BOSTON -- The Food and Drug Administration, which two years ago simplified food labels, is now seeking to do the same for drugs. The agency proposed yesterday that patients get clear and simple information sheets about every drug with every new prescription.
For about half of the more than 900 million new prescriptions written in the United States each year, patients get no package information about side effects or the dangers of combining the drugs with others.
Yesterday, the secretary of health and human services, Donna E. Shalala, announced the plan, which would require pharmacists to provide written information to 75 percent of patients getting new prescriptions by the year 2000, and to 95 percent by 10 years after such a rule went into effect, most likely next year.
The proposal would go into effect after a 90-day period for public comment, followed by agency review.
David A. Kessler, commissioner of the Food and Drug Administration, said yesterday in an interview that failure to get useful information to patients "is just bad medicine."
He said it costs the nation about $20 billion per year in direct costs for treating patients who fail to take their drugs properly or have serious side effects, plus $80 billion in indirect costs, such as lost days at work.
The FDA now requires manufacturers to put inserts for patients inside the packages of only 40 or so drugs, mostly those with the most severe or potentially dangerous side effects.
For example, the drug Accutane, used to treat severe acne, can cause birth defects, and Halcion, a sleeping aid, can cause memory loss; both have package inserts explaining these problems.
But for most drugs, no package insert is required, and only the information the manufacturers or pharmacists give out has reached patients. Dr. Kessler said surveys last year showed that about 50 percent of patients received written information with their drugs, and the quality of those brochures was uneven.
Now, the FDA has proposed that the pharmacists voluntarily offer patients new, comprehensive and clear information on all 3,300 or so drugs available. The pharmacists, the agency proposes, will have until 2006 to get the information into the hands of 95 percent of patients.
If they fail, the brochures would become mandatory.
To make sure the FDA's requirements are met, the agency will do surveys asking whether patients are getting the inserts and whether they find them clear and complete.
The National Council on Patient Information and Education, speaking for pharmacists and drug companies, among others, said in a statement yesterday that the group was pleased with the FDA proposal and "looks forward to working closely with the FDA to define the characteristics of what is 'useful' written medication information."
The agency offered a prototype two-page insert for an antibiotic as an example. It includes a box with the most important information, followed by simple questions and answers about who should take the drug, how to take it, possible side effects and storage.
The FDA tried to enact a mandatory set of rules in 1980, but the rule was dropped because it was said to be too cumbersome for pharmacists to keep filing cabinets full of information to distribute to customers about each drug.
"Now, all that information is on a single CD-ROM," said Dr. Kessler, "And it will take no more than about $1,500 per year for each pharmacy to carry out this plan, and even less for many." He said there is an exception for businesses that cannot afford the computer program.
