THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Thursday, August 24, 1995 TAG: 9508240486
SECTION: BUSINESS PAGE: D1 EDITION: FINAL
SOURCE: ASSOCIATED PRESS
DATELINE: WASHINGTON LENGTH: Medium: 67 lines
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 on Wednesday unveiled a program 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.
The goal is to have at least 75 percent of Americans receive adequate information, in layman's terms, about prescription drugs by 2000, and 95 percent by 2006.
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. Examples include the acne drug Accutane, which can cause birth defects, and the sleeping pill Halcion, which can cause short-term memory loss, Kessler said.
Until now, the FDA has had to force warnings on such drugs on a case-by-case basis, often after problems occurred.
For every less dangerous drug, the FDA is pushing all pharmacists to provide ``Medication Guides'' developed under agency guidelines. A small but growing number of drugstores already provides patient information, some of it customized to match the patient's medical history, but little is as detailed as the FDA says patients need.
Still, the pharmacist portion of the program is voluntary - although the FDA vowed to mandate the patient leaflets if pharmacists don't meet its 2000 goal.
The FDA actually tried to mandate patient information in 1981, but President Reagan stalled the regulations after an outcry by pharmacists, said Dr. Sidney Wolfe of the consumer advocacy group Public Citizen. The new FDA program means pharmacists will simply wait until 1999 to act, he said.
``People should be insisting pharmacies . . . tell you things that could save your life,'' Wolfe advised.
``We have created incentives for compliance,'' Kessler responded, adding that a small but growing number of pharmacies already provide some patient information. by CNB