Show 1351: Are You Risking Your Life Trusting Mail Order Medicines?

Have you ever taken a package out of your mailbox on a hot day and noticed that it was warm to the touch? If the pouch contained a tee shirt or a pair of sneakers, you probably didn’t think much more of it. But millions of people get their medications by mail, and some medicines are not supposed to get warm. Do life-saving medicines lose potency during shipping?

Does It Matter if Medicines Lose Potency During Shipping?

Our guest, Loretta Boesing, is a mother with a young son who needed a liver transplant to save his life when he was two years old. Immediately, he required injections of medication twice daily to keep his body from rejecting the transplanted liver. Loretta has been very conscientious about this. But when her insurance required her to get the medicine by mail order, it arrived on a hot day (102 F) and was warm or possibly hot to the touch. Within two weeks, her son was suffering the effects of rejection because the medicine was no longer doing its job. In the hospital, the same compound was able to reverse the setback, because the hospital’s injection had not been subjected to intense heat.

Problems with Mail Order Pharmacy:

Like many Americans, Loretta was pressured to get her son’s medicine through the mail. Unlike most, she was sufficiently motivated to fight that pressure. After all, her son’s life depends on the medication, and she had discovered the possibility that mail order medicines lose potency when they get too warm. (Extreme cold can also compromise medication effectiveness, but we are more likely to think of that in the winter months.) Loretta found that she had to enlist the media so that her insurance would allow her to pick the medicine up at the pharmacy.

What Loretta Learned:

Millions of people may be taking medications that have not been held within the temperature range that the FDA specifies. It is very difficult for a patient to determine whether these medicines lose potency in transit.

However, pharmacy students in Oklahoma conducted a study in collaboration with Loretta’s group. They mailed out packages to 100 members of the group. Each one contained a data logger and temperature sensor that would tell them if the inside of the package had exceeded the limits for a common medication. Sadly, 80% of the packages did. This trial suggests that ordinary shipping methods may be inappropriate for delicate drugs such as, for example, monoclonal antibodies.

Mail order pharmacies could include these inexpensive temperature monitors in their packages, and some may. We once ordered probiotics for a pet. The supplier shipped them in an insulated container with a temperature strip. (We were relieved to see the probiotics had not gotten too warm.)

Such devices register when a temperature has exceeded a specified maximum.  Manufacturers often include them in shipments of vaccines or frozen foods. But too often, medicines are not treated with the same care you might use in shipping chocolates in hot weather. (That's despite the fact the outcome for your health is far more serious!) Loretta was appalled to learn that often wholesalers ship to pharmacies in the same vehicles used for general package delivery.

Try Independent Pharmacies:

One tip for other patients: Loretta found that many independent pharmacies will deliver prescriptions in temperature-controlled vehicles (possibly a private car with air conditioning). This is an option worth exploring even if it costs a bit more.

We have heard from a very organized reader who logged the temperatures in his Arizona mailbox for more than a month. That experiment convinced him to switch from mail order delivery of his medications to picking them up at the pharmacy and taking them straight home.

Like Loretta, he found

"Neither the drug companies nor the FDA seemed to provide helpful information when I asked them about this problem."

Who Is in Charge?

Loretta contacted the FDA, thinking that the organization that sets temperature guidelines would be involved in enforcing them. The Food and Drug Administration told her it is not responsible. The mail order pharmacies say they can’t control the shipping companies. Of course, the shipping companies say it’s not their problem if customers choose their services for shipping. Ultimately, she contacted the National Association of Boards of Pharmacy, but got very little traction there, either.

As a result, she has been addressing individual state Boards of Pharmacy. The Oklahoma Board of Pharmacy has recently issued new regulations that should make medicines shipped in that state safer for patient. She and her organization are approaching Boards of Pharmacy in other states to educate them that life-saving drugs lose potency when exposed to extreme conditions en route.

Perhaps if consumers apply enough pressure, the professional organizations will respond. Loretta suggests that some pharmacists suffer moral injury because they are dispensing drugs that they know may not be as effective as they ought to be. The patients receiving those drugs may suffer even more when life-saving medications begin to fail.

This Week's Guest:

Loretta Boesing founded Unite for Safe Medications after a series of events led to Loretta’s son being unable to access his medications safely. She is an expert on the unregulated temperature extremes in mail order pharmacy. www.uniteforsafemeds.com
The phone number for Unite for Safe Medications is 877-474-9777

[caption id="attachment_127181" align="alignnone" width="215"] Loretta Boesing, founder of Unite for Safe Medications[/caption]