The Coronavirus disease 19 (COVID-19) pandemic has disrupted both transportation and health systems. While about 40% of Americans have delayed seeking medical care during the pandemic, it remains unclear to what extent transportation is contributing to missed care. To understand the relationship between transportation and unmet health care needs during the pandemic, this paper synthesizes existing knowledge on transportation patterns and barriers across five types of health care needs. While the literature is limited by the absence of detailed data for trips to health care, key themes emerged across populations and settings. We find that some patients, many of whom already experience transportation disadvantage, likely need extra support during the pandemic to overcome new travel barriers related to changes in public transit or the inability to rely on others for rides. Telemedicine is working as a partial substitute for some visits but cannot fulfill all health care needs, especially for vulnerable groups. Structural inequality during the pandemic has likely compounded health care access barriers for low-income individuals and people of color, who face not only disproportionate health risks, but also greater difficulty in transportation access and heightened economic hardship due to COVID-19. Partnerships between health and transportation systems hold promise for jointly addressing disparities in health- and transportation-related challenges but are largely limited to Medicaid-enrolled patients. Our findings suggest that transportation and health care providers should look for additional strategies to ensure that transportation access is not a reason for delayed medical care during and after the COVID-19 pandemic.
IMPORTANCE Transmucosal immediate-release fentanyls (TIRFs), indicated solely for breakthrough cancer pain in opioid-tolerant patients, are subject to a US Food and Drug Administration (FDA) Risk Evaluation and Mitigation Strategy (REMS) to prevent them from being prescribed inappropriately. OBJECTIVES To evaluate knowledge assessments of pharmacists, prescribers, and patients regarding appropriate TIRF use; to describe sponsor assessments, based on claims data, of whether the REMS program was meeting its goals; and to characterize how the FDA responded to REMS assessments. DESIGN, SETTING, AND PARTICIPANTS Qualitative analysis of 4877 pages of FDA documents obtained through a Freedom of Information Act request, including 6 annual REMS assessment reports (2012-2017), FDA evaluations of these reports, and FDA-sponsor correspondence about safety issues. EXPOSURE A REMS program to reduce the risk of adverse outcomes, including misuse, abuse, addiction, and overdose, arising from use of TIRFs. MAIN OUTCOMES AND MEASURES (1) Knowledge assessments of pharmacists, prescribers, and patients; (2) survey and claims-based prescribing assessments; (3) FDA and TIRF sponsor communications; (4) modifications to the REMS program; and (5) disenrollment of noncompliant prescribers. RESULTS Twelve months after initiation of the program, 24 of 302 pharmacists (7.9%), 35 of 302 prescribers (11.6%), and 5 of 192 patients (2.6%) incorrectly reported that TIRFs can be prescribed to opioid-nontolerant patients, with similar levels of misunderstanding maintained in the subsequent reports. At 60 months, product-specific analyses of claims data indicated that between 34.6% and 55.4% of patients prescribed TIRFs were opioid-nontolerant. In the 48-month survey, 106 of 310 prescribers (34.2%) reported prescribing TIRFs for opioid-tolerant patients with chronic, noncancer pain; at 60 months, 54 of 302 prescribers (18.4%) and 148 of 310 patients (47.7%) erroneously reported that TIRFs were FDA-approved for such use. Over the 60-month period examined, there were few substantive changes made to the REMS to address evidence of high rates of off-label TIRF use, and, although the REMS program had a noncompliance plan, there was no report of prescribers being disenrolled for inappropriate prescribing. CONCLUSIONS AND RELEVANCE In this review of FDA documents pertaining to the TIRF REMS, surveys of pharmacists, prescribers, and patients reflected generally high levels of knowledge regarding proper TIRF prescribing, yet some survey items as well as claims-based analyses indicated substantial rates of inappropriate TIRF use. Despite these findings, the FDA did not require substantive changes to the program.
Background Public health emergencies may significantly impact emergency medical services responses to cardiovascular emergencies. We compared emergency medical services responses to out‐of‐hospital cardiac arrest (OHCA) and ST‐segment‒elevation myocardial infarction (STEMI) during the 2020 COVID‐19 pandemic to 2018 to 2019 and evaluated the impact of California's March 19, 2020 stay‐at‐home order. Methods and Results We conducted a population‐based cross‐sectional study using Los Angeles County emergency medical services registry data for adult patients with paramedic provider impression (PI) of OHCA or STEMI from February through May in 2018 to 2020. After March 19, 2020, weekly counts for PI‐OHCA were higher (173 versus 135; incidence rate ratios, 1.28; 95% CI, 1.19‒1.37; P <0.001) while PI‐STEMI were lower (57 versus 65; incidence rate ratios, 0.87; 95% CI, 0.78‒0.97; P =0.02) compared with 2018 and 2019. After adjusting for seasonal variation in PI‐OHCA and decreased PI‐STEMI, the increase in PI‐OHCA observed after March 19, 2020 remained significant ( P =0.02). The proportion of PI‐OHCA who received defibrillation (16% versus 23%; risk difference [RD], −6.91%; 95% CI, −9.55% to −4.26%; P <0.001) and had return of spontaneous circulation (17% versus 29%; RD, −11.98%; 95% CI, −14.76% to −9.18%; P <0.001) were lower after March 19 in 2020 compared with 2018 and 2019. There was also a significant increase in dead on arrival emergency medical services responses in 2020 compared with 2018 and 2019, starting around the time of the stay‐at‐home order ( P <0.001). Conclusions Paramedics in Los Angeles County, CA responded to increased PI‐OHCA and decreased PI‐STEMI following the stay‐at‐home order. The increased PI‐OHCA was not fully explained by the reduction in PI‐STEMI. Field defibrillation and return of spontaneous circulation were lower. It is critical that public health messaging stress that emergency care should not be delayed.
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