Coping with drug shortages: A study of government-enterprise option cooperation stockpiling strategies for drugs in shortage considering API surrogate stockpiling subsidies.

Drug shortage is a global problem, and the development of government-enterprise cooperative stockpiles of drugs in shortage, combining physical and production capacity, has become one of the most important means of coping with drug shortages. However, existing studies have tended to overlook the fact that shortages of Active Pharmaceutical Ingredients (APIs) have become an important constraint on production capacity stockpiling and that the lack of incentives and provisions for coordination of benefits have led to a double marginal effect of joint stockpiling by government and enterprises of drugs in shortage. Accordingly, this study introduced the option contract to the drug supply system composed of government and pharmaceutical enterprises and used the subsidy of API storage in lieu as an important initiative to incentivize the reserve of APIs, to construct a model of shortage drug reserve under the government's leadership. This study aims to improve the effect of government-enterprise joint stockpiling of drugs in shortage, which is of great theoretical and practical significance. According to the classification of production license types of pharmaceutical enterprises, this study established a three-level supply chain decentralized decision-making model consisting of the government, formulation enterprises, and API enterprises, and a two-level supply chain centralized decision-making model consisting of the government and API Formulation (API-F) integrated enterprises, respectively. By solving the inverse order derivation, the government-enterprise option cooperation conditions and optimal decision-making strategy were derived. The study results showed that: (i) The addition of enterprise API stockpiling mode can help the government conventional reserves, and enterprise production capacity reserves, broaden the way of drug reserves, and improve the effect of government-enterprise option cooperation; (ii) when the probability of drug shortages is high, the government should prefer the cooperation of API-F integrated enterprises, which is conducive to reducing intermediate links and government costs and improving the supply responsiveness to shortages of medicines; (iii) Setting appropriate government subsidies for API storage can incentivize enterprises to stockpile APIs and improve drug production capacity and physical supply response capability. This study took the problem of socialized stockpiling of drugs in shortage as an entry point and explored the problems and solution strategies in the government-enterprise cooperative stockpiling of drugs in shortage, which not only made some theoretical contributions to the application of options contract in the government-enterprise cooperative stockpiling of drugs in shortage but also provided new ideas and theoretical basis for the improvement of the stockpiling work of drugs in shortage.

Create a COVID-19 commission.

We need a definitive public reference for the history of events.

Avaliação da qualidade na gestão de estoque em laboratório clínico no município de Fortaleza, Ceará / Quality assessment in stock management in a clinical laboratory in Fortaleza Municipality, Ceará

Objetivo: Este trabalho visa discutir sobre a correta gestão de insumos em um laboratório de análises clínicas. Nesse tipo de atividade, o Sistema de Gestão da Qualidade embasa uma série de processos visando garantir a fidedignidade dos resultados, pautados em processos bem estabelecidos. A gestão de insumos e estoque é uma atividade integrada entre os diversos setores existentes na empresa, fundamental para a garantia da qualidade do exame. Dessa forma, falhas na política de qualidade podem desencadear prejuízos materiais, institucionais e humanos. Métodos: Para tanto, realizou-se análise em um laboratório clínico privado de Fortaleza, Ceará, de modo observacional, prospectivo e descritivo, desenvolvido como estudo de caso. Resultados: Verificou-se que, apesar de sistemas de gestão de estoque serem adotados, não há treinamento efetivo e documentação detalhada que norteie todos os processos do setor. Conclusão: A ausência de processos bem definidos de gestão de estoque pode ser interferente importante na correta liberação dos laudos de exames, gerando prejuízos importantes à organização e ao cliente.

Objective: This paper aims to discuss the correct management of inputs in a clinical analysis laboratory. In this type of activity, the Quality Management System is based on a series of processes aimed at guaranteeing the reliability of results, based on well-established processes. The management of inputs and stock is an integrated activity among the various sectors existing in the company, essential for ensuring the quality of the exam. Thus, failures in quality policy can trigger material, institutional and human losses. Methods: For this purpose, an analysis was carried out in a private clinical laboratory in Fortaleza, Ceará, in an observational, prospective and descriptive manner, developed as a case study. Results: It was found that, although inventory management systems are adopted, there is no effective training and detailed documentation to guide all processes in the sector. Conclusion: The absence of well-defined inventory management processes can be an important interferer in the correct release of examination reports, generating significant losses to the organization and the customer.

