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Defining and using quality metrics for adverse events case processing.
Measurement of case quality in pharmacovigilance is a relatively new development. Until pharmaceutical companies began outsourcing their case processing operations, the only measure of effectiveness of their internal operations was compliance with regulatory reporting timelines. Now that these operations are performed by vendors, over the last two years vendor management organizations within pharmaceutical companies and Health Authorities have come up with a way to measure the “quality” of Adverse Event (AE) cases. This paper captures our experience and learning in defining and using case quality metrics while working with large and small pharmaceutical companies
The inherent challenge in defining objective case quality metrics arises from the subjective nature of the work and from attempting to balance sponsor expectations vis-à-vis operational efficiencies. Until about 2009 compliance to reporting timelines of expedited reports by the Marketing Authorization Holders (MAH) was the only valid metric of the effectiveness of an AE processing operation evaluated by global health authorities (such as USFDA, EMEA, UK MHRA). This changed in 2009 due to the public focus on drug safety led by recalls of prominent drugs like Avandia, Vioxx etc.