Shortage of generic neurologic therapeutics
An escalating threat to patient care
Abstract
Objective:
To assess longitudinal trends in shortages of generic drugs used for neurologic conditions over a 15-year period in the United States.
Methods:
Drug shortage data from the University of Utah Drug Information Service (UUDIS) from 2001 to 2015 were analyzed. Medications were included that were likely to be prescribed by a neurologist to treat a primary neurologic condition or critical for care of a patient with a neurologic condition. Trends in shortage length were assessed using standard descriptive statistics.
Results:
A total of 2,081 shortages were reported by UUDIS and 311 (15%) involved medications for neurologic conditions. After excluding discontinued products, 291 shortages were analyzed. The median number of neurologic drugs in shortage was 21 per month with a median duration of 7.4 months. During the three 5-year periods of 2001–2005, 2006–2010, and 2011–2015, a median of 12.5, 14, and 45 drugs were in shortage, respectively. A maximum of 50 drugs in shortage was reached in December 2012 and December 2014. By the end of the study period, 30 neurologic drugs remained in shortage. In over half of the shortages, manufacturers did not provide a reason for the shortage. When reported, manufacturing delays, followed by supply/demand issues, raw material shortages, regulatory issues, and business decisions were cited.
Conclusions:
Continued drug shortages may compromise the care of patients with neurologic conditions. Manufacturers, together with professional organizations, patient advocacy groups, and the government, need to continue to address this issue, which may escalate with a growing burden of neurologic disease.
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Information & Authors
Information
Published In
Neurology®
Volume 89 • Number 24 • December 12, 2017
Pages: 2431-2437
Copyright
© 2017 American Academy of Neurology.
Publication History
Received: March 31, 2017
Accepted: September 21, 2017
Published online: November 15, 2017
Published in print: December 12, 2017
Authors
Author Contributions
All authors contributed to the gathering of information, data analysis, and writing and editing of this manuscript.
Disclosure
J. Omorodion, R. Algahtani, and M. Zocchi report no disclosures relevant to the manuscript. E. Fox received an honorarium from Roseman University for developing and providing continuing education for pharmacists. The University of Utah Drug Information Service receives some funding from Vizient for providing drug shortage information. J. Pines is a paid advisor and conducts research funded by Abbott Point-of-Care. He is an advisor to Janssen Pharmaceuticals, Boehringer-Ingelheim, and Bristol-Myers Squibb. He is funded by Adeptus Health Inc., the NIH, and the Robert Wood Johnson Foundation. H. Kaminski serves on the editorial board of Experimental Neurology. He is co-editor of Neuromuscular Disorders in Clinical Practice and Myasthenia Gravis and Related Disorders. He serves on data and safety monitoring committees for Novartis and NeuroNext with monetary compensation. He provides consulting services for Alnylam, UCB, RA Pharmaceuticals, and Momenta Therapeutics. He is funded by an NIH grant, the Muscular Dystrophy Association, and Neumann Professorship. Dr. Kaminski has patent US 8,961,981 issued. Go to Neurology.org for full disclosures.
Study Funding
There was no sponsorship for this study, though there was institutional financial support from the George Washington University METEOR (Mentored Experience to Expand Opportunities in Research) Program.
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