2015年3月6日讯/生物谷BIOON/--4日,美国食品药品监督管理局(Food and Drug Administration;FDA)公布推出官方第一个移动应用APP,专门为公众提供及时、准确的药物短缺信息。通过该APP可以了解药物供应的情况、解决药品的短缺和断货等问题。
药物短缺意味着病人的医疗需要无法得到满足,也会导致医疗专家们不得不依靠替代药物,这会大大影响效率,也会带来比短缺药物更大的风险。
“FDA明白,医疗专家和药剂师们需要得到关于药物短缺实时的信息以做出准确的治疗判断”,Valerie Jensen,FDA药物评估和研究中心Center for Drug Evaluation and Research(CDER)副总监说到,”该移动应用是一个创新的工具,可以更便捷地为公众提供关于重要药物的短缺信息。"
App用户可以按照药品的通用名或有效成分以及治疗种类检索或者浏览药物。APP也能为FDA判断潜在的药物短缺或者供应问题提供帮助。
FDA开发出药物短缺信息的APP这一举动,是FDA之前提出的"为防止和减缓药物短缺策略性计划"而努力的一部分。
这个APP可以通过iTunes和Google play免费下载,通过搜索FDA药物短缺。
今年来,全球范围内移动医疗行业蓬勃发展,一批具有创新和巨大应用价值的产品获得FDA批准顺利进入市场,为公众健康提供了更多保护方案。同时,为了避免移动医疗应用缺乏监管而存在的潜在风险造成伤害,FDA也已于2013年9月正式公告移动医疗应用(Mobile Medical Application Final Guidance)指导的最终版本,移动医疗在发展上也开始有初步的依循规范,更有助于移动医疗的发展。
2014年,通过FDA 510(k)审核的移动医疗项目类别主要有APP、软件工具、移动医疗设备、移动医疗设备+APP四个类别,互联网医疗创业公司占比例最多,受到FDA的青睐,同时,传统医疗巨头也在该领域快马加鞭,纷纷布局。
2015年1月23 日FDA允许首款移动医疗应用软件上市,它可以让糖尿病患者自动地、安全地与其他实时使用苹果移动器械如苹果手机的人分享来自一种动态血糖监视仪的数据。
Provides public with rapid access to information on drugs in short supply
Today,the U.S. Food and Drug Administration launched the agency’s first mobile application (app) specifically designed to speed public access to valuable information about drug shortages.
The app identifies current drug shortages, resolved shortages and discontinuations of drug products.
Drugs in short supply can delay or deny needed care for patients. Drug shortages may also lead health care professionals to rely on alternative drug
products, which may be less effective or associated with higher risks than the drug in shortage.
“The FDA understands that health care professionals and pharmacists need real-time information about drug shortages to make treatment decisions,” said Valerie Jensen, associate director of the Drug Shortage Staff in the FDA’s Center for Drug Evaluation and Research. “The new mobile app is an innovative tool that will offer easier and faster access to important drug shortage information.”
App users can search or browse by a drug’s generic name or active ingredient, and browse by therapeutic category. The app can also be used to report a suspected drug shortage or supply issue to the FDA.
The agency developed the drug shortages app to improve access to information about drug shortages, as part of the FDA’s efforts outlined in the Strategic Plan for Preventing and Mitigating Drug Shortages.
The app is available for free download via iTunes (for Apple devices) and the Google Play store (for Android devices) by searching “FDA Drug Shortages.”