Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

MERCK AND SYNTEX ADVERSE DRUG REACTION REPORTING SYSTEMS

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."

You may also be interested in...



Part D Discount Liability Coming Into Focus: CMS Releases Drug Cost Data

Newly released Medicare Part D data sheds light on the sales hit that branded pharmaceutical manufacturers will face when the coverage gap discount program gets under way in 2011

FDA Skin Infections Guidance Spurs Debate On Endpoint Relevance

FDA appears headed for a showdown with clinicians and the pharmaceutical industry over the proposed new clinical trial endpoints for acute bacterial skin and skin structure infections, the guidance's approach for justifying a non-inferiority margin and proposed changes in the types of patients that should be enrolled in trials

Shire Hopes To Sow Future Deals With $50M Venture Fund

Specialty drug maker Shire has quietly begun scouting deals with a brand-new $50 million venture fund, the latest of several in-house investment arms to launch with their parent company's pipelines, not profits, as the measure of their worth

Latest Headlines
See All
UsernamePublicRestriction

Register

PS008283

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel