The FDA has very strict recommendations about how medicines should be stored and shipped. The question is: do drug companies and wholesalers comply with those guidelines? Getting a straight answer out of the FDA has been like pulling teeth. How would you know if the medicine transported from China or India was handled correctly?
We recently learned that:
“The bottleneck in the global supply chain for APIs [active pharmaceutical ingredients] is now shipping, particularly ocean freight.” (FiercePharma, March, 31, 2020).
That suggests that some pharmaceutical ingredients could be transported from China to India on container ships. If that is true, they may not be maintained under ideal temperature or humidity-controlled conditions. This reader is concerned.
How Is Medicine Transported?
Q. I never realized that medicine could deteriorate during transportation. I use a mail order service because I have to. Before, I let pills sit in the mailbox no matter what the temperature. After reading your column, that will not happen again.
A. Many medicines should be kept at room temperature (68 to 77 degrees F). The FDA does allow temporary temperature excursions during shipping and storage from 59 to 86 degrees F.
A cargo ship traveling from India to China may not always stay within those limits. What about the cargo bay on an airplane flying at more than 30,000 feet? We have our doubts.
When the FDA recently requested the recall of all ranitidine (Zantac) products, it noted that the nitrosamine impurity (NDMA) in these products:
“increases over time and when stored at higher than room temperatures…”
NDMA is a probable carcinogen.
What is the Temperature in Your Mailbox?
Leaving drugs in a mailbox during a hot summer or cold winter day would likely exceed the FDA’s storage guidance. Liquid drugs like insulin or epinephrine may degrade faster if exposed to extreme temperatures. Then they may not work as expected. We don’t know if other drugs, like ranitidine, would degrade and develop impurities if stored improperly.
How do you get your medicines? Do they come by mail or by a shipping company such as UPS or FedEx? Have you ever looked to see whether the cargo section of those trucks is heated or cooled? How do medicines get from warehouses to your local pharmacy? Are those trucks temperature controlled? We have our doubts there too.
Boards of pharmacy are supposed to monitor the shipment of drugs within their states. Do they verify that FDA guidelines are followed?
Do you ever wonder whether medicine transported by ship, plane or truck is maintained within the guidelines? Share your thoughts in the comment section below.