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1.
Am J Obstet Gynecol ; 231(2): 265.e1-265.e8, 2024 08.
Artículo en Inglés | MEDLINE | ID: mdl-38710272

RESUMEN

BACKGROUND: Workplace microaggressions are a longstanding but understudied problem in the surgical specialties. Microaggressions in health care are linked to negative emotional and physical health outcomes and can contribute to burnout and suboptimal delivery of patient care. They also negatively impact recruitment, retention, and promotion, which often results in attrition. Further attrition at the time of an impending surgical workforce shortage risks compromising the delivery of health care to the diverse US population, and may jeopardize the financial stability of health care organizations. To date, studies on microaggressions have consisted of small focus groups comprising women faculty or trainees at a single institution. To our knowledge, there are no large, multiorganizational, gender-inclusive studies on microaggressions experienced by practicing surgeons. OBJECTIVE: This study aimed to examine the demographic and occupational characteristics of surgeons who do and do not report experiencing workplace microaggressions and whether these experiences would influence a decision to pursue a career in surgery again. STUDY DESIGN: We developed and internally validated a web-based survey to assess surgeon experiences with microaggressions and the associated sequelae. The survey was distributed through a convenience sample of 9 American College of Surgeons online Communities from November 2022 to January 2023. All American College of Surgeons Communities comprised members who had completed residency or fellowship training and had experience in the surgical workforce. The survey contained demographic, occupational, and validated microaggression items. Analyses include descriptive and chi-square statistics, t tests, and bivariable and multivariable logistic regression. RESULTS: The survey was completed by 377 American College of Surgeons members with the following characteristics: working as a surgeon (80.9%), non-Hispanic White (71.8%), general surgeons (71.0%), aged ≥50 years (67.4%), fellowship-trained (61.0%), and women (58.4%). A total of 254 (67.4%) respondents reported experiencing microaggressions. Younger surgeons (P=.002), women (P<.001), and fellowship-trained surgeons (P=.001) were more likely to report experiencing microaggressions than their counterparts. Surgeons working in academic medical centers or health care systems with teaching responsibilities were more likely to experience microaggressions than those in private practice (P<.01). Surgeons currently working as a surgeon or those who are unable to work reported more experience with microaggressions (P=.003). There was no difference in microaggressions experienced among respondents based on surgical specialty, race/ethnicity, or whether the surgeons reported having a disability. In multivariable logistic regression, women had higher odds of experiencing microaggressions compared with men (adjusted odds ratio, 15.9; 95% confidence interval, 7.7-32.8), and surgeons in private practice had significantly lower odds of experiencing microaggressions compared with surgeons in academic medicine (adjusted odds ratio, 0.3; 95% confidence interval, 0.1-0.8) or in health care systems with teaching responsibilities (adjusted odds ratio, 0.2; 95% confidence interval, 0.1-0.6). Among surgeons responding to an online survey, respondents reporting microaggressions were less likely to say that they would choose a career in surgery again (P<.001). CONCLUSION: Surgeons reporting experience with microaggressions represent a diverse range of surgical specialties and subspecialties. With the continued expansion of surgeon gender and race/ethnicity representation, deliberate efforts to address and eliminate workplace microaggressions could have broad implications for improving recruitment and retention of surgeons.


Asunto(s)
Agresión , Cirujanos , Lugar de Trabajo , Humanos , Femenino , Adulto , Cirujanos/estadística & datos numéricos , Masculino , Persona de Mediana Edad , Estados Unidos , Encuestas y Cuestionarios , Selección de Profesión , Sociedades Médicas
4.
Am J Law Med ; 48(2-3): 266-274, 2022 07.
Artículo en Inglés | MEDLINE | ID: mdl-36715257

RESUMEN

The United States has a long and controversial history with abortion that did not end with Roe v. Wade. Almost immediately thereafter, anti-choice politicians commenced a decades-long effort to restrict access to abortion, recently culminating in the Dobbs decision that overturned Roe. One successful attempt to restrict access immediately following Roe was the Hyde Amendment. With more Americans covered by federally funded health insurance than ever, the Hyde Amendment creates an insurmountable barrier to abortion care for those who lack other sources of financing.Despite the impacts of the Hyde Amendment, support for discontinuing the amendment has been weak. For the first time in over forty years, the United States is in a position to change its abortion funding policy. Beyond ending Hyde, the EACH Act has been introduced in Congress to ensure permanent funding for abortion through all federally funded insurance programs. To secure funding for abortion and reduce barriers to access, advocates must press the federal government to pass legislation such as the EACH Act.


