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Contains 3 Component(s), Includes Credits
This article will cover the significant areas, including: beyond-use dating for categories 1, 2, and 3 CSPs, requirements for clean room personnel qualification and evaluation, the need for a designated person(s) to ensure the sterile environment maintains quality, environmental monitoring changes and the need for increased testing and cleaning.
On November 1, 2022 USP released the revised version of General Chapter <797> Pharmaceutical Compounding--Sterile Preparations, which becomes enforceable November 1, 2023. Although revisions were proposed (and subsequently appealed) in previous years, this version will represent a significant change from the 2008 standards which are currently enforceable. Home infusion pharmacists, pharmacy technicians, nurses, and dietitians will need to comprehend how the updated standards apply to their sterile compounding operations. This article will cover the significant areas, including: beyond-use dating for categories 1, 2, and 3 CSPs, requirements for clean room personnel qualification and evaluation, the need for a designated person(s) to ensure the sterile environment maintains quality, environmental monitoring changes and the need for increased testing and cleaning.
Learning Objectives:
- Review the latest updates to USP General Chapter <797> compared to the 2008 version which remains enforceable until November 1, 2023.
- Understand the difference between Category 1, 2, and 3 compounded sterile preparations (CSPs) and list the specific requirements for each.
- Describe the requirements for personnel qualification and evaluation.
- Explain the increased frequencies for environmental monitoring and cleaning.
Abby Roth, BS, CMQ/OE
Founder
Pure Microbiology
Abby Roth, founder of Pure Microbiology, has over 18 years of experience in supporting the testing and consulting needs of the pharmaceutical, medical device, and compounding industries. Her background in pharmaceutical microbiology includes extensive knowledge of environmental monitoring. Abby served as a USP Compounding EC member during the 2015-2020 cycle. She is an involved member of the Controlled Environment Testing Association (CETA), serving on the Board of Directors, speaking at its annual meetings, and chairing committees for the revision of four CETA Application Guides. Abby has been invited to speak for state boards of pharmacy and for national organizations.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Abby Roth has no relevant financial relationships with ineligible companies to disclose.
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Contains 2 Component(s) Includes a Live Web Event on 03/12/2025 at 12:00 PM (EDT)
Join us for an inspiring webinar showcasing the exceptional work of this year’s finalists for the NHIA Outstanding Abstract Achievement Award.
Join us for an inspiring webinar showcasing the exceptional work of this year’s finalists for the NHIA Outstanding Abstract Achievement Award. These innovative researchers and practitioners have made significant contributions to the field, addressing critical challenges and advancing best practices. During this session, each finalist will present their abstract, highlighting key findings, methodologies, and the real-world impact of their work. The award winner will be announced live at the 2025 NHIA Annual Conference in Washington D.C.
Katie Laskin, PharmD, BCSCP, CNSC
Clinical Pharmacist
Yale New Haven Home Infusion
Katie Laskin, PharmD, BCSCP, CNSC is a Clinical Pharmacist with Yale New Haven Health's Home Infusion program. She received her PharmD from the University of Connecticut in 2005 and has been working in home infusion in various roles since 2006. She is a Board Certified Sterile Compiunding Pharmacist and a Certified Nutrition Support Clinician.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Katie Laskin has no relevant financial relationships with ineligible companies to disclose.
Natalie Garcia, PharmD
Pharmacy Resident
Option Care Health
Leslie Myers, PharmD, IgCP
CSI Pharmacy
Amy Braglia-Tarpey, MS, RD, CNSC
Amerita
Kascha Brown, PharmD
Pharmacy Resident
Option Care Health
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Contains 3 Component(s), Includes Credits
This article provides information on standardized assessment tools, common home infusion-related infections, and interdisciplinary involvement in patient monitoring and communication among providers.
Home infusion clinicians need to effectively address sepsis in patients through early recognition, prompt intervention, and a collaborative approach. This article provides information on standardized assessment tools, common home infusion-related infections, and interdisciplinary involvement in patient monitoring and communication among providers.
Learning Objectives:
- Describe sepsis and its clinical manifestations in the home infusion setting.
- Identify key risk factors of sepsis in home infusion patients to facilitate early recognition and intervention.
- Discuss monitoring strategies for home infusion therapy patients to prevent and manage infections.
- Determine the most common home infusion-related infections and their prevention strategies.
