El farmacéutico hospitalario en tiempos de COVID-19 / The hospital pharmacist in times of COVID-19

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Do Brazilian hospital pharmacists record, document, archive and disseminate their clinical practice?

An exploratory study was conducted to present the approach of Brazilian hospital pharmacists to registering, documenting, archiving and disseminating clinical practice. The data were collected using an electronic questionnaire (n=348). In fact, 97.41% of pharmacists record their clinical practice, out of which 64.01% (n=217) do in electronic form, mainly in private hospitals (p<0.000), in the central, southern and southeastern regions (p=0.040), and by professionals with 1-5 years of experience (p=0.001). The main software used is non-specific to clinical practice: an electronic spreadsheet (47.93%; n=104) and text editor (13.37%; n=29). The archiving of records is performed by 87.61% (n=297) of professionals, where 80.13% (n=238) do so in physical form; however, 77.31% (n=184) of these files are kept for less than the standard recommended time. Documentation in medical records is carried out by 55.17% (n=192) of pharmacists, increasing among those with 1-5 years of clinical practice (p=0.001), and dissemination is performed by 74.71% (n=260) of hospital pharmacists, with a lower frequency in public hospitals (p=0.012) and among professionals with fewer hours dedicated exclusively to clinical pharmacy (p=0.012). These results can undergird the revision of competency-based training programs of Brazilian clinical pharmacists to remain pharmacists as a valuable health team member

MAPEX: mirar profundo, mirar lejos / No disponible

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[Ethical and methodological quality of non-interventional post-authorization studies promoted by Hospital Pharmacy Departments]. / Calidad ética y metodológica de los estudios posautorización de tipo observacional promovidos por Servicios de Farmacia Hospitalaria.

OBJECTIVES: To describe the ethical and methodological quality of non-interventional post-authorization studies promoted by Hospital Pharmacy Departments (HPD). METHODS: HPD promoted studies in the 2009-2011 period included in the Spanish Agency of Medicines and Medical Devices (AEMPS) registry and/or published in "Farmacia Hospitalaria" were identified. The most relevant ethical and methodological characteristics were analyzed. Studies promoted by HPD were also compared with studies not promoted by HPD. RESULTS: Twenty two studies promoted by HPD, and registered in the AEMPS were identified. Within the registered studies HPD promoted studies had lower sample size estimation (41,5% vs 80%) and international scope (0% vs 24%) compared to non HPD promoted studies with significant differences (p < 0,05). None of the published studies in the journal Farmacia Hospitalaria have been registered in the AEMPS and had lower methodological quality than the registered studies promoted by HPD in characteristics such as presence of control group (3,8% vs 27,3%) (p = 0,0072) and the sample size estimation of (19,2% vs 42,8%) (p < 0,05). CONCLUSION: The management and the methodological and ethical characteristics of the studies promoted by HPD should be improved according to the regulation. The registration in the AEMPS might have a positive impact on the quality of these research protocols.

Objetivos: Describir la calidad ética y metodológica de los estudios posautorización de tipo observacional con medicamentos de uso humano promovidos por los Servicios de Farmacia Hospitalaria (SFH). Métodos: Se identificaron los estudios promovidos por los SFH registrados en la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS) durante 2009-2011 y/o publicados en la revista Farmacia Hospitalaria en el mismo período. Se analizaron los aspectos éticos y metodológicos más relevantes. Con el fin de conocer las diferencias de los estudios promovidos por los SFH respecto a estudios realizados por otros promotores, se compararon con los estudios registrados durante 2003-2007. Resultados: Se registraron en la AEMPS 22 estudios promovidos por SFH, que comparados con aquellos realizados por promotores diferentes, mostraron un menor cumplimiento de los aspectos éticos recogidos en la normativa, así como resultados más discretos y estadísticamente significativos (p < 0,05), respecto a justificación del tamaño muestral (41,5% vs 80%) o ámbito internacional (0% vs 24%). Respecto a los estudios publicados en la revista Farmacia Hospitalaria (n = 52), ninguno fue registrado en la AEMPS. En comparación con los estudios registrados promovidos por SFH, presentaron menor calidad metodológica, en aspectos tales como presencia de grupo control (3,8% vs 27,3%) (p = 0,0072) o justificación del tamaño muestral (19,2% vs 42,8%) (p < 0,05). Conclusión: Existen aspectos administrativos, metodológicos y éticos de los estudios promovidos por los SFH que deben ser mejorados según la normativa. El registro en la AEMPS, parece tener un efecto positivo en el rigor científico y ético de los protocolos de investigación.

