Long-term use of prescription opioids for non-cancer pain and mortality: a population-based, propensity-weighted cohort study.

OBJECTIVE: The objective of this study was to identify factors associated with long-term opioid use and to assess the association between long-term use and death. STUDY DESIGN: Retrospective cohort study combining several population-wide databases and covering a population of five million inhabitants, including all adults who were initiated on opioid treatment from 2014 to 2018 for non-cancer pain. METHODS: We used logistic regression models to identify factors associated with chronic opioid use and carried out survival analyses using multivariable Cox regression modelling for all-cause mortality during follow-up using inverse probability of treatment weighting (IPTW) and propensity scores based on the probability of using opioids chronically. RESULTS: Among 760,006 patients, 82,423 (10.85%) used opioids for 90 days or more after initiation. Initial therapy characteristics associated with higher risk for long-term use were initiating with long- and short-acting opioids (when compared to tramadol, odds ratio [OR]: 2.63, 95% confidence interval [CI]: 2.57, 2.69 and OR: 1.60, 95%CI: 1.46, 1.76, respectively), using higher daily doses (when compared to 50 morphine milligramme equivalent [MME] or less, prescribing 50 to 89 daily MME, OR: 1.76, 95%CI: 1.65, 1.87; 90 to 119 daily MME, OR: 2.44, 95%CI: 1.99, 3.01; and more than 120 daily MME, OR: 1.77, 95%CI: 1.64, 1.91), and overlapping with gabapentinoids (OR: 2.26, 95%CI: 2.20, 2.32), benzodiazepines (OR: 1.32, 95%CI: 1.30, 1.35), and antipsychotics (OR: 1.21, 95%CI: 1.16, 1.26). After IPTW, chronic opioid use was associated with higher risk of all-cause mortality when compared to short-term use (Hazard Ratio (HR): 1.37, 95%CI: 1.32, 1.42). Sensitivity analyses provided similar results. CONCLUSION: These findings may help healthcare managers to identify and address patients at higher risk of long-term use and riskier prescription patterns.

Epidemiology of schizophrenia and its management over 8-years period using real-world data in Spain.

BACKGROUND: Real-World Data (RWD) studies provide important insights in disease epidemiology, in real clinical populations, with long follow-up periods. The aim of the present study was to describe the epidemiology of schizophrenia spectrum disorders (SD) during an 8-year period in Spain. METHODS: A retrospective cohort of subjects aged 15 to 64 years was followed-up using electronic healthcare databases of the Valencia region (2008-2015). SD cases included outpatient and inpatient settings (ICD 9 codes 295.XX). Prevalence of SD was assessed. Incidence rate (IR) in the subpopulation aged between 15 and 34 years was also provided. Healthcare utilization (HCU) rates, including outpatient, specialists, hospitalizations and antipsychotic dispensations were estimated. RESULTS: The cohort included 3,976,071 subjects; 24,749 of them had a prevalent diagnosis of SD. The overall prevalence for SD was 6.2 per 1000 persons. SD were 76% more prevalent in men than women. IR in the subpopulation aged between 15 and 34 years was 50.25 per 100,000 persons years and was more than 2 times higher for men than for women. 83.4% of the overall outpatient visits from the cohort of patients were related to SD. The 21,095 overall hospitalizations with the SD code resulted in 286,139 days of hospitalization, with a median of 4 days (IQR: 1.6-9.2) per person-year. 93.2% of subjects diagnosed with SD were ever treated with some antipsychotic drug during the study period, and 70% of the patients were ever treated with antipsychotic polypharmacy. CONCLUSIONS: This large population-based study using RWD provides novel and recent information SD in a southern European country. The prevalence and IR of SD showed is greater than previously published and higher in men than in women. The fact of having used a large arsenal of electronic data (including outpatient and inpatient) for 8 years may have influenced. SD represents high burden and healthcare utilization. Contrary to guidelines recommendations the majority of patients were ever treated with antipsychotic polypharmacy.

Adherence to oral anticoagulants in patients with atrial fibrillation-a population-based retrospective cohort study linking health information systems in the Valencia region, Spain: a study protocol.

