[Scientific research in times of pandemics.] / La ricerca scientifica in tempi di pandemia.

When a pandemic occurs, scientific research moves fast in order to achieve readily results, such as effective therapies to fight the SARS-CoV-2 and vaccines. But this high-speed science, engaged by the emergency and characterized by the explosion of online publications in preprint form not subject to scrutiny by peer reviewers, carries some risks. And it represents a challenge to maintain research integrity and to comply with those globally recognized standard principles of fairness. Competition and the pressure to publish immediately - a way of encouraging rapid data sharing - can favor the dissemination of incomplete if not erroneous results obtained from partial studies, which feed false news, such as the benefits of a drug, and illusory hopes. It is commonly through press releases that "speed science" disseminates information to an audience that wants to be informed and reassured. Financial and political interests often mix with the urgency to find solutions. Covid-19 has highlighted in particular the risk of a politicization of science at the expense of transparency.

[The importance of the logistic warehouse in pandemic period: the experience of the USL Umbria 1 (Perugia, Italy) during covid-19.] / L'importanza del magazzino logistico in periodo di pandemia: l'esperienza dell'USL Umbria 1 durante covid-19.

The pandemic period has generated major problems in the pharmacies of hospitals and local health care companies regarding the distribution of drugs to patients undergoing treatment with chronic drugs. This is because the patient, during the lockdown, was forced to leave the house and go several miles away to reach the place where the drug was dispensed. Moreover, very often, the place was placed in covid-19 hospitals, like the one in Perugia, and was also a risk for the patient himself. The logistical organization allows, in addition to the advantages of traceability, efficiency and savings, with the arrival of the drug at home, a very high patient compliance that also translates into greater security in a pandemic period. To the Usl Umbria 1 of Perugia (Italy) has been centralized the activity of warehouse for all the South area that includes three hospitals and four sanitary districts. Such warehouse, through computerized procedure, guarantees the direct distribution with sending of the medicines directly to the district of belonging of the patient. In this way the patient was not forced to make long and risky trips to continue their chronic therapies. Moreover, this logistic warehouse has also allowed to cope with the correct management of many medicinal specialties that have been used against the SARS-CoV-2 virus avoiding their temporary deficiency for patients already on therapy according to the normal therapeutic indications (anti-inflammatory, antiretroviral and immunomodulatory). This paper aims to demonstrate how logistical organization is of vital importance for a National Health System that has to face increasing costs, ensure the traceability of all processes and, last but not least, survive a worldwide pandemic period.

Healthcare risk management during the SARS-CoV-2 virus pandemic in the European Union: The guaranteed access to medicines.

BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.

It Takes a Village : Contending With Drug Shortages During Disasters.

Critical drug shortages have been widely documented during the coronavirus disease 2019 (COVID-19) pandemic, particularly for IV sedatives used to facilitate mechanical ventilation. Surges in volume of patients requiring mechanical ventilation coupled with prolonged ventilator days and the high sedative dosing requirements observed quickly led to the depletion of "just-in-time" inventories typically maintained by institutions. This manuscript describes drug shortages in the context of global, manufacturing, regional and institutional perspectives in times of a worldwide crisis such as a pandemic. We describe etiologic factors that lead to drug shortages including issues related to supply (eg, manufacturing difficulties, supply chain breakdowns) and variables that influence demand (eg, volatile prescribing practices, anecdotal or low-level data, hoarding). In addition, we describe methods to mitigate drug shortages as well as conservation strategies for sedatives, analgesics and neuromuscular blockers that could readily be applied at the bedside. The COVID-19 pandemic has accentuated the need for a coordinated, multi-pronged approach to optimize medication availability as individual or unilateral efforts are unlikely to be successful.

Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic.

