Effectiveness of a continuing education program of drugs with fiscalized substance to improve pharmacy staff competencies: A multicenter, cluster-randomized controlled trial

Background: Drugs with fiscalized substances without a correct prescription may lead to undesirable side effects. Pharmacy staff needs to improve their competencies (knowledge, skills, and attitudes) to contribute to providing ambulatory pharmacy services and minimizing medication errors. Continuing education programs (CEP) could favor access to relevant and quality information on health promotion, disease prevention, and the rational use of drugs. Objective: To evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies to enhance the use of drugs with fiscalized substances. Methods: A multicenter, prospective, parallel-group, cluster-randomized, controlled clinical trial was conducted in drugstores and pharmacies in Colombia (ambulatory retail establishments). The intervention group (IG) received a CEP: a web-based social networking site, a virtual course, a dispensing information system, and face-to-face training. The control group (CG) received general written material on the correct use of drugs. We measured pharmacy staff’s skills, attitudes, and knowledge self-reported scores, and the simulated patient technique was used to assess the participant skills and attitudes in real practice. We used a questionnaire designed for this study, which was evaluated by a group of experts and piloted and showed a Cronbach’s alpha of 0.96. Results: Three hundred five drugstores and pharmacies were enrolled in two groups: IG (n = 153) and CG (n = 152). Out of the 750 potential participants, 88% (n=659) agreed to participate. The pharmacy staff’s skills, attitudes, and knowledge self-reported scores post-intervention were higher than baseline in both groups; however, the IG had statistically significantly higher scores than the CG. Post-intervention, the self-efficacy skills and attitudes in the IG improved by 88% (22 of 25) and in six of the seven assessed knowledge components (p<0.001). However, the dispensing criteria evaluated with simulated patient methodology showed no statistically significant differences between groups in the pharmacy staff’s skills and attitudes in real practice. Conclusions: Providing a continuing education program using different educational strategies improved the pharmacy staff’s competencies (assessed knowledge and self-reported skills and attitudes) to enhance the use of drugs with fiscalized substances. However, there were no improvements in skills and attitudes in real practice. These findings could show that pharmacy staff needs additional and continuous training/sustainability.Committee for Development Research and the sustainability of the University of AntioquiaprogramRandox Laboratorie

Evaluation of the effects of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in Colombia drugstores and drugstores/pharmacies: study protocol of a multicenter, clusterrandomized controlled trial

We thank the University of Antioquia, Laproff Laboratories, and all the people who participated in the study and were essential for its successful completion.Background: Health disorders, due to the use of drugs with fiscalized substances, including controlled substances, have become a common problem in Colombia. Multiple reasons can help explain this problem, including selfmedication, since access to these drugs may be easier. Also, there is a lack of knowledge that these drugs are safer than illicit drugs. The use of these drugs without a valid medical prescription and follow-up can have negative consequences such as drug abuse, addiction, and overdose, and eventually, have negative health consequences. Pharmacy staff is essential to both assure the correct drug use and minimize prescription errors to help outpatients have better management of their pharmacotherapy. For this reason, it is necessary to increase key competencies like knowledge, skills, and attitudes in the pharmacy staff of ambulatory (outpatients) pharmacies. Methods: This study is a prospective, cluster-randomized, parallel-group, multicenter trial of drugstores and drugstores/pharmacies (ambulatory pharmacies). The study is designed to determine the effectiveness of a drug with fiscalized substance dispensation, health education, and pharmacovigilance continuing education program in drugstores and drugstores/pharmacies. Pharmacy staff will be randomly selected and assigned to one of the study groups (intervention or control). The intervention group will receive a continuing education program for over 12 months. The control group will receive only general information about the correct use of complex dosage forms. The primary objective is to evaluate the effectiveness of a continuing education program to improve pharmacy staff competencies (knowledge, skills, and attitudes) to improve the ambulatory (outpatient) pharmacy services: dispensation, health education, and pharmacovigilance of drugs with fiscalized substances. The secondary outcomes include (a) processes associated with the management of drugs with fiscalized substances in drugstores and drugstores/pharmacies, including regulation compliance; (b) degree of implementation of ambulatory (outpatient) pharmacy services targeting these drugs in drugstores and drugstores/pharmacies; (c) patient satisfaction with such services; and (d) pharmacy staff satisfaction with the continuing education program. Discussion: This clinical trial will establish whether providing a continuing education program for the adequate utilization of drugs with fiscalized substances improves pharmacy staff competencies regarding these drugs. Trial registration: ClinicalTrials.gov NCT03388567. Registered on 28 November 2017. First drugstore or drugstore/ pharmacy randomized on December 1, 2018. Protocol version: 0017102017MC Keywords: Dispensation, Health education, Pharmacovigilance, Drugstores, Pharmacies, Pharmacy staff, Fiscalized substances, Controlled drugsCommittee for Development Research (CDR)University of AntioquiaLaproff Laboratorie

