Perception of a New Prolonged-Release Buprenorphine Formulation in Patients with Opioid Use Disorder: The PREDEPO Study.

AIM: The aim of the study was to assess the acceptance of patients with opioid use disorder (OUD) to switching their opioid dependence treatment (ODT) for a prolonged-release buprenorphine (PRB) injection according to their prior ODT (buprenorphine/naloxone [B/N] or methadone). METHODS: This was an observational, retrospective/cross-sectional, multicentre study of adult patients diagnosed with OUD on ODT. Data collected from diaries were analysed to know their interest and opinion on PRB. Questions with fixed response options were included, and several Likert scales were used. RESULTS: A total of 98 patients were enrolled (B/N: 50.0%, methadone: 50.0%). The mean age was 46.9 ± 8.43 years and 79.6% were males. PRB was similarly perceived by both groups in most variables analysed, receiving a mean score of 7.2/10 (B/N: 7.4, methadone: 7.0; p = 0.520), and approximately 65% of patients said they were willing to switch to PRB (B/N: 63.3%, methadone: 65.3%; p = 0.833). Of these, a higher percentage in the B/N group considered that switching would be easy/very easy (B/N: 90.3%, methadone: 46.9%; p < 0.001) and that they would start PRB when available (B/N: 64.5%, methadone: 34.3%; p = 0.005). More than 90% would prefer the monthly injection (B/N: 93.6%, methadone: 100%; p = 0.514). One-third of patients in both groups were unsure/would not switch their ODT to PRB (B/N: 36.7%, methadone: 34.7%; p = 0.833). The main reason was administration by injection. CONCLUSION: Two-thirds of patients would switch their treatment for PRB, and most patients on B/N considered that switching would be easy. PRB could be a suitable alternative for OUD management.

Patients'satisfaction and experience in treatment with opioid substitution therapy in Spain. The PREDEPO study. / Satisfacción y experiencia de pacientes en tratamiento con sustitutivos opioides en España. Estudio PREDEPO.

The aim of this study was to compare patients' satisfaction, experience, objectives, and opinion based on their current opioid substitution therapy (OST) (buprenorphine/naloxone (B/N) or methadone). The PREDEPO study is an observational, cross-sectional, multicentric study performed in Spain. Adult patients diagnosed with opioid use disorder (OUD) receiving OST were included. They were asked to fill in a questionnaire regarding their current OST. A total of 98 patients were enrolled (B/N: 50%, methadone: 50%). Mean age was 47 ± 8 years old and 80% were male. Treatment satisfaction was similar between groups. The most frequently reported factor for being "very/quite satisfied" was "being able to distribute the dose at different times throughout the day" (44% B/N vs. 63% methadone; p = .122). A significantly lower proportion of patients in the B/N group versus the methadone group reported that having to collect the medication daily was "very/quite annoying" (19% vs. 52%, p = .032). Treatment objectives reported by the majority of patients were similar between groups ("not feeling in withdrawal anymore", "reduce/definitely stop drug use", "improve my health", and "stop thinking about using daily") except for "not having money problems anymore" (73% B/N vs. 92% methadone; p = .012).  These results suggest there are several unmet expectations regarding current OST. There is a need for new treatments that reduce the burden of OUD, avoid the need for daily dosing, and are less stigmatizing which in turn could improve patient management, adherence and, quality of life.

