Pain

Chronic pain is persistent or recurring pain lasting more than 3 months past normal healing time. Primary care professionals usually refer patients experiencing chronic pain to pain specialists to better identify, treat, and manage the pain. Chronic noncancer-related pain affects more Americans than diabetes mellitus, cardiac disease, and cancer combined.¹ Veterans are no exception. The prevalence of severe pain was significantly higher in veterans compared with that of nonveterans who had back pain (21.6 vs 16.7%, respectively), jaw pain (37.5 vs 22.9%, respectively), severe headaches or migraine (26.4 vs 15.9%, respectively), and neck pain (27.7 vs 21.4%, respectively).² At an individual level, those who experience chronic pain can expect impaired functional capacity, reduced ability to work, sleep disturbance, reduced social interactions, and considerable psychological distress. At a societal level, the cost of treating chronic pain is exorbitant, exceeding $600 billion annually, yet treatment outcomes remain variable at best.³ Greater efforts are needed to improve and standardize patient outcomes.

Interventional pain procedures performed under fluoroscopic or ultrasound guidance by specialist physicians have shown mixed responses in previous studies. Past systematic reviews demonstrate reductions in pain scores after lumbar or caudal epidural steroid injections (ESIs) and radiofrequency ablation of nerves supplying lumbar and thoracic facet joints.^4-7 However, one review found insufficient evidence to support injection therapy for chronic low back pain.⁸ Unfortunately, the majority of the included studies evaluated outcomes using the visual analogue scale (VAS) or other limited factors, such as physical examination findings. Current biopsychosocial conceptualizations of chronic pain are beginning to recognize the complex nature of the experience of pain and highlighting the significance of multimodal management.⁹ It is vital that our assessment of chronic pain, like our treatment options, be multidimensional and reflect these underpinning principles.

The Pain Outcomes Questionnaire-For Veterans (POQ-VA) was developed within the Veterans Health Administration (VHA) by Clark and colleagues in 2003. It represents a brief but psychometrically sound pain outcomes instrument that assesses all key domains and meets accreditation body standards. The POQ-VA is valid and reliable for evaluating effectiveness of treatment of chronic noncancer pain in veterans in routine clinical practice.¹⁰ This review is the first study to use the POQ-VA to assess the impact of interventional pain procedures on veterans with chronic noncancer pain.

The aim of this study was to perform a retrospective review of POQ-VA scores before and after injection-based interventional treatment for chronic pain to determine whether the procedure affected patient outcomes. We hypothesized that POQ-VA scores would improve across multiple domains in the veteran population postprocedure. This study was approved by the Institutional Review Board (IRB-2018-053) at the Providence Veterans Affairs Medical Center (VAMC) in Rhode Island.

Methods

Using the Computerized Patient Record System, all adult veteran patients who had attended at least 2 appointments between April 1, 2009, and April 1, 2019 at the Providence VAMC interventional pain clinic were identified. POQ-VA reports were extracted provided the following criteria were met: (1) the veteran received an injection-based interventional treatment for chronic pain, including trigger point injections, ESIs, nerve blocks, and radiofrequency ablations; (2) the veteran completed POQ-VA both pre- and posttreatment; and (3) posttreatment POQ-VA reports were completed within 6 months of treatment. All patients who did not fit these criteria were excluded from the study.

After deidentification, 112 pre- and posttreatment POQ-VA reports were identified. All subsequent statistical analyses were conducted using Stata SE version 15. Descriptive statistics including mean, range, SD, and percent change were computed for POQ-VA domain—pain, mobility, activities of daily living (ADL), vitality, negative affect, fear, and total raw score—as well as for each POQ-VA question. Given that POQ-VA domain scores were found to be approximately normally distributed without outliers, domain scores were treated as continuous variables, and a paired samples t test was conducted to compare means among POQ-VA domains. Individual question responses were analyzed using nonparametric testing methods to account for the lack of normal distribution in each question, treating the range of 0 to 10 as an ordinal variable. A Wilcoxon matched-pairs signed-rank test was conducted to compare means among individual question responses before and after treatment.

Results

Of 112 included patients, 102 (91%) were male and 10 (9%) were female. The mean age was 62 years (range, 35-90). Diagnosis and procedures varied due to patient symptoms varying from muscle pain, nerve pain, degenerative disc disease, and osteoarthritis.

POQ-VA scores across all domains, including total raw score, showed statistically significant improvement after treatment (Table 1). Directionally, the POQ-VA scores for all 20 questions reflect a positive treatment response and 17 had statistically significant changes (P < .05) (Table 2). The changes in self-perceived energy level, safety, and feelings of tension were not statistically significant. Esteem had the greatest magnitude decrease, falling from 5.2 preprocedure to 3.8 postprocedure (P < .001). Other similarly significant magnitudes of improvement were seen from pre- to postprocedure in questions pertaining to grooming (2.2 to 1.6, P = .003) and the ability to use the bathroom (3.4 to 2.6, P < .001).

Discussion

The most important finding of this study was the ability of the POQ-VA to detect statistically significant positive responses to injection therapy across all domains. The largest improvements were in self-reported pain intensity, pain-related impairment in mobility and ADLs, and self-reported dysphoric effects. The single largest improvement posttreatment was a reduction in scores related to low self-esteem.

Chronic pain can be assessed in a variety of ways ranging from physical examination findings and subjective numerical ratings to extensive patient-reported questionnaires. The International Association for the Study of Pain acknowledges that pain is a complex experience and recommends assessment should be comprehensive.¹¹ Many patient-reported questionnaires are available to clinicians, including some that address pain in a specific body part, such as the Oswestry Low Back Pain Disability Questionnaire, or those that focus on depression or quality-of-life measures, such as the SF-36.^12,13

One major benefit of using the POQ-VA is its potential to demonstrate benefits across multiple domains, reflecting the complex nature of chronic pain. The POQ-VA also separates domain or scale scores, allowing clinicians to identify individuals with different patterns of dysfunction across domains.¹⁰ This separation also provides insight into which treatment options are best for chronic pain patients with predominant patterns or lower scores in certain domains. The use of a single summary score, as seen in other questionnaires such as the Roland-Morris Activity Scale, may conceal treatment-induced changes in specific outcome domains.¹⁴ Additionally, like many other similar instruments, the POQ-VA is easy to understand and use, requires no special training, takes little time to complete, and can be completed in person or over the phone.

As chronic pain has been studied further and its complexity recognized, more instruments have been developed and modified to reflect these new elements. There is no one scale applicable to all populations. A discussion about the strengths and weaknesses of each available assessment tool is outside the scope of this review. However, to date, the POQ-VA is the only instrument that has been validated to detect change following treatment of chronic pain in an exclusively veteran population.¹⁰ This validation emphasizes the importance of this study as it supports the use of this outcome measure to monitor treatment of pain in VA facilities.

One of the secondary findings indicated that injection therapy improved veterans’ physical activity levels and self-esteem and lowered pain scores as well as kinesiophobia and anxiety. The role of interventional procedures has been well established in the field of chronic pain, but their efficacy has been less clear. Injections are costly and not without risk, and these factors relegate them to fourth-line treatment options in most situations.¹⁵ Several meta-analyses have demonstrated small improvements in pain scores and patient-reported questionnaires after medial branch blocks, and lumbar or caudal ESIs for chronic back pain.^5-7 However, an updated Cochrane Review concluded that there was insufficient evidence to support the use of injection therapy in subacute and chronic low back pain.⁸ The review acknowledged the limited methodologic quality of the trials and could not definitively report that injection therapy did not have benefits for certain subgroups of patients. The ability of researchers to detect benefit from an intervention is intrinsically linked to how outcomes are determined. The most interesting finding of our study was the patient-reported improved self-esteem scores. Many trials included in the systematic reviews discussed used outcome measures that did not have the multidimensional scope to demonstrate such a potential benefit.

Limitations

Our relatively small sample size represents the main shortcoming of this study. Because many posttreatment questionnaires were never collected, unfortunately, much potential data was lost. Most procedures performed were corticosteroid injections for the treatment of low back pain. This represented a combination of lumbar ESI, caudal ESI, medial branch blocks, and sacroiliac joint injections. The limited numbers meant that a further regression analysis of each injection type was not possible. Since few interventions treated pain in other areas of the body, it is difficult to determine whether procedures such as hip joint injections and ilioinguinal nerve blocks provided overall benefit. In the same vein, there is an inability to comment on which injection for chronic low back pain was the most efficacious.

The veteran population, while similar to the general population experiencing chronic pain, is more likely to experience PTSD and other mental health conditions.² According to medical literature, no randomized controlled trials have been published examining pain interventions exclusively in veterans, so the applicability of these results needs further investigation. This study suggests there are potential benefits for the veteran population, not solely perhaps from receiving injection therapy, but to having access to an interventional pain clinic led by a pain physician within a network of other specialties. While limited by the inherent biases of a retrospective review, this study highlights the potential value in continuing to study this subgroup of patients, especially in the setting of an interdisciplinary approach.

Conclusions

The POQ-VA is the only instrument to date that has been validated to detect change following treatment of chronic pain in an exclusively veteran population. Our study is the first univariate analysis since the instrument’s validation in 2003. Our descriptive and inferential statistics suggest that the majority of veterans undergoing injection therapy for chronic pain had statistically significant improvements in POQ-VA measures within a 6-month period following treatment. In order to conduct more rigorous, multivariate studies, continued and more widespread use of the POQ-VA instrument is warranted.

Chronic pain is persistent or recurring pain lasting more than 3 months past normal healing time. Primary care professionals usually refer patients experiencing chronic pain to pain specialists to better identify, treat, and manage the pain. Chronic noncancer-related pain affects more Americans than diabetes mellitus, cardiac disease, and cancer combined.¹ Veterans are no exception. The prevalence of severe pain was significantly higher in veterans compared with that of nonveterans who had back pain (21.6 vs 16.7%, respectively), jaw pain (37.5 vs 22.9%, respectively), severe headaches or migraine (26.4 vs 15.9%, respectively), and neck pain (27.7 vs 21.4%, respectively).² At an individual level, those who experience chronic pain can expect impaired functional capacity, reduced ability to work, sleep disturbance, reduced social interactions, and considerable psychological distress. At a societal level, the cost of treating chronic pain is exorbitant, exceeding $600 billion annually, yet treatment outcomes remain variable at best.³ Greater efforts are needed to improve and standardize patient outcomes.

Interventional pain procedures performed under fluoroscopic or ultrasound guidance by specialist physicians have shown mixed responses in previous studies. Past systematic reviews demonstrate reductions in pain scores after lumbar or caudal epidural steroid injections (ESIs) and radiofrequency ablation of nerves supplying lumbar and thoracic facet joints.^4-7 However, one review found insufficient evidence to support injection therapy for chronic low back pain.⁸ Unfortunately, the majority of the included studies evaluated outcomes using the visual analogue scale (VAS) or other limited factors, such as physical examination findings. Current biopsychosocial conceptualizations of chronic pain are beginning to recognize the complex nature of the experience of pain and highlighting the significance of multimodal management.⁹ It is vital that our assessment of chronic pain, like our treatment options, be multidimensional and reflect these underpinning principles.

The Pain Outcomes Questionnaire-For Veterans (POQ-VA) was developed within the Veterans Health Administration (VHA) by Clark and colleagues in 2003. It represents a brief but psychometrically sound pain outcomes instrument that assesses all key domains and meets accreditation body standards. The POQ-VA is valid and reliable for evaluating effectiveness of treatment of chronic noncancer pain in veterans in routine clinical practice.¹⁰ This review is the first study to use the POQ-VA to assess the impact of interventional pain procedures on veterans with chronic noncancer pain.

The aim of this study was to perform a retrospective review of POQ-VA scores before and after injection-based interventional treatment for chronic pain to determine whether the procedure affected patient outcomes. We hypothesized that POQ-VA scores would improve across multiple domains in the veteran population postprocedure. This study was approved by the Institutional Review Board (IRB-2018-053) at the Providence Veterans Affairs Medical Center (VAMC) in Rhode Island.

Methods

Using the Computerized Patient Record System, all adult veteran patients who had attended at least 2 appointments between April 1, 2009, and April 1, 2019 at the Providence VAMC interventional pain clinic were identified. POQ-VA reports were extracted provided the following criteria were met: (1) the veteran received an injection-based interventional treatment for chronic pain, including trigger point injections, ESIs, nerve blocks, and radiofrequency ablations; (2) the veteran completed POQ-VA both pre- and posttreatment; and (3) posttreatment POQ-VA reports were completed within 6 months of treatment. All patients who did not fit these criteria were excluded from the study.

After deidentification, 112 pre- and posttreatment POQ-VA reports were identified. All subsequent statistical analyses were conducted using Stata SE version 15. Descriptive statistics including mean, range, SD, and percent change were computed for POQ-VA domain—pain, mobility, activities of daily living (ADL), vitality, negative affect, fear, and total raw score—as well as for each POQ-VA question. Given that POQ-VA domain scores were found to be approximately normally distributed without outliers, domain scores were treated as continuous variables, and a paired samples t test was conducted to compare means among POQ-VA domains. Individual question responses were analyzed using nonparametric testing methods to account for the lack of normal distribution in each question, treating the range of 0 to 10 as an ordinal variable. A Wilcoxon matched-pairs signed-rank test was conducted to compare means among individual question responses before and after treatment.

Results

Of 112 included patients, 102 (91%) were male and 10 (9%) were female. The mean age was 62 years (range, 35-90). Diagnosis and procedures varied due to patient symptoms varying from muscle pain, nerve pain, degenerative disc disease, and osteoarthritis.

POQ-VA scores across all domains, including total raw score, showed statistically significant improvement after treatment (Table 1). Directionally, the POQ-VA scores for all 20 questions reflect a positive treatment response and 17 had statistically significant changes (P < .05) (Table 2). The changes in self-perceived energy level, safety, and feelings of tension were not statistically significant. Esteem had the greatest magnitude decrease, falling from 5.2 preprocedure to 3.8 postprocedure (P < .001). Other similarly significant magnitudes of improvement were seen from pre- to postprocedure in questions pertaining to grooming (2.2 to 1.6, P = .003) and the ability to use the bathroom (3.4 to 2.6, P < .001).

Discussion

The most important finding of this study was the ability of the POQ-VA to detect statistically significant positive responses to injection therapy across all domains. The largest improvements were in self-reported pain intensity, pain-related impairment in mobility and ADLs, and self-reported dysphoric effects. The single largest improvement posttreatment was a reduction in scores related to low self-esteem.

