based on changes in RIOSORD risk class, an 11% and 0% decrease in respiratory risk was observed in the Buprenorphine and Alternative Opioid groups, respectively. This finding may be considered clinically significant given a change in risk was observed as predicted by RIOSORD score. Further research is needed to clarify the effect that opioid rotations have on respiratory depression risk and other safety outcomes.

Oral buprenorphine utilization, concomitant benzodiazepines and opioid analgesics, and payment source: Trends from 2015 to 2019

IntroductionThis study describes utilization patterns of oral buprenorphine products indicated for the treatment of opioid use disorder with a focus on patterns consistent with prescribing guidelines and the safe use conditions during induction and maintenance treatment outlined by the Risk Evaluation and Mitigation Strategy (REMS) Program, including trends over time. MethodsUsing an anonymized longitudinal patient-level dataset that captures information on medical and pharmacy claims in the United States (October 1, 2014 through March 31, 2020), buprenorphine prescriptions, days' supply, and daily dose were described overall and stratified by induction (month 1) vs. maintenance (month 2–6) treatment, along with duration of concomitant benzodiazepines or opioid analgesics. ResultsOverall, there were 1.5 million buprenorphine treatment episodes initiated between January 1, 2015 to September 30, 2019 (2015: 258,899; 2019: 351,378). Treatment episodes included an average of 6.8 buprenorphine prescriptions (standard deviation [SD] = 6.7), 16.8 days' supply per prescription (SD = 10.5), 94.2 total days' supply per treatment episode (SD = 71.4), and a mean daily dose of 13.6 mg (SD = 6.3), with the number of prescriptions and total days' supply per treatment episode declining over the study period. There was a lower mean number of days' supply per prescription in the first month of treatment compared to months 2–6 (month 1: 15.8 [SD = 11.0]; month 2–6: 19.0 [SD = 10.1]) and daily dose per prescription (month 1: 13.3 mg [SD = 6.4]; months 2–6: 14.3 mg [SD = 6.2]), and a higher mean number of prescriptions per month (month 1: 2.5 per month [SD = 1.7]; months 2–6: 1.8 per month [SD = 1.2]). From 2015 to 2019, there appeared to be a shift in payer mix, with increases in Medicaid/Medicare and declines in cash and commercial insurance. Concomitant benzodiazepine and opioid analgesic use declined over time; in 2019, 16.6 % and 14.3 % of treatment episodes had any concomitant benzodiazepine or opioid analgesic, respectively, and <5 % had chronic (>90 overlapping days) concomitant use (3.0 % and 0.4 %, respectively). ConclusionsThe number of oral buprenorphine treatment episodes increased over the study period, and prescribing was generally consistent with the REMS and other treatment guidelines. There was a decline in concomitant buprenorphine and benzodiazepine or opioid analgesics, and chronic concomitant use was rare.

Availability of medications for opioid use disorder in outpatient and inpatient pharmacies in South Florida: a secret shopper survey

BackgroundDespite the proven efficacy of medications for opioid use disorder (MOUD) and recent reduction in barriers to prescribers, numerous obstacles exist for patients seeking MOUD. Prior studies have used telephone surveys to investigate pharmacy-related barriers to MOUD. We applied this methodology to evaluate inpatient and outpatient pharmacy barriers to MOUD in South Florida.MethodsRandomly selected pharmacies in South Florida (Miami-Dade, Broward, and Palm Beach Counties) were called using a standardized script with a “secret shopper” approach until 200 successful surveys had been completed. The primary outcome was the availability of any buprenorphine products. Second, a list of all 48 acute care hospitals within the aforementioned counties was compiled, and hospitals were contacted by telephone using a second structured script.ResultsA total of 1374 outpatient pharmacies and 48 inpatient pharmacies were identified. 378 randomly selected outpatient pharmacies were contacted to accrue 200 successful calls (53% success rate). All 48 inpatient pharmacies were contacted to successfully complete 25 inpatient surveys (52%). Of the 200 outpatient pharmacies contacted, 38% had any buprenorphine available. There was a significant difference in buprenorphine availability by county, with Miami-Dade having the least availability and Palm Beach having the most availability (27% vs. 47%, respectively; p = 0.04). Of the 38% with buprenorphine available, 82% had a sufficient supply for a two-week prescription of buprenorphine 8 mg twice daily. Of the pharmacies that did not have buprenorphine, 55% would be willing to order with a median estimated time to receive an order of 2 days (IQR 1.25–3 days). Of the 25 surveyed inpatient pharmacies, 88% reported having buprenorphine on inpatient formulary, and 55% of hospitals had at least one restriction on ordering of buprenorphine beyond federal regulations.ConclusionsThe results of this study highlight significant pharmacy-related barriers to comprehensive OUD treatment across the healthcare system including both acute care hospital pharmacies and outpatient community pharmacies. Despite efforts to increase the number of MOUD providers, there still remain downstream obstacles to MOUD access.