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Online intervention aims to prevent teen depression
AT PAS 17
SAN FRANCISCO – One in eight teenagers experienced at least one major depressive episode in 2015, according to the National Institute for Mental Health. Yet the recent uptick in teen suicide rates suggests that U.S. mental health care services are not meeting their needs.
A team at the University of Illinois in Chicago, led by Benjamin Van Voorhees, MD, MPH, hopes so, and they have spent the past several years developing and testing such a program with a National Institute of Mental Health (NIMH) grant.
“Adolescents are in a really plastic moment in their psychobehavioral repertoire and brain development as they program themselves to adapt to adult life,” Dr. Van Voorhees said in an interview. “Right now we have nothing to offer those individuals other than an occasional referral to an overtaxed mental health system. The only rational strategy is a mass dissemination model, which is going to have to be technology.”
The CATCH-IT program is aimed at teens showing early signs of depression or predepressive symptoms as determined through screening during well checks or other visits for acute or chronic concerns. The study uses multiple screening tools in selecting participants, but Dr. Van Voorhees estimates that screening in practice would require about 1-2 minutes of a medical assistant’s or nurse’s time, followed by 1-2 minutes of the practitioner’s time for positive screens – “and one in five of those screens is going to be positive,” he said.
“The thing we want to convey to primary care practitioners is that these individuals are coming through your office every day, we’re doing nothing for them, and in some ways we are ignoring their enormous future potential adverse trajectory toward mental disorders,” he said.
The program includes 14 modules drawing on cognitive behavioral therapy, behavioral activation, interpersonal psychotherapy, and community resiliency. Six archetypal teens – such as teen living with a single mom or one whose parents are divorcing – are featured in each of the modules to demonstrate six ways of applying the strategies taught in that module. The archetypal teens are around 14-15 years old, but the program is aimed at teens aged 13-18 years, with a reading level at about grade 6, Dr. Van Voorhees said.
Two and a half years after those teens used the CATCH-IT intervention, they showed “a sustained reduction in automatic negative thoughts and educational impairment,” but no difference in their perceptions of support from family or friends. The lack of a control group in that pilot limits what conclusions can be drawn about the program’s effectiveness, but the researchers did learn that motivational interviewing led to greater engagement with the program, compared with teens who received a brief recommendation of it.
Therefore, in the subsequent – and still ongoing – study, physicians used motivational interviewing when offering teens the opportunity to join the program. That study does include a control group, in which participants are assigned a generic health education program online instead of CATCH-IT, and the randomized participants have been stratified by site, gender, and depression risk level.
The researchers first assessed the baseline characteristics of the population, recruited from 38 clinics in two cities. The study enrolled 369 teens aged 13-18 years – 248 in Chicago and 121 in Boston. All were identified as high risk for depression based on elevated scores on the Center for Epidemiological Studies Depression (CES-D) scale or the Kiddie Schedule for Affective Disorders Scale (K-SADS). Two thirds (68%) of participants are female, and most (63%) are in high school. About a third (34%) are in middle school. The racial/ethnic breakdown of the sample is 21% Hispanic, 26% black, 43% white, 4% Asian, 6% multiracial, and 1% other (which adds up to 101% due to rounding). More than half of the participants’ mothers (60%) and fathers (53%) were college graduates.
The teens completed the CES-D, the Screen for Child Related Anxiety Disorders (SCARED), the Beck Hopelessness Scale (BHS), the CRAFFT screening for adolescent substance misuse and the Disruptive Behaviors Disorder Scale (DBD-A). A parent of each teen also filled out the CES-D and DBD-A.
The baseline results did not suggest any concerns about substance use, hopelessness, or disruptive behaviors such as ADHD or conduct disorder. But the average scores on the CES-D and SCARED sat just at the threshold for a potential depressive or anxiety disorders. A CES-D score of at least 16 suggests a possible depressive disorder, and a SCARED score of at least 25 suggests a possible anxiety disorder. The mean scores on the teens’ CES-D were 17.7 in the Chicago cohort, 15.4 in the Boston cohort and 16.9 for the whole group. Similarly, the SCARED mean scores were 26.3 in the Chicago cohort, 23.5 in the Boston cohort and 25.3 overall.
Scores from K-SADS showed subthreshold levels of depressed mood in 36% of teens in both cities, and a nearly identical subthreshold level of irritability. Subthreshold anhedonia was identified in 20% of the overall population. One percent of the overall population had current suicidal ideation.
The next steps are to analyze outcomes among the participants, as the team is doing currently. They have just passed the 1-year anniversary of the trial and are analyzing the data they collected over the past year. The study will run an additional year for longer-term data collection.
One of the abstracts presented at PAS explored the economic implications of incorporating CATCH-IT in primary care.
“The cost for implementation is where the challenge is,” Dr. Van Voorhees said. “Screening takes time, and calling people takes time.” But when spread across a practice’s overall clientele in a year, the costs drop considerably, he said, and savings from effective identification and depression prevention may outweigh costs. The researchers have not yet conducted a cost-effectiveness study because they still are analyzing data on outcomes.
But Dr. Van Voorhees is optimistic about the possibilities of the program.
“What this entire model is about is, how do we understand what’s going on in the environment of the primary care clinic to find these people, identify them, and motivate them, and how can we give them something relevant enough to actually complete,” Dr. Van Voorhees said in the interview. “Then, let’s actually see if it changes their behavioral trajectory.”
The National Institute of Mental Health funded the research. Dr. Van Voorhees has consulted for Prevail Health Solutions, Mevident, Social Kinetics, and Hong Kong University on development of Internet-based interventions.
AT PAS 17
SAN FRANCISCO – One in eight teenagers experienced at least one major depressive episode in 2015, according to the National Institute for Mental Health. Yet the recent uptick in teen suicide rates suggests that U.S. mental health care services are not meeting their needs.
A team at the University of Illinois in Chicago, led by Benjamin Van Voorhees, MD, MPH, hopes so, and they have spent the past several years developing and testing such a program with a National Institute of Mental Health (NIMH) grant.
“Adolescents are in a really plastic moment in their psychobehavioral repertoire and brain development as they program themselves to adapt to adult life,” Dr. Van Voorhees said in an interview. “Right now we have nothing to offer those individuals other than an occasional referral to an overtaxed mental health system. The only rational strategy is a mass dissemination model, which is going to have to be technology.”
The CATCH-IT program is aimed at teens showing early signs of depression or predepressive symptoms as determined through screening during well checks or other visits for acute or chronic concerns. The study uses multiple screening tools in selecting participants, but Dr. Van Voorhees estimates that screening in practice would require about 1-2 minutes of a medical assistant’s or nurse’s time, followed by 1-2 minutes of the practitioner’s time for positive screens – “and one in five of those screens is going to be positive,” he said.
“The thing we want to convey to primary care practitioners is that these individuals are coming through your office every day, we’re doing nothing for them, and in some ways we are ignoring their enormous future potential adverse trajectory toward mental disorders,” he said.
The program includes 14 modules drawing on cognitive behavioral therapy, behavioral activation, interpersonal psychotherapy, and community resiliency. Six archetypal teens – such as teen living with a single mom or one whose parents are divorcing – are featured in each of the modules to demonstrate six ways of applying the strategies taught in that module. The archetypal teens are around 14-15 years old, but the program is aimed at teens aged 13-18 years, with a reading level at about grade 6, Dr. Van Voorhees said.
Two and a half years after those teens used the CATCH-IT intervention, they showed “a sustained reduction in automatic negative thoughts and educational impairment,” but no difference in their perceptions of support from family or friends. The lack of a control group in that pilot limits what conclusions can be drawn about the program’s effectiveness, but the researchers did learn that motivational interviewing led to greater engagement with the program, compared with teens who received a brief recommendation of it.
Therefore, in the subsequent – and still ongoing – study, physicians used motivational interviewing when offering teens the opportunity to join the program. That study does include a control group, in which participants are assigned a generic health education program online instead of CATCH-IT, and the randomized participants have been stratified by site, gender, and depression risk level.
The researchers first assessed the baseline characteristics of the population, recruited from 38 clinics in two cities. The study enrolled 369 teens aged 13-18 years – 248 in Chicago and 121 in Boston. All were identified as high risk for depression based on elevated scores on the Center for Epidemiological Studies Depression (CES-D) scale or the Kiddie Schedule for Affective Disorders Scale (K-SADS). Two thirds (68%) of participants are female, and most (63%) are in high school. About a third (34%) are in middle school. The racial/ethnic breakdown of the sample is 21% Hispanic, 26% black, 43% white, 4% Asian, 6% multiracial, and 1% other (which adds up to 101% due to rounding). More than half of the participants’ mothers (60%) and fathers (53%) were college graduates.
The teens completed the CES-D, the Screen for Child Related Anxiety Disorders (SCARED), the Beck Hopelessness Scale (BHS), the CRAFFT screening for adolescent substance misuse and the Disruptive Behaviors Disorder Scale (DBD-A). A parent of each teen also filled out the CES-D and DBD-A.
The baseline results did not suggest any concerns about substance use, hopelessness, or disruptive behaviors such as ADHD or conduct disorder. But the average scores on the CES-D and SCARED sat just at the threshold for a potential depressive or anxiety disorders. A CES-D score of at least 16 suggests a possible depressive disorder, and a SCARED score of at least 25 suggests a possible anxiety disorder. The mean scores on the teens’ CES-D were 17.7 in the Chicago cohort, 15.4 in the Boston cohort and 16.9 for the whole group. Similarly, the SCARED mean scores were 26.3 in the Chicago cohort, 23.5 in the Boston cohort and 25.3 overall.
Scores from K-SADS showed subthreshold levels of depressed mood in 36% of teens in both cities, and a nearly identical subthreshold level of irritability. Subthreshold anhedonia was identified in 20% of the overall population. One percent of the overall population had current suicidal ideation.
The next steps are to analyze outcomes among the participants, as the team is doing currently. They have just passed the 1-year anniversary of the trial and are analyzing the data they collected over the past year. The study will run an additional year for longer-term data collection.
One of the abstracts presented at PAS explored the economic implications of incorporating CATCH-IT in primary care.
“The cost for implementation is where the challenge is,” Dr. Van Voorhees said. “Screening takes time, and calling people takes time.” But when spread across a practice’s overall clientele in a year, the costs drop considerably, he said, and savings from effective identification and depression prevention may outweigh costs. The researchers have not yet conducted a cost-effectiveness study because they still are analyzing data on outcomes.