Chronic pain can be assessed in a variety of ways ranging from physical examination findings and subjective numerical ratings to extensive patient-reported questionnaires. The International Association for the Study of Pain acknowledges that pain is a complex experience and recommends assessment should be comprehensive.¹¹ Many patient-reported questionnaires are available to clinicians, including some that address pain in a specific body part, such as the Oswestry Low Back Pain Disability Questionnaire, or those that focus on depression or quality-of-life measures, such as the SF-36.^12,13

One major benefit of using the POQ-VA is its potential to demonstrate benefits across multiple domains, reflecting the complex nature of chronic pain. The POQ-VA also separates domain or scale scores, allowing clinicians to identify individuals with different patterns of dysfunction across domains.¹⁰ This separation also provides insight into which treatment options are best for chronic pain patients with predominant patterns or lower scores in certain domains. The use of a single summary score, as seen in other questionnaires such as the Roland-Morris Activity Scale, may conceal treatment-induced changes in specific outcome domains.¹⁴ Additionally, like many other similar instruments, the POQ-VA is easy to understand and use, requires no special training, takes little time to complete, and can be completed in person or over the phone.

As chronic pain has been studied further and its complexity recognized, more instruments have been developed and modified to reflect these new elements. There is no one scale applicable to all populations. A discussion about the strengths and weaknesses of each available assessment tool is outside the scope of this review. However, to date, the POQ-VA is the only instrument that has been validated to detect change following treatment of chronic pain in an exclusively veteran population.¹⁰ This validation emphasizes the importance of this study as it supports the use of this outcome measure to monitor treatment of pain in VA facilities.

One of the secondary findings indicated that injection therapy improved veterans’ physical activity levels and self-esteem and lowered pain scores as well as kinesiophobia and anxiety. The role of interventional procedures has been well established in the field of chronic pain, but their efficacy has been less clear. Injections are costly and not without risk, and these factors relegate them to fourth-line treatment options in most situations.¹⁵ Several meta-analyses have demonstrated small improvements in pain scores and patient-reported questionnaires after medial branch blocks, and lumbar or caudal ESIs for chronic back pain.^5-7 However, an updated Cochrane Review concluded that there was insufficient evidence to support the use of injection therapy in subacute and chronic low back pain.⁸ The review acknowledged the limited methodologic quality of the trials and could not definitively report that injection therapy did not have benefits for certain subgroups of patients. The ability of researchers to detect benefit from an intervention is intrinsically linked to how outcomes are determined. The most interesting finding of our study was the patient-reported improved self-esteem scores. Many trials included in the systematic reviews discussed used outcome measures that did not have the multidimensional scope to demonstrate such a potential benefit.

Limitations

Our relatively small sample size represents the main shortcoming of this study. Because many posttreatment questionnaires were never collected, unfortunately, much potential data was lost. Most procedures performed were corticosteroid injections for the treatment of low back pain. This represented a combination of lumbar ESI, caudal ESI, medial branch blocks, and sacroiliac joint injections. The limited numbers meant that a further regression analysis of each injection type was not possible. Since few interventions treated pain in other areas of the body, it is difficult to determine whether procedures such as hip joint injections and ilioinguinal nerve blocks provided overall benefit. In the same vein, there is an inability to comment on which injection for chronic low back pain was the most efficacious.

The veteran population, while similar to the general population experiencing chronic pain, is more likely to experience PTSD and other mental health conditions.² According to medical literature, no randomized controlled trials have been published examining pain interventions exclusively in veterans, so the applicability of these results needs further investigation. This study suggests there are potential benefits for the veteran population, not solely perhaps from receiving injection therapy, but to having access to an interventional pain clinic led by a pain physician within a network of other specialties. While limited by the inherent biases of a retrospective review, this study highlights the potential value in continuing to study this subgroup of patients, especially in the setting of an interdisciplinary approach.

Conclusions

The POQ-VA is the only instrument to date that has been validated to detect change following treatment of chronic pain in an exclusively veteran population. Our study is the first univariate analysis since the instrument’s validation in 2003. Our descriptive and inferential statistics suggest that the majority of veterans undergoing injection therapy for chronic pain had statistically significant improvements in POQ-VA measures within a 6-month period following treatment. In order to conduct more rigorous, multivariate studies, continued and more widespread use of the POQ-VA instrument is warranted.

Chronic pain is persistent or recurring pain lasting more than 3 months past normal healing time. Primary care professionals usually refer patients experiencing chronic pain to pain specialists to better identify, treat, and manage the pain. Chronic noncancer-related pain affects more Americans than diabetes mellitus, cardiac disease, and cancer combined.¹ Veterans are no exception. The prevalence of severe pain was significantly higher in veterans compared with that of nonveterans who had back pain (21.6 vs 16.7%, respectively), jaw pain (37.5 vs 22.9%, respectively), severe headaches or migraine (26.4 vs 15.9%, respectively), and neck pain (27.7 vs 21.4%, respectively).² At an individual level, those who experience chronic pain can expect impaired functional capacity, reduced ability to work, sleep disturbance, reduced social interactions, and considerable psychological distress. At a societal level, the cost of treating chronic pain is exorbitant, exceeding $600 billion annually, yet treatment outcomes remain variable at best.³ Greater efforts are needed to improve and standardize patient outcomes.

Interventional pain procedures performed under fluoroscopic or ultrasound guidance by specialist physicians have shown mixed responses in previous studies. Past systematic reviews demonstrate reductions in pain scores after lumbar or caudal epidural steroid injections (ESIs) and radiofrequency ablation of nerves supplying lumbar and thoracic facet joints.^4-7 However, one review found insufficient evidence to support injection therapy for chronic low back pain.⁸ Unfortunately, the majority of the included studies evaluated outcomes using the visual analogue scale (VAS) or other limited factors, such as physical examination findings. Current biopsychosocial conceptualizations of chronic pain are beginning to recognize the complex nature of the experience of pain and highlighting the significance of multimodal management.⁹ It is vital that our assessment of chronic pain, like our treatment options, be multidimensional and reflect these underpinning principles.

The Pain Outcomes Questionnaire-For Veterans (POQ-VA) was developed within the Veterans Health Administration (VHA) by Clark and colleagues in 2003. It represents a brief but psychometrically sound pain outcomes instrument that assesses all key domains and meets accreditation body standards. The POQ-VA is valid and reliable for evaluating effectiveness of treatment of chronic noncancer pain in veterans in routine clinical practice.¹⁰ This review is the first study to use the POQ-VA to assess the impact of interventional pain procedures on veterans with chronic noncancer pain.

The aim of this study was to perform a retrospective review of POQ-VA scores before and after injection-based interventional treatment for chronic pain to determine whether the procedure affected patient outcomes. We hypothesized that POQ-VA scores would improve across multiple domains in the veteran population postprocedure. This study was approved by the Institutional Review Board (IRB-2018-053) at the Providence Veterans Affairs Medical Center (VAMC) in Rhode Island.

Methods

Using the Computerized Patient Record System, all adult veteran patients who had attended at least 2 appointments between April 1, 2009, and April 1, 2019 at the Providence VAMC interventional pain clinic were identified. POQ-VA reports were extracted provided the following criteria were met: (1) the veteran received an injection-based interventional treatment for chronic pain, including trigger point injections, ESIs, nerve blocks, and radiofrequency ablations; (2) the veteran completed POQ-VA both pre- and posttreatment; and (3) posttreatment POQ-VA reports were completed within 6 months of treatment. All patients who did not fit these criteria were excluded from the study.

After deidentification, 112 pre- and posttreatment POQ-VA reports were identified. All subsequent statistical analyses were conducted using Stata SE version 15. Descriptive statistics including mean, range, SD, and percent change were computed for POQ-VA domain—pain, mobility, activities of daily living (ADL), vitality, negative affect, fear, and total raw score—as well as for each POQ-VA question. Given that POQ-VA domain scores were found to be approximately normally distributed without outliers, domain scores were treated as continuous variables, and a paired samples t test was conducted to compare means among POQ-VA domains. Individual question responses were analyzed using nonparametric testing methods to account for the lack of normal distribution in each question, treating the range of 0 to 10 as an ordinal variable. A Wilcoxon matched-pairs signed-rank test was conducted to compare means among individual question responses before and after treatment.

Results

Of 112 included patients, 102 (91%) were male and 10 (9%) were female. The mean age was 62 years (range, 35-90). Diagnosis and procedures varied due to patient symptoms varying from muscle pain, nerve pain, degenerative disc disease, and osteoarthritis.

POQ-VA scores across all domains, including total raw score, showed statistically significant improvement after treatment (Table 1). Directionally, the POQ-VA scores for all 20 questions reflect a positive treatment response and 17 had statistically significant changes (P < .05) (Table 2). The changes in self-perceived energy level, safety, and feelings of tension were not statistically significant. Esteem had the greatest magnitude decrease, falling from 5.2 preprocedure to 3.8 postprocedure (P < .001). Other similarly significant magnitudes of improvement were seen from pre- to postprocedure in questions pertaining to grooming (2.2 to 1.6, P = .003) and the ability to use the bathroom (3.4 to 2.6, P < .001).

Discussion

The most important finding of this study was the ability of the POQ-VA to detect statistically significant positive responses to injection therapy across all domains. The largest improvements were in self-reported pain intensity, pain-related impairment in mobility and ADLs, and self-reported dysphoric effects. The single largest improvement posttreatment was a reduction in scores related to low self-esteem.

Chronic pain can be assessed in a variety of ways ranging from physical examination findings and subjective numerical ratings to extensive patient-reported questionnaires. The International Association for the Study of Pain acknowledges that pain is a complex experience and recommends assessment should be comprehensive.¹¹ Many patient-reported questionnaires are available to clinicians, including some that address pain in a specific body part, such as the Oswestry Low Back Pain Disability Questionnaire, or those that focus on depression or quality-of-life measures, such as the SF-36.^12,13

One major benefit of using the POQ-VA is its potential to demonstrate benefits across multiple domains, reflecting the complex nature of chronic pain. The POQ-VA also separates domain or scale scores, allowing clinicians to identify individuals with different patterns of dysfunction across domains.¹⁰ This separation also provides insight into which treatment options are best for chronic pain patients with predominant patterns or lower scores in certain domains. The use of a single summary score, as seen in other questionnaires such as the Roland-Morris Activity Scale, may conceal treatment-induced changes in specific outcome domains.¹⁴ Additionally, like many other similar instruments, the POQ-VA is easy to understand and use, requires no special training, takes little time to complete, and can be completed in person or over the phone.

As chronic pain has been studied further and its complexity recognized, more instruments have been developed and modified to reflect these new elements. There is no one scale applicable to all populations. A discussion about the strengths and weaknesses of each available assessment tool is outside the scope of this review. However, to date, the POQ-VA is the only instrument that has been validated to detect change following treatment of chronic pain in an exclusively veteran population.¹⁰ This validation emphasizes the importance of this study as it supports the use of this outcome measure to monitor treatment of pain in VA facilities.

One of the secondary findings indicated that injection therapy improved veterans’ physical activity levels and self-esteem and lowered pain scores as well as kinesiophobia and anxiety. The role of interventional procedures has been well established in the field of chronic pain, but their efficacy has been less clear. Injections are costly and not without risk, and these factors relegate them to fourth-line treatment options in most situations.¹⁵ Several meta-analyses have demonstrated small improvements in pain scores and patient-reported questionnaires after medial branch blocks, and lumbar or caudal ESIs for chronic back pain.^5-7 However, an updated Cochrane Review concluded that there was insufficient evidence to support the use of injection therapy in subacute and chronic low back pain.⁸ The review acknowledged the limited methodologic quality of the trials and could not definitively report that injection therapy did not have benefits for certain subgroups of patients. The ability of researchers to detect benefit from an intervention is intrinsically linked to how outcomes are determined. The most interesting finding of our study was the patient-reported improved self-esteem scores. Many trials included in the systematic reviews discussed used outcome measures that did not have the multidimensional scope to demonstrate such a potential benefit.

Limitations

Our relatively small sample size represents the main shortcoming of this study. Because many posttreatment questionnaires were never collected, unfortunately, much potential data was lost. Most procedures performed were corticosteroid injections for the treatment of low back pain. This represented a combination of lumbar ESI, caudal ESI, medial branch blocks, and sacroiliac joint injections. The limited numbers meant that a further regression analysis of each injection type was not possible. Since few interventions treated pain in other areas of the body, it is difficult to determine whether procedures such as hip joint injections and ilioinguinal nerve blocks provided overall benefit. In the same vein, there is an inability to comment on which injection for chronic low back pain was the most efficacious.

The veteran population, while similar to the general population experiencing chronic pain, is more likely to experience PTSD and other mental health conditions.² According to medical literature, no randomized controlled trials have been published examining pain interventions exclusively in veterans, so the applicability of these results needs further investigation. This study suggests there are potential benefits for the veteran population, not solely perhaps from receiving injection therapy, but to having access to an interventional pain clinic led by a pain physician within a network of other specialties. While limited by the inherent biases of a retrospective review, this study highlights the potential value in continuing to study this subgroup of patients, especially in the setting of an interdisciplinary approach.

Conclusions

The POQ-VA is the only instrument to date that has been validated to detect change following treatment of chronic pain in an exclusively veteran population. Our study is the first univariate analysis since the instrument’s validation in 2003. Our descriptive and inferential statistics suggest that the majority of veterans undergoing injection therapy for chronic pain had statistically significant improvements in POQ-VA measures within a 6-month period following treatment. In order to conduct more rigorous, multivariate studies, continued and more widespread use of the POQ-VA instrument is warranted.

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

A version of this article first appeared on Medscape.com.

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

A version of this article first appeared on Medscape.com.

CHICAGO – Access to medical cannabis (MC) cut opioid prescriptions for patients with chronic noncancer back pain and patients with osteoarthritis, according to preliminary data presented at the annual meeting of the American Academy of Orthopaedic Surgeons.

For those with chronic back pain, the average morphine milligram equivalents (MME) per day dropped from 15.1 to 11.0 (n = 186; P < .01). More than one-third of the patients (38.7%) stopped taking morphine after they filled prescriptions for medical cannabis.

LPETTET/Getty Images

Opioid prescriptions were filled 6 months before access to MC and then were compared with 6 months after access to MC.

In analyzing subgroups, the researchers found that patients who started at less than 15 MME/day and more than 15 MME/day showed significant decreases after filling the MC prescription.

Almost half (48.5%) of the patients in the group that started at less than 15 MME daily dropped to 0 MME/day, and 13.5% of patients who were getting more than 15 MME/day stopped using opioids.

Data on filled opioid prescriptions were gathered from a Prescription Drug Monitoring Program (PDMP) system for patients diagnosed with chronic musculoskeletal noncancer back pain who were eligible for MC access between February 2018 and July 2019.

Medical cannabis has shown benefit in treating chronic pain, but evidence has been limited on whether it can reduce opioid use, which can lead to substance abuse, addiction, overdose, and death, the researchers noted.

Researchers found that using MC via multiple routes of administration seemed to be important.

