Real-World Prescription Data for Intrathecal Drug Delivery: A Retrospective Analysis in 32,784 Patients

David Hao; Christopher A Di Capua; Cindy Dumas; Stuart Rosenblum; Rachel Thorne; Sanjeet Narang

doi:10.1016/j.neurom.2024.07.007

Real-World Prescription Data for Intrathecal Drug Delivery: A Retrospective Analysis in 32,784 Patients

Neuromodulation. 2024 Sep 2:S1094-7159(24)00661-5. doi: 10.1016/j.neurom.2024.07.007. Online ahead of print.

Authors

David Hao¹, Christopher A Di Capua², Cindy Dumas³, Stuart Rosenblum⁴, Rachel Thorne³, Sanjeet Narang⁵

Affiliations

¹ Department of Anesthesiology, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA. Electronic address: david.hao@mgh.harvard.edu.
² Department of Anesthesiology, Critical Care, and Pain Medicine, Massachusetts General Hospital, Boston, MA, USA.
³ Advanced Infusion Solutions Healthcare, Dallas, TX, USA.
⁴ Oregon Interventional Pain Consultants, Portland, OR, USA.
⁵ Department of Anesthesiology, Critical Care and Pain Medicine, Beth Israel Deaconess Medical Center, Beth Israel Lahey Health, Boston, MA, USA.

PMID: 39230529
DOI: 10.1016/j.neurom.2024.07.007

Abstract

Objectives: Currently, there are three monotherapy drugs approved by the United States Food and Drug Administration (FDA) for use in intrathecal drug delivery systems (IDDS): morphine, ziconotide, and baclofen. In practice, use includes alternate drugs, drug combinations, and drug concentrations. There is a paucity of real-world data examining prescription patterns for IDDS. Our analysis explores a one-year sample of prescription intrathecal (IT) medications from a large pharmaceutical data base to characterize medication usage in IDDS.

Materials and methods: Data were provided by an accredited pharmacy as a deidentified data base of IT drug prescriptions. Statistical analyses included rates of monotherapy vs combination therapies, frequencies of various IT prescriptions, use of on- vs off-label medications, and opioid vs nonopioid formulations.

Results: Data were extracted from February 1, 2021 to February 14, 2022. No patients were excluded. The initial sample comprised 49,917 individual IT prescriptions for 32,784 patients. Monotherapies constituted 55.0% of all prescriptions (27,475/49,917). Of these, 23,257 prescriptions (84.6%) were opioid based, with the most common medications being morphine (46.5%), hydromorphone (39.4%), and fentanyl (13.5%). Although 29.3% of all prescriptions were for one of the FDA-approved medications, only 7.9% used FDA-approved concentrations; 9865 patients underwent ≥one prescription change in the study period-16.7% of whom were initially prescribed medications that met the approved, on-label indications for the pump before being switched to off-label concentrations or combinations to address clinical needs.

Conclusions: Despite the prevalence of IDDS for managing chronic, intractable pain, minimal data exist on real-world prescription practices. Our study found that FDA-approved IT formulations accounted for the minority of prescriptions, indicating significant practice variation, with off-label prescriptions being common.

Keywords: Food and Drug Administration; pain; prescription practices; targeted intrathecal drug delivery.