Drug Shortages Prior to and During the COVID-19 Pandemic.

Importance: Drug 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. Objective: To estimate the proportion of supply chain issue reports associated with drug shortages overall and with the COVID-19 pandemic. Design, Setting, and Participants: This 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. Exposure: Presence 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 Measures: The 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). Results: A 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 Relevance: In 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.

Puff Bars, Tobacco Policy Evasion, and Nicotine Dependence: Content Analysis of Tweets.

BACKGROUND: Puff Bars are e-cigarettes that continued marketing flavored products by exploiting the US Food and Drug Administration exemption for disposable devices. OBJECTIVE: This study aimed to examine discussions related to Puff Bar on Twitter to identify tobacco regulation and policy themes as well as unanticipated outcomes of regulatory loopholes. METHODS: Of 8519 original tweets related to Puff Bar collected from July 13, 2020, to August 13, 2020, a random 20% subsample (n=2661) was selected for qualitative coding of topics related to nicotine dependence and tobacco policy. RESULTS: Of the human-coded tweets, 2123 (80.2%) were coded as relevant to Puff Bar as the main topic. Of those tweets, 698 (32.9%) discussed tobacco policy, including flavors (n=320, 45.9%), regulations (n=124, 17.8%), purchases (n=117, 16.8%), and other products (n=110, 15.8%). Approximately 22% (n=480) of the tweets referenced dependence, including lack of access (n=273, 56.9%), appetite suppression (n=59, 12.3%), frequent use (n=47, 9.8%), and self-reported dependence (n=110, 22.9%). CONCLUSIONS: This study adds to the growing evidence base that the US Food and Drug Administration ban of e-cigarette flavors did not reduce interest, but rather shifted the discussion to brands utilizing a loophole that allowed flavored products to continue to be sold in disposable devices. Until comprehensive tobacco policy legislation is developed, new products or loopholes will continue to supply nicotine demand.

Effective Care Practices in Patients Receiving Prolonged Mechanical Ventilation. An Ethnographic Study.

Rationale: Patients receiving prolonged mechanical ventilation experience low survival rates and incur high healthcare costs. However, little is known about how to optimally organize and manage their care.Objectives: To identify a set of effective care practices for patients receiving prolonged mechanical ventilation.Methods: We performed a focused ethnographic evaluation at eight long-term acute care hospitals in the United States ranking in either the lowest or highest quartile of risk-adjusted mortality in at least four of the five years between 2007 and 2011.Measurements and Main Results: We conducted 329 hours of direct observation, 196 interviews, and 39 episodes of job shadowing. Data were analyzed using thematic content analysis and a positive-negative deviance approach. We found that high- and low-performing hospitals differed substantially in their approach to care. High-performing hospitals actively promoted interdisciplinary communication and coordination using a range of organizational practices, including factors related to leadership (e.g., leaders who communicate a culture of quality improvement), staffing (e.g., lower nurse-to-patient ratios and ready availability of psychologists and spiritual care providers), care protocols (e.g., specific yet flexible respiratory therapy-driven weaning protocols), team meetings (e.g., interdisciplinary meetings that include direct care providers), and the physical plant (e.g., large workstations that allow groups to interact). These practices were believed to facilitate care that is simultaneously goal directed and responsive to individual patient needs, leading to more successful liberation from mechanical ventilation and improved survival.Conclusions: High-performing long-term acute care hospitals employ several organizational practices that may be helpful in improving care for patients receiving prolonged mechanical ventilation.

Determinants of Intensive Care Unit Telemedicine Effectiveness. An Ethnographic Study.

