Female barrier methods

Keyword(s):  
2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 15-15
Author(s):  
David Michael Waterhouse ◽  
Caleb Burdette ◽  
Dan Davies ◽  
David R. Drosick ◽  
Molly Mendenhall

15 Background: Biosimilars are clinically equivalent and highly similar to brand yet cost significantly less. Financial savings are shared by patients, practices and payers, ranging anywhere from 21-24% based on 10/01/20 ASP data from CMS. The effective conversion to biosimilar products is vitally important to total cost-of-care savings and can be achieved without negatively affecting patient outcomes. Physician understanding and confidence in biosimilar products is seen as a major conversion barrier. Methods: Interchangeability is an FDA designation that allows generic drugs to be substituted for reference drugs at the pharmacy, without a physician’s consent. Currently no biosimilar has that FDA approval for interchangeability. Building on previous pharmacy auto-substitution processes with therapeutic interchange, a formalized biosimilar policy and SOP was developed to automate conversion from the reference biologic product to the P&T/Physician approved biosimilar. Workflow changes were instituted to alleviate the provider burden of patient-by-patient decisions and placed them with the pharmacy review team. Full staff support and understanding on biosimilar usage was endorsed through mandatory biosimilar education of physicians, advanced practice providers, pharmacists, nurses, financial navigators and prior authorization team members and tracked using meeting attendance and the online E-learning system. Patient education was verified using established teaching visits by tracking documentation in the electronic health record (EHR). Quantitative metrics and reports were developed to assist in tracking the number of unique patients receiving the brand or biosimilar agents. Billed product units per month were also tracked to facilitate auditing and assure accuracy. Baseline brand/biosimilar utilization data for Rituximab, Trastuzumab, and Bevacizumab was collected from July 1, 2019 through December 31, 2020. Results: During the baseline period of 7/01/19 – 12/31/19, biosimilar conversion ranged from 0% (trastuzumab) to 8.4% (rituximab). Following full staff education and physician consent, systematic auto-conversion to biosimilar products was initiated on January 1, 2020. Conversion rates based upon billed biosimilar units likewise improved from 11.7% (baseline) to 90.2% (2021 Q1) for rituximab, 8.4% to 87.4% for trastuzumab, and 0% to 90.0% for bevacizumab. Conclusions: Rapid and near-complete conversion from brand product to FDA approved biosimilar is feasible, measurable and can be scaled.[Table: see text]


2000 ◽  
Vol 27 (4) ◽  
pp. 841-858 ◽  
Author(s):  
Melissa L. Gilliam ◽  
Richard J. Derman
Keyword(s):  

Author(s):  
Elisabeth Woodhams ◽  
Melissa Gilliam
Keyword(s):  

2021 ◽  
Vol 6 (3) ◽  
pp. 174-184
Author(s):  
K. Ts. Erdyneev ◽  
V. A. Sorokovikov ◽  
D. N. Sambuev ◽  
V. P. Saganov ◽  
B. B. Dambaev ◽  
...  

Introduction. Epidural fibrosis is an urgent problem in modern spinal surgery and orthopedics. The formation of connective tissue in the epidural space after performing surgical interventions on the spinal column inevitably leads to adhesion of the latter to the dura mater and compression of neural structures, followed by the formation of clinical and neurological symptoms. The  search for literary sources in domestic and foreign scientific databases has demonstrated the presence of several works studying the effectiveness of barrier methods for preventing the development of epidural fibrosis. It should be noted that the results of these studies are ambiguous and largely contradictory.The purpose was to study the effectiveness of using a spatially cross-linked polymer in the postoperative lumbar epidural fibrosis prevention in an experiment.Materials and methods. The study included 26 male Wistar rats (average body weight 338.5±9.07 g), which were divided into two groups: Group I (control, n = 12): animals underwent laminectomy at the level of vertebral bodies LVII – SI  without application of spatially crosslinked polymer; Group II (experimental, n = 14): animals underwent laminectomy at the level of vertebral bodies LVII – SI  followed by application of a spatially cross-linked polymer to the dura mater. The morphological and instrumental parameters were studied.Results. Significant differences were noted in the severity of epidural fibrosis (χ2 = 14.846, p = 0.003), the number of newly formed vessels (F = 14.371, p<0.001), the number of fibroblasts (F = 11.158, p<0.001), as well as in the severity of vertebral stenosis channe l according to multislice computed tomography (χ2 = 17.207, p=0.002) between the control and experimental groups of animals.Conclusion. Application of a spatially cross-linked polymer to the dura mater is an effective way to prevent the development of postoperative epidural fibrosis.


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