My grandfather Joseph was a pharmacist who practiced around the beginning of the 20th century. I still have his scale and the glass beaker he used to accurately measure liquids. There was a time when a neighborhood pharmacy like his was a cornerstone of the community. The pharmacist knew his customers personally and could offer advice and remedies for a wide range of health problems. Chain drugstores have made life challenging for independent pharmacists. Many insurance companies require patients to rely upon mail order med deliveries. That may seem convenient, but is it safe?
Would You Buy Fish Online?
Online ordering has become BIG business. People love the convenience of one-stop shopping. The click of a mouse can get you batteries, sunscreen, a portable phone charger, toys, shampoo or cat litter. Having such items delivered to your front door or apartment building seems incredibly convenient.
During the pandemic many people learned how to do their grocery shopping online and some continue to enjoy the convenience. We doubt that a lot of folks order fresh fish, ice cream or chocolate on the hottest days of the summer, though. And that’s the problem with medications.
An unintended consequence of the shift in how people get their prescription medicines is that many drugs are now exposed to temperature extremes. This summer, one of the hottest on record, has created a huge challenge for mail-order pharmacy services.
Mail Order Med Deliveries During HOT Weather:
The FDA has stringent guidelines about temperatures for storing and shipping prescription drugs. Many are supposed to be held at room temperature. That’s around 20 to 25 degrees C, which is 68 to 77 F. Think about that for more than a nanosecond. That’s a 9 degree range.
Do you think that the maker of pills in Mumbai, India, is shipping your medicine from the manufacturing plant to a dock or airport in a truck that is keeping its trailer at room temperature? Is the cargo area on the airplane or container ship staying steady at room temperature? No matter how many times we ask the FDA how carefully it is monitoring the transport of medicines from China to India to the US, we never get a straight answer.
What happens to medicine that lands at a port of entry, say Los Angeles, Houston or Baltimore? How long does it take for the container to be inspected by customs officials? Is it kept at room temperature throughout that process?
What about shipping pharmaceuticals from the port of entry to warehouses and pharmacies across the United States? The FDA allows for “short-term excursions outside the label conditions” but is not very specific about how long a “short term” lasts. For most drugs, the FDA limits such excursions between 59 and 86 degrees F. The next time a UPS, FedEx or US postal truck pulls up to your house, ask the driver if the cab and cargo area are air conditioned. Wait for the laugh.
A New York Times Exposé:
According to a New York Times investigation by Emily Baumgaertner (Aug. 13, 2024), the cargo areas of delivery trucks can reach 150 degrees F. A study published in the Journal of the American Pharmacists Association (May-June 2023) tested temperatures of packages during shipping.
The researchers found that simulated mail order med deliveries were often out of spec:
“Evaluated packages spent an average of 68.3% of transit time OOR [out of range].”
They concluded that:
“Package temperatures were outside of the recommended range for most of the transit time regardless of the shipping method, carrier, or season.”
An FDA representative told the New York Times that:
“medicines that are not stored properly may not work as well or may cause harm, even if they are not expired.”
Although the FDA sets strict guidelines on storage temperatures, it has limited ability to enforce its standards.
The researchers who tested package temperatures point out:
“Federal oversight of manufacturer, wholesaler, and pharmacy practices requires medication storage in adherence to USP <659> standards (68℉–77℉) within and among these parties. Mandatory inspections and routine surveillance practices exist to assess compliance with this temperature requirement. These include monitoring of temperatures during transit, insulating packages, and reporting potential excursions. In contrast, there are currently no regulations that require monitoring or reporting of storage conditions for nonspecialty oral medications after they leave the pharmacy.”
That was a bit complicated. The key phrase is:
“…there are currently no regulations that require monitoring or reporting of storage conditions for nonspecialty oral medications after they leave the pharmacy.”
Imagine a town setting the speed limit on its main street at 35 MPH. If the police department is not allowed to arrest speeders, the law would make little difference. People could drive through town at 85 MPH and no one would be capable of stopping them. Why do boards of pharmacy in all states ignore the FDA’s rules so completely?
A Whistle Blower Questions Mail Order Med Deliveries:
Whistle blowers rarely get rewarded. They often get fired and banished from the industry that they care about. Over the last 40 years we have heard from people who worked for cigarette companies, generic drug companies and chain drug stores. This is the first person who revealed secrets about mail order med deliveries.
A Pharmacy Tech Speaks Up!
Q. You recently wrote about the problem of mail order medicines being left in the cold for hours. This is a real problem.
I used to work as a pharmacy technician for a mail order pharmacy owned by a major insurance company. Temperature was our enemy, but we did our best.
We shipped medications that had to be kept cool, like insulin, in little Styrofoam coolers with ice packs. Staying aware of weekend schedules, we never shipped perishable medications on Friday so that they wouldn’t sit in hot warehouses too long.
We were acutely aware of destinations and asked patients who wouldn’t be home at delivery if we could ship to workplaces or neighbors who would take the package indoors immediately. Even so, we had daily calls from people who received hot or freezing medications.
Our pharmacists’ best guess was “It should still be okay,” since we had no control over the shippers’ procedures. We always replaced questionable meds, but we often had the same problem with the replacements.
A. Thank you for explaining the mail order drug problem so clearly. We normally hear from patients, who also have no control over shipping.
