Citation

Mallama CA, Trinidad JP, Swain RS, Zhao Y, Woods C, McAninch JK. Pharmacoepidemiol. Drug Saf. 2019; ePub(ePub): ePub.

Affiliation

Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, USA.

Copyright

(Copyright © 2019, John Wiley and Sons)

DOI

10.1002/pds.4869

PMID

31402548

Abstract

PURPOSE: The purpose of the study is to describe and compare the number and characteristics of opioid-involved fatal cases captured in the National Poison Data System (NPDS) and in US death certificates.

METHODS: NPDS, which collects data on all calls to US poison control centers, and Drug-Involved Mortality (DIM), which combines information from literal text of US death certificates and National Vital Statistics Systems, were queried for opioid-involved fatal cases from 2010 to 2015. Characteristics of the two case series were compared.

RESULTS: DIM contained 154 016 opioid-involved overdose deaths, and NPDS contained 2524 fatal opioid exposures, a ratio of 61:1. The number of opioid deaths remained stable in NPDS but increased in DIM over the 6-year period. On average, deaths involving opioids with higher mean dosage strength (in morphine milligram equivalents) per unit among dispensed prescriptions were more likely to be captured in DIM relative to NPDS, as compared with those with a lower mean dosage strength per unit. The increase in fentanyl-related deaths seen in DIM since 2013 was not observed in NPDS.

CONCLUSIONS: NPDS is a valuable drug safety surveillance resource due to its timeliness and drug specificity. However, it captures only a small fraction of opioid-involved fatal poisonings, and comparisons with data derived from death certificate literal text indicate that caution is warranted in making inferences about opioid-involved fatality trends over time or comparisons across opioids.

Published 2019. This article is a U.S. Government work and is in the public domain in the USA.

Language: en

Keywords

analgesics; drug overdose; epidemiology; opioid; pharmacoepidemiology; postmarketing; product surveillance; vital statistics