Analysis of the toxic and lethal doses of one over-the-counter drug product in humans and the ingredients that may be abused: Building a drug database to prevent drug overdoses.

Abstract

Pharmacists who provide medication to patients immediately before they overdose should intervene appropriately; however, little information exists on the types and amounts of over-the-counter (OTC) drugs that are dangerous. This study investigated the toxicity and characteristics of overdosing on a single package of commercially available OTC drugs in humans. We researched 14,107 OTC drugs. The number of products that could contain a lethal dose if taken as a single package was 1,223 (8.7%) and a toxic dose was 2,982 (21.1%). A single product containing a lethal dose to humans by therapeutic category included skin drugs (n = 672, 25.0%), psychotropic drugs (n = 288, 17.9%), and public health drugs (n = 92, 26.1%) in descending order. Comparing before and after April 2023, the number of OTC pharmaceuticals that contained ingredients that may be abused, significantly increased: psychotropic drugs (44.9% increase), respiratory drugs (8.2% increase), and urogenital and anal organs drugs (3.5% increase) (p < 0.05). These products had not been previously designated as hazardous despite their potential for abuse. The registrants in the "Drug Database for Overdose Prevention" that made these public included 199 pharmacists, registered sellers, and doctors as of July 31, 2024. The city with the most users was Osaka (377 users) and an average engagement time of 41.8 seconds, followed by Sapporo, Fukuoka, and Nagoya. These areas were consistent with urban centers and high numbers of emergency transports due to overdose. Our findings provide important pharmaceutical information that pharmacists can use for their gatekeeper activities.