In an audio recording reviewed by NBC News, an FDA drug information specialist explained to Boesing that it was state pharmacy boards, not the agency, which handle issues with mailed prescriptions.
But the FDA specialist also made clear Boesing’s comments weren’t unusual.
“Every summer and every dead of winter, we get these calls because people’s insulin is sitting in their mailbox,” the specialist said in the call.
Boesing, who now runs a nonprofit advocacy group focused on improving pharmaceutical safety, also called the Department of Labor, which oversees federally-regulated insurance plans. She was told that, while her complaint about being forced to get medications this way was a common one, the agency could not do anything for her.
“It’s just unfortunately the nature of the industry right now,” the agency representative said in another audio recording that was reviewed for this article. “They’re not in violation of a law. It might be unethical, it might be unfair, but it’s not illegal.”
Hannah Davis of Panama City, Florida, recalls a UPS driver handing her a hot-to-the-touch package with her oral cancer medication inside on a 97-degree day in September 2018. Worried, she called the drug manufacturer, who said not to take it. She said CVS, her pharmacy, agreed to send a replacement only after she told them what the manufacturer said.
Davis wrote letters to the National Cancer Institute, the FDA, and the Florida Division of Consumer Services. In responses that were reviewed by NBC News, all referred her elsewhere.
After more than a year of complaints to CVS and her state pharmacy board, and letters to multiple government agencies and elected officials, Davis said, CVS earlier this year began sending the medication to her by courier.
While she’s now happy with how her medication arrives, Davis said, the entire experience was disheartening. “You just get tired of fighting with them,” she said.
CVS Caremark declined to comment on the particulars of Boesing’s and Davis’ stories, but said in a statement that both issues had been resolved, and that “the overwhelming majority of members express satisfaction with our service.”
‘How is this allowed?’
Many large mail-order pharmacies voluntarily meet independent accreditation standards every three years that evaluate their standards for safe medication delivery.
But government oversight of mail-order pharmacies is largely a system of blind trust, experts said. Inquiries to the state boards of pharmacy of all 50 states — the government agencies with enforcement authority over pharmacies — along with records requests for their inspection forms, revealed that most don’t have specific rules for how pharmacies should ship customers’ medication.
“The responsibility of proper temperature storage and soundness of packaging is largely a gray area,” Tracy West, deputy executive director of Washington state’s board of pharmacy, said in an email.
Only six states have pharmacy rules explicitly addressing proper packaging or temperature monitoring for home delivery, and just two — Georgia and Utah — have inspection forms that ask if those rules are being followed. Some said they have no authority to regulate delivery at all. Others said that their regulations often go further than what’s written on the page, but the vast majority ultimately passed the buck, saying it is up to the pharmacy to ensure safe shipping.
Local pharmacists around the country said that temperature oversight from pharmacy boards is strict when it comes to how they store medication, but all that goes out the window when it comes to shipping.
A shipment of Humira sent to an Arlington, Texas home in January 2020. Like many mailed refrigerated medications, it was packaged in a foam cooler with cold gel packs to control its temperature. (Obtained by NBC News)
A shipment of Humira sent to an Arlington, Texas home in January 2020. Like many mailed refrigerated medications, it was packaged in a foam cooler with cold gel packs to control its temperature. (Obtained by NBC News)
People who receive room-temperature medications said they often come in plain gray envelopes, like the kind clothing might ship in. An Austin, Texas woman received her medication in these U.S. Postal Service envelopes in August 2020. (Obtained by NBC News)
People who receive room-temperature medications said they often come in plain gray envelopes, like the kind clothing might ship in. An Austin, Texas woman received her medication in these U.S. Postal Service envelopes in August 2020. (Obtained by NBC News)
Teresa Dickinson, an independent pharmacy owner in Arizona and the former president of the advocacy group Pharmacists United for Truth and Transparency, remembers being reprimanded by her state pharmacy board during an inspection because her thermostat read 78 degrees. “The board of pharmacy made a big deal that it needed to be 77,” she said. “If it was such a big deal with the board of pharmacy that I was 1 degree over, then how is this allowed?”
Adding another wrinkle, drugs are often shipped from warehouses outside the state. While boards license out-of-state pharmacies, they typically only inspect facilities physically within their borders.
“We would rely on the home state to be doing effective regulation,” Matt Martineau, executive director of the board of pharmacy in Wyoming, said. “There would be lots of ways for something to fall through the gaps, so to speak.”
A federal investigation
Last summer, an NBC News investigation into heat illness among delivery workers found that UPS delivery trucks, which are largely not air-conditioned, can hit temperatures well above 120 degrees. When NBC News sent temperature logging devices across the country, the interior of a standard bubble mailer reached above 104 degrees in four of five packages — generally the hottest temperature that the U.S. Pharmacopeia (USP), a nonpartisan group that sets national standards for drug handling, advises room temperature medicines can be exposed to.
Equally worrying is accidental freezing, packaging experts said. Freezing temperatures or a poorly placed ice pack can freeze a drug, rendering medication like insulin ineffective. And if the package reaches the patient and the drug has thawed, there may be no visible trace of potential harm.
In February, NBC News sent the temperature devices to five cities through UPS, FedEx and the Postal Service. Three went below freezing for hours during transit, and one, sent to Brooklyn from Rochester, New York, spent more than 38 hours below freezing, bottoming out at 9 degrees Fahrenheit for two hours.