Anthony Casapao, PharmD, MPH, BCIDP, FIDSA
Clinical Associate Professor
University of Florida College of Pharmacy
He earned his Doctor of Pharmacy degree from Wingate University. He then completed postgraduate pharmacy practice and infectious diseases residency training at St. Vincent’s Medical Center and the University of Pittsburgh Medical Center, respectively. He continued his love of infectious diseases by completing a fellowship in health economics and outcomes research at Wayne State University. He further developed his research skills by completing a master's degree in public health with a concentration in Epidemiology and Biostatistics at Harvard University.
His research focuses on pharmacoepidemiology, evaluating post-marketing data, and applying more extensive data to understand public health problems and explore possible solutions. He also focuses on the off-label use of antimicrobials with comparative effectiveness methodologies, expanding on previous subject knowledge, applying more robust data, and providing confirmatory conclusions for controversial data. His substantial research focuses on antimicrobial resistance and the clinical implications of anti-infective therapies from a One Health perspective.
Dr. Casapao has published extensively in peer-reviewed journals and is a Fellow of the Infectious Diseases Society of America. At the University of Florida, he teaches, mentors, and guides students through their professional development, particularly in infectious diseases.NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Anthony Casapao has no relevant financial relationships with ineligible companies to disclose.
Tiffany Hart, BS
PharmD Candidate
University of Florida College of Pharmacy
Tiffany Hart is a PharmD candidate at the University of Florida College of Pharmacy, expected to graduate in May of 2025. She previously earned a Bachelor of Science in Psychology with a focus on counseling psychology from the University of Florida. Tiffany has a particular interest in pediatrics, neonatology, infectious disease, and psychiatric pharmacy, and is passionate about advancing care in these specialties through clinical practice and research. Tiffany is currently pursuing a residency program with the goal of becoming a clinical pediatric pharmacist, where she hopes to integrate her interests in pediatric care and infectious disease to improve patient outcomes.
In addition to her academic achievements, Tiffany is an active student leader at the University of Florida. She co-founded the Asian Student Pharmacist Coalition (ASPC) in 2022 and served as President for two terms, fostering community and advocating for diversity within the pharmacy program. Tiffany is also a dedicated Student Ambassador and Pharmacy Early Acceptance Program Mentor, roles through which she champions student advocacy and enhances representation of the profession. Although this is Tiffany's first publication, she is excited to continue contributing to medical writing and research throughout her career.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Tiffany Hart has no relevant financial relationships with ineligible companies to disclose.
Olga Afanaseva, MS
PharmD Candidate
University of Florida College of Pharmacy
I am a second-year PharmD student at the University of Florida College of Pharmacy. I was born in Russia and relocated to the United States with my family in 2018. I am passionate about clinical pharmacy and infectious diseases, with a strong interest in pharmacotherapy and patient care.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Olga Afanaseva has no relevant financial relationships with ineligible companies to disclose.
Timber Abinsay, AA
PharmD Candidate
University of Florida College of Pharmacy
Timber Abinsay is currently a second year pharmacy student at the University of Florida College of Pharmacy at the Jacksonville Campus and is expected to graduate in May 2027. She plans on doing a residency after graduation and her current areas of interest are Emergency Medicine, Critical Care, and Ambulatory Care. She hopes to make a difference in the lives of her patients and to advocate for her patients care which is her main motivation for being a pharmacist.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Timber Abinsay has no relevant financial relationships with ineligible companies to disclose.
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Contains 2 Component(s)
Multi-drug resistant tuberculosis (MDR-TB) has become a leading world health crisis. MDR-TB is defined as resistance to the potent cornerstone TB drugs, isoniazid and rifampin. Approximately, 3% of newly infected cases and 20% of pre-existing TB cases are diagnosed with MDR-TB.
Multi-drug resistant tuberculosis (MDR-TB) has become a leading world health crisis. MDR-TB is defined as resistance to the potent cornerstone TB drugs, isoniazid and rifampin. Approximately, 3% of newly infected cases and 20% of pre-existing TB cases are diagnosed with MDR-TB.
