a mailbox on a country road on a sunny day

Many insurance companies love mail order pharmacies. That’s because they can often save money by having patients get their medicines from large services rather than local pharmacies. Pharmacy benefit managers (PBMs) are the middlemen between drug companies, pharmacies and payers. Many large PBMs own or control mail order pharmacies. If patients don’t get their medicines through this channel, they may have to pay more for their prescriptions. Are there any concerns about mail order medicines that have been ignored by PBMs, the FDA and insurance companies?

A retired professor of molecular biology performed an experiment that would suggest the answer is yes.

Mail Order Medicines and the Postal Service:

Q. I read your column concerning pharmaceutical drugs left in a cold mailbox in winter. A few years ago, I measured summer temperatures in our mailbox with an accurate electronic thermometer.

I was concerned that my drugs might be damaged with the very high temperatures here in Tempe, AZ. The mail is delivered in the afternoon when the sun hits the mailbox.

I am attaching an Excel file of what I found. The temperature of the mailbox was significantly higher than the air temperature. The average daily mailbox temperature between August and October was 121 F. Clearly those high temperatures would be expected to have some effect on many drugs.

Since doing that project, I stopped having my drugs sent by mail and now use an in-store pharmacy. Neither the drug companies nor the FDA seemed to provide helpful information when I asked them about this problem.

Do High Temperatures Affect Mail Order Medicines?

A. Your spreadsheet is fascinating. On some days, the temperature in your mailbox reached 130 to 140 F. That is way outside the acceptable storage range, even for a short period of time.

Guidelines for medications generally call for storage at room temperature (68 to 77 F). During shipping, temporary fluctuations are allowed between 59 and 86 F. Even on the coolest days of your two-month project, your mailbox hit at least 95 F.

How Heat Might Impact Mail Order Medicines:

Some medications could deteriorate rapidly under high heat or extreme cold. Drugs for asthma, diabetes, thyroid and anxiety could be especially vulnerable.

Researchers in the division of Pulmonary and Critical Care Medicine at the Cart T. Hayden VA Medical Center in Phoenix, Arizona performed an interesting experiment (Chest, Dec. 2005). They had heard that the asthma drug formoterol (Foradil) was “aggregating in mailboxes in the summer in Arizona.”

These investigators exposed capsules of formoterol to temperatures between 104 and 158 F for three hours and at 158 F for 15 to 180 minutes. The results were worrisome.

They concluded:

“These data demonstrate that the exposure of formoterol to heat decreases drug delivery and that caution should be used when mailing, transporting or storing formoterol.

“The use of mail-order pharmacies appears to be increasing both in the private sector as well as in the Veterans Healthcare Administration. It is usually assumed that the conditions of mail shipment approximate room temperature and humidity. However, it seems likely that shipped medications might be subjected to extremes in temperature such as those during the time spent in a mailbox prior to patient pick up. In addition, medications already in the patient’s possession might be subjected to environmental extremes such as being left in an automobile for an extended time on a hot day.

“The present study demonstrates that heating formoterol to temperatures that might be encountered during an Arizona summer lowers powder delivery. Combined with the reports from patients who received deformed formoterol capsules in mailboxes during summer months, it seems likely that temperature led to the decrease in powder delivery.”

What Should You Do About Mail Order Medicines?

Arizona gets especially hot during the summer. But you do not have to live in Phoenix or Tempe to be exposed to high temperatures. When medicines sit in a hot car or a mail box for hours, they will almost assuredly be exposed to temperatures outside the mandated shipping range (59 to 86 F). And in the winter they could easily be exposed to freezing temperatures.

Mail order pharmacies and the FDA need to address this weakness in our drug delivery system. Medications that are exposed to severe temperature fluctuations may not perform as anticipated. They may also deteriorate more rapidly.

The People’s Pharmacy Solution:

We think that there is an answer to the dilemma that patients are faced with when they receive mail order medicines. There are affordable temperature and humidity sensors that can be placed in every prescription (and vitamin) package. These disposable monitors will reveal if the contents of the package have been exposed to temperatures outside the limits for that medication (or dietary supplement).

We think mail order pharmacies and PBMs have an obligation to their clients to verify that drugs are kept within the guidelines during shipping. If they cannot demonstrate that successfully they should either send another package or refund the patient’s money and allow people to purchase their medication in a pharmacy at no additional cost.

What do you think?

Share your own experience with mail order medicines in the comment section below.

