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Food addiction is pervasive among psychiatric patients
COPENHAGEN – Food addiction is threefold more prevalent among individuals with clinically diagnosed mental disorders than in the general population, according to a report from the Food Addiction Denmark (FADK) project.
This finding provides support for the hypothesis that food addiction is a key link in the chain connecting psychiatric disorders to increased risk of obesity, which in turn contributes to the substantially shorter life expectancy of psychiatric patients, Christina Horsager, MD, a cofounder of the project, said at the annual congress of the European College of Neuropsychopharmacology.
The FADK project is designed to fill in major gaps in the understanding of food addiction. The project included a 2018 Danish nationwide questionnaire survey of 1,394 individuals with various mental disorders and 1,699 others from the general population. The questionnaire included the Yale Food Addiction Scale Version 2.0 (Psychol Addict Behav. 2016 Feb;30[1]:113-21), which was used to identify affected individuals, as well as psychopathology rating scales, explained Dr. Horsager, of the child and adolescent psychiatry department at Aalborg (Denmark) University Hospital.
The prevalence of food addiction was 9% in the general population and 26.5% in individuals with mental disorders. The highest prevalence was, not surprisingly, in individuals with a DSM-5 diagnosis of an eating disorder. The rate was 30% in individuals with a DSM-5 personality disorder, 28% in those with a mood disorder, 17% with autism and other pervasive developmental disorders, just under 12% with a psychoactive substance use disorder, and 16% among patients with ADHD and other behavioral disorders.
But then again, the medications for ADHD tend to suppress appetite.
Obesity was significantly more prevalent among survey respondents who met criteria for food addiction, by a margin of 44.7% to 33.4%.
Food addiction is not an official DSM disorder. In fact, it’s a highly controversial construct: Some behavioral scientists think it has the classic hallmarks of a bona fide eating or substance use disorder; others don’t. Dr. Horsager highlighted the first systematic review of the evidence regarding food addiction, in which the University of Florida, Gainesville, authors concluded: “Overall, findings support food addiction as a unique construct consistent with criteria for other substance use disorder diagnoses. ... Though both behavioral and substance-related factors are implicated in the addictive process, symptoms appear to better fit criteria for substance use disorder than behavioral addiction” (Nutrients. 2018 Apr 12;10[4]:477. doi: 10.3390/nu10040477).
Food addiction is characterized by a compulsion to overeat calorie-dense, highly processed, super-palatable, sugar- and fat-laden foods. In this era of an ongoing global obesity epidemic, the public has become enthralled with the concept; a recent Google search of the term “food addiction” coughed up 288 million results.
The Food Addiction Denmark project findings warrant prospective studies examining whether treatment of food addiction might improve the prognosis of patients with mental disorders, according to Dr. Horsager.
She reported having no financial conflicts regarding her presentation.
COPENHAGEN – Food addiction is threefold more prevalent among individuals with clinically diagnosed mental disorders than in the general population, according to a report from the Food Addiction Denmark (FADK) project.
This finding provides support for the hypothesis that food addiction is a key link in the chain connecting psychiatric disorders to increased risk of obesity, which in turn contributes to the substantially shorter life expectancy of psychiatric patients, Christina Horsager, MD, a cofounder of the project, said at the annual congress of the European College of Neuropsychopharmacology.
The FADK project is designed to fill in major gaps in the understanding of food addiction. The project included a 2018 Danish nationwide questionnaire survey of 1,394 individuals with various mental disorders and 1,699 others from the general population. The questionnaire included the Yale Food Addiction Scale Version 2.0 (Psychol Addict Behav. 2016 Feb;30[1]:113-21), which was used to identify affected individuals, as well as psychopathology rating scales, explained Dr. Horsager, of the child and adolescent psychiatry department at Aalborg (Denmark) University Hospital.
The prevalence of food addiction was 9% in the general population and 26.5% in individuals with mental disorders. The highest prevalence was, not surprisingly, in individuals with a DSM-5 diagnosis of an eating disorder. The rate was 30% in individuals with a DSM-5 personality disorder, 28% in those with a mood disorder, 17% with autism and other pervasive developmental disorders, just under 12% with a psychoactive substance use disorder, and 16% among patients with ADHD and other behavioral disorders.
But then again, the medications for ADHD tend to suppress appetite.
Obesity was significantly more prevalent among survey respondents who met criteria for food addiction, by a margin of 44.7% to 33.4%.
Food addiction is not an official DSM disorder. In fact, it’s a highly controversial construct: Some behavioral scientists think it has the classic hallmarks of a bona fide eating or substance use disorder; others don’t. Dr. Horsager highlighted the first systematic review of the evidence regarding food addiction, in which the University of Florida, Gainesville, authors concluded: “Overall, findings support food addiction as a unique construct consistent with criteria for other substance use disorder diagnoses. ... Though both behavioral and substance-related factors are implicated in the addictive process, symptoms appear to better fit criteria for substance use disorder than behavioral addiction” (Nutrients. 2018 Apr 12;10[4]:477. doi: 10.3390/nu10040477).
Food addiction is characterized by a compulsion to overeat calorie-dense, highly processed, super-palatable, sugar- and fat-laden foods. In this era of an ongoing global obesity epidemic, the public has become enthralled with the concept; a recent Google search of the term “food addiction” coughed up 288 million results.
The Food Addiction Denmark project findings warrant prospective studies examining whether treatment of food addiction might improve the prognosis of patients with mental disorders, according to Dr. Horsager.
She reported having no financial conflicts regarding her presentation.
COPENHAGEN – Food addiction is threefold more prevalent among individuals with clinically diagnosed mental disorders than in the general population, according to a report from the Food Addiction Denmark (FADK) project.
This finding provides support for the hypothesis that food addiction is a key link in the chain connecting psychiatric disorders to increased risk of obesity, which in turn contributes to the substantially shorter life expectancy of psychiatric patients, Christina Horsager, MD, a cofounder of the project, said at the annual congress of the European College of Neuropsychopharmacology.
The FADK project is designed to fill in major gaps in the understanding of food addiction. The project included a 2018 Danish nationwide questionnaire survey of 1,394 individuals with various mental disorders and 1,699 others from the general population. The questionnaire included the Yale Food Addiction Scale Version 2.0 (Psychol Addict Behav. 2016 Feb;30[1]:113-21), which was used to identify affected individuals, as well as psychopathology rating scales, explained Dr. Horsager, of the child and adolescent psychiatry department at Aalborg (Denmark) University Hospital.
The prevalence of food addiction was 9% in the general population and 26.5% in individuals with mental disorders. The highest prevalence was, not surprisingly, in individuals with a DSM-5 diagnosis of an eating disorder. The rate was 30% in individuals with a DSM-5 personality disorder, 28% in those with a mood disorder, 17% with autism and other pervasive developmental disorders, just under 12% with a psychoactive substance use disorder, and 16% among patients with ADHD and other behavioral disorders.
But then again, the medications for ADHD tend to suppress appetite.
Obesity was significantly more prevalent among survey respondents who met criteria for food addiction, by a margin of 44.7% to 33.4%.
Food addiction is not an official DSM disorder. In fact, it’s a highly controversial construct: Some behavioral scientists think it has the classic hallmarks of a bona fide eating or substance use disorder; others don’t. Dr. Horsager highlighted the first systematic review of the evidence regarding food addiction, in which the University of Florida, Gainesville, authors concluded: “Overall, findings support food addiction as a unique construct consistent with criteria for other substance use disorder diagnoses. ... Though both behavioral and substance-related factors are implicated in the addictive process, symptoms appear to better fit criteria for substance use disorder than behavioral addiction” (Nutrients. 2018 Apr 12;10[4]:477. doi: 10.3390/nu10040477).
Food addiction is characterized by a compulsion to overeat calorie-dense, highly processed, super-palatable, sugar- and fat-laden foods. In this era of an ongoing global obesity epidemic, the public has become enthralled with the concept; a recent Google search of the term “food addiction” coughed up 288 million results.
The Food Addiction Denmark project findings warrant prospective studies examining whether treatment of food addiction might improve the prognosis of patients with mental disorders, according to Dr. Horsager.
She reported having no financial conflicts regarding her presentation.
REPORTING FROM ECNP 2019
A cigarette in one hand and a Fitbit on the other
A cardiologist friend of mine told me a story about one of his patients. The man had recently been in to see him for an office visit. He had quite a scare needing two stents after an episode of prolonged chest pain and, during the office visit, apparently had said that he had “found religion” and was going to change his ways. He showed off the Fitbit that he had gotten and shared his excitement about using a new app to track his diet on his smart phone. His blood pressure was a little elevated, so my friend added a third antihypertensive in an effort to get his blood pressure under control. He referred the patient back to his primary care physician to address his elevated hemoglobin A1c.
My friend saw the patient again a couple of weeks later – this time at the mall. As he was driving through the parking lot, he noticed his patient sitting on a bench outside the entrance. He also noticed a cigarette in his patient’s right hand and saw the Fitbit still on his wrist. Now, it’s not that there is anything wrong with wearing a Fitbit, but …
My friend is an incredibly respectful person, and very nice. He decided not to say hello and risk embarrassing his patient, so he walked to a different door far from the bench and went inside. Nonetheless, the image bothered him. It bothered him enough to repeat the story to me 2 weeks later. It bothers me too.
The other day I was talking to a healthy young nurse with whom I work. She has been trying to get into shape, and her goal is to get to the gym 5 days a week after work. She read on a popular website that she should use a heart rate monitor to keep track of her training and that, if her heart rate is too slow, she should run faster and, if her heart rate is too fast, she should slow down. She was discouraged the other day, however, because her watch indicated that her pulse was going up to 170 while she was running hard, and she had heard that could be dangerous for her heart.
When she doesn’t push hard, though, she told me that her heart rate often plateaus at about 110, sometimes 115. She has been finding it difficult to achieve her calculated target heart rate of 120-160 beats per minute. She is frustrated and was going to skip her workout that evening. I explained to her that she should stop checking her pulse and just run – if she felt she was running too slow she could run faster.
With everything that we have learned about science and technology, the reality is that we are still people, with all our weaknesses and strengths. We often set goals with ambivalence, then rush forward hoping that a technological solution will move us in the direction we think we want to move. Unfortunately, owning a Fitbit will not make us more fit, and checking our pulse every five minutes while working out will not lead to a better exercise session. With the availability of so much technology for tracking our daily exercise, vital signs, and various other measures of health, we need to be more careful than ever to determine specifically what it is that we are trying to accomplish with the use of our technology.
When it comes to good health, it is the fundamentals that matter, and achieving the fundamentals requires being mindful and making repeated efforts to master them. For almost all adults, the most important habits to develop are still related to diet and exercise. Consuming the right diet and exercising adequately requires that the correct choices be made each and every day, all day long. Technology can help but will not do it for us. We need to be thoughtful about how we use technology and explicit about how we expect it to help. After a reasonable amount of time, we should evaluate to see if it is working for us. If it is, then we should continue to use it. If it is not, then we should stop using it or make a different change, like performing a new type of exercise.
Our goal should be to have intelligent empathic integration of technological and behavioral techniques to achieve an optimal health outcome. Putting running shoes by the bed at night is a great thing to do to encourage us to run in the morning. Choosing motivational music can help us get the energy and enthusiasm to go for that run (our favorites include the Rocky theme song and “I Didn’t Come this Far to Only Come this Far”). A visual reminder over the refrigerator can “nudge” us to make good choices as we open the door.
For those who want to learn more about how to integrate behavioral management into their advice for patients we highly recommend reading “Switch: How to Change Things When Change Is Hard” by Chip Heath and “Nudge: Improving Decisions About Health, Wealth, and Happiness” by Richard Thaler. We have always been, and remain, excited about the promise of technology to help us accomplish our goals. That said, we told the nurse to stop checking her pulse, to put on some music, and to appreciate the leaves on the trees this autumn while she was running. As for the gentleman outside the mall, well …
We are interested in your thoughts. Please email us at fpnews@mdedge.com.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
A cardiologist friend of mine told me a story about one of his patients. The man had recently been in to see him for an office visit. He had quite a scare needing two stents after an episode of prolonged chest pain and, during the office visit, apparently had said that he had “found religion” and was going to change his ways. He showed off the Fitbit that he had gotten and shared his excitement about using a new app to track his diet on his smart phone. His blood pressure was a little elevated, so my friend added a third antihypertensive in an effort to get his blood pressure under control. He referred the patient back to his primary care physician to address his elevated hemoglobin A1c.
My friend saw the patient again a couple of weeks later – this time at the mall. As he was driving through the parking lot, he noticed his patient sitting on a bench outside the entrance. He also noticed a cigarette in his patient’s right hand and saw the Fitbit still on his wrist. Now, it’s not that there is anything wrong with wearing a Fitbit, but …
My friend is an incredibly respectful person, and very nice. He decided not to say hello and risk embarrassing his patient, so he walked to a different door far from the bench and went inside. Nonetheless, the image bothered him. It bothered him enough to repeat the story to me 2 weeks later. It bothers me too.
The other day I was talking to a healthy young nurse with whom I work. She has been trying to get into shape, and her goal is to get to the gym 5 days a week after work. She read on a popular website that she should use a heart rate monitor to keep track of her training and that, if her heart rate is too slow, she should run faster and, if her heart rate is too fast, she should slow down. She was discouraged the other day, however, because her watch indicated that her pulse was going up to 170 while she was running hard, and she had heard that could be dangerous for her heart.
When she doesn’t push hard, though, she told me that her heart rate often plateaus at about 110, sometimes 115. She has been finding it difficult to achieve her calculated target heart rate of 120-160 beats per minute. She is frustrated and was going to skip her workout that evening. I explained to her that she should stop checking her pulse and just run – if she felt she was running too slow she could run faster.
With everything that we have learned about science and technology, the reality is that we are still people, with all our weaknesses and strengths. We often set goals with ambivalence, then rush forward hoping that a technological solution will move us in the direction we think we want to move. Unfortunately, owning a Fitbit will not make us more fit, and checking our pulse every five minutes while working out will not lead to a better exercise session. With the availability of so much technology for tracking our daily exercise, vital signs, and various other measures of health, we need to be more careful than ever to determine specifically what it is that we are trying to accomplish with the use of our technology.
When it comes to good health, it is the fundamentals that matter, and achieving the fundamentals requires being mindful and making repeated efforts to master them. For almost all adults, the most important habits to develop are still related to diet and exercise. Consuming the right diet and exercising adequately requires that the correct choices be made each and every day, all day long. Technology can help but will not do it for us. We need to be thoughtful about how we use technology and explicit about how we expect it to help. After a reasonable amount of time, we should evaluate to see if it is working for us. If it is, then we should continue to use it. If it is not, then we should stop using it or make a different change, like performing a new type of exercise.
