کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
6239777 1609018 2014 8 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
The characteristics and fulfillment of conditional prescription drug approvals in Canada
ترجمه فارسی عنوان
ویژگی ها و انجام تایید داروهای تجویزی مشروط در کانادا
کلمات کلیدی
داروهای تجویزی، کانادا، تصویب قانونی، مقررات،
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی سیاست های بهداشت و سلامت عمومی
چکیده انگلیسی

BackgroundIn order to more quickly approve drugs for rare and serious conditions, many countries have developed approval pathways that require companies to fulfill conditions after marketing. This analysis assessed the use and outcomes of Canada's Notice of Compliance with Conditions (NOC/c) program.MethodsTwo publicly available databases from Health Canada were used to study the characteristics of the drugs approved using a NOC/c. Further, Kaplan-Meier analysis was used to estimate the median time-to-fulfillment for approval conditions.ResultsSeventy NOC/c approvals have been made, most commonly for cancer treatments. The conditions of the approvals were only publicly available for 24 of these approvals (34%). Approval conditions were fulfilled for 29 approvals (41%), remained outstanding for 34 (49%), had been revoked for 7 (10%). The median time to the fulfillment of conditions was about five years (1828 days; 95%CI: 1222-2325).DiscussionCanadians have limited information on why conditional approvals are granted. As drugs are typically marketed for 5 years before conditions are met, better information should be provided to clinicians and patients so they can better understand treatment options. Further, steps to speed the fulfillment of conditions, such as time-limited approvals and the capability to levy financial penalties, should be added to the NOC/c regime.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Health Policy - Volume 116, Issues 2–3, June 2014, Pages 154-161
نویسندگان
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