Ted Bosworth

LONDON – Four questions from the eight-question COPD Assessment Test (CAT) provide about the same prognostic accuracy in patients with chronic obstructive pulmonary disease (COPD) as does the full CAT, according to an analysis presented at the annual congress of the European Respiratory Society.

When the four- and eight-question versions were compared for exacerbation and other clinical outcomes over a 1-year period of follow-up, “both strategies demonstrated similar discrimination,” reported Carlos H. Martinez, MD, division of pulmonary and critical care medicine, University of Michigan Health System, Ann Arbor.

The CAT is an eight-item tool for evaluating the health status of patients with COPD as well as for predicting risk of COPD-related events, particularly exacerbations. The test is designed for self-administration by patients. For each of the questions, which address symptoms and activity limitations, patients are asked to answer on a scale ranging from one (indicating no clinical burden) to five (indicating severe burden). Based on the maximum score of 40, a score below 10 signifies a low impact from COPD, a score of 10-20 signifies a medium impact, and a score above 20 signifies a high impact.

©designer491/Thinkstock

In this study, a simplified version of the CAT that employed just four of the questions was evaluated in 880 participants in the observational SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study), which was funded by the National Heart, Lung, and Blood Institute and has prospectively enrolled COPD patients at seven participating centers. Ever-smokers from SPIROMICS were eligible for this analysis if they had a forced expiratory volume in one second (FEV₁₎/forced vital capacity (FVC) ratio of greater than or equal to 0.70 and an FVC above the lower limit of normal.

The four questions that were retained were about cough, phlegm, chest tightness, and breathlessness. The four questions that were eliminated were about activity limitation, sleep, energy, and the effect of lung symptoms on willingness to leave the house.

With the traditional test, using a cut point of greater than or equal to 10, 51.8% were classified as having a significant COPD burden. In this group, 15.3% experienced one or more exacerbations during 1 year of follow-up. With the simplified version focused on respiratory-related symptoms alone and using a cut point of greater than or equal to 7, 45.8% were classified as having a significant COPD burden, and 15.6% had one or more exacerbations during the same period of follow-up.

“The two strategies largely identified the same individuals,” according to Dr. Martinez, who reported the agreement as 88.5% (Kappa 0.77; P less than .001). He further noted that there was no difference in the area under the curve (AUC) to predict exacerbations at 1 year.

In further analysis, “subjects identified by either method also had more depression and anxiety symptoms, poorer sleep quality, and greater fatigue [than did the lower risk group],” Dr. Martinez added.

An AUC ROC (receiver operating characteristic) statistical analysis to compare the traditional and abbreviated CATs for cross-sectional associations showed close agreement. The values were nearly identical for such variables as dyspnea, impairment as measured with the 6-minute walking distance (6MWD) test, and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ). Similarly, the AUC ROC values diverged little or not at all for longitudinal comparisons of any exacerbation or exacerbations requiring steroids or antibiotics.

The data from this study provide “a proof of concept that simpler strategies could be used for identifying these patients [at risk of exacerbations] in primary care,” Dr. Martinez maintained. Although further validation of this four-question assessment tool is needed, Dr. Martinez implied that there is value in a relatively rapid self-assessment tool that could be interpreted quickly by clinicians.

LONDON – Four questions from the eight-question COPD Assessment Test (CAT) provide about the same prognostic accuracy in patients with chronic obstructive pulmonary disease (COPD) as does the full CAT, according to an analysis presented at the annual congress of the European Respiratory Society.

When the four- and eight-question versions were compared for exacerbation and other clinical outcomes over a 1-year period of follow-up, “both strategies demonstrated similar discrimination,” reported Carlos H. Martinez, MD, division of pulmonary and critical care medicine, University of Michigan Health System, Ann Arbor.

The CAT is an eight-item tool for evaluating the health status of patients with COPD as well as for predicting risk of COPD-related events, particularly exacerbations. The test is designed for self-administration by patients. For each of the questions, which address symptoms and activity limitations, patients are asked to answer on a scale ranging from one (indicating no clinical burden) to five (indicating severe burden). Based on the maximum score of 40, a score below 10 signifies a low impact from COPD, a score of 10-20 signifies a medium impact, and a score above 20 signifies a high impact.

