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.

The experiences of using polio outbreak simulation exercises to strengthen national outbreaks preparedness and response plans in sub-Saharan Africa.

INTRODUCTION: globally, by 2020 the paralytic poliomyelitis disease burden decreased to over 99% of the reported cases in 1988 when resolution 41.8 was endorsed by the World Health Assembly (WHA) for global polio eradication. It is clearly understood that, if there is Wild Poliovirus (WPV) and circulating Vaccines Derived Poliovirus (cVDPV) in the world, no country is safe from polio outbreaks. All countries remain at high risk of re-importation depending on the level of the containment of the types vaccine withdrawn, the laboratory poliovirus isolates, and the population immunity induced by the vaccination program. In this regard, countries to have polio outbreak preparedness and response plans, and conducting the polio outbreak simulation exercises for these plans remain important. METHODS: we conducted a cross-section qualitative study to review to 8 countries conducted polio outbreak simulation exercises in the East and Southern Africa from 2016 to 2018. The findings were categorized into 5 outbreak response thematic areas analyzed qualitatively and summarized them on their strengths and weaknesses. RESULTS: we found out that, most countries have the overall technical capacities and expertise to deal with outbreaks to a certain extent. Nevertheless, we noted that the national polio outbreak preparedness and response plans were not comprehensive enough to provide proper guidance in responding to outbreaks. The guidelines were inadequately aligned with the WHO POSOPs, and IHR 2005. Additionally, most participants who participated in the simulation exercises were less familiar with their preparedness and response plans, the WHO POSOPs, and therefore reported to be sensitized. CONCLUSION: we also realized that, in all countries where the polio simulation exercise conducted, their national polio outbreak preparedness and response plan was revised to be improved in line with the WHO POSOPs and IHR 2005. we, therefore, recommend the polio outbreak simulation exercises to be done in every country with an interval of 3-5 years.

Staffing Up For The Surge: Expanding The New York City Public Hospital Workforce During The COVID-19 Pandemic.

Confronted with the coronavirus disease 2019 (COVID-19) pandemic, New York City Health + Hospitals, the city's public health care system, rapidly expanded capacity across its eleven acute care hospitals and three new field hospitals. To meet the unprecedented demand for patient care, NYC Health + Hospitals redeployed staff to the areas of greatest need and redesigned recruiting, onboarding, and training processes. The hospital system engaged private staffing agencies, partnered with the Department of Defense, and recruited volunteers throughout the country. A centralized onboarding team created a single-source portal for medical care providers requiring credentialing and established new staff positions to increase efficiency. Using new educational tools focused on COVID-19 content, the hospital system trained twenty thousand staff members, including nearly nine thousand nurses, within a two-month period. Creation of multidisciplinary teams, frequent enterprisewide communication, willingness to shift direction in response to changing needs, and innovative use of technology were the key factors that enabled the hospital system to meet its goals.

Assessing the incremental costs and savings of introducing electronic immunization registries and stock management systems: evidence from the better immunization data initiative in Tanzania and Zambia.

INTRODUCTION: Poor data quality and use have been identified as key challenges that negatively impact immunization programs in low- and middle-income countries (LMICs). In addition, many LMICs have a shortage of health personnel, and staff available have demanding workloads across several health programs. In order to address these challenges, the Better Immunization Data (BID) Initiative introduced a comprehensive suite of interventions, including an electronic immunization registry aimed at improving the quality, reliability, and use of immunization data in Arusha Region, Tanzania, and Southern Province of Zambia. The objective of this study was to assess the incremental costs of implementing the BID interventions in immunization programs in these two countries. METHODS: We conducted a micro-costing study to estimate the economic costs of service delivery and logistics for the immunization programs with and without the BID interventions in a sample of health facilities and district program offices in each country. Structured questionnaires were used to interview immunization program staff at baseline and post-intervention to assess annual resource utilization and costs. Cost outcomes were reported as annual cost per facility, cost per district and changes in resource costs due to the BID interventions (i.e., costs associated with health worker time, start-up costs, etc.). Sub-group analyses were conducted by health facility to assess variation in costs by volume served and location (rural versus urban). One-way sensitivity analyses were conducted to identify influential parameters. Costs were reported in 2017 US dollars. RESULTS: In Tanzania, the average annual reduction in resource costs was estimated at US$10,236 (95% confidence interval: $7,606-$14,123) per health facility, while the average annual reduction in resource costs per district was estimated at $6,542. In Zambia, reductions in resource costs were modest at an estimated annual average of $628 (95% confidence interval: $209-$1,467) per health facility and $236 per district. Resource cost reductions were mainly attributable to reductions in time required for immunization service delivery and reporting. One-way sensitivity analyses identified key cost drivers, all related to reductions in health worker time. CONCLUSION: The introduction of electronic immunization registries and stock management systems through the BID Initiative was estimated to result in potential time savings in both countries. Health worker time was the area most impacted by the interventions, suggesting that time savings gained could be utilized for patient care. Information generated through this work provides evidence to inform stakeholder decision-making for scale-up of the BID interventions in Tanzania and Zambia and to inform other Low-to-Middle-Income Countries (LMICs) interested in similar interventions.

