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Is pain or dependency driving elevated opioid use among long-term cancer survivors?

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Rates of opioid prescribing were about 1.2 times higher overall among cancer survivors up to 10 years after diagnosis, compared with matched controls, with more than threefold higher rates of opioid prescriptions for survivors of some cancers, according to a Canadian population-based cohort study.

Searching for the cause of these elevated rates reveals the complexity of the survivorship experience, and may also point the way to areas where there’s work to be done, according to physicians whose practices touch the lives of cancer survivors.

In a retrospective matched cohort study of participants in the Ontario Health Insurance Plan and the Ontario Drug Benefits Program, Rinku Sutradhar, PhD, of the University of Toronto, and her colleagues, identified patients aged 18-64 who had a cancer diagnosis at least 5 years previously. Patients were included only if they had not had a cancer recurrence or another malignancy. When compared 1:1 to age- and sex-matched controls, the 8,601 cancer survivors had a relative rate of opioid prescribing of 1.220 (95% confidence interval [CI], 1.209-1.232), the investigators reported (Cancer 2017 Aug 17. doi: 10.1002/cncr.30839).

Opioid prescribing rates varied according to the type of cancer the survivor had had, with a relative rate of 3.119 for noncolorectal gastrointestinal cancer survivors and a rate of 2.066 for lung cancer survivors. Individuals with nonprostate genitourinary cancers had a prescribing rate of 1.619. All of these differences were statistically significant.

Elevated prescribing rates were not seen in patients with brain, breast, colorectal, head and neck, or prostate cancers. The relative rate of prescribing for hematologic cancers was 1.383, a difference that approached, but did not quite reach, statistical significance (P = .0512).

When multivariable analysis was used to stratify individuals by length of time since cancer diagnosis, a significantly elevated relative rate of opioid prescribing persisted; for those 5-10 years from diagnosis, the relative rate was 1.190 (95% CI, 1.040-1.362, P = .011), while for those diagnosed at least 10 years ago, the relative rate was 1.244 (95% CI, 1.090-1.420; P = .00118).

Multivariable analysis was also used to control for income, rural residence, and comorbidities. However, the study could capture only opioids that were obtained with a prescription, and could not track whether medications were taken by the person for whom they were prescribed, Dr. Sutradhar and her colleagues said.

Cancer survivors may have a higher prevalence of chronic pain than the general population for reasons related both to their initial diagnosis and the sequelae of treatments such as surgery, chemotherapy, and radiation therapy, the investigators noted, adding, “it is also possible that a higher rate of opioid prescribing among survivors is due to a dependency that originated from opioid use earlier in the disease trajectory.”

Because of the potential for opioid use disorder and the many adverse effects that can be associated with long-term opioid use, they said, “primary care providers who treat cancer survivors should be encouraged to critically examine reasons for lingering opioid use among their patients.”

The oncologist’s perspective

Walter M. Stadler, MD, an oncologist who treats genitourinary and hematologic cancers, also wonders whether it’s pain or dependency that’s driving the increased prescribing rates in cancer survivors.

Dr. Walter M. Stadler
“If you see these differences in opiate prescribing, is that because they are having pain, and more pain than we recognized in the past, or is this due to inappropriate long-term prescribing in patients who essentially may not have that much more pain, but have become dependent on these drugs?” asked Dr. Stadler, director of the genitourinary program at the University of Chicago’s Cancer Research Center. “Either one is in essence a problem … but we don’t know what the underlying cause may be. We can’t tell that from this particular study,” said Dr. Stadler, who also serves as the hematology/oncology section chief at the university.

One opportunity to reassess which medications and treatment modalities are appropriate for the cancer survivor, said Dr. Stadler, is at the point of discharge from oncology care, which usually happens at about the 5-year mark for patients with no evidence of disease. Survivorship has received more attention since the 2005 Institute of Medicine report calling for increased attention to cancer survivors’ ongoing care. However, he said, “it’s not clear that we do a very good job in terms of educating either the patient or their primary care physician in regards to the kinds of things that we expect, the kinds of things that need to be done, or even a good summary of the therapy that was provided.”

There are resources that can help, he said. “That’s why organizations like [the American Society for Clinical Oncology] have put together some more formal survivorship plans that should be provided when patients are transitioned.”

The realities of clinical life can get in the way of implementation, though. Oncologists are already stretched thin, and most electronic health record systems don’t integrate well with survivorship documentation. Finding staff who can spend the time to gather and package all the necessary information can also be a problem: “People are expensive, and none of us have extra cash lying around,” said Dr. Stadler.

Still, he said, “like a lot of good papers, this raises some issues and areas for further investigation.” First, he said, physicians must assess whether cancer survivors are having chronic pain, and then sort things out from there. “What are the pain syndromes – and what are we doing about them? – because it’s not something that’s been well addressed.”
 

 

 

What can primary care offer?

Larissa Nekhlyudov, MD, is an internal medicine physician whose clinical practice straddles two domains. She sees patients, including some cancer survivors, as a primary care provider; she also provides care in a survivorship clinic to adult survivors of childhood cancers. There, she is able to focus more on survivorship care, developing a care plan and communicating with primary care providers about care elements her patients need.

Dr. Larissa Nekhlyudov
In her roles as a clinician at the Dana-Farber Cancer Institute pediatric cancer survivorship clinic, as a primary care provider at Brigham & Women’s Hospital, and in teaching and research at Harvard Medical School, Boston, , she said she appreciates and emphasizes the heterogeneity of the survivor experience. Though some survivors may be relatively symptom free after treatment, for some, both physical and psychological effects may linger for a lifetime, she said, adding that she was not particularly surprised by the increased opioid-prescribing rates found in the recent study.

It’s reasonable to think that there might be an increased risk for chronic pain syndromes in some of the types of cancer in which elevated opioid prescribing rates were seen, said Dr. Nekhlyudov. “Maybe this is okay.

“Pain in cancer survivors is so multidimensional that it’s quite possible that some of these cancer survivors – gynecologic, lung, other gastrointestinal, genitourinary – might have peripheral neuropathy, adhesions, and so many potential late effects,” said Dr. Nekhlyudov. “However, narcotics are not necessarily the preferred and the only method to treat this pain,” she said, noting that optimal survivorship care might seek to transition these patients to nonopioid therapies or, at least, a multimodal approach.

When she’s wearing her survivorship care hat, said Dr. Nekhlyudov, managing pain medication isn’t always at the top of the to-do list in an office visit. “It’s certainly not uncommon that patients will have a variety of pain issues. But in the survivorship domain, I think that we don’t take the role of managing their pain medications; that piece belongs, really, to their primary care provider,” she said.

“In many ways, it’s difficult to distinguish how much of their pain is related to their cancer, versus not, and figuring out alternatives,” said Dr. Nekhlyudov, applauding the authors’ recognition of the need for a multimodal approach in cancer survivors with pain. However, she said, “that sounds really great on paper, but it’s really not readily available.”

Even in the resource-rich greater Boston area where she practices, said Dr. Nekhlyudov, “it’s very difficult for cancer patients – and noncancer patients – to get hooked into a multidisciplinary, holistic program for pain.”

Although the long-term perspective is helpful, Dr. Nekhlyudov hopes for research that can help identify at what point, and by whom, the opioids were initiated in the cancer survivor population. “What is their trajectory from the time of diagnosis? Are these patients who are started on narcotics during their cancer treatment, and then continue on forever, or are some of these patients being started later, because of late effects?”

In any case, she said, “one of the key pieces is the ownership for this really belongs with both oncologists and the primary care providers.”

Mental health implications of survivorship

Viewing the issue through the lens of mental health offers a slightly different perspective. Thomas B. Strouse, MD, is a psychiatrist who holds the Maddie Katz Chair in palliative care research and education at the University of California, Los Angeles. He said he laments the current “opioidophobia” that calls into question any long-term opioid prescribing.

Acknowledging that there’s certainly a serious nationwide problem with both prescription and nonprescription opioid abuse, Dr. Strouse said he still finds it unfortunate that the current situation has “reactivated for many people a certain set of reflexes that say that any chronic opioid use is always a bad thing. That’s simply not true,” he said.

“Whether opioids are the right treatment for all of those patients, of course, is an entirely fair question. But it’s unfortunate, or wrong, for everybody to approach this article and to say that we know that for all of these patients, chronic opioid therapy is not appropriate,” he added.

Chronic pain that lingers after cancer treatments affects “a very significant minority of cancer survivors,” he said. It’s also true that the meaning of pain can be different for cancer survivors, said Dr. Strouse. For a cancer survivor, “any new pain is cancer pain until proven otherwise,” he said.

Further, pivoting from the attentive, multidisciplinary, wraparound care often received during cancer treatment to the relatively unsupported survivorship experience can be a rough transition for some. Despite the grim reason for the connection, “frequently, it’s the best experience of patients’ lives from a human relations perspective. … We don’t think enough about the loss that the end of cancer treatment may mean for people who may have otherwise unsatisfactory relationships in their lives,” he said.

Dr. Strouse, who works extensively with cancer survivors, said that the elevated rate of opioid prescribing seen in this study “opens the door to a bigger discussion about the challenges in the relatively empty domain of survivorship.” After discharge from cancer care, patients are all too often left without a navigator to help them through the years when, though their treatment is complete, anxiety, financial and social strain, and pain may linger.

The study, he said, should be a call to physicians for “a more meaningful commitment to understanding the burdens of survivorship, and actually offering meaningful clinical services to those people in an integrated and appropriate way.” This might include determining a patient’s absolute minimum opioid requirement, with a goal of getting the patient off opioids, but also making sure the patient has knowledge of and access to alternative pharmacologic and nonpharmacologic treatments for pain. “That seems like a reasonable approach,” said Dr. Strouse.

None of the study’s authors or the physicians interviewed for commentary had relevant conflicts of interest.

 

 

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Rates of opioid prescribing were about 1.2 times higher overall among cancer survivors up to 10 years after diagnosis, compared with matched controls, with more than threefold higher rates of opioid prescriptions for survivors of some cancers, according to a Canadian population-based cohort study.

Searching for the cause of these elevated rates reveals the complexity of the survivorship experience, and may also point the way to areas where there’s work to be done, according to physicians whose practices touch the lives of cancer survivors.

In a retrospective matched cohort study of participants in the Ontario Health Insurance Plan and the Ontario Drug Benefits Program, Rinku Sutradhar, PhD, of the University of Toronto, and her colleagues, identified patients aged 18-64 who had a cancer diagnosis at least 5 years previously. Patients were included only if they had not had a cancer recurrence or another malignancy. When compared 1:1 to age- and sex-matched controls, the 8,601 cancer survivors had a relative rate of opioid prescribing of 1.220 (95% confidence interval [CI], 1.209-1.232), the investigators reported (Cancer 2017 Aug 17. doi: 10.1002/cncr.30839).

Opioid prescribing rates varied according to the type of cancer the survivor had had, with a relative rate of 3.119 for noncolorectal gastrointestinal cancer survivors and a rate of 2.066 for lung cancer survivors. Individuals with nonprostate genitourinary cancers had a prescribing rate of 1.619. All of these differences were statistically significant.

Elevated prescribing rates were not seen in patients with brain, breast, colorectal, head and neck, or prostate cancers. The relative rate of prescribing for hematologic cancers was 1.383, a difference that approached, but did not quite reach, statistical significance (P = .0512).

When multivariable analysis was used to stratify individuals by length of time since cancer diagnosis, a significantly elevated relative rate of opioid prescribing persisted; for those 5-10 years from diagnosis, the relative rate was 1.190 (95% CI, 1.040-1.362, P = .011), while for those diagnosed at least 10 years ago, the relative rate was 1.244 (95% CI, 1.090-1.420; P = .00118).

Multivariable analysis was also used to control for income, rural residence, and comorbidities. However, the study could capture only opioids that were obtained with a prescription, and could not track whether medications were taken by the person for whom they were prescribed, Dr. Sutradhar and her colleagues said.

Cancer survivors may have a higher prevalence of chronic pain than the general population for reasons related both to their initial diagnosis and the sequelae of treatments such as surgery, chemotherapy, and radiation therapy, the investigators noted, adding, “it is also possible that a higher rate of opioid prescribing among survivors is due to a dependency that originated from opioid use earlier in the disease trajectory.”

Because of the potential for opioid use disorder and the many adverse effects that can be associated with long-term opioid use, they said, “primary care providers who treat cancer survivors should be encouraged to critically examine reasons for lingering opioid use among their patients.”

The oncologist’s perspective

Walter M. Stadler, MD, an oncologist who treats genitourinary and hematologic cancers, also wonders whether it’s pain or dependency that’s driving the increased prescribing rates in cancer survivors.

Dr. Walter M. Stadler
“If you see these differences in opiate prescribing, is that because they are having pain, and more pain than we recognized in the past, or is this due to inappropriate long-term prescribing in patients who essentially may not have that much more pain, but have become dependent on these drugs?” asked Dr. Stadler, director of the genitourinary program at the University of Chicago’s Cancer Research Center. “Either one is in essence a problem … but we don’t know what the underlying cause may be. We can’t tell that from this particular study,” said Dr. Stadler, who also serves as the hematology/oncology section chief at the university.

One opportunity to reassess which medications and treatment modalities are appropriate for the cancer survivor, said Dr. Stadler, is at the point of discharge from oncology care, which usually happens at about the 5-year mark for patients with no evidence of disease. Survivorship has received more attention since the 2005 Institute of Medicine report calling for increased attention to cancer survivors’ ongoing care. However, he said, “it’s not clear that we do a very good job in terms of educating either the patient or their primary care physician in regards to the kinds of things that we expect, the kinds of things that need to be done, or even a good summary of the therapy that was provided.”

There are resources that can help, he said. “That’s why organizations like [the American Society for Clinical Oncology] have put together some more formal survivorship plans that should be provided when patients are transitioned.”

The realities of clinical life can get in the way of implementation, though. Oncologists are already stretched thin, and most electronic health record systems don’t integrate well with survivorship documentation. Finding staff who can spend the time to gather and package all the necessary information can also be a problem: “People are expensive, and none of us have extra cash lying around,” said Dr. Stadler.

Still, he said, “like a lot of good papers, this raises some issues and areas for further investigation.” First, he said, physicians must assess whether cancer survivors are having chronic pain, and then sort things out from there. “What are the pain syndromes – and what are we doing about them? – because it’s not something that’s been well addressed.”
 

 

 

What can primary care offer?

Larissa Nekhlyudov, MD, is an internal medicine physician whose clinical practice straddles two domains. She sees patients, including some cancer survivors, as a primary care provider; she also provides care in a survivorship clinic to adult survivors of childhood cancers. There, she is able to focus more on survivorship care, developing a care plan and communicating with primary care providers about care elements her patients need.

Dr. Larissa Nekhlyudov
In her roles as a clinician at the Dana-Farber Cancer Institute pediatric cancer survivorship clinic, as a primary care provider at Brigham & Women’s Hospital, and in teaching and research at Harvard Medical School, Boston, , she said she appreciates and emphasizes the heterogeneity of the survivor experience. Though some survivors may be relatively symptom free after treatment, for some, both physical and psychological effects may linger for a lifetime, she said, adding that she was not particularly surprised by the increased opioid-prescribing rates found in the recent study.

It’s reasonable to think that there might be an increased risk for chronic pain syndromes in some of the types of cancer in which elevated opioid prescribing rates were seen, said Dr. Nekhlyudov. “Maybe this is okay.

“Pain in cancer survivors is so multidimensional that it’s quite possible that some of these cancer survivors – gynecologic, lung, other gastrointestinal, genitourinary – might have peripheral neuropathy, adhesions, and so many potential late effects,” said Dr. Nekhlyudov. “However, narcotics are not necessarily the preferred and the only method to treat this pain,” she said, noting that optimal survivorship care might seek to transition these patients to nonopioid therapies or, at least, a multimodal approach.

When she’s wearing her survivorship care hat, said Dr. Nekhlyudov, managing pain medication isn’t always at the top of the to-do list in an office visit. “It’s certainly not uncommon that patients will have a variety of pain issues. But in the survivorship domain, I think that we don’t take the role of managing their pain medications; that piece belongs, really, to their primary care provider,” she said.

“In many ways, it’s difficult to distinguish how much of their pain is related to their cancer, versus not, and figuring out alternatives,” said Dr. Nekhlyudov, applauding the authors’ recognition of the need for a multimodal approach in cancer survivors with pain. However, she said, “that sounds really great on paper, but it’s really not readily available.”

Even in the resource-rich greater Boston area where she practices, said Dr. Nekhlyudov, “it’s very difficult for cancer patients – and noncancer patients – to get hooked into a multidisciplinary, holistic program for pain.”

Although the long-term perspective is helpful, Dr. Nekhlyudov hopes for research that can help identify at what point, and by whom, the opioids were initiated in the cancer survivor population. “What is their trajectory from the time of diagnosis? Are these patients who are started on narcotics during their cancer treatment, and then continue on forever, or are some of these patients being started later, because of late effects?”

In any case, she said, “one of the key pieces is the ownership for this really belongs with both oncologists and the primary care providers.”

Mental health implications of survivorship

Viewing the issue through the lens of mental health offers a slightly different perspective. Thomas B. Strouse, MD, is a psychiatrist who holds the Maddie Katz Chair in palliative care research and education at the University of California, Los Angeles. He said he laments the current “opioidophobia” that calls into question any long-term opioid prescribing.

Acknowledging that there’s certainly a serious nationwide problem with both prescription and nonprescription opioid abuse, Dr. Strouse said he still finds it unfortunate that the current situation has “reactivated for many people a certain set of reflexes that say that any chronic opioid use is always a bad thing. That’s simply not true,” he said.

“Whether opioids are the right treatment for all of those patients, of course, is an entirely fair question. But it’s unfortunate, or wrong, for everybody to approach this article and to say that we know that for all of these patients, chronic opioid therapy is not appropriate,” he added.

Chronic pain that lingers after cancer treatments affects “a very significant minority of cancer survivors,” he said. It’s also true that the meaning of pain can be different for cancer survivors, said Dr. Strouse. For a cancer survivor, “any new pain is cancer pain until proven otherwise,” he said.

Further, pivoting from the attentive, multidisciplinary, wraparound care often received during cancer treatment to the relatively unsupported survivorship experience can be a rough transition for some. Despite the grim reason for the connection, “frequently, it’s the best experience of patients’ lives from a human relations perspective. … We don’t think enough about the loss that the end of cancer treatment may mean for people who may have otherwise unsatisfactory relationships in their lives,” he said.

Dr. Strouse, who works extensively with cancer survivors, said that the elevated rate of opioid prescribing seen in this study “opens the door to a bigger discussion about the challenges in the relatively empty domain of survivorship.” After discharge from cancer care, patients are all too often left without a navigator to help them through the years when, though their treatment is complete, anxiety, financial and social strain, and pain may linger.

The study, he said, should be a call to physicians for “a more meaningful commitment to understanding the burdens of survivorship, and actually offering meaningful clinical services to those people in an integrated and appropriate way.” This might include determining a patient’s absolute minimum opioid requirement, with a goal of getting the patient off opioids, but also making sure the patient has knowledge of and access to alternative pharmacologic and nonpharmacologic treatments for pain. “That seems like a reasonable approach,” said Dr. Strouse.

None of the study’s authors or the physicians interviewed for commentary had relevant conflicts of interest.

 

 

 

Rates of opioid prescribing were about 1.2 times higher overall among cancer survivors up to 10 years after diagnosis, compared with matched controls, with more than threefold higher rates of opioid prescriptions for survivors of some cancers, according to a Canadian population-based cohort study.

Searching for the cause of these elevated rates reveals the complexity of the survivorship experience, and may also point the way to areas where there’s work to be done, according to physicians whose practices touch the lives of cancer survivors.

In a retrospective matched cohort study of participants in the Ontario Health Insurance Plan and the Ontario Drug Benefits Program, Rinku Sutradhar, PhD, of the University of Toronto, and her colleagues, identified patients aged 18-64 who had a cancer diagnosis at least 5 years previously. Patients were included only if they had not had a cancer recurrence or another malignancy. When compared 1:1 to age- and sex-matched controls, the 8,601 cancer survivors had a relative rate of opioid prescribing of 1.220 (95% confidence interval [CI], 1.209-1.232), the investigators reported (Cancer 2017 Aug 17. doi: 10.1002/cncr.30839).

Opioid prescribing rates varied according to the type of cancer the survivor had had, with a relative rate of 3.119 for noncolorectal gastrointestinal cancer survivors and a rate of 2.066 for lung cancer survivors. Individuals with nonprostate genitourinary cancers had a prescribing rate of 1.619. All of these differences were statistically significant.

Elevated prescribing rates were not seen in patients with brain, breast, colorectal, head and neck, or prostate cancers. The relative rate of prescribing for hematologic cancers was 1.383, a difference that approached, but did not quite reach, statistical significance (P = .0512).

When multivariable analysis was used to stratify individuals by length of time since cancer diagnosis, a significantly elevated relative rate of opioid prescribing persisted; for those 5-10 years from diagnosis, the relative rate was 1.190 (95% CI, 1.040-1.362, P = .011), while for those diagnosed at least 10 years ago, the relative rate was 1.244 (95% CI, 1.090-1.420; P = .00118).

Multivariable analysis was also used to control for income, rural residence, and comorbidities. However, the study could capture only opioids that were obtained with a prescription, and could not track whether medications were taken by the person for whom they were prescribed, Dr. Sutradhar and her colleagues said.

Cancer survivors may have a higher prevalence of chronic pain than the general population for reasons related both to their initial diagnosis and the sequelae of treatments such as surgery, chemotherapy, and radiation therapy, the investigators noted, adding, “it is also possible that a higher rate of opioid prescribing among survivors is due to a dependency that originated from opioid use earlier in the disease trajectory.”

Because of the potential for opioid use disorder and the many adverse effects that can be associated with long-term opioid use, they said, “primary care providers who treat cancer survivors should be encouraged to critically examine reasons for lingering opioid use among their patients.”

The oncologist’s perspective

Walter M. Stadler, MD, an oncologist who treats genitourinary and hematologic cancers, also wonders whether it’s pain or dependency that’s driving the increased prescribing rates in cancer survivors.

Dr. Walter M. Stadler
“If you see these differences in opiate prescribing, is that because they are having pain, and more pain than we recognized in the past, or is this due to inappropriate long-term prescribing in patients who essentially may not have that much more pain, but have become dependent on these drugs?” asked Dr. Stadler, director of the genitourinary program at the University of Chicago’s Cancer Research Center. “Either one is in essence a problem … but we don’t know what the underlying cause may be. We can’t tell that from this particular study,” said Dr. Stadler, who also serves as the hematology/oncology section chief at the university.

One opportunity to reassess which medications and treatment modalities are appropriate for the cancer survivor, said Dr. Stadler, is at the point of discharge from oncology care, which usually happens at about the 5-year mark for patients with no evidence of disease. Survivorship has received more attention since the 2005 Institute of Medicine report calling for increased attention to cancer survivors’ ongoing care. However, he said, “it’s not clear that we do a very good job in terms of educating either the patient or their primary care physician in regards to the kinds of things that we expect, the kinds of things that need to be done, or even a good summary of the therapy that was provided.”

There are resources that can help, he said. “That’s why organizations like [the American Society for Clinical Oncology] have put together some more formal survivorship plans that should be provided when patients are transitioned.”

The realities of clinical life can get in the way of implementation, though. Oncologists are already stretched thin, and most electronic health record systems don’t integrate well with survivorship documentation. Finding staff who can spend the time to gather and package all the necessary information can also be a problem: “People are expensive, and none of us have extra cash lying around,” said Dr. Stadler.

Still, he said, “like a lot of good papers, this raises some issues and areas for further investigation.” First, he said, physicians must assess whether cancer survivors are having chronic pain, and then sort things out from there. “What are the pain syndromes – and what are we doing about them? – because it’s not something that’s been well addressed.”
 

 

 

What can primary care offer?

Larissa Nekhlyudov, MD, is an internal medicine physician whose clinical practice straddles two domains. She sees patients, including some cancer survivors, as a primary care provider; she also provides care in a survivorship clinic to adult survivors of childhood cancers. There, she is able to focus more on survivorship care, developing a care plan and communicating with primary care providers about care elements her patients need.

Dr. Larissa Nekhlyudov
In her roles as a clinician at the Dana-Farber Cancer Institute pediatric cancer survivorship clinic, as a primary care provider at Brigham & Women’s Hospital, and in teaching and research at Harvard Medical School, Boston, , she said she appreciates and emphasizes the heterogeneity of the survivor experience. Though some survivors may be relatively symptom free after treatment, for some, both physical and psychological effects may linger for a lifetime, she said, adding that she was not particularly surprised by the increased opioid-prescribing rates found in the recent study.

It’s reasonable to think that there might be an increased risk for chronic pain syndromes in some of the types of cancer in which elevated opioid prescribing rates were seen, said Dr. Nekhlyudov. “Maybe this is okay.

“Pain in cancer survivors is so multidimensional that it’s quite possible that some of these cancer survivors – gynecologic, lung, other gastrointestinal, genitourinary – might have peripheral neuropathy, adhesions, and so many potential late effects,” said Dr. Nekhlyudov. “However, narcotics are not necessarily the preferred and the only method to treat this pain,” she said, noting that optimal survivorship care might seek to transition these patients to nonopioid therapies or, at least, a multimodal approach.

When she’s wearing her survivorship care hat, said Dr. Nekhlyudov, managing pain medication isn’t always at the top of the to-do list in an office visit. “It’s certainly not uncommon that patients will have a variety of pain issues. But in the survivorship domain, I think that we don’t take the role of managing their pain medications; that piece belongs, really, to their primary care provider,” she said.

“In many ways, it’s difficult to distinguish how much of their pain is related to their cancer, versus not, and figuring out alternatives,” said Dr. Nekhlyudov, applauding the authors’ recognition of the need for a multimodal approach in cancer survivors with pain. However, she said, “that sounds really great on paper, but it’s really not readily available.”

Even in the resource-rich greater Boston area where she practices, said Dr. Nekhlyudov, “it’s very difficult for cancer patients – and noncancer patients – to get hooked into a multidisciplinary, holistic program for pain.”

Although the long-term perspective is helpful, Dr. Nekhlyudov hopes for research that can help identify at what point, and by whom, the opioids were initiated in the cancer survivor population. “What is their trajectory from the time of diagnosis? Are these patients who are started on narcotics during their cancer treatment, and then continue on forever, or are some of these patients being started later, because of late effects?”

In any case, she said, “one of the key pieces is the ownership for this really belongs with both oncologists and the primary care providers.”

Mental health implications of survivorship

Viewing the issue through the lens of mental health offers a slightly different perspective. Thomas B. Strouse, MD, is a psychiatrist who holds the Maddie Katz Chair in palliative care research and education at the University of California, Los Angeles. He said he laments the current “opioidophobia” that calls into question any long-term opioid prescribing.

Acknowledging that there’s certainly a serious nationwide problem with both prescription and nonprescription opioid abuse, Dr. Strouse said he still finds it unfortunate that the current situation has “reactivated for many people a certain set of reflexes that say that any chronic opioid use is always a bad thing. That’s simply not true,” he said.

“Whether opioids are the right treatment for all of those patients, of course, is an entirely fair question. But it’s unfortunate, or wrong, for everybody to approach this article and to say that we know that for all of these patients, chronic opioid therapy is not appropriate,” he added.

Chronic pain that lingers after cancer treatments affects “a very significant minority of cancer survivors,” he said. It’s also true that the meaning of pain can be different for cancer survivors, said Dr. Strouse. For a cancer survivor, “any new pain is cancer pain until proven otherwise,” he said.

Further, pivoting from the attentive, multidisciplinary, wraparound care often received during cancer treatment to the relatively unsupported survivorship experience can be a rough transition for some. Despite the grim reason for the connection, “frequently, it’s the best experience of patients’ lives from a human relations perspective. … We don’t think enough about the loss that the end of cancer treatment may mean for people who may have otherwise unsatisfactory relationships in their lives,” he said.

Dr. Strouse, who works extensively with cancer survivors, said that the elevated rate of opioid prescribing seen in this study “opens the door to a bigger discussion about the challenges in the relatively empty domain of survivorship.” After discharge from cancer care, patients are all too often left without a navigator to help them through the years when, though their treatment is complete, anxiety, financial and social strain, and pain may linger.

The study, he said, should be a call to physicians for “a more meaningful commitment to understanding the burdens of survivorship, and actually offering meaningful clinical services to those people in an integrated and appropriate way.” This might include determining a patient’s absolute minimum opioid requirement, with a goal of getting the patient off opioids, but also making sure the patient has knowledge of and access to alternative pharmacologic and nonpharmacologic treatments for pain. “That seems like a reasonable approach,” said Dr. Strouse.

None of the study’s authors or the physicians interviewed for commentary had relevant conflicts of interest.

 

 

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It’s been 5 days since Texas came under siege from Hurricane Harvey and it left up to 51 inches of rain in its wake. Several Southern cities suffered almost complete loss of homes and businesses. The Houston metropolitan area reported 14 deaths, including one of a police officer who was trying to report for duty. Hundreds of thousands of homes have been damaged or lost, and thousands of people are now in makeshift shelters across the city. We have slowly begun the process of repair and rebuilding, and many Houstonians are returning to work. Many others, including well-known local celebrities like J.J. Watt and MattressMack, are volunteering their time and giving money to help those who were not so fortunate. The rescue and recovery efforts have been lauded for the absence of issues tied to politics, religion, or race.

Despite this, we must not forget that this was a natural disaster unlike anything that’s been seen in recent decades. Much like Katrina and Sandy, Hurricane Harvey brought to the people who have lived through the initial trauma the fear, nightmares, emotional distress, and sleep disturbances associated with posttraumatic stress disorder (PTSD). They will require significant support and monitoring to determine whether there is a need for medical intervention, such as cognitive-behavioral therapy, behavioral modification, or pharmacotherapy. However, we are also witnessing something psychiatrists are just becoming more knowledgeable about – PTSD due to indirect trauma.

Courtesy U.S. Department of Defense
From left, Navy Petty Officer 1st Class Komi Gayakpa and Marine Corps Lance Cpls. Arturo Platamartinez and Alejandro Lopez carry children to safety while performing search and rescue operations in Lumberton, Tex., Aug. 31, 2017, in Harvey's aftermath.
Just in the 2 days of being back to work, I have heard many stories of people who witnessed the flooding in nearby neighborhoods or on the news. Some have helped friends, family, or strangers clean up damaged homes. Most have feelings of immense guilt in surviving Harvey with little to no damage, while fellow Houstonians lost almost everything. Again and again, I shared my patients’ helplessness and inadequacy over not being able to do more. Some even share the same sleep disturbances, trouble concentrating, rumination, intrusive thoughts, and mood changes as the flood victims, although to a lesser degree. While only time will tell if these symptoms blossom into PTSD, the new diagnostic criteria offered by the DSM-5 give mental health care professionals the opportunity to identify at-risk individuals in these situations whom we might have previously missed.

Taking early warnings in stride

When the anchors and journalists began reporting about a tropical cyclone heading toward the Gulf of Mexico on Aug. 17, most Houstonians – myself included – flipped the channel. Living off the Southern Coast of the United States meant seeing more than our fair share of storm systems, including hurricanes. Each time, no matter the damage or the loss, Texans would pull themselves up by their bootstraps and band together to rebuild their beloved city.

So, it’s no surprise that even as Harvey was upgraded to a hurricane and prepared to breach land, we went about business as usual. However, less than a week later, countless residents of the Lone Star State prepared for what promised to be one of the worst storms in recent history.

Moving to Houston from Dallas for college back in 1998, I fell in love with the city and made it my home. I was here when Tropical Storm Allison made landfall in 2001, leaving up to 37 inches of rain and massive flooding in its wake. The Texas Medical Center, where I was working at the Baylor Human Genome Lab for the summer, suffered about $2 billion worth of damage.

I watched as the images and videos of the city under water splashed across my television screen. I witnessed the floodwaters firsthand as my friends and I carefully drove to an overpass and found a vast body of water where a convergence of three highways used to be visible. I was fortunate not to have been affected by the flood, but the fear of West Nile virus worried me for days because of the mosquito infestation that followed. Eventually, the city recovered, the water receded, and we persevered.

In 2005, in the wake of Katrina, Southern Texans were warned of an impending Category 3 hurricane named Rita. Having been inundated with local and national news coverage of the devastation, and hearing the personal stories of evacuees from New Orleans, Houstonians definitely took more notice this time. More than 3 million people from Houston and the surrounding areas evacuated inland before it arrived, but the chaos resulted in indirect deaths from panicked people trying to leave.

I, along with my two best friends and my boyfriend, were among the many who made the lengthy drive to Dallas, where my parents were anxiously waiting. What should have been a 4-hour drive turned into 10, and that was the result of all the back roads we took to get around the majority of the traffic. There were mass outages around the city, but within a few days, we were all back home. Rita left behind much less damage than predicted, and after the water receded, we persevered.

My third encounter with a hurricane was the Category 2 Ike 3 years later. There were mixed emotions going into this one, with many citizens split between evacuating and staying behind. I was in residency by then, and with only a voluntary evacuation for Houston (compared with a mandatory one in Galveston and the coastal cities), I opted to remain. I had already prepared for the worst by barricading all the glass and stocking up on supplies. In addition, I was living in a two-story townhome in an area considered part of a 200-year flood plain, so I figured I was safe. When Ike struck the city, I was up for several hours listening to the howl of the wind and the insistent smacks of rain against my windows. I left town once the coast was clear, not because of flooding, but because Ike knocked out power and water for much of Houston in the middle of a horridly hot September. I stayed with my parents for about a week until my complex had fixed everything, and seeing that the water had receded, I persevered.

 

 

Harvey’s vast destruction

This past week, when Category 4 Hurricane Harvey struck my beloved city, I could not have imagined the losses that were waiting for us. After finishing up a short workday on Friday, Aug. 25, I made my last run for supplies before the weekend. Like many others, I had been keeping an eye on the news as we heard about the destruction Harvey had wreaked on Rockport, South Padre, and Corpus Christi. We all knew that this one was the real deal, that Harvey was going to challenge us in every way possible. For the next 4 days I hunkered down in my house, waiting out the periods of torrential rain while keeping a close eye on the news. At worst, my neighborhood flooded up to the front sidewalk, but water never entered my home, as it did for so many unfortunate individuals. I never lost power, air conditioning, or Internet access. The most distressing thing to happen to me was the inability to leave my home for fear of being caught in the floodwater.