©designer491/Thinkstock

In this study, a simplified version of the CAT that employed just four of the questions was evaluated in 880 participants in the observational SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study), which was funded by the National Heart, Lung, and Blood Institute and has prospectively enrolled COPD patients at seven participating centers. Ever-smokers from SPIROMICS were eligible for this analysis if they had a forced expiratory volume in one second (FEV₁₎/forced vital capacity (FVC) ratio of greater than or equal to 0.70 and an FVC above the lower limit of normal.

The four questions that were retained were about cough, phlegm, chest tightness, and breathlessness. The four questions that were eliminated were about activity limitation, sleep, energy, and the effect of lung symptoms on willingness to leave the house.

With the traditional test, using a cut point of greater than or equal to 10, 51.8% were classified as having a significant COPD burden. In this group, 15.3% experienced one or more exacerbations during 1 year of follow-up. With the simplified version focused on respiratory-related symptoms alone and using a cut point of greater than or equal to 7, 45.8% were classified as having a significant COPD burden, and 15.6% had one or more exacerbations during the same period of follow-up.

“The two strategies largely identified the same individuals,” according to Dr. Martinez, who reported the agreement as 88.5% (Kappa 0.77; P less than .001). He further noted that there was no difference in the area under the curve (AUC) to predict exacerbations at 1 year.

In further analysis, “subjects identified by either method also had more depression and anxiety symptoms, poorer sleep quality, and greater fatigue [than did the lower risk group],” Dr. Martinez added.

An AUC ROC (receiver operating characteristic) statistical analysis to compare the traditional and abbreviated CATs for cross-sectional associations showed close agreement. The values were nearly identical for such variables as dyspnea, impairment as measured with the 6-minute walking distance (6MWD) test, and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ). Similarly, the AUC ROC values diverged little or not at all for longitudinal comparisons of any exacerbation or exacerbations requiring steroids or antibiotics.

The data from this study provide “a proof of concept that simpler strategies could be used for identifying these patients [at risk of exacerbations] in primary care,” Dr. Martinez maintained. Although further validation of this four-question assessment tool is needed, Dr. Martinez implied that there is value in a relatively rapid self-assessment tool that could be interpreted quickly by clinicians.

LONDON – Four questions from the eight-question COPD Assessment Test (CAT) provide about the same prognostic accuracy in patients with chronic obstructive pulmonary disease (COPD) as does the full CAT, according to an analysis presented at the annual congress of the European Respiratory Society.

When the four- and eight-question versions were compared for exacerbation and other clinical outcomes over a 1-year period of follow-up, “both strategies demonstrated similar discrimination,” reported Carlos H. Martinez, MD, division of pulmonary and critical care medicine, University of Michigan Health System, Ann Arbor.

The CAT is an eight-item tool for evaluating the health status of patients with COPD as well as for predicting risk of COPD-related events, particularly exacerbations. The test is designed for self-administration by patients. For each of the questions, which address symptoms and activity limitations, patients are asked to answer on a scale ranging from one (indicating no clinical burden) to five (indicating severe burden). Based on the maximum score of 40, a score below 10 signifies a low impact from COPD, a score of 10-20 signifies a medium impact, and a score above 20 signifies a high impact.

©designer491/Thinkstock

In this study, a simplified version of the CAT that employed just four of the questions was evaluated in 880 participants in the observational SPIROMICS (Subpopulations and Intermediate Outcomes in COPD Study), which was funded by the National Heart, Lung, and Blood Institute and has prospectively enrolled COPD patients at seven participating centers. Ever-smokers from SPIROMICS were eligible for this analysis if they had a forced expiratory volume in one second (FEV₁₎/forced vital capacity (FVC) ratio of greater than or equal to 0.70 and an FVC above the lower limit of normal.

The four questions that were retained were about cough, phlegm, chest tightness, and breathlessness. The four questions that were eliminated were about activity limitation, sleep, energy, and the effect of lung symptoms on willingness to leave the house.

