Interest Groups and Health Facility Regulation - Future Directions for Health Policy and Systems Research Comment on "What Lies Behind Successful Regulation? A Qualitative Evaluation of Pilot Implementation of Kenya's Health Facility Inspection Reforms".

In their paper, Tama and colleagues observe that one key challenge in a pilot, multi-component intervention to strengthen health facility regulation was the reaction from health facility owners and providers to regulatory processes. In this commentary, we propose that future research and action on health facility regulation in low- and middle-income countries (LMICs) contexts adopt an explicit focus on addressing the role of interests and interest groups in health systems 'hardware' and 'software.' Research on policy processes in LMICs consist of fewer investigations into the political economy of national or sub-national interest groups, such as physician associations or associations of health facility owners. A growing body of literature explores supply-side and demand-side interest groups, power relations within and between these stakeholders, and their advocacy approaches within LMIC health sector policy processes. We posit that such analyses will also help identify facilitators and challenges to implementation and scale-up of similar reforms to health facility regulation.

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.

Transforming an Academic Radiochemistry Facility for Positron Emission Tomography Drug cGMP Compliance.

In light of the United States Food and Drug Administration (FDA) requirement of 21 CFR 212 current Good Manufacturing Practice (cGMP) for FDA-approved position emission tomography (PET) drugs, the University of California Los Angeles (UCLA) Biomedical Cyclotron (BMC) transformed from a pre-cGMP era academic cyclotron and radiochemistry facility to a current cGMP-compliant PET drug manufacturer. In this article, we share the financial and regulatory compliance aspects of the "transformation" required to develop a sustainable quality system to support the production of two PET drugs under Abbreviated New Drug Applications (ANDAs).

EMTALA (Emergency Medical Treatment and Active Labor Act) Obligations: A Case Report and Review of the Literature.

BACKGROUND: The Emergency Medical Treatment and Active Labor Act (EMTALA) was enacted in 1986 in the United States to address "patient dumping," or refusing to provide emergency care to patients and instead transferring them to other hospitals. Under EMTALA, the "reverse-dumping" provision prevents hospitals from refusing patients who require specialized capabilities or facilities if the hospital has the capacity to treat them. Despite this provision, patients continue to be transferred to distant tertiary care centers. METHODS: We reviewed the literature on EMTALA in the context of a critically ill woman with an infection associated with an orthopaedic implant who was rejected from 2 geographically closer tertiary care centers and was ultimately transferred by helicopter ambulance to an academic teaching hospital that was 169 miles away from her home. RESULTS: After transfer to our tertiary care, level-I trauma center, the patient spent 61 days in the intensive care unit; she required 9 operative procedures, which totaled 1,520 minutes of operative time. Eighteen medical specialties and 8 ancillary medical consulting teams were involved in her care. She underwent 1,436 laboratory and 83 radiographic studies. The total reimbursement from Medi-Cal (California's Medicaid program) for her care in our tertiary care center was $463,753; the hospital charges were more than tenfold higher. CONCLUSIONS: Dumping and reverse dumping continue despite compromise of patient care and the high financial burden of the accepting institutions. This may be due to ineffective monitoring and enforcement, lack of uniformity among the courts, and lack of incentive to receive uninsured or poorly funded patients. Under EMTALA, it is difficult for tertiary care centers to argue lack of specialized capabilities or capacity to accept patients, and neither hospitals nor physicians are compensated for the charges of providing care to uninsured or underinsured patients. Moving forward, efforts to better align financial incentives through cost-sharing between community hospitals and tertiary care centers, increased clinician literacy regarding the provisions of EMTALA, and increased transparency with hospital transfers may help improve EMTALA compliance and patient care.