Patients who used only a single administration route showed a statistically insignificant decrease in MME/day from 20.0 to 15.1 (n = 68; P = .054), whereas patients who used two or more routes showed a significant decrease from 13.2 to 9.5 (n = 76; P < .01).

“We have many patients who are benefiting from a single route of delivery for chronic orthopedic pain,” Ari Greis, DO, a physical medicine and rehabilitation specialist in Bryn Mawr, Pa., and a coauthor of the MC studies for both back pain and OA, said in an interview. “However, our data shows a greater reduction in opioid consumption in patients using more than one route of delivery.”

He said delivery modes in the studies included vaporized cannabis oil or flower; sublingual tinctures; capsules or tablets; and topical lotions, creams, and salves.

Dr. Greis is the director of the medical cannabis department at Rothman Orthopaedic Institute in Bryn Mawr, and is a senior fellow in the Institute of Emerging Health Professions and the Lambert Center for the Study of Medicinal Cannabis and Hemp, both in Philadelphia.
 

Medical cannabis also reduces opioids for OA

The same team of researchers, using the data from the PDMP system, showed that medical cannabis also helped reduce opioid use for osteoarthritis.

For patients using opioids for OA, there was a significant decrease in average MME/day of prescriptions filled by patients following MC access – from 18.2 to 9.8 (n = 40; P < .05). The average drop in MME/day was 46.3%. The percentage of patients who stopped using opioids was 37.5%. Pain score on a 0-10 visual analog scale decreased significantly from 6.6 (n = 36) to 5.0 (n = 26; P < .01) at 3 months and 5.4 (n = 16; P < .05) at 6 months.

Gary Stewart, MD, an orthopedic surgeon in Morrow, Ga., who was not part of the studies, told this news organization that the studies offer good preliminary data to offer help with the opioid issue.

“I sometimes feel that we, as orthopedic surgeons and physicians in general, are working with one hand behind our back. We’re taking something that is a heroin or morphine derivative and giving it to our patients when we know it has a high risk of building tolerance and addiction. But at the same time, we have no alternative,” he said.

He said it’s important to remember the results from the relatively small study are preliminary and observational. People used different forms and amounts of MC and the data show only that prescriptions were filled, but not whether the cannabis was used. Prospective, controlled studies where opioids go head-to-head with MC are needed, he said.

“Still, this can lead us to more studies to give us an option [apart from] an opioid that we know is highly addictive,” he said.

Dr. Stewart is a member of the AAOS Opioid Task Force. Dr. Greis and several coauthors have disclosed no relevant financial relationships, and other coauthors report financial ties to companies unrelated to the research presented.

A version of this article first appeared on Medscape.com.

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

A version of this article first appeared on Medscape.com.

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

A version of this article first appeared on Medscape.com.

A French research team has developed a microRNA (miRNA) signature for diagnosing endometriosis through a simple saliva test. Its validation in a larger cohort could soon allow doctors to have a cheap, noninvasive, and accurate tool to use in diagnosing a disease that, for the time being, is difficult to identify with any certainty. The researchers suggest that their methodology could be used as a blueprint to investigate other pathologies, both benign and malignant.

ENDO-miRNA study

miRNAs regulate as much as 60% of gene expression at the posttranscriptional level. In the setting of endometriosis, several authors have evaluated the relevance of a blood-based miRNA signature, but the results are discordant because of methodological and control group issues. Other researchers have also sought to develop a miRNA saliva test. A French team wanted to determine whether it was possible to define a saliva-based diagnostic miRNome signature that would allow patients with and without endometriosis to be differentiated and, from there, develop the first specific diagnostic test for the disease.

The prospective ENDO-miRNA study included saliva samples obtained from women with chronic pelvic pain suggestive of endometriosis. Exploratory procedures were performed to look for lesions. All the patients underwent either a laparoscopic procedure (therapeutic or diagnostic laparoscopy) and/or MRI imaging. For the patients who underwent laparoscopy, diagnosis was confirmed by histology. For the patients diagnosed with endometriosis without laparoscopic evaluation, all had MRI imaging with features of deep endometriosis.

One part of the study involved the identification of a biomarker based on genomewide miRNA expression profiling by small RNA sequencing using next-generation sequencing. The second part involved the development of a saliva-based miRNA diagnostic signature according to expression and accuracy profiling using a random forest algorithm.
 

High sensitivity, specificity

Among the 200 patients (mean age, 31 years) enrolled in the study, 76.5% (n = 153) were diagnosed with endometriosis. On average, their pain was statistically more severe than that of the women in the control group. The Visual Analogue Scale (VAS) scores were, respectively: dysmenorrhea 6 versus 5.0 (P < .001), dyspareunia 5.28 versus 4.95 (P < .001), and urinary pain during menstruation 4.35 versus 2.84 (P < .001).

Next-generation sequencing identified an average of 2,561 expressed miRNAs in the saliva samples. The feature selection method generated a subset of 109 miRNAs composing the endometriosis diagnostic signature. Among those miRNAs, 29 were associated with the main signaling pathways of endometriosis: PI3K/AKT, PTEN, Wnt/beta-catenin, HIF1-alpha/NF kappa B, and YAP/TAZ/EGFR.

The accuracy and reproducibility of the signature were tested on several data sets randomly composed of the same proportion of controls and patients with endometriosis. The respective sensitivity, specificity, and area under the curve for the diagnostic miRNA signature were 96.7%, 100%, and 98.3%, respectively.

The study’s results support the use of a saliva-based miRNA signature for diagnosing whether a patient is discordant/complex (chronic pelvic pain suggestive of endometriosis and both negative clinical examination and imaging findings) or has early-stage or advanced-stage endometriosis.

A version of this article first appeared on Medscape.com.

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.

The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”

The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.

The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.

Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.

Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at sandoz4887@sedgwick.com to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.

A version of this article first appeared on Medscape.com.

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.

The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”

The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.

The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.

Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.

Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at sandoz4887@sedgwick.com to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.

A version of this article first appeared on Medscape.com.

Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.

The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”

The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.

The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.

Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.

Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at sandoz4887@sedgwick.com to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.

A version of this article first appeared on Medscape.com.

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

 

 

Results

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; jessica.uche@va.gov

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

 

 

Results

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; jessica.uche@va.gov

doi:10.12788/jcom.0089

From Neurology/Chronic Pain Management Services, Department of Veterans Affairs (VA) Maryland Health Care System, Baltimore VA Medical Center, Baltimore, MD (Dr. Uche), and School of Nursing, Washburn University, Topeka, KS (Drs. Jamison and Waugh).

Abstract

Objective: The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the Empower Veterans Program (EVP) offered by a Veterans Administration facility in the northeastern United States.

Methods: This quality improvement project used data collected from veterans with chronic pain who completed the veterans health care facility’s EVP between August 2017 and August 2019. Pre- and post-intervention data on pain intensity, pain interference, quality of life, and pain catastrophizing were compared using paired t-tests.

Results: Although data were abstracted from 115 patients, the final sample included 67 patients who completed both pre-and postintervention questionnaires. Baseline measures of completers and noncompleters were similar. Comparison of pre and post mean scores on completers showed statistically significant findings (P = .004) based on the Bonferroni correction. The medium and large effect sizes (Cohen’s d) indicated clinically significant improvements for veterans who completed the program. Veterans reported high levels of satisfaction with the program.

Conclusion: Veterans with chronic high-impact noncancer pain who completed the EVP had reduced pain intensity, pain interference, pain catastrophizing as well as improved quality of life and satisfaction with their health.

Keywords: musculoskeletal pain, Veterans Affairs, complementary and integrative health, acceptance and commitment therapy, mind-body therapies, whole health, multidisciplinary pain management.

More than 100 million American adults suffer from chronic pain; costs associated with managing chronic pain are approximately $635 billion each year.¹ Chronic pain is prevalent among military veterans, affecting one-third of the 9 million veterans who receive care from Veterans Health Administration (VHA) facilities.² The biopsychosocial impact of chronic pain on the general population, and specifically on veterans, has been compounded by the opioid crisis. The effects of chronic pain and the opioid crisis have fueled interest in the use of complementary and integrative health (CIH) modalities in the management of chronic noncancer pain. Providers are increasingly developing treatment programs that incorporate CIH in their management of chronic noncancer pain.

One such program is the Empower Veterans Program (EVP). Originally developed at the Atlanta Veterans Affairs Health Care System, the EVP is a CIH modality based on the biopsychosocial model of pain developed by psychiatrist George Engel in 1977.³ The biopsychosocial model of pain recognizes that pain is a complex, multidimensional, biopsychosocial experience. Under this model, the mind and body work in unison as interconnected entities. Because the model acknowledges biological, psychological, and social components of pain and illness,⁴ treatment focuses on all aspects of a person’s health, life, and relationships.

The EVP fits into the VHA Pain Management Stepped Care Model and is an adjunctive complement for that model.^5-7 The EVP complements care at the first step, where patient/family provide self-care and where care is provided by patient-aligned primary care teams, at the second step, which includes secondary consultation with multidisciplinary pain medicine specialty teams and other specialists, and at the third step, with the addition of tertiary interdisciplinary pain centers.

The VA Maryland Health Care System (VAMHCS) implemented the EVP as part of a quality improvement project for the management of chronic pain. The objectives of the program were to reduce pain intensity, pain catastrophizing, and pain interference, as well as improve functionality and quality of life among veterans with chronic high-impact noncancer pain. More than 2 years after the program was implemented, collected data had not been analyzed. The purpose of this quality improvement project was to abstract and analyze the previously collected data from veterans with high-impact chronic pain who attended an EVP offered by the VAMHCS. The results of the data analysis were used to inform decisions regarding the future of the program.

Methods

This quality improvement project used the Plan-Do-Study-Act (PDSA) process.⁸ The first 2 phases of the PDSA cycle (Plan and Do) were completed by a team of VA employees from the VAMHCS, who donated their time to establish and implement the program at the project site. This team consisted of psychologists, a physical therapist, a social worker, and a chaplain, and included support from medical administrative staff. This team planned and implemented the EVP at the VA facility based on the model developed at the Atlanta VA Health Care System. During the “Do” phase, the team collected data on pain intensity, pain interference, quality of life, and pain negative cognition (catastrophizing) before the intervention and post intervention. They also collected data on program outcome (patient treatment satisfaction) post intervention. Because these employees did not have time to retrieve and analyze the data, they welcomed the opportunity to have the data analyzed by the investigators during the Study phase of the PDSA cycle. Based on the results of the analysis, recommendations for program changes were made during the Act phase of the cycle.

Intervention

The EVP was developed as a 10-week (30 hours) interdisciplinary CIH approach that coached veterans with chronic pain to live fuller lives based on their individual values and what matters to them. EVP is the “What Else” management modality for the 5% of veterans with high-impact chronic pain.⁹ The EVP provided functional restoration through its components of whole health, mindfulness training, coaching calls, acceptance and commitment therapy, and mindful movement. It used the Wheel of Health with the 4 key components of me, self-care, professional care, and community.^10,11

Veterans who had a diagnosis of chronic nonmalignant pain for 3 months or more and who agreed to participate in the EVP at this facility attended 3-hour classes every Tuesday with a cohort of 8 to 12 peers and engaged in one-on-one coaching with interdisciplinary team members. During the class sessions, veterans were coached to understand and accept their pain and commit to maintaining function despite their pain. Mindful movement by the physical therapist emphasized the pivotal place of exercise in pain management. The therapist used the mantra “Motion is Lotion.”⁹ The guiding principle of the EVP was that small incremental changes can have a big impact on the individual’s whole life. Emphasis was placed on increasing self-efficacy and mindful awareness for veterans with high-impact pain by giving them “Skills before Pills.”⁹

Outcome Measures

Outcome measures included the Numerical Pain Rating Scale (NPRS), the Multidimensional Pain Inventory (MPI), the World Health Organization Quality of Life assessment (WHOQOL-BREF), the Pain Catastrophizing Scale (PCS), and the Pain Treatment Satisfaction Scale (PTSS). Cronbach alpha coefficients were calculated to assess internal consistency reliability of these measures in the sample of veterans who completed the EVP.

NPRS. The NPRS is ubiquitous as a screening tool in many health care environments and its use is mandated by the VA health care system.¹² The choice of the NPRS as the tool for pain screening in the VA health care system was based on a large body of research that supports the reliability and validity of the NPRS as a single index of pain intensity or severity. Studies suggest that the NPRS is valid for use in the assessment of acute, cancer, or chronic nonmalignant pain and in varied clinical settings.¹³ The NPRS has 4 items, each on a scale of 0 to 10. For the purpose of this project, only 3 items were used. The 3 items assessed the worst pain, usual pain, and the current pain (right now). The higher the score, the higher the pain intensity. Cronbach alpha coefficients on the NPRS obtained from the current sample of veterans were 0.85 on both pre- and postintervention assessments.

MPI. The MPI is an easily accessible, reliable, and valid self-report questionnaire that measures the impact of pain on an individual’s life, quality of social support, and general activity.¹⁴ This instrument is a short version of the West Haven-Yale MPI.¹⁵ The MPI contains 9 items rated on a scale from 0 to 6. The higher the score, the greater pain interference a person is experiencing. The MPI produces reliable, valid information for diagnostic purposes and for therapy outcome studies.¹⁶ The MPI had a Cronbach alpha of 0.90 on pre-intervention and 0.92 on postintervention assessments in the current sample.

WHOQOL-BREF. The WHOQOL-BREF is a measure of quality of life and is an abbreviated version of the WHOQOL-100. Quality of life is defined by the World Health Organization¹⁷ “as an individuals’ perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.” The WHOQOL-BREF contains 26 items. The first 2 items were examined separately; the first item asks individuals to rate their overall quality of life and the second asks individuals how satisfied they are with their health. The remaining 24 items were used to calculate the following 4 domain scores: physical health, psychological health, social relationship, and environment.¹⁸ Each item is measured on a scale of 1 to 5. Higher scores denote higher or better quality of life. Domain scores have demonstrated good reliability and validity.^19-21 Cronbach alpha coefficients for the domain subscales ranged from 0.63 to 0.84 in the current sample, with the lowest alphas for the 3-item Social Relationships Domain.

PCS. The PCS is a widely used measure of catastrophic thinking related to pain. Catastrophizing has been conceived by Sullivan and colleagues as “an exaggerated negative mental set brought to bear during actual or anticipated painful experience.”²² The PCS provides a total score and scores for the following subscales: rumination, magnification, and helplessness.²³ It has been used in a variety of chronic pain populations and has demonstrated good reliability and validity in clinical as well as nonclinical samples.^24-26 The PCS has 13 items rated on a scale of 0 to 4. Higher scores mean greater negative pain cognition (catastrophizing). In the current sample, the PCS total scale had a Cronbach alpha coefficient of 0.95 and 0.94 on the 2 assessments. The coefficients for the subscales ranged from 0.81 to 0.90.

