Spinal stimulator devices becoming more versatile

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LAKE BUENA VISTA, FLA. – Innovation in the design of spinal cord stimulators for control of chronic pain syndromes includes wireless devices to eliminate surgical implantation of the battery and devices with high frequency conduction to reduce paresthesias, according to an update at the Pain Care for Primary Care meeting.

“Paresthesias have been poorly tolerated by some patients, but this effect was not observed in a trial with high frequency stimulation,” explained Paul J. Cristo, MD, of the department of anesthesiology and critical care medicine, Johns Hopkins University, Baltimore.

 

Dr. Paul Cristo

Spinal cord stimulation for chronic pain control is not a new concept. The first device received Food and Drug Administration approval in 1989. Typically, these devices involve implantation of electrodes in the epidural space to deliver a low level of electricity that for many, but not all, individuals alleviates pain. With traditional devices, a battery and programmable generator is implanted in the buttock or abdomen to supply impulses.

Innovations since their introduction have included incremental reductions in the size of the generator and battery, facilitating implantation, and batteries that function longer or can be recharged. Some batteries now deliver stimulation for 10 or more years before they must be surgically replaced. In addition, several manufacturers now market devices that do not interfere with MRI.

The mechanism by which these devices relieve pain remains incompletely understood, according to Dr. Cristo. He cited animal studies that support several mechanisms, such as stimulation of A alpha and A beta afferent fibers to interrupt pain signals and release of serotonin and norepinephrine to inhibit pain transmission.

High-frequency stimulation

Up until last year, all devices provided neurostimulation through low frequency pulses. One of the major adverse effects has been a tingling sensation that some patients tolerate poorly. The first device to deliver high frequency pulses was approved by the FDA last year. According to Dr. Cristo, the advantage of high frequency energy is that it eliminates the risk of paresthesias.

In the registration trial with the high frequency device, which is now marketed under the name Senza by the Nevro Company, 198 chronic pain patients were randomized to an experimental or traditional device (Anesthesiology. 2015 Oct;123[4]:851-60). With the novel device, the spinal cord stimulation was delivered at a frequency of 10 kHz. Conventional spinal stimulators operate at frequencies of less than 100 Hz.

At 3 months, the proportion of patients classified as responders was greater for both back pain (84.5% vs. 43.8%) and leg pain (83.1% vs. 55.5%) when the novel and traditional devices were compared, but paresthesias, which were commonly reported on the traditional device, were not reported at all with the high frequency device.

Wireless stimulators

Wireless spinal stimulators are another relatively recent innovation with the potential to expand the proportion of chronic pain patients who may benefit from these devices. The first such device, marketed by Stimwave under the brand name Freedom SCS System, with a sister device for peripheral nerve stimulation called the StimQ PNS System, still requires implantation of a wire to deliver electrical stimulation, but the power source is external.

“The patient wears a belt that is equipped with a wireless programming device,” Dr. Cristo explained. He suggested that some may find the belt cumbersome, but a less invasive procedure is particularly attractive for patients with multiple comorbidities that make them poor candidates for device implantation.

Candidates for spinal cord stimulation are typically offered a trial to gauge response and tolerability before the device is implanted, according to Dr. Cristo. He said that pain relief of 50% or greater is generally considered a criterion for long-term benefit, but clinicians should also consider favorable effects on other outcomes, such as quality of sleep or mood.

“For some patients who do not respond to first-line options, spinal cord stimulation can substantially reduce pain levels,” Dr. Cristo said. “I use these in my own practice most commonly for failed back pain syndrome, pelvic pain, and complex regional pain syndromes.”

Although spinal cord stimulation is not first-line, Dr. Cristo also cautioned that success appears to be better when this treatment is initiated within a reasonable time frame after chronic pain has been diagnosed.

“Specifically, there is an 85% success rate if the pain has been diagnosed within 2 years. If we wait more than 15 years after the chronic pain has been diagnosed, the success rate drops to 8%,” reported Dr. Cristo, citing a published analysis.

For primary care physicians with chronic pain patients, Dr. Cristo said, “I think they should be aware of this option, because it can be effective, but they should also be aware of the time frame in which it is most likely to offer relief.”

 

 

Dr. Cristo reports financial relationships with Algiarty, Grünenthal, Quest Diagnostics, and Recro Pharma. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

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LAKE BUENA VISTA, FLA. – Innovation in the design of spinal cord stimulators for control of chronic pain syndromes includes wireless devices to eliminate surgical implantation of the battery and devices with high frequency conduction to reduce paresthesias, according to an update at the Pain Care for Primary Care meeting.

“Paresthesias have been poorly tolerated by some patients, but this effect was not observed in a trial with high frequency stimulation,” explained Paul J. Cristo, MD, of the department of anesthesiology and critical care medicine, Johns Hopkins University, Baltimore.

 

Dr. Paul Cristo

Spinal cord stimulation for chronic pain control is not a new concept. The first device received Food and Drug Administration approval in 1989. Typically, these devices involve implantation of electrodes in the epidural space to deliver a low level of electricity that for many, but not all, individuals alleviates pain. With traditional devices, a battery and programmable generator is implanted in the buttock or abdomen to supply impulses.

Innovations since their introduction have included incremental reductions in the size of the generator and battery, facilitating implantation, and batteries that function longer or can be recharged. Some batteries now deliver stimulation for 10 or more years before they must be surgically replaced. In addition, several manufacturers now market devices that do not interfere with MRI.

The mechanism by which these devices relieve pain remains incompletely understood, according to Dr. Cristo. He cited animal studies that support several mechanisms, such as stimulation of A alpha and A beta afferent fibers to interrupt pain signals and release of serotonin and norepinephrine to inhibit pain transmission.

High-frequency stimulation

Up until last year, all devices provided neurostimulation through low frequency pulses. One of the major adverse effects has been a tingling sensation that some patients tolerate poorly. The first device to deliver high frequency pulses was approved by the FDA last year. According to Dr. Cristo, the advantage of high frequency energy is that it eliminates the risk of paresthesias.

In the registration trial with the high frequency device, which is now marketed under the name Senza by the Nevro Company, 198 chronic pain patients were randomized to an experimental or traditional device (Anesthesiology. 2015 Oct;123[4]:851-60). With the novel device, the spinal cord stimulation was delivered at a frequency of 10 kHz. Conventional spinal stimulators operate at frequencies of less than 100 Hz.

At 3 months, the proportion of patients classified as responders was greater for both back pain (84.5% vs. 43.8%) and leg pain (83.1% vs. 55.5%) when the novel and traditional devices were compared, but paresthesias, which were commonly reported on the traditional device, were not reported at all with the high frequency device.

Wireless stimulators

Wireless spinal stimulators are another relatively recent innovation with the potential to expand the proportion of chronic pain patients who may benefit from these devices. The first such device, marketed by Stimwave under the brand name Freedom SCS System, with a sister device for peripheral nerve stimulation called the StimQ PNS System, still requires implantation of a wire to deliver electrical stimulation, but the power source is external.

“The patient wears a belt that is equipped with a wireless programming device,” Dr. Cristo explained. He suggested that some may find the belt cumbersome, but a less invasive procedure is particularly attractive for patients with multiple comorbidities that make them poor candidates for device implantation.

Candidates for spinal cord stimulation are typically offered a trial to gauge response and tolerability before the device is implanted, according to Dr. Cristo. He said that pain relief of 50% or greater is generally considered a criterion for long-term benefit, but clinicians should also consider favorable effects on other outcomes, such as quality of sleep or mood.

“For some patients who do not respond to first-line options, spinal cord stimulation can substantially reduce pain levels,” Dr. Cristo said. “I use these in my own practice most commonly for failed back pain syndrome, pelvic pain, and complex regional pain syndromes.”

Although spinal cord stimulation is not first-line, Dr. Cristo also cautioned that success appears to be better when this treatment is initiated within a reasonable time frame after chronic pain has been diagnosed.

“Specifically, there is an 85% success rate if the pain has been diagnosed within 2 years. If we wait more than 15 years after the chronic pain has been diagnosed, the success rate drops to 8%,” reported Dr. Cristo, citing a published analysis.

For primary care physicians with chronic pain patients, Dr. Cristo said, “I think they should be aware of this option, because it can be effective, but they should also be aware of the time frame in which it is most likely to offer relief.”

 

 

Dr. Cristo reports financial relationships with Algiarty, Grünenthal, Quest Diagnostics, and Recro Pharma. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

LAKE BUENA VISTA, FLA. – Innovation in the design of spinal cord stimulators for control of chronic pain syndromes includes wireless devices to eliminate surgical implantation of the battery and devices with high frequency conduction to reduce paresthesias, according to an update at the Pain Care for Primary Care meeting.

“Paresthesias have been poorly tolerated by some patients, but this effect was not observed in a trial with high frequency stimulation,” explained Paul J. Cristo, MD, of the department of anesthesiology and critical care medicine, Johns Hopkins University, Baltimore.

 

Dr. Paul Cristo

Spinal cord stimulation for chronic pain control is not a new concept. The first device received Food and Drug Administration approval in 1989. Typically, these devices involve implantation of electrodes in the epidural space to deliver a low level of electricity that for many, but not all, individuals alleviates pain. With traditional devices, a battery and programmable generator is implanted in the buttock or abdomen to supply impulses.

Innovations since their introduction have included incremental reductions in the size of the generator and battery, facilitating implantation, and batteries that function longer or can be recharged. Some batteries now deliver stimulation for 10 or more years before they must be surgically replaced. In addition, several manufacturers now market devices that do not interfere with MRI.

The mechanism by which these devices relieve pain remains incompletely understood, according to Dr. Cristo. He cited animal studies that support several mechanisms, such as stimulation of A alpha and A beta afferent fibers to interrupt pain signals and release of serotonin and norepinephrine to inhibit pain transmission.

High-frequency stimulation

Up until last year, all devices provided neurostimulation through low frequency pulses. One of the major adverse effects has been a tingling sensation that some patients tolerate poorly. The first device to deliver high frequency pulses was approved by the FDA last year. According to Dr. Cristo, the advantage of high frequency energy is that it eliminates the risk of paresthesias.

In the registration trial with the high frequency device, which is now marketed under the name Senza by the Nevro Company, 198 chronic pain patients were randomized to an experimental or traditional device (Anesthesiology. 2015 Oct;123[4]:851-60). With the novel device, the spinal cord stimulation was delivered at a frequency of 10 kHz. Conventional spinal stimulators operate at frequencies of less than 100 Hz.

At 3 months, the proportion of patients classified as responders was greater for both back pain (84.5% vs. 43.8%) and leg pain (83.1% vs. 55.5%) when the novel and traditional devices were compared, but paresthesias, which were commonly reported on the traditional device, were not reported at all with the high frequency device.

Wireless stimulators

Wireless spinal stimulators are another relatively recent innovation with the potential to expand the proportion of chronic pain patients who may benefit from these devices. The first such device, marketed by Stimwave under the brand name Freedom SCS System, with a sister device for peripheral nerve stimulation called the StimQ PNS System, still requires implantation of a wire to deliver electrical stimulation, but the power source is external.

“The patient wears a belt that is equipped with a wireless programming device,” Dr. Cristo explained. He suggested that some may find the belt cumbersome, but a less invasive procedure is particularly attractive for patients with multiple comorbidities that make them poor candidates for device implantation.

Candidates for spinal cord stimulation are typically offered a trial to gauge response and tolerability before the device is implanted, according to Dr. Cristo. He said that pain relief of 50% or greater is generally considered a criterion for long-term benefit, but clinicians should also consider favorable effects on other outcomes, such as quality of sleep or mood.

“For some patients who do not respond to first-line options, spinal cord stimulation can substantially reduce pain levels,” Dr. Cristo said. “I use these in my own practice most commonly for failed back pain syndrome, pelvic pain, and complex regional pain syndromes.”

Although spinal cord stimulation is not first-line, Dr. Cristo also cautioned that success appears to be better when this treatment is initiated within a reasonable time frame after chronic pain has been diagnosed.

“Specifically, there is an 85% success rate if the pain has been diagnosed within 2 years. If we wait more than 15 years after the chronic pain has been diagnosed, the success rate drops to 8%,” reported Dr. Cristo, citing a published analysis.

For primary care physicians with chronic pain patients, Dr. Cristo said, “I think they should be aware of this option, because it can be effective, but they should also be aware of the time frame in which it is most likely to offer relief.”

 

 

Dr. Cristo reports financial relationships with Algiarty, Grünenthal, Quest Diagnostics, and Recro Pharma. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

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EXPERT ANALYSIS FROM PAIN CARE FOR PRIMARY CARE

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Core curriculum for opioid prescribing preempts certification

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LAKE BUENA VISTA, FLA. – If the Food and Drug Administration moves to require some form of certification to prescribe opioids, an educational program based on the FDA’s own risk evaluation and mitigation strategy (REMS) report of 2012 is already in place to fulfill that purpose, according to a pain specialist who explained the principles of this program at Pain Care for Primary Care.

Some form of certification process for opioid prescribing has been discussed for many years, explained David E. J. Bazzo, MD, clinical professor of family medicine at the University of California, San Diego, but “there has been renewed interest as a result of the continuing public health crisis regarding opioid overdoses.”

 

Dr. David Bazzo

The core curriculum provided by the Collaborative for REMS Education (CO*RE) curriculum is based on clinical competencies to meet the requirements of the FDA REMS blueprint, which was issued in July 2012. The focus of REMS is on opioids with an extended-release (ER) or long-acting (LA) formulation. It is not the only such program available, but Dr. Bazzo noted that CO*RE was actually initiated in 2010 and provided some of the basis for the FDA REMS that followed 2 years later.

The CO*RE program, which can be completed at no cost, is available online. Those who complete the program are provided with a completer certificate, which Dr. Bazzo expects to be honored by the FDA if it does decide to require proof of competency. The program involves the participation of 13 organizations, such as the American Pain Society (APS), the American Society of Addiction Medicine (ASAM), and the American College of Emergency Physicians (ACEP).