With the traditional test, using a cut point of greater than or equal to 10, 51.8% were classified as having a significant COPD burden. In this group, 15.3% experienced one or more exacerbations during 1 year of follow-up. With the simplified version focused on respiratory-related symptoms alone and using a cut point of greater than or equal to 7, 45.8% were classified as having a significant COPD burden, and 15.6% had one or more exacerbations during the same period of follow-up.

“The two strategies largely identified the same individuals,” according to Dr. Martinez, who reported the agreement as 88.5% (Kappa 0.77; P less than .001). He further noted that there was no difference in the area under the curve (AUC) to predict exacerbations at 1 year.

In further analysis, “subjects identified by either method also had more depression and anxiety symptoms, poorer sleep quality, and greater fatigue [than did the lower risk group],” Dr. Martinez added.

An AUC ROC (receiver operating characteristic) statistical analysis to compare the traditional and abbreviated CATs for cross-sectional associations showed close agreement. The values were nearly identical for such variables as dyspnea, impairment as measured with the 6-minute walking distance (6MWD) test, and quality of life as measured by the St. George’s Respiratory Questionnaire (SGRQ). Similarly, the AUC ROC values diverged little or not at all for longitudinal comparisons of any exacerbation or exacerbations requiring steroids or antibiotics.

The data from this study provide “a proof of concept that simpler strategies could be used for identifying these patients [at risk of exacerbations] in primary care,” Dr. Martinez maintained. Although further validation of this four-question assessment tool is needed, Dr. Martinez implied that there is value in a relatively rapid self-assessment tool that could be interpreted quickly by clinicians.

LONDON – Having an elevated level of high-density lipoprotein cholesterol (HDL-C) is associated with an increased rate of lung function decline over time, according to results from a cohort analysis of more than 30,000 adults presented at the annual congress of the European Respiratory Society.

For forced expiratory volume in 1 second (FEV₁), “there was a highly statistically significant inverse association for HDL-C for both cross-sectional and longitudinal measures of lung function,” reported Elizabeth C. Oelsner, MD, Columbia University Medical Center, New York. Those in the top quartile for HDL-C, on average, had a 9-mL greater decline in FEV¹, compared with patients in the lowest quartile (P less than .001). To put this in perspective, Dr. Oelsner said this decline is comparable “to a 10-year increment in pack-years of smoking.”

The study, which pooled six population-based cohorts in the United States, included 31,843 adults for whom there were baseline HDL-C levels and at least two longitudinally collected spirometry readings. According to Dr. Oelsner, quality control criteria were rigorously applied. For example, spirometry measures were obtained according to contemporary standards issued by the American Thoracic Society (ATS).

The average age of the study patients was 57 years, and 45% were classified as never smokers. The mean FEV₁ decline over a median follow-up of 5 years was 37 mL per year (range of 22-49 mL/year across the six cohorts). Approximately 15% of individuals had airflow limitation at baseline. There were more than 300,000 total person-years of observation in the pooled data.

In a fully adjusted cross-sectional analysis, each 1 mmol/L increase (38.67 mg/dL) in HDL-C was associated with a 9-mL lower FEV₁, according to Dr. Oelsner. He said the list of adjusted variables included age, gender, pack-years of smoking, weight, and height.

Results were consistent across age groups, presence or absence of smoking history, body mass index, and the presence or absence of airflow limitations at baseline, according to Dr. Oelsner.

HDL-C’s inverse correlation with lung function has been shown in other studies, such as the MESA Lung Study, another population-based analysis, according to Dr. Oelsner. In that study, a 0.4% increase in emphysema on CT lung scans was observed for every 10 mg/dL increase in HDL-C (Am J Respir Crit Care Med. 2010;181:A2878).

In this study, “being in the highest quartile for HDL at baseline was associated with an odds ratio of 1.2 for incident airflow limitation relative to being in the lowest [quartile],” Dr. Oelsner said.

The risk of a decline in airway function from an elevated HDL-C, if confirmed, should be considered in the context of the well-known protective effect exerted by HDL against cardiovascular events, according to Dr. Oelsner. However, she added, these data suggest that “having an excessively high HDL-C may incur risk just as an excessively low HDL may incur risk.” She noted, “there may be a limitation to the good of the good cholesterol.”

