Data sources for drug utilization research in Latin American countries-A cross-national study: DASDUR-LATAM study.

PURPOSE: Drug utilization research (DUR) contributes to inform policymaking and to strengthen health systems. The availability of data sources is the first step for conducting DUR. However, documents that systematize these data sources in Latin American (LatAm) countries are not known. We compiled the potential data sources for DUR in the LatAm region. METHODS: A network of DUR experts from nine LatAm countries was assembled and experts conducted: (i) a website search of the government, academic, and private health institutions; (ii) screening of eligible data sources, and (iii) liaising with national experts in pharmacoepidemiology (via an online survey). The data sources were characterized by accessibility, geographic granularity, setting, sector of the data, sources and type of the data. Descriptive analyses were performed. RESULTS: We identified 125 data sources for DUR in nine LatAm countries. Thirty-eight (30%) of them were publicly and conveniently available; 89 (71%) were accessible with limitations, and 18 (14%) were not accessible or lacked clear rules for data access. From the 125 data sources, 76 (61%) were from the public sector only; 46 (37%) were from pharmacy records; 43 (34%) came from ambulatory settings and; 85 (68%) gave access to individual patient-level data. CONCLUSIONS: Although multiple sources for DUR are available in LatAm countries, the accessibility is a major challenge. The procedures for accessing DUR data should be transparent, feasible, affordable, and protocol-driven. This inventory could permit a comparison of drug utilization between countries identifying potential medication-related problems that need further exploration.

[Leftover and expired medicines in households: Is their storage and disposal a public health problem?] / Medicamentos sobrantes y caducados en el hogar ¿su almacenaje y desecho representan un problema de salud pública?

Leftover and expired medicines in households must be disposed of in such a way as to ensure the population's safety, while generating the lowest possible negative impact on the environment. In this context, the aim of this study was to explore drug disposal practices related to home medicine cabinets among medical students in Quito, Ecuador. Between December 2018 and January 2019, 498 students from different semesters were surveyed. Data show that up to 30.3% of students had flushed their medicines down the toilet at least once, while 7.2% acknowledged that they had removed the medicines from their packaging to deposit them in a household garbage disposal. A secondary aim of the study was to analyze expired and leftover drugs in participants' medicine cabinets. Metformin was the most common medication found, followed by acetaminophen, spironolactone, and ibuprofen. This study shows the urgent need to develop multisectoral strategies for the implementation of policies on pharmaceutical domestic waste, which will make it possible to control and reduce the negative impact on both the environment and public health.

Los medicamentos sobrantes y caducados en el hogar deberían ser eliminados de una manera que garantice la seguridad de la población, y que tenga un impacto negativo mínimo en el medio ambiente. Desde esta perspectiva se desarrolló el presente estudio cuyo objetivo fue conocer las prácticas de desecho de medicamentos del botiquín familiar en estudiantes de medicina en Quito-Ecuador. Entre diciembre de 2018 y enero de 2019, se encuestaron 498 estudiantes de diferentes semestres, y se evidenció que hasta un 30,3% de estudiantes alguna vez desechó los medicamentos a través del inodoro, y un 7,2% reconoció que sacaba los medicamentos del empaque primario, para depositarlos en la basura común. Como objetivo secundario se analizaron los medicamentos caducados y sobrantes del botiquín familiar de los encuestados. Se encontró que los medicamentos más frecuentes fueron metformina, seguido por acetaminofén, espironolactona e ibuprofeno. El estudio muestra la necesidad de desarrollar estrategias multisectoriales para la implementación de políticas sobre el desecho doméstico, las cuales permitirán controlar, y en el mejor de los casos, disminuir el impacto negativo tanto ambiental como en salud pública.

Medicamentos sobrantes y caducados en el hogar ¿su almacenaje y desecho representan un problema de salud pública? / Leftover and expired medicines in households: Is their storage and disposal a public health problem?

