[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.

[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.

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.

[Building the scientific commons. Conflictualities and pluralism in the light of clinical trials Covid-19]. / Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19.

TITLE: Faire du commun dans les sciences - Conflictualités et pluralisme à l'épreuve des essais cliniques COVID-19. ABSTRACT: La crise de la COVID-19 s'est ouverte sur un déficit de moyens thérapeutiques permettant de lutter efficacement contre cette maladie pour les cas les plus graves et sur de nombreuses initiatives visant à mettre en évidence un traitement efficace. Si différentes options ont été explorées, parmi lesquelles la transfusion de plasma de patients guéris, la lutte contre les mécanismes immunitaires déclenchant une réponse trop forte (les orages cytokiniques) ou, à moyen terme, la vaccination, ce sont dans un premier temps surtout les médicaments antiviraux qui ont nourri les espoirs. Après l'identification d'un certain nombre de principes actifs montrant des effets in vitro, il s'agissait d'obtenir rapidement des réponses quant à leurs effets bénéfiques in vivo et aux risques induits. Aussi, s'est-on senti en droit d'attendre que la science nous apporte les connaissances nécessaires sur ces médicaments, qu'elle nous parle, une fois sollicitée, de manière claire et d'une seule voix ; et cela, dans une situation d'urgence où la synchronisation des rythmes de la recherche et du soin n'a rien d'une évidence.

COVID-19, host response treatment, and the need for political leadership.

Health officials and scientists have warned that we face the threat of a potentially devastating influenza pandemic. Instead, we are now in the midst of a global coronavirus (COVID-19) pandemic. National and international pandemic preparedness plans have focused on developing vaccines and antiviral treatments. Another way to confront the COVID-19 pandemic (and future pandemics) might be to treat patients with inexpensive and widely available generic drugs that target the host response to infection, not the virus itself. The feasibility of this idea was tested during the Ebola outbreak in West Africa in 2014. This experience should inform our approach to treating COVID-19 patients. It could also save lives during outbreaks of other emerging infectious diseases and episodes of everyday acute critical illness. If this "bottom up" syndromic approach to treating acute critical illness were shown to be effective, it could have a dramatic impact on health, equity and security throughout the world. HIGHLIGHTS: Uncertainty about the outcome of COVID-19 is driving the social, economic and political distress associated with the pandemic. Treating the host response to COVID-19 with inexpensive and widely available generic drugs might save lives and mitigate this distress. Undertaking research on this idea will require political leadership.

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.

How Do We Combat Bogus Medicines in the Age of the COVID-19 Pandemic?

The COVID-19 pandemic has brought concurrent challenges. The increased incidence of fake and falsified product distribution is one of these problems with tremendous impact, especially in low- and middle-income countries. Up to a tenth of medicines including antibiotics and antimalarial drugs in the African market are considered falsified. Pandemics make this worse by creating an ecosystem of confusion, distraction, and vulnerability stemming from the pandemic as health systems become more stressed and the workload of individuals increased. These environments create opportunities for substandard and falsified medicines to be more easily introduced into the marketplace by unscrupulous operators. In this work we discuss some of the challenges with fake or falsified product distribution in the context of COVID-19 and proposed strategies to best manage this problem.