Asunto(s)
Aborto Inducido , Reforma de la Atención de Salud , Embarazo , Femenino , Estados Unidos , Humanos , Gobierno Federal , Aborto Legal
5.
Value Health ; 24(2): 182-187, 2021 02.
Artículo en Inglés | MEDLINE | ID: mdl-33518024

RESUMEN

OBJECTIVE: Buprenorphine is an essential medication for the treatment of opioid use disorder (OUD), but studies show it has been underused over the last 2 decades. We sought to evaluate utilization of and spending on buprenorphine formulations in Medicaid and to evaluate the impact of key market and regulatory factors affecting availability of different formulations and generic versions. METHODS: We first identified all buprenorphine formulations approved by the Food and Drug Administration for OUD using Drugs@FDA. We then used National Drug Codes to identify each drug in the Medicaid State Drug Utilization Data and extracted annual utilization rates and spending between 2002 and 2018 by drug and according to whether a brand-name or generic version was dispensed. We compared these trends to market and regulatory factors that affected competition, which we identified through searching the Federal Register, Westlaw, PubMed, and Google News. RESULTS: Brand-name buprenorphine-naloxone sublingual tablet and film formulations (Suboxone) were dispensed 2.7 times more (n = 634 213 140) and reimbursed 4.4 times more (n = $4 440 556 473) than all other formulations combined (n = 237 769 689; $1 018 988 133). We identified numerous market and regulatory factors that contributed to an estimated 9-year delay in generic versions of the tablet formulation and 6-year delay for generic versions of the film formulation. CONCLUSIONS: Brand-name buprenorphine formulations have been widely used in Medicaid, leading to substantial costs, in part because generic versions were delayed by multiple years owing to market and regulatory factors. Timely availability of low-cost generics could have helped encourage OUD treatment with buprenorphine during the height of the opioid crisis.


Asunto(s)
Buprenorfina/economía , Buprenorfina/uso terapéutico , Medicaid/economía , Antagonistas de Narcóticos/economía , Antagonistas de Narcóticos/uso terapéutico , Trastornos Relacionados con Opioides/tratamiento farmacológico , Buprenorfina/administración & dosificación , Combinación Buprenorfina y Naloxona/economía , Combinación Buprenorfina y Naloxona/uso terapéutico , Utilización de Medicamentos , Medicamentos Genéricos/economía , Medicamentos Genéricos/uso terapéutico , Competencia Económica , Humanos , Antagonistas de Narcóticos/administración & dosificación , Tratamiento de Sustitución de Opiáceos/economía , Tratamiento de Sustitución de Opiáceos/métodos , Patentes como Asunto , Estados Unidos
6.
BMC Infect Dis ; 21(1): 712, 2021 Jul 29.
Artículo en Inglés | MEDLINE | ID: mdl-34325673

