At year end, consumers watching the evening news or reading the newspaper were shocked to learn about the high incidence of hospital medical errors. The widely publicized Institute of Medicine (IOM) Quality of Care in America Committee report failed to surprise most health professionals, but the damning statistics certainly startled consumers. The report's release drew the attention from national media, powerful consumer organizations, Congress, and the president.

Why wouldn't consumers be shocked at the numbers? The report, which focused primarily on hospital medical errors, estimated that at least 44,000—and maybe as many as 98,000—Americans die each year as a result of such mistakes. Those numbers make medical errors one of the leading causes of death in this country.

Looking solely at medication errors, the committee estimated that they account for 7,000 deaths a year, a rate surpassing annual workplace deaths. The report concluded that medication-related errors occur frequently in hospitals, and that hospital-based errors cost the nation about $2 billion a year.

Consumer Errors Overlooked
As shocked as consumers were by the IOM findings, the overall situation is far worse. As the report noted, "these figures offer only a very modest estimate of the magnitude of the problem since hospital patients represent only a small proportion of the total population at risk, and direct hospital costs are only a fraction of total costs."

Because the majority of consumers are treated with prescription drugs outpatients, it is even more shocking that they take 50 percent of all prescriptions incorrectly. That is not the consumer's fault. They depend on pharmaceutical companies to provide doctors and pharmacists with the information they need to take medicines optimally.

Luckily, many of consumers' medication errors are innocuous—they are simply annoying, or cause people to miss a day of work because they feel unwell. However, some patients suffer serious medical consequences, and some die because they have taken medications incorrectly. Consumer medication error-related deaths may be far greater than those of hospital personnel. That possibility is disturbing because proper patient education can prevent many adverse events. Those who have criticized DTC in the past may reconsider when they recognize the powerful role DTC ads can play in consumer education.

Writing on the Wall
The IOM report is the most recent example of the growing momentum around the issue of patient safety. The expectations of consumers, politicians, media, regulatory agencies, and the courts—as shown by last year's New Jersey Supreme Court ruling—are rapidly increasing for accountability from all involved with health care, including pharmaceutical companies.

Although the IOM report focused primarily on hospitals, recommending that FDA increase its attention to the safe pre- and postmarket use of medications. It strongly suggested that FDA "develop and enforce standards for the design of drug packaging and labeling that will maximize safety in use."

Demand for Patient Safety
The message is clear. Consumers are alert to the issue of patient safety more than ever before. Consumer organizations will take up the gauntlet, and the popular media and politicians will keep the issue before the public. Consumers will see pharmaceutical companies as either part of the solution or part of the problem. Those that give consumers confidence they are working in the public's best interest will be viewed as part of the solution. It is just a matter of time until regulators take the steps that companies fail to initiate.

Many do an excellent job of providing the information that consumers want and need. Importantly, regulations currently allow pharmaceutical companies to develop patient information in a manner appropriate for consumer understanding. The alternative is a regulatory mandate requiring material to be written according to an ironclad "checklist." That regulation could ensure that marketers clearly present product risks—but cost them an opportunity to instruct patients on side effect management and motivate them toward compliance. Losing that opportunity will cost both companies and consumers.

Dr. Dorothy L. Smith is a consumer education expert and president of Consumer Health Information Corporation. The full-service company specializes in patient labeling, program development, and strategic planning for DTC campaigns.

Do you have a DTC question? E-mail it to dlsmith@consumer-health.com or call (703)734-0650.

Published in Pharmaceutical Executive, February 2000. Copyrighted material; All rights reserved.