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PATIENT DRUG INFORMATION SHOULD HAVE EQUAL PRIORITY WITH DEVELOPMENT

Executive Summary

PATIENT DRUG INFORMATION SHOULD HAVE EQUAL PRIORITY WITH DEVELOPMENT of pharmaceuticals, proposed guidelines on patient information developed by the International Medical Benefit/Risk Foundation recommend. "Pharmaceutical manufacturers, and their academic and regulatory colleagues, should give as much priority to improving patient information and communication as they do to developing the drugs themselves," the guidelines state. The foundation presented the report at an Oct. 22 briefing in Washington, D.C. At a minimum, the guidelines recommend, patient information should include the following items: "the names (both the pharmacological and brand names) and dosage of the drug; the drug's intended medical purposes and benefits; how to take the drug properly; special precautions in relation to patients' age, gender, occupation, or concurrent medication; the probability and seriousness of adverse effects; and what actions to take if problems are perceived." The guidelines are contained in a report written by the foundation's Committee on Patient Information. The committee looked at current patient information and education activities, problems and needs in North America, Europe and Japan, and held a workshop to gather input. Explaining why the foundation decided to study the international status of patient information on medicines, IMBRF Executive Director William Lowrance called the issue of patient understanding "one of the weakest links in the entire chain from drug discovery to ultimate use." FDA is working on a program that would require expanded patient information on the efficacy and side effects of prescription drugs at the pharmacy point of sale ("The Pink Sheet" Sept. 27, T&G-1). "The agency may have a proposal on its MedGuide program ready in early 1994. During the briefing, committee member Kenneth Rabin, the managing director of InterScience Communications, said relevant people at FDA have the guidelines/report and that FDA Marketing Practices and Communication Branch Chief Louis Morris, PhD, commented on the report during its drafting. Morris is involved in the development of MedGuide. Committee member Peter Carpenter, Stanford University, noted that it is the committee's view that "each regulatory agency as they consider what is appropriate in their particular country will look at this and use these guidelines as criteria in deciding what is appropriate for their particular situation." Carpenter said: "I reviewed this material with [HHS Assistant Secretary for Health Philip] Lee last week and my impression is that it will have the desired effect within HHS, which is it is an externally provided perspective, which hopefully they will use in evaluating what they're going to propose." Lee was the architect of a mandatory Patient Package Insert program proposed during the Carter Administration. Although the PPI proposal of the 1970s met with considerable opposition, FDA's MedGuide program could receive wider acceptance and easier implementation if it were integrated into the government's health care reform efforts. Carpenter added: "We are now on the verge of a health care revolution in this country, which is going to be very outcome oriented. And I'm convinced that successful pharmaceutical companies are going to have to demonstrate that their product, not just simply the physical compound, but the package, the information, everything that surrounds it, is cost effective." The Medical Benefit/Risk Foundation, established in 1991, is a nonprofit organization headquartered in Geneva that receives financial support from a consortium of multinational pharmaceutical corporations. The briefing was sponsored by Interscience Communications.
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