Especificaciones técnicas de dispositivos médicos para la gestión de casos de COVID-19 en los servicios de salud. Recomendaciones interinas, 3 marzo 2020 / Technical specifications of medical devices for the case management of COVID-19 in healthcare settings. Interim recommendations, 3 March 2020

En diciembre de 2019 , un nuevo coronavirus (SARS-CoV-2) fue identificado como el agente etiológico de neumonía (COVID-19) en personas expuestas a un mercado de mariscos en Wuhan, China.* • Existen varias incertidumbres respecto a la historia natural de la enfermedad por el 2019-nCoV, incluyendo fuente(s), los mecanismos de transmisión, la capacidad de diseminación del virus, y la persistencia del virus en el ambiente y fómites. El 17 de febrero de 2020, el Centro para el Control y la Prevención de Enfermedades de China publicó un estudio con 72,314 casos registrados, de los cuales 44,672 (62%) fueron confirmados para SARS-CoV-2. Entre los casos confirmados, el 31,2% tenía más de 60 años y representaba 81% del total de las muertes. La tasa global de letalidad fue del 2,3%. Las comorbilidades más prevalentes fueron hipertensión, diabetes y enfermedades cardiovasculares. El espectro de la enfermedad se distribuyó en 81% de casos leves (casos de no-neumonía y neumonía leve), 14% de casos graves (disnea, frecuencia respiratoria mayor que 30/min, saturación de oxígeno en sangre menor a 93%, relación PaO2/FiO2 menor a 300, y/o infiltrados pulmonares mayor que 50% en un plazo de 24­48 horas), y 5% de pacientes en estado crítico, con insuficiencia respiratoria, shock séptico y/o disfunción o fallo multiorgánico.† • La implementación de terapias de apoyo oportunas, eficaces y seguras (oxígeno, antibióticos, hidratación y alivio de la fiebre/dolor) es la piedra angular de la terapia para los pacientes que desarrollan manifestaciones graves de COVID-19.‡ • Hasta el momento, no existe un tratamiento específico como antivirales para COVID-19. Han habido informes anecdóticos sobre el uso de estos agentes; sin embargo, su eficacia y seguridad aún no se han determinado.

• In December 2019 a novel coronavirus (SARS-CoV-2) was identified as the causative agent of pneumonia (COVID-19) among people exposed to a seafood market in Wuhan, China. • There are gaps in the knowledge about the natural history of COVID-19, including viral shedding, reservoirs and patterns of transmission. On February 17, 2020, the Chinese Center for Disease Control and Prevention published a study with 72,314 recorded cases, of which 44,672 (62%) were confirmed for COVID-19. Among the confirmed cases, 31.2% were over 60 years of age and accounted for 81% of the total deaths. The overall case-fatality rate was 2.3%. The most prevalent comorbid conditions were hypertension, diabetes, and cardiovascular disease. The spectrum of disease included 81% of mild cases (non-pneumonia and mild pneumonia cases), 14% severe (dyspnea, respiratory frequency higher than ≥) 30/min, blood oxygen saturation lesser than ≤ 93%, PaO2/FiO2 ratio lesser than ≤ 300, and/or lung infiltrates > 50% within 24­48 hours), and 5% of critically ill patients, with respiratory failure, septic shock, and/or multiple organ dysfunction or failure. • The implementation of timely, effective, and safe supportive therapies (oxygen, antibiotics, hydration & fever/pain relief) is the cornerstone of therapy for patients that develop severe manifestations of COVID-19.• At the moment, there is no specific treatment for COVID-19, such as antivirals. There have been anecdotal reports on the use of these agents; however, its efficacy and safety are yet to be determined. The medical devices listed in this document provide minimum standards and technical description and specifications of medical devices for supportive treatment of COVID-19. • These medical devices are not limited, and to be adaptable to all countries in the region irrespective of their different health care systems and socioeconomic disparities. In addition, they are recommended for: o Early supportive therapy and monitoring of severe acute respiratory illness (SARI) when COVID-19 infection is suspected; o Management of hypoxemic respiratory failure and Acute Respiratory Distress Syndrome (ARDS) in COVID-19 patients; o Management of septic shock in COVID-19 patients.

