Hospice & Palliative Medicine

Patients with advanced dementia should have increased access to comprehensive care wherever they live, including the facilities in which they spend the last months of their lives, a federal health care advisory panel has recommended.

Advanced care planning, palliative care, and increased access to hospice admission all would improve the quality of life for both patients and families, Dr. Laurel Coleman said at a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. Despite their proven benefits, however, these strategies aren’t universally available.

© Lighthaunter/Thinkstock

“Palliative care and hospice admission, for example, are both tools that make it much less likely that people with advanced dementia will die in a hospital, “ said Dr. Coleman, chair of the council’s clinical research and care subcommittee, which made the recommendations. “They have lower levels of pain and distress, and are less likely to have feeding tubes and restraints and other invasive measures implemented during the final stages of life.”

Hospice accessibility “is what keeps us up at night,” she said. Prognostication of life expectancy is difficult in advanced dementia, and hospice units typically only admit patients expected to live less than 6 months.

Other problems that impede appropriate hospice admission for these patients include incorrect coding – frailty instead of advanced dementia, for example – and the unintended consequences of new policies designed to restrict fraud and long-term hospital stays, said Dr. Coleman, a geriatrician at Maine Medical Center in Portland and a member of the palliative care team at Central Maine Medical Center in Lewiston. “Some of these things just make it unnecessarily hard for these patents to enter hospice.”

Because advanced dementia care is so fragmented, the majority of patients in the United States don’t get optimal care. “It’s really a case of luck – being at the right place in the right time. And if you’re not, you’re out of luck,” she noted.

Ideally, the federal government would support programs that care for dementia patients across the spectrum of their illness, said Dr. Coleman and her cochair, Dr. Susan Mitchell. They held up the Beatitudes Campus of Glendale, Ariz., as a prime example of what could be done to accommodate dementia patients and their families in a holistic setting that supports everyone throughout the course of the disease. The early memory program focuses on cognitively stimulating activities and full medical support that increases as needed. There is an emphasis on preempting disruptive behavior rather than responding to it after it develops. The advanced dementia care unit steps up all these goals as disease progresses.

Another unique aspect of the facility is its research arm and a full professional education program, said Dr. Mitchell, a geriatrician and director of palliative care research at the Institute for Aging Research, Boston. This focuses on building clinicians’ expertise in caring for dementia patients, preparing them to take on leadership roles in the field.

However, she said, “this is a highly aspirational goal. Implementing units like these [with federal support] will be like parting the Red Sea: Important, but extremely difficult.”

Despite the perhaps pie-in-the-sky goal, the subcommittee recommended that the Department of Health & Human Services pursue the idea of creating pilot “dementia-friendly communities” that would serve patients from diagnosis to death. “HHS should support a piloting process of 10-15 communities” that would be funded by a request for proposals from communities interested in participating. Ideally, these facilities would reflect diversity in culture and be split between rural and urban locales.

“Should the evaluation of the pilot programs justify replication, then the goal would be widespread adoption of dementia-friendly communities by 2020,” the committee noted.

As members of a federal working group, Dr. Coleman and Dr. Mitchell had no financial disclosures.

[email protected]

On Twitter @alz_gal

Patients with advanced dementia should have increased access to comprehensive care wherever they live, including the facilities in which they spend the last months of their lives, a federal health care advisory panel has recommended.

Advanced care planning, palliative care, and increased access to hospice admission all would improve the quality of life for both patients and families, Dr. Laurel Coleman said at a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. Despite their proven benefits, however, these strategies aren’t universally available.

© Lighthaunter/Thinkstock

“Palliative care and hospice admission, for example, are both tools that make it much less likely that people with advanced dementia will die in a hospital, “ said Dr. Coleman, chair of the council’s clinical research and care subcommittee, which made the recommendations. “They have lower levels of pain and distress, and are less likely to have feeding tubes and restraints and other invasive measures implemented during the final stages of life.”

Hospice accessibility “is what keeps us up at night,” she said. Prognostication of life expectancy is difficult in advanced dementia, and hospice units typically only admit patients expected to live less than 6 months.

Other problems that impede appropriate hospice admission for these patients include incorrect coding – frailty instead of advanced dementia, for example – and the unintended consequences of new policies designed to restrict fraud and long-term hospital stays, said Dr. Coleman, a geriatrician at Maine Medical Center in Portland and a member of the palliative care team at Central Maine Medical Center in Lewiston. “Some of these things just make it unnecessarily hard for these patents to enter hospice.”

Because advanced dementia care is so fragmented, the majority of patients in the United States don’t get optimal care. “It’s really a case of luck – being at the right place in the right time. And if you’re not, you’re out of luck,” she noted.

Ideally, the federal government would support programs that care for dementia patients across the spectrum of their illness, said Dr. Coleman and her cochair, Dr. Susan Mitchell. They held up the Beatitudes Campus of Glendale, Ariz., as a prime example of what could be done to accommodate dementia patients and their families in a holistic setting that supports everyone throughout the course of the disease. The early memory program focuses on cognitively stimulating activities and full medical support that increases as needed. There is an emphasis on preempting disruptive behavior rather than responding to it after it develops. The advanced dementia care unit steps up all these goals as disease progresses.

Another unique aspect of the facility is its research arm and a full professional education program, said Dr. Mitchell, a geriatrician and director of palliative care research at the Institute for Aging Research, Boston. This focuses on building clinicians’ expertise in caring for dementia patients, preparing them to take on leadership roles in the field.

However, she said, “this is a highly aspirational goal. Implementing units like these [with federal support] will be like parting the Red Sea: Important, but extremely difficult.”

Despite the perhaps pie-in-the-sky goal, the subcommittee recommended that the Department of Health & Human Services pursue the idea of creating pilot “dementia-friendly communities” that would serve patients from diagnosis to death. “HHS should support a piloting process of 10-15 communities” that would be funded by a request for proposals from communities interested in participating. Ideally, these facilities would reflect diversity in culture and be split between rural and urban locales.

“Should the evaluation of the pilot programs justify replication, then the goal would be widespread adoption of dementia-friendly communities by 2020,” the committee noted.

As members of a federal working group, Dr. Coleman and Dr. Mitchell had no financial disclosures.

[email protected]

On Twitter @alz_gal

Patients with advanced dementia should have increased access to comprehensive care wherever they live, including the facilities in which they spend the last months of their lives, a federal health care advisory panel has recommended.

Advanced care planning, palliative care, and increased access to hospice admission all would improve the quality of life for both patients and families, Dr. Laurel Coleman said at a meeting of the Advisory Council on Alzheimer’s Research, Care, and Services. Despite their proven benefits, however, these strategies aren’t universally available.

© Lighthaunter/Thinkstock

“Palliative care and hospice admission, for example, are both tools that make it much less likely that people with advanced dementia will die in a hospital, “ said Dr. Coleman, chair of the council’s clinical research and care subcommittee, which made the recommendations. “They have lower levels of pain and distress, and are less likely to have feeding tubes and restraints and other invasive measures implemented during the final stages of life.”

Hospice accessibility “is what keeps us up at night,” she said. Prognostication of life expectancy is difficult in advanced dementia, and hospice units typically only admit patients expected to live less than 6 months.

Other problems that impede appropriate hospice admission for these patients include incorrect coding – frailty instead of advanced dementia, for example – and the unintended consequences of new policies designed to restrict fraud and long-term hospital stays, said Dr. Coleman, a geriatrician at Maine Medical Center in Portland and a member of the palliative care team at Central Maine Medical Center in Lewiston. “Some of these things just make it unnecessarily hard for these patents to enter hospice.”