But Dr. Van Voorhees is optimistic about the possibilities of the program.
“What this entire model is about is, how do we understand what’s going on in the environment of the primary care clinic to find these people, identify them, and motivate them, and how can we give them something relevant enough to actually complete,” Dr. Van Voorhees said in the interview. “Then, let’s actually see if it changes their behavioral trajectory.”
The National Institute of Mental Health funded the research. Dr. Van Voorhees has consulted for Prevail Health Solutions, Mevident, Social Kinetics, and Hong Kong University on development of Internet-based interventions.
AT PAS 17
SAN FRANCISCO – One in eight teenagers experienced at least one major depressive episode in 2015, according to the National Institute for Mental Health. Yet the recent uptick in teen suicide rates suggests that U.S. mental health care services are not meeting their needs.
A team at the University of Illinois in Chicago, led by Benjamin Van Voorhees, MD, MPH, hopes so, and they have spent the past several years developing and testing such a program with a National Institute of Mental Health (NIMH) grant.
“Adolescents are in a really plastic moment in their psychobehavioral repertoire and brain development as they program themselves to adapt to adult life,” Dr. Van Voorhees said in an interview. “Right now we have nothing to offer those individuals other than an occasional referral to an overtaxed mental health system. The only rational strategy is a mass dissemination model, which is going to have to be technology.”
The CATCH-IT program is aimed at teens showing early signs of depression or predepressive symptoms as determined through screening during well checks or other visits for acute or chronic concerns. The study uses multiple screening tools in selecting participants, but Dr. Van Voorhees estimates that screening in practice would require about 1-2 minutes of a medical assistant’s or nurse’s time, followed by 1-2 minutes of the practitioner’s time for positive screens – “and one in five of those screens is going to be positive,” he said.
“The thing we want to convey to primary care practitioners is that these individuals are coming through your office every day, we’re doing nothing for them, and in some ways we are ignoring their enormous future potential adverse trajectory toward mental disorders,” he said.
The program includes 14 modules drawing on cognitive behavioral therapy, behavioral activation, interpersonal psychotherapy, and community resiliency. Six archetypal teens – such as teen living with a single mom or one whose parents are divorcing – are featured in each of the modules to demonstrate six ways of applying the strategies taught in that module. The archetypal teens are around 14-15 years old, but the program is aimed at teens aged 13-18 years, with a reading level at about grade 6, Dr. Van Voorhees said.
Two and a half years after those teens used the CATCH-IT intervention, they showed “a sustained reduction in automatic negative thoughts and educational impairment,” but no difference in their perceptions of support from family or friends. The lack of a control group in that pilot limits what conclusions can be drawn about the program’s effectiveness, but the researchers did learn that motivational interviewing led to greater engagement with the program, compared with teens who received a brief recommendation of it.
Therefore, in the subsequent – and still ongoing – study, physicians used motivational interviewing when offering teens the opportunity to join the program. That study does include a control group, in which participants are assigned a generic health education program online instead of CATCH-IT, and the randomized participants have been stratified by site, gender, and depression risk level.
The researchers first assessed the baseline characteristics of the population, recruited from 38 clinics in two cities. The study enrolled 369 teens aged 13-18 years – 248 in Chicago and 121 in Boston. All were identified as high risk for depression based on elevated scores on the Center for Epidemiological Studies Depression (CES-D) scale or the Kiddie Schedule for Affective Disorders Scale (K-SADS). Two thirds (68%) of participants are female, and most (63%) are in high school. About a third (34%) are in middle school. The racial/ethnic breakdown of the sample is 21% Hispanic, 26% black, 43% white, 4% Asian, 6% multiracial, and 1% other (which adds up to 101% due to rounding). More than half of the participants’ mothers (60%) and fathers (53%) were college graduates.
The teens completed the CES-D, the Screen for Child Related Anxiety Disorders (SCARED), the Beck Hopelessness Scale (BHS), the CRAFFT screening for adolescent substance misuse and the Disruptive Behaviors Disorder Scale (DBD-A). A parent of each teen also filled out the CES-D and DBD-A.
The baseline results did not suggest any concerns about substance use, hopelessness, or disruptive behaviors such as ADHD or conduct disorder. But the average scores on the CES-D and SCARED sat just at the threshold for a potential depressive or anxiety disorders. A CES-D score of at least 16 suggests a possible depressive disorder, and a SCARED score of at least 25 suggests a possible anxiety disorder. The mean scores on the teens’ CES-D were 17.7 in the Chicago cohort, 15.4 in the Boston cohort and 16.9 for the whole group. Similarly, the SCARED mean scores were 26.3 in the Chicago cohort, 23.5 in the Boston cohort and 25.3 overall.
Scores from K-SADS showed subthreshold levels of depressed mood in 36% of teens in both cities, and a nearly identical subthreshold level of irritability. Subthreshold anhedonia was identified in 20% of the overall population. One percent of the overall population had current suicidal ideation.
The next steps are to analyze outcomes among the participants, as the team is doing currently. They have just passed the 1-year anniversary of the trial and are analyzing the data they collected over the past year. The study will run an additional year for longer-term data collection.
One of the abstracts presented at PAS explored the economic implications of incorporating CATCH-IT in primary care.
“The cost for implementation is where the challenge is,” Dr. Van Voorhees said. “Screening takes time, and calling people takes time.” But when spread across a practice’s overall clientele in a year, the costs drop considerably, he said, and savings from effective identification and depression prevention may outweigh costs. The researchers have not yet conducted a cost-effectiveness study because they still are analyzing data on outcomes.
But Dr. Van Voorhees is optimistic about the possibilities of the program.
“What this entire model is about is, how do we understand what’s going on in the environment of the primary care clinic to find these people, identify them, and motivate them, and how can we give them something relevant enough to actually complete,” Dr. Van Voorhees said in the interview. “Then, let’s actually see if it changes their behavioral trajectory.”
The National Institute of Mental Health funded the research. Dr. Van Voorhees has consulted for Prevail Health Solutions, Mevident, Social Kinetics, and Hong Kong University on development of Internet-based interventions.
Pegboard test useful in upper-extremity motor assessments in Parkinson’s
Pegboard tests are an effective way to assess the progression of upper-extremity motor deficits in patients with early-stage Parkinson’s disease (PD), according to a research letter from Sebastian Heitzel, PhD, and his associates.
As part of the prospective MODEP study, motor performance of early-stage PD patients, midstage PD patients, and a healthy control group were assessed biannually over a 4-year period using the pegboard test. E-PD and M-PD patients performed significantly worse on all pegboard tasks than did people in the control group.
Movement Disorder Society Unified Parkinson’s Disease Rating Scale part III scores worsened in E-PD patients, compared with controls, but slightly improved in M-PD patients.
“Pegboard is cost- and time-effective, does not require medically trained staff, and provides objective and reliable markers of upper-extremity motor deficits,” the investigators noted.
Find the full research letter in Movement Disorders (2017. doi: 10.1002/mds.27062).
Pegboard tests are an effective way to assess the progression of upper-extremity motor deficits in patients with early-stage Parkinson’s disease (PD), according to a research letter from Sebastian Heitzel, PhD, and his associates.
As part of the prospective MODEP study, motor performance of early-stage PD patients, midstage PD patients, and a healthy control group were assessed biannually over a 4-year period using the pegboard test. E-PD and M-PD patients performed significantly worse on all pegboard tasks than did people in the control group.
Movement Disorder Society Unified Parkinson’s Disease Rating Scale part III scores worsened in E-PD patients, compared with controls, but slightly improved in M-PD patients.
“Pegboard is cost- and time-effective, does not require medically trained staff, and provides objective and reliable markers of upper-extremity motor deficits,” the investigators noted.
Find the full research letter in Movement Disorders (2017. doi: 10.1002/mds.27062).
Pegboard tests are an effective way to assess the progression of upper-extremity motor deficits in patients with early-stage Parkinson’s disease (PD), according to a research letter from Sebastian Heitzel, PhD, and his associates.
As part of the prospective MODEP study, motor performance of early-stage PD patients, midstage PD patients, and a healthy control group were assessed biannually over a 4-year period using the pegboard test. E-PD and M-PD patients performed significantly worse on all pegboard tasks than did people in the control group.
Movement Disorder Society Unified Parkinson’s Disease Rating Scale part III scores worsened in E-PD patients, compared with controls, but slightly improved in M-PD patients.
“Pegboard is cost- and time-effective, does not require medically trained staff, and provides objective and reliable markers of upper-extremity motor deficits,” the investigators noted.
Find the full research letter in Movement Disorders (2017. doi: 10.1002/mds.27062).
FROM MOVEMENT DISORDERS
Coping when a patient commits suicide
SAN DIEGO – Most psychiatrists raised their hands in a conference room at the annual meeting of the American Psychiatric Association when a presenter asked whether they’d ever had a patient die from suicide. Moments later, one rose and described her own devastating experience with a patient who killed himself.
“We’d talked for 100 nights over 12 years. If a call came in at night, I knew who it was,” she said. Then he committed suicide, forcing her to question her assumptions about her ability to help others.
“I had this unconscious fantasy that I could will people to keep on living,” she said.
“We spend so much time with our patients,” added another audience member, that “it’s almost like a family member dying. Just overwhelming sadness.”
A 2015 meta-analysis estimated that there is 1 suicide for every 676 inpatient admissions, and a 20-year prospective study found that 1% of 6,891 psychiatric outpatients committed suicide (Acta Psychiatr Scand. 2015 Mar;131[3]:174-84), (J Consult Clin Psychol. 2000 Jun;68[3]:371-7).
To make things more complex for psychiatrists, suicides and attempted suicides are frequent triggers for malpractice suits, accounting for 5.4% overall and 17% of those directed at psychiatrists, said psychologist and copresenter Jane Tillman, PhD, director of the Erikson Institute for Education and Research of the Austen Riggs Center in Stockbridge, Mass., and assistant clinical professor at the Yale Child Study Center in New Haven, Conn. (However, a 2014 U.S. study found that “in malpractice, psychiatry accounted for a small percentage of overall claims and settlements” (Ann Clin Psychiatry. 2014 May;26[2]:91-6).
