PORTLAND, ORE. – Long-term exposure to commonly used estrogen-based contraceptives was not associated with malignant melanoma in a single-center retrospective study of more than 77,000 women.

This null result belied decades-old studies performed when contraceptives contained much higher doses of estrogen, Kelly A. Mueller of Northwestern University, Chicago, said in a poster presented at the annual meeting of the Society for Investigative Dermatology. Current microdosing of ethinyl estradiol (EE) “is not associated with subsequent diagnosis of melanoma in our population, and is not inconsistent with the full prescribing information for commonly prescribed contraceptives containing EE,” she said. The study also shows how large retrospective analyses of long-term follow-up data can inform pharmacovigilance for rare, serious medical events.

©Zerbor/Thinkstock

PORTLAND, ORE. – Long-term exposure to commonly used estrogen-based contraceptives was not associated with malignant melanoma in a single-center retrospective study of more than 77,000 women.

This null result belied decades-old studies performed when contraceptives contained much higher doses of estrogen, Kelly A. Mueller of Northwestern University, Chicago, said in a poster presented at the annual meeting of the Society for Investigative Dermatology. Current microdosing of ethinyl estradiol (EE) “is not associated with subsequent diagnosis of melanoma in our population, and is not inconsistent with the full prescribing information for commonly prescribed contraceptives containing EE,” she said. The study also shows how large retrospective analyses of long-term follow-up data can inform pharmacovigilance for rare, serious medical events.

©Zerbor/Thinkstock

PORTLAND, ORE. – Long-term exposure to commonly used estrogen-based contraceptives was not associated with malignant melanoma in a single-center retrospective study of more than 77,000 women.

This null result belied decades-old studies performed when contraceptives contained much higher doses of estrogen, Kelly A. Mueller of Northwestern University, Chicago, said in a poster presented at the annual meeting of the Society for Investigative Dermatology. Current microdosing of ethinyl estradiol (EE) “is not associated with subsequent diagnosis of melanoma in our population, and is not inconsistent with the full prescribing information for commonly prescribed contraceptives containing EE,” she said. The study also shows how large retrospective analyses of long-term follow-up data can inform pharmacovigilance for rare, serious medical events.

©Zerbor/Thinkstock

SAN FRANCISCO – Cognitive-behavioral therapy for hoarding disorder leaves substantial room for improvement in efficacy, and additional therapeutic attention to maladaptive beliefs regarding perfectionism just might be the answer, Hannah C. Levy, PhD, said at the annual conference of the Anxiety and Depression Association of America.

She presented a secondary analysis of the relationship between cognitive-behavioral therapy (CBT) outcomes and baseline maladaptive beliefs in a wait list–controlled study of 36 patients with hoarding disorder (HD) who were not on psychiatric medication. Her purpose was to identify which cognitive domains predicted treatment outcome. This, in turn, could point the way to new treatment targets.

Bruce Jancin/Frontline Medical News

[email protected]

SAN FRANCISCO – Cognitive-behavioral therapy for hoarding disorder leaves substantial room for improvement in efficacy, and additional therapeutic attention to maladaptive beliefs regarding perfectionism just might be the answer, Hannah C. Levy, PhD, said at the annual conference of the Anxiety and Depression Association of America.

She presented a secondary analysis of the relationship between cognitive-behavioral therapy (CBT) outcomes and baseline maladaptive beliefs in a wait list–controlled study of 36 patients with hoarding disorder (HD) who were not on psychiatric medication. Her purpose was to identify which cognitive domains predicted treatment outcome. This, in turn, could point the way to new treatment targets.

Bruce Jancin/Frontline Medical News

[email protected]

SAN FRANCISCO – Cognitive-behavioral therapy for hoarding disorder leaves substantial room for improvement in efficacy, and additional therapeutic attention to maladaptive beliefs regarding perfectionism just might be the answer, Hannah C. Levy, PhD, said at the annual conference of the Anxiety and Depression Association of America.

She presented a secondary analysis of the relationship between cognitive-behavioral therapy (CBT) outcomes and baseline maladaptive beliefs in a wait list–controlled study of 36 patients with hoarding disorder (HD) who were not on psychiatric medication. Her purpose was to identify which cognitive domains predicted treatment outcome. This, in turn, could point the way to new treatment targets.

Bruce Jancin/Frontline Medical News

[email protected]

LAS VEGAS – Babatunde Akinsete, MD, took a new job about 18 months ago as a lead hospitalist within Adventist Health System of Florida. The role has the expected leadership responsibilities, but those folks he’s now partly supervising are the same ones who used to be his peers.

The same people he spent time “in the trenches” with, complaining about the problems they saw – issues that are now partly his job to help fix.

“It’s tough,” Dr. Akinsete said at the annual meeting of the Society of Hospital Medicine. “How do you motivate people?”

Welcome to managing a practice, circa 2017. The day-to-day doings of an HM group – recruiting, retention, compensation, scheduling and more – are the backbone of the specialty. And SHM’s annual meeting makes the topics a principal point, from a dedicated precourse to dozens of presentations to networking opportunities introducing experienced leaders to nascent ones.

The subject is more relevant than ever these days as the maturing specialty now has three generations of hospitalists practicing side by side, including those who founded the society and laid the groundwork for the specialty some 20 years ago and those who will now infuse it with new blood for the next 20 years, said Jerome Siy, MD, SFHM, an HM17 faculty member and chair of SHM’s Practice Management Committee.

“We’re heading into a cycle of a lot of change,” he said. “Being able to manage change is going to be pretty key.”

The first step in building or bettering a “healthy practice” is building a “culture of ownership,” Dr. Siy said.

“You must have the right culture first if you’re going to tackle any of these issues, whether it’s things like schedules to finances to negotiations,” he added. “Second is this openness and innovation to think outside the box and to allow yourself to hear things that might not work for you. Be open to it because whether you hear something that doesn’t work or not, it may inspire you to figure out … what is the key element you were missing before.”

That’s what Liza Rodriguez Jimenez, MD, is taking away from the meeting. She is moving into a codirector position for her medical group at St. Luke’s in Boise, Idaho. A crash course in alternative-payment models, full-time equivalents (FTEs), relative value units (RVUs) and scheduling was an eye-opener for her.

But to Dr. Siy’s point, it wasn’t the specific examples of how other people do what they do that intrigued Dr. Rodriguez Jimenez. It was more so that people just did it differently.

