Opioid use during pregnancy can result in the newborn being physically dependent on the substance, thus experiencing drug withdrawal, termed neonatal abstinence syndrome (NAS). Buprenorphine and methadone are two drugs used to treat opioid withdrawal and are approved for use in pregnancy. Quantification of these compounds in umbilical cord plasma would help assess in utero exposure of neonates in cases of buprenorphine or methadone use during pregnancy. An LC-MS/MS method using solid-phase extraction sample preparation was developed and validated for the simultaneous quantification of methadone, buprenorphine, norbuprenorphine, and glucuronide metabolites in umbilical cord plasma. The average accuracy (percentage error) and precision (relative standard deviation) were

No description available.

Objectives The objectives of this study included developing and validating a stability-indicating high-performance liquid chromatographic (HPLC) method with ultraviolet (UV) detection for the determination of buprenorphine in a buccal solution for veterinary use, and applying that method to determine the stability of a 3 mg/ml buprenorphine preparation in room temperature and refrigerated storage conditions. This preparation, intended for buccal administration in feline patients, plays an important role in pain management in cats. Methods A stability-indicating HPLC method was developed and validated for system suitability, accuracy, repeatability, intermediate precision, specificity, linearity and robustness based on US Pharmacopeia (USP) General Chapter. The method was then applied to the study of potency changes over 90 days in a buccal buprenorphine solution stored at two temperatures. Results All HPLC-UV method data met acceptable criteria for the quantification of buprenorphine in a buccal solution formulation. The buprenorphine concentrations found in each stability sample remained within the 90–110% of label claim throughout the 90 days of study. All stability test bottles of the buprenorphine buccal solution retained their original appearance. For the room temperature bottles, some white particulate matter was noted in the threads of the container bottles starting at day 21. The pH of the preparations during the course of the study was in the range of 3.57–4.06 and 4.01–4.16 for the room temperature and refrigerated samples, respectively. Conclusions and Relevance Pharmacists have compounded a concentrated 3 mg/ml buccal solution to use easily in the home care or outpatient setting for treatment of feline pain. Prior to this investigation, pharmacists empirically assigned beyond-use dates to this formulation based on standards in USP General ChapterPharmaceutical Compounding – Nonsterile Preparations. This study of a 3 mg/ml buprenorphine buccal solution indicates stability through 90 days.

Purpose In recent years, there has been a significant increase in opioid-related drug use among pregnant mothers, specifically Methadone, Subutex (Buprenorphine) and Suboxone (Buprenorphine and Naloxone) resulting in increased neonatal intensive care unit (NICU) admissions for treatment of neonatal abstinence syndrome (NAS). Standard tests such as urine, meconium, and cord stat blood samples have not been shown to accurately demonstrate maternal abuse of these medications or predict the clinical course of NAS. This study aims to correlate and compare clinical symptoms of NAS with cord/ placental blood concentrations of Buprenorphine, Methadone and their metabolites. Another goal is to demonstrate the ability to correctly identify maternal abuse and concentrations of these medications. Methods The design was an observational study where cord/placental blood samples were obtained from eligible subjects. In addition to the standard cord stat test done by state, samples were analyzed using liquid chromatography mass spectrometry (LC-MS/MS) to quantify the metabolites of Buprenorphine, Norbuprenorphine and Methadone. Investigators performing the LC-MS/MS were blinded. Infants were treated on attending physician’s discretion according to clinical course. All infants were followed until discharge. Demographics and clinical course, including NICU stay, were recorded. Results A total of 19 mothers were enrolled, out of which, 15 (78.9%) mothers were on Subutex, 2 (10.5%) on Suboxone and 2 (10.5%) on Methadone. Data analysis was performed only on subjects with exposure to Subutex due to low sample size for Suboxone and Methadone subjects. Cord stat performed by the state lab was negative in 33.3% of subjects; however, 100% of the cord blood samples tested by LC-/MSMS were positive. The percentage of neonates transferred to NICU for NAS was 60% of which 67% received replacement therapy. Length of stay in NICU for treatment of NAS did not have any correlation to the concentration of the metabolites in cord blood. Pearson’s correlation coefficient (r) between duration of NICU stay and Norbuprenorhine concentration was r = -0.07 (p-value = 0.40); Buprenorphine concentration was r = -0.30 (p-value = 0.14); Norbuprenorphine-glucoronate concentration was r = -0.05 (p-value = 0.43); Buprenorphine-glucoronate concentration was r = -0.31 (p-value = 0.13). No correlation was found after adding the concentrations of all the above metabolites with NICU stay r = -0.24 (p-value = 0.19). Conclusion The cord stat result is inferior to cord/placental blood levels of drug metabolites using LC-MS/MS for diagnosing maternal substance abuse in at risk infants. No correlation was found between the concentrations of metabolites and length of stay in NICU or duration of replacement therapy. This study was limited by a small sample size.