On May 1, 2020, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to allow use of the antiviral drug remdesivir to treat patients with severe coronavirus disease-2019 (COVID-19). Remdesivir is an investigational drug studied in clinical trials for COVID-19 and is available to children and pregnant women through compassionate-use access but is not yet FDA approved. In early May, the US Department of Health and Human Services began to distribute remdesivir, donated by Gilead Sciences, Inc., to hospitals and state health departments for emergency use; multiple shipments have since been distributed. This process has raised questions of how remdesivir should be allocated. The Minnesota Department of Health has collaborated with the Minnesota COVID Ethics Collaborative and multiple clinical experts to issue an Ethical Framework for May 2020 Allocation of Remdesivir in the COVID-19 Pandemic. The framework builds on extensive ethical guidance developed for public health emergencies in Minnesota before the COVID-19 crisis. The Minnesota remdesivir allocation framework specifies an ethical approach to distributing the drug to facilities across the state and then among COVID-19 patients within each facility. This article describes the process of developing the framework and adjustments in the framework over time with emergence of new data, analyzes key issues addressed, and suggests next steps. Sharing this framework and the development process can encourage transparency and may be useful to other states formulating and refining their approach to remdesivir EUA allocation.

Pharmacy Department management and organization.

The WHO declared the SARS- CoV-2 outbreak a pandemic in March 11, 2020.  Spain has been the third country with the highest number of reported cases of  COVID-19. In the face of the pandemic, the authorities of the Autonomous  Community of Madrid led an unprecedented transformation of hospital services  by increasing the number of beds available, setting up temporary field hospitals  in fairgrounds, and transforming hotels into support centers for patients with  mild symptoms of COVID-19. In the light that this crisis will continue to be a real threat for the years to come, our hospital pharmacies need to be better prepared for similar outbreaks in the future. During the COVID-19 pandemic, the  Department of Hospital Pharmacy of Hospital General Universitario Gregorio  Marañón has faced four challenges: an exponential increase in the demand for  resources, constant changes to therapeutic protocols and approaches, regulatory changes, and a dramatic impact on hospital staff (strain on human resources  and psychological impact). This article is aimed at describing the main  organizational changes implemented to the Department of Hospital Pharmacy of  Hospital GU Gregorio Marañón and its relationship with other hospital  pharmacies of the Community of Madrid. An account is provided of the strategies to be adopted for reorganizing a Department of Hospital Pharmacy and achieve a safe and effective use of medications. Strategies range from the creation of  integral hospital task groups (COVID-crisis task group, protocolization task  group, research task group) to the adaptation of the internal organization of the  Department of Hospital Pharmacy, which encompasses aspects related to  management and leadership; a communication plan (internal and external);  staff management, and the reorganization and adaptation of processes. People,  patients and professionals are at the core of these strategies. This paper is a  reflection on key factors of "humanization in COVID times".

Con fecha 11 de marzo de 2020 la Organización Mundial de la Salud declaró el  estado de pandemia por SARS-CoV-2. En algunos momentos de la crisis, España fue el tercer país del mundo en número de casos. Las autoridades de la  Comunidad de Madrid, una de las más afectadas, han respondido con una  transformación hospitalaria sin precedentes, aumentando el número de camas  disponibles, creando hospitales de campaña en recintos feriales y transformando hoteles en centros de apoyo para pacientes leves. Dado que la aparición de  estas crisis continuará siendo una amenaza real en los próximos años, es  necesario revisar la preparación de nuestros servicios de farmacia para afrontar  este tipo de situaciones. El reto al que se ha enfrentado el Servicio de Farmacia  del Hospital General Universitario Gregorio Marañón durante la crisis de la  pandemia COVID-19 ha venido determinado por cuatro circunstancias:  incremento exponencial de la demanda de recursos, cambios constantes en los  protocolos y decisiones terapéuticas, cambios regulatorios y gran impacto en las personas (gestión de recursos y gestión de las emociones). En este trabajo  se describen los principales cambios organizativos de un servicio de farmacia a  través de la experiencia del Hospital General Universitario Gregorio Marañón y  sus relaciones con otros servicios de farmacia de la Comunidad de Madrid. Se  detallan los procedimientos que deben contemplarse para la reorganización de  un servicio de farmacia para lograr un uso seguro y eficiente de los  medicamentos. Se detallan desde la participación en los comités globales de  hospital (comité de crisis COVID, comité de protocolización y comité de  investigación) hasta la organización interna del servicio de farmacia, que  incluyen: gestión y liderazgo, plan de comunicación (interna y externa), gestión  de las personas, reorganización y adaptación de los procesos. Las personas,  pacientes y profesionales son los grandes protagonistas de esta actuación, por lo  que incluimos una reflexión sobre los factores clave para la "humanización en  tiempos de COVID".