“It’s just helpful to know that there are other choices,” Dr. Rodriguez Jimenez said. “In other words, why do we do 7 on, 7 off? I don’t know. We just do. If you don’t know that you don’t know, then how do you know to change it? You get exposed to so much stuff here now that you can theoretically go back and say, ‘why do we do 7 on, 7 off? … And then let the group say we want 5 on, 10 off, 4 on, 3 off. Whatever people decide.”

Nasim Afsar, MD, SFHM, chief quality officer of the department of medicine at UCLA Health in Los Angeles, said that idea of just framing the question differently is a big deal, and a leadership skill in and of itself. For example, say a hospital medicine group’s leaders are trying to discuss whether the practice should continue its comanagement focus.

“If you frame a decision as, ‘We are going to lose this comanagement,’ there’s just something, like a gut feeling, you don’t want to lose stuff,” she said. “As opposed to, if you say, ‘Gosh, think about the gains. That we will have all this free time that we now have where we can develop other aspects of our hospital medicine group.’ So when you frame the same exact thing in terms of loss, it becomes so much more difficult for us to actually let go of that.”

Leadership is more than just framing, of course. Dr. Afsar and former SHM president Eric Howell, MD, MHM, said that leadership traits include using standardized processes to make decisions, as well as getting group members involved in those decisions when necessary and using feedback and motivation properly.

But, at day’s end, practice management is managing the needs of your practice.

For Abdul-Hady Kheder, MD, of Hamilton Hospitalists LLC in Central New Jersey, the meeting opened his eyes to techniques he could use to deal with lower reimbursement figures and less patients.

“What can help my situation will be increasing the volume of the practice,” he said. “Right now, we admit 30%-40% of the patients admitted into the hospital. National average is 60%-90% of total hospital admissions. I think that most probably will balance my financial dilemma.”

For Rodney Hollis, practice administrator for Eskenazi Health of Indianapolis, the meeting was a way to glean tips on improving his practice. One nugget he’s excited about: pairing an experienced hospitalist with a new hire for a year. As a nonclinical administrator, Hollis said he views his role as helping clinicians work on the things they are best at, while he handle the rest.

“The more clinical time that the clinical directors can spend, that’s more advantageous to the group,” Hollis said. “Allowing the nonclinical activities to be done by an administrator helps. We want more responsibility and if there’s something that our clinical is doing that I can do, why not have me do it?”

For Dr. Rodriguez Jimenez, open-ended questions like that one are among the most “insightful” takeaways from the meeting.

“There is no right or wrong way, so maybe we’ve been doing it this way ‘just because,’ ” she said. “Now we need to look at it and say, ‘Can we do it a different way? Can we adapt it? Can we change it?’”

She’s starting to sound like a practice manager already.

LAS VEGAS – Babatunde Akinsete, MD, took a new job about 18 months ago as a lead hospitalist within Adventist Health System of Florida. The role has the expected leadership responsibilities, but those folks he’s now partly supervising are the same ones who used to be his peers.

The same people he spent time “in the trenches” with, complaining about the problems they saw – issues that are now partly his job to help fix.

“It’s tough,” Dr. Akinsete said at the annual meeting of the Society of Hospital Medicine. “How do you motivate people?”

Welcome to managing a practice, circa 2017. The day-to-day doings of an HM group – recruiting, retention, compensation, scheduling and more – are the backbone of the specialty. And SHM’s annual meeting makes the topics a principal point, from a dedicated precourse to dozens of presentations to networking opportunities introducing experienced leaders to nascent ones.

The subject is more relevant than ever these days as the maturing specialty now has three generations of hospitalists practicing side by side, including those who founded the society and laid the groundwork for the specialty some 20 years ago and those who will now infuse it with new blood for the next 20 years, said Jerome Siy, MD, SFHM, an HM17 faculty member and chair of SHM’s Practice Management Committee.

“We’re heading into a cycle of a lot of change,” he said. “Being able to manage change is going to be pretty key.”

The first step in building or bettering a “healthy practice” is building a “culture of ownership,” Dr. Siy said.

“You must have the right culture first if you’re going to tackle any of these issues, whether it’s things like schedules to finances to negotiations,” he added. “Second is this openness and innovation to think outside the box and to allow yourself to hear things that might not work for you. Be open to it because whether you hear something that doesn’t work or not, it may inspire you to figure out … what is the key element you were missing before.”

That’s what Liza Rodriguez Jimenez, MD, is taking away from the meeting. She is moving into a codirector position for her medical group at St. Luke’s in Boise, Idaho. A crash course in alternative-payment models, full-time equivalents (FTEs), relative value units (RVUs) and scheduling was an eye-opener for her.

But to Dr. Siy’s point, it wasn’t the specific examples of how other people do what they do that intrigued Dr. Rodriguez Jimenez. It was more so that people just did it differently.

“It’s just helpful to know that there are other choices,” Dr. Rodriguez Jimenez said. “In other words, why do we do 7 on, 7 off? I don’t know. We just do. If you don’t know that you don’t know, then how do you know to change it? You get exposed to so much stuff here now that you can theoretically go back and say, ‘why do we do 7 on, 7 off? … And then let the group say we want 5 on, 10 off, 4 on, 3 off. Whatever people decide.”

Nasim Afsar, MD, SFHM, chief quality officer of the department of medicine at UCLA Health in Los Angeles, said that idea of just framing the question differently is a big deal, and a leadership skill in and of itself. For example, say a hospital medicine group’s leaders are trying to discuss whether the practice should continue its comanagement focus.

“If you frame a decision as, ‘We are going to lose this comanagement,’ there’s just something, like a gut feeling, you don’t want to lose stuff,” she said. “As opposed to, if you say, ‘Gosh, think about the gains. That we will have all this free time that we now have where we can develop other aspects of our hospital medicine group.’ So when you frame the same exact thing in terms of loss, it becomes so much more difficult for us to actually let go of that.”

Leadership is more than just framing, of course. Dr. Afsar and former SHM president Eric Howell, MD, MHM, said that leadership traits include using standardized processes to make decisions, as well as getting group members involved in those decisions when necessary and using feedback and motivation properly.

But, at day’s end, practice management is managing the needs of your practice.

For Abdul-Hady Kheder, MD, of Hamilton Hospitalists LLC in Central New Jersey, the meeting opened his eyes to techniques he could use to deal with lower reimbursement figures and less patients.

“What can help my situation will be increasing the volume of the practice,” he said. “Right now, we admit 30%-40% of the patients admitted into the hospital. National average is 60%-90% of total hospital admissions. I think that most probably will balance my financial dilemma.”

