A Pilot Study Regarding Pharmacy Law Education Across Doctor of Pharmacy Programs.

Objective. To describe the features of pharmacy law education in Doctor of Pharmacy (PharmD) programs in the United States. Methods. A review of the literature found no prior published data describing the delivery of pharmacy law education across PharmD programs in the United States. Members of the Pharmacy Law Educators Subcommittee of the American Society for Pharmacy Law (ASPL) developed questions for a survey. The survey was administered electronically to all 139 American Association of Colleges of Pharmacy (AACP) member institutions in the summer of 2016. A link to complete the 32-item online survey was distributed via email to the pharmacy law educator or associate dean at each AACP member institution. Results. Of the 139 PharmD programs surveyed, 49 completed the survey instrument, yielding a response rate of 35.2%. Variations between programs were found in the professional background of pharmacy law instructors and assessment strategies for pharmacy law courses, as well as in the structure and placement of the main pharmacy law course within the various curricula. Conclusion. This pilot study represents the first and only known attempt to examine delivery of pharmacy law education across colleges of pharmacy. The variations between programs found in this study highlight the need for further investigation into this area of pharmacy education.

U.S. Food and Drug Administration Inspections: Guide to a Successful Outcome for 503A Sterile Compounding Pharmacies.

The reasons for which pharmaceutical compounding is the focus of intense state and federal scrutiny are now well known. Compounders are faced with an ever-increasing need to prove, by objective standards, the safety, purity, and potency of the formulations they dispense. They must also demonstrate their compliance with regulations often based on current good compounding practices designed for the pharmaceutical industry. In the U.S. today, rigorous unannounced state and federal inspections of compounding facilities are occurring more and more frequently. To achieve a successful outcome, communicating clearly and effectively with inspectors and having ready access to the information they request are as critical as proving compliance. This article describes the author's experience with an unannounced United States Food and Drug Administration inspection of his 503A compounding facility and his response to the findings. Readers will learn what to expect during such an inspection, how to prepare for that event, and how to achieve an excellent outcome. Those who would like more information about any of the topics presented are invited to contact the author at the address provided at the close of this article.

The road to pharmacist prescribing in Alberta Health Services.

PURPOSE: The implementation of policy within a health organization to support a new legislative and regulatory framework of pharmacist prescribing in the Canadian province of Alberta is described. SUMMARY: The evolution of pharmacists' practice activities to encompass medication management through independent prescribing authority has occurred in many jurisdictions around the world. In 2007, Alberta pharmacists were granted the most progressive scope of practice in all of North America. Pursuant to a series of legislative and regulatory initiatives enacted since 2000, the provincial health authority, Alberta Health Services (AHS), has worked to (1) establish a policy framework that supports pharmacist prescribing, (2) provide opportunities for pharmacist prescribing in both inpatient and ambulatory care practice environments, and (3) provide motivation and resources for AHS pharmacists to acquire "additional prescribing authorization" (APA) that enables them to independently prescribe and manage patients' ongoing drug therapy. Pharmacists with APA currently are permitted to prescribe all medications requiring a prescription, with the exception of opiates and other controlled substances; efforts to expand pharmacist prescribing to include those medications are ongoing. Currently, nearly half of all AHS pharmacists have APA. The health authority plans to make APA a standard expectation for all clinical pharmacists working in collaborative practice settings. CONCLUSION: Opportunities provided to Alberta pharmacists by legislation have been embraced by the provincial health authority. The AHS leadership remains committed to ensuring that its pharmacists practice to the full extent of their scope of practice and actively encourages and supports them in their efforts to provide optimal patient care.

El desabastecimiento de los medicamentos: ¿qué hay detrás? Causas, consecuencias y una buena alternativa / What Lies Behind Drug Shortages, the Consequences-and a Good Alternative

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Applying Quality by Design Concepts to Pharmacy Compounding.

