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

Area of Science:

• Pharmacology
• Pain Management
• Real-world Evidence

Background:

• Intrathecal drug delivery systems (IDDS) are used for chronic pain.
• Only three monotherapy drugs are FDA-approved for IDDS: morphine, ziconotide, and baclofen.
• Real-world prescription patterns for IDDS are not well-documented.

Purpose of the Study:

• To analyze real-world prescription patterns of intrathecal (IT) medications used in IDDS.
• To characterize medication usage, including monotherapy vs. combination therapies and on- vs. off-label use.

Main Methods:

• Analysis of a deidentified database of IT drug prescriptions over one year (Feb 2021-Feb 2022).
• Statistical analysis of prescription frequencies, monotherapy vs. combination therapy rates, and on-label vs. off-label medication use.
• Examination of opioid vs. nonopioid formulations.

Main Results:

• Monotherapies comprised 55.0% of 49,917 IT prescriptions.
• Opioid-based medications were prevalent (84.6% of monotherapies), with morphine, hydromorphone, and fentanyl being most common.
• Only 29.3% of prescriptions used FDA-approved medications, and merely 7.9% used FDA-approved concentrations, indicating widespread off-label use.

Conclusions:

• FDA-approved intrathecal formulations represent a minority of prescriptions in real-world practice.
• Significant practice variation exists in IDDS prescribing.
• Off-label use of medications and concentrations is common in IDDS for chronic pain management.