INTRODUCTION: Adherence to oral anticoagulation (OAC) treatment, vitamin K antagonists or new oral anticoagulants, is an essential element for effectiveness. Information on adherence to OAC in atrial fibrillation (AF) and the impact of adherence on clinical outcomes using real-world data barely exists. We aim to describe the patterns of adherence to OAC over time in patients with AF, estimate the associated factors and their impact on clinical events, and assess the same issues with conventional measures of primary and secondary adherence-proportion of days covered (PDC) and persistence-in routine clinical practice. METHODS AND ANALYSIS: This is a population-based retrospective cohort study including all patients with AF treated with OAC from 2010 to date in Valencia, Spain; data will be obtained from diverse electronic records of the Valencia Health Agency. PRIMARY OUTCOME MEASURE: adherence trajectories. SECONDARY OUTCOMES: (1) primary non-adherence; (2) secondary adherence: (a) PDC, (b) persistence. Clinical outcomes: hospitalisation for haemorrhagic or thromboembolic events and death during follow-up. ANALYSIS: (1) description of baseline characteristics, adherence patterns (trajectory models or latent class growth analysis models) and conventional adherence measures; (2) logistic or Cox multivariate regression models, to assess the associations between adherence measures and the covariates, and logistic multinomial regression models, to identify characteristics associated with each trajectory; (3) Cox proportional hazard models, to assess the relationship between adherence and clinical outcomes, with propensity score adjustment applied to further control for potential confounders; (4) to estimate the importance of different healthcare levels in the variations of adherence, logistic or Cox multilevel regression models. ETHICS AND DISSEMINATION: This study has been approved by the corresponding Clinical Research Ethics Committee. We plan to disseminate the project's findings through peer-reviewed publications and presentations at relevant health conferences. Policy reports will also be prepared in order to promote the translation of our findings into policy and clinical practice.

Prevalence of osteoporotic fracture risk factors and antiosteoporotic treatments in the Valencia region, Spain. The baseline characteristics of the ESOSVAL cohort.

UNLABELLED: This study provides information on the prevalence of the most important risk factors for osteoporosis and osteoporotic fracture in a large sample of women and men from the Valencia region and also provides the FRAX 10-year major and hip fracture risks for this population, as well as data about the use of diagnostic tests and antiosteoporotic treatments. INTRODUCTION: The purpose of this study was to describe demographic characteristics, osteoporosis risk factors, the 10-year risk of osteoporotic fracture, and the use of densitometry and antiosteoporotic treatments in the Valencia region, Spain. METHODS: A cross-sectional study using the ESOSVAL cohort baseline data was conducted. We analyze the data from 5,310 women and 5,725 men aged 50 and over who attended to 272 collaborating primary care centers in 2009-2010. We collected the demographic, anthropometric, clinical, and pharmacy data from the electronic medical record. RESULTS: The mean age of participants was 64.3 years old for women and 65.6 years old for men. The most frequent fracture risk factors were sedentary life (22.2 %) and previous fracture (15.8 %) in women and low calcium intake (21.4 %) and current smoker (20.9 %) in men. According to FRAX(®), the 10-year risk of presenting a major fracture was 5.5 % for the women and 2.8 % for the men. The 10-year risk for hip fracture was 1.9 and 1.1 % for the women and the men, respectively; 23.8 % of the women and 5.2 % of the men had a densitometry test, 27.7 % of the women and 3.5 % of the men were taking calcium and/or vitamin D supplements, and 28.2 % of the women (22.0 % in the 50-64 age group) and 2.3 % of the men were taking antiosteoporotic drugs. CONCLUSIONS: The prevalence of certain fracture risk factors not included in the FRAX tool (sedentary life, falls, low calcium intake) is high. In young women, their low risks estimated by FRAX contrast with the high figures for densitometry testing and treatment.

Agreement between semi-automatic radiographic morphometry and Genant semi-quantitative method in the assessment of vertebral fractures.

UNLABELLED: Semi-automatic morphometry is highly reproducible and not time intensive; however, no study has evaluated agreement between semi-automated morphometric methods and the Genant semi-quantitative method performed as a rule by radiologists. Our study shows substantial agreement between both methods; however, semi-automatic morphometry upgrades mild deformities and overestimates the prevalence of fractures. INTRODUCTION: The aim of this study was to evaluate the agreement between radiologists using the Genant semi-quantitative (SQ) method and semi-automated morphometry in the diagnosis of vertebral fractures in post-menopausal women. METHODS: Cross-sectional study was conducted in 2006-2007 in an age-stratified population-based sample of 824 post-menopausal women over the age of 50. From this population two sets of 95 and 50 X-ray were randomly extracted to test inter-rater agreement and agreement between SQ and semi-automated morphometry, and vertebral fractures were classified according to both methods. The Genant method was used to homogenise the diagnosis of fractures. Agreement was evaluated with weighted kappa. We evaluated each vertebral body independently and also the whole vertebral column (T4-L4) classifying women into the worst grade of fracture. For the qualitative interpretation of the agreement, we used the criteria described by Landis and Koch (Biometrics 33:159-174, 1977). RESULTS: The radiologists' agreement was 98.4% (Kappa, 0.75; 95% CI, 0.42-0.89). Agreement between semi-automated morphometry and SQ reached 97.6% and Kappa was 0.86 (95% CI, 0.66-0.94). In the whole evaluation of the spine semi-automated morphometry overestimates, the prevalence of fractures compared with the radiologists were 15.8% of women with fractures and 7.4% of women with moderate-severe fractures by semi-automated morphometry vs. 8.4% and 3.2% by the SQ method. The negative predictive value for MorphoXpress was 99% while the positive was 40%. CONCLUSIONS: Semi-automated morphometry shows high reliability and a substantial agreement with the SQ approach but overestimates the prevalence of fractures. Its role in routine clinical practice is limited because positive results should be reassessed by qualitative or semi-quantitative methods.