Because advanced dementia care is so fragmented, the majority of patients in the United States don’t get optimal care. “It’s really a case of luck – being at the right place in the right time. And if you’re not, you’re out of luck,” she noted.

Ideally, the federal government would support programs that care for dementia patients across the spectrum of their illness, said Dr. Coleman and her cochair, Dr. Susan Mitchell. They held up the Beatitudes Campus of Glendale, Ariz., as a prime example of what could be done to accommodate dementia patients and their families in a holistic setting that supports everyone throughout the course of the disease. The early memory program focuses on cognitively stimulating activities and full medical support that increases as needed. There is an emphasis on preempting disruptive behavior rather than responding to it after it develops. The advanced dementia care unit steps up all these goals as disease progresses.

Another unique aspect of the facility is its research arm and a full professional education program, said Dr. Mitchell, a geriatrician and director of palliative care research at the Institute for Aging Research, Boston. This focuses on building clinicians’ expertise in caring for dementia patients, preparing them to take on leadership roles in the field.

However, she said, “this is a highly aspirational goal. Implementing units like these [with federal support] will be like parting the Red Sea: Important, but extremely difficult.”

Despite the perhaps pie-in-the-sky goal, the subcommittee recommended that the Department of Health & Human Services pursue the idea of creating pilot “dementia-friendly communities” that would serve patients from diagnosis to death. “HHS should support a piloting process of 10-15 communities” that would be funded by a request for proposals from communities interested in participating. Ideally, these facilities would reflect diversity in culture and be split between rural and urban locales.

“Should the evaluation of the pilot programs justify replication, then the goal would be widespread adoption of dementia-friendly communities by 2020,” the committee noted.

As members of a federal working group, Dr. Coleman and Dr. Mitchell had no financial disclosures.

[email protected]

On Twitter @alz_gal

Oncology social workers and oncology psychologists are playing a growing role in providing quality, patient-centered cancer care to VA patients according to Jennifer Dimick, MSSA, LISW, OSW-C.

“We designed this clinic where we had interpersonal care along with learners,” Dimick explained. “One of the things we wanted to do was pilot the different psychosocial standards… and show that it was sustainable so that this care could go out to different clinics in the VA.”

Oncology social workers and oncology psychologists are playing a growing role in providing quality, patient-centered cancer care to VA patients according to Jennifer Dimick, MSSA, LISW, OSW-C.

“We designed this clinic where we had interpersonal care along with learners,” Dimick explained. “One of the things we wanted to do was pilot the different psychosocial standards… and show that it was sustainable so that this care could go out to different clinics in the VA.”

Oncology social workers and oncology psychologists are playing a growing role in providing quality, patient-centered cancer care to VA patients according to Jennifer Dimick, MSSA, LISW, OSW-C.

“We designed this clinic where we had interpersonal care along with learners,” Dimick explained. “One of the things we wanted to do was pilot the different psychosocial standards… and show that it was sustainable so that this care could go out to different clinics in the VA.”

The striking lack of data on the effectiveness and risks of long-term opioid treatment for the increasing number of people in the United States with chronic pain is reflected in the recommendations made by an expert panel convened by the National Institutes of Health.

To address the role of opioids in the treatment of chronic pain, the panelists met during an NIH Pathways to Prevention workshop in late September where more than 20 invited experts spoke on the topic. The panel produced a draft report shortly after the meeting concluded and received public comments, and the final report has been published on the NIH website. An abridged version of the panel’s final report, which highlights key issues surrounding the use of opioids and chronic pain treatment and provides recommendations on the types of research needed in this area, was published online Jan. 13 in the Annals of Internal Medicine (doi:10.7326/M14-2775).

“The overriding question posed to the panel is whether we as a nation are currently approaching chronic pain in the best possible manner that maximizes effectiveness and minimizes harm. The panel determined that the answer was an unequivocal no,” Dr. David Reuben, the panel chair and lead author of the report, said during a Jan. 16 telebriefing that was held to review the panel’s findings and recommendations. “We hope that the information presented in the panel report will shed light on the issues that need further attention and help facilitate research and better practice to improve outcomes for patients,” added Dr. Reuben, who is chief of geriatric medicine and professor of medicine at the University of California, Los Angeles.

The first recommendation in the panel’s position paper is that federal and non-federal agencies should fund research to identify what types of pain, diseases, and patients “are most likely to benefit and incur harm” from opioids. Agencies should also fund the development and evaluation of multi-disciplinary pain interventions, including cost-benefit analyses, and fund research to “develop and validate research measurement tools” that identify patient risk and outcomes, “related to long-term opioid use that can be adapted for clinical settings,” the panel recommended.

The one recommendation that directly pertains to current clinical practice states that “in the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain should be treated with opioids and about how best to monitor patients and mitigate risk for harm.” In addition, the report “identifies several key evidence gaps and research priorities that must be addressed so that physicians can recognize patients for whom opioids are most appropriate and use optimal regimens for these patients.”

Considering professional society guidelines is one of the main take home-messages of the report for clinicians, Dr. David Steffens, another panelist and author of the paper, said during the telebriefing. Dr. Steffens, professor and chair of the department of psychiatry, University of Connecticut, Farmington, observed that during the workshop, “the core part of what we heard was an astounding lack of data on efficacy of these drugs,” and noted that the majority of recommendations are “forward-looking in terms of a need to get more data.”

Among the main conclusions of the position paper is that while opioids are “clearly the best treatment for some patients with chronic pain ... there are probably more effective approaches” for many other patients. “The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system,” the report concludes.

A systematic review of the effectiveness and risks of long-term opioids for chronic pain, prepared specifically for the workshop by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University, Portland, with funding by the Agency for Healthcare Research and Quality, was also published in the same issue of Annals of Internal Medicine (doi:10.7326/M14-2559).

The review, which evaluated evidence in the medical literature about the effectiveness and risks of long-term opioid therapy (more than 3 months) to treat chronic pain in adults, concluded that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” Moreover, evidence indicating that long-term opioid therapy is associated with significant risks for overdoses, abuse, and other sequelae is increasing, according to the review, which defines chronic pain as pain “lasting longer than 3 months or past the normal time for tissue healing.” Dr. Roger Chou, director of the Pacific Northwest EPC and a physician in the OHSU internal medicine clinic, was the lead author of the review.

An estimated 100 million Americans have chronic pain, of whom about 25 million have moderate-to-severe pain that limits activities and adversely affects their quality of life, according to the position paper. Despite other available treatments, opioids are used for long-term management of chronic pain in an estimated 5-8 million Americans and prescriptions for opioids to treat pain increased from 76 million in 1991 to 219 million in 2011. This increase has been accompanied by a rise in opioid overdoses and treatment for addictions to prescription pain medications. The paper cites Centers for Disease Control and Prevention figures estimating that in 2011, there were more than 17,000 opioid-related overdose deaths.

The NIH Pathways to Prevention Workshop was sponsored by the NIH Office of Disease Prevention, the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.

None of the authors of the report had disclosures relevant to the topic. Dr. Chou’s disclosures included having received grants from the AHRQ during the study. He has also been a consultant for the U.S. Department of Health and Human Services and the Providers’ Clinical Support System for Opioid Therapies, which is funded by the Substance Abuse and Mental Health Services Administration.

[email protected]

The striking lack of data on the effectiveness and risks of long-term opioid treatment for the increasing number of people in the United States with chronic pain is reflected in the recommendations made by an expert panel convened by the National Institutes of Health.