Compounding of medications is an important part of the practice of the pharmacy profession. Because compounded medications do not have U.S. Food and Drug Administration approval, a pharmacist has the responsibility to ensure that compounded medications are of suitable quality, safety, and efficacy. The Federal Government and numerous states have updated their laws and regulations regarding pharmacy compounding as a result of recent quality issues. Compounding pharmacists are expected to follow good preparation prodecures in their compounding practices in much the same way pharmaceutical manufacturers are required to follow Current Good Manufacturing Procedures as detailed in the United States Code of Federal Regulations. Application of Quality by Design concepts to the preparation process for a compounded medication can help in understanding the potential pitfalls and the means to mitigate their impact. The goal is to build quality into the compounding process to ensure that the resultant compounded prescription meets the human or animal patients' requirements.

Avaliação da qualidade de águas purificadas utilizadas em farmácias de manipulação / Assessing the quality of purified water used in compounding pharmacies

The Brazilian Food, Drug and Sanitary Agency (ANVISA) published a Resolution (RDC 67) in 2007, repealing RDC 33 of 2000, which established a legally required monthly analysis of a number of microbiological and physicochemical variables in the purified water used in compounded pharmaceutical preparations, which were not specified in the preceding RDC. In view of the amendment, the aim of this study was to assess the quality of purified water used in compounding pharmacies in the region of Araraquara (SP, Brazil) and review the impact of the most recent regulation (RDC 67 of 2007) on this quality. In the study, 744 samples of purified water were collected from 30 pharmacies in the course of four years (2008 to 2011). The variables recorded were: presence of total coliforms and fecal coliforms/E. coli, pH, color, turbidity, total dissolved solids, fluoride and residual free chlorine. The methods used were pharmacopeial standards for water analysis, published by the Brazilian National Health Foundation (FUNASA) and the American Public Health Association (APHA). Among the samples, 78.90% were in compliance with the required standards. No sample contravened the rules for color and fecal coliforms/E. coli. However, 0.54%, 7.80%, 10.75%, 0.54% and 4.56% of the samples were unacceptable in terms of turbidity, fluorides, pH, free residual chlorine and total coliforms respectively. There was a variation in the number of irregular samples by comparing the years of 2008 and 2009 (20.26% and 26.71%, respectively) and the years of 2010 and 2011 (18.33% and 19.91%, respectively). Four years after the RDC n°. 67 of 2007, manipulation pharmacies are still adjusting to the rules, and it is important that ANVISA and others agencies continue monitoring to ensure the quality of purified water...

A RDC n° 67 de 2007, que revogou a RDC nº 33 de 2000, regulamentou análises mensais que avaliam parâmetros microbiológicos e físico-químicos em águas purificadas utilizadas em preparações magistrais, antes não especificados pela RDC n° 33 de 2000. Diante dessas alterações, o objetivo do trabalho foi avaliar a qualidade de águas utilizadas em farmácias de manipulação em Araraquara e região e verificar o impacto da legislação mais recente (RDC nº 67 de 2007) nessa qualidade. Foram analisadas 744 amostras de água purificada em 30 farmácias no decorrer de quatro anos (2008 a 2011). Os parâmetros avaliados foram: presença de coliformes totais e coliformes termotolerantes/E.coli, pH, cor, turbidez, sólidos totais dissolvidos, fluoreto e cloro residual livre. Os métodos utilizados seguiram padrões de farmacopeias, da FUNASA e da APHA. Dentre as amostras analisadas 78,90% estavam em conformidade com os padrões estabelecidos. Não foram encontradas amostras irregulares quanto aos parâmetros cor e coliformes termotolerantes/E. coli. No entanto, 0,54%, 7,80%, 10,75%, 0,54% e 4,56% das amostras estavam irregulares para turbidez, fluoretos, pH, cloro residual livre e coliformes totais, respectivamente. Foi observada uma variação do número de amostras irregulares ao compararmos os anos de 2008 e 2009 (20,26% e 26,71% respectivamente) com os anos de 2010 e 2011 (18,33% e 19,91% respectivamente). Quatro anos após a RDC n° 67 de 2007, as farmácias de manipulação ainda estão se adequando às normas e é importante que a ANVISA e outros órgãos continuem a fiscalização para garantir a qualidade da água purificada...

El Libro Blanco de Grado en Farmacia, tierra de llegada o punto de partida ¿Quo vadis Pharmacy? / The White Book of the Title of Grade in Pharmacy: land of arrival or point of departure. Quo vadis Pharmacy?

