Abuse Prevention Measures for Over-the-Counter (OTC) Drugs: Expansion for Designation of the Drugs with “Potential for Abuse”

Abstract

The Ministry of Health, Labor and Welfare (MHLW) has designated Ephedrine, Codeine (limited to antitussive and expectorant drugs), Bromovalerylurea, Pseudoephedrine and Methylephedrine (limited to liquid preparations for antitussive and expectorant drugs) as pharmaceutical ingredients that may be abused according to the Act on Securing Quality Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices. However, it has been pointed out that the number of cases of abuse of OTC drugs is increasing, and that the ease of obtaining them and the legality of using them are pointed out as factors for the increasing number of abuses. While there are various indications about the abuse of OTC drugs, MHLW has expanded the scope of regulated ingredients that may be abused that the limitations on designated OTC drugs shall be removed, and is working to strengthen measures to prevent abuse.