부산대학교 도서관

Government and public focus on drug safety has increased visibly in recent years as product withdrawals and new label warnings became routine. Pharmacovigilance departments must respond by reinforcing efforts to obtain detailed adverse event information to clarify emerging safety issues, protect patients, and avoid unsuitable regulatory actions. Novartis Pharmaceuticals Corporation had a reliable and fully compliant method for collecting and reporting events. To promote continuous improvement and industry leadership, however, the company divested adverse event receipt from drug information services in 2001. An analysis of serious postmarketing reports at multiple intervals after the reorganization demonstrated that a team charged specifically with receiving adverse events can optimize the collection of medical data.The new process clarifies potential confounding factors for individual cases and improves overall knowledge of each drug's safety profile. Attempts were also made to compare the results with an industry benchmark, but were unsuccessful due to the lack of universal quality standards and the high degree of subjectivity in assessing reports. Customer satisfaction was also of concern, as adverse event reporters often contact the company with related medical questions, and those callers were now obliged to interact with two departments. Therefore, a survey of health professionals and consumers who interacted with the Data Collection Team was conducted. The results showed consistently high approval ratings for the new group, demonstrating little negative response by customers to dealing with more than one department.