PTSS. The PTSS is a 5-item tool that measures patient satisfaction with pain treatment. It includes items that address overall satisfaction, staff warmth, staff skill level, ease of scheduling appointments, and recommendation of the program to other veterans. It was derived from the post-treatment version of The Pain Outcome Questionnaire-VA and has demonstrated reliability and validity.²⁷ The questions are scaled from 0 to 10. High scores on the PTSS denote high patient satisfaction with the EVP. The Cronbach alpha coefficient on the PTSS obtained from the current sample was 0.80.

Data Gathering and Analysis

Prior to starting the Study phase, Washburn University’s Institutional Review Board (IRB) and the VA IRB approved the project. The VA IRB, through its affiliate, gave a Not Human Research Determination and granted a waiver of informed consent and the Health Insurance Portability and Accountability Act authorization. The VA facility’s Research and Development department also approved the quality improvement project.

Once these approvals were obtained, the Study phase began with the abstraction of retrospective data obtained from veterans who participated in the VA health care facility’s EVP between August 2017 and August 2019. Most of the measurement tools changed in August 2019, and for this reason data abstraction was limited to the time period August 2017 to August 2019. The first author (JUU) abstracted data for both program completers and noncompleters. The second (MJ) and third (SW) authors analyzed the data in SPSS 24 and calculated effect sizes.

Veterans who completed the program were compared to veterans who did not complete the program on age, gender, and baseline measures. The investigators used independent samples t-tests to compare completers and noncompleters on age, pain intensity, pain interference, quality of life, and pain catastrophizing. They used the chi-square test of independence to analyze the association between gender and program completion.

Data were included in the pre- and postintervention analysis if the veteran completed the NPRS, MPI, WHOQOL-BREF, and PCS pre and post intervention. This became an important eligibility requirement as some of the tools/measures were changed towards the end of the review period in 2019. Pre- and postintervention data on pain intensity, pain interference, quality of life, pain catastrophizing, and patient satisfaction were compared using paired samples t-test at .004 level of significance based on the Bonferroni correction.²⁸ Data on patient satisfaction with pain treatment were collected at program completion (week 8 or 10) and were analyzed using descriptive statistics.

Effect sizes (Cohen’s d) were calculated to determine the substantive significance or magnitude of the mean differences in scores. Effect sizes (expressed as absolute values of Cohen’s d) were calculated as the mean difference divided by the standard deviation. Values of 0.2 were considered a small effect size, 0.5 a medium effect size, and 0.8 a large effect size.²⁹

 

 

Results

Data were abstracted for 115 veterans who started the EVP. Of these, 48 left the program, leaving 67 veterans (58%) who completed the program. Completers and noncompleters were similar in age, gender, and baseline measures (Table 1). Fifty-three (79%) completers and 35 (73%) noncompleters were male. A chi-square test of independence showed no significant association between gender and program completion (χ^2₁ [N = 115] = .595, P = .440).

Comparison of pre-and postintervention mean scale scores resulted in statistically significant differences for all comparisons (Table 2). These comparisons yielded improvements in the desired direction. For example, the scores on the NPRS, the MPI, and the PCS (along with its subscales) decreased, revealing reductions in pain severity, the impact of pain on the veterans’ lives, and pain catastrophizing. The 2 individual item scores on the WHOQOL-BREF increased, indicating improvements in perceived quality of life and satisfaction with health. The domain scores on the WHOQOL-BREF increased, revealing improvements in pain-related quality of life. The moderate to large effect sizes indicated clinically significant improvements for veterans with chronic high-impact pain who completed the EVP.

Analysis of data obtained using the PTSS yielded high mean scores for items that focused on patient satisfaction with treatment (Table 3). Scaled statistics yielded a mean (SD) of 46.95 (4.40). These results denoted overall patient satisfaction with the EVP.

Discussion

The purpose of this quality improvement project was to abstract and analyze previously collected data from veterans with high-impact chronic pain who attended the EVP. Comparison of pre-intervention and postintervention data obtained from 67 veterans who completed the program revealed improvements in pain intensity, pain interference, negative cognition (catastrophizing), and quality of life. The differences were statistically significant and clinically meaningful, with medium and large effect sizes. In addition, veterans reported high satisfaction with the EVP.

The EVP includes CIH approaches that have demonstrated effectiveness among veterans and other populations with chronic pain. A wealth of studies, for example, support the effectiveness of CIH approaches among veterans.^30-34 Other studies focus on specific CIH approaches that are components of the EVP. Evidence supports, for example, the efficacy of mindfulness-based stress reduction,^35-39 acceptance and commitment therapy,^40-43 brief peer support intervention,⁴⁴ and interdisciplinary biopsychosocial rehabilitation.^45,46

While empirical evidence supports components of the EVP, only one study focused on the outcomes of the Atlanta VA EVP among veterans with chronic pain. Results of a qualitative study conducted by Penney and Haro⁴⁷ described the experience of veterans with the EVP. Those veterans reported adopting new self-care or lifestyle practices for pain management and health, accepting pain, being better able to adjust and set boundaries, feeling more in control, participating in life, and changing their medication use.

The mean baseline scores from the current sample were similar to samples of patients with chronic pain in other studies (NPRS,⁴⁸ MPI,⁴⁸ and PCS^48-51). After converting scores on the WHOQOL-BREF from those that ranged from 4 to 20 to those that ranged from 0 to 100,¹⁸ the scores from the current sample were similar to those of other studies of patients with chronic pain.^48,52,53Several strengths of the project should be noted. Data were collected using well established measurement tools that had previously demonstrated reliability and validity. All the tools used in data collection demonstrated good internal consistency reliabilities in the current sample of veterans. Weaknesses of the project include the use of a convenience sample of veterans and small sample size. Data were not available on the number of veterans who were offered participation or on how many veterans declined enrollment. The sample of veterans who chose to participate in the EVP may or may not have been representative of the population of veterans with high-impact chronic pain. As a pre- and postintervention design with no comparison group, the results are subject to multiple threats to internal validity, including the Hawthorne effect, maturation in the form of healing, and attrition. Reasons for leaving the program had not been recorded, so the investigators had no way of knowing factors that may have contributed to attrition. Also, data on when veterans left the program were unavailable. Research is needed with a control group to reduce the effect of confounding variables on the outcome measures. This project used data collected at a single VA facility, which limits its generalizability.

While completers and noncompleters of the EVP were similar on age, gender, and baseline measures, there may have been unidentified characteristics that influenced program completion. The investigators noticed the presence of more missing data among noncompleters compared to completers on the pre-intervention PCS; thus, noncompleters may have scored lower than completers on this instrument simply because there were more individual items that were unanswered/missing among this group of noncompleters.

Data were analyzed using a limited number of outcome measures that had previously been collected. Other outcome measures might include whether EVP participants reduced their use of medications, clinical resources, and personnel. Future projects, for example, could determine whether the EVP is effective in reducing opioid analgesic medication use and decreasing primary care and emergency department visits. Cost-benefit analyses could be completed to determine whether EVP is associated with financial savings.

Because no follow-up assessments were made to determine whether improvements were maintained over time, the project focus was limited to an evaluation of the short-term changes in the outcome measures. Future projects could include a follow-up assessment of the veterans 1- or 2-years post completion of the EVP.

Data for the project were collected prior to the COVID-19 pandemic, when the EVP was implemented through face-to-face meetings with participants and their peers. It is not clear how changes to the delivery of the program (such as offering it through telehealth) might impact veterans’ satisfaction with the program, willingness to complete it, and other variables of interest.

The results of this project were made available to stakeholders with recommendations for program expansion both at the current location and at other VA facilities, including the recommendation to hire additional personnel that would implement the program. As the VA network of facilities expand the EVP program and adapt it for telehealth delivery, the investigators recommended a similar analysis of data be performed following telehealth delivery. If delivery through telehealth is shown to improve outcome measures, the EVP could provide pain management treatment options for patients challenged by transportation barriers, including rural veterans.

Conclusion

This quality improvement project provided evidence of improvement in measures of pain severity, pain interference, negative cognition (catastrophizing), quality of life, and patient treatment satisfaction among veterans with chronic high-impact pain. Findings have been well received by the northeastern VA as well as the Veterans Integrated Systems Network 5. The results of the analyses were used to inform decisions regarding the future of the program.

Disclaimer: This material is the result of work supported with resources and the use of facilities at the VA Maryland Health Care System, Baltimore, Maryland. The views expressed are those of the authors and do not necessarily represent the views of the Department of Veterans Affairs or the United States Government.

Acknowledgments: The authors thank Dr. Arianna Perra, the recent past coordinator of the Empower Veterans Program (EVP), who provided initial insights and support that motivated the decision to evaluate the program. We also thank the veterans and VA EVP clinicians who contributed data for the evaluation, and Dr. Michael Saenger (Director, TelePain-EVP: EVP) and Dr. Robert Lavin for their ongoing support, care, and concern for veteran patients. We also thank Dr. Beverly Bradley and the neurology service administrative team for their guidance in the process of obtaining necessary VA approvals for this project.

Corresponding author: Jessica U. Uche, DNP, CRNP-Family; jessica.uche@va.gov

doi:10.12788/jcom.0089

Older adults admitted to post-acute settings frequently have complex rehabilitation needs and multimorbidity, which predisposes them to pain management challenges.^1,2 The prevalence of pain in post-acute and long-term care is as high as 65%, and opioid use is common among this population with 1 in 7 residents receiving long-term opioids.^3,4

Opioids that do not adequately control pain represent a missed opportunity for deprescribing. There is limited evidence regarding efficacy of long-term opioid use (> 90 days) for improving pain and physical functioning.⁵ In addition, long-term opioid use carries significant risks, including overdose-related death, dependence, and increased emergency department visits.⁵ These risks are likely to be pronounced among veterans receiving post-acute care (PAC) who are older, have comorbid psychiatric disorders, are prescribed several centrally acting medications, and experience substance use disorder (SUD).⁶

Older adults are at increased risk for opioid toxicity because of reduced drug clearance and smaller therapeutic window.⁵ Centers for Disease Control and Prevention (CDC) guidelines recommend frequently assessing patients for benefit in terms of sustained improvement in pain as well as physical function.⁵ If pain and functional improvements are minimal, opioid use and nonopioid pain management strategies should be considered. Some patients will struggle with this approach. Directly asking patients about the effectiveness of opioids is challenging. Opioid users with chronic pain frequently report problems with opioids even as they describe them as indispensable for pain management.^7,8

Earlier studies have assessed patient perspectives regarding opioid difficulties as well as their helpfulness, which could introduce recall bias. Patient-level factors that contribute to a global sense of distress, in addition to the presence of painful physical conditions, also could contribute to patients requesting opioids without experiencing adequate pain relief. One study in veterans residing in PAC facilities found that individuals with depression, posttraumatic stress disorder (PTSD), and SUD were more likely to report pain and receive scheduled analgesics; this effect persisted in individuals with PTSD even after adjusting for demographic and functional status variables.⁹ The study looked only at analgesics as a class and did not examine opioids specifically. It is possible that distressed individuals, such as those with uncontrolled depression, PTSD, and SUD, might be more likely to report high pain levels and receive opioids with inadequate benefit and increased risk. Identifying the primary condition causing distress and targeting treatment to that condition (ie, depression) is preferable to escalating opioids in an attempt to treat pain in the context of nonresponse. Assessing an individual’s aggregate response to opioids rather than relying on a single self-report is a useful addition to current pain management strategies.

The goal of this study was to pilot a method of identifying opioid-nonresponsive pain using administrative data, measure its prevalence in a PAC population of veterans, and explore clinical and demographic correlates with particular attention to variates that could indicate high levels of psychological and physical distress. Identifying pain that is poorly responsive to opioids would give clinicians the opportunity to avoid or minimize opioid use and prioritize treatments that are likely to improve the resident’s pain, quality of life, and physical function while minimizing recall bias. We hypothesized that pain that responds poorly to opioids would be prevalent among veterans residing in a PAC unit. We considered that veterans with pain poorly responsive to opioids would be more likely to have factors that would place them at increased risk of adverse effects, such as comorbid psychiatric conditions, history of SUD, and multimorbidity, providing further rationale for clinical equipoise in that population.⁶

Methods

This was a small, retrospective cross-sectional study using administrative data and chart review. The study included veterans who were administered opioids while residing in a single US Department of Veterans Affairs (VA) community living center PAC (CLC-PAC) unit during at least 1 of 4 nonconsecutive, random days in 2016 and 2017. The study was approved by the institutional review board of the Ann Arbor VA Health System (#2017-1034) as part of a larger project involving models of care in vulnerable older veterans.

Inclusion criteria were the presence of at least moderate pain (≥ 4 on a 0 to 10 scale); receiving ≥ 2 opioids ordered as needed over the prespecified 24-hour observation period; and having ≥ 2 pre-and postopioid administration pain scores during the observation period. Veterans who did not meet these criteria were excluded. At the time of initial sample selection, we did not capture information related to coprescribed analgesics, including a standing order of opioids. To obtain the sample, we initially characterized all veterans on the 4 days residing in the CLC-PAC unit as those reporting at least moderate pain (≥ 4) and those who reported no or mild pain (< 4). The cut point of 4 of 10 is consistent with moderate pain based on earlier work showing higher likelihood of pain that interferes with physical function.¹⁰ We then restricted the sample to veterans who received ≥ 2 opioids ordered as needed for pain and had ≥ 2 pre- and postopioid administration numeric pain rating scores during the 24-hour observation period. This methodology was chosen to enrich our sample for those who received opioids regularly for ongoing pain. Opioids were defined as full µ-opioid receptor agonists and included hydrocodone, oxycodone, morphine, hydromorphone, fentanyl, tramadol, and methadone.

Outcome of Interest

The primary outcome of interest was an individual’s response to as-needed opioids, which we defined as change in the pain score after opioid administration. The pre-opioid pain score was the score that immediately preceded administration of an as-needed opioid. The postopioid administration pain score was the first score after opioid administration if obtained within 3 hours of administration. Scores collected > 3 hours after opioid administration were excluded because they no longer accurately reflected the impact of the opioid due to the short half-lives. Observations were excluded if an opioid was administered without a recorded pain score; this occurred once for 6 individuals. Observations also were excluded if an opioid was administered but the data were captured on the following day (outside of the 24-hour window); this occurred once for 3 individuals.

We calculated a ∆ score by subtracting the postopioid pain rating score from the pre-opioid score. Individual ∆ scores were then averaged over the 24-hour period (range, 2-5 opioid doses). For example, if an individual reported a pre-opioid pain score of 10, and a postopioid pain score of 2, the ∆ was recorded as 8. If the individual’s next pre-opioid score was 10, and post-opioid score was 6, the ∆ was recorded as 4. ∆ scores over the 24-hour period were averaged together to determine that individual’s response to as-needed opioids. In the previous example, the mean ∆ score is 6. Lower mean ∆ scores reflect decreased responsiveness to opioids’ analgesic effect.

