Análise das solicitações de medicamentos não padronizados de um hospital universitário terciário / Analysis of requests for non-standard medicines from a tertiary university hospital

Introdução: O uso extensivo de medicamentos não padronizados causa aumento de custos em saúde, além de potencial redução de segurança e uso racional de medicamentos. A Comissão de Farmácia e Terapêutica orienta a prescrição de medicamentos, por meio da avaliação e seleção de medicamentos a serem incluídos no formulário de medicamentos padronizados, com base nas melhores evidências científicas disponíveis e no perfil dos pacientes locais, promovendo o uso racional de medicamentos. O objetivo deste trabalho foi analisar as solicitações de fornecimento de medicamentos não padronizados na instituição. Métodos: Trata-se de um estudo observacional e descritivo onde foram analisadas as solicitações de medicamentos não padronizados realizadas entre fevereiro de 2016 e dezembro de 2021, identificando os medicamentos envolvidos e seus respectivos custos. Resultados: Foram realizadas 203 solicitações no período, sendo 174 incluídas no estudo. Os medicamentos que tiveram mais solicitações foram o rituximabe (41), a imunoglobulina humana (31), o sucralfato (23), a nitazoxanida (12) e o eltrombopague (7). As solicitações com maior custo foram as de imunoglobulina humana (US$ 799,702.38), rituximabe (US$ 717,320.26), eltrombopague (US$ 281,062.50), ruxolitinibe (US$ 167,867.46) e bortezomibe (US$ 149,033.52). As principais clínicas que solicitaram medicamentos não padronizado foram a neurologia (47), a hematologia (30), as moléstias infecciosas e parasitárias (17), e a anestesiologia (12). As solicitações de maior custo foram realizadas pela neurologia (US$ 145,519.08), hematologia (US$ 120,980.25), transplante de medula óssea (US$ 51,635.11) e dermatologia (US$ 44,813.40). Conclusão: O estudo demonstrou que há um fluxo estruturado de solicitação de medicamentos não padronizados na instituição, sendo uma importante ferramenta de gerenciamento dessas solicitações, evitando a aquisição desnecessária de itens que não compõem o elenco terapêutico do hospital.

Introduction: Widespread use of non-formulary drugs (NFD) increases cost and may reduce safety and rational use of medicines. The Pharmacy and Therapeutics Committee provides guidance on drug prescription by evaluating and selecting medications to be included in a hospital's formulary based on best scientific evidence available and local patients' profile, promoting rational use of medicines. The objective of this study was to assess non-formulary drugs prescriptions at a tertiary hospital. Methods: This was a retrospective study. NFD prescribed and its associated costs were assessed through NFD request forms received from February 2016 to December 2021. Results: A total of 203 NFD request forms were received, from which 174 were included in this study. The most frequently prescribed NFD included rituximab (n = 41), immunoglobulin (31), sucralfate (23), nitazoxanide (12), and eltrombopag (7), with the highest costs being with immunoglobulin (US$ 799,702.38), rituximab (US$ 717,320.26), eltrombopag (US$ 281,062.50), ruxolitinib (US$ 167,867.46), and bortezomib (US$ 149,033.52). The most frequent requesting specialties were neurology (n = 47), hematology (30), infectious disease (17) and anesthesiology (12), and highest costs requests were from neurology (US$ 145,519.08), hematology (US$ 120,980.25), bone marrow transplant unit (US$ 51,635.11), and dermatology (US$ 44,813.40). Conclusion: This study showed that a structured request flow for NFD prescription is a critical procedure in order to better manage drug prescription within the hospital, promoting rational use of medicines and preventing unnecessary spending with drugs for which the clinical indication may be covered by a drug already in the hospital's formulary.

Rational drug use in hospital settings - areas that can be changed.

Irrational use of drugs occurs at all levels of healthcare. This phenomenon can also be observed in hospitals. Irrational use of a drug contributes to a decrease in the patient's quality of treatment and often causes negative health consequences. For this reason, it is essential to consider methods that can be introduced in hospitals to increase the safety and effectiveness of the drugs used. The article presents selected methods of rationalization of drug management that can be used in hospitals.

Hospital pharmacist challenges in evaluation of scientific evidence and its incorporation to pharmacotherapeutic protocols through therapeutic committees in COVID-19 times.

Type 2 coronavirus pandemics that is plaguing almost all the world has caused  qualitative and quantitative strains in health systems that have had to be responded to. The lack of known vaccines and effective treatments has generated the need to  use drugs with very little evidence for their incorporation into pharmacotherapeutic  protocols agreed by the clinical team. The hospital pharmacist, within the  multidisciplinary team, has been responsible for critically evaluating the alternatives and positioning them in these protocols. Finally, some ethical and legal questions  that should be considered in this scenario are analyzed in this article.