RATIONALE: Telemedicine is an increasingly common care delivery strategy in the ICU. However, ICU telemedicine programs vary widely in their clinical effectiveness, with some studies showing a large mortality benefit and others showing no benefit or even harm. OBJECTIVES: To identify the organizational factors associated with ICU telemedicine effectiveness. METHODS: We performed a focused ethnographic evaluation of 10 ICU telemedicine programs using site visits, interviews, and focus groups in both facilities providing remote care and the target ICUs. Programs were selected based on their change in risk-adjusted mortality after adoption (decreased mortality, no change in mortality, and increased mortality). We used a constant comparative approach to guide data collection and analysis. MEASUREMENTS AND MAIN RESULTS: We conducted 460 hours of direct observation, 222 interviews, and 18 focus groups across six telemedicine facilities and 10 target ICUs. Data analysis revealed three domains that influence ICU telemedicine effectiveness: 1) leadership (i.e., the decisions related to the role of the telemedicine, conflict resolution, and relationship building), 2) perceived value (i.e., expectations of availability and impact, staff satisfaction, and understanding of operations), and 3) organizational characteristics (i.e., staffing models, allowed involvement of the telemedicine unit, and new hire orientation). In the most effective telemedicine programs these factors led to services that are viewed as appropriate, integrated, responsive, and consistent. CONCLUSIONS: The effectiveness of ICU telemedicine programs may be influenced by several potentially modifiable factors within the domains of leadership, perceived value, and organizational structure.

Identifying Strategies for Effective Telemedicine Use in Intensive Care Units: The ConnECCT Study Protocol.

Telemedicine, the use of audiovisual technology to provide health care from a remote location, is increasingly used in intensive care units (ICUs). However, studies evaluating the impact of ICU telemedicine show mixed results, with some studies demonstrating improved patient outcomes, while others show limited benefit or even harm. Little is known about the mechanisms that influence variation in ICU telemedicine effectiveness, leaving providers without guidance on how to best use this potentially transformative technology. The Contributors to Effective Critical Care Telemedicine (ConnECCT) study aims to fill this knowledge gap by identifying the clinical and organizational factors associated with variation in ICU telemedicine effectiveness, as well as exploring the clinical contexts and provider perceptions of ICU telemedicine use and its impact on patient outcomes, using a range of qualitative methods. In this report, we describe the study protocol, data collection methods, and planned future analyses of the ConnECCT study. Over the course of 1 year, the study team visited purposefully sampled health systems across the United States that have adopted telemedicine. Data collection methods included direct observations, interviews, focus groups, and artifact collection. Data were collected at the ICUs that provide in-person critical care as well as at the supporting telemedicine units. Iterative thematic content analysis will be used to identify and define key constructs related to telemedicine effectiveness and describe the relationship between them. Ultimately, the study results will provide a framework for more effective implementation of ICU telemedicine, leading to improved clinical outcomes for critically ill patients.

School closure as an influenza mitigation strategy: how variations in legal authority and plan criteria can alter the impact.

BACKGROUND: States' pandemic influenza plans and school closure statutes are intended to guide state and local officials, but most faced a great deal of uncertainty during the 2009 influenza H1N1 epidemic. Questions remained about whether, when, and for how long to close schools and about which agencies and officials had legal authority over school closures. METHODS: This study began with analysis of states' school-closure statutes and pandemic influenza plans to identify the variations among them. An agent-based model of one state was used to represent as constants a population's demographics, commuting patterns, work and school attendance, and community mixing patterns while repeated simulations explored the effects of variations in school closure authority, duration, closure thresholds, and reopening criteria. RESULTS: The results show no basis on which to justify statewide rather than school-specific or community-specific authority for school closures. Nor do these simulations offer evidence to require school closures promptly at the earliest stage of an epidemic. More important are criteria based on monitoring of local case incidence and on authority to sustain closure periods sufficiently to achieve epidemic mitigation. CONCLUSIONS: This agent-based simulation suggests several ways to improve statutes and influenza plans. First, school closure should remain available to state and local authorities as an influenza mitigation strategy. Second, influenza plans need not necessarily specify the threshold for school closures but should clearly define provisions for early and ongoing local monitoring. Finally, school closure authority may be exercised at the statewide or local level, so long as decisions are informed by monitoring incidence in local communities and schools.