Combating conflicting information on prescription drug labels

Whether patients get accurate information regarding the drugs they're taking can be a hit-or-miss proposition. Beyond the very basics, federal law does not mandate what appears on prescription bottles, so information on side effects and potential interactions provided at the pharmacy can vary dramatically by state or even by store.

A spot check by Consumer Reports in June 2011, for example, found that five chain drugstores in the New York area provided different warnings for the same warfarin prescription, including conflicting information about whether alcohol can be taken with the drug.

Marvin M. Lipman, MD, a College Fellow and the chief medical adviser for Consumer Reports Magazine, recently spoke to ACP Internist about current medication labeling requirements and how primary care physicians can help their patients become better informed about their prescriptions.

Q: What was your opinion of the Consumer Reports findings?

A: Personally, I was not surprised. I had known about this beforehand. The reason we did this little study was to corroborate the fact that there's no uniform agreement as to what goes on the bottle labels and in the patient package insert, in addition to the basics. Regulation is needed in both areas.

Q: Currently, prescription label information is regulated by state pharmacy boards, correct?

A: Yes. There's no federal regulation on medicine bottle labeling except to specify that the patient's name has to be on there, the name of the drug and the dosage. The dosage is left pretty vague, and it's up to the pharmacist to specify how the drug is to be taken as translated from the doctor's prescription. But the major warnings with regard to side effects of the drug should be on the bottle label too, because not enough people go through the fine print on the patient package inserts that come along with the medication.

Q: Is there anything that the primary care physician can do at the time of prescribing that can help the patient know what to look for?

A: Most of the time the direction will be “one, twice a day,” and then it's sort of left up to the pharmacist to translate “one bid” into English for the patient. Whether that's “Take with breakfast,” “Take with dinner,” or “Take every 12 hours” or “Take one after breakfast” or “before breakfast” has to be specified by the pharmacist on the bottle. The doctor doesn't usually take the time to put all that information on the prescription.

Q: What about side effects?

A: Any time a physician prescribes a drug, he or she should warn the patient about the major side effects. That's inherent in drug prescribing. But the major side effects should be on the bottle label. There should be room on the label to describe the more important side effects and what the patient should look out for.

To depend on the patient package insert to do this is fraught with danger, because the patient package insert lists every side effect found in the clinical trials when the drug was being approved and doesn't really isolate the importance of those side effects, or the frequency of the side effects. It doesn't differentiate between side effects that you should notify the doctor about and side effects that you might expect from the medication and shouldn't worry about. The major side effects should be listed right on the bottle label.

Q: Say a patient gets his or her prescription, goes to a pharmacy to get it filled, and doesn't get complete information back from the pharmacy. If that happens, is the primary care physician aware of this disconnect?

A: I don't think so. Unless the doctor is drawing on his or her own personal experience when they get medication from the pharmacy, they're not aware of the bottle the patient gets from the pharmacist.

It's a good idea to have the patient periodically do what we call a brown bag review, and bring all medications to the office every four to six months for review. At that time, the doctor can or should scrutinize each drug and drug label and make sure the patient is taking it correctly. There's really no other way that the doctor can inspect the actual bottle label.

Q: Who needs to address the problem of inconsistent drug labeling—physicians, pharmacists, the FDA?

A: I think the FDA needs to get involved with labeling. It's my own personal opinion that at the time of drug approval, some sort of labeling requirement should be part of the approval process.

What should go in the blurb that accompanies the medication when the patient gets it is very important, and really that should be a federal mandate. It should not be left up to the individual pharmacist or even the state boards of pharmacy, which are pretty loose in regulating the information that the pharmacist passes out to the patient.

It should be federally regulated and it should be specified at the time the drug is approved, with additions, of course, as needed from postmarketing experience with the drug. With the use of the drug in a large portion of the population, new side effects will be found, perhaps a black box warning or something of that sort, and these can be mandated as additions to the original label.

There was a movement afoot in the early 80s—I was on an FDA advisory committee at that time—to work up patient package inserts for drugs. We started doing it, and then the original funding for the effort was withdrawn by Congress, so it was disbanded. But the intent was there, way back.

Q: What's the most important take-home message for primary care physicians?

A: Number one, tell a patient what you want the patient to know when you prescribe the medication. Number two, do a periodic brown bag review to make sure that what's in your chart in the office is what the patient is taking, and what the patient is taking is, conversely, in your chart.

It's worth a physician reminding a patient, “Make sure you're getting what I prescribed, and this is the reason I'm prescribing it. Look at the bottle. Make sure before you walk away from the counter that you're getting the right medication.”