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Insider Blows Whistle on Mail Order Med Deliveries

Mail order med deliveries may sit in a cold or hot mailbox for hours. That's not good. But have you thought about shipping conditions even before that?
USPS vehicle making mail order med deliveries stuck in snow

Whistle blowers rarely get rewarded. They often get fired and banished from the industry that they care about. Over the last 40 years we have heard from people who worked for cigarette companies, generic drug companies and chain drug stores. This is the first person who revealed secrets about mail order med deliveries.

A Pharmacy Tech Speaks Up!

Q. You recently wrote about the problem of mail order medicines being left in the cold for hours. This is a real problem.

I used to work as a pharmacy technician for a mail order pharmacy owned by a major insurance company. Temperature was our enemy, but we did our best.

We shipped medications that had to be kept cool, like insulin, in little Styrofoam coolers with ice packs. Staying aware of weekend schedules, we never shipped perishable medications on Friday so that they wouldn’t sit in hot warehouses too long.

We were acutely aware of destinations and asked patients who wouldn’t be home at delivery if we could ship to workplaces or neighbors who would take the package indoors immediately. Even so, we had daily calls from people who received hot or freezing medications.

Our pharmacists’ best guess was “It should still be okay,” since we had no control over the shippers’ procedures. We always replaced questionable meds, but we often had the same problem with the replacements.

Will It Still Be OK?

A. Thank you for explaining the mail order problem so clearly. We normally hear from patients, who also have no control over shipping.

For example, one reader wrote:

“I ordered CoQ10 capsules. When the bottle arrived, the capsules had swollen. I used a thermometer and found the caps were over 110 F. I got a refund, but I’ll never order medicines or supplements for home delivery again.

“There’s no way of knowing where our medicines originate and how they’re transported. This could affect their quality. I guess someone has to pay with their health to get action taken by the FDA.”

Sadly, the FDA has no jurisdiction over shipping. That is regulated state by state and there is virtually no oversight.

The Complex World of Mail Order Med Deliveries:

Here is a possible scenario of the pharmaceutical supply chain. It that demonstrates the challenges we have faced in trying to better understand the complicated quilted pattern of mail order med deliveries:

1. A molecule is made in a Chinese chemical plant in Shanghai. It is the active pharmaceutical ingredient (API) for a medicine that will ultimately be shipped to the U.S.

2. A different Chinese company makes the inactive ingredients (excipients) for many different pills. In our theoretical case, the binders, fillers and colors are made in Chengdu.

3. The API and the excipients are shipped to India. How they are shipped, by air, by rail, by truck or by ship, remains a mystery to us. How they get from the port of entry to the manufacturing plant in Mumbai is another mystery. Are they shipped under ideal temperature and humidity control conditions?

4. Once the finished pills are manufactured, they then must be shipped to an exit location. How do they get transported to that locale? Again, are they moved in temperature and humidity-controlled containers?

5. Now they must be transported from India to the U.S. Are they flown in temperature-controlled cargo bays or sent on cargo ships?

6. Once the pills arrive in the U.S., they must be inspected at the port of entry. How long will they sit in transit, and will they be in temperature and humidity-controlled containers during the wait?

7. Once inspected, the pills must be transported to major pharmacy distribution centers. Those may be chain drug store warehouses or mail order centers. Who oversees the transport vehicles, especially if they cross state lines? Are these trucks temperature and humidity controlled?

8. Finally, they must be sent from a warehouse to the patient. Some carrier service such as the United States Postal Service (USPS) or UPS is likely involved. Have you ever noticed a USPS or UPS truck deliver products to your door in temperature or humidity-controlled vehicles? We haven’t.

A woman with metastatic breast cancer received a critical medicine (Ibrance) when the temperature in Florida where she lived was 97 degrees F. That was way outside the FDA guidance.

Learn more about how the FDA responded to our questions about oversight of mail order med deliveries. You may be astonished to learn what the FDA’s rules are for storage and transport. We suspect that very few mail order med deliveries fit within those stringent guidelines:

How Safe Are Mail Order Medicines If Not Temperature Controlled?

