Government and Regulations

IHS has announced that it is funding a new project: the National Native Health Research Training Initiative, a cooperative agreement aimed at building capacity, reducing health disparities, and sharing best practices in American Indian and Alaska Native (AI/AN) health research. The funding offers about $225,000 per year for up to 5 years.

Related: IHS Awards Funding for Health Care Self-Governance

The project is designed to promote tribally driven research through education and training opportunities. The initiative “will help expand the community of American Indian and Alaska Native researchers and enhance the ability of tribes to participate in and initiate research projects that address specific needs in their communities,” said IHS Principal Deputy Director Mary Smith.

The funding opportunity is open to a national membership organization of American Indian and Alaska Native scientists, researchers, and students. The organization selected will further the IHS research program objectives with expanded outreach and education efforts for AI/AN students, faculty, and health professionals by, for example, making it easier for tribes to use research findings to address AI/AN needs or by promoting health research methods to better understand the effects of traditional Indian medicine, indigenous knowledge, and traditional ecological knowledge on AI/AN health.

Related: IHS and CMS Partner for Patient Safety Improvements

IHS says it also expects the award recipient to develop regular conference training for health professionals and tribal leaders about health research methods, findings, and best practices to meet the needs and advance the health and health care of AI/AN people.

IHS has announced that it is funding a new project: the National Native Health Research Training Initiative, a cooperative agreement aimed at building capacity, reducing health disparities, and sharing best practices in American Indian and Alaska Native (AI/AN) health research. The funding offers about $225,000 per year for up to 5 years.

Related: IHS Awards Funding for Health Care Self-Governance

The project is designed to promote tribally driven research through education and training opportunities. The initiative “will help expand the community of American Indian and Alaska Native researchers and enhance the ability of tribes to participate in and initiate research projects that address specific needs in their communities,” said IHS Principal Deputy Director Mary Smith.

The funding opportunity is open to a national membership organization of American Indian and Alaska Native scientists, researchers, and students. The organization selected will further the IHS research program objectives with expanded outreach and education efforts for AI/AN students, faculty, and health professionals by, for example, making it easier for tribes to use research findings to address AI/AN needs or by promoting health research methods to better understand the effects of traditional Indian medicine, indigenous knowledge, and traditional ecological knowledge on AI/AN health.

Related: IHS and CMS Partner for Patient Safety Improvements

IHS says it also expects the award recipient to develop regular conference training for health professionals and tribal leaders about health research methods, findings, and best practices to meet the needs and advance the health and health care of AI/AN people.

IHS has announced that it is funding a new project: the National Native Health Research Training Initiative, a cooperative agreement aimed at building capacity, reducing health disparities, and sharing best practices in American Indian and Alaska Native (AI/AN) health research. The funding offers about $225,000 per year for up to 5 years.

Related: IHS Awards Funding for Health Care Self-Governance

The project is designed to promote tribally driven research through education and training opportunities. The initiative “will help expand the community of American Indian and Alaska Native researchers and enhance the ability of tribes to participate in and initiate research projects that address specific needs in their communities,” said IHS Principal Deputy Director Mary Smith.

The funding opportunity is open to a national membership organization of American Indian and Alaska Native scientists, researchers, and students. The organization selected will further the IHS research program objectives with expanded outreach and education efforts for AI/AN students, faculty, and health professionals by, for example, making it easier for tribes to use research findings to address AI/AN needs or by promoting health research methods to better understand the effects of traditional Indian medicine, indigenous knowledge, and traditional ecological knowledge on AI/AN health.

Related: IHS and CMS Partner for Patient Safety Improvements

IHS says it also expects the award recipient to develop regular conference training for health professionals and tribal leaders about health research methods, findings, and best practices to meet the needs and advance the health and health care of AI/AN people.

A novel anti-Zika vaccine based on messenger RNA (mRNA) technology received financial backing from HHS. Moderna Therapeutics, Cambridge, Massachusetts, will get $8.2 million to accelerate the development of the vaccine.

Messenger RNA carries specific genetic codes to parts of the cell. The vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response.

This technology produces vaccine faster than other methods, which require the growth and purification of an attenuated or inactivated virus, HHS says. Moderna also is designing the vaccine to be easy to administer by not requiring any specialized delivery devices.