There is a substantial possibility that the FDA will move to require competency for opioid prescribers. At a recent joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee in which modifications in the REMS were discussed, the majority of those on both advisory committees endorsed mandatory training.

“Why is education so important? It is because we are in a super tough position,” Dr. Bazzo explained. He suggested that physicians need effective agents for controlling pain, but the mortality and morbidity associated with opioids has steadily increased despite the FDA REMS.

“Deaths due to drug abuse or poisoning are just the beginning. For every death, there are 10 treatment admissions for abuse, and 130 people who are addicted,” said Dr. Bazzo, citing data from the Centers for Disease Control and Prevention (CDC).

In addition to an introduction, which outlines the goals of appropriate opioid prescribing, the CO*RE curriculum consists of six units. The first focuses on assessing candidates for opioid therapy, which includes instructions on history taking and documenting the findings. Tools for assessing risks posed by opioids, particularly for abuse, are also outlined.

The second unit describes best practices for initiating therapy, modifying doses, and discontinuing opioids, the third unit provides information on monitoring adherence and aberrant behavior in patients, and the fourth unit provides information about how to counsel patients about what constitutes appropriate use of opioids and the risks of inappropriate use. The fifth unit is largely an overview of key information in the previous four units and the sixth unit outlines the specific features of currently available opioids.

“The bottom line for the program overall is learning how to balance risks and benefits,” Dr. Bazzo explained. He suggested that many clinicians do not fully grasp that opioids are not stand-alone medications but a tool within a more comprehensive strategy for improving function.

“When we give analgesics for chronic pain, the goal is not to eliminate pain. If this is your goal, you will fail 99.9999% of the time. The goal is to improve function,” Dr. Bazzo said. He characterized treatment of chronic pain “as a team sport” that involves a collaboration between specialists and patients to achieve specific endpoints.

“It is a little like treating hypertension. You adjust medications until you get to the goal,” Dr. Bazzo said. This involves defining the goal before the treatment is initiated and then documenting progress toward that goal to guide treatment strategies.

The CO*RE REMS program is consistent with the CDC Guideline for Prescribing Opioids for Chronic Pain (MMWR. 65[1];1–49). It is part of a nationwide effort to reduce deaths related to opioid use.

“The problems with opioids can be greatly reduced if clinicians recognize and adhere to best practices,” Dr. Bazzo maintained.

Dr. Bazzo reports no potential financial conflicts of interest. The meeting was held by the APS and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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LAKE BUENA VISTA, FLA. – If the Food and Drug Administration moves to require some form of certification to prescribe opioids, an educational program based on the FDA’s own risk evaluation and mitigation strategy (REMS) report of 2012 is already in place to fulfill that purpose, according to a pain specialist who explained the principles of this program at Pain Care for Primary Care.

Some form of certification process for opioid prescribing has been discussed for many years, explained David E. J. Bazzo, MD, clinical professor of family medicine at the University of California, San Diego, but “there has been renewed interest as a result of the continuing public health crisis regarding opioid overdoses.”

 

Dr. David Bazzo

The core curriculum provided by the Collaborative for REMS Education (CO*RE) curriculum is based on clinical competencies to meet the requirements of the FDA REMS blueprint, which was issued in July 2012. The focus of REMS is on opioids with an extended-release (ER) or long-acting (LA) formulation. It is not the only such program available, but Dr. Bazzo noted that CO*RE was actually initiated in 2010 and provided some of the basis for the FDA REMS that followed 2 years later.

The CO*RE program, which can be completed at no cost, is available online. Those who complete the program are provided with a completer certificate, which Dr. Bazzo expects to be honored by the FDA if it does decide to require proof of competency. The program involves the participation of 13 organizations, such as the American Pain Society (APS), the American Society of Addiction Medicine (ASAM), and the American College of Emergency Physicians (ACEP).

There is a substantial possibility that the FDA will move to require competency for opioid prescribers. At a recent joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee in which modifications in the REMS were discussed, the majority of those on both advisory committees endorsed mandatory training.

“Why is education so important? It is because we are in a super tough position,” Dr. Bazzo explained. He suggested that physicians need effective agents for controlling pain, but the mortality and morbidity associated with opioids has steadily increased despite the FDA REMS.

“Deaths due to drug abuse or poisoning are just the beginning. For every death, there are 10 treatment admissions for abuse, and 130 people who are addicted,” said Dr. Bazzo, citing data from the Centers for Disease Control and Prevention (CDC).

In addition to an introduction, which outlines the goals of appropriate opioid prescribing, the CO*RE curriculum consists of six units. The first focuses on assessing candidates for opioid therapy, which includes instructions on history taking and documenting the findings. Tools for assessing risks posed by opioids, particularly for abuse, are also outlined.

The second unit describes best practices for initiating therapy, modifying doses, and discontinuing opioids, the third unit provides information on monitoring adherence and aberrant behavior in patients, and the fourth unit provides information about how to counsel patients about what constitutes appropriate use of opioids and the risks of inappropriate use. The fifth unit is largely an overview of key information in the previous four units and the sixth unit outlines the specific features of currently available opioids.

“The bottom line for the program overall is learning how to balance risks and benefits,” Dr. Bazzo explained. He suggested that many clinicians do not fully grasp that opioids are not stand-alone medications but a tool within a more comprehensive strategy for improving function.

“When we give analgesics for chronic pain, the goal is not to eliminate pain. If this is your goal, you will fail 99.9999% of the time. The goal is to improve function,” Dr. Bazzo said. He characterized treatment of chronic pain “as a team sport” that involves a collaboration between specialists and patients to achieve specific endpoints.

“It is a little like treating hypertension. You adjust medications until you get to the goal,” Dr. Bazzo said. This involves defining the goal before the treatment is initiated and then documenting progress toward that goal to guide treatment strategies.

The CO*RE REMS program is consistent with the CDC Guideline for Prescribing Opioids for Chronic Pain (MMWR. 65[1];1–49). It is part of a nationwide effort to reduce deaths related to opioid use.

“The problems with opioids can be greatly reduced if clinicians recognize and adhere to best practices,” Dr. Bazzo maintained.

Dr. Bazzo reports no potential financial conflicts of interest. The meeting was held by the APS and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

LAKE BUENA VISTA, FLA. – If the Food and Drug Administration moves to require some form of certification to prescribe opioids, an educational program based on the FDA’s own risk evaluation and mitigation strategy (REMS) report of 2012 is already in place to fulfill that purpose, according to a pain specialist who explained the principles of this program at Pain Care for Primary Care.

Some form of certification process for opioid prescribing has been discussed for many years, explained David E. J. Bazzo, MD, clinical professor of family medicine at the University of California, San Diego, but “there has been renewed interest as a result of the continuing public health crisis regarding opioid overdoses.”

 

Dr. David Bazzo

The core curriculum provided by the Collaborative for REMS Education (CO*RE) curriculum is based on clinical competencies to meet the requirements of the FDA REMS blueprint, which was issued in July 2012. The focus of REMS is on opioids with an extended-release (ER) or long-acting (LA) formulation. It is not the only such program available, but Dr. Bazzo noted that CO*RE was actually initiated in 2010 and provided some of the basis for the FDA REMS that followed 2 years later.

The CO*RE program, which can be completed at no cost, is available online. Those who complete the program are provided with a completer certificate, which Dr. Bazzo expects to be honored by the FDA if it does decide to require proof of competency. The program involves the participation of 13 organizations, such as the American Pain Society (APS), the American Society of Addiction Medicine (ASAM), and the American College of Emergency Physicians (ACEP).

There is a substantial possibility that the FDA will move to require competency for opioid prescribers. At a recent joint meeting of the FDA’s Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee in which modifications in the REMS were discussed, the majority of those on both advisory committees endorsed mandatory training.

“Why is education so important? It is because we are in a super tough position,” Dr. Bazzo explained. He suggested that physicians need effective agents for controlling pain, but the mortality and morbidity associated with opioids has steadily increased despite the FDA REMS.

“Deaths due to drug abuse or poisoning are just the beginning. For every death, there are 10 treatment admissions for abuse, and 130 people who are addicted,” said Dr. Bazzo, citing data from the Centers for Disease Control and Prevention (CDC).

In addition to an introduction, which outlines the goals of appropriate opioid prescribing, the CO*RE curriculum consists of six units. The first focuses on assessing candidates for opioid therapy, which includes instructions on history taking and documenting the findings. Tools for assessing risks posed by opioids, particularly for abuse, are also outlined.

The second unit describes best practices for initiating therapy, modifying doses, and discontinuing opioids, the third unit provides information on monitoring adherence and aberrant behavior in patients, and the fourth unit provides information about how to counsel patients about what constitutes appropriate use of opioids and the risks of inappropriate use. The fifth unit is largely an overview of key information in the previous four units and the sixth unit outlines the specific features of currently available opioids.

“The bottom line for the program overall is learning how to balance risks and benefits,” Dr. Bazzo explained. He suggested that many clinicians do not fully grasp that opioids are not stand-alone medications but a tool within a more comprehensive strategy for improving function.

“When we give analgesics for chronic pain, the goal is not to eliminate pain. If this is your goal, you will fail 99.9999% of the time. The goal is to improve function,” Dr. Bazzo said. He characterized treatment of chronic pain “as a team sport” that involves a collaboration between specialists and patients to achieve specific endpoints.

“It is a little like treating hypertension. You adjust medications until you get to the goal,” Dr. Bazzo said. This involves defining the goal before the treatment is initiated and then documenting progress toward that goal to guide treatment strategies.

The CO*RE REMS program is consistent with the CDC Guideline for Prescribing Opioids for Chronic Pain (MMWR. 65[1];1–49). It is part of a nationwide effort to reduce deaths related to opioid use.

“The problems with opioids can be greatly reduced if clinicians recognize and adhere to best practices,” Dr. Bazzo maintained.

Dr. Bazzo reports no potential financial conflicts of interest. The meeting was held by the APS and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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EXPERT ANALYSIS FROM PAIN CARE FOR PRIMARY CARE

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For Neuropathic Pain, Marijuana Yields Modest Benefits

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LAKE BUENA VISTA, FLA. – As medical marijuana penetrates mainstream medical practice in the United States and elsewhere, awareness of the potential benefits, potential risks, and local laws governing its use for treatment of chronic pain gain importance, according to a specialist reviewing available data at Pain Care for Primary Care.

For many specific types of chronic pain, more data are needed to judge the benefit-to-risk ratio of marijuana relative to other options, but there are reasonable data suggesting both acceptable safety and meaningful efficacy of this analgesic in neuropathic pain, according to Mark A. Ware, MBBS, associate professor in the departments of anesthesia and family medicine, McGill University, Montreal.

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

In neuropathic pain, the evidence includes at least five randomized trials, according to Dr. Ware. In a recently published review article for which Dr. Ware served as senior author, the degree of neuropathic pain reductions were characterized as being on an order similar to those achieved with opioids and anticonvulsants (J Pain. 2016 Jun;17[6]:654-68). In one study, the number needed to treat (NNT) for a 50% pain reduction was just 2.

In Canada, marijuana is now available for at least some medical uses in every province. In the United States, 23 states have passed laws permitting clinical use of marijuana, according to Dr. Ware. He suggested that legalization of marijuana has fueled a growing acceptance of marijuana as a treatment option whether or not it is prescribed. For this reason, it’s necessary to examine the objective evidence to provide appropriate counseling.

“I think we are past the point where this option can simply be ignored,” Dr. Ware said. Even if they do not intend to prescribe marijuana for chronic pain, “clinicians should become familiar with the evidence regarding benefit and safety as well as the laws regarding its use.” In a study of long-term safety led by Dr. Ware, a standardized cannabis product containing 12.5% tetrahydrocannabinol was dispensed to 215 current or prior users of marijuana with a non-cancer chronic pain syndrome (J Pain. 2015 Dec;16[12]:1233-42). Followed for 1 year, adverse events in this group were compared with 216 control patients who also had chronic pain but were not using cannabis.

The odds ratio (OR) of non-serious adverse events in the categories of respiratory disorders (OR, 1.77) infectious disorders (OR, 1.51), nervous system disorders (OR, 1.77), and psychiatric disorders (OR, 2.74) were all significantly higher in the group treated with cannabis, but almost all were judged to be of mild to moderate severity. There was no significant difference in the risk of serious AEs. Dr. Ware also reported there was no difference between the cannabis group and controls for neurocognitive testing at baseline, 6 months, or the end of 1 year.

Pain control was also monitored over the course of the study. According to Dr. Ware, average pain scores in the cannabis group fell modestly but consistently over the course of the study. Over the same period, the pain scores rose slightly in the control group.

There is a long list of unanswered questions regarding effective use of marijuana in the control of chronic pain, he said. For example, Dr. Ware noted that the optimal composition of cannabinoids has yet to be determined. He noted that more than one of the complex constituents may contribute to pain control, and these constituents are not necessarily the same as those most favored by recreational users seeking a euphoric “high.”

There is also a long list of unanswered questions about safety. Dr. Ware reviewed some evidence that inhaled vaporized marijuana may be safer than traditional smoked marijuana due to a reduced exposure to toxins, but he suggested more rigorous studies are needed to generate objective data that can better quantify the benefit-to-risk of this and other methods of marijuana delivery.

Despite unanswered questions, marijuana is widely available and likely to be considered by patients for chronic pain whether or not it is recommended by physicians. It is for this reason that clinicians need to become familiar with both its potential risks and benefits.

“It will be helpful to patients if you can provide them practical and accurate information about what is and is not known about this treatment,” Dr. Ware suggested.

Dr. Ware reported a financial relationship with CanniMed. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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LAKE BUENA VISTA, FLA. – As medical marijuana penetrates mainstream medical practice in the United States and elsewhere, awareness of the potential benefits, potential risks, and local laws governing its use for treatment of chronic pain gain importance, according to a specialist reviewing available data at Pain Care for Primary Care.

