Encarnación Blanco-Reina

2012 American Geriatrics Society Beers Criteria: Enhanced Applicability for Detecting Potentially Inappropriate Medications in European Older Adults? A Comparison with the Screening Tool of Older Person's Potentially Inappropriate Prescriptions

To determine the prevalence of potentially inappropriate medications (PIMs) and related factors through a comparative analysis of the Screening Tool of Older Persons Potentially Inappropriate Prescriptions (STOPP), the 2003 Beers criteria, and the 2012 AGS update of the Beers criteria.

Distinct phenotype of hepatotoxicity associated with illicit use of anabolic androgenic steroids

We have observed an increase in hepatotoxicity (DILI) reporting related to the use of anabolic androgenic steroids (AAS) for bodybuilding.

Age, Period, and Cohort Effects on Mortality From Ischemic Heart Disease in Southern Spain

INTRODUCTION AND OBJECTIVES Ischemic heart disease is the leading cause of death and one of the top 4 causes of burden of disease worldwide. The aim of this study was to evaluate age-period-cohort effects on mortality from ischemic heart disease in Andalusia (southern Spain) and in each of its 8 provinces during the period 1981-2008. METHODS A population-based ecological study was conducted. In all, 145 539 deaths from ischemic heart disease were analyzed for individuals aged between 30 and 84 years who died in Andalusia in the study period. A nonlinear regression model was estimated for each sex and geographical area using spline functions. RESULTS There was an upward trend in male and female mortality rate by age from the age of 30 years. The risk of death for men and women showed a downward trend for cohorts born after 1920, decreasing after 1960 with a steep slope among men. Analysis of the period effect showed that male and female death risk first remained steady from 1981 to 1990 and then increased between 1990 and 2000, only to decrease again until 2008. CONCLUSIONS There were similar age-period-cohort effects on mortality in all the provinces of Andalusia and for Andalusia as a whole. If the observed cohort and period effects persist, male and female mortality from ischemic heart disease will continue to decline.

Herbal and Dietary Supplement-Induced Liver Injuries in the Spanish DILI Registry

Background & Aims There have been increasing reports of liver injury associated with use of herbal and dietary supplements, likely due to easy access to these products and beliefs among consumers that they are safer or more effective than conventional medications. We aimed to evaluate clinical features and outcomes of patients with herbal and dietary supplement‐induced liver injuries included in the Spanish DILI Registry. Methods We collected and analyzed data on demographic and clinical features, along with biochemical parameters, of 32 patients with herbal and dietary supplement‐associated liver injury reported to the Spanish DILI registry from 1994 through 2016. We used analysis of variance to compare these data with those from cases of liver injury induced by conventional drugs or anabolic androgenic steroid‐containing products. Results Herbal and dietary supplements were responsible for 4% (32 cases) of the 856 DILI cases in the registry; 20 cases of DILI (2%) were caused by anabolic androgenic steroids. Patients with herbal and dietary supplement‐induced liver injury were a mean age of 48 years and 63% were female; they presented a mean level of alanine aminotransferase 37‐fold the upper limit of normal, 28% had hypersensitivity features, and 78% had jaundice. Herbal and dietary supplement‐induced liver injury progressed to acute liver failure in 6% of patients, compared with none of the cases of anabolic androgenic steroid‐induced injury and 4% of cases of conventional drugs. Liver injury after repeat exposure to the same product that caused the first DILI episode occurred in 9% of patients with herbal and dietary supplement‐induced liver injury vs none of the patients with anabolic androgenic steroid‐induced injury and 6% of patients with liver injury from conventional drugs. Conclusion In an analysis of cases of herbal and dietary supplement‐induced liver injury in Spain, we found cases to be more frequent among young women than older patients or men, and to associate with hepatocellular injury and high levels of transaminases. Herbal and dietary supplement‐induced liver injury is more severe than other types of DILI and re‐exposure is more likely. Increasing awareness of the hepatoxic effects of herbal and dietary supplements could help physicians make earlier diagnoses and reduce the risk of serious liver damage.

Assessing Potentially Inappropriate Prescribing in Community-Dwelling Older Patients Using the Updated Version of STOPP-START Criteria: A Comparison of Profiles and Prevalences with Respect to the Original Version

Emerging and changing evidence made it necessary to update STOPP-START criteria, and version 2 was published recently. In this study the objectives were to determine the prevalence of potentially inappropriate medication prescribing (PIM) in primary care using STOPP versions 1 (v1) and 2 (v2), as well as 2012 AGS Beers criteria, and analyze the factors associated with inappropriate prescribing according to STOPP/START v2. A cross-sectional study was carried out including community-dwelling older adults over the age of 65. Sociodemographic, clinical, functional and comprehensive drug therapy data were collected. The primary endpoint was the percentage of patients receiving at least one PIM. This variable was measured using three tools: STOPP v1, 2012 AGS Beers criteria and STOPP v2. Similarly, the percentage of patients receiving at least one potential prescribing omission (PPO) was calculated using START versions 1 and 2. A total of 1,615 prescriptions were reviewed. The median number of medications per patient was 7.1 drugs (±3.8). The prevalence of elderly people exposed to polypharmacy (≥5 medications) was 72.9%, whereas 28.4% of the participants took ≥10 drugs regularly. PIM were present in 18.7%, 37.3% and 40.4% of participants, according to the STOPP v1, 2012 Beers criteria and STOPP v2, respectively. According to STOPP v2, the number of medications taken (OR: 1.14, 1.06–1.25), the presence of a psychological disorder (OR: 2.22, 1.13–4.37) and insomnia (OR: 3.35, 1.80–6.32) were risk factors for taking a PIM. The prevalence of PPOs was 34.7% and 21.8% according to version 1 and 2, respectively. In conclusion, STOPP-START criteria have been remarkably modified, which is evidenced by the different prevalence rates detected using version 2, as compared to version 1. In fact, the level of agreement between version 1 and the updated version is only moderate. Special attention should be paid on benzodiazepines, which keep being the most frequent PIM.