RESUMEN

BACKGROUND: The COVID-19 pandemic has severely disrupted supply chains for many types of Personal Protective Equipment (PPE), particularly surgical N95 filtering facepiece respirators (FFRs; "masks"). As a consequence, an Emergency Use Authorization (EUA) from the FDA has allowed use of industrial N95 respirators and importation of N95-type masks manufactured to international standards; these include KN95 masks from China and FFP2 masks from the European Union. METHODS: We conducted a survey of masks in the inventory of major academic medical centers in Boston, MA to determine provenance and manufacturer or supplier. We then assembled a testing apparatus at a university laboratory and performed a modified test of filtration performance using KCl and ambient particulate matter on masks from hospital inventories; an accompanying website shows how to build and use the testing apparatus. RESULTS: Over 100 different makes and models of traditional and nontraditional filtering facepiece respirators (N95-type masks) were in the inventory of surveyed U.S. teaching hospitals as opposed to 2-5 models under normal circumstances. A substantial number of unfamiliar masks are from unknown manufacturers. Many are not correctly labelled and do not perform to accepted standards and a subset are obviously dangerous; many of these masks are likely to be counterfeit. Due to the absence of publicly available information on mask suppliers and inconsistent labeling of KN95 masks, it is difficult to distinguish between legitimate and counterfeit products. CONCLUSIONS: Many FFRs available for procurement during the COVID-19 pandemic do not provide levels of fit and filtration similar to those of N95 masks and are not acceptable for use in healthcare settings. Based on these results, and in consultation with occupational health officers, we make six recommendations to assist end users in acquiring legitimate products. Institutions should always assess masks from non-traditional supply chains by checking their markings and manufacturer information against data provided by NIOSH and the latest FDA EUA Appendix A. In the absence of verifiable information on the legitimacy of mask source, institutions should consider measuring mask fit and filtration directly. We also make suggestions for regulatory agencies regarding labeling and public disclosure aimed at increasing pandemic resilience.


Asunto(s)
COVID-19 , Exposición Profesional , Dispositivos de Protección Respiratoria , Humanos , Máscaras , Pandemias/prevención & control , SARS-CoV-2 , Ventiladores Mecánicos
7.
J Leg Med ; 41(1-2): 47-81, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34296970

RESUMEN

As the opioid crisis in the United States evolved, so did the relationship between prescribers and pharmaceutical companies that manufacture prescription opioids, with policymakers at both the state and national levels focused on the issue of prescription opioid misuse. This article discusses the role of the prescriber-pharmaceutical company relationship with respect to opioid over- and underprescribing, the evolution of that relationship over time, and its contribution to what is now commonly known as the U.S. opioid crisis or overdose epidemic. The United States saw several "waves" of prescription opioid misuse, and this article characterizes the relationship between prescribers and pharmaceutical companies in similar waves. The article proposes several prescriber- and manufacturer-focused "solutions" that can be implemented to address and lessen the effects of the ongoing crisis. Changes directed at prescribers and manufacturers must be implemented in tandem to ensure such solutions do not, in attempting to fill the existing cracks in the system, create even more.


Asunto(s)
Sobredosis de Droga , Epidemias , Trastornos Relacionados con Opioides , Analgésicos Opioides/efectos adversos , Sobredosis de Droga/tratamiento farmacológico , Sobredosis de Droga/epidemiología , Humanos , Epidemia de Opioides , Trastornos Relacionados con Opioides/epidemiología , Estados Unidos
8.
J Gen Intern Med ; 2019 Dec 05.
Artículo en Inglés | MEDLINE | ID: mdl-31808127

RESUMEN

This paper published with several formatting errors. They have been corrected and the paper has re-published.

10.
JAMA ; 2024 Sep 25.
Artículo en Inglés | MEDLINE | ID: mdl-39320900

RESUMEN

This Viewpoint examines the US Supreme Court's decision in Harrington v Purdue Pharma and the ramifications it could have for public health and medicine.

11.
JAMA ; 331(13): 1083-1084, 2024 04 02.
Artículo en Inglés | MEDLINE | ID: mdl-38436995

RESUMEN

This Viewpoint discusses the Alabama Supreme Court's opinion on in vitro fertilization and how it plays into a larger push for fetal and embryonic personhood.


Asunto(s)
Política , Derechos Sexuales y Reproductivos , Niño , Humanos , Alabama , Estados Unidos , Derechos Sexuales y Reproductivos/legislación & jurisprudencia , Estructuras Embrionarias
12.
PLoS Med ; 15(5): e1002564, 2018 05.
Artículo en Inglés | MEDLINE | ID: mdl-29738523

RESUMEN

In a Guest Editorial, Aaron S. Kesselheim and Michael S. Sinha show how federal and state legislation to allow promotion of drugs for non-approved uses threatens to undermine the FDA's public health mission.


