Buprenorphine Products Research Articles

Perceptions, policies, and practices related to dispensing buprenorphine for opioid use disorder: A national survey of community-based pharmacists

BackgroundIncreasing buprenorphine prescribing for opioid use disorder (OUD) has been a major focus of U.S. opioid response efforts. However, concerns related to dispensing buprenorphine have been identified among pharmacists. ObjectivesThis study aimed to describe perceptions, policies, and practices reported by community-based pharmacists in relation to dispensing buprenorphine for OUD and to compare these responses by practice setting. MethodsA cross-sectional online survey was administered to a random sample of 6376 pharmacists. Responses were collected anonymously from October 16, 2021, to November 7, 2021. ResultsA response rate of 5.1% was achieved with 325 responders, and 281 were eligible to complete the survey. Most reported practicing in a chain (50.9%) or independent pharmacy (34.7%) as a staff pharmacist (39.7%) or pharmacist-in-charge (37.0%). Most (68.1%) indicated they could usually or always fill a buprenorphine prescription promptly. The most common pharmacy policies related to buprenorphine dispensing were checking the prescription drug monitoring program (71.3%), validating the prescriber’s X-waiver (44.9%), accepting only local prescribers (37.4%), and prohibiting refills more than one day early (35.8%). Policies limiting buprenorphine access to local prescribers, local patients, and established patients varied by practice setting and were most common in independent pharmacies. The strongest barriers to buprenorphine dispensing were insurance prior authorization, difficulty reaching prescribers with questions, and concerns about buprenorphine diversion. The strongest facilitators of buprenorphine dispensing were increased communication with prescribers, increased trust with prescribers, increased trust with patients, and increased education for pharmacists. ConclusionMost respondents indicated they were willing and able to dispense buprenorphine products for OUD promptly. However, they also reported discomfort dispensing when factors representing potential risk of diversion are present. Mitigating this hypersensitivity to diversion risk among pharmacists should be a focus of regulatory agencies and professional organizations. Efforts to address the unique concerns of independent pharmacists will also be essential to improve access.

New Dental Warning for Buprenorphine.

The labeling for transmucosal buprenorphine products will now include a warning that the drug may cause serious dental problems such as tooth decay, cavities, oral infections, and tooth loss.Nurses and NPs should complete an oral history and assessment prior to patients beginning treatment. Patients should be informed of these potential adverse effects and encouraged to receive regular dental care.

North Carolina community pharmacists’ buprenorphine dispensing practices and attitudes

BackgroundMany barriers, including stocking behaviors and pharmacist attitudes, can limit access to buprenorphine in pharmacy settings. ObjectivesTo assess North Carolina (NC) pharmacists’ (1) buprenorphine stocking behaviors, (2) awareness and interpretation of federal and state policy regarding buprenorphine, (3) perceptions about changes in buprenorphine demand, and (4) reasons for not dispensing buprenorphine, including attitudes. MethodsA convenience sample of currently practicing community pharmacists was recruited to participate in a 10-minute online survey. The survey included demographic questions and assessed pharmacists’ buprenorphine ordering, stocking, and dispensing behaviors. Descriptive statistics were calculated, and logistic regressions examined associations with whether pharmacists (1) had ever refused to fill a buprenorphine prescription and (2) perceived buprenorphine dispensing limits. ResultsThe majority (96%) of respondents (n = 646, completion rate = 5.5%) kept buprenorphine in stock regularly or ordered it as needed, with generic formulations being stocked most often. Many pharmacists (62%) had refused to fill a buprenorphine prescription. Pharmacists with more negative buprenorphine attitudes were more likely to refuse to fill a buprenorphine prescription. Many pharmacists (31%) believed there were buprenorphine ordering limits, with wholesalers most commonly being perceived as the source. Pharmacists with more negative buprenorphine attitudes were more likely to perceive buprenorphine ordering limits, while pharmacists who worked at national chain, grocery or regional chains, and other pharmacy types were less likely to perceive ordering limits than independent pharmacies. ConclusionAlthough most pharmacies stocked buprenorphine products, pharmacists’ refusal to dispense and perceived ordering limits could limit patient access. Refusal and perceived ordering limits were associated with pharmacist attitudes and pharmacy type. Training that addresses logistical and attitudinal barriers to dispensing buprenorphine may equip pharmacists to address buprenorphine access barriers.