For many specific types of chronic pain, more data are needed to judge the benefit-to-risk ratio of marijuana relative to other options, but there are reasonable data suggesting both acceptable safety and meaningful efficacy of this analgesic in neuropathic pain, according to Mark A. Ware, MBBS, associate professor in the departments of anesthesia and family medicine, McGill University, Montreal.

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

In neuropathic pain, the evidence includes at least five randomized trials, according to Dr. Ware. In a recently published review article for which Dr. Ware served as senior author, the degree of neuropathic pain reductions were characterized as being on an order similar to those achieved with opioids and anticonvulsants (J Pain. 2016 Jun;17[6]:654-68). In one study, the number needed to treat (NNT) for a 50% pain reduction was just 2.

In Canada, marijuana is now available for at least some medical uses in every province. In the United States, 23 states have passed laws permitting clinical use of marijuana, according to Dr. Ware. He suggested that legalization of marijuana has fueled a growing acceptance of marijuana as a treatment option whether or not it is prescribed. For this reason, it’s necessary to examine the objective evidence to provide appropriate counseling.

“I think we are past the point where this option can simply be ignored,” Dr. Ware said. Even if they do not intend to prescribe marijuana for chronic pain, “clinicians should become familiar with the evidence regarding benefit and safety as well as the laws regarding its use.” In a study of long-term safety led by Dr. Ware, a standardized cannabis product containing 12.5% tetrahydrocannabinol was dispensed to 215 current or prior users of marijuana with a non-cancer chronic pain syndrome (J Pain. 2015 Dec;16[12]:1233-42). Followed for 1 year, adverse events in this group were compared with 216 control patients who also had chronic pain but were not using cannabis.

The odds ratio (OR) of non-serious adverse events in the categories of respiratory disorders (OR, 1.77) infectious disorders (OR, 1.51), nervous system disorders (OR, 1.77), and psychiatric disorders (OR, 2.74) were all significantly higher in the group treated with cannabis, but almost all were judged to be of mild to moderate severity. There was no significant difference in the risk of serious AEs. Dr. Ware also reported there was no difference between the cannabis group and controls for neurocognitive testing at baseline, 6 months, or the end of 1 year.

Pain control was also monitored over the course of the study. According to Dr. Ware, average pain scores in the cannabis group fell modestly but consistently over the course of the study. Over the same period, the pain scores rose slightly in the control group.

There is a long list of unanswered questions regarding effective use of marijuana in the control of chronic pain, he said. For example, Dr. Ware noted that the optimal composition of cannabinoids has yet to be determined. He noted that more than one of the complex constituents may contribute to pain control, and these constituents are not necessarily the same as those most favored by recreational users seeking a euphoric “high.”

There is also a long list of unanswered questions about safety. Dr. Ware reviewed some evidence that inhaled vaporized marijuana may be safer than traditional smoked marijuana due to a reduced exposure to toxins, but he suggested more rigorous studies are needed to generate objective data that can better quantify the benefit-to-risk of this and other methods of marijuana delivery.

Despite unanswered questions, marijuana is widely available and likely to be considered by patients for chronic pain whether or not it is recommended by physicians. It is for this reason that clinicians need to become familiar with both its potential risks and benefits.

“It will be helpful to patients if you can provide them practical and accurate information about what is and is not known about this treatment,” Dr. Ware suggested.

Dr. Ware reported a financial relationship with CanniMed. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

LAKE BUENA VISTA, FLA. – As medical marijuana penetrates mainstream medical practice in the United States and elsewhere, awareness of the potential benefits, potential risks, and local laws governing its use for treatment of chronic pain gain importance, according to a specialist reviewing available data at Pain Care for Primary Care.

For many specific types of chronic pain, more data are needed to judge the benefit-to-risk ratio of marijuana relative to other options, but there are reasonable data suggesting both acceptable safety and meaningful efficacy of this analgesic in neuropathic pain, according to Mark A. Ware, MBBS, associate professor in the departments of anesthesia and family medicine, McGill University, Montreal.

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

In neuropathic pain, the evidence includes at least five randomized trials, according to Dr. Ware. In a recently published review article for which Dr. Ware served as senior author, the degree of neuropathic pain reductions were characterized as being on an order similar to those achieved with opioids and anticonvulsants (J Pain. 2016 Jun;17[6]:654-68). In one study, the number needed to treat (NNT) for a 50% pain reduction was just 2.

In Canada, marijuana is now available for at least some medical uses in every province. In the United States, 23 states have passed laws permitting clinical use of marijuana, according to Dr. Ware. He suggested that legalization of marijuana has fueled a growing acceptance of marijuana as a treatment option whether or not it is prescribed. For this reason, it’s necessary to examine the objective evidence to provide appropriate counseling.

“I think we are past the point where this option can simply be ignored,” Dr. Ware said. Even if they do not intend to prescribe marijuana for chronic pain, “clinicians should become familiar with the evidence regarding benefit and safety as well as the laws regarding its use.” In a study of long-term safety led by Dr. Ware, a standardized cannabis product containing 12.5% tetrahydrocannabinol was dispensed to 215 current or prior users of marijuana with a non-cancer chronic pain syndrome (J Pain. 2015 Dec;16[12]:1233-42). Followed for 1 year, adverse events in this group were compared with 216 control patients who also had chronic pain but were not using cannabis.

The odds ratio (OR) of non-serious adverse events in the categories of respiratory disorders (OR, 1.77) infectious disorders (OR, 1.51), nervous system disorders (OR, 1.77), and psychiatric disorders (OR, 2.74) were all significantly higher in the group treated with cannabis, but almost all were judged to be of mild to moderate severity. There was no significant difference in the risk of serious AEs. Dr. Ware also reported there was no difference between the cannabis group and controls for neurocognitive testing at baseline, 6 months, or the end of 1 year.

Pain control was also monitored over the course of the study. According to Dr. Ware, average pain scores in the cannabis group fell modestly but consistently over the course of the study. Over the same period, the pain scores rose slightly in the control group.

There is a long list of unanswered questions regarding effective use of marijuana in the control of chronic pain, he said. For example, Dr. Ware noted that the optimal composition of cannabinoids has yet to be determined. He noted that more than one of the complex constituents may contribute to pain control, and these constituents are not necessarily the same as those most favored by recreational users seeking a euphoric “high.”

There is also a long list of unanswered questions about safety. Dr. Ware reviewed some evidence that inhaled vaporized marijuana may be safer than traditional smoked marijuana due to a reduced exposure to toxins, but he suggested more rigorous studies are needed to generate objective data that can better quantify the benefit-to-risk of this and other methods of marijuana delivery.

Despite unanswered questions, marijuana is widely available and likely to be considered by patients for chronic pain whether or not it is recommended by physicians. It is for this reason that clinicians need to become familiar with both its potential risks and benefits.

“It will be helpful to patients if you can provide them practical and accurate information about what is and is not known about this treatment,” Dr. Ware suggested.

Dr. Ware reported a financial relationship with CanniMed. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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For neuropathic pain, marijuana yields modest benefits

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LAKE BUENA VISTA, FLA. – As medical marijuana penetrates mainstream medical practice in the United States and elsewhere, awareness of the potential benefits, potential risks, and local laws governing its use for treatment of chronic pain gain importance, according to a specialist reviewing available data at Pain Care for Primary Care.

For many specific types of chronic pain, more data are needed to judge the benefit-to-risk ratio of marijuana relative to other options, but there are reasonable data suggesting both acceptable safety and meaningful efficacy of this analgesic in neuropathic pain, according to Mark A. Ware, MBBS, associate professor in the departments of anesthesia and family medicine, McGill University, Montreal.

 

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

In neuropathic pain, the evidence includes at least five randomized trials, according to Dr. Ware. In a recently published review article for which Dr. Ware served as senior author, the degree of neuropathic pain reductions were characterized as being on an order similar to those achieved with opioids and anticonvulsants (J Pain. 2016 Jun;17[6]:654-68). In one study, the number needed to treat (NNT) for a 50% pain reduction was just 2.

In Canada, marijuana is now available for at least some medical uses in every province. In the United States, 23 states have passed laws permitting clinical use of marijuana, according to Dr. Ware. He suggested that legalization of marijuana has fueled a growing acceptance of marijuana as a treatment option whether or not it is prescribed. For this reason, it’s necessary to examine the objective evidence to provide appropriate counseling.

“I think we are past the point where this option can simply be ignored,” Dr. Ware said. Even if they do not intend to prescribe marijuana for chronic pain, “clinicians should become familiar with the evidence regarding benefit and safety as well as the laws regarding its use.” In a study of long-term safety led by Dr. Ware, a standardized cannabis product containing 12.5% tetrahydrocannabinol was dispensed to 215 current or prior users of marijuana with a non-cancer chronic pain syndrome (J Pain. 2015 Dec;16[12]:1233-42). Followed for 1 year, adverse events in this group were compared with 216 control patients who also had chronic pain but were not using cannabis.

The odds ratio (OR) of non-serious adverse events in the categories of respiratory disorders (OR, 1.77) infectious disorders (OR, 1.51), nervous system disorders (OR, 1.77), and psychiatric disorders (OR, 2.74) were all significantly higher in the group treated with cannabis, but almost all were judged to be of mild to moderate severity. There was no significant difference in the risk of serious AEs. Dr. Ware also reported there was no difference between the cannabis group and controls for neurocognitive testing at baseline, 6 months, or the end of 1 year.

Pain control was also monitored over the course of the study. According to Dr. Ware, average pain scores in the cannabis group fell modestly but consistently over the course of the study. Over the same period, the pain scores rose slightly in the control group.

There is a long list of unanswered questions regarding effective use of marijuana in the control of chronic pain, he said. For example, Dr. Ware noted that the optimal composition of cannabinoids has yet to be determined. He noted that more than one of the complex constituents may contribute to pain control, and these constituents are not necessarily the same as those most favored by recreational users seeking a euphoric “high.”

There is also a long list of unanswered questions about safety. Dr. Ware reviewed some evidence that inhaled vaporized marijuana may be safer than traditional smoked marijuana due to a reduced exposure to toxins, but he suggested more rigorous studies are needed to generate objective data that can better quantify the benefit-to-risk of this and other methods of marijuana delivery.

Despite unanswered questions, marijuana is widely available and likely to be considered by patients for chronic pain whether or not it is recommended by physicians. It is for this reason that clinicians need to become familiar with both its potential risks and benefits.

“It will be helpful to patients if you can provide them practical and accurate information about what is and is not known about this treatment,” Dr. Ware suggested.

Dr. Ware reported a financial relationship with CanniMed. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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LAKE BUENA VISTA, FLA. – As medical marijuana penetrates mainstream medical practice in the United States and elsewhere, awareness of the potential benefits, potential risks, and local laws governing its use for treatment of chronic pain gain importance, according to a specialist reviewing available data at Pain Care for Primary Care.

For many specific types of chronic pain, more data are needed to judge the benefit-to-risk ratio of marijuana relative to other options, but there are reasonable data suggesting both acceptable safety and meaningful efficacy of this analgesic in neuropathic pain, according to Mark A. Ware, MBBS, associate professor in the departments of anesthesia and family medicine, McGill University, Montreal.

 

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

In neuropathic pain, the evidence includes at least five randomized trials, according to Dr. Ware. In a recently published review article for which Dr. Ware served as senior author, the degree of neuropathic pain reductions were characterized as being on an order similar to those achieved with opioids and anticonvulsants (J Pain. 2016 Jun;17[6]:654-68). In one study, the number needed to treat (NNT) for a 50% pain reduction was just 2.

In Canada, marijuana is now available for at least some medical uses in every province. In the United States, 23 states have passed laws permitting clinical use of marijuana, according to Dr. Ware. He suggested that legalization of marijuana has fueled a growing acceptance of marijuana as a treatment option whether or not it is prescribed. For this reason, it’s necessary to examine the objective evidence to provide appropriate counseling.

“I think we are past the point where this option can simply be ignored,” Dr. Ware said. Even if they do not intend to prescribe marijuana for chronic pain, “clinicians should become familiar with the evidence regarding benefit and safety as well as the laws regarding its use.” In a study of long-term safety led by Dr. Ware, a standardized cannabis product containing 12.5% tetrahydrocannabinol was dispensed to 215 current or prior users of marijuana with a non-cancer chronic pain syndrome (J Pain. 2015 Dec;16[12]:1233-42). Followed for 1 year, adverse events in this group were compared with 216 control patients who also had chronic pain but were not using cannabis.

The odds ratio (OR) of non-serious adverse events in the categories of respiratory disorders (OR, 1.77) infectious disorders (OR, 1.51), nervous system disorders (OR, 1.77), and psychiatric disorders (OR, 2.74) were all significantly higher in the group treated with cannabis, but almost all were judged to be of mild to moderate severity. There was no significant difference in the risk of serious AEs. Dr. Ware also reported there was no difference between the cannabis group and controls for neurocognitive testing at baseline, 6 months, or the end of 1 year.

Pain control was also monitored over the course of the study. According to Dr. Ware, average pain scores in the cannabis group fell modestly but consistently over the course of the study. Over the same period, the pain scores rose slightly in the control group.

There is a long list of unanswered questions regarding effective use of marijuana in the control of chronic pain, he said. For example, Dr. Ware noted that the optimal composition of cannabinoids has yet to be determined. He noted that more than one of the complex constituents may contribute to pain control, and these constituents are not necessarily the same as those most favored by recreational users seeking a euphoric “high.”

There is also a long list of unanswered questions about safety. Dr. Ware reviewed some evidence that inhaled vaporized marijuana may be safer than traditional smoked marijuana due to a reduced exposure to toxins, but he suggested more rigorous studies are needed to generate objective data that can better quantify the benefit-to-risk of this and other methods of marijuana delivery.