Our goal should be to have intelligent empathic integration of technological and behavioral techniques to achieve an optimal health outcome. Putting running shoes by the bed at night is a great thing to do to encourage us to run in the morning. Choosing motivational music can help us get the energy and enthusiasm to go for that run (our favorites include the Rocky theme song and “I Didn’t Come this Far to Only Come this Far”). A visual reminder over the refrigerator can “nudge” us to make good choices as we open the door.
For those who want to learn more about how to integrate behavioral management into their advice for patients we highly recommend reading “Switch: How to Change Things When Change Is Hard” by Chip Heath and “Nudge: Improving Decisions About Health, Wealth, and Happiness” by Richard Thaler. We have always been, and remain, excited about the promise of technology to help us accomplish our goals. That said, we told the nurse to stop checking her pulse, to put on some music, and to appreciate the leaves on the trees this autumn while she was running. As for the gentleman outside the mall, well …
We are interested in your thoughts. Please email us at fpnews@mdedge.com.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
A cardiologist friend of mine told me a story about one of his patients. The man had recently been in to see him for an office visit. He had quite a scare needing two stents after an episode of prolonged chest pain and, during the office visit, apparently had said that he had “found religion” and was going to change his ways. He showed off the Fitbit that he had gotten and shared his excitement about using a new app to track his diet on his smart phone. His blood pressure was a little elevated, so my friend added a third antihypertensive in an effort to get his blood pressure under control. He referred the patient back to his primary care physician to address his elevated hemoglobin A1c.
My friend saw the patient again a couple of weeks later – this time at the mall. As he was driving through the parking lot, he noticed his patient sitting on a bench outside the entrance. He also noticed a cigarette in his patient’s right hand and saw the Fitbit still on his wrist. Now, it’s not that there is anything wrong with wearing a Fitbit, but …
My friend is an incredibly respectful person, and very nice. He decided not to say hello and risk embarrassing his patient, so he walked to a different door far from the bench and went inside. Nonetheless, the image bothered him. It bothered him enough to repeat the story to me 2 weeks later. It bothers me too.
The other day I was talking to a healthy young nurse with whom I work. She has been trying to get into shape, and her goal is to get to the gym 5 days a week after work. She read on a popular website that she should use a heart rate monitor to keep track of her training and that, if her heart rate is too slow, she should run faster and, if her heart rate is too fast, she should slow down. She was discouraged the other day, however, because her watch indicated that her pulse was going up to 170 while she was running hard, and she had heard that could be dangerous for her heart.
When she doesn’t push hard, though, she told me that her heart rate often plateaus at about 110, sometimes 115. She has been finding it difficult to achieve her calculated target heart rate of 120-160 beats per minute. She is frustrated and was going to skip her workout that evening. I explained to her that she should stop checking her pulse and just run – if she felt she was running too slow she could run faster.
With everything that we have learned about science and technology, the reality is that we are still people, with all our weaknesses and strengths. We often set goals with ambivalence, then rush forward hoping that a technological solution will move us in the direction we think we want to move. Unfortunately, owning a Fitbit will not make us more fit, and checking our pulse every five minutes while working out will not lead to a better exercise session. With the availability of so much technology for tracking our daily exercise, vital signs, and various other measures of health, we need to be more careful than ever to determine specifically what it is that we are trying to accomplish with the use of our technology.
When it comes to good health, it is the fundamentals that matter, and achieving the fundamentals requires being mindful and making repeated efforts to master them. For almost all adults, the most important habits to develop are still related to diet and exercise. Consuming the right diet and exercising adequately requires that the correct choices be made each and every day, all day long. Technology can help but will not do it for us. We need to be thoughtful about how we use technology and explicit about how we expect it to help. After a reasonable amount of time, we should evaluate to see if it is working for us. If it is, then we should continue to use it. If it is not, then we should stop using it or make a different change, like performing a new type of exercise.
Our goal should be to have intelligent empathic integration of technological and behavioral techniques to achieve an optimal health outcome. Putting running shoes by the bed at night is a great thing to do to encourage us to run in the morning. Choosing motivational music can help us get the energy and enthusiasm to go for that run (our favorites include the Rocky theme song and “I Didn’t Come this Far to Only Come this Far”). A visual reminder over the refrigerator can “nudge” us to make good choices as we open the door.
For those who want to learn more about how to integrate behavioral management into their advice for patients we highly recommend reading “Switch: How to Change Things When Change Is Hard” by Chip Heath and “Nudge: Improving Decisions About Health, Wealth, and Happiness” by Richard Thaler. We have always been, and remain, excited about the promise of technology to help us accomplish our goals. That said, we told the nurse to stop checking her pulse, to put on some music, and to appreciate the leaves on the trees this autumn while she was running. As for the gentleman outside the mall, well …
We are interested in your thoughts. Please email us at fpnews@mdedge.com.
Dr. Notte is a family physician and associate chief medical information officer for Abington (Pa.) Jefferson Health. Follow him on Twitter @doctornotte. Dr. Skolnik is professor of family and community medicine at Jefferson Medical College, Philadelphia, and an associate director of the family medicine residency program at Abington Jefferson Health.
Drug crisis continues to evolve beyond opioids
Almost three-quarters of primary care physicians believe that their patients will take their controlled medications as prescribed, but more than half of drug-monitoring lab tests show signs of misuse, according to a new report from Quest Diagnostics.
“ and may miss some of the drug misuse risks affecting their patients,” report coauthor Harvey W. Kaufman, MD, Quest’s senior medical director, said in a written statement.
Analysis of more than 4.4 million drug-monitoring tests showed that 51% involved an inconsistent result, such as detection of a nonprescribed drug or nondetection of a drug that was prescribed. The report also included a survey of 500 primary care physicians, of whom 72% said they trusted their patents to properly use opioids and other controlled substances.
“The intersection of these two data sets reveals, for the first time, the contrast between physician expectations about patient drug use and the evolution of the drug epidemic and actual patient behavior, as revealed by objective lab data, amid a national drug crisis that claimed an estimated 68,500 lives last year,” the report said.
A majority (62%) of the physicians surveyed also said that the opioid crisis will evolve into a new prescription drug crisis, and even more (72%) think that patients with chronic pain will use illicit drugs if they cannot get prescription opioids. Evidence from the drug test dataset suggests that “misuse of nonprescribed fentanyl and nonprescribed gabapentin warrant[s] a closer look,” the report said. In the survey, 78% of respondents reported prescribing gabapentin as an alternative to opioids for patients with chronic pain.
Those two drugs, along with alcohol, are the only three drug groups for which misuse increased from 2017 to 2018, and both are frequently involved in drug mixing, which is the most common form of misuse. Gabapentin went from 9.6% of all nonprescribed misuse in 2017 to 13.4% in 2018, an increase of 40%. Nonprescribed fentanyl was found in 64% of test results that were positive for heroin and 24% that were positive for cocaine, the Quest data showed.
The survey results, however, suggest that gabapentin is not on physicians’ radar, as only 34% said that they were concerned about its misuse, compared with 96% for opioids and 90% for benzodiazepines, according to the report.
“While gabapentin may not have opioids’ addictive potential, it can exaggerate euphoric effects when combined with opioids or anxiety medications. This drug mixing is dangerous,” said report coauthor Jeffrey Gudin, MD, senior medical advisor, prescription drug monitoring, for Quest Diagnostics.
The survey was conducted online among family physicians, general practitioners, and internists from July 31 to Aug. 16, 2019, by the Harris Poll on behalf of Quest and Center for Addiction. The test result data were collected in all 50 states and Washington, D.C., from 2011 to 2018, and results from drug rehabilitation clinics and addiction specialists were excluded from the analysis, so actual misuse rates are probably higher than reported.
Almost three-quarters of primary care physicians believe that their patients will take their controlled medications as prescribed, but more than half of drug-monitoring lab tests show signs of misuse, according to a new report from Quest Diagnostics.
“ and may miss some of the drug misuse risks affecting their patients,” report coauthor Harvey W. Kaufman, MD, Quest’s senior medical director, said in a written statement.
Analysis of more than 4.4 million drug-monitoring tests showed that 51% involved an inconsistent result, such as detection of a nonprescribed drug or nondetection of a drug that was prescribed. The report also included a survey of 500 primary care physicians, of whom 72% said they trusted their patents to properly use opioids and other controlled substances.
“The intersection of these two data sets reveals, for the first time, the contrast between physician expectations about patient drug use and the evolution of the drug epidemic and actual patient behavior, as revealed by objective lab data, amid a national drug crisis that claimed an estimated 68,500 lives last year,” the report said.
A majority (62%) of the physicians surveyed also said that the opioid crisis will evolve into a new prescription drug crisis, and even more (72%) think that patients with chronic pain will use illicit drugs if they cannot get prescription opioids. Evidence from the drug test dataset suggests that “misuse of nonprescribed fentanyl and nonprescribed gabapentin warrant[s] a closer look,” the report said. In the survey, 78% of respondents reported prescribing gabapentin as an alternative to opioids for patients with chronic pain.
Those two drugs, along with alcohol, are the only three drug groups for which misuse increased from 2017 to 2018, and both are frequently involved in drug mixing, which is the most common form of misuse. Gabapentin went from 9.6% of all nonprescribed misuse in 2017 to 13.4% in 2018, an increase of 40%. Nonprescribed fentanyl was found in 64% of test results that were positive for heroin and 24% that were positive for cocaine, the Quest data showed.
The survey results, however, suggest that gabapentin is not on physicians’ radar, as only 34% said that they were concerned about its misuse, compared with 96% for opioids and 90% for benzodiazepines, according to the report.
“While gabapentin may not have opioids’ addictive potential, it can exaggerate euphoric effects when combined with opioids or anxiety medications. This drug mixing is dangerous,” said report coauthor Jeffrey Gudin, MD, senior medical advisor, prescription drug monitoring, for Quest Diagnostics.
The survey was conducted online among family physicians, general practitioners, and internists from July 31 to Aug. 16, 2019, by the Harris Poll on behalf of Quest and Center for Addiction. The test result data were collected in all 50 states and Washington, D.C., from 2011 to 2018, and results from drug rehabilitation clinics and addiction specialists were excluded from the analysis, so actual misuse rates are probably higher than reported.
Almost three-quarters of primary care physicians believe that their patients will take their controlled medications as prescribed, but more than half of drug-monitoring lab tests show signs of misuse, according to a new report from Quest Diagnostics.
“ and may miss some of the drug misuse risks affecting their patients,” report coauthor Harvey W. Kaufman, MD, Quest’s senior medical director, said in a written statement.
Analysis of more than 4.4 million drug-monitoring tests showed that 51% involved an inconsistent result, such as detection of a nonprescribed drug or nondetection of a drug that was prescribed. The report also included a survey of 500 primary care physicians, of whom 72% said they trusted their patents to properly use opioids and other controlled substances.
“The intersection of these two data sets reveals, for the first time, the contrast between physician expectations about patient drug use and the evolution of the drug epidemic and actual patient behavior, as revealed by objective lab data, amid a national drug crisis that claimed an estimated 68,500 lives last year,” the report said.
A majority (62%) of the physicians surveyed also said that the opioid crisis will evolve into a new prescription drug crisis, and even more (72%) think that patients with chronic pain will use illicit drugs if they cannot get prescription opioids. Evidence from the drug test dataset suggests that “misuse of nonprescribed fentanyl and nonprescribed gabapentin warrant[s] a closer look,” the report said. In the survey, 78% of respondents reported prescribing gabapentin as an alternative to opioids for patients with chronic pain.
Those two drugs, along with alcohol, are the only three drug groups for which misuse increased from 2017 to 2018, and both are frequently involved in drug mixing, which is the most common form of misuse. Gabapentin went from 9.6% of all nonprescribed misuse in 2017 to 13.4% in 2018, an increase of 40%. Nonprescribed fentanyl was found in 64% of test results that were positive for heroin and 24% that were positive for cocaine, the Quest data showed.
The survey results, however, suggest that gabapentin is not on physicians’ radar, as only 34% said that they were concerned about its misuse, compared with 96% for opioids and 90% for benzodiazepines, according to the report.
“While gabapentin may not have opioids’ addictive potential, it can exaggerate euphoric effects when combined with opioids or anxiety medications. This drug mixing is dangerous,” said report coauthor Jeffrey Gudin, MD, senior medical advisor, prescription drug monitoring, for Quest Diagnostics.
The survey was conducted online among family physicians, general practitioners, and internists from July 31 to Aug. 16, 2019, by the Harris Poll on behalf of Quest and Center for Addiction. The test result data were collected in all 50 states and Washington, D.C., from 2011 to 2018, and results from drug rehabilitation clinics and addiction specialists were excluded from the analysis, so actual misuse rates are probably higher than reported.
In methamphetamine use disorder, consider off-label drugs
SAN DIEGO – Its toll is obscured by the opioid crisis, but methamphetamine use is on the rise in the United States. There are no approved treatments for methamphetamine use, but a psychiatrist told colleagues that several off-label medications might prove helpful.
However, the evidence supporting the use of these medications for patients taking methamphetamine is not robust, “and none are even close to [Food and Drug Administration] approval,” said Larissa J. Mooney, MD, of the University of California, Los Angeles, and the VA Greater Los Angeles Healthcare System. “But if I use something that’s approved for depression or might be helpful for anxiety symptoms, maybe it would also help reduce their likelihood of relapse in conjunction with an evidence-based behavioral program or treatment with a therapist.”
Dr. Mooney, who spoke at the annual Psych Congress, highlighted a federal report estimating that 0.4% of people aged 18-25 in 2017 used the drug within the past month, compared with 0.3% of those aged 26 and higher.
There were about 758,000 current adult users of methamphetamine in 2017, the report found.
Meanwhile, (Drug Alcohol Depend. 2018 Dec 1;193:14-20). And, Dr. Mooney said, deaths from stimulants are rising, even independent of opioid deaths.
Stimulant users typically have other psychiatric conditions, such as depression, anxiety, and concentration problems, Dr. Mooney said. In those cases, she said, treating those conditions might help with the substance use, too.
For methamphetamine use disorder, she highlighted some medications that might be helpful, although, again, she cautioned that evidence is not strong:
- Bupropion (Wellbutrin). Research suggests that this drug is more effective in patients with less severe methamphetamine use disorder, Dr. Mooney said. “It’s a more stimulating antidepressant, and can be helpful with concentration and attention.”
- Mirtazapine (Remeron). “I keep it in my list of options for some [who are] really anxious and not sleeping well,” she said. “It might be beneficial.”
- Naltrexone (ReVia, Depade, Vivitrol). “There are some early signs of efficacy,” she said, and a randomized, controlled trial is in progress.
- Methylphenidate (Ritalin, Concerta) and topiramate (Topamax). There’s “low-strength” evidence that the drugs can be helpful and lower use of methamphetamine, she said. However, methylphenidate is a stimulant. There’s controversy over the use of stimulants to treat patients with substance use disorders, Dr. Mooney said, and she tends to be conservative about their use in this population.
