1997.01.14 : Prescription Information Program Launched

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Date: Tuesday, Jan. 14, 1997
FOR IMMEDIATE RELEASE
Contact: Food and Drug Administration, Donald McLearn:(301)443-1130 Broadcast Media: (301)827-3434, Consumer Hotline:(301)532-4440

Prescription Information Program Launched

HHS Secretary Donna E. Shalala today launched a cooperative public-private plan designed to provide consumers with better and easy to read information about their prescription drugs. The plan is aimed at improving patient understanding of prescription drugs and reducing the misuses of medications that currently lead to thousands of hospitalizations each year.

Assisted by the Keystone Center, a nationally recognized, non-profit public policy mediating organization, a 34-member steering committee representing the pharmaceutical industry, pharmacists, physicians, consumer and patient advocacy groups, patient drug information data base companies and other interested groups participated in developing the plan.

"Industry, consumers and government have cooperated to produce a plan that will work for patients," Secretary Shalala said. "Working together and using today's computer technology, we can make prescription information more widely available, more understandable and more relevant for each individual patient."

Under the plan, useful drug information must reach 75 percent of patients by the year 2000 and virtually all patients (95 percent) by 2006. The "Action Plan for the Provision of Useful Prescription Medicine Information" was delivered to Secretary Shalala last month.

Today, in a letter to Keystone Vice President John R. Ehrmann, Shalala accepted the plan and set the new program into action.

HHS Assistant Secretary for Health Philip R. Lee, M.D., said the plan "will help patients correctly adhere to medical regimens and prevent inappropriate use of prescription drugs." Hospitalizations caused by improper use of prescription drugs cost an estimated $20 billion per year.

The action plan, which was developed by the representatives of all involved parties, puts on track an effort that has long been high on the public health agenda, said Dr. Lee, who chaired the original HEW Task Force on Prescription Drugs from 1968 to 1969.

FDA Commissioner David A. Kessler said: "When patients get prescription drugs, they deserve the same kind of easy-to-read and easy-to-understand information they get when buying a box of cereal with the Food Label. That's what this is about. "

The plan, which was developed under a 1996 law, parallels the requirements of a proposal made by FDA in 1995 for the development and distribution of medication guides that are easily understood, non-promotional in tone and content, and scientifically accurate. Following publication of the FDA proposal, Congress directed the HHS Secretary to convene a committee of diverse interest groups to develop a long-range, comprehensive action plan to voluntarily improve oral and written communication to patients about their prescription medicines.

The plan fulfills the Congressional mandate by addressing the following requirements:

encourage health care professionals to improve their communications with consumers about prescription medicines;
identify mechanisms and incentives to ensure voluntary efforts to meet the distribution targets for the years 2000 and 2006;
establish criteria for the development and distribution of written leaflets with drug information for patients;
encourage activities to increase consumer understanding of the benefits of such information;
develop mechanisms for periodic evaluation of the voluntary program; and
promote consistency with relevant state board regulations.

In two areas, the steering group presented the Secretary with options rather than recommendations. Responding in today's letter, Shalala said the information provided to patients will cover all uses of the medication that are approved by FDA, and in addition, physicians and pharmacists will be able to provide any further needed information about "off-label" uses as long as it is customized for each individual patient. Thus, information can be made available about uses that generally lack the strong scientific base required for FDA approval, but which are deemed appropriate by the prescriber or dispenser.

In addition, the Secretary said she would continue to evaluate progress made by the private sector in meeting the goals of the plan, and would welcome similar monitoring efforts by industry and consumer organizations.

Note: HHS press releases are available on the World Wide Web at: www.hhs.gov.