Clinical Relevance of Drug Interactions in People Living with Human Immunodeficiency Virus on Antiretroviral Therapy-Update 2022: Systematic Review.

BACKGROUND: The clinical outcomes of antiretroviral drugs may be modified through drug interactions; thus, it is important to update the drug interactions in people living with HIV (PLHIV). AIM: To update clinically relevant drug interactions in PLHIV on antiretroviral therapy with novel drug interactions published from 2017 to 2022. METHODS: A systematic review in Medline/PubMed database from July 2017 to December 2022 using the Mesh terms antiretroviral agents and drug interactions or herb-drug interactions or food-drug interactions. Publications with drug interactions in humans, in English or Spanish, and with full-text access were retrieved. The clinical relevance of drug interactions was grouped into five levels according to the gravity and probability of occurrence. RESULTS: A total of 366 articles were identified, with 219 (including 87 citation lists) were included, which allowed for the identification of 471 drug interaction pairs; among them, 291 were systematically reported for the first time. In total 42 (14.4%) and 137 (47.1%) were level one and two, respectively, and 233 (80.1%) pairs were explained with the pharmacokinetic mechanism. Among these 291 pairs, protease inhibitors (PIs) and ritonavir/cobicistat-boosted PIs, as well as integrase strand transfer inhibitors (InSTIs), with 70 (24.1%) and 65 (22.3%) drug interaction pairs of levels one and two, respectively, were more frequent. CONCLUSIONS: In PLHIV on antiretroviral therapy, we identify 291 drug interaction pairs systematically reported for the first time, with 179 (61.5%) being assessed as clinically relevant (levels one and two). The pharmacokinetic mechanism was the most frequently identified. PIs, ritonavir/cobicistat-boosted PIs, and InSTIs were the antiretroviral groups with the highest number of clinically relevant drug interaction pairs (levels one and two).

Processes implemented and activities carried out by the pharmacists during the COVID­19 pandemic: A scoping review.

OBJECTIVE: To identify and summarize the processes implemented and the  activities performed by community and hospital-based pharmacists during the  COVID­19 pandemic. METHOD: A scoping review was carried out of the PubMed/Medline database  with the aim of identifying articles published until 30 June 2021. The PRISMA  recommendations for this type of review were followed. The articles included  were reviewed and classified according to their main characteristics and  outcomes, according to population, concept and context. The processes and  activities identified were grouped into three categories: those performed in  community and hospital pharmacies, those performed essentially in community  pharmacies, and those performed essentially in hospital  pharmacies. RESULTS: A total of 629 articles were identified, of which 454 were excluded  because they were unrelated to the object of the review and 81 due to meeting  the exclusion criteria. So, 94 articles were included in the analysis.  Most studies were conducted in Europe and the United States. During the  COVID­19 pandemic, the processes implemented and the activities carried out  in both community and hospital-based pharmacies included pharmaceutical  care, efficient and timely management of services, information and education,  psychological support, pharmacovigilance and telepharmacy. Processes  implemented and activities carried out essentially in community pharmacies  were those related to the detection recommendations, and drug indications.  Finally, processes and activities essentially occurring in hospital pharmacies  included those related to participation in drug treatment research, drug  evaluation and guidelines development, and to managing off-label drugs. CONCLUSIONS: During the COVID­19 crisis, pharmacists have led and implemented processes aimed at mitigating the impact of the pandemic on  the population´s health. Pharmaceutical care, efficient and  timely management of services, information and education, psychological  support, pharmacovigilance and telepharmacy, both in community and hospital pharmacies, are the main processes implemented by pharmacists  during the COVID­19 pandemic. These processes and activities, in addition to contributing to the control, prevention and effective and safe treatment of  COVID­19; have ensured the implementation of biosecurity measures, proper  dispensing of medication, the drug rational use, and the provision of evidence- based information and education.

OBJETIVO: Identificar y sintetizar los procesos y actividades realizados por el  farmacéutico en la farmacia comunitaria y hospitalaria durante la pandemia por  COVID-19.Método: Revisión sistemática exploratoria en PubMed/Medline de artículos publicados hasta el 30 de junio de 2021, siguiendo las  recomendaciones PRISMA para este tipo de revisiones. Los artículos incluidos  se clasificaron según sus principales características y resultados, acorde con la  estructura: población, concepto y contexto. Los procesos y las actividades  identificados se agruparon en tres categorías: realizados en farmacia  comunitaria y hospitalaria, llevados a cabo esencialmente en farmacia  comunitaria y realizados esencialmente en farmacia hospitalaria. RESULTADOS: Se identificaron 629 artículos, de los cuales se excluyeron 454  por no estar en relación con el objeto de la revisión y 81 por los criterios de  exclusión; por tanto, se incluyeron 94 en la revisión y análisis. La mayoría de  los estudios se desarrollaron en Europa y Estados Unidos. Entre los procesos y  actividades llevados a cabo por el farmacéutico durante la pandemia, tanto en  farmacia comunitaria como en hospitalaria, destacaron: atención farmacéutica,  gestión eficiente y oportuna de los servicios, información y  educación, apoyo psicológico, farmacovigilancia y telefarmacia. En farmacia  comunitaria destacaron también los relacionados con la detección de COVID-19  y derivación de pacientes, inmunización en farmacias, recomendaciones de  cuidados en el hogar e indicación farmacéutica. Entre los procesos  realizados esencialmente en farmacia hospitalaria destacaron los relacionados  con la participación en investigaciones de tratamientos farmacológicos,  desarrollo de guías de utilización de medicamentos basadas en evidencia y  manejo de medicamentos en indicaciones no aprobadas. CONCLUSIONES: Durante la pandemia por COVID-19, los farmacéuticos han  liderado e implantado procesos orientados a mitigar su impacto en la salud de  la población. Atención farmacéutica, gestión eficiente y oportuna de los  servicios, información y educación, apoyo psicológico, farmacovigilancia y  telefarmacia fueron los principales procesos y actividades realizados en  farmacia comunitaria y hospitalaria durante la pandemia por COVID-19. Dichos  procesos y actividades buscaron, además de contribuir al control,  prevención y tratamiento efectivo y seguro de la COVID-19, asegurar la  implantación de medidas de bioseguridad, la dispensación y uso adecuado de  los medicamentos y la información y educación basadas en la mejor evidencia  disponible.