Readers Share Stories About Mail Order Med Deliveries:
Over the last few decades, we have received hundreds of complaints about mail order drug problems. Here is just one example:
“It’s 97 degrees F in Illinois today. My heart meds were stuck in a mailbox that put off heat like a stove, probably between 130 and 140 degrees. I don’t know how long they sat there, possibly five hours.
“One med is propafenone for atrial fibrillation. The other med is nitroglycerin, which loses strength quickly at high temperatures. Meds should be delivered right to your door from a vehicle with air conditioning, not left in a sizzling mailbox.”
Another reader shared this:
“I ordered CoQ10 capsules. When the bottle arrived, the capsules had swollen. I used a thermometer and found the caps were over 110 F. I got a refund, but I’ll never order medicines or supplements for home delivery again.
“There’s no way of knowing where our medicines originate and how they’re transported. This could affect their quality. I guess someone has to pay with their health to get action taken by the FDA.”
Our interview with Loretta Boesing is incredibly poignant. Her son needed a liver transplant to save his life. Afterwards, he required medicine to keep his body from rejecting the transplant. This was a matter of life and death. Listen to Loretta describe her battle to get his medicine delivered safely at this link. There is a lesson here for all of us!
What Can We Do About Mail Order Med Deliveries?
It is past time for the FDA and boards of pharmacy to come to grips with problems of shipping and storage of crucial medications. Inexpensive temperature monitors should be required for all mail-order medicines. If a drug delivery is out of spec, the company should replace it at no cost.
Sadly, the FDA has no jurisdiction over shipping. That is regulated state by state and there is virtually no oversight.
The Complex World of Mail Order Med Deliveries:
Here is a possible scenario of the pharmaceutical supply chain. It demonstrates the challenges we have faced in trying to better understand the complicated quilted pattern of mail order med deliveries:
1. A molecule is made in a Chinese chemical plant in Shanghai. It is the active pharmaceutical ingredient (API) for a medicine that will ultimately be shipped to the U.S.
2. A different Chinese company makes the inactive ingredients (excipients) for many different pills. In our theoretical case, the binders, fillers and colors are made in Chengdu.
3. The API and the excipients are shipped to India. How they are shipped, by air, by rail, by truck or by ship, remains a mystery to us. How they get from the port of entry to the manufacturing plant in Mumbai is another mystery. Are they shipped under ideal temperature and humidity control conditions?
4. Once the finished pills are manufactured, they then must be shipped to an exit location. How do they get transported to that locale? Again, are they moved in temperature and humidity-controlled containers? Who’s monitoring?
5. Now they must be transported from India to the U.S. Are they flown in temperature-controlled cargo bays or sent on cargo ships?
6. Once the pills arrive in the U.S., they must be inspected at the port of entry. How long will they sit in transit, and will they be in temperature and humidity-controlled containers during the wait?
7. Once inspected, the pills must be transported to major pharmacy distribution centers. Those may be chain drug store warehouses or mail order centers. Who oversees the transport vehicles, especially if they cross state lines? Are these trucks temperature- and humidity-controlled?
8. Finally, they must be sent from a warehouse to the patient. Some carrier service such as the United States Postal Service (USPS) or UPS is likely involved. Have you ever noticed a USPS or UPS truck deliver products to your door in temperature- or humidity-controlled vehicles? We haven’t.
A woman with metastatic breast cancer received a critical medicine (Ibrance) when the temperature in Florida where she lived was 97 degrees F. That was way outside the FDA guidance.
Learn more about how the FDA responded to our questions about oversight of mail order med deliveries at this link. You may be astonished to learn what the FDA’s rules are for storage and transport. We suspect that very few mail order med deliveries fit within those stringent guidelines.
How Safe Are Mail Order Medicines If Not Temperature Controlled?
Were your medications shipped from India to America? Did they go by container ship or cargo plane? How did they get to your pharmacy or your doorstep? Is anyone in charge of mail-order medicines?
The questions on medication transport during and after manufacture are difficult, if not impossible, to answer. One baby step would be to require drug makers to provide country of origin information on drug manufacturing. Brand-name manufacturers already do this. Including this information on the labels of mail order drugs would require a change in regulations and some adjustments in packaging processes.
Even more important, companies that ship from a warehouse or mail order pharmacy to customers should maintain the medication in the proper conditions so that it will be effective when taken. Get in touch with your state Board of Pharmacy to request action on this problem. The very first step for these oversight organizations should be to require temperature monitoring devices in every single package containing medications!
Please share this post with friends and family. We need people to fight for safe medications. Boards of pharmacy have the power if they are willing to wield it. The New York Times article on mail-order medications reveals what happened when the state board of pharmacy in Oklahoma tried to pass legislation requiring that “…drugs be kept in the temperature ranges recommended by U.S.P [United States Pharmacopeia].”
The trade association representing P.B.Ms [pharmacy benefit managers] and other mail-order medicine lobbyists argued against strict requirements for mail order med deliveries.
Marty Lee Hendrick, the executive director of Oklahoma’s board of pharmacy, told the New York Times:
“In some states, pharmacy boards have ‘no appetite’ for stronger rules, Mr. Hendrick said. Others have contacted him about framing their own proposals. He said he had advised them to brace for the lobbyists.
“’I hate to say this, but we’re really probably one big tragedy away from people realizing how serious this is,’ Hendrick said. ‘time will come. I know it will. But these battles end up being wars.’”
Join with The People’s Pharmacy and Loretta Boesing (and Unite for Safe Medications) in encouraging boards of pharmacy to serve the public by passing legislation requiring proper delivery of medicines to pharmacies and especially to patients.