Under the initial 4-year agreement, HHS’ Biomedical Advanced Research and Development Authority (BARDA) will support a phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended to 5 years, with a total of $125.5 million to cover phase 2 and 3 clinical trials and large-scale manufacturing.

The funding is part of an obligated $85 million BARDA “reprogrammed” for Zika work. The funds are also being used to develop other Zika vaccines, blood screening tests, and pathogen reduction technologies.

A novel anti-Zika vaccine based on messenger RNA (mRNA) technology received financial backing from HHS. Moderna Therapeutics, Cambridge, Massachusetts, will get $8.2 million to accelerate the development of the vaccine.

Messenger RNA carries specific genetic codes to parts of the cell. The vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response.

This technology produces vaccine faster than other methods, which require the growth and purification of an attenuated or inactivated virus, HHS says. Moderna also is designing the vaccine to be easy to administer by not requiring any specialized delivery devices.

Under the initial 4-year agreement, HHS’ Biomedical Advanced Research and Development Authority (BARDA) will support a phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended to 5 years, with a total of $125.5 million to cover phase 2 and 3 clinical trials and large-scale manufacturing.

The funding is part of an obligated $85 million BARDA “reprogrammed” for Zika work. The funds are also being used to develop other Zika vaccines, blood screening tests, and pathogen reduction technologies.

A novel anti-Zika vaccine based on messenger RNA (mRNA) technology received financial backing from HHS. Moderna Therapeutics, Cambridge, Massachusetts, will get $8.2 million to accelerate the development of the vaccine.

Messenger RNA carries specific genetic codes to parts of the cell. The vaccine uses mRNA containing the genetic sequence of the Zika virus to generate an immune response.

This technology produces vaccine faster than other methods, which require the growth and purification of an attenuated or inactivated virus, HHS says. Moderna also is designing the vaccine to be easy to administer by not requiring any specialized delivery devices.

Under the initial 4-year agreement, HHS’ Biomedical Advanced Research and Development Authority (BARDA) will support a phase 1 clinical trial, toxicology studies, vaccine formulation, and manufacturing. If additional funding is identified the agreement could be extended to 5 years, with a total of $125.5 million to cover phase 2 and 3 clinical trials and large-scale manufacturing.

The funding is part of an obligated $85 million BARDA “reprogrammed” for Zika work. The funds are also being used to develop other Zika vaccines, blood screening tests, and pathogen reduction technologies.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. You can search these and other label changes in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential bene t from the drug that it is essential that it be considered in assessing the risks and bene ts of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.

NONSTEROIDAL ANTI-INFLAMMATORY DRUGS:

• Updated Warning May 2016

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

• NSAID is contraindicated in the setting of coronary artery bypass graft surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

JUXTAPID (lomitapide) capsules:

• Added section to warning May 2016

Prescribe Juxtapid only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia who do not have HoFH.

KADCYLA (ado-trastuzumab emtansine) injection, for intravenous:

• Edited and updated warning April 2016

Embryo-Fetal Toxicity: Exposure to Kadcyla during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

KYNAMRO (mipomersen sodium) solution for subcutaneous injection:

• Added section to warning May 2016

Prescribe Kynamro only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. You can search these and other label changes in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential bene t from the drug that it is essential that it be considered in assessing the risks and bene ts of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.

NONSTEROIDAL ANTI-INFLAMMATORY DRUGS:

• Updated Warning May 2016

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

• NSAID is contraindicated in the setting of coronary artery bypass graft surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

JUXTAPID (lomitapide) capsules:

• Added section to warning May 2016

Prescribe Juxtapid only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia who do not have HoFH.

KADCYLA (ado-trastuzumab emtansine) injection, for intravenous:

• Edited and updated warning April 2016

Embryo-Fetal Toxicity: Exposure to Kadcyla during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

KYNAMRO (mipomersen sodium) solution for subcutaneous injection:

• Added section to warning May 2016

Prescribe Kynamro only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH.

The FDA’s MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. You can search these and other label changes in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. Boxed warnings are ordinarily used to highlight either adverse reactions so serious in proportion to the potential bene t from the drug that it is essential that it be considered in assessing the risks and bene ts of using the drug; or serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; or FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.

NONSTEROIDAL ANTI-INFLAMMATORY DRUGS:

• Updated Warning May 2016

WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.