La pandemia por coronavirus tipo 2 que está azotando prácticamente todo el mundo ha provocado en los sistemas sanitarios tensiones cualitativas y cuantitativas a las  que ha habido que dar respuesta. La inexistencia de vacunas y de tratamientos  eficaces conocidos ha generado la necesidad de utilizar fármacos con muy escasa  evidencia para su incorporación en protocolos farmacoterapéuticos consensuados  por el equipo clínico. El farmacéutico de hospital, dentro del equipo multidisciplinar,  ha sido en muchas ocasiones el responsable de evaluar críticamente las alternativas para su posicionamiento en estos protocolos. Se analizan en el presente artículo algunas cuestiones éticas y legales que deben ser consideradas en este  escenario.

Hospital Pharmacist experience in the Intensive Care Unit: Plan COVID.

The Intensive Care Unit (ICU) of the University Hospital of Fuenlabrada was  forced to critically increase its capacity in the COVID-19 pandemic. The objective of this work is to describe the activities promoted by the pharmacist in the care  of the critically ill patient in this context. A new organizational structure was  designed, analyzing the tasks necessary to make the processes profitable. Two  pharmacists joined the critical patient care to help the pharmacist who was  already integrated in the ICU team. The development of the operational  structure was carried out on three levels. The healthcare activity highlights the  daily participation of pharmacists in the two clinical sessions in which the ICU  teams evaluated all cases and made decisions. This in turn facilitated the  pharmaceutical validation that was carried out in the critical units themselves. In addition, one of the pharmacists created the Immuno-COVID Committee, in  which they participated together with different specialists for therapeutic  decision-making in the most complex cases. On the other hand, the availability  of human and material resources allowed the implantation of centralized  elaboration in the Pharmacy Service of many intravenous mixtures, including  antibiotics elastomers Pumps for continuous infusion, and non-sterile  elaborations. In logistics management, in addition to the acquisition of COVID- 19 therapies, the reconciliation with nursing activity stands out. The physical presence of the pharmacist favored the detection of needs, the  availability in time of medications in the unit, including sterile and non-sterile  preparations, and coordination with the central pharmacy. In knowledge  management, the participation of the pharmacist in the working group for the  development of the hospital management protocol COVID-19 stands out. The  daily presence in the unit and the joint work with the entire multidisciplinary team demonstrate the value that the pharmacist can bring. In addition to  efficient resource management, support for clinical decision-making and  improvement actions, it provides the climate of inter-professional trust necessary to respond to the complexity of the critical patient and promote joint  projects.

La Unidad de Cuidados Intensivos del Hospital Universitario de Fuenlabrada se  vio obligada a aumentar de manera crítica su capacidad en la pandemia por  COVID-19. El objetivo de este trabajo es describir las actividades impulsadas por el farmacéutico en la atención del paciente crítico en este contexto. Se diseñó  una estructura organizativa nueva, analizando las tareas necesarias para  rentabilizar los procesos. Dos farmacéuticos se incorporaron a la atención del  paciente crítico para ayudar al farmacéutico que ya estaba integrado en el  equipo de la Unidad de Cuidados Intensivos. El desarrollo de la estructura  operativa se llevó a cabo en tres niveles. En la actividad asistencial destaca la  participación diaria de los farmacéuticos en las dos sesiones clínicas en las que  los equipos de la Unidad de Cuidados Intensivos valoraban todos los casos y  tomaban las decisiones. Esto, a su vez, facilitaba la validación farmacéutica que  se realizaba en las propias unidades de críticos. Además, uno de los  farmacéuticos ideó el Comité Inmuno-COVID, en el que participaban junto a  diferentes especialistas para la toma de decisiones terapéuticas en los casos más complejos. Por otro lado, la disponibilidad de recursos humanos y materiales  permitió implantar la elaboración de forma centralizada en el Servicio de Farmacia de muchas mezclas intravenosas, incluyendo elastómeros de  antibioterapia en perfusión continua, y de elaboraciones no estériles. En la  gestión logística, además de la adquisición de las terapias COVID-19, destaca la  conciliación con la actividad de enfermería. La presencia física del farmacéutico  favorecía la detección de necesidades, la disponibilidad en tiempo de  medicamentos en la unidad, incluyendo las elaboraciones estériles y no estériles, y la coordinación con la Farmacia central. En la gestión del conocimiento destaca la participación del farmacéutico en el grupo de trabajo para desarrollo del  protocolo hospitalario de manejo de la COVID-19. La presencia diaria en la  unidad y el trabajo conjunto con todo el equipo multidisciplinar ponen de  manifiesto el valor que el farmacéutico puede aportar. Además de una gestión  eficiente de los recursos, soporte en la toma de decisiones clínicas y acciones de  mejora, proporciona el clima de confianza interprofesional necesario para dar  respuesta a la complejidad del paciente crítico y promover proyectos conjuntos.

