2/13/2023 0 Comments Ridoc office of inspectionsIn most cases, there were similarities in questions asked (top 5 ranking) and their geographical source for sales representative triage versus customers directly.Ĭompliance medical information off-label sales representatives unsolicited. 001) for the rate of 4.8% to 8.1% observed collectively for all customer sources. The Resource Library is designed to match the organization of retail establishment inspection forms. Rhode Island Correctional Industries (RICI) is a rehabilitative program that started in 1934 with the purpose of providing job skills for offenders and is now a thriving local business that employs approximately 130 offenders who will use those skills to lead. For the set of sales representative triage submissions in 20, the "off-label indications/uses" category accounted for 15.3% to 20.5%, respectively, and was statistically significant ( P <. Welcome State of Rhode Island Department of Corrections: Correctional Industries. Questions related to "off-label indications/uses" (ie, compliance topic of most interest to regulatory agencies) accounted for 5.8% of all inquiries and were almost equally distributed in number between sales representative triage and HCW direct calls to the PIMID. In an analysis of all inquires (n = 20,213) received over a 2-year period (2010-2011), it was observed that inquires submitted by sales representatives after unsolicited health care worker (HCW) requests accounted for only 14.8% of requests overall. By tagging all response documents with "compliance topic" codes that reflect the type of off-label inquiry (eg, 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. Especially of interest are unsolicited off-label inquiries triaged via sales representatives. 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. 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).
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