Most all medications have a temperature storage requirement – typically 59-86 F – and pharmas, wholesalers, pharmacies are required to keep medications within that range and if they are outside of that temp range > 24 hrs…  the potency of the medications are generally considered “compromised”…  BUT… when a mail order pharmacy hands off a package containing Rx meds to a delivery carrier ( USPS, Fedex, UPS) seldom is there any concern about the temp that the medications are exposed to and for how long.  When specialty meds – that require being kept at refrigerator/frozen temps…  the mail order pharmacies will typically take extra efforts to try to make sure that the meds are kept in the required temp range.  Sometimes, the delivery carrier does not deliver the Rx meds in the expected time frame and they show up at the pt’s home… outside of the required storage temp and UNUSABLE.  Many times, the med involved is a life critical matter and getting a replacement in a timely manner is not always possible.

 

Oklahoma proposes landmark rule to keep mailed medications safe from extreme temperatures

https://www.nbcnews.com/health/health-news/oklahoma-proposes-rule-keep-drugs-safe-hot-cold-rcna57492

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.”

 

 

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