Organización y funcionamiento del Centro de Operaciones de Emergencias y de los espacios de monitoreo de emergencias y desastres del sector salud / Organization and operation of the Emergency Operations Center and of the emergency and disaster monitoring spaces of the health sector

La publicación describe la organización, los estándares y requisitos mínimos, así como la articulación del Centro de Operaciones de Emergencia y de los Espacios de Monitoreo de Emergencias y Desastres del Sector Salud (COE SALUD). Asimismo, las funciones y los procedimientos para la adecuada gestión de la información del Centro de Operaciones de Emergencia y de los Espacios de Monitoreo de Emergencias y Desastres del sector salud a nivel nacional

Documento técnico: Lineamientos para la implementación del proceso de rehabilitación y del proceso de reconstrucción en los servicios de salud frente a emergencias y desastres 2018 / Technical document: Guidelines for the implementation of the rehabilitation process and the reconstruction process in the health services in the face of emergencies and disasters 2018

La publicación describe las líneas de acción, las directrices y los enfoques estratégicos en el proceso de rehabilitación y en el proceso de reconstrucción, bajo las cuales los servicios de salud deben desarrollar sus intervenciones en emergencias y desastres, a fin de garantizar una adecuada atención de salud frente a emergencias y desastres

Organización y funcionamiento del Centro de Operaciones de Emergencias y de los Espacios de Monitoreo de Emergencias y Desastres del Sector Salud / Organization operations Center and of the Emergency and Disaster Monitoring Spaces of the Health Sector

La presente publicación describe la organización, los estándares y requisitos mínimos, así como la articulación del Centro de Operaciones de Emergencia y de los Espacios de Monitoreo de Emergencias y Desastres del Sector Salud (COE SALUD). Asimismo, las funciones y los procedimientos para la adecuada gestión de la información del Centro de Operaciones de Emergencia y de los Espacios de Monitoreo de Emergencias y Desastres del sector salud a nivel nacional

Política nacional: Hospitales seguros frente a los desastres / National policy: Hospitals safe from disasters

La publicación describe los criterios expresados, las recomendaciones formuladas y los términos empleados para aplicar en la protección de los establecimientos de salud esenciales--especialmente los hospitales--a fin de evitar las consecuencias evitables de los desastres

Inspector Perceptions of the Food and Drug Administration's Newest Recommended Food Facility Inspection Format: Training Matters.

The Food and Drug Administration publishes the Food Code to guide restaurant inspections. The most recent version proposes a three-tier system categorizing violations as priority, priority foundation, and core. This study used a scenario-based questionnaire to examine inspector perceptions and preferences for inspection formats. Results suggest that inspectors would be able to maintain consistent evaluations when changing to the three-tier system, although the classifying terms under the three-tier system were confusing. Additionally, inspectors were not very positive about the new system; they were concerned that the new system would not be easy to understand and use, inspections would take a longer time, it would not accurately reflect the amount of risk associated with violations, and it would not be easy for consumers and managers to understand and use. The results suggest the need for additional training for inspectors before adoption, especially on the rationale and benefits of changing to a three-tier system.

Política nacional: Hospitales seguros frente a los desastres / National policy: Hospitals safe from disasters

La publicación describe los criterios expresados, las recomendaciones formuladas y los términos empleados para aplicar en la protección de los establecimientos de salud esenciales--especialmente los hospitales--a fin de evitar las consecuencias evitables de los desastres

Documento técnico: Lineamientos para la implementación del proceso de rehabilitación y del proceso de reconstrucción en los servicios de salud frente a emergencias y desastres 2017 / Technical document: Guidelines for the implementation of the rehabilitation process and the reconstruction process in the health services in the face of emergencies and disasters 2017

Describe las líneas de acción, las directrices y los enfoques estratégicos en el proceso de rehabilitación y en el proceso de reconstrucción, bajo las cuales los servicios de salud deben desarrollar sus intervenciones en emergencias y desastres, a fin de garantizar una adecuada atención de salud frente a emergencias y desastres

Push is on to lift Medicaid restrictions on substance abuse centers.

Allowing substance abuse centers to be reimbursed under Medicaid could open more beds to patients in need, experts say.