Dr. Jennifer Yen
Having been through three previous major floods, I can honestly say this was unlike anything I had ever experienced. On the first full night of Harvey, I must have checked the rise of water in front of my house every 30 minutes. I was up until nearly 5 a.m., worrying and obsessively watching the news for the most up-to-date predictions. Every time it rained after the first downpour, I could feel the tension take over my body while my mind raced over the possibilities. Through social media, I was privy to the suffering of my friends but helpless to intervene. All the while, Harvey raged on. In spite of the rain and the danger of being swept away, the rescue efforts by neighbors far and wide began. I had never been prouder to call myself a Texan.

We are #The CityWithNoLimits.

We are #HoustonStrong.

We are #TexasStrong.

When the waters recede, we will persevere.
 

Jennifer Yen, MD, is a board-certified child, adolescent, and adult private practice psychiatrist in Houston. She also is a clinical assistant professor of psychiatry at Baylor College of Medicine and serves on the Consumers Issues Committee of the American Academy of Child and Adolescent Psychiatry.

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It’s been 5 days since Texas came under siege from Hurricane Harvey and it left up to 51 inches of rain in its wake. Several Southern cities suffered almost complete loss of homes and businesses. The Houston metropolitan area reported 14 deaths, including one of a police officer who was trying to report for duty. Hundreds of thousands of homes have been damaged or lost, and thousands of people are now in makeshift shelters across the city. We have slowly begun the process of repair and rebuilding, and many Houstonians are returning to work. Many others, including well-known local celebrities like J.J. Watt and MattressMack, are volunteering their time and giving money to help those who were not so fortunate. The rescue and recovery efforts have been lauded for the absence of issues tied to politics, religion, or race.

Despite this, we must not forget that this was a natural disaster unlike anything that’s been seen in recent decades. Much like Katrina and Sandy, Hurricane Harvey brought to the people who have lived through the initial trauma the fear, nightmares, emotional distress, and sleep disturbances associated with posttraumatic stress disorder (PTSD). They will require significant support and monitoring to determine whether there is a need for medical intervention, such as cognitive-behavioral therapy, behavioral modification, or pharmacotherapy. However, we are also witnessing something psychiatrists are just becoming more knowledgeable about – PTSD due to indirect trauma.

Courtesy U.S. Department of Defense
From left, Navy Petty Officer 1st Class Komi Gayakpa and Marine Corps Lance Cpls. Arturo Platamartinez and Alejandro Lopez carry children to safety while performing search and rescue operations in Lumberton, Tex., Aug. 31, 2017, in Harvey's aftermath.
Just in the 2 days of being back to work, I have heard many stories of people who witnessed the flooding in nearby neighborhoods or on the news. Some have helped friends, family, or strangers clean up damaged homes. Most have feelings of immense guilt in surviving Harvey with little to no damage, while fellow Houstonians lost almost everything. Again and again, I shared my patients’ helplessness and inadequacy over not being able to do more. Some even share the same sleep disturbances, trouble concentrating, rumination, intrusive thoughts, and mood changes as the flood victims, although to a lesser degree. While only time will tell if these symptoms blossom into PTSD, the new diagnostic criteria offered by the DSM-5 give mental health care professionals the opportunity to identify at-risk individuals in these situations whom we might have previously missed.

Taking early warnings in stride

When the anchors and journalists began reporting about a tropical cyclone heading toward the Gulf of Mexico on Aug. 17, most Houstonians – myself included – flipped the channel. Living off the Southern Coast of the United States meant seeing more than our fair share of storm systems, including hurricanes. Each time, no matter the damage or the loss, Texans would pull themselves up by their bootstraps and band together to rebuild their beloved city.

So, it’s no surprise that even as Harvey was upgraded to a hurricane and prepared to breach land, we went about business as usual. However, less than a week later, countless residents of the Lone Star State prepared for what promised to be one of the worst storms in recent history.

Moving to Houston from Dallas for college back in 1998, I fell in love with the city and made it my home. I was here when Tropical Storm Allison made landfall in 2001, leaving up to 37 inches of rain and massive flooding in its wake. The Texas Medical Center, where I was working at the Baylor Human Genome Lab for the summer, suffered about $2 billion worth of damage.

I watched as the images and videos of the city under water splashed across my television screen. I witnessed the floodwaters firsthand as my friends and I carefully drove to an overpass and found a vast body of water where a convergence of three highways used to be visible. I was fortunate not to have been affected by the flood, but the fear of West Nile virus worried me for days because of the mosquito infestation that followed. Eventually, the city recovered, the water receded, and we persevered.

In 2005, in the wake of Katrina, Southern Texans were warned of an impending Category 3 hurricane named Rita. Having been inundated with local and national news coverage of the devastation, and hearing the personal stories of evacuees from New Orleans, Houstonians definitely took more notice this time. More than 3 million people from Houston and the surrounding areas evacuated inland before it arrived, but the chaos resulted in indirect deaths from panicked people trying to leave.

I, along with my two best friends and my boyfriend, were among the many who made the lengthy drive to Dallas, where my parents were anxiously waiting. What should have been a 4-hour drive turned into 10, and that was the result of all the back roads we took to get around the majority of the traffic. There were mass outages around the city, but within a few days, we were all back home. Rita left behind much less damage than predicted, and after the water receded, we persevered.

My third encounter with a hurricane was the Category 2 Ike 3 years later. There were mixed emotions going into this one, with many citizens split between evacuating and staying behind. I was in residency by then, and with only a voluntary evacuation for Houston (compared with a mandatory one in Galveston and the coastal cities), I opted to remain. I had already prepared for the worst by barricading all the glass and stocking up on supplies. In addition, I was living in a two-story townhome in an area considered part of a 200-year flood plain, so I figured I was safe. When Ike struck the city, I was up for several hours listening to the howl of the wind and the insistent smacks of rain against my windows. I left town once the coast was clear, not because of flooding, but because Ike knocked out power and water for much of Houston in the middle of a horridly hot September. I stayed with my parents for about a week until my complex had fixed everything, and seeing that the water had receded, I persevered.

 

 

Harvey’s vast destruction

This past week, when Category 4 Hurricane Harvey struck my beloved city, I could not have imagined the losses that were waiting for us. After finishing up a short workday on Friday, Aug. 25, I made my last run for supplies before the weekend. Like many others, I had been keeping an eye on the news as we heard about the destruction Harvey had wreaked on Rockport, South Padre, and Corpus Christi. We all knew that this one was the real deal, that Harvey was going to challenge us in every way possible. For the next 4 days I hunkered down in my house, waiting out the periods of torrential rain while keeping a close eye on the news. At worst, my neighborhood flooded up to the front sidewalk, but water never entered my home, as it did for so many unfortunate individuals. I never lost power, air conditioning, or Internet access. The most distressing thing to happen to me was the inability to leave my home for fear of being caught in the floodwater.

Dr. Jennifer Yen
Having been through three previous major floods, I can honestly say this was unlike anything I had ever experienced. On the first full night of Harvey, I must have checked the rise of water in front of my house every 30 minutes. I was up until nearly 5 a.m., worrying and obsessively watching the news for the most up-to-date predictions. Every time it rained after the first downpour, I could feel the tension take over my body while my mind raced over the possibilities. Through social media, I was privy to the suffering of my friends but helpless to intervene. All the while, Harvey raged on. In spite of the rain and the danger of being swept away, the rescue efforts by neighbors far and wide began. I had never been prouder to call myself a Texan.

We are #The CityWithNoLimits.

We are #HoustonStrong.

We are #TexasStrong.

When the waters recede, we will persevere.
 

Jennifer Yen, MD, is a board-certified child, adolescent, and adult private practice psychiatrist in Houston. She also is a clinical assistant professor of psychiatry at Baylor College of Medicine and serves on the Consumers Issues Committee of the American Academy of Child and Adolescent Psychiatry.

 

It’s been 5 days since Texas came under siege from Hurricane Harvey and it left up to 51 inches of rain in its wake. Several Southern cities suffered almost complete loss of homes and businesses. The Houston metropolitan area reported 14 deaths, including one of a police officer who was trying to report for duty. Hundreds of thousands of homes have been damaged or lost, and thousands of people are now in makeshift shelters across the city. We have slowly begun the process of repair and rebuilding, and many Houstonians are returning to work. Many others, including well-known local celebrities like J.J. Watt and MattressMack, are volunteering their time and giving money to help those who were not so fortunate. The rescue and recovery efforts have been lauded for the absence of issues tied to politics, religion, or race.

Despite this, we must not forget that this was a natural disaster unlike anything that’s been seen in recent decades. Much like Katrina and Sandy, Hurricane Harvey brought to the people who have lived through the initial trauma the fear, nightmares, emotional distress, and sleep disturbances associated with posttraumatic stress disorder (PTSD). They will require significant support and monitoring to determine whether there is a need for medical intervention, such as cognitive-behavioral therapy, behavioral modification, or pharmacotherapy. However, we are also witnessing something psychiatrists are just becoming more knowledgeable about – PTSD due to indirect trauma.

Courtesy U.S. Department of Defense
From left, Navy Petty Officer 1st Class Komi Gayakpa and Marine Corps Lance Cpls. Arturo Platamartinez and Alejandro Lopez carry children to safety while performing search and rescue operations in Lumberton, Tex., Aug. 31, 2017, in Harvey's aftermath.
Just in the 2 days of being back to work, I have heard many stories of people who witnessed the flooding in nearby neighborhoods or on the news. Some have helped friends, family, or strangers clean up damaged homes. Most have feelings of immense guilt in surviving Harvey with little to no damage, while fellow Houstonians lost almost everything. Again and again, I shared my patients’ helplessness and inadequacy over not being able to do more. Some even share the same sleep disturbances, trouble concentrating, rumination, intrusive thoughts, and mood changes as the flood victims, although to a lesser degree. While only time will tell if these symptoms blossom into PTSD, the new diagnostic criteria offered by the DSM-5 give mental health care professionals the opportunity to identify at-risk individuals in these situations whom we might have previously missed.

Taking early warnings in stride

When the anchors and journalists began reporting about a tropical cyclone heading toward the Gulf of Mexico on Aug. 17, most Houstonians – myself included – flipped the channel. Living off the Southern Coast of the United States meant seeing more than our fair share of storm systems, including hurricanes. Each time, no matter the damage or the loss, Texans would pull themselves up by their bootstraps and band together to rebuild their beloved city.

So, it’s no surprise that even as Harvey was upgraded to a hurricane and prepared to breach land, we went about business as usual. However, less than a week later, countless residents of the Lone Star State prepared for what promised to be one of the worst storms in recent history.

Moving to Houston from Dallas for college back in 1998, I fell in love with the city and made it my home. I was here when Tropical Storm Allison made landfall in 2001, leaving up to 37 inches of rain and massive flooding in its wake. The Texas Medical Center, where I was working at the Baylor Human Genome Lab for the summer, suffered about $2 billion worth of damage.

I watched as the images and videos of the city under water splashed across my television screen. I witnessed the floodwaters firsthand as my friends and I carefully drove to an overpass and found a vast body of water where a convergence of three highways used to be visible. I was fortunate not to have been affected by the flood, but the fear of West Nile virus worried me for days because of the mosquito infestation that followed. Eventually, the city recovered, the water receded, and we persevered.

