Objective To assess key aspects of transportation and storage of biological therapies (BTs) on the part of the patients, from the time they collect them from the pharmacy up until the moment of administration. Methods This was a cross-sectional study in the form of a survey completed by outpatients older than 18 years who were administered BTs. The survey was carried out by the authors between August 2016 and January 2017. Results A total of 83 outpatients were interviewed (mean age, 53; standard deviation, 15; 76% female). Sixty percent had rheumatoid arthritis, 24% had psoriatic arthritis, and 16% sustained other rheumatic and inflammatory diseases. Twenty percent had not been informed of the importance of proper refrigeration when they were first prescribed BTs; 77% had acquired the medication at least 7 days before administration; 28% had misplaced the drug in the fridge (65% of them in the freezer); 90% was unaware of the temperature range at which the BT should be kept in the fridge, and only one (1%) of them had once used a thermometer to find out the fridge temperature. Fifty-three percent had suffered frequent power outages the previous summer, 22% had experienced blackouts longer than 48 hours; 37% had taken the BT to another house to avoid wasting it, and four (5%) patients had disposed of the drug due to a prolonged power outage. Conclusion Upon prescribing BTs, it is imperative that physicians brief patients on the relevance of suitable transportation and storage methods, and a treatment failure should prompt a thorough assessment of transportation and storage conditions.
Introducción: la disfunción sexual (DS) es común entre las mujeres con enfermedades crónicas, incluyendo esclerosis sistémica (ES). Se ha asociado con características como la duración de la enfermedad, dolor, disminución de la actividad funcional, entre otras. Desde nuestro conocimiento, aún no contamos con datos locales. Objetivos: evaluar la frecuencia de DS en mujeres con ES; describir las características sociodemográficas, clínicas y psicológicas asociadas con la DS en mujeres con ES. Materiales y métodos: estudio observacional, analítico y de corte transversal. Se incluyeron mujeres de entre 20 y 59 años con diagnóstico de ES, según los criterios de clasificación del European League Against Rheumatism/American College of Rheumatology (ACR/EULAR 2013). Se excluyeron pacientes con enfermedades crónicas no controladas, otras patologías reumatológicas autoinmunes, e inactividad sexual o patología genitourinaria no relacionadas a ES en las últimas 4 semanas. La DS se evaluó con la versión en español del cuestionario índice de función sexual femenina (Female sexual function index, FSFI). Resultados: se incluyeron 56 pacientes. El 78,57% presentó DS y 19,64% era sexualmente inactiva debido a la enfermedad. Escala visual análoga (EVA) de fatiga (coeficiente β: -0,08, IC 95%: -0,14 a -0,02; p<0,01), edad (coeficiente β: -0,23, IC 95%: -0,40 a -0,05; p=0,01) y fibromialgia (coeficiente β: -11,90, IC 95%: -17,98 a -5,82; p<0,01) mostraron una asociación significativa e independiente con DS en el análisis multivariado. Conclusiones: la DS es frecuente entre las mujeres con ES, y las pacientes más jóvenes, sin fibromialgia y con menor fatiga presentaron una mejor funcionalidad sexual.
Backgroundin order to ensure the pharmacological action of thermolabile drugs, it is mandatory to keep the cold chain unbroken from manufacturing to administration since lack of observance of these rules may compromise their efficacy. (1,2)Objectivesto ascertain key aspects of transportation and storage of Biological Therapy (BT) on the part of the patients.Methodssurvey among outpatients who either were treated in the centre or attended the centre for the administration of a BT. Inclusion criteria encompassed patients of over 18 years of age, who were receiving a BT (at least one dose over the last 12 months) whose patient information leaflet indicated, “... must be refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze.” The survey comprised 31 questions about transportation and storage of the BT from the moment of collection from the pharmacy to its administration. This study was approved by the Bioethics Committee. Every patient signed an informed consent form.ResultsEighty-three patients were interviewed (76% female and 24% males), their average age was 53 years old, 60% had Rheumatoid Arthritis, 24% Psoriatic Arthritis, and 16% sustained other conditions. Sixty-four percent were undergoing BT for the first time. Forty-eight percent were enrolled in a patient assistance programme. Had patients been fully informed of the importance of proper transportation and storage of the drug? No, 20% acknowledged that the first time they dealt with a BT, they had not been made aware of the relevance of its correct preservation. Are patients administered the BT immediately after collecting it from the pharmacy? No, 77% collected the drug at least 7 days before administration and though they received the BT in a cooler with ice packs (except in 5 cases) 71% was uninformed of how long it could be kept in this condition. Is the BT duly stored in the patient's refrigerator? No, 28% misplaced the drug (65% in the freezer), and 90% did not know the temperature range at which it should be kept in the fridge. Only 1 patient used a thermometer to control the appliance temperature. Is there another crucial point as to BT storage at home? Yes, 53% of the 83 patients had experienced frequent power cuts in summer; out of these, 59% on a weekly basis. Forty percent of the 83 patients had power cuts of over 12 hours, 28% of over 24 hours, and 22% of over 48 hours. Out of the 83 patients, 37% took the BT to another house to avoid wasting it, and 4 had to dispose of it due to a protracted power cut. Five patients were away from home for over 48 hours during which the BT was in the fridge and they had not assigned another person to take care of the drug during their absence. Is the BT removed from the fridge only for its immediate administration? No, 46% of the respondents travelled to a centre, half of them for over an hour, carrying the BT.Conclusionsbefore administering a BT, it is imperative to brief patients on suitable transportation and storage methods. Thus, treatment failure should prompt a thorough assessment of transportation a...
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