Despite unanswered questions, marijuana is widely available and likely to be considered by patients for chronic pain whether or not it is recommended by physicians. It is for this reason that clinicians need to become familiar with both its potential risks and benefits.

“It will be helpful to patients if you can provide them practical and accurate information about what is and is not known about this treatment,” Dr. Ware suggested.

Dr. Ware reported a financial relationship with CanniMed. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

LAKE BUENA VISTA, FLA. – As medical marijuana penetrates mainstream medical practice in the United States and elsewhere, awareness of the potential benefits, potential risks, and local laws governing its use for treatment of chronic pain gain importance, according to a specialist reviewing available data at Pain Care for Primary Care.

For many specific types of chronic pain, more data are needed to judge the benefit-to-risk ratio of marijuana relative to other options, but there are reasonable data suggesting both acceptable safety and meaningful efficacy of this analgesic in neuropathic pain, according to Mark A. Ware, MBBS, associate professor in the departments of anesthesia and family medicine, McGill University, Montreal.

 

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

In neuropathic pain, the evidence includes at least five randomized trials, according to Dr. Ware. In a recently published review article for which Dr. Ware served as senior author, the degree of neuropathic pain reductions were characterized as being on an order similar to those achieved with opioids and anticonvulsants (J Pain. 2016 Jun;17[6]:654-68). In one study, the number needed to treat (NNT) for a 50% pain reduction was just 2.

In Canada, marijuana is now available for at least some medical uses in every province. In the United States, 23 states have passed laws permitting clinical use of marijuana, according to Dr. Ware. He suggested that legalization of marijuana has fueled a growing acceptance of marijuana as a treatment option whether or not it is prescribed. For this reason, it’s necessary to examine the objective evidence to provide appropriate counseling.

“I think we are past the point where this option can simply be ignored,” Dr. Ware said. Even if they do not intend to prescribe marijuana for chronic pain, “clinicians should become familiar with the evidence regarding benefit and safety as well as the laws regarding its use.” In a study of long-term safety led by Dr. Ware, a standardized cannabis product containing 12.5% tetrahydrocannabinol was dispensed to 215 current or prior users of marijuana with a non-cancer chronic pain syndrome (J Pain. 2015 Dec;16[12]:1233-42). Followed for 1 year, adverse events in this group were compared with 216 control patients who also had chronic pain but were not using cannabis.

The odds ratio (OR) of non-serious adverse events in the categories of respiratory disorders (OR, 1.77) infectious disorders (OR, 1.51), nervous system disorders (OR, 1.77), and psychiatric disorders (OR, 2.74) were all significantly higher in the group treated with cannabis, but almost all were judged to be of mild to moderate severity. There was no significant difference in the risk of serious AEs. Dr. Ware also reported there was no difference between the cannabis group and controls for neurocognitive testing at baseline, 6 months, or the end of 1 year.

Pain control was also monitored over the course of the study. According to Dr. Ware, average pain scores in the cannabis group fell modestly but consistently over the course of the study. Over the same period, the pain scores rose slightly in the control group.

There is a long list of unanswered questions regarding effective use of marijuana in the control of chronic pain, he said. For example, Dr. Ware noted that the optimal composition of cannabinoids has yet to be determined. He noted that more than one of the complex constituents may contribute to pain control, and these constituents are not necessarily the same as those most favored by recreational users seeking a euphoric “high.”

There is also a long list of unanswered questions about safety. Dr. Ware reviewed some evidence that inhaled vaporized marijuana may be safer than traditional smoked marijuana due to a reduced exposure to toxins, but he suggested more rigorous studies are needed to generate objective data that can better quantify the benefit-to-risk of this and other methods of marijuana delivery.

Despite unanswered questions, marijuana is widely available and likely to be considered by patients for chronic pain whether or not it is recommended by physicians. It is for this reason that clinicians need to become familiar with both its potential risks and benefits.

“It will be helpful to patients if you can provide them practical and accurate information about what is and is not known about this treatment,” Dr. Ware suggested.

Dr. Ware reported a financial relationship with CanniMed. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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More states moving to require payment for abuse-deterrent opioids

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LAKE BUENA VISTA, FLA. – The “Guidance for Industry” issued by the Food and Drug Administration last year has encouraged a systematic approach to the development and testing of opioid abuse-deterrent technologies that can be credited with spurring innovation, according to two pain specialists.

“Clinicians trying to understand these products are going to have to get used to hearing about likability studies and other types of evaluations that measure the efficacy of deterrence,” reported Jeffrey A. Gudin, MD, director of pain and palliative care, Englewood Hospital and Medical Center, New Jersey. He suggested that the outline provided by the FDA has been instrumental in defining standards with which different types of strategies can be compared.

At least eight opioids with abuse-deterrent properties already are on the market. Those include a product with a reservoir of the opioid-antagonist naloxone, which is designed for release in the event of tampering; pills constructed with complex polymers that produce a viscous gel when crushed or dissolved to prevent injection or snorting; and a tablet in which the opioid is accompanied with an aversion product. If the tablet is crushed, the aversion product mixes with the opioid, producing discomfort.

Four types of studies are recommended to evaluate abuse-deterrent strategies in the FDA manual for industry. Those include laboratory manipulation studies, pharmacokinetic studies, clinical abuse-deterrent studies, and postmarketing surveillance. The clinical abuse-deterrent studies are the ones that test likability. According to Dr. Gudin, those studies enroll drug-experienced recreational users who test whether pleasurable effects can be derived from the product despite the mechanism for deterrence.

Fulfilling the criteria for effect abuse deterrence “does not mean that the product is abuse proof,” cautioned Martin E. Hale, MD, an orthopedic surgeon and pain management specialist in private practice in Plantation, Fla. Rather, the goal is to provide a sufficient obstacle that the epidemic of opioid abuse and opioid-related deaths can be turned around. “Creating these types of deterrents may help,” Dr. Hale said.

Typically, addicts are seeking an immediate high, which is a very different goal from control of pain symptoms, according to Dr. Gudin. He reported that preventing the rapid onset of euphoria is one of the abuse-deterrent strategies being pursued. He cited one product in clinical development that requires 5 days before it crosses the blood-brain barrier. Such a product, he said, “would still work for the chronic pain patient, but it is not so good for the individuals who wants to get high.”

Not surprisingly, opioids with abuse deterrence cost more than those without, but the effort to remove this obstacle to encourage wider use is being addressed at the level of state legislatures, Dr. Gudin said. By his count, laws have been proposed in 30 states calling for third-party payers to make opioids with abuse deterrence available at the same cost as products without this technology. Four states have passed this legislation already, and an additional four have made passage contingent on studies demonstrating a change in risk of abuse.

In an informal poll at the meeting, a sizable majority of the attendees agreed that they would prefer to prescribe an opioid formulated with an abuse deterrent, particularly if third-party coverage was assured, but Dr. Gudin, like Dr. Hale, emphasized that no deterrent technology is foolproof.

For preventing inappropriate use of opioids, “abuse deterrence is just another tool in the toolkit,” Dr. Gudin said. He cautioned that all the other strategies aimed at keeping opioids out of the hands of abusers still should be employed. He predicted that most ER/LA opioids soon will have some form of abuse deterrence, and the same types of technologies are likely to offered in immediate-release opioids as well. Requiring third-party payers to provide reimbursement would accelerate the transition.

“Let’s face it, what is the downside if payers say they will work with you,” Dr. Gudin said.

Dr. Gudin reports a financial relationship with Teva, and Dr. Hale reports a financial relationship with Purdue.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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LAKE BUENA VISTA, FLA. – The “Guidance for Industry” issued by the Food and Drug Administration last year has encouraged a systematic approach to the development and testing of opioid abuse-deterrent technologies that can be credited with spurring innovation, according to two pain specialists.

“Clinicians trying to understand these products are going to have to get used to hearing about likability studies and other types of evaluations that measure the efficacy of deterrence,” reported Jeffrey A. Gudin, MD, director of pain and palliative care, Englewood Hospital and Medical Center, New Jersey. He suggested that the outline provided by the FDA has been instrumental in defining standards with which different types of strategies can be compared.

At least eight opioids with abuse-deterrent properties already are on the market. Those include a product with a reservoir of the opioid-antagonist naloxone, which is designed for release in the event of tampering; pills constructed with complex polymers that produce a viscous gel when crushed or dissolved to prevent injection or snorting; and a tablet in which the opioid is accompanied with an aversion product. If the tablet is crushed, the aversion product mixes with the opioid, producing discomfort.

Four types of studies are recommended to evaluate abuse-deterrent strategies in the FDA manual for industry. Those include laboratory manipulation studies, pharmacokinetic studies, clinical abuse-deterrent studies, and postmarketing surveillance. The clinical abuse-deterrent studies are the ones that test likability. According to Dr. Gudin, those studies enroll drug-experienced recreational users who test whether pleasurable effects can be derived from the product despite the mechanism for deterrence.

Fulfilling the criteria for effect abuse deterrence “does not mean that the product is abuse proof,” cautioned Martin E. Hale, MD, an orthopedic surgeon and pain management specialist in private practice in Plantation, Fla. Rather, the goal is to provide a sufficient obstacle that the epidemic of opioid abuse and opioid-related deaths can be turned around. “Creating these types of deterrents may help,” Dr. Hale said.

Typically, addicts are seeking an immediate high, which is a very different goal from control of pain symptoms, according to Dr. Gudin. He reported that preventing the rapid onset of euphoria is one of the abuse-deterrent strategies being pursued. He cited one product in clinical development that requires 5 days before it crosses the blood-brain barrier. Such a product, he said, “would still work for the chronic pain patient, but it is not so good for the individuals who wants to get high.”

Not surprisingly, opioids with abuse deterrence cost more than those without, but the effort to remove this obstacle to encourage wider use is being addressed at the level of state legislatures, Dr. Gudin said. By his count, laws have been proposed in 30 states calling for third-party payers to make opioids with abuse deterrence available at the same cost as products without this technology. Four states have passed this legislation already, and an additional four have made passage contingent on studies demonstrating a change in risk of abuse.

In an informal poll at the meeting, a sizable majority of the attendees agreed that they would prefer to prescribe an opioid formulated with an abuse deterrent, particularly if third-party coverage was assured, but Dr. Gudin, like Dr. Hale, emphasized that no deterrent technology is foolproof.

For preventing inappropriate use of opioids, “abuse deterrence is just another tool in the toolkit,” Dr. Gudin said. He cautioned that all the other strategies aimed at keeping opioids out of the hands of abusers still should be employed. He predicted that most ER/LA opioids soon will have some form of abuse deterrence, and the same types of technologies are likely to offered in immediate-release opioids as well. Requiring third-party payers to provide reimbursement would accelerate the transition.

“Let’s face it, what is the downside if payers say they will work with you,” Dr. Gudin said.

Dr. Gudin reports a financial relationship with Teva, and Dr. Hale reports a financial relationship with Purdue.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

LAKE BUENA VISTA, FLA. – The “Guidance for Industry” issued by the Food and Drug Administration last year has encouraged a systematic approach to the development and testing of opioid abuse-deterrent technologies that can be credited with spurring innovation, according to two pain specialists.

“Clinicians trying to understand these products are going to have to get used to hearing about likability studies and other types of evaluations that measure the efficacy of deterrence,” reported Jeffrey A. Gudin, MD, director of pain and palliative care, Englewood Hospital and Medical Center, New Jersey. He suggested that the outline provided by the FDA has been instrumental in defining standards with which different types of strategies can be compared.

At least eight opioids with abuse-deterrent properties already are on the market. Those include a product with a reservoir of the opioid-antagonist naloxone, which is designed for release in the event of tampering; pills constructed with complex polymers that produce a viscous gel when crushed or dissolved to prevent injection or snorting; and a tablet in which the opioid is accompanied with an aversion product. If the tablet is crushed, the aversion product mixes with the opioid, producing discomfort.

Four types of studies are recommended to evaluate abuse-deterrent strategies in the FDA manual for industry. Those include laboratory manipulation studies, pharmacokinetic studies, clinical abuse-deterrent studies, and postmarketing surveillance. The clinical abuse-deterrent studies are the ones that test likability. According to Dr. Gudin, those studies enroll drug-experienced recreational users who test whether pleasurable effects can be derived from the product despite the mechanism for deterrence.

Fulfilling the criteria for effect abuse deterrence “does not mean that the product is abuse proof,” cautioned Martin E. Hale, MD, an orthopedic surgeon and pain management specialist in private practice in Plantation, Fla. Rather, the goal is to provide a sufficient obstacle that the epidemic of opioid abuse and opioid-related deaths can be turned around. “Creating these types of deterrents may help,” Dr. Hale said.

Typically, addicts are seeking an immediate high, which is a very different goal from control of pain symptoms, according to Dr. Gudin. He reported that preventing the rapid onset of euphoria is one of the abuse-deterrent strategies being pursued. He cited one product in clinical development that requires 5 days before it crosses the blood-brain barrier. Such a product, he said, “would still work for the chronic pain patient, but it is not so good for the individuals who wants to get high.”

Not surprisingly, opioids with abuse deterrence cost more than those without, but the effort to remove this obstacle to encourage wider use is being addressed at the level of state legislatures, Dr. Gudin said. By his count, laws have been proposed in 30 states calling for third-party payers to make opioids with abuse deterrence available at the same cost as products without this technology. Four states have passed this legislation already, and an additional four have made passage contingent on studies demonstrating a change in risk of abuse.

In an informal poll at the meeting, a sizable majority of the attendees agreed that they would prefer to prescribe an opioid formulated with an abuse deterrent, particularly if third-party coverage was assured, but Dr. Gudin, like Dr. Hale, emphasized that no deterrent technology is foolproof.

For preventing inappropriate use of opioids, “abuse deterrence is just another tool in the toolkit,” Dr. Gudin said. He cautioned that all the other strategies aimed at keeping opioids out of the hands of abusers still should be employed. He predicted that most ER/LA opioids soon will have some form of abuse deterrence, and the same types of technologies are likely to offered in immediate-release opioids as well. Requiring third-party payers to provide reimbursement would accelerate the transition.

