Developing Prioritization Criteria to Identify Target Drugs for CalRx, the California Generic Drugs Initiative.

OBJECTIVES: This study aimed to establish criteria to identify priority drugs for CalRx, a California-sponsored initiative to support the manufacture and distribution of affordable generic drugs. METHODS: A web-based ranking exercise was implemented with key stakeholders in August 2020, using pricing, spending, and public health criteria identified through a review of academic literature and public health agency reports. A total of 39 of 40 invited stakeholders in 4 different categories-patient advocates, healthcare providers, health insurers, and health policy and economic experts-participated in this study (98% response rate). RESULTS: Drugs that treat large populations, drugs that represent high cost to payors, and drugs that represent high cost to consumers were ranked a priority, receiving > 10% of ranking weights. Drugs that treat conditions with high morbidity or mortality, drugs without therapeutic alternatives, and drugs treating vulnerable populations represented criteria of further interest (9%-10% of weights). Shortage risk and curative effect (8%-9% of the weights), high price increases, communicable disease treatments, and high unit prices (< 8% of the weights) represented the bottom of the priority distribution. CONCLUSIONS: This study suggests that drugs that treat large populations, drugs that represent large costs to payors, and drugs that represent large costs to consumers should be the priority for California's CalRx generic drug initiative. A prioritizing algorithm will assist California in determining top drugs to target from a public health and spending perspective as it plans the rollout of the CalRx initiative and negotiates with drug manufacturers.

Reporting of Infectious Diseases in the United States During the Coronavirus Disease 2019 (COVID-19) Pandemic.

Reporting of infectious diseases other than COVID-19 has been greatly decreased throughout the COVID-19 pandemic. We find this decrease varies by routes of transmission, reporting state, and COVID-19 incidence at the time of reporting. These results underscore the need for continual investment in routine surveillance efforts despite pandemic conditions.

Histovariability in human clavicular cortical bone microstructure and its mechanical implications.

The human clavicle (i.e. collarbone) is an unusual long bone due to its signature S-shaped curve and variability in macrostructure observed between individuals. Because of the complex nature of how the upper limb moves, as well as due to its complex musculoskeletal arrangement, the biomechanics, in particular the mechanical loadings, of the clavicle are not fully understood. Given that bone remodeling can be influenced by bone stress, the histologic organization of Haversian bone offers a hypothesis of responses to force distributions experienced across a bone. Furthermore, circularly polarized light microscopy can be used to determine the orientation of collagen fibers, providing additional information on how bone matrix might organize to adapt to direction of external loads. We examined Haversian density and collagen fiber orientation, along with cross-sectional geometry, to test whether the clavicle midshaft shows unique adaptation to atypical load-bearing when compared with the sternal (medial) and acromial (lateral) shaft regions. Because fractures are most common at the midshaft, we predicted that the cortical bone structure would show both disparities in Haversian remodeling and nonrandomly oriented collagen fibers in the midshaft compared with the sternal and acromial regions. Human clavicles (n = 16) were sampled via thin-sections at the sternal, middle, and acromial ends of the shaft, and paired sample t-tests were employed to evaluate within-individual differences in microstructural or geometric properties. We found that Haversian remodeling is slightly but significantly reduced in the middle of the bone. Analysis of collagen fiber orientation indicated nonrandom fiber orientations that are overbuilt for tensile loads or torsion but are poorly optimized for compressive loads throughout the clavicle. Geometric properties of percent bone area, polar second moment of area, and shape (Imax /Imin ) confirmed the conclusions drawn by existing research on clavicle macrostructure. Our results highlight that mediolateral shape changes might be accompanied by slight changes in Haversian density, but bone matrix organization is predominantly adapted to resisting tensile strains or torsion throughout and may be a major factor in the risk of fracture when experiencing atypical compression.

Global Production of Active Pharmaceutical Ingredients for US Generic Drugs Experiencing Shortages.

This study evaluates the characteristics of generic active pharmaceutical ingredients (APIs) used to manufacture drugs with shortages in the US and facilities producing APIs worldwide.

Mortality Due to Hyperglycemic Crises in the US, 1999-2022.

This study analyzes trends in US mortality attributed to both diabetic ketoacidosis and hyperosmolar hyperglycemic state from 1999-2022.

Mortality Rates Among U.S. Women of Reproductive Age, 1999-2019.

