Millions of Americans receive drugs by mail. But are they safe?
Posted December 8, 2020 6:19 p.m. EST
Updated December 9, 2020 11:24 a.m. EST
Raleigh, N.C. — One evening in mid-June, Megan Becker stepped outside of her Las Vegas home and scooped up a package containing her medication, a monthly injection to prevent debilitating migraines.
It was a sweltering night – the temperature hovered just below 95 degrees. When Becker opened up the package, which arrived a day late, she found that the ice packs were melted and the medicine, which is supposed to be refrigerated, was warm to the touch.
“They literally just dump the box on my front stoop, regardless of the weather,” Becker, an English professor at the University of Nevada, Las Vegas, said. “It’s just such expensive medication and it seems like such a careless way to deliver it.”
Shortly after the drug, Aimovig, hit the market, Becker began picking it up from a nearby pharmacy. But last year, her health insurance confronted her with a choice: switch to the Express Scripts mail-order pharmacy and get it for roughly $50 per month, or pay out of pocket for the more than $600-per-dose medication.
Becker fought to keep picking it up locally, but said she gave up after two months of what she described as maddening calls with Express Scripts.
“I really, really, really did not want to get it this way and I was not given an option,” she said.
Millions of Americans receive their medications by mail but many, like Becker, find themselves forced to do so by their insurance plans or face the prospect of paying exorbitant amounts for the same drugs.
An NBC News investigation found the growth of mail-order pharmacies has caused many people to feel trapped in a system that has left them with crushed pills, damaged vials and lifesaving drugs exposed to extreme weather.
Interviews with more than 65 mail-order pharmacy customers across the nation revealed deep worries over how their medication is delivered — and no affordable alternatives. Many reported receiving drugs in flimsy packaging without temperature indicators, which can cost as little as a dollar per package. Others have had to plead with pharmacies to send them replacement drugs after receiving medication they thought arrived too warm or cold.
The industry is massive, generating billions in annual sales, but it occupies a gray area with little regulation and even less enforcement, NBC News found.
“It’s a quagmire,” said Georgia state Rep. Ron Stephens, a pharmacist, who has sponsored multiple bills to increase patient choice when it comes to pharmacies. “If they’re sending it without a temperature strip, and you’re the recipient of insulin or a lifesaving drug, you’re taking your life into your hands,” the Republican said.
Extreme temperatures can degrade medications, potentially rendering them unsafe or ineffective for patients. Industry guidelines make clear that pharmacies should package and ship medications in accordance with their recommended temperature range. But many mail-order pharmacy customers have no way of knowing whether their medicine has gone too far outside that range for too long.
“[Patients] just might think that they're getting sicker or that it might be their fault,” said Erin Fox, director of drug information at University of Utah Health, who researches drug quality and shortages. “But it's important to think about, ‘Could it be my medicine that is maybe not of high quality or potentially got ruined with high temperatures?”
Proving that a drug had become ineffective or made someone sicker because it was exposed to extreme temperatures is nearly impossible, experts say. By the time such a possibility is considered, the medication itself would likely have already been consumed or thrown away, preventing it from ever being tested. Plus, experts say, without temperature tracking during shipment, there's no way to know how the medication may have been affected by the conditions inside a delivery truck or the temperature outside someone's home.
But some people believe they or their loved ones have experienced a decline in health after receiving medications through the mail, including the family of a young girl from North Carolina.
‘You’re not a pharmacist, ma’am.’
Shortly after she was born, Sophie Dean was diagnosed with cystic fibrosis.
She was two weeks old when doctors put her on a lifesaving pancreatic enzyme to help her digest food and absorb nutrients. The medication worked, allowing Sophie to gain weight and grow.
But in 2015, when she was eight, her parents’ health insurance started requiring that they receive her medication through Express Scripts mail-order pharmacy rather than the specialty pharmacy that had been sending it to them previously.
