Marsha A Wilcox1, Jill Hardin2, James Weaver2, Erica A Voss2. 1. Janssen Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560, USA. MWilcox@its.jnj.com. 2. Janssen Pharmaceutical Research and Development, LLC, 1125 Trenton-Harbourton Rd., Titusville, NJ, 08560, USA.
Abstract
BACKGROUND: Monitoring risk is often an important component of therapy. Some compounds require liver test (LT) monitoring, with the frequency detailed in the product label. Compliance with these instructions is generally unknown. OBJECTIVE: The goal of this short study was to describe LT compliance for compounds with monitoring recommended at 2-week intervals or more frequently in three US administrative claims databases. METHODS: The sample was drawn from three US claims databases during the period 1 January 2015 through 30 June 2018. This study examined nine compounds and five types of LTs. We looked at compounds in a published list of drugs requiring LTs at 2-week intervals or more frequently. Descriptive statistics about the days between tests were reported, as were the number and proportion of tests associated with each drug that met the recommended frequency. RESULTS: Compliance was < 33% with four drugs (ketoconazole, succimer, pentamidine, and felbamate) and > 60% with five drugs (oxaliplatin, rifampin, tolcapone, albendazole, and azathioprine). Among drugs with more than 1000 drug eras observed (all but succimer and tolcapone), LT compliance was highest for oxaliplatin (75.3%) and lowest for pentamidine (20.6%), with little difference in overall compliance by type of test (range 41-46). CONCLUSION: Compliance with frequent LT monitoring differed for the drugs examined. Two strata were found: compliance > 60% (oxaliplatin, rifampin, tolcapone, albendazole, and azathioprine) and compliance 20-30% (ketoconazole, succimer, pentamidine, and felbamate). No drug reached 80% compliance.
BACKGROUND: Monitoring risk is often an important component of therapy. Some compounds require liver test (LT) monitoring, with the frequency detailed in the product label. Compliance with these instructions is generally unknown. OBJECTIVE: The goal of this short study was to describe LT compliance for compounds with monitoring recommended at 2-week intervals or more frequently in three US administrative claims databases. METHODS: The sample was drawn from three US claims databases during the period 1 January 2015 through 30 June 2018. This study examined nine compounds and five types of LTs. We looked at compounds in a published list of drugs requiring LTs at 2-week intervals or more frequently. Descriptive statistics about the days between tests were reported, as were the number and proportion of tests associated with each drug that met the recommended frequency. RESULTS: Compliance was < 33% with four drugs (ketoconazole, succimer, pentamidine, and felbamate) and > 60% with five drugs (oxaliplatin, rifampin, tolcapone, albendazole, and azathioprine). Among drugs with more than 1000 drug eras observed (all but succimer and tolcapone), LT compliance was highest for oxaliplatin (75.3%) and lowest for pentamidine (20.6%), with little difference in overall compliance by type of test (range 41-46). CONCLUSION: Compliance with frequent LT monitoring differed for the drugs examined. Two strata were found: compliance > 60% (oxaliplatin, rifampin, tolcapone, albendazole, and azathioprine) and compliance 20-30% (ketoconazole, succimer, pentamidine, and felbamate). No drug reached 80% compliance.
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