• NSAID is contraindicated in the setting of coronary artery bypass graft surgery.

Gastrointestinal Bleeding, Ulceration, and Perforation

NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.

JUXTAPID (lomitapide) capsules:

• Added section to warning May 2016

Prescribe Juxtapid only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Juxtapid have not been established in patients with hypercholesterolemia who do not have HoFH.

KADCYLA (ado-trastuzumab emtansine) injection, for intravenous:

• Edited and updated warning April 2016

Embryo-Fetal Toxicity: Exposure to Kadcyla during pregnancy can result in embryo-fetal harm. Advise patients of these risks and the need for effective contraception.

KYNAMRO (mipomersen sodium) solution for subcutaneous injection:

• Added section to warning May 2016

Prescribe Kynamro only to patients with a clinical or laboratory diagnosis consistent with homozygous familial hypercholesterolemia (HoFH). The safety and effectiveness of Kynamro have not been established in patients with hypercholesterolemia who do not have HoFH.

HHS has announced $53 million in funding to 44 states, 4 tribes, and the District of Columbia. The money will be used to improve access to treatment for opioid use disorders, reduce opioid-related deaths, and strengthen drug misuse prevention efforts.

Administered by SAMHSA and the CDC, the funding supports 6 programs. Among those:

The Medication-Assisted Treatment Prescription Drug Opioid Addiction Grants will provide up to $11 million to 11 states to expand medication-assisted treatment (MAT) services. The program targets 11 states with the highest rates of primary treatment admissions for heroin and prescription opioids per capita: Alaska, Arizona, Colorado, Connecticut, Illinois, Louisiana, New Hampshire, North Carolina, Oklahoma, Oregon, and Rhode Island.

The Prescription Drug Opioid Overdose Prevention Grants will provide up to $11 million to 12 states for training in preventing opioid overdose-related deaths, as well as funding the purchase and distribution of naloxone to first responders.

The Strategic Prevention Framework Partnerships for Prescription Drugs Grants will provide $9.3 million to 21 states and 4 tribes to help raise awareness about drug use and misuse. The tribes are the Little Traverse Bay Bands of Odawa Indians, Cherokee Nation, Southern Plains Tribal Health Board, and the Nooksack Indian Tribe.

Launched in 2015, the funding is part of the HHS Opioid Initiative. The program concentrates on evidence-based strategies that have the most impact, focusing on improving prescribing practices, expanding access to MAT, and increasing the use of naloxone.

HHS has announced $53 million in funding to 44 states, 4 tribes, and the District of Columbia. The money will be used to improve access to treatment for opioid use disorders, reduce opioid-related deaths, and strengthen drug misuse prevention efforts.

Administered by SAMHSA and the CDC, the funding supports 6 programs. Among those:

The Medication-Assisted Treatment Prescription Drug Opioid Addiction Grants will provide up to $11 million to 11 states to expand medication-assisted treatment (MAT) services. The program targets 11 states with the highest rates of primary treatment admissions for heroin and prescription opioids per capita: Alaska, Arizona, Colorado, Connecticut, Illinois, Louisiana, New Hampshire, North Carolina, Oklahoma, Oregon, and Rhode Island.

The Prescription Drug Opioid Overdose Prevention Grants will provide up to $11 million to 12 states for training in preventing opioid overdose-related deaths, as well as funding the purchase and distribution of naloxone to first responders.

The Strategic Prevention Framework Partnerships for Prescription Drugs Grants will provide $9.3 million to 21 states and 4 tribes to help raise awareness about drug use and misuse. The tribes are the Little Traverse Bay Bands of Odawa Indians, Cherokee Nation, Southern Plains Tribal Health Board, and the Nooksack Indian Tribe.

Launched in 2015, the funding is part of the HHS Opioid Initiative. The program concentrates on evidence-based strategies that have the most impact, focusing on improving prescribing practices, expanding access to MAT, and increasing the use of naloxone.

HHS has announced $53 million in funding to 44 states, 4 tribes, and the District of Columbia. The money will be used to improve access to treatment for opioid use disorders, reduce opioid-related deaths, and strengthen drug misuse prevention efforts.