El objetivo es comparar la satisfacción, experiencia, objetivos y opinión de los pacientes con trastorno por consumo de opioides (TCO) en base a su tratamiento sustitutivo de opioides (TSO) actual (metadona o buprenorfina/naloxona (B/N)). El estudio PREDEPO es un estudio observacional, transversal, multicéntrico desarrollado en España que incluyó pacientes adultos, diagnosticados de TCO y en TSO, quienes contestaron una encuesta sobre su tratamiento actual. Se incluyeron 98 pacientes (B/N:50%, metadona:50%): edad media de 47 ± 8 años y el 80% varones. A nivel de la satisfacción con su tratamiento, los resultados fueron similares entre grupos. El factor "muy/bastante satisfactorio" que se reportó con mayor frecuencia fue "poder repartir las dosis en varios momentos del día" (44% B/N vs. 63% metadona; p = ,122). Se encontraron diferencias significativas en "tener que recoger la medicación diariamente" donde una menor proporción en el grupo B/N contestaron "muy/bastante molesto" versus el grupo metadona (19% vs. 52%, p = ,032). Los objetivos reportados por la mayoría de los pacientes fueron similares entre grupos ("no sentir más síndrome de abstinencia", "disminuir o dejar definitivamente mi consumo de drogas", "mejorar mi estado de salud" y "dejar de pensar en consumir todos los días") excepto en "no tener más problemas de dinero" (72% B/N vs. 92% metadona; p = ,012). Estos resultados evidencian que existen expectativas no cubiertas con los TSO actuales y la necesidad de nuevos tratamientos que disminuyan la carga de la enfermedad, eviten la necesidad de una dosificación diaria y reduzcan el estigma, mejorando así el manejo del paciente, su adherencia y calidad de vida.

Does ICD-11 improve the epidemiological and nosological purposes of mental, behavioral and developmental disorders? / ¿Mejora la CIE-11 los propósitos epidemiológicos y nosológicos de los Trastornos mentales, del comportamiento y del desarrollo?

Editorial of vol 31(3).

Editorial del vol 31(3).

Panniculectomy at the Time of Cesarean Section and Postoperative Wound Complications in Morbidly Obese Women.

OBJECTIVE: To determine whether a modified abdominal panniculectomy at the time of cesarean delivery decreases wound complications in morbidly obese women. STUDY DESIGN: This is a retrospective cohort study of 59 morbidly obese patients who delivered via cesarean section at a single center between 2003 and 2009. A total of 30 morbidly obese patients who underwent modified panniculectomy at the time of cesarean section were compared to a control group of 29 morbidly obese women who underwent cesarean section alone. RESULTS: Of the 30 women who underwent modified panniculectomy at the time of cesarean, 3% (n = 1) developed operative site infection that required readmission. In the control group, 24% (n = 7) developed operative site infection (p = 0.026), and 10% (n = 3) were readmitted (p = 0.35). There was no difference in the postpartum length of hospital stay, intraoperative blood loss, operative time and infant delivery time between the two groups. CONCLUSION: In our cohort, morbidly obese women who underwent panniculectomy at the time of cesarean section had lower incidence of wound complications without significant increase in operative time, hospital length of stay, and infant delivery time. Modified panniculectomy at the time of cesarean may be a useful adjunct in an effort to decrease postoperative infectious morbidity in obese patients. However, the effects of the procedure on long-term healing,future obstetric outcomes, and other medical conditions warrant further evaluation.

Management of opioid-dependent patients: comparison of the cost associated with use of buprenorphine/naloxone or methadone, and their interactions with concomitant treatments for infectious or psychiatric comorbidities.

The objective was to estimate the annual interaction management cost of agonist opioid treatment (AOT) for opioid-dependent (OD) patients with buprenorphine-naloxone (Suboxone®) (B/N) or methadone associated with concomitant treatments for infectious (HIV) or psychiatric comorbidities. A costs analysis model was developed to calculate the associated cost of AOT and interaction management. The AOT cost included pharmaceutical costs, drug preparation, distribution and dispensing, based on intake regimen (healthcare center or take-home) and type and frequency of dispensing (healthcare center or pharmacy), and medical visits. The cost of methadone also included single-dose bottles, monthly costs of custody at pharmacy, urine toxicology drug screenings and nursing visits. Potential interactions between AOT and concomitant treatments (antivirals, antibacterials/antifungals, antipsychotics, anxiolytics, antidepressant and anticonvulsants), were identified to determine the additional use of healthcare resources for each interaction management. The annual cost per patient of AOT was €1,525.97 for B/N and €1,467.29 for methadone. The average annual cost per patient of interaction management was €257.07 (infectious comorbidities), €114.03 (psychiatric comorbidities) and €185.55 (double comorbidity) with methadone and €7.90 with B/N in psychiatric comorbidities. Total annual costs of B/N were €1,525.97, €1,533.87 and €1,533.87 compared to €1,724.35, €1,581.32 and €1,652.84 for methadone per patient with infectious, psychiatric or double comorbidity respectively.Compared to methadone, the total cost per patient with OD was lower with B/N (€47.45-€198.38 per year). This is due to the differences in interaction management costs associated with the concomitant treatment of infectious and/or psychiatric comorbidities.