To address the role of opioids in the treatment of chronic pain, the panelists met during an NIH Pathways to Prevention workshop in late September where more than 20 invited experts spoke on the topic. The panel produced a draft report shortly after the meeting concluded and received public comments, and the final report has been published on the NIH website. An abridged version of the panel’s final report, which highlights key issues surrounding the use of opioids and chronic pain treatment and provides recommendations on the types of research needed in this area, was published online Jan. 13 in the Annals of Internal Medicine (doi:10.7326/M14-2775).

“The overriding question posed to the panel is whether we as a nation are currently approaching chronic pain in the best possible manner that maximizes effectiveness and minimizes harm. The panel determined that the answer was an unequivocal no,” Dr. David Reuben, the panel chair and lead author of the report, said during a Jan. 16 telebriefing that was held to review the panel’s findings and recommendations. “We hope that the information presented in the panel report will shed light on the issues that need further attention and help facilitate research and better practice to improve outcomes for patients,” added Dr. Reuben, who is chief of geriatric medicine and professor of medicine at the University of California, Los Angeles.

The first recommendation in the panel’s position paper is that federal and non-federal agencies should fund research to identify what types of pain, diseases, and patients “are most likely to benefit and incur harm” from opioids. Agencies should also fund the development and evaluation of multi-disciplinary pain interventions, including cost-benefit analyses, and fund research to “develop and validate research measurement tools” that identify patient risk and outcomes, “related to long-term opioid use that can be adapted for clinical settings,” the panel recommended.

The one recommendation that directly pertains to current clinical practice states that “in the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain should be treated with opioids and about how best to monitor patients and mitigate risk for harm.” In addition, the report “identifies several key evidence gaps and research priorities that must be addressed so that physicians can recognize patients for whom opioids are most appropriate and use optimal regimens for these patients.”

Considering professional society guidelines is one of the main take home-messages of the report for clinicians, Dr. David Steffens, another panelist and author of the paper, said during the telebriefing. Dr. Steffens, professor and chair of the department of psychiatry, University of Connecticut, Farmington, observed that during the workshop, “the core part of what we heard was an astounding lack of data on efficacy of these drugs,” and noted that the majority of recommendations are “forward-looking in terms of a need to get more data.”

Among the main conclusions of the position paper is that while opioids are “clearly the best treatment for some patients with chronic pain ... there are probably more effective approaches” for many other patients. “The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system,” the report concludes.

A systematic review of the effectiveness and risks of long-term opioids for chronic pain, prepared specifically for the workshop by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University, Portland, with funding by the Agency for Healthcare Research and Quality, was also published in the same issue of Annals of Internal Medicine (doi:10.7326/M14-2559).

The review, which evaluated evidence in the medical literature about the effectiveness and risks of long-term opioid therapy (more than 3 months) to treat chronic pain in adults, concluded that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” Moreover, evidence indicating that long-term opioid therapy is associated with significant risks for overdoses, abuse, and other sequelae is increasing, according to the review, which defines chronic pain as pain “lasting longer than 3 months or past the normal time for tissue healing.” Dr. Roger Chou, director of the Pacific Northwest EPC and a physician in the OHSU internal medicine clinic, was the lead author of the review.

An estimated 100 million Americans have chronic pain, of whom about 25 million have moderate-to-severe pain that limits activities and adversely affects their quality of life, according to the position paper. Despite other available treatments, opioids are used for long-term management of chronic pain in an estimated 5-8 million Americans and prescriptions for opioids to treat pain increased from 76 million in 1991 to 219 million in 2011. This increase has been accompanied by a rise in opioid overdoses and treatment for addictions to prescription pain medications. The paper cites Centers for Disease Control and Prevention figures estimating that in 2011, there were more than 17,000 opioid-related overdose deaths.

The NIH Pathways to Prevention Workshop was sponsored by the NIH Office of Disease Prevention, the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.

None of the authors of the report had disclosures relevant to the topic. Dr. Chou’s disclosures included having received grants from the AHRQ during the study. He has also been a consultant for the U.S. Department of Health and Human Services and the Providers’ Clinical Support System for Opioid Therapies, which is funded by the Substance Abuse and Mental Health Services Administration.

[email protected]

The striking lack of data on the effectiveness and risks of long-term opioid treatment for the increasing number of people in the United States with chronic pain is reflected in the recommendations made by an expert panel convened by the National Institutes of Health.

To address the role of opioids in the treatment of chronic pain, the panelists met during an NIH Pathways to Prevention workshop in late September where more than 20 invited experts spoke on the topic. The panel produced a draft report shortly after the meeting concluded and received public comments, and the final report has been published on the NIH website. An abridged version of the panel’s final report, which highlights key issues surrounding the use of opioids and chronic pain treatment and provides recommendations on the types of research needed in this area, was published online Jan. 13 in the Annals of Internal Medicine (doi:10.7326/M14-2775).

“The overriding question posed to the panel is whether we as a nation are currently approaching chronic pain in the best possible manner that maximizes effectiveness and minimizes harm. The panel determined that the answer was an unequivocal no,” Dr. David Reuben, the panel chair and lead author of the report, said during a Jan. 16 telebriefing that was held to review the panel’s findings and recommendations. “We hope that the information presented in the panel report will shed light on the issues that need further attention and help facilitate research and better practice to improve outcomes for patients,” added Dr. Reuben, who is chief of geriatric medicine and professor of medicine at the University of California, Los Angeles.

The first recommendation in the panel’s position paper is that federal and non-federal agencies should fund research to identify what types of pain, diseases, and patients “are most likely to benefit and incur harm” from opioids. Agencies should also fund the development and evaluation of multi-disciplinary pain interventions, including cost-benefit analyses, and fund research to “develop and validate research measurement tools” that identify patient risk and outcomes, “related to long-term opioid use that can be adapted for clinical settings,” the panel recommended.

The one recommendation that directly pertains to current clinical practice states that “in the absence of definitive evidence, clinicians and health care systems should follow current guidelines by professional societies about which patients and which types of pain should be treated with opioids and about how best to monitor patients and mitigate risk for harm.” In addition, the report “identifies several key evidence gaps and research priorities that must be addressed so that physicians can recognize patients for whom opioids are most appropriate and use optimal regimens for these patients.”

Considering professional society guidelines is one of the main take home-messages of the report for clinicians, Dr. David Steffens, another panelist and author of the paper, said during the telebriefing. Dr. Steffens, professor and chair of the department of psychiatry, University of Connecticut, Farmington, observed that during the workshop, “the core part of what we heard was an astounding lack of data on efficacy of these drugs,” and noted that the majority of recommendations are “forward-looking in terms of a need to get more data.”

Among the main conclusions of the position paper is that while opioids are “clearly the best treatment for some patients with chronic pain ... there are probably more effective approaches” for many other patients. “The challenge is to identify the conditions in patients for which opioid use is most appropriate, the optimal regimens, the alternatives for those who are unlikely to benefit from opioids, and the best approach to ensuring that every patient’s needs are met by a patient-centered health care system,” the report concludes.

A systematic review of the effectiveness and risks of long-term opioids for chronic pain, prepared specifically for the workshop by the Pacific Northwest Evidence-based Practice Center (EPC) at Oregon Health & Science University, Portland, with funding by the Agency for Healthcare Research and Quality, was also published in the same issue of Annals of Internal Medicine (doi:10.7326/M14-2559).