Administered by SAMHSA and the CDC, the funding supports 6 programs. Among those:

The Medication-Assisted Treatment Prescription Drug Opioid Addiction Grants will provide up to $11 million to 11 states to expand medication-assisted treatment (MAT) services. The program targets 11 states with the highest rates of primary treatment admissions for heroin and prescription opioids per capita: Alaska, Arizona, Colorado, Connecticut, Illinois, Louisiana, New Hampshire, North Carolina, Oklahoma, Oregon, and Rhode Island.

The Prescription Drug Opioid Overdose Prevention Grants will provide up to $11 million to 12 states for training in preventing opioid overdose-related deaths, as well as funding the purchase and distribution of naloxone to first responders.

The Strategic Prevention Framework Partnerships for Prescription Drugs Grants will provide $9.3 million to 21 states and 4 tribes to help raise awareness about drug use and misuse. The tribes are the Little Traverse Bay Bands of Odawa Indians, Cherokee Nation, Southern Plains Tribal Health Board, and the Nooksack Indian Tribe.

Launched in 2015, the funding is part of the HHS Opioid Initiative. The program concentrates on evidence-based strategies that have the most impact, focusing on improving prescribing practices, expanding access to MAT, and increasing the use of naloxone.

The largest gathering of federal health care leadership is less than 2 months away. The AMSUS annual meeting will be held November 29 to December 2, 2016 at the Gaylord National in National Harbor, Maryland. “This meeting is future focused, VADM Michael L. Cowan, MD, executive director of AMSUS recently told Federal Practitioner. “We have leaders from across federal medicine, and they are going to tell you what they are doing and where their organizations are headed. It’s very exciting.”

Keynote speakers include VA Under Secretary for Health David J. Shulkin, MD; United States Surgeon General VADM Vivek H. Murthy, MD, MBA; Deputy Secretary of Defense Robert O. Work; and Director Defense Health Agency VADM Raquel Bono, MD.

The Military Health System will be developing 1 of the 6 education tracks, which will focus on the development and maintenance of a high reliability health care organization. The meeting also will focus on clinical best practices, psychological health and suicide prevention, alternatives to opioids for pain management, advances in blood products, and women in combat.

According to VADM Cowan, the meeting also will highlight some of the advances in the U.S. Air Force’s critical care evacuation system. A transport isolation unit will be on display, which includes a sealed patient care module with positive airway circulation designed to protect patients with infectious diseases and their care providers.

The meeting will provided up to 20 hours of continuing education credit. For more information and to register, visit http://www.amsusmeetings.org.

The largest gathering of federal health care leadership is less than 2 months away. The AMSUS annual meeting will be held November 29 to December 2, 2016 at the Gaylord National in National Harbor, Maryland. “This meeting is future focused, VADM Michael L. Cowan, MD, executive director of AMSUS recently told Federal Practitioner. “We have leaders from across federal medicine, and they are going to tell you what they are doing and where their organizations are headed. It’s very exciting.”

Keynote speakers include VA Under Secretary for Health David J. Shulkin, MD; United States Surgeon General VADM Vivek H. Murthy, MD, MBA; Deputy Secretary of Defense Robert O. Work; and Director Defense Health Agency VADM Raquel Bono, MD.

The Military Health System will be developing 1 of the 6 education tracks, which will focus on the development and maintenance of a high reliability health care organization. The meeting also will focus on clinical best practices, psychological health and suicide prevention, alternatives to opioids for pain management, advances in blood products, and women in combat.

According to VADM Cowan, the meeting also will highlight some of the advances in the U.S. Air Force’s critical care evacuation system. A transport isolation unit will be on display, which includes a sealed patient care module with positive airway circulation designed to protect patients with infectious diseases and their care providers.

The meeting will provided up to 20 hours of continuing education credit. For more information and to register, visit http://www.amsusmeetings.org.

The largest gathering of federal health care leadership is less than 2 months away. The AMSUS annual meeting will be held November 29 to December 2, 2016 at the Gaylord National in National Harbor, Maryland. “This meeting is future focused, VADM Michael L. Cowan, MD, executive director of AMSUS recently told Federal Practitioner. “We have leaders from across federal medicine, and they are going to tell you what they are doing and where their organizations are headed. It’s very exciting.”

Keynote speakers include VA Under Secretary for Health David J. Shulkin, MD; United States Surgeon General VADM Vivek H. Murthy, MD, MBA; Deputy Secretary of Defense Robert O. Work; and Director Defense Health Agency VADM Raquel Bono, MD.

