There is a dirty little secret that many generic drug manufacturers and mail order pharmacies prefer you not know about. They break the rules on a regular basis when it comes to proper storage of medicine.
In an attempt to save money–lots of money–insurance companies and other payers have turned to large mail order pharmacy services. These organizations usually charge less than chain pharmacies or mom and pop drugstores because their overhead is lower.
What they don’t tell you when they offer lower costs on your co-payments is that they violate the rules every time they ship medicine to your doorstep. One reader took us to task for bringing this secret out in the open and pointed out that most medicines that are shipped to pharmacies may also violate the rules for proper storage of medicine:
Q. You wrote about medications being delivered to homes by various companies (UPS, FedEx, USPS) and made it sound as though if you don’t purchase it from your local pharmacy and bring it right home, there might be problems.
How do you think the majority of medications are delivered to the pharmacy? It’s by UPS, FedEx, and USPS! I doubt many pharmacies have their stock delivered by “temperature or humidity controlled vehicles” on a continual basis.
A. You raise a fascinating question that neither the FDA nor the pharmacy industry likes to address. Many yeas ago we met with quality control experts who worked for big brand name drug companies. They were passionate about maintaining and shipping medicine under ideal conditions. They have strict procedures for the proper storage of medicine based on rigorous stability testing.
That meant storage at the plant under both temperature and humidity control within narrow parameters. When they shipped to large pharmacy chain warehouses or drug wholesalers they relied upon trucks that were also temperature and humidity controlled. In addition, the manufacturers frequently inserted their own monitoring systems into the packaging so they could verify that the truckers followed the rules.
The quality control experts admitted to us that once their products were delivered to warehouses, the responsibility for proper storage reverted to the wholesalers and pharmacy chains. The delivery vehicles from warehouses to individual pharmacies are probably not carefully monitored for temperature or humidity.
The difference is that, once delivered to the pharmacy, the drug doesn’t sit in a cold mailbox for hours. Instead, it goes onto shelves that are room temperature.
Proper Storage of Medicine:
Every medication comes with specific guidelines for proper storage. Here are just a few examples:
- AZITHROMYCIN antibiotic tablets should be stored between 59 degrees to 86 degrees Fahrenheit.
- LEVOTHYROXINE (thyroid hormone): Store at controlled room temperature (68 degrees to 77 degrees with excursions permitted between 59 degrees and 86 degrees).
- PRADAXA (dabigatran, an anticoagulant): Store at 77 degrees Fahrenheit. Excursions permitted to 59 degrees to 86 degrees Fahrenheit.
Please note that the FDA recently warned that Pradaxa must be protected from “excessive moisture, heat, and cold.”
These are just a few examples, but we assure you that most medications are meant to be stored at room temperature. But what about that word “excursions”?
The Loophole Called Excursions:
If you visit the USP (United States Pharmacopeia) “General Notices and Requirements” you will discover something intriguing. Companies are allowed short-term violations of the specified storage temperature during shipping and distribution. In most cases the time limit is 24 hours and the deviations (excursions) from the standard temperature are specified. In other words, for a short period of time (a day or less) during shipping, temperatures within a vehicle are allowed to range from 59 to 86 degrees Fahrenheit.
Implications:
It should be obvious that most mail order deliveries during the winter (or summer) violate the USP guidelines when it comes to “excursions.” For one thing, the temperature in delivery trucks is rarely kept between 59 and 86 degrees F. For another, medications are likely to sit for hours in mailboxes that are below freezing in the winter or above 104 degrees F in the summer. This would violate the USP’s recommendations.
What About Drugs Imported from Abroad?
As far as we can tell, the FDA does not involve itself in issues of shipping and distribution. Since the USP has no legal ability to chastise violators of its guidelines, that means that no one is protecting the public from violations during storage or shipping.
A generic manufacturer in India, China, Brazil or Thailand might well store and transport medications in violation of USP guidelines and no one would be the wiser. Because it can take many days to get packages from the manufacturing plant abroad to the U.S. warehouse and then to the pharmacy, we have no way of knowing how those conditions might affect stability. Finally, letting the bottles sit for hours in a freezing delivery vehicle and a mail box does not add to our confidence. Imagine shipping fish, chocolate or milk under such uncontrolled conditions!
What’s the Answer?
We think that generic drug companies and mail order pharmacies should be required to follow USP recommendations for storage and shipment. So should pharmacy chains and mom and pop pharmacies. Either such organizations should abide by the storage and handling guidelines listed in FDA’s official prescribing information or we should admit that this whole enterprise is a sham and buyer beware.
What do you think? Do you have any concerns about the proper storage of medicine and the shipping of your medications? Please comment on this article below, share your own story and vote on this article at the top of the page.
