scholarly journals Multicenter point prevalence evaluation of the utilization and safety of drug therapies for COVID-19 at the onset of the pandemic timeline in the United States

Author(s):  
Nathaniel J Rhodes ◽  
Atheer Dairem ◽  
William J Moore ◽  
Anooj Shah ◽  
Michael J Postelnick ◽  
...  

Abstract Disclaimer In an effort to expedite the publication of articles related to the COVID-19 pandemic, AJHP is posting these manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. Purpose There are currently no FDA-approved medications for the treatment of coronavirus disease 2019 (COVID-19). At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period. Methods We conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19–targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs). Results A total of 352 patients treated for COVID-19 at 15 US hospitals From April 18 to May 8, 2020, were included in the study. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies used included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 antagonists (9%). Five patients (7.5%) were receiving combination therapy. The rate of use of COVID-19–directed drug therapy was higher in patients with vs patients without a history of asthma (14.9% vs 7%, P = 0.037) and in patients enrolled in clinical trials (26.9% vs 3.2%, P < 0.001). Among those receiving drug therapy, 8 patients (12%) experienced an ADR, and ADRs were recognized at a higher rate in patients enrolled in clinical trials (62.5% vs 22%; odds ratio, 5.9; P = 0.028). Conclusion While we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy, including those enrolled in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 treatments.

Author(s):  
Nathaniel J. Rhodes ◽  
Atheer Dairem ◽  
William J. Moore ◽  
Anooj Shah ◽  
Michael J. Postelnick ◽  
...  

AbstractBackgroundThere are currently no FDA-approved medications for the treatment of COVID-19. At the onset of the pandemic, off-label medication use was supported by limited or no clinical data. We sought to characterize experimental COVID-19 therapies and identify safety signals during this period.MethodsWe conducted a non-interventional, multicenter, point prevalence study of patients hospitalized with suspected/confirmed COVID-19. Clinical and treatment characteristics within a 24-hour window were evaluated in a random sample of up to 30 patients per site. The primary objective was to describe COVID-19 targeted therapies. The secondary objective was to describe adverse drug reactions (ADRs).ResultsA total of 352 patients from 15 US hospitals were included. Most patients were treated at academic medical centers (53.4%) or community hospitals (42.6%). Sixty-seven patients (19%) were receiving drug therapy in addition to supportive care. Drug therapies included hydroxychloroquine (69%), remdesivir (10%), and interleukin-6 inhibitors (9%). Five patients (7.5%) were receiving combination therapy. Patients with a history of asthma (14.9% vs. 7%, p = 0.037) and those enrolled in clinical trials (26.9% vs.3.2%, p< 0.001) were more likely to receive therapy. Among those receiving COVID-19 therapy, eight patients (12%) experienced an ADR, and ADRs were more commonly recognized in patients enrolled in clinical trials (62.5% vs 22%, OR = 5.9, p = 0.028).ConclusionsWhile we observed high rates of supportive care for patients with COVID-19, we also found that ADRs were common among patients receiving drug therapy including in clinical trials. Comprehensive systems are needed to identify and mitigate ADRs associated with experimental COVID-19 therapies.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Lindsay A Bliss ◽  
Carol A Vitellas ◽  
Nayanika Challa ◽  
Vivien H Lee

Introduction: The lower proportion of women at the rank of full professor compared to men has been documented in nearly all specialties. Women are under-represented in academic stroke neurology, but there is limited data. Methods: We reviewed all 160 U.S. medical schools and the associated medical centers for vascular neurologists. An internet search of stroke team websites and neurology department websites was performed from August 1, 2020 to August 25, 2020. We included 117 academic medical centers that had at least 1 vascular neurologist on faculty. We included vascular neurology ABPN certified or board eligible (fellowship-trained) neurologists. Data was collected on sex, academic rank, and American Board of Psychiatry and Neurology (ABPN) certification status. ABPN board certification status was verified on the ABPN verify CERT website. Social medical women’s neurology groups were also queried for names of women full professor to cross check. Results: Among 540 academic ABPN vascular neurologists, 182 (33.8%) were women and 358 (66.3%) were men. Among academic ranks, women made up 108/269 (40.1%) of Assistant professors, 49/137 (35.8%) of Associate professors, and 25/134 (18.8%) of full professors. Twenty two academic centers had vascular neurology female professors on faculty, compared to 70 academic centers with male full professors on faculty. Twenty nine academic centers had multiple male professors on faculty compared to only 3 centers with multiple female full professors. Among women, 108 (59.3%) were assistant professor, 49 (26.7%) were associate professor, 25 (13.7%) were full professor. Among men, 161 (45.0%) were assistant professor, 88 (24.6%) were associate professor, and 109 (30.5%) were professor. There was a significant difference between academic rank based upon sex (p <0.0001). Conclusion: Among academic medical centers in the United States, significant sex differences were observed in academic faculty rank for ABPN vascular neurologists, with women less likely than men to be full professors. Further study is warranted to address the gender gap in the field of stroke.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e13609-e13609
Author(s):  
Sarah Hudson-Disalle ◽  
David L. DeRemer ◽  
Larry W Buie ◽  
Mark Hamm ◽  
Jeffrey Pilz ◽  
...  