RESUMEN Los medicamentos sobrantes y caducados en el hogar deberían ser eliminados de una manera que garantice la seguridad de la población, y que tenga un impacto negativo mínimo en el medio ambiente. Desde esta perspectiva se desarrolló el presente estudio cuyo objetivo fue conocer las prácticas de desecho de medicamentos del botiquín familiar en estudiantes de medicina en Quito-Ecuador. Entre diciembre de 2018 y enero de 2019, se encuestaron 498 estudiantes de diferentes semestres, y se evidenció que hasta un 30,3% de estudiantes alguna vez desechó los medicamentos a través del inodoro, y un 7,2% reconoció que sacaba los medicamentos del empaque primario, para depositarlos en la basura común. Como objetivo secundario se analizaron los medicamentos caducados y sobrantes del botiquín familiar de los encuestados. Se encontró que los medicamentos más frecuentes fueron metformina, seguido por acetaminofén, espironolactona e ibuprofeno. El estudio muestra la necesidad de desarrollar estrategias multisectoriales para la implementación de políticas sobre el desecho doméstico, las cuales permitirán controlar, y en el mejor de los casos, disminuir el impacto negativo tanto ambiental como en salud pública.

ABSTRACT: Leftover and expired medicines in households must be disposed of in such a way as to ensure the population's safety, while generating the lowest possible negative impact on the environment. In this context, the aim of this study was to explore drug disposal practices related to home medicine cabinets among medical students in Quito, Ecuador. Between December 2018 and January 2019, 498 students from different semesters were surveyed. Data show that up to 30.3% of students had flushed their medicines down the toilet at least once, while 7.2% acknowledged that they had removed the medicines from their packaging to deposit them in a household garbage disposal. A secondary aim of the study was to analyze expired and leftover drugs in participants' medicine cabinets. Metformin was the most common medication found, followed by acetaminophen, spironolactone, and ibuprofen. This study shows the urgent need to develop multisectoral strategies for the implementation of policies on pharmaceutical domestic waste, which will make it possible to control and reduce the negative impact on both the environment and public health.

Conductas de autocuidado en pacientes ambulatorios con insuficiencia cardíaca crónica / Self-care behaviors in outpatients with chronic heart failure

La insufciencia cardíaca (IC) es una patología compleja que se asocia con mala calidad de vida y una alta mortalidad. Las medidas autocuidado personal en los pacientes con IC son un aspecto importante y útil para mejorar su calidad de vida. Objetivo Determinar la frecuencia de las conductas de autocuidado en pacientes con IC. Diseño Estudio transversal Lugar y Sujetos Pacientes con IC atendidos en la consulta externa de cardiología y medicina interna de cuatro unidades de salud, durante los meses de marzo a mayo del 2018. Mediciones principales Datos demográfcos, comorbilidades, tratamientos farmacológicos y medidas de autocuidado evaluadas con la escala EHFScBS. Resultados Se encuestaron 69 pacientes (33.3% hombres, 66.6% mujeres) con una edad de 62 ± 12 años. El 76.8% de los pacientes tenían dos o más comorbilidades. Los pacientes recibían un promedio de 3.8 medicamentos y la frecuencia de polifarmacia fue del 34%. Se encontró conductas de autocuidado positivas (frecuencia de autocuidado Siempre + Casi siempre), para la toma de medicación acorde a indicaciones médicas (95.6%), consumo de dieta baja en sal (72.4%) y reposo durante el día (62.3%). Una falta o ausencia de medidas de autocuidado (frecuencia de autocuidado Casi nunca + Nunca), se observó en la búsqueda de atención medica si ocurría un aumento del peso en 2 kg en una semana (75.3%) o si se presentaba hinchazón de pies/piernas (53.6%), en la vacunación anual contra la gripe (44.9%) y el ejercicio semanal (42%). Conclusión La ausencia de conductas de autocuidado fue alta. El 75% de los pacientes no buscan atención médica cuando se presentas signos de congestión. Una mejor información sobre las medidas de autocuidado es esencial como parte el tratamiento no farmacológico en los pacientes con IC crónica(AU).

Heart failure (HF) is a complex pathology that is associated with poor quality of life and high mortality. Self-care measures in patients with HF are an important and useful aspect to improve their quality of life. Objective To determine the frequency of self-care behaviors in patients with HF. Design Cross-sectional study. Subjects and settings Patients with HF attended in the outpatient clinic of cardiology and internal medicine at four health care units, during the months of March to May of 2018. Main measurements Demographic data, comorbidities, pharmacological treatments and self-care measures evaluated with the EHFScBS scale. Results 69 patients were surveyed (33.3% men, 66.6% women) with an age of 62 ± 12 years. 76.8% of the patients had two or more comorbidities. The patients received an average of 3.8 medications and the frequency of polypharmacy was 34%. Positive self-care measures were found (selfcare Always + Frequently) for taking medication according to medical indications (95.6%), consumption of low salt diet (72.4%) and rest during the day (62.3%). A lack or absence of self-care measures (self-care Almost never + Never), was observed for the search for medical attention if there was a 2 kg/week weight gain (75.3%) or if there was swelling of feet / legs (53.6%), in the annual vaccination against influenza (44.9%) and weekly exercise (42%). Conclusion The absence of self-care measures was high. 75% of patients do not seek medical attention when they show signs of congestion. Better information on self-care measures is essential as part of non-pharmacological treatment in patients with chronic HF