Procesos y actividades realizados por el farmacéutico en la pandemia por COVID-19: Revisión sistemática exploratoria / Processes implemented and activities carried out by the pharmacists during the COVID-19 pandemic: A scoping review

Objetivo: Identificar y sintetizar los procesos y actividades realizadospor el farmacéutico en la farmacia comunitaria y hospitalaria durante lapandemia por COVID-19.Método: Revisión sistemática exploratoria en PubMed/Medline de artículospublicados hasta el 30 de junio de 2021, siguiendo las recomendacionesPRISMA para este tipo de revisiones. Los artículos incluidos se clasificaronsegún sus principales características y resultados, acorde con la estructura:población, concepto y contexto. Los procesos y las actividades identificados se agruparon en tres categorías: realizados en farmacia comunitariay hospitalaria, llevados a cabo esencialmente en farmacia comunitaria yrealizados esencialmente en farmacia hospitalaria.Resultados: Se identificaron 629 artículos, de los cuales se excluyeron454 por no estar en relación con el objeto de la revisión y 81 por loscriterios de exclusión; por tanto, se incluyeron 94 en la revisión y análisis.La mayoría de los estudios se desarrollaron en Europa y Estados Unidos.Entre los procesos y actividades llevados a cabo por el farmacéuticodurante la pandemia, tanto en farmacia comunitaria como en hospitalaria, destacaron: atención farmacéutica, gestión eficiente y oportuna delos servicios, información y educación, apoyo psicológico, farmacovigilancia y telefarmacia. En farmacia comunitaria destacaron también losrelacionados con la detección de COVID-19 y derivación de pacientes,inmunización en farmacias, recomendaciones de cuidados en el hogar e indicación farmacéutica. Entre los procesos realizados esencialmente enfarmacia hospitalaria destacaron los relacionados con la participaciónen investigaciones de tratamientos farmacológicos, desarrollo de guíasde utilización de medicamentos basadas en evidencia y manejo de medicamentos en indicaciones no aprobadas. (AU)

Objective: To identify and summarize the processes implemented andthe activities performed by community and hospital-based pharmacistsduring the COVID-19 pandemic.Method: A scoping review was carried out of the PubMed/Medlinedatabase with the aim of identifying articles published until 30 June 2021.The PRISMA recommendations for this type of review were followed. Thearticles included were reviewed and classified according to their maincharacteristics and outcomes, according to population, concept andcontext. The processes and activities identified were grouped into threecategories: those performed in community and hospital pharmacies, thoseperformed essentially in community pharmacies, and those performedessentially in hospital pharmacies.Results: A total of 629 articles were identified, of which 454 wereexcluded because they were unrelated to the object of the review and81 due to meeting the exclusion criteria. So, 94 articles were included inthe analysis. Most studies were conducted in Europe and the United States. During the COVID-19 pandemic, the processes implemented and theactivities carried out in both community and hospital-based pharmaciesincluded pharmaceutical care, efficient and timely management of services, information and education, psychological support, pharmacovigilance and telepharmacy. Processes implemented and activities carried outessentially in community pharmacies were those related to the detection and referral of COVID-19 patients, testing and immunization, home carerecommendations, and drug indications. Finally, processes and activitiesessentially occurring in hospital pharmacies included those related toparticipation in drug treatment research, drug evaluation and guidelinesdevelopment, and to managing off-label drugs. (AU)

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. (AU)

Diseño y evaluación de un curso virtual para referenciar casos de COVID-19 desde farmacias-droguerías en Colombia / Design and evaluation of an online course to transfer suspected cases of COVID-19 from pharmacies-drugstores in Colombia