Instead of receiving the medication in an insulated box with a device that indicated if it was exposed to potentially harmful temperatures, as her family had done previously, Express Scripts sent it without any kind of temperature indicator in a cardboard box or often just a thin, gray plastic bag, Erica Dean, Sophie’s mother, said.
And because the mail-order pharmacy didn’t notify them when the package arrived or provide them with a tracking number, the package would sometimes sit on the family’s porch for hours, baking under the North Carolina sun.
Sophie began suffering from debilitating stomach aches. Her appetite evaporated, her mother said, and her body mass index plummeted.
“I started to think, ‘OK, wait a minute.’ We were told when she was two weeks old, ‘Don’t even keep the enzymes in the car because it’s not safe. They won’t be as effective,’” Dean said.
She called the pharmacy asking them to ship it a different way, but she said an Express Scripts representative told her, “You’re not a pharmacist, ma’am.”
Dean said she called again and again. “It was a script, every time. I knew exactly what they were gonna say every time I called,” she said.
“My option was either fill it like they tell me to, or sell my house and my kids and my organs,” Dean said, “That’s just one medication she’s on, and not the most expensive one.”
And then something strange happened. When Sophie landed back in the hospital with severe lung inflammation in 2017, she regained her appetite.
“The doctor is baffled,” Dean recalled. “And he comes in and he says, ‘Ms. Dean, I don't understand. Enlighten me. What's going on?’”
Dean explained that after Sophie was placed on the hospital’s supply of enzymes, her discomfort during mealtimes had all but disappeared.
“At that time, my take was the enzyme source needed to be reviewed,” Dr. Patrick Sobande, Sophie’s then-doctor, said in an email.
Soon after, Sophie’s family secured an exception allowing them to fill the prescription at a local pharmacy. She continued gaining weight, and in the last three years, her mother says she hasn’t had the same digestive issues.
Definitively linking Sophie’s digestive problems with how her medication was delivered would be nearly impossible, multiple pharmacological experts said. The medication is gone — ingested by Sophie long ago — and can’t be tested for changes in potency before and after transit. And there are other potential explanations for her discomfort that aren’t easily disproved.
Cystic fibrosis specialists have long warned families about pancreatic enzymes’ sensitivity to heat.
“Even before mail-order pharmacies, when it came to enzymes, we very explicitly told families never to leave them in their cars, never to leave them in a hot spot in the house,” said Dr. Greg Sawicki, an associate professor of pediatrics at Harvard Medical School who runs the Cystic Fibrosis Center at Boston Children’s Hospital. “It could have very much been that the enzymes were denatured or not working effectively because they were not being stored or shipped properly.”
When asked about Dean’s and Becker’s cases, a representative for Express Scripts Pharmacy said that when patient issues arise, “our team works quickly to resolve them, just as we did with these patients.”
In an interview, Wendy Barnes, Express Scripts’ head of home delivery, said all medications are shipped with tracking information and if a patient’s drug is damaged during transit, the company will expedite a replacement to them, which is what happened with Becker’s warm migraine medication.
“Everything we do is to serve our patients. We want nothing more than for them to have the medication that they need in a timely and efficacious manner,” she said.
“While we are getting it right the majority of the time, any time we’re not, we absolutely need to do better,” she added.
As for Dean’s and Becker’s inability to fill their prescriptions locally without paying out of pocket, Barnes said Express Scripts is not the one imposing the requirement to fill long-term medications by mail. “Those decisions are ones that are often made by someone’s employer or their health plan,” she said.
In a statement, Express Scripts said that only about six percent of its patients are in plans like Dean’s where patients have to use mail service for maintenance medications or pay out of pocket. The rest can choose to fill prescriptions at a local pharmacy, Express Scripts said, but it will likely cost about 30 percent more than doing so by mail.
