User login
FDA approves combo pill for severe, acute pain
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
enough to require an opioid analgesic and for which alternative treatments fail to provide adequate pain relief.
Celecoxib is a nonsteroidal anti-inflammatory drug and tramadol is an opioid agonist. Seglentis contains 56 mg of celecoxib and 44 mg of tramadol.
“The unique co-crystal formulation of Seglentis provides effective pain relief via a multimodal approach,” Craig A. Sponseller, MD, chief medical officer of Kowa Pharmaceuticals America, said in a news release.
Esteve Pharmaceuticals has entered into an agreement with Kowa Pharmaceuticals America to commercialize the pain medicine in the United States, with a launch planned for early 2022.
“Seglentis uses four different and complementary mechanisms of analgesia and offers healthcare providers an important option to treat acute pain in adults that is severe enough to require opioid treatment and for which alternative treatments are inadequate,” Dr. Sponseller said.
Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, the FDA will require a Risk Evaluation and Mitigation Strategy (REMS) for Seglentis.
The label states that the drug should be initiated as two tablets every 12 hours as needed and should be prescribed for the shortest duration consistent with individual patient treatment goals.
Patients should be monitored for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with Seglentis.
Prescribers should discuss naloxone (Narcan) with patients and consider prescribing the opioid antagonist naloxone based on the patient’s risk factors for overdose.
Full prescribing information is available online.
A version of this article was first published on Medscape.com.
Tramadol linked to higher risk of mortality, compared with codeine
Tramadol is increasingly used to manage chronic noncancer pain, but as compared with opioids, it appears to be linked to a higher risk for adverse outcomes, according to new data.
Among a cohort of patients who received a prescription for either tramadol or codeine for orthopedic-related pain, tramadol was significantly associated with a higher risk of mortality, cardiovascular events, and fractures.
However, there was no significant difference in the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders between the two drugs.
“However, this is a retrospective cohort study, and despite it providing information that would otherwise be impossible to gather – such as from randomized controlled trials – clinicians should not solely base their decision on this study,” cautioned lead author Carlen Reyes, MD, PhD, of the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol), Barcelona.
Dr. Reyes noted that the intake of tramadol and codeine was analyzed using the number of “packages” that were dispensed, as an approximation of the real intake. “Logically we could think that the more packages dispensed of one drug, the more dose the patient is taking, but this is not always true given the availability of different doses commercialized of tramadol and different doses prescribed,” she said. “Given that we did not account for the real dose prescribed, we can only suspect an increased risk of these outcomes and reinforce the need for further prospective studies with more specific dose-response analysis comparing tramadol and codeine.”
The paper was published Oct. 19 in JAMA.
Tramadol has been considered to be a relatively safe opioid and was even strongly recommended by the American Academy of Orthopaedic Surgeons for patients experiencing symptomatic knee osteoarthritis. The authors point out that studies looking at opioid use from 2019 to 2020 show that tramadol was the most prescribed opioid in England, the Netherlands, and Spain.
In the United States, the age-adjusted rate of drug overdose deaths from synthetic opioids rose from 1.0 per 100 000 in 2013 to 11.4 in 2019. Most of these deaths were attributable to fentanyl but some were also related to tramadol.
But despite its wide use in managing chronic noncancer pain, results of recent studies suggest adverse outcomes as compared with other agents. Last year, one study found that older patients who received tramadol had a significant increase in the risk of hip fracture vs. those using NSAIDs or codeine. Another study, also published in 2020, showed that patients with osteoarthritis who were treated with tramadol had a 20%-50% higher risk of dying during the first year of treatment than did patients who were treated with NSAIDs.
In the current paper, Dr. Reyes and colleagues evaluated the association of tramadol with mortality and other adverse clinical outcomes in outpatient settings, compared with codeine.
They conducted a retrospective, population-based, propensity score–matched cohort study using a primary care database that routinely collects medical records and pharmacy dispensations for more than 80% of the population of Catalonia, Spain. The cohort included people 18 years or older who had been prescribed tramadol or codeine from 2007 to 2017 and were followed up to Dec. 31, 2017.
After propensity score matching, the final analysis included 368,960 participants: 184,480 in the tramadol arm and 184,480 in the codeine arm.
The mean age of patients was 52.7 years in the tramadol arm and 53.5 years in the codeine arm, and the prevalence of cancer was 3.2% and 3.3%, respectively. The most common diagnoses in this cohort were back pain (47.5% vs. 48.5%), neck/shoulder pain (28.6% vs. 29.5%), and osteoarthritis (15.3% vs. 15.5%). The most commonly used drugs were ibuprofen (34.4% vs. 34.3%) and paracetamol/acetaminophen (37.1% vs. 36.8%)
Higher risk of adverse outcomes
As compared with codeine, tramadol use was significantly associated with a higher risk of mortality (13.00 vs. 5.61 per 1,000 person-years; hazard ratio, 2.31; 95% confidence interval, 2.08-2.56); absolute rate differences (7.37 per 1,000 person-years; 95% CI, 6.09-8.78), cardiovascular events (10.03 vs. 8.67 per 1,000 person-years; HR, 1.15; 95% CI, 1.05-1.27; ARD, 1.36 per 1,000 person-years; 95% CI, 0.45-2.36), and fractures (12.26 vs. 8.13 per 1,000 person-years; HR, 1.50; 95% CI, 1.37-1.65; ARD, 4.10 per 1,000 person-years; 95% CI, 3.02-5.29).
A subgroup and sensitivity analysis showed that the increased mortality risk associated with tramadol was significantly higher in younger persons vs. older ones (HR, 3.14; 95% CI, 1.82-5.41 vs. 2.39; 95% CI, 2.20-2.60]; P < .001 for interaction). In addition, women had a significantly greater risk of cardiovascular events versus men (HR, 1.32; 95% CI, 1.19-1.46] vs. 1.03; 95% CI, 0.9-1.13]; P < .001 for interaction).
Potential for confounding
Weighing in on the data, Daniel Solomon, MD, MPH, chief of clinical sciences, division of rheumatology, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston, noted that because it is extremely unlikely that anyone will ever conduct a large, head-to-head safety trial comparing different opioids, the results of this paper are important to consider.
“However, as the authors appropriately caution, this type of analysis is limited by the strong potential for residual confounding,” he said. “In other words, even though the authors used state-of-the-art methods to limit imbalances between the patients initiating tramadol versus codeine, there is strong reason to believe that imbalances that may account for the differences in adverse events exist.”
For example, he noted that if one looks at the distribution of comorbid conditions in the before-matching group, tramadol initiators demonstrate a higher frequency of chronic kidney disease, diabetes, and overall chronic comorbid diseases. “This suggests to me that prescribers apply selection criteria when choosing who to prescribe which opioid,” Dr. Solomon explained.
“While the authors’ use of propensity score matching limits confounding, it only can improve balance for measured confounders,” he said. “Other factors not measured in this type of data set – blood pressure, pain, physical activity, tobacco use, body mass index – may still demonstrate imbalances even after matching.”
But after these limitations are taken into consideration, the results remain concerning, Dr. Solomon emphasized, particularly the all-cause mortality excess of tramadol versus codeine users. “This study did not include cause of death, which would help the reader understand why users of tramadol were dying more frequently,” he added. “It also might help in understanding whether this is a true biologic effect or residual confounding.”
Perceived safety
In an accompanying editorial, Howard S. Kim, MD, MS, and colleagues from Northwestern University, Chicago, write that the greatest risk of tramadol may involve the perception that it is “inherently safer than other opioids.”
“In actuality, the mechanisms of action and variable metabolism of tramadol in a given population create considerable therapeutic uncertainty and introduce additional risk exposure,” they say, as demonstrated in the current study.
Therefore, when clinicians determine that an opioid is needed for pain relief, it may be a better option to select a pure opioid agonist that has a more predictable therapeutic effect and known adverse effect profile, such as morphine or hydrocodone. “This would allow clinicians and patients to more properly weigh the risks and benefits of initiating opioid therapy through shared decision-making and prompt the level of counseling on safe use, storage, and disposal practices that all opioids deserve,” write the editorialists.
The study was funded by the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina. The research was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Dr. Reyes has disclosed no relevant financial relationships. Dr. Solomon disclosed salary support from research contracts to his hospital from Amgen, AbbVie, Moderna, the Rheumatology Research Foundation, and National Institutes of Health; and royalties from UpToDate. Dr. Kim reported unrelated grant support from the Agency for Healthcare Research and Quality.
A version of this article first appeared on Medscape.com.
Tramadol is increasingly used to manage chronic noncancer pain, but as compared with opioids, it appears to be linked to a higher risk for adverse outcomes, according to new data.
Among a cohort of patients who received a prescription for either tramadol or codeine for orthopedic-related pain, tramadol was significantly associated with a higher risk of mortality, cardiovascular events, and fractures.
However, there was no significant difference in the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders between the two drugs.
“However, this is a retrospective cohort study, and despite it providing information that would otherwise be impossible to gather – such as from randomized controlled trials – clinicians should not solely base their decision on this study,” cautioned lead author Carlen Reyes, MD, PhD, of the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol), Barcelona.
Dr. Reyes noted that the intake of tramadol and codeine was analyzed using the number of “packages” that were dispensed, as an approximation of the real intake. “Logically we could think that the more packages dispensed of one drug, the more dose the patient is taking, but this is not always true given the availability of different doses commercialized of tramadol and different doses prescribed,” she said. “Given that we did not account for the real dose prescribed, we can only suspect an increased risk of these outcomes and reinforce the need for further prospective studies with more specific dose-response analysis comparing tramadol and codeine.”
The paper was published Oct. 19 in JAMA.
Tramadol has been considered to be a relatively safe opioid and was even strongly recommended by the American Academy of Orthopaedic Surgeons for patients experiencing symptomatic knee osteoarthritis. The authors point out that studies looking at opioid use from 2019 to 2020 show that tramadol was the most prescribed opioid in England, the Netherlands, and Spain.
In the United States, the age-adjusted rate of drug overdose deaths from synthetic opioids rose from 1.0 per 100 000 in 2013 to 11.4 in 2019. Most of these deaths were attributable to fentanyl but some were also related to tramadol.
But despite its wide use in managing chronic noncancer pain, results of recent studies suggest adverse outcomes as compared with other agents. Last year, one study found that older patients who received tramadol had a significant increase in the risk of hip fracture vs. those using NSAIDs or codeine. Another study, also published in 2020, showed that patients with osteoarthritis who were treated with tramadol had a 20%-50% higher risk of dying during the first year of treatment than did patients who were treated with NSAIDs.
In the current paper, Dr. Reyes and colleagues evaluated the association of tramadol with mortality and other adverse clinical outcomes in outpatient settings, compared with codeine.
They conducted a retrospective, population-based, propensity score–matched cohort study using a primary care database that routinely collects medical records and pharmacy dispensations for more than 80% of the population of Catalonia, Spain. The cohort included people 18 years or older who had been prescribed tramadol or codeine from 2007 to 2017 and were followed up to Dec. 31, 2017.
After propensity score matching, the final analysis included 368,960 participants: 184,480 in the tramadol arm and 184,480 in the codeine arm.
The mean age of patients was 52.7 years in the tramadol arm and 53.5 years in the codeine arm, and the prevalence of cancer was 3.2% and 3.3%, respectively. The most common diagnoses in this cohort were back pain (47.5% vs. 48.5%), neck/shoulder pain (28.6% vs. 29.5%), and osteoarthritis (15.3% vs. 15.5%). The most commonly used drugs were ibuprofen (34.4% vs. 34.3%) and paracetamol/acetaminophen (37.1% vs. 36.8%)
Higher risk of adverse outcomes
As compared with codeine, tramadol use was significantly associated with a higher risk of mortality (13.00 vs. 5.61 per 1,000 person-years; hazard ratio, 2.31; 95% confidence interval, 2.08-2.56); absolute rate differences (7.37 per 1,000 person-years; 95% CI, 6.09-8.78), cardiovascular events (10.03 vs. 8.67 per 1,000 person-years; HR, 1.15; 95% CI, 1.05-1.27; ARD, 1.36 per 1,000 person-years; 95% CI, 0.45-2.36), and fractures (12.26 vs. 8.13 per 1,000 person-years; HR, 1.50; 95% CI, 1.37-1.65; ARD, 4.10 per 1,000 person-years; 95% CI, 3.02-5.29).
A subgroup and sensitivity analysis showed that the increased mortality risk associated with tramadol was significantly higher in younger persons vs. older ones (HR, 3.14; 95% CI, 1.82-5.41 vs. 2.39; 95% CI, 2.20-2.60]; P < .001 for interaction). In addition, women had a significantly greater risk of cardiovascular events versus men (HR, 1.32; 95% CI, 1.19-1.46] vs. 1.03; 95% CI, 0.9-1.13]; P < .001 for interaction).
Potential for confounding
Weighing in on the data, Daniel Solomon, MD, MPH, chief of clinical sciences, division of rheumatology, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston, noted that because it is extremely unlikely that anyone will ever conduct a large, head-to-head safety trial comparing different opioids, the results of this paper are important to consider.
“However, as the authors appropriately caution, this type of analysis is limited by the strong potential for residual confounding,” he said. “In other words, even though the authors used state-of-the-art methods to limit imbalances between the patients initiating tramadol versus codeine, there is strong reason to believe that imbalances that may account for the differences in adverse events exist.”
For example, he noted that if one looks at the distribution of comorbid conditions in the before-matching group, tramadol initiators demonstrate a higher frequency of chronic kidney disease, diabetes, and overall chronic comorbid diseases. “This suggests to me that prescribers apply selection criteria when choosing who to prescribe which opioid,” Dr. Solomon explained.