No description available.

No description available.

Opioid dependence and opioid related deaths are a public health problem which the United States Centers of Disease Control have declared an epidemic. While opioid agonist therapy for opioid addiction has been accepted as the most effective treatment for opioid dependence among academics, and office based buprenorphine treatment has been available in the Unites States for over 10 years, OB buprenorphine faces many barriers to widespread adoption. Empirical data on the geographic distribution of physicians able to prescribe buprenorphine and the prescribing patterns of those physicians show considerable unevenness in access and utilization of treatment services. Federal-level policies have recently been implemented to expand access to opioid agonist therapy, but the medium and long term impacts of these policy changes on individual outcomes, public health, and geographic access equity are not yet clear. This dissertation compares two recent federal level policies on expanding access to buprenorphine treatment: raising the regulatory limit on the number of patients a provider can treat (implemented July, 2016), and extending prescribing privileges to nurse practitioners and physician assistants (implemented February, 2017), using an empirically supported Agent Based Simulation model. Policies are assessed by a novel, at-a-glance, quantitative access equity metric: the Spatial Potential Access Gini Index, in addition to year-end treatment utilization, opioid overdose deaths, and the amount of illicit medication diversion. In the simulation, expanding access by increasing the patient limit did not result in more equitable spatial access, while extending prescribing to NPs and PAs increased both utilization and spatial access equity. This is likely due to empirically supported model assumptions that NPs and PAs providing primary care often serve in medically underserved areas including rural and remote regions. Extending prescribing to these practitioners opens up new treatment locations changing the spatial distribution of treatment opportunities. Changing patient limits does not change the overall spatial distribution of services, so spatial access equity does not change even if overall treatment supply gets better or worse. The primary contribution of this work is the Spatial Potential Access Lorenz Curve and the Spatial Potential Access Gini Index, measures that aggregate individual-level Spatial Potential Access Scores commonly used in health care geography to map and identify areas of access disparity within a region. The equitability of Spatial Potential Access is calculated by using the Lorenz Curve, which is commonly used to characterize the distribution of wealth or income in a society, from which a Gini Index is calculated. The Spatial Potential Access Gini Index allows for direct comparison of complex quantitative information about the geographic distribution of supply and demand in a region with other regions, or in response to policies that impact supply or demand within the region. The measure has potential applications in simulation studies on the spatial allocation of services, allowing equity assessment of policy alternatives, as well as in empirical work, allowing equity comparisons of different regions, or in hybrid studies in which policy experiments are conducted on data-rich maps.

Ergebnisse einer breit angelegten Repräsentativerhebung zur Substitutionstherapie in Deutschland an 2694 Patienten zeigen, dass trotz hoher und komplexer Ko- und Multimorbidität mit psychischen Erkrankungen nur selten Psychiater an der Therapie beteiligt sind. Nur 16% der Substitutionsärzte (n=223) sind Psychiater oder Psychotherapeuten und nur 21% der substituierten Drogenabhängigen werden von Psychiatern behandelt. Die meisten substituierenden Psychiater sind in Institutsambulanzen psychiatrischer Kliniken tätig (51,3%), kaum in eigener Praxis (7,2%). Der Großteil der Substitutionsversorgung wird von Allgemein- und Hausärzten geleistet. Die relative Abstinenz psychiatrischer Kollegen bei der Substitution drogenabhängiger Patienten wird kritisch diskutiert. / Results of a nationally representative study in 2,694 patients reveal that most physicians (n=223) involved in substitution treatment of opioid-dependent patients are general practitioners, while only 16% have a psychiatric/psychotherapeutic background and only 21% of the addictive patients are treated by psychiatrists. This contrasts with the remarkably complex pattern of co- and multimorbidity with other mental disorders in such patients. Most psychiatrists engaged in substitution treatment work in specialized outpatient wards (51.3%), and few were operative in their own or private practice (7.2%). Implications of these critical findings are discussed.

