snowy mail box, fentanyl

We know we sound like a cracked record when it comes to mail-order medicines. That’s because no one seems to want to take responsibility. The FDA has very strict guidelines for temperature fluctuations when it comes to storage and shipment of drugs. And yet the FDA takes zero responsibility when it comes to mail-order medicines. The company that makes the medicine takes zero responsibility once the meds reach the wholesaler or distribution center. And the distributor takes little, if any, responsibility for maintaining the medications within FDA guidelines.

State boards of pharmacy are supposed to be responsible for how drugs are handled within any given state. We have not seen evidence, though, that boards of pharmacy enforce delivery standards to pharmacies or to the homes of patients. As far as we can tell no one seems to want to take responsibility for monitoring the shipment of medicines. And that includes generic drugs made in China, India, Slovenia or Brazil.

What if Mail-Order Medicines Are a Matter of Life and Death?

This reader raises a very important question!

Q. I have stage 4 metastatic breast cancer. My oncologist prescribed Ibrance, shipped by UPS.

I happened to be outside when the delivery truck pulled up. It was 97 degrees here in Florida with a heat index of well over 100 degrees. That is not appropriate for this medicine that I hope will save my life.

I talked with CVS Specialty Pharmacy, Pfizer and the FDA. I have no interest in filing a lawsuit, but if I can’t get my medication shipped safely, I will. The FDA and Pfizer both recommended I not take the pills delivered that hot day. The order was replaced.

No one seems to know at exactly what temperature any medication starts degrading. How can we make sure everyone gets their medications safely?

A. You have discovered a scary secret about mail-order medicines. A life-saving drug like yours should be shipped under temperature-controlled conditions.

Ibrance (palbociclib) is supposed to be stored between 68 and 77 degrees F. The FDA permits brief temperature “excursions” as low as 59 degrees and as high as 86 degrees F. The delivery truck clearly exceeded that temperature.

In the winter, many delivery vehicles will fall below 59 degrees. In places like North Dakota, Minnesota or Vermont the temperature in the delivery truck may never get above freezing.

Mail-Order Medicines Can Be Expensive!

The cost of replacing your bottle of Ibrance was probably over $11,000 for a month’s supply. You should not have to question the effectiveness of your cancer medicine because it was not maintained within the FDA’s specified temperature limits during shipping.

We do not know what it will take to get someone to take responsibility for enforcing the FDA’s drug storage and transport guidelines. If the Food and Drug Administration cannot monitor transport conditions from China to India to Los Angeles, who can? Do these pills come on container ships or in airplanes? If they are in airplanes, is the temperature maintained within the appropriate range?

We have asked the Food and Drug Administration very specific questions about how the agency monitors shipping from abroad to the U.S. The answers have been unsatisfactory.

Our Questions to the FDA:

1) How are generic drugs shipped from abroad (especially China and India) to the United States?
Surely the FDA has a general sense of how such shipments move from manufacturing plants abroad to the United States. Do they come in container ships? Do they come in the cargo holds of airplanes? In the majority of cases, what is the transportation method most generic drug companies rely upon?
 
2) When generic drugs are shipped from abroad to the U.S., are they in temperature-controlled containers and are those containers monitored?
If containers are monitored, does the FDA ever examine the records?  As you know, the labeling on most medicines allows for temporary temperature fluctuations between 59 and 86 degrees F during shipping. What the health professional who contacted us wants to know is whether the FDA knows if generic drugs shipped from abroad either by airplane or cargo ship ever go below or above those temperature guidelines?

The FDA Response:

1) For the first question, while we don’t track the mechanism of travel, it would be unlikely that finished drugs are transported by cargo ship.  Most finished drugs have a two-year expiration date and distributors will generally not distribute drugs with less than 6 months left in expiry.  The time for cargo ship transport would generally preclude that option.  It is likely that most manufactures [sic] use a common carrier and transport via air. 
2) For the second question, finished drugs should be maintained at appropriate storage conditions.  Specifically, “Written procedures shall be established, and followed, describing the distribution of drug products.”  As finished drugs are labeled with the appropriate storage conditions, the distribution procedures should include these controls.  All related records are subject to inspection.  For finished drugs, temperature excursions in the warehouse or during shipment are deviations and should be evaluated and investigated for impact to quality, identity, purity, potency, and strength (21 CFR 211.192).  This is often covered on manufacturing inspections as one component of shipping validation studies.  All related records are subject to inspection.
We find it astonishing that the FDA uses wording such as:
“it would be unlikely that finished drugs are transported by cargo ship”
or
“it would be likely that most manufacturers use a common carrier and transport via air.”