‘Sorry for the inconvenience’
Sending drugs by mail is not new. The Department of Veterans Affairs has been shipping prescriptions since the 1970s. But in the last 20 years, the number of users nationwide has roughly doubled, with federal data showing an estimated 26 million people receiving their medication by mail.
Much of how prescriptions work in the U.S. is now determined by companies like Express Scripts — called pharmacy benefit managers — which work with insurers and employers to negotiate drug prices, and often operate their own mail-order pharmacies. Many patients are effectively forced onto their services, particularly those with long-term prescriptions for chronic conditions, either by financial incentives to fill those prescriptions by mail or because coverage is withheld if they don’t.
NBC News reviewed letters like this one from Express Scripts, dotted with notes a patient took during phone calls, informing them that their prescription would no longer be covered by their health insurance unless filled through the company’s mail-order pharmacy.
“For these medications, convenient home delivery is required by your plan. If you choose to continue filling the medications above at a retail pharmacy every month, unfortunately, you'll have to pay the full cost.”
This one informing a patient they would pay full cost unless they switched to OptumRX’s home delivery or withdrew from the program.
“After 2 refills, you will have to pay the full cost, if you don't switch to a 3-month supply and fill through OptumRx home delivery. You can continue to fill a 1-month supply at your current retail pharmacy, but you must disenroll from the Mail Service Member Select program.”
And another from CVS Caremark, announcing that, going forward, refills for a long-term medication could only be filled by mail or at CVS pharmacies.
“We are writing because you have reached your 30-day refill limit and must start filling the medications listed below in 90-day supplies at CVS Pharmacy or through CVS Caremark Mail Service Pharmacy. If you fill them anywhere else, or in 30-day supplies, they will no longer be covered and you'll have to pay 100 percent of the cost.”
The ability to receive drugs by mail is a lifeline for many, especially the homebound, the elderly and rural residents. Some customers said that despite being skeptical at first, they now prefer the convenience of getting their drugs shipped to their front door.
But pharmacy experts said the safety of mail-order drugs remains an open question, particularly because few regulators and academics have studied the effects.
“Nobody has performed a systematic study to know whether those medications are effective or not,” said Mansoor Khan, a professor of pharmaceutical sciences at the Texas A&M College of Pharmacy and a former Food and Drug Administration director of product quality research.
The pharmacy benefit managers that operate the three largest mail-order pharmacies — Express Scripts, CVS Caremark, and OptumRx — took home 72 percent of mailed prescription revenue in 2019, to the tune of $113 billion, according to one industry analysis. They all ship drugs through regular delivery services, often in the cargo area of un-air conditioned trucks, which can hit temperatures well over 100 degrees in the summer.
Like Express Scripts, CVS Caremark and OptumRx said their mail-order services are cheaper, more convenient and provide longer-term refills than retail pharmacies, leading to more patients taking medication properly.
The companies all said they also use specific packaging for temperature-sensitive medication which protects against extreme highs and lows on the medication’s journey to a patient’s door.
The Pharmaceutical Care Management Association, a trade group that represents pharmacy benefit managers, said that its members use proprietary software to monitor weather and map the potential temperatures a sensitive package may be exposed to on its delivery route, and that their mail-order pharmacies are safe, convenient and reliable.
Patients told a different story.
"I would give anything to just be able to pick up the prescriptions from our local pharmacy instead of worrying so much about the temperature of medications being shipped to me every three months," said a Utah mother who receives her son's insulin and several medications for her daughter by mail.
"I have no car, no driver’s license. I need my medication delivered to me, otherwise I’ve got to plead and beg all my family and friends to go get it. And if they can’t deliver it to me the way it’s supposed to be, I’m pretty much screwed," said a Missour woman who receives her psoriatic arthritis medicine by mail.
"I recently had an issue with mail-order insulin … My doctor and I believe the shipment was frozen. [The pharmacy] said to me, ‘We are sorry for the inconvenience.’ Inconvenience? I could have died. Without this medicine, I will die," said a Michigan woman who receives insulin by mail.