Introducción: es necesario diseñar, implementar y evaluar la aceptación, pertinencia y usabilidad de un curso virtual orientado a favorecer la identificación y referenciación de casos sospechosos de COVID-19 desde farmacias-droguerías en Colombia. Método: el diseño del curso se fundamentó en una ruta propuesta para la atención de usuarios sospechosos de COVID-19 que acuden a farmacias, complementada con información obtenida de una búsqueda en PubMed/Medline y en sitios Web de organizaciones referentes en el tema. La información se estructuró en un curso virtual, se elaboró y aplicó un instrumento para evaluar la cobertura, aceptabilidad y pertinencia del curso. Resultados: se diseñó el curso virtual ¿Cómo actuamos frente al COVID-19 desde las droguerías? organizado en 7 unidades con conceptos claves para identificar y referenciar casos sospechosos de COVID-19, desde farmacias-droguerías, disponible en https://udearroba.udea.edu.co/externos/my/. Entre abril/2020 y abril/2021 se registraron 863 personas, 382 (44,3%) finalizaron el curso y se les envió el instrumento de evaluación, y fue regresado por 240 (62,8%). En este grupo, la satisfacción con el curso y material didáctico fue del 95,8% y 97,1%, respectivamente. Además, el 97,9% manifestó que el curso contribuye a identificar y referenciar casos sospechosos de COVID-19; y el 93,3% que, el acceso y navegación por el curso, resultó sencillo. Conclusiones: se diseña, implementa y evalúa un curso virtual, abierto y usable, orientado a favorecer la identificación y referenciación de casos sospechosos de COVID-19, desde las farmacias-droguerías y, aunque los participantes declaran que contribuye con dicha finalidad, se requiere de un estudio diseñado para valorar esta aportación. (AU)

Introduction: it is needing to design, implement and evaluate the acceptance, relevance, and usability of an online course aimed at promoting the detection and referral of suspected cases of COVID-19 from pharmacies-drugstores. Method: the design of the course was based on a proposed route for the care of users suspected of COVID-19 attending pharmacies, complemented by information obtained through a search in PubMed/Medline and on Websites of leading organizations in the field. The information was structured in an online course, a formulary was developed and applied to assess the coverage, acceptability, and relevance of the course. Results: an online course (How do we act against COVID-19 from the drugstores?) was designed and organized in 7 units and with key concepts to identify and refer suspected cases of COVID-19 from pharmacies-drugstores, available in https://udearroba.udea.edu.co/externos/my/. From April/2020 to April/2021, 863 persons were registered, 382 (44.3%) finished and were sent the formulary for evaluation the course, which was returned by 240 (62.8%). In this group, the satisfaction with the course and education materials was 95.8% and 97.1%, respectively. Also, 97.9% people assert that the course contribute to identify and to refer suspected cases of COVID-19; and 93.3% that, the navigation through the course provides easy access of the contents. Conclusions: a virtual, open, and usable course is designed, implemented, and evaluated, and although the participants state that the course promoting the detection and referral of suspected cases of COVID-19, from pharmacies-drugstores, it is needing to conduct a study to assess this question. (AU)

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.

Programas e intervenciones educativas ofrecidas al personal farmacéutico para mejorar la prestación de los servicios asistenciales farmacéuticos: una revisión estructurada / Educational programs and interventions offered to pharmacy staff to improve the delivery of pharmaceutical assistance services: A structured review

Resumen Objetivo: Describir los programas y las intervenciones educativas ofrecidas al personal farmacéutico, para mejorar la prestación de los servicios asistenciales farmacéuticos y los métodos utilizados para evaluar la efectividad de estos programas. Métodos: Se realizó una revisión estructurada, se utilizó la base de datos PubMed/Medline entre 2007 y 2019, sobre el desarrollo, la descripción, la evaluación del impacto, la efectividad o la comparación de una intervención educativa, un entrenamiento específico o un programa educativo dirigido al personal farmacéutico de farmacias comunitarias (ambulatorias) y/o hospitalarias. Resultados: En total, 1290 referencias bibliográficas fueron identificadas: se incluyeron 26 referencias adicionales y se seleccionaron 90 artículos para su revisión y análisis. Se encontró que el 70 % (63) de los estudios fueron realizados en países desarrollados, principalmente en Estados Unidos, Australia, Canadá e Inglaterra. El 67 % (60) de los estudios se realizaron a nivel ambulatorio, el 10 % (9) a nivel hospitalario y el 23 % (21), en ambos contextos. Las intervenciones fueron clasificadas en tres categorías: Entrenamientos Específicos (41 %), programas de Educación Continua (43 %) y de Desarrollo Profesional Continuo, (16 %). De las metodologías o métodos de provisión de la intervención, la más común fue la presencial en el 72 % (65) de los estudios, seguido de metodologías apoyadas con herramientas virtuales en el de las intervenciones educativas varió entre menos de 1 hora y 120 horas. Conclusión: Se describen los programas y las intervenciones educativas ofrecidas al personal farmacéutico, principalmente para mejorar sus competencias laborales y la prestación de los servicios asistenciales farmacéuticos, además de los métodos utilizados para evaluar la efectividad de las intervenciones educativas.