This is the Food and Drug Administration! It should not be dealing in speculation or likelihoods. The FDA should know precisely how generic drugs are transported to the U.S. Are medications maintained at all stages, from the original manufacturing plant to your local pharmacy, within temperature guidelines? As far as we can tell, the FDA does not monitor and does not know the answer to that question.

How Do Your Medicines Get Shipped?

Once medications arrive at a port like New Orleans, Houston, Los Angeles or New York, how long do they have to wait to be inspected and clear customs? Are they maintained under proper storage conditions during that time? Are they in temperature-controlled and humidity-controlled containers?

How are the pills shipped to drug wholesalers or large pharmacy distribution centers? Are the trucks temperature and humidity controlled? And finally, how are medications shipped to pharmacies or directly to patients?

These are questions that no one in authority wants to answer. Too much money is at stake. Mail-order medicines are big business. Why aren’t boards of pharmacy monitoring mail-order medicines much more carefully?

We think people like the woman who wrote to us deserve better answers. What do you think? Please share your thoughts below in the comment section.

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  1. C
    Dallas, TX.
    Reply

    My concerns: Prefer NOT to take any meds made/shipped to US because of QC issues and risks during shipping. SO–how can I find a reliable manufacturer for LORSARTAN? I’ve tried and gety answers like: “Not sure where manufactured, but it was packaged in Minnesota…and it’d not on the recall list!”

    Same for Levothyroxine.

  2. Bobby
    MD
    Reply

    Even in the best circumstances error and omissions happen on a regular basis. Shipping drug via mail and/or common carriers is absurd. There should be no delivery of drugs to peoples homes. The time the drugs leave the drug maker and arrive to you are in the hands of people who have no knowledge of what is in the boxes and even if they did would not have knowledge of how these drugs should be handled and stored. And the comments such as, “well it should be okay” are ridiculous and insulting. The person saying that has no idea how long a prescription was sitting in a distribution facility or on a truck in extreme temperatures. So to say something like that is like saying the recommend storage instructions aren’t don’t really matter. And anything that comes from China or many other countries could be coming on freighter ships or in cargo holds with no temperature control; who knows. But the important thing is that the drugs companies are earning more this quarter than last quarter.

  3. Becky
    Georgia
    Reply

    I had the same issue with Rheumatoid Arthritis medicine years ago. It was shipped in a cooler with the ice pack under the medicine rather than on top of the medicine. It was summer and the meds were warm when I received it. I called and they reshipped it. Possibly a new person packing the coolers. Yes, that cost all of us $ for that error.
    The medicine was not available at any drug store. It had to be shipped to me. That could possibly be due to the expense of the drug. It’s too expensive/dangerous to have it in a store.

  4. Walter Glenn
    Florida
    Reply

    If you sign up for informed delivery service at USPS they will give you a day or two notice before the items are being delivered.

  5. Jane
    Reply

    Charging $11,000.00 per month for any kind of medicine oughta be against the law…no matter who’s paying for it. Things have gotten way out of control… drug prices are unreasonably high and have been for a long time. Sad.

  6. Neil
    Pearl City, Illinois
    Reply

    In early 2015, while living in Ripley, Tn, The V.A. Hospital in Memphis sent my Epi-Pens via USPS. They were put in my mailbox on a day that was 34 degrees. I was not at home when they were delivered and I got home about four hours after the mail is usually delivered. I called the Memphis V.A. pharmacy and spoke with the pharmacist about the efficacy of this drug after having been left for hours in temperatures which are way below the temperature threshold. He said “I think that they should still be OK”. My response (minus any profanities which I may have used) was that if I ever need to use those Epi-Pens I need them to work. What I don’t need is for a pharmacist to say that he thinks they should still be OK. The next day I drove 56.4 miles to Memphis V.A. and gave them the ones which they had sent and they gave me new ones. This is what happens when bean counters handle medical issues for which they haven’t been trained.

  7. Michael
    Wisconsin
    Reply

    The OFEV I take are over $124,000 a year at full cost. They are to be kept at less that 77 degrees Fahrenheit. They arrive in the mail, in the summer at well over that. In the winter well under that. How they are shipped to the pharmacy from the manufacturer is anyones guess.

