Scaled integration of FDA approved biosimilars: Closing the knowledge and adoption gaps.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 15-15
Author(s):  
David Michael Waterhouse ◽  
Caleb Burdette ◽  
Dan Davies ◽  
David R. Drosick ◽  
Molly Mendenhall
Keyword(s):  
Generic Drugs ◽  
Baseline Period ◽  
Cost Of Care ◽  
Learning System ◽  
Staff Support ◽  
Barrier Methods ◽  
Team Members ◽  
Conversion Rates ◽  
Review Team ◽  
Utilization Data

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]

Regulatory requirements and comparison in approval of new and generic drugs in United States of America and Japan:-Implication for Future strategies

2020 ◽  
Vol 07 ◽  
Author(s):  
Paramjeet Malik ◽  
Neelam Pawar ◽  
Kavita Bahmani
Keyword(s):  
Generic Drugs ◽  
Drug Product ◽  
Drug Approval ◽  
Approval Process ◽  
Regulatory Requirements ◽  
Team Members ◽  
Regulatory Authorities ◽  
Effective Manner ◽  
Review Team

: Safety, efficacy and quality of a therapeutic product is the major concern for the pharmaceutical companies. FDA and PMDA are the main regulatory authorities in USA & JAPAN respectively that ensures the maintenance of these required parameters by forming standard guidelines and process for drug approval. These regulatory authorities’ reviews each step of a pharmaceutical drug product from its discovery phase to marketed product. Dossier plays an important role during the approval process of a drug product, as it allows both applicant and review team members to evaluate the data in an effective manner. A dossier consists of five modules containing informative data of various stages of a drug product but in a brief pattern with folders and subfolders. In the present paper, the authors focus on in-depth review of approval process for new and generic drugs in USA and Japan.

scholarly journals 888. Improving outcomes with revised preoperative universal decolonization protocol

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S479-S479
Author(s):  
Silvia I Gnass
Keyword(s):  
Surgical Procedures ◽  
Baseline Period ◽  
Surgical Team ◽  
Team Members ◽  
Surgical Infection ◽  
Before And After ◽  
Trial Basis ◽  
The Impact ◽  
Before And After Study ◽  
Patient Infection

Abstract Background In order to improve outcomes, including reduced surgical infection rate and costs, a revised universal preoperative decolonization protocol was implemented on a trial basis. Methods In a 12 month before and after study at a public teaching hospital in southern California, an alcohol based nasal antiseptic was introduced in place of nasal povidone iodine (PVI) for all surgical patients pre-operatively, paired with chlorhexidine (CHG) bathing which was already in place. All surgical procedures were included, the most common being cholecystectomy, cesarean section and hip fracture. The alcohol nasal antiseptic was selected to replace the PVI nasal antiseptic based on efficacy, staff preference and cost. At the same time, surgical team members began self-application of the alcohol nasal antiseptic each day prior to surgical procedures. This was not mandatory and compliance was not tracked, though informal feedback and observation revealed most surgical team members were applying the nasal antiseptic prior to cases daily. Results In comparison to the 6 month baseline period where there were 27 SSI in 1188 procedures, during the 6 month study period there were 10 SSI in 1253 procedures, representing a 63% reduction (p=.0162) for all types of procedures. We have observed a reduction of 17 SSIs in 2019, compared to the previous year, during the 6 months period. That means a saving of $589,420 during the same period. Conclusion Preoperative universal decolonization with alcohol based nasal antiseptic in place of nasal PVI, paired with CHG bathing, was effective in reducing SSI rate and associated costs. Further study is needed to measure and assess the impact of surgical team member nasal decolonization on patient infection risk and rate. Disclosures All Authors: No reported disclosures

Organization and Structure of the Cardiothoracic Intensive Care Unit

2015 ◽  
pp. 86-104
Author(s):  
Michael H. Wall
Keyword(s):  
Intensive Care Unit ◽  
Critical Care ◽  
Intensive Care ◽  
Patient Outcomes ◽  
Nurse Practitioners ◽  
Physician Assistants ◽  
Cost Of Care ◽  
Team Members ◽  
Low Intensity

The purpose of this chapter is to emphasize and describe the team nature of critical care medicine in the Cardiothoracic Intensive Care Unit. The chapter will review the importance of various team members and discuss various staffing models (open vs closed, high intensity vs low intensity, etc.) on patient outcomes and cost. The chapter will also examine the roles of nurse practitioners and physician assistants (NP/PAs) in critical care, and will briefly review the growing role of the tele-ICU. Most studies support the concept that a multi-disciplinary ICU team, led by an intensivist, improves patient outcomes and decreases overall cost of care. The role of the tele-ICU and 24 hour in-house intensivist staffing in improving outcomes is controversial, and more research is needed in this area. Finally, a brief discussion of billing for critical care will be discussed.