Demographic and clinical data were obtained from electronic health record review using a standardized assessment form. These data included information about medical and psychiatric comorbidities, specialist consultations, and CLC-PAC unit admission indications and diagnoses. Medications of interest were categorized as antidepressants, antipsychotics, benzodiazepines, muscle relaxants, hypnotics, stimulants, antiepileptic drugs/mood stabilizers (including gabapentin and pregabalin), and all adjuvant analgesics. Adjuvant analgesics were defined as medications administered for pain as documented by chart notes or those ordered as needed for pain, and analyzed as a composite variable. Antidepressants with analgesic properties (serotonin-norepinephrine reuptake inhibitors and tricyclic antidepressants) were considered adjuvant analgesics. Psychiatric information collected included presence of mood, anxiety, and psychotic disorders, and PTSD. SUD information was collected separately from other psychiatric disorders.

Analyses

The study population was described using tabulations for categorical data and means and standard deviations for continuous data. Responsiveness to opioids was analyzed as a continuous variable. Those with higher mean ∆ scores were considered to have pain relatively more responsive to opioids, while lower mean ∆ scores indicated pain less responsive to opioids. We constructed linear regression models controlling for average pre-opioid pain rating scores to explore associations between opioid responsiveness and variables of interest. All analyses were completed using Stata version 15. This study was not adequately powered to detect differences across the spectrum of opioid responsiveness, although the authors have reported differences in this article.

Results

Over the 4-day observational period there were 146 resident-days. Of these, 88 (60.3%) reported at least 1 pain score of ≥ 4. Of those, 61 (41.8%) received ≥ 1 as-needed opioid for pain. We identified 46 resident-days meeting study criteria of ≥ 2 pre- and postanalgesic scores. We identified 41 unique individuals (Figure 1). Two individuals were admitted to the CLC-PAC unit on 2 of the 4 observation days, and 1 individual was admitted to the CLC-PAC unit on 3 of the 4 observation days. For individuals admitted several days, we included data only from the initial observation day.

Response to opioids varied greatly in this sample. The mean (SD) ∆ pain score was 3.4 (1.6) and ranged from 0.5 to 6.3. Using linear regression, we found no relationship between admission indication, medical comorbidities (including active cancer), and opioid responsiveness (Table).

A poorer response to opioids was associated with a significantly higher as-needed opioid dosage (β = −0.02; 95% CI, −0.04 to −0.01; P = .002) as well as a trend toward higher total opioid dosage (β = −0.005; 95% CI, −0.01 to 0.0003; P = .06) (Figure 4). Thirty-eight (92.7%) participants received nonopioid adjuvant analgesics for pain. More than half (56.1%) received antidepressants or gabapentinoids (51.2%), although we did not assess whether they were prescribed for pain or another indication. We did not identify a relationship between any specific psychoactive drug class and opioid responsiveness in this sample.

Discussion

This exploratory study used readily available administrative data in a CLC-PAC unit to assess responsiveness to opioids via a numeric mean ∆ score, with higher values indicating more pain relief in response to opioids. We then constructed linear regression models to characterize the relationship between the mean ∆ score and factors known to be associated with difficult-to-control pain and psychosocial distress. As expected, opioid responsiveness was highly variable among residents; some residents experienced essentially no reduction in pain, on average, despite receiving opioids. Psychiatric comorbidity, higher dosage in OMEs, and the presence of a pain service consult significantly correlated with poorer response to opioids. To our knowledge, this is the first study to quantify opioid responsiveness and describe the relationship with clinical correlates in the understudied PAC population.

Earlier research has demonstrated a relationship between the presence of psychiatric disorders and increased likelihood of receiving any analgesics among veterans residing in PAC.⁹ Our study adds to the literature by quantifying opioid response using readily available administrative data and examining associations with psychiatric diagnoses. These findings highlight the possibility that attempting to treat high levels of pain by escalating the opioid dosage in patients with a comorbid psychiatric diagnosis should be re-addressed, particularly if there is no meaningful pain reduction at lower opioid dosages. Our sample had a variety of admission diagnoses and medical comorbidities, however, we did not identify a relationship with opioid responsiveness, including an active cancer diagnosis. Although SUDs were highly prevalent in our sample, there was no relationship with opioid responsiveness. This suggests that lack of response to opioids is not merely a matter of drug tolerance or an indication of drug-seeking behavior.

Factors Impacting Response

Many factors could affect whether an individual obtains an adequate analgesic response to opioids or other pain medications, including variations in genes encoding opioid receptors and hepatic enzymes involved in drug metabolism and an individual’s opioid exposure history.¹³ The phenomenon of requiring more drug to produce the same relief after repeated exposures (ie, tolerance) is well known.¹⁴ Opioid-induced hyperalgesia is a phenomenon whereby a patient’s overall pain increases while receiving opioids, but each opioid dose might be perceived as beneficial.¹⁵ Increasingly, psychosocial distress is an important factor in opioid response. Adverse selection is the process culminating in those with psychosocial distress and/or SUDs being prescribed more opioids for longer durations.¹⁶ Our data suggests that this process could play a role in PAC settings. In addition, exaggerating pain to obtain additional opioids for nonmedical purposes, such as euphoria or relaxation, also is possible.¹⁷

When clinically assessing an individual whose pain is not well controlled despite escalating opioid dosages, prescribers must consider which of these factors likely is predominant. However, the first step of determining who has a poor opioid response is not straightforward. Directly asking patients is challenging; many individuals perceive opioids to be helpful while simultaneously reporting inadequately controlled pain.^7,8 The primary value of this study is the possibility of providing prescribers a quick, simple method of assessing a patient’s response to opioids. Using this method, individuals who are responding poorly to opioids, including those who might exaggerate pain for secondary gain, could be identified. Health care professionals could consider revisiting pain management strategies, assess for the presence of OUD, or evaluate other contributors to inadequately controlled pain. Although we only collected data regarding response to opioids in this study, any pain medication administered as needed (ie, nonsteroidal anti-inflammatory drugs, acetaminophen) could be analyzed using this methodology, allowing identification of other helpful pain management strategies. We began the validation process with extensive chart review, but further validation is required before this method can be applied to routine clinical practice.

Patients who report uncontrolled pain despite receiving opioids are a clinically challenging population. The traditional strategy has been to escalate opioids, which is recommended by the World Health Organization stepladder approach for patients with cancer pain and limited life expectancy.¹⁸ Applying this approach to a general population of patients with chronic pain is ineffective and dangerous.¹⁹ The CDC and the VA/US Department of Defense (VA/DoD) guidelines both recommend carefully reassessing risks and benefits at total daily dosages > 50 OME and avoid increasing dosages to > 90 OME daily in most circumstances.^5,20 Our finding that participants taking higher dosages of opioids were not more likely to have better control over their pain supports this recommendation.

Limitations

This study has several limitations, the most significant is its small sample size because of the exploratory nature of the project. Results are based on a small pilot sample enriched to include individuals with at least moderate pain who receive opioids frequently at 1 VA CLC-PAC unit; therefore, the results might not be representative of all veterans or a more general population. Our small sample size limits power to detect small differences. Data collected should be used to inform formal power calculations before subsequent larger studies to select adequate sample size. Validation studies, including samples from the same population using different dates, which reproduce findings are an important step. Moreover, we only had data on a single dimension of pain (intensity/severity), as measured by the pain scale, which nursing staff used to make a real-time clinical decision of whether to administer an as-needed opioid. Future studies should consider using pain measures that provide multidimensional assessment (ie, severity, functional interference) and/or were developed specifically for veterans, such as the Defense and Veterans Pain Rating Scale.²¹

Our study was cross-sectional in nature and addressed a single 24-hour period of data per participant. The years of data collection (2016 and 2017) followed a decline in overall opioid prescribing that has continued, likely influenced by CDC and VA/DoD guidelines.²² It is unclear whether our observations are an accurate reflection of individuals’ response over time or whether prescribing practices in PAC have shifted.

We did not consider the type of pain being treated or explore clinicians’ reasons for prescribing opioids, therefore limiting our ability to know whether opioids were indicated. Information regarding OUD and other SUDs was limited to what was documented in the chart during the CLC-PAC unit admission. We did not have information on length of exposure to opioids. It is possible that opioid tolerance could play a role in reducing opioid responsiveness. However, simple tolerance would not be expected to explain robust correlations with psychiatric comorbidities. Also, simple tolerance would be expected to be overcome with higher opioid dosages, whereas our study demonstrates less responsiveness. These data suggests that some individuals’ pain might be poorly opioid responsive, and psychiatric factors could increase this risk. We used a novel data source in combination with chart review; to our knowledge, barcode medication administration data have not been used in this manner previously. Future work needs to validate this method, using larger sample sizes and several clinical sites. Finally, we used regression models that controlled for average pre-opioid pain rating scores, which is only 1 covariate important for examining effects. Larger studies with adequate power should control for multiple covariates known to be associated with pain and opioid response.

Conclusions

Opioid responsiveness is important clinically yet challenging to assess. This pilot study identifies a way of classifying pain as relatively opioid nonresponsive using administrative data but requires further validation before considering scaling for more general use. The possibility that a substantial percentage of residents in a CLC-PAC unit could be receiving increasing dosages of opioids without adequate benefit justifies the need for more research and underscores the need for prescribers to assess individuals frequently for ongoing benefit of opioids regardless of diagnosis or mechanism of pain.

Acknowledgments

The authors thank Andrzej Galecki, Corey Powell, and the University of Michigan Consulting for Statistics, Computing and Analytics Research Center for assistance with statistical analysis.

Older adults admitted to post-acute settings frequently have complex rehabilitation needs and multimorbidity, which predisposes them to pain management challenges.^1,2 The prevalence of pain in post-acute and long-term care is as high as 65%, and opioid use is common among this population with 1 in 7 residents receiving long-term opioids.^3,4

Opioids that do not adequately control pain represent a missed opportunity for deprescribing. There is limited evidence regarding efficacy of long-term opioid use (> 90 days) for improving pain and physical functioning.⁵ In addition, long-term opioid use carries significant risks, including overdose-related death, dependence, and increased emergency department visits.⁵ These risks are likely to be pronounced among veterans receiving post-acute care (PAC) who are older, have comorbid psychiatric disorders, are prescribed several centrally acting medications, and experience substance use disorder (SUD).⁶

Older adults are at increased risk for opioid toxicity because of reduced drug clearance and smaller therapeutic window.⁵ Centers for Disease Control and Prevention (CDC) guidelines recommend frequently assessing patients for benefit in terms of sustained improvement in pain as well as physical function.⁵ If pain and functional improvements are minimal, opioid use and nonopioid pain management strategies should be considered. Some patients will struggle with this approach. Directly asking patients about the effectiveness of opioids is challenging. Opioid users with chronic pain frequently report problems with opioids even as they describe them as indispensable for pain management.^7,8

Earlier studies have assessed patient perspectives regarding opioid difficulties as well as their helpfulness, which could introduce recall bias. Patient-level factors that contribute to a global sense of distress, in addition to the presence of painful physical conditions, also could contribute to patients requesting opioids without experiencing adequate pain relief. One study in veterans residing in PAC facilities found that individuals with depression, posttraumatic stress disorder (PTSD), and SUD were more likely to report pain and receive scheduled analgesics; this effect persisted in individuals with PTSD even after adjusting for demographic and functional status variables.⁹ The study looked only at analgesics as a class and did not examine opioids specifically. It is possible that distressed individuals, such as those with uncontrolled depression, PTSD, and SUD, might be more likely to report high pain levels and receive opioids with inadequate benefit and increased risk. Identifying the primary condition causing distress and targeting treatment to that condition (ie, depression) is preferable to escalating opioids in an attempt to treat pain in the context of nonresponse. Assessing an individual’s aggregate response to opioids rather than relying on a single self-report is a useful addition to current pain management strategies.

The goal of this study was to pilot a method of identifying opioid-nonresponsive pain using administrative data, measure its prevalence in a PAC population of veterans, and explore clinical and demographic correlates with particular attention to variates that could indicate high levels of psychological and physical distress. Identifying pain that is poorly responsive to opioids would give clinicians the opportunity to avoid or minimize opioid use and prioritize treatments that are likely to improve the resident’s pain, quality of life, and physical function while minimizing recall bias. We hypothesized that pain that responds poorly to opioids would be prevalent among veterans residing in a PAC unit. We considered that veterans with pain poorly responsive to opioids would be more likely to have factors that would place them at increased risk of adverse effects, such as comorbid psychiatric conditions, history of SUD, and multimorbidity, providing further rationale for clinical equipoise in that population.⁶

Methods

This was a small, retrospective cross-sectional study using administrative data and chart review. The study included veterans who were administered opioids while residing in a single US Department of Veterans Affairs (VA) community living center PAC (CLC-PAC) unit during at least 1 of 4 nonconsecutive, random days in 2016 and 2017. The study was approved by the institutional review board of the Ann Arbor VA Health System (#2017-1034) as part of a larger project involving models of care in vulnerable older veterans.

Inclusion criteria were the presence of at least moderate pain (≥ 4 on a 0 to 10 scale); receiving ≥ 2 opioids ordered as needed over the prespecified 24-hour observation period; and having ≥ 2 pre-and postopioid administration pain scores during the observation period. Veterans who did not meet these criteria were excluded. At the time of initial sample selection, we did not capture information related to coprescribed analgesics, including a standing order of opioids. To obtain the sample, we initially characterized all veterans on the 4 days residing in the CLC-PAC unit as those reporting at least moderate pain (≥ 4) and those who reported no or mild pain (< 4). The cut point of 4 of 10 is consistent with moderate pain based on earlier work showing higher likelihood of pain that interferes with physical function.¹⁰ We then restricted the sample to veterans who received ≥ 2 opioids ordered as needed for pain and had ≥ 2 pre- and postopioid administration numeric pain rating scores during the 24-hour observation period. This methodology was chosen to enrich our sample for those who received opioids regularly for ongoing pain. Opioids were defined as full µ-opioid receptor agonists and included hydrocodone, oxycodone, morphine, hydromorphone, fentanyl, tramadol, and methadone.

Outcome of Interest

The primary outcome of interest was an individual’s response to as-needed opioids, which we defined as change in the pain score after opioid administration. The pre-opioid pain score was the score that immediately preceded administration of an as-needed opioid. The postopioid administration pain score was the first score after opioid administration if obtained within 3 hours of administration. Scores collected > 3 hours after opioid administration were excluded because they no longer accurately reflected the impact of the opioid due to the short half-lives. Observations were excluded if an opioid was administered without a recorded pain score; this occurred once for 6 individuals. Observations also were excluded if an opioid was administered but the data were captured on the following day (outside of the 24-hour window); this occurred once for 3 individuals.

