Potential clinical impact of compounded versus noncompounded intrathecal baclofen

To assess the differences between commercial and pharmacy-compounded preparations of baclofen for intrathecal administration.

Random sample.

Pharmacies in the United States advertising compounded intrathecal baclofen preparation.

Not applicable.

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.

Comparison of concentration and density variations.

Twenty-nine ITB samples in concentrations of 2000, 3000, 4000, 5000, and 6000 microg/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.

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.