Trends in gastrointestinal bleeding in the Region of Valencia (2000-2005). Relationship to sales of nonsteroidal anti-inflammatory drugs and acid suppression medication

Objective Describe 2000-2005 time trends of prescription for NSAIDs, proton pump inhibitors (PPIs) and hospital admissions for gastrointestinal (GI) bleeding. Methods Time series analysis of gastrointestinal (GI) bleeding admission and drugs’ Defined Daily Dose per 1000 people per day (DDD/1000/day) in the Region of Valencia, Spain, from January 2000 to December 2005.ResultsDispensation of NSAIDs went from 42.7 DDD/1000 people/day in 2000 to 58.3 DDD/1000 people/day in 2005. During the same period, dispensation of PPIs went from 26.3 DDD/1000 people/day to 68.5 DDD/1000 people/day (both are statistically significant). The rate of hospitalisations for gastrointestinal bleeding during this period oscillated between 142 and 126 admission per 100 000 inhabitants/year. No year showed significant differences compared to 2000.ConclusionA substantial increase in the NSAID use from 2000 to 2005 was not accompanied by changes in GI bleeding hospitalisation rates in Valencia, but GI bleeding rates continued to be high, suggesting a need to improve NSAIDs use (AU)

Objetivo Describir las tendencias temporales durante el periodo 2000-2005 de la prescripción de AINE, inhibidores de la bomba de protones (IBP) y los ingresos hospitalarios por hemorragia gastrointestinal (GI).Métodos Análisis de series cronológicas de ingresos por hemorragia GI y de las dosis diarias definidas (DDD) de medicamento por cada 1.000 personas y día (DDD/1.000/día) en la Comunidad Valenciana desde enero de 2000 hasta diciembre de 2005.ResultadosLa dispensación de AINE ha aumentado desde 42,7 DDD/1.000/día en 2000 a 58,3 DDD/1.000/día, y la de IBP pasó de 26,3 DDD/1.000/día a 68,5 DDD/1000/día (ambos son cambios estadísticamente significativos). La tasa de ingresos por hemorragias GI durante este periodo pasó de 142 a 126 por cada 100.000 habitantes/año. En relación a 2000, ninguno de los años analizados muestra diferencias significativas. Conclusiones El aumento sustancial del uso de AINEs entre 2000 y 2005 no se vio acompañado de cambios en la tasa de ingresos hospitalarios en Valencia, pero la tasa de hemorragias GI siguieron siendo altas, lo que sugiere que es necesario mejorar la utilización de los AINE (AU)

Trends in gastrointestinal bleeding in the Region of Valencia (2000-2005). Relationship to sales of nonsteroidal anti-inflammatory drugs and acid suppression medication.

OBJECTIVE: To describe 2000-2005 time trends of prescription for NSAIDs, proton pump inhibitors (PPIs) and hospital admissions for gastrointestinal (GI) bleeding. METHODS: Time series analysis of gastrointestinal (GI) bleeding admission and drugs' Defined Daily Dose per 1000 people per day (DDD/1000/day) in the Region of Valencia, Spain, from January 2000 to December 2005. RESULTS: Dispensation of NSAIDs went from 42.7 DDD/1000 people/day in 2000 to 58.3 DDD/1000 people/day in 2005. During the same period, dispensation of PPIs went from 26.3 DDD/1000 people/day to 68.5 DDD/1000 people/day (both are statistically significant). The rate of hospitalisations for gastrointestinal bleeding during this period oscillated between 142 and 126 admission per 100 000 inhabitants/year. No year showed significant differences compared to 2000. CONCLUSION: A substantial increase in the NSAID use from 2000 to 2005 was not accompanied by changes in GI bleeding hospitalisation rates in Valencia, but GI bleeding rates continued to be high, suggesting a need to improve NSAIDs use.

