Plan will give consumers better prescription drug info

A new public-private plan for giving patients useful, easy-to-read information about their prescription drugs aims to help consumers better understand their medicines and reduce the medicine misuses that yearly lead to thousands of hospitalizations.

The voluntary plan calls for the information to reach 75 percent of patients by the year 2000 and virtually all patients (95 percent) by 2006.

It parallels requirements of a 1995 FDA proposal for medication guides that would be easily understood, nonpromotional in tone and content, and scientifically accurate. (See "FDA's Rx for Better Medication Information" in the November 1995 FDA Consumer.) Following publication of the proposal, Congress directed HHS Secretary Donna E. Shalala to convene a committee of diverse interest groups to develop a long-range, voluntary plan to improve oral and written communication to patients about their prescription medicines.

The plan fulfills the congressional mandate by:

* encouraging health-care professionals to communicate better with patients about prescription medicines

* ensuring that voluntary efforts meet the distribution targets for the years 2000 and 2006

* establishing criteria for developing useful written drug information for patients

* encouraging activities to increase patients' understanding of the benefits of the information

* providing periodic evaluation of the voluntary program

* promoting consistency with relevant state board regulations.

A 34-member steering committee developed the Action Plan for the Provision of Useful Prescription Medicine Information with assistance from The Keystone Center, a nationally recognized, nonprofit organization for mediating public policy. The steering committee represents the pharmaceutical industry, pharmacists, doctors, consumer and patient advocacy groups, patient drug information database companies, and other interested groups.

In accepting the plan in a Jan. 13 letter to Keystone, Secretary Shalala said the information provided to patients will cover all uses that FDA has approved for a medicine. In addition, she said, doctors and pharmacists may provide any further needed information about "off-label" use, provided they customize the information for each patient. Information can therefore be made available about uses that generally lack the strong scientific base required for FDA approval but are deemed appropriate by the prescriber or dispenser. She said she would continue to evaluate progress by the private sector in meeting the plan's goals and welcomed similar monitoring by industry and consumer groups.