FDA warns about dental problems associated with buprenorphine medications

In early January 2022, FDA released a Drug Safety Communication surrounding dental problems following use of buccal and sublingual buprenorphine products for the treatment of pain and opioid use disorder.

Rural and urban differences in undersupply of buprenorphine provider availability in the United States, 2018

BackgroundMedications to treat opioid use disorder (OUD) including buprenorphine products are evidence-based and cost-effective tools for combating the opioid crisis. However, limited availability to buprenorphine is pervasive in the United States (US) and may serve to exacerbate the deadly epidemic. Although prior research points to rural counties as especially needy of strategies that improve buprenorphine availability, it is important to investigate the availability of waivered providers according to treatment need as defined by the county-level rate of opioid-overdose deaths (OOD). This study examined differences in buprenorphine provider availability relative to treatment need among rural and urban counties in the US.MethodsBuprenorphine provider availability relative to need in each county was defined as the number of waivered providers divided by the rate of OODs (i.e., number of OODs/100,000 population), according to 2018 data. Counties with ratios in the bottom tertile of their state were classified as buprenorphine undersupplied. We estimated logit models to statistically test the association of rurality and state main effects and their interaction terms (independent variables) and the county classified as buprenorphine undersupplied (dependent variable).ResultsA total of 38 states and 2595 counties had sufficient non-suppressed data to remain in the analysis. A larger percent of urban counties (36.43%) than rural counties (32.01%) were classified as buprenorphine undersupplied (p = 0.001). The likelihood of a rural county being undersupplied varied considerably by state (Chi Square = 82.88, p = 0.000). All states with significant (p < 0.05 or p < 0.10) interaction terms showed lower likelihood of buprenorphine undersupply in rural counties.ConclusionsThe rural–urban distribution in undersupply of waivered buprenorphine providers relative to need varied markedly by state. Strategies for improving access to buprenorphine-waivered providers should be state-centric and informed by county-specific indicators of need.

The effect of Medicaid expansion on state-level utilization of buprenorphine for opioid use disorder in the United States

BackgroundResearch on the impact of Medicaid expansion on buprenorphine utilization has largely focused on the Medicaid program. Less is known about its associations with total buprenorphine utilization and non-Medicaid payers. MethodsMonthly prescription data (June 2013-May 2018) for proprietary and generic sublingual as well as buccal buprenorphine products were purchased from IQVIA®. Population-adjusted state-level utilization measures were constructed for Medicaid, commercial insurance, Medicare, cash, and total utilization. A difference-in-differences (DID) approach with population weights estimated the association between Medicaid expansion and buprenorphine utilization, while controlling for treatment capacity. ResultsMonthly total buprenorphine prescriptions increased by 68% overall and increased 283% for Medicaid, 30% for commercial insurance, and 143% for Medicare. Cash prescriptions decreased by 10%. The DID estimate for Medicaid expansion was not statistically significant for total utilization (−19.780, 95% CI = −45.118, 5.558, p = .123). For Medicaid buprenorphine utilization, there was a significant increase of 27.120 prescriptions per 100,000 total state residents (95% CI = 9.458, 44.782, p = .003) in expansion states versus non-expansion states post-Medicaid expansion. Medicaid expansion had a negative effect on commercial insurance (DID estimate = −37.745, 95% CI = −62.946, −12.544, p = .004), cash utilization (DID estimate = −6.675, 95% CI = −12.627, −0.723, p = .029), and Medicare utilization (DID estimate = −1.855, 95% CI = −3.697, −0.013, p = .048). DiscussionThe associations between Medicaid expansion and buprenorphine utilization varied across different types of payers, such that the overall impact of Medicaid expansion on buprenorphine utilization was not significant.