  8. Deborah
    Rio Rancho, NM
    Reply

    I ordered COQ10 capsules and when the bottle arrived via UPS, the capsules had swollen in size. I took a temperature and the caps were over 110F. Thankfully, I got a refund from Amazon, but I’ll never order medicines or supplements for home delivery. There’s no way of knowing where our medicines originate; how they’re transported and under what held conditions precluded their safety before we ingest them. This has to be cleared up by the FDA who is responsible for drug safety. I guess someone has to pay with their health to get action taken by the FDA after Congress intercedes.

    • Bea
      KS
      Reply

      Even if you go to the store to buy it, how do you know how the product was delivered. Most likely the same way. Outside Heat of 80+ or Frost of 10+

  9. Roz
    Florida
    Reply

    Several months ago I wrote a letter regarding the method of shipments that Express Scripts uses.
    My letter was addressed to the President of the company. I received several calls from their Customer Service Department. I repeated my concern about the shipping methods they use, as I live in Florida and the summer gets very warm here for medications left in the mailboxes!
    Then they called me and a Pharmacist called me and tried to explain how the drugs are okay and nothing will happen to them in the heat of Florida! I am now using my local pharmacy for my Rx needs! I told them I would, they were not concerned.
    To-date, I have not heard from the President of Express Script.

  10. Gerri
    Reply

    P.S. I am going to print out this information and send it to Tricare for Life. I have complained about this problem for years. Thank you, People’s Pharmacy!

    • Karen
      Dallas, Texas
      Reply

      I too contacted Express Scripts about my cancer drugs being left in my mailbox in the Texas heat. I too was told by the pharmacist it was nothing to worry about. I have offered several times to pay for special shipping but they refuse to do it. I’ve asked if I can get it at my local pharmacy and have been denied even that. They say my policy requires that I get it through Express Scripts and it’s way too expensive to get it locally without insurance. I don’t know what else to try.

  11. Gerri
    Reply

    I have Tricare for Life. (Military). I am forced by Tricare for Life to accept my more expensive medications (Restasis and Lumigan for glaucoma) by mail or pay the full price which is unaffordable. No wonder my glaucoma medication isn’t working. There is no temperature control in mail order. My option now is to lose my eyesight or get laser surgery. I have complained to Tricare for Life before for leaving my medications in my hot mailbox. I live in a hot climate and they use to ship it in ice packs but they stopped doing that years ago. I am glad People’s Pharmacy is spotlighting this.

  12. Jane
    Colorado
    Reply

    First, good luck to Rebecca in finding out where her meds are coming from. Second, I’m guessing all the stuff we hear about from you guys about quality control, shipping problems etc is the tip of an iceberg so huge it’s terrifying. The exclusive pursuit of high profits, coupled with zero accountability or concern, will continue unchecked I have no doubt.

  13. Pepi
    FL
    Reply

    I would ask the same questions of delivery to the corner pharmacy; there’s not much of a difference. Where do the ingredients come from? No body really knows.

  14. Carolyn
    Texas
    Reply

    I plan to refuse to take any medicine that comes from foreign countries, especially India and China. We should not have to put up with this.

  15. Rebecca
    Lansing, MI
    Reply

    I was a rural mail carrier for many years and often wondered about this very thing as I put medicine packets into my vehicle when temps were either very hot or very cold, then likewise into unprotected mailboxes. Gosh, even Uncle Milton’s Ant Farm sent their starter ants with a warning that said deliver in person only and maintain a reasonable temperature!

  16. TPM
    Winter Springs, FL
    Reply

    I live in Florida, where summer temperatures are often over 90 degrees. My mail order pharmacy is pressing us to use an automatic renewal for our three month prescriptions. This means that I will have little idea when insulin will be shipped. It’s shipped in a cooler, but what happens if it arrives on a Friday before we take a long weekend away?

    Some less stable medicines such as albuterol are never shipped in a cooler; sometimes it’s arrived in the mailbox on the same day as a cooler arrives. I have taken this problem up with OptumRx, but never before worried about how the drugs were stored before they arrived at the distribution center or pharmacy.

    It is amazing that we are “protected” from lower cost drugs shipped from Canada, but not from the exorbitantly priced drugs shipped from pharmacies in our own country. The mail order pharmacy told us we could get our drugs from a local pharmacy, at 3x the copay, and only 30 days at a time, difficult for a person with mobility problems.

    Also, my brother has had drugs stolen from his rural mailbox. The thief left the ripped open empty mailing envelope. His doctor has accused him of being a drug abuser.

  17. Mike
    Dallas, TX
    Reply

    I realize it’s not a solution to the broader concern, but CVS Specialty Pharmacy will also ship your prescription to any local CVS pharmacy, so it’s at least not sitting out on your front porch exposed to the elements and theft.

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