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Executive Summary

MERCK AND SYNTEX ADVERSE DRUG REACTION REPORTING SYSTEMS have been among the most successful at generating thorough information, FDA's John Harter, MD, commented April 29 at a meeting of the agency's Arthritis Advisory Cmte. Discussing line item information of a group of adverse reaction reports (ADR) for nonsteroidal anti-inflammatory drugs, Harter explained that Merck has achieved "consistently better results in acquiring data" from health professionals. For example, 2.3% of the reports on Dolobid lacked information on patients' sex. Among the reports on eleven NSAIDs, sex information was lacking in 20.6% of the cases. Information "not reported" for a specific category in reports on Merck's NSAIDs (Dolobid, Indocin, Clinoril) averaged 30%, Harter said, while the average for some companies was in the 60% range. In addition to Merck, Harter singled out the Syntex ADR report collection system for its "very high percentage of reported and very little of not-reported [items] on the forms." In a presentation to the meeting, Merck explained that it has a two-tiered reporting system. In addition to leaving a report form with a health professional, Merck detail reps are required to submit a separate form. In a survey of 157 ADRs for Clinoril, Merck estimated that 36% of the reports would not have been submitted were it not for the company representative-initiated forms. In 92 instances, the reports were initiated by the professional representative; in 58 of those cases, Merck said, the physician or health professional never submitted the ADR form. The Syntex approach stresses follow-up communications. The company attempts to call all MDs or sources of reports by phone, a Syntex representative explained. In addition, "all initial telephone contacts are followed up by a letter to the reporting professional that provides information about similar events which have been previously reported to Syntex," he explained. The letter also specifically asks for information that was missing from the initial report. Commenting on the Syntex follow-up letters, Harter suggested that the information provided to MDs on similar reports may "be one of the reasons (MDs) sometimes report." Letters on adverse reactions that some other companies send to reporters seem "so defensive and sort of protective of the drug, that I think it really turns the MDs off." The Syntex approach, the FDAer pointed out is more labor-intensive than Merck's. With Merck's system, "at least you get from your representative something on the first form," he said. However, he added, "you really don't ask them what about this case makes you want to report it. I think that's important because that piece of information might shed some light on the whole thing."

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