Pain Medicine 2015; 16: 22 Wiley Periodicals, Inc.
In Response to Dr. Verdolin Dear Editor, I appreciate Dr. Verdolin taking the time to consider our opinions and opine on his thoughts on the very important issue of intrathecal drug delivery. It was an honor to participate in this forum with Dr. Loeser, a world leader in the field, and I think we have left many areas open to opinion and interpretation, and that Dr. Verdolin has stepped through a few of these doors. He points out the work of my friends Dr. Griner, Dr. Hamza, Dr. Witt, and others on the recommendation of using extremely low doses of morphine. This ultra-low dosing or microdosing became a “theory” a few years ago and involves the weaning of all oral opioids, followed by the initiation of very low-dose intrathecal morphine. In this strategy, the weaning of the opioid is theorized to lead to a more responsive central nervous system, and thus a better outcome at low doses. The supporters of this theory believe that this would lead to lower complication rates, less hormonal effects, and lower incidence of granuloma. Unfortunately, there are some major holes in this theory. The first is that the need for an intrathecal device has been questioned in those who could be weaned off all oral opioids. In the severe pain patient, many clinicians find that the weaning of oral opioids is only feasible once an intrathecal device is in place and the pain is under better control. If the patient can be weaned off oral agents, one must question the medical necessity of the device. The second issue is the lack of well-controlled studies comparing very low-dose intrathecal morphine with comprehensive medical management, with higher doses of morphine, or with placebo. The lack of comparative studies makes it very difficult to draw any conclusions regarding efficacy or side effect reduction. Very lowvolume infusions could also lead to drug pooling in the
22
area of the catheter tip because of lack of cerebral spinal spread, which may lead to complications. This also requires future study on safety. Another important issue addressed by Dr. Verdolin is the issue of drug selection. The Polyanalgesic Consensus Conference (PACC) that is referenced in his response covers many of those issues. Some of the most important considerations are the drug choice, which should initially be the Food and Drug Administration (FDA)-labeled drugs morphine and ziconotide. In more than half of patients, these drugs are unsuccessful in creating good efficacy or cause untoward side effects. In those cases, drug admixtures and combinations have been shown to improve outcomes and to reduce the amount of granuloma formation and drug escalation. To accomplish these goals, the use of compounded drugs are necessary, but must be accomplished with the highest of standards and regulations. In many cases, the use of commercially available drugs leads to nonviable solutions that cause difficulties. Because of the risk and benefit of these issues, I would recommend that a patient-centric strategy be developed that weighs what is in the best interest of the patient in every case. I again thank Dr. Verdolin for his keen eye, and focus on some important issues. Dr. Loeser and I do not expect everyone reading this segment to agree on the best practices with our views, but the main goal is to promote an atmosphere of discussion regarding the best results for patient safety and efficacy. TIMOTHY RAY DEER, MD Center for Pain Relief, Inc., Charleston, West Virginia, USA
Copyright of Pain Medicine is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
In Response to Dr. Verdolin Dear Editor, I appreciate Dr. Verdolin taking the time to consider our opinions and opine on his thoughts on the very important issue of intrathecal drug delivery. It was an honor to participate in this forum with Dr. Loeser, a world leader in the field, and I think we have left many areas open to opinion and interpretation, and that Dr. Verdolin has stepped through a few of these doors. He points out the work of my friends Dr. Griner, Dr. Hamza, Dr. Witt, and others on the recommendation of using extremely low doses of morphine. This ultra-low dosing or microdosing became a “theory” a few years ago and involves the weaning of all oral opioids, followed by the initiation of very low-dose intrathecal morphine. In this strategy, the weaning of the opioid is theorized to lead to a more responsive central nervous system, and thus a better outcome at low doses. The supporters of this theory believe that this would lead to lower complication rates, less hormonal effects, and lower incidence of granuloma. Unfortunately, there are some major holes in this theory. The first is that the need for an intrathecal device has been questioned in those who could be weaned off all oral opioids. In the severe pain patient, many clinicians find that the weaning of oral opioids is only feasible once an intrathecal device is in place and the pain is under better control. If the patient can be weaned off oral agents, one must question the medical necessity of the device. The second issue is the lack of well-controlled studies comparing very low-dose intrathecal morphine with comprehensive medical management, with higher doses of morphine, or with placebo. The lack of comparative studies makes it very difficult to draw any conclusions regarding efficacy or side effect reduction. Very lowvolume infusions could also lead to drug pooling in the
22
area of the catheter tip because of lack of cerebral spinal spread, which may lead to complications. This also requires future study on safety. Another important issue addressed by Dr. Verdolin is the issue of drug selection. The Polyanalgesic Consensus Conference (PACC) that is referenced in his response covers many of those issues. Some of the most important considerations are the drug choice, which should initially be the Food and Drug Administration (FDA)-labeled drugs morphine and ziconotide. In more than half of patients, these drugs are unsuccessful in creating good efficacy or cause untoward side effects. In those cases, drug admixtures and combinations have been shown to improve outcomes and to reduce the amount of granuloma formation and drug escalation. To accomplish these goals, the use of compounded drugs are necessary, but must be accomplished with the highest of standards and regulations. In many cases, the use of commercially available drugs leads to nonviable solutions that cause difficulties. Because of the risk and benefit of these issues, I would recommend that a patient-centric strategy be developed that weighs what is in the best interest of the patient in every case. I again thank Dr. Verdolin for his keen eye, and focus on some important issues. Dr. Loeser and I do not expect everyone reading this segment to agree on the best practices with our views, but the main goal is to promote an atmosphere of discussion regarding the best results for patient safety and efficacy. TIMOTHY RAY DEER, MD Center for Pain Relief, Inc., Charleston, West Virginia, USA
Copyright of Pain Medicine is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