The review, which evaluated evidence in the medical literature about the effectiveness and risks of long-term opioid therapy (more than 3 months) to treat chronic pain in adults, concluded that “reliable conclusions about the effectiveness of long-term opioid therapy for chronic pain are not possible due to the paucity of research to date.” Moreover, evidence indicating that long-term opioid therapy is associated with significant risks for overdoses, abuse, and other sequelae is increasing, according to the review, which defines chronic pain as pain “lasting longer than 3 months or past the normal time for tissue healing.” Dr. Roger Chou, director of the Pacific Northwest EPC and a physician in the OHSU internal medicine clinic, was the lead author of the review.

An estimated 100 million Americans have chronic pain, of whom about 25 million have moderate-to-severe pain that limits activities and adversely affects their quality of life, according to the position paper. Despite other available treatments, opioids are used for long-term management of chronic pain in an estimated 5-8 million Americans and prescriptions for opioids to treat pain increased from 76 million in 1991 to 219 million in 2011. This increase has been accompanied by a rise in opioid overdoses and treatment for addictions to prescription pain medications. The paper cites Centers for Disease Control and Prevention figures estimating that in 2011, there were more than 17,000 opioid-related overdose deaths.

The NIH Pathways to Prevention Workshop was sponsored by the NIH Office of Disease Prevention, the NIH Pain Consortium, the National Institute on Drug Abuse, and the National Institute of Neurological Disorders and Stroke.

None of the authors of the report had disclosures relevant to the topic. Dr. Chou’s disclosures included having received grants from the AHRQ during the study. He has also been a consultant for the U.S. Department of Health and Human Services and the Providers’ Clinical Support System for Opioid Therapies, which is funded by the Substance Abuse and Mental Health Services Administration.

[email protected]

Many patients with type 2 diabetes have “material need insecurities” – trouble paying for food, medications, housing, or utilities – which greatly impact control of the disease and their use of health care resources, according to a report published online Dec. 29 in JAMA Internal Medicine.

If these pressing but nonmedical needs aren’t identified and addressed, increasing access to health care and diabetes treatments will likely be futile, said Dr. Seth A. Berkowitz of Massachusetts General Hospital and Harvard Medical School, Boston, and his associates.

© Tashatuvango/Thinkstockphotos.com

Most previous research into such material needs have focused on a single need in isolation. In their study, Dr. Berkowitz and his colleagues assessed several material needs simultaneously, to obtain a more accurate picture of the real-world experience of diabetes patients at the lower end of the socioeconomic scale. They surveyed 411 patients attending two community health centers, an academic internal medicine practice, or a diabetes specialty clinic in the Boston area during a 1-year period. The mean patient age was 62 years; 48% were women, and 79% were of non-Hispanic white ethnicity. Health insurance coverage was very high, since Massachusetts has near-universal coverage; only 4% of the study participants were uninsured or self-pay clients, and less than 35 lacked coverage of prescription medication.

Eighty respondents reported having a limited or uncertain availability of food due to its cost. This likely included many who relied on cheap, calorie-dense, highly processed foods because of the inaccessibility of healthier alternatives recommended for glycemic control. A total of 104 respondents reported that they underused medications because of costs; 44 reported housing instability, including homelessness, evictions, frequent moves, or residing with friends or relatives to share living expenses; and 72 reported that they couldn’t consistently afford household heating or cooling.

Diabetes patients who had food, medication, housing, or utility insecurities were significantly more likely than others to have poor diabetes control, poor lipid profiles, poor control of hypertension, and to require more outpatient and emergency department/inpatient visits. Moreover, every additional material need insecurity raised the odds of poor diabetes control by 39%, the odds of outpatient visits by 9%, and the odds of emergency department/inpatient visits by 22%, Dr. Berkowitz and his associates said (JAMA Intern. Med. 2014 Dec. 29 [doi:10.1001/jamainternmed.2014.6888]). These findings indicate that to achieve diabetes control, many patients need not just standard medications but comprehensive interventions that also address access to food, medication, and stable housing. Programs that link patients to government and community resources would be beneficial, as would direct supplementation of healthy foods and “bundling” of low-cost (generic) medications such as metformin, statins, and ACE inhibitors, the investigators said.

This study was supported by the Institutional National Research Service, the Ryoichi Sasakawa Fellowship Fund, the division of general internal medicine at Massachusetts General Hospital, and the National Institutes of Health. Dr. Berkowitz and his associates reported having no relevant financial conflicts of interest.

Many patients with type 2 diabetes have “material need insecurities” – trouble paying for food, medications, housing, or utilities – which greatly impact control of the disease and their use of health care resources, according to a report published online Dec. 29 in JAMA Internal Medicine.

If these pressing but nonmedical needs aren’t identified and addressed, increasing access to health care and diabetes treatments will likely be futile, said Dr. Seth A. Berkowitz of Massachusetts General Hospital and Harvard Medical School, Boston, and his associates.

© Tashatuvango/Thinkstockphotos.com

Most previous research into such material needs have focused on a single need in isolation. In their study, Dr. Berkowitz and his colleagues assessed several material needs simultaneously, to obtain a more accurate picture of the real-world experience of diabetes patients at the lower end of the socioeconomic scale. They surveyed 411 patients attending two community health centers, an academic internal medicine practice, or a diabetes specialty clinic in the Boston area during a 1-year period. The mean patient age was 62 years; 48% were women, and 79% were of non-Hispanic white ethnicity. Health insurance coverage was very high, since Massachusetts has near-universal coverage; only 4% of the study participants were uninsured or self-pay clients, and less than 35 lacked coverage of prescription medication.

Eighty respondents reported having a limited or uncertain availability of food due to its cost. This likely included many who relied on cheap, calorie-dense, highly processed foods because of the inaccessibility of healthier alternatives recommended for glycemic control. A total of 104 respondents reported that they underused medications because of costs; 44 reported housing instability, including homelessness, evictions, frequent moves, or residing with friends or relatives to share living expenses; and 72 reported that they couldn’t consistently afford household heating or cooling.

Diabetes patients who had food, medication, housing, or utility insecurities were significantly more likely than others to have poor diabetes control, poor lipid profiles, poor control of hypertension, and to require more outpatient and emergency department/inpatient visits. Moreover, every additional material need insecurity raised the odds of poor diabetes control by 39%, the odds of outpatient visits by 9%, and the odds of emergency department/inpatient visits by 22%, Dr. Berkowitz and his associates said (JAMA Intern. Med. 2014 Dec. 29 [doi:10.1001/jamainternmed.2014.6888]). These findings indicate that to achieve diabetes control, many patients need not just standard medications but comprehensive interventions that also address access to food, medication, and stable housing. Programs that link patients to government and community resources would be beneficial, as would direct supplementation of healthy foods and “bundling” of low-cost (generic) medications such as metformin, statins, and ACE inhibitors, the investigators said.

This study was supported by the Institutional National Research Service, the Ryoichi Sasakawa Fellowship Fund, the division of general internal medicine at Massachusetts General Hospital, and the National Institutes of Health. Dr. Berkowitz and his associates reported having no relevant financial conflicts of interest.

Many patients with type 2 diabetes have “material need insecurities” – trouble paying for food, medications, housing, or utilities – which greatly impact control of the disease and their use of health care resources, according to a report published online Dec. 29 in JAMA Internal Medicine.

If these pressing but nonmedical needs aren’t identified and addressed, increasing access to health care and diabetes treatments will likely be futile, said Dr. Seth A. Berkowitz of Massachusetts General Hospital and Harvard Medical School, Boston, and his associates.

