Guidance on the need for contraception related to use of pharmaceuticals: the Japan Agency for Medical Research and Development Study Group for providing information on the proper use of pharmaceuticals in patients with reproductive potential

Nao Suzuki, Yasushi Takai, Masahito Yonemura, Hiromitsu Negoro, Shinya Motonaga, Noriko Fujishiro, Eishin Nakamura, Seido Takae, Saori Yoshida, Koji Uesugi, Takashi Ohira, Aiko Katsura, Michio Fujiwara, Itsuko Horiguchi, Kenjiro Kosaki, Hiroshi Onodera, Hiroyuki Nishiyama

Research output: Contribution to journalArticlepeer-review

Abstract

Background: The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) have published guidelines on the use of cancer treatments in young people of reproductive potential. However, no such guideline is available in Japan. Therefore, this project aimed to gather relevant data and draft a respective guidance paper. Methods: From April 2019 to March 2021, the Study Group for Providing Information on the Proper Use of Pharmaceuticals in Patients with Reproductive Potential at the Japan Agency for Medical Research and Development gathered opinions from experts in reproductive medicine, toxicology, and drug safety measures. The group considered these opinions, the FDA and EMA guidelines, and relevant Japanese guidelines and prepared a guidance paper, which they sent to 19 related organizations for comment. Results: By November 2020, the draft guidance paper was completed and sent to the related organizations, 17 of which provided a total of 156 comments. The study group finalized the guidance paper in March 2021. Conclusions: The “Guidance on the Need for Contraception Related to Use of Pharmaceuticals” (The report of the Study Group for Providing Information on the Proper Use of Pharmaceuticals in Patients with Reproductive Potential, Research on Regulatory Science of Pharmaceuticals and Medical Devices, Japan Agency for Medical Research and Development: JP20mk0101139) is expected to help Japanese healthcare professionals provide fertility-related care and advice to adolescents, and young adults with cancer and their families.

Original languageEnglish
Pages (from-to)829-839
Number of pages11
JournalInternational Journal of Clinical Oncology
Volume27
Issue number5
DOIs
Publication statusPublished - 2022 May

Keywords

  • Adolescent and young adults
  • Anticancer drugs
  • Birth control
  • Dissemination of information
  • Oncofertility
  • Proper use of drugs

ASJC Scopus subject areas

  • Surgery
  • Hematology
  • Oncology

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