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?