Dronedarone and renal impairment: evaluation of Spanish postmarketing reports and review of literature.

BACKGROUND: Renal impairment associated with dronedarone use is hardly known. Our aim is to describe the characteristics of spontaneous reports involving renal adverse reactions with use of dronedarone. METHODS: In the Spanish Pharmacovigilance database, reports with renal reactions and dronedarone until May 2014 were retrieved and analyzed. Also, a review of case reports of renal failure and dronedarone was conducted in MEDLINE. RESULTS: Dronedarone was found as a suspected drug in 192 reports, 10 (5.2%) of these reports described renal reactions. Renal reactions appeared until 3 months after the onset of dronedarone treatment. In 5 out of 10 cases, dronedarone was withdrawn and the patient recovered. The Reporting Odds Ratio was 2.88 [95% CI 1.52 - 5.46; p < 0.05]. Additionally, eight cases were found in the medical literature. In five of them, the patient outcome was described as recovered. One patient had to undergo hemodialysis for the treatment of their renal impairment. CONCLUSIONS: The effect of dronedarone on the renal function is supported by limited information; therefore, the cases from spontaneous reporting system and those from the medical literature could give relevant additional information. Our analysis shows a potential relationship between dronedarone use and renal impairment. Further studies are needed to confirm these findings.

Association of musculoskeletal complaints and gliptin use: review of spontaneous reports.

PURPOSE: Gliptins are new oral antidiabetic drugs that increase insulin levels through dipeptidyl peptidase-4 inhibition. Recently, the association of serious musculoskeletal (MSk) adverse effects with the gliptin use has been suggested. The aim is to describe and analyze the characteristics of spontaneous reports related to these adverse effects and gliptin use. METHODS: All spontaneous reports with MSk disorders associated with gliptins gathered in the Spanish pharmacovigilance database until May 2012 were described and analyzed using a case/non-case method. RESULTS: Gliptins were reported as the suspected drug in 332 cases: 208 involved sitagliptin, 115 vildagliptin, and nine saxagliptin. In 34 patients (10.2% of total reports with gliptins), MSk reactions were described (22 women [64.7%] and 12 men [35.3%]). Their mean age was 65.1 years; 41.2% were younger than 65 years. Only seven cases were serious, but the gliptin had to be withdrawn in 22 patients because of intolerance and/or persistence of MSk discomfort, and patients recovered after its discontinuation. A positive re-challenge was observed in two cases. In seven cases, the patients were on previous chronic treatment with statins, and began to present MSk complaints shortly after starting a gliptin. The reporting odds ratio (ROR) for myalgia and arthralgia were strongly associated with gliptin use (ROR 1.96 [95% CI 1.12-3.43], p < 0.05 and ROR 2.69 [95% CI 1.38-5.24], p < 0.05, respectively). CONCLUSIONS: Musculoskeletal disorders are adverse reactions strongly associated with gliptins that, despite not being serious, may impair the treatment adherence in patients with type 2 diabetes. Future observational studies could confirm these findings.

Prevalencia de factores de riesgo para tromboembolismo venoso en pacientes hospitalizados: estudio multicéntrico en cinco hospitales de la ciudad de Quito - Ecuador / Prevalence of risk factors for venous thromboembolism among hospital inpatients: multicenter study at five hospitals from Quito-Ecuador