“While the authors’ use of propensity score matching limits confounding, it only can improve balance for measured confounders,” he said. “Other factors not measured in this type of data set – blood pressure, pain, physical activity, tobacco use, body mass index – may still demonstrate imbalances even after matching.”
But after these limitations are taken into consideration, the results remain concerning, Dr. Solomon emphasized, particularly the all-cause mortality excess of tramadol versus codeine users. “This study did not include cause of death, which would help the reader understand why users of tramadol were dying more frequently,” he added. “It also might help in understanding whether this is a true biologic effect or residual confounding.”
Perceived safety
In an accompanying editorial, Howard S. Kim, MD, MS, and colleagues from Northwestern University, Chicago, write that the greatest risk of tramadol may involve the perception that it is “inherently safer than other opioids.”
“In actuality, the mechanisms of action and variable metabolism of tramadol in a given population create considerable therapeutic uncertainty and introduce additional risk exposure,” they say, as demonstrated in the current study.
Therefore, when clinicians determine that an opioid is needed for pain relief, it may be a better option to select a pure opioid agonist that has a more predictable therapeutic effect and known adverse effect profile, such as morphine or hydrocodone. “This would allow clinicians and patients to more properly weigh the risks and benefits of initiating opioid therapy through shared decision-making and prompt the level of counseling on safe use, storage, and disposal practices that all opioids deserve,” write the editorialists.
The study was funded by the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina. The research was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Dr. Reyes has disclosed no relevant financial relationships. Dr. Solomon disclosed salary support from research contracts to his hospital from Amgen, AbbVie, Moderna, the Rheumatology Research Foundation, and National Institutes of Health; and royalties from UpToDate. Dr. Kim reported unrelated grant support from the Agency for Healthcare Research and Quality.
A version of this article first appeared on Medscape.com.
Tramadol is increasingly used to manage chronic noncancer pain, but as compared with opioids, it appears to be linked to a higher risk for adverse outcomes, according to new data.
Among a cohort of patients who received a prescription for either tramadol or codeine for orthopedic-related pain, tramadol was significantly associated with a higher risk of mortality, cardiovascular events, and fractures.
However, there was no significant difference in the risk of falls, delirium, constipation, opioid abuse/dependence, or sleep disorders between the two drugs.
“However, this is a retrospective cohort study, and despite it providing information that would otherwise be impossible to gather – such as from randomized controlled trials – clinicians should not solely base their decision on this study,” cautioned lead author Carlen Reyes, MD, PhD, of the Institut Universitari d’Investigació en Atenció Primària (IDIAP Jordi Gol), Barcelona.
Dr. Reyes noted that the intake of tramadol and codeine was analyzed using the number of “packages” that were dispensed, as an approximation of the real intake. “Logically we could think that the more packages dispensed of one drug, the more dose the patient is taking, but this is not always true given the availability of different doses commercialized of tramadol and different doses prescribed,” she said. “Given that we did not account for the real dose prescribed, we can only suspect an increased risk of these outcomes and reinforce the need for further prospective studies with more specific dose-response analysis comparing tramadol and codeine.”
The paper was published Oct. 19 in JAMA.
Tramadol has been considered to be a relatively safe opioid and was even strongly recommended by the American Academy of Orthopaedic Surgeons for patients experiencing symptomatic knee osteoarthritis. The authors point out that studies looking at opioid use from 2019 to 2020 show that tramadol was the most prescribed opioid in England, the Netherlands, and Spain.
In the United States, the age-adjusted rate of drug overdose deaths from synthetic opioids rose from 1.0 per 100 000 in 2013 to 11.4 in 2019. Most of these deaths were attributable to fentanyl but some were also related to tramadol.
But despite its wide use in managing chronic noncancer pain, results of recent studies suggest adverse outcomes as compared with other agents. Last year, one study found that older patients who received tramadol had a significant increase in the risk of hip fracture vs. those using NSAIDs or codeine. Another study, also published in 2020, showed that patients with osteoarthritis who were treated with tramadol had a 20%-50% higher risk of dying during the first year of treatment than did patients who were treated with NSAIDs.
In the current paper, Dr. Reyes and colleagues evaluated the association of tramadol with mortality and other adverse clinical outcomes in outpatient settings, compared with codeine.
They conducted a retrospective, population-based, propensity score–matched cohort study using a primary care database that routinely collects medical records and pharmacy dispensations for more than 80% of the population of Catalonia, Spain. The cohort included people 18 years or older who had been prescribed tramadol or codeine from 2007 to 2017 and were followed up to Dec. 31, 2017.
After propensity score matching, the final analysis included 368,960 participants: 184,480 in the tramadol arm and 184,480 in the codeine arm.
The mean age of patients was 52.7 years in the tramadol arm and 53.5 years in the codeine arm, and the prevalence of cancer was 3.2% and 3.3%, respectively. The most common diagnoses in this cohort were back pain (47.5% vs. 48.5%), neck/shoulder pain (28.6% vs. 29.5%), and osteoarthritis (15.3% vs. 15.5%). The most commonly used drugs were ibuprofen (34.4% vs. 34.3%) and paracetamol/acetaminophen (37.1% vs. 36.8%)
Higher risk of adverse outcomes
As compared with codeine, tramadol use was significantly associated with a higher risk of mortality (13.00 vs. 5.61 per 1,000 person-years; hazard ratio, 2.31; 95% confidence interval, 2.08-2.56); absolute rate differences (7.37 per 1,000 person-years; 95% CI, 6.09-8.78), cardiovascular events (10.03 vs. 8.67 per 1,000 person-years; HR, 1.15; 95% CI, 1.05-1.27; ARD, 1.36 per 1,000 person-years; 95% CI, 0.45-2.36), and fractures (12.26 vs. 8.13 per 1,000 person-years; HR, 1.50; 95% CI, 1.37-1.65; ARD, 4.10 per 1,000 person-years; 95% CI, 3.02-5.29).
A subgroup and sensitivity analysis showed that the increased mortality risk associated with tramadol was significantly higher in younger persons vs. older ones (HR, 3.14; 95% CI, 1.82-5.41 vs. 2.39; 95% CI, 2.20-2.60]; P < .001 for interaction). In addition, women had a significantly greater risk of cardiovascular events versus men (HR, 1.32; 95% CI, 1.19-1.46] vs. 1.03; 95% CI, 0.9-1.13]; P < .001 for interaction).
Potential for confounding
Weighing in on the data, Daniel Solomon, MD, MPH, chief of clinical sciences, division of rheumatology, Brigham and Women’s Hospital, and professor of medicine, Harvard Medical School, Boston, noted that because it is extremely unlikely that anyone will ever conduct a large, head-to-head safety trial comparing different opioids, the results of this paper are important to consider.
“However, as the authors appropriately caution, this type of analysis is limited by the strong potential for residual confounding,” he said. “In other words, even though the authors used state-of-the-art methods to limit imbalances between the patients initiating tramadol versus codeine, there is strong reason to believe that imbalances that may account for the differences in adverse events exist.”
For example, he noted that if one looks at the distribution of comorbid conditions in the before-matching group, tramadol initiators demonstrate a higher frequency of chronic kidney disease, diabetes, and overall chronic comorbid diseases. “This suggests to me that prescribers apply selection criteria when choosing who to prescribe which opioid,” Dr. Solomon explained.
“While the authors’ use of propensity score matching limits confounding, it only can improve balance for measured confounders,” he said. “Other factors not measured in this type of data set – blood pressure, pain, physical activity, tobacco use, body mass index – may still demonstrate imbalances even after matching.”
But after these limitations are taken into consideration, the results remain concerning, Dr. Solomon emphasized, particularly the all-cause mortality excess of tramadol versus codeine users. “This study did not include cause of death, which would help the reader understand why users of tramadol were dying more frequently,” he added. “It also might help in understanding whether this is a true biologic effect or residual confounding.”
Perceived safety
In an accompanying editorial, Howard S. Kim, MD, MS, and colleagues from Northwestern University, Chicago, write that the greatest risk of tramadol may involve the perception that it is “inherently safer than other opioids.”
“In actuality, the mechanisms of action and variable metabolism of tramadol in a given population create considerable therapeutic uncertainty and introduce additional risk exposure,” they say, as demonstrated in the current study.
Therefore, when clinicians determine that an opioid is needed for pain relief, it may be a better option to select a pure opioid agonist that has a more predictable therapeutic effect and known adverse effect profile, such as morphine or hydrocodone. “This would allow clinicians and patients to more properly weigh the risks and benefits of initiating opioid therapy through shared decision-making and prompt the level of counseling on safe use, storage, and disposal practices that all opioids deserve,” write the editorialists.
The study was funded by the Fundació Institut Universitari per a la recerca a l’Atenció Primària de Salut Jordi Gol i Gurina. The research was supported by the National Institute for Health Research Oxford Biomedical Research Centre. Dr. Reyes has disclosed no relevant financial relationships. Dr. Solomon disclosed salary support from research contracts to his hospital from Amgen, AbbVie, Moderna, the Rheumatology Research Foundation, and National Institutes of Health; and royalties from UpToDate. Dr. Kim reported unrelated grant support from the Agency for Healthcare Research and Quality.
A version of this article first appeared on Medscape.com.
FDA OKs new high-dose naloxone product for opioid overdose
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
ZIMHI from Adamis Pharmaceuticals is administered using a single-dose, prefilled syringe that delivers 5 mg of naloxone hydrochloride solution through intramuscular or subcutaneous injection.
Naloxone is an opioid antagonist that works by blocking or reversing the effects of the opioid, including extreme drowsiness, slowed breathing, or loss of consciousness.
Opioid-related overdose deaths — driven partly by prescription drug overdoses — remain a leading cause of death in the United States.
ZIMHI “provides an additional option in the treatment of opioid overdoses,” the FDA said in a statement announcing approval.
In a statement from Adamis Pharmaceuticals, Jeffrey Galinkin, MD, an anesthesiologist and former member of the FDA advisory committee for analgesics and addiction products, said he is “pleased to see this much-needed, high-dose naloxone product will become part of the treatment tool kit as a countermeasure to the continued surge in fentanyl related deaths.”
“The higher intramuscular doses of naloxone in ZIMHI should result in more rapid and higher levels of naloxone in the systemic circulation, which in turn, should result in more successful resuscitations,” Dr. Galinkin said.
Last spring the FDA approved a higher-dose naloxone hydrochloride nasal spray (Kloxxado) for the emergency treatment of opioid overdose.
Kloxxado delivers 8 mg of naloxone into the nasal cavity, which is twice as much as the 4 mg of naloxone contained in Narcan nasal spray.
The FDA approved ZIMHI (and Kloxxado) through the 505(b)(2) regulatory pathway, which allows the agency to refer to previous findings of safety and efficacy for an already-approved product, as well as to review findings from further studies of the product.
The company plans to launch ZIMHI in the first quarter of 2022.
A version of this article first appeared on Medscape.com.
New antimigraine drugs linked with less risk for adverse events
“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
Methods
The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.
The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.
The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
Results
Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.
Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.
With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)
When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.
Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
Balancing efficacy and tolerability
“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.
“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.
With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”
The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”
Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.
Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.
“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
Methods
The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.
The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.
The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
Results
Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.
Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.
With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)
When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.
Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
Balancing efficacy and tolerability
“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.
“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.
With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”
The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”
Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.
Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.
“[T]he lack of cardiovascular risks of these new classes of migraine-specific treatments may provide alternative treatment options for individuals for whom currently available acute treatments have failed or for those with cardiovascular contraindications,” write lead author Chun-Pai Yang, MD, PhD, of Taichung (Taiwan) Veterans General Hospital and colleagues, in the paper, published online in JAMA Network Open.
Methods
The new study compared the outcomes for acute migraine management using the ditan, lasmiditan (a 5-hydroxytryptamine [5HT]1F–receptor agonist), and the two gepants, rimegepant, and ubrogepant (calcitonin gene–related peptide [CGRP] antagonists), with standard triptan (selective 5-HT1B/1D–receptor agonist) therapy.
The researchers evaluated 64 double-blind randomized clinical trials which included 46,442 patients, the majority of whom (74%-87%) were women with an age range of 36-43 years.
The primary outcome evaluated was the odds ratio for freedom from pain at 2 hours after a single dose and secondary outcomes were the OR for pain relief at 2 hours following a dose, as well as any adverse events.
Results
Dr. Yang and colleagues found that virtually all medications with widespread clinical use, regardless of class, were associated with higher ORs for pain freedom when compared with placebo.
Compared to ditan and gepant agents, however, triptans were associated with significantly higher ORs for pain freedom. The odds ratio ranges were 1.72-3.40 for lasmiditan, 1.58-3.13 for rimegepant, and 1.54-3.05 for ubrogepant.
With respect to pain relief at 2 hours, while all medications were more effective than placebo, triptans were associated with higher ORs when compared with the other drug classes: lasmiditan (range: OR, 1.46; 95% confidence interval, 1.09-1.96 to OR, 3.31; 95% CI, 2.41-4.55), rimegepant (range: OR, 1.33; 95% CI, 1.01-1.76 to OR, 3.01; 95% CI, 2.33-3.88), and ubrogepant (range: OR, 1.38; 95% CI, 1.02-1.88 to OR, 3.13; 95% CI, 2.35-4.15)
When assessing tolerability, the researchers found that overall, triptans were associated with the higher ORs for any adverse events (AE) with a trend of dose-response relationship. Lasmiditan (in the ditan class) was associated with the highest risk for AEs among all treatments. Most of the AEs were mild to moderate and included chest pain, tightness, heaviness, and pressure.
