There are very stringent guidelines about how medicines should be stored. The manufacturer and the FDA agree about the proper temporary and long-term storage temperatures. We fear that pharmaceutical distributors, mail order drug services and consumers may not pay careful attention if medicine freezes. As this reader notes, that could lead to serious consequences:

Do Some Frozen Medicines Lose Effectiveness?

Q. I experienced a problem with “frozen” medication. Combivent Respimat inhalation spray was shipped to me during an unusually cold spell. I noticed I was not getting the same relief for my breathing, and the relief I did get didn’t last the expected six hours.

I called Boehringer Ingelheim, the manufacturer. The representative I spoke to instructed me to stop using the inhaled meds immediately. They shipped me a replacement right away. Is it safe to get mail-order medicine in the winter?

A. You raise a fascinating question. Most medicines are supposed to be maintained within a relatively narrow temperature range (68 to 77 degrees Fahrenheit). For short periods of time it is generally OK if temperature fluctuates between 59 to 86 degrees.

During either winter or summer, shipped medications may spend hours outside those parameters. One woman wrote:

My husband was sent some Androgel by mail order, but we had to go out of town for a funeral at the last minute. The meds spent eight days riding around in a truck before they could be delivered.

“Routine blood tests revealed that the meds were no good. The manufacturer was so concerned it tracked down exactly where the drugs had been and at what temperatures. Apparently, they spent too much time in temps over 85 degrees, so the company refunded our money.”

What Should You Do if Your Medicine Freezes?

First, report the problem immediately to the company that shipped the medicine. Liquid medicines can be especially vulnerable to temperature fluctuations. But even some pills may be affected.

Next, contact the original manufacturer of the medicine. Ask what you should do if your medicine freezes while being delivered by the United States Postal Service, FedEx or UPS, or while sitting in a mail box.

Finally, be extra careful in cold or hot weather. Some people leave their bag of medicine in the car while running errands. If you are gone longer than a few minutes the medicine may freeze in the winter or get way too hot in the summer.

Other Messages from Readers:

W.H. shared this FDA notification:

There was an FDA warning letter to an in vitro manufacturer for using ambient shipping methods which were contrary to the labeled requirements on the product.

“Although this case resulted in a warning letter, I would think that such violations are routine. I too have wondered about my mail box out in the sun on a summers day (in Texas), or the temperature inside a truck trailer in July any place in south. While I have seen a slight uptick in better packaging, this is certainly not routine. Moreover it reflects that the shipper recognizes the problem, but only deals with it selectively.”

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm397698.htm

B.B.S. has insider knowledge from the pharmaceutical industry:

I have worked in the pharmaceutical industry for over 20 years in clinical research. When drugs are being tested, strict guidelines are utilized to assure that the drug under investigation is shipped and maintained at the acceptable temperature range for that drug. If not, they are discarded and strict documentation is required of the event.

“Many drugs may become unstable or ineffective outside of the designated temperature. It has always concerned me that such strict guidelines are followed during clinical trials in which the effectiveness and safety of the drug is determined but who knows what happens on the way to the consumer.”

Drugs Are Too Pricey to Waste:

You would never think of leaving fresh fish or chocolate in a hot mail box during the summer. Why would you leave your medicine in an adverse environment. Ounce for ounce, some medicines are pricier than gold. Do not risk having them go bad.

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