Whenever I teach a class on drug temperature management, especially to those outside the realm of drug manufacturing, but in supporting service industries such as warehousing, transportation, and logistics, I always begin with the same routine — a headache.

This always occurs after the round of introductions as the class settles in. I apologetically interrupt my overview of the agenda and ask if anyone in the room has any aspirin, acetaminophen, or ibuprofen that they would be willing to part with in order to take the edge off my “nasty headache.” Invariably, some kind Samaritan always comes to my aid. They rummage through their backpack or their purse, as the case may be, in search of the analgesic and enthusiastically hold it out for my taking. I graciously accept.

In return for their benevolence, (and in clear view of the entire class), I hastily fumble through my backpack and pull out a pre-packaged four-ounce cup of yogurt, a napkin and a spoon. I place it down in front of my benefactor.

“Just a small token of my appreciation in return for your kindness,” I say with a smile as I begin opening the bottle to remove a few tablets.

I remain standing in front of them waiting for them to open the cup of yogurt. They never do. Rather, they look at it and at me, with great suspicion. I begin a friendly interrogation. The conversation typically goes like this:

“Why don’t you open and enjoy that yogurt I’ve been carrying around with me? Really, it’s okay. I don’t want it,” I assure them.

“No, thanks,” they politely reply as they begin to withdraw and search for some excuse.

“No, seriously,” I say calmly. “It’s perfectly good. I’ve been carrying it around with me for days now.”

They chuckle nervously and begin to squirm in their seat.

“Well, what do you think may be wrong with it that you hesitate eating it?” I ask. “Do you not trust me?”

“Uh . . . it’s been in your backpack?” they reply.

“Oh, you mean like this?” I ask, shaking the bottle of medicine they handed to me moments ago. “Not to worry,” I say. “Even though it hasn’t been properly stored in a ‘refrigerator’ (which I emphasize using air quotes with my fingers), it’s sealed. It should be safe. Well, it’s probably safe.”

“Yeah, no, thank you,” they reply.

“It has an expiration date on it,” I insist. “It’s not past its expiration date so it should be good . . . right? By the way, what’s the expiration date on this?” (Referring to the bottle of medicine they gave me.)

Unsure, they shake their head and shrug their shoulders.

Slowly stepping back and in a skeptical tone, I ask, “So, you think it’s okay for me to take this bottle of whatever you offered me, not knowing who you are, really, not knowing where this has been, how its been stored, or if it’s expired? Have I got that right?”

I then launch into a lecture on the importance of storage temperatures and expiration dating, how they are defined, what they mean, and how we are conditioned from an early age to have a different perception on how we treat food over that of medicine.

Typically, we do not waver in our unconditional trust in the medicines we take, yet we’ve become a society of hyper-vigilant hand-sanitizing germaphobes. We willingly throw out the food in our refrigerator past its “sell by” date, but rarely do so for expired prescriptions and over-the-counter remedies lurking in our medicine cabinet.

And there’s another pet peeve of mine that always makes its way into my workshops — medicine cabinets!

I like to bring to the attention of my students the meaning of drug expiration dating. All drugs — prescription and OTC varieties — are required to have an expiration date, which indicates when, under ideal storage conditions, a medication will reach a minimum threshold equivalent to 90% of its efficacy. I tell my students that “ideal storage conditions” is a lot like EPA’s MPG ratings on automobiles. MPG is a standard that does not compensate for road conditions, weather, altitude, driving habits, and numerous other variables. It assigns miles–per-gallon-rating for simulated highway driving and one for simulated city driving for every model of vehicle. But in truth, when was the last time you succeeded in attaining the MPG ratings stated for your vehicle? I never have.

Expiration dating on medicines is determined by data collected from a standard series of stability testing, like the International Conference on Harmonization (ICH). The ICH is to drug stability as the EPA is to MPG ratings. Both use a set of standards that do not necessarily reflect real-world conditions.

We are taught early on to store the majority of our medications safely out of the reach of children in a space conveniently provided in most homes — the medicine cabinet — which happens to be located in the hottest, wettest room in the house. Alternatively, we store them high in a kitchen cabinet, the second hottest, moistest room in the house. Heat, fluctuating temperatures and humidity are the leading cause of degradation to medicines — more so than any other environmental factor.

By this time I often see light bulbs going on in the eyes of my students. This is my approach to educating those within and outside the industry. Instead of harping on regulations and best practices from the position of our daily jobs and responsibilities, I try to relate the importance of temperature management from the perspective of the user and stress that just because the cause-and-effect of a degraded drug is often less immediate or less perceptible than that of food, it is by no means less critical. CP

---

Kevin O’Donnell
Contributing Editor

Kevin O’Donnell is senior partner at Exelsius Cold Chain Management Consultancy – U.S. He is the former chair for the International Air Transport Association (IATA) Time & Temperature Task Force, a member of the USP Expert Committee on Packaging, Storage and Distribution, a temporary advisor and certified mentor to the World Health Organization (WHO), co-author of PDA Technical Report No. 39, and a member of the International Safe Transit Association (ISTA) Thermal Council. He blogs at www.clutchcargo.us. He can be reached at kevin.odonnell@exelsius.us.