All-oral direct-acting antiviral therapy against hepatitis C virus (HCV) in human immunodeficiency virus/HCV-coinfected subjects in real-world practice: Madrid coinfection registry findings.

We evaluated treatment outcomes in a prospective registry of human immunodeficiency virus/hepatitis C virus (HCV)-coinfected patients treated with interferon-free direct-acting antiviral agent-based therapy in hospitals from the region of Madrid between November 2014 and August 2016. We assessed sustained viral response at 12 weeks after completion of treatment and used multivariable logistic regression to identify predictors of treatment failure. We evaluated 2,369 patients, of whom 59.5% did not have cirrhosis, 33.9% had compensated cirrhosis, and 6.6% had decompensated cirrhosis. The predominant HCV genotypes were 1a (40.9%), 4 (22.4%), 1b (15.1%), and 3 (15.0%). Treatment regimens included sofosbuvir (SOF)/ledipasvir (61.9%), SOF plus daclatasvir (14.6%), dasabuvir plus ombitasvir/paritaprevir/ritonavir (13.2%), and other regimens (10.3%). Ribavirin was used in 30.6% of patients. Less than 1% of patients discontinued therapy owing to adverse events. The frequency of sustained viral response by intention-to-treat analysis was 92.0% (95% confidence interval, 90.9%-93.1%) overall, 93.8% (92.4%-95.0%) for no cirrhosis, 91.0% (88.8%-92.9%) for compensated cirrhosis, and 80.8% (73.7%-86.6%) for decompensated cirrhosis. The factors associated with treatment failure were male sex (adjusted odds ratio, 1.75; 95% confidence interval, 1.14-2.69), Centers for Diseases Control and Prevention category C (adjusted odds ratio, 1.65; 95% confidence interval, 1.12-2.41), a baseline cluster of differentiation 4-positive (CD4+) T-cell count <200/mm3 (adjusted odds ratio, 2.30; 95% confidence interval, 1.35-3.92), an HCV RNA load ≥800,000 IU/mL (adjusted odds ratio, 1.63; 95% confidence interval, 1.14-2.36), compensated cirrhosis (adjusted odds ratio, 1.35; 95% confidence interval, 0.96-1.89), decompensated cirrhosis (adjusted odds ratio, 2.92; 95% confidence interval, 1.76-4.87), and the use of SOF plus simeprevir, SOF plus ribavirin, and simeprevir plus daclatasvir. CONCLUSION: In this large real-world study, direct-acting antiviral agent-based therapy was safe and highly effective in coinfected patients; predictors of failure included gender, human immunodeficiency virus-related immunosuppression, HCV RNA load, severity of liver disease, and the use of suboptimal direct-acting antiviral agent-based regimens. (Hepatology 2018;68:32-47).

Overview of biosimilar medicines in Spain: market dynamics, policies, evidence-based insights and avenues for a sustainable market.

INTRODUCTION: After 17 years on the market, biosimilar medicines have contributed significantly to the sustainability of healthcare in Spain, providing cost-effective treatment options and savings of more than €1 billion by 2022 alone. To fully exploit this potential and meet the European pharmaceutical strategy's objectives of increased access and a resilient supply chain, Member States need to optimize their biosimilars policies. AREAS COVERED: We conducted an exhaustive review of biosimilar medicines in Spain, first describing their regulatory framework. Biosimilar policies at both national and regional level have been collected and updated figures on the biosimilars market are provided based on official data. Knowledge and acceptance of biosimilar medicines among patients and medical societies based on biosimilar positioning documents is reviewed. National evidence on the contribution of biosimilars to savings and sustainability is also included in this study. EXPERT OPINION: In Spain, there is a need to further build confidence in biosimilars, develop a strong national biosimilars policy and address regional variability, improve public procurement and adapt clinical practice guidelines following the commercialization of biosimilars. By implementing a holistic and evidence-based policy, Spain can fully exploit the benefits of biosimilar medicines and ensure better and equitable access across the healthcare system.

[Tracing the map of medication errors outside the hospital environment in the Madrid Community]. / Trazando el mapa de errores de medicación en el ámbito extrahospitalario de la Comunidad de Madrid.