Ten local pharmacists in eight states said they also frequently deal with the consequences of forced mail order. The pharmacists described longtime customers coming into their stores to ask why their insurance will no longer cover in-person refills. Others ask if it is safe to take medication left on a doorstep for hours, or beg for emergency refills while waiting on a delayed delivery.
“I do everything I can to help patients avoid mail order,” Terry Traster, who owns a pharmacy serving several small towns in rural Illinois, said. “What I am most worried about is they will get drugs that don't work, or — what could even be worse — instead of not working, could actually be harmful because they degrade.”
Most drugs can be subjected to temperatures higher or lower than their labeled guidelines for short periods of time, experts say.
One of the challenges, patients said, is not knowing if a package will arrive when they’re not home, potentially leaving it exposed to the elements for hours. Only about a third of the more than 65 mail-order pharmacy customers interviewed said they were offered signature delivery. Of those, several said that the option cost extra.
A UPS driver, captured by a doorbell camera, leaves a package of refrigerated medication on a Florida doorstep in February 2020. (Denise Church)
Many complained about overly broad delivery windows. People from Minnesota to Florida said they’ve had to take off work to ensure temperature-sensitive drugs weren’t left sitting on a doorstep or a driveway all day, or worse, sent back to a delivery warehouse if they weren’t home to sign for the package.
Unopened insulin is supposed to be refrigerated — kept between 36 and 46 degrees Fahrenheit. But Kim Munson, of Lakeview, Minnesota, said she has come home to find her daughter Kinsley’s mailed insulin left on a sunny porch in July, or sitting for hours by a pile of snow in January. Express Scripts replaced Munson’s January shipment, but after several calls, she gave her daughter insulin from the July shipment and hoped for the best.
“The package could be on the doorstep for hours,” Munson said. “I can’t just stop my life to be at home because this package is going to come between the hours of 8 a.m. and 8 p.m.”
Like other mail-order pharmacies, Express Scripts said that the packaging it uses to keep refrigerated medications within a specific temperature range during shipping will keep those medications within safe ranges even if the package is sitting outside for several hours after delivery.
But the hours it can take to navigate the customer service system, get a pharmacy representative on the phone, and then convince them to replace a shipment is like having a second job, Munson said. Her daughter’s insulin has twice arrived in broken vials. Replacing the first was such a hassle she gave up trying with the second, instead dipping into a stash of spare vials she keeps for emergencies.
When asked about Munson’s case, a representative for Express Scripts said, “The safety and satisfaction of our millions of patients is always our top priority,” and that as with Dean and Becker, Express Scripts works quickly to resolve any patient issues.
“This is a life-sustaining drug that keeps my child alive,” Munson, who had Express Scripts on speed dial, said. “It’s incredibly infuriating.”
Her frustration was a common refrain among mail-order pharmacy customers.
"It’s no joke. We can have [$8,000] worth of medication sitting in 100 degrees because we have NO choice in how we receive it," said a Florida woman who receives her refrigerated rheumatoid arthritis medication by mail
"My dog is on medication. And he receives his medication with a temperature sticker on it, verifying that the medication comes at the right temperature … Why do they do that for dog meds but they don’t do that for humans," questioned an Arizona woman who receives room-temperature medication for epilepsy and migraines and refrigerated medication for her dog by mail
"Recently, our small pharmacy was purchased by a much larger national pharmacy. The agents can't even pronounce the name of the medication and last time, when I asked for needles, they told me that they were not in stock! Kind of hard to inject an injectable without needles," said a Pennsylvania mother who receives her son’s growth hormone deficiency medication by mail
‘You get tired of fighting with them’
Oversight of mail-order pharmacies rests with state pharmacy boards, but board officials across the country said they rarely, if ever, receive complaints about drugs damaged in delivery.
Interviews with customers revealed that most weren’t aware of their state pharmacy board and simply didn’t know where to complain.