Opioid prescribing and prescription monitoring program use after buprenorphine discontinuation

AbstractIntroductionPrescription opioid use is not recommended in individuals with a history of opioid use disorder. Still, patients often experience pain or craving after buprenorphine discontinuation leading to opioid use. As complete, accessible, patient level records of controlled substance use, prescription monitoring programs (PMPs) may offer a useful tool to recognize recent treatment with buprenorphine and prevent new opioid use.ObjectiveThe objective of this study was to estimate the incidence of new opioid use after buprenorphine discontinuation and to measure the rate of provider and pharmacist PMP query prior to dispensing opioid analgesics to individuals with a recent history of buprenorphine treatment.MethodsA cohort of patients who initiated and discontinued a buprenorphine product between June 30, 2016 and July 4, 2018 was identified from the Texas PMP. Eligible participants were then followed for an additional 180 days to determine if they filled a prescription for an opioid medication after discontinuation. Records of PMP query were then used to measure the frequency with which prescribers and pharmacists queried the PMP prior to dispensing an opioid prescription after buprenorphine discontinuation.ResultsOf the 7081 eligible participants, 16.5% filled an opioid prescription after treatment discontinuation. Pharmacists or prescribers checked the PMP prior to prescribing or dispensing in only 116 of these 1169 instances (9.9%). Of those who filled an opioid prescription after discontinuation, 36.8% did so at a pharmacy where they previously filled a buprenorphine prescription.ConclusionsA considerable number of patients filled an opioid prescription after buprenorphine discontinuation. Despite the availability of the PMP, prescribers and pharmacists rarely use it when deciding whether to dispense an opioid prescription to an individual who recently discontinued buprenorphine. Reform focused on PMP workflow integration and usability may be a useful tool to reduce opioid use after buprenorphine discontinuation.

Prolonged-Release Buprenorphine Therapy in Opioid Use Disorder Can Address Stigma and Improve Patient Quality of Life.

Treatment for opioid use disorder (OUD) including opioid agonist therapy (OAT) is effective. Medication with the oral administration of methadone and buprenorphine has well-known limitations (establishing consistent optimal dosing levels, misuse, diversion, and accidental exposure). Treatment may require attendance at treatment services for collection and consumption of medication; this is associated with stigma and discrimination. Novel therapeutic options include approved, injectable, prolonged-release buprenorphine (PRB) products providing consistently optimal drug levels and less frequent dosing. This work assesses the lived experience of persons currently engaged in OUD therapy to define the potential value of novel therapeutic options in order to inform treatment decisions.One hundred and twenty-two people engaged with treatment services participated in this assessment. Seventy-two percent of participants believed that novel therapeutic options would improve quality of life and 67% stated it would reduce stigma and discrimination. Participants were neither concerned about the efficacy of (net score negative 30%), or lack of control over (net score negative 36%) treatment, nor about reduced contact with treatment services (net score negative 11%). Results from this assessment indicate that the provision of choice including novel therapeutic options is likely to improve quality of life and reduce the stigma of persons with OUD.

Brixadi, Sublocade competitor, resubmits application to FDA

While the Food and Drug Administration (FDA) granted tentative approval to Brixadi, a weekly and monthly injection of buprenorphine in December 2018, Indivior's Sublocade has exclusivity. Now Braeburn, owner of Brixadi, is back at the FDA with a resubmission for a New Drug Application, after the FDA cited deficiencies during an inspection at a third‐party manufacturing facility, according to the Pennsylvania‐based company. “Braeburn has worked closely with the third‐party manufacturer to address the deficiencies identified” by the FDA, the company stated in a June 15 press release. Brixadi is an extended‐release weekly (8 mg, 16 mg, 24 mg and 32 mg) and monthly (64 mg, 96 mg and 128 mg) injection for subcutaneous use that is under review by the FDA for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. “If approved, Brixadi would be used as part of a complete treatment plan to include counseling and psychosocial support,” according to the press release. “During the clinical development program, the safety profile of BRIXADI was generally consistent with the known safety profile of oral buprenorphine with the exception of mild‐to‐moderate injection‐site reactions.”

