Adverse Drug Reactions Conference on Clarifying International Reporting Requirements - June 2000 IBC's series of events addressing adverse drug reactions have made it easier for the pharmaceutical industry to track trends in reporting requirements. The conference documentation includes key topics such as: Signal identification and causality assessment Case studies regarding MedDRA Reporting requirements for ADRs from clinical trials Safety reporting and evaluation of biotech products Pharmacovigilance issues in collaborations Impact of EU Data Protection Directive on ADR reporting Executive Summaries from MedDRA at Work: the Bristol-Myers Squibb Experience, presented by Patricia Mozzicato, M.D, Bristol-Myers Squibb Pharmaceutical Research Institute at IBC Life Sciences, Adverse Drug Reactions Conference For further information and details of the comprehensive documentation available from this event, please visit: www.ibc-lifesci.com/ly1180 1. MedDRA at Work: the Bristol-Myers Squibb Experience [top] Patricia Mozzicato, M.D, Bristol-Myers Squibb Pharmaceutical Research Institute Executive Summary In the late 1990s, the Drug Safety & Pharmacovigilance (DSP) department at Bristol-Myers Squibb (B-MS) needed to replace the Company's adverse event (AE) database due to Y2K issues, the age of the technology, and due to the requirement for enhanced pharmacovigilance tools. B-MS's safety department developed a Web-based application for the design of the new AE database (CARES 2.0). Besides Y2K compliance, the new AE database was also E2B compliant and had strengthened pharmacovigilance tools. It was decided to bring MedDRA into the new database to complete the state-of-the-art system. As the new AE database began to take shape, the safety department was faced with 3 main issues related to MedDRA: 1) conversion of existing cases; 2) training of database users; and 3) maintenance of the dictionary. The safety department had been using COSTART 5th edition as the coding dictionary for adverse events, ICD-9 for indications, and text for medical history and cause of death terms. The verbatim reporter terms (VRTs), rather than the coded terms, were converted into MedDRA using several algorithms which removed punctuation and extraneous words, which attempted to make MedDRA matches on terms truncated by removal of suffixes (-ies, -y, -ing, etc.), and which then attempted matches on alphabetized strings. Approximately 75% of all terms were successfully matched to MedDRA terms in this way; this figure represented 99% of all adverse event terms (the remaining 1% were manually mapped). All users of the new AE database were required to participate in "in-house" MedDRA training using supplemental materials such as the MSSO's Introductory Guide, handouts, and "hands-on" exercises. Data entry users were instructed on how to deal with VRTs that did not make an immediate match to an existing MedDRA term. Feedback from the user community at B-MS has thus far been positive. A single appointed physician (with back-ups) makes synonym mappings for reporter terms that do not make an immediate match to an existing MedDRA term (to promote consistency). A safety department MedDRA committee has been established which 1) reviews routine synonym mappings; 2) recommends Change Requests to the MSSO; 3) reviews MedDRA-related SOPs and Work Practices; and 4) engages in outreach activities to other B-MS departments. Communications with the MSSO are managed by a single MSSO Contact. The key lessons learned by B-MS are: 1) medical oversight of conversion process is essential; 2) flexibility in approaches to conversion, training, and maintenance are needed; and 3) despite its imperfections, MedDRA can work under creative management.