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.
Will It Still Be OK?
A. Thank you for explaining the mail order problem so clearly. We normally hear from patients, who also have no control over shipping.
For example, one reader wrote:
“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.”
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 that 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?
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. 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?
How were your medications shipped from India to America? 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 drugs. Brand-name manufacturers already do this (even for veterinary medicines, as shown). 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, shipping from the warehouse to the customer should maintain the medication in the proper conditions so that it will still be effective when taken. Get in touch with your state Board of Pharmacy to request action on this problem.