Switching pharmacies leads to gaps in medication possession in individuals treated with buprenorphine

BackgroundNot all pharmacies stock and dispense buprenorphine, potentially complicating continuous access to care for patients with opioid use disorder (OUD). This may become problematic if a patient’s primary pharmacy can no longer provide buprenorphine, and the patient cannot locate a new pharmacy. ObjectivesTo identify how often patients treated with buprenorphine for OUD switch pharmacies and to estimate the association between switching pharmacies and a clinically significant gap in therapy of 7 days or longer. MethodsA retrospective repeated measures longitudinal cohort design was used. Patients initiating treatment with a buprenorphine product indicated for OUD were identified from the 2016-2018 Texas Prescription Monitoring Program. The predictor of interest—switching pharmacies—was defined by comparing the dispensaries used between subsequent prescriptions. The outcome of interest was defined as a gap in medication possession of 7 days or longer on the basis of the National Quality Forum’s definition of continuity of pharmacotherapy for OUD. A generalized estimating equation approach was used to estimate a repeated measures logistic regression measuring the association between switching pharmacies and a gap in therapy. ResultsOf 13,375 eligible patients, 29.6% switched pharmacies at least once during treatment, and 51.6% of these did so more than once. The median time to initial switch was 30 days (interquartile range: 13-66 days). When patients switched pharmacies, they were significantly more likely to have a gap in therapy of between 7 and 29 days (adjusted odds ratio 1.67 [95% CI 1.57–1.78]). ConclusionPatients receiving buprenorphine switch pharmacies early and frequently in treatment, which leads to clinically significant gaps in therapy. Although qualitative explanatory work is needed to understand why patients switch pharmacies so often, pharmacists and prescribers must ensure that patients have reliable access to a convenient source of buprenorphine to prevent gaps in therapy.

1124 Maternal and neonatal outcomes in women with opioid use disorder treated with buprenorphine versus buprenorphine/naloxone

This study specifically assessed whether the formulation of buprenorphine impacts maternal and neonatal complications. This retrospective cohort study evaluated all women enrolled in our treatment program between 2015-2020. Inclusion criteria included those prescribed a buprenorphine product and delivery outcome. Women on methadone in this program were excluded. The primary outcome was the rate of NAS requiring medical treatment in those treated with and without naloxone. Secondary outcomes included gestational age at delivery, rates of NOWS, and neonatal length of stay. 310 patients were included with 129 (41.6%) receiving the mono-product and 181 treated with the combination product (58.4%). No significant differences were identified in GA at program start, total daily dose, educational, or housing, as seen in Table 1. Maternal outcomes did not differ between groups for the gestational age at delivery, birthweight, or frequency of preterm birth. Neonatal outcomes were also similar between groups for the frequency of medication treatment for NOWS, neonatal length of stay, and frequency of anomalies observed between these subpopulations. No cases of fetal death or acute withdrawal related to misuse with IV injection were reported. This large cohort study did not identify a difference in obstetric or neonatal outcomes with combination products versus mono-buprenorphine products. Neonatal outcomes were similar and no safety concerns were observed. Both formulations of buprenorphine should be considered as appropriate for use in obstetric populations.

Mechanisms of QT prolongation by buprenorphine cannot be explained by direct hERG channel block.

