Reconocimiento de la prescripción enfermera en España, una batalla a punto de culminar / The recognition of prescribing by nurses, a battle that is about to be won

No disponible

Implementação da nova regulamentação para prescrição e dispensação de antimicrobianos: possibilidades e desafios / Implementation of new regulations for prescribing and dispensing of antibiotics: challenges and possibilities

Introdução: O uso e a prescrição inadequados de antimicrobianos e a pressão da indústria farmacêutica para a sua utilização transformaram a resistência bacteriana a esses medicamentos em um problema mundial de saúde pública. Objetivo: O objetivo do estudo foi analisar o processo de implantação da Resolução da Diretoria Colegiada (RDC) da Agência Nacional de Vigilância Sanitária (Anvisa) de nº 20/2011, que dispõe sobre o controle dos antimicrobianos. Método: Utilizou-se o Modelo de Múltiplos Fluxos de Kingdon para examinar a inserção do tema do controle dos antimicrobianos na agenda governamental e sua posterior conformação em política pública. Foram empregadas diversas estratégias metodológicas, como a revisão bibliográfica, a análise de documentos, a busca de notícias veiculadas na mídia e informações advindas de entrevistas com informantes-chave. Conclusão: Apesar da existência de legislações e regulamentações sobre o uso e a prescrição de antimicrobianos, além da ampliação do acesso da população aos profissionais de saúde para evitar a automedicação e promover o uso correto, esforços como a educação sanitária para profissionais e a população e o reforço da fiscalização sanitária devem ser efetivamente implementados, não apenas para alcançar o uso racional, mas também para diminuir a resistência aos antimicrobianos.(AU)

Introduction: Inappropriate use and prescription of antimicrobials and the pressure from the pharmaceutical industry for their use have turned bacterial resistance into a global public health problem. Objective: This study aimed to analyze the implementation process of ANVISA's Board of Directors Resolution (RDC) 20/2011 for antimicrobials control. Method: Kingdon's Multiple Streams Model was used to examine the inclusion of antimicrobial control into the government agenda and its subsequent shaping into public policy. Several methodological strategies were employed, such as bibliographic review, document analysis, the search for stories in the media and information from interviews with key informants. Conclusion: In addition to legislation and regulations of the use and prescription of antimicrobials, easier population's access to health professionals to avoid self-medication and promote correct use, it is necessary to implement efforts such as education of professionals and the general population, not only to achieve rational use, but also to reduce antimicrobial resistance.(AU)

Breve reseña sobre la farmacología de los cannabinoides / Brief review on the pharmacology of cannabinoids

Intensa resulta la controversia entre los que promueven el uso de los cannabinoides con fines terapéuticos y quienes consideran que es temprana aún la introducción de estos en la clínica, por sus efectos deletéreos para la salud humana en las diferentes etapas y condicionales del desarrollo biológico. Paralelamente se debate, entre las autoridades encargadas de velar por la salud de sus conciudadanos, la polémica de legalizar o no el consumo de la Cannabis sativa en cualquiera de sus formas y derivados naturales. Ambas polémicas han fundamentado el estudio de todas las formas de presentación y consumo de esta planta, así como de sus derivados sintéticos dados sus efectos sobre la salud de enfermos y sanos. En esta breve reseña se exponen aspectos relevantes de su farmacología, debido al interés y enorme caudal de información generado por un sinnúmero de investigadores dedicados al estudio de dicha planta y sus derivados

The controversy among those that promote the use of cannabinoids with therapeutic aims is intense and who consider that it is still early for their introduction in the clinic, due to their lethal effects for the human health in the different stages and conditionals of the biological development. In parallel it is debated, among the authorities in charge of looking after the health of their fellow citizens, the polemic of legalizing or not the consumption of the Cannabis sativa in any of their forms and natural derived. Both polemics have based the study of all the forms of presentation and consumption of this herb, as well as of its synthetic derived due to their effects on the health of sick and healthy people. In this brief review outstanding aspects of their pharmacology are exposed, due to the interest and enormous flow of information generated by a large number of investigators dedicated to the study of this herb and its derived elements

Impact of safety concerns and regulatory changes on the usage of erythropoiesis-stimulating agents and RBC transfusions.