© Tashatuvango/Thinkstockphotos.com

Most previous research into such material needs have focused on a single need in isolation. In their study, Dr. Berkowitz and his colleagues assessed several material needs simultaneously, to obtain a more accurate picture of the real-world experience of diabetes patients at the lower end of the socioeconomic scale. They surveyed 411 patients attending two community health centers, an academic internal medicine practice, or a diabetes specialty clinic in the Boston area during a 1-year period. The mean patient age was 62 years; 48% were women, and 79% were of non-Hispanic white ethnicity. Health insurance coverage was very high, since Massachusetts has near-universal coverage; only 4% of the study participants were uninsured or self-pay clients, and less than 35 lacked coverage of prescription medication.

Eighty respondents reported having a limited or uncertain availability of food due to its cost. This likely included many who relied on cheap, calorie-dense, highly processed foods because of the inaccessibility of healthier alternatives recommended for glycemic control. A total of 104 respondents reported that they underused medications because of costs; 44 reported housing instability, including homelessness, evictions, frequent moves, or residing with friends or relatives to share living expenses; and 72 reported that they couldn’t consistently afford household heating or cooling.

Diabetes patients who had food, medication, housing, or utility insecurities were significantly more likely than others to have poor diabetes control, poor lipid profiles, poor control of hypertension, and to require more outpatient and emergency department/inpatient visits. Moreover, every additional material need insecurity raised the odds of poor diabetes control by 39%, the odds of outpatient visits by 9%, and the odds of emergency department/inpatient visits by 22%, Dr. Berkowitz and his associates said (JAMA Intern. Med. 2014 Dec. 29 [doi:10.1001/jamainternmed.2014.6888]). These findings indicate that to achieve diabetes control, many patients need not just standard medications but comprehensive interventions that also address access to food, medication, and stable housing. Programs that link patients to government and community resources would be beneficial, as would direct supplementation of healthy foods and “bundling” of low-cost (generic) medications such as metformin, statins, and ACE inhibitors, the investigators said.

This study was supported by the Institutional National Research Service, the Ryoichi Sasakawa Fellowship Fund, the division of general internal medicine at Massachusetts General Hospital, and the National Institutes of Health. Dr. Berkowitz and his associates reported having no relevant financial conflicts of interest.

SAN FRANCISCO – Obtaining palliative medicine consultations for geriatric trauma patients may help avoid futile interventions, suggests a retrospective cohort study reported at the annual clinical congress of the American College of Surgeons.

“The bulk of trauma in the United States has become geriatrics, and it’s falls from standing height,” noted lead investigator Dr. Christine C. Toevs, a trauma surgeon at Allegheny General Hospital in Pittsburgh; these older patients often have multiple comorbidities and are frail, and thus have a poor prognosis even with the best of care. “Clearly, this is a patient population that would benefit greatly from routine palliative medicine consultation,” she said.

Dr. Toevs and her colleagues performed a retrospective study of the charts of 5,261 trauma patients treated at their Level 1 trauma center during 2011-2013. One-third were geriatric, defined as aged 65 years or older.

Overall, 15% of geriatric patients and 2% of nongeriatric patients received a palliative medicine consult. The majority in both groups had a traumatic brain injury.

Within the geriatric age-group, about 90% of the patients who had a consult did not undergo tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube placement. Mortality was about 8% in this age-group overall, but 16% in the subset who received a consult.

“It seems that palliative medicine consult within the geriatric patient population does result in [fewer] procedures,” Dr. Toevs commented. “And studies have shown that when we talk to families and patients who participate in their care, they really do not want these procedures.”

Within the nongeriatric age–group, roughly 60% of patients with a consult did not undergo tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube placement. Mortality was about 3% in this age-group overall but 30% for those receiving the consult.

“Younger patients who receive palliative medicine consults seem to have the most severe injuries, not unexpectedly. These tend to be patients with the most severe traumatic brain injuries who still during their hospitalization are not demonstrating any signs of waking up. I think we all agree younger patients need a little more time than older patients, but some families don’t want to go down that route at all,” Dr. Toevs said. “So it’s reasonable before placing a trach in these patients with brain injuries, young or old, to have these discussions.”

Among all patients with a palliative medicine consult, geriatric patients were more likely to be discharged to a skilled nursing facility (32% vs. 15%), whereas nongeriatric patients were more likely to be discharged to a long-term acute care facility (13% vs. 5%) or rehabilitation facility (18% vs. 12%).

Whether avoiding long-term acute care facilities is a better outcome for geriatric patients “depends on how you look at it,” according to Dr. Toevs. “The bulk of the data suggest that 90% of all patients say that they really don’t want all that we do for them at the end of life, so most of us would consider this a better outcome.”

Three-fourths of all geriatric patients with a tracheostomy were discharged to a long-term acute care facility, although data suggest that few such patients survive to discharge. “So what we are doing is we are relocating the death rather than actually addressing the issues of what kind of life do they want,” she commented. “Do they really want the end of their lives to be in an ICU or a step-down ICU in a long-term acute care hospital? So if the patients ultimately get trached, the outcomes tend to be much worse as you can imagine and, in my mind, we have not done nearly as good a job as we should have initially; we should have in some way preempted this, and we didn’t explain to everyone well enough that this really was not considered a good outcome.”

The investigators plan further research in this area, according to Dr. Toevs, who disclosed that she had no relevant conflicts of interest. “We are looking at long-term survival data if we do send them to places after geriatric trauma – what really happens to them, what’s their survival at 6 months and a year – so that we can give [these] data to their families,” she elaborated. “We are also working with our rehab doctors to look at functional assessments and prognostication of these patients, and ultimately, really being able to quantify the benefits of palliative medicine and the goals of care discussions with these patients.”

Invited discussant Dr. Henri R. Ford, chief of surgery at the Children’s Hospital Los Angeles asked, “What were the specific criteria used, on average, to decide whether somebody should get a palliative medicine consultation? Have you tried to standardize that pretty much across the board for all of your trauma patients?”

Use of these consults at her hospital has increased since she began pushing for them, according to Dr. Toevs. “What I would like to do is to make it as routine as possible – every person on the trauma service gets a rehab consult; to some degree, every person on the trauma service should get a palliative medicine consult. It ought to be a checkbox. We are not quite there yet. But right now, I’m pushing for 80% and above, just to make it routine to begin the discussion: Do they have an advance directive? Do they have a power of attorney? Have they thought about these things long term?”

“Did you also compare the injury severity scores for the various patients, not only for the geriatric but also for those who received palliative medicine consultations versus those who did not?” Dr. Ford further asked. “That would be very, very interesting for us in terms of understanding selection bias.”

The investigators looked at these scores in another study, finding that they were lower for geriatric patients than for nongeriatric patients, as expected. “But because of their frailty, they do much poorer. And we are trying to correlate that long term when we are working with our rehab doctors and trying to look at the ability to prognosticate basically upon functional status prior to injury.”

Dr. Toevs disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Obtaining palliative medicine consultations for geriatric trauma patients may help avoid futile interventions, suggests a retrospective cohort study reported at the annual clinical congress of the American College of Surgeons.

“The bulk of trauma in the United States has become geriatrics, and it’s falls from standing height,” noted lead investigator Dr. Christine C. Toevs, a trauma surgeon at Allegheny General Hospital in Pittsburgh; these older patients often have multiple comorbidities and are frail, and thus have a poor prognosis even with the best of care. “Clearly, this is a patient population that would benefit greatly from routine palliative medicine consultation,” she said.

