With prescription labels, try to read the fine print | Tales of the Whales

It was one of the main frustrations of my daily battle with the horrible side effects of chemotherapy.

I’m talking about the small, printed instructions on over-the-counter drugs and prescription packaging. Folks, I have to ask, why do so many drug manufacturers persist in this boneheaded practice?

I mean, here’s a guy whose throbbing head, or guts, or who knows what, feels like it’s about to burst open. Chew the earth. He is 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 the print so small he can’t read the instructions without a strong magnifying glass.

I’m 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 closet fall into this category.

Good news: The Food and Drug Administration (FDA) is dealing with this problem. Still, I have to wonder why the drug manufacturers were allowed to get away with this. It is not a trivial matter. People need to be able to see and understand what those labels are telling them. But if nano-literacy causes someone to confuse “one pill once a day” with “two pills, three times a day,” the error can be fatal.

Furthermore, why did it take so long to do something about it?

My cynical guess: Drug manufacturers, who are interested in getting their products to the shelves as quickly and cheaply as possible, refused to pay the extra expense for paper and print it in a large enough font that anyone has to to read it. may actually do so. But Dark Robert suspects this issue may have something to do with Big Pharma’s powerful lobbying arm.

Maybe it’s unfair.

The FDA also encourages drug manufacturers to use print that is easy to read. A font size of 12 points or larger is recommended, a significant improvement over 6 points. But the verbs “encourage” and “recommend” assure me nothing. Too many rogue businesses don’t pay attention to them. I want to hear something like the “mandate” and the “request” to hold your feet to the fire.

And to be fair, the FDA is limited in its power. While it has jurisdiction over what prescription drug manufacturers can say in official prescribing information for doctors, it has no authority over what pharmacists actually print on the label of your amber bottles. Because the FDA has no control over those labels, there may be information that isn’t there, even if you could read it. It can be a challenge. And there is much that is missing.

Sometimes pharmacies offer more patient-friendly printed information that can be read without a magnifying glass or a doctorate of any kind.

If you have a problem with your prescription drug, the FDA encourages you to report it. It seems it’s not about chile and beer either. It requires not only the name of the product, but also the name of the company that manufactures it, the expiration date, the batch 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 easy for consumers to understand.

For starters, Graedon writes, the name of the drug company doesn’t appear on every Rx label.

Much more troublesome, however, is the expiration date. If you can read the fine print, you may find a “removal date”. It is almost always one year from the day the prescription was filled. But that’s not the expiration date. Pharmacies rarely include the actual expiration date on the label, except for prescriptions dispensed in the original manufacturer’s packaging, and this makes it difficult to accurately fill out the FDA Form 3500B.

Where are the lot numbers? A magnifying glass won’t do you any good if the information isn’t there. But come on, look for the batch number on the label of your amber bottle. Chances are it won’t be there. Graedon notes that if the pharmacy dispenses pills in the original manufacturer’s container, the consumer will find a batch number and an expiration date. But if the pharmacist pours the pills from a large bottle into a smaller amber bottle and puts a label on it, there is an excellent chance that there will be no expiration date or lot number, even if the consumer takes out his scanning electron microscope to to read the fine print.

“Imagine there’s drug withdrawal,” Graedon writes. “Actually, you don’t have to imagine. There have been so many FDA recalls due to contamination or other manufacturing issues that it’s hard to keep track of them. How do you know if your pills have been recalled if there is no batch number on the bottle? Good question. The pharmacy probably doesn’t keep a record of the lot number it dispensed to you. If the pharmacy has switched manufacturers to get a better price, it will be hard for you to tell if your pills were in the recalled lots.”

The FDA’s Form 3500B also requires an NDC number, but nowhere on the FDA form does it explain what it is or where to find it. NDC is the National Drug Code. It is usually a unique 10-digit number, although 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? There is an excellent chance that it will not be identified as an NDC number, if at all. It might be a barcode that you won’t be able to read. Not all states require the NDC number on the prescription label. So, type 4 on your FDA Form 5500B. Key information is not available to patients.

And that’s not all. Sometimes the first numbers actually reveal the distributor rather than the manufacturer. Or, the first three issues could be a repackaging. Remember, many generic manufacturers sell to repackagers instead of distributing the drugs themselves.

The final set of numbers is the package code. It tells the FDA how the manufacturer, repackager, or distributor sells the product to the pharmacy. In other words, did the bottle bought by the pharmacy have 100 pills or 1,000 pills?

It’s not just trying to read the fine print. Can you understand the words? Can you understand side effect warnings? TV commercials for drugs often use technical language that most people will not understand.

Graedon cites an ad for the diabetes drug Jardiance:

“Ketoacidosis is a serious side effect that can be fatal. A rare but life-threatening bacterial skin infection of the skin of the perineum may 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 saying it three times quickly.

Ask your pharmacist for patient prescription information. Then talk to your pharmacist about any questions you may have. It’s important to read and understand the side effects and directions on your medication label, even if you can’t read the fine print. And don’t trust your memory. Write down all the key information and keep it handy.

Be smart, be safe.

Robert Whale can be reached at [email protected].