Considering that prescription drugs are now the fourth leading cause of death in the US, just behind cancer, heart disease, and stroke, and given that 2.2 million people experience drug-related disabilities or serious drug reactions each year, you would think the pharmaceutical industry would take seriously the responsibility to let patients know about potential side effects. But a new study by the Food and Drug Administration shows that in many cases, the printed information provided with prescription drugs fails to get the message across.
According to an FDA press release, the study examined the printed information provided with two prescription medications — lisinopril and metformin — at pharmacies across the country. The researchers found that 94 percent of patients did indeed receive printed information with their prescription, but 25 percent of the time that information didn’t meet minimum criteria for being readable, unbiased, and accurate. “Most consumers (94 percent),” says the release, “received CMI [consumer medical information] with new prescriptions, [but] only about 75 percent of this information met the minimum criteria for usefulness as defined by a panel of stakeholders.”
While it’s encouraging to learn that the FDA cares about the information consumers receive with their prescriptions, the finding that 94 percent of consumers receive printed info with their prescriptions — inadequate or otherwise — seems overly optimistic to say the least, as does the conclusion that 75 percent of the information provided actually is complete and clear. Look more carefully at the report and you’ll notice that it was funded by the National Association of Boards of Pharmacy through a subcontract with the University of Florida. Certainly the Boards of Pharmacy don’t want their members to look bad, which just might bias their results a tad.
In fact, although this FDA study (biased though it may be) raises concerns, other studies, conducted by researchers who don’t have industry ties, paint a far bleaker picture. For instance, a March 2008 study out of the University of Tennessee Medical School found that printed information was completely absent from 46.9% of medications dispensed at outpatient clinics affiliated with university hospitals. (For those of you interested in counting, that’s more than 700% worse than the figure quoted in the FDA industry-sponsored study.) The Tennessee study also found that the information that was provided averaged a 10th-grade level in reading difficulty, and the point size was so teeny in many cases that it was almost impossible to decipher. Given that the average US adult reads at a seventh-grade level (yes, pathetic, but that’s a different subject), and that, according to Oxford Journals, “The National Adult Literacy Survey [NALS, (Kirsch et al., 1993)] found 40–44 million Americans, or about a quarter of the adult population, are functionally illiterate,” it’s clear that many patients can’t possibly understand the warnings and contraindications as presented, even if they do get information with their prescription.
Take a closer look at the University of Florida industry-sponsored final report on this latest study and you’ll see that the FDA press release stretches what the report actually says. While the source document does indicate that most pharmacies provide supplemental information with prescriptions, as the FDA claims, the report also notes that, “The leaflets [provided with medications] ranged from 33 words to 2,482 words for the same drug….” Right away, that discrepancy raises a red flag. Then the report concludes, “A total of 274 (75%) of prescriptions for lisinopril and 233 (64%) for metformin met 60% or more of all sub-criteria.”
Hmmm. While the FDA claims in its release that 75 percent of the prescriptions included adequate information, the actual report paints a different picture. That 75 percent of “adequate literature” number cited by the FDA actually refers to material that met only 60 percent of the required criteria. That’s an F grade in any legitimate school in the country. In fact, only seven percent of all prescriptions reviewed for Lisinopril and only .6 percent of those for Metformin (yes, less than one percent) met at least 80 percent of the criteria for clear, complete, and accurate information. By the way, it probably should be noted that if you get five pages of literature with your prescription and it’s 90 percent accurate and complete — if the missing 10 percent happens to refer to a side effect that might prove deadly for you, it’s not good enough. Now think about the fact that 99.4 percent of all Metformin prescriptions come without complete and accurate safety information, and multiply that statistic by the thousands of prescriptions out there for other medications, and you have a lot of uninformed people taking dangerous drugs, ignorant of the risks.
While pharmacies must, by law, provide accurate labels that describe how to take a given medication, they don’t have to provide additional safety information, though it’s considered “good practice” to do so. The FDA recommends guidelines for supplemental medication literature, but as seen in this study, the information provided by pharmacies can vary wildly from one store to the next, and according to the head of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, “The current voluntary system has failed to provide consumers with the quality information they need in order to use medicines effectively and safely.”
Considering how dangerous prescription medications are, that’s an understatement. But the fact is that written information isn’t everything. In fact, most patients rely on doctors for information about their prescriptions. They want to hear from the doctor directly about dangers and benefits, and they trust that the doctor will give them the full story. Unfortunately, that’s a bad bet because many doctors are as ill-informed as their patients. They rely too heavily on marketing literature from drug companies and don’t dig into the actual research studies done on the drugs being prescribed. Doctors need to educate themselves beyond what the drug companies tell them in their marketing pitch so they can convey accurate information to consumers.
Should you be in the unfortunate position of having to take a prescription medication, do not rely on the pharmacy or the doctor to tell you what you need to know. Remember — even the guidelines established by the FDA for providing full disclosure only scratch the surface. Given that medical professionals and the literature supplied fall short even of that goal, you’ve got to do your homework. Do as much research as you can before taking any pharmaceutical so that you don’t become another casualty.