Over the past decade, companies have increasingly mandated the use of mail-order pharmacy warehouses instead of traditional pharmacies. Aggressive business strategies and the COVID lockdowns of 2020 have led to an increase in the popularity of mail-order prescriptions. Today, patients trying to pick up their prescriptions at traditional pharmacies often face the following issues: rejection Insurance claims or Significantly increased costseffectively Mail Order Option.
All of these mail-order prescription warehouses have their primary distribution centers in Arizona.
High temperatures can cause drugs to deteriorate more quickly, resulting in partial or complete loss of efficacy and even conversion of drug components into toxic substances.
Despite the heatwaves, the Arizona Legislature used tax credits to encourage large mail-order pharmacies, such as: Amazon and pharmacy benefit managers. Express Script, CVS Caremark, Walgreens, Humanaand UnitedHealth It will build a large pharmacy center in the Phoenix area, which will ship tens of millions of prescriptions each month to many other states via UPS, FedEx and other delivery services.
This is an incredibly lucrative business. Pharmacy benefit managers were virtually nonexistent 25 years ago, but today Three of the companies are ranked in the Fortune 10In 2022, PBM revenues will be reached $1.25 trillionMany of those come from patients enrolled in the taxpayer-funded Medicare and Medicaid programs. Humana alone has 85% of income From government programs.
These companies: Prescription drug cost savingsbut recently Survey results The House Oversight and Accountability Committee report found that thesesavings” will go to American taxpayers and the PBMs themselves.
But that's not the only problem.
Medicines are fragile organic substances. Even under ideal storage conditions, they undergo chemical changes and expire. Accelerates deterioration, Partially or completely neutralize the effects of a drug,or Change the configuration In Poison.
Therefore, the United States Pharmacopeia Article 659 states: Drugs that are not refrigerated should be stored between 68 and 77 degrees Fahrenheit. Maximum allowable deviation is 58-86 degreesHowever, these periods may not exceed 24 hours.
Not to mention, summer temperatures in Arizona and other states often exceed 86 degrees.
In 2023 alone, Arizona will see 53 days of rain. Temperatures reached or exceeded 110 degreesAnd that figure doesn't take into account the huge greenhouse effect of unair-conditioned UPS, FedEx and U.S. Postal Service delivery trucks and mailbox ovens, which can take deliveries about a week to reach patients.
Data released by a professor of geological sciences at San Francisco State University show the Indoor temperature Vehicle Almost doubles after 1 hour of exposure to the sunEven if the outdoor temperature is around 70 to 80 degrees, the temperature inside the car Exceeding the limit USP/FDA Acceptable Limits Just 20 minutes laterSome PBMs areTemperature Controlled Packaging“, experiment and Consumer Reports Showing their failure.
Pharmaceuticals The most highly regulated industry in the worldSo why is this being ignored?
There are two reasons.
First, in 2017, USP, a 50-year-old company, was forced to close in tandem with the expansion of large-scale mail-order pharmacies. Temperature Requirements For pharmaceutical use.
The USP's new rule was released without any data, references or scientific justification. It states that drugs may exceed existing standards. Excessive heat The high will be 86 degrees, rising another 18 degrees.Mean kinetic temperature” expression.
The problem is that the MKT formula is outdated. Founded in 1971and it is Arrhenius equationThe original MKT research dates back to the late 1800s. Temperatures above 87 degrees were not considered. degree, and I doubt it applies to everyone. 150,000 types of medicines They are regulating now.
That is, the formula for MKT is Form a hypothesisMicrobial growth in fresh produce Like Milk and butter under Mild The change in room temperature is not intended to assess the stability of prescription drugs that typically bake in the bed of a delivery truck during Arizona summers that exceed the expanded USP maximum temperature of 104 degrees.
The second reason is the Arizona State Board of Pharmacy.
The FDA is the primary regulatory agency for all pharmaceutical products with three exceptions: pharmacist licensing, inventory, and storage. Temperature is a factor of storage and therefore falls under the jurisdiction of state boards of pharmacy.
Because Arizona's burgeoning PBM warehouses ship millions of prescription drugs to many states, the Arizona Board of Pharmacy's negligence could impact patients in Arizona and across the nation, resulting in less effective, ineffective, or more toxic medications.
The Arizona Board of Pharmacy is unelected. Arizona Governor Katie HobbsIt is time to take immediate steps to protect patients from these extreme temperatures.
