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Package Performance Qualification: What It Is, Why It’s Important and How It Works

On January 14, 2021, NASP published a podcast featuring Katie Kraverath, Senior Business Development Manager for Temptime Corporation and Bill Barrows, Program Director, Partner’s Healthcare Specialty Pharmacy, hosted by Sheila Arquette, Executive Director of NASP. In this special NASP podcast focused on Package Performance Qualification (PPQ) testing, they discussed:

  • the evolving regulatory environment
  • how PPQ testing plays a role in compliance and
  • how it can also help ensure the efficacy of temperature-sensitive medication is maintained throughout shipping.

Accrediting agencies like URAC continue to revise their standards with the goal of ensuring the best patient outcomes. Similarly, payers and Pharmacy Benefit Managers (PBMs) are also making conditions for network participation more stringent. PPQ testing is one such requirement that both have put in place. PPQ testing uses electronic temperature sensors to verify that packouts used to send medication to patients is actually keeping medication within the temperature range they should. It differs from operational qualification testing, which is conducted by the manufacturer in a temperature-controlled chamber, by testing packouts in real-life situations.

While in many instances specialty pharmacies can conduct PPQ testing on their own, Katie notes that third-party testing is growing in popularity. That’s due in part to the payer and PBM requirements, some of which specifically call for third-party PPQ testing and reporting. “These payer contracts are really vital for specialty pharmacies to maximize their revenue potential and growth,” says Katie. “Needless to say they are very interested in making sure they comply.” URAC, on the other hand, has no such mandate. However, as URAC has expanded their requirements to include PPQ testing of controlled room temperature (CRT) packouts, which can be challenging, specialty pharmacies are turning to third parties for help.

Third-party testing has a number of advantages outside of compliance. It can save specialty pharmacies a lot of time, for instance, and an experienced third-party can help improve packout configurations as well as assist in developing SOPs for consistent, accurate packing protocols. Plus, an initial round of third-party PPQ testing will satisfy both PBM and URAC requirements, and additional bi-annual third-party testing will help maintain compliance with URAC standards. Beyond meeting accreditation and payer requirements, Bill says ensuring the efficacy of the medications they send to patients is critical – and testing just gives the pharmacy and patients added peace of mind.

You can access the full podcast to hear more about what Katie and Bill had to say about the importance of PPQ testing.