Prescription Drug Information Often Incomprehensible to Patients

Kate Johnson

February 28, 2012

February 28, 2012 (Palm Springs, California) — Patient information provided with prescription medication is not sufficiently comprehensible to the majority of patients, according to a study presented here at the American Academy of Pain Medicine 28th Annual Meeting.

"What we're advocating is that if the FDA [US Food and Drug Administration] wants to use materials like these, they should request that the pharmaceutical companies do more rigorous testing of the materials to make sure that people can not only read them, but can understand what they're reading," said lead author Sidney Schnoll, MD, PhD, vice president of pharmaceutical risk management services for PinneyAssociates, and clinical professor of internal medicine and psychiatry at the Medical College of Virginia, Virginia Commonwealth University, in Richmond.

Dr. Sidney Schnoll

In the study, 52 participants (33 males, 19 females), with a mean age of 52 years, were tested for their comprehension of real patient information material for an existing antidepressant.

"We changed the name, we changed the manufacturer, but the materials were absolutely identical otherwise; same font, same size," Dr. Schnoll explained in an interview with Medscape Medical News.

The information included the medication guide (MG), which is required to be dispensed with all antidepressant prescriptions, a patient package insert (PPI), and the consumer medication information (CMI) that is provided by many pharmacies.

Most of the participants (69.2%) were white; 30.8% were black. Most (86.5%) had at least a high school education. A total of 28.8% of the participants read at an eighth grade level or below.

"We wanted to see whether people who had up to, but not more than, a high school education — which is a large percentage of the population in this country — could actually understand, comprehend the materials," he said.

Participants were given 45 minutes to review the material and were then asked to complete the Rapid Estimate of Adult Literacy in Medicine (REALM), which is required by the FDA to test the comprehension of over-the-counter drug labels.

In addition, during one-on-one interviews, participants were asked open-ended, scenario-based questions; they were allowed to consult the materials for their answers.

A total of 88.2% of participants looked at all 3 pieces of information (90.2% CMI, 98.0% PPI, and 94.1% MG). The mean review time was 5.2 minutes for the CMI, 16.5 minutes for the PPI, and 2.5 minutes for the MG. Only 44.2% of participants consulted any material when responding to the interview questions, and the majority reported that only 1 of the 3 documents was helpful (46.2% CMI, 26.9% MG, and 21.2% PPI).

The percentage of correct answers to the 7 questions was not adequate, said Dr. Schnoll.

The most significant question had to do with the serious adverse event of suicide in adolescents and teenagers, he explained. We asked: "Suppose a teenager has been prescribed a drug, what serious problem specific to teenagers and young adults should her parents watch for when she begins taking the drug?"

In total, 61.5% of participants answered that question correctly. "That's not encouraging," he said.

The 3 questions that were answered correctly by most participants were the name of the drug (84.6% answered correctly), whether patients stopping the drug should stop abruptly or taper their dose (86.5% answered correctly), and what problem the drug treats (73.1% answered correctly).

The 3 questions that were answered incorrectly by most participants were the significance of fever, sweating, and nausea (i.e., serotonin syndrome; 84.6% answered incorrectly); the safety of taking pain medication with this drug (80.8% answered incorrectly); and the risk for dehydration with this drug (82.7% answered incorrectly).

"We feel very strongly that this information is not adequately presented to patients," said Dr. Schnoll. "If the patient is only at a high school level, they're not comprehending the material. The FDA asks for literacy levels, but literacy is not comprehension.... All materials that go to patients should have not only literacy levels checked, but also comprehension in the appropriate population. They already do this for over-the-counter medications. Labels in over-the-counter medications require what's called an 'actual use' study."

Michael Brennan, MD, from the Pain Center of Fairfield, and a senior attending physician at Bridgeport Hospital in Fairfield, Connecticut, welcomes the findings.

"If you've ever tried to read a package insert, it's brutal," he told Medscape Medical News. "If we can't create information about drugs that most patients can understand, we're not going to make a grain of difference."

"If this study validates that package information is untenable, the FDA needs to embrace that and...create a new model for educating clinicians and patients."

Dr. Schnoll reports being a paid employee of PinneyAssociates, which provides consultation to numerous pharmaceutical companies but does not receive any direct support from them. Dr. Brennan reports being a speaker for Jansen/J&J, Pfizer, Lilly, Forrest labs, Depomed, Millenium, and AFTI; being a consultant and serving on the speaker's bureau for Purdue Pharma, Covidien, Teva/Cephalon, and Endo; and owning stock in Apricus Biosciences, and Pain Therapeutics.

American Academy of Pain Medicine (AAPM) 28th Annual Meeting: Abstract 221. Presented February 24, 2012.

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