When asked after these data were presented whether she would prefer to have a low or high HDL-C, Dr. Oelsner responded, “Everything in moderation.” She also suggested that studies of treatments designed to raise HDL-C to reduce cardiovascular risk should take lung function into consideration. She warned that adverse effects on lung function are a potential “off-target risk” from such therapies.

LONDON – Having an elevated level of high-density lipoprotein cholesterol (HDL-C) is associated with an increased rate of lung function decline over time, according to results from a cohort analysis of more than 30,000 adults presented at the annual congress of the European Respiratory Society.

For forced expiratory volume in 1 second (FEV₁), “there was a highly statistically significant inverse association for HDL-C for both cross-sectional and longitudinal measures of lung function,” reported Elizabeth C. Oelsner, MD, Columbia University Medical Center, New York. Those in the top quartile for HDL-C, on average, had a 9-mL greater decline in FEV¹, compared with patients in the lowest quartile (P less than .001). To put this in perspective, Dr. Oelsner said this decline is comparable “to a 10-year increment in pack-years of smoking.”

The study, which pooled six population-based cohorts in the United States, included 31,843 adults for whom there were baseline HDL-C levels and at least two longitudinally collected spirometry readings. According to Dr. Oelsner, quality control criteria were rigorously applied. For example, spirometry measures were obtained according to contemporary standards issued by the American Thoracic Society (ATS).

The average age of the study patients was 57 years, and 45% were classified as never smokers. The mean FEV₁ decline over a median follow-up of 5 years was 37 mL per year (range of 22-49 mL/year across the six cohorts). Approximately 15% of individuals had airflow limitation at baseline. There were more than 300,000 total person-years of observation in the pooled data.

In a fully adjusted cross-sectional analysis, each 1 mmol/L increase (38.67 mg/dL) in HDL-C was associated with a 9-mL lower FEV₁, according to Dr. Oelsner. He said the list of adjusted variables included age, gender, pack-years of smoking, weight, and height.

Results were consistent across age groups, presence or absence of smoking history, body mass index, and the presence or absence of airflow limitations at baseline, according to Dr. Oelsner.

HDL-C’s inverse correlation with lung function has been shown in other studies, such as the MESA Lung Study, another population-based analysis, according to Dr. Oelsner. In that study, a 0.4% increase in emphysema on CT lung scans was observed for every 10 mg/dL increase in HDL-C (Am J Respir Crit Care Med. 2010;181:A2878).

In this study, “being in the highest quartile for HDL at baseline was associated with an odds ratio of 1.2 for incident airflow limitation relative to being in the lowest [quartile],” Dr. Oelsner said.

The risk of a decline in airway function from an elevated HDL-C, if confirmed, should be considered in the context of the well-known protective effect exerted by HDL against cardiovascular events, according to Dr. Oelsner. However, she added, these data suggest that “having an excessively high HDL-C may incur risk just as an excessively low HDL may incur risk.” She noted, “there may be a limitation to the good of the good cholesterol.”

When asked after these data were presented whether she would prefer to have a low or high HDL-C, Dr. Oelsner responded, “Everything in moderation.” She also suggested that studies of treatments designed to raise HDL-C to reduce cardiovascular risk should take lung function into consideration. She warned that adverse effects on lung function are a potential “off-target risk” from such therapies.

LONDON – Having an elevated level of high-density lipoprotein cholesterol (HDL-C) is associated with an increased rate of lung function decline over time, according to results from a cohort analysis of more than 30,000 adults presented at the annual congress of the European Respiratory Society.

For forced expiratory volume in 1 second (FEV₁), “there was a highly statistically significant inverse association for HDL-C for both cross-sectional and longitudinal measures of lung function,” reported Elizabeth C. Oelsner, MD, Columbia University Medical Center, New York. Those in the top quartile for HDL-C, on average, had a 9-mL greater decline in FEV¹, compared with patients in the lowest quartile (P less than .001). To put this in perspective, Dr. Oelsner said this decline is comparable “to a 10-year increment in pack-years of smoking.”