Abstract Objective: To describe the educational programs and interventions offered to pharmacy staff, to improve the delivery of pharmaceutical healthcare services and the methods used to evaluate the programs' effectiveness. Methods: A structured review was performed using the PubMed/Medline database from 2007 to 2019. Results: In total, 1290 bibliographic references were identified; besides, 26 references identified by other sources were included and 90 articles for review and analysis were selected. It was found that 70% (63) of the studies were made in developed countries, mainly in the United States, Australia, Canada, and England. 67% (60) of the studies were carried out at the outpatient level, 10% (9) at the hospital level, and 23% (21) in both contexts. The interventions were classified into three categories: Specific settings (41%), Continuing Education (43%), and Continuing Professional Development (16%) programs. The most common methodology or delivery methods for the intervention were face-to-face in 72% (65) of the studies, followed by methodologies supported by virtual tools in 28% (25) and 11% (10) of the studies combined face-to-face and virtual methods. The duration of the educational interventions ranged from less than 1 hour to 120 hours. Conclusion: The educational programs and interventions offered to the pharmacy staff are described, mainly to improve their labor competencies. Additionally the provision of pharmaceutical healthcare services and the methods used to evaluate the effectiveness of the educational intervention.

COVID-19 in Colombia endpoints. Are we different, like Europe?

The infection by the new coronavirus (SARS-CoV-2) has taken the dimension of a pandemic, affecting more than 160 countries in a few weeks. In Colombia, despite the implementation of the rules established by the national government, exists an elevate concern both for mortality and for the limited capacity of the health system to respond effectively to the needs of patients infected. For Colombia, assuming a case fatality rate among people infected with SARS-CoV-2 of 0.6% (average data from the information reported for Latin American countries for March 18) (Table 1), the number of deaths, in one or two weeks, could be 16 and 243, respectively. These estimates differ markedly from those documented in countries such as Spain and Italy, in which COVID-19 case fatality rates exceed 8% (case of Italy) and from the percentage of patients who have required intensive care, which has ranged from 9% to 11% of patients in Mediterranean European countries. These differences could be explained due to: a) the percentage of the population at risk (individuals older than 60 years); b) a higher epidemiological exposure to viral respiratory infections associated with more frequent exposure to them, due to geographic and climatic conditions; c) less spread of the virus by location in the tropical zone; and d) earlier preventive measures to contain the spread of SARS-CoV-2 infection. Therefore, it is possible to establish that the situation in this country will be different from in European Mediterranean and that Colombia could have different endpoints from Spain and Italy.

Primary health care policy and vision for community pharmacy and pharmacists in Colombia.

Colombia is a decentralized republic with a population of 50 million, constituted by 32 departments (territorial units) and 1,204 municipalities. The health system provides universal coverage and equal access to health care services to 95% of the population. Primary health care is seen as a practical approach that guarantees the health and well-being of whole-of-society. The National Pharmaceutical Policy (NPP, 2012) goal is "to develop strategies that enable the Colombian population equitable access to effective medicines, through quality pharmaceutical services (PS)". There are 4,351 providers certified to deliver PS: 3,699 (85%) ambulatory and 652 (15%) hospital care. The goals for PS are: a) promoting healthy lifestyles; b) preventing risk factors arising from medication errors; c) promoting rational use of medicines; and d) implementing Pharmaceutical Care. There are a number of ways that ambulatory patients access medications: through intermediary private companies, public and private hospitals pharmacies, and retail establishments (drugstores and pharmacies). Intermediary private companies are similar to Pharmaceutical Benefits Management in the U.S. health system, and act as intermediaries between health insurers, pharmaceutical laboratories, and patients. Pharmacists are being employed by these companies and in health insurance companies managing, auditing and delivering rational use of medicines programs. In 2014 there were approximately 20,000 pharmacies and drugstores, (private establishments) where a significant number of prescription-only medicines are sold without medical prescription. Colombian laws allow personal without pharmacy education to be a "director" in these establishments, so the training and education of persons working in drugstores and pharmacies is an important challenge. There about 8,000 registered pharmaceutical chemists with 25% to 30% working in patient care. Since the 90´s, there are more favorable conditions for pharmacist's participation and contribution to health system and patient's health outcome. These environmental facilitators include: a) laws and regulations regarding pharmaceutical services (2005-2007), b) establishment of a NPP (2012), and c) opportunities associated with the consolidation of private health management companies providing health services with an interest in pharmaceutical services (since 1995). Finally, telepharmacy, comprehensive care routes for pharmaceutical services, and further strengthen of postgraduate training in pharmacy practice are future strategies to improve the pharmacy profession in Colombia. They provide an opportunity to influence the recognition and value of the pharmacist as the health care professional.