“Let’s face it, what is the downside if payers say they will work with you,” Dr. Gudin said.

Dr. Gudin reports a financial relationship with Teva, and Dr. Hale reports a financial relationship with Purdue.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company.

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Consistent Urine Screens Recommended for Patients on Opioids

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LAKE BUENA VISTA, FLA. – Many clinicians dread discussing a screening test that suggests patients have not been compliant with their scheduled pain medication. Nevertheless, Edwin A. Salsitz, MD, said, those tests should be embraced for their value.

“Every single body that publishes guidelines regarding the use of opioids for chronic pain calls for the use of specimen testing. It is a standard of care,” reported Dr. Salsitz, medical director of office-based opioid therapy at Mount Sinai Beth Israel in New York.

“Urine drug testing is being performed for the patient, not to the patient, and it should increase, not decrease communication,” Dr. Salsitz said at the meeting. Most of all, “just because a urine test is positive, don’t dismiss the patient. That is not the point.”

Among biologic specimens used to monitor compliance with treatment plans, urine is the one most commonly performed, according to Dr. Salsitz, but it is not the only one. A growing number of centers are moving to saliva tests, he said, and those have several advantages. For example, collection of specimens is easier and opportunities for cheating are reduced.

Hair specimens pose an even lower risk of cheating, and they have a much longer drug detection window. Relative to blood and saliva specimens, which become positive almost immediately after drug exposures but lose validity within 24-48 hours, hair specimens do not become positive for days but still can prove positive for drugs months after exposure. Urine samples, which do not become positive for several hours after a drug exposure, typically remain reliable for several days.

Urine testing remains the most widely used screening tool and also the focus of most efforts to cheat, Dr. Salsitz said. He said an Internet search for strategies used to cheat on urine drug testing would generate pages of recommendations. For men, options include a prosthetic penis that permits cheating even for observed urine samples. Strapped to the body, the lifelike prosthetic includes a place to store a sample of urine that can be excreted by the prosthetic into a collection receptacle. This type of sophisticated effort to “game the system” can be a challenge when managing patients most intent on noncompliance.

For periodic drug screening at his own center, Dr. Salsitz reported that he often uses point-of-care urine testing. Although he conceded that those kits, which employ a dipstick technology similar to pregnancy tests, are not as reliable as laboratory analyses of urine samples, they are relatively inexpensive and provide immediate results. However, laboratory testing still may be needed if the patient denies drug use after a positive result or if a more comprehensive analysis of drug exposures is needed.

“I would not make a major clinical decision on the basis of point-of-care testing alone,” Dr. Salsitz reported. Indeed, he expressed caution about relying on specimen screening alone when other reasons exist to be concerned about noncompliance.

“It is unwise to accept at face value a urinary drug test report that seems to support an impression of clinical stability if, in fact, there is other clinical evidence to the contrary,” Dr. Salsitz said.

Successful screening strategies for noncompliance require an objective, nonjudgmental, and systematic approach, Dr. Salsitz said. Implementing a uniform policy common for all patients reduces the risk of conveying a sense of distrust. Indeed, uniform testing circumvents bias that could, for example, permit well-liked patients to avoid detection of noncompliance.

“In one study, reliance on aberrant behavior alone to trigger urine drug testing was estimated to miss almost half of those using drugs problematically,” Dr. Salsitz reported. However, he noted that the same study suggested that urine screening by itself also was insufficient. Rather, he said, “Monitoring urine and behavior identified more patients with inappropriate drug taking than either alone.”

Emphasizing that biologic specimen screening is “just a tool” in managing chronic pain patients on opioids, Dr. Salsitz reported several cases where he verified false-positive results with a point-of-care urine test using his own specimen, thereby validating claims made to him by patients. In one case, results were positive after he consumed a poppy bagel. “When the patient stopped eating poppy seed bagels, he stopped having positive tests,” Dr. Salsitz reported. In another case, a positive result occurred after consuming a commercially available tea made with coca leaves.

Dr. Salsitz reports that he has no relevant financial relationships to disclose. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

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LAKE BUENA VISTA, FLA. – Many clinicians dread discussing a screening test that suggests patients have not been compliant with their scheduled pain medication. Nevertheless, Edwin A. Salsitz, MD, said, those tests should be embraced for their value.

“Every single body that publishes guidelines regarding the use of opioids for chronic pain calls for the use of specimen testing. It is a standard of care,” reported Dr. Salsitz, medical director of office-based opioid therapy at Mount Sinai Beth Israel in New York.

“Urine drug testing is being performed for the patient, not to the patient, and it should increase, not decrease communication,” Dr. Salsitz said at the meeting. Most of all, “just because a urine test is positive, don’t dismiss the patient. That is not the point.”

Among biologic specimens used to monitor compliance with treatment plans, urine is the one most commonly performed, according to Dr. Salsitz, but it is not the only one. A growing number of centers are moving to saliva tests, he said, and those have several advantages. For example, collection of specimens is easier and opportunities for cheating are reduced.

Hair specimens pose an even lower risk of cheating, and they have a much longer drug detection window. Relative to blood and saliva specimens, which become positive almost immediately after drug exposures but lose validity within 24-48 hours, hair specimens do not become positive for days but still can prove positive for drugs months after exposure. Urine samples, which do not become positive for several hours after a drug exposure, typically remain reliable for several days.

Urine testing remains the most widely used screening tool and also the focus of most efforts to cheat, Dr. Salsitz said. He said an Internet search for strategies used to cheat on urine drug testing would generate pages of recommendations. For men, options include a prosthetic penis that permits cheating even for observed urine samples. Strapped to the body, the lifelike prosthetic includes a place to store a sample of urine that can be excreted by the prosthetic into a collection receptacle. This type of sophisticated effort to “game the system” can be a challenge when managing patients most intent on noncompliance.

For periodic drug screening at his own center, Dr. Salsitz reported that he often uses point-of-care urine testing. Although he conceded that those kits, which employ a dipstick technology similar to pregnancy tests, are not as reliable as laboratory analyses of urine samples, they are relatively inexpensive and provide immediate results. However, laboratory testing still may be needed if the patient denies drug use after a positive result or if a more comprehensive analysis of drug exposures is needed.

“I would not make a major clinical decision on the basis of point-of-care testing alone,” Dr. Salsitz reported. Indeed, he expressed caution about relying on specimen screening alone when other reasons exist to be concerned about noncompliance.

“It is unwise to accept at face value a urinary drug test report that seems to support an impression of clinical stability if, in fact, there is other clinical evidence to the contrary,” Dr. Salsitz said.

Successful screening strategies for noncompliance require an objective, nonjudgmental, and systematic approach, Dr. Salsitz said. Implementing a uniform policy common for all patients reduces the risk of conveying a sense of distrust. Indeed, uniform testing circumvents bias that could, for example, permit well-liked patients to avoid detection of noncompliance.

“In one study, reliance on aberrant behavior alone to trigger urine drug testing was estimated to miss almost half of those using drugs problematically,” Dr. Salsitz reported. However, he noted that the same study suggested that urine screening by itself also was insufficient. Rather, he said, “Monitoring urine and behavior identified more patients with inappropriate drug taking than either alone.”

Emphasizing that biologic specimen screening is “just a tool” in managing chronic pain patients on opioids, Dr. Salsitz reported several cases where he verified false-positive results with a point-of-care urine test using his own specimen, thereby validating claims made to him by patients. In one case, results were positive after he consumed a poppy bagel. “When the patient stopped eating poppy seed bagels, he stopped having positive tests,” Dr. Salsitz reported. In another case, a positive result occurred after consuming a commercially available tea made with coca leaves.

Dr. Salsitz reports that he has no relevant financial relationships to disclose. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

LAKE BUENA VISTA, FLA. – Many clinicians dread discussing a screening test that suggests patients have not been compliant with their scheduled pain medication. Nevertheless, Edwin A. Salsitz, MD, said, those tests should be embraced for their value.

“Every single body that publishes guidelines regarding the use of opioids for chronic pain calls for the use of specimen testing. It is a standard of care,” reported Dr. Salsitz, medical director of office-based opioid therapy at Mount Sinai Beth Israel in New York.

“Urine drug testing is being performed for the patient, not to the patient, and it should increase, not decrease communication,” Dr. Salsitz said at the meeting. Most of all, “just because a urine test is positive, don’t dismiss the patient. That is not the point.”

Among biologic specimens used to monitor compliance with treatment plans, urine is the one most commonly performed, according to Dr. Salsitz, but it is not the only one. A growing number of centers are moving to saliva tests, he said, and those have several advantages. For example, collection of specimens is easier and opportunities for cheating are reduced.

Hair specimens pose an even lower risk of cheating, and they have a much longer drug detection window. Relative to blood and saliva specimens, which become positive almost immediately after drug exposures but lose validity within 24-48 hours, hair specimens do not become positive for days but still can prove positive for drugs months after exposure. Urine samples, which do not become positive for several hours after a drug exposure, typically remain reliable for several days.

Urine testing remains the most widely used screening tool and also the focus of most efforts to cheat, Dr. Salsitz said. He said an Internet search for strategies used to cheat on urine drug testing would generate pages of recommendations. For men, options include a prosthetic penis that permits cheating even for observed urine samples. Strapped to the body, the lifelike prosthetic includes a place to store a sample of urine that can be excreted by the prosthetic into a collection receptacle. This type of sophisticated effort to “game the system” can be a challenge when managing patients most intent on noncompliance.

For periodic drug screening at his own center, Dr. Salsitz reported that he often uses point-of-care urine testing. Although he conceded that those kits, which employ a dipstick technology similar to pregnancy tests, are not as reliable as laboratory analyses of urine samples, they are relatively inexpensive and provide immediate results. However, laboratory testing still may be needed if the patient denies drug use after a positive result or if a more comprehensive analysis of drug exposures is needed.

“I would not make a major clinical decision on the basis of point-of-care testing alone,” Dr. Salsitz reported. Indeed, he expressed caution about relying on specimen screening alone when other reasons exist to be concerned about noncompliance.

“It is unwise to accept at face value a urinary drug test report that seems to support an impression of clinical stability if, in fact, there is other clinical evidence to the contrary,” Dr. Salsitz said.

Successful screening strategies for noncompliance require an objective, nonjudgmental, and systematic approach, Dr. Salsitz said. Implementing a uniform policy common for all patients reduces the risk of conveying a sense of distrust. Indeed, uniform testing circumvents bias that could, for example, permit well-liked patients to avoid detection of noncompliance.

“In one study, reliance on aberrant behavior alone to trigger urine drug testing was estimated to miss almost half of those using drugs problematically,” Dr. Salsitz reported. However, he noted that the same study suggested that urine screening by itself also was insufficient. Rather, he said, “Monitoring urine and behavior identified more patients with inappropriate drug taking than either alone.”

Emphasizing that biologic specimen screening is “just a tool” in managing chronic pain patients on opioids, Dr. Salsitz reported several cases where he verified false-positive results with a point-of-care urine test using his own specimen, thereby validating claims made to him by patients. In one case, results were positive after he consumed a poppy bagel. “When the patient stopped eating poppy seed bagels, he stopped having positive tests,” Dr. Salsitz reported. In another case, a positive result occurred after consuming a commercially available tea made with coca leaves.

Dr. Salsitz reports that he has no relevant financial relationships to disclose. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

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LAKE BUENA VISTA, FLA. – Many clinicians dread discussing a screening test that suggests patients have not been compliant with their scheduled pain medication. Nevertheless, Edwin A. Salsitz, MD, said, those tests should be embraced for their value.

“Every single body that publishes guidelines regarding the use of opioids for chronic pain calls for the use of specimen testing. It is a standard of care,” reported Dr. Salsitz, medical director of office-based opioid therapy at Mount Sinai Beth Israel in New York.

“Urine drug testing is being performed for the patient, not to the patient, and it should increase, not decrease communication,” Dr. Salsitz said at the meeting. Most of all, “just because a urine test is positive, don’t dismiss the patient. That is not the point.”

Among biologic specimens used to monitor compliance with treatment plans, urine is the one most commonly performed, according to Dr. Salsitz, but it is not the only one. A growing number of centers are moving to saliva tests, he said, and those have several advantages. For example, collection of specimens is easier and opportunities for cheating are reduced.

Hair specimens pose an even lower risk of cheating, and they have a much longer drug detection window. Relative to blood and saliva specimens, which become positive almost immediately after drug exposures but lose validity within 24-48 hours, hair specimens do not become positive for days but still can prove positive for drugs months after exposure. Urine samples, which do not become positive for several hours after a drug exposure, typically remain reliable for several days.

Urine testing remains the most widely used screening tool and also the focus of most efforts to cheat, Dr. Salsitz said. He said an Internet search for strategies used to cheat on urine drug testing would generate pages of recommendations. For men, options include a prosthetic penis that permits cheating even for observed urine samples. Strapped to the body, the lifelike prosthetic includes a place to store a sample of urine that can be excreted by the prosthetic into a collection receptacle. This type of sophisticated effort to “game the system” can be a challenge when managing patients most intent on noncompliance.

For periodic drug screening at his own center, Dr. Salsitz reported that he often uses point-of-care urine testing. Although he conceded that those kits, which employ a dipstick technology similar to pregnancy tests, are not as reliable as laboratory analyses of urine samples, they are relatively inexpensive and provide immediate results. However, laboratory testing still may be needed if the patient denies drug use after a positive result or if a more comprehensive analysis of drug exposures is needed.

“I would not make a major clinical decision on the basis of point-of-care testing alone,” Dr. Salsitz reported. Indeed, he expressed caution about relying on specimen screening alone when other reasons exist to be concerned about noncompliance.