Proceso 10. Ética / No disponible

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Estudio jurisprudencial de la responsabilidad legal del personal sanitario en la reformulación de medicamentos / common law study of the legal responsability of health care staff related to drug reformulation

Objetivo: Analizar la responsabilidad del personal sanitario alelaborar reformulaciones (modificación de la dosis, forma farmacéuticao vía de administración de especialidades farmacéuticas)desde la jurisprudencia del Tribunal Supremo y la AudienciaNacional.Método: Búsqueda y análisis de jurisprudencia y estudios jurídicosen las bases de datos “El Derecho”, “Difusión Jurídica” e“Indret”.Resultados: El personal sanitario tiene una obligación demedios –no de resultados– aplicando unas normas de cuidadoque constituyen la “Lex Artis”, y que pueden ir más allá de lasmeras normas jurídicas. La falta a estas normas de cuidado, ladenegación de auxilio o la falta de respeto a la autonomía delpaciente pueden ser comportamientos negligentes. Se encontraron4 casos en la jurisprudencia. En los dos casos en que secumplieron las normas de cuidado, incluyendo la reformulación,los profesionales sanitarios fueron absueltos, mientras queen otros dos casos en que no se aplicaron reformulaciones,cuando las “Lex Artis” así lo imponía, los profesionales fueroncondenados.Conclusiones: La reformulación de especialidades farmacéuticas,incluidas en la Lex Artis, es una práctica aceptada por elTribunal Supremo y la Audiencia Nacional, siendo causa de condenael no recurrir a las mismas cuando los conocimientos científicosdel momento así lo aconsejen

Objective: To analyze the responsibility of health care staff indrug reformulation (change of dose, pharmaceutical form or routeof administration of medicinal products) based on the commonlaw of the High Court and the National Court.Method: Search and analysis of common law and legal studiesincluded in databases “El Derecho”, “Difusión Jurídica” and“Indret”.Results: Health care staff has means –not outcomes– obligationsaccording to the care standards included in the “Lex Artis”that can go beyond the mere legal standards. Failure to apply thiscare standards, denial of assistance or disrespect to the autonomyof the patient can be negligent behaviors. We found 4 cases incommon law. In the two cases in which care standards were compliedwith, including reformulation, health care professionals wereacquitted, whereas in the other two cases in which reformulationswere not used even though the “Lex Artis” required them, theprofessionals were condemned.Conclusions: Reformulation of medicinal products, as setforth in the Lex Artis, is a practice accepted by the High Courtand the National Court and failure to use it when the scientificknowledge advises so is a cause for conviction

A survey of ethical issues surrounding supply of information to members of the public by hospital pharmacy medicines information centres.

OBJECTIVES: To examine ways in which medicines information pharmacists approach ethical dilemmas encountered in information supply, to appreciate the factors affecting any observed variation in responses, and to identify and training deficits among medicines information (MI) pharmacists in this area. METHOD: A questionnaire was circulated to all medicines information pharmacists working in the hospital pharmacy service in the United Kingdom. The survey presented ten realistic scenarios involving requests for information on a variety of topics from 'lay' callers. MAIN OUTCOME MEASURES: Respondents were asked to identify any perceived ethical dilemmas presented by the scenarios and to indicate their preferred replies. Details on training given or received in this area were also requested. RESULTS: The overall response rate was 151 of 286 questionnaires mailed (52.8%), representing 137 discrete DI centres throughout the UK. Postgraduate clinical qualifications were possessed by 71% of respondents. Just 32 (21.2%) indicated that they gave training on ethical issues surrounding information supply while 57 (37.1%) said they had received such training. Over half (54.3%) had neither received nor delivered training on ethical issues. Of the 32 who said they gave training, 21 had received training themselves. Only 4 (2.6%) said they had a protocol in place for dealing with enquiries from members of the public. CONCLUSIONS: There was considerable variation in how respondents thought the scenarios might be resolved, emphasising the varying levels of appreciation of the issues and lack of a uniform approach to management. An interesting dichotomy emerged between liberal and conservative approaches. Liberal pharmacists clearly believed that all MI data is in the public domain and should be produced and evaluated on request because patients have a "right" to it. The conservative pharmacists had a more protective attitude toward the patient and believed that patients should not be given information by MI pharmacists directly; rather that it should be channelled through the patient's doctor. These two approaches are not incompatible, and may be adopted by the same pharmacist at different times. From their observations, the authors propose a basis of an ethical guideline for MI pharmacists.