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Payers, manufacturers and patients now expect proof of quality year-round, and temperature-controlled shipping is often where that proof falls short.
For many years, specialty pharmacies treated accreditation as a gate to clear every three years. Jonathan Ogurchak, CEO and co-founder of Zeal Specialty Pharmacy, remembers his first accreditation cycle at Accredo around 2009, when outpatient pharmacy teams were still learning what a survey involved and tended to rest easy once it was behind them. Speaking on an ACHC-hosted webinar with MaxQ, he described how that approach has given way to something closer to a daily audit, with pharmacies expected to show their quality between survey visits as well as during them.
Payers and PBMs now write quality requirements into network contracts, manufacturers ask about accreditation and performance when pharmacies apply to limited distribution networks, and patients who can get a package from Amazon within hours expect the same reliability from the pharmacy shipping their medication. Each of them wants evidence. Temperature-controlled shipping is one of the places where that evidence most often goes missing, because once a packout leaves the building, the data behind it is the only record of what happened inside the box.
The guidance pharmacies work from points in the same direction. USP General Chapter <1079> lays out good storage and distribution practices for drug products using a risk-based approach, and a companion chapter, <1079.5>, is devoted to the qualification of shipping systems. ACHC's educational flyer on drug storage and distribution, built on <1079>, suggests pharmacies account for seasonal lane conditions, validate past expected delivery times (noting that many companies set 36 hours as a minimum), and run at least three replicate tests per season using a representative package and payload.
Why packout proof matters to patients
Ogurchak kept bringing the conversation back to the person opening the box. "If I were a patient and something showed up at my house in the middle of summer and the gel packs were a little bit mushy, you'd want to know that your drug is not going to be compromised." In rare and orphan disease populations, where patient counts are small, he noted that every miss and near miss ends up under the microscope.
He learned early in his career how expensive the answer can be. At a former employer, he was responsible for approving IVIG reshipments whenever a patient or physician called to say a delivery might have gone out of range. He described each replacement as roughly a $20,000 shipment, and on some days he signed off on five or six of them. What bothered him most was that nobody had data showing whether the packouts held temperature in the first place, so every uncertain call ended the same way, with another box going out the door. "Why aren't we doing more to actually show that these packouts are compliant and they're doing what they need to do?" he remembered asking.
Revalidating the validation
At Zeal, the compliance director keeps shippers in her office for testing, and the team sends trial shipments across the country to confirm what the packaging vendor's documentation already says. Ogurchak calls the practice revalidating the validation, a way to show the pharmacy is "not just taking your word for it" and to keep its own layer of data behind every packout decision.
The practice came up again during audience questions, when an attendee asked whether a pharmacy holding vendor documentation would still need internal testing for an accreditation survey. Ogurchak explained that surveyors mainly want to see a defined process that the pharmacy follows, and vendor testing covers much of that ground. He still considers internal verification a best practice, especially since accreditation expectations for temperature-sensitive shipping have tightened and relaxed over the years.
Balaji Jayakumar, COO at MaxQ, walked through how the two layers fit together. The packaging manufacturer supplies a design qualification (DQ) report showing that a shipper keeps its payload in range through summer and winter temperature profiles for the expected transit time, with a safety margin built in. The pharmacy then runs a performance qualification (PQ), sending a dummy or real payload to ZIP codes it actually serves to confirm the design holds up on its own lanes. In his words, "there is a validation followed by a verification that can actually help check all the boxes."
The test profile behind the DQ matters as well. ISTA's 7D procedure measures "the relative ability of a package to protect a product when exposed to test cycles of temperature conditions," and ACHC's flyer references the related ISTA 7E procedure for parcel shipments. Balaji told the audience that 7D is the more rigorous of the two and the better fit for lanes with extreme summers or winters, which is why MaxQ tests to 7D by default.
Proof a patient can feel
For Ogurchak, all of this leads back to trust. Patients judge a pharmacy by what shows up at the door and how the follow-up call goes, and a single bad delivery can outweigh months of good ones. "Trust is a funny thing," he said. "You have a lot of opportunities to gain that trust, but you only get that one opportunity to lose it."
Verified packouts also shape what a patient has to deal with after the medication is safely in the refrigerator. In Zeal's early days, the pharmacy relied on oversized coolers to reach the transit times it needed, and patients in many areas could not throw them away with their regular trash. Matching the shipper to the product mix eased that burden for patients and lowered the pharmacy's costs along the way. "We leverage MaxQ for our coolers because they have a smaller form factor that gets us the temperature range we need…plus, we're spending less in shipping costs because it doesn't weigh as much," Ogurchak said.
Pharmacies that want to follow Zeal's lead can fold this work into a change they already make twice a year. Running PQ shipments on the hardest lanes during the summer and winter packout changeover, then filing the results beside the vendor's DQ report, gives the next surveyor, payer auditor or manufacturer partner one place to look. It also gives the pharmacist on the phone with a worried patient an answer backed by data.
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MaxQ provides a design qualification report with every specialty pharmacy shipper and works
alongside pharmacy teams to plan and run performance qualification on their own lanes.
To talk through your current packouts and shipping lanes, book a 30-minute packout review with our team:
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The full webinar recording is available HERE
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