For Rodney Hollis, practice administrator for Eskenazi Health of Indianapolis, the meeting was a way to glean tips on improving his practice. One nugget he’s excited about: pairing an experienced hospitalist with a new hire for a year. As a nonclinical administrator, Hollis said he views his role as helping clinicians work on the things they are best at, while he handle the rest.

“The more clinical time that the clinical directors can spend, that’s more advantageous to the group,” Hollis said. “Allowing the nonclinical activities to be done by an administrator helps. We want more responsibility and if there’s something that our clinical is doing that I can do, why not have me do it?”

For Dr. Rodriguez Jimenez, open-ended questions like that one are among the most “insightful” takeaways from the meeting.

“There is no right or wrong way, so maybe we’ve been doing it this way ‘just because,’ ” she said. “Now we need to look at it and say, ‘Can we do it a different way? Can we adapt it? Can we change it?’”

She’s starting to sound like a practice manager already.

LAS VEGAS – Babatunde Akinsete, MD, took a new job about 18 months ago as a lead hospitalist within Adventist Health System of Florida. The role has the expected leadership responsibilities, but those folks he’s now partly supervising are the same ones who used to be his peers.

The same people he spent time “in the trenches” with, complaining about the problems they saw – issues that are now partly his job to help fix.

“It’s tough,” Dr. Akinsete said at the annual meeting of the Society of Hospital Medicine. “How do you motivate people?”

Welcome to managing a practice, circa 2017. The day-to-day doings of an HM group – recruiting, retention, compensation, scheduling and more – are the backbone of the specialty. And SHM’s annual meeting makes the topics a principal point, from a dedicated precourse to dozens of presentations to networking opportunities introducing experienced leaders to nascent ones.

The subject is more relevant than ever these days as the maturing specialty now has three generations of hospitalists practicing side by side, including those who founded the society and laid the groundwork for the specialty some 20 years ago and those who will now infuse it with new blood for the next 20 years, said Jerome Siy, MD, SFHM, an HM17 faculty member and chair of SHM’s Practice Management Committee.

“We’re heading into a cycle of a lot of change,” he said. “Being able to manage change is going to be pretty key.”

The first step in building or bettering a “healthy practice” is building a “culture of ownership,” Dr. Siy said.

“You must have the right culture first if you’re going to tackle any of these issues, whether it’s things like schedules to finances to negotiations,” he added. “Second is this openness and innovation to think outside the box and to allow yourself to hear things that might not work for you. Be open to it because whether you hear something that doesn’t work or not, it may inspire you to figure out … what is the key element you were missing before.”

That’s what Liza Rodriguez Jimenez, MD, is taking away from the meeting. She is moving into a codirector position for her medical group at St. Luke’s in Boise, Idaho. A crash course in alternative-payment models, full-time equivalents (FTEs), relative value units (RVUs) and scheduling was an eye-opener for her.

But to Dr. Siy’s point, it wasn’t the specific examples of how other people do what they do that intrigued Dr. Rodriguez Jimenez. It was more so that people just did it differently.

“It’s just helpful to know that there are other choices,” Dr. Rodriguez Jimenez said. “In other words, why do we do 7 on, 7 off? I don’t know. We just do. If you don’t know that you don’t know, then how do you know to change it? You get exposed to so much stuff here now that you can theoretically go back and say, ‘why do we do 7 on, 7 off? … And then let the group say we want 5 on, 10 off, 4 on, 3 off. Whatever people decide.”

Nasim Afsar, MD, SFHM, chief quality officer of the department of medicine at UCLA Health in Los Angeles, said that idea of just framing the question differently is a big deal, and a leadership skill in and of itself. For example, say a hospital medicine group’s leaders are trying to discuss whether the practice should continue its comanagement focus.

“If you frame a decision as, ‘We are going to lose this comanagement,’ there’s just something, like a gut feeling, you don’t want to lose stuff,” she said. “As opposed to, if you say, ‘Gosh, think about the gains. That we will have all this free time that we now have where we can develop other aspects of our hospital medicine group.’ So when you frame the same exact thing in terms of loss, it becomes so much more difficult for us to actually let go of that.”

Leadership is more than just framing, of course. Dr. Afsar and former SHM president Eric Howell, MD, MHM, said that leadership traits include using standardized processes to make decisions, as well as getting group members involved in those decisions when necessary and using feedback and motivation properly.

But, at day’s end, practice management is managing the needs of your practice.

For Abdul-Hady Kheder, MD, of Hamilton Hospitalists LLC in Central New Jersey, the meeting opened his eyes to techniques he could use to deal with lower reimbursement figures and less patients.

“What can help my situation will be increasing the volume of the practice,” he said. “Right now, we admit 30%-40% of the patients admitted into the hospital. National average is 60%-90% of total hospital admissions. I think that most probably will balance my financial dilemma.”

For Rodney Hollis, practice administrator for Eskenazi Health of Indianapolis, the meeting was a way to glean tips on improving his practice. One nugget he’s excited about: pairing an experienced hospitalist with a new hire for a year. As a nonclinical administrator, Hollis said he views his role as helping clinicians work on the things they are best at, while he handle the rest.

“The more clinical time that the clinical directors can spend, that’s more advantageous to the group,” Hollis said. “Allowing the nonclinical activities to be done by an administrator helps. We want more responsibility and if there’s something that our clinical is doing that I can do, why not have me do it?”

For Dr. Rodriguez Jimenez, open-ended questions like that one are among the most “insightful” takeaways from the meeting.

“There is no right or wrong way, so maybe we’ve been doing it this way ‘just because,’ ” she said. “Now we need to look at it and say, ‘Can we do it a different way? Can we adapt it? Can we change it?’”

She’s starting to sound like a practice manager already.

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD, of the division of geriatric medicine and palliative care, New York University, and his associates.

Creative-Family/Thinkstock

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD, of the division of geriatric medicine and palliative care, New York University, and his associates.

Creative-Family/Thinkstock

Statin therapy given as primary prevention to adults aged 65 years and older produced no benefit in any primary or secondary outcomes, according to post-hoc analysis of the ALLHAT trial published online May 22 in JAMA Internal Medicine.

Many older Americans take statins for primary cardiovascular prevention even though the evidence supporting such use is both sparse and conflicting, particularly for patients aged 75 years and older, said Benjamin H. Han, MD, of the division of geriatric medicine and palliative care, New York University, and his associates.