We calculated a ∆ score by subtracting the postopioid pain rating score from the pre-opioid score. Individual ∆ scores were then averaged over the 24-hour period (range, 2-5 opioid doses). For example, if an individual reported a pre-opioid pain score of 10, and a postopioid pain score of 2, the ∆ was recorded as 8. If the individual’s next pre-opioid score was 10, and post-opioid score was 6, the ∆ was recorded as 4. ∆ scores over the 24-hour period were averaged together to determine that individual’s response to as-needed opioids. In the previous example, the mean ∆ score is 6. Lower mean ∆ scores reflect decreased responsiveness to opioids’ analgesic effect.

Demographic and clinical data were obtained from electronic health record review using a standardized assessment form. These data included information about medical and psychiatric comorbidities, specialist consultations, and CLC-PAC unit admission indications and diagnoses. Medications of interest were categorized as antidepressants, antipsychotics, benzodiazepines, muscle relaxants, hypnotics, stimulants, antiepileptic drugs/mood stabilizers (including gabapentin and pregabalin), and all adjuvant analgesics. Adjuvant analgesics were defined as medications administered for pain as documented by chart notes or those ordered as needed for pain, and analyzed as a composite variable. Antidepressants with analgesic properties (serotonin-norepinephrine reuptake inhibitors and tricyclic antidepressants) were considered adjuvant analgesics. Psychiatric information collected included presence of mood, anxiety, and psychotic disorders, and PTSD. SUD information was collected separately from other psychiatric disorders.

Analyses

The study population was described using tabulations for categorical data and means and standard deviations for continuous data. Responsiveness to opioids was analyzed as a continuous variable. Those with higher mean ∆ scores were considered to have pain relatively more responsive to opioids, while lower mean ∆ scores indicated pain less responsive to opioids. We constructed linear regression models controlling for average pre-opioid pain rating scores to explore associations between opioid responsiveness and variables of interest. All analyses were completed using Stata version 15. This study was not adequately powered to detect differences across the spectrum of opioid responsiveness, although the authors have reported differences in this article.

Results

Over the 4-day observational period there were 146 resident-days. Of these, 88 (60.3%) reported at least 1 pain score of ≥ 4. Of those, 61 (41.8%) received ≥ 1 as-needed opioid for pain. We identified 46 resident-days meeting study criteria of ≥ 2 pre- and postanalgesic scores. We identified 41 unique individuals (Figure 1). Two individuals were admitted to the CLC-PAC unit on 2 of the 4 observation days, and 1 individual was admitted to the CLC-PAC unit on 3 of the 4 observation days. For individuals admitted several days, we included data only from the initial observation day.

Response to opioids varied greatly in this sample. The mean (SD) ∆ pain score was 3.4 (1.6) and ranged from 0.5 to 6.3. Using linear regression, we found no relationship between admission indication, medical comorbidities (including active cancer), and opioid responsiveness (Table).

A poorer response to opioids was associated with a significantly higher as-needed opioid dosage (β = −0.02; 95% CI, −0.04 to −0.01; P = .002) as well as a trend toward higher total opioid dosage (β = −0.005; 95% CI, −0.01 to 0.0003; P = .06) (Figure 4). Thirty-eight (92.7%) participants received nonopioid adjuvant analgesics for pain. More than half (56.1%) received antidepressants or gabapentinoids (51.2%), although we did not assess whether they were prescribed for pain or another indication. We did not identify a relationship between any specific psychoactive drug class and opioid responsiveness in this sample.

Discussion

This exploratory study used readily available administrative data in a CLC-PAC unit to assess responsiveness to opioids via a numeric mean ∆ score, with higher values indicating more pain relief in response to opioids. We then constructed linear regression models to characterize the relationship between the mean ∆ score and factors known to be associated with difficult-to-control pain and psychosocial distress. As expected, opioid responsiveness was highly variable among residents; some residents experienced essentially no reduction in pain, on average, despite receiving opioids. Psychiatric comorbidity, higher dosage in OMEs, and the presence of a pain service consult significantly correlated with poorer response to opioids. To our knowledge, this is the first study to quantify opioid responsiveness and describe the relationship with clinical correlates in the understudied PAC population.

Earlier research has demonstrated a relationship between the presence of psychiatric disorders and increased likelihood of receiving any analgesics among veterans residing in PAC.⁹ Our study adds to the literature by quantifying opioid response using readily available administrative data and examining associations with psychiatric diagnoses. These findings highlight the possibility that attempting to treat high levels of pain by escalating the opioid dosage in patients with a comorbid psychiatric diagnosis should be re-addressed, particularly if there is no meaningful pain reduction at lower opioid dosages. Our sample had a variety of admission diagnoses and medical comorbidities, however, we did not identify a relationship with opioid responsiveness, including an active cancer diagnosis. Although SUDs were highly prevalent in our sample, there was no relationship with opioid responsiveness. This suggests that lack of response to opioids is not merely a matter of drug tolerance or an indication of drug-seeking behavior.

Factors Impacting Response

Many factors could affect whether an individual obtains an adequate analgesic response to opioids or other pain medications, including variations in genes encoding opioid receptors and hepatic enzymes involved in drug metabolism and an individual’s opioid exposure history.¹³ The phenomenon of requiring more drug to produce the same relief after repeated exposures (ie, tolerance) is well known.¹⁴ Opioid-induced hyperalgesia is a phenomenon whereby a patient’s overall pain increases while receiving opioids, but each opioid dose might be perceived as beneficial.¹⁵ Increasingly, psychosocial distress is an important factor in opioid response. Adverse selection is the process culminating in those with psychosocial distress and/or SUDs being prescribed more opioids for longer durations.¹⁶ Our data suggests that this process could play a role in PAC settings. In addition, exaggerating pain to obtain additional opioids for nonmedical purposes, such as euphoria or relaxation, also is possible.¹⁷

When clinically assessing an individual whose pain is not well controlled despite escalating opioid dosages, prescribers must consider which of these factors likely is predominant. However, the first step of determining who has a poor opioid response is not straightforward. Directly asking patients is challenging; many individuals perceive opioids to be helpful while simultaneously reporting inadequately controlled pain.^7,8 The primary value of this study is the possibility of providing prescribers a quick, simple method of assessing a patient’s response to opioids. Using this method, individuals who are responding poorly to opioids, including those who might exaggerate pain for secondary gain, could be identified. Health care professionals could consider revisiting pain management strategies, assess for the presence of OUD, or evaluate other contributors to inadequately controlled pain. Although we only collected data regarding response to opioids in this study, any pain medication administered as needed (ie, nonsteroidal anti-inflammatory drugs, acetaminophen) could be analyzed using this methodology, allowing identification of other helpful pain management strategies. We began the validation process with extensive chart review, but further validation is required before this method can be applied to routine clinical practice.

Patients who report uncontrolled pain despite receiving opioids are a clinically challenging population. The traditional strategy has been to escalate opioids, which is recommended by the World Health Organization stepladder approach for patients with cancer pain and limited life expectancy.¹⁸ Applying this approach to a general population of patients with chronic pain is ineffective and dangerous.¹⁹ The CDC and the VA/US Department of Defense (VA/DoD) guidelines both recommend carefully reassessing risks and benefits at total daily dosages > 50 OME and avoid increasing dosages to > 90 OME daily in most circumstances.^5,20 Our finding that participants taking higher dosages of opioids were not more likely to have better control over their pain supports this recommendation.

Limitations

This study has several limitations, the most significant is its small sample size because of the exploratory nature of the project. Results are based on a small pilot sample enriched to include individuals with at least moderate pain who receive opioids frequently at 1 VA CLC-PAC unit; therefore, the results might not be representative of all veterans or a more general population. Our small sample size limits power to detect small differences. Data collected should be used to inform formal power calculations before subsequent larger studies to select adequate sample size. Validation studies, including samples from the same population using different dates, which reproduce findings are an important step. Moreover, we only had data on a single dimension of pain (intensity/severity), as measured by the pain scale, which nursing staff used to make a real-time clinical decision of whether to administer an as-needed opioid. Future studies should consider using pain measures that provide multidimensional assessment (ie, severity, functional interference) and/or were developed specifically for veterans, such as the Defense and Veterans Pain Rating Scale.²¹

Our study was cross-sectional in nature and addressed a single 24-hour period of data per participant. The years of data collection (2016 and 2017) followed a decline in overall opioid prescribing that has continued, likely influenced by CDC and VA/DoD guidelines.²² It is unclear whether our observations are an accurate reflection of individuals’ response over time or whether prescribing practices in PAC have shifted.

We did not consider the type of pain being treated or explore clinicians’ reasons for prescribing opioids, therefore limiting our ability to know whether opioids were indicated. Information regarding OUD and other SUDs was limited to what was documented in the chart during the CLC-PAC unit admission. We did not have information on length of exposure to opioids. It is possible that opioid tolerance could play a role in reducing opioid responsiveness. However, simple tolerance would not be expected to explain robust correlations with psychiatric comorbidities. Also, simple tolerance would be expected to be overcome with higher opioid dosages, whereas our study demonstrates less responsiveness. These data suggests that some individuals’ pain might be poorly opioid responsive, and psychiatric factors could increase this risk. We used a novel data source in combination with chart review; to our knowledge, barcode medication administration data have not been used in this manner previously. Future work needs to validate this method, using larger sample sizes and several clinical sites. Finally, we used regression models that controlled for average pre-opioid pain rating scores, which is only 1 covariate important for examining effects. Larger studies with adequate power should control for multiple covariates known to be associated with pain and opioid response.

Conclusions

Opioid responsiveness is important clinically yet challenging to assess. This pilot study identifies a way of classifying pain as relatively opioid nonresponsive using administrative data but requires further validation before considering scaling for more general use. The possibility that a substantial percentage of residents in a CLC-PAC unit could be receiving increasing dosages of opioids without adequate benefit justifies the need for more research and underscores the need for prescribers to assess individuals frequently for ongoing benefit of opioids regardless of diagnosis or mechanism of pain.

Acknowledgments

The authors thank Andrzej Galecki, Corey Powell, and the University of Michigan Consulting for Statistics, Computing and Analytics Research Center for assistance with statistical analysis.

Older adults admitted to post-acute settings frequently have complex rehabilitation needs and multimorbidity, which predisposes them to pain management challenges.^1,2 The prevalence of pain in post-acute and long-term care is as high as 65%, and opioid use is common among this population with 1 in 7 residents receiving long-term opioids.^3,4

Opioids that do not adequately control pain represent a missed opportunity for deprescribing. There is limited evidence regarding efficacy of long-term opioid use (> 90 days) for improving pain and physical functioning.⁵ In addition, long-term opioid use carries significant risks, including overdose-related death, dependence, and increased emergency department visits.⁵ These risks are likely to be pronounced among veterans receiving post-acute care (PAC) who are older, have comorbid psychiatric disorders, are prescribed several centrally acting medications, and experience substance use disorder (SUD).⁶

Older adults are at increased risk for opioid toxicity because of reduced drug clearance and smaller therapeutic window.⁵ Centers for Disease Control and Prevention (CDC) guidelines recommend frequently assessing patients for benefit in terms of sustained improvement in pain as well as physical function.⁵ If pain and functional improvements are minimal, opioid use and nonopioid pain management strategies should be considered. Some patients will struggle with this approach. Directly asking patients about the effectiveness of opioids is challenging. Opioid users with chronic pain frequently report problems with opioids even as they describe them as indispensable for pain management.^7,8

Earlier studies have assessed patient perspectives regarding opioid difficulties as well as their helpfulness, which could introduce recall bias. Patient-level factors that contribute to a global sense of distress, in addition to the presence of painful physical conditions, also could contribute to patients requesting opioids without experiencing adequate pain relief. One study in veterans residing in PAC facilities found that individuals with depression, posttraumatic stress disorder (PTSD), and SUD were more likely to report pain and receive scheduled analgesics; this effect persisted in individuals with PTSD even after adjusting for demographic and functional status variables.⁹ The study looked only at analgesics as a class and did not examine opioids specifically. It is possible that distressed individuals, such as those with uncontrolled depression, PTSD, and SUD, might be more likely to report high pain levels and receive opioids with inadequate benefit and increased risk. Identifying the primary condition causing distress and targeting treatment to that condition (ie, depression) is preferable to escalating opioids in an attempt to treat pain in the context of nonresponse. Assessing an individual’s aggregate response to opioids rather than relying on a single self-report is a useful addition to current pain management strategies.

The goal of this study was to pilot a method of identifying opioid-nonresponsive pain using administrative data, measure its prevalence in a PAC population of veterans, and explore clinical and demographic correlates with particular attention to variates that could indicate high levels of psychological and physical distress. Identifying pain that is poorly responsive to opioids would give clinicians the opportunity to avoid or minimize opioid use and prioritize treatments that are likely to improve the resident’s pain, quality of life, and physical function while minimizing recall bias. We hypothesized that pain that responds poorly to opioids would be prevalent among veterans residing in a PAC unit. We considered that veterans with pain poorly responsive to opioids would be more likely to have factors that would place them at increased risk of adverse effects, such as comorbid psychiatric conditions, history of SUD, and multimorbidity, providing further rationale for clinical equipoise in that population.⁶

Methods

This was a small, retrospective cross-sectional study using administrative data and chart review. The study included veterans who were administered opioids while residing in a single US Department of Veterans Affairs (VA) community living center PAC (CLC-PAC) unit during at least 1 of 4 nonconsecutive, random days in 2016 and 2017. The study was approved by the institutional review board of the Ann Arbor VA Health System (#2017-1034) as part of a larger project involving models of care in vulnerable older veterans.

Inclusion criteria were the presence of at least moderate pain (≥ 4 on a 0 to 10 scale); receiving ≥ 2 opioids ordered as needed over the prespecified 24-hour observation period; and having ≥ 2 pre-and postopioid administration pain scores during the observation period. Veterans who did not meet these criteria were excluded. At the time of initial sample selection, we did not capture information related to coprescribed analgesics, including a standing order of opioids. To obtain the sample, we initially characterized all veterans on the 4 days residing in the CLC-PAC unit as those reporting at least moderate pain (≥ 4) and those who reported no or mild pain (< 4). The cut point of 4 of 10 is consistent with moderate pain based on earlier work showing higher likelihood of pain that interferes with physical function.¹⁰ We then restricted the sample to veterans who received ≥ 2 opioids ordered as needed for pain and had ≥ 2 pre- and postopioid administration numeric pain rating scores during the 24-hour observation period. This methodology was chosen to enrich our sample for those who received opioids regularly for ongoing pain. Opioids were defined as full µ-opioid receptor agonists and included hydrocodone, oxycodone, morphine, hydromorphone, fentanyl, tramadol, and methadone.

