Preparing for COVID-19-related Drug Shortages.
Ontology highlight
ABSTRACT:
SUBMITTER: Shuman AG
PROVIDER: S-EPMC7393783 | biostudies-literature | 2020 Aug
REPOSITORIES: biostudies-literature
Publications
Preparing for COVID-19-related Drug Shortages.
Shuman Andrew G AG Fox Erin E Unguru Yoram Y
Annals of the American Thoracic Society 20200801 8
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Project description:ImportanceDrug shortages are a chronic and worsening issue that compromises patient safety. Despite the destabilizing impact of the COVID-19 pandemic on pharmaceutical production, it remains unclear whether issues affecting the drug supply chain were more likely to result in meaningful shortages during the pandemic.ObjectiveTo estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic.Design, setting, and participantsThis longitudinal cross-sectional study used data from the IQVIA Multinational Integrated Data Analysis database, comprising more than 85% of drug purchases by US pharmacies from wholesalers and manufacturers, from 2017 to 2021. Data were analyzed from January to May 2023.ExposurePresence of a supply chain issue report to the US Food and Drug Administration or the American Society of Health-Systems Pharmacists (ASHP).Main outcomes and measuresThe main outcome was drug shortage, defined as at least 33% decrease in units purchased within 6 months of a supply chain issue report. Random-effects logistic regression models compared the marginal odds of shortages for drugs with vs without reports. Interaction terms assessed heterogeneity prior to vs during the COVID-19 pandemic and by drug characteristics (formulation, age, essential medicine status, clinician- vs self-administered, sales volume, and number of manufacturers).ResultsA total of 571 drugs exposed to 731 supply chain issue reports were matched to 7296 comparison medications with no reports. After adjusting for drug characteristics, 13.7% (95% CI, 10.4%-17.8%) of supply chain issue reports were associated with subsequent drug shortages vs 4.1% (95% CI, 3.6%-4.8%) of comparators (marginal odds ratio [mOR], 3.7 [95% CI, 2.6-5.1]). Shortages increased among both drugs with and without reports in February to April 2020 (34.2% of drugs with supply chain issue reports and 9.5% of comparison drugs; mOR, 4.9 [95% CI, 2.1-11.6]), and then decreased after May 2020 (9.8% of drugs with reports and 3.6% of comparison drugs; mOR, 2.9 [95% CI, 1.6-5.3]). Significant associations were identified by formulation (parenteral mOR, 1.9 [95% CI, 1.1-3.2] vs oral mOR, 5.4 [95% CI, 3.3-8.8]; P for interaction = .008), WHO essential medicine status (essential mOR, 2.2 [95% CI, 1.3-5.2] vs nonessential mOR, 4.6 [95% CI, 3.2-6.7]; P = .02), and for brand-name vs generic status (brand-name mOR, 8.1 [95% CI, 4.0-16.0] vs generic mOR, 2.4 [95% CI, 1.7-3.6]; P = .002).Conclusions and relevanceIn this national cross-sectional study, supply chain issues associated with drug shortages increased at the beginning of the COVID-19 pandemic. Ongoing policy work is needed to protect US drug supplies from future shocks and to prioritize clinically valuable drugs at greatest shortage risk.
| S-EPMC10998160 | biostudies-literature
Project description:Coronavirus disease 2019 (COVID-19) arising from Wuhan, China, is currently outbreaking worldwide. The World Health Organization (WHO) has declared COVID-19 to be a global pandemic. COVID-19 could cause a wide range of symptoms ranging from self-limiting fever, sore throat, and cough to more severe symptoms that could lead to acute respiratory distress syndrome. As a result of the lockdown and increased demand, drug shortages could become a growing global issue. This article aims to shed light on the potential impact of drug shortages as a result of this pandemic on patient outcomes and the role of pharmacists and pharmacy policymakers in alleviating this emerging problem.
| S-EPMC7235598 | biostudies-literature
Project description:The Coronavirus disease 2019 (COVID-19) pandemic caused by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) has resulted in economic and social lockdowns in most countries all over the globe. Early identification of infected individuals is regarded as one of the most important prerequisites for fighting the pandemic and for returning to a 'New Normal'. Large-scale testing is therefore crucial, but is facing several challenges including shortage of sample collection tools and of molecular biological reagents, and the need for safe electronic communication of medical reports. We present the successful establishment of a holistic SARS-CoV-2 testing platform that covers proband registration, sample collection and shipment, sample testing, and report issuing. The RT-PCR-based virus detection, being central to the platform, was extensively validated: sensitivity and specificity were defined as 96.8% and 100%, respectively; intra-run and inter-run precision were <3%. A novel type of sample swab and an in-house-developed RNA extraction system were shown to perform as good as commercially available products. The resulting flexibility guarantees independence from the current bottlenecks in SARS-CoV-2 testing. Based on our technology, we offered testing at local, national, and global levels. In the present study, we report the results from approx. 18,000 SARS-CoV-2 tests in almost 10,000 individuals from a low-frequency SARS-CoV-2 pandemic area in a homogenous geographical region in north-eastern Germany for a period of 10 weeks (21 March to 31 May 2020). Among the probands, five SARS-CoV-2 positive cases were identified. Comparative analysis of corresponding virus genomes revealed a diverse origin from three of the five currently recognized SARS-CoV-2 phylogenetic clades. Our study exemplifies how preventive SARS-CoV-2 testing can be set up in a rapid and flexible manner. The application of our test has enabled a safe maintenance/resume of critical local infrastructure, e.g., nursing homes where more than 5000 elderlies and caretakers got tested. The strategy outlined by the present study may serve as a blueprint for the implementation of large-scale preventive SARS-CoV-2 testing elsewhere.