Why not use them to treat methamphetamine users in the same way that opioids such as methadone are used to treat opioid use addiction? “We don’t have an equivalent stimulant that works in the same way,” she said. “They don’t stay in the system for 24 hours. If you take a prescription stimulant, by the end of the day it wears off. It won’t stay in the same way as agonist treatments for opioid disorder.”
Even so, she said, “it makes sense that stimulants might be helpful.”
Dr. Mooney disclosed an advisory board relationship with Alkermes and grant/research support from the National Institute on Drug Abuse.
SAN DIEGO – Its toll is obscured by the opioid crisis, but methamphetamine use is on the rise in the United States. There are no approved treatments for methamphetamine use, but a psychiatrist told colleagues that several off-label medications might prove helpful.
However, the evidence supporting the use of these medications for patients taking methamphetamine is not robust, “and none are even close to [Food and Drug Administration] approval,” said Larissa J. Mooney, MD, of the University of California, Los Angeles, and the VA Greater Los Angeles Healthcare System. “But if I use something that’s approved for depression or might be helpful for anxiety symptoms, maybe it would also help reduce their likelihood of relapse in conjunction with an evidence-based behavioral program or treatment with a therapist.”
Dr. Mooney, who spoke at the annual Psych Congress, highlighted a federal report estimating that 0.4% of people aged 18-25 in 2017 used the drug within the past month, compared with 0.3% of those aged 26 and higher.
There were about 758,000 current adult users of methamphetamine in 2017, the report found.
Meanwhile, (Drug Alcohol Depend. 2018 Dec 1;193:14-20). And, Dr. Mooney said, deaths from stimulants are rising, even independent of opioid deaths.
Stimulant users typically have other psychiatric conditions, such as depression, anxiety, and concentration problems, Dr. Mooney said. In those cases, she said, treating those conditions might help with the substance use, too.
For methamphetamine use disorder, she highlighted some medications that might be helpful, although, again, she cautioned that evidence is not strong:
- Bupropion (Wellbutrin). Research suggests that this drug is more effective in patients with less severe methamphetamine use disorder, Dr. Mooney said. “It’s a more stimulating antidepressant, and can be helpful with concentration and attention.”
- Mirtazapine (Remeron). “I keep it in my list of options for some [who are] really anxious and not sleeping well,” she said. “It might be beneficial.”
- Naltrexone (ReVia, Depade, Vivitrol). “There are some early signs of efficacy,” she said, and a randomized, controlled trial is in progress.
- Methylphenidate (Ritalin, Concerta) and topiramate (Topamax). There’s “low-strength” evidence that the drugs can be helpful and lower use of methamphetamine, she said. However, methylphenidate is a stimulant. There’s controversy over the use of stimulants to treat patients with substance use disorders, Dr. Mooney said, and she tends to be conservative about their use in this population.
Why not use them to treat methamphetamine users in the same way that opioids such as methadone are used to treat opioid use addiction? “We don’t have an equivalent stimulant that works in the same way,” she said. “They don’t stay in the system for 24 hours. If you take a prescription stimulant, by the end of the day it wears off. It won’t stay in the same way as agonist treatments for opioid disorder.”
Even so, she said, “it makes sense that stimulants might be helpful.”
Dr. Mooney disclosed an advisory board relationship with Alkermes and grant/research support from the National Institute on Drug Abuse.
SAN DIEGO – Its toll is obscured by the opioid crisis, but methamphetamine use is on the rise in the United States. There are no approved treatments for methamphetamine use, but a psychiatrist told colleagues that several off-label medications might prove helpful.
However, the evidence supporting the use of these medications for patients taking methamphetamine is not robust, “and none are even close to [Food and Drug Administration] approval,” said Larissa J. Mooney, MD, of the University of California, Los Angeles, and the VA Greater Los Angeles Healthcare System. “But if I use something that’s approved for depression or might be helpful for anxiety symptoms, maybe it would also help reduce their likelihood of relapse in conjunction with an evidence-based behavioral program or treatment with a therapist.”
Dr. Mooney, who spoke at the annual Psych Congress, highlighted a federal report estimating that 0.4% of people aged 18-25 in 2017 used the drug within the past month, compared with 0.3% of those aged 26 and higher.
There were about 758,000 current adult users of methamphetamine in 2017, the report found.
Meanwhile, (Drug Alcohol Depend. 2018 Dec 1;193:14-20). And, Dr. Mooney said, deaths from stimulants are rising, even independent of opioid deaths.
Stimulant users typically have other psychiatric conditions, such as depression, anxiety, and concentration problems, Dr. Mooney said. In those cases, she said, treating those conditions might help with the substance use, too.
For methamphetamine use disorder, she highlighted some medications that might be helpful, although, again, she cautioned that evidence is not strong:
- Bupropion (Wellbutrin). Research suggests that this drug is more effective in patients with less severe methamphetamine use disorder, Dr. Mooney said. “It’s a more stimulating antidepressant, and can be helpful with concentration and attention.”
- Mirtazapine (Remeron). “I keep it in my list of options for some [who are] really anxious and not sleeping well,” she said. “It might be beneficial.”
- Naltrexone (ReVia, Depade, Vivitrol). “There are some early signs of efficacy,” she said, and a randomized, controlled trial is in progress.
- Methylphenidate (Ritalin, Concerta) and topiramate (Topamax). There’s “low-strength” evidence that the drugs can be helpful and lower use of methamphetamine, she said. However, methylphenidate is a stimulant. There’s controversy over the use of stimulants to treat patients with substance use disorders, Dr. Mooney said, and she tends to be conservative about their use in this population.
Why not use them to treat methamphetamine users in the same way that opioids such as methadone are used to treat opioid use addiction? “We don’t have an equivalent stimulant that works in the same way,” she said. “They don’t stay in the system for 24 hours. If you take a prescription stimulant, by the end of the day it wears off. It won’t stay in the same way as agonist treatments for opioid disorder.”
Even so, she said, “it makes sense that stimulants might be helpful.”
Dr. Mooney disclosed an advisory board relationship with Alkermes and grant/research support from the National Institute on Drug Abuse.
REPORTING FROM PSYCH CONGRESS 2019
Dismantling the opioid crisis
Dr. John Hickner’s editorial, “Doing our part to dismantle the opioid crisis” (J Fam Pract 2019;68:308) had important inaccuracies.
The Joint Commission, for which I serve as an executive vice president, did not “dub pain assessment the ‘fifth vital sign’. ” The concept of the fifth vital sign was developed by the American Pain Society in the 1990s.1 It gained national attention through a Veterans Health Administration initiative in 1999.2 And in 2001, the Joint Commission (then the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) issued its Pain Standards.
Dr. Hickner wrote that the push to assess for pain as the fifth vital sign was a central cause of the opioid epidemic; however, this is contrary to published data on the epidemic. Total opioid prescriptions had been steadily increasing in the United States for at least a decade before the Pain Standards went into effect in 2001 (FIGURE).3 Between 1991 and 1997, the number of prescriptions increased from 76 million to 97 million. The rate of increase from 1997 to 2011 appears to have been more rapid, which is likely due to the 1995 approval of the new sustained-release opioid OxyContin and the associated aggressive marketing campaigns to physicians.
Your readers should know that we, at the Joint Commission, are also “doing our part to dismantle the opioid crisis.” In 2016, we completely revised our Pain Standards, adding new criteria to help address the epidemic. Some adjustments include: requiring improved availability of nonpharmacologic therapy, encouraging engagement of patients in pain management plans, enhancing accessibility of Physician Drug Monitoring Program tools, and monitoring opioid prescribing.
David W. Baker, MD, FACP, executive vice president
The Joint Commission, Oakbrook Terrace, IL
1. American Pain Society. Principles of Analgesic Use in the Treatment of Acute Pain and Chronic Cancer Pain. 2nd ed. Skokie, Illinois: American Pain Society; 1989.
2. Department of Veteran’s Affairs. Pain: the fifth vital sign. www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed September 30, 2019.
3 National Institute on Drug Abuse. America’s addiction to opioids: heroin and prescription drug abuse. https://archives.drugabuse.gov/testimonies/2014/americas-addiction-to-opioids-heroin-prescription-drug-abuse. Published May 14, 2014. Accessed September 30, 2019.
Dr. John Hickner’s editorial, “Doing our part to dismantle the opioid crisis” (J Fam Pract 2019;68:308) had important inaccuracies.
The Joint Commission, for which I serve as an executive vice president, did not “dub pain assessment the ‘fifth vital sign’. ” The concept of the fifth vital sign was developed by the American Pain Society in the 1990s.1 It gained national attention through a Veterans Health Administration initiative in 1999.2 And in 2001, the Joint Commission (then the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) issued its Pain Standards.
Dr. Hickner wrote that the push to assess for pain as the fifth vital sign was a central cause of the opioid epidemic; however, this is contrary to published data on the epidemic. Total opioid prescriptions had been steadily increasing in the United States for at least a decade before the Pain Standards went into effect in 2001 (FIGURE).3 Between 1991 and 1997, the number of prescriptions increased from 76 million to 97 million. The rate of increase from 1997 to 2011 appears to have been more rapid, which is likely due to the 1995 approval of the new sustained-release opioid OxyContin and the associated aggressive marketing campaigns to physicians.
Your readers should know that we, at the Joint Commission, are also “doing our part to dismantle the opioid crisis.” In 2016, we completely revised our Pain Standards, adding new criteria to help address the epidemic. Some adjustments include: requiring improved availability of nonpharmacologic therapy, encouraging engagement of patients in pain management plans, enhancing accessibility of Physician Drug Monitoring Program tools, and monitoring opioid prescribing.
David W. Baker, MD, FACP, executive vice president
The Joint Commission, Oakbrook Terrace, IL
Dr. John Hickner’s editorial, “Doing our part to dismantle the opioid crisis” (J Fam Pract 2019;68:308) had important inaccuracies.
The Joint Commission, for which I serve as an executive vice president, did not “dub pain assessment the ‘fifth vital sign’. ” The concept of the fifth vital sign was developed by the American Pain Society in the 1990s.1 It gained national attention through a Veterans Health Administration initiative in 1999.2 And in 2001, the Joint Commission (then the Joint Commission on Accreditation of Healthcare Organizations or JCAHO) issued its Pain Standards.
Dr. Hickner wrote that the push to assess for pain as the fifth vital sign was a central cause of the opioid epidemic; however, this is contrary to published data on the epidemic. Total opioid prescriptions had been steadily increasing in the United States for at least a decade before the Pain Standards went into effect in 2001 (FIGURE).3 Between 1991 and 1997, the number of prescriptions increased from 76 million to 97 million. The rate of increase from 1997 to 2011 appears to have been more rapid, which is likely due to the 1995 approval of the new sustained-release opioid OxyContin and the associated aggressive marketing campaigns to physicians.
Your readers should know that we, at the Joint Commission, are also “doing our part to dismantle the opioid crisis.” In 2016, we completely revised our Pain Standards, adding new criteria to help address the epidemic. Some adjustments include: requiring improved availability of nonpharmacologic therapy, encouraging engagement of patients in pain management plans, enhancing accessibility of Physician Drug Monitoring Program tools, and monitoring opioid prescribing.
David W. Baker, MD, FACP, executive vice president
The Joint Commission, Oakbrook Terrace, IL
1. American Pain Society. Principles of Analgesic Use in the Treatment of Acute Pain and Chronic Cancer Pain. 2nd ed. Skokie, Illinois: American Pain Society; 1989.
2. Department of Veteran’s Affairs. Pain: the fifth vital sign. www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed September 30, 2019.
3 National Institute on Drug Abuse. America’s addiction to opioids: heroin and prescription drug abuse. https://archives.drugabuse.gov/testimonies/2014/americas-addiction-to-opioids-heroin-prescription-drug-abuse. Published May 14, 2014. Accessed September 30, 2019.
1. American Pain Society. Principles of Analgesic Use in the Treatment of Acute Pain and Chronic Cancer Pain. 2nd ed. Skokie, Illinois: American Pain Society; 1989.
2. Department of Veteran’s Affairs. Pain: the fifth vital sign. www.va.gov/PAINMANAGEMENT/docs/Pain_As_the_5th_Vital_Sign_Toolkit.pdf. Published October 2000. Accessed September 30, 2019.
3 National Institute on Drug Abuse. America’s addiction to opioids: heroin and prescription drug abuse. https://archives.drugabuse.gov/testimonies/2014/americas-addiction-to-opioids-heroin-prescription-drug-abuse. Published May 14, 2014. Accessed September 30, 2019.
SUDs are almost always comorbid with other disorders
SAN DIEGO – Substance use disorders rarely ride alone, a psychiatrist told colleagues, and it’s crucial to treat the accompanying mental illness that is almost always present.
“If you’re really depressed and you’re smoking marijuana, the smoking could have made it worse, but you were probably depressed before,” said Timothy E. Wilens, MD, of Harvard Medical School and Massachusetts General Hospital, both in Boston. Dr. Wilens spoke at the annual Psych Congress.
He pointed to numbers supporting the link between substance use and mental illness. He also offered several tips about treating substance use disorder (SUD).
In ADHD, consider the big picture. If a person has both ADHD and SUD, treat both if the level of substance abuse is lower. But focus on the SUD in more severe cases, he said, and realize that “most likely your treatment for ADHD isn’t going to work as well.”
The same goes for the anxiolytic buspirone (Buspar) in patients with depression and SUD.
Consider N-acetyl cysteine in cannabis use disorder. N-acetyl cysteine, a nutraceutical used as an asthma medication, has shown promise in trials as a treatment for cannabis use disorder, Dr. Wilens said. It helps patients avoid the temptation to smoke. “They won’t say they’ve lost all their cravings, but you’ll hear, ‘I just didn’t need to do it; I’m not smoking as much.’ If you hear that from your patients, you know it’s working. It’s a subtle effect, but it can help.”
Scamming’ drugs shouldn’t be your main worry. Substance use research suggests that users of pharmaceutical drugs for nonmedical uses rarely get them directly from practitioners (7%), but instead mainly get them through friends, Dr. Wilens said. “If you work with this population and treat ADHD or anxiety, you’re paranoid that everyone coming in wants to scam medicines. Be more concerned about oversupplying them with immediate-release medications and not [taking] them to task about keeping the medication safely stored.”
Interventions such as Alcoholics Anonymous are as “effective as any other treatment for substance abuse, and it’s not costly,” Dr. Wilens said. He added that the Rational Recovery program, an alternative to Alcoholics Anonymous, also seems to work well. The approaches to ending substance use differ in that Alcoholics Anonymous’s orientation is spiritual and Rational Recovery’s is cognitive.
Dr. Wilens reported various disclosures, including consulting relationships with Ironshore Pharmaceuticals, KemPharm, and Neurovance/Otsuka.
SAN DIEGO – Substance use disorders rarely ride alone, a psychiatrist told colleagues, and it’s crucial to treat the accompanying mental illness that is almost always present.