In recent years, aminoglycosides have become a part of the backbone of MDR-TB treatments. The most common aminoglycosides used for pulmonary TB are amikacin and streptomycin. Despite the lack of data on specific amikacin dosing and duration of treatment, it is still widely used as an add-on therapy in non-responsive MDR-TB patients. This article will review amikacin dosing and its use based on current guidelines; explore amikacin pharmacokentics and pharmacodynamics and dosing; explore the relationship between aminoglycosides and ototoxicity; and distinguish between monitoring methods in the home infusion setting.
LEARNING OBJECTIVES:
- Provide an overview of tuberculosis, multi-drug resistant tuberculosis (MDR-TB), and history of amikacin use.
- Understand aminoglycoside dosing and its use based on current guidelines.
- Comprehend amikacin pharmacokinetics and pharmacodynamics.
- Appreciate the relationship between aminoglocosides and ototoxicity.
- Distinguish between monitoring methods in the home infusion setting.
Vy Karp (Dang)
PharmD
Optum Infusion Services
Vy Karp (Dang), Pharm.D, HDDP is an Infusion Clinical Pharmacist at Optum Infusion Services in Wallingfor, Connecticut. She earned a Bachelor’s degree in Health Sciences at University of California, Irvine and a Doctor of Pharmacy degree at Roseman University of Health Sciences College of Pharmacy. Karp was a pharmacy practice resident in Las Vegas. She has practiced in infectious disease, genetics, oncology, and emergency medicine. Her current practice focuses on parenteral nutrition, acute care, inotropes, IV anti-infective agents, and pain management. She also provides clinical care for high-cost IV drugs including immunoglobulins (IGs), enzyme replacement therapies (eg. Fabrazyme), Radicava, Solaris, Entyvio, biologics, and alpha-1 proteinase inhibitors (eg. Glassia, Zemaira). Dang is currently licensed in Arizona, Connecticut, Massachusetts, Nevada and Ohio.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Vy Karp (Dang) has no relevant financial relationships with ineligible companies to disclose.
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Contains 3 Component(s), Includes Credits Recorded On: 09/20/2023
This presentation will focus on evaluating stability studies of parenteral drugs as a vital step in determining an appropriate BUD for CSPs.
When manufacturer product labeling provides limited or no guidance on usage timeframes, published stability studies can help justify extending the beyond-use date (BUD) of a compounded sterile preparation (CSP). This presentation, tailored for pharmacists, pharmacy technicians, nurses, and dietitians, will focus on evaluating stability studies of parenteral drugs as a vital step in determining an appropriate BUD for CSPs.
Learning Objectives:
- Navigate the literature resources and review drug stability studies for validity.
- Assess the applicability of a drug stability study to assigning a beyond-use date to a compounded sterile preparation.
- Differentiate the changes made in USP <797>, analyze how these impact the beyond-use date.
Michelle Simpson, PharmD, BCSCP, MWC
Clinical Program Manager
National Home Infusion Association
Michelle C. Simpson, PharmD, BCSCP, MWC, is a Board Certified Sterile Compounding Pharmacist with an established career in home infusion. She is the Clinical Program Manager for the National Home Infusion Association (NHIA), where she is responsible for research studies, non-profit foundation initiatives, data benchmarking, and clinical education development. Michelle is Editor in Chief of Infusion Journal, a peer-reviewed scholarly publication that features independent original research on infusion therapies and is published by the National Home Infusion Foundation (NHIF). Michelle is Co-Editor of Extended Stability for Parenteral Drugs, 7th Edition, a publication of the American Society of Health-System Pharmacists (ASHP).
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Michelle Simpson has no relevant financial relationships with ineligible companies to disclose.
Christpher Roy, PharmD, BCSCP
Pharmacist Training Specialist
Option Care Health
Chris Roy, PharmD, BCSCP, began his career with Option Care Health in 2018 as a PGY-1 resident. Since that point, he has held roles as a Clinical Pharmacist, Pharmacy Supervisor, and currently is the Pharmacist Training Specialist with Option Care Health. Chris believes that proper training and education are key to the future of the pharmacy profession and necessary to further the home infusion industry.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Christopher Roy has no relevant financial relationships with ineligible companies to disclose.
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Contains 3 Component(s), Includes Credits Recorded On: 11/14/2023
With a growing number of biosimilars available and interchangeable options emerging, this session explores what the future holds for these innovative therapies.