El objetivo fue estimar en pacientes con dependencia a opiáceos (DO), el coste anual del manejo de interacciones del tratamiento sustitutivo con buprenorfina/naloxona (Suboxone®) (B/N) o metadona, asociado con tratamientos concomitantes por comorbilidades infecciosas (VIH) o psiquiátricas. Se realizó un análisis de costes (€, 2013), del tratamiento sustitutivo y del manejo de interacciones. El coste del tratamiento de B/N incluyó costes farmacológicos, elaboración, distribución y dispensación, en función del régimen de administración (centro asistencial o domiciliaria) y del tipo y frecuencia de dispensación (centro asistencial o farmacia), y visitas al especialista para prescripción. El coste de tratamiento con metadona incluyó, además, frascos monodosis, coste de custodia en farmacia, determinación en orina y visitas a enfermería. Se identificaron las interacciones para determinar los recursos sanitarios adicionales consumidos por la administración conjunta del tratamiento sustitutivo y concomitante (antirretrovirales, bactericidas/antifúngicos, antipsicóticos, ansiolíticos, antidepresivos y anticonvulsivos). El coste anual/paciente estimado del tratamiento sustitutivo fue de 1.525,97€ (B/N) y 1.467,29€ (metadona). El coste promedio anual/paciente estimado del manejo de interacciones fue de 257,07€ (infecciosas), 114,03€ (psiquiátricas) y 185,55€ (ambas) con metadona, y de 7,90€ con B/N por comorbilidades psiquiátricas. El coste total anual/paciente estimado de B/N fue 1.525,97€, 1.533,87€ y 1.533,87€ comparado con 1.724,35€, 1.581,32€ y 1.652,84€ de metadona, en pacientes que presentan comorbilidad infecciosa, psiquiátrica o ambas, respectivamente. Comparado con metadona, el coste total por paciente con DO de B/N fue menor (47,45€-198,38€ anuales) derivado de la diferencia del coste por manejo de interacciones del tratamiento concomitante de las comorbilidades infecciosas y/o psiquiátricas.

Practical steps to improve chronic hepatitis C treatment in people with opioid use disorder.

OBJECTIVES: People with a history of injecting drugs have high prevalence of hepatitis C virus (HCV) infection, and many have opioid use disorder (OUD). Modern HCV therapies with improved efficacy and tolerability are available, but access is often limited for this group, who may be underserved for health care and face social inequity. This work develops practical steps to improve HCV care in this population. METHODS: Practical steps to improve HCV care in OUD populations were developed based on clinical experience from Spain, structured assessment of published evidence. RESULTS: Options for improving care at engagement/screening stages include patient education programs, strong provider-patient relationship, peer support, and adoption of rapid effective screening tools. To facilitate work up/treatment, start options include simplified work up process, integration of HCV and OUD care, and continuous psychosocial support prior, during, and after HCV treatment. CONCLUSION: It is important to plan on local basis to set up a joint integrated approach between specific drug treatment services and local points of HCV care. The elements for a specific integrated program should be chosen from options identified, including education services, peer input, organization to make HCV screening and treatment easier by co-location of services, and wider access to prescribing direct-acting antiviral (DAA) therapy.