A problem of inhaled drug substitutions: an analysis of data from Russian database on adverse events
https://doi.org/10.18093/0869-0189-2018-28-4-424-429
Abstract
The aim of this study was to analyze the possibility of inhaled drug substitutions.
Methods. The authors analyzed spontaneous reports from the Federal database of adverse events associated with switching a patient from the reference ipratropium bromide/fenoterol combination to a generic one.
Results. The drug substitution within one INN was reported in 15% of all reports about adverse events related to prescription of this INN. A great deal of these reports was related to drug substitution in elderly. Generally, the reference drug was well tolerated, but its substitution to a generic drug resulted in lower efficacy (18.8%) or development of adverse events, mostly respiratory (51.8% of all adverse events).
Conclusion. The inhaled drug substitution could be associated with a potential risk of adverse events or lower efficacy. The substitution of inhaled drugs within one INN should be made with caution.
About the Authors
Sergey K. Zyryanov
The Peoples' Friendship University of Russia
City Teaching Hospital No.24, Moscow Healthcare Department
Russian Federation
Russian Federation
Doctor of Medicine, Professor, Head of Department of General and Clinical Pharmacology, The Peoples' Friendship University of Russia; Deputy Director for Therapy, City Teaching Hospital No.24, Moscow Healthcare Department
tel.: (495) 787-38-03
ul. Miklukho-Maklaya 6, Moscow, 117198, Russia
ul. Pistsovaya 10, Moscow, 127015, Russia
Karina E. Zatolochina
The Peoples' Friendship University of Russia
Russian Federation
Russian Federation
Candidate of Medicine, Assistant Lecturer, Department of General and Clinical Pharmacology, The Peoples' Friendship University of Russia
tel.: (926) 280-03-79
ul. Miklukho-Maklaya 6, Moscow, 117198, Russia
Irina L. Asetskaya
The Peoples' Friendship University of Russia
Federal Informational and Methodological Center for Expertise, Control and Analysis of Medical Products Circulation
Russian Federation
Russian Federation
Candidate of Medicine, Assistant Professor, Associate Professor, Department of General and Clinical Pharmacology, The Peoples' Friendship University of Russia; Leading Specialist, Center for Monitoring Efficacious, Safe and Rational Use of Medical Products, Federal Informational and Methodological Center for Expertise, Control and Analysis of Medical Products Circulation
tel.: (495) 787-38-03
ul. Miklukho-Maklaya 6, Moscow, 117198, Russia
Slavyanskaya ploshchad’ 4, build. 1, Moskva, 109074, Russia
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Review
For citations:
Zyryanov S.K., Zatolochina K.E., Asetskaya I.L. A problem of inhaled drug substitutions: an analysis of data from Russian database on adverse events. PULMONOLOGIYA. 2018;28(4):424-429. (In Russ.) https://doi.org/10.18093/0869-0189-2018-28-4-424-429
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