The Military Health System will be developing 1 of the 6 education tracks, which will focus on the development and maintenance of a high reliability health care organization. The meeting also will focus on clinical best practices, psychological health and suicide prevention, alternatives to opioids for pain management, advances in blood products, and women in combat.

According to VADM Cowan, the meeting also will highlight some of the advances in the U.S. Air Force’s critical care evacuation system. A transport isolation unit will be on display, which includes a sealed patient care module with positive airway circulation designed to protect patients with infectious diseases and their care providers.

The meeting will provided up to 20 hours of continuing education credit. For more information and to register, visit http://www.amsusmeetings.org.

More than 102,000 people in Colombia have been infected with Zika virus since October 2015—when their epidemic began—and more than 18,000 of those are pregnant women. In the U.S., 731 women have been diagnosed with laboratory evidence of possible Zika infection, as have 1,156 in U.S. territories.

To help keep those numbers from rising, the CDC and Colombia’s Instituto Nacional de Salud have signed a memorandum of understanding to collaborate on Zika virus response in Colombia. The collaboration—including surveillance and epidemiology—will provide “critical scientific information to help the United States, Colombia, and other countries prepare for the unprecedented challenges posed by Zika,” says CDC Director Thomas R. Frieden, MD.

Colombia has been a “superb partner” in efforts thus far, Frieden says: Since 2016, the CDC and the Instituto Nacional de Salud  have worked together on Proyecto VEZ (Vigilancia de Embarazadas con Zika) to enhance surveillance of women infected with Zika during pregnancy in 3 sites in Colombia. To date, the project has enrolled more than 900 women.

The 2 agencies are also beginning a prospective study, ZEN Colombia (Zika en Embarazadas y Niños en Colombia) to investigate the long-term effects of the virus infection in pregnant women, their male partners, and their children.

More than 102,000 people in Colombia have been infected with Zika virus since October 2015—when their epidemic began—and more than 18,000 of those are pregnant women. In the U.S., 731 women have been diagnosed with laboratory evidence of possible Zika infection, as have 1,156 in U.S. territories.

To help keep those numbers from rising, the CDC and Colombia’s Instituto Nacional de Salud have signed a memorandum of understanding to collaborate on Zika virus response in Colombia. The collaboration—including surveillance and epidemiology—will provide “critical scientific information to help the United States, Colombia, and other countries prepare for the unprecedented challenges posed by Zika,” says CDC Director Thomas R. Frieden, MD.

Colombia has been a “superb partner” in efforts thus far, Frieden says: Since 2016, the CDC and the Instituto Nacional de Salud  have worked together on Proyecto VEZ (Vigilancia de Embarazadas con Zika) to enhance surveillance of women infected with Zika during pregnancy in 3 sites in Colombia. To date, the project has enrolled more than 900 women.

The 2 agencies are also beginning a prospective study, ZEN Colombia (Zika en Embarazadas y Niños en Colombia) to investigate the long-term effects of the virus infection in pregnant women, their male partners, and their children.

More than 102,000 people in Colombia have been infected with Zika virus since October 2015—when their epidemic began—and more than 18,000 of those are pregnant women. In the U.S., 731 women have been diagnosed with laboratory evidence of possible Zika infection, as have 1,156 in U.S. territories.

To help keep those numbers from rising, the CDC and Colombia’s Instituto Nacional de Salud have signed a memorandum of understanding to collaborate on Zika virus response in Colombia. The collaboration—including surveillance and epidemiology—will provide “critical scientific information to help the United States, Colombia, and other countries prepare for the unprecedented challenges posed by Zika,” says CDC Director Thomas R. Frieden, MD.

Colombia has been a “superb partner” in efforts thus far, Frieden says: Since 2016, the CDC and the Instituto Nacional de Salud  have worked together on Proyecto VEZ (Vigilancia de Embarazadas con Zika) to enhance surveillance of women infected with Zika during pregnancy in 3 sites in Colombia. To date, the project has enrolled more than 900 women.

The 2 agencies are also beginning a prospective study, ZEN Colombia (Zika en Embarazadas y Niños en Colombia) to investigate the long-term effects of the virus infection in pregnant women, their male partners, and their children.

