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.
“it would be unlikely that finished drugs are transported by cargo ship”
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.
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.“it would be likely that most manufacturers use a common carrier and transport via air.”