By Anne Blythe
As periods of extreme heat become more common in North Carolina and across the country, and global heat records keep getting shattered, public policymakers are paying more attention to the impact of climate change on health.
The National Integrated Heat Health Information System released the first National Heat Strategy earlier this month; it acknowledges the public health threat of the rising temperatures and recognizes the need to develop plans and policies that help curb the negative consequences of the “leading weather-related killer.”
“Extreme heat is not just an environmental crisis, it’s a serious threat to our public health — and communities across the country are struggling to respond,” federal Health and Human Services Secretary Xavier Becerra said at the rollout of the plan.
A related topic that has been gaining attention only recently is the impact that extreme heat can have on prescription medications in transit — especially when those pharmaceuticals are delivered through mail-order shipments.
The New York Times highlighted the issue earlier this month.
Jay Campbell, executive director of the North Carolina Board of Pharmacy, told NC Health News that he has received a spate of calls recently about the subject.
“This seems to be primarily an issue that comes up for your mail-order pharmacies,” Campbell said.
Why not add temperature trackers?
State law requires pharmacies operating outside North Carolina that ship, mail or deliver a prescription medication approved by the U.S. Food and Drug Administration to register with the state pharmacy board and ensure that a pharmacist is working with them and meets state licensure requirements.
Those pharmacies have the responsibility of the safe transport of the drugs, but a study published in Journal of the American Pharmacists Association raised questions about the fluctuation of temperatures during transit. Researchers sent packages with data loggers inside them between New Jersey, California and Tennessee during different seasons and found that the parcels stayed within suitable temperature ranges only about a third of the time.
Extreme temperatures can degrade the effectiveness of medications, whether it is through evaporation of liquid, changing the pressure of aerosols or alteration of other components of drugs.
The United States Pharmacopoeia, a 200-year-old independent organization that works to build trust “in the supply of safe, quality medicines,” recommends that medications be stored routinely at temperatures between 68 and 77 degrees Fahrenheit, with room for excursions where temperatures might drop briefly to 59 degrees or go as high as 89 degrees for a short time.
With some drugs, such as diabetes medications that might turn cloudy, the degradation is more obvious than with other medications. Other protein-based medications, such as the hugely popular arthritis drug Enbrel, are also at risk from high temperatures, which can degrade proteins. Even strips for testing blood sugar for people with diabetes and other at-home blood tests can degrade in the heat.
The question Campbell often gets, he said, is how enforcement works in situations when a drug has been damaged. People can seek relief from their pharmacists. They also can file a complaint with the pharmacy board. Cloudy insulin aside, though, providing proof of such degradation is not always cut and dried. Nor is it always possible to determine where the breakdowns occurred.
Even if pharmacies take all the steps to keep the medications within the proper temperature ranges during transit, a package might be slipped into a dark mailbox or dropped off at someone’s door and sit in the hot sun for hours before the recipient gets home from work or realizes it awaits them outside.
If packages contained temperature monitoring devices, they could alert the recipient to any abnormalities along the way, advocates for reform say.
Federal law does not require such devices, and North Carolina law, Campbell said, prevents the state from requiring anything more restrictive than “federal statutes or regulations governing the delivery of prescription medications by mail or common carrier.”
“It seems to me that there’s a good public safety argument in requiring that temperature sensitive drugs have some sort of warning in their packaging,” Campbell said.
A change in law would be necessary to require temperature monitoring devices.
Pharmacy benefits policies part of the mix
Penny Shelton, executive director of the North Carolina Association of Pharmacists, said her organization has spent the past couple of years focusing on a bill that would revise pharmacy benefits manager provisions in state law.
In recent years, Shelton said, the state has been losing pharmacies. One hundred have closed in North Carolina since 2022, she added, a trend she says is related to the topic they are trying to get lawmakers to give more attention.
The House passed HB246 unanimously in April 2023, but the proposal has stalled in the Senate.
That bill is not directly linked to the issue about transport of pharmaceuticals during extreme heat, but it could have an impact on part of the problem. Health plans contract with or, in some cases, own pharmacy benefit managers. The managers are intermediaries that administer the pharmacy benefit aspects of a person’s health insurance. That often leaves the patient with little choice over where they get their medications. Many pharmacy benefits managers only offer mail-order providers, a practice referred to as “steering.”
“It’s not that we don’t think that’s important,” Shelton said about temperature monitoring devices in pharmaceutical packaging. “We do. But we think patients should have a choice about their pharmacies. We have a number of legislative issues we’re fighting for.”
Pharmacy benefit managers played a role several years ago in thwarting an attempt in Oklahoma to require pharmacies to keep medications in specific temperature ranges during transport. The effort was abandoned after lobbyists and the Pharmaceutical Care Management Association, which represents the benefit managers, spoke out against the proposal.
In a letter to the executive director of the Oklahoma State Board of Pharmacy, the association’s vice president of state affairs and its state regulatory and legal affairs director contended that the proposal was “not grounded in science and evidence” and that it appeared “to be based on speculation and an attempt to resolve a perceived issue.”
“Non-resident and resident pharmacies undergo rigorous testing of materials and processes to validate the maintenance of the integrity and stability of medications,” the association’s executives said in their letter.
Specific tracking
As debate over transport temperatures gets more attention, some in the pharmacy industry are focusing on cold storage facilities where temperature-sensitive vaccines, tissues, compounds and other biopharma therapies can be stored.
Alcami Corporation recently expanded the customizable cold storage options at its new facility in Garner. In a recent video call, David Vogt, senior director of pharma storage at the facility, explained to NC Health News how the company ensures that the products they store are maintained at appropriate temperatures.
“Our facility here is essentially a large warehouse where we have typical room temperature storage as well as some very specific control temperature conditions — particularly cold conditions,” Vogt said. “So we store everything here from refrigerated, which is 5 degrees Celsius, to minus 20 degrees Celsius, minus 40 Celsius, minus 75, all the way down to cryostorage, which is in liquid nitrogen.”
Whether it’s traditional small molecule or biological-based products — such as those in newer gene therapies — temperature can have a huge effect on the quality and effectiveness of those products if they’re not maintained continuously in proper conditions, Vogt said.
“So for us here in Garner, that’s really our target business to make sure we’re partnering with our pharmaceutical and biopharma clients to ensure the safety and quality of the products that they’re trusting us to store,” Vogt said.
What usually happens, he said, is that most of the cold products come to the facility on a qualified truck.
“The truck is, actually, it’s validated and what we call mapped to ensure that it’s maintaining those conditions throughout the time it’s transporting the materials,” Vogt said. “But in addition to that, we also include temperature trackers, we call them — temperature monitoring devices — with all of our shipments, so that gives us real live data to see how did that truck and how did that shipment behave from point A to point B.”
Although the warehouse was not created because of the more frequent extreme heat that climate change has brought on, Vogt acknowledged that the Garner facility is a piece in a supply chain puzzle.
“Our piece of the puzzle is really our ability to ensure that we’re maintaining the quality of your product in the conditions at which it needs to be stored,” Vogt said. “We’re making sure that the transportation of that material from point A to point B is done in a controlled fashion so that it is protected from the extreme heats that we’re experiencing.”
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