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Are Your Medicines Delivered in Cold Weather?

Do you get your medicines delivered? Many insurance companies require people to get their drugs through the mail. Are there concerns about cold temperature?
Photo of a winter frozen mail box under snow

Baby, it’s cold out there! Depending upon where you live, the temperature could be below freezing at some point during the day. If you get your medicines delivered by the United States Postal Service or almost any other delivery organization, the chances are good that they will be out of the temperature range mandated by the FDA. This person describes just such a scenario.

Medicines Delivered Out of Spec:

Q. In early 2015, the VA Hospital sent my EpiPens via USPS. They landed in my mailbox on a day that was 34 degrees out. I was not at home when they arrived, and I got home about four hours after the mail is usually delivered.

I called the VA pharmacy to ask whether this drug would be less effective after spending hours way below the temperature threshold. He said: “I think that they should still be OK”. My response (minus any profanities I may have used) was that if I ever need to use those EpiPens, they must work. I don’t need a pharmacist to say that he thinks they should still be OK.

The next day I drove 56 miles to the VA and turned in the ones they had sent. In exchange, they gave me new ones.

A. You were right to be concerned. The official prescribing information from the company states:

“Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). Do not refrigerate.”

Most home refrigerators maintain a temperature of 36 to 37 degrees F. Consequently, the mail-order service from the VA did not treat your injectable epinephrine appropriately.

We fear that many other mail-order medicines may also be exposed to temperatures outside the FDA-mandated range.

FDA’s Instructions on Storage:

Most medications are supposed to be stored between 68 and 77 degrees F. That goes for drugs like atorvastatin to lower cholesterol and gabapentin for pain. The asthma drug Advair (fluticasone and salmeterol) comes with this recommendation about storage and handling:

“Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C).”

“Excursions” are not well defined by the FDA. The agency often uses the phrase:

“short-term excursions outside the label storage conditions (such as might occur during shipping)”

We find that woefully inadequate. Does the FDA define short-term as hours or days? What about drugs made in China, India or Slovakia and shipped to the U.S.? Would weeks be considered short-term? We do not have a clue.

Medicines Delivered in Northern States:

Anyone who gets Advair delivered in Colorado, Idaho, North or South Dakota, Illinois, New Hampshire or Maine (to name just a few cold spots these days), is not likely get medicines delivered above 59 degrees F. That means they are out of the recommended range. And remember, many medicines are shipped to mail-order distribution centers in trucks that are also not temperature controlled.

The FDA has been very clear about storage and handling for most medications. Sadly, it claims to have no authority over how your medicines are delivered. In fact, we have been disappointed in the way the FDA monitors storage and delivery from drugs manufactured abroad. Are such products shipped in temperature- and humidity-controlled containers? The FDA has not been clear about that fundamental question.

Why bother to provide specific guidelines if no one cares if your medicines are delivered out of the recommended range?

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I suspect the bigger concern is heat. We live in North Carolina and used to have meds delivered by mail. When I realized that the medications would sit for hours in a black mailbox on a sunny 100 degree day in the summer I decided to find another way to get the meds. Shipping meds by mail should not be permitted.

Similar concerns, if a bit less consequential, relate to delivery of supplements. Cold, I suspect, is less of a problem than heat, but I have to wonder what the effect of frigid temps will be on, for example, the borage oil that is on its way to me. Similar questions about lots of other things.

I am a former pharmacy technician who worked in a mail order pharmacy owned by a major insurance company. Temperature was our enemy, but we did our best. Medications that had to be kept cool, like insulin, were shipped in little styrofoam coolers with ice packs. We never shipped perishable medications on Friday, so they wouldn’t sit in hot warehouses over the weekend.

We were acutely aware of destinations and asked patients who wouldn’t be home if we could give specific instructions to shippers re: safe places to put the delivery, or could ship to workplaces or neighbors who would take the package indoors immediately. Still, we had calls daily from people who received hot or freezing medications.

“It should still be okay” was our pharmacists’ best guess, since we had no control over the shippers’ procedures. We always replaced questionable meds, but then we had the same problem again with shipping the replacements.

I was told by the company that my insurance uses to ship meds, that I could not get my Advair locally, that getting it locally wasn’t financially covered. I had to have it mailed. I live in Florida. Temps are way above suggested storage temps in the spring,summer, and into fall.

The meds company told me to go rent a mail box at the PO if I wanted properly maintained temperatures !!!

It seems to me that my drugstore gets its medicines the same way I do. A truck brings them, and said truck lives outside and is subject to prevailing temperature range outside. Right?

One question is how the temperature range was determined in the first place. Was it arbitrary? Was it due to testing to determine efficacy after exposure to lower temperatures? Even then, how long was the exposure? What were the precise temperatures?

I appreciate articles like this but they seem to primarily serve to create doubt and fears without giving us anything to base how we should respond. Not that the article should not be written but a comment or two about how the standards were established would help.

Further, based on the article (and it did not even cover the too much heat problem), it seems that total environmental control ought to be required, extending from production to storage to delivery. And that, clearly, will add much to the cost as climate-controlled facilities and vehicles are retrofitted to meet the standards.

As seems to be the case across the board, the interest seems to be in prescribing drugs and collecting vast amounts of money with little or no concern about if they are safe or effective or stored properly or anything else.

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