Dr. Toevs and her colleagues performed a retrospective study of the charts of 5,261 trauma patients treated at their Level 1 trauma center during 2011-2013. One-third were geriatric, defined as aged 65 years or older.

Overall, 15% of geriatric patients and 2% of nongeriatric patients received a palliative medicine consult. The majority in both groups had a traumatic brain injury.

Within the geriatric age-group, about 90% of the patients who had a consult did not undergo tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube placement. Mortality was about 8% in this age-group overall, but 16% in the subset who received a consult.

“It seems that palliative medicine consult within the geriatric patient population does result in [fewer] procedures,” Dr. Toevs commented. “And studies have shown that when we talk to families and patients who participate in their care, they really do not want these procedures.”

Within the nongeriatric age–group, roughly 60% of patients with a consult did not undergo tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube placement. Mortality was about 3% in this age-group overall but 30% for those receiving the consult.

“Younger patients who receive palliative medicine consults seem to have the most severe injuries, not unexpectedly. These tend to be patients with the most severe traumatic brain injuries who still during their hospitalization are not demonstrating any signs of waking up. I think we all agree younger patients need a little more time than older patients, but some families don’t want to go down that route at all,” Dr. Toevs said. “So it’s reasonable before placing a trach in these patients with brain injuries, young or old, to have these discussions.”

Among all patients with a palliative medicine consult, geriatric patients were more likely to be discharged to a skilled nursing facility (32% vs. 15%), whereas nongeriatric patients were more likely to be discharged to a long-term acute care facility (13% vs. 5%) or rehabilitation facility (18% vs. 12%).

Whether avoiding long-term acute care facilities is a better outcome for geriatric patients “depends on how you look at it,” according to Dr. Toevs. “The bulk of the data suggest that 90% of all patients say that they really don’t want all that we do for them at the end of life, so most of us would consider this a better outcome.”

Three-fourths of all geriatric patients with a tracheostomy were discharged to a long-term acute care facility, although data suggest that few such patients survive to discharge. “So what we are doing is we are relocating the death rather than actually addressing the issues of what kind of life do they want,” she commented. “Do they really want the end of their lives to be in an ICU or a step-down ICU in a long-term acute care hospital? So if the patients ultimately get trached, the outcomes tend to be much worse as you can imagine and, in my mind, we have not done nearly as good a job as we should have initially; we should have in some way preempted this, and we didn’t explain to everyone well enough that this really was not considered a good outcome.”

The investigators plan further research in this area, according to Dr. Toevs, who disclosed that she had no relevant conflicts of interest. “We are looking at long-term survival data if we do send them to places after geriatric trauma – what really happens to them, what’s their survival at 6 months and a year – so that we can give [these] data to their families,” she elaborated. “We are also working with our rehab doctors to look at functional assessments and prognostication of these patients, and ultimately, really being able to quantify the benefits of palliative medicine and the goals of care discussions with these patients.”

Invited discussant Dr. Henri R. Ford, chief of surgery at the Children’s Hospital Los Angeles asked, “What were the specific criteria used, on average, to decide whether somebody should get a palliative medicine consultation? Have you tried to standardize that pretty much across the board for all of your trauma patients?”

Use of these consults at her hospital has increased since she began pushing for them, according to Dr. Toevs. “What I would like to do is to make it as routine as possible – every person on the trauma service gets a rehab consult; to some degree, every person on the trauma service should get a palliative medicine consult. It ought to be a checkbox. We are not quite there yet. But right now, I’m pushing for 80% and above, just to make it routine to begin the discussion: Do they have an advance directive? Do they have a power of attorney? Have they thought about these things long term?”

“Did you also compare the injury severity scores for the various patients, not only for the geriatric but also for those who received palliative medicine consultations versus those who did not?” Dr. Ford further asked. “That would be very, very interesting for us in terms of understanding selection bias.”

The investigators looked at these scores in another study, finding that they were lower for geriatric patients than for nongeriatric patients, as expected. “But because of their frailty, they do much poorer. And we are trying to correlate that long term when we are working with our rehab doctors and trying to look at the ability to prognosticate basically upon functional status prior to injury.”

Dr. Toevs disclosed that she had no relevant conflicts of interest.

SAN FRANCISCO – Obtaining palliative medicine consultations for geriatric trauma patients may help avoid futile interventions, suggests a retrospective cohort study reported at the annual clinical congress of the American College of Surgeons.

“The bulk of trauma in the United States has become geriatrics, and it’s falls from standing height,” noted lead investigator Dr. Christine C. Toevs, a trauma surgeon at Allegheny General Hospital in Pittsburgh; these older patients often have multiple comorbidities and are frail, and thus have a poor prognosis even with the best of care. “Clearly, this is a patient population that would benefit greatly from routine palliative medicine consultation,” she said.

Dr. Toevs and her colleagues performed a retrospective study of the charts of 5,261 trauma patients treated at their Level 1 trauma center during 2011-2013. One-third were geriatric, defined as aged 65 years or older.

Overall, 15% of geriatric patients and 2% of nongeriatric patients received a palliative medicine consult. The majority in both groups had a traumatic brain injury.

Within the geriatric age-group, about 90% of the patients who had a consult did not undergo tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube placement. Mortality was about 8% in this age-group overall, but 16% in the subset who received a consult.

“It seems that palliative medicine consult within the geriatric patient population does result in [fewer] procedures,” Dr. Toevs commented. “And studies have shown that when we talk to families and patients who participate in their care, they really do not want these procedures.”

Within the nongeriatric age–group, roughly 60% of patients with a consult did not undergo tracheostomy and percutaneous endoscopic gastrostomy (PEG) tube placement. Mortality was about 3% in this age-group overall but 30% for those receiving the consult.

“Younger patients who receive palliative medicine consults seem to have the most severe injuries, not unexpectedly. These tend to be patients with the most severe traumatic brain injuries who still during their hospitalization are not demonstrating any signs of waking up. I think we all agree younger patients need a little more time than older patients, but some families don’t want to go down that route at all,” Dr. Toevs said. “So it’s reasonable before placing a trach in these patients with brain injuries, young or old, to have these discussions.”

Among all patients with a palliative medicine consult, geriatric patients were more likely to be discharged to a skilled nursing facility (32% vs. 15%), whereas nongeriatric patients were more likely to be discharged to a long-term acute care facility (13% vs. 5%) or rehabilitation facility (18% vs. 12%).

Whether avoiding long-term acute care facilities is a better outcome for geriatric patients “depends on how you look at it,” according to Dr. Toevs. “The bulk of the data suggest that 90% of all patients say that they really don’t want all that we do for them at the end of life, so most of us would consider this a better outcome.”

Three-fourths of all geriatric patients with a tracheostomy were discharged to a long-term acute care facility, although data suggest that few such patients survive to discharge. “So what we are doing is we are relocating the death rather than actually addressing the issues of what kind of life do they want,” she commented. “Do they really want the end of their lives to be in an ICU or a step-down ICU in a long-term acute care hospital? So if the patients ultimately get trached, the outcomes tend to be much worse as you can imagine and, in my mind, we have not done nearly as good a job as we should have initially; we should have in some way preempted this, and we didn’t explain to everyone well enough that this really was not considered a good outcome.”

The investigators plan further research in this area, according to Dr. Toevs, who disclosed that she had no relevant conflicts of interest. “We are looking at long-term survival data if we do send them to places after geriatric trauma – what really happens to them, what’s their survival at 6 months and a year – so that we can give [these] data to their families,” she elaborated. “We are also working with our rehab doctors to look at functional assessments and prognostication of these patients, and ultimately, really being able to quantify the benefits of palliative medicine and the goals of care discussions with these patients.”