Organization and Structure of the Cardiothoracic Intensive Care Unit

Oncology ◽  
2017 ◽  
pp. 709-727
Author(s):  
Michael H. Wall
Keyword(s):  
Intensive Care Unit ◽  
Critical Care ◽  
Intensive Care ◽  
Patient Outcomes ◽  
Nurse Practitioners ◽  
Physician Assistants ◽  
Cost Of Care ◽  
Team Members ◽  
Low Intensity

The purpose of this chapter is to emphasize and describe the team nature of critical care medicine in the Cardiothoracic Intensive Care Unit. The chapter will review the importance of various team members and discuss various staffing models (open vs closed, high intensity vs low intensity, etc.) on patient outcomes and cost. The chapter will also examine the roles of nurse practitioners and physician assistants (NP/PAs) in critical care, and will briefly review the growing role of the tele-ICU. Most studies support the concept that a multi-disciplinary ICU team, led by an intensivist, improves patient outcomes and decreases overall cost of care. The role of the tele-ICU and 24 hour in-house intensivist staffing in improving outcomes is controversial, and more research is needed in this area. Finally, a brief discussion of billing for critical care will be discussed.

scholarly journals Using a certified electronic health record technology platform to screen, test and refer patients with prediabetes

JAMIA Open ◽  
2021 ◽  
Vol 4 (4) ◽  
Author(s):  
Kate Kirley ◽  
Tamkeen Khan ◽  
Gina Aquino ◽  
Ameldia Brown ◽  
Scott Meier ◽  
...  
Keyword(s):  
Electronic Health Record ◽  
Diabetes Prevention Program ◽  
Screen Test ◽  
Primary Care Providers ◽  
Baseline Period ◽  
Health Record ◽  
Patient Portal ◽  
Care Providers ◽  
Conversion Rates ◽  
Electronic Health

Abstract The objective of this study was to determine if certified electronic health record technology (CEHRT) can be used to identify and refer patients with prediabetes to lifestyle change programs (LCPs) recognized by the National Diabetes Prevention Program (DPP). This pilot utilized a prediabetes registry, patient portal, and clinical decision support to increase referrals. Data from 36 primary care providers showed 4930 patients were eligible for DPP LCP, 293 referrals were generated, compared to 20 referrals in the baseline period, and 116 patients enrolled. Referral to enrollment conversion rates were 41% in the study period and 69% in the post-study 1-year period. CEHRT functionalities can support systematic identification and management of prediabetes. The referral rate increased 7-fold compared to the baseline period, with high referral to enrollment conversion rates. CEHRT coupled with active provider engagement can serve as a tool to identify prediabetes patients and facilitate LCP referrals and enrollment.

scholarly journals Learning while doing: program evaluation of the Medical Library Association Systematic Review Project

2018 ◽  
Vol 106 (3) ◽  
Author(s):  
Catherine Boden ◽  
Marie T. Ascher ◽  
Jonathan D. Eldredge
Keyword(s):  
Systematic Review ◽  
Program Evaluation ◽  
Systematic Reviews ◽  
Professional Growth ◽  
Large Scale ◽  
Team Members ◽  
Short Answer ◽  
Medical Library ◽  
Review Team ◽  
Short Answer Questions

Objectives: The Medical Library Association (MLA) Systematic Review Project aims to conduct systematic reviews to identify the state of knowledge and research gaps for fifteen top-ranked questions in the profession. In 2013, fifteen volunteer-driven teams were recruited to conduct the systematic reviews. The authors investigated the experiences of participants in this large-scale, volunteer-driven approach to answering priority research questions and fostering professional growth among health sciences librarians.Methods: A program evaluation was conducted by inviting MLA Systematic Review Project team members to complete an eleven-item online survey. Multiple-choice and short-answer questions elicited experiences about outputs, successes and challenges, lessons learned, and future directions. Participants were recruited by email, and responses were collected over a two-week period beginning at the end of January 2016.Results: Eighty (8 team leaders, 72 team members) of 198 potential respondents completed the survey. Eighty-four percent of respondents indicated that the MLA Systematic Review Project should be repeated in the future and were interested in participating in another systematic review. Team outputs included journal articles, conference presentations or posters, and sharing via social media. Thematic analysis of the short-answer questions yielded five broad themes: learning and experience, interpersonal (networking), teamwork, outcomes, and barriers.Discussion: A large-scale, volunteer-driven approach to performing systematic reviews shows promise as a model for answering key questions in the profession and demonstrates the value of experiential learning for acquiring synthesis review skills and knowledge. Our project evaluation provides recommendations to optimize this approach.

scholarly journals Internal Reviews Benefit Programs of the Review Team Members and the Program Under Review

2010 ◽  
Vol 2 (4) ◽  
pp. 604-609 ◽  
Author(s):  
Kathryn M. Andolsek ◽  
Alisa Nagler ◽  
Leslie Dodd ◽  
John L. Weinerth
Keyword(s):  
Medical Education ◽  
Graduate Medical Education ◽  
Review Process ◽  
Review Committee ◽  
Team Members ◽  
Internal Review ◽  
Institutional Review ◽  
Review Team ◽  
Duke University ◽  
Program Information