Dr. Yang and colleagues note that, “although these two new classes of antimigraine drugs may not be as efficacious as triptans, these novel abortive agents without cardiovascular risks might offer an alternative to current specific migraine treatments for patients at risk of cardiovascular disease.”
Balancing efficacy and tolerability
“When choosing an acute medication for a patient there is always a balance between efficacy and tolerability,” headache specialist and associate director of North Shore Headache and Spine Lauren Natbony, MD, said in an interview.
“A medication can only be effective if a patient is able to tolerate it and will actually use it,” Dr. Natbony said.
With respect to the current review, Dr. Natbony pointed out, “response to acute therapy can differ between migraine attacks and may be based on variables not controlled for, such as how early in an attack the medication was taken, associated symptoms such as nausea that may make oral medications less efficacious, etc.”
The authors acknowledge that the focus on short-term responses and AEs after a single dose is a limitation of the study. They also pointed out what they considered to be a strength of the study, which was its network meta-analysis design. According to the authors, this design allowed for “multiple direct and indirect comparisons, ranking the efficacy and safety of individual pharmacologic interventions and providing more precise estimates than those of RCTs and traditional meta-analysis.”
Funding for this study was provided through grants from the Ministry of Science and Technology, Taiwan; the Brain Research Center; and National Yang Ming Chiao Tung University.
Dr. Yang has received personal fees and grants from various pharmaceutical companies. He has also received grants from the Taiwan Ministry of Technology and Science, the Brain Research Center, National Yang Ming Chiao Tung University, and Taipei Veterans General Hospital outside the submitted work. The other authors and Dr. Natbony disclosed no relevant financial relationships.
FROM JAMA NETWORK OPEN
Lumbar epidural steroid jab lowers bone formation in older women
Among postmenopausal women who received an epidural steroid injection (ESI) in the lumbar spine to treat back and leg pain arising from a compressed nerve in the spine, levels of bone formation biomarkers were decreased. The decrease in levels persisted more than 12 weeks, results from a new study show.
In addition, serum cortisol levels decreased by 50% at week 1 after the ESI, indicating systemic absorption of the steroid.
“The extent and duration of these effects suggest that patients who receive multiple [ESIs in the lumbar spine] may be at particular risk for harmful skeletal consequences,” Shannon Clare reported in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research.
Further studies are needed of the relationship between these short-term changes in bone turnover and bone loss and the risk for fracture among the burgeoning population treated with ESIs, added Ms. Clare, of the Hospital for Special Surgery, New York.
The researchers examined changes in serum levels of bone formation and resorption markers and other analytes in 24 women who received a lumbar ESI for radicular back pain and in 8 other women from the hospital population who served as control persons.
Among the women who received ESI, 1 week after the injection, serum levels of two bone formation biomarkers – total procollagen type 1 N-terminal peptide (P1NP) and osteocalcin – were about 27% lower than at baseline. The suppression persisted beyond 12 weeks.
Serum levels of the bone resorption biomarker C-terminal telopeptide of type I collagen (CTX) did not differ significantly after ESI.
“Our results are notable because we found that the duration of suppression of bone formation extended beyond 12 weeks, a far longer duration than seen previously with intra-articular injections” of glucocorticoids, said Ms. Clare and senior author Emily M. Stein, MD, director of research for the Metabolic Bone Service and an endocrinologist at the Hospital for Special Surgery and is associate professor of medicine at Weill Cornell Medicine, both in New York.
The findings suggest that patients should not receive multiple doses within a 12-week period, they told this news organization in a joint email response.
Women are not typically screened for osteopenia or osteoporosis before ESI. However, “our results suggest that physicians should consider screening women for osteoporosis who receive ESI, particularly those who are treated with multiple doses,” said Ms. Clare and Dr. Stein. “Steroid exposure should be minimized as much as possible by having patients space injections as far as they can tolerate.”
Systemic absorption, negative impact on bone turnover markers
“The hypothesis that [ESIs] interfere with the vertebral osseous microenvironment and increase the risk of vertebral fractures has been supported with evidence in the literature,” Mohamad Bydon, MD, professor of neurosurgery, orthopedic surgery, and health services research at the Mayo Clinic, Rochester, Minn., said in an interview.
Prior studies have demonstrated a decrease in bone mineral density (BMD) and an increase in vertebral fractures following ESI, added Dr. Bydon, senior author of a 2018 review of the effect of ESI on BMD and vertebral fracture risk that was published in Pain Medicine. He was not involved with the current study.
“The article by Clare et al. provides evidence on the systemic absorption of glucocorticoids by demonstrating a drop in serum cortisol following ESI,” he noted. “The measurement of bone metabolism biomarkers offers molecular confirmation of clinical and radiological observations of previous studies” showing that ESI affects the vertebrae.
More than 9 million ESIs each year
Each year, more than 9 million ESIs are administered to patients in the United States to relieve radicular back and leg pain that may be caused by a herniated disc or spinal stenosis (a gradual narrowing of the open spaces in the spinal column, which is common in older adults), the researchers explained.
Some patients experience sufficient pain relief with ESIs. Others may not be eligible for surgery and may receive multiple ESIs annually for many years because they provide pain relief.
It is well established that oral and intravenous glucocorticoids profoundly suppress bone formation and transiently increase bone resorption, causing substantial bone loss and increased fracture risk within 3 months of administration, Ms. Clare explained in the session.
Long-term use of high-dose inhaled glucocorticoids has been associated with bone loss and fractures. However, the effect of ESIs on bone has been less well studied.
The researchers hypothesized that ESIs are systemically absorbed and cause suppression of bone formation without a compensatory decrease in bone resorption.
They enrolled 24 patients who had undergone lumbar ESIs and 8 control patients. The mean age of the patients in the two groups was 63 years and 68 years, respectively. Most patients were White (88% and 100%, respectively). The mean body mass index was 27 kg/m2 and 28 kg/m2, respectively. On average, the patients had entered menopause 12 and 16 years earlier, respectively.
In the group that received steroid injections, almost two-thirds (15 patients, 63%) received triamcinolone. The rest received dexamethasone (six patients, 25%) or betamethasone (three patients, 12%) at doses that were equivalent to 80 mg triamcinolone.
The patients’ baseline serum levels of 25-hydroxy vitamin D, parathyroid hormone, cortisol, P1NP, osteocalcin, and CTX were within the reference ranges and were similar in the two groups.
The researchers also determined serum levels of cortisol (to assess suppression of endogenous glucocorticoids), osteocalcin, P1NP, and CTX in the patients and control persons at 1, 4, 12, 26, and 52 weeks after patients had received the ESI.
The researchers acknowledged that the small sample is a study limitation. In addition, the first serum samples were taken 1 week after the injection, and so any earlier changes in analyte levels were not captured. The patients also received different types of steroids, although the doses were similar when converted to triamcinolone equivalents.
The study was supported by a Spine Service grant from the Hospital for Special Surgery. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among postmenopausal women who received an epidural steroid injection (ESI) in the lumbar spine to treat back and leg pain arising from a compressed nerve in the spine, levels of bone formation biomarkers were decreased. The decrease in levels persisted more than 12 weeks, results from a new study show.
In addition, serum cortisol levels decreased by 50% at week 1 after the ESI, indicating systemic absorption of the steroid.
“The extent and duration of these effects suggest that patients who receive multiple [ESIs in the lumbar spine] may be at particular risk for harmful skeletal consequences,” Shannon Clare reported in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research.
Further studies are needed of the relationship between these short-term changes in bone turnover and bone loss and the risk for fracture among the burgeoning population treated with ESIs, added Ms. Clare, of the Hospital for Special Surgery, New York.
The researchers examined changes in serum levels of bone formation and resorption markers and other analytes in 24 women who received a lumbar ESI for radicular back pain and in 8 other women from the hospital population who served as control persons.
Among the women who received ESI, 1 week after the injection, serum levels of two bone formation biomarkers – total procollagen type 1 N-terminal peptide (P1NP) and osteocalcin – were about 27% lower than at baseline. The suppression persisted beyond 12 weeks.
Serum levels of the bone resorption biomarker C-terminal telopeptide of type I collagen (CTX) did not differ significantly after ESI.
“Our results are notable because we found that the duration of suppression of bone formation extended beyond 12 weeks, a far longer duration than seen previously with intra-articular injections” of glucocorticoids, said Ms. Clare and senior author Emily M. Stein, MD, director of research for the Metabolic Bone Service and an endocrinologist at the Hospital for Special Surgery and is associate professor of medicine at Weill Cornell Medicine, both in New York.
The findings suggest that patients should not receive multiple doses within a 12-week period, they told this news organization in a joint email response.
Women are not typically screened for osteopenia or osteoporosis before ESI. However, “our results suggest that physicians should consider screening women for osteoporosis who receive ESI, particularly those who are treated with multiple doses,” said Ms. Clare and Dr. Stein. “Steroid exposure should be minimized as much as possible by having patients space injections as far as they can tolerate.”
Systemic absorption, negative impact on bone turnover markers
“The hypothesis that [ESIs] interfere with the vertebral osseous microenvironment and increase the risk of vertebral fractures has been supported with evidence in the literature,” Mohamad Bydon, MD, professor of neurosurgery, orthopedic surgery, and health services research at the Mayo Clinic, Rochester, Minn., said in an interview.
Prior studies have demonstrated a decrease in bone mineral density (BMD) and an increase in vertebral fractures following ESI, added Dr. Bydon, senior author of a 2018 review of the effect of ESI on BMD and vertebral fracture risk that was published in Pain Medicine. He was not involved with the current study.
“The article by Clare et al. provides evidence on the systemic absorption of glucocorticoids by demonstrating a drop in serum cortisol following ESI,” he noted. “The measurement of bone metabolism biomarkers offers molecular confirmation of clinical and radiological observations of previous studies” showing that ESI affects the vertebrae.
More than 9 million ESIs each year
Each year, more than 9 million ESIs are administered to patients in the United States to relieve radicular back and leg pain that may be caused by a herniated disc or spinal stenosis (a gradual narrowing of the open spaces in the spinal column, which is common in older adults), the researchers explained.
Some patients experience sufficient pain relief with ESIs. Others may not be eligible for surgery and may receive multiple ESIs annually for many years because they provide pain relief.
It is well established that oral and intravenous glucocorticoids profoundly suppress bone formation and transiently increase bone resorption, causing substantial bone loss and increased fracture risk within 3 months of administration, Ms. Clare explained in the session.
Long-term use of high-dose inhaled glucocorticoids has been associated with bone loss and fractures. However, the effect of ESIs on bone has been less well studied.
The researchers hypothesized that ESIs are systemically absorbed and cause suppression of bone formation without a compensatory decrease in bone resorption.
They enrolled 24 patients who had undergone lumbar ESIs and 8 control patients. The mean age of the patients in the two groups was 63 years and 68 years, respectively. Most patients were White (88% and 100%, respectively). The mean body mass index was 27 kg/m2 and 28 kg/m2, respectively. On average, the patients had entered menopause 12 and 16 years earlier, respectively.
In the group that received steroid injections, almost two-thirds (15 patients, 63%) received triamcinolone. The rest received dexamethasone (six patients, 25%) or betamethasone (three patients, 12%) at doses that were equivalent to 80 mg triamcinolone.
The patients’ baseline serum levels of 25-hydroxy vitamin D, parathyroid hormone, cortisol, P1NP, osteocalcin, and CTX were within the reference ranges and were similar in the two groups.
The researchers also determined serum levels of cortisol (to assess suppression of endogenous glucocorticoids), osteocalcin, P1NP, and CTX in the patients and control persons at 1, 4, 12, 26, and 52 weeks after patients had received the ESI.
The researchers acknowledged that the small sample is a study limitation. In addition, the first serum samples were taken 1 week after the injection, and so any earlier changes in analyte levels were not captured. The patients also received different types of steroids, although the doses were similar when converted to triamcinolone equivalents.
The study was supported by a Spine Service grant from the Hospital for Special Surgery. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Among postmenopausal women who received an epidural steroid injection (ESI) in the lumbar spine to treat back and leg pain arising from a compressed nerve in the spine, levels of bone formation biomarkers were decreased. The decrease in levels persisted more than 12 weeks, results from a new study show.
In addition, serum cortisol levels decreased by 50% at week 1 after the ESI, indicating systemic absorption of the steroid.
“The extent and duration of these effects suggest that patients who receive multiple [ESIs in the lumbar spine] may be at particular risk for harmful skeletal consequences,” Shannon Clare reported in an oral presentation at the annual meeting of the American Society for Bone and Mineral Research.
Further studies are needed of the relationship between these short-term changes in bone turnover and bone loss and the risk for fracture among the burgeoning population treated with ESIs, added Ms. Clare, of the Hospital for Special Surgery, New York.
The researchers examined changes in serum levels of bone formation and resorption markers and other analytes in 24 women who received a lumbar ESI for radicular back pain and in 8 other women from the hospital population who served as control persons.
Among the women who received ESI, 1 week after the injection, serum levels of two bone formation biomarkers – total procollagen type 1 N-terminal peptide (P1NP) and osteocalcin – were about 27% lower than at baseline. The suppression persisted beyond 12 weeks.
Serum levels of the bone resorption biomarker C-terminal telopeptide of type I collagen (CTX) did not differ significantly after ESI.
“Our results are notable because we found that the duration of suppression of bone formation extended beyond 12 weeks, a far longer duration than seen previously with intra-articular injections” of glucocorticoids, said Ms. Clare and senior author Emily M. Stein, MD, director of research for the Metabolic Bone Service and an endocrinologist at the Hospital for Special Surgery and is associate professor of medicine at Weill Cornell Medicine, both in New York.
The findings suggest that patients should not receive multiple doses within a 12-week period, they told this news organization in a joint email response.