PURPOSE: Safety concerns raised in the recent oncology trials with erythropoiesis-stimulating agents (ESAs) have led to regulatory restrictions on their use. We wished to determine the impact of these changes on the use of ESAs and RBC transfusions. METHODS: In a retrospective observational study of patients treated at a comprehensive cancer center in 2006-2008, data on all ESA doses dispensed, RBCs transfused, and hemoglobin levels on the days of transfusions and ESA initiations were analyzed. RESULTS: Compared with 2006, the total patients treated was 14% higher (28,339 versus 24,806) in 2007 and 22% higher (30,254) in 2008. Patients receiving ESAs decreased by 26% and 61%, and ESA units dispensed decreased by 29% (from 30,206 units to 21,409 units) and 80% (6,102 units) in 2007 and 2008, respectively. However, RBC transfusions increased by only 2% (from 38,218 units to 38,948 units) in 2007 and by 8% (41,438) in 2008. The mean hemoglobin on the day of transfusion was the same for each year (8.4 g/dl); however, an increasing proportion of patients initiated ESAs at lower hemoglobin (< 10 g/dl) levels. After adjusting for demographics and diagnostic variables for 3 years (n = 83,399), a multivariate logistic regression showed a significant decline in ESA use (p < .0001) without an increase in RBC transfusions. CONCLUSIONS: Recent ESA safety concerns and regulatory restrictions have significantly decreased ESA use. The lack of a significant impact on transfusions may be related to a lower hemoglobin threshold used to initiate ESAs or treatment of patients less likely to respond.

The use of compound topical anesthetics: a review.

BACKGROUND: The author reviewed the history of, federal regulations regarding, risks of and adverse drug reactions of five compound topical anesthetics: tetracaine, adrenaline/epinephrine and cocaine (TAC); lidocaine, adrenaline/epinephrine and tetracaine (LET); lidocaine, tetracaine and phenylephrine (TAC 20 percent Alternate); lidocaine, prilocaine and tetracaine (Profound); and lidocaine, prilocaine, tetracaine and phenylephrine with thickeners (Profound PET). TYPES OF STUDIES REVIEWED: The author reviewed clinical trials, case reports, descriptive articles, and U.S. Food and Drug Administration (FDA) regulations and recent public advisory warnings regarding the federal approval of and risks associated with the use of compound topical anesthetics. RESULTS: Compound topical anesthetics are neither FDA-regulated nor -unregulated. Some compounding pharmacies bypass the new FDA drug approval process, which is based on reliable scientific data and ensures that a marketed drug is safe, effective, properly manufactured and accurately labeled. Two deaths have been attributed to the lay use of compound topical anesthetics. In response, the FDA has announced the strengthening of its efforts against unapproved drug products. CLINICAL IMPLICATIONS: Compound topical anesthetics may be an effective alternative to local infiltration for some minimally invasive dental procedures; however, legitimate concerns exist in regard to their safety. Until they become federally regulated, compound topical anesthetics remain unapproved drug products whose benefits may not outweigh their risks for dental patients.

Ley de garantías y uso racional de los medicamentos y productos sanitarios. 1. Comentarios generales / Garanties Law and rational use of drugs and medical devices. 1. General comments

Se inicia una serie de comentarios sobre la Ley de garantías y uso racional de los medicamentos y productos sanitarios que empieza con una introducción que incluye el sumario o índice general comparativo con el de la anterior Ley del medicamento de 1990 y su estructura general

It is initiated a series of commentaries above the Guaranties Law and rational use of drugs and medical devices to begin by a introduction with the summary either general index comparative with the previous Drugs Law 1990, and the structure

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

El seguimiento farmacoterapéutico: un componente de la calidad en la atención al paciente / Pharmacotherapy follow-up: as a quality component in patient care

La gestión de la Calidad Total busca la satisfacción del usuario, la implicación activa de los profesionales responsables de su salud y la incorporación de estrategias para la mejora continua de las actividades clínicas, incorporando la búsqueda de la seguridad del paciente como componente principal. La gestión de la seguridad del paciente minimiza las lesiones no intencionadas atribuibles a procesos de la atención sanitaria, incluido el uso de medicamentos. Los principios de seguridad del paciente se aplican en ambos niveles asistenciales y a todos los profesionales sanitarios. Gestionar el riesgo es cuidar al paciente. La Seguridad del paciente pretende resolver problemas y prevenir errores. La aportación del farmacéutico a la seguridad del paciente se realiza con la Atención Farmacéutica y en concreto con el Seguimiento Farmacoterapéutico (SFT) que previene, detecta y resuelve Problemas Relacionados con los Medicamentos (PRM). Uno de los principales problemas para avanzar, es la dificultad para homogeneizar resultados; existen diferencias en las definiciones, al igual que ocurre en el ámbito del medicamento, donde se mezcla permanentemente proceso y resultado: Efecto adverso, Acontecimiento no deseado, Errores de medicación, PRM, etc. Se ha de homogenizar la taxonomia; disponer de una información común permitiría conocer mejor la prevalencia, sus tipos, sus causas, su gravedad así como sus consecuencias. Se quiere caminar hacia la seguridad del paciente evaluando tecnologías su efectividad y su seguridad, acreditando establecimientos y acreditando competencia profesional. Este es el camino también para el SFT que comparte los principios básicos de calidad de la seguridad del paciente. El farmacéutico tiene la responsabilidad profesional y ética de poner a disposición de los pacientes el conocimiento, la experiencia y el método, igual que las acciones emprendidas por los sistemas sanitarios. Existe la oportunidad de estar, de ser los responsables de esta aportación, porque la seguridad del paciente, en general, y en relación al uso de los medicamentos en particular, va a desarrollarse