Hospital Pharmacy in the multidisciplinary team of COVID inpatient units.

Since the implementation of the Antimicrobial Therapy Optimization Programme, hospital pharmacy specialists have collaborated with infectious disease specialists on a regular basis in most hospitals in Spain.  Cooperation between these professionals ensures the integrated management of patients with infectious diseases and the appropriate use of antimicrobials in  hospitals. The COVID-19 pandemic forced hospital pharmacists to abruptly  suspend all their structured activities and concentrate on the health crisis.  Realtime information sharing between different medicine specialties is an  effective strategy to generate and maintain treatment protocols adapted to each center, with continuous evidence-based modifications as new publications appear. Hospital pharmacies had to reorganize their activities to  respond to the pandemic. On the one side were patients with COVID-19, and on  the other were routine hospital pharmacy tasks, with the added difficulty of  adapting to individual protection measures. New communication and  collaboration strategies were adopted. Protocols were established for the  management of COVID-19 patients, with continuous changes; special  medications had to be prepared and distributed; circuits were designed for the  home- or institution-based care of patients; internal circuits were created to  minimize the movements of hospital staff and professionals caring for COVID-19  patients. The most effective antiviral drug and anti inflammatory therapy  remains elusive. In this scenario, hospital pharmacists emerge as a key player,  as they have a deep understanding of the mechanisms of action of drugs and  potential interactions. In a setting where experimental drugs preferably tested in clinical trials are being used, the role of hospital pharmacists in interdisciplinary  teams has become essential for the optimization of clinical outcomes.

La colaboración entre los especialistas en farmacia hospitalaria y enfermedades infecciosas está implantada en la mayoría de los hospitales españoles desde 2012, a raíz de los Programas de Optimización de  Antibióticos. Los objetivos principales de esta colaboración son el abordaje integral de los pacientes con enfermedades infecciosas y el uso  adecuado de los antimicrobianos en el hospital. Las actividades estructuradas y  organizadas que los farmacéuticos tenían dentro de los grupos se vieron  truncadas por la pandemia por SARS­CoV-2, que requirió una alta dedicación. El  intercambio de información en tiempo real entre las especialidades ha sido una  vía efectiva para generar y mantener protocolos de tratamiento adaptados a  cada centro, con continuas modificaciones basadas en las publicaciones que iban apareciendo. Los servicios de farmacia se tuvieron que reorganizar para dar  respuesta, por un lado, a los pacientes que ingresaban por esta infección, y por otro, para continuar con las actividades anteriores, con las dificultades  añadidas que exigían las normativas para la protección del personal sanitario. Hubo que reinventarse para establecer otros sistemas de comunicación y de colaboración, protocolizando el tratamiento farmacológico de estos  pacientes, con modificaciones continuas, gestión de medicamentos a través de  medicamentos especiales, diseño de circuitos para tratar a pacientes en su  domicilio y en centros sociosanitarios y modificación de circuitos internos para  minimizar los desplazamientos de los profesionales en el hospital, así como del  personal que atendía a pacientes con SARS-CoV-2. A día de hoy, se desconoce el mejor fármaco antiviral y el mejor tratamiento antiinflamatorio, pero la  colaboración del farmacéutico hospitalario es fundamental, pues dispone del  conocimiento de los mecanismos de acción de fármacos tan diferentes y de las  interacciones que pueden ocasionar. La urgente necesidad de utilizar fármacos  experimentales, preferiblemente dentro de ensayos clínicos, coloca al  farmacéutico en un papel clave dentro del equipo interdisciplinario  imprescindible para conseguir los mejores resultados.

Ifema hospital model. Implementation and start-up of the Pharmacy Department.