Primary health care policy and vision for community pharmacy and pharmacists in Colombia

Colombia is a decentralized republic with a population of 50 million, constituted by 32 departments (territorial units) and 1,204 municipalities. The health system provides universal coverage and equal access to health care services to 95% of the population. Primary health care is seen as a practical approach that guarantees the health and well-being of whole-of-society. The National Pharmaceutical Policy (NPP, 2012) goal is "to develop strategies that enable the Colombian population equitable access to effective medicines, through quality pharmaceutical services (PS)". There are 4,351 providers certified to deliver PS: 3,699 (85%) ambulatory and 652 (15%) hospital care. The goals for PS are: a) promoting healthy lifestyles; b) preventing risk factors arising from medication errors; c) promoting rational use of medicines; and d) implementing Pharmaceutical Care. There are a number of ways that ambulatory patients access medications: through intermediary private companies, public and private hospitals pharmacies, and retail establishments (drugstores and pharmacies). Intermediary private companies are similar to Pharmaceutical Benefits Management in the U.S. health system, and act as intermediaries between health insurers, pharmaceutical laboratories, and patients. Pharmacists are being employed by these companies and in health insurance companies managing, auditing and delivering rational use of medicines programs. In 2014 there were approximately 20,000 pharmacies and drugstores, (private establishments) where a significant number of prescription-only medicines are sold without medical prescription. Colombian laws allow personal without pharmacy education to be a "director" in these establishments, so the training and education of persons working in drugstores and pharmacies is an important challenge. There about 8,000 registered pharmaceutical chemists with 25% to 30% working in patient care. Since the 90's, there are more favorable conditions for pharmacist's participation and contribution to health system and patient's health outcome. These environmental facilitators include: a) laws and regulations regarding pharmaceutical services (2005-2007), b) establishment of a NPP (2012), and c) opportunities associated with the consolidation of private health management companies providing health services with an interest in pharmaceutical services (since 1995). Finally, telepharmacy, comprehensive care routes for pharmaceutical services, and further strengthen of postgraduate training in pharmacy practice are future strategies to improve the pharmacy profession in Colombia. They provide an opportunity to influence the recognition and value of the pharmacist as the health care professional

No disponible

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, cluster-randomized controlled trial.

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 self-medication, 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.

[Hypo or hyperglycemia associated with fluoroquinolone use]. / Disglucemia asociada a fluoroquinolonas: una revisión estructurada.

Fluoroquinolone type antimicrobials can cause hypo or hyperglycemia in certain patients. We performed a structured review about this side effect, searching articles published in English or Spanish with full text access in PubMed/Medline. The following MESH terms were used: Hypoglycemia, Hyperglycemia, Quinolones, Ciprofloxacin, Levofloxacin, Moxifloxacin. Additionally, we evaluated the clinical relevance of potential drug interactions, based on the probability of occurrence and the severity of the interaction effect. We obtained 42 publications about the issue; 22 references were selected, where the severity of the interaction in patients with risk factors was evaluated. Patients receiving antidiabetic medications and with risk factors such as advanced age and renal failure may be more likely to have a severe hypoglycemia. In these patients, this drug interaction should be considered clinically relevant since its risk is high or very high.

Percepción de los estudiantes de los programas de Química Farmacéutica, Tecnología en Regencia de Farmacia y Medicina de la Universidad de Antioquia frente al uso terapéutico de los cannabinoides / Perception of the students of the programs of Pharmaceutical Chemistry, Technology in Regency of Pharmacy and Medicine of the University of Antioquia about the therapeutic use of cannabinoids

Resumen Introducción: La planta Cannabis sativa (marihuana) contiene un número aproximado de 60 cannabinoides, de los cuales, el delta-9-tetrahidrocannabinol es el componente más estudiado para ser utilizado con fines medicinales. El conocimiento adecuado por parte de los ciudadanos de esta estrategia terapéutica es un proceso clave para garantizar la aceptación y la buena adherencia al tratamiento. Objetivo: Establecer la percepción que tienen los estudiantes de pregrado de Química Farmacéutica, Tecnología en Regencia de Farmacia y Medicina de la Universidad de Antioquia, en cuanto al uso de los productos de extractos de cannabis como tratamiento medicinal. Método: Estudio observacional de corte transversal, a partir de encuestas a estudiantes a través de un formulario en línea. Resultados: Se aplicaron 374 encuestas, 232 (62%) estudiantes de pregrado de Química Farmacéutica y Tecnología en Regencia de Farmacia y 142 (38%) de Medicina. De los estudiantes, 222 (59,4%) eran del sexo femenino, con una edad promedio de 22,5 años, y 348 (94%) viven en estrato socioeconómico bajo y medio. El 60,2% de los estudiantes dicen tener un conocimiento inadecuado sobre la utilización de la marihuana medicinal, la utilización de cannabinoides medicinales, la reglamentación y la seguridad. Relacionado con la opinión sobre la utilización medicinal, 356 (95,2%) de los encuestados estuvieron de acuerdo. Conclusiones: La mayoría de los estudiantes manifestaron un conocimiento inadecuado sobre la utilización de los cannabinoides terapéuticos. Además, gran parte de los estudiantes están de acuerdo con la utilización de la marihuana medicinal.