Utilización de fármacos en niños en cuidados intensivos: estudio de las prescripciones off-label

OBJECTIVE This study aims to assess the prescription profile and license status of drugs used in a neonatal and pediatric intensive care unit (NPICU). METHODS A prospective observational study was conducted on a dynamic cohort of children admitted to an NPICU (N=81) in a tertiary hospital (Granada, Spain). All prescriptions were classified as off-label or unlicensed based on the summary of product characteristics (SPC). RESULTS Of a total of 601 prescriptions, the patients received a mean of 7.4 ± 6 drugs each. The most commonly prescribed drugs corresponded to classes J (anti-infectious, systemic use) N (nervous system) and C (cardiovascular). A little over one-half of the prescriptions were off-label (52%), usually due to dosages differing from the SPC recommendations (79%), followed by different indications (13.5%), age (5%) and administration route (2.5%). In this NPICU, unlicensed usage represented only 5% of all prescriptions. CONCLUSIONS This study contributes data on prescription of this kind in a Spanish NPICU, revealing at least one off-label prescription in 89% of the children and at least one unlicensed use in 22.3%. These are high figures, but are to be expected given the inclusion of newborn infants and the critical care setting. Even though such usage follows clinical protocols, we underscore the dual need to base treatment on the best available evidence, and to upgrade the SPC accordingly.

Estudio de las prescripciones farmacológicas en niños a nivel de atención primaria: evaluación de los usos off-label o fuera de ficha técnica

Resumen Objetivo Evaluar el perfil de prescripción y los usos off-label (fuera de ficha técnica [FT]) y unlicensed (medicamentos no autorizados específicamente para niños) de medicamentos a nivel ambulatorio. Diseño Estudio transversal. Emplazamiento Consultas de pediatría de 2 centros de salud urbanos y sala de urgencia general del Hospital Materno-Infantil de Málaga. Participantes Niños de 0-14 años que acudiesen a consulta y se les prescribiese al menos un medicamento. Mediciones principales Variables sociodemográficas, motivo de consulta y medicación. Clasificación de las prescripciones según información contenida en FT. Resultados Se incluyeron un total de 388 niños, una submuestra de 105 (27%) atendidos en urgencias, y se valoraron 462 prescripciones, que involucraron 74 principios activos diferentes. Cada niño recibió un promedio de 1,7 fármacos (IC 95%: 1,6-1,9), siendo los más prescritos ibuprofeno, paracetamol, amoxicilina-clavulánico y budesonida. El grupo terapéutico más empleado y con mayor variedad de fármacos fue el respiratorio. El 27,4% de las prescripciones (IC 95%: 23,5-31) fueron off-label, constituyéndose como causa más frecuente el uso del fármaco para una edad distinta de la autorizada (60%; IC 95%: 54,1-63), seguida de distinta dosis (21,5%; IC 95%: 18-25), diferente indicación (12%; IC 95%: 9,2-15) y el 7% por distinta vía de administración (IC 95%: 5,4-10). Conclusiones La tasa de usos off-label presenta cifras intermedias, pudiendo recibir este tipo de prescripciones una tercera parte de los niños. Esto no significa que sean prescripciones incorrectas, pero es recomendable respaldarlas con la mejor evidencia, así como seguir las directrices de la normativa sobre medicamentos en situaciones especiales.

Age-period-cohort effects on mortality from cerebrovascular disease in southern Spain.

BACKGROUND The aim of this article is to evaluate the age-period-cohort effects on mortality from cerebrovascular disease in Andalusia (southern Spain) as a whole and in each of its 8 provinces during the period 1981-2008. METHODS A population-based ecologic study was conducted. In all, 145,867 deaths were analyzed for individuals between the ages of 15 and 84 years who died in Andalusia in the period of study. A nonlinear regression model was estimated for each gender group and geographic area. The effects of age, year of death, and birth cohort were parameterized using spline smoothing functions. RESULTS There is an upward trend in mortality from the age of 25 years. The risk of death was downward for cohorts born after 1896, decreasing after 1970 with steep slope. The analysis of the period effect showed that death rate first declined from 1981 to 1995 and then increased between 1995 and 2000, only to decrease again until 2008. CONCLUSIONS There is a similar age-period-cohort effect on male and female mortality from cerebrovascular disease in all the provinces of Andalusia and for Andalusia as a whole. A significant reduction of male and female mortality has been observed during the last decade.

Age-period-cohort effect on lung cancer mortality in southern Spain.

The aim of this study was to evaluate the age–period–cohort effects on lung cancer mortality in Andalusia (southern Spain) as a whole as well as in each of its eight provinces during the period between 1981 and 2008. A population-based ecological study was conducted. In all, 74 255 deaths from lung cancer were analysed for individuals aged between 40 and 84 years who died in Andalusia during the period of study. A nonlinear regression model was estimated for both sexes and each geographical area. The effects of age, year of death and birth cohort were parameterized using B-spline smoothing functions. There is an upward trend in mortality by age until around the age of 75 years, from which point the trend turns downwards for men and remains stable for women. The analysis of the cohort effect revealed a steady fall in the lung cancer mortality risk for male generations born after 1950. The mortality risk for women is increasing for the generations born after 1932. The death rates for men declined from 1995 until the end of the study period. For women, the death rates increased from the end of the 1990s. There is a similar age–period–cohort effect on lung cancer mortality in all the provinces of Andalusia and for Andalusia as a whole. If the current trends continue, it can be expected that these effects will continue to reduce male mortality and increase female mortality.