OBJECTIVE: Preparation of a map of medication errors reported by health professionals outside hospitals within the framework of Medication Errors Reporting for the Community of Madrid during the period 2008-2009. DESIGN: Retrospective observational study. LOCATION: Notification database of medication errors in the Community of Madrid. PARTICIPANTS: Notifications sent to the web page: Safe Use of Medicines and Health Products of the Community of Madrid. MEASUREMENTS: Information on the originator of the report, date of incident, shift, type of error and causes, outcome, patient characteristics, stage, place where it was produced and detected, if the medication was administered, lot number, expiry date and the general nature of the drug and a brief description of the incident. RESULTS: There were 5470 medication errors analysed, of which 3412 came from outside hospitals (62%), occurring mainly in the prescription stage (56.92%) and being more reported pharmacists. No harm was done in 92.9% of cases, but there was harm in 4.8% and in 2.3% there was an error that could not be followed up. CONCLUSIONS: The centralization of information has led to the confirmation that the prescription is a vulnerable point in the chain of drug therapy. Cleaning up prescription databases, preventing the marketing of commercial presentations that give rise to confusion, enhanced information to professionals and patients, and establishing standardised procedures, and avoiding the use of ambiguous prescriptions, illegible, or abbreviations, are useful strategies to try to minimise these errors.

Adaptation of oral medication in people institutionalized in nursing homes for whom medication is crushed: The ADECUA Study.

PURPOSE: To evaluate the effect of pharmacist interventions in the adaptation of pharmaceutical forms in elders institutionalized in nursing homes whose medicines are crushed, which may have a clinical relevance. METHODS: Quasi-experimental, multicenter, transversal and prospective study carried out in 10 nursing homes. Subjects for whom drugs were being crushed were identified. Their treatments were reviewed in order to identify drugs that should not be crushed. In these cases, we proposed an alternative to the physician and we evaluated the degree of acceptance, its association to other variables and the pre-post adaptation index (tablets that can be crushed and capsules that can be opened/ total number of tablets and capsules before and after the intervention). Moreover, health professionals received a training course. RESULTS: Medication was being crushed for 33% (618/1875) of residents (mean: 5 drugs susceptible of crushing). 220 pharmaceutical interventions were performed, mostly in extended release or gastro-resistant drugs (48% were accepted). Switch was the type of intervention more frequent (79%), mainly to Purpose: To evaluate the effect of pharmacist interventions in the adaptation of pharmaceutical forms in elders institutionalized in nursing homes whose medicines are crushed, which may have a clinical relevance. METHODS: Quasi-experimental, multicenter, transversal and prospective study carried out in 10 nursing homes. Subjects for whom drugs were being crushed were identified. Their treatments were reviewed in order to identify drugs that should not be crushed. In these cases, we proposed an alternative to the physician and we evaluated the degree of acceptance, its association to other variables and the pre-post adaptation index (tablets that can be crushed and capsules that can be opened/ total number of tablets and capsules before and after the intervention). Moreover, health professionals received a training course. RESULTS: Medication was being crushed for 33% (618/1875) of residents (mean: 5 drugs susceptible of crushing). 220 pharmaceutical interventions were performed, mostly in extended release or gastro-resistant drugs (48% were accepted). Switch was the type of intervention more frequent (79%), mainly to.

Objetivo: Evaluar el efecto de la intervención del farmacéutico en la adecuación de formas farmacéuticas en ancianos institucionalizados en residencias de mayores a los que se les tritura la medicación y cuya alteración pueda tener relevancia clínica. Método: Estudio cuasiexperimental, multicéntrico, transversal y prospectivo de diseño antes-después en 10 residencias de mayores. Se identificaron los residentes a los que se les trituraba la medicación y se revisó su tratamiento para identificar los medicamentos que no se pueden triturar. Se comunicó al médico responsable la alternativa disponible y se evaluó el grado de aceptación, su asociación con otras variables medidas y el índice de adecuación pre-post, (comprimidos/cápsulas triturables respecto al total de comprimidos/cápsulas antes y después de la intervención). Se impartió además un curso formativo dirigido a los profesionales sanitarios. Resultados: Se trituraba la medicación al 33% (618/1.875) de los pacientes institucionalizados (media: 5 fármacos susceptibles de trituración). Se realizaron 220 intervenciones, mayoritariamente por tratarse de fármacos de liberación prolongada o gastrorresistentes, de las que se aceptaron el 48%. El tipo de intervención más frecuente fue el cambio (79%), mayoritariamente a formas de liberación inmediata o a otro principio activo. El índice de adecuación pasó del 93% al 95% (p < 0,001). La satisfacción de los profesionales con el curso fue elevada. Conclusiones: La intervención del farmacéutico ha mejorado la correcta administración de los medicamentos, aumentando con ello su seguridad y eficacia.