Creative-Family/Thinkstock

The Nurses Organization of Veterans Affairs (NOVA) is a national nonprofit professional organization whose members are VA nurses working at VHA facilities throughout the country and caring for America’s heroes. For more than 35 years, NOVA has been the voice of VA nurses. Speaking strongly on behalf of its more than 3,000 members, NOVA leaders recently met in Washington, DC, for the annual Capitol Hill meetings and Legislative Roundtable.

With the elections over and new members taking their seats in the 115th Congress, NOVA leadership spoke candidly about ongoing VA transformation, choice, recruitment and retention, and access to care with respect to the new advanced practice registered nurse (APRN) regulation being implemented across VHA facilities. The APRN regulation allowing APRNs to practice to their full authority within the VA cleared in December. It grants 3 of the 4 APRN roles (nurse practitioners, certified nurse-midwives, and clinical nurse specialists) the ability to practice to the full extent of their education and training.

Armed with copies of the organization’s 2017 Legislative Priority Goals, NOVA leadership met with congressional members and staff of the House and Senate VA committees. Among NOVA’s priorities for the 115th Congress are the following:

• Effects of the federal hiring freeze
• VA transformation
• CHOICE/community-integrated health care
• Information technology
• Retention/recruitment and staffing

For a complete list of the 2017 Legislative Priority Goals, visit vanurse.org

Committee members were eager to hear the opinions of NOVA experts on the Choice Act and on the status of hiring initiatives at their facilities. A key staffing provision of the Veterans Access, Choice, and Accountability Act included an increase in hiring authority and a more generous loan repayment for those looking to work at the VA. In addition, Congress authorized $5 million in funding to hire more medical professionals. A VA internal audit found that the need for additional doctors, nurses, and specialty care was the highest barrier or challenge to providing access to care. NOVA testified on this issue before the 114th Congress.

Staff of House and Senate VA Committees shared other legislative priorities, including the reauthorization of the Choice Act and continued oversight of many areas within the VA, to include a sharp look at access and coordination of care and accountability.

The meeting concluded with the NOVA Legislative Roundtable discussion. Held at the Washington, DC, offices of the Disabled American Veterans service organization, the roundtable was attended by more than 25 organizations that have a stake in veterans’ health care. Leaders from various professional nursing organizations, veterans service organizations, VA Office of Nursing Services, the American Federation of Government Employees, and staff from both the House and Senate VA committees were in attendance.

A lively discussion was held regarding the future of VA health care, APRN implementation, workforce/ retention and recruitment issues, as well as telehealth and the opioid epidemic as it relates to VA patients. The release of the President’s proposed budget also was discussed. As is often the case with a new administration, a “skinny” or outline of a budget proposal is released in advance of an actual detailed budget, which included a substantial 10% increase in VA’s anticipated budget for overall discretionary items (over FY 2017) and an 8.3% increase for medical care (over FY 2017). The agency estimates it will treat about 7.1 million patients in FY 2018, and veterans who served in the ongoing operations in Iraq and Afghanistan are estimated to reach 995,196 in 2018.

For more information about NOVA or to become a member, visit vanurse.org.

The Nurses Organization of Veterans Affairs (NOVA) is a national nonprofit professional organization whose members are VA nurses working at VHA facilities throughout the country and caring for America’s heroes. For more than 35 years, NOVA has been the voice of VA nurses. Speaking strongly on behalf of its more than 3,000 members, NOVA leaders recently met in Washington, DC, for the annual Capitol Hill meetings and Legislative Roundtable.

With the elections over and new members taking their seats in the 115th Congress, NOVA leadership spoke candidly about ongoing VA transformation, choice, recruitment and retention, and access to care with respect to the new advanced practice registered nurse (APRN) regulation being implemented across VHA facilities. The APRN regulation allowing APRNs to practice to their full authority within the VA cleared in December. It grants 3 of the 4 APRN roles (nurse practitioners, certified nurse-midwives, and clinical nurse specialists) the ability to practice to the full extent of their education and training.

Armed with copies of the organization’s 2017 Legislative Priority Goals, NOVA leadership met with congressional members and staff of the House and Senate VA committees. Among NOVA’s priorities for the 115th Congress are the following:

• Effects of the federal hiring freeze
• VA transformation
• CHOICE/community-integrated health care
• Information technology
• Retention/recruitment and staffing

For a complete list of the 2017 Legislative Priority Goals, visit vanurse.org

Committee members were eager to hear the opinions of NOVA experts on the Choice Act and on the status of hiring initiatives at their facilities. A key staffing provision of the Veterans Access, Choice, and Accountability Act included an increase in hiring authority and a more generous loan repayment for those looking to work at the VA. In addition, Congress authorized $5 million in funding to hire more medical professionals. A VA internal audit found that the need for additional doctors, nurses, and specialty care was the highest barrier or challenge to providing access to care. NOVA testified on this issue before the 114th Congress.

Staff of House and Senate VA Committees shared other legislative priorities, including the reauthorization of the Choice Act and continued oversight of many areas within the VA, to include a sharp look at access and coordination of care and accountability.

The meeting concluded with the NOVA Legislative Roundtable discussion. Held at the Washington, DC, offices of the Disabled American Veterans service organization, the roundtable was attended by more than 25 organizations that have a stake in veterans’ health care. Leaders from various professional nursing organizations, veterans service organizations, VA Office of Nursing Services, the American Federation of Government Employees, and staff from both the House and Senate VA committees were in attendance.

A lively discussion was held regarding the future of VA health care, APRN implementation, workforce/ retention and recruitment issues, as well as telehealth and the opioid epidemic as it relates to VA patients. The release of the President’s proposed budget also was discussed. As is often the case with a new administration, a “skinny” or outline of a budget proposal is released in advance of an actual detailed budget, which included a substantial 10% increase in VA’s anticipated budget for overall discretionary items (over FY 2017) and an 8.3% increase for medical care (over FY 2017). The agency estimates it will treat about 7.1 million patients in FY 2018, and veterans who served in the ongoing operations in Iraq and Afghanistan are estimated to reach 995,196 in 2018.

For more information about NOVA or to become a member, visit vanurse.org.

The Nurses Organization of Veterans Affairs (NOVA) is a national nonprofit professional organization whose members are VA nurses working at VHA facilities throughout the country and caring for America’s heroes. For more than 35 years, NOVA has been the voice of VA nurses. Speaking strongly on behalf of its more than 3,000 members, NOVA leaders recently met in Washington, DC, for the annual Capitol Hill meetings and Legislative Roundtable.

