Q. I would like to comment on the question of drugs sitting in mailboxes in cold weather. When I worked at a major chain drug store in West Virginia years ago, I remember receiving a pint bottle of a liquid medication that was frozen as solid as a rock.

The huge 18-wheelers in which drugs are delivered from the chain warehouse to individual stores are not temperature controlled. If the truck leaves the chain warehouse at 8 AM and makes its final delivery at 6 PM, the drugs have been sitting in a stone-cold truck for ten hours. So mail order is not the only situation in which drugs might be at risk from extreme weather.

A. Thank you for pointing out this weak link in the drug delivery supply chain. This is something that has worried us for quite a while. We hope that pharmacies will address this problem before too many more years go by.

For some medications, freezing won’t change the composition. But others should be held within a temperature range above freezing to keep them at their best. Large manufacturers are often careful to ship their products in climate-controlled vehicles, but shipping from warehouse to chain store is often, as you have noted, in trucks that have no way of controlling the temperature at all. 

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  1. WH
    Reply

    There was a recent FDA warning letter to an in vitro manufacturer for using ambient shipping methods which were contrary to the labeled requirements on the product.
    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm397698.htm
    Although this case resulted in a warning letter, I would think–as others have noted–that sch 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.

  2. MR
    Reply

    My husband received some Androgel from mail order (because we had to) and we had to go out of town for a funeral at the last minute. The meds spent 8 days riding around in a truck trying to get to us. Consequently, after some routine blood tests, we found out the meds were no good. The manufacturer was so concerned they opened a report and tracked down exactly where the had been and at what temperatures. It was determined they spent too much time in temps over 85 degrees and they refunded our money.

  3. LKD
    Reply

    I live in Georgia where high temps can be an issue. We use a post office box for almost all our mail, and they are temperature controlled. Plus, there is less chance of the medications being stolen. The VA mails almost all our prescriptions except for one insulin which they ship directly to our apartment in an insulated container with ice packs. We have to call it in separately and directly instead of using their automated refill program, and they only ship those meds so they arrive before the weekend.

  4. BSS
    Reply

    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.

  5. Jack Davis
    Reply

    I would think the same thing would apply to warm/hot weather?

  6. BKB
    Reply

    Have studies been conducted for when medications get too hot? I would think there would be more problems with drugs in a delivery vehicle in the heat of the summer. As consumers, we’re told not to leave medications in a hot car.

  7. JY
    Reply

    What about heat? I wondered about mail order Rx’s that sit in a hot mailbox in the sun, until one gets home from work.

  8. Linda S.
    Reply

    Many drug distributors have begun using styrofoam coolers with temp recorders in the package. It’s a small device that records if the inside of the container has gone outside of the acceptable temp. There’s a card inside to sign off upon receipt of the container. Our vaccines come this way. The practice should be expanded.

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