Industry-Based Medical Communications: Benchmarking Survey of Quality Assurance Practices

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5. Justin Hileman, PharmD Assistant Clinical Professor University of California San Francisco School of Pharmaw, San Francisco. California Angie 5. Graham, PharmD Drug Information Coordinator Stanford Hospital 6 Clinics, Palo Alto, California

Joyce Serrano Morln, PhornD Medical Communications Scientist, Genentech. Inc., South San Francisco, California Borry Grobman, PhormD Medical Communications Senior Manager Genentech, Inc., South San Francisco, California

Key Words Quality assurance; Medical communications: Medical information; Drug information; Industry Presented at the 2002 Drug Information Association 13Ih Annual Workshop on Medical Communications, Tampa, Florida. Correspondence Address S. Justin Hileman. PharmD, 1040 NW 5th St., Boca Raton, FL 33486 (e-mail: shileman @nove.edu)

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Industry-Based Medical Communications: Benchmarking Survey of Quality Assurance Practices The quality of information provided by pharmaceutical and biotechnology companies in response to unsolicited requests is of great importance. A survey was conducted to benchmark the quality assumnce practices of medical communications departments, their vendors, and their corpomte partners. Survey questions were developed based on Genentech Medical Communications quality assurance practices. Between September and December 2001. the survey, a letter requestingparticipation, and a postage-paidreturn envelope were

Quality assurance (QA) has been described as a formal mechanism to evaluate the quality of products and services and ensure that goals are established and assessed and that solutions are proposed if goals are not met (1).The quality assurance practices reportedly used in industry medical communications departments to date primarily involve peer evaluation and user satisfaction surveys. Quality assurance can identify strengths and areas for improvement in the medical communications process. The Core Curriculum (2) publication by Graves and Baker highlights QA as a key activity of industry-based drug information that can include response review, standards and style of written responses, turnaround time, telephone script reviews, and QA meetings. It has been said that obtaining complete, accurate, practical, and timely responses from pharmaceutical companies can be challenging (3). Often, the scope of questions received by medical communications departments is broad, with topics ranging from storage to clinical application. Responding to these questions requires a wide knowledge of general science and clinical medicine. Additionally, medical communications specialists may be required to respond

mailed to 743 companies. Responses could be mailed, faxed, e-mailed, or provided by telephone. Twenty-nine responses (4%)to our survey were received. The majority of respondents have response documents reviewed for quality assurance purposes. About half of departments perform quality assurance on themselves; one-third record calls. The majority of those who use a vendor pe$orm quality assurance on them; half record calls. There was little qual

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