“If you’re really depressed and you’re smoking marijuana, the smoking could have made it worse, but you were probably depressed before,” said Timothy E. Wilens, MD, of Harvard Medical School and Massachusetts General Hospital, both in Boston. Dr. Wilens spoke at the annual Psych Congress.
He pointed to numbers supporting the link between substance use and mental illness. He also offered several tips about treating substance use disorder (SUD).
In ADHD, consider the big picture. If a person has both ADHD and SUD, treat both if the level of substance abuse is lower. But focus on the SUD in more severe cases, he said, and realize that “most likely your treatment for ADHD isn’t going to work as well.”
The same goes for the anxiolytic buspirone (Buspar) in patients with depression and SUD.
Consider N-acetyl cysteine in cannabis use disorder. N-acetyl cysteine, a nutraceutical used as an asthma medication, has shown promise in trials as a treatment for cannabis use disorder, Dr. Wilens said. It helps patients avoid the temptation to smoke. “They won’t say they’ve lost all their cravings, but you’ll hear, ‘I just didn’t need to do it; I’m not smoking as much.’ If you hear that from your patients, you know it’s working. It’s a subtle effect, but it can help.”
Scamming’ drugs shouldn’t be your main worry. Substance use research suggests that users of pharmaceutical drugs for nonmedical uses rarely get them directly from practitioners (7%), but instead mainly get them through friends, Dr. Wilens said. “If you work with this population and treat ADHD or anxiety, you’re paranoid that everyone coming in wants to scam medicines. Be more concerned about oversupplying them with immediate-release medications and not [taking] them to task about keeping the medication safely stored.”
Interventions such as Alcoholics Anonymous are as “effective as any other treatment for substance abuse, and it’s not costly,” Dr. Wilens said. He added that the Rational Recovery program, an alternative to Alcoholics Anonymous, also seems to work well. The approaches to ending substance use differ in that Alcoholics Anonymous’s orientation is spiritual and Rational Recovery’s is cognitive.
Dr. Wilens reported various disclosures, including consulting relationships with Ironshore Pharmaceuticals, KemPharm, and Neurovance/Otsuka.
SAN DIEGO – Substance use disorders rarely ride alone, a psychiatrist told colleagues, and it’s crucial to treat the accompanying mental illness that is almost always present.
“If you’re really depressed and you’re smoking marijuana, the smoking could have made it worse, but you were probably depressed before,” said Timothy E. Wilens, MD, of Harvard Medical School and Massachusetts General Hospital, both in Boston. Dr. Wilens spoke at the annual Psych Congress.
He pointed to numbers supporting the link between substance use and mental illness. He also offered several tips about treating substance use disorder (SUD).
In ADHD, consider the big picture. If a person has both ADHD and SUD, treat both if the level of substance abuse is lower. But focus on the SUD in more severe cases, he said, and realize that “most likely your treatment for ADHD isn’t going to work as well.”
The same goes for the anxiolytic buspirone (Buspar) in patients with depression and SUD.
Consider N-acetyl cysteine in cannabis use disorder. N-acetyl cysteine, a nutraceutical used as an asthma medication, has shown promise in trials as a treatment for cannabis use disorder, Dr. Wilens said. It helps patients avoid the temptation to smoke. “They won’t say they’ve lost all their cravings, but you’ll hear, ‘I just didn’t need to do it; I’m not smoking as much.’ If you hear that from your patients, you know it’s working. It’s a subtle effect, but it can help.”
Scamming’ drugs shouldn’t be your main worry. Substance use research suggests that users of pharmaceutical drugs for nonmedical uses rarely get them directly from practitioners (7%), but instead mainly get them through friends, Dr. Wilens said. “If you work with this population and treat ADHD or anxiety, you’re paranoid that everyone coming in wants to scam medicines. Be more concerned about oversupplying them with immediate-release medications and not [taking] them to task about keeping the medication safely stored.”
Interventions such as Alcoholics Anonymous are as “effective as any other treatment for substance abuse, and it’s not costly,” Dr. Wilens said. He added that the Rational Recovery program, an alternative to Alcoholics Anonymous, also seems to work well. The approaches to ending substance use differ in that Alcoholics Anonymous’s orientation is spiritual and Rational Recovery’s is cognitive.
Dr. Wilens reported various disclosures, including consulting relationships with Ironshore Pharmaceuticals, KemPharm, and Neurovance/Otsuka.
REPORTING FROM PSYCH CONGRESS 2019
How to use lofexidine for quick opioid withdrawal
SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.
Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.
In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.
Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.
SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.
Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.
In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.
Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.
SAN DIEGO – Lofexidine (Lucemyra), the new kid on the block in the United States for opioid withdrawal, can help patients get through the process in a few days, instead of a week or more, according to Thomas Kosten, MD, a psychiatry professor and director of the division of addictions at Baylor College of Medicine, Houston.
Lofexidine relieves symptom withdrawal and has significant advantages over clonidine, a similar drug, including easier dosing and no orthostatic hypertension.
In a video interview at the annual Psych Congress, Dr. Kosten went into the nuts and bolts of how to use lofexidine with buprenorphine and naltrexone – plus benzodiazepines when needed – to help people safely go through withdrawal and in just a few days.
Once chronic pain patients are off opioids, the next question is what to do for their pain. In a presentation before the interview, Dr. Kosten said he favors tricyclic antidepressants, especially desipramine because it has the fewest side effects. The effect size with tricyclic antidepressants is larger than with gabapentin and other options. They take a few weeks to kick in, however, so he’s thinking about a unique approach: using ketamine – either infusions or the new nasal spray esketamine (Spravato) – to tide people over in the meantime. It’s becoming well known that ketamine works amazingly fast for depression and suicidality, and there is emerging support that it might do the same for chronic pain. Dr. Kosten is a consultant for US Worldmeds, maker of lofexidine.
REPORTING FROM PSYCH CONGRESS 2019
Buprenorphine merits more attention for treatment of opioid use disorder
SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.
She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.
Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.
But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.
Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”
Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”
The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”
Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.
The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.
The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.
When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.
But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.
Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.
“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’
She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”
And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”
Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).
SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.
She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.
Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.
But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.
Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”
Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”
The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”
Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.
The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.
The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.
When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.
But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.
Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.
“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’
She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”
And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”
Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).
SAN DIEGO – Prescribing buprenorphine for the treatment of opioid use disorder requires strict discernment on the part of clinicians, Arwen Podesta, MD, said at the annual Psych Congress.
She encouraged clinicians to be prepared for a visit from the Drug Enforcement Administration, understand the unique properties of buprenorphine, and make sure that patients grasp the importance of sublingual administration.
Research shows that only 5% of physicians are allowed to prescribe buprenorphine – an opioid – by way of a DEA waiver, Dr. Podesta said. About half do not prescribe the drug. Barriers to prescribing buprenorphine include factors such as low reimbursement and untrained support staff, said Dr. Podesta, a board-certified psychiatrist who subspecializes in addiction medicine and practices in New Orleans.
But she noted that the Substance Abuse and Mental Health Services Administration has recommended that medication-assisted therapy (MAT) – methadone, buprenorphine, and naltrexone – be considered in all patients with opioid use disorder. The drugs are safe and effective when used correctly, the federal agency has said.
Remember, Dr. Podesta said, that “patients taking MAT are considered to be in recovery.” In the big picture, she added, “we have to improve access to care because we have so many people who don’t have access to treatment.”
Getting permission from the DEA to prescribe buprenorphine – a schedule III controlled substance – comes with a price, Dr. Podesta said. “We have special scrutiny from the DEA,” she said. They come in and want to see your records. It sounds very punitive, although it’s their jobs.”
The best approach is to document that you know what you’re doing, she said. “It’s your job to educate them about why you’re using buprenorphine and produce the records to show that.”
Being aware of buprenorphine’s unique properties is important, she said. The drug is safer on the overdose front than are other opioids, Dr. Podesta said, but it can be very dangerous in patients without opioid tolerance. According to the DEA, as an analgesic, buprenorphine is 20-30 times more potent than morphine. Also, like morphine, patients who take buprenorphine are likely to experience euphoria, papillary restriction, and respiratory depression and sedation.
The buprenorphine/naloxone formulation is preferred to treat opioid use disorder, she noted.
The reason that naloxone, which treats opioid overdoses, is part of the drug combo is because as an add-on, it reduces the risk that buprenorphine will be crushed and snorted for an opioid high, she said. Those who take the combo drug via that method could end up with sudden and nasty withdrawal symptoms.
When the drug combo is administered sublingually, the idea is that the “good stuff” (buprenorphine) is absorbed in the mouth, while the “bad stuff” (naloxone) is harmlessly absorbed in the gut, Dr. Podesta said. This happens because the drugs are absorbed differently.
But patients can mistakenly trigger symptoms of withdrawal if, for example, they put the combo drug on their tongue and then go to sleep. “That’s a peril,” she said, and it’s important to make sure patients know what to do – and what not to do.
Dr. Podesta emphasized the importance of choosing language related to patients with addictions carefully and respectfully.
“We have stigma,” she said. “We have been saying that patients are ‘dirty’ or ‘clean,’ and if they’re ‘clean,’ they’re the opposite of ‘dirty.’
She also suggested that clinicians drop the use of the word “contract” to describe treatment agreements between patients and clinicians. “Call it an ‘agreement,’ ” she said. “It seems more mutual and less punitive or risky for the patient to sign, especially when they’re in a precarious comfort zone.”
And consider that even the words “substance abuse” can be misleading, she said. “Many [patients] are taking the medications that the doctor prescribed and following instructions to the letter.”
Dr. Podesta disclosed consulting with Kaleo, Pear Therapeutics, and JayMac, and serving on the speakers bureau of Alkermes, Orexo, and US WorldMeds. She is the author of “Hooked: A Concise Guide to the Underlying Mechanics of Addiction and Treatment for Patients, Families, and Providers” (Dog Ear Publishing, 2016).
REPORTING FROM PSYCH CONGRESS 2019
Clinical Pharmacists Improve Patient Outcomes and Expand Access to Care
The US is in the midst of a chronic disease crisis. According to the latest published data available, 60% of Americans have at least 1 chronic condition, and 42% have ≥ 2 chronic conditions.1 Estimates by the Health Resources and Services Administration (HRSA) indicate a current shortfall of 13 800 primary care physicians and a projected escalation of that shortage to be between 14 800 and 49 300 physicians by the year 2030.2
The US Public Health Service (USPHS) has used pharmacists since 1930 to provide direct patient care to underserved and vulnerable populations. Clinical pharmacists currently serve in direct patient care roles within the Indian Health Service (IHS), Federal Bureau of Prisons (BOP), Immigration and Customs Enforcement (ICE), and the United States Coast Guard (USCG) in many states (Figure). These pharmacists play a vital role in improving access to care and delivering quality care by managing acute and chronic diseases in collaborative practice settings and pharmacist-managed clinics.
It has previously been reported that in the face of physician shortages and growing demand for primary health care providers, pharmacists are well-equipped and motivated to meet this demand.3 A review of the previous 2 years of outcomes reported by clinical pharmacists certified through the USPHS National Clinical Pharmacy Specialist (NCPS) Committee are presented to demonstrate the impact of pharmacists in advancing the health of the populations they serve and to showcase a model for ameliorating the ongoing physician shortage.
Background
The USPHS NCPS Committee serves to promote uniform competency among clinical pharmacists by establishing national standards for protocols, collaborative practice agreements (CPAs), credentialing and privileging of pharmacists, and by collecting, reviewing, and publishing health care outcomes. The committee, whose constituents include pharmacist and physician subject matter experts from across USPHS agencies, reviews applications and protocols and certifies pharmacists (civilian and uniformed) to recognize an advanced scope of practice in managing various diseases and optimizing medication therapy. NCPScertified pharmacists manage a wide spectrum of diseases, including coagulopathy, asthma, diabetes mellitus (DM), hepatitis C, HIV, hypertension, pain, seizure disorders, and tobacco use disorders.
Clinical pharmacists practicing chronic disease management establish a clinical service in collaboration with 1 or more physicians, physician assistants, or nurse practitioners. In this collaborative practice, the health care practitioner(s) refer patients to be managed by a pharmacist for specific medical needs, such as anticoagulation management, or for holistic medication- focused care (eg, cardiovascular risk reduction, DM management, HIV, hepatitis, or mental health). The pharmacist may order and interpret laboratory tests, check vital signs, perform a limited physical examination, and gather other pertinent information from the patient and the medical record in order to provide the best possible care to the patient.
Medications may be started, stopped, or adjusted, education is provided, and therapeutic lifestyle interventions may be recommended. The pharmacist-run clinic provides the patient more frequent interaction with a health care professional (pharmacist) and focused disease management. As a result, pharmacists increase access to care and allow the medical team to handle a larger panel of patients as the practitioner delegates specified diseases to the pharmacist- managed clinic(s). The number of NCPS-certified pharmacists grew 46% from 2012 (n = 230) to 2017 (n = 336), reflecting an evolution of pharmacists’ practice to better meet the need of patients across the nation.
Methods
The NCPS Committee requires NCPS pharmacists to report data annually from all patients referred for pharmacist management for specific diseases in which they have been certified. The data reflect the patient’s clinical outcome goal status at the time of referral as well as the same status at the end of the reporting period or on release from the pharmacist-run clinic. These data describe the impact prescribing pharmacists have on patients reaching clinical outcome goals acting as the team member specializing in the medication selection and dosing aspect of care.
These records were reviewed for the fiscal year (FY) periods of October 1, 2015 to September 30, 2016 (FY 2016) and October 1, 2016 to September 30, 2017 (FY 2017). A systematic review of submitted reports resulted in 181 reports that included all requested data points for the disease as published here for FYs 2016 and 2017. These include 66 reports from FY 2016 and 115 reports from FY 2017; they cover 76 BOP and IHS facilities located across 24 states. Table 1 shows the number of outcome reports collected from 104 075 patient visits in pharmacist-run clinics in FYs 2016 and 2017.
Results
The following tables represent the standardized outcomes collected by NCPS-certified pharmacists providing direct patient care. Patients on anticoagulants (eg, warfarin) require special monitoring and education for drug interactions and adverse effects. NCPS-certified pharmacists were able to achieve a mean patient time in therapeutic range (TTR) of 67.6% (regardless of indication) over the 2 years (calculated per each facility by Rosendaal method of linear interpolation then combined in a weighted average per visit). The TTR produced by NCPS-certified pharmacists are consistent with Chest Guidelines and Expert Panel Report suggesting that TTR should be between 65% and 70%.4 Table 2 shows data from 100 reports with 68 255 patient visits for anticoagulation management.
DM management can be complex and time-intensive. NCPS data indicate pharmacist intervention resulted in a mean decrease in hemoglobin A1c (HbA1c) of 1.8% from a baseline of 10.2% (decrease calculated per each facility then combined by weighted average per visit). Table 3 shows data from 30 reports with 16 518 patient visits for DM care.