Invited discussant Dr. Henri R. Ford, chief of surgery at the Children’s Hospital Los Angeles asked, “What were the specific criteria used, on average, to decide whether somebody should get a palliative medicine consultation? Have you tried to standardize that pretty much across the board for all of your trauma patients?”

Use of these consults at her hospital has increased since she began pushing for them, according to Dr. Toevs. “What I would like to do is to make it as routine as possible – every person on the trauma service gets a rehab consult; to some degree, every person on the trauma service should get a palliative medicine consult. It ought to be a checkbox. We are not quite there yet. But right now, I’m pushing for 80% and above, just to make it routine to begin the discussion: Do they have an advance directive? Do they have a power of attorney? Have they thought about these things long term?”

“Did you also compare the injury severity scores for the various patients, not only for the geriatric but also for those who received palliative medicine consultations versus those who did not?” Dr. Ford further asked. “That would be very, very interesting for us in terms of understanding selection bias.”

The investigators looked at these scores in another study, finding that they were lower for geriatric patients than for nongeriatric patients, as expected. “But because of their frailty, they do much poorer. And we are trying to correlate that long term when we are working with our rehab doctors and trying to look at the ability to prognosticate basically upon functional status prior to injury.”

Dr. Toevs disclosed that she had no relevant conflicts of interest.

An extended-release formulation of hydrocodone with properties that are “expected to reduce, but not totally prevent” abuse has been approved, the Food and Drug Administration announced on Nov. 20.

The hydrocodone-only product is indicated for treating pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the FDA statement. It is not approved for as-needed pain relief, and because of its risks for abuse, misuse, and addiction, “should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management,” the FDA statement said.

The product will be marketed as Hysingla ER, by Purdue Pharma, the manufacturer of extended-release oxycodone marketed as OxyContin.

Hysingla ER comes in 20-mg, 30-mg, 40-mg, 60-mg , 100-mg, and 120-mg strengths, taken once a day; daily doses of 80 mg or more should not be prescribed to people who have not previously been treated with an opioid. These amounts are higher than immediate-release hydrocodone combination products, but the range is “comparable” to currently available extended-release opioids, the statement points out.

The tablet has properties that make it difficult to crush, break, or dissolve. It also forms a thick gel when put in liquid, which “resists passage through a hypodermic needle,” according to the prescribing information. While the product’s physical and chemical properties are expected to make abuse by these routes difficult, abuse by these routes is still possible, the FDA statement said.

As part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids, Purdue is required to provide health care professionals with information on how to safely prescribe the drug and to provide documents to patients, including a medication guide with each prescription, about how to safely use, store, and dispose of these products.

The company is also required to conduct postmarketing studies to evaluate the impact of the abuse-deterrent properties on the risk of abuse and the impact of that abuse in the community, according to the statement.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain,” she added.

In October, hydrocodone was switched from a schedule III to the stricter schedule II category.

Hysingla ER is expected to be available in early 2015, according to a statement by Purdue.

In August 2014, hydrocodone was switched from a schedule III to a schedule II controlled substance.

The prescribing information is available at http://www.purduepharma.com/wp-content/uploads/hysinglaerpi.pdf.

[email protected]

An extended-release formulation of hydrocodone with properties that are “expected to reduce, but not totally prevent” abuse has been approved, the Food and Drug Administration announced on Nov. 20.

The hydrocodone-only product is indicated for treating pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the FDA statement. It is not approved for as-needed pain relief, and because of its risks for abuse, misuse, and addiction, “should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management,” the FDA statement said.

The product will be marketed as Hysingla ER, by Purdue Pharma, the manufacturer of extended-release oxycodone marketed as OxyContin.

Hysingla ER comes in 20-mg, 30-mg, 40-mg, 60-mg , 100-mg, and 120-mg strengths, taken once a day; daily doses of 80 mg or more should not be prescribed to people who have not previously been treated with an opioid. These amounts are higher than immediate-release hydrocodone combination products, but the range is “comparable” to currently available extended-release opioids, the statement points out.

The tablet has properties that make it difficult to crush, break, or dissolve. It also forms a thick gel when put in liquid, which “resists passage through a hypodermic needle,” according to the prescribing information. While the product’s physical and chemical properties are expected to make abuse by these routes difficult, abuse by these routes is still possible, the FDA statement said.

As part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids, Purdue is required to provide health care professionals with information on how to safely prescribe the drug and to provide documents to patients, including a medication guide with each prescription, about how to safely use, store, and dispose of these products.

The company is also required to conduct postmarketing studies to evaluate the impact of the abuse-deterrent properties on the risk of abuse and the impact of that abuse in the community, according to the statement.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain,” she added.

In October, hydrocodone was switched from a schedule III to the stricter schedule II category.

Hysingla ER is expected to be available in early 2015, according to a statement by Purdue.

In August 2014, hydrocodone was switched from a schedule III to a schedule II controlled substance.

The prescribing information is available at http://www.purduepharma.com/wp-content/uploads/hysinglaerpi.pdf.

[email protected]

An extended-release formulation of hydrocodone with properties that are “expected to reduce, but not totally prevent” abuse has been approved, the Food and Drug Administration announced on Nov. 20.

The hydrocodone-only product is indicated for treating pain “severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate,” according to the FDA statement. It is not approved for as-needed pain relief, and because of its risks for abuse, misuse, and addiction, “should only be prescribed to people for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient pain management,” the FDA statement said.

The product will be marketed as Hysingla ER, by Purdue Pharma, the manufacturer of extended-release oxycodone marketed as OxyContin.

Hysingla ER comes in 20-mg, 30-mg, 40-mg, 60-mg , 100-mg, and 120-mg strengths, taken once a day; daily doses of 80 mg or more should not be prescribed to people who have not previously been treated with an opioid. These amounts are higher than immediate-release hydrocodone combination products, but the range is “comparable” to currently available extended-release opioids, the statement points out.

The tablet has properties that make it difficult to crush, break, or dissolve. It also forms a thick gel when put in liquid, which “resists passage through a hypodermic needle,” according to the prescribing information. While the product’s physical and chemical properties are expected to make abuse by these routes difficult, abuse by these routes is still possible, the FDA statement said.

As part of the FDA’s Risk Evaluation and Mitigation Strategy (REMS) for extended-release and long-acting opioids, Purdue is required to provide health care professionals with information on how to safely prescribe the drug and to provide documents to patients, including a medication guide with each prescription, about how to safely use, store, and dispose of these products.

The company is also required to conduct postmarketing studies to evaluate the impact of the abuse-deterrent properties on the risk of abuse and the impact of that abuse in the community, according to the statement.

“While the science of abuse deterrence is still evolving, the development of opioids that are harder to abuse is helpful in addressing the public health crisis of prescription drug abuse in the U.S.,” Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in the statement. “Encouraging the development of opioids with abuse-deterrent properties is just one component of a broader approach to reducing abuse and misuse and will better enable the agency to balance addressing this problem with ensuring that patients have access to appropriate treatments for pain,” she added.

In October, hydrocodone was switched from a schedule III to the stricter schedule II category.

Hysingla ER is expected to be available in early 2015, according to a statement by Purdue.

In August 2014, hydrocodone was switched from a schedule III to a schedule II controlled substance.

The prescribing information is available at http://www.purduepharma.com/wp-content/uploads/hysinglaerpi.pdf.