Abstract Background The Accreditation Council for Graduate Medical Education (ACGME) mandates that sponsoring institutions conduct internal reviews. In 1998, the ACGME Institutional Review Committee gave Duke University Hospital a citation for an inadequate internal review (IR) process. Since then, we have instituted several iterative changes. We describe the evolution of Duke University Hospital's current internal review process. Intervention We implemented a new review team composition, template report, use of the program information form, and centralization of documentation to improve our internal review process. In 2007, a more formal evaluation of the outcome and impact of these changes was instituted. This included a yearly survey of all participants and review team members, a review of programs, and a tracking process for the decisions of our Graduate Medical Education Committee (GMEC) on the status of reviewed programs. Results Participants from both the program under review and the review team evaluated the process favorably. Review teams reported they learned from the best practices of the program being reviewed. Program directors from the reviewed programs reported the process improved their documentation. Both groups reported the process better prepared them for their next ACGME Review Committee site visit. The GMEC has recommended “probationary sponsorship” for fewer programs since the IR process changes have been implemented. The IR process was recognized as a best practice in Duke University Hospital's 2004 ACGME institutional review. Conclusion We believe our IR process, review-team composition, template report, program information form, and centralized documentation now fully meets accreditation standards. Participants are reasonably satisfied and report value from the process. More programs are judged to be within substantial compliance by the GMEC.

Outpatient documentation of advance care planning (ACP).

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 169-169
Author(s):  
Jennifer Carrie Obel ◽  
Bruce Brockstein ◽  
Tiffany Benfield ◽  
Chad Konchak ◽  
Ari Robicsek ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Time Frame ◽  
Baseline Period ◽  
Cost Of Care ◽  
Future Research ◽  
Newly Diagnosed ◽  
Incurable Cancer ◽  
Code Status ◽  
Period 2 ◽  
Pilot Implementation

169 Background: To increase and systematize outpatient ACP, our quality improvement team developed enhancements in 2 oncologists’ cohorts of newly diagnosed, incurable cancer patients (pts). At 1st consultation, an ACP form is given to pts; a nurse assesses knowledge about medical POAs and goals of care. Pts return for chemotherapy teaching and ACP education session conducted by a nurse utilizing an ACP workbook describing end-of-life (EOL) scenarios. After reviewing the workbook, the nurse or social worker fills out an Advance Directive Note (ADN). At next visit, the oncologist reviews the plan, cosigns the ADN and inputs code status orders (CSOs). Alternatively, oncologists may choose to create the ADN. Methods: An EOL quality database of 9 metrics was created via the Electronic Health Record to measure quality of EOL care for cancer patients. Before pilot implementation, baseline assessment of ACP documentation in deceased cancer pts was obtained utilizing the EOL database for a 3 month time frame (12/12-2/13) for 2 oncologists (GI and thoracic oncology). These rates are compared to ACP documentation for newly diagnosed incurable cancer patients in the outpatient clinic during the 3 month pilot occurring from 3/13-5/13. Results: During the pilot, 5/13 (38%) new thoracic oncology patients and 13/17 (76%) GI patients had outpatient ADNs. The average days to ADN placement from 1st visit, was 14 and 10 in thoracic and GI, respectively. GI oncology placed 6/13 ADNs on the 1st visit; 12/13 GI pts had ADNs placed less than 10 days from 1st visit. GI oncology also placed 10/17 outpatient CSOs of which 8/10 were less than 10 days from 1st visit. In the same thoracic oncologist’s deceased patients during the baseline period, 2/20 (10%) had outpatient ADNs compared to 7/20 who had inpatient ADNs; 2/20 thoracic patients had outpatient CSOs compared to 15/20 with inpatient CSOs. In two comparable practices which did not participate in the pilot from 3/13-5/13, 0/26 and 1/26 new patients had outpatient ADNs and CSOs, respectively. Conclusions: Outpatient ACP is feasible early in the care of cancer patients through systematic improvement in work flow and motivated providers. Future research will focus on whether ACP soon after a cancer diagnosis affects downstream metrics of quality and cost of care during EOL.

Classics in the Field of Behavioral Disorders

1992 ◽  
Vol 18 (1) ◽  
pp. 18-23 ◽  
Author(s):  
Brian Enright ◽  
Richard White ◽  
Kay F. Haney ◽  
H. William Heller ◽  
Fred Spooner
Keyword(s):  
Special Education ◽  
Behavioral Disorders ◽  
Second Phase ◽  
Exceptional Children ◽  
Team Members ◽  
Review Team ◽  
History Of

Co-editors, Associate Editors, and Cohort Review Team members for Teaching Exceptional Children were asked to nominate qualified individuals to identify seminal articles in the area of behavioral disorders. The nominees identified in this first phase of the study recommended the top 19 classic contributions in behavioral disorders. In the second phase of the study, a self-identified panel of 172 persons in the area of behavioral disorders rank ordered these 19 classic works. Results are discussed in relation to another study that examined seminal contributions in the broader area of special education and in relation to the history of behavioral disorders.

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