Medtronic plc announced the U.S. launch of the Control Workflow, an evidence-based approach for use with the SynchroMed II intrathecal drug delivery system ("Medtronic pain pump") that helps physicians wean patients off oral opioids and treat chronic intractable pain. The Medtronic pain pump provides effective pain relief at a fraction of the oral dose with fewer side effects and has been shown to reduce or eliminate the use of oral opioids.^1-7 Prior to the Control Workflow, a retrospective claims analysis (n=389) found that 51 percent of chronic non-malignant pain patients eliminated the use of oral opioids after one year on the pump.⁵
 
Given the current opioid epidemic and ongoing pain management crisis, there is a need for solutions that effectively address chronic pain. Many people use oral opioids to treat pain; however, there is limited evidence on the effectiveness and benefits of long-term oral opioid therapy.⁸ The Control Workflow in combination with the Medtronic pain pump encourages oral opioid elimination and can be used as an alternative to long-term oral opioid therapy for appropriate patients.
 
"The Control Workflow assists me in identifying appropriate patients who could benefit from targeted drug delivery using the Medtronic pain pump, which is especially important with the current opioid epidemic in the United States," said John A. Hatheway, M.D., owner and provider, Northwest Pain Care, Spokane, Wash. "The workflow is especially helpful for patients who may be on high doses or cannot tolerate systemic opioids, or for those who are not finding pain relief with systemic opioid therapy. By placing the medication at the source of the pain, we can often provide better pain relief with fewer side effects at a fraction of the oral dose."
 
The Control Workflow includes oral opioid weaning considerations that can be tailored to individual patients and assists physicians in identifying patients likely to have positive outcomes with the Medtronic pain pump. It supports oral opioid tapering and drug holidays, allowing for treatment with the lowest effective dose of intrathecal medication, which may improve pain relief compared to a combination of oral and intrathecal treatment.⁶ This evidence-based approach was developed by clinicians and provides comprehensive guidance on therapy initiation, catheter placement, and dosing that could impact successful outcomes with the goal of sustained pain relief and functional improvement.^1,6
 
"There is a significant unmet need in chronic pain and device-delivered options are underutilized for appropriate patients, so we continue to innovate to maximize the value of proven treatments," said Charlie Covert, vice president and general manager of the Targeted Drug Delivery business, part of the Restorative Therapies Group at Medtronic. "We rolled out the Control Workflow to help simplify targeted drug delivery therapy, support oral opioid weaning, and offer more patients an effective alternative for pain relief. This is an important part of our commitment to help address the opioid epidemic and pain management crises. We will continue to partner with stakeholders to provide clinical guidance that helps physicians understand when to consider device-delivered treatments."
 
Many patients take progressively higher doses of oral opioids without improvement in pain control, function, and quality of life.⁸ It is suspected the chronic use of oral opioids may treat end-of-dose withdrawal rather than underlying pain, and patients frequently report that their opioid doses merely "take the edge off" their pain.⁹
 
Using the Control Workflow with the Medtronic pain pump gives some chronic pain patients another option that may prove more effective than other therapies. These patients include those taking high dose oral opioids with low efficacy or those who can't tolerate oral opioids due to the side effects, such as constipation, drowsiness, or changes in cognition.
 
Targeted Drug Delivery, an Alternative to Oral Opioids
Oral opioid misuse is a significant issue, and it's more important than ever for patients suffering from chronic pain to have access to proven alternatives. Targeted drug delivery (TDD) may enable systemic opioid reduction or elimination and may be considered as an alternative to oral treatment for chronic pain.³ In a single-center, retrospective chart review (n=99) of patients with chronic non-malignant pain who agreed to transition from systemic opioids to TDD with the goal of eliminating systemic opioids, 84 percent were able to eliminate opioid therapy within one year.¹¹
 
References
¹ Hamza M, Doleys D, Wells M, et al. Prospective study of 3-year follow-up of low-dose intrathecal opioids in the management of chronic nonmalignant pain. Pain Med. 2012;13(10): 1304-1313.
² Smith TJ, Staats PS, Deer T, et al. Randomized clinical trial of an implantable drug delivery system compared with comprehensive medical management for refractory cancer pain: impact on pain, drug-related toxicity, and survival. Journal of clinical oncology: official journal of the American Society of Clinical Oncology. 2002;20(19):4040-4049.
³ Deer T, Chapple I, Classen A, et al. Intrathecal drug delivery for treatment of chronic low back pain: report from the National Outcomes Registry for Low Back Pain. Pain Med. 2004;5(1): 6-13.
⁴ Atli A, Theodore BR, Turk DC, Loeser JD. Intrathecal opioid therapy for chronic nonmalignant pain: a retrospective cohort study with 3-year follow-up. Pain Med. 2010;11(7):1010-1016.
⁵ Hatheway JA, Caraway D, David G, et al. Oral opioid elimination after implantation of an intrathecal drug delivery system significantly reduced health-care expenditures. Neuromodulation : journal of the International Neuromodulation Society. 2015;18(3):207-213.
⁶ Grider JS, Etscheidt MA, Harned ME, et al. Trialing and maintenance dosing using a low-dose intrathecal opioid method for chronic nonmalignant pain: a prospective 36-month study. Neuromodulation : journal of the International Neuromodulation Society. 2016;19(2):206-219.
⁷ Onofrio BM, Yaksh TL. Long-term pain relief produced by intrathecal morphine infusion in 53 patients. J Neurosurg. 1990;72(2):200-209.
⁸ Chou R, Deyo RA, Devine B, et al. The effectiveness and risks of long-term opioid treatment of chronic pain: evidence report/technology assessment No. 218. AHRQ publication no. 14-E005- EF. Rockville, MD: Agency for Healthcare Research and Quality; 2014.
⁹ Managing Opioid Withdrawal. This Changed My Practice - UBC CCP. https://thischangedmypractice.com/ managing-opioid-withdrawal/. VGH JPPN 3300, 910 W 10th Ave. Vancouver, BC Canada V5Z 1M9.
¹⁰ Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington DC, United States: The National Academies Press; 2011.
¹¹ Caraway D, Walker V, Becker L, Hinnenthal J. Successful Discontinuation of Systemic Opioids After Implantation of an Intrathecal Drug Delivery System. Neuromodulation: journal of the International Neuromodulation Society. 2015;18(6):508-516.