
                         Roanoke Times
                 Copyright (c) 1995, Landmark Communications, Inc.

DATE: THURSDAY, August 24, 1995                   TAG: 9508240063
SECTION: NATIONAL/INTERNATIONAL                    PAGE: A-1   EDITION: METRO 
SOURCE: Associated Press
DATELINE: WASHINGTON                                LENGTH: Medium

THE CURE MAKING MANY ILL

UNCLEAR INSTRUCTIONS for taking medicine are causing health problems of major proportions, the FDA says.

Nearly half of Americans get no written instructions before using powerful prescription drugs, and the nation spends $20 billion a year treating side effects and illnesses from improper use of medicines, the government says.

Now the Food and Drug Administration is proposing a solution: Give patients easy-to-understand information about how to take a prescribed medicine and what side effects to anticipate.

``Patient information is absolutely critical,'' FDA Commissioner David Kessler said in an interview. ``The days of physicians writing a prescription and the pharmacist filling it and the patient being in the dark - that's just not good care.''

The FDA unveiled a program Wednesday to push pharmacists to prepare special patient-information leaflets for every prescription they dispense. The proposal will take effect after a 90-day period for public comment.

Now, 45 percent of patients get no written information about their medicines, other than dosage instructions - such as take two pills once a day with food. Others get instructions of varying thoroughness.

Questions can abound: Does that mean right before dinner or right after? What about a missed dose? What side effects can occur and should they prompt a call to the doctor? What other drugs will interact dangerously with this one? Should all the pills be taken, or just until the condition wanes?

Ideally, the doctor would have discussed all that beforehand. But patients can forget oral instructions, and studies show doctors frequently don't provide all the necessary information.

Texas is the only state to require written patient instructions with every prescription.

Under the program announced Wednesday, every drug considered to have ``serious and significant'' health risks at the time it hits the market must provide written patient information.

by CNB