“They spoke to me about affective experiences like feeling incredibly sad. Some felt angry and rageful,” Dr. Tillman told the APA audience. “One young therapist, a trainee, told me that her patient’s father called to tell her the patient had died by suicide. ‘After I spoke to the patient’s father,’ the therapist recalled, ‘the mother got onto the phone and screamed. I broke down and started crying. Hearing the sound of a mother who had lost her child went right through me.’ ”
Another therapist felt “angry at everyone” and guilty, too, after a patient killed herself without calling for help. And Dr. Tillman heard from therapists who worried about their professional lives, how they’d be viewed, and whether they’d be cut off from their peers.
“I had the sense of people pulling away from me and me pulling away from them,” one therapist told Dr. Tillman. “Some reached out to me early but they didn’t follow through, and I didn’t follow through.”
Young therapists face unique challenges, Dr. Tillman said. “They felt foolish, as if they’d been grandiose,” she said. “They pathologize hope.”
Copresenter Dr. Plakun, associate medical director and director of biopsychosocial advocacy at Austen Riggs, offered these tips to psychiatrists:
• Support colleagues whose patients kill themselves. “Convene and participate in a nonjudgmental review of the suicide. Be there, try to be part of this discussion, share your own experiences. And [be] aware of the inevitability of countertransference of guilt, anger, and blaming.”
• “If you are the person who had a patient die by suicide, avoid isolation; call your insurance carrier for consultation about risk management issues, and prepare yourself for contact with the family.”
• Take special care before meetings with family: Understand the confidentiality issues and remember where the focus belongs. “You’re there to meet the family’s needs, not yours primarily. There’s no reason to castigate yourself and take blame. But that doesn’t mean you can’t express genuine sorrow about the loss.”
• Seek professional support and focus on self-care. “Try to preserve a space in our families and in our personal friendships where we can continue to live our lives and not be haunted by these things in our relationships with partners, spouses, children. And we need to grieve well. It’s a terrible loss, and it’s something that we need to pay attention to and take seriously.”
Dr. Plakun and Dr. Tillman reported no relevant disclosures.
SAN DIEGO – Most psychiatrists raised their hands in a conference room at the annual meeting of the American Psychiatric Association when a presenter asked whether they’d ever had a patient die from suicide. Moments later, one rose and described her own devastating experience with a patient who killed himself.
“We’d talked for 100 nights over 12 years. If a call came in at night, I knew who it was,” she said. Then he committed suicide, forcing her to question her assumptions about her ability to help others.
“I had this unconscious fantasy that I could will people to keep on living,” she said.
“We spend so much time with our patients,” added another audience member, that “it’s almost like a family member dying. Just overwhelming sadness.”
A 2015 meta-analysis estimated that there is 1 suicide for every 676 inpatient admissions, and a 20-year prospective study found that 1% of 6,891 psychiatric outpatients committed suicide (Acta Psychiatr Scand. 2015 Mar;131[3]:174-84), (J Consult Clin Psychol. 2000 Jun;68[3]:371-7).
To make things more complex for psychiatrists, suicides and attempted suicides are frequent triggers for malpractice suits, accounting for 5.4% overall and 17% of those directed at psychiatrists, said psychologist and copresenter Jane Tillman, PhD, director of the Erikson Institute for Education and Research of the Austen Riggs Center in Stockbridge, Mass., and assistant clinical professor at the Yale Child Study Center in New Haven, Conn. (However, a 2014 U.S. study found that “in malpractice, psychiatry accounted for a small percentage of overall claims and settlements” (Ann Clin Psychiatry. 2014 May;26[2]:91-6).
“They spoke to me about affective experiences like feeling incredibly sad. Some felt angry and rageful,” Dr. Tillman told the APA audience. “One young therapist, a trainee, told me that her patient’s father called to tell her the patient had died by suicide. ‘After I spoke to the patient’s father,’ the therapist recalled, ‘the mother got onto the phone and screamed. I broke down and started crying. Hearing the sound of a mother who had lost her child went right through me.’ ”
Another therapist felt “angry at everyone” and guilty, too, after a patient killed herself without calling for help. And Dr. Tillman heard from therapists who worried about their professional lives, how they’d be viewed, and whether they’d be cut off from their peers.
“I had the sense of people pulling away from me and me pulling away from them,” one therapist told Dr. Tillman. “Some reached out to me early but they didn’t follow through, and I didn’t follow through.”
Young therapists face unique challenges, Dr. Tillman said. “They felt foolish, as if they’d been grandiose,” she said. “They pathologize hope.”
Copresenter Dr. Plakun, associate medical director and director of biopsychosocial advocacy at Austen Riggs, offered these tips to psychiatrists:
• Support colleagues whose patients kill themselves. “Convene and participate in a nonjudgmental review of the suicide. Be there, try to be part of this discussion, share your own experiences. And [be] aware of the inevitability of countertransference of guilt, anger, and blaming.”
• “If you are the person who had a patient die by suicide, avoid isolation; call your insurance carrier for consultation about risk management issues, and prepare yourself for contact with the family.”
• Take special care before meetings with family: Understand the confidentiality issues and remember where the focus belongs. “You’re there to meet the family’s needs, not yours primarily. There’s no reason to castigate yourself and take blame. But that doesn’t mean you can’t express genuine sorrow about the loss.”
• Seek professional support and focus on self-care. “Try to preserve a space in our families and in our personal friendships where we can continue to live our lives and not be haunted by these things in our relationships with partners, spouses, children. And we need to grieve well. It’s a terrible loss, and it’s something that we need to pay attention to and take seriously.”
Dr. Plakun and Dr. Tillman reported no relevant disclosures.
SAN DIEGO – Most psychiatrists raised their hands in a conference room at the annual meeting of the American Psychiatric Association when a presenter asked whether they’d ever had a patient die from suicide. Moments later, one rose and described her own devastating experience with a patient who killed himself.
“We’d talked for 100 nights over 12 years. If a call came in at night, I knew who it was,” she said. Then he committed suicide, forcing her to question her assumptions about her ability to help others.
“I had this unconscious fantasy that I could will people to keep on living,” she said.
“We spend so much time with our patients,” added another audience member, that “it’s almost like a family member dying. Just overwhelming sadness.”
A 2015 meta-analysis estimated that there is 1 suicide for every 676 inpatient admissions, and a 20-year prospective study found that 1% of 6,891 psychiatric outpatients committed suicide (Acta Psychiatr Scand. 2015 Mar;131[3]:174-84), (J Consult Clin Psychol. 2000 Jun;68[3]:371-7).
To make things more complex for psychiatrists, suicides and attempted suicides are frequent triggers for malpractice suits, accounting for 5.4% overall and 17% of those directed at psychiatrists, said psychologist and copresenter Jane Tillman, PhD, director of the Erikson Institute for Education and Research of the Austen Riggs Center in Stockbridge, Mass., and assistant clinical professor at the Yale Child Study Center in New Haven, Conn. (However, a 2014 U.S. study found that “in malpractice, psychiatry accounted for a small percentage of overall claims and settlements” (Ann Clin Psychiatry. 2014 May;26[2]:91-6).
“They spoke to me about affective experiences like feeling incredibly sad. Some felt angry and rageful,” Dr. Tillman told the APA audience. “One young therapist, a trainee, told me that her patient’s father called to tell her the patient had died by suicide. ‘After I spoke to the patient’s father,’ the therapist recalled, ‘the mother got onto the phone and screamed. I broke down and started crying. Hearing the sound of a mother who had lost her child went right through me.’ ”
Another therapist felt “angry at everyone” and guilty, too, after a patient killed herself without calling for help. And Dr. Tillman heard from therapists who worried about their professional lives, how they’d be viewed, and whether they’d be cut off from their peers.
“I had the sense of people pulling away from me and me pulling away from them,” one therapist told Dr. Tillman. “Some reached out to me early but they didn’t follow through, and I didn’t follow through.”
Young therapists face unique challenges, Dr. Tillman said. “They felt foolish, as if they’d been grandiose,” she said. “They pathologize hope.”
Copresenter Dr. Plakun, associate medical director and director of biopsychosocial advocacy at Austen Riggs, offered these tips to psychiatrists:
• Support colleagues whose patients kill themselves. “Convene and participate in a nonjudgmental review of the suicide. Be there, try to be part of this discussion, share your own experiences. And [be] aware of the inevitability of countertransference of guilt, anger, and blaming.”
• “If you are the person who had a patient die by suicide, avoid isolation; call your insurance carrier for consultation about risk management issues, and prepare yourself for contact with the family.”
• Take special care before meetings with family: Understand the confidentiality issues and remember where the focus belongs. “You’re there to meet the family’s needs, not yours primarily. There’s no reason to castigate yourself and take blame. But that doesn’t mean you can’t express genuine sorrow about the loss.”
• Seek professional support and focus on self-care. “Try to preserve a space in our families and in our personal friendships where we can continue to live our lives and not be haunted by these things in our relationships with partners, spouses, children. And we need to grieve well. It’s a terrible loss, and it’s something that we need to pay attention to and take seriously.”
Dr. Plakun and Dr. Tillman reported no relevant disclosures.
AT APA
... The mother of direction
If you weren’t a young male living in the United States in the 1960s, it may be hard for you to understand my situation. It was a little more than 6 months from my college graduation. Because I couldn’t think of anything else to do, I had applied for and been accepted in a postgraduate fellowship in art history. However, it was clear that this country was becoming entangled in a confusing, unpopular – and from my personal perspective – a dangerous war.
While I was in college I was protected from the draft. But upon graduation, if I were to pursue my studies in something as unrelated to the war effort as art history, I would be ripe for the picking. I’m not sure why, but luckily I had been banking science credits for a rainy day. And in the winter of 1965-1966, it was raining big time.
I was not alone. Even if the term “gap year” had been coined, taking a year off to “find oneself” was not an option for young American males on the verge of high school or college graduation. I share this unflattering anecdote as evidence that there are times when circumstances can provide a floundering young person with a much needed sense of direction.
In May 2017, the Chicago Board of Education approved a plan sponsored by Mayor Rahm Emanuel that will require all high school students planning to graduate to provide evidence that they have secured a job or have been accepted by a college, trade apprenticeship, structured gap year program, or the military. (“Chicago won’t allow high school students to graduate without a plan for the future,” by Emma Brown, the Washington Post, July 3, 2017). Critics of the plan complain, probably with good reason, that the cash-strapped school system with more than 300,000 students doesn’t have the resources to provide its students with the counseling they will need to create the required post-graduation plans.
