On Novemeber 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 pharmacies 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:

1. Review the latest updates to USP General Chapter <797> compared to the 2008 version which remains enforceable until November 1, 2023. 
2. Understand the difference between Category 1, 2, and 3 compounded sterile preparations (CSPs) and list the specific requirements for each.
3. Describe the requirements for personnel qualification and evaluation.
4. Explain the increased frequencies for environmental monitoring and cleaning.

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.

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:

1. Provide an overview of tuberculosis, multi-drug resistant tuberculosis (MDR-TB), and history of amikacin use.
2. Understand aminoglycoside dosing and its use based on current guidelines.
3. Comprehend amikacin pharmacokinetics and pharmacodynamics.
4. Appreciate the relationship between aminoglocosides and ototoxicity.
5. Distinguish between monitoring methods in the home infusion setting.

When the usage timeframe in the manufacturer product labeling is limited or omitted, published stability studies can potentially support extending the beyond-use date assigned to a compounded sterile preparation. This presentation will focus on the process of evaluating stability studies of parenteral drugs as a critical step in determining an appropriate beyond-use date for a compounded sterile preparation. 

Learning Objectives:

1. Navigate the literature resources and review drug stability studies for validity.
2. Assess the applicability of a drug stability study to assigning a beyond-use date to a compounded sterile preparation.
3. Differentiate the changes made in USP <797>, analyze how these impact the beyond-use date. 

What is the future of biosimilars in the home and alternate site? There are numerous options now available and even now interchangeable options. We will take a look at various concepts related to biosimilars including transition from the parent product to a biosimilar, determining what is interchangeable, and more. 

Learning Objectives:

1. Review the legislative impact for pharmacies as it relates to interchangeability of approved molecules in clinical practice. 
2. Review current requirements for FDA approval of biosimilars and interchangeability requirements for biosimilars.
3. Describe potential processes to overcome barriers to biosimilar adoption (prescribing, financial, operational).

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. 

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:

1. Increase understanding of the connection between well-being and workplace culture. 
2. Describe components of a healthy and joyful workplace. 
3. Discuss strategies to help you create a culture of wellness at your organization. 
4. Discuss ways to prioritize physical, mental and interpersonal wellness. 

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

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. 

Gastroparesis, also known as delayed gastric emptying, is a disorder that impairs the stomach's ability to move food effectively to the small intestine. This condition results from inadequate or absent stomach muscle function, leading to delayed digestion and a range of symptoms such as nausea, vomiting, early fullness, postprandial discomfort, and epigastric pain. This comprehensive activity will delve into the complexities of gastroparesis, offering a detailed overview of its diagnosis, symptoms, complications, and treatment strategies. The role of the home infusion clinical team in providing essential nutrition support will also be discussed. Furthermore, a clinical case study will be presented to illustrate practical approaches to managing this challenging condition. This activity is designed for pharmacists, pharmacy technicians, and nurses.

1. Identify the prevalence and clinical conditions associated with gastroparesis.
2. Recognize diagnostic options for gastroparesis and reliability associated with each option.
3. Distinguish the symptoms marked by gastroparesis and treatment method established for this condition.
4. Describe post viral gastroparesis and the relative mechanism of action.

NHIA General CE Information