Medicinal cannabis in Latin America: History, current state of regulation, and the role of the pharmacist in a new clinical experience with cannabidiol oil.

OBJECTIVE: Cannabis sativa was introduced in Latin America in the 16th century. Nevertheless, many years have elapsed, and scientific progress and the medicinal use of C sativa have been restricted by the national laws of the countries in the region. SUMMARY: In Argentina, the first law on medical cannabis, approved in 2017 (#17,350), establishes a regulatory framework for the medical use and scientific research of this plant and its derivatives. In 2018, the first clinical research protocol in Latin America was approved at Hospital de Pediatria Garrahan (Buenos Aires, Argentina) to evaluate the efficacy and safety of cannabidiol (CBD) oil for the treatment of pediatric patients with refractory epilepsy. In this context, the role of pharmacists in the health care system related to the study protocol and the medicinal use of CBD has evolved from dispensing to active participation in clinical follow-up and research protocols. CONCLUSION: Considering this experience, here we discuss the active role of the clinical pharmacist in the use of medicinal cannabis. Medicinal cannabis should be controlled in a legal framework based on clinical evidence, and the participation of the pharmacist in research and clinical protocols, as well as the dispensing and provision of information on the medicinal products should be emphasized in the clinical setting.

Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future.

BACKGROUND: Global pediatric research has recently received increased attention by health professionals, and research and government institutions. Since the approval of the FDA Pediatric Exclusivity Provision and the EU Paediatric Regulation, pharmaceutical companies have begun to look to developing/transitional countries for international pediatric research collaboration as a way of facilitating the recruitment of patients to clinical trials. Among countries identified as being 'developing/transitional' some were in the North, Central, and South American regions. OBJECTIVE AND METHODS: The aim of this study was to ascertain views from local practitioners on awareness and understanding of pediatric clinical research and to clarify resources and training required by pediatricians engaging in such research in the North, Central, and South American regions. A brief survey was disseminated via Sociedad Iberoamericana de Neonatología (SIBEN) and several other randomly selected pediatric institutions. This survey provided information for a Paediatric Global Research meeting at WorldPharma 2010 (Copenhagen, Denmark). RESULTS: Pediatricians (n = 55) from seven countries in Latin America and Guyana replied to the survey. They appeared to be enthusiastic about embracing the opportunity to participate in meaningful research to improve treatment of children worldwide. However, some challenges remain to be addressed around good clinical practice in the conduct of trials, education, and training of professionals, and the availability and use of resources. CONCLUSION: The survey indicated a considerable depth of interest in the improvement of the pediatric clinical research environment in Latin America. There is some momentum toward the development of a Latin American network for the facilitation and supervision of pediatric clinical research.

[Health care team and parents' opinion about pediatric patients identification]. / Evaluación de la opinión del equipo de salud y padres sobre la identificación de los pacientes pediátricos.

INTRODUCTION: Patient misidentification continues to be a quality and safety significant issue. The Joint Commission International listed patient identification as the first of ten life-saving patient-safety solutions. Identification wrist bands are the goal in the identification strategy. At the Hospital Nacional de Pediatría "Prof. Dr. J.P. Garrahan" we inquired about perception and agreement of this practice within hospital staff and parents. METHOD: A short questionnaire was used with; in the first part a four point Lickert scale, and in the second one an open unstructured response. The questionnaire was distributed among health care workers and parent's patients. For families, the third question was not administrated. The survey explored about purpose and opportunity regarding the use of wrist band identification. A one day cutoff was made to obtain baseline data for properly use of identification bands. RESULTS: A total of 300 questionnaires were analyzed, 100 for each cluster (physicians, nurses, and parents); 82% responded that the wrist band should stay along the whole hospitalizing period. A range of 64% to 74% within the groups responded that it is helpful to prevent errors. There was no statistical difference between parents and physicians. Overall, percentage of patient with correct identification band in the hospital was 34%. CONCLUSIONS: We concluded that the wrist band identification is not a health care workers priority behavior yet. Initiatives on safety patient identifications, including families and healthcare workers, must be developed in the near future.