With the elections over and new members taking their seats in the 115th Congress, NOVA leadership spoke candidly about ongoing VA transformation, choice, recruitment and retention, and access to care with respect to the new advanced practice registered nurse (APRN) regulation being implemented across VHA facilities. The APRN regulation allowing APRNs to practice to their full authority within the VA cleared in December. It grants 3 of the 4 APRN roles (nurse practitioners, certified nurse-midwives, and clinical nurse specialists) the ability to practice to the full extent of their education and training.

Armed with copies of the organization’s 2017 Legislative Priority Goals, NOVA leadership met with congressional members and staff of the House and Senate VA committees. Among NOVA’s priorities for the 115th Congress are the following:

• Effects of the federal hiring freeze
• VA transformation
• CHOICE/community-integrated health care
• Information technology
• Retention/recruitment and staffing

For a complete list of the 2017 Legislative Priority Goals, visit vanurse.org

Committee members were eager to hear the opinions of NOVA experts on the Choice Act and on the status of hiring initiatives at their facilities. A key staffing provision of the Veterans Access, Choice, and Accountability Act included an increase in hiring authority and a more generous loan repayment for those looking to work at the VA. In addition, Congress authorized $5 million in funding to hire more medical professionals. A VA internal audit found that the need for additional doctors, nurses, and specialty care was the highest barrier or challenge to providing access to care. NOVA testified on this issue before the 114th Congress.

Staff of House and Senate VA Committees shared other legislative priorities, including the reauthorization of the Choice Act and continued oversight of many areas within the VA, to include a sharp look at access and coordination of care and accountability.

The meeting concluded with the NOVA Legislative Roundtable discussion. Held at the Washington, DC, offices of the Disabled American Veterans service organization, the roundtable was attended by more than 25 organizations that have a stake in veterans’ health care. Leaders from various professional nursing organizations, veterans service organizations, VA Office of Nursing Services, the American Federation of Government Employees, and staff from both the House and Senate VA committees were in attendance.

A lively discussion was held regarding the future of VA health care, APRN implementation, workforce/ retention and recruitment issues, as well as telehealth and the opioid epidemic as it relates to VA patients. The release of the President’s proposed budget also was discussed. As is often the case with a new administration, a “skinny” or outline of a budget proposal is released in advance of an actual detailed budget, which included a substantial 10% increase in VA’s anticipated budget for overall discretionary items (over FY 2017) and an 8.3% increase for medical care (over FY 2017). The agency estimates it will treat about 7.1 million patients in FY 2018, and veterans who served in the ongoing operations in Iraq and Afghanistan are estimated to reach 995,196 in 2018.

For more information about NOVA or to become a member, visit vanurse.org.

Image by Graham Beards

Researchers have found evidence to suggest that thrombocytosis is a strong predictor of cancer, particularly lung and colorectal cancer.

The team therefore believes patients with thrombocytosis should be evaluated for an underlying malignancy, as such investigation could speed up cancer diagnosis and save lives.

“We know that early diagnosis is absolutely key in whether people survive cancer,” said Sarah Bailey, PhD, of the University of Exeter Medical School in the UK.

“Our research suggests that substantial numbers of people could have their cancer diagnosed up to 3 months earlier if thrombocytosis prompted investigation for cancer. This time could make a vital difference in achieving earlier diagnosis.”

Dr Bailey and her colleagues described their research in the British Journal of General Practice.

The team conducted a prospective cohort study using Clinical Practice Research Datalink data spanning the period from 2000 to 2013.

They compared the 1-year cancer incidence in 40,000 patients (age 40 and older) with thrombocytosis (platelet count >400 × 10⁹/L) and 10,000 matched controls with normal platelet counts.

Patients with thrombocytosis had a higher incidence of cancer than individuals with normal platelet counts.

The cancer incidence was 6.2% (1355/21,826) in women with thrombocytosis and 2.2% (119/5370) in women with normal platelet counts.

The cancer incidence was 11.6% (1098/9435) in men with thrombocytosis and 4.1% (106/2599) in men with normal platelet counts.

If patients in the thrombocytosis group had a second raised platelet count recorded within 6 months of their index date, the risk of cancer increased to 18.1% for men and 10.1% for women.

Lung and colorectal cancer were more common among patients with thrombocytosis than among individuals with normal platelet counts.

And about one-third of patients with thrombocytosis and lung/colorectal cancer had no other symptoms that would indicate they had cancer.

In addition, the researchers found that “substantial proportions” of lung/colorectal cancer diagnoses could be expedited if thrombocytosis were routinely investigated.

The team calculated that if 5% of patients with cancer have thrombocytosis before a cancer diagnosis, one-third of them have the potential to have their diagnosis expedited by at least 3 months if their doctor investigates the possibility of cancer based on the presence of thrombocytosis. This equates to 5500 earlier diagnoses annually.

“The UK lags well behind other developed countries on early cancer diagnosis,” said study author Willie Hamilton, MD, of the University of Exeter Medical School.

“In 2014, 163,000 people died of cancer in this country. Our findings on thrombocytosis show a strong association with cancer, particularly in men—far stronger than that of a breast lump for breast cancer in women. It is now crucial that we roll out cancer investigation of thrombocytosis. It could save hundreds of lives each year.” 

Image by Graham Beards

Researchers have found evidence to suggest that thrombocytosis is a strong predictor of cancer, particularly lung and colorectal cancer.

The team therefore believes patients with thrombocytosis should be evaluated for an underlying malignancy, as such investigation could speed up cancer diagnosis and save lives.

“We know that early diagnosis is absolutely key in whether people survive cancer,” said Sarah Bailey, PhD, of the University of Exeter Medical School in the UK.

“Our research suggests that substantial numbers of people could have their cancer diagnosed up to 3 months earlier if thrombocytosis prompted investigation for cancer. This time could make a vital difference in achieving earlier diagnosis.”

Dr Bailey and her colleagues described their research in the British Journal of General Practice.

The team conducted a prospective cohort study using Clinical Practice Research Datalink data spanning the period from 2000 to 2013.

They compared the 1-year cancer incidence in 40,000 patients (age 40 and older) with thrombocytosis (platelet count >400 × 10⁹/L) and 10,000 matched controls with normal platelet counts.

Patients with thrombocytosis had a higher incidence of cancer than individuals with normal platelet counts.

The cancer incidence was 6.2% (1355/21,826) in women with thrombocytosis and 2.2% (119/5370) in women with normal platelet counts.

The cancer incidence was 11.6% (1098/9435) in men with thrombocytosis and 4.1% (106/2599) in men with normal platelet counts.

If patients in the thrombocytosis group had a second raised platelet count recorded within 6 months of their index date, the risk of cancer increased to 18.1% for men and 10.1% for women.