Suggestion of a form for outpatient reporting of suspected adverse drug reactions in Colombia

Introducción: La obtención de información precisa y oportuna relacionada con las reacciones adversas medicamentosas resulta clave; utiliza estrategia como notiicación voluntaria o por un profesional sanitario, ante la autoridad competente. Objetivo: Diseñar una propuesta de formato de reporte de reacciones adversas medicamentosas (RAM) por pacientes ambulatorios en Colombia, basado en recomendaciones de otros países y en requerimientos mínimos deinidos para este tipo de formatos. Metodología: Revisión estructurada en PUBMED/MEDLINE de artículos publicados en inglés o español, utilizando los términos Pharmacovigilance AND Patients; y Pharmacovigilance reporting AND patient report. Se incluyeron artículos con información sobre reporte de RAM por pacientes. Con el soporte de la información de la revisión, al igual que con los requerimientos establecidos en las Guías del International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A y E2B (R3), se construyó una lista de chequeo, la cual fue confrontada con la revisión de los formatos para el reporte por pacientes de 50 países pertenecientes al Uppsala Monitoring Center. Finalmente, se deinieron los ítems a incluir en la propuesta de formato. Resultados: Se identiicaron 104 artículos, de los cuales 5 cumplieron con los criterios de inclusión. Se elaboró una lista de chequeo con 34 ítems, la cual fue confrontada con 33 formatos, de los 50 países a los que se pudo acceder y, con ello, se deinió el contenido del formato de reporte de RAM por pacientes. Conclusión: Se diseña y presenta una propuesta de formato de reporte de RAM por pacientes ambulatorios en Colombia, con la información identiicada como clave. El formato requiere de un proceso de validación y valoración de su funcionalidad en la contribución al logro de los objetivos de la farmacovigilancia.Introduction: Obtaining accurate and timely information related to adverse drug reactions is key; uses strategy as voluntary reporting by health professionals or to the competent authority. Objective: To design a proposal of format for reporting adverse drug reactions (ADRs) by outpatients in Colombia based on recommendations from other countries and definite minimum requirements for this type of format. Methodology: We completed a structured review in PubMed/MEDLINE database of articles published in English or Spanish, using the terms Pharmacovigilance AND Patients, and Pharmacovigilance reporting and patient report. Articles with information about patients reporting ADR where included. With the support of the information from the review, as with the requirements established in the guidelines from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A and E2B (R3). We developed a checklist, and then we contrasted the items with the information registered in the format for reporting by patients from 50 countries belonging to the Uppsala Monitoring Center with. Finally, we defined the items to be included in the proposed format. Results: From structured review, we identified 104 articles, of which five met the inclusion criteria. We developed a checklist with 34 items, and then we confronted the 34 items with information registered in 33 of the 50 formats of the countries that we may&nbsp;accessed. We defined the contents of the ADR report format by patients. Conclusion: We design and develop a proposal of ADR reporting format by outpatient in Colombia, which has the information identified as key. The&nbsp;format requires a process of validation and evaluation of its functionality in contributing to achieving the objectives of pharmacovigilance

Suggestion of a form for outpatient reporting of suspected adverse drug reactions in Colombia