| S-EPMC7399816 | biostudies-literature
Project description: Not available
| S-EPMC7274639 | biostudies-literature
Project description: Not available
| S-EPMC2790674 | biostudies-literature
Project description:PurposeThere have been numerous reports of shortages of injectable drugs for cancer in the last decade. We assessed physician experiences with drug shortages in a population-based cohort of medical oncologists caring for patients with lung or colorectal cancer.MethodsWe surveyed medical oncologists caring for patients with lung or colorectal cancer in the Cancer Care Outcomes Research and Surveillance Consortium from 2012 to 2013 (participation rate, 53%). Oncologists reported experiences with shortages of leucovorin, fluorouracil, dexamethasone, cyanocobalamin, paclitaxel, cisplatin, and etoposide in the prior year and whether they had used a less-effective alternative because of a shortage. We used multivariable logistic regression to assess for associations between physician or practice characteristics and encountering shortages.ResultsAmong 330 respondents, 74% reported experiences with a shortage of at least one drug in our survey, and 28% reported using a less-effective alternative because of a shortage. Although physician demographic characteristics did not predict reports of drug shortages, practice characteristics did. Veterans Affairs (VA) oncologists were less likely to report experiencing any shortage than oncologists in single-specialty group practice (odds ratio [OR], 0.4; 95% CI, 0.2 to 0.9). The reported use of a less effective alternative to any drug was also less common among VA oncologists (OR, 0.3; 95% CI, 0.1 to 0.9) and oncologists affiliated with health maintenance organizations (OR, 0.4; 95% CI, 0.2 to 0.9) compared with physicians in single-specialty groups.ConclusionMost oncologists encountered drug shortages in the year before our survey, but experiences with shortages varied with practice structure. Further research is needed to quantitatively assess the impact of drug shortages on patients and evaluate various strategies for managing them.
| S-EPMC4371121 | biostudies-literature
Project description: Not available
| S-EPMC7401308 | biostudies-literature
Project description:This study investigates the forces that contributed to severe shortages in personal protective equipment in the US during the COVID-19 crisis. Problems from a dysfunctional costing model in hospital operating systems were magnified by a very large demand shock triggered by acute need in healthcare and panicked marketplace behavior that depleted domestic PPE inventories. The lack of effective action on the part of the federal government to maintain and distribute domestic inventories, as well as severe disruptions to the PPE global supply chain, amplified the problem. Analysis of trade data shows that the US is the world's largest importer of face masks, eye protection, and medical gloves, making it highly vulnerable to disruptions in exports of medical supplies. We conclude that market prices are not appropriate mechanisms for rationing inputs to health because health is a public good. Removing the profit motive for purchasing PPE in hospital costing models, strengthening government capacity to maintain and distribute stockpiles, developing and enforcing regulations, and pursuing strategic industrial policy to reduce US dependence on imported PPE will help to better protect healthcare workers with adequate supplies of PPE.
| S-EPMC7531934 | biostudies-literature
Project description:The COVID-19 outbreak put healthcare systems across the globe under immense pressure to meet the unprecedented demand for critical supplies and personal protective equipment (PPE). The traditional cost-effective supply chain paradigm failed to respond to the increased demand, putting healthcare workers (HCW) at a much higher infection risk relative to the general population. Recognizing PPE shortages and high infection risk for HCWs, the World Health Organization (WHO) recommends allocations based on ethical principles. In this paper, we model the infection risk for HCWs as a function of usage and use it as the basis for distribution planning that balances government procurement decisions, hospitals' PPE usage policies, and WHO ethical allocation guidelines. We propose an infection risk model that integrates PPE allocation decisions with disease progression estimates to quantify infection risk among HCWs. The proposed risk function is used to derive closed-form allocation decisions under WHO ethical guidelines in both deterministic and stochastic settings. The modelling is then extended to dynamic distribution planning. Although nonlinear, we reformulate the resulting model to make it solvable using off-the-shelf software. The risk function successfully accounts for virus prevalence in space and in time and leads to allocations that are sensitive to the differences between regions. Comparative analysis shows that the allocation policies lead to significantly different levels of infection risk, especially under high virus prevalence. The best-outcome allocation policy that aims to minimize the total infected cases outperforms other policies under this objective and that of minimizing the maximum number of infections per period.
| S-EPMC10091728 | biostudies-literature
Project description:(1) Background: The COVID-19 pandemic provided a unique opportunity to investigate how moral reasoning is influenced by individuals' exposure to a crisis and by personal, societal and temporal proximity. We examined how Italians and Germans judged different behaviors that arose because of the pandemic, which affected health and societal matters. (2) Methods: Over the course of four months and three assessment periods, we used an observational online survey to assess participants' judgments regarding seven scenarios that addressed distributive shortages during the pandemic. (3) Results: Overall, there was no clear answering pattern across all scenarios. For a variation of triage and pandemic restrictions, most participants selected a mean value, which can be interpreted as deferring the choice. For the other scenarios, most participants used the extremes of the scale, thereby reflecting a clear opinion of the public regarding the moral issue. In addition, moral reasoning varied across the two countries, assessment periods, fear, and age. (4) Conclusions: By using scenarios that were taken from real-life experiences, the current study addresses criticism that moral research mostly relies on unrealistic scenarios that lack in external validity, plausibility, and proximity to everyday situations. In addition, it shows how lay people regard measures of public health and societal decision-making.
| S-EPMC9566015 | biostudies-literature