[email protected]

Medicare fee-for-service beneficiaries suffering from poor-prognosis cancer who received hospice care were found to have lower rates of hospitalizations, admissions to intensive care units, and invasive procedures than those who did not receive hospice care, according to a study published in JAMA.

“Our findings highlight the potential importance of frank discussions between physicians and patients about the realities of care at the end of life, an issue of particular importance as the Medicare administration weighs decisions around reimbursing physicians for advance care planning,” said Dr. Ziad Obermeyer of the emergency medicine department at Brigham and Women’s Hospital in Boston, and his associates.

In a matched cohort study, Dr. Obermeyer and his colleagues examined the records of 86,851 patients with poor-prognosis cancer – such as brain, pancreatic, and metastatic malignancies – using a nationally representative, 20% sample of Medicare fee-for-service beneficiaries who died in 2011. Of that group, 51,924 individuals (60%) entered hospice care prior to death, with the median time from first diagnosis to death being 13 months (JAMA 2014;312:1888-96).

The researchers then matched patients in hospice vs. nonhospice care, using factors such as age, sex, region, time from first diagnosis to death, and baseline care utilization. Each sample group consisted of 18,165 individuals, with the non–hospice-care group acting as the control. The median hospice duration for the hospice group was 11 days.

Dr. Obermeyer and his associates discovered that hospice beneficiaries had significantly lower rates of hospitalization (42%), intensive care unit admission (15%), invasive procedures (27%), and deaths in hospitals or nursing facilities (14%), compared with their nonhospice counterparts, who had a 65% rate of hospitalization, a 36% rate of intensive care unit admission, a 51% rate of invasive procedures, and a 74% rate of deaths in hospitals or nursing facilities.

Furthermore, the authors found that nonhospice beneficiaries had a higher rate of health care utilization, largely for acute conditions that were not directly related to their cancer, and higher overall costs. On average, costs for hospice beneficiaries were $62,819, while costs for nonhospice beneficiaries were $71,517.

“Hospice enrollment of 5 to 8 weeks produced the greatest savings; shorter stays produced fewer savings, likely because of both hospice initiation costs, and need for intensive symptom palliation in the days before death,” Dr. Obermeyer and his coauthors wrote. “Cost trajectories began to diverge in the week after hospice enrollment, implying that baseline differences between hospice and nonhospice beneficiaries were not responsible for cost differences,” they added.

The study was supported by grants from the National Institutes of Health, the National Cancer Institute, and the Agency for Healthcare Research and Quality. The authors reported no relevant conflicts of interest.

[email protected]

Medicare fee-for-service beneficiaries suffering from poor-prognosis cancer who received hospice care were found to have lower rates of hospitalizations, admissions to intensive care units, and invasive procedures than those who did not receive hospice care, according to a study published in JAMA.

“Our findings highlight the potential importance of frank discussions between physicians and patients about the realities of care at the end of life, an issue of particular importance as the Medicare administration weighs decisions around reimbursing physicians for advance care planning,” said Dr. Ziad Obermeyer of the emergency medicine department at Brigham and Women’s Hospital in Boston, and his associates.

In a matched cohort study, Dr. Obermeyer and his colleagues examined the records of 86,851 patients with poor-prognosis cancer – such as brain, pancreatic, and metastatic malignancies – using a nationally representative, 20% sample of Medicare fee-for-service beneficiaries who died in 2011. Of that group, 51,924 individuals (60%) entered hospice care prior to death, with the median time from first diagnosis to death being 13 months (JAMA 2014;312:1888-96).

The researchers then matched patients in hospice vs. nonhospice care, using factors such as age, sex, region, time from first diagnosis to death, and baseline care utilization. Each sample group consisted of 18,165 individuals, with the non–hospice-care group acting as the control. The median hospice duration for the hospice group was 11 days.

Dr. Obermeyer and his associates discovered that hospice beneficiaries had significantly lower rates of hospitalization (42%), intensive care unit admission (15%), invasive procedures (27%), and deaths in hospitals or nursing facilities (14%), compared with their nonhospice counterparts, who had a 65% rate of hospitalization, a 36% rate of intensive care unit admission, a 51% rate of invasive procedures, and a 74% rate of deaths in hospitals or nursing facilities.

Furthermore, the authors found that nonhospice beneficiaries had a higher rate of health care utilization, largely for acute conditions that were not directly related to their cancer, and higher overall costs. On average, costs for hospice beneficiaries were $62,819, while costs for nonhospice beneficiaries were $71,517.

“Hospice enrollment of 5 to 8 weeks produced the greatest savings; shorter stays produced fewer savings, likely because of both hospice initiation costs, and need for intensive symptom palliation in the days before death,” Dr. Obermeyer and his coauthors wrote. “Cost trajectories began to diverge in the week after hospice enrollment, implying that baseline differences between hospice and nonhospice beneficiaries were not responsible for cost differences,” they added.

The study was supported by grants from the National Institutes of Health, the National Cancer Institute, and the Agency for Healthcare Research and Quality. The authors reported no relevant conflicts of interest.

[email protected]

Medicare fee-for-service beneficiaries suffering from poor-prognosis cancer who received hospice care were found to have lower rates of hospitalizations, admissions to intensive care units, and invasive procedures than those who did not receive hospice care, according to a study published in JAMA.

“Our findings highlight the potential importance of frank discussions between physicians and patients about the realities of care at the end of life, an issue of particular importance as the Medicare administration weighs decisions around reimbursing physicians for advance care planning,” said Dr. Ziad Obermeyer of the emergency medicine department at Brigham and Women’s Hospital in Boston, and his associates.

In a matched cohort study, Dr. Obermeyer and his colleagues examined the records of 86,851 patients with poor-prognosis cancer – such as brain, pancreatic, and metastatic malignancies – using a nationally representative, 20% sample of Medicare fee-for-service beneficiaries who died in 2011. Of that group, 51,924 individuals (60%) entered hospice care prior to death, with the median time from first diagnosis to death being 13 months (JAMA 2014;312:1888-96).

The researchers then matched patients in hospice vs. nonhospice care, using factors such as age, sex, region, time from first diagnosis to death, and baseline care utilization. Each sample group consisted of 18,165 individuals, with the non–hospice-care group acting as the control. The median hospice duration for the hospice group was 11 days.

Dr. Obermeyer and his associates discovered that hospice beneficiaries had significantly lower rates of hospitalization (42%), intensive care unit admission (15%), invasive procedures (27%), and deaths in hospitals or nursing facilities (14%), compared with their nonhospice counterparts, who had a 65% rate of hospitalization, a 36% rate of intensive care unit admission, a 51% rate of invasive procedures, and a 74% rate of deaths in hospitals or nursing facilities.

Furthermore, the authors found that nonhospice beneficiaries had a higher rate of health care utilization, largely for acute conditions that were not directly related to their cancer, and higher overall costs. On average, costs for hospice beneficiaries were $62,819, while costs for nonhospice beneficiaries were $71,517.

“Hospice enrollment of 5 to 8 weeks produced the greatest savings; shorter stays produced fewer savings, likely because of both hospice initiation costs, and need for intensive symptom palliation in the days before death,” Dr. Obermeyer and his coauthors wrote. “Cost trajectories began to diverge in the week after hospice enrollment, implying that baseline differences between hospice and nonhospice beneficiaries were not responsible for cost differences,” they added.

The study was supported by grants from the National Institutes of Health, the National Cancer Institute, and the Agency for Healthcare Research and Quality. The authors reported no relevant conflicts of interest.

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