USP Works to Simplify Rx Drug Labels

Take two tablets by mouth twice daily.” This printed instruction, common on prescription pill bottles, might seem straightforward. Yet in a study, nearly half of patients misunderstood what it or other common label instructions meant. Now the U.S. Pharmacopeia (USP) the non-profit organization that sets quality and safety standards for drugs approved by the Food and Drug Administration is aiming to simplify, clarify and standardize the labels that are affixed to those drugs. A U.S. Pharmacopeia proposal, developed in conjunction with a group of independent experts, was released early this year for public comment. If adopted by state pharmacy boards nationwide, its developers hope it will help remove one of the many barriers that discourage people from taking their prescription drugs. Medication compliance, or “adherence,” as it’s called, is a big problem. Despite the fact that 87 percent of people in a recent survey said they thought prescription medicines were important to their health, only about half of those surveyed take their drugs as directed. People skip doses, take the wrong number of pills, and take pills at the wrong time of day, among many other problems. Poor adherence results in up to $290 billion annually in medical expenses each year, according to NEHI, a health research organization. In general, people are more compliant with drugs for acute conditions such as a bladder infection than for chronic problems like diabetes. But both are problematic, and the reasons people offer for not taking their drugs are as varied as the drugs they're not taking. In that patient survey, 59 percent said they stopped taking their medication because they were feeling better and didn't think it was necessary to continue, while 25 percent said they stopped because they weren't feeling any better. Thirty-seven percent were worried about side effects, while 24 percent said their drugs were too expensive. With such varied reasons for noncompliance, experts agree that solutions must be varied, too. While no single strategy or technology will get everyone to take their medicine as directed, experts agree that clear instructions on the pill bottle are a basic requirement if that’s to happen. Many of the USP recommendations seem commonsensical: place patient information and instructions at the top of the label in bigger type than the doctor or pharmacy name or information on refills and expiration; use everyday words like high blood pressure instead of hypertension; keep auxiliary information, such as warnings, simple and straightforward. (Source: Michelle Andrews; 2/15/11; this column is produced through a collaboration between The Post and Kaiser Health News. KHN, an editorially independent news service, is a program of the Kaiser Family Foundation, a nonpartisan health-care-policy organization that is not affiliated with Kaiser Permanente. )