Sex-Based Differences Entangling With Electronic Health Record Documentation

Abstract

high-dose colchicine in the treatment of acute gout. 4 Consistent with the recommendations of the European League Against Rheumatism, low-dose colchicine was found to be equally effective as high-dose drug in the reduction of gouty pain; the rate of gastrointestinal adverse events with lowdose colchicine was one-third that observed with high-dose colchicine. In response to these study findings, the FDA approved Colcrys, which, consequently, became the first colchicine product to ever be approved for the treatment of acute gout. Considering that the Waxman-Hatch Act (https://www. govinfo.gov/content/pkg/STATUTE-98/pdf/STATUTE-98-Pg1585.pdf) resulted in market exclusivity for a newly approved drug, URL Pharma received this benefit. In addition to a period of exclusivity, the manufacturer was able to remove all generic competitors from the market. Upon FDA approval, the manufacturer increased the price of colchicine from what had previously been only a few cents to $5 a tablet. A second colchicine brand-name product (Mitigare) was approved in 2015 at the very conclusion of the 4-year Colcrys monopoly.An additional point considering the study findings 1 is the fact that the potential uses for colchicine currently extend beyond acute gout. The increase in potential indications will likely result in even more demand for this drug. As the authors noted, 1 colchicine has been found to have value in the treatment of pericarditis, as well as prevention of additional cardiovascular complications after myocardial infarction. Currently, the Montreal Heart Institute (NCT04322682) 5 is studying colchicine in the treatment of COVID-19 infection. Early results as of October 2020 suggest that early in-hospital initiation of low-dose colchicine treatment within 3 days of myocardial infarction significantly reduces the risk of future ischemic cardiovascular events. Notably, all the colchicine products used for these indications have been trade products; there have been no approved independent colchicine generics marketed after the approval of Colcrys.Wouters et al 6 estimated the investment required to bring a new medicine to market. The median capitalized research and development investment was estimated to be between $985.3 and $1335.9 million. Such investments inevitably require an appropriate return on investment, which usually translates into a high selling price of the drug. However, such investment and its resultant cost should be associated with potential worth to society. The ideal investment would be a new molecular entity that provides an objective, meaningful improvement in public health. Colchicine does not fit this example. Only a fraction of an investment was required for Colcrys, a product that has provided no increased value and an unnecessary, long-term cost burden to the health care system. The current study findings 1 illustrate that we can never allow such an egregious case to take place again.

Primary Care Physician Gender and Electronic Health Record Workload

“…In previous research, while female physicians reported similar numbers of medically complex patients, they reported greater numbers of psychosocially complex and frustrating patients. 3 Patient-level data would enable further evaluation of whether patient complexity explains the gender differences in EHR care, and whether adjusting panelsize expectations for patient complexity would reduce gender differences in workload. Fourth, we used the hospital physician database to identify physician gender, which at the time of this study required respondents to categorize themselves as either male or female; therefore, we could not capture information on physicians who were transgender or nonbinary; similar limitations at the time applied to available patient gender (legal gender as listed in Epic).…”

“…Recent data suggest that female physicians spend more time working in the electronic health record (EHR) than do male physicians. [1][2][3] This increased EHR time may contribute to the documented higher rates of burnout among female physicians nationwide compared with their male colleagues. 4 In particular, time spent in the EHR inbasket, within which physicians respond to messages from patients, staff, and colleagues, has been linked to burnout.…”

Identifying and adapting interventions to reduce documentation burden and improve nurses’ efficiency in using electronic health record systems (The IDEA Study): protocol for a mixed methods study

“…3 Information Management Group, Centre for Addiction and Mental Health, Toronto, ON, Canada. 4 Lunenfeld-Tanenbaum Research Institute, Sinai Health, Toronto, ON, Canada. 5 Bloomberg Faculty of Nursing, University of Toronto, Toronto, ON, Canada.…”

“…Nurses represent the largest group of healthcare providers in Canada and have been reported to be the primary users of EHR systems [1,2]. While EHR systems serve as the backbone of documentation for all clinical activities [3], studies have shown that nurses spend a greater amount of time documenting their assessments, care, and outcomes in the EHR now than in the past [4,5]. While previous initiatives have focused on expanding the design and functionalities of EHRs for research purposes to support clinical decision-making and assist with patient risk assessments [6][7][8][9], the growing burden caused by documentation requirements has overshadowed these efforts and led to inefficiencies in the EHR, taking time away from patient care activities and reducing joy in the profession [7,[9][10][11][12][13][14].…”