國際間管制藥品製造管理規範及制度研究

Three major global issues of drug abuse in recent years include the emergency of new psychoactive substances, over prescribing of control substances, and permission of legal use of cannabis in many countries. Iatrogenic addition resulted from inappropriate prescription is increasing, especially for opioid analgesics. The present study will review literature on Extended-release（ER）and Long-acting（LA）Opioid Analgesics Risk Evaluation and Mitigation Strategies (REMS), to analyze the efficacies of the measures employed to reduce the risk of abuse from prescriptional ER/LR opioids analgesics. The study will also compare and contrast the efficacies of other strategies similar to REMS that are implemented in other countries. These strategies may involve the educational programs health care professionals, pharmacy personals, and patients, prescribing guideline or special prescribing requirement, additional requirements for licensing ER/LA opioids, and recent research and development on Abuse-Deterrent Opioids (ADF). We will also search the laws and regulation regarding to planting (opium poppy, cannabis, coca)、pharmaceutical raw materials、manufacture、transportation、storage and authorities, in United Nations, European Union ,United States, Canada, New Zealand, Australia, England, Germany, Netherlands, France, Italy, Sweden, Finland, Japan, Singapore, China, Taiwan and Hong Kong. The advantages and disadvantages of management systems for substance control in various countries will be compared and contrasted. Finally, based on the above findings, feasible and comprehensive recommendations will be summarized in the final report for policy making.