Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics

Wilkes, Denise; Orillosa, Susan J.; Hustak, Erik C.; Williams, Courtney; Doulatram, Gulshan; Solanki, Daneshvari R.; García, Eduardo; Huang, Li Yen Mae

doi:10.1093/pm/pnx132

Cited by 6 publications

(7 citation statements)

References 16 publications

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“…There are several studies confirming our finding of significant declines in systemic average daily opioid dose following start of intrathecal drug‐delivery system therapy . Overall, regardless of discontinuation status, our study population's average daily morphine milligram equivalents decreased 55% from 100.4 mg/day over the one‐year baseline period to 44.5 mg/day over the one‐year post‐washout follow‐up.…”

Section: Discussionsupporting

confidence: 81%

“…Conversely, there was an actual increase in average daily dose prior to the start of intrathecal drug-delivery system therapy among patients who continued systemic opioids following intrathecal drug-delivery system therapy. Given the strong correlation between baseline dose levels and systemic opioid discontinuation following intrathecal drug-delivery system therapy, and the variability in dosing patterns and levels observed in our population, it is not surprising that previously reported discontinuation rates are highly variable, ranging from 24% to 100% (4)(5)(6)(7)(8)(9)(10)(11).…”

Section: Discussionmentioning

confidence: 72%

“…It has previously been shown that an intrathecal drug-delivery system can eliminate or reduce the use of systemic opioids among patients with chronic noncancer pain (4)(5)(6)(7)(8)(9)(10)(11). Using commercial health insurance claims data from 2008 to 2011, we examined opioid discontinuation and all-cause healthcare utilization among patients newly implanted with an intrathecal drug-delivery system, finding that 51% of patients had eliminated use of systemic opioids at one year following intrathecal drug-delivery system implantation (9).…”

Section: Introductionmentioning

confidence: 99%

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Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis

Hatheway

Bansal

Ricker

2020

Neuromodulation: Technology at the Neural Interface

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Objective: The study evaluated systemic opioid utilization before and after initiation of intrathecal drug therapy in patients with chronic, noncancer pain, as well as the effect of opioid elimination on payer costs. Methods: This was a retrospective cohort analysis of administrative claims data (2011-2016), evaluating patients using systemic opioids for chronic, noncancer pain, newly implanted with an intrathecal drug-delivery system. Patients were excluded for spasticity, cancer, and device explant. The primary outcome was reduction or discontinuation of systemic morphine milligram equivalents during a 395-day follow-up period. The secondary outcome was total commercial insurer payments. Results: Of 9223 total patients, 631 met selection criteria. From baseline to 395-day follow-up, average daily morphine milligram equivalents decreased in 81.5% of patients, and 43.3% discontinued systemic opioid therapy entirely. Among patients who continued systemic opioids, average daily morphine milligram equivalents decreased in 74.9% of patients. Logistic regression found that morphine milligram equivalents of <50 mg/day prior to initiation of intrathecal drug delivery was associated with two times the odds of discontinuation vs. ≥90 mg/day (odds ratio = 2.08, 95% confidence interval 1.42-3.02, p = 0.001). Mean annual payer costs were reduced 29% for patients who discontinued vs. continued systemic opioids (−$11,115 per patient). Conclusions: A meaningful proportion of patients discontinue or decrease systemic opioid use following initiation of intrathecal drug delivery. Standard of care should include opioid dose tapering prior to intrathecal drug delivery to maximize the probability of systemic opioid discontinuation.

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Section: Discussionsupporting

confidence: 81%

Section: Discussionmentioning

confidence: 72%

Section: Introductionmentioning

confidence: 99%

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Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis

Hatheway

Bansal

Ricker

2020

Neuromodulation: Technology at the Neural Interface

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“…Whereas PACC guidelines outline more traditional and standard dosing practices for TDD, three recent studies of TDD in chronic pain focused on utilization of ultra low-dose intrathecal morphine monotherapy as the sole treatment for nonmalignant pain with emphasis on the weaning and total elimination of all systemic opioids prior to pump implant. Work by Hamza (12) and Grider (13) recently replicated by Wilkes et al (17) indicate the potential for long-term (up to three years) pain management with intrathecal morphine doses of less than 1.0 mg/day in select patients.…”

Section: Discussionmentioning

confidence: 98%

Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry

Schultz¹,

Abd‐Elsayed

Calodney

et al. 2021

Neuromodulation: Technology at the Neural Interface

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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 followup), 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.

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“…The PACC guidelines also review this concept of low opioid dosing for IDD, but further research in the form of randomized control trials is needed (78). While this concept of low-dose IDD is touched on in the PACC guidelines and described in the literature (88,90), there is no current standardized or method of achieving low dosing recommended in the literature.…”

Section: Opioidsmentioning

confidence: 99%

Intrathecal Drug Delivery: Advances and Applications in the Management of Chronic Pain Patient

et al. 2022

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Advances in our understanding of the biology of spinal systems in organizing and defining the content of exteroceptive information upon which higher centers define the state of the organism and its role in the regulation of somatic and automatic output, defining the motor response of the organism, along with the unique biology and spatial organization of this space, have resulted in an increased focus on therapeutics targeted at this extracranial neuraxial space. Intrathecal (IT) drug delivery systems (IDDS) are well-established as an effective therapeutic approach to patients with chronic non-malignant or malignant pain and as a tool for management of patients with severe spasticity and to deliver therapeutics that address a myriad of spinal pathologies. The risk to benefit ratio of IDD makes it a useful interventional approach. While not without risks, this approach has a significant therapeutic safety margin when employed using drugs with a validated safety profile and by skilled practioners. The present review addresses current advances in our understanding of the biology and dynamics of the intrathecal space, therapeutic platforms, novel therapeutics, delivery technology, issues of safety and rational implementation of its therapy, with a particular emphasis upon the management of pain.

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Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics

Cited by 6 publications

References 16 publications

Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis

Systemic Opioid Reduction and Discontinuation Following Implantation of Intrathecal Drug-Delivery Systems for Chronic Pain: A Retrospective Cohort Analysis

Targeted Drug Delivery for Chronic Nonmalignant Pain: Longitudinal Data From the Product Surveillance Registry

Intrathecal Drug Delivery: Advances and Applications in the Management of Chronic Pain Patient

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