As biosimilars continue to expand their footprint in healthcare, their role in home and alternate site settings is becoming increasingly significant. With a growing number of biosimilars available and interchangeable options emerging, this session explores what the future holds for these innovative therapies. This session will delve into key concepts such as transitioning from parent products to biosimilars, understanding interchangeability, and addressing practical considerations for their use in clinical practice. Learners will gain valuable insights into the legislative, regulatory, and operational factors shaping biosimilar adoption in these care settings. This session is designed for pharmacists, pharmacy technicians, and nurses.
Learning Objectives:
- Review the legislative impact for pharmacies as it relates to interchangeability of approved molecules in clinical practice.
- Review current requirements for FDA approval of biosimilars and interchangeability requirements for biosimilars.
- Describe potential processes to overcome barriers to biosimilar adoption (prescribing, financial, operational).
Jonathan Ogurchak, PharmD, CSP
Co-Founder & CEO
STACK
Jonathan Ogurchak is the Founder & CEO of STACK, a compliance management software designed to simplify the “outside of the dispense” complexities associated with running successful pharmacy organizations. He is also Managing Partner of Rhythm Group, consulting and technology solutions organization, and is a Certified Consultant with Accreditation Commission for Health Care (ACHC). Jonathan has designed programs and services for both Accredo and PANTHERx Specialty Pharmacy focusing on implementing innovative uses for technology, including high-touch pharmacist-driven programs focused on dosing efficiency, clinical monitoring of patient outcomes, and integrated patient engagement. Jonathan is on faculty for the Master of Pharmacy Business Administration (MPBA) program through the University of Pittsburgh, leading the Specialty Pharmacy Management curriculum. He currently serves on the editorial board for Specialty Pharmacy Times, holds CSP Certification through the Specialty Pharmacy Certification Board, and serves as an Educational Consultant for the National Association of Specialty Pharmacy (NASP).
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Jonathan Ogurchak has no relevant financial relationships with ineligible companies to disclose.
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Contains 2 Component(s) Recorded On: 04/10/2024
Amid the demand for infusion services and persistent nursing shortages, the relationship between specialty pharmacies and nursing agencies is vital.
Amid the demand for infusion services and persistent nursing shortages, the relationship between specialty pharmacies and nursing agencies is vital. Join AlayaCare and leading industry experts for a roundtable discussion on the importance of a trusted network in delivering top-tier home infusion services. Learn strategies for boosting collaboration, remaining competitive, tackling staffing challenges, and improving patient outcomes.
Learning Objectives:
- Recognize the crucial role of collaboration between specialty pharmacies and nursing agencies in delivering home infusion care.
- Explore methods to improve visibility into care provided, enhancing patient outcomes and satisfaction.
- Discover how strategic partnerships and innovative solutions can help address the ongoing nursing shortage crisis.
- Learn techniques to leverage networks for streamlined referral processes and consolidated patient referrals.
- Gain insights into revenue recognition strategies and how to maintain a competitive edge in the infusion market landscape.
This program is generously supported by NHIA member AlayaCare.
Kaila Raimondo
Market Leader, Infusion
AlayaCare
Kaila Raimondo is the Market Leader for Home Infusion and Skilled Nursing at AlayaCare. With a background in solution engineering and customer success, she is committed to adapting healthcare technology to meet the unique needs of the home infusion market. Kaila supports organizations in implementing new technology and achieving better outcomes across the United States. Her dedication to utilizing innovative solutions positions her as a driving force in advancing healthcare technology and surpassing market expectations.
No Disclosures to Report
Leslie Myers
Director of Clinical Services
CureCare
Leslie Myers is a motivated and strategic Clinical Pharmacist with a Doctor of Pharmacy degree and more than 15 years of experience including multiple leadership roles and extensive experience in specialty pharmacy. Currently, she holds the position as the Director of Clinical Services at CureCare, one of the largest independent nursing providers of specialty therapy infusions
No Disclosures to Report
Susan Bauer
Director of Clinical Quality & Compliance
AOM Infusion
Susan has been in the home infusion industry for the past 37 years in varying roles, providing field nursing, in office chemotherapy infusions, managing the nursing departments for various organizations both locally and nationally and overseeing quality programs. Susan is currently employed with AOM Infusion in New York and has been with the organization since the inception of the nursing department in 2001, growing a strong and talented nursing team. Her current role at AOM is Director of Clinical Quality and Compliance. She is responsible for overseeing the company’s quality initiatives as well as the company’s compliance program.