Hospital Pharmacy Service: Facing the logistics of medicines procurement.

COVID crisis has abruptly broken into our hospitals, and many difficulties have  emerged, including those related to supply logistics. A huge number of new  patients, a fast internal reorganization process and many other changes were  suddenly established. These circumstances revealed the need to increase stocks  of drugs, both for basic treatment as well as for specific SARS-CoV-2 infection  management. At the same time, other problems (shortages, new and complex  purchasing procedures, etc.) surfaced, so they could risk safety along the  pharmacotherapeutic process. The main objective was to develop and implement all the necessary measures within the logistics circuit in order to ensure the  availability of medicines for patients, as safely and effectively as possible, during the Coronavirus crisis. Firstly, two pharmacists were appointed to coordinate the whole process, and a preliminary analysis of the following aspects was carried  out an estimation of needs to make an initial drug provisioning, a storage  feasibility study and a global analysis of the logistics process to detect critical  points. Three different circuits for medicines supply were established as some  drugs were operated by Agencia Española de Medicamentos y Productos  Sanitarios (AEMPS) or Servicio Madrileño de Salud (SERMAS), and others were  under no restrictions. For stocks control, inventory was frequently reviewed and  monitoring of prescription trends was implemented. For all new medicinal  products, compliance with security standards was reviewed and relabeling was  carried out if necessary. Criteria were defined for the storage of overstocks and  it was placed an isolated area for quarantined drugs. Shortages inevitably  occurred but their effects were partly mitigated by AEMPS and SERMAS. After  all, we consider that the implemented procedure for logistics management may  be reproducible, and the key points we have identified are the following: to  enhance our quality management system, to develop an Action Plan for  Healthcare Emergencies and to ensure the adequate training for all pharmacy  staff. Furthermore, we also should address other aspects: to establish storage  optimization strategies, to focus on a more advanced logistics management  model, as well as to take advantage of the extraordinary multidisciplinary  network, which has been consolidated during this COVID pandemic.

La crisis COVID ha irrumpido en los hospitales de forma abrupta, y ha planteado  muchas dificultades de partida a todos los niveles, incluyendo la logística de  adquisiciones. El aumento radical de pacientes, una aceleradísima reorganización interna y otros cambios pusieron de manifiesto un drástico incremento de  necesidades, tanto de medicamentos básicos, como de aquellos específicos para  soporte y tratamiento de la infección por SARSCoV-2. Paralelamente, surgieron  otras dificultades como desabastecimientos, procedimientos de compra nuevos y más complejos, etc., que podían comprometer la seguridad del proceso de  utilización de medicamentos. Nuestro objetivo consistió en establecer todas las  medidas necesarias dentro del proceso logístico para garantizar de forma segura y eficaz la disponibilidad de los medicamentos para los pacientes durante la  crisis COVID. En primer lugar, se designaron los farmacéuticos responsables del  proceso, y se realizó un análisis preliminar de los siguientes aspectos:  estimación de necesidades para realizar una compra inicial, estudio de viabilidad de almacenamiento y análisis logístico global para detectar puntos críticos. Se establecieron tres circuitos de adquisiciones, según se tratase de medicamentos intervenidos por la Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), por el Servicio Madrileño de  Salud (SERMAS) o medicamentos no sujetos a restricciones. Para el control de stocks se implementaron revisiones frecuentes de inventario y seguimiento de las tendencias de prescripción. En las especialidades nuevas  recibidas se revisó el cumplimiento de los estándares de seguridad y se realizó  reetiquetado en caso necesario. Se establecieron unos criterios para el  almacenamiento de los sobrestocks y se destinó un área independiente para  medicamentos en cuarentena. Los desabastecimientos fueron inevitables pero  amortiguados por la gestión del SERMAS y la AEMPS. Una vez superada la crisis, consideramos que el procedimiento implantado para la gestión logística es  reproducible, y sus puntos clave para aplicabilidad futura son: mantener y  potenciar nuestro sistema de gestión de calidad, elaborar un plan de actuación  para emergencias sanitarias y garantizar la adecuada formación de todo el  personal. Asimismo, existen otros aspectos que debemos abordar: establecer  estrategias de optimización del almacenamiento, enfocarnos hacia un modelo de  gestión logística más avanzado, así como aprovechar la extraordinaria red  multidisciplinar consolidada durante la crisis.