“It is unwise to accept at face value a urinary drug test report that seems to support an impression of clinical stability if, in fact, there is other clinical evidence to the contrary,” Dr. Salsitz said.

Successful screening strategies for noncompliance require an objective, nonjudgmental, and systematic approach, Dr. Salsitz said. Implementing a uniform policy common for all patients reduces the risk of conveying a sense of distrust. Indeed, uniform testing circumvents bias that could, for example, permit well-liked patients to avoid detection of noncompliance.

“In one study, reliance on aberrant behavior alone to trigger urine drug testing was estimated to miss almost half of those using drugs problematically,” Dr. Salsitz reported. However, he noted that the same study suggested that urine screening by itself also was insufficient. Rather, he said, “Monitoring urine and behavior identified more patients with inappropriate drug taking than either alone.”

Emphasizing that biologic specimen screening is “just a tool” in managing chronic pain patients on opioids, Dr. Salsitz reported several cases where he verified false-positive results with a point-of-care urine test using his own specimen, thereby validating claims made to him by patients. In one case, results were positive after he consumed a poppy bagel. “When the patient stopped eating poppy seed bagels, he stopped having positive tests,” Dr. Salsitz reported. In another case, a positive result occurred after consuming a commercially available tea made with coca leaves.

Dr. Salsitz reports that he has no relevant financial relationships to disclose. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

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LAKE BUENA VISTA, FLA. – Many clinicians dread discussing a screening test that suggests patients have not been compliant with their scheduled pain medication. Nevertheless, Edwin A. Salsitz, MD, said, those tests should be embraced for their value.

“Every single body that publishes guidelines regarding the use of opioids for chronic pain calls for the use of specimen testing. It is a standard of care,” reported Dr. Salsitz, medical director of office-based opioid therapy at Mount Sinai Beth Israel in New York.

“Urine drug testing is being performed for the patient, not to the patient, and it should increase, not decrease communication,” Dr. Salsitz said at the meeting. Most of all, “just because a urine test is positive, don’t dismiss the patient. That is not the point.”

Among biologic specimens used to monitor compliance with treatment plans, urine is the one most commonly performed, according to Dr. Salsitz, but it is not the only one. A growing number of centers are moving to saliva tests, he said, and those have several advantages. For example, collection of specimens is easier and opportunities for cheating are reduced.

Hair specimens pose an even lower risk of cheating, and they have a much longer drug detection window. Relative to blood and saliva specimens, which become positive almost immediately after drug exposures but lose validity within 24-48 hours, hair specimens do not become positive for days but still can prove positive for drugs months after exposure. Urine samples, which do not become positive for several hours after a drug exposure, typically remain reliable for several days.

Urine testing remains the most widely used screening tool and also the focus of most efforts to cheat, Dr. Salsitz said. He said an Internet search for strategies used to cheat on urine drug testing would generate pages of recommendations. For men, options include a prosthetic penis that permits cheating even for observed urine samples. Strapped to the body, the lifelike prosthetic includes a place to store a sample of urine that can be excreted by the prosthetic into a collection receptacle. This type of sophisticated effort to “game the system” can be a challenge when managing patients most intent on noncompliance.

For periodic drug screening at his own center, Dr. Salsitz reported that he often uses point-of-care urine testing. Although he conceded that those kits, which employ a dipstick technology similar to pregnancy tests, are not as reliable as laboratory analyses of urine samples, they are relatively inexpensive and provide immediate results. However, laboratory testing still may be needed if the patient denies drug use after a positive result or if a more comprehensive analysis of drug exposures is needed.

“I would not make a major clinical decision on the basis of point-of-care testing alone,” Dr. Salsitz reported. Indeed, he expressed caution about relying on specimen screening alone when other reasons exist to be concerned about noncompliance.

“It is unwise to accept at face value a urinary drug test report that seems to support an impression of clinical stability if, in fact, there is other clinical evidence to the contrary,” Dr. Salsitz said.

Successful screening strategies for noncompliance require an objective, nonjudgmental, and systematic approach, Dr. Salsitz said. Implementing a uniform policy common for all patients reduces the risk of conveying a sense of distrust. Indeed, uniform testing circumvents bias that could, for example, permit well-liked patients to avoid detection of noncompliance.

“In one study, reliance on aberrant behavior alone to trigger urine drug testing was estimated to miss almost half of those using drugs problematically,” Dr. Salsitz reported. However, he noted that the same study suggested that urine screening by itself also was insufficient. Rather, he said, “Monitoring urine and behavior identified more patients with inappropriate drug taking than either alone.”

Emphasizing that biologic specimen screening is “just a tool” in managing chronic pain patients on opioids, Dr. Salsitz reported several cases where he verified false-positive results with a point-of-care urine test using his own specimen, thereby validating claims made to him by patients. In one case, results were positive after he consumed a poppy bagel. “When the patient stopped eating poppy seed bagels, he stopped having positive tests,” Dr. Salsitz reported. In another case, a positive result occurred after consuming a commercially available tea made with coca leaves.

Dr. Salsitz reports that he has no relevant financial relationships to disclose. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

LAKE BUENA VISTA, FLA. – Many clinicians dread discussing a screening test that suggests patients have not been compliant with their scheduled pain medication. Nevertheless, Edwin A. Salsitz, MD, said, those tests should be embraced for their value.

“Every single body that publishes guidelines regarding the use of opioids for chronic pain calls for the use of specimen testing. It is a standard of care,” reported Dr. Salsitz, medical director of office-based opioid therapy at Mount Sinai Beth Israel in New York.

“Urine drug testing is being performed for the patient, not to the patient, and it should increase, not decrease communication,” Dr. Salsitz said at the meeting. Most of all, “just because a urine test is positive, don’t dismiss the patient. That is not the point.”

Among biologic specimens used to monitor compliance with treatment plans, urine is the one most commonly performed, according to Dr. Salsitz, but it is not the only one. A growing number of centers are moving to saliva tests, he said, and those have several advantages. For example, collection of specimens is easier and opportunities for cheating are reduced.

Hair specimens pose an even lower risk of cheating, and they have a much longer drug detection window. Relative to blood and saliva specimens, which become positive almost immediately after drug exposures but lose validity within 24-48 hours, hair specimens do not become positive for days but still can prove positive for drugs months after exposure. Urine samples, which do not become positive for several hours after a drug exposure, typically remain reliable for several days.

Urine testing remains the most widely used screening tool and also the focus of most efforts to cheat, Dr. Salsitz said. He said an Internet search for strategies used to cheat on urine drug testing would generate pages of recommendations. For men, options include a prosthetic penis that permits cheating even for observed urine samples. Strapped to the body, the lifelike prosthetic includes a place to store a sample of urine that can be excreted by the prosthetic into a collection receptacle. This type of sophisticated effort to “game the system” can be a challenge when managing patients most intent on noncompliance.

For periodic drug screening at his own center, Dr. Salsitz reported that he often uses point-of-care urine testing. Although he conceded that those kits, which employ a dipstick technology similar to pregnancy tests, are not as reliable as laboratory analyses of urine samples, they are relatively inexpensive and provide immediate results. However, laboratory testing still may be needed if the patient denies drug use after a positive result or if a more comprehensive analysis of drug exposures is needed.

“I would not make a major clinical decision on the basis of point-of-care testing alone,” Dr. Salsitz reported. Indeed, he expressed caution about relying on specimen screening alone when other reasons exist to be concerned about noncompliance.

“It is unwise to accept at face value a urinary drug test report that seems to support an impression of clinical stability if, in fact, there is other clinical evidence to the contrary,” Dr. Salsitz said.

Successful screening strategies for noncompliance require an objective, nonjudgmental, and systematic approach, Dr. Salsitz said. Implementing a uniform policy common for all patients reduces the risk of conveying a sense of distrust. Indeed, uniform testing circumvents bias that could, for example, permit well-liked patients to avoid detection of noncompliance.

“In one study, reliance on aberrant behavior alone to trigger urine drug testing was estimated to miss almost half of those using drugs problematically,” Dr. Salsitz reported. However, he noted that the same study suggested that urine screening by itself also was insufficient. Rather, he said, “Monitoring urine and behavior identified more patients with inappropriate drug taking than either alone.”

Emphasizing that biologic specimen screening is “just a tool” in managing chronic pain patients on opioids, Dr. Salsitz reported several cases where he verified false-positive results with a point-of-care urine test using his own specimen, thereby validating claims made to him by patients. In one case, results were positive after he consumed a poppy bagel. “When the patient stopped eating poppy seed bagels, he stopped having positive tests,” Dr. Salsitz reported. In another case, a positive result occurred after consuming a commercially available tea made with coca leaves.

Dr. Salsitz reports that he has no relevant financial relationships to disclose. The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned the same company.

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Stigmatizing of chronic pain begins with clinicians, experts say

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LAKE BUENA VISTA, FLA. – Discomfort treating chronic pain, inadequate empathy for pain complaints, and failure to set appropriate boundaries for scheduled pain medications are among the key obstacles to effective chronic pain management by primary care physicians, according to two experts.

For those with doubts about their abilities or the validity of pain complaints, “how you feel about treating chronic pain is going to be perceived by the patient,” cautioned Louis Kuritzky, MD, clinical assistant professor, University of Florida, Gainesville. “The mindset of the clinician is important.”

When clinicians consider chronic pain patients difficult or burdensome, patients can develop a sense of stigmatization without anything explicit being expressed by the treating physician, Dr. Kuritzky said. This can be self-defeating. The clinician-patient relationship and the chance of successful therapy are in trouble before either gets started.

Primary care physicians – not chronic pain specialists – provide most of the care for chronic pain, according to several experts at the meeting, held by the American Pain Society and Global Medical Academy. Yet, chronic pain management receives limited attention in family medicine or internal medicine training. According to one survey cited at the meeting, the majority of primary care physicians report that they are uncomfortable treating these complaints.

“What are the two things that primary care specialists struggle with most? Pain and psychiatric disorders,” said Robert M. McCarron, DO, DFAPA, director of pain psychiatry in the division of pain medicine at the University of California, Davis, in Sacramento. Like Dr. Kuritzky, he believes the physician-patient relationship often sours when patients sense their clinician’s discomfort.

“They feel the angst from us, and it becomes a countertransference,” Dr. McCarron said.

The first steps, Dr. Kuritzky and Dr. McCarron said, are to develop a genuine empathy for the burden of the pain and the confidence that effective options exist – even when pain includes a psychiatric component.

Although both Dr. Kuritzky and Dr. McCarron conceded that treating chronic pain is challenging, they also agreed that effective pain control is built upon a systematic approach starting with a structured assessment. While recognizing that both physical complaints and psychiatric comorbidity may be involved, each expert counseled that the immediate goal is not typically complete pain control. Rather, it is some reasonable degree of improvement.

“Identify functional improvements that the patient considers to be important and set realistic goals,” Dr. Kuritzky said. An incremental reduction in the burden of pain, whether the level of discomfort or the restoration of an activity that pain had prevented, can be the first step for a patient trying to escape from the vicious cycle of that sustains pain-related disability.

Not least of the reasons that many primary physicians are reluctant to treat chronic pain is their fear that a prescription of analgesics will lead to dependence or abuse, Dr. Kuritzky and Dr. McCarron said. They noted that patients often insist on pain medications even when clinicians are not convinced that these are in their best interest. The defense, according to Dr. Kuritzky, is for physicians to exercise their fiduciary duty.

“In our fiduciary capacity, we have been entrusted to act on behalf of the best interests of our patients,” Dr. Kuritzky explained. He urged clinicians to explain to patients when they feel a scheduled medication such as an opioid poses a greater potential for harm than benefit. This explanation, when offered with confidence, is persuasive for many patients, he said.

Dr. McCarron said it is important not to ignore the mind-body connection. Pain often has an emotional component even when a physical basis is present. He suggested that primary care physicians often are uncomfortable with the psychosomatic aspect common to chronic pain. But this discomfort prove counterproductive.

“Authentic suffering and distress from the symptom or symptoms should be the diagnostic and treatment focus” independent of etiology, Dr. McCarron maintained. He suggested that clinicians who can develop empathy for the very real symptoms of pain are better prepared to pursue the steps needed to bring chronic pain under control.

Dr. Kuritzky and Dr. McCarron reported no conflicts of interest. Global Academy and this organization are owned by the same company.

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LAKE BUENA VISTA, FLA. – Discomfort treating chronic pain, inadequate empathy for pain complaints, and failure to set appropriate boundaries for scheduled pain medications are among the key obstacles to effective chronic pain management by primary care physicians, according to two experts.

For those with doubts about their abilities or the validity of pain complaints, “how you feel about treating chronic pain is going to be perceived by the patient,” cautioned Louis Kuritzky, MD, clinical assistant professor, University of Florida, Gainesville. “The mindset of the clinician is important.”

When clinicians consider chronic pain patients difficult or burdensome, patients can develop a sense of stigmatization without anything explicit being expressed by the treating physician, Dr. Kuritzky said. This can be self-defeating. The clinician-patient relationship and the chance of successful therapy are in trouble before either gets started.

Primary care physicians – not chronic pain specialists – provide most of the care for chronic pain, according to several experts at the meeting, held by the American Pain Society and Global Medical Academy. Yet, chronic pain management receives limited attention in family medicine or internal medicine training. According to one survey cited at the meeting, the majority of primary care physicians report that they are uncomfortable treating these complaints.

“What are the two things that primary care specialists struggle with most? Pain and psychiatric disorders,” said Robert M. McCarron, DO, DFAPA, director of pain psychiatry in the division of pain medicine at the University of California, Davis, in Sacramento. Like Dr. Kuritzky, he believes the physician-patient relationship often sours when patients sense their clinician’s discomfort.

“They feel the angst from us, and it becomes a countertransference,” Dr. McCarron said.

The first steps, Dr. Kuritzky and Dr. McCarron said, are to develop a genuine empathy for the burden of the pain and the confidence that effective options exist – even when pain includes a psychiatric component.