Abstract Introduction: Cannabis sativa (marijuana) contains approximately 60 cannabinoids, of which, delta-9-tetrahydrocannabinol is the most studied component to be used for medicinal purposes. Adequate knowledge by citizens of this therapeutic strategy is a key process to guarantee the acceptance and the good adherence to the treatment. Objective: To establish the perception of undergraduate students of Pharmaceutical Chemistry, Technology in Regency of pharmacy and medicine of the University of Antioquia, as regards to the use of cannabis extracts products as medicinal treatment. Method: Observational cross-sectional study, based on surveys to students through an online form. Results: 374 surveys were obtained, 232 (62%) from students of Pharmaceutical Chemistry and Technology in Regency of Pharmacy, and 142 (38%) from Medicine. 222 (59.4%) of the students that were female, with a mean age of 22.5 years, and 348 (94%) live in low and middle socioeconomic strata. 60.2% of students claim to have inadequate knowledge regarding the use of medical marijuana, the use of medicinal cannabinoids, regulation and safety. Related to the opinion of the medicinal use, 356 (95.2%) respondents agreed. Conclusions: Most of the students expressed inadequate knowledge about the use of therapeutic cannabinoids. In addition, the vast majority of students agree with the use of medical marijuana.

Disglucemia asociada a fluoroquinolonas: una revisión estructurada / Hypo or hyperglycemia associated with fluoroquinolone use

Fluoroquinolone type antimicrobials can cause hypo or hyperglycemia in certain patients. We performed a structured review about this side effect, searching articles published in English or Spanish with full text access in PubMed/Medline. The following MESH terms were used: Hypoglycemia, Hyperglycemia, Quinolones, Ciprofloxacin, Levofloxacin, Moxifloxacin. Additionally, we evaluated the clinical relevance of potential drug interactions, based on the probability of occurrence and the severity of the interaction effect. We obtained 42 publications about the issue; 22 references were selected, where the severity of the interaction in patients with risk factors was evaluated. Patients receiving antidiabetic medications and with risk factors such as advanced age and renal failure may be more likely to have a severe hypoglycemia. In these patients, this drug interaction should be considered clinically relevant since its risk is high or very high.

Caracterización de aspectos relacionados con la utilización de los medicamentos fiscalizados en droguerías y farmacias-droguerías de Medellín y el Área Metropolitana / Characterization of aspects related to the use of controlled drugs in Drugstores and pharmacies-drugstores in Medellin and the Metropolitan Area

Resumen Introducción: Los fallos prevenibles en la cadena del medicamento se relacionan con los Problemas Relacionados con la Utilización de Medicamentos, y están asociados a errores de medicación (prescripción, dispensación, administración o uso), incluyendo los fallos en el Sistema de Suministro de Medicamentos (disponibilidad y calidad). Objetivo: Identificar información básica de los Establecimientos Farmacéuticos (EF), caracterizar algunos procesos relacionados con la utilización de medicamentos fiscalizados (MF), incluyendo cumplimiento de la normatividad, y determinar el nivel de percepción del riesgo y las necesidades de educación continua del personal farmacéutico (PF). Metodología: Se realizó un estudio de corte transversal. Se utilizó un cuestionario sobre los procesos enfocados en la utilización de MF, durante mayo a septiembre de 2016. Resultados: Se visitaron 700 establecimientos y se encuestaron a igual cantidad de PF. El 88% (617) de los establecimientos eran de estratos socioeconómicos bajo y medio. Los MF más dispensados fueron: amitriptilina 91,4% (640), tramadol 90% (630) y trazodona 60% (419). El 71,6% (501) de los encuestados consideró que el expendedor de drogas es el personal más idóneo para dispensar MF. El 25% (177) de los encuestados percibieron como muy deficiente a regular el proceso de información y educación que ellos brindan, y el 32% (223) con igual percepción en la responsabilidad que tienen con el uso y resultados en salud de los pacientes. Conclusiones: Se identifica la información general de los establecimientos, al igual que de los procesos relacionados con la utilización de MF. La percepción de los encuestados sobre el personal idóneo para la dispensación correcta de MF podría ser inadecuado. Un alto porcentaje del PF percibe falencias de educación enfocada en la utilización correcta de los MF.

Abstract Introduction: Preventable failures in the drug chain are related to Drugs Problems Related Use and are associated with medication errors (prescription, dispensing, administration or use by the patient or caregiver), including failures In the Medication Supply System (availability and quality). Objective: Recognize basic information of the Pharmaceutical Establishments (PE), to characterize some processes related to the use of controlled drugs (CD), including compliance with the regulations, and determine the level of risk perception and the continuing education needs of the staff pharmacy. Methodology: A cross-sectional, epidemiological study was performed. A questionnaire was used on the processes focused on the use of CD, between May to September of 2016. Results: 700 PE were visited and an equal number of staff pharmacy were interviewed. Eighty-eight percent (617) of PE are socioeconomic low and medium status, and have an average of 15.3 years of operation (SD 13.6 years). The most favored CD were: mitriptyline 91.4% (640), tramadol 90% (630) and trazodone 60% (419). 76.6% (536) of the respondents considered that the Pharmacy Technician is the most suitable personnel to dispense CD. 25% (177) of the respondents perceived as very poor to regulate the process of information and education that they provide, and 32% (223) with equal perception in the responsibility that they have with the use and results in patients' health. Conclusions: It identifies the general information of PE, as well as of processes related to the use of CD. The perception of respondents about the SP that is suitable for the correct dispensing of CD may be inadequate. A high percentage of the SP perceives educational failures focused on the correct use of CD.