Las Facultades de Farmacia españolas, tanto públicas como privadas, aunaron sus esfuerzos, bajo los auspicios de la Agencia Nacional de Evaluación de la Calidad y Acreditación (ANECA), con objeto de elaborar un Libro Blanco del Título de Grado en Farmacia, en el marco del Espacio Europeo de Educación Superior (EEES). En este trabajo se pasa revista a las condiciones de contorno de dicho Proyecto, marcadas por las Directivas europeas existentes, señalándose referentes adoptados como guias y modelos: Comité consultivo de la Unión Europea para la formación de los farmacéuticos, Grupo consultivo de Vancouver (OMS), Declaración de Viena de Buenas Prácticas de Educación Farmacéutica (FIP), Declaración de los Principios Generales de la Profesión Farmacéutica del Consejo General de C.O.F., Declaraciones de La Laguna y de Malta de la Asociación Europea de Facultades de Farmacia (EAFP), y del Grupo Profesional Farmacéutico de la Unión Europea (PGEU). El Libro Blanco presta una especial atención a las interfaces con la Informática, Biología Molecular, y Asistencial, de cara a la inclusión de nuevas materias en los Planes de Estudios, y de nuevos descriptores, en su caso. La Orden CIN/2137/2008, por la que se rigen los estudios, constituye en realidad una proyección y un reflejo de la propuesta formulada en el Libro Blanco, y un sustancial avance desde el punto de vista de las competencias profesionales consolidadas o adquiridas por vez primera para Farmacia, de conformidad con los nuevos roles que se asignan en la actualidad a la profesión, dirigidos hacia el paciente. Por último se formula una reflexión con connotaciones históricas en torno a de dónde venimos y hacia dónde vamos, indicándose el valor de las ciencias farmacéuticas y las áreas de mayor demanda, así como la riqueza y el carácter pluridisciplinar de la profesión y de los estudios (AU)

The both public and private Spanish Pharmacy Faculties jointed their efforts under the sponsorship of the Accreditation and Quality Evaluation National Agency (ANECA), with the purpose of to prepare a White Book of the Title of Grade in Pharmacy, in the context of the European higher education space (EEES). In this paper the outline conditions of that Project, i.e., the European Directives, are marked. A number of referents have been adopted as guide and models: the Consultative Committee of the European Union for the pharmacist’s formation, the Consultative Grouping of Vancouver (WHO), the Statement of Good Pharmacy Education Practice of Vienna (FIP), the Statements of General Principles of the Pharmaceutical Profession elaborated by the “Consejo General de Colegios Oficiales de Farmacéuticos”, as well as the Statements of La Laguna and Malta of the European Association of Faculties of Pharmacy (EAFP) and of the Pharmaceutical Group of the European Union (PGEU). The White Book paid a special attention to the borderlines with the informatics, molecular biology and care pharmacy, the incorporation of new matters to the curriculum being proposed as well as that of new descriptors. The CIN/2137/2008 regulation is, as a matter of fact, a projection and a reflex of the White Book and represents a substantial advance from the point of view of consolidated or new acquired professional competences for Pharmacy, in good agreement with the new roles assigned to the profession, directed towards the patient. A reflection with historical connotations is formulated at the end in connection with where we come from and towards where we want go on, emphasizing the value of pharmaceutical sciences and denoting the richness and interdisciplinary character of either the profession and studies of Pharmacy (AU)

Multiple organ failure - death of consumer protection?

The enormously profitable complementary medicines, dietary supplements and traditional medicines markets are largely unregulated internationally and South Africa. Attempts to ensure that consumers are not exposed to harmful or ineffective products have met with varying success around the world.