Introducción: La obtención de información precisa y oportuna relacionada con las reacciones adversas medicamentosas resulta clave; utiliza estrategia como notiicación voluntaria o por un profesional sanitario, ante la autoridad competente. Objetivo: Diseñar una propuesta de formato de reporte de reacciones adversas medicamentosas (RAM) por pacientes ambulatorios en Colombia, basado en recomendaciones de otros países y en requerimientos mínimos deinidos para este tipo de formatos. Metodología: Revisión estructurada en PUBMED/MEDLINE de artículos publicados en inglés o español, utilizando los términos Pharmacovigilance AND Patients; y Pharmacovigilance reporting AND patient report. Se incluyeron artículos con información sobre reporte de RAM por pacientes. Con el soporte de la información de la revisión, al igual que con los requerimientos establecidos en las Guías del International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A y E2B (R3), se construyó una lista de chequeo, la cual fue confrontada con la revisión de los formatos para el reporte por pacientes de 50 países pertenecientes al Uppsala Monitoring Center. Finalmente, se deinieron los ítems a incluir en la propuesta de formato. Resultados: Se identiicaron 104 artículos, de los cuales 5 cumplieron con los criterios de inclusión. Se elaboró una lista de chequeo con 34 ítems, la cual fue confrontada con 33 formatos, de los 50 países a los que se pudo acceder y, con ello, se deinió el contenido del formato de reporte de RAM por pacientes. Conclusión: Se diseña y presenta una propuesta de formato de reporte de RAM por pacientes ambulatorios en Colombia, con la información identiicada como clave. El formato requiere de un proceso de validación y valoración de su funcionalidad en la contribución al logro de los objetivos de la farmacovigilancia.Introduction: Obtaining accurate and timely information related to adverse drug reactions is key; uses strategy as voluntary reporting by health professionals or to the competent authority. Objective: To design a proposal of format for reporting adverse drug reactions (ADRs) by outpatients in Colombia based on recommendations from other countries and definite minimum requirements for this type of format. Methodology: We completed a structured review in PubMed/MEDLINE database of articles published in English or Spanish, using the terms Pharmacovigilance AND Patients, and Pharmacovigilance reporting and patient report. Articles with information about patients reporting ADR where included. With the support of the information from the review, as with the requirements established in the guidelines from the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E2A and E2B (R3). We developed a checklist, and then we contrasted the items with the information registered in the format for reporting by patients from 50 countries belonging to the Uppsala Monitoring Center with. Finally, we defined the items to be included in the proposed format. Results: From structured review, we identified 104 articles, of which five met the inclusion criteria. We developed a checklist with 34 items, and then we confronted the 34 items with information registered in 33 of the 50 formats of the countries that we may&nbsp;accessed. We defined the contents of the ADR report format by patients. Conclusion: We design and develop a proposal of ADR reporting format by outpatient in Colombia, which has the information identified as key. The&nbsp;format requires a process of validation and evaluation of its functionality in contributing to achieving the objectives of pharmacovigilance

Cumplimiento de la normatividad en la publicidad de medicamentos de venta libre en Colombia

En Colombia la información sobre el cumplimiento de la normativa de publicidad de medicamentos de venta libre es limitada

Gacetero en línea una herramienta para la consulta de localidades asociadas a registros biológicos.

Este producto es elaborado por el Programa de Evaluación y Monitoreo del Estado de la Biodiversidad (PEM) en el marco del convenio 005 (13-014) entre el Instituto Humboldt y el Fondo Adaptación, este contiene la información sobre el gacetero en línea que permita la indexación, visualización y consulta de localidades georreferenciadas y asociadas a registros biológicos que son publicados a través del SiB Colombia. Como insumo para la construcción de la herramienta, cerca de 10 entidades sistematizaron, estandarizaron y georreferenciaron los registros biológicos depositados en sus colecciones respectivas.BogotáSubdirección de Servicios Científicos y Proyectos Especiale

Skills and practices of pharmacy staff for dispensing of drugs with fiscalized substances in drugstores and pharmacies

OBJETIVE To evaluate the skills and practices of pharmacy staff during the dispensing of tramadol (drug with fiscalized substance) in drugstores and pharmacies in Medellin, Colombia. METHODS A cross-sectional study was performed. The simulated patient technique was used. The main outcomes included the information provided on the dispensed drug (tramadol), the use of tools to provide information, and the information provided on drug precautions and use recommendations. RESULTS We visited 305 drugstores and pharmacies. The average dispensing time was 2.3 min (SD 1.1 min). In nine drugstores and pharmacies (3.0%), tramadol was not dispensed because it was not in stock. In 17 drugstores and pharmacies (5.7%), the simulated patients were actively informed by the dispensing pharmacy staff; of these, 16 provided oral information and one provided oral and written information. Eight patients (2.7%) received information regarding tramadol use. However, 99% of patients were not informed about tramadol side effects such as dependence, sedation, or hypnosis, and none of the simulated female patients were informed on the precautions related to tramadol use during pregnancy or lactation. CONCLUSIONS Communication skills and appropriate practices of pharmacy staff are critical to patient self-care. However, this study shows their difficulty in counseling about precautions and use recommendations of drugs with fiscalized substances. These outcomes could inform future studies focusing on the rational use of these drugs in drugstores and pharmacies. It is necessary to improve the pharmacy staff competencies through continuing education programs, to facilitate access to information and training

Comparación entre el ACI-318-19 y la NSR-10 para diseño estructural de pórticos de concreto en zonas de amenaza sísmica alta: Comparison between ACI-318-19 and NSR-10 for structural design of concrete frames in high seismic hazard zones

