There is little regulation of how pharmacies ship drugs to patients, though extremes of hot or cold can make medicine unsafe or ineffective.
Patients who get their prescription medications by mail in Oklahoma may soon have better protections for the safety of those drugs than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts.
“This is a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule Wednesday. “We’ve got a tremendous amount of prescriptions that get mailed to patients. … What we did today was make sure our patients in Oklahoma are receiving safe products.”
Exposure to extreme temperatures can degrade or weaken drugs, potentially changing their dosage or chemical makeup and rendering them ineffective or unsafe for patients. But while government oversight of how pharmacies store medications to keep them in defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found oversight of shipping to patients — during which drugs might be exposed to heat waves and below-freezing temperatures — is largely a system of blind trust. Mail-order pharmacy is a booming business, with soaring profits for some of the nation’s largest companies last year and more than 26 million people receiving their medication by mail in 2017 — more than double the number two decades earlier, according to federal data.
NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, did not have specific rules for how pharmacies should ship customers’ medication, few asked about this process in their inspections, and many said it was simply up to the pharmacy to ensure safe shipping.
Industry standards are clear that pharmacies should ship medications in their safe temperature range — set by the manufacturer after extensive testing under Food and Drug Administration guidelines — yet many patients have no way of knowing if the medications that arrive at their door have stayed within that range.
“So many insurance providers are really pushing patients to use mail order,” said Erin Fox, director of drug information at the University of Utah Health hospital system, who researches drug quality and shortages. “Unfortunately, many patients don’t have a choice in their insurance coverage to be able to use a local pharmacy, so having these protections is important.”
The proposed Oklahoma rule is the first of its kind to set clear guidelines on temperature safety during transit. It would require all pharmacies shipping or delivering medication to use packaging tested to ensure drugs do not go outside their safe temperature ranges, require them to be able to assess the safety of a medication if there are delays in delivery, and mandate that they give patients notification of shipping and delivery.
“Oklahoma is at the forefront in developing regulations on this topic,” said Desmond Hunt, the storage and distribution expert and senior principal scientist at United States Pharmacopeia, the nonprofit that sets the quality and safety standards for medications that are used by the FDA, manufacturers and pharmacy boards. “How this evolves within Oklahoma may be a blueprint or a template for other states.”
In 2020, state pharmacy board officials across the country told NBC News they rarely, if ever, receive complaints about drugs damaged in delivery. Interviews with dozens of mail-order pharmacy customers revealed that most weren’t aware of their state boards and simply didn’t know where to complain.
Oklahoma’s proposed regulation takes aim at that issue, requiring all medication delivered to patients in the state to include information about how to report safety concerns to the board.
The board began evaluating its shipping rules earlier this year after a presentation from researchers at Southwestern Oklahoma State University’s pharmacy school on a study examining the risks of exposure to extreme temperature for mailed medication, according to meeting minutes. The board created a task force, which included representatives from two of the largest pharmacies in the country, Express Scripts and Walgreens, that met several times this year and drafted the proposed rule, in consultation with Hunt from the standard-setting nonprofit.
The task force found that not all shipped medications were treated the same. Expensive refrigerated medications like biologic drugs shipped by large companies were more likely to have temperature monitors than other drugs, task force members said at the board meeting Wednesday. The proposed rule would extend that same standard of care to all medications moving through the state, regardless of shipper or medication cost.
“I would expect a 15-cent pill to be treated the same as a $2,000 vial that comes through, because if it’s not safe for the patient to take, then as a board of pharmacy, we’re not really doing our duty,” Hendrick said.
Express Scripts and Walgreens did not respond to requests for comment on the proposed rule, but Hendrick said the task force came to a consensus, and he is optimistic that it could be in effect by July, after public comment and review by the Legislature and governor. After that, the board plans to begin detailed inspections of how pharmacies ship drugs to patients.
Hendrick is hopeful other states will follow Oklahoma’s lead. “The landscape of pharmacy has changed,” he said, with more people getting their medications delivered, especially since the pandemic began. “[These rules] give an example to other states for possible modification of their rules or even implementing rules to start to control or at least be aware of this problem.”
Reporter: Adiel Kaplan
Adiel Kaplan is a reporter with the NBC News Investigative Unit.