If you watch the news, you know we have experienced extreme cold weather conditions in addition to lots of snow in the Northeast. A colleague of mine told me that a few weeks ago, she came home after work to receive frozen medication in her mailbox. Prescription medication has temperature limits. If the medication is designed to be shipped chilled, consumers understand that if it gets too warm, the drug will lose potency.
However, the reverse probably is not as obvious to everyone. If a drug is designed to be used at ambient temperatures, and it gets cold during the shipping process, it can also lose potency.
My colleague is smarter than I am. She suspected this was the case. I don’t think I would have.
She had received a package containing Atorvastin and Lexoxyl from a mail order supplier -
Upon calling, she was referred to a pharmacist who stated that “the manufacturer did not specify temperature limits” for the medications she was prescribed; further, she said that cold temperatures were not generally a factor unless it was a diabetes drug. My colleague was surprised, and asked “don’t all prescription drugs have upper and lower temperature limits.” She was emphatically told that there were not any limits specified by the manufacturer for these drugs and that because it was cold - it was most likely okay.
After thinking about this for a while, she decided it was better to be safe than sorry. She called the US Federal Drug Agency and was told that for the drugs she had ordered, the storage temperature limits were 68 to 77 degrees for Atorvastin and between 59 and 86 degrees for Lexoxyl.
Clearly, having these drugs sit in a mailbox all day when the temperature was subzero would have driven these drugs outside their proper temperature ranges. And yes, according to the helpful FDA lady, these drugs’ potency would be affected as a result of this. The FDA representative also said that the mail order supplier could have enclosed a temperature indicator in the packaging so that she could have seen the temperature profile in the packaging and insure that it was within the proper limits.
Just as clearly, Express Scripts violated FDA regulations. Here is the legalese: “The regulation governing state licensing of wholesale prescription drug distributors (21 CFR 205.50 (c)) states that all prescription drugs shall be stored at appropriate temperatures and under appropriate conditions in accordance with requirements… The regulation also states that if no storage requirements are established for a prescription drug, the drug may be held at [controlled room temperature … to help ensure that its identity, strength, quality and purity are not adversely affected.”
It may be that this was a onetime failure by Express Scripts. That seems unlikely.