Lung and colorectal cancer were more common among patients with thrombocytosis than among individuals with normal platelet counts.

And about one-third of patients with thrombocytosis and lung/colorectal cancer had no other symptoms that would indicate they had cancer.

In addition, the researchers found that “substantial proportions” of lung/colorectal cancer diagnoses could be expedited if thrombocytosis were routinely investigated.

The team calculated that if 5% of patients with cancer have thrombocytosis before a cancer diagnosis, one-third of them have the potential to have their diagnosis expedited by at least 3 months if their doctor investigates the possibility of cancer based on the presence of thrombocytosis. This equates to 5500 earlier diagnoses annually.

“The UK lags well behind other developed countries on early cancer diagnosis,” said study author Willie Hamilton, MD, of the University of Exeter Medical School.

“In 2014, 163,000 people died of cancer in this country. Our findings on thrombocytosis show a strong association with cancer, particularly in men—far stronger than that of a breast lump for breast cancer in women. It is now crucial that we roll out cancer investigation of thrombocytosis. It could save hundreds of lives each year.” 

Image by Graham Beards

Researchers have found evidence to suggest that thrombocytosis is a strong predictor of cancer, particularly lung and colorectal cancer.

The team therefore believes patients with thrombocytosis should be evaluated for an underlying malignancy, as such investigation could speed up cancer diagnosis and save lives.

“We know that early diagnosis is absolutely key in whether people survive cancer,” said Sarah Bailey, PhD, of the University of Exeter Medical School in the UK.

“Our research suggests that substantial numbers of people could have their cancer diagnosed up to 3 months earlier if thrombocytosis prompted investigation for cancer. This time could make a vital difference in achieving earlier diagnosis.”

Dr Bailey and her colleagues described their research in the British Journal of General Practice.

The team conducted a prospective cohort study using Clinical Practice Research Datalink data spanning the period from 2000 to 2013.

They compared the 1-year cancer incidence in 40,000 patients (age 40 and older) with thrombocytosis (platelet count >400 × 10⁹/L) and 10,000 matched controls with normal platelet counts.

Patients with thrombocytosis had a higher incidence of cancer than individuals with normal platelet counts.

The cancer incidence was 6.2% (1355/21,826) in women with thrombocytosis and 2.2% (119/5370) in women with normal platelet counts.

The cancer incidence was 11.6% (1098/9435) in men with thrombocytosis and 4.1% (106/2599) in men with normal platelet counts.

If patients in the thrombocytosis group had a second raised platelet count recorded within 6 months of their index date, the risk of cancer increased to 18.1% for men and 10.1% for women.

Lung and colorectal cancer were more common among patients with thrombocytosis than among individuals with normal platelet counts.

And about one-third of patients with thrombocytosis and lung/colorectal cancer had no other symptoms that would indicate they had cancer.

In addition, the researchers found that “substantial proportions” of lung/colorectal cancer diagnoses could be expedited if thrombocytosis were routinely investigated.

The team calculated that if 5% of patients with cancer have thrombocytosis before a cancer diagnosis, one-third of them have the potential to have their diagnosis expedited by at least 3 months if their doctor investigates the possibility of cancer based on the presence of thrombocytosis. This equates to 5500 earlier diagnoses annually.

“The UK lags well behind other developed countries on early cancer diagnosis,” said study author Willie Hamilton, MD, of the University of Exeter Medical School.

“In 2014, 163,000 people died of cancer in this country. Our findings on thrombocytosis show a strong association with cancer, particularly in men—far stronger than that of a breast lump for breast cancer in women. It is now crucial that we roll out cancer investigation of thrombocytosis. It could save hundreds of lives each year.” 

Antihemophilic factor

Personalized prophylaxis with a recombinant factor VIII product allowed for reduced dosing while still providing protection from bleeds in a small study of patients with severe hemophilia A.

Researchers tested pharmacokinetic (PK)-guided prophylaxis with simoctocog alfa in previously treated patients with severe hemophilia A.

The approach reduced the dose administered and increased the dosing interval compared to standard prophylaxis, without compromising protection from bleeds.

Researchers reported these results in the journal Haemophilia. The research was sponsored by Octapharma AG, the company marketing simoctocog alfa as Nuwiq.

Simoctocog alfa is a fourth-generation recombinant human factor VIII product produced in a human cell line.

In this phase 3b study, researchers tested PK-guided prophylaxis with simoctocog alfa in 66 previously treated adults with severe hemophilia A.

The patients’ mean age at baseline was 33.6. Most (62%) had received on-demand treatment in the 6 months prior to starting the study. Prophylaxis was largely irregular in the 38% of patients who received prophylaxis.

At baseline, the mean annualized bleeding rates (ABRs) were 38.9 in the entire cohort, 45.6 in the on-demand cohort, and 27.8 in the prophylaxis cohort.

Study design

The study had 3 phases. The first was the 72-hour PK phase. Patients received a single dose of simoctocog alfa (60 ± 5 IU kg^–1) and had blood samples taken at various time points. This helped the researchers determine the patients’ personalized prophylaxis regimen.

The second phase of the study was the standard prophylaxis phase, which lasted 1 to 3 months. In this phase, patients received simoctocog alfa at a dose of 30 to 40 IU kg^–1 every other day or 3 times a week until they began personalized prophylaxis.

The third phase was the 6-month personalized prophylaxis phase. A patient’s personalized prophylaxis regimen was based on individual PK modeling for each patient according to whether their PK profile most closely fit a 1- or 2-compartment model. In cases of uncertainty, the researchers used a non-compartment model.

A 2-compartment PK model was used for 36 patients, a 1-compartment model was used for 23 patients, and a non-compartment model was used for 7 patients.

Dosing

In total, the patients received 6612 infusions of simoctocog alfa.

During standard prophylaxis, the mean treatment duration was 2.7 months. Patients received a mean of 34.0 infusions and a total dose of 1157.6 IU kg^–1.

During the personalized prophylaxis phase, the mean treatment duration was 6.2 months. Patients received a mean of 58.8 infusions and a total dose of 2574.4 IU kg^–1.

The median dosing interval was 3.5 days during personalized prophylaxis, 3.5 days in the 1- and 2-compartment model groups, and 2.3 days in the non-compartment group. Fifty-seven percent of patients had twice-weekly dosing or less.

In the standard prophylaxis period, patients were dosed every other day or 3 times a week.