Even if there are too many devils in too many details in the Chicago plan, the principle underlying it is worth a try and deserves consideration by other school systems. It is not a universal military service requirement. Although, I wonder at times if this country should consider such a thing. It also is not a scheme cooked up by the business community to provide itself with cheap labor, although, it probably will.
In my mind, . Hopefully something that is productive or creative or at least something that improves your chances of living a life that is more likely to provide you with some degree of happiness. It offers a broad enough range of choices so that it is not overly prescriptive. If well administered, the plan would send the message to the graduating student that you must at least have a Plan A.
Regardless of whether a student’s patients come from affluent families with a myriad of post-graduation opportunities or from an economically challenged neighborhood in Chicago, I suspect that many of them would benefit from an artificial dose of necessity in the form of a message that doing nothing is not going to be an option.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
If you weren’t a young male living in the United States in the 1960s, it may be hard for you to understand my situation. It was a little more than 6 months from my college graduation. Because I couldn’t think of anything else to do, I had applied for and been accepted in a postgraduate fellowship in art history. However, it was clear that this country was becoming entangled in a confusing, unpopular – and from my personal perspective – a dangerous war.
While I was in college I was protected from the draft. But upon graduation, if I were to pursue my studies in something as unrelated to the war effort as art history, I would be ripe for the picking. I’m not sure why, but luckily I had been banking science credits for a rainy day. And in the winter of 1965-1966, it was raining big time.
I was not alone. Even if the term “gap year” had been coined, taking a year off to “find oneself” was not an option for young American males on the verge of high school or college graduation. I share this unflattering anecdote as evidence that there are times when circumstances can provide a floundering young person with a much needed sense of direction.
In May 2017, the Chicago Board of Education approved a plan sponsored by Mayor Rahm Emanuel that will require all high school students planning to graduate to provide evidence that they have secured a job or have been accepted by a college, trade apprenticeship, structured gap year program, or the military. (“Chicago won’t allow high school students to graduate without a plan for the future,” by Emma Brown, the Washington Post, July 3, 2017). Critics of the plan complain, probably with good reason, that the cash-strapped school system with more than 300,000 students doesn’t have the resources to provide its students with the counseling they will need to create the required post-graduation plans.
Even if there are too many devils in too many details in the Chicago plan, the principle underlying it is worth a try and deserves consideration by other school systems. It is not a universal military service requirement. Although, I wonder at times if this country should consider such a thing. It also is not a scheme cooked up by the business community to provide itself with cheap labor, although, it probably will.
In my mind, . Hopefully something that is productive or creative or at least something that improves your chances of living a life that is more likely to provide you with some degree of happiness. It offers a broad enough range of choices so that it is not overly prescriptive. If well administered, the plan would send the message to the graduating student that you must at least have a Plan A.
Regardless of whether a student’s patients come from affluent families with a myriad of post-graduation opportunities or from an economically challenged neighborhood in Chicago, I suspect that many of them would benefit from an artificial dose of necessity in the form of a message that doing nothing is not going to be an option.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
If you weren’t a young male living in the United States in the 1960s, it may be hard for you to understand my situation. It was a little more than 6 months from my college graduation. Because I couldn’t think of anything else to do, I had applied for and been accepted in a postgraduate fellowship in art history. However, it was clear that this country was becoming entangled in a confusing, unpopular – and from my personal perspective – a dangerous war.
While I was in college I was protected from the draft. But upon graduation, if I were to pursue my studies in something as unrelated to the war effort as art history, I would be ripe for the picking. I’m not sure why, but luckily I had been banking science credits for a rainy day. And in the winter of 1965-1966, it was raining big time.
I was not alone. Even if the term “gap year” had been coined, taking a year off to “find oneself” was not an option for young American males on the verge of high school or college graduation. I share this unflattering anecdote as evidence that there are times when circumstances can provide a floundering young person with a much needed sense of direction.
In May 2017, the Chicago Board of Education approved a plan sponsored by Mayor Rahm Emanuel that will require all high school students planning to graduate to provide evidence that they have secured a job or have been accepted by a college, trade apprenticeship, structured gap year program, or the military. (“Chicago won’t allow high school students to graduate without a plan for the future,” by Emma Brown, the Washington Post, July 3, 2017). Critics of the plan complain, probably with good reason, that the cash-strapped school system with more than 300,000 students doesn’t have the resources to provide its students with the counseling they will need to create the required post-graduation plans.
Even if there are too many devils in too many details in the Chicago plan, the principle underlying it is worth a try and deserves consideration by other school systems. It is not a universal military service requirement. Although, I wonder at times if this country should consider such a thing. It also is not a scheme cooked up by the business community to provide itself with cheap labor, although, it probably will.
In my mind, . Hopefully something that is productive or creative or at least something that improves your chances of living a life that is more likely to provide you with some degree of happiness. It offers a broad enough range of choices so that it is not overly prescriptive. If well administered, the plan would send the message to the graduating student that you must at least have a Plan A.
Regardless of whether a student’s patients come from affluent families with a myriad of post-graduation opportunities or from an economically challenged neighborhood in Chicago, I suspect that many of them would benefit from an artificial dose of necessity in the form of a message that doing nothing is not going to be an option.
Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Email him at [email protected].
Implementation of a Patient Medication Disposal Program at a VA Medical Center
Opioid overdoses have quadrupled since 1999, with 78 Americans dying every day of opioid overdoses. More than half of all opioid overdose deaths involve prescription opioids.1 Attacking this problem from both ends—prescribing and disposal—can have a greater impact than focusing on a single strategy.
Background
In 2016, the CDC issued opioid prescription guidelines that included encouraging health care providers to discuss “options for safe disposal of unused opioids.”2 Pharmacies are prohibited from directly taking possession of controlled substances from a user. Historically, the Richard L. Roudebush VAMC (RLRVAMC) in Indianapolis, Indiana, recommended that patients follow FDA guidance for household medication disposal, which includes a list of medications that should be flushed down the toilet.3 As more data became available about the negative downstream environmental effects of pharmaceuticals on the water supply, this method of destruction made many patients feel uncomfortable.4,5
The Secure and Responsible Drug Disposal Act of 2010 presented additional options for hospitals and pharmacies to assist the public with medication disposal.6,7 These options offer convenience and anonymity for the end user, reduce potential for diversion, and enhance patient safety by ridding homes of unwanted and expired medications.
Prior to the 2010 act, the only legal methods of controlled substance disposal were via trash disposal, flushing, or delivery to law enforcement, typically at a community-based drug take-back event. These methods were not always convenient, environmentally friendly, or safe for other family members and pets in the home. The Secure and Responsible Drug Disposal Act of 2010 added 2 additional collection options for pharmacies: collection receptacles and mail-back programs.
The RLRVAMC treats > 62,000 veterans annually. The RLRVAMC Pharmacy Service had been providing pharmaceutical mail-back envelopes to patients since May 2015 with moderate success (271 lb of medications returned and a 22.8% envelope return rate through September 2016). Although the mail-back envelopes offer at-home convenience, there was no on-site disposal option. It is not uncommon for patients to bring medications to their appointment or the emergency department (ED). When medication reconciliation is performed, some medications are discontinued, and the prescriber wants them to be safely out of the patient’s possession to avoid confusion and/or accidental overdose. The purpose of this project was to offer more disposal options to patients through the addition of an on-site medication collection receptacle that would be in compliance with U.S. Drug Enforcement Agency (DEA) regulations.
Methods
A policy was developed between the RLRVAMC pharmacy and police departments for the management of a medication collection receptacle. Police would oversee the disposal program so that the pharmacy would not have to change its DEA registration to collector status. The 2 access keys to the receptacle were maintained by police and secured within a key accountability system in the police station.
Full liners are removed from the receptacle by 2 police officers and sealed securely according to vendor guidelines. In accordance with DEA regulations, a form is completed that documents the dates the inner liner was acquired, installed, removed, and transferred for destruction as well as the unique identification number and size of the liner, the address of the location where it was installed, and the names and signatures of the 2 employees that witnessed the removal.
Arrangements are made to have a mail courier present during the removal of the liner. Once removed, the liner is immediately sealed and released to the mail courier who transports the liner to the DEA authorized reverse distributor. The reverse distributor is a licensed entity that has the authority to take control of the medications, including controlled substances, for disposal. The liner tracking numbers are kept in a police log book so that delivery can be confirmed and destruction certificates obtained from the vendor’s website at a later date. The records are kept for 3 years.
Funding was obtained for a 38-gallon collection receptacle and 12 liners from Pharmacy Benefits Management Services (PBM). Approval was obtained from RLRVAMC leadership to locate the receptacle in a high-traffic area, anchored to the floor, under video surveillance, and away from the ED entrance (a DEA requirement). Public Affairs promoted the receptacle to veterans. E-mails were sent to staff to provide education on regulatory requirements. Weight and frequency of medications returned were obtained from data collected by the reverse distributor. Descriptive statistics are reported.
Results
The Federal Supply Schedule cost to procure a DEA-compliant receptacle was $1,450. The additional 12 inner liners cost $2,024.97.8 Staff from Engineering Service were able to install the receptacle at no additional cost to the facility. The collection receptacle was opened to the public in May 2016. From May through October 2016, the facility collected and returned 10 liners to the reverse distributor containing 452 lb of medications. An additional 30 lb of drugs were returned through the mailback envelope program for a total weight of 482 lb over the 6-month period (Figure). The average time between inner liner changes was 2.6 weeks.
Discussion
The most challenging aspect of implementation was identification of a location for the receptacle. The location chosen, an alcove in the hallway between the coffee shop and outpatient pharmacy, was most appropriate. It is a high-traffic area, under video surveillance, and provides easy access for patients. Another challenge was determining the frequency of liner changes. There was no historic data to assist with predicting how quickly the liner would fill up. Initially, Police Service checked the receptacle every week, and it was emptied about every 2 weeks. Aspatients cleaned out their medicine cabinets, the liner needed to be replaced closer to every 4 weeks. An ongoing challenge has been determining how full the liner is without requiring the police to open the receptacle. Consideration is being given to installing a scale in the receptacle under the liner and having the display affixed to the outside of the container.
The receptacle seemed to be the preferred method of disposal, considering that it generated nearly 15 times more waste than did the mail-back envelopes during the same time period. Anecdotal patient feedback has been extremely positive on social media and by word-of-mouth.
