Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry. Issue 7 (15th January 2021) - Schultz, David M.
Abstract: Objectives: To assist in assessment of therapy risks and benefits of targeted drug delivery (TDD) for chronic nonmalignant pain using registry data on product performance, adverse events, and elective device replacement. Materials and Methods: The Product Surveillance Registry (PSR) (NCT01524276) is an ongoing prospective, long‐term, multicenter registry enrolling consented patients implanted with an intrathecal drug delivery system. Patients are followed prospectively with participating investigators providing pump and catheter performance data for events related to the device, procedure, and therapy. Event descriptions include patient symptoms and outcomes. Results: Registry data from the 4646 patients (59.7% female) treated with TDD for chronic, nonmalignant pain at 59 registry sites between August 2003 and October 2019, with over 17, 000 patient‐years (4646 patients with 44 months average follow‐up), were analyzed. Registry discontinuation was largely (46.2% of discontinued patients) due to study site closure and patient death; exit due to an adverse or device event was limited to 10.2%. Conclusions: Treating chronic pain with escalating doses of strong systemic opioids often leads to inconsistent pain control, impaired function, untenable side effects, and reduced quality of life and this practice has contributed to the current opioid crisis in the United States. TDD has been an available therapy for these patients for greater than 30 years, and data from this real‐world registry offer supporting evidence to the long‐term safety of this therapy as an alternative to systemic opioids, as well as insights into patient acceptance and satisfaction.