The study, which pooled six population-based cohorts in the United States, included 31,843 adults for whom there were baseline HDL-C levels and at least two longitudinally collected spirometry readings. According to Dr. Oelsner, quality control criteria were rigorously applied. For example, spirometry measures were obtained according to contemporary standards issued by the American Thoracic Society (ATS).

The average age of the study patients was 57 years, and 45% were classified as never smokers. The mean FEV₁ decline over a median follow-up of 5 years was 37 mL per year (range of 22-49 mL/year across the six cohorts). Approximately 15% of individuals had airflow limitation at baseline. There were more than 300,000 total person-years of observation in the pooled data.

In a fully adjusted cross-sectional analysis, each 1 mmol/L increase (38.67 mg/dL) in HDL-C was associated with a 9-mL lower FEV₁, according to Dr. Oelsner. He said the list of adjusted variables included age, gender, pack-years of smoking, weight, and height.

Results were consistent across age groups, presence or absence of smoking history, body mass index, and the presence or absence of airflow limitations at baseline, according to Dr. Oelsner.

HDL-C’s inverse correlation with lung function has been shown in other studies, such as the MESA Lung Study, another population-based analysis, according to Dr. Oelsner. In that study, a 0.4% increase in emphysema on CT lung scans was observed for every 10 mg/dL increase in HDL-C (Am J Respir Crit Care Med. 2010;181:A2878).

In this study, “being in the highest quartile for HDL at baseline was associated with an odds ratio of 1.2 for incident airflow limitation relative to being in the lowest [quartile],” Dr. Oelsner said.

The risk of a decline in airway function from an elevated HDL-C, if confirmed, should be considered in the context of the well-known protective effect exerted by HDL against cardiovascular events, according to Dr. Oelsner. However, she added, these data suggest that “having an excessively high HDL-C may incur risk just as an excessively low HDL may incur risk.” She noted, “there may be a limitation to the good of the good cholesterol.”

When asked after these data were presented whether she would prefer to have a low or high HDL-C, Dr. Oelsner responded, “Everything in moderation.” She also suggested that studies of treatments designed to raise HDL-C to reduce cardiovascular risk should take lung function into consideration. She warned that adverse effects on lung function are a potential “off-target risk” from such therapies.

LONDON – AF-219, a promising targeted therapy for chronic cough derailed by taste disturbances, has been revived by new studies suggesting that there is a therapeutic window that preserves benefits but reduces the risk of the adverse effect, according to new data presented at the annual congress of the European Respiratory Society.

The median duration of chronic cough of the patients on which the new data is based was 13 years. For patients with this type of durable cough history, there is a major unmet need for effective agents, reported Dr. Jacky Smith, MB, ChB, PhD, and professor of respiratory medicine at the University of Manchester (England).

The P2X3 antagonist AF-219 “is showing real promise as an antitussive agent when used at low doses,” Dr. Smith said.

P2X3 receptors are expressed by afferent neurons on the vagus nerves and appear to be a strong trigger of cough when stimulated, according to previous work by Dr. Smith and others. AF-219 is an oral antagonist of P2X3 and produced a 75% reduction in cough frequency when administered in a dose of 600 mg twice daily in a previously reported double-blind, placebo-controlled pilot study (Abdulqawi R et al. Lancet. 2015;385:1198-205). “However, there was a small wrinkle. All of the patients had taste disturbances. At this dose, it was primarily loss of taste,” Dr. Smith explained. As P2X3 is also found on neurons mediating taste, the adverse event was consistent with the mechanism of AF-219.

A series of studies have since been conducted to show that much lower doses than the twice-daily 600 mg dose employed in the original trial provide an antitussive effect but impose a much reduced risk of affecting taste.

In the latest dose-ranging study, 30 patients, who on average were aged 60 years, were randomized in a crossover design to receive placebo or active therapy in sequential doses over 4 days each of 7.5 mg, 15 mg, 30 mg, or 50 mg twice daily. At the end of the initial 16-day study period and a washout of 14 to 21 days, the patients who were initially randomized to placebo were evaluated on the sequential doses of active therapy, and those previously treated with active therapy took placebo.