On the 20th of March 2020, triggered by the public health emergency declared,  the Health Authorities in Madrid reported a legal instruction (Orden 371/2020)  indicating the organization of a provisional hospital to admit patients with  COVID-19 at the Trade Fair Institution (IFEMA). Several pharmacists working in  the Pharmacy and Medical Devices Department of the Madrid Regional Health  Service were called to manage the Pharmacy Department of the  abovementioned hospital. Required permissions to set up a PD were here  authorized urgently. Tackling human and material resources, and computer  systems for drug purchase and electronic prescription, were some of the initial  issues that hindered the pharmaceutical provision required for patients from the  very day one. Once the purchase was assured, mainly by direct purchase from suppliers, drug dispensing up to 1,250 hospitalized patients (25 nursing units) and 8 ICU patients was taken on. Dispensing was carried out  through either drug stocks in the nursing units or individual patient dispensing  for certain drugs. Moreover, safety issues related to prescription were  considered, and as the electronic prescription was implemented we attained  100% prescriptions review and validation. The constitution of a multidisciplinary  Pharmacy and Therapeutics Committee let agree to a pharmacotherapy guide,  pres cription protocols, therapeutic equivalences, interactions, and drug  dispensing circuits. The Pharmacy Department strategy was to ensure a very  quick response to basic tasks keeping the aim to offer a pharmaceutical care of  the highest quality whenever possible. Working under a health emergency  situation, with many uncertainties and continuous pressure was a plight.  However, the spirit of collaboration in and out of the Pharmacy Department was  aligned with the whole hospital motivation to offer the highest quality of  healthcare. These were possibly the keys to allow caring for almost 4,000  patients during the 42 days that the hospital lasted.

El día 20 de marzo de 2020 la Consejería de Sanidad publicó una Orden  (371/2020) para la apertura de un centro hospitalario provisional para atender a  pacientes COVID-19 en la Institución Ferial de Madrid (IFEMA), por razón de  emergencia sanitaria. Se dispuso un equipo de farmacéuticos de la Subdirección  General de Farmacia y Productos Sanitarios para la apertura de un Servicio de  Farmacia, que obtuvo la autorización correspondiente por el órgano competente, con carácter de urgencia. La gestión de recursos humanos,  materiales y de herramientas informáticas para la adquisición y prescripción  electrónica fueron unas de las primeras dificultades que se solaparon con el  primer reto de garantizar la prestación farmacéutica a los pacientes que atendía  el hospital desde el mismo día uno. Asegurada la adquisición, fundamentalmente  mediante la compra directa a proveedores, se planteó la  dispensación para un máximo de 1.250 pacientes de hospitalización (25  controles de enfermería) y una Unidad de Cuidados Intensivos de 8 pacientes;  se establecieron botiquines en las unidades de enfermería y circuitos  individualizados de dispensación para determinados medicamentos. A su vez,  desde el primer momento se trabajó en la seguridad en la prescripción, llegando  a la revisión y validación del 100% de los tratamientos, una vez instaurada la  prescripción electrónica. La creación de una  Comisión de Farmacia y Terapéutica multidisciplinar permitió consensuar la guía farmacoterapéutica, protocolos de  prescripción, equivalencias terapéuticas, interacciones y circuitos de  dispensación de medicamentos. La estrategia del Servicio de Farmacia se basó  en asegurar una respuesta rápida en las funciones básicas, sin perder la visión  de incorporar una atención farmacéutica de la máxima calidad posible a medida  que iba siendo factible. A pesar de un escenario adverso, de incertidumbre y  presión continuas por la emergencia sanitaria, se ha mantenido un espíritu de  colaboración y contribución dentro y fuera del Servicio de Farmacia, alineado con un objetivo común de trabajo en equipo para brindar una atención sanitaria rápida y de la mayor calidad posible. Posiblemente éstas han sido las claves del  éxito que han permitido atender a casi 4.000 pacientes en los 42 días de vida  del hospital.

PRACTITIONER UPDATE.

OBJECTIVE: To review the development and implementation of prescription formularies by managed care organizations, identify their current applications, and recognize future trends in the managed care pharmacy environment. DATA SOURCES: Current journal articles and texts regarding the use of formularies and the managed care environment. DATA SYNTHESIS: Not applicable. CONCLUSION: Formulary systems have proven to be a valuable means to control the pharmacy benefit and can be expected to expand in both scope and sophistication.

Top Evidentiary Gaps in Managed Care Pharmacy: A Research Agenda.

