Uptake of new drugs in the early post‐approval period in the Mini‐Sentinel distributed database. Issue 9 (4th May 2016)

• Record Type: Journal Article
• Authors: Mott, Katrina; Graham, David J.; Toh, Sengwee; Gagne, Joshua J.; Levenson, Mark; Ma, Yong; Reichman, Marsha E.
• Is Part Of: Pharmacoepidemiology and drug safety. Volume 25:Issue 9(2016)
• Page Start: 1023
• Page End: 1032
• Publication Date: 2016-05-04
• Subjects: active surveillance -- drug safety -- distributed databases -- new molecular entities -- Sentinel -- pharmacoepidemiology -- pharmacoepidemiology; Pharmacoepidemiology -- Periodicals; Chemotherapy -- Periodicals; Epidemiology -- Periodicals; 615.705
• DOI: 10.1002/pds.4013
• Languages: English
• ISSNs: 1053-8569

Abstract

Abstract: Purpose: Several factors limit the statistical power of drug safety surveillance during the early post‐approval period, including uptake of the drug and lag in data availability. This study characterized new drug uptake in the Mini‐Sentinel Distributed Database and determined statistical power to detect levels of risk in post‐launch safety assessments. Methods: The cumulative exposure among initiators of 46 new molecular entities approved from 2008 to 2011 was assessed. Using a Poisson estimation method, minimum incidence rate ratios (IRRs) detectable, with 80% power, were calculated under varying background incidence rates. Results: Twelve products (26.1%) had more than 15 000 new users after 2 years. With comparator group incidence rate of 1/1000 person‐years, 16 (33.3%) products had enough exposure to detect an IRR of 5 with 24 months of data collected that would be available for assessment at 33 months post‐launch. With an incidence rate of 5/1000 person‐years, 23 (50%) products had enough exposure to detect an IRR of ≥3 with 2 years of data collected. At 33 months post‐launch, only two (4.3%) of the drugs examined had enough data availability to detect IRR of <2, and eight (17.4%) of <3, with a background rate of 1/1000 person‐years. Conclusion: This study highlights the importance of drug uptake and data availability in early post‐approval drug safety surveillance in Mini‐Sentinel. There is limited ability to detect rate ratios below three for events with background rates of 1/1000 person‐years or lower. This is largely due to low product uptake. Copyright © 2016 John Wiley & Sons, Ltd.