In 2005, in the wake of Katrina, Southern Texans were warned of an impending Category 3 hurricane named Rita. Having been inundated with local and national news coverage of the devastation, and hearing the personal stories of evacuees from New Orleans, Houstonians definitely took more notice this time. More than 3 million people from Houston and the surrounding areas evacuated inland before it arrived, but the chaos resulted in indirect deaths from panicked people trying to leave.

I, along with my two best friends and my boyfriend, were among the many who made the lengthy drive to Dallas, where my parents were anxiously waiting. What should have been a 4-hour drive turned into 10, and that was the result of all the back roads we took to get around the majority of the traffic. There were mass outages around the city, but within a few days, we were all back home. Rita left behind much less damage than predicted, and after the water receded, we persevered.

My third encounter with a hurricane was the Category 2 Ike 3 years later. There were mixed emotions going into this one, with many citizens split between evacuating and staying behind. I was in residency by then, and with only a voluntary evacuation for Houston (compared with a mandatory one in Galveston and the coastal cities), I opted to remain. I had already prepared for the worst by barricading all the glass and stocking up on supplies. In addition, I was living in a two-story townhome in an area considered part of a 200-year flood plain, so I figured I was safe. When Ike struck the city, I was up for several hours listening to the howl of the wind and the insistent smacks of rain against my windows. I left town once the coast was clear, not because of flooding, but because Ike knocked out power and water for much of Houston in the middle of a horridly hot September. I stayed with my parents for about a week until my complex had fixed everything, and seeing that the water had receded, I persevered.

 

 

Harvey’s vast destruction

This past week, when Category 4 Hurricane Harvey struck my beloved city, I could not have imagined the losses that were waiting for us. After finishing up a short workday on Friday, Aug. 25, I made my last run for supplies before the weekend. Like many others, I had been keeping an eye on the news as we heard about the destruction Harvey had wreaked on Rockport, South Padre, and Corpus Christi. We all knew that this one was the real deal, that Harvey was going to challenge us in every way possible. For the next 4 days I hunkered down in my house, waiting out the periods of torrential rain while keeping a close eye on the news. At worst, my neighborhood flooded up to the front sidewalk, but water never entered my home, as it did for so many unfortunate individuals. I never lost power, air conditioning, or Internet access. The most distressing thing to happen to me was the inability to leave my home for fear of being caught in the floodwater.

Dr. Jennifer Yen
Having been through three previous major floods, I can honestly say this was unlike anything I had ever experienced. On the first full night of Harvey, I must have checked the rise of water in front of my house every 30 minutes. I was up until nearly 5 a.m., worrying and obsessively watching the news for the most up-to-date predictions. Every time it rained after the first downpour, I could feel the tension take over my body while my mind raced over the possibilities. Through social media, I was privy to the suffering of my friends but helpless to intervene. All the while, Harvey raged on. In spite of the rain and the danger of being swept away, the rescue efforts by neighbors far and wide began. I had never been prouder to call myself a Texan.

We are #The CityWithNoLimits.

We are #HoustonStrong.

We are #TexasStrong.

When the waters recede, we will persevere.
 

Jennifer Yen, MD, is a board-certified child, adolescent, and adult private practice psychiatrist in Houston. She also is a clinical assistant professor of psychiatry at Baylor College of Medicine and serves on the Consumers Issues Committee of the American Academy of Child and Adolescent Psychiatry.

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Short Takes

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Fri, 09/14/2018 - 11:57
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Hospitalized-patient one-year mortality risk (HOMR) score an excellent prognostic tool

The HOMR score, derived from administrative data, accurately predicts mortality. This study derived the score from medical records which providers can access and found it still accurately determines 1-year mortality.

Citation: Casey G, van Walraven C. Prognosticating with the hospitalized-patient one-year mortality risk score using information abstracted from the medical record. J Hosp Med. 2017 April; 12(4):224-30.

New drug for C. difficile recurrence

Bezlotoxumab is now approved to reduce recurrence of Clostridium difficile. This is an injectable human monoclonal antibody to C. difficile toxin and must be used in conjunction with antibiotics.

Citation: U.S. Food and Drug Administration. Drug Label. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf. Accessed 7 May 2017.

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Hospitalized-patient one-year mortality risk (HOMR) score an excellent prognostic tool

The HOMR score, derived from administrative data, accurately predicts mortality. This study derived the score from medical records which providers can access and found it still accurately determines 1-year mortality.

Citation: Casey G, van Walraven C. Prognosticating with the hospitalized-patient one-year mortality risk score using information abstracted from the medical record. J Hosp Med. 2017 April; 12(4):224-30.

New drug for C. difficile recurrence

Bezlotoxumab is now approved to reduce recurrence of Clostridium difficile. This is an injectable human monoclonal antibody to C. difficile toxin and must be used in conjunction with antibiotics.

Citation: U.S. Food and Drug Administration. Drug Label. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf. Accessed 7 May 2017.

Hospitalized-patient one-year mortality risk (HOMR) score an excellent prognostic tool

The HOMR score, derived from administrative data, accurately predicts mortality. This study derived the score from medical records which providers can access and found it still accurately determines 1-year mortality.

Citation: Casey G, van Walraven C. Prognosticating with the hospitalized-patient one-year mortality risk score using information abstracted from the medical record. J Hosp Med. 2017 April; 12(4):224-30.

New drug for C. difficile recurrence

Bezlotoxumab is now approved to reduce recurrence of Clostridium difficile. This is an injectable human monoclonal antibody to C. difficile toxin and must be used in conjunction with antibiotics.

Citation: U.S. Food and Drug Administration. Drug Label. Available online at https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/761046s000lbl.pdf. Accessed 7 May 2017.

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Case Study - New Onset Seizures in the Elderly

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Thu, 12/15/2022 - 14:53
 

Andrew N. Wilner, MD, FAAN, FACP

Angels Neurological Centers

Abington, MA

 

Case

A 79-year-old woman had 2 generalized tonic-clonic seizures. She had no prior seizures. The patient’s family called 911.

Past medical history was remarkable for asthma, diet-controlled type 2 diabetes, gastroesophageal reflux disease, hypercholesterolemia, hypertension, and osteoporosis. She had a right-sided posterior communicating artery aneurysm coiled and stented 2 years previously.

Medications included aspirin, clopidogrel, an inhaler, ranitidine, and valsartan.

In the emergency room, the patient was initially confused but quickly returned to baseline. Vital signs and neurological examination were normal except for mild ptosis of the right eye, a chronic finding due to compression of the right 3rd nerve by the posterior communicating aneurysm.

Laboratories

Visible on head computed tomography (CT) scan was a thrombosed aneurysmal sac measuring  2.5 x 2 cm (Figure 1) which had increased in size from 2 years ago. Laboratory testing revealed an elevated lactic acid of 4.6 (normal: 0.871-2.1 mmol/L) and decreased CO2 of 20 (normal: 22-30 mEq/l) consistent with recent convulsions. Complete blood count, chemistry, urinalysis, and chest x-ray were normal.

Hospital Course

The patient was treated with levetiracetam and had no further seizures. After a diagnostic angiogram, a stent was placed to divert cerebral blood flow from the aneurysm. The patient was discharged with a prescription for levetiracetam 750 mg twice a day. A routine electroencephalogram (EEG) was unremarkable.

Discussion

Approximately 100,000 new cases of epilepsy are diagnosed in the United States each year.1 The incidence of new onset seizures is highest in the elderly.2 In this age group, the most common cause of provoked new onset epilepsy is acute stroke.2 Brain tumors, dementia, head trauma, and systemic disorders (eg, hepatic failure, hypoglycemia, hyperglycemia, hyponatremia, hypocalcemia, hypothyroidism, infections, and uremia) can all precipitate seizures.2

Seizures due to unruptured cerebral aneurysms are rare, but may be more common with giant aneurysms (2.5 cm or larger).3,4 Unruptured aneurysms may cause seizures due to subclinical hemorrhage, thrombus, or mass effect on the mesial temporal lobe.5 In this patient, mass effect on the right mesial temporal lobe is clearly evident on the magnetic resonance image (MRI)  and is the likely explanation for her seizures (Figure 2).

Conclusion

This unusual case emphasizes the wide range of etiologies for new onset seizures in the elderly and need for a thorough diagnostic evaluation.3

References

1. Browne TR, Holmes GL. Epilepsy [published correction appears in N Engl J Med. 2001;344(25):1956]. N Engl J Med. 2001;344(15):1145-1151.

2. Brodie MJ, Kwan P. Epilepsy in elderly people. BMJ. 2005;331(7528):1317-1322.

3. Cagavi F, Kalayci M, Unal A, Atasoy HT, Cağavi Z, Açikgöz B. Giant unruptured anterior communicating artery aneurysm presenting with seizure. J Clin Neurosci. 2006;13(3):390-394.

4. Hänggi D, Winkler PA, Steiger JH. Primary epileptogenic unruptured intracranial aneurysms: incidence and effect of treatment on epilepsy. Neurosurgery. 2010;66(6):1161-1165.

5. Andereggen L, Andres RH. “Sentinel seizure” as a warning sign preceding fatal rupture of a giant middle cerebral artery aneurysm. World Neurosurg. 2017;100:709.e11-709.e13.

 

Figure 1. CT brain axial image without contrast demonstrating a giant aneurysm adjacent to right mesial temporal lobe

Image courtesy of Andrew N. Wilner, MD, FAAN, FACP.
Abbreviations: MRI, magnetic resonance imaging; T2W-TSE, T2-weighted turbo spin echo.

 

Figure 2. MRI brain coronal image T2W-TSE revealing a giant aneurysm compressing right mesial temporal lobe

 

Image courtesy of Andrew N. Wilner, MD, FAAN, FACP.
Abbreviation: CT: computed tomography.

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Andrew N. Wilner, MD, FAAN, FACP

Angels Neurological Centers

Abington, MA

 

Case

A 79-year-old woman had 2 generalized tonic-clonic seizures. She had no prior seizures. The patient’s family called 911.

Past medical history was remarkable for asthma, diet-controlled type 2 diabetes, gastroesophageal reflux disease, hypercholesterolemia, hypertension, and osteoporosis. She had a right-sided posterior communicating artery aneurysm coiled and stented 2 years previously.

Medications included aspirin, clopidogrel, an inhaler, ranitidine, and valsartan.

In the emergency room, the patient was initially confused but quickly returned to baseline. Vital signs and neurological examination were normal except for mild ptosis of the right eye, a chronic finding due to compression of the right 3rd nerve by the posterior communicating aneurysm.

Laboratories

Visible on head computed tomography (CT) scan was a thrombosed aneurysmal sac measuring  2.5 x 2 cm (Figure 1) which had increased in size from 2 years ago. Laboratory testing revealed an elevated lactic acid of 4.6 (normal: 0.871-2.1 mmol/L) and decreased CO2 of 20 (normal: 22-30 mEq/l) consistent with recent convulsions. Complete blood count, chemistry, urinalysis, and chest x-ray were normal.

Hospital Course

The patient was treated with levetiracetam and had no further seizures. After a diagnostic angiogram, a stent was placed to divert cerebral blood flow from the aneurysm. The patient was discharged with a prescription for levetiracetam 750 mg twice a day. A routine electroencephalogram (EEG) was unremarkable.