INTRODUCTION: High and increasing levels of pregnancy-related mortality and morbidity in the U.S. indicate that the underlying health status of reproductive-aged women may be far from optimal, yet few studies have examined mortality trends and disparities exclusively among this population. METHODS: All-cause and cause-specific mortality data for 1999-2019 were obtained from the Centers for Disease Control and Prevention WONDER Underlying Cause of Death database. Levels and trends in mortality between 1999 and 2019 for women aged 15-44 years stratified by age, race/ethnicity, and state were examined. Given the urgent need to address pregnancy-related health disparities, the correlation between all-cause and pregnancy-related mortality rates across states for the years 2015-2019 was also examined. RESULTS: Age-adjusted, all-cause mortality rates among women aged 15-44 years improved between 2003 and 2011 but worsened between 2011 and 2019. The recent increase in mortality among this age group was not driven solely by increases in external causes of death. Patterns differed by age, race/ethnicity, and geography, with non-Hispanic American Indian and Alaskan Native women having 2.3 and non-Hispanic Black women having 1.4 times the risk of all-cause mortality in 2019 compared with that of non-Hispanic White women. Age-adjusted all-cause mortality rates and pregnancy-related mortality rates were strongly correlated at the state level (r=0.75). CONCLUSIONS: Increasing mortality among reproductive-aged women has substantial implications for maternal, women's, and children's health. Given the high correlation between pregnancy-related mortality and all-cause mortality at the state level, addressing the structural factors that shape mortality risks may have the greatest likelihood of improving women's health outcomes across the life course.

Stress-Induced (Takotsubo) Cardiomyopathy After Liver Transplant Rescued with Venoarterial Extracorporeal Membrane Oxygenation.

Here, we report the case of a 55 year old male patient without significant preexisting cardiovascular disease who received a deceased donor liver transplant. Intraoperatively, the patient developed cardiogenic shock secondary to stress-induced cardiomyopathy or Takotsubo syndrome (TTS), which was refractory to high-dose vasoactive, inotropic medical therapy. The patient was successfully managed with venoarterial extracorporeal membrane oxygenation (VA-ECMO) for 7 days, with complete recovery of cardiac function and maintenance of the hepatic graft. Given the anticipated need for only a short period of support and the expectation of full myocardial recovery, such patients may represent excellent candidates for the use of VA-ECMO.

Disparities In County COVID-19 Vaccination Rates Linked To Disadvantage And Hesitancy.

We analyzed trends in adult COVID-19 vaccine coverage over time based on COVID-19 vaccine hesitancy and social vulnerability. We found that each of these variables carries an independent association with disparities across counties in COVID-19 vaccine coverage. Counties that score high on both hesitancy and vulnerability are especially likely to have lower COVID-19 vaccination rates compared with the rest of the country.

Association between exenatide use and incidence of Alzheimer's disease.

INTRODUCTION: Recent developments suggest that insulin-sensitizing agents used to treat type II diabetes (T2DM) may also prove useful in reducing the risk of Alzheimer's disease (AD). The objective of this study is to analyze the association between exenatide use among Medicare beneficiaries with T2DM and the incidence of AD. METHODS: We performed a retrospective cohort analysis on claims data from a 20% random sample of Medicare beneficiaries with T2DM from 2007 to 2013 (n = 342,608). We compared rates of incident AD between 2009 and 2013 according to exenatide use in 2007-2008, measured by the number of 30-day-equivalent fills. We adjusted for demographics, comorbidities, and use of other drugs. Unmeasured confounding was assessed with an instrumental variables approach. RESULTS: The sample was mostly female (65%), White (76%), and 74 years old on average. Exenatide users were more likely to be male (38% vs. 35%), White (87% vs. 76%), and younger (by 4.2 years) than non-users. Each additional 30-day-equivalent claim was associated with a 2.4% relative reduction in incidence (odds ratio 0.976; 95% confidence interval 0.963-0.989; P < .001). There was no evidence of unmeasured confounding. DISCUSSION: Exenatide use is associated with a reduced incidence of AD among Medicare beneficiaries aged 65 years or older with T2DM. The association shown in this study warrants consideration by clinicians prescribing insulin sensitizing agents to patients.

Change in Epidemiology of Creutzfeldt-Jakob Disease in the US, 2007-2020.

This cross-sectional study uses Centers for Disease Control and Prevention multiple cause of death data to examine recent US trends in Creutzfeldt-Jakob disease.

False or Misleading Claims in Online Direct-to-Consumer Ketamine Advertising in Maryland.

This cross-sectional study evaluates the prevalence of false or misleading information in online direct-to-consumer advertising for off-label and unapproved ketamine in Maryland.