Outcome of Interest

The primary outcome of interest was an individual’s response to as-needed opioids, which we defined as change in the pain score after opioid administration. The pre-opioid pain score was the score that immediately preceded administration of an as-needed opioid. The postopioid administration pain score was the first score after opioid administration if obtained within 3 hours of administration. Scores collected > 3 hours after opioid administration were excluded because they no longer accurately reflected the impact of the opioid due to the short half-lives. Observations were excluded if an opioid was administered without a recorded pain score; this occurred once for 6 individuals. Observations also were excluded if an opioid was administered but the data were captured on the following day (outside of the 24-hour window); this occurred once for 3 individuals.

We calculated a ∆ score by subtracting the postopioid pain rating score from the pre-opioid score. Individual ∆ scores were then averaged over the 24-hour period (range, 2-5 opioid doses). For example, if an individual reported a pre-opioid pain score of 10, and a postopioid pain score of 2, the ∆ was recorded as 8. If the individual’s next pre-opioid score was 10, and post-opioid score was 6, the ∆ was recorded as 4. ∆ scores over the 24-hour period were averaged together to determine that individual’s response to as-needed opioids. In the previous example, the mean ∆ score is 6. Lower mean ∆ scores reflect decreased responsiveness to opioids’ analgesic effect.

Demographic and clinical data were obtained from electronic health record review using a standardized assessment form. These data included information about medical and psychiatric comorbidities, specialist consultations, and CLC-PAC unit admission indications and diagnoses. Medications of interest were categorized as antidepressants, antipsychotics, benzodiazepines, muscle relaxants, hypnotics, stimulants, antiepileptic drugs/mood stabilizers (including gabapentin and pregabalin), and all adjuvant analgesics. Adjuvant analgesics were defined as medications administered for pain as documented by chart notes or those ordered as needed for pain, and analyzed as a composite variable. Antidepressants with analgesic properties (serotonin-norepinephrine reuptake inhibitors and tricyclic antidepressants) were considered adjuvant analgesics. Psychiatric information collected included presence of mood, anxiety, and psychotic disorders, and PTSD. SUD information was collected separately from other psychiatric disorders.

Analyses

The study population was described using tabulations for categorical data and means and standard deviations for continuous data. Responsiveness to opioids was analyzed as a continuous variable. Those with higher mean ∆ scores were considered to have pain relatively more responsive to opioids, while lower mean ∆ scores indicated pain less responsive to opioids. We constructed linear regression models controlling for average pre-opioid pain rating scores to explore associations between opioid responsiveness and variables of interest. All analyses were completed using Stata version 15. This study was not adequately powered to detect differences across the spectrum of opioid responsiveness, although the authors have reported differences in this article.

Results

Over the 4-day observational period there were 146 resident-days. Of these, 88 (60.3%) reported at least 1 pain score of ≥ 4. Of those, 61 (41.8%) received ≥ 1 as-needed opioid for pain. We identified 46 resident-days meeting study criteria of ≥ 2 pre- and postanalgesic scores. We identified 41 unique individuals (Figure 1). Two individuals were admitted to the CLC-PAC unit on 2 of the 4 observation days, and 1 individual was admitted to the CLC-PAC unit on 3 of the 4 observation days. For individuals admitted several days, we included data only from the initial observation day.

Response to opioids varied greatly in this sample. The mean (SD) ∆ pain score was 3.4 (1.6) and ranged from 0.5 to 6.3. Using linear regression, we found no relationship between admission indication, medical comorbidities (including active cancer), and opioid responsiveness (Table).

A poorer response to opioids was associated with a significantly higher as-needed opioid dosage (β = −0.02; 95% CI, −0.04 to −0.01; P = .002) as well as a trend toward higher total opioid dosage (β = −0.005; 95% CI, −0.01 to 0.0003; P = .06) (Figure 4). Thirty-eight (92.7%) participants received nonopioid adjuvant analgesics for pain. More than half (56.1%) received antidepressants or gabapentinoids (51.2%), although we did not assess whether they were prescribed for pain or another indication. We did not identify a relationship between any specific psychoactive drug class and opioid responsiveness in this sample.

Discussion

This exploratory study used readily available administrative data in a CLC-PAC unit to assess responsiveness to opioids via a numeric mean ∆ score, with higher values indicating more pain relief in response to opioids. We then constructed linear regression models to characterize the relationship between the mean ∆ score and factors known to be associated with difficult-to-control pain and psychosocial distress. As expected, opioid responsiveness was highly variable among residents; some residents experienced essentially no reduction in pain, on average, despite receiving opioids. Psychiatric comorbidity, higher dosage in OMEs, and the presence of a pain service consult significantly correlated with poorer response to opioids. To our knowledge, this is the first study to quantify opioid responsiveness and describe the relationship with clinical correlates in the understudied PAC population.

Earlier research has demonstrated a relationship between the presence of psychiatric disorders and increased likelihood of receiving any analgesics among veterans residing in PAC.⁹ Our study adds to the literature by quantifying opioid response using readily available administrative data and examining associations with psychiatric diagnoses. These findings highlight the possibility that attempting to treat high levels of pain by escalating the opioid dosage in patients with a comorbid psychiatric diagnosis should be re-addressed, particularly if there is no meaningful pain reduction at lower opioid dosages. Our sample had a variety of admission diagnoses and medical comorbidities, however, we did not identify a relationship with opioid responsiveness, including an active cancer diagnosis. Although SUDs were highly prevalent in our sample, there was no relationship with opioid responsiveness. This suggests that lack of response to opioids is not merely a matter of drug tolerance or an indication of drug-seeking behavior.

Factors Impacting Response

Many factors could affect whether an individual obtains an adequate analgesic response to opioids or other pain medications, including variations in genes encoding opioid receptors and hepatic enzymes involved in drug metabolism and an individual’s opioid exposure history.¹³ The phenomenon of requiring more drug to produce the same relief after repeated exposures (ie, tolerance) is well known.¹⁴ Opioid-induced hyperalgesia is a phenomenon whereby a patient’s overall pain increases while receiving opioids, but each opioid dose might be perceived as beneficial.¹⁵ Increasingly, psychosocial distress is an important factor in opioid response. Adverse selection is the process culminating in those with psychosocial distress and/or SUDs being prescribed more opioids for longer durations.¹⁶ Our data suggests that this process could play a role in PAC settings. In addition, exaggerating pain to obtain additional opioids for nonmedical purposes, such as euphoria or relaxation, also is possible.¹⁷

When clinically assessing an individual whose pain is not well controlled despite escalating opioid dosages, prescribers must consider which of these factors likely is predominant. However, the first step of determining who has a poor opioid response is not straightforward. Directly asking patients is challenging; many individuals perceive opioids to be helpful while simultaneously reporting inadequately controlled pain.^7,8 The primary value of this study is the possibility of providing prescribers a quick, simple method of assessing a patient’s response to opioids. Using this method, individuals who are responding poorly to opioids, including those who might exaggerate pain for secondary gain, could be identified. Health care professionals could consider revisiting pain management strategies, assess for the presence of OUD, or evaluate other contributors to inadequately controlled pain. Although we only collected data regarding response to opioids in this study, any pain medication administered as needed (ie, nonsteroidal anti-inflammatory drugs, acetaminophen) could be analyzed using this methodology, allowing identification of other helpful pain management strategies. We began the validation process with extensive chart review, but further validation is required before this method can be applied to routine clinical practice.

Patients who report uncontrolled pain despite receiving opioids are a clinically challenging population. The traditional strategy has been to escalate opioids, which is recommended by the World Health Organization stepladder approach for patients with cancer pain and limited life expectancy.¹⁸ Applying this approach to a general population of patients with chronic pain is ineffective and dangerous.¹⁹ The CDC and the VA/US Department of Defense (VA/DoD) guidelines both recommend carefully reassessing risks and benefits at total daily dosages > 50 OME and avoid increasing dosages to > 90 OME daily in most circumstances.^5,20 Our finding that participants taking higher dosages of opioids were not more likely to have better control over their pain supports this recommendation.

Limitations

This study has several limitations, the most significant is its small sample size because of the exploratory nature of the project. Results are based on a small pilot sample enriched to include individuals with at least moderate pain who receive opioids frequently at 1 VA CLC-PAC unit; therefore, the results might not be representative of all veterans or a more general population. Our small sample size limits power to detect small differences. Data collected should be used to inform formal power calculations before subsequent larger studies to select adequate sample size. Validation studies, including samples from the same population using different dates, which reproduce findings are an important step. Moreover, we only had data on a single dimension of pain (intensity/severity), as measured by the pain scale, which nursing staff used to make a real-time clinical decision of whether to administer an as-needed opioid. Future studies should consider using pain measures that provide multidimensional assessment (ie, severity, functional interference) and/or were developed specifically for veterans, such as the Defense and Veterans Pain Rating Scale.²¹

Our study was cross-sectional in nature and addressed a single 24-hour period of data per participant. The years of data collection (2016 and 2017) followed a decline in overall opioid prescribing that has continued, likely influenced by CDC and VA/DoD guidelines.²² It is unclear whether our observations are an accurate reflection of individuals’ response over time or whether prescribing practices in PAC have shifted.

We did not consider the type of pain being treated or explore clinicians’ reasons for prescribing opioids, therefore limiting our ability to know whether opioids were indicated. Information regarding OUD and other SUDs was limited to what was documented in the chart during the CLC-PAC unit admission. We did not have information on length of exposure to opioids. It is possible that opioid tolerance could play a role in reducing opioid responsiveness. However, simple tolerance would not be expected to explain robust correlations with psychiatric comorbidities. Also, simple tolerance would be expected to be overcome with higher opioid dosages, whereas our study demonstrates less responsiveness. These data suggests that some individuals’ pain might be poorly opioid responsive, and psychiatric factors could increase this risk. We used a novel data source in combination with chart review; to our knowledge, barcode medication administration data have not been used in this manner previously. Future work needs to validate this method, using larger sample sizes and several clinical sites. Finally, we used regression models that controlled for average pre-opioid pain rating scores, which is only 1 covariate important for examining effects. Larger studies with adequate power should control for multiple covariates known to be associated with pain and opioid response.

Conclusions

Opioid responsiveness is important clinically yet challenging to assess. This pilot study identifies a way of classifying pain as relatively opioid nonresponsive using administrative data but requires further validation before considering scaling for more general use. The possibility that a substantial percentage of residents in a CLC-PAC unit could be receiving increasing dosages of opioids without adequate benefit justifies the need for more research and underscores the need for prescribers to assess individuals frequently for ongoing benefit of opioids regardless of diagnosis or mechanism of pain.

Acknowledgments

The authors thank Andrzej Galecki, Corey Powell, and the University of Michigan Consulting for Statistics, Computing and Analytics Research Center for assistance with statistical analysis.

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

A version of this article first appeared on WebMD.com.

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

A version of this article first appeared on WebMD.com.

A visit with a friendly dog may be just what the doctor ordered for patients coming to the hospital for emergency care.

Patients in the emergency room who spent just 10 minutes with a trained therapy dog reported less pain, anxiety, and depression and improved well-being, researchers from the University of Saskatchewan in Canada found.

“The ER is an important community resource but also a scary place for most people,” James Stempien, MD, provincial department head of emergency medicine with the Saskatchewan Health Authority, who worked on the study, said in an interview.

“People tend to visit the ER on the worst day of their life, either for them or a loved one. Interacting with a therapy dog can make the ER visit a little calmer. We have also seen benefit for the staff that get to interact with the dogs as well,” he says.

“Thanks to our wonderful therapy dog volunteer teams, the cost is minimal and the result is priceless,” Dr. Stempien says.

The study, published in the journal PLOS One, builds on earlier “uncontrolled” studies by the Saskatchewan team.

Those studies showed that most ER patients wanted to visit with the therapy dog, if given a chance. After the encounter, patients reported feeling more comfortable, happier, and less distressed while waiting in the ER.

“A controlled trial was the natural next step,” says study investigator Colleen Dell, PhD, of One Health and Wellness at the University of Saskatchewan.

The study was done at the Royal University Hospital (RUH) in Saskatoon, Saskatchewan -- the first emergency department in Canada to introduce therapy dogs to improve the experience of waiting patients.

Nearly 200 adults visiting the ER received either a 10-minute visit with a therapy dog and its handler in addition to usual care or just usual care.

The therapy dog visit had a positive impact on patient pain and related measures of anxiety, depression, and well-being.

“This did not occur in patients in the ER who did not visit with a therapy dog.

“This gives us confidence in the intervention,” Dr. Dell says.

Pain is a major reason that patients come to the ER, and interactions with a therapy dog may distract from that pain, the researchers believe.

The study results lend more evidence to research that shows animals can help in medical settings, says Kara Rauscher, a licensed social worker and interim director of behavioral health for Nashville CARES in Tennessee, who wasn’t involved in the study.

“There are clearly opportunities to replicate this study in other emergency departments to strengthen our understanding of the potential benefits of these programs,” she says.

Part of her work at Nashville CARES, an AIDS service organization, has been supporting care that moves away from questions like, “What’s wrong with you?” to patient-focused questions like, “What happened to you?” It is a practice known as trauma-informed care.

“This includes bringing in therapy dogs for staff to spend time with during the workday; anecdotally, our staff reported a reduction in stress and improvements in mood,” Ms. Rauscher says.

A version of this article first appeared on WebMD.com.

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

A version of this article first appeared on Medscape.com.

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

A version of this article first appeared on Medscape.com.

Twelve physicians in Michigan and Ohio were sentenced to prison because of their involvement in distributing 6.6 million opioid pills, according to the U.S. Department of Justice (DOJ). The defendants’s activities also resulted in more than $250 million in false billings.

“It is unconscionable that doctors and health care professionals would violate their oath to do no harm and exploit vulnerable patients struggling with addiction,” said Assistant Attorney General Kenneth Polite Jr., of the Justice Department’s Criminal Division, in the announcement. “These are not just crimes of greed, these are crimes that make this country’s opioid crisis even worse – and that is why the department will continue to relentlessly pursue these cases.”

Francisco Patino, MD, 66, a Wayne County, Michigan-based emergency medicine physician and part owner of one of the clinics involved, purchased cars, jewelry, and vacations as a result of the fraudulent activity, according to federal officials. He will face sentencing at a later date on a variety of counts related to defrauding the United States, health care fraud, money laundering, and wire fraud after his conviction in a 2021 trial.

Prosecutors also allege that he laundered money through a diet program and spent funds on sponsoring mixed martial arts fighters, the Detroit News reported.

