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Jun 04 2014

Analysis of Med Info Responses to HCP Submitted via Third Party

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Citation: Fuentes RJ, Kim R, Idowu K, Susla G. Analysis of Medical Information Responses to Unsolicited Health Care Worker Inquiries Submitted via Sales Representatives or Customers Directly.Therapeutic Innovation & Regulatory Science.2014 March;48(2):155-61. Published online before print July 18, 2013.doi: 10.1177/2168479013495208 http://dij.sagepub.com/content/48/2/155.abstract

In the field of medical communications a topic of great interest is the unsolicited off-label inquiries that are communicated to Med Info departments via sales representatives. Authors from MedImmunereport an analysis of inquiries (n = 20,213) received over a 2-year period (2010-2011), including those triaged by sales representatives.

Abstract: Unsolicited inquiries for off-label medical/product information are the focus of compliance monitoring programs as described in regulatory guidance published by the US Office of the Inspector General (OIG) and the US Food and Drug Administration (FDA). Pharmaceutical industry medical information departments (PIMIDs) are encouraged to monitor and report on patterns of activity, including the source and frequency and types of off-label inquiries received. Especially of interest are unsolicited off-label inquiries triaged via sales representatives. By tagging all response documents with “compliance topic” codes that reflect the type of off-label inquiry (e.g., unapproved indications/uses, more detailed or extended data, adverse events, etc.) and specifically tracking for the inquiry source route, our PIMID was able to analyze and compare customer inquiries including those triaged by sales representatives.

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