Buprenorphine is a μ-opioid receptor (MOR) partial agonist used to manage pain and addiction. QTC prolongation that crosses the 10 msec threshold of regulatory concern was observed at a supratherapeutic dose in two thorough QT studies for the transdermal buprenorphine product BUTRANS®. Because QTC prolongation can be associated with Torsades de Pointes (TdP), a rare but potentially fatal ventricular arrhythmia, these results have led to further investigation of the electrophysiological effects of buprenorphine. Drug-induced QTC prolongation and TdP are most commonly caused by acute inhibition of hERG current (IhERG) that contribute to the repolarizing phase of the ventricular action potentials (APs). Concomitant inhibition of inward late Na+ (INaL) and/or L-type Ca2+ (ICaL) current can offer some protection against proarrhythmia. Therefore, we characterized the effects of buprenorphine and its major metabolite norbuprenorphine on cardiac hERG, Ca2+, and Na+ ion channels, as well as cardiac APs. For comparison, methadone, a MOR agonist associated with QTC prolongation and high TdP risk, and naltrexone and naloxone, two opioid receptor antagonists, were also studied. Whole cell recordings were performed at 37°C on cells stably expressing hERG, CaV1.2, and NaV1.5 proteins. Microelectrode array (MEA) recordings were made on human induced pluripotent stem cell-derived cardiomyocytes (iPSC-CMs). The results showed that buprenorphine, norbuprenorphine, naltrexone, and naloxone had no effect on IhERG, ICaL, INaL, and peak Na+ current (INaP) at clinically relevant concentrations. In contrast, methadone inhibited IhERG, ICaL, and INaL. Experiments on iPSC-CMs showed a lack of effect for buprenorphine, norbuprenorphine, naltrexone, and naloxone, and delayed repolarization for methadone at clinically relevant concentrations. The mechanism of QTC prolongation is opioid moiety-specific. This remains undefined for buprenorphine, while for methadone it involves direct hERG channel block. There is no evidence that buprenorphine use is associated with TdP. Whether this lack of TdP risk can be generalized to other drugs with QTC prolongation not mediated by acute hERG channel block warrants further study.

The Impact on Future Prescribing Patterns of Opioid Use Disorder (OUD) Education and Waiver Provision During Residency.

Family medicine residency programs vary in the extent of training offered on opioid use disorder (OUD) in their curricula. The purpose of this study was to determine the impact of OUD education and buprenorphine waiver provision on postresidency buprenorphine prescribing patterns. Three North Carolina family medicine residency programs differed in the extent to which they taught OUD, including buprenorphine waiver provision. Program A required OUD education and assisted residents in obtaining a waiver; Program B offered OUD education and did not assist with obtaining a waiver; and Program C did not offer OUD education. In November 2019, graduates from these 3 programs were surveyed regarding the extent to which they engaged in treatment of OUD. Descriptive statistics were used to characterize the survey participants and their responses. Of the 62 graduates invited to participate, 49 (79.0%) responded. Across the 3 programs, the percentage of graduates with a waiver varied significantly (P < .0001): Program A (84.2%), Program B (33.3%), and Program C (0.0%). Of those who were not waivered, Program B had a larger percentage that desired to prescribe buprenorphine products (70.0%) as compared with Program C (9.1%) (P = .009). Family medicine residency graduates from programs with more integrated OUD education were more likely to obtain and use a waiver to prescribe buprenorphine-containing medications postgraduation.

Treatment of Opioid Dependence with Depot Buprenorphine (CAM2038) in Custodial Settings Is Safe, Effective and Cost-Effective

Background: Opioid agonist treatment (OAT) is effective but resource intensive to administer safely in custodial settings, leading to significant under-treatment of opioid dependence in these settings worldwide. Methods: This open-label trial compared depot buprenorphine, CAM2038 (weekly for 4 weeks then monthly) to oral methadone ( https://www.anzctr.org.au ACTRN12618000942257). Modelled treatment costs included a comparison group on sublingual buprenorphine-naloxone. Men and women, aged>18 years of various security classifications with a diagnosis of moderate to severe DSM-5 opioid use disorder and a custodial sentence of at least six months were recruited from correctional centres in New South Wales, Australia. Findings: Between November 2018 and July 2019, 67 patients not in OAT treatment at recruitment commenced depot buprenorphine. Sixty-two patients already stable on oral methadone treatment were recruited to the comparison arm. Patients treated with depot buprenorphine commonly reported at least one adverse event related to study drug (63/67, 94%), typically mild and transient. No diversion of depot buprenorphine was identified. Retention in depot buprenorphine treatment was 92%. Self-reported use of non-prescribed opioids (primarily buprenorphine-naloxone) and injecting drug use decreased significantly among depot buprenorphine patients by 16 weeks (p<0·0001). Monthly treatment costs were: $112AUD for injectable depot buprenorphine, $339AUD for oral methadone and $1,299AUD for sublingual buprenorphine-naloxone. Interpretation: The first published study to explore depot buprenorphine in custodial settings shows treatment retention, substance use and safety outcomes comparable to those observed in community settings and for other OAT used in custodial settings, without increased risk of diversion. Depot buprenorphine is a more efficient and less costly OAT delivery method requiring less health and custodial staff resources to administer. Enhanced access to depot buprenorphine should be considered for custodial settings worldwide. Trial Registration: (https://www.anzctr.org.au ACTRN12618000942257). Funding: NSW Health funded the study, and had input into design, data collection, analysis, interpretation and write-up. The JHFMHN provided clinical support for the study. Camurus AB provided CAM2038 for study participants with no right of veto of publication or dissemination of results. Declaration of Interests: AJD reports grants from Braeburn/Camurus AB, to conduct clinical studies with buprenorphine products and travel support to Hunter New England Local Health District, which employs AJD. He is an honorary investigator on an Indivior-funded study of buprenorphine products and has served on an advisory board for Mundipharma. PSH reports grants from Braeburn/Camurus AB, to conduct clinical studies with buprenorphine products and has served on advisory boards for Lundbeck, Indivior, AbbVie and Gilead. NL reports grants from Braeburn and Camurus AB to conduct sponsored, and investigator-led clinical studies with CAM2038. NL served on Advisory Boards for Mundipharma, Indivior and Chiesi Pharmaceuticals. MC was employed by the NSW Ministry of Health, sponsors of the study. All other authors declare no competing interests. Ethics Approval Statement: The trial was approved by JHFMHN and the Aboriginal Health and Medical Research Council (AHMRC) Human Research Ethics Committees (Protocol JH File No G561/17 & HREC/ 18/JH/3), as well as the CSNSW Ethics Committee. Participation was voluntary and written, informed consent was obtained from all participants prior to the conduct of any study procedure.

FDA issues guidance on endpoints for OUD medications

Last week, the Food and Drug Administration (FDA) issued guidance to help pharmaceutical companies develop drugs to treat opioid use disorder (OUD), defining the endpoints that are acceptable. This guidance, which is final, builds on the draft guidance as well as another guidance about depot buprenorphine products issued last year.

Operationalizing and selecting outcome measures for the HEALing Communities Study

BackgroundThe Helping to End Addiction Long-termSM (HEALing) Communities Study (HCS) is a multisite, parallel-group, cluster randomized wait-list controlled trial evaluating the impact of the Communities That HEAL intervention to reduce opioid overdose deaths and associated adverse outcomes. This paper presents the approach used to define and align administrative data across the four research sites to measure key study outcomes. MethodsPriority was given to using administrative data and established data collection infrastructure to ensure reliable, timely, and sustainable measures and to harmonize study outcomes across the HCS sites. ResultsThe research teams established multiple data use agreements and developed technical specifications for more than 80 study measures. The primary outcome, number of opioid overdose deaths, will be measured from death certificate data. Three secondary outcome measures will support hypothesis testing for specific evidence-based practices known to decrease opioid overdose deaths: (1) number of naloxone units distributed in HCS communities; (2) number of unique HCS residents receiving Food and Drug Administration-approved buprenorphine products for treatment of opioid use disorder; and (3) number of HCS residents with new incidents of high-risk opioid prescribing. ConclusionsThe HCS has already made an impact on existing data capacity in the four states. In addition to providing data needed to measure study outcomes, the HCS will provide methodology and tools to facilitate data-driven responses to the opioid epidemic, and establish a central repository for community-level longitudinal data to help researchers and public health practitioners study and understand different aspects of the Communities That HEAL framework.

