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POISON CONTROL DATA: NEW FORM TO ENTER USE IN JANUARY

Executive Summary

POISON CONTROL DATA: NEW FORM TO ENTER USE IN JANUARY that contains codes for 120 adverse clinical effects "broken down by body system," Ciba-Geigy Assistant Director, Central Regulatory Affairs Timothy Dring said Nov. 12 at a Nonprescription Drug Manufacturers Association meeting. He explained that the form in current use captures "no specific clinical effects" of a substance exposure. Dring chairs the Industry Subcommittee of the American Association of Poison Control Centers' National Data Collection System (NDCS) Redesign Project. In conjunction with the implementation of the new form, the NDCS, which was begun in 1983 to collect data from the approximately 73 poison control centers in the U.S., will be renamed the Toxic Exposure Surveillance System (TESS). The new data collection form will also record the duration of the clinical effects of substance exposure and may improve the correlation of clinical effects of an exposure "to the overall effect," i.e., death, permanently disabling symptoms or more minor outcomes, Dring explained. The lists of reasons for exposure and route of exposure that can be coded on the form will be expanded and the accuracy of identification of substances will be improved, Dring said. TESS data entry will be performed electronically by some poison control centers this year, he noted, and by January 1993 data entry should be done on-line at all of the centers. TESS "has the potential to offer some very useful postmarketing surveillance information" for OTC drugs, Dring said. He described TESS as a "possible fourth leg that you can use in your postmarketing surveillance efforts after the FDA spontaneous reporting system, literature, and company databases." TESS data does have "limitations," Dring noted, including the lack of "absolutely accurate denominator information." Additionally, TESS reports represent "a subjective judgment...It does not serve as a definitive assessment of causality," he cautioned. The Ciba-Geigy exec encouraged makers of OTCs to ensure that the "poisindex," by which poison control centers code the substance of a particular exposure, is updated to reflect each firm's current product line. "It really behooves you to make sure that that system...is kept up to date on your products." The Denver-based software firm Micromedex developed the poisindex database to which all members of the American Association of Poison Control Centers must subscribe to participate in NDCS. Dring suggested that "since Micromedex can't go around to each company and solicit them for information, it is much easier for the company to go to Micromedex" with updates in product lines and brand names. * FDA Consultant and Office of OTC Drugs Director-apparent Michael Weintraub, MD, told NDMA that FDA recently has experienced "nearly a doubling" in the number of drug adverse events reported to its spontaneous reporting system. Possible reasons for the increase include new requirements of the Joint Commission on Accreditation of Health Care Organizations and "anticipation of the commissioner's initiative" on adverse effect reporting, Weintraub said. In April, FDA met with the American Medical Association, the American Society of Hospital Pharmacists and the American Nursing Association to enlist the three groups in developing strategies aimed at increasing the number of adverse event reports to the agency, with a particular emphasis on rare or unexpected events ("The Pink Sheet" June 8, T&G-5). Weintraub described the initiative as "still in its formative stage." Weintraub noted "a problem with the denominator" in all the postmarketing surveillance methods used for OTC drugs. He said he expected to see "more information from user studies...the patient intercept at pharmacies." Another "potential method" for measuring OTC drug exposure would be to fund health maintenance organizations to offer OTC drug benefits, "so that they could be tracked as well" as prescription drugs currently are. Weintraub admitted that such a project "would have to be funded in innovative and creative ways."
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