(FamilyConservationPAC.com) – Over the past decade, companies have increasingly mandated using mail-order pharmacy warehouses instead of traditional pharmacies.
Due to aggressive business tactics and the COVID-19 lockdowns in 2020, mail-order prescriptions have become increasingly popular.
As a result, patients who attempt to fill their prescriptions at a regular pharmacy may encounter declined insurance claims or significantly higher costs, ultimately nudging them towards mail-order options.
These mail-order prescription warehouses all have major distribution hubs in Arizona.
Despite the brutally hot climate, Arizona legislators used tax credits to incentivize massive mail-order pharmacies like Amazon and pharmacy benefit managers, including Express Scripts, CVS Caremark, Walgreens, Humana, and United Health, to build massive pharmacy centers in the Phoenix area.
Pharmacy warehouses deliver millions of prescriptions monthly to other states using UPS, FedEx, and other services.
The pharmaceutical benefit management industry has become highly profitable. Just 25 years ago, there were hardly any pharmacy benefit managers. Still, today, three rank among the top ten Fortune companies.
By 2022, pharmacy benefit managers’ revenue had reached $1.25 trillion, with a significant portion of patients enrolled in taxpayer-funded Medicare and Medicaid programs.
Humana alone receives some 85% of its income from government programs.
These companies claim to reduce prescription drug costs. Still, recent findings from the House Committee on Oversight and Accountability have questioned whether these “savings” are going to American taxpayers or the PBMs themselves.
But that isn’t the only problem.
Pharmaceuticals are fragile, organic substances. Even under ideal storage conditions, they undergo chemical alterations and expire. Higher temperatures can speed up degradation, render drugs wholly or partially ineffective, or even alter their composition into poisons.
That’s why the United States Pharmacopeia Sec. 659 requires non-refrigerated drugs to be kept between 68 and 77 degrees Fahrenheit, with maximum allowable excursions of 58 to 86 degrees, provided these periods do not exceed 24 hours.
Needless to say, Arizona and other states’ summers frequently exceed 86 degrees.
2023, Arizona experienced 53 days with temperatures reaching or exceeding 110 degrees. This count does not include the intense heat trapped inside non-air-conditioned UPS, FedEx, and U.S. Postal Service delivery trucks and mailboxes.
Consequently, deliveries took about a week to reach their destinations.
Data published by the San Francisco State University faculty of geosciences shows that a vehicle’s interior temperature will nearly double after an hour in the sun.
Even with mild outdoor temperatures (70-80 degrees), vehicle temperatures can exceed the maximum allowable USP/FDA limit after just 20 minutes.
“Although some PBMs may offer “temperature-controlled packaging,” tests and consumer reports show that they sometimes fail to maintain the required conditions.”
Pharmaceuticals are the most strictly regulated industry in the world. Why is this being ignored?
There are two reasons.
The first is that in 2017, concurrent with the expansion of massive mail-order pharmacies, the USP changed its five-decade-old temperature requirements for pharmaceuticals.
The USP’s new rule was announced without data, bibliography, or scientific justification. It stated that drugs may now exceed the established excessive heat maximum of 86 degrees by 18 degrees, as extended temperatures “average out” according to a convoluted “mean kinetic temperature” formula.
The MKT formula is outdated. It was established in 1971 and is based on the Arrhenius Equation, which dates back to the late 1800s.
Moreover, the original MKT studies never considered temperatures above 87 degrees and are of questionable applicability to all 150,000 available drug products they now regulate.
That’s because the MKT formula was created to hypothesize microbial replication in perishable foods like milk and butter under mild variations in room temperatures — not to assess the stability of prescription drugs baking in the back of delivery trucks during Arizona summers, which routinely exceed even the expanded USP’s maximum temperature of 104 degrees.
The second reason is the Arizona State Board of Pharmacy.
The FDA is the primary regulatory authority for all pharmaceutical products, with three exceptions: pharmacist licensure, inventory, and storage. Temperature is a storage component and thus falls under the authority of state pharmacy boards.
Because Arizona’s burgeoning PBM warehouses ship millions of prescription drugs across many states, the Arizona State Board of Pharmacy’s neglect could affect patients in Arizona and across the country, potentially rendering medicines less effective, ineffective, or toxic.
Are your mail-in order medications toxic?
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