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Investigating Serious Adverse Drug Reactions in Patients Receiving Erythropoiesis-Stimulating Agents: A Root Cause
Sony Jacob1,2, Judy Nichols2, Iain C Macdougall3
1The Southern Network on Adverse Reactions (SONAR) Program, University of South Carolina College of Pharmacy, Columbia, SC.
American Journal of Therapeutics
|September 1, 2018
Summary
Serious adverse drug reactions (sADRs) in chronic kidney disease (CKD) patients receiving erythropoiesis-stimulating agents were analyzed. A structured framework successfully identified causes and led to eradication strategies for these rare but significant events.
Area of Science:
- Pharmacovigilance
- Nephrology
- Drug Safety
Background:
- Identified unexpected serious adverse drug reactions (sADRs) in patients with chronic kidney disease (CKD) treated with erythropoiesis-stimulating agents (ESAs).
- Observed cases included pure red cell aplasia (PRCA) with epoetin formulations and fatal anaphylaxis with peginesatide.
- Highlighted the need for a structured approach to analyze and manage sADRs in this vulnerable patient population.
Purpose of the Study:
- To develop and apply a structured framework for describing and analyzing serious adverse drug reactions (sADRs) in CKD patients.
- To conduct root cause analyses for identified sADRs associated with specific ESAs.
- To devise and implement eradication strategies for these adverse events.
Main Methods:
- Utilized a 10-step framework named "ANTICIPATE" for evaluating signal identification, incidence, causality, and eradication of sADRs.
- Systematically reviewed initial case reports identified by clinicians.
- Performed root cause analysis for each identified sADR.
Main Results:
- Analyzed 13 PRCA cases (epoetin), 2 antibody-mediated PRCA cases (HX575), and 5 fatal anaphylaxis cases (peginesatide).
- Identified likely causes: subcutaneous administration (Eprex), tungsten leaching (HX575), and phenol stabilizer (peginesatide).
- Successfully implemented eradication strategies including route change, syringe modification, and preservative removal.
Conclusions:
- Despite small case numbers, eradication efforts were successful for two sADRs and proposed for a third.
- Demonstrated the utility of the structured "ANTICIPATE" framework in managing sADRs.
- The framework is applicable to other clinical settings for analyzing and mitigating drug-related adverse events.
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