In addition to diet and exercise, medication management plays a vital role in managing hypertension. Patients managed by an NCPS-certified pharmacist experienced a mean decrease in blood pressure from 144/83 to 133/77, putting them in goal for both systolic and diastolic ranges (decrease calculated per each facility then combined by weighted average per visit). Table 4 shows data from 16 reports and 7997 patient visits for treatment of hypertension.
HIV viral suppression is vital in order to best manage patients with HIV and reduce the risk of transmission. Pharmacistled clinics have shown a 32.9% absolute improvement in patients at goal (viral load < 50 copies/mL), from a mean baseline of 46.0% to a mean final assessment of 71.6% of patients at goal (combined by weighted average visits). Table 5 shows data from 6 reports covering 1532 patient encounters for management of HIV.
Nicotine dependence includes the use of cigarettes, cigars, pipe tobacco, chewing tobacco, and vaping products containing nicotine. NCPS-certified pharmacists have successfully helped patients improve their chance of quitting, with a 6-month quit rate of 22.2% (quit rate calculated per each facility then combined by weighted average by visits), which is higher than the national average of 9.4% as reported by the Centers for Disease and Control and Prevention. 5 Table 6 shows 29 reports covering 9773 patient visits for treatment of nicotine dependence.
Discussion
These data demonstrate the ability of advanced practice pharmacists in multiple locations within the federal sector to improve targeted clinical outcomes in patients with varying diseases. These results are strengthened by their varied origins as well as the improvements observed across the board. Limitations include the general lack of a comparable dataset, manual method of selfreporting by the individual facilities, and the relatively limited array of diseases reported. Although NCPS-certified pharmacists are currently providing care for patients with hepatitis C, asthma, seizure, pain and other diseases not reported here, there are insufficient data collected for FYs 2016 and 2017 to merit inclusion within this report.
Pharmacists are trusted, readily available medication experts. In a clinical role, NCPS-certified pharmacists have increased access to primary care services and demonstrated beneficial impact on important health outcomes as exhibited by the data reported above. Clinical pharmacy is a growing field, and NCPS has displayed continual growth in both the number of NCPS-certified pharmacists and the number of patient encounters performed by these providers. As more pharmacists in all settings collaborate with medical providers to offer high-quality clinical care, these providers will have more opportunity to delegate disease management. Continued reporting of clinical pharmacy outcomes is expected to increase confidence in pharmacists as primary care providers, increase utilization of pharmacy clinical services, and assist in easing the burden of primary care provider shortages across our nation.
Although these outcomes indicate demonstrable benefit in patient-centered outcomes, the need for ongoing assessment and continued improvement is not obviated. Future efforts may benefit from a comparison of alternative approaches to better facilitate the establishment of best practices. Alignment of clinical outcomes with the Centers for Medicare and Medicaid Services (CMS) Electronic Clinical Quality Measures, where applicable, also may prove beneficial by automating the reporting process and thereby decreasing the burden of reporting as well as providing an avenue for standard comparison across multiple populations. Clinical pharmacy interventions have positive outcomes based on the NCPS model, and the NCPS Committee invites other clinical settings to report outcomes data with which to compare.
Conclusion
The NCPS Committee has documented positive outcomes of clinical pharmacy intervention and anticipates growth of the pharmacy profession as additional states and health systems recognize the capacity of the pharmacist to provide high-quality, multidisciplinary patient care. Clinical pharmacists are prepared to address critical health care needs as the US continues to face a PCP shortage.2 The NCPS Committee challenges those participating in clinical pharmacy practice to report outcomes to amplify this body of evidence.
Acknowledgments
NCPS-certified pharmacists provided the outcomes detailed in this report. For document review and edits: Federal Bureau of Prison Publication Review Workgroup; RADM Ty Bingham, USPHS; CAPT Cindy Gunderson, USPHS; CAPT Kevin Brooks, USPHS.
1. Buttorff C, Ruder T, Bauman M. Multiple Chronic Conditions in the United States. Santa Monica, CA: Rand Corp; 2017.
2. Dall T, West T, Chakrabarti R, Reynolds R, Iacobucci W. The complexities of physician supply and demand: projections from 2016 to 2030, 2018 update. Association of American Medical Colleges. March 2018.
3. Giberson S, Yoder S, Lee MP. Improving patient and health system outcomes through advanced pharmacy practice. A report to the U.S. Surgeon General 2011. https://www .accp.com/docs/positions/misc/improving_patient_and _health_system_outcomes.pdf. Updated December 2011. Accessed September 11, 2019.
4. Lip G, Banerjee A, Boriani G, et al. Antithrombotic therapy for atrial fibrillation. CHEST guideline and Expert Panel Report. Chest. 2018;154(5):1121-1201.
5. Babb S, Marlarcher A, Schauer G, Asman K, Jamal A. Quitting smoking among adults—United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017;65(52):1457-1464.
The US is in the midst of a chronic disease crisis. According to the latest published data available, 60% of Americans have at least 1 chronic condition, and 42% have ≥ 2 chronic conditions.1 Estimates by the Health Resources and Services Administration (HRSA) indicate a current shortfall of 13 800 primary care physicians and a projected escalation of that shortage to be between 14 800 and 49 300 physicians by the year 2030.2
The US Public Health Service (USPHS) has used pharmacists since 1930 to provide direct patient care to underserved and vulnerable populations. Clinical pharmacists currently serve in direct patient care roles within the Indian Health Service (IHS), Federal Bureau of Prisons (BOP), Immigration and Customs Enforcement (ICE), and the United States Coast Guard (USCG) in many states (Figure). These pharmacists play a vital role in improving access to care and delivering quality care by managing acute and chronic diseases in collaborative practice settings and pharmacist-managed clinics.
It has previously been reported that in the face of physician shortages and growing demand for primary health care providers, pharmacists are well-equipped and motivated to meet this demand.3 A review of the previous 2 years of outcomes reported by clinical pharmacists certified through the USPHS National Clinical Pharmacy Specialist (NCPS) Committee are presented to demonstrate the impact of pharmacists in advancing the health of the populations they serve and to showcase a model for ameliorating the ongoing physician shortage.
Background
The USPHS NCPS Committee serves to promote uniform competency among clinical pharmacists by establishing national standards for protocols, collaborative practice agreements (CPAs), credentialing and privileging of pharmacists, and by collecting, reviewing, and publishing health care outcomes. The committee, whose constituents include pharmacist and physician subject matter experts from across USPHS agencies, reviews applications and protocols and certifies pharmacists (civilian and uniformed) to recognize an advanced scope of practice in managing various diseases and optimizing medication therapy. NCPScertified pharmacists manage a wide spectrum of diseases, including coagulopathy, asthma, diabetes mellitus (DM), hepatitis C, HIV, hypertension, pain, seizure disorders, and tobacco use disorders.
Clinical pharmacists practicing chronic disease management establish a clinical service in collaboration with 1 or more physicians, physician assistants, or nurse practitioners. In this collaborative practice, the health care practitioner(s) refer patients to be managed by a pharmacist for specific medical needs, such as anticoagulation management, or for holistic medication- focused care (eg, cardiovascular risk reduction, DM management, HIV, hepatitis, or mental health). The pharmacist may order and interpret laboratory tests, check vital signs, perform a limited physical examination, and gather other pertinent information from the patient and the medical record in order to provide the best possible care to the patient.
Medications may be started, stopped, or adjusted, education is provided, and therapeutic lifestyle interventions may be recommended. The pharmacist-run clinic provides the patient more frequent interaction with a health care professional (pharmacist) and focused disease management. As a result, pharmacists increase access to care and allow the medical team to handle a larger panel of patients as the practitioner delegates specified diseases to the pharmacist- managed clinic(s). The number of NCPS-certified pharmacists grew 46% from 2012 (n = 230) to 2017 (n = 336), reflecting an evolution of pharmacists’ practice to better meet the need of patients across the nation.
Methods
The NCPS Committee requires NCPS pharmacists to report data annually from all patients referred for pharmacist management for specific diseases in which they have been certified. The data reflect the patient’s clinical outcome goal status at the time of referral as well as the same status at the end of the reporting period or on release from the pharmacist-run clinic. These data describe the impact prescribing pharmacists have on patients reaching clinical outcome goals acting as the team member specializing in the medication selection and dosing aspect of care.
These records were reviewed for the fiscal year (FY) periods of October 1, 2015 to September 30, 2016 (FY 2016) and October 1, 2016 to September 30, 2017 (FY 2017). A systematic review of submitted reports resulted in 181 reports that included all requested data points for the disease as published here for FYs 2016 and 2017. These include 66 reports from FY 2016 and 115 reports from FY 2017; they cover 76 BOP and IHS facilities located across 24 states. Table 1 shows the number of outcome reports collected from 104 075 patient visits in pharmacist-run clinics in FYs 2016 and 2017.
Results
The following tables represent the standardized outcomes collected by NCPS-certified pharmacists providing direct patient care. Patients on anticoagulants (eg, warfarin) require special monitoring and education for drug interactions and adverse effects. NCPS-certified pharmacists were able to achieve a mean patient time in therapeutic range (TTR) of 67.6% (regardless of indication) over the 2 years (calculated per each facility by Rosendaal method of linear interpolation then combined in a weighted average per visit). The TTR produced by NCPS-certified pharmacists are consistent with Chest Guidelines and Expert Panel Report suggesting that TTR should be between 65% and 70%.4 Table 2 shows data from 100 reports with 68 255 patient visits for anticoagulation management.
DM management can be complex and time-intensive. NCPS data indicate pharmacist intervention resulted in a mean decrease in hemoglobin A1c (HbA1c) of 1.8% from a baseline of 10.2% (decrease calculated per each facility then combined by weighted average per visit). Table 3 shows data from 30 reports with 16 518 patient visits for DM care.
In addition to diet and exercise, medication management plays a vital role in managing hypertension. Patients managed by an NCPS-certified pharmacist experienced a mean decrease in blood pressure from 144/83 to 133/77, putting them in goal for both systolic and diastolic ranges (decrease calculated per each facility then combined by weighted average per visit). Table 4 shows data from 16 reports and 7997 patient visits for treatment of hypertension.
HIV viral suppression is vital in order to best manage patients with HIV and reduce the risk of transmission. Pharmacistled clinics have shown a 32.9% absolute improvement in patients at goal (viral load < 50 copies/mL), from a mean baseline of 46.0% to a mean final assessment of 71.6% of patients at goal (combined by weighted average visits). Table 5 shows data from 6 reports covering 1532 patient encounters for management of HIV.
Nicotine dependence includes the use of cigarettes, cigars, pipe tobacco, chewing tobacco, and vaping products containing nicotine. NCPS-certified pharmacists have successfully helped patients improve their chance of quitting, with a 6-month quit rate of 22.2% (quit rate calculated per each facility then combined by weighted average by visits), which is higher than the national average of 9.4% as reported by the Centers for Disease and Control and Prevention. 5 Table 6 shows 29 reports covering 9773 patient visits for treatment of nicotine dependence.
Discussion
These data demonstrate the ability of advanced practice pharmacists in multiple locations within the federal sector to improve targeted clinical outcomes in patients with varying diseases. These results are strengthened by their varied origins as well as the improvements observed across the board. Limitations include the general lack of a comparable dataset, manual method of selfreporting by the individual facilities, and the relatively limited array of diseases reported. Although NCPS-certified pharmacists are currently providing care for patients with hepatitis C, asthma, seizure, pain and other diseases not reported here, there are insufficient data collected for FYs 2016 and 2017 to merit inclusion within this report.
Pharmacists are trusted, readily available medication experts. In a clinical role, NCPS-certified pharmacists have increased access to primary care services and demonstrated beneficial impact on important health outcomes as exhibited by the data reported above. Clinical pharmacy is a growing field, and NCPS has displayed continual growth in both the number of NCPS-certified pharmacists and the number of patient encounters performed by these providers. As more pharmacists in all settings collaborate with medical providers to offer high-quality clinical care, these providers will have more opportunity to delegate disease management. Continued reporting of clinical pharmacy outcomes is expected to increase confidence in pharmacists as primary care providers, increase utilization of pharmacy clinical services, and assist in easing the burden of primary care provider shortages across our nation.
Although these outcomes indicate demonstrable benefit in patient-centered outcomes, the need for ongoing assessment and continued improvement is not obviated. Future efforts may benefit from a comparison of alternative approaches to better facilitate the establishment of best practices. Alignment of clinical outcomes with the Centers for Medicare and Medicaid Services (CMS) Electronic Clinical Quality Measures, where applicable, also may prove beneficial by automating the reporting process and thereby decreasing the burden of reporting as well as providing an avenue for standard comparison across multiple populations. Clinical pharmacy interventions have positive outcomes based on the NCPS model, and the NCPS Committee invites other clinical settings to report outcomes data with which to compare.
Conclusion
The NCPS Committee has documented positive outcomes of clinical pharmacy intervention and anticipates growth of the pharmacy profession as additional states and health systems recognize the capacity of the pharmacist to provide high-quality, multidisciplinary patient care. Clinical pharmacists are prepared to address critical health care needs as the US continues to face a PCP shortage.2 The NCPS Committee challenges those participating in clinical pharmacy practice to report outcomes to amplify this body of evidence.
Acknowledgments
NCPS-certified pharmacists provided the outcomes detailed in this report. For document review and edits: Federal Bureau of Prison Publication Review Workgroup; RADM Ty Bingham, USPHS; CAPT Cindy Gunderson, USPHS; CAPT Kevin Brooks, USPHS.
The US is in the midst of a chronic disease crisis. According to the latest published data available, 60% of Americans have at least 1 chronic condition, and 42% have ≥ 2 chronic conditions.1 Estimates by the Health Resources and Services Administration (HRSA) indicate a current shortfall of 13 800 primary care physicians and a projected escalation of that shortage to be between 14 800 and 49 300 physicians by the year 2030.2
The US Public Health Service (USPHS) has used pharmacists since 1930 to provide direct patient care to underserved and vulnerable populations. Clinical pharmacists currently serve in direct patient care roles within the Indian Health Service (IHS), Federal Bureau of Prisons (BOP), Immigration and Customs Enforcement (ICE), and the United States Coast Guard (USCG) in many states (Figure). These pharmacists play a vital role in improving access to care and delivering quality care by managing acute and chronic diseases in collaborative practice settings and pharmacist-managed clinics.
It has previously been reported that in the face of physician shortages and growing demand for primary health care providers, pharmacists are well-equipped and motivated to meet this demand.3 A review of the previous 2 years of outcomes reported by clinical pharmacists certified through the USPHS National Clinical Pharmacy Specialist (NCPS) Committee are presented to demonstrate the impact of pharmacists in advancing the health of the populations they serve and to showcase a model for ameliorating the ongoing physician shortage.
