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URAC v 4.0 is Here – Changes to Performance Qualification Testing

In late 2019, URAC revised its Specialty Pharmacy standard to v 4.0.  While there were a number of updates, one in particular could have a major impact on your operations.  P-OPS 8: Distribution requires that: 

“Shipments are packaged to maintain temperature and integrity based on USP recommendations and manufacturer guidelines. Disruptions to the shipping process are handled to ensure the patient has a continuous supply of medication.”

To do that, URAC v 4.0 expands on previous requirements around Qualification – or Performance Qualification (PQ) – testing. There are two key differences that specialty pharmacies either seeking or looking to renew URAC accreditation need to be aware of.

PQ testing must now be conducted:

  • On frozen and room temperature products – not just refrigerated products as previously
  • Twice a year instead of once on each packout size, type and shipment method while also taking into account the geographic distribution of products and different seasonal temperature profiles

Specialty pharmacies have two options for conducting PQ testing. They can conduct testing on their own, following URAC protocols, or they can use a third-party vendor. There are several benefits to using a third party. In addition to satisfying URAC requirements, it may also help qualify for participation in certain pharmacy networks to gain access to reimbursements. Relying on a third-party vendor with years of experience and proven PQ testing processes also frees up time and resources internally to focus on other important projects.

Third-Party PQ Testing – How Does it Work?

In a recent VUEPoint Case Study, AON Pharmacy shared how they partnered with Temptime, who used their EDGE wireless sensors to perform PQ testing on packouts going from their Florida location for delivery to Florida, New Jersey and Indiana as they pursued URAC accreditation.  The different tests and temperature profiles validated that their packouts were performing as anticipated, and provided the detailed data and documentation to back it up.

PQ Testing Data for Shipment from Florida to Indiana in July

Getting Down to the Details

US Specialty Care (USSC) authored a White Paper, “Safeguarding the Integrity of Medications: Shipping Matters,” last year. In it they provided a comprehensive overview of their testing, including best practices implemented to validate their packouts.  A detailed section – “What You Need to Know About Testing” – may be especially useful for specialty pharmacies looking to perform their own PQ testing

You can access an on-demand URAC v 4.0 webinar for more information about the new standards, including P-OPS 8: Distribution. Or to learn more about how Temptime can help you with third party PQ testing, contact us at… or visit EDGE PQ Performance Qualification Testing.