Although both Dr. Kuritzky and Dr. McCarron conceded that treating chronic pain is challenging, they also agreed that effective pain control is built upon a systematic approach starting with a structured assessment. While recognizing that both physical complaints and psychiatric comorbidity may be involved, each expert counseled that the immediate goal is not typically complete pain control. Rather, it is some reasonable degree of improvement.

“Identify functional improvements that the patient considers to be important and set realistic goals,” Dr. Kuritzky said. An incremental reduction in the burden of pain, whether the level of discomfort or the restoration of an activity that pain had prevented, can be the first step for a patient trying to escape from the vicious cycle of that sustains pain-related disability.

Not least of the reasons that many primary physicians are reluctant to treat chronic pain is their fear that a prescription of analgesics will lead to dependence or abuse, Dr. Kuritzky and Dr. McCarron said. They noted that patients often insist on pain medications even when clinicians are not convinced that these are in their best interest. The defense, according to Dr. Kuritzky, is for physicians to exercise their fiduciary duty.

“In our fiduciary capacity, we have been entrusted to act on behalf of the best interests of our patients,” Dr. Kuritzky explained. He urged clinicians to explain to patients when they feel a scheduled medication such as an opioid poses a greater potential for harm than benefit. This explanation, when offered with confidence, is persuasive for many patients, he said.

Dr. McCarron said it is important not to ignore the mind-body connection. Pain often has an emotional component even when a physical basis is present. He suggested that primary care physicians often are uncomfortable with the psychosomatic aspect common to chronic pain. But this discomfort prove counterproductive.

“Authentic suffering and distress from the symptom or symptoms should be the diagnostic and treatment focus” independent of etiology, Dr. McCarron maintained. He suggested that clinicians who can develop empathy for the very real symptoms of pain are better prepared to pursue the steps needed to bring chronic pain under control.

Dr. Kuritzky and Dr. McCarron reported no conflicts of interest. Global Academy and this organization are owned by the same company.

LAKE BUENA VISTA, FLA. – Discomfort treating chronic pain, inadequate empathy for pain complaints, and failure to set appropriate boundaries for scheduled pain medications are among the key obstacles to effective chronic pain management by primary care physicians, according to two experts.

For those with doubts about their abilities or the validity of pain complaints, “how you feel about treating chronic pain is going to be perceived by the patient,” cautioned Louis Kuritzky, MD, clinical assistant professor, University of Florida, Gainesville. “The mindset of the clinician is important.”

When clinicians consider chronic pain patients difficult or burdensome, patients can develop a sense of stigmatization without anything explicit being expressed by the treating physician, Dr. Kuritzky said. This can be self-defeating. The clinician-patient relationship and the chance of successful therapy are in trouble before either gets started.

Primary care physicians – not chronic pain specialists – provide most of the care for chronic pain, according to several experts at the meeting, held by the American Pain Society and Global Medical Academy. Yet, chronic pain management receives limited attention in family medicine or internal medicine training. According to one survey cited at the meeting, the majority of primary care physicians report that they are uncomfortable treating these complaints.

“What are the two things that primary care specialists struggle with most? Pain and psychiatric disorders,” said Robert M. McCarron, DO, DFAPA, director of pain psychiatry in the division of pain medicine at the University of California, Davis, in Sacramento. Like Dr. Kuritzky, he believes the physician-patient relationship often sours when patients sense their clinician’s discomfort.

“They feel the angst from us, and it becomes a countertransference,” Dr. McCarron said.

The first steps, Dr. Kuritzky and Dr. McCarron said, are to develop a genuine empathy for the burden of the pain and the confidence that effective options exist – even when pain includes a psychiatric component.

Although both Dr. Kuritzky and Dr. McCarron conceded that treating chronic pain is challenging, they also agreed that effective pain control is built upon a systematic approach starting with a structured assessment. While recognizing that both physical complaints and psychiatric comorbidity may be involved, each expert counseled that the immediate goal is not typically complete pain control. Rather, it is some reasonable degree of improvement.

“Identify functional improvements that the patient considers to be important and set realistic goals,” Dr. Kuritzky said. An incremental reduction in the burden of pain, whether the level of discomfort or the restoration of an activity that pain had prevented, can be the first step for a patient trying to escape from the vicious cycle of that sustains pain-related disability.

Not least of the reasons that many primary physicians are reluctant to treat chronic pain is their fear that a prescription of analgesics will lead to dependence or abuse, Dr. Kuritzky and Dr. McCarron said. They noted that patients often insist on pain medications even when clinicians are not convinced that these are in their best interest. The defense, according to Dr. Kuritzky, is for physicians to exercise their fiduciary duty.

“In our fiduciary capacity, we have been entrusted to act on behalf of the best interests of our patients,” Dr. Kuritzky explained. He urged clinicians to explain to patients when they feel a scheduled medication such as an opioid poses a greater potential for harm than benefit. This explanation, when offered with confidence, is persuasive for many patients, he said.

Dr. McCarron said it is important not to ignore the mind-body connection. Pain often has an emotional component even when a physical basis is present. He suggested that primary care physicians often are uncomfortable with the psychosomatic aspect common to chronic pain. But this discomfort prove counterproductive.

“Authentic suffering and distress from the symptom or symptoms should be the diagnostic and treatment focus” independent of etiology, Dr. McCarron maintained. He suggested that clinicians who can develop empathy for the very real symptoms of pain are better prepared to pursue the steps needed to bring chronic pain under control.

Dr. Kuritzky and Dr. McCarron reported no conflicts of interest. Global Academy and this organization are owned by the same company.

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Prophylaxis key to preventing medication overuse migraine

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LAKE BUENA VISTA, FLA. – The etiology of intractable daily headaches is broad and includes life-threatening diagnoses. But a large proportion of those headaches results from overuse of therapies for migraine, making them in some cases an iatrogenic and avoidable complication, according to a headache specialist.

After ruling out serious systemic diseases, one of the first questions to ask patients with chronic daily headache is whether they have a history of migraine and, if this history is positive, how often they have been taking medications to abort symptoms, reported Wendy L. Wright, MS, a headache specialist and family nurse practitioner in private practice in Amherst, N.H.

Wendy Wright

“Use of any medicine for the treatment of migraine more than 2 or 3 times per week can result in medication overuse headache,” according to Ms. Wright, who maintained that medication overuse headache is “almost always transformed migraine.”

Medication overuse headaches do not stem from prescription drugs only, Ms. Wright said at the meeting, which was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this organization are owned by the same company. She cited data indicating that acetaminophen is implicated in almost half of overuse headaches, but most patients are taking this drug or others in combinations. One study found that at the time that overuse headache developed, the average number of daily doses of headache drugs, including different types of drugs, was 5.2, Ms. Wright said.

Controlling medication overuse headaches is challenging and often requires several steps, she said. Overuse of butalbital, for example, requires tapering.

“You do not want to cold turkey individuals who have been taking high doses of butalbiltal because they can actually have a seizure,” Ms. Wright cautioned.

A more prudent strategy outlined by Ms. Wright involves a slow taper of the medication that the patient has been overusing while simultaneously uptitrating prophylactic therapies, such as beta blockers, divalproex, or topiramate. For butalbital, specifically, Ms. Wright recommended reducing the dose by about 10% per week with complete withdrawal in 2 to 3 months. For treatment of migraine, abortive medications should be used that have a different mechanism of action from the one implicated in the overuse complication.

“Here is one of my strategies: 0.5 mg to 1.0 mg per day of prednisone along with a [proton pump inhibitor],” Ms. Wright reported. “I taper the prednisone over 21 days, but at the same time I am pulling away their abortive medications.”

As migraine transforms from medication overuse into chronic daily headache, the presentation often shifts from its rapid attack-like onset into a less severe presentation, often losing the aura for those who had aura previously, Ms. Wright said. For migraine patients who develop chronic daily headache, other etiologies, such as meningitis or a tumor, must be considered. However, suspicion of an overuse syndrome should intensify for patients who report taking drugs like triptans 10 or more days per month or analgesics such as acetaminophen or nonsteroidal anti-inflammatory medications 15 days or more per days per month.

In some cases, patients take it upon themselves to increase the frequency of drugs they use to control migraine. This is particularly common for nonprescription agents, such as acetaminophen, that patients consider to be benign. However, many patients come to her specialty clinic from another provider who increased the frequency of abortive medications without understanding or considering the overuse phenomenon. Patients should be educated about the risks of medication overuse, but clinicians can avoid overuse by increasing their focus on prophylaxis.

Prophylaxis is particularly useful in patients with known triggers or a consistent pattern of migraine, such as migraine related to the menstrual cycle, Ms. Wright said. She referred to joint guidelines from the American Headache Society and the American Academy of Neurology (AHS/AAN) that have outlined available prophylactic therapies grouped by level of supporting evidence (Headache. 2012 Jun;52[6]:930-45).

Medication overuse headache is such a well-recognized phenomenon that it has been given its own ICD-10 code for reimbursement, but Ms. Wright said. In addition to prophylactic therapies recommended by AHS/AAN, she recommended pursuing adjunctive nonpharmacologic strategies for migraine prevention. Acupuncture is one such option. In addition, patients must be educated about the risks.

Ms. Wright has financial relationships with Merck, Pfizer, and Takeda.

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LAKE BUENA VISTA, FLA. – The etiology of intractable daily headaches is broad and includes life-threatening diagnoses. But a large proportion of those headaches results from overuse of therapies for migraine, making them in some cases an iatrogenic and avoidable complication, according to a headache specialist.

After ruling out serious systemic diseases, one of the first questions to ask patients with chronic daily headache is whether they have a history of migraine and, if this history is positive, how often they have been taking medications to abort symptoms, reported Wendy L. Wright, MS, a headache specialist and family nurse practitioner in private practice in Amherst, N.H.

Wendy Wright

“Use of any medicine for the treatment of migraine more than 2 or 3 times per week can result in medication overuse headache,” according to Ms. Wright, who maintained that medication overuse headache is “almost always transformed migraine.”

Medication overuse headaches do not stem from prescription drugs only, Ms. Wright said at the meeting, which was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this organization are owned by the same company. She cited data indicating that acetaminophen is implicated in almost half of overuse headaches, but most patients are taking this drug or others in combinations. One study found that at the time that overuse headache developed, the average number of daily doses of headache drugs, including different types of drugs, was 5.2, Ms. Wright said.

Controlling medication overuse headaches is challenging and often requires several steps, she said. Overuse of butalbital, for example, requires tapering.

“You do not want to cold turkey individuals who have been taking high doses of butalbiltal because they can actually have a seizure,” Ms. Wright cautioned.

A more prudent strategy outlined by Ms. Wright involves a slow taper of the medication that the patient has been overusing while simultaneously uptitrating prophylactic therapies, such as beta blockers, divalproex, or topiramate. For butalbital, specifically, Ms. Wright recommended reducing the dose by about 10% per week with complete withdrawal in 2 to 3 months. For treatment of migraine, abortive medications should be used that have a different mechanism of action from the one implicated in the overuse complication.

“Here is one of my strategies: 0.5 mg to 1.0 mg per day of prednisone along with a [proton pump inhibitor],” Ms. Wright reported. “I taper the prednisone over 21 days, but at the same time I am pulling away their abortive medications.”

As migraine transforms from medication overuse into chronic daily headache, the presentation often shifts from its rapid attack-like onset into a less severe presentation, often losing the aura for those who had aura previously, Ms. Wright said. For migraine patients who develop chronic daily headache, other etiologies, such as meningitis or a tumor, must be considered. However, suspicion of an overuse syndrome should intensify for patients who report taking drugs like triptans 10 or more days per month or analgesics such as acetaminophen or nonsteroidal anti-inflammatory medications 15 days or more per days per month.

In some cases, patients take it upon themselves to increase the frequency of drugs they use to control migraine. This is particularly common for nonprescription agents, such as acetaminophen, that patients consider to be benign. However, many patients come to her specialty clinic from another provider who increased the frequency of abortive medications without understanding or considering the overuse phenomenon. Patients should be educated about the risks of medication overuse, but clinicians can avoid overuse by increasing their focus on prophylaxis.

Prophylaxis is particularly useful in patients with known triggers or a consistent pattern of migraine, such as migraine related to the menstrual cycle, Ms. Wright said. She referred to joint guidelines from the American Headache Society and the American Academy of Neurology (AHS/AAN) that have outlined available prophylactic therapies grouped by level of supporting evidence (Headache. 2012 Jun;52[6]:930-45).

Medication overuse headache is such a well-recognized phenomenon that it has been given its own ICD-10 code for reimbursement, but Ms. Wright said. In addition to prophylactic therapies recommended by AHS/AAN, she recommended pursuing adjunctive nonpharmacologic strategies for migraine prevention. Acupuncture is one such option. In addition, patients must be educated about the risks.

Ms. Wright has financial relationships with Merck, Pfizer, and Takeda.

LAKE BUENA VISTA, FLA. – The etiology of intractable daily headaches is broad and includes life-threatening diagnoses. But a large proportion of those headaches results from overuse of therapies for migraine, making them in some cases an iatrogenic and avoidable complication, according to a headache specialist.

After ruling out serious systemic diseases, one of the first questions to ask patients with chronic daily headache is whether they have a history of migraine and, if this history is positive, how often they have been taking medications to abort symptoms, reported Wendy L. Wright, MS, a headache specialist and family nurse practitioner in private practice in Amherst, N.H.

Wendy Wright

“Use of any medicine for the treatment of migraine more than 2 or 3 times per week can result in medication overuse headache,” according to Ms. Wright, who maintained that medication overuse headache is “almost always transformed migraine.”

Medication overuse headaches do not stem from prescription drugs only, Ms. Wright said at the meeting, which was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this organization are owned by the same company. She cited data indicating that acetaminophen is implicated in almost half of overuse headaches, but most patients are taking this drug or others in combinations. One study found that at the time that overuse headache developed, the average number of daily doses of headache drugs, including different types of drugs, was 5.2, Ms. Wright said.