Background
The USPHS NCPS Committee serves to promote uniform competency among clinical pharmacists by establishing national standards for protocols, collaborative practice agreements (CPAs), credentialing and privileging of pharmacists, and by collecting, reviewing, and publishing health care outcomes. The committee, whose constituents include pharmacist and physician subject matter experts from across USPHS agencies, reviews applications and protocols and certifies pharmacists (civilian and uniformed) to recognize an advanced scope of practice in managing various diseases and optimizing medication therapy. NCPScertified pharmacists manage a wide spectrum of diseases, including coagulopathy, asthma, diabetes mellitus (DM), hepatitis C, HIV, hypertension, pain, seizure disorders, and tobacco use disorders.
Clinical pharmacists practicing chronic disease management establish a clinical service in collaboration with 1 or more physicians, physician assistants, or nurse practitioners. In this collaborative practice, the health care practitioner(s) refer patients to be managed by a pharmacist for specific medical needs, such as anticoagulation management, or for holistic medication- focused care (eg, cardiovascular risk reduction, DM management, HIV, hepatitis, or mental health). The pharmacist may order and interpret laboratory tests, check vital signs, perform a limited physical examination, and gather other pertinent information from the patient and the medical record in order to provide the best possible care to the patient.
Medications may be started, stopped, or adjusted, education is provided, and therapeutic lifestyle interventions may be recommended. The pharmacist-run clinic provides the patient more frequent interaction with a health care professional (pharmacist) and focused disease management. As a result, pharmacists increase access to care and allow the medical team to handle a larger panel of patients as the practitioner delegates specified diseases to the pharmacist- managed clinic(s). The number of NCPS-certified pharmacists grew 46% from 2012 (n = 230) to 2017 (n = 336), reflecting an evolution of pharmacists’ practice to better meet the need of patients across the nation.
Methods
The NCPS Committee requires NCPS pharmacists to report data annually from all patients referred for pharmacist management for specific diseases in which they have been certified. The data reflect the patient’s clinical outcome goal status at the time of referral as well as the same status at the end of the reporting period or on release from the pharmacist-run clinic. These data describe the impact prescribing pharmacists have on patients reaching clinical outcome goals acting as the team member specializing in the medication selection and dosing aspect of care.
These records were reviewed for the fiscal year (FY) periods of October 1, 2015 to September 30, 2016 (FY 2016) and October 1, 2016 to September 30, 2017 (FY 2017). A systematic review of submitted reports resulted in 181 reports that included all requested data points for the disease as published here for FYs 2016 and 2017. These include 66 reports from FY 2016 and 115 reports from FY 2017; they cover 76 BOP and IHS facilities located across 24 states. Table 1 shows the number of outcome reports collected from 104 075 patient visits in pharmacist-run clinics in FYs 2016 and 2017.
Results
The following tables represent the standardized outcomes collected by NCPS-certified pharmacists providing direct patient care. Patients on anticoagulants (eg, warfarin) require special monitoring and education for drug interactions and adverse effects. NCPS-certified pharmacists were able to achieve a mean patient time in therapeutic range (TTR) of 67.6% (regardless of indication) over the 2 years (calculated per each facility by Rosendaal method of linear interpolation then combined in a weighted average per visit). The TTR produced by NCPS-certified pharmacists are consistent with Chest Guidelines and Expert Panel Report suggesting that TTR should be between 65% and 70%.4 Table 2 shows data from 100 reports with 68 255 patient visits for anticoagulation management.
DM management can be complex and time-intensive. NCPS data indicate pharmacist intervention resulted in a mean decrease in hemoglobin A1c (HbA1c) of 1.8% from a baseline of 10.2% (decrease calculated per each facility then combined by weighted average per visit). Table 3 shows data from 30 reports with 16 518 patient visits for DM care.
In addition to diet and exercise, medication management plays a vital role in managing hypertension. Patients managed by an NCPS-certified pharmacist experienced a mean decrease in blood pressure from 144/83 to 133/77, putting them in goal for both systolic and diastolic ranges (decrease calculated per each facility then combined by weighted average per visit). Table 4 shows data from 16 reports and 7997 patient visits for treatment of hypertension.
HIV viral suppression is vital in order to best manage patients with HIV and reduce the risk of transmission. Pharmacistled clinics have shown a 32.9% absolute improvement in patients at goal (viral load < 50 copies/mL), from a mean baseline of 46.0% to a mean final assessment of 71.6% of patients at goal (combined by weighted average visits). Table 5 shows data from 6 reports covering 1532 patient encounters for management of HIV.
Nicotine dependence includes the use of cigarettes, cigars, pipe tobacco, chewing tobacco, and vaping products containing nicotine. NCPS-certified pharmacists have successfully helped patients improve their chance of quitting, with a 6-month quit rate of 22.2% (quit rate calculated per each facility then combined by weighted average by visits), which is higher than the national average of 9.4% as reported by the Centers for Disease and Control and Prevention. 5 Table 6 shows 29 reports covering 9773 patient visits for treatment of nicotine dependence.
Discussion
These data demonstrate the ability of advanced practice pharmacists in multiple locations within the federal sector to improve targeted clinical outcomes in patients with varying diseases. These results are strengthened by their varied origins as well as the improvements observed across the board. Limitations include the general lack of a comparable dataset, manual method of selfreporting by the individual facilities, and the relatively limited array of diseases reported. Although NCPS-certified pharmacists are currently providing care for patients with hepatitis C, asthma, seizure, pain and other diseases not reported here, there are insufficient data collected for FYs 2016 and 2017 to merit inclusion within this report.
Pharmacists are trusted, readily available medication experts. In a clinical role, NCPS-certified pharmacists have increased access to primary care services and demonstrated beneficial impact on important health outcomes as exhibited by the data reported above. Clinical pharmacy is a growing field, and NCPS has displayed continual growth in both the number of NCPS-certified pharmacists and the number of patient encounters performed by these providers. As more pharmacists in all settings collaborate with medical providers to offer high-quality clinical care, these providers will have more opportunity to delegate disease management. Continued reporting of clinical pharmacy outcomes is expected to increase confidence in pharmacists as primary care providers, increase utilization of pharmacy clinical services, and assist in easing the burden of primary care provider shortages across our nation.
Although these outcomes indicate demonstrable benefit in patient-centered outcomes, the need for ongoing assessment and continued improvement is not obviated. Future efforts may benefit from a comparison of alternative approaches to better facilitate the establishment of best practices. Alignment of clinical outcomes with the Centers for Medicare and Medicaid Services (CMS) Electronic Clinical Quality Measures, where applicable, also may prove beneficial by automating the reporting process and thereby decreasing the burden of reporting as well as providing an avenue for standard comparison across multiple populations. Clinical pharmacy interventions have positive outcomes based on the NCPS model, and the NCPS Committee invites other clinical settings to report outcomes data with which to compare.
Conclusion
The NCPS Committee has documented positive outcomes of clinical pharmacy intervention and anticipates growth of the pharmacy profession as additional states and health systems recognize the capacity of the pharmacist to provide high-quality, multidisciplinary patient care. Clinical pharmacists are prepared to address critical health care needs as the US continues to face a PCP shortage.2 The NCPS Committee challenges those participating in clinical pharmacy practice to report outcomes to amplify this body of evidence.
Acknowledgments
NCPS-certified pharmacists provided the outcomes detailed in this report. For document review and edits: Federal Bureau of Prison Publication Review Workgroup; RADM Ty Bingham, USPHS; CAPT Cindy Gunderson, USPHS; CAPT Kevin Brooks, USPHS.
1. Buttorff C, Ruder T, Bauman M. Multiple Chronic Conditions in the United States. Santa Monica, CA: Rand Corp; 2017.
2. Dall T, West T, Chakrabarti R, Reynolds R, Iacobucci W. The complexities of physician supply and demand: projections from 2016 to 2030, 2018 update. Association of American Medical Colleges. March 2018.
3. Giberson S, Yoder S, Lee MP. Improving patient and health system outcomes through advanced pharmacy practice. A report to the U.S. Surgeon General 2011. https://www .accp.com/docs/positions/misc/improving_patient_and _health_system_outcomes.pdf. Updated December 2011. Accessed September 11, 2019.
4. Lip G, Banerjee A, Boriani G, et al. Antithrombotic therapy for atrial fibrillation. CHEST guideline and Expert Panel Report. Chest. 2018;154(5):1121-1201.
5. Babb S, Marlarcher A, Schauer G, Asman K, Jamal A. Quitting smoking among adults—United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017;65(52):1457-1464.
1. Buttorff C, Ruder T, Bauman M. Multiple Chronic Conditions in the United States. Santa Monica, CA: Rand Corp; 2017.
2. Dall T, West T, Chakrabarti R, Reynolds R, Iacobucci W. The complexities of physician supply and demand: projections from 2016 to 2030, 2018 update. Association of American Medical Colleges. March 2018.
3. Giberson S, Yoder S, Lee MP. Improving patient and health system outcomes through advanced pharmacy practice. A report to the U.S. Surgeon General 2011. https://www .accp.com/docs/positions/misc/improving_patient_and _health_system_outcomes.pdf. Updated December 2011. Accessed September 11, 2019.
4. Lip G, Banerjee A, Boriani G, et al. Antithrombotic therapy for atrial fibrillation. CHEST guideline and Expert Panel Report. Chest. 2018;154(5):1121-1201.
5. Babb S, Marlarcher A, Schauer G, Asman K, Jamal A. Quitting smoking among adults—United States, 2000-2015. MMWR Morb Mortal Wkly Rep. 2017;65(52):1457-1464.
Advancing Order Set Design
In the current health care environment, hospitals are constantly challenged to improve quality metrics and deliver better health care outcomes. One means to achieving quality improvement is through the use of order sets, groups of related orders that a health care provider (HCP) can place with either a few keystrokes or mouse clicks.1
Historically, design of order sets has largely focused on clicking checkboxes containing evidence-based practices. According to Bates and colleagues and the Institute for Safe Medication Practices, incorporating evidence-based medicine (EBM) into order sets is not by itself sufficient.2,3Execution of proper design coupled with simplicity and provider efficiency is paramount to HCP buy-in, increased likelihood of order set adherence, and to potentially better outcomes.
In this article, we outline advancements in order set design. These improvements increase provider efficiency and ease of use; incorporate human factors engineering (HFE); apply failure mode and effects analysis; and include EBM.
Methods
An inpatient nicotine replacement therapy (NRT) order was developed as part of a multifaceted solution to improve tobacco cessation care at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, a complexity level 1a facility. This NRT order set used the 4-step order set design framework the authors’ developed (for additional information about the NRT order set, contact the authors). We distinguish order set design technique between 2 different inpatient NRT order sets. The first order set in the comparison (Figure 1) is an inpatient NRT order set of unknown origin—it is common for US Department of Veterans Affairs (VA) medical facilities to share order sets and other resources. The second order set (Figure 2) is an inpatient NRT order set we designed using our 4-step process for comparison in this article. No institutional review board approval was required as this work met criteria for operational improvement activities exempt from ethics review.
Justin Iannello, DO, MBA, was the team leader and developer of the 4-step order set design technique. The intervention team consisted of 4 internal medicine physicians with expertise in quality improvement and patient safety: 1 certified professional in patient safety and certified as a Lean Six Sigma Black Belt; 2 physicians certified as Lean Six Sigma Black Belts; and 1 physician certified as a Lean Six Sigma Green Belt. Two inpatient clinical pharmacists and 1 quality management specialist also were involved in its development.
Development of a new NRT order set was felt to be an integral part of the tobacco cessation care delivery process. An NRT order set perceived by users as value-added required a solution that merged EBM with standardization and applied quality improvement principles. The result was an approach to order set design that focused on 4 key questions: Is the order set efficient and easy to use/navigate? Is human factors engineering incorporated? Is failure mode and effects analysis applied? Are evidence-based practices included?
Ease of Use and Navigation
Implementing an order set that is efficient and easy to use or navigate seems straightforward but can be difficult to execute. Figure 1 shows many detailed options consisting of different combinations of nicotine patches, lozenges, and gum. Also included are oral tobacco cessation options (bupropion and varenicline). Although more options may seem better, confusion about appropriate medication selection can occur.
According to Heath and Heath, too many options can result in lack of action.4 For example, Heath and Heath discuss a food store that offered 6 free samples of different jams on one day and 24 jams the following day. The customers who sampled 6 different types of jam were 10 times more likely to buy jam. The authors concluded that the more options available, the more difficulty a potential buyer has in deciding on a course of action.4
In clinical situations where a HCP is using an order set, the number of options can mean the difference between use vs avoidance if the choices are overwhelming. HCPs process layers of detail every day when creating differential diagnoses and treatment plans. While that level of detail is necessary clinically, that same level of detail included in orders sets can create challenges for HCPs.
Figure 2 advances the order set in Figure 1 by providing a simpler and cleaner design, so HCPs can more easily review and process the information. This order set design minimizes the number of options available to help users make the right decision, focusing on value for the appropriate setting and audience. In other words, order sets should not be a “one size fits all” approach.
Order sets should be tailored to the appropriate clinical setting (eg, inpatient acute care, outpatient clinic setting, etc) and HCP (eg, hospitalist, tobacco cessation specialist, etc). We are comparing NRT order sets designed for HCPs who do not routinely prescribe oral tobacco cessation products in the inpatient setting. When possible, autogenerated bundle orders should also be used according to evidence-based recommendations (such as nicotine patch tapers) for ease of use and further simplification of order sets.
Finally, usability testing known as “evaluating a product or service by testing it with representative users” helps further refine an order set.5Usability testing should be applied during all phases of order set development with end user(s) as it helps identify problems with order set design prior to implementation. By applying usability testing, the order set becomes more meaningful and valued by the user.
Human Factors Engineering
HFE is “the study of all the factors that make it easier to do the work in the right way.”6 HFE seeks to identify, align, and apply processes for people and the world within which they live and work to promote safe and efficient practices, especially in relation to the technology and physical design features in their work environment.6
The average American adult makes about 35,000 decisions per day.7 Thus, there is potential for error at any moment. Design that does not take HFE into account can be dangerous. For example, when tube feed and IV line connectors look similar and are compatible, patients may inadvertently receive food administered directly into their bloodstream.8
HFE can and should be applied to order sets. Everything from the look, feel, and verbiage of an order set affects potential outcomes. For example, consider the impact even seemingly minor modifications can have on outcomes simply by guiding users in a different way: Figure 1 provides NRT options based on cigarette use per day, whereas Figure 2 conveys pack use per day in relation to the equivalent number of cigarettes used daily. These differences may seem small; however, it helps guide users to the right choice when considering that health care providers have been historically trained on social history gathering that emphasizes packs per day and pack-years.
Failure Mode and Effects Analysis
Failure mode and effects analysis (FMEA) is “a structured way to identify and address potential problems, or failures and their resulting effects on the system or process before an adverse event occurs.”9 The benefit of an order set must be weighed against the risk during development. FMEA should be applied during order set design to assess and limit risk just as with any other clinical care process.