Women are not typically screened for osteopenia or osteoporosis before ESI. However, “our results suggest that physicians should consider screening women for osteoporosis who receive ESI, particularly those who are treated with multiple doses,” said Ms. Clare and Dr. Stein. “Steroid exposure should be minimized as much as possible by having patients space injections as far as they can tolerate.”
Systemic absorption, negative impact on bone turnover markers
“The hypothesis that [ESIs] interfere with the vertebral osseous microenvironment and increase the risk of vertebral fractures has been supported with evidence in the literature,” Mohamad Bydon, MD, professor of neurosurgery, orthopedic surgery, and health services research at the Mayo Clinic, Rochester, Minn., said in an interview.
Prior studies have demonstrated a decrease in bone mineral density (BMD) and an increase in vertebral fractures following ESI, added Dr. Bydon, senior author of a 2018 review of the effect of ESI on BMD and vertebral fracture risk that was published in Pain Medicine. He was not involved with the current study.
“The article by Clare et al. provides evidence on the systemic absorption of glucocorticoids by demonstrating a drop in serum cortisol following ESI,” he noted. “The measurement of bone metabolism biomarkers offers molecular confirmation of clinical and radiological observations of previous studies” showing that ESI affects the vertebrae.
More than 9 million ESIs each year
Each year, more than 9 million ESIs are administered to patients in the United States to relieve radicular back and leg pain that may be caused by a herniated disc or spinal stenosis (a gradual narrowing of the open spaces in the spinal column, which is common in older adults), the researchers explained.
Some patients experience sufficient pain relief with ESIs. Others may not be eligible for surgery and may receive multiple ESIs annually for many years because they provide pain relief.
It is well established that oral and intravenous glucocorticoids profoundly suppress bone formation and transiently increase bone resorption, causing substantial bone loss and increased fracture risk within 3 months of administration, Ms. Clare explained in the session.
Long-term use of high-dose inhaled glucocorticoids has been associated with bone loss and fractures. However, the effect of ESIs on bone has been less well studied.
The researchers hypothesized that ESIs are systemically absorbed and cause suppression of bone formation without a compensatory decrease in bone resorption.
They enrolled 24 patients who had undergone lumbar ESIs and 8 control patients. The mean age of the patients in the two groups was 63 years and 68 years, respectively. Most patients were White (88% and 100%, respectively). The mean body mass index was 27 kg/m2 and 28 kg/m2, respectively. On average, the patients had entered menopause 12 and 16 years earlier, respectively.
In the group that received steroid injections, almost two-thirds (15 patients, 63%) received triamcinolone. The rest received dexamethasone (six patients, 25%) or betamethasone (three patients, 12%) at doses that were equivalent to 80 mg triamcinolone.
The patients’ baseline serum levels of 25-hydroxy vitamin D, parathyroid hormone, cortisol, P1NP, osteocalcin, and CTX were within the reference ranges and were similar in the two groups.
The researchers also determined serum levels of cortisol (to assess suppression of endogenous glucocorticoids), osteocalcin, P1NP, and CTX in the patients and control persons at 1, 4, 12, 26, and 52 weeks after patients had received the ESI.
The researchers acknowledged that the small sample is a study limitation. In addition, the first serum samples were taken 1 week after the injection, and so any earlier changes in analyte levels were not captured. The patients also received different types of steroids, although the doses were similar when converted to triamcinolone equivalents.
The study was supported by a Spine Service grant from the Hospital for Special Surgery. The authors disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Retraining the brain may eliminate chronic back pain
Psychological therapy that changes an individual’s beliefs about pain not only provides lasting chronic pain relief but also alters brain regions related to pain generation, new research shows.
In the first randomized controlled test of pain-reprocessing therapy (PRT), two-thirds of patients with chronic back pain (CBP) who received 4 weeks of PRT were pain free or nearly pain free afterward – and for most patients, relief was maintained for 1 year, the researchers found.
“Primary chronic back pain can be dramatically reduced or even eliminated by psychological treatment focused on changing how threatening we perceive the pain to be,” first author Yoni Ashar, PhD, department of psychiatry, Weill Cornell Medicine, New York, said in an interview.
“ given that large reductions in pain have rarely been observed in studies that tested psychological therapies for chronic back pain.
The study was published online Sept. 29, 2021, in JAMA Psychiatry.
Rethinking pain
CBP is a leading cause of disability, and treatment is often ineffective. In about 85% of cases of primary CBP, a definitive cause of the pain can’t be identified. In these cases, fear, avoidance, and beliefs that pain indicates injury may contribute to ongoing CBP.
PRT educates patients about the role of the brain in generating chronic pain; helps them reappraise their pain as they engage in movements that they had been afraid to undertake; and helps them address emotions that may exacerbate pain.
The study included 151 adults (54% women; mean age, 41 years) who had primary CBP of low to moderate severity (mean pain intensity, 4 of 10) for an average of 10 years.
A total of 50 participants were randomly allocated to undergo PRT (one telehealth session with a physician and eight PRT sessions over 4 weeks), 51 to receive placebo (subcutaneous saline injection in the back), and 50 to continue their routine, usual ongoing care.
Large group differences in pain were observed after treatment. The mean pain score was 1.18 in the PRT group, 2.84 in the placebo group, and 3.13 in the usual-care group. Hedges’ g was –1.14 for PRT versus placebo and –1.74 for PRT versus usual care (P < .001).
Two-thirds (66%) of adults in the PRT group were pain free or nearly pain free following treatment (pain-intensity score of 0 or 1 out of 10), compared with 20% of those in the placebo group and 10% of those who received usual care.
Treatment effects were maintained at 1-year follow-up. The mean pain score was 1.51 in the PRT group, 2.79 in the placebo group, and 3.00 in the usual-care group. Neither age nor sex moderated the effect of PRT on pain intensity.
Retraining the brain
The researchers said the effects of PRT on pain were mediated by lessening the belief that pain indicates tissue damage. Of note, PRT also reduced experimentally evoked back pain and spontaneous pain during functional MRI, with large effect sizes.
“The idea is that by thinking about the pain as safe rather than threatening, patients can alter the brain networks reinforcing the pain, and neutralize it,” Dr. Ashar said in a news release.
The authors noted that study participants were relatively well educated and active. The participants reported having longstanding low to moderate pain and disability at baseline.
The physician and therapists were experts in delivering PRT. Future studies should test generalizability to other patient populations, therapists, and treatment contexts.
“Our clinical experience shows that PRT is effective for other primary chronic pain conditions as well,” said Dr. Ashar, including primary knee pain and tension headache.
Restoring function
Commenting on the findings, Shaheen E. Lakhan, MD, PhD, neurologist and pain specialist in Newton, Mass., said he has long experience using psychological approaches to address pain, with good results.
“Imagine telling a person suffering from decades of chronic pain that your pain is all in your head. I’ve done that for years as a board-certified pain physician managing only the most severe and debilitating forms of pain. When used to ground brain retraining, I could ultimately restore function to people living with chronic pain,” Dr. Lakhan said.
“The statement is true – the brain ultimately processes signals from throughout the body, forms the perception of pain, and links it to emotional brain centers, among others. Pain is an important survival mechanism so that when your body is at threat of injury, you protect yourself from further damage and withdraw. The problem lies when pain outlasts its welcome and chronifies,” said Dr. Lakhan, senior vice president of research and development of Click Therapeutics in Boston.
The investigators in this study “eloquently prove” that with 4 weeks of PRT, patients can learn that chronic pain is largely a “brain-generated false alarm and that constantly affirming this truth can actually reduce or eliminate it,” Dr. Lakhan said.
“Further, the brain areas implicated with pain are calmed after going through the therapy to both resting pain and pain induced by extending the back,” he noted.
“Pain-reprocessing therapy can improve the lives of chronic [pain patients] who have low to moderate levels of pain and disability; however, much work needs to be done to make this scalable and universally available and covered by insurers as a treatment modality,” Dr. Lakhan added.
He cautioned that he has not seen therapies such as this work when there is significant depression, withdrawal, or lack of control over one’s situation such that one behaves in a helpless manner – “a terrible state of mind called learned helplessness.”
The study was funded by the National Institutes of Health, the National Center for Advancing Translational Sciences, the Radiological Society of North America, the German Research Foundation, the Psychophysiologic Disorders Association, the Foundation for the Study of the Therapeutic Encounter, and community donations. Dr. Ashar received grants from the National Institutes of Health during the conduct of the study and personal fees from UnitedHealth Group, Lin Health, Pain Reprocessing Therapy Center, and Mental Health Partners of Boulder County outside the submitted work. Dr. Lakhan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Psychological therapy that changes an individual’s beliefs about pain not only provides lasting chronic pain relief but also alters brain regions related to pain generation, new research shows.
In the first randomized controlled test of pain-reprocessing therapy (PRT), two-thirds of patients with chronic back pain (CBP) who received 4 weeks of PRT were pain free or nearly pain free afterward – and for most patients, relief was maintained for 1 year, the researchers found.
“Primary chronic back pain can be dramatically reduced or even eliminated by psychological treatment focused on changing how threatening we perceive the pain to be,” first author Yoni Ashar, PhD, department of psychiatry, Weill Cornell Medicine, New York, said in an interview.
“ given that large reductions in pain have rarely been observed in studies that tested psychological therapies for chronic back pain.
The study was published online Sept. 29, 2021, in JAMA Psychiatry.
Rethinking pain
CBP is a leading cause of disability, and treatment is often ineffective. In about 85% of cases of primary CBP, a definitive cause of the pain can’t be identified. In these cases, fear, avoidance, and beliefs that pain indicates injury may contribute to ongoing CBP.
PRT educates patients about the role of the brain in generating chronic pain; helps them reappraise their pain as they engage in movements that they had been afraid to undertake; and helps them address emotions that may exacerbate pain.
The study included 151 adults (54% women; mean age, 41 years) who had primary CBP of low to moderate severity (mean pain intensity, 4 of 10) for an average of 10 years.
A total of 50 participants were randomly allocated to undergo PRT (one telehealth session with a physician and eight PRT sessions over 4 weeks), 51 to receive placebo (subcutaneous saline injection in the back), and 50 to continue their routine, usual ongoing care.
Large group differences in pain were observed after treatment. The mean pain score was 1.18 in the PRT group, 2.84 in the placebo group, and 3.13 in the usual-care group. Hedges’ g was –1.14 for PRT versus placebo and –1.74 for PRT versus usual care (P < .001).
Two-thirds (66%) of adults in the PRT group were pain free or nearly pain free following treatment (pain-intensity score of 0 or 1 out of 10), compared with 20% of those in the placebo group and 10% of those who received usual care.
Treatment effects were maintained at 1-year follow-up. The mean pain score was 1.51 in the PRT group, 2.79 in the placebo group, and 3.00 in the usual-care group. Neither age nor sex moderated the effect of PRT on pain intensity.
Retraining the brain
The researchers said the effects of PRT on pain were mediated by lessening the belief that pain indicates tissue damage. Of note, PRT also reduced experimentally evoked back pain and spontaneous pain during functional MRI, with large effect sizes.
“The idea is that by thinking about the pain as safe rather than threatening, patients can alter the brain networks reinforcing the pain, and neutralize it,” Dr. Ashar said in a news release.
The authors noted that study participants were relatively well educated and active. The participants reported having longstanding low to moderate pain and disability at baseline.
The physician and therapists were experts in delivering PRT. Future studies should test generalizability to other patient populations, therapists, and treatment contexts.
“Our clinical experience shows that PRT is effective for other primary chronic pain conditions as well,” said Dr. Ashar, including primary knee pain and tension headache.
Restoring function
Commenting on the findings, Shaheen E. Lakhan, MD, PhD, neurologist and pain specialist in Newton, Mass., said he has long experience using psychological approaches to address pain, with good results.
“Imagine telling a person suffering from decades of chronic pain that your pain is all in your head. I’ve done that for years as a board-certified pain physician managing only the most severe and debilitating forms of pain. When used to ground brain retraining, I could ultimately restore function to people living with chronic pain,” Dr. Lakhan said.
“The statement is true – the brain ultimately processes signals from throughout the body, forms the perception of pain, and links it to emotional brain centers, among others. Pain is an important survival mechanism so that when your body is at threat of injury, you protect yourself from further damage and withdraw. The problem lies when pain outlasts its welcome and chronifies,” said Dr. Lakhan, senior vice president of research and development of Click Therapeutics in Boston.
The investigators in this study “eloquently prove” that with 4 weeks of PRT, patients can learn that chronic pain is largely a “brain-generated false alarm and that constantly affirming this truth can actually reduce or eliminate it,” Dr. Lakhan said.
“Further, the brain areas implicated with pain are calmed after going through the therapy to both resting pain and pain induced by extending the back,” he noted.
“Pain-reprocessing therapy can improve the lives of chronic [pain patients] who have low to moderate levels of pain and disability; however, much work needs to be done to make this scalable and universally available and covered by insurers as a treatment modality,” Dr. Lakhan added.
He cautioned that he has not seen therapies such as this work when there is significant depression, withdrawal, or lack of control over one’s situation such that one behaves in a helpless manner – “a terrible state of mind called learned helplessness.”
The study was funded by the National Institutes of Health, the National Center for Advancing Translational Sciences, the Radiological Society of North America, the German Research Foundation, the Psychophysiologic Disorders Association, the Foundation for the Study of the Therapeutic Encounter, and community donations. Dr. Ashar received grants from the National Institutes of Health during the conduct of the study and personal fees from UnitedHealth Group, Lin Health, Pain Reprocessing Therapy Center, and Mental Health Partners of Boulder County outside the submitted work. Dr. Lakhan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
Psychological therapy that changes an individual’s beliefs about pain not only provides lasting chronic pain relief but also alters brain regions related to pain generation, new research shows.