Research agendas play valuable roles in clearly identifying high-priority topics that reflect potential to improve health care quality. The purpose of this report is to present work completed by the Academy of Managed Care Pharmacy (AMCP) and AMCP Foundation Joint Research Committee. This committee set forth to develop a research agenda for our 2 organizations that focuses on critical evidence needs in managed care pharmacy. This document reviews results from 2 surveys that were conducted to better understand unmet research needs within managed care pharmacy and to inform professional efforts of managed care pharmacists. The first survey collected qualitative data from key opinion leaders (KOLs) regarding the top evidentiary gaps in managed care pharmacy and barriers to closing those gaps. The second survey was sent to AMCP members and AMCP Foundation stakeholders, used a mixed methods quantitative-qualitative design, and incorporated concepts from initial KOL responses. The key outcome from these proceedings is the research agenda, which identifies and prioritizes 4 evidentiary gaps in managed care pharmacy: (1) real-world evidence to inform managed care pharmacy decision making, (2) value-based models in managed care pharmacy to address total cost of care, (3) impact of benefit design or utilization management strategies on patient outcomes, and (4) impact of direct patient care services provided by managed care pharmacy on patient outcomes. The agenda was intended to be broad and will evolve over time. AMCP and the AMCP Foundation hope that this research agenda inspires the AMCP membership, researchers, and funding agencies to close these gaps in knowledge and understanding. DISCLOSURES: Chairs and members of the Joint Research Committee oversaw and conducted the work outlined in this report with the support of AMCP and the AMCP Foundation. No outside funding was received. Gembarski, Couto, Wilson, and Eichenbrenner declare no conflicts of interest, real or apparent, with any product or service mentioned in this report. Gembarski is employed by BCBS Michigan; Couto is employed by Cigna; Wilson is employed by HealthCore, a wholly owned subsidiary of Anthem; and Eichenbrenner is employed by the AMCP Foundation.

Managing conflicts of interest in pharmacy and therapeutics committees: A proposal for multicentre formulary development.

WHAT IS KNOWN AND OBJECTIVE: While many countries have central agencies responsible for formulary development, within the United States, each hospital, health care system, or insurance provider has their own pharmacy and therapeutic committee, leading to both inefficiencies and inequalities across formularies. The number and variety of processes within pharmacy and therapeutic committees also increases the likelihood that conflicts of interest will influence the development of formularies. We sought to determine how such influences could be reduced by reviewing international evidence related to the presence and harms of conflicts of interest in formulary development. METHODS: Several approaches have been taken to reduce the influence of conflicts of interest in pharmacy and therapeutics committee processes, including include disclosure, recusal, exclusion, universal consideration and dual committees. The feasibility of each of these approaches is considered in the context of the United States. RESULTS AND DISCUSSION: A proposal is drawn from the discussion of various approaches to conflicts of interest in pharmacy and therapeutics committees: multicenter formulary development. WHAT IS NEW AND CONCLUSION: Multicentre formulary development, where resources are pooled across institutions, may lead to a reduction in the influence of conflicts of interest in pharmacy and therapeutics committee processes in the United States, increasing the chances of including the most safe, efficacious and cost-effective drugs on formularies.

AMCP Partnership Forum: Principles for Sound Pharmacy and Therapeutics (P&T) Committee Practices: What's Next?

It has been nearly 20 years since the Academy of Managed Care Pharmacy (AMCP) and other stakeholders adopted the Principles for a Sound Formulary System. Since that time, best practices for pharmacy and therapeutics (P&T) committees have matured throughout the health care system. On March 28, 2019, AMCP convened a group of thought leaders representing clinicians, academia, patient advocacy, payer organizations, and the pharmaceutical industry to consider P&T committee best practices in today's evolving health care system. Specifically, the group provided perspectives on (a) P&T committee composition and relevant stakeholders, (b) evaluation of emerging evidence for formulary decisions and recommendations around training of P&T committee members, and (c) characteristics and best practices of successful committees. DISCLOSURES: This AMCP Partnership Forum and the development of the proceedings document were supported by Amgen, Genentech, Merck, National Pharmaceutical Council, Novo Nordisk, Pharmaceutical Research and Manufacturers of America, Precision for Value, and Takeda. This proceedings document presents common themes and comments from individuals participating in the forum and is not necessarily endorsed by all participants nor should it be construed to reflect group consensus. Eric Jen, PharmD, and Cynthia Reilly, MS, BSPharm, declare no conflicts of interest, real or apparent, with any product or service mentioned in this article. Jen is an employee of Precision for Value, a sponsor of the Partnership Forum. Development of these proceedings was done as an in-kind sponsorship. Reilly is an employee of AMCP.

AMCP Partnership Forum: Optimizing Prior Authorization for Appropriate Medication Selection.

