The FDA has encouraged drug manufacturers to use print that is easy to read. The recommendation is for a font size of 12-point or larger. Oh, how we wish we could read the fine print on over-the-counter medication labels, as well as prescription packaging. And let’s not forget dietary supplements and herbal products. This reader complains that he cannot read the fine print on his medicine.
Reading and Comprehending the Words on the Label?
Q. When my pharmacist dispensed a prescription for the antifungal drug fluconazole, he included the official prescribing information. It boggles my mind.
First, the print is too small to read without a magnifying glass. Second, the details are beyond my comprehension. After all, I only have a PhD in atmospheric sciences. What are we supposed to do with this useless paper?
A. We completely agree that the print is too small and the words are too big on the package insert you sent us. Sometimes pharmacies offer more patient-friendly printed information that can be read without a magnifying glass or a PhD of any sort.
Can You Read the Fine Print on Pharmacy Labels?
The FDA has jurisdiction over what the manufacturers of prescription drugs can say in the official prescribing information for physicians. The agency does not have any authority over what pharmacists print on the label of your amber prescription bottles.
Have you ever tried to read the fine print on your prescription without a magnifying glass? It can be challenging. And there is a lot that is missing. Because the FDA does not have control over these labels, there may be information that is lacking even if you could read it.
Reporting a Drug Problem to the FDA:
If you experience a problem with your prescription medicine the FDA encourages you to report it on FORM FDA 3500B.
It asks: “What kind of problem was it?”
- Were hurt or had a bad side effect (including new or worsening symptoms)
- Used a product incorrectly which could have or led to a problem
- Noticed a problem with the quality of the product
- Had problems after switching from one product maker to another maker
The FDA goes on to require:
- Name of the company that makes the product
- Expiration date
- Lot number
- NDC number
Trying to find this information can be challenging, if not impossible. For one thing, the name of the drug company is not always found on every Rx label. Far more problematical, though, is the expiration date. If you can read the fine print you may find a “discard date.” It almost always is one year from the day the prescription was filled. 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 that makes it hard to fill out the FORM FDA 3500B accurately.
Where Are the Lot Numbers?
A Magnifying Glass Won’t Help You Read the Fine Print If It Is Not There!
But wait, there’s more. Try to find the lot number on the label of your amber bottle. We bet it won’t be there. If the pharmacy dispenses your pills in the manufacturer’s original container, you 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 sticks a label on it, chances are very good that there will be no expiration date or lot number, even if you get out your magnifying glass to read the fine print.
Imagine there is a drug recall. Actually, you don’t have to imagine. There have been so many FDA recalls because of contamination or some other manufacturing problem that we have lost count. 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 knowing whether your pills were in the recalled lots.
What Is the NDC Number?
But wait, there’s more. The FDA’s 3500B form requires an NDC number. 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.
But wait, there’s still more. 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 next set of numbers tells the FDA the dose and form of the medicine. In other words, 100 mg in a capsule, tablet or liquid.
The final set of numbers represents 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 the pharmacy purchased have 100 pills or 1000 pills?
So, where is the NDC number on your prescription label? Chances are good 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.
OTC Drugs and Dietary Supplements:
If you think your prescription drug label is hard to read, try making sense of an OTC medication. I have a little bottle of Tylenol sitting on my display table. It has 24 caplets. If I wanted to read the fine print I would need a very strong magnifying glass. My bifocals are not up to the task. Ditto for the 50-pill bottle of Aleve sitting in my photo studio.
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.
For example, an ad for the diabetes drug Jardiance states:
“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.”
Many viewers are not familiar with terms such as “ketoacidosis,” “perineum” or “sulfonylurea.”
Symptoms of ketoacidosis include nausea, stomach pain, fatigue and trouble breathing.
The perineum is the area between the genitals and the anus. It is hardly surprising that a drug company might not want to explain that particular adverse reaction in too much detail.
A sulfonylurea drug is a diabetes pill such as glimepiride or glyburide. Try pronouncing sulfonylurea quickly three times.
If You Can’t Read the Fine Print, ASK the Pharmacist!
Ask your pharmacist for the patient information about your prescription. Then talk to him or her 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. We have a free Drug Safety Questionnaire. We encourage you to download and print it and have your pharmacist fill it out the next time you fill any prescription.