On placebo, there was no change in cough frequency. On active therapy, there were incremental reductions in cough at 7.5 and 15 mg, but the differences relative to placebo did not reach statistical significance. Significant reductions in cough frequency relative to placebo were reached on both the 30 mg (P = 0.001) and the 50 mg dose (P = 0.002). The reductions on these two doses, however, were not significantly different from each other, suggesting that 30 mg may be an adequate dose to achieve clinically relevant antitussive benefits.

Taste disturbances, which were reported in 6.7% of patients taking both the 7.5 mg and 15 mg dose, increased to 46.7% in those taking the 30 mg dose and then to 53.3% of those taking the 50 mg dose. Lack of taste was only reported by 6.7% of those taking the 50 mg dose and none of those taking lower doses. Other adverse events, such as nasal dryness and rhinitis, were infrequent (less than 10%) and not dose related.

“Significantly lower doses than we originally tested appear to provide near maximum antitussive effects but with a much reduced risk of changes in taste,” Dr. Smith reported.

She added that in this dose-ranging study, there was a correlation between increasing dose and increasing cough-specific measures of quality of life.

“These data support a separation of the dose response relationships for antitussive effects and taste disturbance,” Dr. Smith reported. “Studies of longer duration are needed to test sustained efficacy and tolerability.”

LONDON – AF-219, a promising targeted therapy for chronic cough derailed by taste disturbances, has been revived by new studies suggesting that there is a therapeutic window that preserves benefits but reduces the risk of the adverse effect, according to new data presented at the annual congress of the European Respiratory Society.

The median duration of chronic cough of the patients on which the new data is based was 13 years. For patients with this type of durable cough history, there is a major unmet need for effective agents, reported Dr. Jacky Smith, MB, ChB, PhD, and professor of respiratory medicine at the University of Manchester (England).

The P2X3 antagonist AF-219 “is showing real promise as an antitussive agent when used at low doses,” Dr. Smith said.

P2X3 receptors are expressed by afferent neurons on the vagus nerves and appear to be a strong trigger of cough when stimulated, according to previous work by Dr. Smith and others. AF-219 is an oral antagonist of P2X3 and produced a 75% reduction in cough frequency when administered in a dose of 600 mg twice daily in a previously reported double-blind, placebo-controlled pilot study (Abdulqawi R et al. Lancet. 2015;385:1198-205). “However, there was a small wrinkle. All of the patients had taste disturbances. At this dose, it was primarily loss of taste,” Dr. Smith explained. As P2X3 is also found on neurons mediating taste, the adverse event was consistent with the mechanism of AF-219.

A series of studies have since been conducted to show that much lower doses than the twice-daily 600 mg dose employed in the original trial provide an antitussive effect but impose a much reduced risk of affecting taste.

In the latest dose-ranging study, 30 patients, who on average were aged 60 years, were randomized in a crossover design to receive placebo or active therapy in sequential doses over 4 days each of 7.5 mg, 15 mg, 30 mg, or 50 mg twice daily. At the end of the initial 16-day study period and a washout of 14 to 21 days, the patients who were initially randomized to placebo were evaluated on the sequential doses of active therapy, and those previously treated with active therapy took placebo.

On placebo, there was no change in cough frequency. On active therapy, there were incremental reductions in cough at 7.5 and 15 mg, but the differences relative to placebo did not reach statistical significance. Significant reductions in cough frequency relative to placebo were reached on both the 30 mg (P = 0.001) and the 50 mg dose (P = 0.002). The reductions on these two doses, however, were not significantly different from each other, suggesting that 30 mg may be an adequate dose to achieve clinically relevant antitussive benefits.

Taste disturbances, which were reported in 6.7% of patients taking both the 7.5 mg and 15 mg dose, increased to 46.7% in those taking the 30 mg dose and then to 53.3% of those taking the 50 mg dose. Lack of taste was only reported by 6.7% of those taking the 50 mg dose and none of those taking lower doses. Other adverse events, such as nasal dryness and rhinitis, were infrequent (less than 10%) and not dose related.