In the first randomized controlled test of pain-reprocessing therapy (PRT), two-thirds of patients with chronic back pain (CBP) who received 4 weeks of PRT were pain free or nearly pain free afterward – and for most patients, relief was maintained for 1 year, the researchers found.
“Primary chronic back pain can be dramatically reduced or even eliminated by psychological treatment focused on changing how threatening we perceive the pain to be,” first author Yoni Ashar, PhD, department of psychiatry, Weill Cornell Medicine, New York, said in an interview.
“ given that large reductions in pain have rarely been observed in studies that tested psychological therapies for chronic back pain.
The study was published online Sept. 29, 2021, in JAMA Psychiatry.
Rethinking pain
CBP is a leading cause of disability, and treatment is often ineffective. In about 85% of cases of primary CBP, a definitive cause of the pain can’t be identified. In these cases, fear, avoidance, and beliefs that pain indicates injury may contribute to ongoing CBP.
PRT educates patients about the role of the brain in generating chronic pain; helps them reappraise their pain as they engage in movements that they had been afraid to undertake; and helps them address emotions that may exacerbate pain.
The study included 151 adults (54% women; mean age, 41 years) who had primary CBP of low to moderate severity (mean pain intensity, 4 of 10) for an average of 10 years.
A total of 50 participants were randomly allocated to undergo PRT (one telehealth session with a physician and eight PRT sessions over 4 weeks), 51 to receive placebo (subcutaneous saline injection in the back), and 50 to continue their routine, usual ongoing care.
Large group differences in pain were observed after treatment. The mean pain score was 1.18 in the PRT group, 2.84 in the placebo group, and 3.13 in the usual-care group. Hedges’ g was –1.14 for PRT versus placebo and –1.74 for PRT versus usual care (P < .001).
Two-thirds (66%) of adults in the PRT group were pain free or nearly pain free following treatment (pain-intensity score of 0 or 1 out of 10), compared with 20% of those in the placebo group and 10% of those who received usual care.
Treatment effects were maintained at 1-year follow-up. The mean pain score was 1.51 in the PRT group, 2.79 in the placebo group, and 3.00 in the usual-care group. Neither age nor sex moderated the effect of PRT on pain intensity.
Retraining the brain
The researchers said the effects of PRT on pain were mediated by lessening the belief that pain indicates tissue damage. Of note, PRT also reduced experimentally evoked back pain and spontaneous pain during functional MRI, with large effect sizes.
“The idea is that by thinking about the pain as safe rather than threatening, patients can alter the brain networks reinforcing the pain, and neutralize it,” Dr. Ashar said in a news release.
The authors noted that study participants were relatively well educated and active. The participants reported having longstanding low to moderate pain and disability at baseline.
The physician and therapists were experts in delivering PRT. Future studies should test generalizability to other patient populations, therapists, and treatment contexts.
“Our clinical experience shows that PRT is effective for other primary chronic pain conditions as well,” said Dr. Ashar, including primary knee pain and tension headache.
Restoring function
Commenting on the findings, Shaheen E. Lakhan, MD, PhD, neurologist and pain specialist in Newton, Mass., said he has long experience using psychological approaches to address pain, with good results.
“Imagine telling a person suffering from decades of chronic pain that your pain is all in your head. I’ve done that for years as a board-certified pain physician managing only the most severe and debilitating forms of pain. When used to ground brain retraining, I could ultimately restore function to people living with chronic pain,” Dr. Lakhan said.
“The statement is true – the brain ultimately processes signals from throughout the body, forms the perception of pain, and links it to emotional brain centers, among others. Pain is an important survival mechanism so that when your body is at threat of injury, you protect yourself from further damage and withdraw. The problem lies when pain outlasts its welcome and chronifies,” said Dr. Lakhan, senior vice president of research and development of Click Therapeutics in Boston.
The investigators in this study “eloquently prove” that with 4 weeks of PRT, patients can learn that chronic pain is largely a “brain-generated false alarm and that constantly affirming this truth can actually reduce or eliminate it,” Dr. Lakhan said.
“Further, the brain areas implicated with pain are calmed after going through the therapy to both resting pain and pain induced by extending the back,” he noted.
“Pain-reprocessing therapy can improve the lives of chronic [pain patients] who have low to moderate levels of pain and disability; however, much work needs to be done to make this scalable and universally available and covered by insurers as a treatment modality,” Dr. Lakhan added.
He cautioned that he has not seen therapies such as this work when there is significant depression, withdrawal, or lack of control over one’s situation such that one behaves in a helpless manner – “a terrible state of mind called learned helplessness.”
The study was funded by the National Institutes of Health, the National Center for Advancing Translational Sciences, the Radiological Society of North America, the German Research Foundation, the Psychophysiologic Disorders Association, the Foundation for the Study of the Therapeutic Encounter, and community donations. Dr. Ashar received grants from the National Institutes of Health during the conduct of the study and personal fees from UnitedHealth Group, Lin Health, Pain Reprocessing Therapy Center, and Mental Health Partners of Boulder County outside the submitted work. Dr. Lakhan disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
A Facility-Wide Plan to Increase Access to Medication for Opioid Use Disorder in Primary Care and General Mental Health Settings
In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.1 This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.2 Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.5
Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.6,7 This is particularly true in rural settings, where addiction care services are typically scarce.8 OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.9 For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.10,11
Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.14
The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.15 SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an in-person national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.16, 17
US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).18
This article describes the VACHSquality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.
SCOUTT Team
A VACHS interdisciplinary team was formed and attended the national SCOUTT kickoff conference in 2018.15 Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.
Implementation Steps
The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.
To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training
The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The onboarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).
The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix
Templated progress notes were created for buprenorphine initiation and buprenorphine maintenance with links to recommended laboratory tests and urine toxicology test ordering, home induction guides, prescription drug monitoring database, naloxone prescribing, and pharmacy order sets. Communication with specialty HCPs was facilitated by development of e-consultation within the EHR and instant messaging options within the local intranet. In the SCOUTT team model, the prescriber independently completed assessment/follow-up without nursing or clinical pharmacy support.
Analysis
We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ2 analyses were conducted on before and after measures when total values were available.
Results
There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).
Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.
Interpretation
SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.
Summary and Future Directions
Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hopefully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.
We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and follow-up of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.
Acknowledgments/Funding
This material is based upon work supported by the US Department of Veterans Affairs (VA), Office of Mental Health and Suicide Prevention, Veterans Health Administration; the VA Health Services Research and Development (HSR&D) Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEC) grants #19-001. Supporting organizations had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.
1. Centers for Disease Control and Prevention. Understanding the epidemic. Updated March 17, 2021. Accessed September 17, 2021. https://www.cdc.gov/drugoverdose/epidemic/index.html
2. Blanco C, Volkow ND. Management of opioid use disorder in the USA: present status and future directions. Lancet. 2019;393(10182):1760-1772. doi:10.1016/S0140-6736(18)33078-2
3. Seal KH, Shi Y, Cohen G, et al. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan [published correction appears in JAMA. 2012 Jun 20;307(23):2489]. JAMA. 2012;307(9):940-947. doi:10.1001/jama.2012.234
4. Bohnert AS, Ilgen MA, Trafton JA, et al. Trends and regional variation in opioid overdose mortality among Veterans Health Administration patients, fiscal year 2001 to 2009. Clin J Pain. 2014;30(7):605-612. doi:10.1097/AJP.0000000000000011
5. US Department of Health and Human Services, Working Group on Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics. HHS guide for clinicians on the appropriate dosage reduction or discontinuation of Long-term opioid analgesics. Published October 2019. Accessed September 17, 2021. https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf
6. Sullivan LE, Chawarski M, O’Connor PG, Schottenfeld RS, Fiellin DA. The practice of office-based buprenorphine treatment of opioid dependence: is it associated with new patients entering into treatment?. Drug Alcohol Depend. 2005;79(1):113-116. doi:10.1016/j.drugalcdep.2004.12.008
7. LaBelle CT, Han SC, Bergeron A, Samet JH. Office-based opioid treatment with buprenorphine (OBOT-B): statewide implementation of the Massachusetts collaborative care model in community health centers. J Subst Abuse Treat. 2016;60:6-13. doi:10.1016/j.jsat.2015.06.010
8. Rubin R. Rural veterans less likely to get medication for opioid use disorder. JAMA. 2020;323(4):300. doi:10.1001/jama.2019.21856
9. Kahan M, Srivastava A, Ordean A, Cirone S. Buprenorphine: new treatment of opioid addiction in primary care. Can Fam Physician. 2011;57(3):281-289.
10. Fiellin DA, Moore BA, Sullivan LE, et al. Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict. 2008;17(2):116-120. doi:10.1080/10550490701860971
11. Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006;355(4):365-374. doi:10.1056/NEJMoa055255
12. Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013;131(1-2):127-135. doi:10.1016/j.drugalcdep.2012.12.008
13. Alford DP, LaBelle CT, Richardson JM, et al. Treating homeless opioid dependent patients with buprenorphine in an office-based setting. J Gen Intern Med. 2007;22(2):171-176. doi:10.1007/s11606-006-0023-1
14. Wyse JJ, Gordon AJ, Dobscha SK, et al. Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: Historical perspective, lessons learned, and next steps. Subst Abus. 2018;39(2):139-144. doi:10.1080/08897077.2018.1452327
15. Gordon AJ, Drexler K, Hawkins EJ, et al. Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative: Expanding access to medication treatment for opioid use disorder within Veterans Health Administration facilities. Subst Abus. 2020;41(3):275-282. doi:10.1080/08897077.2020.1787299
16. Codell N, Kelley AT, Jones AL, et al. Aims, development, and early results of an interdisciplinary primary care initiative to address patient vulnerabilities. Am J Drug Alcohol Abuse. 2021;47(2):160-169. doi:10.1080/00952990.2020.1832507
17. DeRonne BM, Wong KR, Schultz E, Jones E, Krebs EE. Implementation of a pharmacist care manager model to expand availability of medications for opioid use disorder. Am J Health Syst Pharm. 2021;78(4):354-359. doi:10.1093/ajhp/zxaa405
18. Oliva EM, Bowe T, Tavakoli S, et al. Development and applications of the Veterans Health Administration’s Stratification Tool for Opioid Risk Mitigation (STORM) to improve opioid safety and prevent overdose and suicide. Psychol Serv. 2017;14(1):34-49. doi:10.1037/ser0000099
19. US Department of Defense, US Department of Veterans Affairs, Opioid Therapy for Chronic Pain Work Group. VA/DoD clinical practice guideline for opioid therapy for chronic pain. Published February 2017. Accessed August 20, 2021. https://www.va.gov/HOMELESS/nchav/resources/docs/mental-health/substance-abuse/VA_DoD-CLINICAL-PRACTICE-GUIDELINE-FOR-OPIOID-THERAPY-FOR-CHRONIC-PAIN-508.pdf
In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.1 This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.2 Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.5
Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.6,7 This is particularly true in rural settings, where addiction care services are typically scarce.8 OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.9 For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.10,11
Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.14
The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.15 SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an in-person national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.16, 17
US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).18
This article describes the VACHSquality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.
SCOUTT Team
A VACHS interdisciplinary team was formed and attended the national SCOUTT kickoff conference in 2018.15 Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.
Implementation Steps
The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.
To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training
The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The onboarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).
The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix
Templated progress notes were created for buprenorphine initiation and buprenorphine maintenance with links to recommended laboratory tests and urine toxicology test ordering, home induction guides, prescription drug monitoring database, naloxone prescribing, and pharmacy order sets. Communication with specialty HCPs was facilitated by development of e-consultation within the EHR and instant messaging options within the local intranet. In the SCOUTT team model, the prescriber independently completed assessment/follow-up without nursing or clinical pharmacy support.
Analysis
We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ2 analyses were conducted on before and after measures when total values were available.
Results
There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).
Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.
Interpretation
SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.
Summary and Future Directions
Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hopefully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.
We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and follow-up of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.
Acknowledgments/Funding
This material is based upon work supported by the US Department of Veterans Affairs (VA), Office of Mental Health and Suicide Prevention, Veterans Health Administration; the VA Health Services Research and Development (HSR&D) Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEC) grants #19-001. Supporting organizations had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.