Interacciones medicamentosas de antiinfecciosos que desencadenan enfermedad renal: Aproximación para establecer y valorar su relevancia clínica. Revisión sistemática cualitativa / Interactions of anti-infectious drugs that trigger renal disease: Approach to establish and assess its clinical relevance. Systematic qualitative review

Resumen Introducción: Las interacciones medicamentosas de anti-infecciosos pueden desencadenar enfermedad renal; sin embargo, la información de este efecto es limitada, por tanto, la identificación, prevención y manejo de las interacciones medicamentosas clínicamente relevantes se considera un aspecto clave en la consecución de los objetivos terapéuticos en pacientes en tratamiento con anti-infecciosos. Objetivo: Identificar y valorar la relevancia clínica de interacciones medicamentosas de anti-infecciosos que causan enfermedad renal. Metodología: Revisión sistemática cualitativa de interacciones medicamentosas de anti-infecciosos asociadas a enfermedad renal. La relevancia clínica de las interacciones medicamentosas se valoró acorde con la probabilidad de ocurrencia y la gravedad del efecto. La búsqueda se realizó en la base de datos PubMed/Medline, de artículos publicados en inglés o español, entre agosto de 2006 y agosto de 2016, utilizando los siguientes términos Mesh y operadores boléanos: "Renal Insufficiency" OR "Anti-Infective Agents" OR "Antifungal Agents" OR "Anti-Bacterial Agents" AND "Drug Interactions" OR "Herb-Drug Interactions" OR "Food-Drug Interactions". Resultados: Se identificaron 44 publicaciones y se incluyeron 9; en ellas, se identificaron 12 interacciones medicamentosas asociadas a enfermedad renal. Las combinaciones asociadas a enfermedad renal fueron: inhibidores de proteasa/nifedipino, cobicistat/fenofibrato/pravastatina, tenofovir/metformina, macrólidos/ estatinas, macrólidos/bloqueadores de los canales de calcio, quinolonas/warfarina, valaciclovir/loxoprofen y ácido fusídico/pravastatina. Conclusiones: Los inhibidores de proteasa, macrólidos y quinolonas, al igual que el tenofovir, cobicistat, valaciclovir y ácido fusídico pueden generar enfermedad renal cuando se utilizan simultáneamente con otros medicamentos, en especial con estatinas, bloqueadores de canales de calcio, warfarina, metformina o loxoprofen. MÉD.UIS. 2017;30(3):101-9.

Abstract Introduction: Drug interactions of anti-infectives can trigger renal disease; however, information on this effect is limited. Therefore, the identification, prevention and management of clinically relevant drug interactions are a key aspect in the achievement of therapeutic objectives in patients receiving anti-infectives. Objective: To identify and assess the clinical relevance of anti-infective drug interactions that causes kidney disease. Methodology: Systematic qualitative review of drug interactions of anti-infectives associated with renal disease. The clinical relevance of drug interactions was assessed according to the probability of occurrence and severity of the effect. The search was done in the PubMed/Medline database of articles published in english or spanish, between august 2006 and august 2016, using the following Mesh terms and Boolean Operators: "Renal Insufficiency" OR " Anti-Bacterial Agents "OR" Drug Interactions "OR" HerbDrug Interactions "OR" Food-Drug Interactions ". Results: We identified 44 publications and nine were included. In these nine articles, 12 drug interactions associated with renal disease were identified. Combinations associated with renal disease were protease inhibitors/ nifedipine, cobicistat/fenofibrate/pravastatin, tenofovir/metformin, macrolides/statins, statins/calcium channel blockers, quinolones/ warfarin, valaciclovir/loxoprofen and fusidic acid/Pravastatin. Conclusions: Protease inhibitors, macrolides and quinolones, as well as tenofovir, cobicistat, valaciclovir and fusidic acid can generate renal disease when used simultaneously with other drugs, especially with statins, calcium channel blockers, warfarin, metformin or loxoprofen. MÉD.UIS. 2017;30(3):101-9

Relevancia clínica de la interacción de la warfarina y del acetaminofén: estudio de cohortes retrospective / Clinical relevance of the interaction of warfarin and acetaminophen: retrospective cohort study

Resumen Objetivo: Evaluar el uso concomitante de la warfarina y el acetaminofén en una población ambulatoria de pacientes anticoagulados, como posible factor de riesgo en el aumento de la Relación Normalizada Internacional (INR). Métodos: Estudio de cohortes retrospectivo. Se analizó la información de 1.458 pacientes anticoagulados con la warfarina. El factor de riesgo fue la utilización conjunta de warfarina- acetaminofén; el tiempo de seguimiento fue de 1 mes y como evento final se consideró un incremento del INR igual o mayor a 0,5 unidades. La asociación del factor de riesgo con el evento final se estableció con el riesgo relativo (RR) y el riesgo atribuible poblacional (RAP). Resultados: 63 pacientes cumplieron criterios de inclusión, 21 pacientes expuestos y 42 pacientes no expuestos. En los individuos expuestos se observó un aumento estadísticamente significativo en el INR al mes siguiente de haber iniciado el tratamiento con el acetaminofén comparado con el momento de ingreso al estudio (mes 1: mediana 3,06 vs. mes 0: mediana 2,63), (valor p = 0,003). En contraste, en los sujetos no expuestos no se observaron diferencias estadísticamente significativas en los valores del INR (mes 0: mediana 2,63 vs. mes 1: mediana 2,75), (valor p = 0,115). El uso de la warfarina y el acetaminofén representó un RR de 2,5 veces mayor de incrementar el INR mayor o igual de 0,5 unidades. Conclusión: El uso concomitante de la warfarina y el acetaminofén está asociado a un aumento del INR igual o mayor de 0,5 unidades, lo cual podría generar un mayor efecto anticoagulante y, por tanto, un mayor riesgo potencial de sangrado.

