Recent Updates
The Oct. 2009 issue of Anesthesiology published results of research by Medtronic, Inc. in collaboration with several expert pain physicians, to provide additional information about potentially manageable risks for patients receiving intrathecal opioid therapy for non-cancer pain. The research publication is part of a longer-term effort by Medtronic to raise awareness of risks associated with intrathecal opioid therapy and ways to ensure the appropriate use of the therapy.
In 2006, Medtronic communicated with physicians about the potentially manageable risks related to patient mortality with intrathecal opioid therapy and ways in which they could be reduced. The Anesthesiology publication was submitted to ensure that information is available for the medical community, and to help physicians manage this therapy with the ultimate goal of improving patient safety. In addition to physician awareness of the risk, attention to the labeling for the therapy (device and drug) will also help guide the appropriate use of this therapy.
Intrathecal Opioid Therapy Risks
Intrathecal opioid therapy uses an implanted pump to deliver opioid (“narcotic” pain) medication into the fluid-filled space surrounding the spinal cord (intrathecal space). There are risks associated with the use of any opioid pain medication given via any route of administration. Receiving too much opioid medication—through the pump or in combination with oral medications or patches—can cause an overdose and lead to respiratory depression. In rare cases death has occurred.
Data included in the Anesthesiology publication show that patients with non-cancer pain treated with intrathecal opioid therapy experience a higher risk of mortality compared to similar patients treated with other interventional therapies. According to the publication, respiratory depression may be one significant risk factor that increased mortality.
No device malfunctions associated with overinfusion were identified among cases where the devices were available for analysis. The authors concluded that it may be possible to reduce mortality in patients receiving intrathecal opioid therapy for non-cancer pain by raising awareness of the risks among patients and physicians.
Appropriate Use of Intrathecal Opioid Therapy
Intrathecal opioid therapy is an important treatment option for select patients when used appropriately. There are important steps in ensure the safe use of the therapy:
Efforts to Address Patient Safety
Given the importance of intrathecal opioid therapy for chronic pain, a group of several pain management societies are working on developing treatment guidelines for intrathecal opioid therapy. These guidelines will ensure physicians utilizing the therapy understand best medical practice for optimizing therapy and ensuring patient safety.
There are also patient safety initiatives underway by patient organizations focused on chronic pain to encourage the safe use of all opioid therapies.