Identifying and interpreting enforcement trends inside the regulatory actions for 503B outsourced compounders can assist health care facilities in choosing appropriate 503B partners. Furthermore, an understanding of the FDA’s current focus can help hospital and health system pharmacies monitor their outsourcing partners while improving their own compounding programs. Utilizing the largest independent database of FDA compounding activities and documents outside of the FDA itself, Lou Diorio, RPh, FAPhA, of LDT Health Solutions will analyze the long-term trends and current developments in FDA inspections of 503B compounders.
USP <800> requires the use of CSTDs for drug administration and recommends the use of CSTDs where possible for drug preparation. While most pharmacies have implemented CSTDs in the pharmacy, usage on the units is not as consistent, leaving facilities at risk for regulatory actions. In this webinar, Fred Massoomi and Seth Eisenberg will review opportunities to ensure appropriate CSTD adoptions throughout the facility.
Expedite Workflow and Manage HD Challenges with CSTDs
November 12, 2021
In this webinar, Scott Soefje, director of pharmacy cancer care services at the Mayo Clinic, will review challenges pharmacy faces in preparing hazardous drugs. Attendees will learn how CSTDs can be used to overcome these challenges, increase workflow efficiency, and help enhance safety and compliance.
To Crush or Not to Crush: Challenges & Risks of Crushing & Compounding Medications In the New Era
November 5, 2021
With the COVID-19 pandemic, pharmacy continues to manage new challenges in medication handling, including risks related to product selection, preparation, and administration. In this webinar, Huda Cotta-Dethlefs, PharmD, will explore how to improve communication among all members of the health care team under today’s circumstances and beyond for safer patient outcomes. The presentation will explore solutions to some of the clinical and practical challenges in medication handling, with a focus on compounding and medication crushing, as well as unit dose purchasing options.
Training Pharmacy Technicians for USP <800> Compliance
October 22, 2021
Pharmacies face challenges in training technicians to demonstrate competence and compliance, especially regarding USP <800> guidelines. In this webinar, Abby Roth will provide strategies that pharmacists can use to maximize the capabilities of a fully trained technician support system.
Maintaining a state of control is essential in the cleanroom. In this webinar, Patti Kienle will review updates to USP standards, clarify environmental monitoring guidelines, detail how to conduct air and surface sampling, and identify locations for HD wipe sampling.
Strategies to Prevent Medication Tampering and Diversion
July 16, 2021
The process of diversion prevention can begin with strategies to eliminate medication tampering. In this webinar, Kimberly New, JD, BSN, RN, will illustrate how to provide a foundation for success by implementing security measures that prevent tampering. Further, attendees will learn how to ensure continuous practice improvement via structured reporting and scheduled audits.
USP <800> Compliance Update: A Sneak Peek at PP&P’s Latest Data
July 14, 2021
Protecting health care personnel from HD exposure is an essential pharmacy responsibility, and USP <800> establishes guidelines to mitigate this risk. In this webinar, based on PP&P’s most recent survey data, Fred Massoomi and Deanne Halvorsen will review regulatory requirements, recent inspection focal points, and the current state of compliance to USP <800> by hospitals nationwide.
Drug Shortages: Conquering Supply Chain Issues with Data and Automation
June 25, 2021
To effectively manage drug shortages, pharmacists must apply a holistic, data-driven approach that goes beyond the supply chain. In this webinar, Tina Moen, PharmD, and Nate Peaty, PharmD, MS, will explore how data aggregation and automation can revolutionize a pharmacy’s drug inventory status situational awareness. They will also discuss the latest drug shortage management options available to successfully respond to evolving trends and provide optimal/evidence based patient care in this critical workflow.
Identifying Sources of Contamination in the Cleanroom
June 18, 2021
Even with a compliant environmental monitoring program and a robust cleaning regimen, pharmacy is subject to contamination events in the cleanroom. In this webinar, Jim Wagner will discuss how to identify and mitigate potential points of contamination.
PECs are active all day, every day, for years at a time. As such, they must be maintained on an ongoing basis. In this webinar, Fred Massoomi, PharmD, FASHP, will discuss the types of maintenance necessary for different PECs, how to determine the lifespan of the PEC, and ways to ensure adherence to maintenance expectations.
Patricia C. Kienle, RPh, MPA, BCSCP, FASHP, director of accreditation and medication safety for Cardinal Health, brings her expertise to help pharmacy identify gaps to achieving USP <800> compliance. In this webinar, Patti will share tips on establishing policies & procedures, how to conduct an assessment of risk, how to define the role of the Designated Person, and more.
Gain Buy-In for CSTDs: A Personal Story from a Pharmacist Cancer Survivor
January 22, 2021
Mark Stanfield, BFA, PharmD, Oncology Pharmacy Specialist at Providence Hood River Cancer Center in Hood River, OR, shares his unique personal story of standing up for the safety of his health system’s patients as well as his own. After receiving a cancer diagnosis, Mark led an effort to update his acute care hospital’s closed system drug-transfer device (CSTD). In this webinar, he will outline the necessary steps to convert to a safer system, discussing the system’s benefits and advantages and providing pointers on how other pharmacies can gain buy-in and exercise influence, regardless of hospital bed size.