Reports in Brazil of Zika transmitted via blood transfusion call attention to the need for better ways to protect the blood supply. To that end, a blood screening test is getting a boost from the Office of the Assistant Secretary for Preparedness and Response (ASPR), with a $4.1 million agreement with Hologic, Inc., of Marlborough, Mass. This is the second screening test ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is helping advance that may be used to test donated blood for Zika. Last April, ASPR announced support of a clinical study of a test developed by Roche Molecular Systems, Inc., of Branchburg, New Jersey.

Under the 1-year agreement, Hologic will advance development of its Procleix Zika Virus Assay, which is designed to detect Zika virus RNA in donated blood plasma up to 7 days post-infection. It runs on Hologic’s Panther automated system, which is already FDA cleared for some infectious disease in vitro diagnostic testing.

The contract could be extended to 18 months with an additional $6.2 million to support the clinical study to evaluate the sensitivity and specificity of the blood donation screening test in actual use, a necessary step before FDA approval.

The money is part of the $374 million HHS has repurposed for domestic Zika response and preparedness activities. BARDA has obligated $41.4 million of these “reprogrammed” funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners.

Reports in Brazil of Zika transmitted via blood transfusion call attention to the need for better ways to protect the blood supply. To that end, a blood screening test is getting a boost from the Office of the Assistant Secretary for Preparedness and Response (ASPR), with a $4.1 million agreement with Hologic, Inc., of Marlborough, Mass. This is the second screening test ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is helping advance that may be used to test donated blood for Zika. Last April, ASPR announced support of a clinical study of a test developed by Roche Molecular Systems, Inc., of Branchburg, New Jersey.

Under the 1-year agreement, Hologic will advance development of its Procleix Zika Virus Assay, which is designed to detect Zika virus RNA in donated blood plasma up to 7 days post-infection. It runs on Hologic’s Panther automated system, which is already FDA cleared for some infectious disease in vitro diagnostic testing.

The contract could be extended to 18 months with an additional $6.2 million to support the clinical study to evaluate the sensitivity and specificity of the blood donation screening test in actual use, a necessary step before FDA approval.

The money is part of the $374 million HHS has repurposed for domestic Zika response and preparedness activities. BARDA has obligated $41.4 million of these “reprogrammed” funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners.

Reports in Brazil of Zika transmitted via blood transfusion call attention to the need for better ways to protect the blood supply. To that end, a blood screening test is getting a boost from the Office of the Assistant Secretary for Preparedness and Response (ASPR), with a $4.1 million agreement with Hologic, Inc., of Marlborough, Mass. This is the second screening test ASPR’s Biomedical Advanced Research and Development Authority (BARDA) is helping advance that may be used to test donated blood for Zika. Last April, ASPR announced support of a clinical study of a test developed by Roche Molecular Systems, Inc., of Branchburg, New Jersey.

Under the 1-year agreement, Hologic will advance development of its Procleix Zika Virus Assay, which is designed to detect Zika virus RNA in donated blood plasma up to 7 days post-infection. It runs on Hologic’s Panther automated system, which is already FDA cleared for some infectious disease in vitro diagnostic testing.

The contract could be extended to 18 months with an additional $6.2 million to support the clinical study to evaluate the sensitivity and specificity of the blood donation screening test in actual use, a necessary step before FDA approval.

The money is part of the $374 million HHS has repurposed for domestic Zika response and preparedness activities. BARDA has obligated $41.4 million of these “reprogrammed” funds to develop Zika vaccines, diagnostics, blood screening tests, and pathogen reduction technologies through private sector partners.

In 2015, 7 of the top 10 causes of death were chronic diseases, according to the CDC, and many disproportionately affect “health disparity populations”: minorities, underserved rural populations, and other disadvantaged groups who generally have lower detection rates, leading to late-stage diagnosis and treatment and worse outcomes.

In response to a need for “more robust, ecological approaches to address chronic diseases” among those groups, the National Institute on Minority Health and Health Disparities (NIMHD) is launching the Transdisciplinary Collaborative Centers (TCC) for Health Disparities Research on Chronic Disease Prevention program.

The program comprises 2 centers of community organizations, academic institutions, clinicians and health care systems, and state and local public health agencies. The 2 centers will share about $20 million to conduct research into community-based, multilevel interventions to combat heart disease, cancer, diabetes, and other chronic diseases. The emphasis will be on prevention, early detection, and early treatment.