Prior authorization (PA) and step therapy (ST) are utilization management tools that have been in use by managed care organizations for decades. These processes require that health care providers obtain advanced approval to qualify a specific product for coverage from a health plan before it is delivered to the patient. These tools are intended to ensure that patients have access to evidence-based medications while payers remain good stewards of limited health care resources. PA and ST are growing in use to support appropriate use of medications and manage associated costs but may pose challenges related to administrative burden and access to care. In June 2019, the Academy of Managed Care Pharmacy (AMCP) conducted a multistakeholder forum to identify processes for optimizing PA and ST utilization management programs. Health care leaders representing academia, health plans, integrated delivery systems, pharmacy benefit managers, employers, federal government agencies, national health care provider organizations, and patient advocacy organizations participated in the forum. Participants explored current operations of these programs, evaluated stakeholder perspectives on opportunities to improve these programs, and provided recommendations for next steps. They also reviewed current federal and state legislative and regulatory activities to reform PA and ST processes and offered guidance to support program improvements. The goal of the forum was to gather stakeholder input to inform the development of recommendations to improve efficiencies around PA and ST processes; provide recommendations to address administrative burdens; increase the visibility of the clinical and economic value of PA and ST utilization management programs; collect, review, and disseminate data-driven, real-world experiences of PA programs that support clinical and economic value; collect and disseminate best practices around PA appeals and denial processes; and improve channels of communications between health insurance providers, health care professionals, and patients to minimize care delays and improve clarity of coverage authorization requirements. DISCLOSURES: This AMCP Partnership Forum was sponsored by Mallinckrodt Pharmaceuticals, Merck, the National Pharmaceutical Council, and Takeda. These proceedings were prepared as a summary of what occurred at the forum to represent common themes; they are not necessarily endorsed by all attendees nor should they be construed as reflecting group consensus.

Retos del farmacéutico de hospital en la evaluación de la evidencia científica y su incorporación a los protocolos farmacoterapéuticos a través de las comisiones en tiempos de COVID-19 / Hospital pharmacist challenges in evaluation of scientific evidence and its incorporation to pharmacotherapeutic protocols through therapeutic committees in COVID-19 times

La pandemia por coronavirus tipo 2 que está azotando prácticamente todo el mundo ha provocado en los sistemas sanitarios tensiones cualitativas y cuantitativas a las que ha habido que dar respuesta. La inexistencia de vacunas y de tratamientos eficaces conocidos ha generado la necesidad de utilizar fármacos con muy escasa evidencia para su incorporación en protocolos farmacoterapéuticos consensuados por el equipo clínico. El farmacéutico de hospital, dentro del equipo multidisciplinar, ha sido en muchas ocasiones el responsable de evaluar críticamente las alternativas para su posicionamiento en estos protocolos. Se analizan en el presente artículo algunas cuestiones éticas y legales que deben ser consideradas en este escenario

Type 2 coronavirus pandemics that is plaguing almost all the world has caused qualitative and quantitative strains in health systems that have had to be responded to. The lack of known vaccines and effective treatments has generated the need to use drugs with very little evidence for their incorporation into pharmacotherapeutic protocols agreed by the clinical team. The hospital pharmacist, within the multidisciplinary team, has been responsible for critically evaluating the alternatives and positioning them in these protocols. Finally, some ethical and legal questions that should be considered in this scenario are analyzed in this article

Modelo hospital de IFEMA. Implantación y puesta en marcha de su Servicio de Farmacia / Ifema hospital model. Implementation and start-up of the Pharmacy Department

El día 20 de marzo de 2020 la Consejería de Sanidad publicó una Orden (371/2020) para la apertura de un centro hospitalario provisional para atender a pacientes COVID-19 en la Institución Ferial de Madrid (IFEMA), por razón de emergencia sanitaria. Se dispuso un equipo de farmacéuticos de la Subdirección General de Farmacia y Productos Sanitarios para la apertura de un Servicio de Farmacia, que obtuvo la autorización correspondiente por el órgano competente, con carácter de urgencia. La gestión de recursos humanos, materiales y de herramientas informáticas para la adquisición y prescripción electrónica fueron unas de las primeras dificultades que se solaparon con el primer reto de garantizar la prestación farmacéutica a los pacientes que atendía el hospital desde el mismo día uno. Asegurada la adquisición, fundamentalmente mediante la compra directa a proveedores, se planteó la dispensación para un máximo de 1.250 pacientes de hospitalización (25 controles de enfermería) y una Unidad de Cuidados Intensivos de 8 pacientes; se establecieron botiquines en las unidades de enfermería y circuitos individualizados de dispensación para determinados medicamentos. A su vez, desde el primer momento se trabajó en la seguridad en la prescripción, llegando a la revisión y validación del 100% de los tratamientos, una vez instaurada la prescripción electrónica. La creación de una omisión de Farmacia y Terapéutica multidisciplinar permitió consensuar la guía farmacoterapéutica, protocolos de prescripción, equivalencias terapéuticas, interacciones y circuitos de dispensación de medicamentos. La estrategia del Servicio de Farmacia se basó en asegurar una res-puesta rápida en las funciones básicas, sin perder la visión de incorporar una atención farmacéutica de la máxima calidad posible a medida que iba siendo factible. A pesar de un escenario adverso, de incertidumbre y presión continuas por la emergencia sanitaria, se ha mantenido un espíritu de colaboración y contribución dentro y fuera del Servicio de Farmacia, alineado con un objetivo común de trabajo en equipo para brindar una atención sanitaria rápida y de la mayor calidad posible. Posiblemente éstas han sido las claves del éxito que han permitido atender a casi 4.000 pacientes en los 42 días de vida del hospital