Limitations
One limitation of this disposal program is that the specific amount of controlled substance waste vs noncontrolled substance waste cannot be determined since the liner contents are not inventoried. The University of Findlay in Ohio partnered with local law enforcement to host 7 community medication take-back events over a 3-year period, inventoried the drugs, and found that about one-third of the dosing units (eg, tablet or capsule) returned in the analgesic category were controlled substances, suggesting that take-back events may play a role in reducing unauthorized access to prescription painkillers.9 By witnessing the changing of inner liners, it can be anecdotally confirmed that a significant amount of controlled substances were collected and returned at RLRVAMC. These results have been shared with respective VISN leadership, and additional facilities are installing receptacles.
Conclusion
Changes to DEA regulations offer medical centers more options for developing a comprehensive drug disposal program. Implementation of a pharmaceutical take-back program can assist patients with disposal of unwanted and expired medications, promote safety and environmental stewardship, and reduce the risk of diversion.
1. Centers for Disease Control and Prevention. Opioid overdose. http://www.cdc.gov/drugoverdose/index.html. Updated April 16, 2017. Accessed June 5, 2017.
2. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49.
3. U.S. Food and Drug Administration. Disposal of unused medicines: what you should know. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#Flush_List. Updated April 21, 2017. Accessed June 5, 2017.
4. Li WC. Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil. Environ Pollut. 2014;187:193-201.
5. Boxall AB. The environmental side effects of medication. EMBO Rep. 2004;5(12):1110-1116.
6. Peterson DM. New DEA rules expand options for controlled substance disposal. J Pain Palliat Care Pharmacother. 2015;29(1):22-26.
7. U.S. Department of Justice, Drug Enforcement Administration. Drug disposal information. https:// www.deadiversion.usdoj.gov/drug_disposal/index.html. Accessed June 5, 2016.
8. GSA Advantage! Online shopping. https://www.gsaadvantage.gov. Accessed June 5, 2017.
9. Perry LA, Shinn BW, Stanovich J. Quantification of an ongoing community-based medication take-back program. J Am Pharm Assoc (2003). 2014;54(3):275-279.
Opioid overdoses have quadrupled since 1999, with 78 Americans dying every day of opioid overdoses. More than half of all opioid overdose deaths involve prescription opioids.1 Attacking this problem from both ends—prescribing and disposal—can have a greater impact than focusing on a single strategy.
Background
In 2016, the CDC issued opioid prescription guidelines that included encouraging health care providers to discuss “options for safe disposal of unused opioids.”2 Pharmacies are prohibited from directly taking possession of controlled substances from a user. Historically, the Richard L. Roudebush VAMC (RLRVAMC) in Indianapolis, Indiana, recommended that patients follow FDA guidance for household medication disposal, which includes a list of medications that should be flushed down the toilet.3 As more data became available about the negative downstream environmental effects of pharmaceuticals on the water supply, this method of destruction made many patients feel uncomfortable.4,5
The Secure and Responsible Drug Disposal Act of 2010 presented additional options for hospitals and pharmacies to assist the public with medication disposal.6,7 These options offer convenience and anonymity for the end user, reduce potential for diversion, and enhance patient safety by ridding homes of unwanted and expired medications.
Prior to the 2010 act, the only legal methods of controlled substance disposal were via trash disposal, flushing, or delivery to law enforcement, typically at a community-based drug take-back event. These methods were not always convenient, environmentally friendly, or safe for other family members and pets in the home. The Secure and Responsible Drug Disposal Act of 2010 added 2 additional collection options for pharmacies: collection receptacles and mail-back programs.
The RLRVAMC treats > 62,000 veterans annually. The RLRVAMC Pharmacy Service had been providing pharmaceutical mail-back envelopes to patients since May 2015 with moderate success (271 lb of medications returned and a 22.8% envelope return rate through September 2016). Although the mail-back envelopes offer at-home convenience, there was no on-site disposal option. It is not uncommon for patients to bring medications to their appointment or the emergency department (ED). When medication reconciliation is performed, some medications are discontinued, and the prescriber wants them to be safely out of the patient’s possession to avoid confusion and/or accidental overdose. The purpose of this project was to offer more disposal options to patients through the addition of an on-site medication collection receptacle that would be in compliance with U.S. Drug Enforcement Agency (DEA) regulations.
Methods
A policy was developed between the RLRVAMC pharmacy and police departments for the management of a medication collection receptacle. Police would oversee the disposal program so that the pharmacy would not have to change its DEA registration to collector status. The 2 access keys to the receptacle were maintained by police and secured within a key accountability system in the police station.
Full liners are removed from the receptacle by 2 police officers and sealed securely according to vendor guidelines. In accordance with DEA regulations, a form is completed that documents the dates the inner liner was acquired, installed, removed, and transferred for destruction as well as the unique identification number and size of the liner, the address of the location where it was installed, and the names and signatures of the 2 employees that witnessed the removal.
Arrangements are made to have a mail courier present during the removal of the liner. Once removed, the liner is immediately sealed and released to the mail courier who transports the liner to the DEA authorized reverse distributor. The reverse distributor is a licensed entity that has the authority to take control of the medications, including controlled substances, for disposal. The liner tracking numbers are kept in a police log book so that delivery can be confirmed and destruction certificates obtained from the vendor’s website at a later date. The records are kept for 3 years.
Funding was obtained for a 38-gallon collection receptacle and 12 liners from Pharmacy Benefits Management Services (PBM). Approval was obtained from RLRVAMC leadership to locate the receptacle in a high-traffic area, anchored to the floor, under video surveillance, and away from the ED entrance (a DEA requirement). Public Affairs promoted the receptacle to veterans. E-mails were sent to staff to provide education on regulatory requirements. Weight and frequency of medications returned were obtained from data collected by the reverse distributor. Descriptive statistics are reported.
Results
The Federal Supply Schedule cost to procure a DEA-compliant receptacle was $1,450. The additional 12 inner liners cost $2,024.97.8 Staff from Engineering Service were able to install the receptacle at no additional cost to the facility. The collection receptacle was opened to the public in May 2016. From May through October 2016, the facility collected and returned 10 liners to the reverse distributor containing 452 lb of medications. An additional 30 lb of drugs were returned through the mailback envelope program for a total weight of 482 lb over the 6-month period (Figure). The average time between inner liner changes was 2.6 weeks.
Discussion
The most challenging aspect of implementation was identification of a location for the receptacle. The location chosen, an alcove in the hallway between the coffee shop and outpatient pharmacy, was most appropriate. It is a high-traffic area, under video surveillance, and provides easy access for patients. Another challenge was determining the frequency of liner changes. There was no historic data to assist with predicting how quickly the liner would fill up. Initially, Police Service checked the receptacle every week, and it was emptied about every 2 weeks. Aspatients cleaned out their medicine cabinets, the liner needed to be replaced closer to every 4 weeks. An ongoing challenge has been determining how full the liner is without requiring the police to open the receptacle. Consideration is being given to installing a scale in the receptacle under the liner and having the display affixed to the outside of the container.
The receptacle seemed to be the preferred method of disposal, considering that it generated nearly 15 times more waste than did the mail-back envelopes during the same time period. Anecdotal patient feedback has been extremely positive on social media and by word-of-mouth.
Limitations
One limitation of this disposal program is that the specific amount of controlled substance waste vs noncontrolled substance waste cannot be determined since the liner contents are not inventoried. The University of Findlay in Ohio partnered with local law enforcement to host 7 community medication take-back events over a 3-year period, inventoried the drugs, and found that about one-third of the dosing units (eg, tablet or capsule) returned in the analgesic category were controlled substances, suggesting that take-back events may play a role in reducing unauthorized access to prescription painkillers.9 By witnessing the changing of inner liners, it can be anecdotally confirmed that a significant amount of controlled substances were collected and returned at RLRVAMC. These results have been shared with respective VISN leadership, and additional facilities are installing receptacles.
Conclusion
Changes to DEA regulations offer medical centers more options for developing a comprehensive drug disposal program. Implementation of a pharmaceutical take-back program can assist patients with disposal of unwanted and expired medications, promote safety and environmental stewardship, and reduce the risk of diversion.
Opioid overdoses have quadrupled since 1999, with 78 Americans dying every day of opioid overdoses. More than half of all opioid overdose deaths involve prescription opioids.1 Attacking this problem from both ends—prescribing and disposal—can have a greater impact than focusing on a single strategy.
Background
In 2016, the CDC issued opioid prescription guidelines that included encouraging health care providers to discuss “options for safe disposal of unused opioids.”2 Pharmacies are prohibited from directly taking possession of controlled substances from a user. Historically, the Richard L. Roudebush VAMC (RLRVAMC) in Indianapolis, Indiana, recommended that patients follow FDA guidance for household medication disposal, which includes a list of medications that should be flushed down the toilet.3 As more data became available about the negative downstream environmental effects of pharmaceuticals on the water supply, this method of destruction made many patients feel uncomfortable.4,5
The Secure and Responsible Drug Disposal Act of 2010 presented additional options for hospitals and pharmacies to assist the public with medication disposal.6,7 These options offer convenience and anonymity for the end user, reduce potential for diversion, and enhance patient safety by ridding homes of unwanted and expired medications.
Prior to the 2010 act, the only legal methods of controlled substance disposal were via trash disposal, flushing, or delivery to law enforcement, typically at a community-based drug take-back event. These methods were not always convenient, environmentally friendly, or safe for other family members and pets in the home. The Secure and Responsible Drug Disposal Act of 2010 added 2 additional collection options for pharmacies: collection receptacles and mail-back programs.
The RLRVAMC treats > 62,000 veterans annually. The RLRVAMC Pharmacy Service had been providing pharmaceutical mail-back envelopes to patients since May 2015 with moderate success (271 lb of medications returned and a 22.8% envelope return rate through September 2016). Although the mail-back envelopes offer at-home convenience, there was no on-site disposal option. It is not uncommon for patients to bring medications to their appointment or the emergency department (ED). When medication reconciliation is performed, some medications are discontinued, and the prescriber wants them to be safely out of the patient’s possession to avoid confusion and/or accidental overdose. The purpose of this project was to offer more disposal options to patients through the addition of an on-site medication collection receptacle that would be in compliance with U.S. Drug Enforcement Agency (DEA) regulations.