Deberes y responsabilidades profesionales en la farmacia actual / Duties and professional responsibilities in the current pharmacy

El estatuto jurídico del medicamento en la UE elaborado desde 1965, a través de diversas Directivas comunitarias, ha sido codificado en la Directiva 2001/83, que establece un código comunitario sobre medicamentos de uso humano y modificado posteriormente. Además la UE, viene trabajando, con los EEUU y Japón, en las llamadas Conferencias de Armonización, que ya han supuesto unos avances considerables en la armonización de exigencias científicas y legales para la salida al mercado de nuevos medicamentos y para asegurar que todos los medicamentos que llegan a los pacientes sean de calidad, seguros y eficaces. En la conferencia magistral se analiza la situación del ejercicio farmacéutico ante los retos de la sociedad actual. Si la legislación internacional sobre el medicamento evoluciona superando los viejos nacionalismos científicos y jurídicos, la profesión, en su conjunto y a través de sus diversas organizaciones, debe mostrarse muy favorable hacia esta corriente armonizadora. Se analiza el régimen de responsabilidades y deberes del farmacéutico y su incidencia en un buen uso del medicamento en nuestra sociedad y, sobre todo, favoreciendo un ambiente positivo para impulsar la innovación terapéutica(AU)

The legal status of the drug in the EU developed since 1965 through various EU Directives, has been codified in Directive 2001/83 establishing a Community code on human medicines and subsequently amended. Furthermore, the EU has been working with the U.S. and Japan, calls for Harmonisation conferences, which have led to considerable advances in the harmonization of scientific and legal requirements for the marketing of new drugs and to ensure that all medicines reaching patients are high quality, safeand effective. In the keynote address examines the situation of Pharmacy Practice and the challenges of today's society. If international law is evolving drug overcoming the old national scientific and legal profession as a whole and through its various organizations, should be very favorable towards this current harmonization. We analyze the system of responsibilities and duties of the pharmacist and its impact on a good use of the drug in our society and, above all, promoting a positive environment to promote therapeutic innovation(AU)

Ética e historia farmacoterapéutica / Ethics and the patient’s pharmacotherapeutic record

El objetivo del presente trabajo es hacer una reflexión ética sobre los datos personales y de salud que están inundando nuestros ordenadores. El respeto a la confidencialidad y a la autonomía del paciente cuando se establece el seguimiento farmacoterapéutico exige un tratamiento ético de los datos que allí se contienen. Conceptos como, por ejemplo, consentimiento informado, confidencialidad, derecho de acceso y derecho de rectificación son términos que acompañan el quehacer clínico y que, poco a poco, hemos de incorporar a nuestra terminología farmacéutica. La obtención y el tratamiento de esta información pueden serlas causas de uno de los principales problemas éticos y legales que se plantean en el seguimiento farmacoterapéutico personalizado. Este trabajo pretende definir el concepto de seguimiento farmacoterapéutico personalizado y abordar diferentes aspectos, entre ellos la finalidad de la historia farmacoterapéutica, su custodia, conservación y confidencialidad, y el consentimiento informado. No se trata simplemente de hacer una extrapolación de la ética médica a la farmacéutica, sino de, basándonos en la normativa legal, abordar el tratamiento de los datos de la historia farmacoterapéutica desde unos principios éticos mínimos, como el respeto a la confidencialidad, la autonomía y la libertad del individuo (AU)

The objective of this study is to consider the ethical aspects of the personal and health data flooding our computers. Respect for confidentiality and the patient's autonomy when establishing the pharmacotherapeutic follow-up requires the ethical treatment of the data contained therein. Concepts like informed consent, confidentiality, right of access and right to correction are terms that go hand in hand with clinical work and which we must slowly incorporate into our pharmaceutical terminology. The collection and handling of this information may be the cause of one of the main ethical and legal problems arising in personalised pharmacotherapeutic follow-up. This study aims to define the concept of personalised pharmacotherapeutic follow-up and approach different aspects, including the purpose of the patient’s pharmacotherapeutic record, its custody, conservation and confidentiality, as well as informed consent. Our aim is not to simply extrapolate pharmaceutical ethics from medical ethics, but rather to approach, on the basis of current regulations, the treatment of data in patients' pharmacotherapeutic records according to certain minimum ethical principles, like respect for the patient's confidentiality, autonomy and freedom (AU)

Regulation of compounding by the food and drug administration: a tale of 2 circuits.

Federal regulation of the traditional art of pharmacy practice compounding is an unsettled area of the law and the profession. For many years, the Food and Drug Administration (FDA) was not interested in compounding. Attempts to regulate by FDA and Congress have caused difficulty within the profession, litigation with inconsistent results, and an unsettled state of affairs. There are a number of possible resolutions.