アブストラクト
Japanese
| Title | 緊急避妊薬の規制に関する課題と展望 |
|---|---|
| Subtitle | 総説 |
| Authors | 亀井美和子1,4, 齋藤カルメン2, 中島理恵3, 長津雅則4, 小林江梨子2 |
| Authors (kana) | かめいみわこ |
| Organization | 1帝京平成大学薬学部, 2城西国際大学薬学部, 3日本大学薬学部, 4公益社団法人日本薬剤師会 |
| Journal | 医薬品相互作用研究 |
| Volume | 48 |
| Number | 2 |
| Page | 47-55 |
| Year/Month | 2024 / |
| Article | 報告 |
| Publisher | 医薬品相互作用研究会 |
| Abstract | 「1. はじめに」 緊急避妊薬Emergency Contraceptive Pills(以下ECPという)は, 避妊せずに行われた性交, または避妊手段が失敗した可能性がある性交後に緊急的に服用する薬剤であり, WHOのエッセンシャルドラッグには, レボノルゲストレルを成分とする薬剤と, ウリプリスタル酢酸エステルを成分とする薬剤が指定されている. いずれの薬剤も, 排卵の阻止もしくは延期により避妊効果を発揮するとされている. また最近改訂されたWHO Guideline on Self-care Interventions for Health and Well-beingでは, 希望する人に処方箋なしでECPが入手可能となるよう勧告されている. 海外の状況をみると, 約90か国・地域において, 処方箋なしでECPが入手可能となっている. 我が国では, 2011年に国内で初めて緊急避妊薬としてノルレボゲストレル0.75mg含有製剤が処方箋医薬品として承認・販売開始され, その後, 2016年に1.5mg含有製剤が承認・販売開始, 2019年にはその後発医薬品が承認・販売開始された. |
| Practice | 薬学 |
| Keywords | Emergency contraceptive pills, pharmacy, pharmacist, pilot sale, OTC switch, pharmaceutical regulations |
English
| Title | Challenges and Prospects of Emergency Contraceptive Pill Regulations in Japan |
|---|---|
| Subtitle | |
| Authors | Miwako KAMEI1,4, Carmen SAITO2, Rie NAKAJIMA3, Masanori NAGATSU4, Eriko KOBAYASHI2 |
| Authors (kana) | |
| Organization | 1Faculty of Pharmaceutical Sciences, Teikyo Heisei University, 2Faculty of Pharmaceutical Sciences, Josai International University, 3School of Pharmacy, Nihon University, 4Japan Pharmaceutical Association |
| Journal | Journal of Drug Interaction Research |
| Volume | 48 |
| Number | 2 |
| Page | 47-55 |
| Year/Month | 2024 / |
| Article | Report |
| Publisher | Research On Drug Interactions |
| Abstract | [Abstract] Emergency contraceptive pills (ECPs) are recognized as essential drugs by the World Health Organization and available without a prescription in around 90 countries and regions worldwide. However, in Japan, they were approved as prescription-only drugs in 2011. To improve access to ECPs, the committee of the Review Conference on Diversion from Medical Use to Guidance Required and General Use at the Ministry of Health, Labor and Welfare began discussing the possibility of making ECPs available as OTC drugs (a so-called OTC switch). Although an OTC switch of ECP was deemed inappropriate in 2017, discussions resumed in 2021, leading to the approval of a pilot sale in select pharmacies meeting certain requirements. The pilot sale started in November 2023, with several surveys conducted to research whether ECPs could be sold appropriately at pharmacies. In this paper, we provide an outline of the challenges and prospects of ECP regulations based on observations from the first two months of the pilot sale, including an overview of other countries' regulations and detailed background information on the discussions surrounding ECPs in Japan. |
| Practice | Pharmaceutical sciences |
| Keywords | Emergency contraceptive pills, pharmacy, pharmacist, pilot sale, OTC switch, pharmaceutical regulations |
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