Partnering with a 503B outsourced compounder is essential for many hospital pharmacies, but there are a variety of factors to weigh before making a decision. In this webinar, Eric S. Kastango, MBA, RPh, FASHP, vice president and managing partner at Kastango Consulting, provides guidance to the pharmacy, including how to respond to FDA 483s, and what to look for when visiting an outsourced compounding facility, the effects of drug shortages, and more.
To Crush or Not to Crush: Challenges & Risks of Crushing & Compounding Medications In the New Era
November 20, 2020
With the COVID-19 pandemic, pharmacy must manage new challenges in medication handling, including risks related to product selection, preparation, and administration. In this webinar, Rob Accetta, RPh, BCGP, C-MTM, will explore how to improve communication among all members of the health care team under today’s circumstances and beyond for safer patient outcomes. The presentation will explore solutions to some of the clinical and practical challenges in medication handling, with a focus on compounding and medication crushing. Attendees will learn about an FDA-approved product that provides a safe alternative when clinically appropriate.
The Opioid Crisis: Pharmacy Practices to Prevent Abuse
September 25, 2020
Jeffrey Swanson, head of sales at Pharma Logistics, outlines how pharmacists can help prevent opioid abuse and overdose. In an effort to prevent diversion and misuse of opioid prescriptions, attendees will learn: How to identify signs that a patient may be struggling with opioid use disorder; Best practices for working collaboratively with prescribers; How to counsel patients suspected of opioid use disorder; Safe disposal methods for unused opioids.
Cleanroom Construction During the COVID-19 Pandemic
August 28, 2020
Bhavesh Shah, RPh, BCOP, director of specialty and hematology/oncology services at Boston Medical Center, discusses his hospital’s experience implementing a new cleanroom amidst the COVID-19 crisis. Topics such as financing, certification, and emergency considerations are examined, providing useful tips for facilities to use during and following the pandemic.
Fred Massoomi, PharmD, FASHP, demonstrates how cleaning fundamentals relate to USP standards for cleaning primary engineering controls (PECs). He will review the fundamentals of effective cleanroom cleaning practices, dispelling myths about compliant cleaning. Participants will also learn how to troubleshoot cleaning programs.
Mattias Paulsson, deputy chief pharmacist at the Uppsala University Children’s Hospital in Sweden, discusses the advantages of compounding hazardous drugs via robot technology, with a focus on staff and medication safety, cost savings, and workflow efficiency. In addition, training and quality assurance requirements are addressed.
IV Workflow Drives USP Compliance: A Case Study in Managing Failure Investigations
December 17, 2019
Sarah Emanuele, PharmD, manager of pharmacy systems and operations at the University of Wisconsin, shares her experience leveraging IV workflow software to monitor staff practices in the cleanroom, from garbing to environmental monitoring and cleaning.
USP Compliance: Safe Implementation of PECs Under USP <797> and <800>
October 18, 2019
Jim Wagner reviews the impact of the changes to USP <797> with regard to PEC implementation & USP <800> requirements for containment, best positioning of PECs for improving workflow, and provides important insight into airflow considerations.
Insourcing Ready To Administer Syringes with IV Robotics: A Hospital Case Study
September 27, 2019
Kevin Hansen lists considerations for insourcing RTA syringes with IV robotics, outlines an implementation strategy for IV robotic insourcing, and interprets compounding standards to appropriately apply extended beyond-use dates to compounded sterile preparations.
Leveraging IV Automation to Improve Safety, Quality, and Efficiency in the Cleanroom
September 13, 2019
Dennis Killian reviews considerations for insourcing RTA syringes with IV robotics, demonstrates how one facility evaluated and implemented insourcing RTA syringes with IV robotics, and discusses strategies to optimize an IV robotics sterile compounding program.
Cleanroom Design Under <800>: Cleanroom Layout
November 9, 2018
Learn the necessary elements to establish a cleanroom layout under USP <800>. Topics include door and pass-through placement, hood and refrigerator placement, air pressure relationships between the buffer room and ante-room locations, and more.
Safe Preparation and Administration Strategies for IV Push Medications
November 1, 2018
Kevin Hansen shares his approach for developing effective IV preparation and administration strategies that focuses on identifying the most appropriate admixture options and safe compounding practices.
Cleanroom Design Under <800>: Preparing for Construction
June 15, 2018
In this webinar, learn to prepare for cleanroom construction under USP <800>. Topics include HVAC and ventilation requirements, strategies for communicating with engineers and facilities departments, and design tips.
Our expert panel discusses how to: establish policies and procedures to manage the GPO exclusion rule, understand the impact of Medicaid carve-out decisions, identify the requirements for utilizing contract pharmacies, and access available tools to develop a successful mock audit program.
Listen to this informative discussion as our panel of experts addresses how hospitals can improve medication order management, including automating much of the manual, paper-based medication order process, adding real-time communication among those involved, and enabling access to customized reporting to avert errors during the medication ordering process.