The median weekly dose was 100.0 IU kg^–1 during standard prophylaxis and 95.0 IU kg^–1 during personalized prophylaxis. It was 97.5 IU kg^–1 during months 1 to 4 of personalized prophylaxis and 92.8 IU kg^–1 during months 5 and 6 of personalized prophylaxis.

Bleeding and safety

Similar percentages of patients were bleed-free during the roughly 3-month standard prophylaxis period and the roughly 6-month personalized prophylaxis period—76.9% and 73.8%, respectively.

However, the mean ABR was 3.16 for the standard prophylaxis period and 1.45 for the personalized prophylaxis period. The median ABR was 0 for both periods.

In all, there were 95 breakthrough bleeds—46 during standard prophylaxis and 49 during personalized prophylaxis—in 23 of the patients. All of these bleeds were treated with at least 1 dose of simoctocog alfa.

There were no serious adverse events associated with treatment, and none of the patients developed factor VIII inhibitors.

One patient experienced malaise and dizziness after a single infusion during the standard prophylaxis period. These events were considered treatment-related, but both events resolved. 

Antihemophilic factor

Personalized prophylaxis with a recombinant factor VIII product allowed for reduced dosing while still providing protection from bleeds in a small study of patients with severe hemophilia A.

Researchers tested pharmacokinetic (PK)-guided prophylaxis with simoctocog alfa in previously treated patients with severe hemophilia A.

The approach reduced the dose administered and increased the dosing interval compared to standard prophylaxis, without compromising protection from bleeds.

Researchers reported these results in the journal Haemophilia. The research was sponsored by Octapharma AG, the company marketing simoctocog alfa as Nuwiq.

Simoctocog alfa is a fourth-generation recombinant human factor VIII product produced in a human cell line.

In this phase 3b study, researchers tested PK-guided prophylaxis with simoctocog alfa in 66 previously treated adults with severe hemophilia A.

The patients’ mean age at baseline was 33.6. Most (62%) had received on-demand treatment in the 6 months prior to starting the study. Prophylaxis was largely irregular in the 38% of patients who received prophylaxis.

At baseline, the mean annualized bleeding rates (ABRs) were 38.9 in the entire cohort, 45.6 in the on-demand cohort, and 27.8 in the prophylaxis cohort.

Study design

The study had 3 phases. The first was the 72-hour PK phase. Patients received a single dose of simoctocog alfa (60 ± 5 IU kg^–1) and had blood samples taken at various time points. This helped the researchers determine the patients’ personalized prophylaxis regimen.

The second phase of the study was the standard prophylaxis phase, which lasted 1 to 3 months. In this phase, patients received simoctocog alfa at a dose of 30 to 40 IU kg^–1 every other day or 3 times a week until they began personalized prophylaxis.

The third phase was the 6-month personalized prophylaxis phase. A patient’s personalized prophylaxis regimen was based on individual PK modeling for each patient according to whether their PK profile most closely fit a 1- or 2-compartment model. In cases of uncertainty, the researchers used a non-compartment model.

A 2-compartment PK model was used for 36 patients, a 1-compartment model was used for 23 patients, and a non-compartment model was used for 7 patients.

Dosing

In total, the patients received 6612 infusions of simoctocog alfa.

During standard prophylaxis, the mean treatment duration was 2.7 months. Patients received a mean of 34.0 infusions and a total dose of 1157.6 IU kg^–1.

During the personalized prophylaxis phase, the mean treatment duration was 6.2 months. Patients received a mean of 58.8 infusions and a total dose of 2574.4 IU kg^–1.

The median dosing interval was 3.5 days during personalized prophylaxis, 3.5 days in the 1- and 2-compartment model groups, and 2.3 days in the non-compartment group. Fifty-seven percent of patients had twice-weekly dosing or less.

In the standard prophylaxis period, patients were dosed every other day or 3 times a week.

The median weekly dose was 100.0 IU kg^–1 during standard prophylaxis and 95.0 IU kg^–1 during personalized prophylaxis. It was 97.5 IU kg^–1 during months 1 to 4 of personalized prophylaxis and 92.8 IU kg^–1 during months 5 and 6 of personalized prophylaxis.

Bleeding and safety

Similar percentages of patients were bleed-free during the roughly 3-month standard prophylaxis period and the roughly 6-month personalized prophylaxis period—76.9% and 73.8%, respectively.

However, the mean ABR was 3.16 for the standard prophylaxis period and 1.45 for the personalized prophylaxis period. The median ABR was 0 for both periods.

In all, there were 95 breakthrough bleeds—46 during standard prophylaxis and 49 during personalized prophylaxis—in 23 of the patients. All of these bleeds were treated with at least 1 dose of simoctocog alfa.

There were no serious adverse events associated with treatment, and none of the patients developed factor VIII inhibitors.

One patient experienced malaise and dizziness after a single infusion during the standard prophylaxis period. These events were considered treatment-related, but both events resolved. 

Antihemophilic factor

Personalized prophylaxis with a recombinant factor VIII product allowed for reduced dosing while still providing protection from bleeds in a small study of patients with severe hemophilia A.

Researchers tested pharmacokinetic (PK)-guided prophylaxis with simoctocog alfa in previously treated patients with severe hemophilia A.

The approach reduced the dose administered and increased the dosing interval compared to standard prophylaxis, without compromising protection from bleeds.

Researchers reported these results in the journal Haemophilia. The research was sponsored by Octapharma AG, the company marketing simoctocog alfa as Nuwiq.

Simoctocog alfa is a fourth-generation recombinant human factor VIII product produced in a human cell line.

In this phase 3b study, researchers tested PK-guided prophylaxis with simoctocog alfa in 66 previously treated adults with severe hemophilia A.

The patients’ mean age at baseline was 33.6. Most (62%) had received on-demand treatment in the 6 months prior to starting the study. Prophylaxis was largely irregular in the 38% of patients who received prophylaxis.

At baseline, the mean annualized bleeding rates (ABRs) were 38.9 in the entire cohort, 45.6 in the on-demand cohort, and 27.8 in the prophylaxis cohort.

Study design

The study had 3 phases. The first was the 72-hour PK phase. Patients received a single dose of simoctocog alfa (60 ± 5 IU kg^–1) and had blood samples taken at various time points. This helped the researchers determine the patients’ personalized prophylaxis regimen.

The second phase of the study was the standard prophylaxis phase, which lasted 1 to 3 months. In this phase, patients received simoctocog alfa at a dose of 30 to 40 IU kg^–1 every other day or 3 times a week until they began personalized prophylaxis.