On the 20th of March 2020, triggered by the public health emergency declared, the Health Authorities in Madrid reported a legal instruction (Orden 371/2020) indicating the organization of a provisional hospital to admit patients with COVID-19 at the Trade Fair Institution (IFEMA).Several pharmacists working in the Pharmacy and Medical Devices Department of the Madrid Regional Health Service were called to manage the Pharmacy Department of the abovementioned hospital. Required permissions to set up a PD were here authorized urgently. Tackling human and material resources, and computer systems for drug purchase and electronic prescription, were some of the initial issues that hindered the pharmaceutical provision required for patients from the very day one. Once the purchase was assured, mainly by direct purchase from suppliers, drug dispensing up to 1,250 hospitalized patients (25 nursing units) and 8 ICU patients was taken on. Dispensing was carried out through either drug stocks in the nursing units or individual patient dispensing for certain drugs. Moreover, safety issues related to prescription were considered, and as the electronic prescription was implemented we attained 100% prescriptions review and validation. The constitution of a multidisciplinary Pharmacy and Therapeutics Committee let agree to a pharmacotherapy guide, prescription protocols, therapeutic equivalences, interactions, and drug dispensing circuits. The Pharmacy Department strategy was to ensure a very quick response to basic tasks keeping the aim to offer a pharmaceutical care of the highest quality whenever possible. Working under a health emergency situation, with many uncertainties and continuous pressure was a plight. However, the spirit of collaboration in and out of the Pharmacy Department was aligned with the whole hospital motivation to offer the highest quality of healthcare. These were possibly the keys to allow caring for almost 4,000 patients during the 42 days that the hospital lasted

Los Comités de Ética Asistencial y los Comités de Ética de la Investigación en España: organización, regulación y funciones / Healthcare Ethics Committees and Institutional Review Boards in Spain: organization, regulation and functions

En las últimas décadas hemos asistido a una evolución en la medicina que obliga a una reflexión ética más cuidadosa y a una organización e institucionalización de los procesos de toma de decisiones que puedan resultar controvertidos. Los Comités de Ética Asistencial se constituyen para analizar y asesorar en la resolución de los conflictos éticos que se producen durante la práctica clínica asistencial y garantizar que los pacientes estén informados y puedan tomar las decisiones referentes a su salud, de acuerdo con su libre y propia voluntad. El objetivo de los Comités de Ética de la Investigación es la protección y el respeto de las personas participantes en estudios de investigación. En ambos casos, juegan un papel importante en la protección de los derechos, la equidad y la dignidad de la personas. Un marco normativo adecuado permite dar respuesta a los nuevos retos científicos y garantiza la protección de los ciudadanos en el ámbito de la salud. Sin embargo, la extensa red de comités locales, autonómicos y estatales en España, puede comprometer la eficiencia en la gestión administrativa de los procedimientos de evaluación y en la resolución de conflictos y dar lugar a duplicidades o incoherencias en los mismos. En este artículo se realiza una revisión y descripción de los diferentes comités de ética asistencial y de la investigación en España y se analizan aspectos relevantes en relación a su organización, regulación y ámbito de actuación

Recent decades have witnessed major advances in medical science that require a careful ethical reflection, organization and institutionalization of controversial decision-making processes. The Healthcare Ethics Committees (HECs) are independent interdisciplinary bodies to provide support in ethical dilemmas in healthcare settings, ensuring that patients are informed about their treatments and procedures and make their own decisions. The Institutional Review Boards (IRBs) are focus on the rights and welfare of the potential participants in the research. Nevertheless both HECs and IRBs play an important role in promoting respect and protection of dignity and human right in an attempt to achieve health equity and social justice. The regulation of HECs and IRBs provides an appropriate framework to address new scientific challenges in the field of health. Nevertheless the large number of local, regional and national HECs and IRBs in Spain might compromise the efficiency in the assessment procedures leading to duplication of reports and inconsistent opinions. In this article a review and description of the different HECs and IRBs in Spain is performed and relevant issues related to their organization, regulation and functions are also analyzed