Discussion

Approximately 100,000 new cases of epilepsy are diagnosed in the United States each year.1 The incidence of new onset seizures is highest in the elderly.2 In this age group, the most common cause of provoked new onset epilepsy is acute stroke.2 Brain tumors, dementia, head trauma, and systemic disorders (eg, hepatic failure, hypoglycemia, hyperglycemia, hyponatremia, hypocalcemia, hypothyroidism, infections, and uremia) can all precipitate seizures.2

Seizures due to unruptured cerebral aneurysms are rare, but may be more common with giant aneurysms (2.5 cm or larger).3,4 Unruptured aneurysms may cause seizures due to subclinical hemorrhage, thrombus, or mass effect on the mesial temporal lobe.5 In this patient, mass effect on the right mesial temporal lobe is clearly evident on the magnetic resonance image (MRI)  and is the likely explanation for her seizures (Figure 2).

Conclusion

This unusual case emphasizes the wide range of etiologies for new onset seizures in the elderly and need for a thorough diagnostic evaluation.3

References

1. Browne TR, Holmes GL. Epilepsy [published correction appears in N Engl J Med. 2001;344(25):1956]. N Engl J Med. 2001;344(15):1145-1151.

2. Brodie MJ, Kwan P. Epilepsy in elderly people. BMJ. 2005;331(7528):1317-1322.

3. Cagavi F, Kalayci M, Unal A, Atasoy HT, Cağavi Z, Açikgöz B. Giant unruptured anterior communicating artery aneurysm presenting with seizure. J Clin Neurosci. 2006;13(3):390-394.

4. Hänggi D, Winkler PA, Steiger JH. Primary epileptogenic unruptured intracranial aneurysms: incidence and effect of treatment on epilepsy. Neurosurgery. 2010;66(6):1161-1165.

5. Andereggen L, Andres RH. “Sentinel seizure” as a warning sign preceding fatal rupture of a giant middle cerebral artery aneurysm. World Neurosurg. 2017;100:709.e11-709.e13.

 

Figure 1. CT brain axial image without contrast demonstrating a giant aneurysm adjacent to right mesial temporal lobe

Image courtesy of Andrew N. Wilner, MD, FAAN, FACP.
Abbreviations: MRI, magnetic resonance imaging; T2W-TSE, T2-weighted turbo spin echo.

 

Figure 2. MRI brain coronal image T2W-TSE revealing a giant aneurysm compressing right mesial temporal lobe

 

Image courtesy of Andrew N. Wilner, MD, FAAN, FACP.
Abbreviation: CT: computed tomography.

 

Andrew N. Wilner, MD, FAAN, FACP

Angels Neurological Centers

Abington, MA

 

Case

A 79-year-old woman had 2 generalized tonic-clonic seizures. She had no prior seizures. The patient’s family called 911.

Past medical history was remarkable for asthma, diet-controlled type 2 diabetes, gastroesophageal reflux disease, hypercholesterolemia, hypertension, and osteoporosis. She had a right-sided posterior communicating artery aneurysm coiled and stented 2 years previously.

Medications included aspirin, clopidogrel, an inhaler, ranitidine, and valsartan.

In the emergency room, the patient was initially confused but quickly returned to baseline. Vital signs and neurological examination were normal except for mild ptosis of the right eye, a chronic finding due to compression of the right 3rd nerve by the posterior communicating aneurysm.

Laboratories

Visible on head computed tomography (CT) scan was a thrombosed aneurysmal sac measuring  2.5 x 2 cm (Figure 1) which had increased in size from 2 years ago. Laboratory testing revealed an elevated lactic acid of 4.6 (normal: 0.871-2.1 mmol/L) and decreased CO2 of 20 (normal: 22-30 mEq/l) consistent with recent convulsions. Complete blood count, chemistry, urinalysis, and chest x-ray were normal.

Hospital Course

The patient was treated with levetiracetam and had no further seizures. After a diagnostic angiogram, a stent was placed to divert cerebral blood flow from the aneurysm. The patient was discharged with a prescription for levetiracetam 750 mg twice a day. A routine electroencephalogram (EEG) was unremarkable.

Discussion

Approximately 100,000 new cases of epilepsy are diagnosed in the United States each year.1 The incidence of new onset seizures is highest in the elderly.2 In this age group, the most common cause of provoked new onset epilepsy is acute stroke.2 Brain tumors, dementia, head trauma, and systemic disorders (eg, hepatic failure, hypoglycemia, hyperglycemia, hyponatremia, hypocalcemia, hypothyroidism, infections, and uremia) can all precipitate seizures.2

Seizures due to unruptured cerebral aneurysms are rare, but may be more common with giant aneurysms (2.5 cm or larger).3,4 Unruptured aneurysms may cause seizures due to subclinical hemorrhage, thrombus, or mass effect on the mesial temporal lobe.5 In this patient, mass effect on the right mesial temporal lobe is clearly evident on the magnetic resonance image (MRI)  and is the likely explanation for her seizures (Figure 2).

Conclusion

This unusual case emphasizes the wide range of etiologies for new onset seizures in the elderly and need for a thorough diagnostic evaluation.3

References

1. Browne TR, Holmes GL. Epilepsy [published correction appears in N Engl J Med. 2001;344(25):1956]. N Engl J Med. 2001;344(15):1145-1151.

2. Brodie MJ, Kwan P. Epilepsy in elderly people. BMJ. 2005;331(7528):1317-1322.

3. Cagavi F, Kalayci M, Unal A, Atasoy HT, Cağavi Z, Açikgöz B. Giant unruptured anterior communicating artery aneurysm presenting with seizure. J Clin Neurosci. 2006;13(3):390-394.

4. Hänggi D, Winkler PA, Steiger JH. Primary epileptogenic unruptured intracranial aneurysms: incidence and effect of treatment on epilepsy. Neurosurgery. 2010;66(6):1161-1165.

5. Andereggen L, Andres RH. “Sentinel seizure” as a warning sign preceding fatal rupture of a giant middle cerebral artery aneurysm. World Neurosurg. 2017;100:709.e11-709.e13.

 

Figure 1. CT brain axial image without contrast demonstrating a giant aneurysm adjacent to right mesial temporal lobe

Image courtesy of Andrew N. Wilner, MD, FAAN, FACP.
Abbreviations: MRI, magnetic resonance imaging; T2W-TSE, T2-weighted turbo spin echo.

 

Figure 2. MRI brain coronal image T2W-TSE revealing a giant aneurysm compressing right mesial temporal lobe

 

Image courtesy of Andrew N. Wilner, MD, FAAN, FACP.
Abbreviation: CT: computed tomography.

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POEM found safe, effective for treating achalasia after failed Heller myotomy

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Peroral endoscopic myotomy (POEM) safely and effectively treated achalasia in patients with persistent symptoms after Heller myotomy, according to the results of a retrospective study of 180 patients treated at 13 centers worldwide.

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Peroral endoscopic myotomy (POEM) safely and effectively treated achalasia in patients with persistent symptoms after Heller myotomy, according to the results of a retrospective study of 180 patients treated at 13 centers worldwide.

 

Peroral endoscopic myotomy (POEM) safely and effectively treated achalasia in patients with persistent symptoms after Heller myotomy, according to the results of a retrospective study of 180 patients treated at 13 centers worldwide.

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Key clinical point: Peroral endoscopic myotomy (POEM) safely and effectively treated achalasia in patients with persistent symptoms after Heller myotomy.

Major finding: Rates of clinical success were 81% when patients had previously undergone Heller myotomy and 94% when they had not (P = .01). Rates of adverse events (8% and 13%, respectively), as well as rates of postprocedural symptomatic reflux (30% and 32%) and reflux esophagitis (44% and 52%), were similar between groups.

Data source: A multicenter retrospective study of 180 patients with achalasia, half of whom had symptoms despite prior Heller myotomy.

Disclosures: Dr. Ngamruengphong had no disclosures. Three coinvestigators disclosed consulting relationships with Boston Scientific, Medtronic, Sandhill Scientific, Erbe, and Cosmo Pharmaceuticals.

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FDA clears first 2D mammography device with patient-controlled compression

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Thu, 12/15/2022 - 17:52

 

The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.

Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.

The mammography system was cleared through the FDA’s 510(k) process after the agency determined that it was at least as safe and effective as Senographe Pristina, which is already on the market. A clinical validation showed that the addition of the self-compression remote did not negatively impact image quality or significantly increase exam time.

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”

Read more details of the clearance on the FDA’s website.

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The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.

Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.

The mammography system was cleared through the FDA’s 510(k) process after the agency determined that it was at least as safe and effective as Senographe Pristina, which is already on the market. A clinical validation showed that the addition of the self-compression remote did not negatively impact image quality or significantly increase exam time.

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”

Read more details of the clearance on the FDA’s website.

 

The Food and Drug Administration has granted premarket clearance to the first 2D digital mammography system that allows patients to control the amount of compression applied to their own breasts before the mammogram x-ray is taken.

Senographe Pristina with Self-Compression uses a handheld wireless remote control that allows women to adjust the compression force after breast positioning and during a mammography exam. The technologist positions the patient and initiates compression, then guides the patient to gradually increase compression using the remote control until adequate compression is reached. The technologist checks the applied compression and breast positioning and makes the final decision on whether the compression is adequate or needs to be adjusted, according to the FDA’s Sept. 1 announcement.

The mammography system was cleared through the FDA’s 510(k) process after the agency determined that it was at least as safe and effective as Senographe Pristina, which is already on the market. A clinical validation showed that the addition of the self-compression remote did not negatively impact image quality or significantly increase exam time.

“Regular mammograms are an important tool in detecting breast cancer,” Alberto Gutierrez, PhD, director of the FDA’s Office of In Vitro Diagnostics and Radiological Health, said in a statement. “However, some patients may experience anxiety or stress about the discomfort from the compression during the mammogram. This device allows patients some control over the amount of compression for their exam.”

Read more details of the clearance on the FDA’s website.

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Hurricane Harvey tests Houston physicians’ mettle

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As Houston-area citizens evacuated or hunkered down at home in anticipation of Hurricane Harvey, doctors like Mary L. Brandt, MD, FACS, packed a bag and headed to work.

“I came in on Saturday morning [Aug. 23] – I was on call – and so I packed a big suitcase and a big bag of food because I anticipated I would be here until Thursday,” Dr. Brandt said in an interview, “So I became part of the ‘ride-out crew.’ ”

Hospitals were hit hard by Hurricane Harvey, and many struggled against the effects of the Category 4 storm, which made landfall then stalled over Texas for almost a week, pummeling the area.

The National Guard Malcolm McClendon/Texas Military Department/Wikimedia Commons/Public Domain
A contingent from the Texas Army National Guard and Texas Task Force 1 escort a woman in labor after an emergency airlift to a local hospital in Beaumont, Tex., Aug. 30.
Preparations began well before the hurricane arrived. As weather experts and government officials warned of the storm’s imminent arrival, Houston’s Texas Children’s Hospital wasted no time making necessary plans in addition to the safeguards their facilities already had in place, Dr. Brandt said.

“We all know this [flooding] could happen, so all the facilities in the medical center have flood gates, and generators are out of the basement so that there is not any risk of losing all electricity, but then the issue becomes the staff,” Dr. Brandt said. “They can’t get to and from the facility, and that’s particularly true if they live in the periphery of Houston, which is common.”

The situation was the same for many area hospitals. Just 2 miles away from Texas Children’s Hospital, SreyRam Kuy, MD, FACS, associate chief of staff at the Michael E DeBakey VA Medical Center, and her colleagues prepared to run the hospital with a skeleton crew.

“We were preparing when it was still a tropical storm, and we talked to the staff ahead of time to let them know this would be a marathon, not a sprint,” Dr. Kuy said in an interview. “We had people staying in the hospital ahead of time because we were worried that when the hurricane hit, we would not be able to have people return.”

But when Harvey made landfall with Category 4 intensity, many medical facilities were caught by surprise.