The research programs will “translate community needs into practice” at local clinics, churches, and community centers, says NIMHD. Projects include developing interventions to control hypertension among American Indians, Alaska Natives, and Native Hawaiians and other Pacific Islanders. In another project researchers will apply community-engaged research in Flint, Michigan, investigating the effectiveness of interventions aimed at improving physical activity and healthy food consumption.

The new program “looks beyond individual behavioral risk factors,” NIMHD says, to engage the family, community, health care systems, and policy impacts that affect health. NIMHD Director Dr. Eliseo Pérez-Stable says, “Multilevel interventions that take into account complex interactions between individuals and their environments can better address determinants of health and enhance chronic disease prevention and health promotion for local communities.”

In 2015, 7 of the top 10 causes of death were chronic diseases, according to the CDC, and many disproportionately affect “health disparity populations”: minorities, underserved rural populations, and other disadvantaged groups who generally have lower detection rates, leading to late-stage diagnosis and treatment and worse outcomes.

In response to a need for “more robust, ecological approaches to address chronic diseases” among those groups, the National Institute on Minority Health and Health Disparities (NIMHD) is launching the Transdisciplinary Collaborative Centers (TCC) for Health Disparities Research on Chronic Disease Prevention program.

The program comprises 2 centers of community organizations, academic institutions, clinicians and health care systems, and state and local public health agencies. The 2 centers will share about $20 million to conduct research into community-based, multilevel interventions to combat heart disease, cancer, diabetes, and other chronic diseases. The emphasis will be on prevention, early detection, and early treatment.

The research programs will “translate community needs into practice” at local clinics, churches, and community centers, says NIMHD. Projects include developing interventions to control hypertension among American Indians, Alaska Natives, and Native Hawaiians and other Pacific Islanders. In another project researchers will apply community-engaged research in Flint, Michigan, investigating the effectiveness of interventions aimed at improving physical activity and healthy food consumption.

The new program “looks beyond individual behavioral risk factors,” NIMHD says, to engage the family, community, health care systems, and policy impacts that affect health. NIMHD Director Dr. Eliseo Pérez-Stable says, “Multilevel interventions that take into account complex interactions between individuals and their environments can better address determinants of health and enhance chronic disease prevention and health promotion for local communities.”

In 2015, 7 of the top 10 causes of death were chronic diseases, according to the CDC, and many disproportionately affect “health disparity populations”: minorities, underserved rural populations, and other disadvantaged groups who generally have lower detection rates, leading to late-stage diagnosis and treatment and worse outcomes.

In response to a need for “more robust, ecological approaches to address chronic diseases” among those groups, the National Institute on Minority Health and Health Disparities (NIMHD) is launching the Transdisciplinary Collaborative Centers (TCC) for Health Disparities Research on Chronic Disease Prevention program.

The program comprises 2 centers of community organizations, academic institutions, clinicians and health care systems, and state and local public health agencies. The 2 centers will share about $20 million to conduct research into community-based, multilevel interventions to combat heart disease, cancer, diabetes, and other chronic diseases. The emphasis will be on prevention, early detection, and early treatment.

The research programs will “translate community needs into practice” at local clinics, churches, and community centers, says NIMHD. Projects include developing interventions to control hypertension among American Indians, Alaska Natives, and Native Hawaiians and other Pacific Islanders. In another project researchers will apply community-engaged research in Flint, Michigan, investigating the effectiveness of interventions aimed at improving physical activity and healthy food consumption.

The new program “looks beyond individual behavioral risk factors,” NIMHD says, to engage the family, community, health care systems, and policy impacts that affect health. NIMHD Director Dr. Eliseo Pérez-Stable says, “Multilevel interventions that take into account complex interactions between individuals and their environments can better address determinants of health and enhance chronic disease prevention and health promotion for local communities.”

Do you have a patient with back pain? Suggest acupuncture and yoga. Osteoarthritis? Acupuncture and tai chi. Those are some of the approaches that are safe and effective in treating chronic pain, according to researchers from the National Center for Complementary and Integrative Health (NCCIH). They also gave a nod to massage for neck pain and relaxation techniques for severe headaches and migraine.

