J Pharmacoepidemiol Risk Manage.  2021 Mar;13(1):10-16. 10.56142/2021.13.1.10.

Methodologies for Health Risk Assessment of Mutagenic Impurities in Medications and the Role of Pharmacoepidemiology

• Kang YJ
• Kim MS
• Lee MT
• You SH
• Lee JE
• Eom JH
• Jung SY

• KMID: 2534643
• DOI: http://doi.org/10.56142/2021.13.1.10

Abstract

Recently, public concerns on the human health risk of N-nitrosodimethylamine (NDMA) contamination in medications have been raised. The need for making the standard to evaluate the health risk assessment of contaminated medications has emerged. We reviewed the methodologies for risk assessment of contaminated medications and the role of pharmacoepidemiology. We reviewed International Council of Harmonization guideline, which includes risk characterization and health risk assessment in individuals. The guideline can be applied to scenarios to evaluate individual risk and real-world data with a cohort design. Also, another approach for health risk assessment is a pharmacoepidemiology study using healthcare database. This methodology can determine the risk by comparing the cancer incidence rates of the general population and the exposed group. It is necessary for comprehensive human health risk assessments that consider mutagenic impurities from various sources by establishing a system linking multiple data for patient safety.

Keyword

N-Nitrosodimethylamine; Methodology; Risk Assessment; Drug Contamination