A characterization and disproportionality analysis of medication error related adverse events reported to the FAERS database

ABSTRACT

Objectives: To characterize adverse reactions associated with medication errors (ME) reported in US Food and Drug Administration Adverse Event Reporting System (US-FAERS), and to identify the potential signals of disproportionate reporting (SDR) for different drugs.

Methods: ME associated Individual Case Study Report (ICSRs) were identified. ICSRs were categorized by patient age groups, affected stages of medication process and Anatomical Therapeutic Chemical classification system. Disproportionality analyses were performed for different age groups.

Results: 46,8677 ICSRs were retrieved. An increasing trend in reporting of cases of ME was observed during the studied period. Immunosuppressants and psycholeptic drugs were most frequently involved. Administration errors were reported most frequently, followed by prescribing and dispensing errors. In neonates, SDR following wrong drug administration, wrong dose, and accidental overdose were associated with methylergonovine, zidovudine, and acetaminophen. In elderlies, SDR were found for dose omission and underdose error associated with etanercept and evolocumab.

Conclusion: While a detailed root-cause analysis for ME characteristic can rarely be performed on such a dataset, data mining for signals in spontaneous reporting database may assist in identifying potential ME in a more standardized and objective manner. Continued use of spontaneous reporting system for identifying MEs is encouraged to prevent unnecessary patient harm.

KEYWORDS:

• Medication error
• patient safety
• adverse events
• signal detection

Acknowledgments

F Mazhar is enrolled in the Ph.D. in Experimental and Clinical Pharmacological Sciences, the University of Milano that supports his fellowship.

Author contributions

C Carnovale conceptualized and designed the study, interpreted the data drafted the manuscript, revised, and approved the final manuscript as submitted. F mazhar participated in the conceptualization and design of the study, carried out the initial analyses, revised the manuscript and approved the final manuscript as submitted. M Pozzi participated in the conceptualization and design of the study, participated in the analysis and interpretation of the data, revised the article, and approved the final article as submitted. M Gentili participated in the conceptualization and design of the study, participated in the analysis and interpretation of the data, revised the article, and approved the final article as submitted. E Clementi participated in the conceptualization and design of the study, participated in the analysis and interpretation of the data, coordinated and supervised data collection, critically reviewed the manuscript and approved the final manuscript as submitted. S Radice conceptualized and designed the study, interpreted the data, coordinated, and supervised data collection, critically reviewed the manuscript and approved the final manuscript as submitted.

Declaration of interest

The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Supplementary material

Supplementary data for this article can be accessed here.

Additional information

Funding

This work was supported by funds from the Regional Centre of Pharmacovigilance of Lombardy (to E Clementi) the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA, to E Clementi) and by the Italian Ministry of Health (Ricerca Corrente 2018, to M Pozzi).