Methods
A policy was developed between the RLRVAMC pharmacy and police departments for the management of a medication collection receptacle. Police would oversee the disposal program so that the pharmacy would not have to change its DEA registration to collector status. The 2 access keys to the receptacle were maintained by police and secured within a key accountability system in the police station.
Full liners are removed from the receptacle by 2 police officers and sealed securely according to vendor guidelines. In accordance with DEA regulations, a form is completed that documents the dates the inner liner was acquired, installed, removed, and transferred for destruction as well as the unique identification number and size of the liner, the address of the location where it was installed, and the names and signatures of the 2 employees that witnessed the removal.
Arrangements are made to have a mail courier present during the removal of the liner. Once removed, the liner is immediately sealed and released to the mail courier who transports the liner to the DEA authorized reverse distributor. The reverse distributor is a licensed entity that has the authority to take control of the medications, including controlled substances, for disposal. The liner tracking numbers are kept in a police log book so that delivery can be confirmed and destruction certificates obtained from the vendor’s website at a later date. The records are kept for 3 years.
Funding was obtained for a 38-gallon collection receptacle and 12 liners from Pharmacy Benefits Management Services (PBM). Approval was obtained from RLRVAMC leadership to locate the receptacle in a high-traffic area, anchored to the floor, under video surveillance, and away from the ED entrance (a DEA requirement). Public Affairs promoted the receptacle to veterans. E-mails were sent to staff to provide education on regulatory requirements. Weight and frequency of medications returned were obtained from data collected by the reverse distributor. Descriptive statistics are reported.
Results
The Federal Supply Schedule cost to procure a DEA-compliant receptacle was $1,450. The additional 12 inner liners cost $2,024.97.8 Staff from Engineering Service were able to install the receptacle at no additional cost to the facility. The collection receptacle was opened to the public in May 2016. From May through October 2016, the facility collected and returned 10 liners to the reverse distributor containing 452 lb of medications. An additional 30 lb of drugs were returned through the mailback envelope program for a total weight of 482 lb over the 6-month period (Figure). The average time between inner liner changes was 2.6 weeks.
Discussion
The most challenging aspect of implementation was identification of a location for the receptacle. The location chosen, an alcove in the hallway between the coffee shop and outpatient pharmacy, was most appropriate. It is a high-traffic area, under video surveillance, and provides easy access for patients. Another challenge was determining the frequency of liner changes. There was no historic data to assist with predicting how quickly the liner would fill up. Initially, Police Service checked the receptacle every week, and it was emptied about every 2 weeks. Aspatients cleaned out their medicine cabinets, the liner needed to be replaced closer to every 4 weeks. An ongoing challenge has been determining how full the liner is without requiring the police to open the receptacle. Consideration is being given to installing a scale in the receptacle under the liner and having the display affixed to the outside of the container.
The receptacle seemed to be the preferred method of disposal, considering that it generated nearly 15 times more waste than did the mail-back envelopes during the same time period. Anecdotal patient feedback has been extremely positive on social media and by word-of-mouth.
Limitations
One limitation of this disposal program is that the specific amount of controlled substance waste vs noncontrolled substance waste cannot be determined since the liner contents are not inventoried. The University of Findlay in Ohio partnered with local law enforcement to host 7 community medication take-back events over a 3-year period, inventoried the drugs, and found that about one-third of the dosing units (eg, tablet or capsule) returned in the analgesic category were controlled substances, suggesting that take-back events may play a role in reducing unauthorized access to prescription painkillers.9 By witnessing the changing of inner liners, it can be anecdotally confirmed that a significant amount of controlled substances were collected and returned at RLRVAMC. These results have been shared with respective VISN leadership, and additional facilities are installing receptacles.
Conclusion
Changes to DEA regulations offer medical centers more options for developing a comprehensive drug disposal program. Implementation of a pharmaceutical take-back program can assist patients with disposal of unwanted and expired medications, promote safety and environmental stewardship, and reduce the risk of diversion.
1. Centers for Disease Control and Prevention. Opioid overdose. http://www.cdc.gov/drugoverdose/index.html. Updated April 16, 2017. Accessed June 5, 2017.
2. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49.
3. U.S. Food and Drug Administration. Disposal of unused medicines: what you should know. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#Flush_List. Updated April 21, 2017. Accessed June 5, 2017.
4. Li WC. Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil. Environ Pollut. 2014;187:193-201.
5. Boxall AB. The environmental side effects of medication. EMBO Rep. 2004;5(12):1110-1116.
6. Peterson DM. New DEA rules expand options for controlled substance disposal. J Pain Palliat Care Pharmacother. 2015;29(1):22-26.
7. U.S. Department of Justice, Drug Enforcement Administration. Drug disposal information. https:// www.deadiversion.usdoj.gov/drug_disposal/index.html. Accessed June 5, 2016.
8. GSA Advantage! Online shopping. https://www.gsaadvantage.gov. Accessed June 5, 2017.
9. Perry LA, Shinn BW, Stanovich J. Quantification of an ongoing community-based medication take-back program. J Am Pharm Assoc (2003). 2014;54(3):275-279.
1. Centers for Disease Control and Prevention. Opioid overdose. http://www.cdc.gov/drugoverdose/index.html. Updated April 16, 2017. Accessed June 5, 2017.
2. Dowell D, Haegerich TM, Chou R. CDC guideline for prescribing opioids for chronic pain—United States, 2016. MMWR Recomm Rep. 2016;65(1):1-49.
3. U.S. Food and Drug Administration. Disposal of unused medicines: what you should know. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/EnsuringSafeUseofMedicine/SafeDisposalofMedicines/ucm186187.htm#Flush_List. Updated April 21, 2017. Accessed June 5, 2017.
4. Li WC. Occurrence, sources, and fate of pharmaceuticals in aquatic environment and soil. Environ Pollut. 2014;187:193-201.
5. Boxall AB. The environmental side effects of medication. EMBO Rep. 2004;5(12):1110-1116.
6. Peterson DM. New DEA rules expand options for controlled substance disposal. J Pain Palliat Care Pharmacother. 2015;29(1):22-26.
7. U.S. Department of Justice, Drug Enforcement Administration. Drug disposal information. https:// www.deadiversion.usdoj.gov/drug_disposal/index.html. Accessed June 5, 2016.
8. GSA Advantage! Online shopping. https://www.gsaadvantage.gov. Accessed June 5, 2017.
9. Perry LA, Shinn BW, Stanovich J. Quantification of an ongoing community-based medication take-back program. J Am Pharm Assoc (2003). 2014;54(3):275-279.
Modified, CB-derived NK cells target CLL and BL
Natural killer (NK) cells derived from cord blood (CB) can be modified to fight chronic lymphocytic leukemia (CLL) and Burkitt lymphoma (BL), according to research published in Leukemia.
Using a viral vector, researchers transduced CB-derived NK cells with a chimeric antigen receptor (CAR), interleukin-15 (IL-15), and an inducible caspase-9-based suicide gene.
The CAR directed the NK cells to kill CD19-expressing cells, IL-15 prolonged the NK cells’ survival and enhanced their antitumor activity, and the suicide gene allowed researchers to kill off the NK cells in the event of a severe inflammatory response.
“Natural killer cells are the immune system’s most potent killers, but they are short-lived, and cancers manage to evade a patient’s own NK cells to progress,” said study author Katy Rezvani, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston.
“Our cord-blood derived NK cells, genetically equipped with a receptor that focuses them on B-cell malignancies and with interleukin-15 to help them persist longer—potentially for months instead of 2 or 3 weeks—are designed to address these challenges.”
Dr Rezvani and her colleagues tested their CB-derived CAR NK cells in primary CLL cells and a mouse model of BL. Compared to unmodified NK cells, the CAR NK cells killed malignant cells more efficiently and extended the survival of mice.
Another experiment showed the CB-derived CAR NK cells killed CLL cells more efficiently than NK cells that were taken from CLL patients and modified in the same way. The researchers said this highlights the need to transplant CAR-engineered NK cells derived from healthy CB rather than using a patient’s own cells.
Additional experiments in the mouse model of BL showed that a single infusion of low-dose CAR NK cells resulted in prolonged survival.
When CAR NK cells were given at a higher dose, none of the mice died of BL. Half of them survived 100 days and beyond. However, all mice treated with other types of NK cells died by day 41.
Some mice treated with the higher dose of CAR NK cells died of cytokine release syndrome (CRS).
To counteract this toxicity, the researchers activated the suicide gene (iC9) via treatment with a small-molecule dimerizer, AP1903.
The team found that adding as little as 10 nM of AP1903 to cell cultures induced apoptosis/necrosis of the CAR NK cells within 4 hours but had no effect on non-CAR CB-derived NK cells. Similar results were observed in the mouse model.
Next steps
A phase 1/2 trial of these CB-derived CAR NK cells opened at MD Anderson in June for patients with relapsed or refractory CLL, acute lymphocytic leukemia, or non-Hodgkin lymphoma.
Dr Rezvani, the principal investigator of the trial, said the protocol calls for vigilance for signs of CRS, treatment with steroids and tocilizumab for low-grade CRS, and AP1903 added to activate the suicide gene for grade 3 or 4 CRS.
She and her colleagues noted that CB-derived NK cells do not cause graft-vs-host disease. Therefore, they can be an off-the-shelf product, prepared in advance with the necessary receptor and given to patients promptly.
The researchers are developing CB-derived CAR NK cells for other targets in hematologic and solid tumor malignancies.
MD Anderson and the researchers have intellectual property related to the engineered NK cells, which is being managed in accordance with the institution’s conflict-of-interest rules.
Funding for this research was provided by MD Anderson’s Moon Shots Program, the National Cancer Institute of the National Institutes of Health Cancer Center Support Grant (CA016672) to MD Anderson, and grants from the Leukemia and Lymphoma Society and the American Cancer Society. 
Natural killer (NK) cells derived from cord blood (CB) can be modified to fight chronic lymphocytic leukemia (CLL) and Burkitt lymphoma (BL), according to research published in Leukemia.
Using a viral vector, researchers transduced CB-derived NK cells with a chimeric antigen receptor (CAR), interleukin-15 (IL-15), and an inducible caspase-9-based suicide gene.
The CAR directed the NK cells to kill CD19-expressing cells, IL-15 prolonged the NK cells’ survival and enhanced their antitumor activity, and the suicide gene allowed researchers to kill off the NK cells in the event of a severe inflammatory response.