Evaluación de la opinión del equipo de salud y padres sobre la identificación delos pacientes pediátricos / Health care team and parents opinion about pediatric patients identification

Introducción. La correcta identificación del paciente es esencial para la seguridad de la atención:la pulsera identificadora del paciente internado es una estrategia en la prevención del error médico.Sin embargo, en la realidad, la identificación de la totalidad de los pacientes es un tema pendiente.Objetivo. Conocer la opinión del equipo de salud y los padres respecto al procedimiento de identificaciónde los pacientes en el Hospital Nacionalde Pediatría ¶Prof. Dr. Juan P. Garrahan÷ y medir la adhesión a esta práctica.Método. Se realizó una encuesta al equipo de salud en una semana, autoadministrada y anónima, de tres preguntas sencillas con respuesta cerrada (4 ítems con escala de Likert), acerca de la opinión sobre la identificación de los pacientes, conun espacio abierto para observaciones. El mismo cuestionario, con excepción de la tercera pregunta, fue administrado a los padres de los pacientes. Serealizó un corte de un día evaluando porcentaje de pacientes correctamente identificados.Resultados. Se realizaron 300 encuestas a médicos (100), enfermeros (100) y padres (100). El 82 por cientocontestó que los pacientes debían tener pulsera identificadora en todo momento durante la internación.Un 64-74 por ciento contestó que era útil para prevenir errores. No se encontraron diferencias significativas entre padres y médicos. Sin embargo,sólo el 34 por ciento de los pacientes se encontraban correctamente dentificados. Conclusiones. La discrepancia entre la opinión y la práctica indica que la identificación de los pacientes no representa aún un eslabón prioritarioen la seguridad y la calidad de la atención.Por lo tanto, es necesario desarrollar estrategias para mejorar la cultura de la seguridad.(AU)

Introduction. Patient misidentification continues to be a quality and safety significant issue. The Joint Commission International listed patient identification as the first of ten life-saving patient-safety solutions. Identification wrist bands are the goal in the identification strategy. At the Hospital Nacional de Pediatría "Prof. Dr. J.P. Garrahan" we inquired about perception and agreement of this practice within hospital staff and parents.Method. A short questionnaire was used with; in the first part a four point Lickert scale, and in the second one an open unstructured response. The questionnaire was distributed among health care workers and parents patients. For families, the third question was not administrated. The survey explored about purpose and opportunity regarding the use of wrist band identification. A one day cutoff was made to obtain baseline data for properly use of identification bands.Results. A total of 300 questionnaires were analyzed, 100 for each cluster (physicians, nurses, and parents); 82% responded that the wrist band should stay along the whole hospitalizing period. A range of 64% to 74% within the groups responded that it is helpful to prevent errors. There was not statistical difference between parents and physicians. Overall, percentage of patient with correct identification band in the hospital was 34%.Conclusions. We concluded that the wrist band identification is not a health care workers priority behavior yet. Initiatives on safety patient identifications, including families and health care workers, must be developed in the near future.(AU)

Evaluación de la opinión del equipo de salud y padres sobre la identificación delos pacientes pediátricos / Health care team and parents opinion about pediatric patients identification