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  1. CEH
    Texas
    Reply

    I, too, in Texas, have been concerned about this topic! I was very pleased to see this article – well, not because of what it says, but because I had my suspicions! I have Googled the topic and not found anything as decisive as this article. I have become suspicious of all supplements, even those at stores in Texas between May and December. I try to buy my supplements between December and April to last all summer. It takes a lot of calculating and even pill-counting. Not enough research has been done on the claims for many supplements, but at least my supplements are more likely to help me if they aren’t damaged by heat!

    I know some medicines cannot be bought in advance and stockpiled; maybe some can be mailed in larger amounts to take weather into consideration. I will be needing some medicines in the summer. The cost is lower via mail order. Even in pharmacies, the medicine has been delivered to them by truck.

    I will mention this to my doctors. Maybe if more of us do that, changes will be more likely.

  2. Ann
    Gresham, OR
    Reply

    I have all my medicines delivered to my PO Box in a climate controlled PO in town. So I don’t need to worry about the extremes in temperature, from my outside mail box.

  3. Becky
    Gastonia NC
    Reply

    I have had mail order medicine for many years, sent to addresses in 3 states. It is delivered to the front door, and that is covered and not in as extreme temperatures as the mailbox. Temperatures are still a concern.

  4. Kathy
    Washington
    Reply

    USPS now offers informed delivery, and you can receive notification when a package has been delivered. Then it is on us to pick up our mail as soon as possible.

  5. Peter
    FL
    Reply

    I want a local pharmacy that knows me and monitors all my meds. If it prevents one error it is worth the extra cost.

  6. Ellen
    Chapel Hill, NC
    Reply

    I had wondered about this issue also when I read the ideal low and high temperatures on enclosed drug materials. I know our mailbox gets too hot in the summer and too low in the winter, certainly outside the temperature limits set by the drug manufacturer, and decided for that reason not to sign up for an online pharmacy. My other question is whether the drug deliveries to pharmacists are kept in properly controlled temperatures all the way from production to delivery inside a receiving pharmacy store. The efficacy of drugs, so expensive anyway, should be monitored more closely for temperatures they are exposed to during all phases of a delivery route.

    Hearing aid batteries are another product that is affected by too high or too low temperatures.

    Customers certainly deserve more attention to this matter, and perhaps doctors need to be more aware of this issue, also, since I asked one once. The response was a bit of a blank look. Could the FDA make sure doctors are properly informed?

    Ellen
    Chapel Hill, NC

  7. Grandma Goose
    Vermont
    Reply

    Thank you for mentioning cold. We live in Vermont and winter temperatures are usually below freezing for several months of the year.

  8. Ted
    Fl
    Reply

    Why don’t they ship drugs in styrofoam? It’s inexpensive and effective.

  9. patricia
    WI
    Reply

    i agree with the peoples pharmacy that the cost of safeguarding medications belongs to the producer and distributor.

  10. ANN MARIE
    Cheektowaga NY
    Reply

    I get my meds in the mail. I have always been concerned about the delivery in hot or cold temps. once in a while the postman rings my doorbell. I cannot expect him to do this for everyone or even me. this is not his job. I agree that the pharm. Co. needs to figure this out before more people get sick or die. we as customers are not always home or not sure when the postman will deliver the mail. it is not always at the same time every day.

  11. Thai
    Reply

    Joe and Terry, Perhaps you and pharmacist associates could start a petition or inquiry, or whatever will get the attention of the FDA or whomever regulates our drug supply? They have authority to lean on pharmaceutical companies to tighten up supply chain temperature control, even to manufacturers who want to produce drugs and ship to the U.S. market. Do a grassroots thing with consumers if it takes that, anything to rattle their cages till they act on this significant problem to Americans’ health! Thanks so much for what you do for consumers.

  12. Maryel S
    Reply

    Years ago my mother had a complete reversal of health after receiving doctor’s samples of heart and blood pressure medicines. The hospital asked for the drugs she had been taking after she died so they could test them. My family was told nothing but we concluded that the drugs had deteriorated in the salesman’s trunk during the hot weather. Our motto after that incident has been to refuse all doctor samples.

  13. Bill
    Katy, TX
    Reply

    Even a single, horizontal letter slot,as we have in our stacked mail boxes, could allow natural convection to keep the interiors close to ambient. Freezing temperatures are another issue. However, I suspect that many drugs are less prone to freeze damage than they are to high temperatures.

  14. Lorna
    Pleasant Garden, NC
    Reply

    Extremely hot/cold mail boxes are not the only part of US drug delivery system that could cause problems. Pharmaceuticals are shipped to local distribution centers by truck and the temperatures in the truck trailers can also be very hot or cold & could also pose a threat to temperature sensitive medications.