“We didn’t know how bad it would be, I honestly don’t think anyone in the city or the state had any idea of how tremendous the impact would be, particularly with the flooding,” Dr. Kuy said. “We had staff going 5, 6 days here at the hospital, working continuously, sleeping on the floor, and because of that, we were able to perform multiple emergency surgeries during the disaster, including laparoscopic treatment of ruptured appendicitis and replacement of an infection aortic graft, which required massive transfusion.” The VA hospital broke from its core mission of caring for veterans, treating “homeless folks and nonveterans who were brought here by the Coast Guard, or the ambulances, or by air.”

At Texas Children’s Hospital, Dr. Brandt and her colleagues were dealing with similar situations, staying on their feet and moving quickly as rescued patients arrived by air.

“We were near the area that was flooding really terribly, and so the Coast Guard had been coming in and bringing kids,” Dr. Brandt said. “Sometimes, we knew what was coming and sometimes we didn’t. It was pretty much controlled chaos.”

Staff shared responsibilities, often taking on tasks far outside their usual roles.

“We didn’t have enough people working the cafeteria, and so, at one point, I put on my hair net, grabbed a ladle, and served in the lunch line,” Dr. Kuy said.

Throughout the storm and flooding, medical professionals fought through exhaustion and depleting supplies, all with little or no knowledge of how their own homes and families were faring.

“We had people here for so long, and they had no idea what was happening in their own homes,” Dr. Kuy said. “They were watching on the news, seeing the reports and watching their own neighborhoods flooded.”

Dr. Brandt and her colleagues would watch as reports came in of what was happening beyond the hospital walls.

“We have some meeting areas, we would watch the weather together and that goes from the janitors to the head of the hospital who was in the hospital with us,” she said.

Despite the chaos outside, morale did not waiver for either Dr. Kuy’s or Dr. Brandt’s crew.

“I remember walking throughout the hospital, doing my rounds, checking up on the units. I went to talk with some of the staff nurses, and what struck me was as I walk in I see these big smiles on their faces, I absolutely did not expect that,” Dr. Kuy said. “They had been in the hospital for 5 days, they were exhausted. It just makes me so proud to serve along these kinds of people.”

As travel became possible, Dr. Kuy and other area physicians – as well as volunteers from across the country – began to shift their focus to evacuation shelters, treating ambulatory patients there.

“The response has been phenomenal,” said Dr. Kuy. “I met an ER doctor from North Carolina who came to volunteer, we have FEMA [Federal Emergency Management Agency] doctors from all across the state, and then of course, all the people from the different VA [hospitals].”

Pediatricians have sent their support as well, offering time and supplies to help take care of the patients at Texas Children’s Hospital, Dr. Brandt said.

At presstime, volunteers were still needed. The Texas Department of State Health Services opened a web portal for volunteer opportunities, and lifted restriction on out-of-state doctors from practicing medicine without state registration.

While there is still much that needs to be done to recover, those on the ground said that they feel an overwhelming feeling of community as people face what will inevitably be a tough road ahead.

“Houston has a reputation and a culture of helping neighbors and it has been astounding to watch what’s happening,” said Dr. Brandt. “No matter how tired people are or how stressful any cases are, everyone’s morale stays high.”
 

 

 

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As Houston-area citizens evacuated or hunkered down at home in anticipation of Hurricane Harvey, doctors like Mary L. Brandt, MD, FACS, packed a bag and headed to work.

“I came in on Saturday morning [Aug. 23] – I was on call – and so I packed a big suitcase and a big bag of food because I anticipated I would be here until Thursday,” Dr. Brandt said in an interview, “So I became part of the ‘ride-out crew.’ ”

Hospitals were hit hard by Hurricane Harvey, and many struggled against the effects of the Category 4 storm, which made landfall then stalled over Texas for almost a week, pummeling the area.

The National Guard Malcolm McClendon/Texas Military Department/Wikimedia Commons/Public Domain
A contingent from the Texas Army National Guard and Texas Task Force 1 escort a woman in labor after an emergency airlift to a local hospital in Beaumont, Tex., Aug. 30.
Preparations began well before the hurricane arrived. As weather experts and government officials warned of the storm’s imminent arrival, Houston’s Texas Children’s Hospital wasted no time making necessary plans in addition to the safeguards their facilities already had in place, Dr. Brandt said.

“We all know this [flooding] could happen, so all the facilities in the medical center have flood gates, and generators are out of the basement so that there is not any risk of losing all electricity, but then the issue becomes the staff,” Dr. Brandt said. “They can’t get to and from the facility, and that’s particularly true if they live in the periphery of Houston, which is common.”

The situation was the same for many area hospitals. Just 2 miles away from Texas Children’s Hospital, SreyRam Kuy, MD, FACS, associate chief of staff at the Michael E DeBakey VA Medical Center, and her colleagues prepared to run the hospital with a skeleton crew.

“We were preparing when it was still a tropical storm, and we talked to the staff ahead of time to let them know this would be a marathon, not a sprint,” Dr. Kuy said in an interview. “We had people staying in the hospital ahead of time because we were worried that when the hurricane hit, we would not be able to have people return.”

But when Harvey made landfall with Category 4 intensity, many medical facilities were caught by surprise.

“We didn’t know how bad it would be, I honestly don’t think anyone in the city or the state had any idea of how tremendous the impact would be, particularly with the flooding,” Dr. Kuy said. “We had staff going 5, 6 days here at the hospital, working continuously, sleeping on the floor, and because of that, we were able to perform multiple emergency surgeries during the disaster, including laparoscopic treatment of ruptured appendicitis and replacement of an infection aortic graft, which required massive transfusion.” The VA hospital broke from its core mission of caring for veterans, treating “homeless folks and nonveterans who were brought here by the Coast Guard, or the ambulances, or by air.”

At Texas Children’s Hospital, Dr. Brandt and her colleagues were dealing with similar situations, staying on their feet and moving quickly as rescued patients arrived by air.

“We were near the area that was flooding really terribly, and so the Coast Guard had been coming in and bringing kids,” Dr. Brandt said. “Sometimes, we knew what was coming and sometimes we didn’t. It was pretty much controlled chaos.”

Staff shared responsibilities, often taking on tasks far outside their usual roles.

“We didn’t have enough people working the cafeteria, and so, at one point, I put on my hair net, grabbed a ladle, and served in the lunch line,” Dr. Kuy said.

Throughout the storm and flooding, medical professionals fought through exhaustion and depleting supplies, all with little or no knowledge of how their own homes and families were faring.

“We had people here for so long, and they had no idea what was happening in their own homes,” Dr. Kuy said. “They were watching on the news, seeing the reports and watching their own neighborhoods flooded.”

Dr. Brandt and her colleagues would watch as reports came in of what was happening beyond the hospital walls.

“We have some meeting areas, we would watch the weather together and that goes from the janitors to the head of the hospital who was in the hospital with us,” she said.

Despite the chaos outside, morale did not waiver for either Dr. Kuy’s or Dr. Brandt’s crew.

“I remember walking throughout the hospital, doing my rounds, checking up on the units. I went to talk with some of the staff nurses, and what struck me was as I walk in I see these big smiles on their faces, I absolutely did not expect that,” Dr. Kuy said. “They had been in the hospital for 5 days, they were exhausted. It just makes me so proud to serve along these kinds of people.”

As travel became possible, Dr. Kuy and other area physicians – as well as volunteers from across the country – began to shift their focus to evacuation shelters, treating ambulatory patients there.

“The response has been phenomenal,” said Dr. Kuy. “I met an ER doctor from North Carolina who came to volunteer, we have FEMA [Federal Emergency Management Agency] doctors from all across the state, and then of course, all the people from the different VA [hospitals].”

Pediatricians have sent their support as well, offering time and supplies to help take care of the patients at Texas Children’s Hospital, Dr. Brandt said.

At presstime, volunteers were still needed. The Texas Department of State Health Services opened a web portal for volunteer opportunities, and lifted restriction on out-of-state doctors from practicing medicine without state registration.

While there is still much that needs to be done to recover, those on the ground said that they feel an overwhelming feeling of community as people face what will inevitably be a tough road ahead.

“Houston has a reputation and a culture of helping neighbors and it has been astounding to watch what’s happening,” said Dr. Brandt. “No matter how tired people are or how stressful any cases are, everyone’s morale stays high.”
 

 

 

 

As Houston-area citizens evacuated or hunkered down at home in anticipation of Hurricane Harvey, doctors like Mary L. Brandt, MD, FACS, packed a bag and headed to work.

“I came in on Saturday morning [Aug. 23] – I was on call – and so I packed a big suitcase and a big bag of food because I anticipated I would be here until Thursday,” Dr. Brandt said in an interview, “So I became part of the ‘ride-out crew.’ ”

Hospitals were hit hard by Hurricane Harvey, and many struggled against the effects of the Category 4 storm, which made landfall then stalled over Texas for almost a week, pummeling the area.

The National Guard Malcolm McClendon/Texas Military Department/Wikimedia Commons/Public Domain
A contingent from the Texas Army National Guard and Texas Task Force 1 escort a woman in labor after an emergency airlift to a local hospital in Beaumont, Tex., Aug. 30.
Preparations began well before the hurricane arrived. As weather experts and government officials warned of the storm’s imminent arrival, Houston’s Texas Children’s Hospital wasted no time making necessary plans in addition to the safeguards their facilities already had in place, Dr. Brandt said.

“We all know this [flooding] could happen, so all the facilities in the medical center have flood gates, and generators are out of the basement so that there is not any risk of losing all electricity, but then the issue becomes the staff,” Dr. Brandt said. “They can’t get to and from the facility, and that’s particularly true if they live in the periphery of Houston, which is common.”

The situation was the same for many area hospitals. Just 2 miles away from Texas Children’s Hospital, SreyRam Kuy, MD, FACS, associate chief of staff at the Michael E DeBakey VA Medical Center, and her colleagues prepared to run the hospital with a skeleton crew.

“We were preparing when it was still a tropical storm, and we talked to the staff ahead of time to let them know this would be a marathon, not a sprint,” Dr. Kuy said in an interview. “We had people staying in the hospital ahead of time because we were worried that when the hurricane hit, we would not be able to have people return.”

But when Harvey made landfall with Category 4 intensity, many medical facilities were caught by surprise.

“We didn’t know how bad it would be, I honestly don’t think anyone in the city or the state had any idea of how tremendous the impact would be, particularly with the flooding,” Dr. Kuy said. “We had staff going 5, 6 days here at the hospital, working continuously, sleeping on the floor, and because of that, we were able to perform multiple emergency surgeries during the disaster, including laparoscopic treatment of ruptured appendicitis and replacement of an infection aortic graft, which required massive transfusion.” The VA hospital broke from its core mission of caring for veterans, treating “homeless folks and nonveterans who were brought here by the Coast Guard, or the ambulances, or by air.”

At Texas Children’s Hospital, Dr. Brandt and her colleagues were dealing with similar situations, staying on their feet and moving quickly as rescued patients arrived by air.

“We were near the area that was flooding really terribly, and so the Coast Guard had been coming in and bringing kids,” Dr. Brandt said. “Sometimes, we knew what was coming and sometimes we didn’t. It was pretty much controlled chaos.”

Staff shared responsibilities, often taking on tasks far outside their usual roles.

“We didn’t have enough people working the cafeteria, and so, at one point, I put on my hair net, grabbed a ladle, and served in the lunch line,” Dr. Kuy said.

Throughout the storm and flooding, medical professionals fought through exhaustion and depleting supplies, all with little or no knowledge of how their own homes and families were faring.