Controlling medication overuse headaches is challenging and often requires several steps, she said. Overuse of butalbital, for example, requires tapering.

“You do not want to cold turkey individuals who have been taking high doses of butalbiltal because they can actually have a seizure,” Ms. Wright cautioned.

A more prudent strategy outlined by Ms. Wright involves a slow taper of the medication that the patient has been overusing while simultaneously uptitrating prophylactic therapies, such as beta blockers, divalproex, or topiramate. For butalbital, specifically, Ms. Wright recommended reducing the dose by about 10% per week with complete withdrawal in 2 to 3 months. For treatment of migraine, abortive medications should be used that have a different mechanism of action from the one implicated in the overuse complication.

“Here is one of my strategies: 0.5 mg to 1.0 mg per day of prednisone along with a [proton pump inhibitor],” Ms. Wright reported. “I taper the prednisone over 21 days, but at the same time I am pulling away their abortive medications.”

As migraine transforms from medication overuse into chronic daily headache, the presentation often shifts from its rapid attack-like onset into a less severe presentation, often losing the aura for those who had aura previously, Ms. Wright said. For migraine patients who develop chronic daily headache, other etiologies, such as meningitis or a tumor, must be considered. However, suspicion of an overuse syndrome should intensify for patients who report taking drugs like triptans 10 or more days per month or analgesics such as acetaminophen or nonsteroidal anti-inflammatory medications 15 days or more per days per month.

In some cases, patients take it upon themselves to increase the frequency of drugs they use to control migraine. This is particularly common for nonprescription agents, such as acetaminophen, that patients consider to be benign. However, many patients come to her specialty clinic from another provider who increased the frequency of abortive medications without understanding or considering the overuse phenomenon. Patients should be educated about the risks of medication overuse, but clinicians can avoid overuse by increasing their focus on prophylaxis.

Prophylaxis is particularly useful in patients with known triggers or a consistent pattern of migraine, such as migraine related to the menstrual cycle, Ms. Wright said. She referred to joint guidelines from the American Headache Society and the American Academy of Neurology (AHS/AAN) that have outlined available prophylactic therapies grouped by level of supporting evidence (Headache. 2012 Jun;52[6]:930-45).

Medication overuse headache is such a well-recognized phenomenon that it has been given its own ICD-10 code for reimbursement, but Ms. Wright said. In addition to prophylactic therapies recommended by AHS/AAN, she recommended pursuing adjunctive nonpharmacologic strategies for migraine prevention. Acupuncture is one such option. In addition, patients must be educated about the risks.

Ms. Wright has financial relationships with Merck, Pfizer, and Takeda.

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Opioid overdoses falling at centers adhering to guidelines

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LAKE BUENA VISTA, FLA. – Mortality related to prescription opioids is still climbing nationwide but not in centers or regions where there has been widespread implementation of guidelines for appropriate use, according to an expert involved in implementing guidelines in Washington state.

“If you follow guidelines for use of opioids, you can do what we did in Washington state and change the direction of those mortality curves,” reported David J. Tauben, MD, chief of pain medicine at the University of Washington, Seattle.

Dr. David Tauben

In data presented at the meeting, Dr. Tauben showed that the steep increase in opioid-related deaths and hospitalizations dating back to 1997 plateaued in Washington soon after the guidelines were implemented in 2007 and have followed a steep downward trajectory through the last year of follow-up in 2014.

Those data contrast starkly with nationwide figures updated June 21, 2016, on the Centers for Disease Control and Prevention website. In those figures, which also track data through 2014, the rates of deaths tied to drug overdose overall and to related to prescription opioids specifically have continued to climb. On the CDC website, which states that deaths related to prescription opioids have quadrupled since 1999, it was noted that more patients died from drug overdoses in 2014 than in any previous year. Prescriptions opioids were characterized as the “driving force” of this ongoing epidemic.

Washington state’s guidelines were created by the State Agency Medical Directors’ Group. But Dr. Tauben said that the principles of appropriate use of prescription opioids are well established and most recently were described in the CDC’s March 15, 2016, Morbidity and Mortality Weekly Report (MMWR). He suggested that adherence to these recommendations, which guide who to treat, how to treat, and how to assess for those most at risk for complications from opioids, can be expected to produce the same result.

Not least important, clinicians can keep the risk of overdose low by keeping doses low. Collating data from several studies, Dr. Tauben showed that the risk of overdose remains modest at opioid equivalent doses of 20 mg to about 50 mg per day. Graphically, the daily 50-mg equivalent was characterized as “the point of deflection where patients get in trouble.” In three of four published studies, the rise of rates in overdose was precipitous at about this point.

Keeping patients at a daily dose of 50 mg or below is further supported by the fact that “there is no evidence that a higher dose provides any additional benefit,” Dr. Tauben said. He also cited a study showing that patients at higher doses are more likely to have psychiatric comorbidity that complicates the pain complaint and may be better treated by alternative strategies.

At the University of Washington, chronic pain now is addressed routinely with a collaborative team approach that not only includes pain specialists but nursing care coordinators, pharmacists, physical therapists, and others, Dr. Tauben said. He considers increased physical activity, one of the goals in a collaborative multidisciplinary approach to chronic pain, a “miracle cure,” but acknowledged that designing comprehensive treatment that includes such strategies takes time and, at least initially, increases costs. However, he believes there is a clear return on investment.

“The evidence shows that effective control of chronic pain ultimately reduces costs,” Dr. Tauben said. Citing several studies, Dr. Tauben explained that chronic pain patients are major consumers of health care services and that consumption diminishes markedly when pain is controlled. He believes that most institutions would adopt and fund multidisciplinary pain care if fully informed of the cost benefits.

Although he acknowledged that many clinicians consider chronic pain patients challenging, Dr. Tauben said comprehensive pain management strategies are effective in most patients. After many years in general practice, Dr. Tauben switched to a focus on chronic pain because of the large unmet need and the success that can be achieved when a multidisciplinary treatment approach is applied.

“I became a pain specialist because it was the most satisfying part of my career,” Dr. Tauben reported.

To see the June 21 CDC data on opioid overdose, visit http//www.cdc.gov/drugoverdose/date/overdose.html. The March 15 MMWR report on the CDC guideline for prescribing opioids for chronic pain can be found at www.cdc.gov/mmwr/volumes/65/rr/6501e1.htm.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company. Dr. Tauben reported no potential financial conflicts of interest.

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LAKE BUENA VISTA, FLA. – Mortality related to prescription opioids is still climbing nationwide but not in centers or regions where there has been widespread implementation of guidelines for appropriate use, according to an expert involved in implementing guidelines in Washington state.

“If you follow guidelines for use of opioids, you can do what we did in Washington state and change the direction of those mortality curves,” reported David J. Tauben, MD, chief of pain medicine at the University of Washington, Seattle.

Dr. David Tauben

In data presented at the meeting, Dr. Tauben showed that the steep increase in opioid-related deaths and hospitalizations dating back to 1997 plateaued in Washington soon after the guidelines were implemented in 2007 and have followed a steep downward trajectory through the last year of follow-up in 2014.

Those data contrast starkly with nationwide figures updated June 21, 2016, on the Centers for Disease Control and Prevention website. In those figures, which also track data through 2014, the rates of deaths tied to drug overdose overall and to related to prescription opioids specifically have continued to climb. On the CDC website, which states that deaths related to prescription opioids have quadrupled since 1999, it was noted that more patients died from drug overdoses in 2014 than in any previous year. Prescriptions opioids were characterized as the “driving force” of this ongoing epidemic.

Washington state’s guidelines were created by the State Agency Medical Directors’ Group. But Dr. Tauben said that the principles of appropriate use of prescription opioids are well established and most recently were described in the CDC’s March 15, 2016, Morbidity and Mortality Weekly Report (MMWR). He suggested that adherence to these recommendations, which guide who to treat, how to treat, and how to assess for those most at risk for complications from opioids, can be expected to produce the same result.

Not least important, clinicians can keep the risk of overdose low by keeping doses low. Collating data from several studies, Dr. Tauben showed that the risk of overdose remains modest at opioid equivalent doses of 20 mg to about 50 mg per day. Graphically, the daily 50-mg equivalent was characterized as “the point of deflection where patients get in trouble.” In three of four published studies, the rise of rates in overdose was precipitous at about this point.

Keeping patients at a daily dose of 50 mg or below is further supported by the fact that “there is no evidence that a higher dose provides any additional benefit,” Dr. Tauben said. He also cited a study showing that patients at higher doses are more likely to have psychiatric comorbidity that complicates the pain complaint and may be better treated by alternative strategies.

At the University of Washington, chronic pain now is addressed routinely with a collaborative team approach that not only includes pain specialists but nursing care coordinators, pharmacists, physical therapists, and others, Dr. Tauben said. He considers increased physical activity, one of the goals in a collaborative multidisciplinary approach to chronic pain, a “miracle cure,” but acknowledged that designing comprehensive treatment that includes such strategies takes time and, at least initially, increases costs. However, he believes there is a clear return on investment.

“The evidence shows that effective control of chronic pain ultimately reduces costs,” Dr. Tauben said. Citing several studies, Dr. Tauben explained that chronic pain patients are major consumers of health care services and that consumption diminishes markedly when pain is controlled. He believes that most institutions would adopt and fund multidisciplinary pain care if fully informed of the cost benefits.

Although he acknowledged that many clinicians consider chronic pain patients challenging, Dr. Tauben said comprehensive pain management strategies are effective in most patients. After many years in general practice, Dr. Tauben switched to a focus on chronic pain because of the large unmet need and the success that can be achieved when a multidisciplinary treatment approach is applied.

“I became a pain specialist because it was the most satisfying part of my career,” Dr. Tauben reported.

To see the June 21 CDC data on opioid overdose, visit http//www.cdc.gov/drugoverdose/date/overdose.html. The March 15 MMWR report on the CDC guideline for prescribing opioids for chronic pain can be found at www.cdc.gov/mmwr/volumes/65/rr/6501e1.htm.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company. Dr. Tauben reported no potential financial conflicts of interest.

LAKE BUENA VISTA, FLA. – Mortality related to prescription opioids is still climbing nationwide but not in centers or regions where there has been widespread implementation of guidelines for appropriate use, according to an expert involved in implementing guidelines in Washington state.

“If you follow guidelines for use of opioids, you can do what we did in Washington state and change the direction of those mortality curves,” reported David J. Tauben, MD, chief of pain medicine at the University of Washington, Seattle.

Dr. David Tauben

In data presented at the meeting, Dr. Tauben showed that the steep increase in opioid-related deaths and hospitalizations dating back to 1997 plateaued in Washington soon after the guidelines were implemented in 2007 and have followed a steep downward trajectory through the last year of follow-up in 2014.

Those data contrast starkly with nationwide figures updated June 21, 2016, on the Centers for Disease Control and Prevention website. In those figures, which also track data through 2014, the rates of deaths tied to drug overdose overall and to related to prescription opioids specifically have continued to climb. On the CDC website, which states that deaths related to prescription opioids have quadrupled since 1999, it was noted that more patients died from drug overdoses in 2014 than in any previous year. Prescriptions opioids were characterized as the “driving force” of this ongoing epidemic.

Washington state’s guidelines were created by the State Agency Medical Directors’ Group. But Dr. Tauben said that the principles of appropriate use of prescription opioids are well established and most recently were described in the CDC’s March 15, 2016, Morbidity and Mortality Weekly Report (MMWR). He suggested that adherence to these recommendations, which guide who to treat, how to treat, and how to assess for those most at risk for complications from opioids, can be expected to produce the same result.

Not least important, clinicians can keep the risk of overdose low by keeping doses low. Collating data from several studies, Dr. Tauben showed that the risk of overdose remains modest at opioid equivalent doses of 20 mg to about 50 mg per day. Graphically, the daily 50-mg equivalent was characterized as “the point of deflection where patients get in trouble.” In three of four published studies, the rise of rates in overdose was precipitous at about this point.

Keeping patients at a daily dose of 50 mg or below is further supported by the fact that “there is no evidence that a higher dose provides any additional benefit,” Dr. Tauben said. He also cited a study showing that patients at higher doses are more likely to have psychiatric comorbidity that complicates the pain complaint and may be better treated by alternative strategies.

At the University of Washington, chronic pain now is addressed routinely with a collaborative team approach that not only includes pain specialists but nursing care coordinators, pharmacists, physical therapists, and others, Dr. Tauben said. He considers increased physical activity, one of the goals in a collaborative multidisciplinary approach to chronic pain, a “miracle cure,” but acknowledged that designing comprehensive treatment that includes such strategies takes time and, at least initially, increases costs. However, he believes there is a clear return on investment.

“The evidence shows that effective control of chronic pain ultimately reduces costs,” Dr. Tauben said. Citing several studies, Dr. Tauben explained that chronic pain patients are major consumers of health care services and that consumption diminishes markedly when pain is controlled. He believes that most institutions would adopt and fund multidisciplinary pain care if fully informed of the cost benefits.

Although he acknowledged that many clinicians consider chronic pain patients challenging, Dr. Tauben said comprehensive pain management strategies are effective in most patients. After many years in general practice, Dr. Tauben switched to a focus on chronic pain because of the large unmet need and the success that can be achieved when a multidisciplinary treatment approach is applied.

“I became a pain specialist because it was the most satisfying part of my career,” Dr. Tauben reported.

To see the June 21 CDC data on opioid overdose, visit http//www.cdc.gov/drugoverdose/date/overdose.html. The March 15 MMWR report on the CDC guideline for prescribing opioids for chronic pain can be found at www.cdc.gov/mmwr/volumes/65/rr/6501e1.htm.

The meeting was held by the American Pain Society and Global Academy for Medical Education. Global Academy and this news organization are owned by the same company. Dr. Tauben reported no potential financial conflicts of interest.

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