Potential Clinical Impact of Compounded Versus Noncompounded Intrathecal Baclofen
Presented to the American Academy of Physical Medicine and Rehabilitation, September 26, 2007, Boston, MA.
Abstract
Moberg-Wolff E. Potential clinical impact of compounded versus noncompounded intrathecal baclofen.
Objective
To assess the differences between commercial and pharmacy-compounded preparations of baclofen for intrathecal administration.
Design
Random sample.
Setting
Pharmacies in the United States advertising compounded intrathecal baclofen preparation.
Participants
Not applicable.
Interventions
Intrathecal baclofen (ITB) samples were collected from 1 Food and Drug Administration–approved commercial source and 6 compounding pharmacies. An independent analysis of drug concentration and density was conducted. Information regarding ordering process, manufacturing, packaging, storage, and expiration was collected.
Main Outcome Measure
Comparison of concentration and density variations.
Results
Twenty-nine ITB samples in concentrations of 2000, 3000, 4000, 5000, and 6000μg/mL were analyzed. Over 40% of compounded samples were more than 5% above or below labeled concentration. Twenty-two percent of compounded samples were more than 10% above or below labeled concentration. The only samples with no concentration deviation and consistent drug density were the commercially available, noncompounded products.
Conclusions
Compounding pharmacies have variable practices in the provision of ITB. A high incidence of concentration inaccuracy existed. The use of compounded ITB may result in unintended dose alterations. Variable clinical efficacy, or life-threatening overdose or withdrawal may occur in patients who are sensitive to slight dose fluctuations. Given the variability of these compounded ITB samples, informed consent to use these products and understanding of potential side effects should be reviewed with patients.
Department of Physical Medicine and Rehabilitation, Medical College of Wisconsin, Milwaukee, WI
Reprint requests to Elizabeth Moberg-Wolff, MD, FAAPMR, 999 N 92nd St, Ste 350 CCC, Milwaukee, WI 53201
Medical College of Wisconsin was supported by grant funding from Medtronic Neurologic, Inc, for independent testing of the samples in this study.
No commercial party having a direct financial interest in the results of the research supporting this article has or will confer a benefit on the authors or on any organization with which the authors are associated. Moberg-Wolff discloses involvement with Medtronic Neurologic, Inc as a teaching consultant.
ABSTRACT