Introducción. La correcta identificación del paciente es esencial para la seguridad de la atención:la pulsera identificadora del paciente internado es una estrategia en la prevención del error médico.Sin embargo, en la realidad, la identificación de la totalidad de los pacientes es un tema pendiente.Objetivo. Conocer la opinión del equipo de salud y los padres respecto al procedimiento de identificaciónde los pacientes en el Hospital Nacionalde Pediatría “Prof. Dr. Juan P. Garrahan” y medir la adhesión a esta práctica.Método. Se realizó una encuesta al equipo de salud en una semana, autoadministrada y anónima, de tres preguntas sencillas con respuesta cerrada (4 ítems con escala de Likert), acerca de la opinión sobre la identificación de los pacientes, conun espacio abierto para observaciones. El mismo cuestionario, con excepción de la tercera pregunta, fue administrado a los padres de los pacientes. Serealizó un corte de un día evaluando porcentaje de pacientes correctamente identificados.Resultados. Se realizaron 300 encuestas a médicos (100), enfermeros (100) y padres (100). El 82 por cientocontestó que los pacientes debían tener pulsera identificadora en todo momento durante la internación.Un 64-74 por ciento contestó que era útil para prevenir errores. No se encontraron diferencias significativas entre padres y médicos. Sin embargo,sólo el 34 por ciento de los pacientes se encontraban correctamente dentificados. Conclusiones. La discrepancia entre la opinión y la práctica indica que la identificación de los pacientes no representa aún un eslabón prioritarioen la seguridad y la calidad de la atención.Por lo tanto, es necesario desarrollar estrategias para mejorar la cultura de la seguridad.

Introduction. Patient misidentification continues to be a quality and safety significant issue. The Joint Commission International listed patient identification as the first of ten life-saving patient-safety solutions. Identification wrist bands are the goal in the identification strategy. At the Hospital Nacional de Pediatría "Prof. Dr. J.P. Garrahan" we inquired about perception and agreement of this practice within hospital staff and parents.Method. A short questionnaire was used with; in the first part a four point Lickert scale, and in the second one an open unstructured response. The questionnaire was distributed among health care workers and parent's patients. For families, the third question was not administrated. The survey explored about purpose and opportunity regarding the use of wrist band identification. A one day cutoff was made to obtain baseline data for properly use of identification bands.Results. A total of 300 questionnaires were analyzed, 100 for each cluster (physicians, nurses, and parents); 82% responded that the wrist band should stay along the whole hospitalizing period. A range of 64% to 74% within the groups responded that it is helpful to prevent errors. There was not statistical difference between parents and physicians. Overall, percentage of patient with correct identification band in the hospital was 34%.Conclusions. We concluded that the wrist band identification is not a health care workers priority behavior yet. Initiatives on safety patient identifications, including families and health care workers, must be developed in the near future.

Detección, análisis y prevención en el uso de medicamentos con similitud fonética, ortográfica o de envasado en Argentina / Detection, analysis and prevention of look alike and sound alike drugs in Argentina

RESUMEN. INTRODUCCIÓN: existe una gran cantidad de medicamentos con similitud visual, fonética u ortográfica en sus nombres comerciales y/o principios activos, lo cual genera errores operativos de medicación y ocasionan daños a los pacientes. Este problema se conoce con la sigla LASA (en inglés: Look-Alike, Sound-Alike). OBJETIVO: Identificar productos medicinales comercialesy/o sus principios activos con características LASA en el mercado farmacéutico argentino. MÉTODO: se realizó una revisión bibliográfica sobre antecedentes LASA internacionales y nacionales. Los nombres comerciales y genéricos de medicamentos se relevaron en las páginas Web de Alfabeta®, Kairos ®y Manual Farmacéutico® durante julio de 2008, y el criterio de búsqueda fue el de raíz y terminación de nombres comerciales y principios activos. Se relevaron además las similitudes visuales de los medicamentos en los lugares de trabajo de los investigadores y se generó un archivo fotográfico. Se implementó un registro de reporte voluntario de error cuyos datos se analizaron para caracterizar los factores determinantes de los errores detectados. RESULTADOS: Se hallaron 927 conjuntos de medicamentos LASA sobre un total de 20.517 evaluados. A través del registro voluntario se reportaron 80 errores LASA. CONCLUSIÓN: los medicamentos LASA son un problema de salud pública en Argentina. Es necesario detectarlos, difundirlos y prevenirlos para evitar consecuencias negativas en los pacientes.