Respiratory depression following medications for opioid use disorder (MOUD)-approved buprenorphine product oral exposures; National Poison Database System 2003–2019

Background Medications for opioid use disorder (MOUD) including buprenorphine is recommended for patients with opioid use disorders. We sought to evaluate the frequencies of respiratory depression, intubation, and naloxone administration, and clinical outcomes among patients reported to the National Poison Database System (NPDS) following single-substance and multiple-substance buprenorphine oral exposures. Methods NPDS was queried for all MOUD-approved buprenorphine product exposures between 1 January 2003 and 31 December 2019. Data abstracted included year, route, gender, age, site of exposure, management site, medical outcome, recorded “related” respiratory depression (“respiratory rate <10 breaths/min and/or a SpO2 (pulse oximetry)≤90%), reported administration of naloxone and intubation in oral exposure cases followed to known outcome. Concomitant products were also recorded in multiple-substance buprenorphine cases. Results 27,275 (11,010 multiple and 16,265 single) buprenorphine oral exposures were identified and followed to known outcome. A 65-fold increase in reported cases was reported over the study interval. A steady increase in the frequency of more serious outcomes by year was also observed. Respiratory depression occurred at a frequency of 11.8% (pediatric single-substance), 11.2% (pediatric multiple-substance), 11.3% (adult single-substance), and 11.9% (adult multiple-substance). Among oral exposures of buprenorphine and only one other product, benzodiazepines, opioids, ethanol, and amphetamines were most common. Conclusions Oral exposures have increased substantially between 2003 and 2019. More serious outcomes including deaths following oral exposures to buprenorphine have also increased over the same interval for both adult and pediatric patients. Clinically significant rates of respiratory depression in both adult and pediatric patients when taken alone and with additional substances were observed.

Notes from the Field: Emergency Visits for Complications of Injecting Transmucosal Buprenorphine Products - United States, 2016-2018.

Notes from the Field: Emergency Visits for Complications of Injecting Transmucosal Buprenorphine Products - United States, 2016-2018.

Chronic prescription opioid use predicts stabilization on buprenorphine for the treatment of opioid use disorder

IntroductionPrescription opioid misuse is a risk factor for opioid use disorder (OUD). Patients who misuse prescribed opioids and those who misuse illicit opioids are demographically and medically distinct groups, and research has shown there is heterogeneity in treatment response between these groups. The objective of this study was to measure the adjusted odds of successful stabilization on buprenorphine in patients with baseline prescription opioid use compared to those not prescribed opioids. MethodsA cohort of patients newly prescribed a buprenorphine product indicated for OUD between January 1 and November 30, 2018, were identified from the Texas Prescription Monitoring Program. We excluded those under the age of 15 and those who filled an opioid prescription after initiating buprenorphine to limit misclassification. We then stratified the cohort based on type of prescription opioid use in the pre-index period. We defined chronic opioid use as being prescribed opioids for a period of 90 out of 120 days, ending no sooner than 90 days prior to treatment initiation. We defined acute opioid use as filling any opioid prescription in the 90 days prior to initiating buprenorphine. The outcome of interest—stabilization on buprenorphine—was met by filling two prescriptions totaling 30-days' supply with no more than a six-day gap in therapy. We used multiple logistic regression to estimate the odds of stabilization in the prescription opioid use categories compared to those with no pre-index, opioid prescriptions. ResultsAmong 6756 eligible patients, 44.1% used prescription opioids in the 90 days prior to buprenorphine initiation. Of these, 62.2% met the criteria for acute prescription opioid use and 37.8% for chronic prescription opioid use. Patients with prescription opioid use at baseline were more likely to be older and insured compared to those with no prescription opioid use. After adjustment for covariates, both prescription opioid use groups were significantly more likely to be successfully stabilized on therapy (Acute: aOR = 1.53, 95% CI = 1.37–1.72; Chronic: aOR = 2.43, 95% CI = 2.08–2.85). In a second model, those with chronic prescription opioid use were significantly more likely than those with acute prescription opioid use to be successfully stabilized (aOR = 1.60, 95% CI = 1.31–1.90). ConclusionPersistence to buprenorphine treatment for OUD is, in part, dependent on baseline prescription opioid use. This study suggests that patients with chronic prescription opioid use may be more likely than nonprescription opioid users to be successfully stabilized on treatment and may thus benefit more from pharmacotherapy with buprenorphine than those with no prescription opioid use. Failing to account for this variation in future studies of buprenorphine treatment persistence may lead to significant residual confounding and biased results. Extending access to buprenorphine among those with prescription OUD may have a significant impact on opioid related morbidity and mortality.

