Many people are encouraged by their insurance company or their pharmacy benefit manager (PBM) to buy their medicines through the mail. They are told they will save money. Mail-order prescriptions are also touted as highly convenient. The insurers remind you that there is no more standing in line at the pharmacy counter. And the PBMs point out that you can easily refill your prescription online. But is there a downside to getting mail-order prescriptions? This mother says yes!
When Temperatures Exceed Allowable Range:
Q. When medications lose their potency during shipping, it can be life-threatening. This happened to my son.
Sometimes people don’t realize how unsafe it is to expose medicines to high temperatures. Others may think, as I did prior to my son ending up in transplant rejection, “They wouldn’t do it if it weren’t safe.” I was wrong.
Children’s liquid oral medications can quickly lose potency at high temperatures. Other drugs can also become less effective.
When I called the mail order specialty pharmacy about my concerns with my son’s immune-suppressing medicine being exposed to high heat, they said that they could ship my son’s medications to the local pharmacy instead of my house. I asked, “Will they be shipped in the same hot, non-temperature-controlled trucks in the same way that they ship to my doorstep?” SHE SAID YES.
Shouldn’t mail order pharmacies be required to ship medicines safely for vulnerable patients?
A. Absolutely! The guidelines for medications call for storage at room temperature (68 to 77 F). During shipping, temporary fluctuations are allowed between 59 and 86 F.
To achieve this, shippers would have to use temperature-controlled containers from the point of manufacture (even if it’s abroad) to the final customer. There are many instances where there is a breakdown in this process.
Who’s in Charge?
The FDA points out that while it issues guidelines for how medications should be shipped or stored, it doesn’t have the authority to oversee what happens in individual states. That responsibility lies with the Board of Pharmacy in each state.
This organization oversees pharmacy practices. What we have been unable to ascertain is whether Boards of Pharmacy monitor the temperature and humidity of drug shipments to pharmacies and wholesalers within their states.
The FDA’s Answer:
In response to our question about how the FDA oversees transportation of pharmaceuticals within the US, here is what we were told:
“Similar to shipping any product into the U.S., once the product is imported into the U.S., the specific transportation needs of the shipment would be determined by the firm as it is dependent upon the specifications of the particular product. The required specific storage conditions of drug products are outlined on the product’s labeling, which is intended to maintain the safety, purity, and potency of the product. It should be noted that most drug products are relatively stable at room temperature for limited periods of time, although some are temperature-sensitive. In addition, most drug manufacturers have data to support the stability of their products at somewhat elevated temperatures and other adverse conditions.”
We’re not quite sure what that means. Pharmaceuticals are “relatively stable at room temperature for limited periods of time, although some are temperature-sensitive.”
We don’t find that reassuring. What about when mail-order prescriptions are shipped in a hot truck in the summer or a cold truck in the winter? What about when mail order prescriptions are left in a mail box or on a doorstep? “Somewhat elevated temperatures and other adverse conditions” may not be as uncommon as the FDA appears to think.
So Many Opportunities for Fluctuations:
We are even more concerned about how drugs get from China to India and then to the U.S. Are they shipped in the cargo hold of an airplane where the temperature may not be controlled? Are they shipped on container ships, where it is unlikely that either temperature or humidity are maintained within the narrow limits the FDA recommends?
We have asked the FDA to share information about typical shipping practices from abroad, especially when it comes to generic drugs. To date, we have been disappointed with the lack of clarity.
Share your own experience with mail-order prescriptions in the comment section below.