The third phase was the 6-month personalized prophylaxis phase. A patient’s personalized prophylaxis regimen was based on individual PK modeling for each patient according to whether their PK profile most closely fit a 1- or 2-compartment model. In cases of uncertainty, the researchers used a non-compartment model.

A 2-compartment PK model was used for 36 patients, a 1-compartment model was used for 23 patients, and a non-compartment model was used for 7 patients.

Dosing

In total, the patients received 6612 infusions of simoctocog alfa.

During standard prophylaxis, the mean treatment duration was 2.7 months. Patients received a mean of 34.0 infusions and a total dose of 1157.6 IU kg^–1.

During the personalized prophylaxis phase, the mean treatment duration was 6.2 months. Patients received a mean of 58.8 infusions and a total dose of 2574.4 IU kg^–1.

The median dosing interval was 3.5 days during personalized prophylaxis, 3.5 days in the 1- and 2-compartment model groups, and 2.3 days in the non-compartment group. Fifty-seven percent of patients had twice-weekly dosing or less.

In the standard prophylaxis period, patients were dosed every other day or 3 times a week.

The median weekly dose was 100.0 IU kg^–1 during standard prophylaxis and 95.0 IU kg^–1 during personalized prophylaxis. It was 97.5 IU kg^–1 during months 1 to 4 of personalized prophylaxis and 92.8 IU kg^–1 during months 5 and 6 of personalized prophylaxis.

Bleeding and safety

Similar percentages of patients were bleed-free during the roughly 3-month standard prophylaxis period and the roughly 6-month personalized prophylaxis period—76.9% and 73.8%, respectively.

However, the mean ABR was 3.16 for the standard prophylaxis period and 1.45 for the personalized prophylaxis period. The median ABR was 0 for both periods.

In all, there were 95 breakthrough bleeds—46 during standard prophylaxis and 49 during personalized prophylaxis—in 23 of the patients. All of these bleeds were treated with at least 1 dose of simoctocog alfa.

There were no serious adverse events associated with treatment, and none of the patients developed factor VIII inhibitors.

One patient experienced malaise and dizziness after a single infusion during the standard prophylaxis period. These events were considered treatment-related, but both events resolved. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

Photo courtesy of Novartis

The US Food and Drug Administration (FDA) has approved a new formulation of deferasirox known as Jadenu Sprinkle granules.

The granules are approved for use in the same population as Jadenu film-coated tablets.

Both formulations of Jadenu have accelerated approval from the FDA for the treatment of chronic iron overload due to blood transfusions in patients age 2 and older.

The formulations also have accelerated FDA approval for the treatment of chronic iron overload in patients age 10 and older with non-transfusion-dependent-thalassemia and a liver iron concentration of at least 5 mg Fe per gram of dry weight and a serum ferritin greater than 300 mcg/L.

Continued FDA approval for Jadenu in these indications may be contingent upon verification and description of clinical benefit in confirmatory trials.

Jadenu Sprinkle granules are intended for patients who have difficulty swallowing whole tablets. The granules can be sprinkled over soft foods (eg, yogurt or applesauce) prior to consumption.

Like Jadenu film-coated tablets, Jadenu Sprinkle granules are available in 3 strengths—90 mg, 180 mg, and 360 mg.

Both formulations of Jadenu are products of Novartis. For more details on Jadenu, see the prescribing information. 

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

[email protected]

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

[email protected]

WASHINGTON – The National Institutes of Health on Monday released its first COPD National Action Plan, a five-point initiative to reduce the burden of chronic obstructive pulmonary disease and increase research into prevention and treatment.

On the same day, the National Heart, Lung, and Blood Institute and other supporters of the plan described its evolution and why they thought the plan’s implementation was important.

• Empower people with COPD, their families, and caregivers to recognize and reduce the burden of COPD.
• Improve the prevention, diagnosis, treatment, and management of COPD by increasing the quality of care delivered across the health care continuum.
• Collect, analyze, report, and disseminate COPD-related public health data that drive change and track progress.
• Increase and sustain research to better understand the prevention, pathogenesis, diagnosis, treatment, and management of COPD.
• Translate national policy, educational, and program recommendations into research and public health care actions.

“Chronic obstructive pulmonary disease is the third-leading cause of death in this country; it’s just behind heart disease and cancer,” Dr. Kiley noted. “What’s really disappointing and discouraging is it’s the only cause of death in this country where the numbers are not declining.”

COPD “got the attention of Congress a number of years ago,” he added. “They encouraged the National Institutes of Health to work with the community stakeholders and other federal agencies to develop a national action plan to respond to the growing burden of this disease.”

COPD’s stakeholder community, the federal government, and other partners worked together to develop a set of core goals that the National Action Plan would address, Dr. Kiley continued. “It was meant to obtain the broadest amount of input possible so that we could get it right from the start.”

Another of the plan’s advocates, MeiLan Han, MD, medical director of the women’s respiratory health program at the University of Michigan, Ann Arbor, illustrated the need to increase and sustain COPD research related to the disease.

[polldaddy:9806142]

“I see the suffering and disease toll that this takes on my patients, and I can’t convince you enough of the level of frustration that I have as a physician in not being able to provide the level of care that I want to be able to provide,” said Dr. Han, who served as a panelist at the press conference.

“We face some serious barriers to being able to provide adequate care for patients,” she added. Those barriers include lack of access to providers who are knowledgeable about COPD, as well as lack of access to affordable and conveniently located pulmonology rehabilitation and education materials. From a research standpoint, Dr. Han added, medicine still doesn’t know enough about the disease. “We certainly have good treatments, but we need better treatments,” she said.

“What’s clear is that we as society can no longer afford to brush this under the table and ignore this problem,” Dr. Han added.

The National Action Plan and information about how to get involved are available at copd.nih.gov.

[email protected]

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

[email protected]

On Twitter @karioakes

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

[email protected]

On Twitter @karioakes

In an accelerated approval process, the Food and Drug Administration has approved the use of the monoclonal antibody pembrolizumab for treatment of certain solid tumors that have a common biomarker, a first for the agency.

Pembrolizumab (Keytruda) was approved to treat patients whose tumors are metastatic or unresectable, and which have the biomarker microsatellite instability-high (MSI-H), also known as mismatch repair deficient (dMMR). This biomarker is found in many kinds of solid tumors, especially in colorectal and other gastrointestinal cancers, as well as endometrial cancer, and may make tumors more susceptible to host immune system activity. “Approximately 5% of patients with metastatic colorectal cancer have MSI-H or dMMR tumors,” according to the FDA statement announcing the approval.

[email protected]

On Twitter @karioakes