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Prescriber Compliance With Liver Monitoring Guidelines for Pazopanib in the Postapproval Setting: Results From a
Sumitra Shantakumar, Beth L Nordstrom1, Susan A Hall2
1Evidera, Lexington.
Journal of Patient Safety
|April 22, 2017
Summary
Pazopanib liver monitoring compliance was reasonable at the start of treatment but decreased over time. Real-world data show gaps in adherence to FDA guidelines for monitoring liver function during pazopanib therapy.
Area of Science:
- Oncology
- Pharmacovigilance
- Hepatology
Background:
- Pazopanib, approved in 2009 for advanced renal cell carcinoma, carries a boxed warning for hepatotoxicity.
- Clinical trials revealed liver chemistry abnormalities, necessitating detailed prescriber guidelines for liver monitoring.
- Post-approval studies were mandated to evaluate adherence to these monitoring recommendations.
Purpose of the Study:
- To assess prescriber compliance with US Food and Drug Administration (FDA) liver monitoring guidelines for pazopanib.
- To evaluate real-world adherence in diverse healthcare settings.
- To provide feedback on the effectiveness of drug labeling for safety monitoring.
Main Methods:
- A 4-year cohort study utilizing a distributed network approach across US Veterans Affairs, US outpatient oncology, and Dutch databases.
- Prescriber compliance measures were derived from the original pazopanib label guidelines.
- Analysis focused on baseline and periodic liver chemistry testing rates.
Main Results:
- Compliance with baseline liver chemistry testing was 73%-74%, decreasing to 37%-39% for testing every 4 weeks.
- Monitoring compliance was highest near pazopanib initiation and declined over time.
- For patients requiring weekly testing, compliance was 56%; serious liver enzyme elevations leading to discontinuation were infrequent.
Conclusions:
- Prescriber compliance with pazopanib liver monitoring guidelines is reasonable at treatment initiation but significantly declines in subsequent weeks.
- Real-world data highlight challenges in sustained adherence to pharmacovigilance recommendations.
- Findings offer insights into the practical application and effectiveness of FDA-mandated drug monitoring guidelines.
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