Abstract Motivation: To assess concomitant use of warfarin and acetaminophen in an outpatient population of patients receiving blood-thinning drugs as a possible risk factor for the increase of International Normalised Ratio (INR). Methods: Retrospective cohort study. The information pertaining 1,458 patients receiving blood-thinning drugs with warfarin was analysed. The risk factor was the joint intake of warfarin and acetaminophen; follow-up time was 1 month and the final event considered was a INR increase of or higher than 0.5 units. The association of the risk factor with the final event was establish with the Relative Risk (RR) and the Population Attributable Risk (PAR). Results: 63 patients met the inclusion criteria, of whom 21 were exposed patients and 42 were unexposed patients. In the exposed patients a statistically significant increase of INR on the month following the onset of treatment with acetaminophen was observed, compared to the baseline values (month 1: median 3.06 vs. month 0: median 2.63), (p = 0.003). In contrast, no statistically significant differences of INR values were observed in unexposed individuals (month 0: median 2.63 vs. month 1: median 2.75) (p = 0.115). The combination of warfarin and acetaminophen represented a RR 2.5 times higher to increase INR greater than or equal to 0.5 units. Conclusion: Concomitant use of warfarin and acetaminophen is associated to an increase of INR equal to or greater than 0.5 units, which could generate a higher blood-thinning effect and, thus, cause a potentially higher risk of bleeding.

Efecto de la interacción clopidogrel-omeprazol en el reingreso hospitalario de pacientes por recidiva de síndrome coronario agudo: estudio de casos y controles / Effect of drug interaction between clopidogrel and omeprazole in hospital readmision of patients by a recurrent acute coronary syndrome: A case-control study

OBJETIVO: Evaluar el efecto de la interacción clopidogrel-omeprazol en el reingreso hospitalario de pacientes por recidiva de síndrome coronario agudo (SCA). DISEÑO: Estudio de casos y controles. Emplazamiento: IPS Universitaria Clínica León XIII, Medellín, Colombia. Participantes: Se seleccionaron a partir de una población prevalente, entre 2009-2010, pacientes con uso de clopidogrel de forma ambulatoria (menor a un año y superior a 30 días), y la estancia hospitalaria por un SCA o la presencia de un SCA previo. Medidas principales: Un paciente-caso se definió como aquel que presentó una recidiva de SCA y un paciente-control se definió como aquel que no presentó recidiva de SCA. Ambos grupos utilizaron ambulatoriamente clopidogrel debido al SCA previo. Como factor de riesgo se definió la utilización conjunta de omeprazol y clopidogrel ambulatoriamente. RESULTADOS: Durante el estudio se formuló clopidogrel a 1.680 pacientes. En este grupo se identificaron 50 casos readmitidos con SCA y 76 controles. No se encontró asociación estadísticamente significativa entre el uso de clopidogrel-omeprazol y un mayor riesgo de reingreso hospitalario por SCA (OR: 1,05; IC 95%: 0,516-2,152; p = 0,8851). CONCLUSIONES: En este pequeño grupo de pacientes con SCA previo, la utilización simultánea de clopidogrel con omeprazol no aumenta el riesgo de un reingreso hospitalario por recurrencia de este tipo de evento coronario

OBJECTIVE: To evaluate the effect of drug interaction between omeprazol and clopidogrel in hospital readmission of patients with acute coronary syndrome (ACS). DESIGN: Case-control study. Location: University Clinic Leon XIII, Medellin, Colombia. Participants: We selected from a prevalent population, between 2009-2010, use of clopidogrel patients on an outpatient basis (less than one year and more than 30 days), and hospital stay for ACS or the presence of a previous ACS. Main measures: A case-patient was defined as one who had a recurrence of ACS and a patient controlis defined as one that no recurrence of ACS. Both groups used ambulatory priorclopidogrel due to ACS. As defined risk factor the joint use of omeprazole and clopidogrel outpatients. RESULTS: During the study, 1680 patients clopidogrel formulated. This group identified 50 cases readmitted with ACS and 76 controls. No statistically significant association was found between use of clopidogrel-omeprazole and increased risk of hospital readmission for ACS (OR: 1.05; 95% CI: 0.516-2.152; P = 0.8851). CONCLUSIONS: In this small group of patients with previous SCA, the simultaneous use of clopidogrel with omeprazole does not increase the risk of a readmission by recurrence of this type of coronary event