COVID-19 and Fake News in the Dominican Republic.

The first case of novel coronavirus disease (COVID-19) in the Dominican Republic coincided with a period of political crisis. Distrust in governmental institutions shaped the critical phase of early response. Having a weak public health infrastructure and a lack of public trust, the Ministry of Health (MoH) began the fight against COVID-19 with a losing streak. Within 45 days of the first reported case, the political crisis and turmoil caused by "fake news" are limiting the capacity and success of the MoH response to the pandemic.

In and Beyond COVID-19: US Academic Pharmaceutical Science and Engineering Community Must Engage to Meet Critical National Needs.

The supply of affordable, high-quality pharmaceuticals to US patients has been on a critical path for decades. In and beyond the COVID-19 pandemic, this critical path has become tortuous. To regain reliability, reshoring of the pharmaceutical supply chain to the USA is now a vital national security need. Reshoring the pharmaceutical supply with old know-how and outdated technologies that cause inherent unpredictability and adverse environmental impact will neither provide the security we seek nor will it be competitive and affordable. The challenge at hand is complex akin to redesigning systems, including corporate and public research and development, manufacturing, regulatory, and education ones. The US academic community must be engaged in progressing solutions needed to counter emergencies in the COVID-19 pandemic and in building new methods to reshore the pharmaceutical supply chain beyond the pandemic.

Improving patient access to hepatitis C antiviral medicines in Switzerland: Understanding the financial risks for community pharmacies.

RATIONALE: As observed in other countries, some patients may experiment difficulties in obtaining their hepatitis C antiviral medicines (HCVm) in Swiss community pharmacies. There is a lack of data related to access to HCVm at the patient level and notably related to the potential financial risks for the community pharmacies. AIMS: (a) To evaluate the potential financial risks for community pharmacist associated with the delivery of HCVm in the Swiss healthcare system; (b) to explore the attitudes and experiences of community pharmacists related to these risks and their consequences for the patients. METHOD: A three-step approach was chosen as follows: (a) estimation of costs, incomes, and gross financial results directly related to 3-month treatment with Harvoni based on the drug delivery process (data from 68 patients over 2 years); (b) sensitivity analyses; (c) exploration of local community pharmacists' attitudes and experiences related to the delivery of HCVm in the canton of Vaud (Western Switzerland). RESULTS: Two main risks were identified: (a) Incomes do not always cover costs; (b) reimbursement issues could lead to an increase in the requirement for working capital. According to the survey, 23% (14/60) of pharmacies refused to deliver HCVm to at least one patient, and these patients had to find a solution mostly on their own. CONCLUSIONS: The scenario analysis clarifies the causes of the possible refusal to deliver HCVm. With the growing number of high-priced medicines, the healthcare systems should have a clear strategy to encourage their delivery by community pharmacies by ensuring seamless and collaborative care for patients. The community pharmacists could be accountable to provide such services-if they get the education, training, and remuneration.