Establishing an Adverse Event Collection Team in a Pharmaceutical Company Safety Department: Impact on Report Quality an
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Establishing an Adverse Event Collection Team in a Pharmaceutical Company Safety Department: Impact on Report Quality and Customer Satisfaction
Thomor Umroth, BS, M A Manager Global Safety Intelligence
Alon 1. Bess, MD Vice President Clinical Safety 6. Epidemiology. Novartis Pharmaceuticals Corp., East Hanover, New jersey
Key Words Pharmacovigilance; Drug safety: Adverse drug experiences; Data quality; Customer satisfaction Correspondence Address Thomas Umrath, BS. MA, Manager Global Safety Intelligence Clinical Safety G Epidemioloa, Novartis Pharmaceuticals Corp.. I Health Plaza, East Hanover, NJ 07936- 1080.
Government and public focus on drug safety has increased visibly in recent yems as product withdrawals and new lab$ warnings became mtine. Phannacovigilance departments must respond by reinforcing efforts to obtain detailed adverse event information to clarify emerging safety issues, protect patients, and avoid unsuitableregulatory actions. Novartis Pharmaceuticals Corporation had a reliable and Nly compliant method for cdlecting and reporting events. To promote continuous improvement and industry leadership, howeva the company divested adverse event receipt f..n drug information services in 2001. An analysis of serious postmarkding reports at multiple intervalsafter the reorpization demonstrated that a team chatged speci3dly with receiving adverse events can optimize the cdlechon of medid data.
I#TROD UCTlO N PURPOSE This analysis assessed the impact of a safety data collection team on the quality or completeness of adverse events. It also attempted to qualify those findings against published benchmarks. In the pharmaceutical industry many postmarketing adverse drug experiences (ADEs) are received by companies under the guise of product inquiries. At Novartis, the majority of reports arrived in the drug information and consumer information departments. These groups addressed customers' questions and recorded postmarketing ADE data in a template. The data collection algorithm was standardized and varied little for report seriousness or labeling status. Follow-up on reports was subsequently conducted by the drug safety group, also in a standard manner using computer-generated letters and generic patient information forms. For serious events, additional letters were sent if
The new process darifies potential confounding factors for individual cases and improves o v d l knowledge of each drug's safe@ profile. Attempts were also made to compare the results with an industry benchmaric, but were unsucces@ due to the lack of universal quality standards and the high degree of subjedivi$yin assessing reports. Customer satisfaction was also of concern, as adverseevent reporters often contact the company with related medid questions, and those callers were now obliged to int a c t with two departments. Therefore, a survey of h d t h professionals and consumers who int a c t e d with the Data cdlection Team was conducted. The d t s showed consistentlyhigh approvalratings for the new group, demonstmting little n
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