[Interruption to treatment with combined lopinavir/ritonavir therapy in HIV positive patients]. / Interrupción del tratamiento con la terapia combinada lopinavir/ritonavir en pacientes VIH+.

OBJECTIVE: To describe the extent of interruptions to treatment with therapies which include the combination of lopinavir-ritonavir within the SNS (Spanish National Health System), as well as identify the causes of these interruptions and analyse the factors associated with the same. METHOD: Retrospective cohort of 197 seropositive patients, who began treatment with lopinavir-ritonavir between January 2000 and October 2002. The patients attended the outpatient pharmaceutical care unit and were followed-up until December 2002. Interruptions and their causes were identified and the factors associated with the interruption were analysed using proportional hazard models. RESULTS: The mean follow-up period was 263 days and 38.6% of patients interrupted therapy. The most common causes of interruption were intolerance (30.3%), non-compliance (21.1%) and therapy failure (5.26%). The mean treatment period was 487 days (95% CI: 432 to 542) and 50% of patients who interrupted treatment did so within the first 4 months. No associations were found between patient or treatment characteristics and the risk of interruption. CONCLUSIONS: The percentage of interruptions was lower than those in other observational studies, but greater than those in clinical trials. The significance of the causes of interruption was similar and no factor associated with the risk of interruption was found.

Interrupción del tratamiento con la terapia combinada lopinavir/ritonavir en pacientes VIH+ / No disponible

Objetivo: Describir, en el entorno del Sistema Nacional deSalud (SNS), la magnitud de la interrupción del tratamiento conterapias que incluyen la combinación lopinavir/ritonavir, identificarlas causas de estas interrupciones y analizar los factores asociadosa las mismas.Método: Cohorte retrospectiva de 197 pacientes seropositivosque iniciaron tratamiento con lopinavir/ritonavir entre enerode 2000 y octubre de 2002 en la unidad de atención farmacéuticaa pacientes externos, y fueron seguidos hasta diciembre de 2002.Se identificaron los casos de interrupción y sus causas y se analizaron,utilizando modelos de riesgos proporcionales, los factoresasociados a la interrupción.Resultados: La duración media de seguimiento fue de 263días. El 38,6% de los pacientes interrumpió el tratamiento, siendolas causas más frecuentes la intolerancia (30,3%), el incumplimiento(21,1%) y el fracaso terapéutico (5,26%). La mediana deduración del tratamiento fue de 487 días (IC95%: 432-542) y el50% de los casos que interrumpieron lo hicieron antes de4 meses. No se hallaron asociaciones entre características de lospacientes o del tratamiento y el riesgo de interrupción.Conclusiones: El porcentaje de interrupciones fue inferior alde otros estudios observacionales pero superior al de los ensayosclínicos. La importancia de las causas de interrupción fue similar.No se halló ningún factor asociado al riesgo de interrupción

Objective: To describe the extent of interruptions to treatmentwith therapies which include the combination of lopinavirritonavirwithin the SNS (Spanish National Health System), as wellas identify the causes of these interruptions and analyse the factorsassociated with the same.Method: Retrospective cohort of 197 seropositive patients,who began treatment with lopinavir-ritonavir between January2000 and October 2002. The patients attended the outpatientpharmaceutical care unit and were followed-up until December2002. Interruptions and their causes were identified and the factorsassociated with the interruption were analysed using proportionalhazard models.Results: The mean follow-up period was 263 days and38.6% of patients interrupted therapy. The most common causesof interruption were intolerance (30.3%), non-compliance(21.1%) and therapy failure (5.26%). The mean treatment periodwas 487 days (95% CI: 432 to 542) and 50% of patients whointerrupted treatment did so within the first 4 months. No associationswere found between patient or treatment characteristics andthe risk of interruption.Conclusions: The percentage of interruptions was lower thanthose in other observational studies, but greater than those in clinicaltrials. The significance of the causes of interruption was similarand no factor associated with the risk of interruption wasfound

«Lenguaje común» frente a independencia del patrocinador en la evaluación económica de medicamentos / No disponible

No disponible

[HIV-infected patients' perceived satisfaction with an outpatient pharmaceutical care unit (OPCU)]. / Originales Breves Satisfacción percibida por pacientes infectados por el VIH con la unidad de atención farmacéutica a pacientes externos (UFPE).

