Prescription drugs will soon come with user-friendly patient information
A public-private plan to give consumers better information about prescription drugs has been approved by U.S. Health and Human Services Secretary Donna E. Shalala.
The plan—which was devised by a committee representing pharmaceutical companies, pharmacists, physicians, consumer advocacy groups, and patient drug information database companies—aims to reduce the misuse of medication, which leads to thousands of unnecessary hospitalizations a year.
“It’s long been a concern of the Food and Drug Administration that patients did not get enough information with prescription drugs,” said Thomas J. McGinnis, RPh, the FDA associate director for pharmacy affairs.
Under the Action Plan for the Provision of Useful Prescription Medicine Information, easy-to-understand drug information must reach 75 percent of patients by 2000 and 95 percent of patients by 2006. A 1992 survey found that 55 percent of patients were getting useful information about prescription drugs, McGinnis said.
Pharmacists will have a major role in the plan’s success because it will be up to them to ensure that patients are getting the correct prescription information, according to William Zellmer, MPh, vice-president of professional and public affairs for the American Society of Health–System Pharmacists, which represents 31,000 U.S. pharmacists.
Software from database companies will help pharmacists get prescription information to patients. The cost of the plan ultimately will be passed on to consumers, Zellmer and McGinnis said.
Zellmer said the voluntary plan is the result of a “strong desire to keep the federal government out of this.” But if the government’s goals are not met, the FDA will take over the program.
McGinnis said a 1995 study found that drug-related morbidity and mortality resulted in healthcare costs of $76.6 billion a year. There are no valid statistics for the number of deaths caused each year by misuse of prescription drugs, he said.
Zellmer said the plan is intended to reduce life-threatening drug interactions. For example, patients who take ketoconazole, a prescription anti-fungal drug, will be alerted to the life-threatening consequences of combining it with Seldane (terfenadine), an over-the-counter antihistamine. “It’s quite possible lives will be saved,” he said.
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