Identificación y caracterización de herramientas para evaluar la alergia a las penicilinas: Revisión estructurada / Identification and characterization of tools used to assess penicillin allergy: structured review

Introducción: Las reacciones alérgicas son uno de los problemas de seguridad más graves asociadas al uso de medicamentos, siendo la alergia a los antibióticos betalactámicos la más prevalente. Las pruebas de alergia a las penicilinas pueden ayudar a identificar pacientes hospitalizados y ambulatorios que podrían tolerar y usar de manera segura este grupo de antibióticos y evitar rótulos que limiten el uso de antibióticos betalactámicos por tiempo indefinido. Objetivo: Identificar las herramientas disponibles en la literatura para valorar el antecedente de alergia a las penicilinas y proponer una herramienta que consolide la información extraída. Metodología: Revisión estructurada en PubMed/MEDLINE entre 1 junio 2015 hasta 30 noviembre 2022, utilizando los términos MeSH: (((“skin tests”[MeSH Terms]) OR (“skin irritancy tests”[MeSH Terms])) AND (“penicillins”[All Fields])) AND (“drug hypersensitivity”[MeSH Terms]). Publicaciones en inglés y español con acceso a texto completo y estudios realizados en humanos, sobre herramientas disponibles para evaluar la alergia a penicilinas fueron incluidos. Resultados: Se identificaron201 artículos, de los cuales se incluyeron 108. Dentro de las herramientas para evaluar la alergia a las penicilinas se identificaron: a) pruebas in vivo: pruebas cutáneas, pruebas de provocación oral, pruebas del parche; y b) pruebas in vitro: pruebas de IgE específica, determinación de triptasa, histamina. De los 1181 pacientes reportados con alergia a las penicilinas, sólo el 2 % de ellos se confirmó la presencia de alergia. Conclusión: Las pruebas cutáneas y de provocación oral sumado a algunas combinaciones in vivo/in vitro, fueron las herramientas más utilizadas para evaluar la alergia a las penicilinas. (AU)

Introduction: Allergic reactions are one of the most serious safety problems associated with the use of medications, with allergy to beta-lactam antibiotics being the most prevalent. In fact, the American Academy of Allergy, Asthma and Immunology (AAAAI) states that penicillin allergy testing can help identify inpatients and outpatients who could safely tolerate and use this group of antibiotics and avoid labels that limit the use of beta-lactam antibiotics indefinitely. Objective: To identify the tools available in the literature to assess the history of allergy to penicillins and propose a tool that consolidates the information extracted. Methodology: Structured review on PubMed/MEDLINE between June 1, 2015 until November 30, 2022; using the search terms MeSH: (((“skin tests”[MeSH Terms]) OR (“skin irritancy tests”[MeSH Terms])) AND (“penicillins”[All Fields])) AND (“drug hypersensitivity”[MeSH Terms]). Papers in English and Spanish with access to full text and human trials, regarding available tools used to evaluate penicillin allergies were included. Results: A total of 201 articles were identified, of which after an independent evaluation, 108 were included. Among the tools to evaluate penicillin allergy, in vivo tests were identified: skin tests, oral provocation tests, patch tests and in vitro tests: specific IgE tests, determination of tryptase, histamine, T lymphocytes and basophilic activation tests. Of the patients (1181) reported with penicillin allergy, 905 (77 %) had their allergy assessed with skin testing or oral challenge tests, and only 2 % of them had a confirmed allergic reaction. Conclusion: Skin tests and oral provocation tests added to some in vivo/in vitro combinations were the most used tools to evaluate penicillin allergy. (AU)

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)

Effect and associated factors of a clinical pharmacy model in the incidence of medication errors in the hospital Pablo Tobón Uribe eacpharmodel study: stepped wedge randomized controlled Trial (NCT03338725).