In the United States, opioid use disorder (OUD) is a major public health challenge. In 2018 drug overdose deaths were 4 times higher than they were in 1999.1 This increase highlights a critical need to expand treatment access. Medication for opioid use disorder (MOUD), including methadone, naltrexone, and buprenorphine, improves outcomes for patients retained in care.2 Compared with the general population, veterans, particularly those with co-occurring posttraumatic stress disorder (PTSD) or depression, are more likely to receive higher dosages of opioid medications and experience opioid-related adverse outcomes (eg, overdose, OUD).3,4 As a risk reduction strategy, patients receiving potentially dangerous full-dose agonist opioid medication who are unable to taper to safer dosages may be eligible to transition to buprenorphine.5
Buprenorphine and naltrexone can be prescribed in office-based settings or in addiction, primary care, mental health, and pain clinics. Office-based opioid treatment with buprenorphine (OBOT-B) expands access to patients who are not reached by addiction treatment programs.6,7 This is particularly true in rural settings, where addiction care services are typically scarce.8 OBOT-B prevents relapse and maintains opioid-free days and may increase patient engagement by reducing stigma and providing treatment within an existing clinical care team.9 For many patients, OBOT-B results in good retention with just medical monitoring and minimal or no ancillary addiction counseling.10,11
Successful implementation of OBOT-B has occurred through a variety of care models in selected community health care settings.8,12,13 Historically in the Veterans Health Administration (VHA), MOUD has been prescribed in substance use disorder clinics by mental health practitioners. Currently, more than 44% of veterans with OUD are on MOUD.14
The VHA has invested significant resources to improve access to MOUD. In 2018, the Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative launched, with the aim to improve access within primary care, mental health, and pain clinics.15 SCOUTT emphasizes stepped-care treatment, with patients engaging in the step of care most appropriate to their needs. Step 0 is self-directed care/self-management, including mutual support groups; step-1 environments include office-based primary care, mental health, and pain clinics; and step-2 environments are specialty care settings. Through a series of remote webinars, an in-person national 2-day conference, and external facilitation, SCOUTT engaged 18 teams representing each Veterans Integrated Service Network (VISN) across the country to assist in implementing MOUD within 2 step-1 clinics. These teams have developed several models of providing step-1 care, including an interdisciplinary team-based primary care delivery model as well as a pharmacist care manager model.16, 17
US Department of Veterans Affairs (VA) Connecticut Health Care System (VACHS), which delivers care to approximately 58,000 veterans, was chosen to be a phase 1 SCOUTT site. Though all patients in VACHS have access to specialty care step-2 clinics, including methadone and buprenorphine programs, there remained many patients not yet on MOUD who could benefit from it. Baseline data (fiscal year [FY] 2018 4th quarter), obtained through electronic health record (EHR) database dashboards indicated that 710 (56%) patients with an OUD diagnosis were not receiving MOUD. International Classification of Disease, 10th Revision codes are the foundation for VA population management dashboards, and based their data on codes for opioid abuse and opioid dependence. These tools are limited by the accuracy of coding in EHRs. Additionally, 366 patients receiving long-term opioid prescriptions were identified as moderate, high, or very high risk for overdose or death based on an algorithm that considered prescribed medications, sociodemographics, and comorbid conditions, as characterized in the VA EHR (Stratification Tool for Opioid Risk Mitigation [STORM] report).18
This article describes the VACHSquality-improvement effort to extend OBOT-B into step-1 primary care and general mental health clinics. Our objectives are to (1) outline the process for initiating SCOUTT within VACHS; (2) examine barriers to implementation and the SCOUTT team response; (3) review VACHS patient and prescriber data at baseline and 1 year after implementation; and (4) explore future implementation strategies.
SCOUTT Team
A VACHS interdisciplinary team was formed and attended the national SCOUTT kickoff conference in 2018.15 Similar to other SCOUTT teams, the team consisted of VISN leadership (in primary care, mental health, and addiction care), pharmacists, and a team of health care practitioners (HCPs) from step-2 clinics (including 2 addiction psychiatrists, and an advanced practice registered nurse, a registered nurse specializing in addiction care), and a team of HCPs from prospective step-1 clinics (including a clinical psychologist and 2 primary care physicians). An external facilitator was provided from outside the VISN who met remotely with the team to assist in facilitation. Our team met monthly, with the goal to identify local barriers and facilitators to OBOT-B and implement interventions to enhance prescribing in step-1 primary care and general mental health clinics.
Implementation Steps
The team identified multiple barriers to dissemination of OBOT-B in target clinics (Table). The 3 main barriers were limited leadership engagement in promoting OBOT-B in target clinics, inadequate number of HCPs with active X-waivered prescribing status in the targeted clinics, and the need for standardized processes and tools to facilitate prescribing and follow-up.
To address leadership engagement, the SCOUTT team held quarterly presentations of SCOUTT goals and progress on target clinic leadership calls (usually 15 minutes) and arranged a 90-minute multidisciplinary leadership summit with key leadership representation from primary care, general mental health, specialty addiction care, nursing, and pharmacy. To enhance X-waivered prescribers in target clinics, the SCOUTT team sent quarterly emails with brief education points on MOUD and links to waiver trainings. At the time of implementation, in order to prescribe buprenorphine and meet qualifications to treat OUD, prescribers were required to complete specialized training as necessitated by the Drug Addiction Treatment Act of 2000. X-waivered status can now be obtained without requiring training
The SCOUTT team advocated for X-waivered status to be incentivized by performance pay for primary care practitioners and held quarterly case-based education sessions during preexisting allotted time. The onboarding process for new waivered prescribers to navigate from waiver training to active prescribing within the EHR was standardized via development of a standard operating procedure (SOP).
The SCOUTT team also assisted in the development of standardized processes and tools for prescribing in target clinics, including implementation of a standard operating procedure regarding prescribing (both initiation of buprenorphine, and maintenance) in target clinics. This procedure specifies that target clinic HCPs prescribe for patients requiring less intensive management, and who are appropriate for office-based treatment based on specific criteria (eAppendix
Templated progress notes were created for buprenorphine initiation and buprenorphine maintenance with links to recommended laboratory tests and urine toxicology test ordering, home induction guides, prescription drug monitoring database, naloxone prescribing, and pharmacy order sets. Communication with specialty HCPs was facilitated by development of e-consultation within the EHR and instant messaging options within the local intranet. In the SCOUTT team model, the prescriber independently completed assessment/follow-up without nursing or clinical pharmacy support.
Analysis
We examined changes in MOUD receipt and prescriber characteristics at baseline (FY 2018 4th quarter) and 1 year after implementation (FY 2019 4th quarter). Patient data were extracted from the VHA Corporate Data Warehouse (CDW), which contains data from all VHA EHRs. The VA STORM, is a CDW tool that automatically flags patients prescribed opioids who are at risk for overdose and suicide. Prescriber data were obtained from the Buprenorphine/X-Waivered Provider Report, a VA Academic Detailing Service database that provides details on HCP type, X-waivered status, and prescribing by location. χ2 analyses were conducted on before and after measures when total values were available.
Results
There was a 4% increase in patients with an OUD diagnosis receiving MOUD, from 552 (44%) to 582 (48%) (P = .04), over this time. The number of waivered prescribers increased from 67 to 131, the number of prescribers of buprenorphine in a 6-month span increased from 35 to 52, and the percentage of HCPs capable of prescribing within the EHR increased from 75% to 89% (P =.01).
Initially, addiction HCPs prescribed to about 68% of patients on buprenorphine, with target clinic HCPs prescribing to 24% (with the remaining coming from other specialty HCPs). On follow-up, addiction professionals prescribed to 63%, with target clinic clincians prescribing to 32%.
Interpretation
SCOUTT team interventions succeeded in increasing the number of patients receiving MOUD, a substantial increase in waivered HCPs, an increase in the number of waivered HCPs prescribing MOUD, and an increase in the proportion of patients receiving MOUD in step-1 target clinics. It is important to note that within the quality-improvement framework and goals of our SCOUTT team that the data were not collected as part of a research study but to assess impact of our interventions. Within this framework, it is not possible to directly attribute the increase in eligible patients receiving MOUD solely to SCOUTT team interventions, as other factors may have contributed, including improved awareness of HCPs.
Summary and Future Directions
Since implementation of SCOUTT in August 2018, VACHS has identified several barriers to buprenorphine prescribing in step-1 clinics and implemented strategies to overcome them. Describing our approach will hopefully inform other large health care systems (VA or non-VA) on changes required in order to scale up implementation of OBOT-B. The VACHS SCOUTT team was successful at enhancing a ready workforce in step-1 clinics, though noted a delay in changing prescribing practice and culture.
We recommend utilizing academic detailing to work with clinics and individual HCPs to identify and overcome barriers to prescribing. Also, we recommend implementation of a nursing or clinical pharmacy collaborative care model in target step-1 clinics (rather than the HCP-driven model). A collaborative care model reflects the patient aligned care team (PACT) principle of team-based efficient care, and PACT nurses or clinical pharmacists should be able to provide the minimal quarterly follow-up of clinically stable patients on MOUD within the step-1 clinics. Templated notes for assessment, initiation, and follow-up of patients on MOUD are now available from the SCOUTT national program and should be broadly implemented to facilitate adoption of the collaborative model in target clinics. In order to accomplish a full collaborative model, the VHA would need to enhance appropriate staffing to support this model, broaden access to telehealth, and expand incentives to teams/clinicians who prescribe in these settings.
Acknowledgments/Funding
This material is based upon work supported by the US Department of Veterans Affairs (VA), Office of Mental Health and Suicide Prevention, Veterans Health Administration; the VA Health Services Research and Development (HSR&D) Quality Enhancement Research Initiative (QUERI) Partnered Evaluation Initiative (PEC) grants #19-001. Supporting organizations had no further role in the study design; in the collection, analysis and interpretation of data; in the writing of the report; or in the decision to submit the paper for publication.
1. Centers for Disease Control and Prevention. Understanding the epidemic. Updated March 17, 2021. Accessed September 17, 2021. https://www.cdc.gov/drugoverdose/epidemic/index.html
2. Blanco C, Volkow ND. Management of opioid use disorder in the USA: present status and future directions. Lancet. 2019;393(10182):1760-1772. doi:10.1016/S0140-6736(18)33078-2
3. Seal KH, Shi Y, Cohen G, et al. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan [published correction appears in JAMA. 2012 Jun 20;307(23):2489]. JAMA. 2012;307(9):940-947. doi:10.1001/jama.2012.234
4. Bohnert AS, Ilgen MA, Trafton JA, et al. Trends and regional variation in opioid overdose mortality among Veterans Health Administration patients, fiscal year 2001 to 2009. Clin J Pain. 2014;30(7):605-612. doi:10.1097/AJP.0000000000000011
5. US Department of Health and Human Services, Working Group on Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics. HHS guide for clinicians on the appropriate dosage reduction or discontinuation of Long-term opioid analgesics. Published October 2019. Accessed September 17, 2021. https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf
6. Sullivan LE, Chawarski M, O’Connor PG, Schottenfeld RS, Fiellin DA. The practice of office-based buprenorphine treatment of opioid dependence: is it associated with new patients entering into treatment?. Drug Alcohol Depend. 2005;79(1):113-116. doi:10.1016/j.drugalcdep.2004.12.008
7. LaBelle CT, Han SC, Bergeron A, Samet JH. Office-based opioid treatment with buprenorphine (OBOT-B): statewide implementation of the Massachusetts collaborative care model in community health centers. J Subst Abuse Treat. 2016;60:6-13. doi:10.1016/j.jsat.2015.06.010
8. Rubin R. Rural veterans less likely to get medication for opioid use disorder. JAMA. 2020;323(4):300. doi:10.1001/jama.2019.21856
9. Kahan M, Srivastava A, Ordean A, Cirone S. Buprenorphine: new treatment of opioid addiction in primary care. Can Fam Physician. 2011;57(3):281-289.
10. Fiellin DA, Moore BA, Sullivan LE, et al. Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict. 2008;17(2):116-120. doi:10.1080/10550490701860971
11. Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006;355(4):365-374. doi:10.1056/NEJMoa055255
12. Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013;131(1-2):127-135. doi:10.1016/j.drugalcdep.2012.12.008
13. Alford DP, LaBelle CT, Richardson JM, et al. Treating homeless opioid dependent patients with buprenorphine in an office-based setting. J Gen Intern Med. 2007;22(2):171-176. doi:10.1007/s11606-006-0023-1
14. Wyse JJ, Gordon AJ, Dobscha SK, et al. Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: Historical perspective, lessons learned, and next steps. Subst Abus. 2018;39(2):139-144. doi:10.1080/08897077.2018.1452327
15. Gordon AJ, Drexler K, Hawkins EJ, et al. Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative: Expanding access to medication treatment for opioid use disorder within Veterans Health Administration facilities. Subst Abus. 2020;41(3):275-282. doi:10.1080/08897077.2020.1787299
16. Codell N, Kelley AT, Jones AL, et al. Aims, development, and early results of an interdisciplinary primary care initiative to address patient vulnerabilities. Am J Drug Alcohol Abuse. 2021;47(2):160-169. doi:10.1080/00952990.2020.1832507
17. DeRonne BM, Wong KR, Schultz E, Jones E, Krebs EE. Implementation of a pharmacist care manager model to expand availability of medications for opioid use disorder. Am J Health Syst Pharm. 2021;78(4):354-359. doi:10.1093/ajhp/zxaa405
18. Oliva EM, Bowe T, Tavakoli S, et al. Development and applications of the Veterans Health Administration’s Stratification Tool for Opioid Risk Mitigation (STORM) to improve opioid safety and prevent overdose and suicide. Psychol Serv. 2017;14(1):34-49. doi:10.1037/ser0000099
19. US Department of Defense, US Department of Veterans Affairs, Opioid Therapy for Chronic Pain Work Group. VA/DoD clinical practice guideline for opioid therapy for chronic pain. Published February 2017. Accessed August 20, 2021. https://www.va.gov/HOMELESS/nchav/resources/docs/mental-health/substance-abuse/VA_DoD-CLINICAL-PRACTICE-GUIDELINE-FOR-OPIOID-THERAPY-FOR-CHRONIC-PAIN-508.pdf
1. Centers for Disease Control and Prevention. Understanding the epidemic. Updated March 17, 2021. Accessed September 17, 2021. https://www.cdc.gov/drugoverdose/epidemic/index.html
2. Blanco C, Volkow ND. Management of opioid use disorder in the USA: present status and future directions. Lancet. 2019;393(10182):1760-1772. doi:10.1016/S0140-6736(18)33078-2
3. Seal KH, Shi Y, Cohen G, et al. Association of mental health disorders with prescription opioids and high-risk opioid use in US veterans of Iraq and Afghanistan [published correction appears in JAMA. 2012 Jun 20;307(23):2489]. JAMA. 2012;307(9):940-947. doi:10.1001/jama.2012.234
4. Bohnert AS, Ilgen MA, Trafton JA, et al. Trends and regional variation in opioid overdose mortality among Veterans Health Administration patients, fiscal year 2001 to 2009. Clin J Pain. 2014;30(7):605-612. doi:10.1097/AJP.0000000000000011
5. US Department of Health and Human Services, Working Group on Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics. HHS guide for clinicians on the appropriate dosage reduction or discontinuation of Long-term opioid analgesics. Published October 2019. Accessed September 17, 2021. https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf
6. Sullivan LE, Chawarski M, O’Connor PG, Schottenfeld RS, Fiellin DA. The practice of office-based buprenorphine treatment of opioid dependence: is it associated with new patients entering into treatment?. Drug Alcohol Depend. 2005;79(1):113-116. doi:10.1016/j.drugalcdep.2004.12.008
7. LaBelle CT, Han SC, Bergeron A, Samet JH. Office-based opioid treatment with buprenorphine (OBOT-B): statewide implementation of the Massachusetts collaborative care model in community health centers. J Subst Abuse Treat. 2016;60:6-13. doi:10.1016/j.jsat.2015.06.010
8. Rubin R. Rural veterans less likely to get medication for opioid use disorder. JAMA. 2020;323(4):300. doi:10.1001/jama.2019.21856
9. Kahan M, Srivastava A, Ordean A, Cirone S. Buprenorphine: new treatment of opioid addiction in primary care. Can Fam Physician. 2011;57(3):281-289.