Aims: To examine how patients with experience of being involuntarily discharged from medication-assisted treatment with methadone or buprenorphine have coped with the consequences following the discharge. The study also aim to examine how the patients cope with the stigma related to their abuse of heroin and how they manage to cope with the rules regarding themedication-assisted treatment. Method: Three patients with experience of involuntary discharge from medication-assisted treatment have been interviewed. All were heroin abusing men living in Stockholm. The interviewees were recruited through the Swedish Drug Users Union and through a shelter for homeless people with drug problems. Results: All the discharged patients experienced a hard time after the discharge. One went back to abuse heroin and the other two began to buy methadone or burprenorphine on the black market. All of them also experienced it difficult to cope with the stigma and considered that there were many obstacles in their life caused by the treatment rules. Conclusion: The discharge led to harsh consequences for all the patients. Heroin addicts need to deal with a lot of stigma related both to their drug abuse and the medical assisted treatment and find it difficult to manage that.

Studiens syfte är att undersöka hur behandlingspersonal vid en opiatmottagning i en stor stad i Sverige ser på substitutionsbehandling och vilken betydelse behandlingsformen har för klientgruppen. Studien baseras på fyra kvalitativa semistrukturerade intervjuer med personal som har olika professioner (kurator, sjuksköterska, läkare samt psykolog) vid en för studien relevant behandlingsenhet. För att analysera det inkomna materialet har följande fem teorier använts: biologiska teorier, systemteorier, stämplingsteori, behavioristiska teorier samt psykodynamiska teorier/anknytningsteori. Resultaten visar att personalen överlag har en liknande syn på bakgrunden till ett drogmissbruk då samtliga anser att orsaken beror på både genetiska och sociala faktorer. Personalen anser även att behandlingsenhetens klienter är i behov av kemiskt framställda opiater (buprenorfin eller metadon) för att kunna bryta med sitt drogmissbruk, detta då det bidrar till att klienterna kan börja fokusera på andra livsområden utöver droganvändandet. Vidare visar resultaten att personalen anser att behandlingens längd varierar från individ till individ. Gruppen opiatberoende anses vara en resurskrävande grupp och önskemål finns gällande bättre samarbete med – för klienten – relevanta myndigheter. Sammanfattningsvis anser personalen att klienterna – genom behandlingen – får hjälp att uppnå ett drogfritt liv, bli en del av samhället, känna sig tillfreds med sig själva; genom detta får klienterna ett bättre och mer stabilt liv. / The purpose of this study is to examine how personnel working at a opiate substitution treatment clinic in a large city in Sweden view the treatment method and how important they reckon that the treatment is for the clientele. The study is based on four qualitative semi-structured interviews with a professional team that consists of counsellor, nurse, doctor and psychologist. To analyze the data the following five theories have been used: biological theories, system theories, labeling theory, behavioristic theories and psychodynamic theories/attachment theory. The results show that the professional team generally have a similar view on the background variables of drug addiction as they generally believe it depends on genetic and social factors. The main consensus of the team is that the clients are in need of chemically manufactured opiates (buprenorphine or methadone) to end their drug addiction because it helps the clients to focus on other areas, besides drugs, in their lives. The results also show that the team believe that the length of the treatment varies from individual to individual. Opiate addicts are considered to be a resource-demanding group and the team would like a better co-operation with relevant authorities. In conclusion the personnel believe that the clients – with help from the treatment method – can reach a life without drugs, become a part of the society and feel satisfied with themselves; with this the clients get a better and more stabile life.