Background The World Health Organization considers medication errors to be an issue that requires attention at all levels of care, to reduce the severe and preventable harm related to drug therapy. Different standards for clinical pharmaceutical practices have been proposed by various organizations across the world, where the pharmacist, as part of the multidisciplinary health team, can help improve patient safety. Objective To assess the impact of the introduction of a clinical pharmacy practice model on medication error in patients of a university hospital. Setting The study was conducted in a tertiary care hospital, Medellín, Colombia. Methods A randomized, controlled cluster-wedge staggered trial with a duration of 14 months was conducted to compare the clinical pharmacy practice model with the usual care process in the hospital. Five hospital health care units were included, which were initially assigned to the control group, and after an observation period of 2 months, they were randomly assigned to the intervention group. The trial protocol was registered in ClinicalTrials.gov (identifier NCT03338725). Main outcome measure The incidence of medication errors in hospitalized patients was the main outcome measure. Results The incidence of medication error was 13.3% and 22.8% for the intervention group and control group, respectively. The probability of presenting a medication error was 48% lower when the patient was in the intervention group (RR 0.52; 95% CI: 0.34-0.79). The probability of presenting a medication error over time was 44% lower in the intervention group (p = 0.0005); meanwhile, the resolution of a medication error over time was 70% higher in the intervention group (p = 0. 0029). Conclusion The clinical pharmacy practice model, made up of strategies focused on reducing medication errors, significantly reduces medication errors in patients during hospitalization compared with usual practice. This work assessed the effect of a clinical pharmacy model on the incidence of medication errors and demonstrated its effectiveness in reducing these errors in hospitalized patients. Trial registration ClinicalTrials.gov, NCT03338725. Registered on 9 November 2017. First patient randomized on February 2, 2018.

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.

Pharmacist's Role and Pharmaceutical Care During the COVID-19 Pandemic.

Pharmacists play a vital role in public health during the COVID-19 pandemic. In this chapter, we present the most significant contributions that pharmacists could make to communitarian and hospital settings. It includes the provision of essential services, such as continuous access to medication and supplies, support to medical services, education and information to the population and the health team to reduce the misuse of medications, patient monitoring and follow-up, and the detection and referral of suspected cases of COVID-19. The chapter ends with a discussion over certain elements related to innovation needs, such as telepharmacy services.

How to link patients with suspicious COVID-19 to health system from the community pharmacies? A route proposal.

Colombia confirmed its first case of the COVID-19 on March 6th, 2020. On March 16th, 2020, 54 cases have been confirmed (36 imported and 18 associated), therefore, Colombia is at highest alert, and it is now trying to avoid or minimize the last stage of "community transmission". We present a route proposal that shows how the community pharmacist may develop his responsibility to contribute to the early detection and appropriate referral of possible cases of the COVID-19. In the route have been considered three possible entrances depending on the needs of the users: anti-flu drugs, symptoms related to COVID-19 infection or the request for items for hygiene and prevention of transmission such as alcohol and face masks. Later, self-care education should be given, and the possible cases should be reported to the telephone lines designated by the mayor or the governor, continuing the healthcare process. Community pharmacies and pharmacy staff play a crucial role in minimizing the stage of "community transmission" of COVID-19, through properly detection and management of possible cases and customer education.

Rol del farmacéutico en la atención integral de pacientes con hepatitis C: revisión sistemática / The role of pharmacists in the comprehensive care of patients with hepatitis C: a systematic review

Resumen Objetivo: identificar y caracterizar las acciones/intervenciones realizadas desde los servicios farmacéuticos en el abordaje de pacientes con hepatitis C y proponer una vía clínica para la gestión de la enfermedad que incluya la participación del farmacéutico. Método: revisión sistemática en PubMed y EMBASE empleando los términos "Hepatitis C", "Pharmaceutical Services", "Community Pharmacy Services", y "Pharmacies"; artículos publicados hasta el 31 de marzo de 2019, cuyo tema central fueran las actividades realizadas por los servicios farmacéuticos en la atención a pacientes con hepatitis C. Se recopiló información sobre la actividad realizada, responsable, si la intervención era individual o colectiva y el entorno de aplicación. Las actividades se agruparon en promoción y prevención, gestión administrativa, atención farmacéutica, investigación y otros servicios de apoyo. De acuerdo con esto, se propuso una vía clínica para el manejo de la hepatitis C con participación del farmacéutico. Resultados: se incluyeron 60 artículos, principalmente de estudios descriptivos. La mayoría de las publicaciones reportó intervenciones realizadas en Estados Unidos y España. Se identificó la participación del personal farmacéutico en cada una de las etapas del proceso de atención, que incluye la provisión de servicios de reducción del daño, tamizaje del virus de la hepatitis C, vinculación de los pacientes al tratamiento, prescripción de medicamentos y órdenes de laboratorio. Conclusiones: se identifican y caracterizan las acciones/intervenciones realizadas desde el servicio farmacéutico para el manejo de la hepatitis C y se propone una vía clínica en la que se integran los servicios profesionales farmacéuticos a las demás actividades de la atención del paciente.

