"Protecting Consumers From Medication Mistakes"

Far too many individuals know the frustration of picking up prescription medication from the pharmacy and being left confused by the written information that is attached to or enclosed in the medication's paper bag. This information can be unclear, difficult to understand, and in a print size that is too small for many people, particularly seniors, to easily read. Adding to the frustration, information about the very same medication can also differ significantly from pharmacy to pharmacy.

This patient information matters. It is critical for patients to know the risks and benefits associated with a prescription drug; how to take the medication appropriately and how much to take; what side effects could occur; when to seek medical attention if certain side effects occur; and what foods, drinks or other medications should be avoided when taking that prescription. In addition, this information should be up-to-date, accurate, clear and easy-to-read.

In an ideal world, all patients would receive extensive counseling about the risks, benefits and safe administration of their prescription drugs from their physicians and pharmacists. In the real world, however, these conversations are often limited and sometimes non-existent. It is all too easy for us, in the rush of everyday life, not to engage our doctors about the details of the medications they are prescribing or to take the time at the pharmacy for a consultation with the pharmacist.

As a consequence, we often rely on the written information we receive with our medications, either on the drug labels or in package inserts. Ensuring that patients have access to accurate, up-to-date, and consumer-friendly information about their prescribed medications is, therefore, an important component of drug safety. This is particularly true for older patients who may be taking multiple medications, and who may be experiencing vision or cognitive problems.

It is troubling to know that the Institute of Medicine has identified poor labeling as a critical source of medication errors that injure at least 1.5 million Americans every year. In addition, a Food and Drug Administration (FDA) study found that, while 94 percent of consumers receive information leaflets with their new prescriptions, only 75 percent of these leaflets meet even the minimum criteria for usefulness.

Improving the written information that accompanies prescription medications is one way that we can help to improve patient safety. The Senate Special Committee on Aging, of which I am the Ranking Member, recently held a hearing to examine this important issue. The FDA is considering several proposals to address prescription drug information that is provided to patients.

One proposal, about which I raised concern, would shift entirely to electronic labeling in lieu of paper. There are patients and health care providers who reside in rural areas with limited Internet access and many seniors who simply do not use the Internet. There are also times when electronic technologies are not available due to temporary power outages or during the aftermath of natural disasters.

In expressing similar concerns about a paperless system, one of the witnesses at our hearing, a pharmacist, pointed out that military pharmacists and medical personnel practicing under extremely challenging situations and without Internet access because of security concerns would also be left without drug information if we were to eliminate paper and shift entirely to electronic labeling.

Another proposal to improve patient information would consolidate different types of information and require that this information be more concise. One consumer group has recommended a "drug fact sheet" that could potentially be a model for prescription drug information.

The best and most concise written information, however, is no substitute for the importance of patients discussing their medications with their doctors and pharmacists. Consumer Reports, for example, recommends that patients confirm with their physician or pharmacist their basic understanding about the medication; patients should ask what food, supplements, vitamins that should be avoided; they should ask when they should stop taking the medication; and they should ask about possible side effects-both common and rare-as well as which side effects are the most serious.

Ensuring that all patients have access to accurate, up-to-date, and consumer-friendly information about their prescribed medications is an important issue, particularly to seniors who often take multiple medications. It is one that the FDA must address.