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.

A Commons for a Supply Chain in the Post-COVID-19 Era: The Case for a Reformed Strategic National Stockpile.

Policy Points Reflecting on current response deficiencies, we offer a model for a national contingency supply chain cell (NCSCC) construct to manage the medical materials supply chain in support of emergencies, such as COVID-19. We develop the following: a framework for governance and response to enable a globally independent supply chain; a flexible structure to accommodate the requirements of state and county health systems for receiving and distributing materials; and a national material "control tower" to improve transparency and real-time access to material status and location. CONTEXT: Much of the discussion about the failure of the COVID-19 supply chain has centered on personal protective equipment (PPE) and the degree of vulnerability of care. Prior research on supply chain risks have focused on mitigating the risk of disruptions of specific purchased materials within a bounded region or on the shifting status of cross-border export restrictions. But COVID-19 has impacted every purchase category, region, and border. This paper is responsive to the National Academies of Sciences, Engineering and Medicine recommendation to study and monitor disasters and to provide governments with course of action to satisfy legislative mandates. METHODS: Our analysis draws on our observations of the responses to COVID-19 in regard to acquisition and contracting problem-solving, our review of field discussions and interactions with experts, a critique of existing proposals for managing the strategic national stockpile in the United States a mapping of the responses to national contingency planning phases, and the identification of gaps in current national healthcare response policy frameworks and proposals. FINDINGS: Current proposals call for augmenting a system that has failed to deliver the needed response to COVID-19. These proposals do not address the key attributes for pandemic plan renewal: flexibility, traceability and transparency, persistence and responsiveness, global independence, and equitable access. We offer a commons-based framework for achieving the opportunities and risks which are responsive to a constellation of intelligence assets working in and across focal targets of global supply chain risk. CONCLUSIONS: The United States needs a "commons-based strategy" that is not simply a stockpile repository but instead is a network of repositories, fluid inventories, and analytic monitoring governed by the experts. We need a coordinated effort, a "commons" that will direct both conventional and new suppliers to meet demands and to eliminate hoarding and other behaviors.

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.

Estimating Shortages in Capacity to Deliver Continuous Kidney Replacement Therapy During the COVID-19 Pandemic in the United States.

RATIONALE & OBJECTIVE: During the coronavirus disease 2019 (COVID-19) pandemic, New York encountered shortages in continuous kidney replacement therapy (CKRT) capacity for critically ill patients with acute kidney injury stage 3 requiring dialysis. To inform planning for current and future crises, we estimated CKRT demand and capacity during the initial wave of the US COVID-19 pandemic. STUDY DESIGN: We developed mathematical models to project nationwide and statewide CKRT demand and capacity. Data sources included the Institute for Health Metrics and Evaluation model, the Harvard Global Health Institute model, and published literature. SETTING & POPULATION: US patients hospitalized during the initial wave of the COVID-19 pandemic (February 6, 2020, to August 4, 2020). INTERVENTION: CKRT. OUTCOMES: CKRT demand and capacity at peak resource use; number of states projected to encounter CKRT shortages. MODEL, PERSPECTIVE, & TIMEFRAME: Health sector perspective with a 6-month time horizon. RESULTS: Under base-case model assumptions, there was a nationwide CKRT capacity of 7,032 machines, an estimated shortage of 1,088 (95% uncertainty interval, 910-1,568) machines, and shortages in 6 states at peak resource use. In sensitivity analyses, varying assumptions around: (1) the number of pre-COVID-19 surplus CKRT machines available and (2) the incidence of acute kidney injury stage 3 requiring dialysis requiring CKRT among hospitalized patients with COVID-19 resulted in projected shortages in 3 to 8 states (933-1,282 machines) and 4 to 8 states (945-1,723 machines), respectively. In the best- and worst-case scenarios, there were shortages in 3 and 26 states (614 and 4,540 machines). LIMITATIONS: Parameter estimates are influenced by assumptions made in the absence of published data for CKRT capacity and by the Institute for Health Metrics and Evaluation model's limitations. CONCLUSIONS: Several US states are projected to encounter CKRT shortages during the COVID-19 pandemic. These findings, although based on limited data for CKRT demand and capacity, suggest there being value during health care crises such as the COVID-19 pandemic in establishing an inpatient kidney replacement therapy national registry and maintaining a national stockpile of CKRT equipment.

