USA stockpiling of remdesivir: How should the world respond?

The race to find an effective treatment for coronavirus disease 2019 (COVID-19) is still on, with only two treatment options currently authorized for emergency use and/or recommended for patients hospitalized with severe respiratory symptoms: low-dose dexamethasone and remdesivir. The USA decision to stockpile the latter has resulted in widespread condemnation and in similar action being taken by some other countries. In this commentary we discuss whether stockpiling remdesivir is justified in light of the currently available evidence.

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 All countries remain at high risk of re-importation depending on the level of the containment of the types vaccine withdrawn, the laboratory poliovirus isolates, and the population immunity induced by the vaccination program.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.

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.

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.

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.

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.

Personal medication preparedness among veteran and nonveteran men and women in the California population.

INTRODUCTION: The health of people with chronic medical conditions is particularly vulnerable to the disruptions caused by public health disasters, especially when there is massive damage to the medical infrastructure. Government agencies and national organizations recommend that people with chronic illness prepare for disasters by stockpiling extra supplies of medications. PROBLEM: A wide range of chronic illnesses has long been documented among veterans of the US armed forces. Veterans with chronic illness could be at great risk of complications due to disaster-related medication disruptions; however, the prevalence of personal medication preparedness among chronically ill veterans is not currently known. METHODS: Data was used from the 2009 California Health Interview Survey on 28,167 respondents who reported taking daily medications. After adjusting for differences in age, health status, and other characteristics, calculations were made of the percentage of respondents who had a two-week supply of emergency medications and, among respondents without a supply, the percentage who said they could obtain one. Veteran men, veteran women, nonveteran men, and nonveteran women were compared. RESULTS: Medication supplies among veteran men (81.9%) were higher than among nonveteran women (74.8%; P < .0001) and veteran women (81.1%; P = 0.014). Among respondents without medication supplies, 67.2% of nonveteran men said that they could obtain a two-week supply, compared with 60.1% of nonveteran women (P = .012). Discussion Among adults in California with chronic illness, veteran men are more likely to have personal emergency medication supplies than are veteran and nonveteran women. Veteran men may be more likely to be prepared because of their training to work in combat zones and other emergency situations, which perhaps engenders in them a culture of preparedness or self-reliance. It is also possible that people who choose to enlist in the military are different from the general population in ways that make them more likely to be better prepared for emergencies. CONCLUSION: Veterans in California have a relatively high level of emergency medication preparedness. Given the health complications that can result from disaster-related medication disruptions, this is a promising finding. Disasters are a national concern, however, and the personal preparedness of veterans in all parts of the nation should be assessed; these findings could serve as a useful reference point for such work in the future.

Oseltamivir storage, distribution and dispensing following the 2009 H1N1 influenza outbreak in Mexico.

PROBLEM: During an influenza outbreak or pandemic, timely access to antivirals is essential to reduce disease severity and transmission. Best practices in antiviral procurement, storage, distribution, prescription and dispensing must be followed for prompt drug delivery. APPROACH: Mexico implemented a national pandemic preparedness plan in 2006 and created a strategic antiviral stockpile. Oseltamivir powder was stored centrally in bulk for distribution to all 31 states and the capital district during an influenza outbreak. LOCAL SETTING: San Luis Potosí, in northern Mexico, was one of the states most intensely affected by the 2009 H1N1 influenza outbreak. RELEVANT CHANGES: The oseltamivir powder was meant to be reconstituted locally but had to be reconstituted centrally during the 2009 influenza outbreak. Doubts arose surrounding the shelf-life of the reconstituted product. As a result of these problems, the first supply of the drug reached San Luis Potosí 11 days after the influenza outbreak had begun. Furthermore, dispensing criteria at the state level had to be changed in conformity with the availability of oseltamivir. LESSONS LEARNT: Antiviral demand forecasts should be based on clearly defined distribution and dispensing criteria and decentralization of some of the medication stockpile should be considered. Mexico's national pandemic preparedness plan needs to be updated in accordance with the lessons learnt in 2009 to improve strategic stockpile management and ensure rapid delivery of oseltamivir to the population.