It has been one of the chief frustrations of my daily battle with the awful side effects of chemotherapy.
I’m talking about the tiny, printed instructions on over-the-counter medicines and prescription packaging. Folks, I gotta ask, why do so many drug manufacturers persist in this boneheaded practice?
I mean, here’s a guy whose throbbing head, or gut, or who knows what, feels like it is about to bust open. He’s chewing up the ground. He’s desperate to make the pain go away. And when he opens his medicine cabinet, what does he find? Hopefully, the pills or liquids he needs, but with print so small he can’t read the instructions without a powerful magnifying glass.
I am that guy. And for people like me whose eyesight is poor, even a magnifying glass may not be strong enough. Many of the bottles I have in my cabinet fit into this category.
Good news: the Food and Drug Administration (FDA) is onto this problem. Still, I have to wonder why drug manufacturers have been allowed to get away with it. It’s not a trivial matter. People must be able to see and understand what those labels tell them. But if the nano-lettering causes one to mistake “one pill once a day” for “two pills, three times a day,” the error may be fatal.
Further, why has it taken so long to do something about it?
My cynical guess: drug manufacturers, who are interested in getting their products on the shelves as quickly and cheaply as possible, have balked at paying the added expense for the paper, and printing it in a large enough typeface that anyone who has to read it may in fact do so. But Dark Robert suspects this problem may have something to do with Big Pharma’s powerful lobbying arm.
Maybe that’s unfair.
The FDA also encourages drug manufacturers to use print that is easy to read. It recommends a font size of 12 points or larger, a significant improvement over 6 points. But the verbs “encourage” and “recommend” do nothing to assure me. Too many rogue businesses pay no attention to them. I want to hear something like the holding-feet-to-the-fire “mandate” and “require.”
And to be fair, the FDA is limited in its power. While it has jurisdiction over what the manufacturers of prescription drugs can say in the official prescribing information for physicians, it lacks any authority over what pharmacists actually print on the label of your amber prescription bottles. Because the FDA does not have control over those labels, there may be information that isn’t there, even if you could read it. It can be challenging. And there is a lot that is missing.
Sometimes pharmacies offer more patient-friendly printed information that can be read without a magnifying glass or a PhD of any sort.
If you have a problem with your prescription medicine, the FDA encourages you to report it. Turns out, that’s not skittles and beer, either. It requires not only the name of the product, but also the name of the company that makes it, the expiration date, the lot number, and the NDC number.
Trying to find this information can be a pain, and sometimes impossible, according to pharmacologist Joe Graedon, who has dedicated his career to making drug information understandable to consumers.
For starters, Graedon writes, the name of the drug company does not appear on every Rx label.
Far more troublesome, though, is the expiration date. If you can read the fine print, you may find a “discard date.” It is almost always one year from the day the prescription was filled. But that is not the expiration date. Pharmacies rarely include the actual expiration date on the label, except on prescriptions dispensed in the original manufacturer’s packaging, and this makes it hard to fill out the FDA’s 3500B form accurately.
Where are the lot numbers? A magnifying glass will do you no good if the information isn’t there. But go ahead, look for the lot number on the label of your amber bottle. Odds are, it won’t be there. Graedon notes that if the pharmacy dispenses pills in the manufacturer’s original container, the consumer will find a lot number and an expiration date. But if the pharmacist pours the pills from a big bottle into a smaller amber bottle, and slaps a label on it, chances are excellent there will be no expiration date or lot number, even if the consumer gets out his or her scanning electron microscope to read the fine print.
“Imagine there is a drug recall,” Graedon writes. “Actually, you don’t have to imagine. There have been so many FDA recalls because of contamination or some other manufacturing problem that it’s hard to keep track of them. How can you know if your pills have been recalled if there is no lot number on the bottle? Good question. The pharmacy probably does not keep a record of the lot number it dispensed to you. If the pharmacy changed manufacturers to get a better price, you will have a hard time figuring out whether your pills were in the recalled lots.”
The FDA’s 3500B form also requires an NDC number, but nowhere on the FDA’s form does it explain what that is and where to find it. The NDC is the National Drug Code. It is usually a unique 10-digit number, though sometimes it is 11 digits. The first set of numbers tells the FDA who the manufacturer is.
So, where is the NDC number on your prescription label? Chances are excellent that it will not be identified as the NDC number, if it is there at all. It could be a bar code that you will not be able to read. Not all states require the NDC number on the prescription label. So, strike 4 on the FDA’s 5500B form. Key information is unavailable to patients.
And that’s not all. Sometimes those first numbers actually reveal the distributor, rather than the manufacturer. Or, the first three numbers could be a repackager. Remember, many generic manufacturers sell to repackagers instead of distributing the drugs themselves.
The final set of numbers represents the package code. It tells the FDA how the manufacturer, re-packager or distributor sells the product to the pharmacy. In other words, did the bottle the pharmacy purchased have 100 pills or 1,000 pills?
It’s not just the trying to read the fine print. Can you make sense of the words? Can you understand side effect warnings? TV drug commercials often use technical language that most people won’t understand.
Graedon cites an ad for the diabetes drug Jardiance:
“Ketoacidosis is a serious side effect that may be fatal. A rare but life-threatening bacterial skin infection in the skin of the perineum could occur…Taking Jardiance with a sulfonylurea or insulin may cause low blood sugar.”
A sulfonylurea drug is a diabetes pill such as glimepiride or glyburide. Try pronouncing it quickly three times.
Ask your pharmacist for the patient information about your prescription. Then talk to the pharmacist about any questions you may have. It is important to read and understand the side effects and instructions on the label of your medicine, even if you can’t read the fine print. And do not trust your memory. Write down all the key information and keep it handy.
Be smart, be safe.
Robert Whale can be reached at robert.whale@auburn-reporter.com.