10. Fiellin DA, Moore BA, Sullivan LE, et al. Long-term treatment with buprenorphine/naloxone in primary care: results at 2-5 years. Am J Addict. 2008;17(2):116-120. doi:10.1080/10550490701860971
11. Fiellin DA, Pantalon MV, Chawarski MC, et al. Counseling plus buprenorphine-naloxone maintenance therapy for opioid dependence. N Engl J Med. 2006;355(4):365-374. doi:10.1056/NEJMoa055255
12. Haddad MS, Zelenev A, Altice FL. Integrating buprenorphine maintenance therapy into federally qualified health centers: real-world substance abuse treatment outcomes. Drug Alcohol Depend. 2013;131(1-2):127-135. doi:10.1016/j.drugalcdep.2012.12.008
13. Alford DP, LaBelle CT, Richardson JM, et al. Treating homeless opioid dependent patients with buprenorphine in an office-based setting. J Gen Intern Med. 2007;22(2):171-176. doi:10.1007/s11606-006-0023-1
14. Wyse JJ, Gordon AJ, Dobscha SK, et al. Medications for opioid use disorder in the Department of Veterans Affairs (VA) health care system: Historical perspective, lessons learned, and next steps. Subst Abus. 2018;39(2):139-144. doi:10.1080/08897077.2018.1452327
15. Gordon AJ, Drexler K, Hawkins EJ, et al. Stepped Care for Opioid Use Disorder Train the Trainer (SCOUTT) initiative: Expanding access to medication treatment for opioid use disorder within Veterans Health Administration facilities. Subst Abus. 2020;41(3):275-282. doi:10.1080/08897077.2020.1787299
16. Codell N, Kelley AT, Jones AL, et al. Aims, development, and early results of an interdisciplinary primary care initiative to address patient vulnerabilities. Am J Drug Alcohol Abuse. 2021;47(2):160-169. doi:10.1080/00952990.2020.1832507
17. DeRonne BM, Wong KR, Schultz E, Jones E, Krebs EE. Implementation of a pharmacist care manager model to expand availability of medications for opioid use disorder. Am J Health Syst Pharm. 2021;78(4):354-359. doi:10.1093/ajhp/zxaa405
18. Oliva EM, Bowe T, Tavakoli S, et al. Development and applications of the Veterans Health Administration’s Stratification Tool for Opioid Risk Mitigation (STORM) to improve opioid safety and prevent overdose and suicide. Psychol Serv. 2017;14(1):34-49. doi:10.1037/ser0000099
19. US Department of Defense, US Department of Veterans Affairs, Opioid Therapy for Chronic Pain Work Group. VA/DoD clinical practice guideline for opioid therapy for chronic pain. Published February 2017. Accessed August 20, 2021. https://www.va.gov/HOMELESS/nchav/resources/docs/mental-health/substance-abuse/VA_DoD-CLINICAL-PRACTICE-GUIDELINE-FOR-OPIOID-THERAPY-FOR-CHRONIC-PAIN-508.pdf
Old wives’ tales, traditional medicine, and science
Sixteen-year-old Ana and is sitting on the bench with her science teacher, Ms. Tehrani, waiting for the bus to take them back to their village after school. Ana wants to hear her science teacher’s opinion about her grandmother.
Do you respect your grandmother?
Why yes, of course, why to do you ask?
So you think my grandmother is wise when she tells me old wife tales?
Like what?
Well, she says not to take my medicine because it will have bad effects and that I should take her remedies instead.
What else does she tell you?
Well, she says that people are born how they are and that they belong to either God or the Devil, not to their parents.
What else?
She thinks I am a fay child; she has always said that about me.
What does that mean?
It means that I have my own ways, fairy ways, and that I should go out in the forest and listen.
Do you?
Yes.
What do you hear?
I hear about my destiny.
What do you hear?
I hear that I must wash in witch hazel. My grandmother taught me how to find it and how to prepare it. She said I should sit in the forest and wait for a sign.
What sign?
I don’t know.
Well, what do you think about your grandmother?
I love her but …
But what?
I think she might be wrong about all of this, you know, science and all that.
But you do it, anyway?
Yes.
Why?
Aren’t we supposed to respect our elders, and aren’t they supposed to be wise?
Ms. Tehrani is in a bind. What to say? She has no ready answer, feeling caught between two beliefs: the unscientific basis of ineffective old wives’ treatments and the purported wisdom of our elders. She knows Ana’s family and that there are women in that family going back generations who are identified as medicine women or women with the special powers of the forest.
Ana wants to study science but she is being groomed as the family wise mother. Ana is caught between the ways of the past and the ways of the future. She sees that to go with the future is to devalue her family tradition. If she chooses to study medicine, can she keep the balance between magical ways and the ways of science?
Ms. Tehrani decides to expose her class to Indigenous and preindustrial cultural practices and what science has to say. She describes how knowledge is passed down through the generations, and how some of this knowledge has now been proved correct by science, such as the use of opium for pain management and how some knowledge has been corrected by science. She asks the class: What myths have been passed down in your family that science has shown to be effective or ineffective? What does science have to say about how we live our lives?
After a baby in the village dies, Ms. Tehrani asks the local health center to think about implementing a teaching course on caring for babies, a course that will discuss tradition and science. She is well aware of the fact that Black mothers tend not to follow the advice of the pediatricians who now recommend that parents put babies to sleep on their backs. Black women trust the advice of their paternal and maternal grandmothers more than the advice of health care providers, research by Deborah Stiffler, PhD, RN, CNM, shows (J Spec Pediatr Nurs. 2018 Apr;23[2]:e12213). While new Black mothers feel that they have limited knowledge and are eager to learn about safe sleep practices, their grandmothers were skeptical – and the grandmothers often won that argument. Black mothers believed that their own mothers knew best, based on their experience raising infants.
In Dr. Stiffler’s study, one grandmother commented: “Girls today need a mother to help them take care of their babies. They don’t know how to do anything. When I was growing up, our moms helped us.”
One new mother said: I “listen more to the elderly people because like the social workers and stuff some of them don’t have kids. They just go by the book … so I feel like I listen more to like my grandparents.”
Integrating traditions
When Ana enters medical school she is faced with the task of integration of traditional practice and Western medicine. Ana looks to the National Center for Complementary and Integrative Health (NCCIH), the U.S. government’s lead agency for scientific research on complementary and integrative health approaches for support in her task. The NCCIH was established in 1998 with the mission of determining the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care.
The NCCIH notes that more than 30% of adults use health care approaches that are not part of conventional medical care or that have origins outside of usual Western practice, and 17.7% of American adults had used a dietary supplement other than vitamins and minerals in the past year, most commonly fish oil. This agency notes that large rigorous research studies extend to only a few dietary supplements, with results showing that the products didn’t work for the conditions studied. The work of the NCCIH is mirrored worldwide.
The 2008 Beijing Declaration called on World Health Organization member states and other stakeholders to integrate traditional medicine and complementary alternative medicines into national health care systems. The WHO Congress on Traditional Medicine recognizes that traditional medicine (TM) may be more affordable and accessible than Western medicine, and that it plays an important role in meeting the demands of primary health care in many developing countries. From 70% to 80% of the population in India and Ethiopia depend on TM for primary health care, and 70% of the population in Canada and 80% in Germany are reported to have used TM as complementary and/or alternative medical treatment.
After graduation and residency, Ana returns to her village and helps her science teacher consider how best to shape the intergenerational transmission of knowledge, so that it is both honored by the elders and also shaped by the science of medicine.
Every village, regardless of where it is in the world, has to contend with finding the balance between the traditional medical knowledge that is passed down through the family and the discoveries of science. When it comes to practicing medicine and psychiatry, a respect for family tradition must be weighed against the application of science: this is a long conversation that is well worth its time.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). Dr. Heru has no conflicts of interest. Contact Dr. Heru at [email protected].
Sixteen-year-old Ana and is sitting on the bench with her science teacher, Ms. Tehrani, waiting for the bus to take them back to their village after school. Ana wants to hear her science teacher’s opinion about her grandmother.
Do you respect your grandmother?
Why yes, of course, why to do you ask?
So you think my grandmother is wise when she tells me old wife tales?
Like what?
Well, she says not to take my medicine because it will have bad effects and that I should take her remedies instead.
What else does she tell you?
Well, she says that people are born how they are and that they belong to either God or the Devil, not to their parents.
What else?
She thinks I am a fay child; she has always said that about me.
What does that mean?
It means that I have my own ways, fairy ways, and that I should go out in the forest and listen.
Do you?
Yes.
What do you hear?
I hear about my destiny.
What do you hear?
I hear that I must wash in witch hazel. My grandmother taught me how to find it and how to prepare it. She said I should sit in the forest and wait for a sign.
What sign?
I don’t know.
Well, what do you think about your grandmother?
I love her but …
But what?
I think she might be wrong about all of this, you know, science and all that.
But you do it, anyway?
Yes.
Why?
Aren’t we supposed to respect our elders, and aren’t they supposed to be wise?
Ms. Tehrani is in a bind. What to say? She has no ready answer, feeling caught between two beliefs: the unscientific basis of ineffective old wives’ treatments and the purported wisdom of our elders. She knows Ana’s family and that there are women in that family going back generations who are identified as medicine women or women with the special powers of the forest.
Ana wants to study science but she is being groomed as the family wise mother. Ana is caught between the ways of the past and the ways of the future. She sees that to go with the future is to devalue her family tradition. If she chooses to study medicine, can she keep the balance between magical ways and the ways of science?
Ms. Tehrani decides to expose her class to Indigenous and preindustrial cultural practices and what science has to say. She describes how knowledge is passed down through the generations, and how some of this knowledge has now been proved correct by science, such as the use of opium for pain management and how some knowledge has been corrected by science. She asks the class: What myths have been passed down in your family that science has shown to be effective or ineffective? What does science have to say about how we live our lives?
After a baby in the village dies, Ms. Tehrani asks the local health center to think about implementing a teaching course on caring for babies, a course that will discuss tradition and science. She is well aware of the fact that Black mothers tend not to follow the advice of the pediatricians who now recommend that parents put babies to sleep on their backs. Black women trust the advice of their paternal and maternal grandmothers more than the advice of health care providers, research by Deborah Stiffler, PhD, RN, CNM, shows (J Spec Pediatr Nurs. 2018 Apr;23[2]:e12213). While new Black mothers feel that they have limited knowledge and are eager to learn about safe sleep practices, their grandmothers were skeptical – and the grandmothers often won that argument. Black mothers believed that their own mothers knew best, based on their experience raising infants.
In Dr. Stiffler’s study, one grandmother commented: “Girls today need a mother to help them take care of their babies. They don’t know how to do anything. When I was growing up, our moms helped us.”
One new mother said: I “listen more to the elderly people because like the social workers and stuff some of them don’t have kids. They just go by the book … so I feel like I listen more to like my grandparents.”
Integrating traditions
When Ana enters medical school she is faced with the task of integration of traditional practice and Western medicine. Ana looks to the National Center for Complementary and Integrative Health (NCCIH), the U.S. government’s lead agency for scientific research on complementary and integrative health approaches for support in her task. The NCCIH was established in 1998 with the mission of determining the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care.
The NCCIH notes that more than 30% of adults use health care approaches that are not part of conventional medical care or that have origins outside of usual Western practice, and 17.7% of American adults had used a dietary supplement other than vitamins and minerals in the past year, most commonly fish oil. This agency notes that large rigorous research studies extend to only a few dietary supplements, with results showing that the products didn’t work for the conditions studied. The work of the NCCIH is mirrored worldwide.
The 2008 Beijing Declaration called on World Health Organization member states and other stakeholders to integrate traditional medicine and complementary alternative medicines into national health care systems. The WHO Congress on Traditional Medicine recognizes that traditional medicine (TM) may be more affordable and accessible than Western medicine, and that it plays an important role in meeting the demands of primary health care in many developing countries. From 70% to 80% of the population in India and Ethiopia depend on TM for primary health care, and 70% of the population in Canada and 80% in Germany are reported to have used TM as complementary and/or alternative medical treatment.
After graduation and residency, Ana returns to her village and helps her science teacher consider how best to shape the intergenerational transmission of knowledge, so that it is both honored by the elders and also shaped by the science of medicine.