“Natural killer cells are the immune system’s most potent killers, but they are short-lived, and cancers manage to evade a patient’s own NK cells to progress,” said study author Katy Rezvani, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston.
“Our cord-blood derived NK cells, genetically equipped with a receptor that focuses them on B-cell malignancies and with interleukin-15 to help them persist longer—potentially for months instead of 2 or 3 weeks—are designed to address these challenges.”
Dr Rezvani and her colleagues tested their CB-derived CAR NK cells in primary CLL cells and a mouse model of BL. Compared to unmodified NK cells, the CAR NK cells killed malignant cells more efficiently and extended the survival of mice.
Another experiment showed the CB-derived CAR NK cells killed CLL cells more efficiently than NK cells that were taken from CLL patients and modified in the same way. The researchers said this highlights the need to transplant CAR-engineered NK cells derived from healthy CB rather than using a patient’s own cells.
Additional experiments in the mouse model of BL showed that a single infusion of low-dose CAR NK cells resulted in prolonged survival.
When CAR NK cells were given at a higher dose, none of the mice died of BL. Half of them survived 100 days and beyond. However, all mice treated with other types of NK cells died by day 41.
Some mice treated with the higher dose of CAR NK cells died of cytokine release syndrome (CRS).
To counteract this toxicity, the researchers activated the suicide gene (iC9) via treatment with a small-molecule dimerizer, AP1903.
The team found that adding as little as 10 nM of AP1903 to cell cultures induced apoptosis/necrosis of the CAR NK cells within 4 hours but had no effect on non-CAR CB-derived NK cells. Similar results were observed in the mouse model.
Next steps
A phase 1/2 trial of these CB-derived CAR NK cells opened at MD Anderson in June for patients with relapsed or refractory CLL, acute lymphocytic leukemia, or non-Hodgkin lymphoma.
Dr Rezvani, the principal investigator of the trial, said the protocol calls for vigilance for signs of CRS, treatment with steroids and tocilizumab for low-grade CRS, and AP1903 added to activate the suicide gene for grade 3 or 4 CRS.
She and her colleagues noted that CB-derived NK cells do not cause graft-vs-host disease. Therefore, they can be an off-the-shelf product, prepared in advance with the necessary receptor and given to patients promptly.
The researchers are developing CB-derived CAR NK cells for other targets in hematologic and solid tumor malignancies.
MD Anderson and the researchers have intellectual property related to the engineered NK cells, which is being managed in accordance with the institution’s conflict-of-interest rules.
Funding for this research was provided by MD Anderson’s Moon Shots Program, the National Cancer Institute of the National Institutes of Health Cancer Center Support Grant (CA016672) to MD Anderson, and grants from the Leukemia and Lymphoma Society and the American Cancer Society.
Natural killer (NK) cells derived from cord blood (CB) can be modified to fight chronic lymphocytic leukemia (CLL) and Burkitt lymphoma (BL), according to research published in Leukemia.
Using a viral vector, researchers transduced CB-derived NK cells with a chimeric antigen receptor (CAR), interleukin-15 (IL-15), and an inducible caspase-9-based suicide gene.
The CAR directed the NK cells to kill CD19-expressing cells, IL-15 prolonged the NK cells’ survival and enhanced their antitumor activity, and the suicide gene allowed researchers to kill off the NK cells in the event of a severe inflammatory response.
“Natural killer cells are the immune system’s most potent killers, but they are short-lived, and cancers manage to evade a patient’s own NK cells to progress,” said study author Katy Rezvani, MD, PhD, of The University of Texas MD Anderson Cancer Center in Houston.
“Our cord-blood derived NK cells, genetically equipped with a receptor that focuses them on B-cell malignancies and with interleukin-15 to help them persist longer—potentially for months instead of 2 or 3 weeks—are designed to address these challenges.”
Dr Rezvani and her colleagues tested their CB-derived CAR NK cells in primary CLL cells and a mouse model of BL. Compared to unmodified NK cells, the CAR NK cells killed malignant cells more efficiently and extended the survival of mice.
Another experiment showed the CB-derived CAR NK cells killed CLL cells more efficiently than NK cells that were taken from CLL patients and modified in the same way. The researchers said this highlights the need to transplant CAR-engineered NK cells derived from healthy CB rather than using a patient’s own cells.
Additional experiments in the mouse model of BL showed that a single infusion of low-dose CAR NK cells resulted in prolonged survival.
When CAR NK cells were given at a higher dose, none of the mice died of BL. Half of them survived 100 days and beyond. However, all mice treated with other types of NK cells died by day 41.
Some mice treated with the higher dose of CAR NK cells died of cytokine release syndrome (CRS).
To counteract this toxicity, the researchers activated the suicide gene (iC9) via treatment with a small-molecule dimerizer, AP1903.
The team found that adding as little as 10 nM of AP1903 to cell cultures induced apoptosis/necrosis of the CAR NK cells within 4 hours but had no effect on non-CAR CB-derived NK cells. Similar results were observed in the mouse model.
Next steps
A phase 1/2 trial of these CB-derived CAR NK cells opened at MD Anderson in June for patients with relapsed or refractory CLL, acute lymphocytic leukemia, or non-Hodgkin lymphoma.
Dr Rezvani, the principal investigator of the trial, said the protocol calls for vigilance for signs of CRS, treatment with steroids and tocilizumab for low-grade CRS, and AP1903 added to activate the suicide gene for grade 3 or 4 CRS.
She and her colleagues noted that CB-derived NK cells do not cause graft-vs-host disease. Therefore, they can be an off-the-shelf product, prepared in advance with the necessary receptor and given to patients promptly.
The researchers are developing CB-derived CAR NK cells for other targets in hematologic and solid tumor malignancies.
MD Anderson and the researchers have intellectual property related to the engineered NK cells, which is being managed in accordance with the institution’s conflict-of-interest rules.
Funding for this research was provided by MD Anderson’s Moon Shots Program, the National Cancer Institute of the National Institutes of Health Cancer Center Support Grant (CA016672) to MD Anderson, and grants from the Leukemia and Lymphoma Society and the American Cancer Society.
AYA cancer survivors struggle with social functioning
New research suggests young cancer survivors struggle to get their social lives “back to normal” within the first 2 years of their diagnosis.
The study showed that adolescents and young adults (AYAs) with cancer had significantly worse social functioning than the general population around the time of cancer diagnosis as well as 1 year and 2 years later.
These findings were published in Cancer.
“The research is important to help these young survivors better reintegrate into society,” said study author Brad Zebrack, PhD, of the University of Michigan in Ann Arbor.
He and his colleagues collected data from 141 AYA cancer patients (ages 14 to 39) who visited 1 of 5 US medical facilities between March 2008 and April 2010.
The patients completed a self-report measure of social functioning within the first 4 months of diagnosis, then again at 12 months and 24 months.
Compared to the general population, the AYA cancer patients had significantly worse social functioning scores at all time points:
- Around the time of diagnosis—52.0 vs 85.1 (P<0.001)
- At 12 months—73.1 vs 85.1 (P<0.001)
- At 24 months—69.2 vs 85.1 (P<0.001).
Overall, the patients did experience improvements in social functioning from baseline to the 12-month time point, but their scores remained stable after that.
The researchers noted that 9% of patients had consistently high/normal social functioning, 47% had improvements in social functioning over time, 13% had worsening social functioning over time, and 32% had consistently low social functioning.
“This finding highlights the need to screen, identify, and respond to the needs of high-risk young adult-adolescent patients at the time of diagnosis and then monitor them over time,” Dr Zebrack said.
“They are likely the ones most in need of help in managing work, school, and potentially problematic relationships with family members and friends.”
New research suggests young cancer survivors struggle to get their social lives “back to normal” within the first 2 years of their diagnosis.
The study showed that adolescents and young adults (AYAs) with cancer had significantly worse social functioning than the general population around the time of cancer diagnosis as well as 1 year and 2 years later.
These findings were published in Cancer.
“The research is important to help these young survivors better reintegrate into society,” said study author Brad Zebrack, PhD, of the University of Michigan in Ann Arbor.
He and his colleagues collected data from 141 AYA cancer patients (ages 14 to 39) who visited 1 of 5 US medical facilities between March 2008 and April 2010.
The patients completed a self-report measure of social functioning within the first 4 months of diagnosis, then again at 12 months and 24 months.
Compared to the general population, the AYA cancer patients had significantly worse social functioning scores at all time points:
- Around the time of diagnosis—52.0 vs 85.1 (P<0.001)
- At 12 months—73.1 vs 85.1 (P<0.001)
- At 24 months—69.2 vs 85.1 (P<0.001).
Overall, the patients did experience improvements in social functioning from baseline to the 12-month time point, but their scores remained stable after that.
The researchers noted that 9% of patients had consistently high/normal social functioning, 47% had improvements in social functioning over time, 13% had worsening social functioning over time, and 32% had consistently low social functioning.
“This finding highlights the need to screen, identify, and respond to the needs of high-risk young adult-adolescent patients at the time of diagnosis and then monitor them over time,” Dr Zebrack said.
“They are likely the ones most in need of help in managing work, school, and potentially problematic relationships with family members and friends.”
New research suggests young cancer survivors struggle to get their social lives “back to normal” within the first 2 years of their diagnosis.
The study showed that adolescents and young adults (AYAs) with cancer had significantly worse social functioning than the general population around the time of cancer diagnosis as well as 1 year and 2 years later.
These findings were published in Cancer.
“The research is important to help these young survivors better reintegrate into society,” said study author Brad Zebrack, PhD, of the University of Michigan in Ann Arbor.
He and his colleagues collected data from 141 AYA cancer patients (ages 14 to 39) who visited 1 of 5 US medical facilities between March 2008 and April 2010.
The patients completed a self-report measure of social functioning within the first 4 months of diagnosis, then again at 12 months and 24 months.
Compared to the general population, the AYA cancer patients had significantly worse social functioning scores at all time points:
- Around the time of diagnosis—52.0 vs 85.1 (P<0.001)
- At 12 months—73.1 vs 85.1 (P<0.001)
- At 24 months—69.2 vs 85.1 (P<0.001).
Overall, the patients did experience improvements in social functioning from baseline to the 12-month time point, but their scores remained stable after that.
The researchers noted that 9% of patients had consistently high/normal social functioning, 47% had improvements in social functioning over time, 13% had worsening social functioning over time, and 32% had consistently low social functioning.
