Cold chain packing patent yields safer drug transit

Geriatric Use

Of the 375 patients who received VYXEOS (daunorubicin 44 mg/m 2 and cytarabine 100 mg/m 2 ) liposome in clinical studies, 57% were 65 years and over. No overall differences in safety were observed between these patients and younger patients, with the exception of bleeding events, which occurred more frequently in patients 65 years and older compared to younger patients (77% vs. 59%).

Renal Impairment

Dosage adjustment is not required for patients with mild (creatinine clearance [CL CR ] 60 mL/min to 89 mL/min by Cockcroft Gault equation [C-G]) or moderate (CL CR 30 mL/min to 59 mL/min) renal impairment. VYXEOS has not been studied in patients with severe renal impairment (CL CR 15 mL/min to 29 mL/min) or end-stage renal disease.

Hepatic Impairment

Dosage adjustment is not required for patients with a bilirubin level less than or equal to 3 mg/dL. VYXEOS has not been studied in patients with bilirubin level greater than 3 mg/dL.

PATIENT COUNSELING INFORMATION

Hemorrhage Inform patients of the risk of fatal bleeding. Advise patients of the need for periodic monitoring of blood counts and of the importance of keeping scheduled appointments for blood work and necessary transfusions. Advise patients to contact a healthcare provider for new onset fever or symptoms of infection or if they notice signs of bruising or bleeding [see Warnings and Precautions and Adverse Reactions].

Cardiotoxicity Advise patients to contact their healthcare provider if they develop symptoms of heart failure [see Warnings and Precautions]. Hypersensitivity Reactions Inform patients of the risk of hypersensitivity reactions, including anaphylaxis. Describe the symptoms of hypersensitivity reactions, including anaphylaxis, and instruct the patient to seek medical attention immediately if they experience such symptoms [see Warnings and Precautions]. Embryo-Fetal Toxicity VYXEOS can cause fetal harm when administered during pregnancy. Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS and to inform their healthcare provider of a known or suspected pregnancy before and during treatment with VYXEOS [see Warnings and Precautions and Use in Specific Populations]. Lactation Advise patients not to breastfeed during treatment with VYXEOS and for at least 2 weeks after the last dose [see Use in Specific Populations]. Infertility Advise males of reproductive potential that VYXEOS may cause temporary or permanent infertility [see Use in Specific Populations]. Concomitant Medications Advise patients to speak with their physicians about any other medication they are currently taking [see Drug Interactions].

From AllianceRx Walgreens Prime:

Rx Packing Patent Yields Safer Cold Chain Transit

By the end of 2020, AllianceRx Walgreens Prime will roll out its patented process to customize packing configurations for the safe transit and delivery of refrigerated specialty medications, adhering to drug manufacturers’ requirements of 2° to 8° C.

At an AllianceRx Walgreens Prime lab in Pittsburgh, a team has designed, tested and validated the predictive process via dataintensive research in environmental simulation chambers and on actual shipments since July 2017.

The patent granted in March 2020 culminated an effort begun by Walgreen Co. in 2014 to “expedite our ability to find opportunities to improve our cold chain process,” said Ed Musisko, AllianceRx Walgreens Prime’s senior director of data science and analytics, a co-inventor and patent holder.

Since 2018, more than 98% of refrigerated orders in the Pittsburgh beta site have used, and continue to use, the predictive process. “To date, no orders shipped [this way] required reshipment due to instability,” said Luke Holbrook, AllianceRx Walgreens Prime’s manager of engineering and logistics, a co-inventor of the new process and patent holder.

Although the predictive packout process is able to protect temperature integrity of frozen and room temperature medication shipments as well, AllianceRx Walgreens Prime has, so far, devoted its use to refrigerated medications, which account for approximately 60% of its shipments to patients, noted Joe Renna, AllianceRx Walgreens Prime’s senior director of facilities management and logistics and engineering.

These customized packouts help reduce the reshipping of spoiled medications and save on materials and shipping expenses versus the universal packouts typically used by specialty pharmacies, Mr. Musisko said.

‘A Breakthrough’

“This is a breakthrough for our pharmacists because we can see the same visual as our packout technicians,” said Ojas Sampat, PharmD, AllianceRx Walgreens Prime’s logistics manager. “As a result, our pharmacists have more confidence in the packout; they can see the trail of temperatures along the path to delivery (not while in transit but after); they can reassure patients when they speak with them; and they’re very excited because they can assist with any temperature-stability questions.” Jeff Reichard, PharmD, BCOP, the director of pharmacy at UNC Health–Home Delivery and Specialty Pharmacy, in Chapel Hill, N.C., an expert on cold chain management, said, “This sounds like an algorithm they’ve validated that could provide better guidance to reduce their supply costs without any impact on patients or the quality of goods. The big savings opportunity would be in potentially mitigating medication replacement costs, which could be thousands of dollars at a time, if a package doesn’t maintain cold chain integrity.

“Reshipping has risen in the COVID era because national couriers are stretched beyond their normal shipping schedules, placing a real strain on delivery turnaround times. That requires specialty pharmacies to pack out longer to maintain cold chain, and use more expedited shipping schedules,” Dr. Reichard said.

“The clinical value of this program could help to support the timely delivery of medications,” he added. “If patients don’t get their medications, they can’t be on their medications.”

How the Patented Process Works

The patented process uses a series of algorithms and thermal equations that predict how a medication will fare along its shipping path. “We map out the route to destination, carrier and vehicle type, weather reports and expected temperatures across our shipping window,” Mr. Musisko explained. “We’ve developed an array of packout configurations for minimally 36-hour shipping windows, and tested and validated them against respective outputs of the algorithms.”

Several AllianceRx Walgreens Prime specialty pharmacies will ship nationally using its predictive packout application. The company said it has no plans to license the technology. —Al Heller