FMEA examines both level of risk and frequency of risk occurrence associated with a new proposed process. For example, let’s evaluate an order set designed for pain control after surgery that consists of multiple high-risk opioids along with antihistamine medications for as-needed itch relief (a non-life-threatening adverse event (AE) of opioids well known by the medical community). An interdisciplinary FMEA team consisting of subject matter experts may examine how the process should flow in step-by-step detail and then discuss the benefit of a process and risk for potential error. A FMEA team would then analyze what could go wrong with each part of the process and assign a level of risk and risk frequency for various steps in the process, and then decide that certain steps should be modified or eliminated. Perhaps after FMEA, a facility might conclude that the risk of serious complications is high when you combine opioid use with antihistamine medications. The facility could decide to remove antihistamine medications from an order set if it is determined that risks outweigh benefits. While a root cause analysis might identify the cause of an AE after order set use, these situations can be prevented with FMEA.
When applying FMEA to Figure 1, while bupropion is known as an evidence-based oral tobacco cessation option, there is the possibility that bupropion could be inadvertently prescribed from the order set in a hospitalized patient with alcohol withdrawal and withdrawal seizure history. These potentially dangerous situations can be avoided with FMEA. Thus, although bupropion may be evidence-based for NRT, decisions regarding order set design using EBM alone are insufficient.
The practitioner must consider possible unintended consequences within order sets and target treatment options to the appropriate setting and audience. Although Figure 1 may appear to be more inclusive, the interdisciplinary committee designing the inpatient NRT order set felt there was heightened risk with introducing bupropion in Figure 1 and decided the risk would be lowered by removing bupropion from the redesigned NRT order set (Figure 2). In addition to the goal of balancing availability of NRT options with acceptable risk, Figure 2 also focused on building an NRT order set most applicable to the inpatient setting.
Including Evidence-Based Practices
EBM has become a routine part of clinical decision making. Therefore, including EBM in order set design is vital. EBM for NRT has demonstrated that combination therapy is more effective than is monotherapy to help tobacco users quit. Incremental doses of NRT are recommended for patients who use tobacco more frequently.10
As shown in Figures 1 and 2, both order set designs incorporate EBM for NRT. Although the importance of implementing EBM is evident, critical factors, such as HFE and FMEA make a difference with well-designed order sets.
Results
The 4-step order set design technique was used during development of an inpatient NRT order set at the JAHVH. Results for the inpatient Joint Commission Tobacco Treatment Measures were obtained from the Veterans Health Administration quality metric reporting system known as Strategic Analytics for Improvement and Learning (SAIL). SAIL performance measure outcomes, which include the inpatient Joint Commission Tobacco Treatment Measures, are derived from chart reviews conducted by the External Peer Review Program. Outcomes demonstrated that TOB-2 and TOB-3 (2 inpatient Joint Commission Tobacco Treatment Measures) known as tob20 and tob40, respectively, within SAIL improved by more than 300% after development of an NRT order set using the 4-step order set design framework along with implementation of a multifaceted tobacco cessation care delivery system at JAHVH.
Discussion
While the overall tobacco cessation care delivery system contributed to improved outcomes with the inpatient Joint Commission Tobacco Treatment Measures at JAHVH, the NRT order set was a cornerstone of the design. Although using our order set design technique does not necessarily guarantee successful outcomes, we believe using the 4-step order set design process increases the value of order sets and has potential to improve quality outcomes.
Limitations
Although improved outcomes following implementation of our NRT order set suggest correlation, causation cannot be proven. Also while the NRT order set is believed to have helped tremendously with outcomes, the entire tobacco cessation care delivery system at JAHVH contributed to the results. In addition, the inpatient Joint Commission Tobacco Treatment Measures help improve processes for tobacco cessation care. However, we are uncertain whether the results of our improvement efforts helped patients stop tobacco use. Further studies are needed to determine impact on population health. Finally, our results were based on improvement work done at a single center. Further studies are necessary to see whether results are reproducible.
Conclusion
There was significant improvement with the inpatient Joint Commission Tobacco Treatment Measures outcomes following development of a tobacco cessation care delivery system that included design of an inpatient NRT order set using a 4-step process we developed. This 4-step structure includes emphasis on efficiency and ease of use; human factors engineering; failure mode and effects analysis; and incorporation of evidence-based medicine (Box.) Postimplementation results showed improvement of the inpatient Joint Commission Tobacco Treatment Measures by greater than 3-fold at a single hospital.
The next steps for this initiative include testing the 4-step order set design process in multiple clinical settings to determine the effectiveness of this approach in other areas of clinical care.
1. Order set. http://clinfowiki.org/wiki/index.php/Order_set. Updated October 15, 2015. Accessed August 30, 2019.
2. Bates DW, Kuperman GJ, Wang S, et al. Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality. J Am Med Inform Assoc. 2003;10(6):523-530.
3. Institute for Safe Medication Practices. Guidelines for standard order sets. https://www.ismp.org/tools/guidelines/standardordersets.pdf. Published January 12, 2010. Accessed August 30, 2019.
4. Heath C, Heath D. Switch: How to Change Things When Change Is Hard. New York, NY: Crown Business; 2010:50-51.
5. US Department of Health and Human Services. Usability testing. https://www.usability.gov/how-to-and-tools/methods/usability-testing.html. Accessed August 30, 2019.
6. World Health Organization. What is human factors and why is it important to patient safety? www.who.int/patientsafety/education/curriculum/who_mc_topic-2.pdf. Accessed August 30, 2019.
7. Sollisch J. The cure for decision fatigue. Wall Street Journal. June 10, 2016. https://www.wsj.com/articles/the-cure-for-decision-fatigue-1465596928. Accessed August 30, 2019.
8. ECRI Institute. Implementing the ENFit initiative for preventing enteral tubing misconnections. https://www.ecri.org/components/HDJournal/Pages/ENFit-for-Preventing-Enteral-Tubing-Misconnections.aspx. Published March 29, 2017. Accessed August 30, 2019.
9. Guidance for performing failure mode and effects analysis with performance improvement projects. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/downloads/GuidanceForFMEA.pdf. Accessed August 30, 2019.
10. Diefanbach LJ, Smith PO, Nashelsky JM, Lindbloom E. What is the most effective nicotine replacement therapy? J Fam Pract. 2003;52(6):492-497.
In the current health care environment, hospitals are constantly challenged to improve quality metrics and deliver better health care outcomes. One means to achieving quality improvement is through the use of order sets, groups of related orders that a health care provider (HCP) can place with either a few keystrokes or mouse clicks.1
Historically, design of order sets has largely focused on clicking checkboxes containing evidence-based practices. According to Bates and colleagues and the Institute for Safe Medication Practices, incorporating evidence-based medicine (EBM) into order sets is not by itself sufficient.2,3Execution of proper design coupled with simplicity and provider efficiency is paramount to HCP buy-in, increased likelihood of order set adherence, and to potentially better outcomes.
In this article, we outline advancements in order set design. These improvements increase provider efficiency and ease of use; incorporate human factors engineering (HFE); apply failure mode and effects analysis; and include EBM.
Methods
An inpatient nicotine replacement therapy (NRT) order was developed as part of a multifaceted solution to improve tobacco cessation care at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, a complexity level 1a facility. This NRT order set used the 4-step order set design framework the authors’ developed (for additional information about the NRT order set, contact the authors). We distinguish order set design technique between 2 different inpatient NRT order sets. The first order set in the comparison (Figure 1) is an inpatient NRT order set of unknown origin—it is common for US Department of Veterans Affairs (VA) medical facilities to share order sets and other resources. The second order set (Figure 2) is an inpatient NRT order set we designed using our 4-step process for comparison in this article. No institutional review board approval was required as this work met criteria for operational improvement activities exempt from ethics review.
Justin Iannello, DO, MBA, was the team leader and developer of the 4-step order set design technique. The intervention team consisted of 4 internal medicine physicians with expertise in quality improvement and patient safety: 1 certified professional in patient safety and certified as a Lean Six Sigma Black Belt; 2 physicians certified as Lean Six Sigma Black Belts; and 1 physician certified as a Lean Six Sigma Green Belt. Two inpatient clinical pharmacists and 1 quality management specialist also were involved in its development.
Development of a new NRT order set was felt to be an integral part of the tobacco cessation care delivery process. An NRT order set perceived by users as value-added required a solution that merged EBM with standardization and applied quality improvement principles. The result was an approach to order set design that focused on 4 key questions: Is the order set efficient and easy to use/navigate? Is human factors engineering incorporated? Is failure mode and effects analysis applied? Are evidence-based practices included?
Ease of Use and Navigation
Implementing an order set that is efficient and easy to use or navigate seems straightforward but can be difficult to execute. Figure 1 shows many detailed options consisting of different combinations of nicotine patches, lozenges, and gum. Also included are oral tobacco cessation options (bupropion and varenicline). Although more options may seem better, confusion about appropriate medication selection can occur.
According to Heath and Heath, too many options can result in lack of action.4 For example, Heath and Heath discuss a food store that offered 6 free samples of different jams on one day and 24 jams the following day. The customers who sampled 6 different types of jam were 10 times more likely to buy jam. The authors concluded that the more options available, the more difficulty a potential buyer has in deciding on a course of action.4
In clinical situations where a HCP is using an order set, the number of options can mean the difference between use vs avoidance if the choices are overwhelming. HCPs process layers of detail every day when creating differential diagnoses and treatment plans. While that level of detail is necessary clinically, that same level of detail included in orders sets can create challenges for HCPs.
Figure 2 advances the order set in Figure 1 by providing a simpler and cleaner design, so HCPs can more easily review and process the information. This order set design minimizes the number of options available to help users make the right decision, focusing on value for the appropriate setting and audience. In other words, order sets should not be a “one size fits all” approach.
Order sets should be tailored to the appropriate clinical setting (eg, inpatient acute care, outpatient clinic setting, etc) and HCP (eg, hospitalist, tobacco cessation specialist, etc). We are comparing NRT order sets designed for HCPs who do not routinely prescribe oral tobacco cessation products in the inpatient setting. When possible, autogenerated bundle orders should also be used according to evidence-based recommendations (such as nicotine patch tapers) for ease of use and further simplification of order sets.
Finally, usability testing known as “evaluating a product or service by testing it with representative users” helps further refine an order set.5Usability testing should be applied during all phases of order set development with end user(s) as it helps identify problems with order set design prior to implementation. By applying usability testing, the order set becomes more meaningful and valued by the user.
Human Factors Engineering
HFE is “the study of all the factors that make it easier to do the work in the right way.”6 HFE seeks to identify, align, and apply processes for people and the world within which they live and work to promote safe and efficient practices, especially in relation to the technology and physical design features in their work environment.6
The average American adult makes about 35,000 decisions per day.7 Thus, there is potential for error at any moment. Design that does not take HFE into account can be dangerous. For example, when tube feed and IV line connectors look similar and are compatible, patients may inadvertently receive food administered directly into their bloodstream.8
HFE can and should be applied to order sets. Everything from the look, feel, and verbiage of an order set affects potential outcomes. For example, consider the impact even seemingly minor modifications can have on outcomes simply by guiding users in a different way: Figure 1 provides NRT options based on cigarette use per day, whereas Figure 2 conveys pack use per day in relation to the equivalent number of cigarettes used daily. These differences may seem small; however, it helps guide users to the right choice when considering that health care providers have been historically trained on social history gathering that emphasizes packs per day and pack-years.
Failure Mode and Effects Analysis
Failure mode and effects analysis (FMEA) is “a structured way to identify and address potential problems, or failures and their resulting effects on the system or process before an adverse event occurs.”9 The benefit of an order set must be weighed against the risk during development. FMEA should be applied during order set design to assess and limit risk just as with any other clinical care process.
FMEA examines both level of risk and frequency of risk occurrence associated with a new proposed process. For example, let’s evaluate an order set designed for pain control after surgery that consists of multiple high-risk opioids along with antihistamine medications for as-needed itch relief (a non-life-threatening adverse event (AE) of opioids well known by the medical community). An interdisciplinary FMEA team consisting of subject matter experts may examine how the process should flow in step-by-step detail and then discuss the benefit of a process and risk for potential error. A FMEA team would then analyze what could go wrong with each part of the process and assign a level of risk and risk frequency for various steps in the process, and then decide that certain steps should be modified or eliminated. Perhaps after FMEA, a facility might conclude that the risk of serious complications is high when you combine opioid use with antihistamine medications. The facility could decide to remove antihistamine medications from an order set if it is determined that risks outweigh benefits. While a root cause analysis might identify the cause of an AE after order set use, these situations can be prevented with FMEA.
When applying FMEA to Figure 1, while bupropion is known as an evidence-based oral tobacco cessation option, there is the possibility that bupropion could be inadvertently prescribed from the order set in a hospitalized patient with alcohol withdrawal and withdrawal seizure history. These potentially dangerous situations can be avoided with FMEA. Thus, although bupropion may be evidence-based for NRT, decisions regarding order set design using EBM alone are insufficient.
The practitioner must consider possible unintended consequences within order sets and target treatment options to the appropriate setting and audience. Although Figure 1 may appear to be more inclusive, the interdisciplinary committee designing the inpatient NRT order set felt there was heightened risk with introducing bupropion in Figure 1 and decided the risk would be lowered by removing bupropion from the redesigned NRT order set (Figure 2). In addition to the goal of balancing availability of NRT options with acceptable risk, Figure 2 also focused on building an NRT order set most applicable to the inpatient setting.
Including Evidence-Based Practices
EBM has become a routine part of clinical decision making. Therefore, including EBM in order set design is vital. EBM for NRT has demonstrated that combination therapy is more effective than is monotherapy to help tobacco users quit. Incremental doses of NRT are recommended for patients who use tobacco more frequently.10
As shown in Figures 1 and 2, both order set designs incorporate EBM for NRT. Although the importance of implementing EBM is evident, critical factors, such as HFE and FMEA make a difference with well-designed order sets.
Results
The 4-step order set design technique was used during development of an inpatient NRT order set at the JAHVH. Results for the inpatient Joint Commission Tobacco Treatment Measures were obtained from the Veterans Health Administration quality metric reporting system known as Strategic Analytics for Improvement and Learning (SAIL). SAIL performance measure outcomes, which include the inpatient Joint Commission Tobacco Treatment Measures, are derived from chart reviews conducted by the External Peer Review Program. Outcomes demonstrated that TOB-2 and TOB-3 (2 inpatient Joint Commission Tobacco Treatment Measures) known as tob20 and tob40, respectively, within SAIL improved by more than 300% after development of an NRT order set using the 4-step order set design framework along with implementation of a multifaceted tobacco cessation care delivery system at JAHVH.
Discussion
While the overall tobacco cessation care delivery system contributed to improved outcomes with the inpatient Joint Commission Tobacco Treatment Measures at JAHVH, the NRT order set was a cornerstone of the design. Although using our order set design technique does not necessarily guarantee successful outcomes, we believe using the 4-step order set design process increases the value of order sets and has potential to improve quality outcomes.