How were your medications shipped from India to America? How did they get to your pharmacy or your doorstep? Is anyone in charge of mail-order medicines?

The questions on medication transport during and after manufacture are difficult, if not impossible, to answer. One baby step would be to require drug makers to provide country of origin information on drugs. Brand-name manufacturers already do this (even for veterinary medicines, as shown). Including this information on the labels of mail order drugs would require a change in regulations and some adjustments in packaging processes. Even more important, shipping from the warehouse to the customer should maintain the medication in the proper conditions so that it will still be effective when taken. Get in touch with your state Board of Pharmacy to request action on this problem.

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About the Author
Joe Graedon is a pharmacologist who has dedicated his career to making drug information understandable to consumers. His best-selling book, The People’s Pharmacy, was published in 1976 and led to a syndicated newspaper column, syndicated public radio show and web site. In 2006, Long Island University awarded him an honorary doctorate as “one of the country's leading drug experts for the consumer.” .
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I never realized the issue with transportation of medicine. I used a mail otder service because I have to. I used to let them sit in the mailbox no matter what the temperature. That will not happen again. Thank you for this article.

Thank you so much for this report. I’m privileged that I don’t have to get mail-order medications to please my insurance company OR to “save” on getting them from a retail pharmacy. But, as you say, the problem originates a VERY LONG TIME before I finally get my meds. Ugh!

For an enlightening in-depth examination of the issue of overseas manufacture of medications, see the book “Bottle of Lies” by Katherine Eban. You will see that the problem of controlling quality of medications produced in non-western countries, where many of our current medications or active ingredients originate, is too difficult for the US FDA to effectively regulate. I suggest that rather than concentrate on foreign inspections, the FDA should set up inspection stations at US ports of entry where statistical sampling of each lot of meds can be subjected to detailed analysis for compliance. Then non-compliant lots can be rejected with test results, and the manufacturer will eventually get the message. If the pharmaceutical providers begin to insist on proper transportation conditions so that they will be paid, it will start to happen.

I bet when a drug company initially develops a drug and does trials, they are very careful about production and storage. So maybe the drug shows effectiveness, and the FDA approves it. After that, manufacturing is outsourced. The product we end up taking after all these delivery issues may be a very different quality from the one that was approved. Regardless of whether it was mailed, it likely faced many temperature issues before that.
I do think bringing production home to the U.S. under stricter regulation would be the right thing to do, but given how costly drugs are already I doubt this could ever happen.

In my opinion, we should not be using meds manufactured in China or India. It’s that simple. The argument that having them made in the USA would make the meds too expensive only calls for needed regulations to be in place.

Even if you get your meds from the corner pharmacy, they have the same issues with weather. They have to be transported to each pharmacy from wherever the distribution center is. So actually, there isn’t any medicine that can be considered safe, as far as temperature is concerned.

The 8th step in your scenario could also include delivery to your local pharmacy. Those same mistreated drugs may be the ones you pick up at your local pharmacy.

What about the deliveries to pharmacies?Aren ‘t the problems the same for pharmacies as far as products being in extreme weather conditions? How do pharmacies make medicines safer from the elements?

One question I have is how different is the shipping conditions to a pharmacy? Granted they won’t sit in a hot or freezing mailbox, but what about the shipping warehouses and end-delivery trucks?

I receive Copaxone every month which is a biological medication to treat Multiple Sclerosis. I used to get it at a local pharmacy but no pharmacies in my city fill specialty medications anymore. I had a problem with two deliveries in a row last year. The first was frozen which the pharmacy promptly replaced, but then the replacement was also frozen. The pharmacy always gives instructions to the shipper with the front door code to leave the pkg inside my apt building. But it is often left outside on the porch, each driver is different. I now make sure I receive text alerts from UPS and FedEx so I know exactly when to go downstairs so it doesn’t sit in the heat or cold.

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