Lista de Dispositivos Médicos Prioritarios en el contexto de COVID-19 / List of Priority Medical Devices in the context of COVID-19. Provisional recommendations, 11 May 2020

Este documento resulta una actualización a las recomendaciones interinas de la OPS para la gestión de casos de COVID19 en los servicios de salud*

This document updates PAHO's interim recommendations for case management of COVID-19 in health services. The list of priority medical devices in the context of COVID-19 provides technical descriptions and specifications for the management of patients with suspected and/or confirmed COVID-19 infection at different levels of health care.

Investing in antibiotics to alleviate future catastrophic outcomes: What is the value of having an effective antibiotic to mitigate pandemic influenza?

Over 95% of post-mortem samples from the 1918 pandemic, which caused 50 to 100 million deaths, showed bacterial infection complications. The introduction of antibiotics in the 1940s has since reduced the risk of bacterial infections, but growing resistance to antibiotics could increase the toll from future influenza pandemics if secondary bacterial infections are as serious as in 1918, or even if they are less severe. We develop a valuation model of the option to withhold wide use of an antibiotic until significant outbreaks such as pandemic influenza or foodborne diseases are identified. Using real options theory, we derive conditions under which withholding wide use is beneficial, and calculate the option value for influenza pandemic scenarios that lead to secondary infections with a resistant Staphylococcus aureus strain. We find that the value of withholding an effective novel oral antibiotic can be positive and significant unless the pandemic is mild and causes few secondary infections with the resistant strain or if most patients can be treated intravenously. Although the option value is sensitive to parameter uncertainty, our results suggest that further analysis on a case-by-case basis could guide investment in novel agents as well as strategies on how to use them.

Pharmaceutical lobbying and pandemic stockpiling of Tamiflu: a qualitative study of arguments and tactics.

Background: Little is known about how pharmaceutical companies lobby authorities or experts regarding procurement or the use of vaccines and antivirals. This paper investigates how members of Denmark's pandemic planning committee experienced lobbying efforts by Roche, manufacturer of Tamiflu, the antiviral that was stockpiled before the 2009 A(H1N1) pandemic. Methods: Analysis of interviews with six of seven members of the Danish core pandemic committee, supplemented with documentary analysis. We sought to identify (1) arguments and (2) tactics used in lobbying, and to characterize interviewees' views on the impact of (3) lobbying and (4) scientific evidence on the decision to stockpile Tamiflu. Results: Roche lobbied directly (in its own name) and through a seemingly independent third party. Roche used two arguments: (1) the procurement agreement had to be signed quickly because the drug would be delivered on a first-come, first-served basis and (2) Denmark was especially vulnerable to an influenza crisis because it had smaller Tamiflu stocks than other countries. Most interviewees suspected that lobbying had an impact on Tamiflu procurement. Conclusions: Our study highlights risks posed by pharmaceutical lobbying. Arguments and tactics deployed by Roche are likely to be repeated whenever many countries are negotiating drug procurements in a monopolistic market.

Shortage of Peritoneal Dialysis Solution and the Food and Drug Administration's Response.

Although the number of new drug shortages has been lower in recent years than in the past, severe shortages have occurred that have affected large numbers of patients. A new law entitled the Food and Drug Administration Safety and Innovation Act was enacted in July of 2012, which requires companies to notify the Food and Drug Administration of anticipated shortages. This notification requirement has allowed the Food and Drug Administration to work closely with manufacturers earlier to mitigate and, often, prevent shortages. However, not all shortages are able to be prevented, and the shortage of peritoneal dialysis solution is one that has had a significant effect on patients. The Food and Drug Administration continues to use all available tools to address this shortage with manufacturers, including temporary availability of imported peritoneal dialysis solution from Ireland. Mitigating shortages is a top priority for the Food and Drug Administration, and communication with all stakeholders is essential.

Evaluation of emergency drug releases from the Centers for Disease Control and Prevention Quarantine Stations.