Limitations
Although improved outcomes following implementation of our NRT order set suggest correlation, causation cannot be proven. Also while the NRT order set is believed to have helped tremendously with outcomes, the entire tobacco cessation care delivery system at JAHVH contributed to the results. In addition, the inpatient Joint Commission Tobacco Treatment Measures help improve processes for tobacco cessation care. However, we are uncertain whether the results of our improvement efforts helped patients stop tobacco use. Further studies are needed to determine impact on population health. Finally, our results were based on improvement work done at a single center. Further studies are necessary to see whether results are reproducible.
Conclusion
There was significant improvement with the inpatient Joint Commission Tobacco Treatment Measures outcomes following development of a tobacco cessation care delivery system that included design of an inpatient NRT order set using a 4-step process we developed. This 4-step structure includes emphasis on efficiency and ease of use; human factors engineering; failure mode and effects analysis; and incorporation of evidence-based medicine (Box.) Postimplementation results showed improvement of the inpatient Joint Commission Tobacco Treatment Measures by greater than 3-fold at a single hospital.
The next steps for this initiative include testing the 4-step order set design process in multiple clinical settings to determine the effectiveness of this approach in other areas of clinical care.
In the current health care environment, hospitals are constantly challenged to improve quality metrics and deliver better health care outcomes. One means to achieving quality improvement is through the use of order sets, groups of related orders that a health care provider (HCP) can place with either a few keystrokes or mouse clicks.1
Historically, design of order sets has largely focused on clicking checkboxes containing evidence-based practices. According to Bates and colleagues and the Institute for Safe Medication Practices, incorporating evidence-based medicine (EBM) into order sets is not by itself sufficient.2,3Execution of proper design coupled with simplicity and provider efficiency is paramount to HCP buy-in, increased likelihood of order set adherence, and to potentially better outcomes.
In this article, we outline advancements in order set design. These improvements increase provider efficiency and ease of use; incorporate human factors engineering (HFE); apply failure mode and effects analysis; and include EBM.
Methods
An inpatient nicotine replacement therapy (NRT) order was developed as part of a multifaceted solution to improve tobacco cessation care at the James A. Haley Veterans’ Hospital (JAHVH) in Tampa, Florida, a complexity level 1a facility. This NRT order set used the 4-step order set design framework the authors’ developed (for additional information about the NRT order set, contact the authors). We distinguish order set design technique between 2 different inpatient NRT order sets. The first order set in the comparison (Figure 1) is an inpatient NRT order set of unknown origin—it is common for US Department of Veterans Affairs (VA) medical facilities to share order sets and other resources. The second order set (Figure 2) is an inpatient NRT order set we designed using our 4-step process for comparison in this article. No institutional review board approval was required as this work met criteria for operational improvement activities exempt from ethics review.
Justin Iannello, DO, MBA, was the team leader and developer of the 4-step order set design technique. The intervention team consisted of 4 internal medicine physicians with expertise in quality improvement and patient safety: 1 certified professional in patient safety and certified as a Lean Six Sigma Black Belt; 2 physicians certified as Lean Six Sigma Black Belts; and 1 physician certified as a Lean Six Sigma Green Belt. Two inpatient clinical pharmacists and 1 quality management specialist also were involved in its development.
Development of a new NRT order set was felt to be an integral part of the tobacco cessation care delivery process. An NRT order set perceived by users as value-added required a solution that merged EBM with standardization and applied quality improvement principles. The result was an approach to order set design that focused on 4 key questions: Is the order set efficient and easy to use/navigate? Is human factors engineering incorporated? Is failure mode and effects analysis applied? Are evidence-based practices included?
Ease of Use and Navigation
Implementing an order set that is efficient and easy to use or navigate seems straightforward but can be difficult to execute. Figure 1 shows many detailed options consisting of different combinations of nicotine patches, lozenges, and gum. Also included are oral tobacco cessation options (bupropion and varenicline). Although more options may seem better, confusion about appropriate medication selection can occur.
According to Heath and Heath, too many options can result in lack of action.4 For example, Heath and Heath discuss a food store that offered 6 free samples of different jams on one day and 24 jams the following day. The customers who sampled 6 different types of jam were 10 times more likely to buy jam. The authors concluded that the more options available, the more difficulty a potential buyer has in deciding on a course of action.4
In clinical situations where a HCP is using an order set, the number of options can mean the difference between use vs avoidance if the choices are overwhelming. HCPs process layers of detail every day when creating differential diagnoses and treatment plans. While that level of detail is necessary clinically, that same level of detail included in orders sets can create challenges for HCPs.
Figure 2 advances the order set in Figure 1 by providing a simpler and cleaner design, so HCPs can more easily review and process the information. This order set design minimizes the number of options available to help users make the right decision, focusing on value for the appropriate setting and audience. In other words, order sets should not be a “one size fits all” approach.
Order sets should be tailored to the appropriate clinical setting (eg, inpatient acute care, outpatient clinic setting, etc) and HCP (eg, hospitalist, tobacco cessation specialist, etc). We are comparing NRT order sets designed for HCPs who do not routinely prescribe oral tobacco cessation products in the inpatient setting. When possible, autogenerated bundle orders should also be used according to evidence-based recommendations (such as nicotine patch tapers) for ease of use and further simplification of order sets.
Finally, usability testing known as “evaluating a product or service by testing it with representative users” helps further refine an order set.5Usability testing should be applied during all phases of order set development with end user(s) as it helps identify problems with order set design prior to implementation. By applying usability testing, the order set becomes more meaningful and valued by the user.
Human Factors Engineering
HFE is “the study of all the factors that make it easier to do the work in the right way.”6 HFE seeks to identify, align, and apply processes for people and the world within which they live and work to promote safe and efficient practices, especially in relation to the technology and physical design features in their work environment.6
The average American adult makes about 35,000 decisions per day.7 Thus, there is potential for error at any moment. Design that does not take HFE into account can be dangerous. For example, when tube feed and IV line connectors look similar and are compatible, patients may inadvertently receive food administered directly into their bloodstream.8
HFE can and should be applied to order sets. Everything from the look, feel, and verbiage of an order set affects potential outcomes. For example, consider the impact even seemingly minor modifications can have on outcomes simply by guiding users in a different way: Figure 1 provides NRT options based on cigarette use per day, whereas Figure 2 conveys pack use per day in relation to the equivalent number of cigarettes used daily. These differences may seem small; however, it helps guide users to the right choice when considering that health care providers have been historically trained on social history gathering that emphasizes packs per day and pack-years.
Failure Mode and Effects Analysis
Failure mode and effects analysis (FMEA) is “a structured way to identify and address potential problems, or failures and their resulting effects on the system or process before an adverse event occurs.”9 The benefit of an order set must be weighed against the risk during development. FMEA should be applied during order set design to assess and limit risk just as with any other clinical care process.
FMEA examines both level of risk and frequency of risk occurrence associated with a new proposed process. For example, let’s evaluate an order set designed for pain control after surgery that consists of multiple high-risk opioids along with antihistamine medications for as-needed itch relief (a non-life-threatening adverse event (AE) of opioids well known by the medical community). An interdisciplinary FMEA team consisting of subject matter experts may examine how the process should flow in step-by-step detail and then discuss the benefit of a process and risk for potential error. A FMEA team would then analyze what could go wrong with each part of the process and assign a level of risk and risk frequency for various steps in the process, and then decide that certain steps should be modified or eliminated. Perhaps after FMEA, a facility might conclude that the risk of serious complications is high when you combine opioid use with antihistamine medications. The facility could decide to remove antihistamine medications from an order set if it is determined that risks outweigh benefits. While a root cause analysis might identify the cause of an AE after order set use, these situations can be prevented with FMEA.
When applying FMEA to Figure 1, while bupropion is known as an evidence-based oral tobacco cessation option, there is the possibility that bupropion could be inadvertently prescribed from the order set in a hospitalized patient with alcohol withdrawal and withdrawal seizure history. These potentially dangerous situations can be avoided with FMEA. Thus, although bupropion may be evidence-based for NRT, decisions regarding order set design using EBM alone are insufficient.
The practitioner must consider possible unintended consequences within order sets and target treatment options to the appropriate setting and audience. Although Figure 1 may appear to be more inclusive, the interdisciplinary committee designing the inpatient NRT order set felt there was heightened risk with introducing bupropion in Figure 1 and decided the risk would be lowered by removing bupropion from the redesigned NRT order set (Figure 2). In addition to the goal of balancing availability of NRT options with acceptable risk, Figure 2 also focused on building an NRT order set most applicable to the inpatient setting.
Including Evidence-Based Practices
EBM has become a routine part of clinical decision making. Therefore, including EBM in order set design is vital. EBM for NRT has demonstrated that combination therapy is more effective than is monotherapy to help tobacco users quit. Incremental doses of NRT are recommended for patients who use tobacco more frequently.10
As shown in Figures 1 and 2, both order set designs incorporate EBM for NRT. Although the importance of implementing EBM is evident, critical factors, such as HFE and FMEA make a difference with well-designed order sets.
Results
The 4-step order set design technique was used during development of an inpatient NRT order set at the JAHVH. Results for the inpatient Joint Commission Tobacco Treatment Measures were obtained from the Veterans Health Administration quality metric reporting system known as Strategic Analytics for Improvement and Learning (SAIL). SAIL performance measure outcomes, which include the inpatient Joint Commission Tobacco Treatment Measures, are derived from chart reviews conducted by the External Peer Review Program. Outcomes demonstrated that TOB-2 and TOB-3 (2 inpatient Joint Commission Tobacco Treatment Measures) known as tob20 and tob40, respectively, within SAIL improved by more than 300% after development of an NRT order set using the 4-step order set design framework along with implementation of a multifaceted tobacco cessation care delivery system at JAHVH.
Discussion
While the overall tobacco cessation care delivery system contributed to improved outcomes with the inpatient Joint Commission Tobacco Treatment Measures at JAHVH, the NRT order set was a cornerstone of the design. Although using our order set design technique does not necessarily guarantee successful outcomes, we believe using the 4-step order set design process increases the value of order sets and has potential to improve quality outcomes.
Limitations
Although improved outcomes following implementation of our NRT order set suggest correlation, causation cannot be proven. Also while the NRT order set is believed to have helped tremendously with outcomes, the entire tobacco cessation care delivery system at JAHVH contributed to the results. In addition, the inpatient Joint Commission Tobacco Treatment Measures help improve processes for tobacco cessation care. However, we are uncertain whether the results of our improvement efforts helped patients stop tobacco use. Further studies are needed to determine impact on population health. Finally, our results were based on improvement work done at a single center. Further studies are necessary to see whether results are reproducible.
Conclusion
There was significant improvement with the inpatient Joint Commission Tobacco Treatment Measures outcomes following development of a tobacco cessation care delivery system that included design of an inpatient NRT order set using a 4-step process we developed. This 4-step structure includes emphasis on efficiency and ease of use; human factors engineering; failure mode and effects analysis; and incorporation of evidence-based medicine (Box.) Postimplementation results showed improvement of the inpatient Joint Commission Tobacco Treatment Measures by greater than 3-fold at a single hospital.
The next steps for this initiative include testing the 4-step order set design process in multiple clinical settings to determine the effectiveness of this approach in other areas of clinical care.
1. Order set. http://clinfowiki.org/wiki/index.php/Order_set. Updated October 15, 2015. Accessed August 30, 2019.
2. Bates DW, Kuperman GJ, Wang S, et al. Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality. J Am Med Inform Assoc. 2003;10(6):523-530.
3. Institute for Safe Medication Practices. Guidelines for standard order sets. https://www.ismp.org/tools/guidelines/standardordersets.pdf. Published January 12, 2010. Accessed August 30, 2019.
4. Heath C, Heath D. Switch: How to Change Things When Change Is Hard. New York, NY: Crown Business; 2010:50-51.
5. US Department of Health and Human Services. Usability testing. https://www.usability.gov/how-to-and-tools/methods/usability-testing.html. Accessed August 30, 2019.
6. World Health Organization. What is human factors and why is it important to patient safety? www.who.int/patientsafety/education/curriculum/who_mc_topic-2.pdf. Accessed August 30, 2019.
7. Sollisch J. The cure for decision fatigue. Wall Street Journal. June 10, 2016. https://www.wsj.com/articles/the-cure-for-decision-fatigue-1465596928. Accessed August 30, 2019.
8. ECRI Institute. Implementing the ENFit initiative for preventing enteral tubing misconnections. https://www.ecri.org/components/HDJournal/Pages/ENFit-for-Preventing-Enteral-Tubing-Misconnections.aspx. Published March 29, 2017. Accessed August 30, 2019.
9. Guidance for performing failure mode and effects analysis with performance improvement projects. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/downloads/GuidanceForFMEA.pdf. Accessed August 30, 2019.
10. Diefanbach LJ, Smith PO, Nashelsky JM, Lindbloom E. What is the most effective nicotine replacement therapy? J Fam Pract. 2003;52(6):492-497.
1. Order set. http://clinfowiki.org/wiki/index.php/Order_set. Updated October 15, 2015. Accessed August 30, 2019.
2. Bates DW, Kuperman GJ, Wang S, et al. Ten commandments for effective clinical decision support: making the practice of evidence-based medicine a reality. J Am Med Inform Assoc. 2003;10(6):523-530.
3. Institute for Safe Medication Practices. Guidelines for standard order sets. https://www.ismp.org/tools/guidelines/standardordersets.pdf. Published January 12, 2010. Accessed August 30, 2019.
4. Heath C, Heath D. Switch: How to Change Things When Change Is Hard. New York, NY: Crown Business; 2010:50-51.
5. US Department of Health and Human Services. Usability testing. https://www.usability.gov/how-to-and-tools/methods/usability-testing.html. Accessed August 30, 2019.
6. World Health Organization. What is human factors and why is it important to patient safety? www.who.int/patientsafety/education/curriculum/who_mc_topic-2.pdf. Accessed August 30, 2019.
7. Sollisch J. The cure for decision fatigue. Wall Street Journal. June 10, 2016. https://www.wsj.com/articles/the-cure-for-decision-fatigue-1465596928. Accessed August 30, 2019.
8. ECRI Institute. Implementing the ENFit initiative for preventing enteral tubing misconnections. https://www.ecri.org/components/HDJournal/Pages/ENFit-for-Preventing-Enteral-Tubing-Misconnections.aspx. Published March 29, 2017. Accessed August 30, 2019.
9. Guidance for performing failure mode and effects analysis with performance improvement projects. https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/QAPI/downloads/GuidanceForFMEA.pdf. Accessed August 30, 2019.
10. Diefanbach LJ, Smith PO, Nashelsky JM, Lindbloom E. What is the most effective nicotine replacement therapy? J Fam Pract. 2003;52(6):492-497.