Every village, regardless of where it is in the world, has to contend with finding the balance between the traditional medical knowledge that is passed down through the family and the discoveries of science. When it comes to practicing medicine and psychiatry, a respect for family tradition must be weighed against the application of science: this is a long conversation that is well worth its time.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). Dr. Heru has no conflicts of interest. Contact Dr. Heru at [email protected].
Sixteen-year-old Ana and is sitting on the bench with her science teacher, Ms. Tehrani, waiting for the bus to take them back to their village after school. Ana wants to hear her science teacher’s opinion about her grandmother.
Do you respect your grandmother?
Why yes, of course, why to do you ask?
So you think my grandmother is wise when she tells me old wife tales?
Like what?
Well, she says not to take my medicine because it will have bad effects and that I should take her remedies instead.
What else does she tell you?
Well, she says that people are born how they are and that they belong to either God or the Devil, not to their parents.
What else?
She thinks I am a fay child; she has always said that about me.
What does that mean?
It means that I have my own ways, fairy ways, and that I should go out in the forest and listen.
Do you?
Yes.
What do you hear?
I hear about my destiny.
What do you hear?
I hear that I must wash in witch hazel. My grandmother taught me how to find it and how to prepare it. She said I should sit in the forest and wait for a sign.
What sign?
I don’t know.
Well, what do you think about your grandmother?
I love her but …
But what?
I think she might be wrong about all of this, you know, science and all that.
But you do it, anyway?
Yes.
Why?
Aren’t we supposed to respect our elders, and aren’t they supposed to be wise?
Ms. Tehrani is in a bind. What to say? She has no ready answer, feeling caught between two beliefs: the unscientific basis of ineffective old wives’ treatments and the purported wisdom of our elders. She knows Ana’s family and that there are women in that family going back generations who are identified as medicine women or women with the special powers of the forest.
Ana wants to study science but she is being groomed as the family wise mother. Ana is caught between the ways of the past and the ways of the future. She sees that to go with the future is to devalue her family tradition. If she chooses to study medicine, can she keep the balance between magical ways and the ways of science?
Ms. Tehrani decides to expose her class to Indigenous and preindustrial cultural practices and what science has to say. She describes how knowledge is passed down through the generations, and how some of this knowledge has now been proved correct by science, such as the use of opium for pain management and how some knowledge has been corrected by science. She asks the class: What myths have been passed down in your family that science has shown to be effective or ineffective? What does science have to say about how we live our lives?
After a baby in the village dies, Ms. Tehrani asks the local health center to think about implementing a teaching course on caring for babies, a course that will discuss tradition and science. She is well aware of the fact that Black mothers tend not to follow the advice of the pediatricians who now recommend that parents put babies to sleep on their backs. Black women trust the advice of their paternal and maternal grandmothers more than the advice of health care providers, research by Deborah Stiffler, PhD, RN, CNM, shows (J Spec Pediatr Nurs. 2018 Apr;23[2]:e12213). While new Black mothers feel that they have limited knowledge and are eager to learn about safe sleep practices, their grandmothers were skeptical – and the grandmothers often won that argument. Black mothers believed that their own mothers knew best, based on their experience raising infants.
In Dr. Stiffler’s study, one grandmother commented: “Girls today need a mother to help them take care of their babies. They don’t know how to do anything. When I was growing up, our moms helped us.”
One new mother said: I “listen more to the elderly people because like the social workers and stuff some of them don’t have kids. They just go by the book … so I feel like I listen more to like my grandparents.”
Integrating traditions
When Ana enters medical school she is faced with the task of integration of traditional practice and Western medicine. Ana looks to the National Center for Complementary and Integrative Health (NCCIH), the U.S. government’s lead agency for scientific research on complementary and integrative health approaches for support in her task. The NCCIH was established in 1998 with the mission of determining the usefulness and safety of complementary and integrative health approaches, and their roles in improving health and health care.
The NCCIH notes that more than 30% of adults use health care approaches that are not part of conventional medical care or that have origins outside of usual Western practice, and 17.7% of American adults had used a dietary supplement other than vitamins and minerals in the past year, most commonly fish oil. This agency notes that large rigorous research studies extend to only a few dietary supplements, with results showing that the products didn’t work for the conditions studied. The work of the NCCIH is mirrored worldwide.
The 2008 Beijing Declaration called on World Health Organization member states and other stakeholders to integrate traditional medicine and complementary alternative medicines into national health care systems. The WHO Congress on Traditional Medicine recognizes that traditional medicine (TM) may be more affordable and accessible than Western medicine, and that it plays an important role in meeting the demands of primary health care in many developing countries. From 70% to 80% of the population in India and Ethiopia depend on TM for primary health care, and 70% of the population in Canada and 80% in Germany are reported to have used TM as complementary and/or alternative medical treatment.
After graduation and residency, Ana returns to her village and helps her science teacher consider how best to shape the intergenerational transmission of knowledge, so that it is both honored by the elders and also shaped by the science of medicine.
Every village, regardless of where it is in the world, has to contend with finding the balance between the traditional medical knowledge that is passed down through the family and the discoveries of science. When it comes to practicing medicine and psychiatry, a respect for family tradition must be weighed against the application of science: this is a long conversation that is well worth its time.
Dr. Heru is professor of psychiatry at the University of Colorado at Denver, Aurora. She is editor of “Working With Families in Medical Settings: A Multidisciplinary Guide for Psychiatrists and Other Health Professionals” (New York: Routledge, 2013). Dr. Heru has no conflicts of interest. Contact Dr. Heru at [email protected].
Opioid prescribing mapped: Alabama highest, New York lowest
Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.
That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.
The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),
Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.
from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.
In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.
Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.
That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.
The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),
Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.
from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.
In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.
Medicare beneficiaries in Alabama were more likely to get a prescription for an opioid than in any other state in 2019, based on newly released data.
That year, opioids represented 6.48% of all drug claims for part D enrollees in the state, just ahead of Utah at 6.41%. Idaho, at 6.07%, was the only other state with an opioid prescribing rate over 6%, while Oklahoma came in at an even 6.0%, according to the latest update of the Centers for Medicare & Medicaid Services’ dataset.
The lowest rate in 2019 belonged to New York, where 2.51% of drug claims, including original prescriptions and refills, involved an opioid. Rhode Island was next at 2.87%, followed by New Jersey (3.23%), Massachusetts (3.26%), and North Dakota (3.39%),
Altogether, Medicare part D processed 1.5 billion drug claims in 2019, of which 66.1 million, or 4.41%, involved opioids. Both of the opioid numbers were down from 2018, when opioids represented 4.68% (70.2 million) of the 1.5 billion total claims, and from 2014, when opioids were involved in 5.73% (81,026,831) of the 1.41 billion drug claims, the CMS data show. That works out to 5.77% fewer opioids in 2019, compared with 2014, despite the increase in total volume.
from 2014 to 2019, with Hawaii showing the smallest decline as it slipped 0.41 percentage points from 3.9% to 3.49%, according to the CMS.
In 2019, part D beneficiaries in Vermont were the most likely to receive a long-acting opioid, which accounted for 20.14% of all opioid prescriptions in the state, while Kentucky had the lowest share of prescriptions written for long-acting forms at 6.41%. The national average was 11.02%, dropping from 11.79% in 2018 and 12.75% in 2014, the CMS reported.
Scientists who unlocked secrets of pain sensation win nobel prize
for their discoveries of receptors for temperature and touch.
Their discoveries paved the way for new treatments for a wide range of disease conditions, including chronic pain.
“Our ability to sense heat, cold, and touch is essential for survival and underpins our interaction with the world around us,” the Nobel committee, in Stockholm, said in a news release.
“In our daily lives we take these sensations for granted, but how are nerve impulses initiated so that temperature and pressure can be perceived? This question has been solved by this year’s Nobel Prize laureates,” the committee added.
Science heats up
Dr. Julius and his collaborators used capsaicin, a pungent compound found in chili peppers that produces a burning sensation, to identify TRPV1, an ion channel activated by painful heat.
“The discovery of TRPV1 was a major breakthrough leading the way to the unravelling of additional temperature-sensing receptors,” the committee said.
Both Dr. Julius and Dr. Patapoutian used menthol to identify another receptor called TRPM8 that is activated by cold. Additional ion channels related to TRPV1 and TRPM8 were identified and found to be activated by a range of different temperatures.
The discoveries fueled other scientists to investigate the roles of these channels in thermal sensation.
“Julius’ discovery of TRPV1 was the breakthrough that allowed us to understand how differences in temperature can induce electrical signals in the nervous system,” the committee noted.
Science under pressure
As the mechanisms for temperature sensation began to unravel, Dr. Patapoutian and his collaborators used cultured pressure-sensitive cells to identify an ion channel activated by mechanical stimuli in the skin and internal organs. It was given the name Piezo1, after the Greek word for pressure.
Through its similarity to Piezo1, a second gene was discovered and named Piezo2. Sensory neurons were found to express high levels of Piezo2 and further studies firmly established that Piezo1 and Piezo2 are ion channels that are directly activated by the exertion of pressure on cell membranes.
“The groundbreaking discoveries of the TRPV1, TRPM8, and Piezo channels by this year’s Nobel Prize laureates have allowed us to understand how heat, cold, and mechanical force can initiate the nerve impulses that allow us to perceive and adapt to the world around us,” the Nobel committee said.
Dr. Julius and Dr. Patapoutian will receive a gold medal and share the $1.14 million prize money.
A version of this article first appeared on Medscape.com.
for their discoveries of receptors for temperature and touch.
Their discoveries paved the way for new treatments for a wide range of disease conditions, including chronic pain.
“Our ability to sense heat, cold, and touch is essential for survival and underpins our interaction with the world around us,” the Nobel committee, in Stockholm, said in a news release.
“In our daily lives we take these sensations for granted, but how are nerve impulses initiated so that temperature and pressure can be perceived? This question has been solved by this year’s Nobel Prize laureates,” the committee added.
Science heats up
Dr. Julius and his collaborators used capsaicin, a pungent compound found in chili peppers that produces a burning sensation, to identify TRPV1, an ion channel activated by painful heat.
“The discovery of TRPV1 was a major breakthrough leading the way to the unravelling of additional temperature-sensing receptors,” the committee said.
Both Dr. Julius and Dr. Patapoutian used menthol to identify another receptor called TRPM8 that is activated by cold. Additional ion channels related to TRPV1 and TRPM8 were identified and found to be activated by a range of different temperatures.
The discoveries fueled other scientists to investigate the roles of these channels in thermal sensation.
“Julius’ discovery of TRPV1 was the breakthrough that allowed us to understand how differences in temperature can induce electrical signals in the nervous system,” the committee noted.
Science under pressure
As the mechanisms for temperature sensation began to unravel, Dr. Patapoutian and his collaborators used cultured pressure-sensitive cells to identify an ion channel activated by mechanical stimuli in the skin and internal organs. It was given the name Piezo1, after the Greek word for pressure.
Through its similarity to Piezo1, a second gene was discovered and named Piezo2. Sensory neurons were found to express high levels of Piezo2 and further studies firmly established that Piezo1 and Piezo2 are ion channels that are directly activated by the exertion of pressure on cell membranes.
“The groundbreaking discoveries of the TRPV1, TRPM8, and Piezo channels by this year’s Nobel Prize laureates have allowed us to understand how heat, cold, and mechanical force can initiate the nerve impulses that allow us to perceive and adapt to the world around us,” the Nobel committee said.
Dr. Julius and Dr. Patapoutian will receive a gold medal and share the $1.14 million prize money.
A version of this article first appeared on Medscape.com.
for their discoveries of receptors for temperature and touch.
Their discoveries paved the way for new treatments for a wide range of disease conditions, including chronic pain.
“Our ability to sense heat, cold, and touch is essential for survival and underpins our interaction with the world around us,” the Nobel committee, in Stockholm, said in a news release.
“In our daily lives we take these sensations for granted, but how are nerve impulses initiated so that temperature and pressure can be perceived? This question has been solved by this year’s Nobel Prize laureates,” the committee added.
Science heats up
Dr. Julius and his collaborators used capsaicin, a pungent compound found in chili peppers that produces a burning sensation, to identify TRPV1, an ion channel activated by painful heat.
“The discovery of TRPV1 was a major breakthrough leading the way to the unravelling of additional temperature-sensing receptors,” the committee said.
Both Dr. Julius and Dr. Patapoutian used menthol to identify another receptor called TRPM8 that is activated by cold. Additional ion channels related to TRPV1 and TRPM8 were identified and found to be activated by a range of different temperatures.
The discoveries fueled other scientists to investigate the roles of these channels in thermal sensation.
“Julius’ discovery of TRPV1 was the breakthrough that allowed us to understand how differences in temperature can induce electrical signals in the nervous system,” the committee noted.
Science under pressure
As the mechanisms for temperature sensation began to unravel, Dr. Patapoutian and his collaborators used cultured pressure-sensitive cells to identify an ion channel activated by mechanical stimuli in the skin and internal organs. It was given the name Piezo1, after the Greek word for pressure.
Through its similarity to Piezo1, a second gene was discovered and named Piezo2. Sensory neurons were found to express high levels of Piezo2 and further studies firmly established that Piezo1 and Piezo2 are ion channels that are directly activated by the exertion of pressure on cell membranes.
“The groundbreaking discoveries of the TRPV1, TRPM8, and Piezo channels by this year’s Nobel Prize laureates have allowed us to understand how heat, cold, and mechanical force can initiate the nerve impulses that allow us to perceive and adapt to the world around us,” the Nobel committee said.
Dr. Julius and Dr. Patapoutian will receive a gold medal and share the $1.14 million prize money.
A version of this article first appeared on Medscape.com.