The principal aim of management of the Quality of Care is to assure patient satisfaction, through the active involvement of health care staff and the incorporation of strategies, whose main aim is to achieve continuous improvement in clinical activities and to incorporate patient safety as one of its principle components. The management of patient safety is a means to minimizing any possible harm to patients in care processes, including the use of medicines. The principles of patient safety can be applied to both levels of patient care and involve all health care professionals. The risk management is an integral part of patient care. Patient safety depends on the solution of problems and the prevention of errors. The pharmacist’s role in patient safety is carried out through Pharmaceutical Care processes and especially through Pharmacotherapy follow-up (PF), which aims to prevent, detect and resolve Drug Therapy Problems (DTP). One of the main difficulties associated with this field is the lack of uniformity of the results obtained throughout the different studies carried out, where differences in definitions occur, as in the classification of drug problems themselves, where process and result are constantly intermingled: Adverse effect, undesirable events, medication errors, DTP, etc. The criteria for classifying such aspects should be uniform, so as to make common information available, which will enable pharmacists to obtain greater knowledge on prevalence, their types, causes, severity and consequences. There is a general desire to improve upon patient safety, to assess the technological processes involved in evaluating effectiveness and safety, and to certify the establishments and health care professionals responsible for such processes. This same approach should also be applied to PF, which is subject to the same basic safety principles. As in the case of all work carried out within the health system, the work of the pharmacist involves the professional and ethical responsibility of making his knowledge, experience and methodology available to his patients. Pharmacists now have the opportunity of making a significant contribution to patient safety, both in general terms and more specifically in the use of medicines, in a field which is currently set for future development

Lessons from Korea's pharmaceutical policy reform: the separation of medical institutions and pharmacies for outpatient care.

In Korea, until recently, both physicians and pharmacists were allowed to prescribe and dispense drugs for outpatient care. Along with other deep-rooted structural problems, this worked against the quality and efficiency of the health care system. To rectify this problem, the Korean government launched a drug policy reform in July 2000. However, the drug policy reform was more drastic than initially intended--driven by political factors, the reform ended up bringing about complete separation of medical institutions and pharmacies. Also, unlike in many other countries, Korea did not take a gradual approach, but instead, it implemented the reform all at once and nation-wide. As a result, the reform has faced criticism and protests, thereby generating unprecedented social turmoil and even strikes by physicians. Still, it is not clear what benefits Korea gained from this reform, when we look at the price which has had to be paid, including greater inconvenience, worsened access to medical care, increased drug spending, increased market share for multinational drug producers, and a greater deficit in the budget of the Korea's national health insurance system. Based on Korea's costly experience, we attempt to draw some policy implications for the future development of a better health care system.

Francisco Vélez de Arciniega en la polémica de la coloquíntida

Se presenta la edición y estudio de un manuscrito escrito en 1611 por Francisco Vélez de Arciniega sobre el uso de la Coloquíntida ( Citrullus colocynthis (L) Schrader). Purgante enérgico, constituían objeto de controversia tanto su interés como la forma de aplicación. Vélez de Arciniega, notable boticario, buen conocedor de la farmacia antigua y moderna, participa en una interesante discusión científica que muestra la modernización del uso de los medicamentos (AU)

Taking an alternative risk.

Pharmacists and other health care providers that recommend "alternative medicines" could be exposed to malpractice as well as product liability claims in the event a patient is either injured by or has treatment inappropriately delayed based on their recommendation of such medicine. For purposes of this article, it is assumed that alternative medicines are nonprescription (over-the-counter [OTC]) food supplements, vitamins, herbs or other substances contained in commercially available products. Many of these products are sold in pharmacies or health food stores and have not been clinically tested or do not have a scientific basis for the use for which they are recommended.