Related Articles

• URAC 4.0 and Package Performance Qualification Testing
• Greatest Cold Chain Challenges for Speciality Pharmacies

Moderator

• W. Hays Waldrop
  Founder and President of IHES and The Council of Supply Chain Executives

Panelists

• Michael Becker
  Director of Quality and Accreditation
  Trellis Rx
• Mel Nelson, PharmD 
  Regional Operations Manager
  Fairview Specialty Pharmacy – specialty, mail service, discharge, ASC-based and hemophilia pharmacies
• Douglas Samojedny, RPh 
  Director of Specialty Operations
  Pharmacy Advantage, Henry Ford Health System

Topic

The last year has brought a lot of changes to the specialty and hospital pharmacy industry. In late 2019, URAC revised its Specialty Pharmacy standard to v 4.0 – updating guidelines around package performance qualification testing (PPQ), which requires documented proof that medication temperatures are monitored and maintained during shipping. In addition to this, more and more PBM’s are requiring PPQ testing in order to participate in their networks while various boards of pharmacies around the country have begun to put greater focus on medication temperature monitoring – both onsite and in transit.

As if this weren’t enough to consider, 2020 has changed everything. At least for the short-term, COVID-19 has increased the volume of medication being sent directly to patients’ homes in many states – a trend that may continue.

To help you navigate the changes as well as the general complexities of cold chain shipments, Temptime, now a part of Zebra technologies, Is bringing together a group of specialty pharmacy experts in operations, quality and accreditation to discuss what you need to know for compliance while also delivering the best patient care. Specifically, they will explore issues critical to the  specialty pharmacy industry, including:

• The science behind cold chain shipping and why it’s critical to maintaining the efficacy of the medication you distribute, and providing the best care to your patients
• What you need to know about the URAC 4.0 updates and how to ensure compliance to maintain accreditation, including new package performance testing
• Guidelines around package performance qualification (PPQ) testing, including third-party testing and how frequently testing should be conducted
• Current and potential impacts of COVID-19 on specialty and hospital pharmacy business models and processes
• The role temperature indicators play in patient medication shipments, the potential return-on-investment, and the impact on patient satisfaction

Biographies

Michael Becker, Director of Quality and Accreditation for Trellis Rx

As the Director of Quality and Accreditation at Trellis Rx, Michael Becker is focused on instilling a culture of quality across the organization. His responsibilities include leading the accreditation process for health systems across the country, overseeing the development of the organization’s educational and professional development initiatives, and managing other quality-related activities including audits, policy management, and reporting. Michael began his specialty career as the Director of Specialty Pharmacy at Noble Health Services in Syracuse, New York. While there, he oversaw national service delivery and the pursuit and ongoing compliance with URAC, ACHC, CPPA, and VIPPS Accreditations. He has also worked as a specialty pharmacy consultant for Therigy on operations, technology, and accreditation related initiatives.

Mel Nelson, PharmD, Regional Operations Manager for Fairview Specialty Pharmacy’s

Mel Nelson is a Regional Operations Manager over Fairview’s specialty, mail service, discharge, ASC-based and hemophilia pharmacies. Ms. Nelson received her Doctor of Pharmacy degree from the University of Minnesota in 2011. She began her pharmacist career at Hennepin County Medical Center with a focus on the management of transplant patients. Since transitioning to Fairview in 2013 she has held successively more significant leadership roles. Ms. Nelson was one of the first Certified Specialty Pharmacists in the country, earning her CSP designation in 2017. She serves on the CSP Exam Prep Subcommittee for the National Association of Specialty Pharmacy and is a frequent trainer and workshop speaker.

Douglas Samojedny RPh, Director of Specialty Operations at Henry Ford Pharmacy Advantage

Douglas Samojedny is the Director of Specialty Operations at Henry Ford Pharmacy Advantage located in Rochester Hills, MI. Douglas graduated from Ferris State University in 1982. Due to his background in both ambulatory pharmacy and the clinical arena, along with impeccable performance reviews, he advanced to a leadership role.  

Over the next 12 years of administrative service, Mr. Samojedny accumulated accolades spanning the gamut of design and innovation.  Among these accomplishments, he was instrumental in building and expanding of pharmacy departments at two surgery centers. Douglas also set up a pharmacy in a long-term care setting, one community mental health facility and four additional retail pharmacy sites.  Individually, he was responsible for streamlining the operational workflow procedures to create a more efficient standard of practice.

In the year 2012, Douglas agreed to join the flourishing Pharmacy Advantage team and took on the role of Operations Manager.  Presently he is the Director of Pharmacy Operations with a wide range of duties. These duties include: supervising dispensing practices, monitoring delivery procedures to safeguard the shipment of quality pharmaceutical products, examining program policies to identify areas of service improvement, executing the proper handling and distribution of specialty medications through close partnerships with manufacturers, payers, and clinical staff.

W. Hays Waldrop, Founder and President of IHES and The Council of Supply Chain Executives

W. Hays Waldrop, Founder and President of IHES and The Council of Supply Chain Executives, has an extensive background in both healthcare and technology. He began his career in the healthcare industry selling orthopedic implants and related surgical products with a market leading orthopedic manufacturer. Since then, he has been recognized twice as one of the Top 100 Healthcare Executives in the talent-rich Nashville, TN area, a multi year Nashville In Charge Healthcare recipient, as well as honored with the Nashville Business Journal’s Healthcare Hero Award. He is a member of both Leadership Healthcare, a division of the Nashville Healthcare Council, and the American College of Healthcare Executives.