“We had people here for so long, and they had no idea what was happening in their own homes,” Dr. Kuy said. “They were watching on the news, seeing the reports and watching their own neighborhoods flooded.”

Dr. Brandt and her colleagues would watch as reports came in of what was happening beyond the hospital walls.

“We have some meeting areas, we would watch the weather together and that goes from the janitors to the head of the hospital who was in the hospital with us,” she said.

Despite the chaos outside, morale did not waiver for either Dr. Kuy’s or Dr. Brandt’s crew.

“I remember walking throughout the hospital, doing my rounds, checking up on the units. I went to talk with some of the staff nurses, and what struck me was as I walk in I see these big smiles on their faces, I absolutely did not expect that,” Dr. Kuy said. “They had been in the hospital for 5 days, they were exhausted. It just makes me so proud to serve along these kinds of people.”

As travel became possible, Dr. Kuy and other area physicians – as well as volunteers from across the country – began to shift their focus to evacuation shelters, treating ambulatory patients there.

“The response has been phenomenal,” said Dr. Kuy. “I met an ER doctor from North Carolina who came to volunteer, we have FEMA [Federal Emergency Management Agency] doctors from all across the state, and then of course, all the people from the different VA [hospitals].”

Pediatricians have sent their support as well, offering time and supplies to help take care of the patients at Texas Children’s Hospital, Dr. Brandt said.

At presstime, volunteers were still needed. The Texas Department of State Health Services opened a web portal for volunteer opportunities, and lifted restriction on out-of-state doctors from practicing medicine without state registration.

While there is still much that needs to be done to recover, those on the ground said that they feel an overwhelming feeling of community as people face what will inevitably be a tough road ahead.

“Houston has a reputation and a culture of helping neighbors and it has been astounding to watch what’s happening,” said Dr. Brandt. “No matter how tired people are or how stressful any cases are, everyone’s morale stays high.”
 

 

 

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More States Get Funding to Fight Opioid Epidemic

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Tue, 08/21/2018 - 15:35
To combat the national opioid epidemic, the CDC is awarding more than $12 million to states and the District of Columbia to implement more programs and prescribing practice evaluations.

The CDC plans to award more than $12 million to 20 states and the District of Columbia to support responses to the opioid overdose epidemic. The new funding brings the number of recipients to 32.

States can use the funds to report nonfatal and fatal opioid overdose and risk factors linked to fatal overdoses more quickly, share data with key stakeholders, and share data with the CDC to improve multistate surveillance and response.

Fourteen states currently get funding under the Prescription Drug Overdose: Prevention for States (PfS) program, and another 8 will get $4.8 million. The money will allow states to enhance prescription drug-monitoring programs and implement and evaluate strategies to improve safe opioid prescribing practices.

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To combat the national opioid epidemic, the CDC is awarding more than $12 million to states and the District of Columbia to implement more programs and prescribing practice evaluations.
To combat the national opioid epidemic, the CDC is awarding more than $12 million to states and the District of Columbia to implement more programs and prescribing practice evaluations.

The CDC plans to award more than $12 million to 20 states and the District of Columbia to support responses to the opioid overdose epidemic. The new funding brings the number of recipients to 32.

States can use the funds to report nonfatal and fatal opioid overdose and risk factors linked to fatal overdoses more quickly, share data with key stakeholders, and share data with the CDC to improve multistate surveillance and response.

Fourteen states currently get funding under the Prescription Drug Overdose: Prevention for States (PfS) program, and another 8 will get $4.8 million. The money will allow states to enhance prescription drug-monitoring programs and implement and evaluate strategies to improve safe opioid prescribing practices.

The CDC plans to award more than $12 million to 20 states and the District of Columbia to support responses to the opioid overdose epidemic. The new funding brings the number of recipients to 32.

States can use the funds to report nonfatal and fatal opioid overdose and risk factors linked to fatal overdoses more quickly, share data with key stakeholders, and share data with the CDC to improve multistate surveillance and response.

Fourteen states currently get funding under the Prescription Drug Overdose: Prevention for States (PfS) program, and another 8 will get $4.8 million. The money will allow states to enhance prescription drug-monitoring programs and implement and evaluate strategies to improve safe opioid prescribing practices.

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Studies of donor CAR T cells placed on hold

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Wed, 09/06/2017 - 00:04
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Studies of donor CAR T cells placed on hold

Henrique Orlandi Mourao
Micrograph showing AML Image from Paulo

The US Food and Drug Administration (FDA) has placed a clinical hold on both phase 1 studies of UCART123, a universal (allogeneic) chimeric antigen receptor (CAR) T-cell therapy targeting CD123.

One study was designed for patients with acute myeloid leukemia (AML), and the other was designed for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The clinical hold is due to the death of the first patient treated in the BPDCN trial.

The hold means no new subjects can be enrolled in either trial, and there can be no further dosing of subjects who are already enrolled.

BPDCN patient

The first patient treated in the BPDCN trial was a 78-year-old male who had received 1 prior therapy. He presented with relapsed/refractory BPDCN with 30% blasts in his bone marrow and cutaneous lesions (biopsy-proven BPDCN) at baseline.

The patient first received pre-conditioning with fludarabine (30 mg/m²/day for 4 days) and cyclophosphamide (1 g/m²/day for 3 days).

On August 16, 2017 (Day 0), the patient received UCART123 at 6.25 x 105 cells/kg, the first dose level explored in the protocol, without complication.

By Day 5, the patient had developed grade 2 cytokine release syndrome (CRS) and a grade 3 lung infection, which improved after a first dose of tocilizumab and the administration of broad-spectrum, intravenous antibiotics.

On Day 8, the patient was found to have more severe CRS (ultimately grade 5) and grade 4 capillary leak syndrome. Despite receiving treatment in keeping with CRS management, including the administration of corticosteroids and tociluzumab as well as intensive care unit support, the patient died on Day 9.

AML patient

The first patient treated in the AML study experienced similar adverse effects as the BPDCN patient but is still alive.

The AML patient was a 58-year-old woman with 84% blasts in her bone marrow at baseline.

On June 27, 2017 (Day 0), the patient received the same pre-conditioning regimen and the same dose of UCART123 as the BPDCN patient, without complication.

By Day 8, the AML patient had developed grade 2 CRS. This worsened to grade 3 on Day 9 and resolved on Day 11 with treatment in the intensive care unit.

The patient also experienced grade 4 capillary leak syndrome on Day 9 that resolved on Day 12.

Next steps

The data safety monitoring board for these trials met on August 28 and recommended lowering the dose of UCART123 to 6.25 x 104 cells/kg in both studies and capping cyclophosphamide to a total dose of 4 g over 3 days.

Cellectis, the company developing UCART123, said it is working with study investigators and the FDA to resume both trials with an amended protocol that includes these dose adjustments.

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Henrique Orlandi Mourao
Micrograph showing AML Image from Paulo

The US Food and Drug Administration (FDA) has placed a clinical hold on both phase 1 studies of UCART123, a universal (allogeneic) chimeric antigen receptor (CAR) T-cell therapy targeting CD123.

One study was designed for patients with acute myeloid leukemia (AML), and the other was designed for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The clinical hold is due to the death of the first patient treated in the BPDCN trial.

The hold means no new subjects can be enrolled in either trial, and there can be no further dosing of subjects who are already enrolled.

BPDCN patient

The first patient treated in the BPDCN trial was a 78-year-old male who had received 1 prior therapy. He presented with relapsed/refractory BPDCN with 30% blasts in his bone marrow and cutaneous lesions (biopsy-proven BPDCN) at baseline.

The patient first received pre-conditioning with fludarabine (30 mg/m²/day for 4 days) and cyclophosphamide (1 g/m²/day for 3 days).

On August 16, 2017 (Day 0), the patient received UCART123 at 6.25 x 105 cells/kg, the first dose level explored in the protocol, without complication.

By Day 5, the patient had developed grade 2 cytokine release syndrome (CRS) and a grade 3 lung infection, which improved after a first dose of tocilizumab and the administration of broad-spectrum, intravenous antibiotics.

On Day 8, the patient was found to have more severe CRS (ultimately grade 5) and grade 4 capillary leak syndrome. Despite receiving treatment in keeping with CRS management, including the administration of corticosteroids and tociluzumab as well as intensive care unit support, the patient died on Day 9.

AML patient

The first patient treated in the AML study experienced similar adverse effects as the BPDCN patient but is still alive.

The AML patient was a 58-year-old woman with 84% blasts in her bone marrow at baseline.

On June 27, 2017 (Day 0), the patient received the same pre-conditioning regimen and the same dose of UCART123 as the BPDCN patient, without complication.

By Day 8, the AML patient had developed grade 2 CRS. This worsened to grade 3 on Day 9 and resolved on Day 11 with treatment in the intensive care unit.

The patient also experienced grade 4 capillary leak syndrome on Day 9 that resolved on Day 12.

Next steps

The data safety monitoring board for these trials met on August 28 and recommended lowering the dose of UCART123 to 6.25 x 104 cells/kg in both studies and capping cyclophosphamide to a total dose of 4 g over 3 days.

Cellectis, the company developing UCART123, said it is working with study investigators and the FDA to resume both trials with an amended protocol that includes these dose adjustments.

Henrique Orlandi Mourao
Micrograph showing AML Image from Paulo

The US Food and Drug Administration (FDA) has placed a clinical hold on both phase 1 studies of UCART123, a universal (allogeneic) chimeric antigen receptor (CAR) T-cell therapy targeting CD123.

One study was designed for patients with acute myeloid leukemia (AML), and the other was designed for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN).

The clinical hold is due to the death of the first patient treated in the BPDCN trial.

The hold means no new subjects can be enrolled in either trial, and there can be no further dosing of subjects who are already enrolled.

BPDCN patient

The first patient treated in the BPDCN trial was a 78-year-old male who had received 1 prior therapy. He presented with relapsed/refractory BPDCN with 30% blasts in his bone marrow and cutaneous lesions (biopsy-proven BPDCN) at baseline.

The patient first received pre-conditioning with fludarabine (30 mg/m²/day for 4 days) and cyclophosphamide (1 g/m²/day for 3 days).

On August 16, 2017 (Day 0), the patient received UCART123 at 6.25 x 105 cells/kg, the first dose level explored in the protocol, without complication.

By Day 5, the patient had developed grade 2 cytokine release syndrome (CRS) and a grade 3 lung infection, which improved after a first dose of tocilizumab and the administration of broad-spectrum, intravenous antibiotics.

On Day 8, the patient was found to have more severe CRS (ultimately grade 5) and grade 4 capillary leak syndrome. Despite receiving treatment in keeping with CRS management, including the administration of corticosteroids and tociluzumab as well as intensive care unit support, the patient died on Day 9.

AML patient

The first patient treated in the AML study experienced similar adverse effects as the BPDCN patient but is still alive.

The AML patient was a 58-year-old woman with 84% blasts in her bone marrow at baseline.

On June 27, 2017 (Day 0), the patient received the same pre-conditioning regimen and the same dose of UCART123 as the BPDCN patient, without complication.

By Day 8, the AML patient had developed grade 2 CRS. This worsened to grade 3 on Day 9 and resolved on Day 11 with treatment in the intensive care unit.

The patient also experienced grade 4 capillary leak syndrome on Day 9 that resolved on Day 12.

Next steps

The data safety monitoring board for these trials met on August 28 and recommended lowering the dose of UCART123 to 6.25 x 104 cells/kg in both studies and capping cyclophosphamide to a total dose of 4 g over 3 days.

Cellectis, the company developing UCART123, said it is working with study investigators and the FDA to resume both trials with an amended protocol that includes these dose adjustments.

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