La enfermedad tromboembólica venosa (ETV), conformada por la trombosis venosa profunda y el tromboembolismo pulmonar, es una importante causa de morbilidad y mortalidad hospitalaria Objetivos Determinar la prevalencia de factores de riesgo para ETV en el ámbito hospitalario y la proporción de pacientes con riesgo ingresados en servicios clínicos y quirúrgicos Diseño Transversal de prevalencia Lugar y sujetos Todos los pacientes (de 18 años o más) ingresados en servicios clínicos o quirúrgicos de cinco hospitales de la ciudad de Quito durante el primer trimestre de 2008 Mediciones principales Identifcación de factores de riesgo demográfcos, clínicos y quirúrgicos mediante revisión del expediente clínico, examen físico y entrevista al paciente. Las guías de consenso internacionales se utilizaron para evaluar el riesgo de ETV Resultados Un total de 443 pacientes (edad media 50 ± 30; 54.9% masculinos) fueron estudiados. El 37.2% estuvieron ingresados en servicios clínicos y 62.8% en servicios quirúrgicos. En 396 pacientes (89.4%; IC95% =86.1% - 92.1%) se encontraron factores de riesgo para ETV. La prevalencia global de factores de riesgo fue similar entre hospitales. En los servicios clínicos y quirúrgicos la prevalencia también fue similar (88.5% vs. 89.9%; p=ns). Los factores más frecuentes fueron edad mayor de 40 años (64.1%; IC95% = 59.5% - 68.4%), cirugía mayor (28.9%; IC95% = 24.8% - 33.2%), encamamiento de cuatro o más días (24.6%; IC95% = 20.8% - 28.8%) y obesidad (23.3%; IC95% =19.5% - 27.4%). Hubo pocas diferencias en la frecuencia de los factores de riesgo entre hospitales. Los pacientes se califcaron como portadores de un riesgo leve (44.9%) moderado (37.5%), alto (12.2%) y muy alto (5.4%) para ETV. Los pacientes en los servicios clínicos tuvieron un nivel de riesgo principalmente moderado en comparación a los sujetos de servicios quirúrgicos (45.5% vs. 32.7%; p<0.01). Un riesgo muy alto solo fue encontrado en pacientes quirúrgicos. La proporción de pacientes con riesgo leve y alto fue similar entre los servicios clínicos y quirúrgicos. Conclusiones Los hallazgos de este estudio demuestran que la prevalencia de factores de riesgo para ETV es elevada en los pacientes hospitalizados en la ciudad de Quito. La identifcación temprana de estos factores junto con una estratifcación de riesgo en los pacientes, es fundamental dentro de la práctica clínica habitual, ya que permitiría emplear medidas preventivas acordes al riesgo de desarrollar ETV.

Venous thromboembolism (VTE), including deep vein thrombosis and pulmonary embolism, represents a signifcant source of morbidity and mortality. Objective To determine the prevalence of VTE risk factors in the hospital care setting and to assess the proportion of at-risk patients in clinical and surgical wards. Design Cross sectional study Subjects and setting All hospital inpatients (aged 18 years or over) admitted to clinical or surgical wards at fve hospitals in the city of Quito-Ecuador during the frst trimester of 2008. Main measurements Demographic, clinical and surgical risk factors were collected from hospital chart review, physical examination and interview. Consensus guidelines were used to assess VTE risk. Results 443 patients (mean age 50 ± 30 years; 54.9% males) were studied; 37.2% were at clinical wards and 62.8% at surgical wards. Risk factors for VTE were identifed in 396 (89.4%; 95%CI=86.1% - 92.1%) patients. The global prevalence of risk factors was similar between hospitals. In medical and surgical wards the prevalence also was similar (88.5% vs. 89.9%; p=ns). Most common risk factors were age (40 years or over; 64.1%; 95%CI= 59.5% - 68.4%), major surgery (28.9%; 95%CI= 24.8% - 33.2%), bed rest (four days or over; 24.6%; 95%CI= 20.8% - 28.8%), and obesity (23.3%; 95%CI=19.5% - 27.4%). Few differences were found in frequency of risk factors between hospitals. Patients were judged to be at low (44.9%), moderate (37.5%), high (12.2%) and very high risk (5.4%) for VTE. Patients in clinical wards mainly had a moderate risk compared with subjects in surgical wards (45.5% vs. 32.7%; p<0.01). A very high risk was found only in surgical patients. The proportion of patients with low and high risk was similar in clinical and surgical wards. Conclusion This study showed that prevalence of VTE risk factors is high in hospital inpatients from Quito-Ecuador. An early identifcation of these factors and risk stratifcation is essential in clinical practice, in order to establish prophylactic measures in patients at risk to developing VTE.