Abstract Objective: To identify and characterize the actions/interventions carried out by pharmaceutical services to approach patients with Hepatitis C and propose a clinical pathway for managing the disease that involves pharmacists. Methodology: A systematic review was conducted in PubMed and EMBASE using the terms "Hepatitis C," "Pharmaceutical Services," "Community Pharmacy Services," and "Pharmacies." Articles published until March 31, 2019, whose central topic was the activities carried out by the pharmaceutical services in the care of patients with Hepatitis C, were included. Information on the activity performed, the person in charge, whether the intervention was individual or collective, and the implementation environment was collected. The activities were grouped into promotion and prevention, administrative management, pharmaceutical care, research, and other support services. Based on the above, a clinical pathway for the management of Hepatitis C involving pharmacists was proposed. Results: Sixty articles were included, mainly descriptive studies. Most publications reported interventions in the United States and Spain. Pharmaceutical staff involvement was identified at each stage of the care process, including the provision of harm reduction services, Hepatitis C virus screening, enrolling patients to treatment, medication prescription, and laboratory orders. Conclusions: The actions/interventions carried out by the pharmaceutical service for Hepatitis C management were identified and characterized. A clinical pathway has been proposed to integrate professional pharmaceutical services with other patient care activities.

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.

Long-term impact of pharmacist intervention in patients with bipolar disorder: extended follow-up to the EMDADER-TAB study.

BACKGROUND: Pharmaceutical care (PC) through the Dader method (DMet) vs. the usual care process (UCP) significantly reduced psychiatric hospitalizations and emergency service consultations during one year of follow-up of outpatients with bipolar I disorder (BD-I). To date, the effect of long-term PC on the use of health services by BD-I patients once pharmacist intervention has ended is unknown. OBJECTIVE: To determine whether the effect of PC measured by the decrease in psychiatric hospitalizations and emergency service consultations is maintained one year after pharmacist intervention ceases. METHODS: This was a retrospective analysis of patients who had previously participated in a randomized, controlled, prospective, single-center clinical trial to compare PC (intervention group) vs. UCP (control group) in BD-I patients. Data were collected from November 2012 to March 2014. The primary outcome was the use of health services measured by the number of psychiatric hospitalizations and emergency service consultations. Descriptive statistics, Student's t-test, Kaplan-Meier function, and Log-Rank test were used. RESULTS: The study included 92 patients: 43 in the intervention group and 49 in the control group. Eleven psychiatric hospitalizations occurred for the intervention group and 19 for the control group. One year after pharmacist intervention ceased, there were no significant differences between the groups in psychiatric hospitalizations (p = 0.261). There were 14 emergency service consultations for the intervention group, and 24 for the control group without significant differences (p = 0.212). CONCLUSIONS: PC through the DMet has no long-term effects on psychiatric hospitalizations and emergency department consultations in patients with BD-I following discontinuation of pharmacist intervention; the effect dissipates when the intervention ceases. Future studies should focus efforts on identifying factors associated with PC that explain why the outcomes derived from this intervention are not maintained in the long term.

Perspective on the Therapeutics of Anti-Snake Venom.

Snakebite envenomation is a life-threatening disease that was recently re-included as a neglected tropical disease (NTD), affecting millions of people in tropical and subtropical areas of the world. Improvement in the therapeutic approaches to envenomation is required to palliate the morbidity and mortality effects of this NTD. The specific therapeutic treatment for this NTD uses snake antivenom immunoglobulins. Unfortunately, access to these vital drugs is limited, principally due to their cost. Different ethnic groups in the affected regions have achieved notable success in treatment for centuries using natural sources, especially plants, to mitigate the effects of snake envenomation. The ethnopharmacological approach is essential to identify the potential metabolites or derivatives needed to treat this important NTD. Here, the authors describe specific therapeutic snakebite envenomation treatments and conduct a review on different strategies to identify the potential agents that can mitigate the effects of the venoms. The study also covers an increased number of literature reports on the ability of natural sources, particularly plants, to treat snakebites, along with their mechanisms, drawbacks and future perspectives.

Effectiveness of the Dader Method for Pharmaceutical Care on Patients with Bipolar I Disorder: Results from the EMDADER-TAB Study.