No Disclosures to Report
Trevor Conant
VP Home Infusion Services
Dynamic Infusion
Trevor has successfully managed and expanded multiple healthcare sector accounts, implementing strategic initiatives to improve service quality and operational efficiency. Currently, he holds the position of Vice President of Home Infusion Services at Dynamic Infusion, overseeing the delivery of nursing solutions across 9 states and managing relationships with over 35 specialty pharmacies. Dynamic Infusion holds accreditation from the Joint Commission and aims to expand its presence to several additional states by year-end, further advancing its provision of infusion nursing services.
No Disclosures to Report
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Contains 2 Component(s) Recorded On: 01/18/2023
This webinar will describe components of a healthy, joyful workplace and discuss strategies to help you create a culture of wellness at your organization.
Moving forward after the Pandemic, it remains critical that healthcare employees across the continuum spend time and energy focusing on their own well-being and on the well-being of their colleagues and workplace culture. This webinar will describe components of a healthy, joyful workplace and discuss strategies to help you create a culture of wellness at your organization.
Learning Objectives:
- Increase understanding of the connection between well-being and workplace culture.
- Describe components of a healthy and joyful workplace.
- Discuss strategies to help you create a culture of wellness at your organization.
- Discuss ways to prioritize physical, mental and interpersonal wellness.
Alissa Putman, PhD, Licensed Psychologist
Organization, Development & Training Consultant
Johns Hopkins Community Physicians
Dr. Alissa Putman is a licensed psychologist, Principal of AGP Consultation and Coaching and an Organization Development and Training Consultant with Johns Hopkins Community Physicians. She has over twenty years of experience providing support to professionals in healthcare and higher education, specializing in executive coaching, leadership and team development, change management, and conflict management. As a consulting psychologist, Dr. Putman helps organizations maximize performance, well-being, engagement and productivity. She has taught over 300 trainings on stress and time management, job burnout, combating negativity, managing change, building resiliency and teambuilding. She is also a certified Unconscious Bias trainer.
NHIA Requires planners, faculty, and others who affect the content of this activity to disclose all financial relationships they have with ineligible companies. All relevant financial relationships are thoroughly vetted and mitigated according to policy.
Alissa Putman has no relevant financial relationships with ineligible companies to disclose.
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Contains 2 Component(s) Recorded On: 05/24/2023
Learn how a comprehensive, integrated solution can solve the challenges of communication and care team coordination across your patients' entire care journey, including accelerated speed to therapy, increased revenue retention, and improved adherence.
Learn how a comprehensive, integrated solution can solve the challenges of communication and care team coordinator across your patients' entire care journey, including accelerated speed to therapy, increased revenue retention, and improved adherence. From clinical and non-clinical frontlike workers to c-suite leadership, you will understand how the entire organization can benefit from an all-in-one digital solution that provides a powerful return on investment by saving essential time, improving compliance and documentation accuracy, and increasing operational efficiency, all while integrating into your pharmacy dispensing system.
Learning Objectives:
- Understand how a comprehensive, digital solution provides a powerful return on investment by saving essential time, improving compliance and documentation accuracy, and increasing operational efficiency.
- Learn how to accelerate your speed to therapy, increase revenue retention, and improve patient adherence.
- Explore ways to improve communication and care team coordination across your patients' entire care journey.
Sponsored by CitusHealth
Jackie Owen, RN, BSN
Clinical Product Specialist
Citus Health
Jackie Owen is an RN, BSN and Clinical Product Specialist for CitusHealth, with prior roles in sales, accounts, RN infusion management and as director of ambulatory infusion centers. Her range of experience is why she understands the need for a great patient engagement and internal communication collaboration platform. With 15 years as an RN in acute, post-acute and primary home infusion — and a previous customer of CitusHealth — Jackie is passionate about the CitusHealth system and enjoys sharing the benefits with current and potential customers.
No Disclosures to Report
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Contains 2 Product(s)
Short bowel syndrome is a frequently encountered disease we see in the home infusion industry. The management of SBS is complex and often patients have a variety of needs including nutritional and medical and surgical management.
Short bowel syndrome is a frequently encountered disease we see in the home infusion industry. The management of SBS is complex and often patients have a variety of needs including nutritional and medical and surgical management.
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