  15. David
    Texas
    Reply

    Living in Texas, I pay the difference and get my Rx’s locally. As a pharmacist I have seen too many effects that can be visualized so how about those that can’t. Where is government protection when needed. Oh I forgot, money talks.

    • Susan
      New Jersey
      Reply

      I have my drugs
      Delivered to my place of employment so they are not sitting in the hot mailbox at home.

  16. Larry M
    Reply

    Not clear that pharmacy delivery is perfect either. Suppose, for example, that the big box from the distribution center sits in the back of the UPS/FedEx/USPS truck all day before delivery to the pharmacy that’s the last stop on the route.

    Do you think that big, aggregated box is a Styrofoam cooler with a freeze-pack? I don’t. Do you think that every distribution/sorting center is temperature-controlled? How about the tractor-trailers that move the goods cross-country? This is really an end-to-end supply chain concern.

    Temperature and humidity tell-tales should be used on all modes of distribution, not just ship-to-home.

    How about product that’s dispensed and counted by the pharmacist and bottled locally? Do you think that the busy assistants will look at every tell-tale before putting it in stock and distributing it to patients who never have an opportunity to see it?

    • Joe Graedon
      Reply

      Larry, you have identified a huge concern of ours as well. We have actually written about this many times. In fact, if you go way back up the supply chain to where the raw chemicals are made (often China), and then shipped to countries like India, Thailand, Slovakia, Brazil, Mexico, etc. where they are formulated, there are concerns about how those products are shipped. Now consider what happens in India or other countries.

      Once the pills are finalized they must be shipped to a port somewhere. Are they being shipped in temperature and humidity-controlled containers? We have no idea. Then they probably get loaded on a container ship. Again…are they in temperature and humidity-controlled storage units as they cross the ocean? This is another step in the chain where there are concerns about quality control. Once they reach a U.S. port, how do they get shipped to distribution points? Temperature and humidity controlled? Who knows?

      We would suggest that the FDA and USP have pretty much ignored the entire shipping saga from chemical plants in China to manufacturers in India to huge distribution centers in the U.S. to individual pharmacies and mail order operations to the end users (patients). If no one is monitoring the process, how confident can we be that the temperature guidelines are being followed?

      • Lisa M
        Orange County CA
        Reply

        These concerns are spot-on. Ideally there would be temperature monitoring all the way through the supply chain. But with drug prices already a huge concern, I can only imagine what the cost of any drug would be after factoring in the expense of temperature monitoring. I doubt it will ever happen.

      • ray
        ga
        Reply

        Cost bit more but i buy local. I looked up one my meds. and it had gone thru 4 pharma. filler was made in china,then ship to india to get the chemical.then to mexico for filler and chemical to be put in pill form. Then to a generic company, then to my pharmacy.( isnt that scary) wives tale I dont know,but my gradmother kept her med in fridge. I am still not sold on generic. drs claim its 100% same yet some generics i take seem only 80% as effective.

        I had not thought of extreme temp change but logic would say it would change. I am disable with back. i have take a drug screen to be sure I take it. long time family dr so I have no reason to question her. once she ask was I taking all my med,another time she ask was I taking more because of my screening. Yes, same amout each day.

        I don’t know if it lost some effectivness or are they truly put together the same. Willing to bet when FDA inspects countries that put our med together are warn ahead of time so they can clean up their equipment or make the pill as suppose to. They could be shady and not put full amount in.

  17. Linda
    Reply

    Would there be any type of shipping small container that could sel-regulate its own temperature via battery pack or something. We could then ship it back for reuse? This is likely an impossible fantasy of mine.

  18. Philip
    tidewater Virginia
    Reply

    Humana’s Mail Order Pharmacy asserted that the heat of summer would have no effect on PRADAXA, despite cautions included with that blood thinner, and that the shipment would not be sent in a cool pack. Shame!

  19. Carolyn
    Broken Arrow OK
    Reply

    This topic is a concern of mine since I take thyroid medication and have used mail ordered pharmacies. Thank you so much for addressing this because after searching everywhere for any information about protecting medication from extreme temperatures during transport, I found nothing. It remains to be seen what, if anything, can be done about this problem.

  20. Bobby
    US
    Reply

    I would make sure that the temps are going to be around 50-70 when your Rx is on its way because most of the delivery and postal trucks I see don’t have a/c or heat and may be sitting outside for some time.

  21. Don
    Hialeah, FL (33016)
    Reply

    What about the delivery system from the drug manufacturer to our neighborhood pharmacy ? Does that time frame pose the same problem?

    • Elizabeth
      Upstate NY
      Reply

      I am on a drug that is mailed from a specialty pharmacy, I’ve often wondered about the effects of the heat and cold. Thanks for looking into this.

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