Are your mail-order meds turning toxic in the heat?
Over the past decade, companies have increasingly mandated the use of mail-order pharmacy warehouses instead of traditional pharmacies. Aggressive business tactics and the 2020 COVID lockdowns boosted the popularity of mail-order prescriptions. Today, patients who try to fill their prescriptions at a traditional pharmacy often face declined insurance claims or significantly higher costs, effectively pushing them toward mail-order options. These mail-order prescription warehouses all have major distribution hubs in Arizona. Higher temperatures can speed up degradation, render drugs partially or completely ineffective, or even alter their composition into poisons. Despite the brutally hot climate, Arizona legislators used tax credits to incentivize huge 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 ship out tens of millions of prescriptions every month to many other states via UPS, FedEx, and other delivery services. It is an incredibly lucrative business. Pharmacy benefit managers barely existed 25 years ago, but today, three are Fortune 10 companies. In 2022, PBM revenues reached $1.25 trillion, much of which comes from patients enrolled in taxpayer-funded Medicare and Medicaid programs. Humana alone receives some 85% of its income from government programs. These companies claim to bring about prescription drugs cost savings, but recent findings by the House Committee on Oversight and Accountability have called into question whether these “savings” are going to American taxpayers or to 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 partially or completely ineffective, or even alter their composition into poisons. That’s why the United States Pharmacopeia Sec. 659 requires non-refrigerated drugs 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. In 2023 alone, Arizona had 53 days during which the temperature hit or exceeded 110. And that number doesn’t account for the significant oven-like greenhouse effect of non-air-conditioned UPS, FedEx, and U.S. Postal Service delivery trucks and mailboxes, with delivery taking about a week to reach patients. Data published by San Francisco State University geosciences faculty shows that the inside temperature of a vehicle will almost 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. While some PBMs will occasionally include “temperature controlled packaging,” experiments and consumer reports indicate their failures. Pharmaceuticals are the most strictly regulated industry in the world, so 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 any data, bibliography, or scientific justification. It stated that drugs may now exceed the established excessive heat maximum of 86 degrees by an additional 18 degrees, as long temperatures “average out” according to a convoluted “mean kinetic temperature” formula. The trouble is that the MKT formula is outdated. It was established in 1971, and it’s 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 things pharmaceutical, with three exceptions: pharmacist licensure, inventory, and storage. Temperature is a component of storage 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 be affecting patients both in Arizona and across the country, potentially rendering medicines less effective, ineffective, or toxic.
Over the past decade, companies have increasingly mandated the use of mail-order pharmacy warehouses instead of traditional pharmacies. Aggressive business tactics and the 2020 COVID lockdowns boosted the popularity of mail-order prescriptions. Today, patients who try to fill their prescriptions at a traditional pharmacy often face declined insurance claims or significantly higher costs, effectively pushing them toward mail-order options.
These mail-order prescription warehouses all have major distribution hubs in Arizona.
Higher temperatures can speed up degradation, render drugs partially or completely ineffective, or even alter their composition into poisons.
Despite the brutally hot climate, Arizona legislators used tax credits to incentivize huge 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 ship out tens of millions of prescriptions every month to many other states via UPS, FedEx, and other delivery services.
It is an incredibly lucrative business. Pharmacy benefit managers barely existed 25 years ago, but today, three are Fortune 10 companies. In 2022, PBM revenues reached $1.25 trillion, much of which comes from patients enrolled in taxpayer-funded Medicare and Medicaid programs. Humana alone receives some 85% of its income from government programs.
These companies claim to bring about prescription drugs cost savings, but recent findings by the House Committee on Oversight and Accountability have called into question whether these “savings” are going to American taxpayers or to 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 partially or completely ineffective, or even alter their composition into poisons.
That’s why the United States Pharmacopeia Sec. 659 requires non-refrigerated drugs 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.
In 2023 alone, Arizona had 53 days during which the temperature hit or exceeded 110. And that number doesn’t account for the significant oven-like greenhouse effect of non-air-conditioned UPS, FedEx, and U.S. Postal Service delivery trucks and mailboxes, with delivery taking about a week to reach patients.
Data published by San Francisco State University geosciences faculty shows that the inside temperature of a vehicle will almost 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. While some PBMs will occasionally include “temperature controlled packaging,” experiments and consumer reports indicate their failures.
Pharmaceuticals are the most strictly regulated industry in the world, so 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 any data, bibliography, or scientific justification. It stated that drugs may now exceed the established excessive heat maximum of 86 degrees by an additional 18 degrees, as long temperatures “average out” according to a convoluted “mean kinetic temperature” formula.
The trouble is that the MKT formula is outdated. It was established in 1971, and it’s 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 things pharmaceutical, with three exceptions: pharmacist licensure, inventory, and storage. Temperature is a component of storage 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 be affecting patients both in Arizona and across the country, potentially rendering medicines less effective, ineffective, or toxic.
Arizona’s Pharmacy Board is unelected, appointed by and only accountable to Arizona Gov. Katie Hobbs. It’s time for her to take immediate steps to protect patients from these temperature extremes.
Originally Published at Daily Wire, World Net Daily, or The Blaze
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