BACKGROUND: Bipolar I disorder (BD-I) is a chronic illness characterized by relapses alternating with periods of remission. Pharmacists can contribute to improved health outcomes in these patients through pharmaceutical care in association with a multidisciplinary health team; however, more evidence derived from randomized controlled trials (RCTs) is needed to demonstrate the effect of pharmaceutical care on patients with BD-I. OBJECTIVE: To assess the effectiveness of a pharmaceutical intervention using the Dader Method on patients with BD-I, measured by the decrease in the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits from baseline through 1 year of follow-up. METHODS: This study is based on the EMDADER-TAB trial, which was an RCT designed to compare pharmaceutical care with the usual care given to outpatients with BD-I in a psychiatric clinic. The main outcome was the use of health care services, using Kaplan-Meier methods and Cox regression. The trial protocol was registered in ClinicalTrials.gov (Identifier NCT01750255). RESULTS: 92 patients were included in the EMDADER-TAB study: 43 pharmaceutical care patients (intervention group) and 49 usual care patients (control group). At baseline, no significant differences in demographic and clinical characteristics were found across the 2 groups. After 1 year of follow-up, the risk of hospitalizations and emergencies was higher for the control group than for the intervention group (HR = 9.03, P = 0.042; HR = 3.38, P = 0.034, respectively); however, the risk of unscheduled outpatient visits was higher for the intervention group (HR = 4.18, P = 0.028). There was no "placebo" treatment, and patients in the control group might have produced positive outcomes and reduced the magnitude of differences compared with the intervention group. CONCLUSIONS: Compared with usual care, pharmaceutical care significantly reduced hospitalizations and emergency service consultations by outpatients with BD-I. DISCLOSURES: This study received funding from the Universidad de Antioquia, Committee for Development Research and Sustainability Program, CODI, (2013-2014 and 2014-2015). Humax Pharmaceutical provided support for the initial development of the EMDADER-TAB trial without commercial interest in the outcomes derived from the trial. Salazar-Ospina reports grants from Credito Beca Francisco José de Caldas Scholarship for Doctoral Programs (528), which also contributed to the support of this study. González-Avendaño is an employee of Humax Pharmaceutical. The other authors have nothing to disclose. Study concept and design were contributed by Benjumea, Faus, and Rodriguez, along with Salazar-Ospina and Amariles. Salazar-Ospina took the lead in data collection, assisted by González-Avendaño, and data interpretation was performed by Salazar-Ospina, Hincapié-García, and González-Avendaño. The manuscript was written primarily by Salazar-Ospina, with assistance from Amariles and González-Avendaño, and revised by all the authors.

Effectiveness of the Dader Method for pharmaceutical care in patients with bipolar I disorder: EMDADER-TAB: study protocol for a randomized controlled trial.

BACKGROUND: Bipolar I disorder (BD-I) is a chronic mental illness characterized by the presence of one or more manic episodes, or both depressive and manic episodes, usually separated by asymptomatic intervals. Pharmacists can contribute to the management of BD-I, mainly with the use of effective and safe drugs, and improve the patient's life quality through pharmaceutical care. Some studies have shown the effect of pharmaceutical care in the achievement of therapeutic goals in different illnesses; however, to our knowledge, there is a lack of randomized controlled trials designed to assess the effect of pharmacist intervention in patients with BD. The aim of this study is to assess the effectiveness of the Dader Method for pharmaceutical care in patients with BD-I. METHODS/DESIGN: Randomized, controlled, prospective, single-center clinical trial with duration of 12 months will be performed to compare the effect of Dader Method of pharmaceutical care with the usual care process of patients in a psychiatric clinic. Patients diagnosed with BD-I aged between 18 and 65 years who have been discharged or referred from outpatients service of the San Juan de Dios Clinic (Antioquia, Colombia) will be included. Patients will be randomized into the intervention group who will receive pharmaceutical care provided by pharmacists working in collaboration with psychiatrists, or into the control group who will receive usual care and verbal-written counseling regarding BD. Study outcomes will be assessed at baseline and at 3, 6, 9, and 12 months after randomization. The primary outcome will be to measure the number of hospitalizations, emergency service consultations, and unscheduled outpatient visits. Effectiveness, safety, adherence, and quality of life will be assessed as secondary outcomes. Statistical analyses will be performed using two-tailed McNemar tests, Pearson chi-square tests, and Student's t-tests; a P value <0.05 will be considered as statistically significant. DISCUSSION: As far as we know, this is the first randomized controlled trial to assess the effect of the Dader Method for pharmaceutical care in patients with BD-I and it could generate valuable information and recommendations about the role of pharmacists in the improvement of therapeutic goals, solution of drug-related problems, and adherence. TRIAL REGISTRATION: Registration number NCT01750255 on August 6, 2012. First patient randomized on 24 November 2011.

