snowy mail box, fentanyl

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

“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.”

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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  1. Margaret\
    Reply

    My insurer uses CVS/Caremark mail order and recently they improved their service by allowing folks to pick up their 90-day prescriptions from the local CVS at the mail-order pricing. That just makes sense. Thanks, CVS.

  2. M. T. C.
    Milwaukee, WI.
    Reply

    Same concern as others. Bought locally Lotemax (gel, 0.5 pc) with co pay of $100 since we were in a cold snap in WI. Mail order pharm sells two for co pay of $100. We were in a cold snap and didn’t want a frozen and thawed Lotemax. What to do in cold winters and hot summers?

  3. M. T. C.
    Milwaukee?
    Reply

    Thanks for studying this issue. I bought one small container of Lotemax (gel 0.5) locally for co-pay of $100. For mail service pharm, two containers cost $100 co-pay. What to do in Wisconsin’s winter and summer?

  4. Joanne
    ohio
    Reply

    The question was asked, “why would you leave your meds out in adverse conditions?” It seems that many older people who need several meds live in condos where they have to walk down the street to collect their mail. Some have to wait for a friend or relative to do that for them, thus mail is exposed to extremely cold or hot temperatures at times. Unfortunately I do not see a solution to this problem. Also, this type of mailbox, as well as mailboxes near the street, invite theft. I wish the insurance companies would be sympathetic to this problem and stop encouraging mail order with enticing savings.

  5. David
    Texas
    Reply

    Biggest problem with mail order prescriptions is fluctuations in temperatures. If it is a critical product, my advice is to buy local even if you pay a “little” more. If pharmacy boards would get appropriate legislation passed one should be able to access products locally without being held hostage by Medical Insurance companies for that last penny. I know the largest company will supply Tier One Drugs with zero co-pay but if sourced locally it is $9.00 for 3 months supply. This is monetary extortion.

  6. Ellen
    Chapel Hill, NC
    Reply

    I am so happy that you are addressing this topic. I have wondered about shipping conditions of mail-order drugs. When I asked my doctor about this, the reply was “I am sure they take care of it.” I remained skeptical about the safety of mailing prescriptions to home since the ideal temperatures given in a drug’s information seems to be narrower than the highs and lows of many days. I also wonder if warehousing and shipping conditions of drugs to pharmacies take care of these temperature issues.

    Is this article complete in the form printed above? The first paragraph breaks off mid-sentence. It also seems like two or three paragraphs might be missing before it moves into the Q & A section.

  7. Doris
    Chapel Hill, NC
    Reply

    This topic is a wonderful one to explore. I have asked my doctor and pharmacist about shipping conditions of drugs to their store and also wondered about mail order conditions. The answer has basically been, “i’m sure they would ship drugs under proper conditions.” I still wondered if drug companies do in deliveries to pharmacies as well as home delivery programs. I am very happy you are raising this important question.

  8. Dave B.
    NW Oregon
    Reply

    There seems to be a HUGE gaps in both Drug Testing & handing regulation by the FDA, and in proper consumer warning about certain drugs’ HUGE vulnerability to very probable temperature excursions.

    One wants to think that ‘the powers that be’ are smarter than to both not predict errant handling and to not move to even try to properly prevent dangerous handling by ANY handler.

  9. Barbara
    Reply

    I haven’t been buying mail order drugs and supplements during hot and cold spells for quite a while, however I can’t help but wonder what kind of conditions these things are subject to on the way to the pharmacy/store.

  10. BBBob
    Willliamsville, NY
    Reply

    Thank you for this information. My standard prescriptions (for blood pressure, blood thinner and prostate) are packaged in plastic bottles and shipped via USPS in sealed “pillow” bags, which I believe offers some insulation value against extreme cold or heat during the time they are left in the mailbox at the curb. We usually are able to pick up our mail within minutes of delivery, but obviously do not know how long the meds spent in a hot or cold delivery truck. Over the past 3 years, since switching to mail delivery, I have observed no perceptible difference in the activity or efficacy of any of my prescriptions.

  11. Buddy
    Atlanta, GA
    Reply

    We NEVER receive medicine by mail if we can help it. I was on a rheumatoid biologic drug years ago at a billing cost of $7,000 per month. I paid $100 for it. There were ice packs in the container but on the bottom, not on the top of the medicine. The medicine was warm. I called it in and received more medicine within 2 days. Ice pack location is critical when shipping product!
    There are too many opportunities for errors when shipping pharmaceuticals. Get it at the drug store!

  12. T
    Reply

    I never have used mail order medications for that very reason. I always wondered if I was the only one who thiught about this. If I pick up a medication and have to run more errands on the way home, I keep the med in my purse during the errands.

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