e13609 Background: Drug shortages are a clear and growing challenge. Prominent shortages included oncology medications and supportive care products essential for the care of cancer patients. Oncology drug shortages often result in disruptions in the timing of chemotherapy treatments, alterations in the dose or regimen administered, or even missed doses when alternative agents are unavailable. The purpose of this survey was to characterize the impact of oncology drug shortages across the United States, including the experiences of health care organizations, resource implications, and the impact on patient safety, patient care, and clinical trials. Methods: A 34-item online survey was distributed to HOPA membership of the Hematology Oncology Pharmacy Association to gather information on shortages of oncology drugs (i.e., all drugs essential in the care of cancer patients, including supportive care agents. Results: Sixty-eight organizations completed the survey; almost all completed by pharmacists, and analysis completed. Sixty-three percent of institutions reported one or more drugs shortages a month, with a 34.33% increase in 2019 from 2018. Sixty four percent of responded had incurred increased costs from oncology drugs shortages, with 7% noting reimbursement issues when switched to brand name therapies due to shortages. Treatment delays, reduced doses or alternative regimens were reported by 74.63% of respondents. The most common disease states which causes a dose delay of treatment included Acute Lymphocytic Leukemia, Lymphoma and Multiple Myeloma with dose reductions noted in 36.36%, 36.36 and 15.91%. The top five oncology drugs on shortage included epirubicin, flutamide, decitabine, mechlorethamine, dactinomycin with the top 5 supportive care drugs on shortage being noted as hydrocortisone, bivalirudin, promethazine, mycophenolate sodium and scopolamine. Respondents noted medication errors related to oncology drug shortages at 4.48%, with noted errors including incorrect conversion from iv to oral etoposide and incorrect EMR drug builds. Oncology Drug shortages impacted clinical trials in 13.4% of respondents in which 54.55% of respondents noting patients not being enrolled in clinical trials. Conclusions: A survey of US oncology pharmacists and technicians indicated that oncology drug shortages occurred frequently in 2020. Shortages led to delays in chemotherapy and changes in treatment or omission, complicated clinical research and increased the risk of medication errors and adverse outcomes.


Children ◽  
2018 ◽  
Vol 5 (12) ◽  
pp. 168 ◽  
Author(s):  
Gautam Ramesh ◽  
Dana Gerstbacher ◽  
Jenna Arruda ◽  
Brenda Golianu ◽  
John Mark ◽  
...  

Pediatric integrative medicine is an emerging field which, to date, has not been described in detail in academic medical centers in the United States. Early research of pediatric integrative medicine modalities shows promise for the treatment of common pediatric conditions such as irritable bowel syndrome, acute and chronic pain, headache, and allergy, among others. In light of the growing prevalence of pediatric illnesses and patient complexity, it is crucial to emphasize the patient’s overall well-being. As academic centers around the world start to develop pediatric integrative medicine programs, the aim of this manuscript is to briefly highlight evidence of effective integrative treatments in pediatric subspecialties, to describe the establishment of our integrative medicine program, to summarize its early efforts, and to discuss potential barriers and keys to success.


2017 ◽  
Vol 124 (4) ◽  
pp. 1208-1210 ◽  
Author(s):  
Jaime Aaronson ◽  
Sharon Abramovitz ◽  
Richard Smiley ◽  
Virginia Tangel ◽  
Ruth Landau

2015 ◽  
Vol 33 (Suppl. 1) ◽  
pp. 57-60
Author(s):  
Daniel K. Podolsky

The forces that are reshaping the delivery of health care through much of the developed world are especially acute within academic centers that carry the responsibility for delivering that care while advancing medical knowledge and ensuring well-trained physicians. Gastroenterology will not be spared any of those forces, and in some ways represents the leading edge of their impact. Though the dynamics vary within the context of the health-care delivery and scientific enterprise of individual countries, common elements are demands for greater accountability and transparency in how academic medical centers demonstrate their value while assuring broad access to their expertise. In the United States, underlying many forms of change in the payment scheme are the common elements that will increasingly place the risk for the cost of care on providers rather than on the payers, be it government or private, as has historically been true. At the same time, academic medical centers, with gastroenterology responsible for addressing the burden of digestive diseases, must remain the stem cells for health care integrating all their missions and providing the foundation of medical advances which will ultimately improve human welfare. What will academic gastroenterology units look like if they are able to effectively respond to these forces? Gastrointestinal (GI) divisions and faculty will own new roles including responsibility for system success in caring for patients. They will evolve their training programs to provide the next generation with skills needed to succeed, including the discipline of system improvement, team leadership and others. And there will be new models that will drive the organization of research that are not as conventionally self-contained within the gastroenterology units, but fostering research teams that have hubs and spokes. The vitality of GI divisions will depend on the willingness to seize ownership of the new value proposition of disease management ensuring that each patient achieves the best outcome with the most effective use of resources and endeavor within their systems to capture some of that value to invest in their training and research missions. In the course of that evolution, gastroenterology will be well served by rebalancing the dependence on existing modalities. If procedural gastroenterology becomes the sole value proposition, it will lead to an increasingly narrow view of the field.


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