Pro-apoptotic effect of Persea americana var. Hass (avocado) on Jurkat lymphoblastic leukemia cells.

Abstract Context: Therapy for leukemia has a limited efficacy. There is a need to search for alternative anti-leukemia therapies. Persea americana Mill var. Hass (Lauraceae) is a tropical fruit (avocado) that might be used against cancer. Objective: To investigate whether P. americana induces death in Jurkat lymphoblastic leukemia cells. Materials and methods: Four ethanol extracts (0.1, 0.5, 1, 2 and 5 mg/mL) from avocado fruit (endocarp, whole seed, seed and leaves) were analyzed against Jurkat cells. Hydrogen peroxide generation by oxidation of 2',7'-dichlorodihydrofluorescein diacetate to the fluorescent compound 2',7'-dichlorfluorescein assay, acridine orange/ethidium bromide staining, flow cytometry analysis of annexin-V/7-amino-actinomycin, mitochondrial membrane potential and immunocytochemistry detection of transcription factor p53, caspase-3 and apoptosis-inducing factor (AIF) were evaluated. Results: Endocarp, seed, whole seed, and leaf (0.1 mg/mL) extracts induced significant apoptosis in Jurkat cells (p < 0.001) in an oxidative stress-dependent fashion via mitochondrial membrane depolarization (52-87%), activation of transcription factor p53 (6.3-25.4%), protease caspase-3 (8.3-20%) and predominance of AIF reactivity (20.6-36%) in all extracts. Similar results were obtained with 0.5 mg/mL extracts. However, extract ≥1 mg/mL concentration induced necrosis (100%). Conclusions: P. americana extracts function as a pro-apoptotic compound. Leukemic cells are eliminated through an oxidative stress mechanism. This study contributes to the understanding of the molecular mechanism of the avocado and its therapeutic action on leukemia.

Farmacia clínica, atención farmacéutica: conceptos, filosofía, práctica profesional y su aplicación en el contexto colombiano / Clinical pharmacy, pharmaceutical care: concepts, philosophy, professional practice and its application to the colombian context

Pharmaceutical care is a healthcare practice that has been implemented recently worldwide. Its aim is the rational medication use and the achievement of desired therapeutic goals that improve the patient quality of life. This review seeks to define and relate the terms: pharmaceutical care, clinical pharmacy and pharmacotherapy follow-up, which are misunderstood in our field. Likewise, it seeks to show the transformation that has had this practice, from the traditional pharmacist (limited to the production and distribution of medicines) into the comprehensive pharmacist nowadays (active participant of interdisciplinary health teams and responsible for all the medication needs at a political, social and economic level). An approach of these terms to the National Health System context is also the goal of this review. Through this, it is intended to homologate the terminology of this practice in our country and to state future reflections and challenges that pharmacists and different entities will have to adopt, enabling this professional practice to achieve the desired therapeutic goals settled by the health team, thus improving the patient quality of life.

Propagación in vitro de Heliconia curtispatha P, planta utilizada contra la mordedura de serpientes por algunas comunidades campesinas de la región colombiana del Urabá / In vitro propagation of Heliconia curtispatha P, plant used against snakebite by some rural communities of the colombian region of Urabá

Heliconia curtispatha Petersen (Zingiberales) comúnmente conocida como platanillo, es usada en la medicina tradicional colombiana por su acción antiedematizante, antihemorrágica y neutralizante del veneno de Bothrops asper (mapaná) responsable del 95% de las mordeduras de serpientes en el país. Lo anterior destaca su utilidad y potencial función, como coadyuvante en el tratamiento del accidente ofídico. La propagación por cultivos in vitro, se convierte en una herramienta valiosa e interesante para su masificación, debido al difícil acceso al material vegetal en su ambiente natural y la carencia de estudios previos en multiplicación in vitro de esta especie. En el presente trabajo se obtienen plántulas a partir de semillas y se evalúa su propagación en medios de cultivo Murashige & Skoog, semisólidos y líquidos suplementados con reguladores de crecimiento tipo citoquinina. Experimentalmente, se favorece la propagación de la Heliconia (2 brotes semana-1) cuando se utiliza medio Murashige & Skoog líquido sin adición de reguladores de crecimiento o al emplear Murashige & Skoog semisólido adicionándole 2 mg.L-1 6-Bencilaminopurina 0.93 brotes.semana -1. Este es el primer reporte de propagación in vitro de H. curtispatha y el primer paso para el estudio de metabolitos secundarios con potencial antiofídico que pueden producirse bajo tales condiciones.