“Significantly lower doses than we originally tested appear to provide near maximum antitussive effects but with a much reduced risk of changes in taste,” Dr. Smith reported.

She added that in this dose-ranging study, there was a correlation between increasing dose and increasing cough-specific measures of quality of life.

“These data support a separation of the dose response relationships for antitussive effects and taste disturbance,” Dr. Smith reported. “Studies of longer duration are needed to test sustained efficacy and tolerability.”

LONDON – AF-219, a promising targeted therapy for chronic cough derailed by taste disturbances, has been revived by new studies suggesting that there is a therapeutic window that preserves benefits but reduces the risk of the adverse effect, according to new data presented at the annual congress of the European Respiratory Society.

The median duration of chronic cough of the patients on which the new data is based was 13 years. For patients with this type of durable cough history, there is a major unmet need for effective agents, reported Dr. Jacky Smith, MB, ChB, PhD, and professor of respiratory medicine at the University of Manchester (England).

The P2X3 antagonist AF-219 “is showing real promise as an antitussive agent when used at low doses,” Dr. Smith said.

P2X3 receptors are expressed by afferent neurons on the vagus nerves and appear to be a strong trigger of cough when stimulated, according to previous work by Dr. Smith and others. AF-219 is an oral antagonist of P2X3 and produced a 75% reduction in cough frequency when administered in a dose of 600 mg twice daily in a previously reported double-blind, placebo-controlled pilot study (Abdulqawi R et al. Lancet. 2015;385:1198-205). “However, there was a small wrinkle. All of the patients had taste disturbances. At this dose, it was primarily loss of taste,” Dr. Smith explained. As P2X3 is also found on neurons mediating taste, the adverse event was consistent with the mechanism of AF-219.

A series of studies have since been conducted to show that much lower doses than the twice-daily 600 mg dose employed in the original trial provide an antitussive effect but impose a much reduced risk of affecting taste.

In the latest dose-ranging study, 30 patients, who on average were aged 60 years, were randomized in a crossover design to receive placebo or active therapy in sequential doses over 4 days each of 7.5 mg, 15 mg, 30 mg, or 50 mg twice daily. At the end of the initial 16-day study period and a washout of 14 to 21 days, the patients who were initially randomized to placebo were evaluated on the sequential doses of active therapy, and those previously treated with active therapy took placebo.

On placebo, there was no change in cough frequency. On active therapy, there were incremental reductions in cough at 7.5 and 15 mg, but the differences relative to placebo did not reach statistical significance. Significant reductions in cough frequency relative to placebo were reached on both the 30 mg (P = 0.001) and the 50 mg dose (P = 0.002). The reductions on these two doses, however, were not significantly different from each other, suggesting that 30 mg may be an adequate dose to achieve clinically relevant antitussive benefits.

Taste disturbances, which were reported in 6.7% of patients taking both the 7.5 mg and 15 mg dose, increased to 46.7% in those taking the 30 mg dose and then to 53.3% of those taking the 50 mg dose. Lack of taste was only reported by 6.7% of those taking the 50 mg dose and none of those taking lower doses. Other adverse events, such as nasal dryness and rhinitis, were infrequent (less than 10%) and not dose related.

“Significantly lower doses than we originally tested appear to provide near maximum antitussive effects but with a much reduced risk of changes in taste,” Dr. Smith reported.

She added that in this dose-ranging study, there was a correlation between increasing dose and increasing cough-specific measures of quality of life.

“These data support a separation of the dose response relationships for antitussive effects and taste disturbance,” Dr. Smith reported. “Studies of longer duration are needed to test sustained efficacy and tolerability.”

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

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

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

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

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

High-frequency stimulation

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

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

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

Wireless stimulators

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

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

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

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

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

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

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

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

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

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

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

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

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

High-frequency stimulation

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

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

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

Wireless stimulators

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

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

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

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

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

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

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

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

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

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

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

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

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

High-frequency stimulation

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

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

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

Wireless stimulators

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

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

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

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

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

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

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

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

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

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

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

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

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

Courtesy Wikimedia Commons/Coaster420/Creative Commons License

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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