Mashiyat Rashid, Dr. Patino’s business partner and part owner of the Tri-County Wellness Group, was sentenced to 15 years in prison and ordered to pay more than $51 million in restitution in connection with his guilty plea to one count of conspiracy to commit health care fraud and wire fraud, in addition to one count of money laundering. As a result of the scheme, Mr. Rashid bought courtside tickets to the NBA Finals, expensive real estate, and private jet flights, according to the DOJ.

Gold bars, indoor basketball courts, luxury cars, and swimming pools were purchases secured by other defendants who were involved in the fraudulent scheme.

Court documents and evidence show that the physicians required that patients receive unnecessary and costly back injections in return for opioids, per the agency charged with enforcing federal law. The scheme, which took place from 2007 to 2018, involved a network of pain clinics across multiple states. Referred to as “pill mills” by the DOJ, the pain clinics dispensed the high-dosage prescriptions, such as oxycodone, to drug dealers and patients with opioid use disorder.

The procedures, billed to insurance, were for facet joint injections. According to the DOJ, the injections were chosen because they generated high reimbursements rather than being medically necessary.

The Detroit News reported in September that some of the medically unnecessary drugs prescribed by Dr. Patino, which included fentanyl, oxycodone, and oxymorphone, per an indictment, were resold “on the street.” Dr. Patino wrote prescriptions for more than 2.2 million pills between 2016 and 2017.

Dr. Patino and Mr. Rashid join physicians and others in the health care field, who are charged or sentenced for their involvement in the scheme. In total, five physicians were convicted in two separate trials and 18 defendants pleaded guilty, per the DOJ. Meanwhile, seven defendants await sentencing.

Included in this group were:

• Spilios Pappas, MD, 63, an emergency medicine specialist in Lucas County, Ohio, sentenced to nine years in prison and ordered to pay $32.2 million in restitution
• Joseph Betro, DO, 60, an emergency medicine physician from Oakland County, Mich., sentenced to nine years in prison and ordered to pay $27.4 million in restitution
• Tariq Omar, MD, 63, a pulmonologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $24.2 million in restitution
• Mohammed Zahoor, MD, 53, a neurologist from Oakland County, Mich., sentenced to eight years in prison and ordered to pay $36.6 million in restitution

The four physicians worked at various clinics under the Tri-County Wellness Group, operated by Mr. Rashid, according to federal officials. During their employment with the clinics, they defrauded Medicare of more than $150 million through the scheme that involved opioids for medically unnecessary services, the DOJ noted.

Shortly after being indicted, Dr. Pappas posted a fundraising page for his legal services, claiming he and the other doctors had no idea what was going on and that he was “sickened and nauseous” when learning of the details of the case.

More than $16 million was forfeited by the defendants to the United States, according to the DOJ.

A version of this article first appeared on Medscape.com.

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

A version of this article first appeared on Medscape.com.

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

A version of this article first appeared on Medscape.com.

PARIS – Following the suspension of the decree that banned the sale of cannabidiol (CBD) flowers, raw cannabis is again available in France for over-the-counter sales. The “feel-good” plant is praised for its relaxing properties.

Scott Harms/iStockphoto

The suspension of the ban, which lasted for 3 weeks, is a mixed blessing for businesses that sell CBD-based products in France. Professional organizations in this booming sector filed a petition with France’s highest administrative court, the Council of State. At the end of January, the court suspended the government decree that banned the sale of cannabis-derived CBD flowers and leaves; however, it has yet to hand down a final decision as to the legality of the decree.

In just a few years, numerous shops have opened across France. They no longer have to settle for selling processed CBD products such as chocolate, oils, cookies – even wine. They can resume the sale of CBD hemp, which mainly comes in clusters of flower buds and can be smoked or used as an infusion.

Cannabis-derived CBD must have less than 0.2% tetrahydrocannabinol (THC) to be considered “feel-good hemp,” which is used in various consumer goods (such as food, cosmetics, and e-cigarette liquids) and is praised for its calming effects. But not all hemp is the same. Medical hemp, which is currently in clinical trials, combines varying doses of CBD and THC. And then there is THC-rich psychotropic hemp, which is illegal to sell.

The government’s decree cites health concerns as a justification for the ban. While uncertainties remain, “research studies have shown that CBD acts on dopamine and serotonin receptors in the brain. ... Therefore, using CBD can produce psychoactive, sedative, and sleep-inducing effects.” In addition to a preventive approach, the authorities cite the difficulties in distinguishing cannabis-derived CBD from THC-rich illegal cannabis – difficulties that complicate efforts in the war on drugs.

The government’s position sows confusion among consumers, who are attracted by the arguments in favor of CBD and intrigued by the promise of the substance’s calming effects. This confusion is heightened by the fact that there are not enough scientific data either to declare that CBD poses a real risk or, alternatively, to confirm that it has beneficial effects. While some studies have suggested that CBD has a potential benefit for treating anxiety, pain, and sleep problems, others suggest that it may instead be a placebo effect.

What actual benefit can be expected from CBD-derived products, in particular from using the plant’s raw extracts? We asked Dan Velea, MD, an addiction psychiatrist in Paris, to give us his thoughts.

What do you think of the government’s position of banning the sale of cannabis-derived CBD flowers and leaves?

Dr. Velea: I don’t understand the reasoning behind this ban. Unlike THC, CBD is not an addictive substance. We’ve suspected that CBD had beneficial effects ever since noting that, just like THC, it could bind to the two types of cannabinoid receptors found in our bodies, CB1 and CB2, but without inducing a psychotropic effect or giving rise to dependence.

The CBD-derived products that are available on the market have infinitesimal amounts of THC – the threshold is 0.2% – which pose no risk. These products seem to be a particularly good alternative for certain at-risk users who are looking for a way that will help them cut down on their use of “traditional” cannabis, which has THC. However, due to a lack of research, the benefits of CBD cannot be confirmed.

Now that the decree’s been suspended, we can leave behind the ideological debate that has been built around cannabis in France. It’s time to focus only on discussions based on science. On that note, we also have to encourage people to do more research into cannabis’s therapeutic value.

You believe that CBD can help people cut down on their cannabis use. Is that based on what you see in your practice as an addiction specialist?

Dr. Velea: Some of my patients have been quite successful in cutting down on their cannabis use by switching to CBD. Knowing the risk and harm associated with the absorption of THC, they prefer to smoke CBD instead. Of course, they don’t get the same dazzling effect that’s produced by THC, very high concentrations of which are often found in cannabis. But for them, the sensation they get from CBD is still pleasant. They describe it as having a soothing and fun effect; they quite like it. Given that the vast majority of people use cannabis recreationally, we can consider that this effect is no small benefit.

Even those who are highly dependent prefer to alternate, using CBD during the day and having just one THC joint in the evening. This makes them feel a lot better. In addition, it clearly reduces the health risks. In my opinion, CBD can be viewed as an alternative for people whose cannabis use is problematic. If a patient asks me about it, I give them an unequivocal answer: There are fewer risks associated with CBD than with regular cannabis.

Isn’t there still a risk for abuse? A dose of cannabidiol that shouldn’t be exceeded?

Dr. Velea: Honestly, apart from the harmful effects of smoking CBD, I don’t see any health risks associated with its use. I’ve never had a patient present with complaints after using these products. No one has ever told me that they became addicted or experienced psychotropic effects. There are no changes in behavior, even at high doses. It should be mentioned that World Health Organization experts hold that there’s no abuse or dependence potential associated with the use of pure CBD. Furthermore, they say that the product is generally well tolerated.

What other actual benefits does CBD have? People mention its relaxing, even anxiolytic, effects.

Dr. Velea: CBD-derived products are praised for their relaxing properties, which particularly help improve one’s sleep. It’s a question of knowing whether these are actual benefits or whether a placebo effect is involved here – something that would be enhanced in a person who firmly believes that these products bring about a sense of well-being. Even when CBD is used for pain relief, we can’t rule out the placebo effect as playing an important role in the outcome.

Some patients with serious diseases have been able to find comfort by using CBD. However, because there haven’t been any well-designed randomized studies, we’ve never been able to show clearly that the beneficial effect comes from the product itself. It’s also possible that the soothing, muscle-relaxing effect induced by CBD’s stimulation of cannabinoid receptors is actually what’s helping to relieve the pain. But this has yet to be proved.

So, what position can a doctor take toward patients who express their desire to use CBD-derived products?

Dr. Velea: Without reliable studies to back them up, it’s difficult to say. Also, at the moment, there are legal gray areas that don’t allow doctors to take a position. As a result, users are put at a disadvantage and not given the opportunity to make the choice to use CBD-derived products in an informed manner. Even so, I think that as long as we don’t have scientific data, the use of these products must be limited to recreational use with the aim of bringing about relaxation. In the case of a sleep disorder, for example, doctors can’t replace standard therapeutic management aimed at improving the patient’s sleep cycles. For now, the only genuinely interesting aspect of CBD that I can see is that it makes it possible to cut down on the use of THC-containing cannabis.

A version of this article first appeared on Medscape.com.

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.

The nonprofit group Public Citizen has filed a petition with the U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA), arguing that the medication’s risks warrant additional safeguards.

Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).

Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.

Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
 

‘Widespread misuse’

There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.

Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.

“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”

This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.

It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.

As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
 

‘Unnoticed’ abuse

There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.

In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.

As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.

In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.

“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.

The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.

It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”

In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.

In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.

“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
 

FDA 2019 warning

In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.

These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.

The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.

A version of this article first appeared on Medscape.com.

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.

The nonprofit group Public Citizen has filed a petition with the U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA), arguing that the medication’s risks warrant additional safeguards.

Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).

Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.

Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
 

‘Widespread misuse’

There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.

Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.

“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”

This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.

It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.

As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
 

‘Unnoticed’ abuse

There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.

In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.

As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.

In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.

“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.

The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.

It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”

In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.

In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.

“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
 

FDA 2019 warning

In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.

These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.

The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.

A version of this article first appeared on Medscape.com.

In a bid to stop abuse and diversion of the anticonvulsant gabapentin, a watchdog group is petitioning federal regulators to make the drug a controlled substance.

The nonprofit group Public Citizen has filed a petition with the U.S. Food and Drug Administration and the Drug Enforcement Administration (DEA), arguing that the medication’s risks warrant additional safeguards.

Gabapentin is a generic drug, best known under the brand name Neurontin. The petition also covers the related drug gabapentin enacarbil (Horizant).

Public Citizen requested that gabapentin come under the DEA’s Schedule V category, which already includes the similar drug pregabalin (Lyrica). Schedule V is the lowest rung on the DEA’s drug schedule, meaning it has lower potential for abuse then Schedule I through IV drugs. This tier also includes cough preparations with less than 200 milligrams of codeine.

Classifying gabapentin as a Schedule V drug would facilitate better tracking of the drug’s use and misuse and put in place educational and limitation requirements to mitigate the risk of addiction, overdose, and death, Michael Abrams, MPH, PhD, senior health researcher with Public Citizen’s Health Research Group, and colleagues write in the petition.
 

‘Widespread misuse’

There is “substantial evidence of widespread misuse” of gabapentin, plausibly helped by “extraordinary levels of off-label prescribing,” Public Citizen said in the petition.

Some estimates have pegged off-label use at more than 90%, with gabapentin prescribed for indications such as chronic cough, hiccups, postoperative pain, and postmenopausal hot flashes, the group said.

“Moreover, there are numerous reports indicating that gabapentin is widely used and diverted on the street to induce ‘highs’ or otherwise self-medicate,” Public Citizen said. “Both gabapentin and pregabalin have been empirically linked to the opioid overdose epidemic as drugs that potentiate the activity of these oftentimes deadly analgesics.”

This news organization tried several times to reach Azurity for comment but did not receive a response. Pfizer included gabapentin in the portfolio of drugs used to create the Viatris spin-off, which took place in 2020. Pfizer referred this news organization to Viatris for comment, but it also did not respond.

It is unclear how the FDA and DEA will respond to the petition. Public Citizen has received a reply from the FDA, in which the agency acknowledged receipt of the petition. However, the “acceptance of the petition for filing is a procedural matter and in no way reflects the agency’s decision on the substantive merits of the petition,” the FDA said in a letter.

As is common practice, the agency assigned a docket number for the petition, FDA-2022-P-0149. The docket’s website allows interested parties to track the issue.
 

‘Unnoticed’ abuse

There have been rising concerns about risks and abuse of gabapentin in recent years. In its petition, Public Citizen noted that the United Kingdom and several U.S. states have already sought tighter control of gabapentin prescriptions.

In 2019, the United Kingdom announced it would reclassify both pregabalin and gabapentin as class C controlled substances because of the rising numbers of deaths linked to the drugs.

As of November 2020, seven states – Alabama, Kentucky, Michigan, North Dakota, Tennessee, Virginia, and West Virginia – had classified gabapentin as a schedule V drug, while another 12 states required prescription monitoring of the drug, Public Citizen noted.

In 2018, researchers at the University of Louisville, Kentucky, a state that has been hit particularly hard by the opioid crisis, tried to draw more attention to the risks of gabapentin.

“Amid the opioid epidemic, abuse of a different prescription painkiller has widely gone unnoticed,” the University said in a press release at the time.

The release highlighted a study led by Rachel Vickers Smith, PhD, assistant professor in the University of Louisville School of Nursing that was published in Psychology of Addictive Behaviors.

It included 33 individuals who reported recent recreational use of gabapentin. Use of the drug was combined with buprenorphine, other opioids, cocaine, and caffeine to produce effects such as muscle relaxation, pain reduction, sleep induction, feeling drunk, and feeling “high.”

In the press release, Dr. Vickers Smith said individuals who abuse gabapentin often mix it with opioids, marijuana, cocaine, and opioid treatment medication, compounding side effects to the central nervous system that include euphoria and sedation.

In addition, some individuals who primarily abused opioid pain medication have turned to gabapentin after law-enforcement actions made it more difficult to obtain prescription opioids, she noted.

“People are looking for other drugs to substitute for opioids, and gabapentin has filled that place for some,” Dr. Vickers Smith said. “Some have said it gives them a high similar to opioids.”
 

FDA 2019 warning

In 2019, the FDA issued a warning about serious breathing difficulties associated with gabapentin and pregabalin in patients with respiratory risk factors.

These factors include opioid use and other drugs that depress the central nervous system, as well as conditions such as chronic obstructive pulmonary disease that reduce lung function. Older patients are also at higher risk, the FDA said.

The agency noted that gabapentinoids are often co-prescribed with opioids for for medical conditions and abused in combination with opioids. Data collected in 2016 from an office-based physician survey showed 14% of patient encounters involving gabapentin also involved opioids, the FDA said.

“Our evaluation shows that the use of these medicines, often referred to as gabapentinoids, has been growing for prescribed medical use, as well as misuse and abuse,” the agency said in its 2019 alert.

A version of this article first appeared on Medscape.com.