ABSTRACT. INTRODUCTION: there is a large amount of drugs with visual, phonetic or spelling similarities in their trade names and/or active ingredients that create operational and medication errors and could cause harm to patients. This problem is known by the acronym LASA (Look-Alike, Sound-Alike). OBJECTIVE: to identify LASA medicines and/oractive ingredients in the Argentine pharmaceutical market. METHOD: the international and national literature on LASA was reviewed. Then a search of trade name and generic medicines in the Alfabeta®, Kairos® and Manual Farmacéutico® internet databases was conducted during July 2008. The researchers surveyed the visual aspect of medicines in their premises work and generated a photographic archive. In addition, a LASA error voluntary report system was implemented and subjected to analysis in order to characterize the factors involved in LASA problem. RESULTS: 927 sets of LASA medications were found among 20.517 medicines assessed and 80 LASA errors were reported through the report system. CONCLUSION: LASA medicines are a public health problem in Argentina. Their detection, communication and prevention are needed to avoid negative consequences for patients.

Detección, análisis y prevención en el uso de medicamentos con similitud fonética, ortográfica o de envasado, en Argentina: uso de medicamentos con similitud visual, fonética u ortográfica / Detection, analyze and use prevention in look alike and sound alike drugs, in Argentina

Introducción: La literatura describe gran cantidad de medicamentos generadores de errores de medicación, por similitud visual, fonética u ortográfica -en inglés- Look-Alike, Sound-Alike (LASA). Objetivos: 1) Identificar productos comerciales y/o principios activos tipo LASA; 2) Diseñar e implementar un registro voluntario; 3) Analizar los factores intervinientes; 4) Elaborar y difundir alertas. Metodologia: Revisión de nombres comerciales y principios activos de los medicamentos del mercado farmacéutico actual. Para relevar similitudes visuales, se realizó detección intensiva sobre stock / existencias de medicamentos utilizados. Se realizó una búsqueda bibliográfica exhaustiva. Resultados: Se identificaron 927 conjuntos de medicamentos LASA, clasificados por categorías, y se elaboró un documento fotográfico para similitudes de envasado. Sobre estos resultados se sugirieron estrategias para minimizar riesgos de confusión por clase. Se reportaron 80 registros de errores y se analizaron los factores intervinientes. Se elaboraron alertas de medicación: generales, de diferentes grupos terapéuticos y dirigidos a población especial. Se diseñó e implementó un sitio WEB como plataforma de expansión del tema LASA: www.errorenmedicina.anm.edu.ar/LASA. Conclusiones: En Argentina LASA alcanza una dimensión importante. Su conocimiento, difusión y la generación de estrategias, tanto desde Laboratorios productores como de las autoridades sanitarias, constituirán los primeros pasos para evitar sus consecuencias negativas en los pacientes.

Introduction: There are a lot of drug names that look or sound like (LASA) other drug names described worldwide that could potentially result in medication errors (ME). Objectives: 1) To identify brand or generic names that generate confusion and error phonetic-orthographic similarity. 2) To design and to implement a voluntary ME LASA report. 3) To analyze contributing factors. 4) To make and spread alerts on reported ME, LASA type. Methods: brand or generic names were review in Argentine pharmaceutical market. The label and package drugs were review from stocks to find look-alike drugs. An exhaustive bibliographic search was made. ME were analyzed and recommendations given. Results: 927 LASA drugs pairs were identified and were classified by categories. Look-alike drugs were photographed. Prevention strategies were made to different classes. Eighty ME were reported and contributing factors were analyzed. Alerts were made such us: LASA drugs, different therapeutic groups and target population alerts. A web site was designed as a LASA expansion platform: www.errorenmedicina.anm.edu.ar/LASA. Conclusion: LASA is a main issue in Argentina and it is necessary to be known. Dissemination and prevention strategies from pharmaceutical industry and national authorities must be made. These are the first steps to avoid patient's negative outcomes.