Oklahoma proposes landmark rule to protect mailed medications from extreme temperatures

Patients who receive their prescription drugs by mail in Oklahoma may soon have better drug safety protections than any other state. On Wednesday, Oklahoma regulators proposed the nation’s first detailed rule to control temperatures during shipping, according to pharmacy experts.

“It’s a huge step,” said Marty Hendrick, executive director of the Oklahoma State Board of Pharmacy, after the board voted to approve the rule on Wednesday. “We have a huge amount of prescriptions that are mailed out to patients. … What we did today was make sure our patients in Oklahoma were getting safe products.

Exposure to extreme temperatures can degrade or weaken drugs, potentially altering their dosage or chemical composition and rendering them ineffective or dangerous for patients. But while government oversight of how pharmacies store drugs to keep them within defined safe temperature ranges is very detailed, an NBC News investigation in 2020 found that oversight of shipment to patients — during of which drugs could be exposed to heat waves and sub-freezing temperatures – is largely a system of blind trust. The mail-order pharmacy is a booming business, with profits soaring for some of the country’s biggest companies last year and more than 26 million people getting their drugs in the mail in 2017, more than doubling the number two decades earlier, according to federal data.

NBC News found that most state pharmacy boards, the regulators responsible for pharmacy safety, had no specific rules about how pharmacies should ship customers’ medications, few asked about this process during their inspections, and many said it was simply up to the pharmacy to ensure safe shipment.

Industry standards make it clear that pharmacies must ship medications within their safe temperature range — set by the manufacturer after extensive testing under Food and Drug Administration guidelines — but many patients have no way whether the drugs that arrive at their doorstep have stayed within this 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, which studies quality and drug shortages. “Unfortunately, many patients don’t have a choice in their insurance coverage to be able to use a local pharmacy, so it’s important to have those protections.”

The proposed rule in Oklahoma is the first of its kind to establish clear guidelines for temperature safety during transit. This would require all pharmacies that ship or deliver drugs to use tested packaging to ensure that drugs do not exceed their safe temperature ranges, would require them to be able to assess the safety of a drug in the event of late delivery and instruct them to notify patients of shipment and delivery.

“Oklahoma is at the forefront of developing regulations on this topic,” said Desmond Hunt, storage and distribution expert and senior principal scientist at United States Pharmacopeia, the nonprofit organization that establishes quality and safety standards for drugs used by the FDA, manufacturers and boards of pharmacy. “How this evolves in Oklahoma may be a blueprint or a model for other states.”

In 2020, state pharmacy board officials across the country told NBC News that they rarely, if ever, receive complaints about drugs being damaged in delivery. Interviews with dozens of mail order pharmacy customers revealed that most were unaware of their state advice and simply did not know where to complain.

Oklahoma’s proposed regulation targets this issue, requiring all medications dispensed to patients in the state to include information on how to report safety concerns to the board.

The board began evaluating its shipping rules earlier this year after a presentation by researchers from Southwestern Oklahoma State University’s School of Pharmacy on a study examining the risks of exposure to extreme temperatures for drugs sent by mail, according to the minutes of the meeting. The board established a task force, which included representatives from two of the nation’s largest pharmacies, Express Scripts and Walgreens, which met several times this year and drafted the proposed rule, in consultation with the organization’s Hunt. normative non-profit.

The task force found that not all drugs shipped were treated equally. Expensive refrigerated drugs like biologics shipped by big companies were more likely to have temperature monitors than other drugs, task force members said at the board meeting on Wednesday. The proposed rule would extend that same standard of care to all drugs that pass through the state, regardless of the shipper or the cost of the drugs.

“I would expect a 15 cent pill to be treated the same as a $2,000 bottle that comes in, because if it’s not safe for the patient, then as advice from pharmacy, we are not really doing our duty.” Hendrik said.

Express Scripts and Walgreens didn’t respond to requests for comment on the proposed rule, but Hendrick said the task force had reached consensus, and he’s optimistic it could be in effect by July, after public comment and review by the Legislature and the Governor. . After that, the council plans to start detailed inspections of how pharmacies ship drugs to patients.

Hendrick hopes other states will follow Oklahoma’s lead. “The pharmacy landscape has changed,” he said, with more people getting their medications delivered, especially since the start of the pandemic. “[These rules] set an example for other states for possible modification of their rules or even implementing rules to start controlling or at least be aware of this problem.

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