“This finding highlights the need to screen, identify, and respond to the needs of high-risk young adult-adolescent patients at the time of diagnosis and then monitor them over time,” Dr Zebrack said.
“They are likely the ones most in need of help in managing work, school, and potentially problematic relationships with family members and friends.”
FDA grants orphan designation to gilteritinib in AML
The US Food and Drug Administration (FDA) has granted orphan drug designation to gilteritinib for the treatment of patients with acute myeloid leukemia (AML).
Gilteritinib, an inhibitor of FLT3 and AXL, has demonstrated activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain, 2 mutations that are seen in up to a third of patients with AML.
Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.
Results from a phase 1/2 study of gilteritinib in AML were presented at the 2017 ASCO Annual Meeting.
The goal of the study was to determine the tolerability and antileukemic activity of once-daily gilteritinib in a FLT3-ITD-enriched, relapsed/refractory AML population.
The drug exhibited “potent” FLT3 inhibition at doses greater than 80 mg/day. In patients who received such doses, the greatest overall response rate was 52%, and the longest median overall survival was 31 weeks.
The maximum tolerated dose of gilteritinib was 300 mg/day. Dose-limiting toxicities included diarrhea and liver function abnormalities.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to gilteritinib for the treatment of patients with acute myeloid leukemia (AML).
Gilteritinib, an inhibitor of FLT3 and AXL, has demonstrated activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain, 2 mutations that are seen in up to a third of patients with AML.
Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.
Results from a phase 1/2 study of gilteritinib in AML were presented at the 2017 ASCO Annual Meeting.
The goal of the study was to determine the tolerability and antileukemic activity of once-daily gilteritinib in a FLT3-ITD-enriched, relapsed/refractory AML population.
The drug exhibited “potent” FLT3 inhibition at doses greater than 80 mg/day. In patients who received such doses, the greatest overall response rate was 52%, and the longest median overall survival was 31 weeks.
The maximum tolerated dose of gilteritinib was 300 mg/day. Dose-limiting toxicities included diarrhea and liver function abnormalities.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
The US Food and Drug Administration (FDA) has granted orphan drug designation to gilteritinib for the treatment of patients with acute myeloid leukemia (AML).
Gilteritinib, an inhibitor of FLT3 and AXL, has demonstrated activity against FLT3 internal tandem duplication (ITD) as well as tyrosine kinase domain, 2 mutations that are seen in up to a third of patients with AML.
Astellas Pharma Inc. is currently investigating gilteritinib in phase 3 trials of AML patients.
Results from a phase 1/2 study of gilteritinib in AML were presented at the 2017 ASCO Annual Meeting.
The goal of the study was to determine the tolerability and antileukemic activity of once-daily gilteritinib in a FLT3-ITD-enriched, relapsed/refractory AML population.
The drug exhibited “potent” FLT3 inhibition at doses greater than 80 mg/day. In patients who received such doses, the greatest overall response rate was 52%, and the longest median overall survival was 31 weeks.
The maximum tolerated dose of gilteritinib was 300 mg/day. Dose-limiting toxicities included diarrhea and liver function abnormalities.
About orphan designation
The FDA grants orphan designation to products intended to treat, diagnose, or prevent diseases/disorders that affect fewer than 200,000 people in the US.
The designation provides incentives for sponsors to develop products for rare diseases. This may include tax credits toward the cost of clinical trials, prescription drug user fee waivers, and 7 years of market exclusivity if the product is approved.
FDA approves generic tranexamic acid
Zydus Cadila has received approval from the US Food and Drug Administration (FDA) to market a tranexamic acid product for use in patients with hemophilia.
The company’s product—Tranexamic Acid Injection, 1000 mg/10 mL (100 mg/mL) Single Dose Vial—can be used to prevent or reduce bleeding in hemophilia patients undergoing tooth extraction.
Zydus Cadila’s tranexamic acid will be produced at a manufacturing facility in Moraiya, Gujarat, India.
Zydus Cadila has received approval from the US Food and Drug Administration (FDA) to market a tranexamic acid product for use in patients with hemophilia.
The company’s product—Tranexamic Acid Injection, 1000 mg/10 mL (100 mg/mL) Single Dose Vial—can be used to prevent or reduce bleeding in hemophilia patients undergoing tooth extraction.
Zydus Cadila’s tranexamic acid will be produced at a manufacturing facility in Moraiya, Gujarat, India.
Zydus Cadila has received approval from the US Food and Drug Administration (FDA) to market a tranexamic acid product for use in patients with hemophilia.
The company’s product—Tranexamic Acid Injection, 1000 mg/10 mL (100 mg/mL) Single Dose Vial—can be used to prevent or reduce bleeding in hemophilia patients undergoing tooth extraction.
Zydus Cadila’s tranexamic acid will be produced at a manufacturing facility in Moraiya, Gujarat, India.
Statewide QI learning collaboratives improve asthma care
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
We can do a better job of taking care of our patients. And in no other area is there more room for quality improvement (QI) than in ambulatory care. In the article by Dolins et al., substantial improvements were reported in outpatient management meeting the standard of care for asthma. In my experience, doing so not only gives children a better functional outcome but also saves costs by avoiding unnecessary ED visits and hospitalization and generates new dollars for pediatric offices through the additional services they provide. We have seen similar improvements in our own work in South Carolina and Tennessee. The practices that have wanted to become involved in our asthma QI are those that are already doing a better than average job. Yet, they still generate substantial additional improvements.
The AAP study relied heavily on national experts and standards. Although their input is valued, the true advantage of QI is the opportunity for pediatricians and their staff at the service delivery level to generate their own changes within the context of a learning collaborative. True improvement and innovation is facilitated by allowing flexibility at the local level and sharing the ideas that result. Those that design the QI efforts of the future need to make sure they allow for local expertise rather than leaning too heavily on centrally predetermined change concepts.
Part IV Maintenance of Certification requirements from the American Board of Pediatrics help provide momentum for successful pediatric QI. The National Improvement Partnership Network has formed pediatric outpatient learning collaboratives to share ideas. As we identify more successes with ambulatory care QI, as more and more organizations like AAP state chapters become involved, as all practices – rather than just the best – recognize the obligation to promote quality, we have a tremendous opportunity to improve the developmental and health outcomes of the children. QI can promote work and cost efficiencies that facilitate our work as pediatricians, making our lives more productive and rewarding.
Francis E. Rushton Jr, MD, is a pediatrician and medical director of South Carolina’s QTIP (Quality Through Innovation in Pediatrics) network and the Quality Director for PHIIT (Pediatric Health Improvement In Tennessee). He reported not having any relevant financial disclosures.
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
Care of children with asthma can be improved using statewide quality improvement (QI) learning collaboratives, said Judith C. Dolins, of the American Academy of Pediatrics (AAP), Elk Grove Village, Ill., and her associates.
AAP chapters demonstrated this through their implementation of the Chapter Quality Network (CQN) project, which was supported by the national organization. This project sought to encourage practice changes in asthma care in a number of states using statewide QI learning collaboratives and lead practices to implement the National Heart, Lung, and Blood Institute’s (NHLBI) 2007 asthma guidelines over the course of four time periods, which the researchers referred to as waves. In nine states, 19 AAP chapters engaged 180 practices to participate, and involved 749 pediatricians treating 45,431 patients (Pediatrics. 2017. doi: 10.1542/peds.2016-1612).
Across all waves, practices had reasonably high baseline use of the stepwise approach (81%-89%) and a controller medication for patients with persistent asthma (74%-88%). The patients with a current written asthma action plan increased from 49%-57% to 75%-91%. Physicians’ and parents’ ratings of asthma in children as “well controlled” rose modestly from 58%-63% to 71%-74% and from 67%-73% to 78%-87%, respectively. Patients receiving self-management materials increased from 57%-62% to 62%-88%.
Here’s how the project worked. The CQN had three linked frameworks.: One provided a methodology for spreading practice changes, another outlined the elements of care, and a third provided a framework so the practices could test, implement, and adapt changes.
A national AAP leadership team of experts in asthma care, QI, and primary care practice systems developed a set of key drivers and interventions, and an implementation guide that included resources, tools and methods, and a set of measures for the chapters. They also designed reporting tools and a curriculum fostering QI learning by chapter leaders. Then, in a state chapter leadership learning network and a practice collaborative model in each state, there were “multiple in-person learning sessions and defined action periods, best practices, and tests of change that were spread and incorporated” for the chapters to use, according to the study report.
Chapters in each state had monthly webinars and two in-person learning sessions for participating practices. They also reviewed data reports at the state and practice level and provided coaching for practices.
Practices were asked to “incorporate optimal NHLBI asthma care practices, including assessment of control, a stepwise approach to treatment, appropriate use of controller medication, and an updated asthma action plan for self-management.” Other interventions included use of an asthma encounter form (which collected 16 measures, including outcome and process measures that were entered into a national database at least monthly); introduction of population registries; workflow assessment; motivational interviews; plan-do-study-act cycles for QI; and review of data for QI.
All the physicians were eligible to earn MOC part 4 credit and continuing medical education credit, and 80% of the physicians did get MOC credit across the 4 waves.
“Our findings are notable for achieving improvement in asthma care through training multiple state coordinating entities instead of directly leading the learning collaborative itself. Few other projects have achieved this level of results in pediatric practice improvement in asthma care on such a widespread scale across multiple states. This project may serve as a model for other statewide and national organizations attempting to achieve improvements in population health through support and training for statewide organizations that, in turn, support individual health care providers and practices,” Ms. Dolins and her associates said. “Although none of the waves achieved the preset goal of 90%, all showed substantial improvement and remarkable consistency in the rate of improvement. We, therefore, regarded the project as an overall success.”
The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.
FROM PEDIATRICS
Key clinical point:
Major finding: In wave 4, during which data were collected for 9 months, the rate of optimal asthma care at each encounter improved from 38% to 72%.
Data source: In nine states, 19 AAP chapters engaged 180 practices to participate in quality improvement learning collaboratives, which involved 749 pediatricians treating 45,431 patients.
Disclosures: The study was funded by the Merck Childhood Asthma Network, American Board of Pediatrics Foundation, American Academy of Pediatrics Friends of Children Fund, the JPB Foundation, and GlaxoSmithKline. Ms. Dolins and Mr. Wise received salary support. Ms. Powell and Dr. Stemmler received consulting fees.