INTRODUCTION: Satisfaction measurements attempt to establish patient views regarding health care. In the setting of pharmaceutical care, the measurements of the generically called "h umanistic"variables is scarce, and the number of validated instruments is inadequate. The goal of this study is to present a specifically-developed satisfaction survey regarding outpatient pharmaceutical care units, and to prove its applicability and inner consistency in a HIV-infected patient population on antiretroviral therapy. METHODS: The survey includes 19 questions within four groups - A. The unit's physical space, location, and organization; B. Dispensation; C. Pharmaceutical consultation, and D. Overall satisfaction with the unit. Each question is scored from 1 to 5. The study was carried out by administering 250 surveys to consecutive patients arriving at the OPCU, Castell6n General Hospital. RESULTS: Responses show a high degree of patient satisfaction with questions posed, with mean values oscillating between 3.0 and 4.8. The highest means corresponded to pharmacist valuation, and the lowest values corresponded to questions within the organizational module. All questions considered, the mean score obtained was 3.96 + 0.95 (median of 4). The survey exhibited high internal reproducibility both for each group and all questions. CONCLUSION: The satisfaction survey discussed here is an accessible, easy-to-use instrument that may be rapidly completed and used in pharmaceutical care units with outpatients as a measurement of patient satisfaction. The high scores HIV-infected patients assign to questions included in the survey suggest a benefit from standardized pharmaceutical care.

Satisfacción percibida por pacientes infectados por el VIH con la unidad de atención farmacéutica a pacientes externos (UFPE) / HIV-infected patients´ perceived satisfaction with an outpatient pharmaceutical care unit (OPCU)

Introducción: Las medidas de la satisfacción pretenden determinar la posición de los pacientes respecto a la atención sanitaria. En el ámbito de la atención farmacéutica, la medida de variables denominadas genéricamente “humanísticas”, es escasa y no existen suficientes instrumentos validados. El objetivo del presente trabajo es presentar una encuesta de satisfacción con las unidades de atención farmacéutica a pacientes externos (UFPE) desarrollada específicamente para ellos, y demostrar su aplicabilidad y consistencia interna en una población de pacientes con infección por el VIH con tratamiento antirretroviral. Métodos: La encuesta consta de 19 cuestiones agrupadas en cuatro grupos; A. Espacio físico, localización y organización de la unidad , B. Dispensación, C. Consulta farmacéutica y D. Satisfacción global con la unidad. Cada cuestión se puntúa entre 1 y 5. El estudio se llevó a cabo entregando 250 encuestas a pacientes que acudieron consecutivamente a la UFPE del Hospital General de Castellón. Resultados: Las respuestas muestran un alto grado de satisfacción de los pacientes con las cuestiones planteadas, variando entre unos valores medios entre 3,0 y 4,8. Las medias más altas correspondieron con la valoración del farmacéutico y las más bajas con las cuestiones del módulo de organización. La puntuación media obtenida considerando todas las cuestiones fue de 3,96 ± 0,95 (mediana 4). La encuesta mostró elevada reproducibilidad interna tanto para cada uno de los grupos como para la totalidad de las cuestiones. Conclusión: La encuesta de satisfacción presentada es un instrumento asequible, fácil y rápido de cumplimentar, que puede ser aplicado en la práctica asistencial en las unidades de atención farmacéutica a pacientes externos para obtener una medida de satisfacción. Las altas puntuaciones que los pacientes infectados por el VIH asignan a las diferentes cuestiones, sugieren el beneficio que obtienen de la atención farmacéutica normalizada

Introduction: Satisfaction measurements attempt to establish patient views regarding health care. In the setting of pharmaceutical care, the measurements of the generically called “humanistic” variables is scarce, and the number of validated instruments is inadequate. The goal of this study is to present a specifically-developed satisfaction survey regarding outpatient pharmaceutical care units, and to prove its applicability and inner consistency in a HIVinfected patient population on antiretroviral therapy. Methods: The survey includes 19 questions within four groups – A. The unit’s physical space, location, and organization; B. Dispensation; C. Pharmaceutical consultation, and D. Overall satisfaction with the unit. Each question is scored from 1 to 5. The study was carried out by administering 250 surveys to consecutive patients arriving at the OPCU, Castellón General Hospital. Results: Responses show a high degree of patient satisfaction with questions posed, with mean values oscillating between 3.0 and 4.8. The highest means corresponded to pharmacist valuation, and the lowest values corresponded to questions within the organizational module. All questions considered, the mean score obtained was 3.96 ± 0.95 (median of 4). The survey exhibited high internal reproducibility both for each group and all questions. Conclusion: The satisfaction survey discussed here is an accessible, easy-to-use instrument that may be rapidly completed and used in pharmaceutical care units with outpatients as a measurement of patient satisfaction. The high scores HIV-infected patients assign to questions included in the survey suggest a benefit from standardized pharmaceutical care