Drugs are being delivered in extreme temperatures

The Times spoke to over a dozen patients who received medications they believed were damaged by heat and humidity during transportation, the majority of whom said they received their medications in manila envelopes or plastic shopping bags without any additional insulation.

Oftentimes these customers were told by mail-order companies that if the medications didn't show physical signs of degradation, like misshapen syringes or melted capsules, they were okay to use. However, research shows that medications can degrade from heat exposure without discoloration.

Missouri resident Loretta Boesing received a shipment of a liquid immunosuppressant medication for her son, who had a liver transplant, delivered in 102-degree weather in a plastic envelope. Soon after, Boesing's son's health worsened as his body began to reject the liver. During a two-week stay at the hospital, he started receiving medication from the hospital pharmacy and started to recover.

Years after, Boesing's insurance changed, and services were administered by CVS Caremark. She filed multiple appeals to continue picking up the medication at the hospital pharmacy, but the appeals were denied, and medications were sent through the mail again. Afterwards, Boesing said her son's liver lab tests started to elevate again.

Michael DeAngelis, a spokesperson for CVS Health, said he wasn't able to comment on Boesing's specific case because of patient privacy laws, but noted the company customizes its packaging using a "sophisticated algorithm" that accounts for FDA and manufacturer data.

"There are hundreds of different possible packaging combinations that we can use to help mitigate weather and temperature issues," DeAngelis said.

In Michigan, Cheri Hicks, a 55-year-old interior designer with type 2 diabetes, noticed her blood sugar skyrocketing despite keeping up her diet and hydration. After her doctor gave her a sample insulin pen, her blood sugar dropped, which suggested to her that the mail-order pack she received three days late due to a snowstorm had most likely frozen and then thawed, which she thinks damaged the insulin.

How extreme temperatures affect drugs

Extreme temperatures can alter the components in many medications, from pancreatic enzymes to the thyroid replacement drug, levothyroxine, to oral contraceptives, experts told Baumgaertner.

A study published last year by independent pharmaceutical researchers, who embedded data-logging thermometers inside simulated shipments, found that packages had spent more than two-thirds of their time in transit outside appropriate temperature ranges "regardless of the shipping method, carrier, or season."

Similarly, researchers from United States Pharmacopeia (USP), a nonpartisan group that sets national standards for drug handling, conducted a study between June and August of 1996 where they packaged and mailed electronic temperatures and humidity indicators to different parts of the country.

They found that more than 90% had exceeded the appropriate temperature range and that more than a quarter had been exposed to what was considered "excessive heat," which is above 104 degrees Fahrenheit. The packages also saw significant spikes in humidity.

Mike Ren, a primary care physician and an assistant professor in the department of family and community medicine at the Baylor College of Medicine, said that liquid medications like insulin or AUVI-Q, the epinephrine injection for allergic reactions, are often at an increased risk of degradation. Exposure to excessive heat can cause the evaporation of liquid components in these medications that were compounded at exact ratios. Similarly, aerosolized medications are vulnerable to extreme temperatures because of potential pressure changes within the canister.

"It's really a double whammy," Ren said, since liquids and aerosolized drugs are also the fast-acting medications people need in an emergency. "A rescue inhaler or an EpiPen — those things are not like a daily blood pressure pill. They need to work immediately."

Many mail-order pharmacies say their packaging is weather-resistant and that they take special precautions when a medication requires specific temperature control.

Bryan Rabakon, SVP of supply chain and engineering for OptumRx,* said that the company uses "a range of technologies from predictive analytics to packaging innovations to protect the integrity of the medications on their journey from the pharmacy to our patients' homes."

OptumRx monitors the duration of the shipment, Rabakon said, and if a medication is in transit for longer than the allotted number of hours, OptumRx automatically reships a new package. However, Rabakon said the company doesn't monitor the temperatures while packages are in transit.

"We did have tags in the past," he said, referring to slips that indicate extreme heat exposure, "but they had a lot of false positives, so we actually discontinued them."

FDA provides strict guidelines for packaging and storing drugs and transporting them between manufacturers, but those rules don't apply to transportation to patients, Baumgaertner reports. A spokesperson for FDA said that mail-order procedures fall under the jurisdiction of each state and noted that "medicines that are not stored properly may not work as well or may cause harm, even if they are not expired."

Attempted action at the state level

Some states have attempted to address issues with mail-order drugs. In 2020, Marty Lee Hendrick, executive director of Oklahoma's pharmacy board, wrote a vague rule regarding the transportation of medication in his state, which passed through the state legislature with ease.

However, when Hendrick saw concerning new data on drug package temperatures in 2022, he built a task force that drafted a much more specific rule requiring drugs to be kept in temperature ranges recommended by USP.

A group of lobbyists argued the proposed rule "micromanages the type of packaging used to deliver the drugs and the temperature in which those packages must be stored."

Similarly, a trade association representing pharmacy benefit managers submitted a letter arguing the proposed rule was "not grounded in science and evidence" but was "based on speculation and an attempt to resolve a perceived issue." Lobbyists also argued that mail-order pharmacies already use vigorous processes to "ensure the integrity and stability" of mail-order drugs and that the new rules would increase the cost of each prescription package by an estimated $23.

Ultimately, the rule was abandoned.

According to Hendrick, there is "no appetite" for stronger rules in some states, while other states have contacted him about their own proposals. He said he advised them to prepare for lobbyists.

"I hate to say this, but we're really probably one big tragedy away from people realizing how serious this is," Hendrick said. "Our time will come. I know it will. But these battles end up being wars." (Baumgaertner, New York Times, 8/13)

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