How Motivations for Using Buprenorphine Products Differ From Using Opioid Analgesics: Evidence from an Observational Study of Internet Discussions Among Recreational Users.

BackgroundOpioid use disorder (OUD) poses medical and societal concerns. Although most individuals with OUD in the United States are not in drug abuse treatment, buprenorphine is considered a safe and effective OUD treatment, which reduces illicit opioid use, mortality, and other drug-related harms. However, as buprenorphine prescriptions increase, so does evidence of misused, abused, or diverted buprenorphine. Users’ motivations for extratreatment use of buprenorphine (ie, misuse or abuse of one’s own prescription or use of diverted medication) may be different from the motivations involved in analgesic opioid products. Previous research is based on small sample sizes and use surveys, and none directly compare the motivations for using buprenorphine products (ie, tablet or film) with other opioid products having known abuse potential.ObjectiveThe aim of the study was to describe and compare the motivation-to-use buprenorphine products, including buprenorphine/naloxone (BNX) sublingual film and oxycodone extended-release (ER), as discussed in online forums.MethodsWeb-based posts from 2012 to 2016 were collected from online forums using the Web Informed Services internet monitoring archive. A random sample of posts was coded for motivation to use. These posts were coded into the following motivation categories: (1) use to avoid withdrawal, (2) pain relief, (3) tapering from other drugs, (4) opioid addiction treatment, (5) recreational use (ie, to get high), and (6) other use. Oxycodone ER, an opioid analgesic with known abuse potential, was selected as a comparator.ResultsAmong all posts, 0.81% (30,576/3,788,922) discussed motivation to use one of the target products. The examination of query-selected posts revealed significantly greater discussion of buprenorphine products than oxycodone ER (P<.001). The posts mentioning buprenorphine products were more likely than oxycodone ER to discuss treatment for OUD, tapering down use, and/or withdrawal management (P<.001). Buprenorphine-related posts discussed recreational use (375/1020, 36.76%), although much less often than in oxycodone ER posts (425/508, 83.7%). Despite some differences, the overall pattern of motivation to use was similar for BNX sublingual film and other buprenorphine products.ConclusionsAn analysis of spontaneous, Web-based discussion among recreational substance users who post on online drug forums supports the contention that motivation-to-use patterns associated with buprenorphine products are different from those reported for oxycodone ER. Although the findings presented here are not expected to reflect the actual use of the target products, they may represent the interests and motivations of those posting on the online forums. Buprenorphine-related posts were more likely to discuss treatment for OUD, tapering, and withdrawal management than oxycodone ER. Although the findings are consistent with a purported link between the limited availability of medication-assisted therapies for substance use disorders and use of diverted buprenorphine products for self-treatment, recreational use was a motivation expressed in more than one-third of buprenorphine posts.