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.

Are there positive lessons for Italy's NHS resulting from the Covid-19 pandemic?

The authors evaluate the importance of prevention measures and health care from their own experience and briefly analyse the factors that may have contributed to the rapid spread of Covid-19 in Italy, and hope this will feed into appropriate and new and improved health policies.

Preventing Asthma Emergencies in Schools.

Asthma is a significant public health issue, impacting quality of life, morbidity, and health care costs nationally. Stock asthma rescue medication policies authorize school districts to maintain unassigned albuterol and enable trained staff members to administer the medication in response to asthma symptoms, exercise premedication, and asthma emergencies. Stock asthma rescue (or reliever) medication laws serve as an important fail-safe measure. Such laws provide districts with the ability to respond if a student has an asthma emergency at school but either lacks a diagnosis or does not have access to their own medication. As of September 2019, 13 states have enacted either a law or regulation authorizing the stocking of asthma rescue medication in schools: Arizona, Colorado, Georgia, Illinois, Missouri, New Hampshire, New Jersey, New Mexico, Oklahoma, Ohio, Texas, Utah, and West Virginia. Three additional states provide stock albuterol asthma guidelines but do not have legislation: Indiana, New York, and Nebraska. Some states have found that these policies reduce the need for 911 calls and emergency medical services transports as a result of asthma exacerbations. Initial data also demonstrate that these policies reach populations in need and improve health outcomes. This case study will describe the current state of asthma in Illinois, an innovative policy solution to address asthma emergencies in schools, and the steps taken to advocate for stock asthma rescue medication in Illinois. Legislation for stock albuterol in Illinois was signed into law in August 2018.

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.

Impact of Essential Medicine Stock Outs on Cancer Therapy Delivery in a Resource-Limited Setting.

PURPOSE: Essential cancer medicine stock outs are occurring at an increasing frequency worldwide and represent a potential barrier to delivery of standard therapy in patients with cancer in low- and middle-income countries. The objective of this study was to measure the impact of cancer medicine stock outs on delivery of optimal therapy in Botswana. METHODS: We conducted a retrospective analysis of patients with common solid tumor malignancies who received systemic cancer therapy in 2016 at Princess Marina Hospital, Gaborone, Botswana. Primary exposure was the duration of cancer medicine stock out during a treatment cycle interval, when the cancer therapy was intended to be administered. Mixed-effects univariable and multivariable logistic regression analyses were used to calculate the association of the primary exposure, with the primary outcome, suboptimal therapy delivery, defined as any dose reduction, dose delay, missed cycle, or switch in intended therapy. RESULTS: A total of 378 patients met diagnostic criteria and received systemic chemotherapy in 2016. Of these, 76% received standard regimens consisting of 1,452 cycle intervals and were included in this analysis. Paclitaxel stock out affected the highest proportion of patients. In multivariable mixed-effects logistic regression, each week of any medicine stock out (odds ratio, 1.9; 95% CI, 1.7 to 2.13; P < .001) was independently associated with an increased risk of a suboptimal therapy delivery event. CONCLUSION: Each week of cancer therapy stock out poses a substantial barrier to receipt of high-quality cancer therapy in low- and middle-income countries. A concerted effort between policymakers and cancer specialists is needed to design implementation strategies to build sustainable systems promoting a reliable supply of cancer medicines.