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Quantifying the persisting orphan-drug shortage public health crisis in the United States.

ABSTRACT: Background: Orphan drugs (ODs) are pharmaceuticals manufactured for rare conditions that affect less than 200,000 people in the US. ODs are therefore produced in small quantities to meet sparse demand. Since 2010, OD shortages have become frequent, but no comprehensive, quantitative studies exist. Objective: The objective of this study is to assess the rates of OD shortages per therapeutic class and their trends over time in the United States. Study design: OD approvals were collected from publicly available information on the US Food and Drug Administration (FDA) website on 13 June 2016. Data on OD shortages were collected from the FDA and the American Society of Health-System Pharmacists (ASHP) websites. We reviewed the number of shortages per year and per therapeutic area. Multiple indications for the same drug were counted individually. Results: Of 569 ODs approved, 50% were approved in the decade ending in 2015. Oncology was found to be the most represented therapeutic area (34% of all OD approvals), followed by endocrinology (11%). Shortage data were available from 2008. In total, there were 66 (12%) OD shortages, with an average shortage duration of 455.5 days. Shortages were observed mainly for oncology products (19 cases, 13% of oncology ODs) and endocrinology products (14 cases, 22% of endocrinology ODs) Conclusion: Despite the FDA strategic plan for preventing and mitigating drug shortages (October 2013), remaining OD shortages still pose an enduring challenge to patient care, with a median shortage duration of almost 15 months. In many instances, ODs are the only available therapy for rare diseases, and OD shortages can lead to serious health deterioration and death. More research is needed to elucidate the causes of shortages and their impact on patients' health.

SUBMITTER: Jaroslawski S

PROVIDER: S-EPMC5560412 | biostudies-other | 2017

REPOSITORIES: biostudies-other

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Project description:To assess spatial accessibility measures to on-premise alcohol outlets at census block, census tract, county, and state levels for the United States.Using network analysis in a geographic information system, we computed distance-based measures (Euclidean distance, driving distance, and driving time) to on-premise alcohol outlets for the entire U.S. at the census block level. We then calculated spatial access-based measures, specifically a population-weighted spatial accessibility index and population-weighted distances (Euclidean distance, driving distance, and driving time) to alcohol outlets at the census tract, county, and state levels. A multilevel model-based sensitivity analysis was conducted to evaluate the associations between different on-premise alcohol outlet accessibility measures and excessive drinking outcomes.The national average population-weighted driving time to the nearest 7 on-premise alcohol outlets was 5.89 min, and the average population-weighted driving distance was 2.63 miles. At the state level, population-weighted driving times ranged from 1.67 min (DC) to 15.29 min (Arizona). Population-weighted driving distances ranged from 0.67 miles (DC) to 7.91 miles (Arkansas). At the county level, population-weighted driving times and distances exhibited significant geographic variations, and averages for both measures increased by the degree of county rurality. The population-weighted spatial accessibility indexes were highly correlated to respective population-weighted distance measures. Sensitivity analysis demonstrated that population weighted accessibility measures were more sensitive to excessive drinking outcomes than were population weighted distance measures.These results can be used to assess the relationship between geographic access to on-premise alcohol outlets and health outcomes. This study demonstrates a flexible and robust method that can be applied or modified to quantify spatial accessibility to public resources such as healthy food stores, medical care providers, and parks and greenspaces, as well as, quantify spatial exposure to local adverse environments such as tobacco stores and fast food restaurants.

Project description:The United States imports a large volume of live wild and domestic animal species; these animals pose a demonstrated risk for introduction of zoonotic diseases. Rodents are imported for multiple purposes, including scientific research, zoo exhibits and the pet trade. Current U.S. public health regulatory restrictions specific to rodent importation pertain only to those of African origin. To understand the impacts of these regulations and the potential public health risks of international rodent trade to the United States, we evaluated live rodent import records during 1999-2013 by shipment volume and geographic origin, source (e.g. wild-caught versus captive- or commercially bred), intended purpose and rodent taxonomy. Live rodent imports increased from 2737 animals during 1999 to 173 761 animals during 2013. Increases in both the number and size of shipments contributed to this trend. The proportion of wild-captured imports declined from 75% during 1999 to <1% during 2013. Nearly all shipments during these years were imported for commercial purposes. Imports from Europe and other countries in North America experienced notable increases in volume. Gerbils and hamsters arriving from Europe and chinchillas, guinea pigs and hamsters arriving from other countries in North America were predominant taxa underlying this trend. After 2003, African-origin imports became sporadic events under the federal permit process. These patterns suggest development of large-scale captive rodent breeding markets abroad for commercial sale in the United States. While the shift from wild-captured imports alleviates many conservation concerns and risks for novel disease emergence, such consolidated sourcing might elevate exposure risks for zoonotic diseases associated with high-density rodent breeding (e.g. lymphocytic choriomeningitis or salmonellosis). A responsive border health system must periodically re-evaluate importation regulations in conjunction with key stakeholders to ensure a balance between the economic benefits of rodent trade against the potential public health risks.

Project description:BackgroundSuicides by any method, plus 'nonsuicide' fatalities from drug self-intoxication (estimated from selected forensically undetermined and 'accidental' deaths), together represent self-injury mortality (SIM)-fatalities due to mental disorders or distress. SIM is especially important to examine given frequent undercounting of suicides amongst drug overdose deaths. We report suicide and SIM trends in the United States of America (US) during 1999-2018, portray interstate rate trends, and examine spatiotemporal (spacetime) diffusion or spread of the drug self-intoxication component of SIM, with attention to potential for differential suicide misclassification.MethodsFor this state-based, cross-sectional, panel time series, we used de-identified manner and underlying cause-of-death data for the 50 states and District of Columbia (DC) from CDC's Wide-ranging Online Data for Epidemiologic Research. Procedures comprised joinpoint regression to describe national trends; Spearman's rank-order correlation coefficient to assess interstate SIM and suicide rate congruence; and spacetime hierarchical modelling of the 'nonsuicide' SIM component.FindingsThe national annual average percentage change over the observation period in the SIM rate was 4.3% (95% CI: 3.3%, 5.4%; p<0.001) versus 1.8% (95% CI: 1.6%, 2.0%; p<0.001) for the suicide rate. By 2017/2018, all states except Nebraska (19.9) posted a SIM rate of at least 21.0 deaths per 100,000 population-the floor of the rate range for the top 5 ranking states in 1999/2000. The rank-order correlation coefficient for SIM and suicide rates was 0.82 (p<0.001) in 1999/2000 versus 0.34 (p = 0.02) by 2017/2018. Seven states in the West posted a ≥ 5.0% reduction in their standardised mortality ratios of 'nonsuicide' drug fatalities, relative to the national ratio, and 6 states from the other 3 major regions a >6.0% increase (p<0.05).InterpretationDepiction of rising SIM trends across states and major regions unmasks a burgeoning national mental health crisis. Geographic variation is plausibly a partial product of local heterogeneity in toxic drug availability and the quality of medicolegal death investigations. Like COVID-19, the nation will only be able to prevent SIM by responding with collective, comprehensive, systemic approaches. Injury surveillance and prevention, mental health, and societal well-being are poorly served by the continuing segregation of substance use disorders from other mental disorders in clinical medicine and public health practice.FundingThis study was partially funded by the National Centre for Injury Prevention and Control, US Centers for Disease Control and Prevention (R49CE002093) and the US National Institute on Drug Abuse (1UM1DA049412-01; 1R21DA046521-01A1).

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Quantifying the persisting orphan-drug shortage public health crisis in the United States.

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