Drug and therapeutics committees in Jordanian hospitals: a nation-wide survey of organization, activities, and drug selection procedures

BACKGROUND: Drug and Therapeutics Committees (DTCs) were founded about a century ago as a guide for dealing with drugs in hospitals. Since then, it has shown a vital role in rational drug use in terms of regulatory and educational activities. OBJECTIVE: To describe structures, functions, and activities of hospital DTCs. METHODS: A questionnaire was developed based on previous studies. Questions consisted of information on respondents' demographics; structures, functions, and activities of DTCs; drug selection process and resources used, and factors and criteria used in drug selection. RESULTS: The overall response rate was 95%. DTCs were mainly present in most large hospitals (45%). All DTCs had hospital pharmacists in their structure and most of them (66%) met monthly. The main responsibilities of DTCs were related to general prescribing policies. The number, frequency, and severity of adverse drug reactions were the most reported criteria for the drug selection process. Legal implications for practical, economic, and organizational factors were the most important factors that were reported for drug selection. CONCLUSIONS: DTCs are mainly present in most large hospitals. The main responsibilities of the DTC in Jordanian hospitals are general prescribing policies, drug selection, hospital formulary editing, and reporting of ADR to external authorities

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Pharmacist perspectives and considerations for implementation of therapeutic oncology biosimilars in practice.

PURPOSE: An overview of therapeutic oncology biosimilars, the U.S. biosimilars regulatory pathway, and the clinical development of selected biosimilar products is provided, including discussion of considerations in adopting biosimilars into oncology practice. SUMMARY: Biosimilars are biologic agents that are highly similar to and have no clinically meaningful differences from an approved reference product in terms of safety, purity, and potency. There is a large market for cancer biologics, and approval of biosimilars has the potential to increase access to care and reduce costs. An abbreviated regulatory pathway for the development and approval of biosimilars defines a stepwise approach to demonstrating biosimilarity and conducting clinical comparative trials to confirm equivalent pharmacokinetics, efficacy, safety, and immunogenicity to the reference product. Three therapeutic biologics (bevacizumab, trastuzumab, and rituximab) have been used extensively in the treatment of a variety of cancers and are targets for biosimilar product development. Preclinical and clinical experience with 2 recently approved biosimilars to bevacizumab and trastuzumab is reviewed. Challenges faced by pharmacy and therapeutics committees when considering oncology biosimilars for formulary inclusion are discussed. CONCLUSION: Increased adoption of biosimilars could potentially lower treatment costs and improve access to biologics for patients with cancer. Key considerations in formulary review of biosimilars include the quality and quantity of data from comparative clinical trials, economic factors, manufacturer reliability, and challenges associated with incorporating biosimilars into practice.

Application of pharmacoeconomics to formulary management in a health system setting.

PURPOSE: A novel value-based approach to evaluate costly specialty drugs for formulary addition was developed. SUMMARY: In February 2016, Stanford Health Care launched the specialty drug subcommittee (SDSC), a subcommittee of the pharmacy and therapeutics committee, responsible for the formulary review of specialty pharmaceuticals. A process was developed for value-based review that includes not only consideration of clinical trial data and institutional acquisition costs but also internal patient outcomes and a cost-effectiveness model using internal financial data. A Markov model was developed to assess the value of trabectedin, which was approved for formulary addition in April 2016, relative to the addition of dacarbazine. The economic model and internal patient outcome analysis were presented to the prescribing oncologist and the SDSC for review. Internal data revealed that fewer patients than had been estimated received trabectedin, with outcomes significantly worse than those observed in the clinical trial leading to Food and Drug Administration approval. In the cost-effectiveness model, trabectedin had higher costs and poorer outcomes compared with dacarbazine. Based on the economic model, low utilization, and real-world outcomes, trabectedin was removed from formulary and a restrictive treatment pathway for nonformulary use, developed by the primary prescriber, was implemented. This process has since been applied to 11 more specialty drugs. CONCLUSION: Internal cost-effectiveness models in combination with real-world patient outcomes data can be effective formulary management tools. Engagement and collaboration with the requesting provider are key to developing thoughtful treatment pathways.