This work is a comparative analysis between the Colombian Earthquake Resistant Construction Standard NSR-10 and the&nbsp; ACI 318-19 Building Code Requirements for Structural Concrete of 2019, which is the basis of the upcoming title C of the NSR-21/22 standard. The current technical requirements in title C of NSR-10 were compared with the requirements of the ACI 318-19 regulation for reinforced concrete frames systems in areas of high-seismic hazard. Initially, a comparative analysis was developed between the body of title C of the NSR-10 and the ACI 318-19 regulation, showing the differences in the disposition of each of the present chapters. From this analysis it is possible to obtain a comparative matrix and the corresponding procedures to each chapter, which facilitated the understanding of the differences in their arrangement. Subsequently, another comparative analysis is developed, where the requirements for elements belonging to structures with special energy dissipation capacity are compared one by one. From this comparison, a more detailed analysis of the most relevant differences is found between the specifications of both regulations, accompanied by a brief discussion of the changes found. Finally, the structural design of two frame buildings is developed, designed under the guidelines of both regulations in order to compare the amounts of reinforcement and volumes of concrete, through which an analysis of the economic impact generated by the application of the new specifications established in the ACI 318-19 code was developed, in which the structural designs of both alternatives yielded a percentage difference in costs of 2.2%.En este trabajo se realiza un análisis comparativo de la Norma Colombiana Sismorresistente NSR-10 y el reglamento ACI 318-19 (base del próximo título C de la norma NSR actualmente en desarrollo), en dicha comparación se detallaron las exigencias técnicas actuales presentes en ambos reglamentos para sistemas de pórticos de concreto reforzado en zonas de amenaza sísmica alta. Inicialmente se realizó un análisis comparativo entre el cuerpo del título C de la NSR-10 y el reglamento ACI 318-19 mostrando las diferencias en la disposición de cada uno de los capítulos presentes en cada normatividad, de este análisis se obtiene una matriz comparativa y los mapas de ruta correspondiente a cada capítulo, los cuales facilitaran la búsqueda y comprensión de las diferencias encontradas en la disposición de los capítulos. Posteriormente se realiza un segundo análisis comparativo confrontando uno a uno los requisitos para elementos pertenecientes a estructuras con capacidad especial de disipación de energía. De esta segunda comparación se detallan las diferencias más relevantes encontradas entre las especificaciones de ambas normativas, acompañada de una breve justificación de los cambios encontrados. Finalmente, se realiza el diseño estructural de dos edificaciones aporticadas de concreto reforzado, siguiendo los lineamientos de ambas normativas con el fin de realizar un comparativo final de las cuantías de refuerzo y volúmenes de concreto por medio del cual, se realizó un análisis del impacto económico que generará la aplicación de las nuevas especificaciones establecidas en el reglamento ACI 318-19, encontrándose una diferencia porcentual de aumento de costos del 2.2%

Comparación entre el ACI-318-19 y la NSR-10 para diseño estructural de pórticos de concreto en zonas de amenaza sísmica alta

En este trabajo se realiza un análisis comparativo de la Norma Colombiana Sismorresistente NSR-10 y el reglamento ACI 318-19 (base del próximo título C de la norma NSR actualmente en desarrollo), en dicha comparación se detallaron las exigencias técnicas actuales presentes en ambos reglamentos para sistemas de pórticos de concreto reforzado en zonas de amenaza sísmica alta. Inicialmente se realizó un análisis comparativo entre el cuerpo del título C de la NSR-10 y el reglamento ACI 318-19 mostrando las diferencias en la disposición de cada uno de los capítulos presentes en cada normatividad, de este análisis se obtiene una matriz comparativa y los mapas de ruta correspondiente a cada capítulo, los cuales facilitaran la búsqueda y comprensión de las diferencias encontradas en la disposición de los capítulos. Posteriormente se realiza un segundo análisis comparativo confrontando uno a uno los requisitos para elementos pertenecientes a estructuras con capacidad especial de disipación de energía. De esta segunda comparación se detallan las diferencias más relevantes encontradas entre las especificaciones de ambas normativas, acompañada de una breve justificación de los cambios encontrados. Finalmente, se realiza el diseño estructural de dos edificaciones aporticadas de concreto reforzado, siguiendo los lineamientos de ambas normativas con el fin de realizar un comparativo final de las cuantías de refuerzo y volúmenes de concreto por medio del cual, se realizó un análisis del impacto económico que generará la aplicación de las nuevas especificaciones establecidas en el reglamento ACI 318-19, encontrándose una diferencia porcentual de aumento de costos del 2.2%

Catálogo de la biodiversidad de Colombia: colecciones de fichas de especies en páramos y humedales.

Este producto es elaborado por el Programa de Evaluación y Monitoreo del Estado de la Biodiversidad (PEM) en el marco del convenio 005 (13-014) entre el Instituto Humboldt y el Fondo Adaptación, el objetivo es integrar y disponer información confiable y robusta sobre la biodiversidad de Colombia a nivel de especie, asociada a ecosistemas de Páramos y humedales de forma estandarizada, abierta y gratuita.BogotáSubdirección de Servicios Científicos y Proyectos Especiale