Asunto(s)
Gobierno Federal , Regulación Gubernamental , Uso Fuera de lo Indicado/legislación & jurisprudencia , Gobierno Estatal , United States Food and Drug Administration/legislación & jurisprudencia , Humanos , Estados Unidos
14.
JAMA ; 330(12): 1129-1130, 2023 09 26.
Artículo en Inglés | MEDLINE | ID: mdl-37639253

RESUMEN

This Viewpoint discusses why the US Food and Drug Administration (FDA) should include e-cigarettes in its proposed cap of the nicotine concentration in combustible cigarettes to address the public health problem of vaping among adolescents.


Asunto(s)
Sistemas Electrónicos de Liberación de Nicotina , Nicotina , Productos de Tabaco , Nicotina/análisis , Fumar , United States Food and Drug Administration/legislación & jurisprudencia , Estados Unidos
15.
JAMA ; 329(20): 1735-1737, 2023 05 23.
Artículo en Inglés | MEDLINE | ID: mdl-37099527

RESUMEN

This Viewpoint discusses recent US court decisions on the availability of mifepristone, a drug used to terminate pregnancies, and how these conflicting court decisions affect the scientific process and decision-making of the US Food and Drug Administration.


Asunto(s)
Aborto Inducido , Legislación Médica , Mifepristona , Ciencia , Decisiones de la Corte Suprema , Femenino , Humanos , Embarazo , Aborto Inducido/legislación & jurisprudencia , Medicina , Mifepristona/uso terapéutico , Estados Unidos , Ciencia/legislación & jurisprudencia
19.
Bioorg Med Chem ; 24(24): 6446-6451, 2016 12 15.
Artículo en Inglés | MEDLINE | ID: mdl-27591793

RESUMEN

Two primary regulatory mechanisms have been proposed to incentivize new antibiotic development: (1) changing Food and Drug Administration (FDA) approval processes to expedite antibiotic approval; and (2) offering enhanced possibilities for market exclusivity. Changes to the FDA regulatory approval process include greater reliance on surrogate endpoints such as biomarkers, use of noninferiority hypothesis designs for key preapproval clinical trials, and development of an expedited development track specific for antibiotics called the Limited Population pathway. The second strategy intended to encourage new antibiotic development has been to provide additional market exclusivity incentives based on regulatory approval. While these pathways have some positive attributes, they also present enhanced risks to patients associated with lower regulatory barriers and the market exclusivity incentives may not efficiently direct resources to the true origins of antibiotic innovation.


Asunto(s)
Antibacterianos/síntesis química , Descubrimiento de Drogas , Animales , Antibacterianos/química , Aprobación de Drogas , Humanos , Estados Unidos , United States Food and Drug Administration
20.
Am J Law Med ; 42(2-3): 223-255, 2016 05.
Artículo en Inglés | MEDLINE | ID: mdl-29086642

RESUMEN

This Article explores the connections between emerging infectious diseases, domestic disease panics, global health, and the law by comparing the American response to Ebola to the initial American response to the AIDS epidemic. We demonstrate that in both cases the arrival of a new deadly disease was initially met with fear, stigma and the use of law to "other" those associated with the disease. We begin by reviewing the initial responses to the AIDS epidemic. We then offer a brief history of emerging infectious disease scares over the past few decades, highlighting the problematic rhetoric that paved the way for the Ebola panic. We then review the 2014 Ebola outbreak, noting its similarities and distinctions from the early AIDS epidemic. Finally, we examine United States policies regarding HIV and Ebola in Africa. We conclude with some tentative observations about the relationship between germ panics, law, and public health.


Asunto(s)
Salud Global , Infecciones por VIH/epidemiología , Fiebre Hemorrágica Ebola/epidemiología , Brotes de Enfermedades/prevención & control , Miedo , Infecciones por VIH/prevención & control , Política de Salud/legislación & jurisprudencia , Fiebre Hemorrágica Ebola/prevención & control , Humanos , Salud Pública , Viaje/legislación & jurisprudencia , Estados Unidos
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