The Centers for Disease Control and Prevention (CDC) Quarantine Stations distribute select lifesaving drug products that are not commercially available or are in limited supply in the United States for emergency treatment of certain health conditions. Following a retrospective analysis of shipment records, the authors estimated an average of 6.66 hours saved per shipment when drug products were distributed from quarantine stations compared to a hypothetical centralized site from CDC headquarters in Atlanta, GA. This evaluation supports the continued use of a decentralized model which leverages CDC's regional presence and maximizes efficiency in the distribution of lifesaving drugs.

The Tamiflu fiasco and lessons learnt.

Oseltamivir (Tamiflu), a neuraminidase inhibitor, was approved for seasonal flu by US Food and Drug Administration in 1999. A number of randomized controlled trials, systematic reviews, and meta-analysis emphasized a favorable efficacy and safety profile. Majority of them were funded by Roche, which also first marketed and promoted this drug. In 2005 and 2009, the looming fear of pandemic flu led to recommendation by prominent regulatory bodies such as World Health Organization (WHO), Centers for Disease Control and Prevention, European Medicines Agency and others for its use in treatment and prophylaxis of influenza, and it's stockpiling as a measure to tide over the crisis. Serious Adverse Events, especially neuropsychiatric events associated with Tamiflu started getting reported leading to a cascade of questions on clinical utility of this drug. A recent Cochrane review and related articles have questioned the risk-benefit ratio of the drug, besides raising doubts about the regulatory decision of approving it. The recommendations for stockpiling the said drug as given by various international organizations viz WHO have also been put to scrutiny. Although many reviewers have labeled the Tamiflu saga as a "costly mistake," the episode leaves us with some important lessons. This article takes a comprehensive relook on the subject, and we proceed to suggest some ways and means to avoid a similar situation in the future.

Building the strategic national stockpile through the NIAID Radiation Nuclear Countermeasures Program.

The possibility of a public health radiological or nuclear emergency in the United States remains a concern. Media attention focused on lost radioactive sources and international nuclear threats, as well as the potential for accidents in nuclear power facilities (e.g., Windscale, Three Mile Island, Chernobyl, and Fukushima) highlight the need to address this critical national security issue. To date, no drugs have been licensed to mitigate/treat the acute and long-term radiation injuries that would result in the event of large-scale, radiation, or nuclear public health emergency. However, recent evaluation of several candidate radiation medical countermeasures (MCMs) has provided initial proof-of-concept of efficacy. The goal of the Radiation Nuclear Countermeasures Program (RNCP) of the National Institute of Allergy and Infectious Diseases (National Institutes of Health) is to help ensure the government stockpiling of safe and efficacious MCMs to treat radiation injuries, including, but not limited to, hematopoietic, gastrointestinal, pulmonary, cutaneous, renal, cardiovascular, and central nervous systems. In addition to supporting research in these areas, the RNCP continues to fund research and development of decorporation agents targeting internal radionuclide contamination, and biodosimetry platforms (e.g., biomarkers and devices) to assess the levels of an individual's radiation exposure, capabilities that would be critical in a mass casualty scenario. New areas of research within the program include a focus on special populations, especially pediatric and geriatric civilians, as well as combination studies, in which drugs are tested within the context of expected medical care management (e.g., antibiotics and growth factors). Moving forward, challenges facing the RNCP, as well as the entire radiation research field, include further advancement and qualification of animal models, dose conversion from animal models to humans, biomarker identification, and formulation development. This paper provides a review of recent work and collaborations supported by the RNCP.

[Modern approaches to the formation of antidote stocks at medical institutions in Russia and foreign countries].

This article analyses the approaches to the formation of specific treatment of acute poisoning in the various countries. The authors present a systematic review of scientific publications about the formation of reserves of antidote agents at medical institutions of the Russian Federation, the US, Canada, France, Spain, Greece, Norway, Czech Republic, Taiwan and Poland. A search for a variety of databases, as well as by reviewing reference lists of publications on the subject of "stockpiling antidote means". It is concluded that the antidote provision at health care institutions in different countries is insufficient. State of affairs with the formation of antidote stocks is better at hospitals of Czech Republic, France and Spain. To determine the range and volume of the stock of fixed assets necessary antidote coordination and approval of the list and the number of mandatory for every medical institution antidotes.

Gestão de estoques / Curso de Capacitação a Distância

Apresentar as principais técnicas de Gestão de Estoques