This has certainly been a strange time as we all learn new ways to work. In some ways it feels as if time is standing still – yet, specialty and mail order pharmacies may find they are busier than ever. Either way, summer will be here before we know it, making now a good time to take a step back and plan ahead for your biannual performance qualification (PQ) testing, especially if you are working toward or looking to renew URAC accreditation.

URAC 4.0 and PQ Testing

In late 2019, URAC revised its standards for specialty and mail-order pharmacies, including new requirements around PQ testing. PQ testing must now be conducted:

  • On frozen and room temperature products in addition to refrigerated products
  • At least twice a year for each:
    • Packout size, type and shipment method
    • Geographic distribution and seasonal temperature profile

You can learn more about the specifics of URAC 4.0 and what it means you to in this on-demand URAC v 4.0 webinar.

Internal vs Third-Party PQ Testing

URAC has no specific requirements on who conducts testing. That means specialty and mail-order pharmacies can choose to use internal resources, following URAC protocols, or hire a third-party vendor. The question is, which is best for your organization?

According to Katie Kraverath, Business Development Manager for Temptime, some pharmacies prefer to keep testing in-house because it can be less expensive. “They also feel like they have more flexibility,” Katie says. “They can test as much as they want with tweaks to packout design, process or shipping dates and locations so they can compare results.”

For others, outsourcing PQ testing to a third-party is the right answer for a variety of reasons. “Pharmacies seeking URAC accreditation for the first time might be new to PQ testing,” explains Katie. “Using an expert third-party eliminates the need for them to develop their own testing regime while giving them insight into an established PQ testing process.” An experienced third-party can also help with packout reconfiguration and the development of successful SOPs should the initial packout perform poorly in testing. Using an external provider also frees up internal resources, allowing pharmacies to redirect staff to other important projects. “Some pharmacy networks are now requiring that specialty pharmacies conduct third-party PQ testing in order to qualify for participation,” Katie adds.

How Third-Party PQ Testing Works

Phase 1: Packout Evaluation

In Phase 1, two sizes of medication packouts with wireless sensors enclosed are shipped to the third party for evaluation. The third party then provides packout configuration recommendations to the pharmacy.

PQ performance qualification packout evaluation for specialty pharmacy medication shipments
Above: Diagram of PQ Testing Phase 1

Phase 2: PQ Testing Evaluation

In Phase 2, the pharmacy prepares packouts based on the third party recommendations, again including wireless sensors.  The packouts are shipped to different locations, based on factors such as geography, transportation mode and excursion time. The time-temperature data is sent to mobile devices and uploaded for evaluation by the third party, and used to create the PQ Validation Report.

Validating temperature sensitive medication packouts for specialty pharmacy medication shipments
Above: Diagram of PQ Testing Phase 2

Why Temptime for PQ Testing

In addition to delivering a complete Performance Quality Validation Report that details the results of your third-party PQ testing – Temptime works closely with you throughout the process to custom design a program that’s specific to your pharmacy. That’s because we do not believe in a one size fits all approach, and tailor your PQ testing based on a number of factors, including:

  • Modes of transportation by which medication is sent – ground or air (or both)
  • Various shipping durations – for example, 24, 48 and/or 72 hours
  • Other excursion allowances, for example +/- 0.5Cº and +/- 1Cº
  • Different temperature profiles such as refrigerated, room temperature (CRT) and/or frozen packouts
  • Specific testing for each unique geographic service area
Diagram of thermal packaging for medication shipments from specialty pharmacy to protect against heat and cold exposures
Above: Packout Recommendation Example

Learn More

You can learn more about Temptime’s third-party PQ testing process in this recent VUEPoint Case Study where AON Pharmacy shared their experiences with PQ testing packouts going from their Florida location for delivery to Florida, New Jersey and Indiana.

For those interested in conducting their own PQ testing, read last year’s white paper “Safeguarding the Integrity of Medications: Shipping Matters,” by US Specialty Care (USSC). Here you’ll find a comprehensive overview of their testing including best practices and a details section “What You Need to Know about Testing”.

Contact Temptime for Third Party PQ Testing