Loretta Boesing’s son Wesley, 11, is on anti-rejection drugs for a liver transplant. When the room-temperature medication arrived on a hot Missouri day in May 2018, she worried it might not be safe to give to him. Dissatisfied with what she said were CVS Caremark’s shifting explanations of why it was shipped without temperature protection, she called the FDA.
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.”
Growth of the mail-order pharmacy industry
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.
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.
All three delivery organizations said they offer a range of delivery and signature options to the mail-order pharmacies using their services, with UPS and the Postal Service adding that it is up to the shipper to choose the options right for its products, and to use packaging that sufficiently protects the medications from extreme temperature exposure or damage.
Concerns over the temperature of mailed medication have caught the attention of federal law enforcement. In 2016, the Justice Department demanded CVS Caremark provide documents as part of an investigation into its “handling of certain temperature-sensitive pharmaceuticals,” according to a CVS financial disclosure.
Investigators were focused on whether CVS knowingly used ineffective methods to insulate shipments of refrigerated medications to customers as far back as 2010, according to two sources familiar with the investigation. The Justice Department declined to comment on the investigation, but sources say the investigation was still active as recently as 2019.
As part of the investigation, the Justice Department requested documents from a 2014 California lawsuit against CVS Caremark, which alleged the company improperly shipped patients’ refrigerated arthritis medication for years.
That case was eventually dismissed, but it revealed that in 2014, a CVS Caremark employee mixed up Celsius and Fahrenheit when dictating freezer temperatures in CVS’ specialty mail-order facilities, leading to ice packs kept far colder than intended. Like a misplaced ice pack, an excessively cold one has the potential to flash-freeze a drug, packaging experts said.
The error was not fixed until after the plaintiff brought it up during litigation — roughly two years later — according to a hearing transcript.
CVS declined to comment on the lawsuit and the investigation.
‘There’s no way out of this’
Home delivery of medications spiked by 20 percent in March and April, when Covid-19 quarantines began around the country. And experts speculate that more people may choose to get their prescriptions this way as they continue to self-isolate.
But those patients are entering a system plagued by recent postal delays and increasingly frequent extreme temperatures.
“If it is a quick shipment, it’s probably going to be fine,” Fox said. “But when you’re hearing about weeklong delays or just sitting in very hot containers that are not refrigerated or temperature controlled at all, that’s concerning and you should be putting temperature monitoring strips in those shipments.”
Industry practices are changing. Last year, the organization that accredits mail-order pharmacies began inspecting pharmacies’ shipping methods for room temperature medication, which it previously only did for refrigerated medication. USP, the standard setting group, has also updated its guidance to spell out specific ways pharmacies can limit the risk of temperature exposure during transit. The guidance went into effect earlier this month, though its enforcement still falls to state pharmacy boards.
In the past decade, at least 12 state legislatures have passed laws trying to prevent pharmacy benefit managers from incentivizing or forcing consumers to get their prescriptions by mail. But many of those laws have loopholes, experts say, and most state laws about insurance don’t apply to the employer-funded plans common among large companies. Those are regulated federally and cover more than an estimated 73 million Americans.
For patients, it’s still an uphill fight. After long battles over insurance coverage, Boesing and Dean no longer get the medications they were concerned about in the mail. But Becker and Munson still do, unhappily and unwillingly.
“There’s no way out of this,” said Munson, who can’t afford the hundreds of dollars more her daughter’s insulin would cost every month if they did not get it by mail.
“All I can do is wish for the best when I open up the styrofoam container and put it in the refrigerator. I just hope and pray that the insulin I eventually will be putting into her body works.”
Samantha Springer, Wilson Wong, Kara Stevick, Gretchen Morgenson and Peter Georgiev contributed.
Graphics and development by Robin Muccari, Jiachuan Wu and Charlotte Li; Photo editing by Elise Wrabetz.