The researchers reviewed 105 U.S. randomized controlled trials from the past 50 years, focusing on 7 complementary treatments: acupuncture, spinal manipulation or osteopathic manipulation, massage therapy, tai chi, yoga, and relaxation techniques (such as mindfulness meditation). They also evaluated findings from studies involving natural product supplements: chondroitin, glucosamine, methylsulfonylmethane (MSM), S-adenosylmethionine (SAMe), and omega-3 fatty acids.

The researchers rated those treatments in 5 painful conditions often seen in primary care: back pain, osteoarthritis, neck pain, fibromyalgia, and severe headaches and migraine.

Although evidence was weaker, they also found that massage, spinal manipulation, and osteopathic manipulation may help in some back pain, and relaxation and tai chi may help patients with fibromyalgia.

No trial reported a serious adverse event linked to a complementary treatment. Most adverse events were gastrointestinal problems from glucosamine, chondroitin, MSM, or SAMe, or minor soreness from exercise.

Do you have a patient with back pain? Suggest acupuncture and yoga. Osteoarthritis? Acupuncture and tai chi. Those are some of the approaches that are safe and effective in treating chronic pain, according to researchers from the National Center for Complementary and Integrative Health (NCCIH). They also gave a nod to massage for neck pain and relaxation techniques for severe headaches and migraine.

The researchers reviewed 105 U.S. randomized controlled trials from the past 50 years, focusing on 7 complementary treatments: acupuncture, spinal manipulation or osteopathic manipulation, massage therapy, tai chi, yoga, and relaxation techniques (such as mindfulness meditation). They also evaluated findings from studies involving natural product supplements: chondroitin, glucosamine, methylsulfonylmethane (MSM), S-adenosylmethionine (SAMe), and omega-3 fatty acids.

The researchers rated those treatments in 5 painful conditions often seen in primary care: back pain, osteoarthritis, neck pain, fibromyalgia, and severe headaches and migraine.

Although evidence was weaker, they also found that massage, spinal manipulation, and osteopathic manipulation may help in some back pain, and relaxation and tai chi may help patients with fibromyalgia.

No trial reported a serious adverse event linked to a complementary treatment. Most adverse events were gastrointestinal problems from glucosamine, chondroitin, MSM, or SAMe, or minor soreness from exercise.

Do you have a patient with back pain? Suggest acupuncture and yoga. Osteoarthritis? Acupuncture and tai chi. Those are some of the approaches that are safe and effective in treating chronic pain, according to researchers from the National Center for Complementary and Integrative Health (NCCIH). They also gave a nod to massage for neck pain and relaxation techniques for severe headaches and migraine.

The researchers reviewed 105 U.S. randomized controlled trials from the past 50 years, focusing on 7 complementary treatments: acupuncture, spinal manipulation or osteopathic manipulation, massage therapy, tai chi, yoga, and relaxation techniques (such as mindfulness meditation). They also evaluated findings from studies involving natural product supplements: chondroitin, glucosamine, methylsulfonylmethane (MSM), S-adenosylmethionine (SAMe), and omega-3 fatty acids.

The researchers rated those treatments in 5 painful conditions often seen in primary care: back pain, osteoarthritis, neck pain, fibromyalgia, and severe headaches and migraine.

Although evidence was weaker, they also found that massage, spinal manipulation, and osteopathic manipulation may help in some back pain, and relaxation and tai chi may help patients with fibromyalgia.

No trial reported a serious adverse event linked to a complementary treatment. Most adverse events were gastrointestinal problems from glucosamine, chondroitin, MSM, or SAMe, or minor soreness from exercise.

In a rare turn, the Senate Veterans Affairs Committee recently focused on what the VA is doing right. “We are changing culture and doing so by celebrating the people who have dedicated their careers to serving veterans,” testified Carolyn Clancy, MD, deputy under secretary for health for organizational excellence. “We are breaking down cultural barriers, like competition, by creating systematic incentives to share what has worked with others in the system.”

Dr. Clancy outlined some of the successes from the VA’s newly developed Diffusion of Excellence Initiative. The goal of the initiative has been to “identify clinical and administrative best practices, disseminate these practices to other sites of care, and encourage standardization of practices that deliver positive outcomes for veterans and their families,” Dr. Clancy reported. So far the initiative has generated more than 260 ongoing innovations at 70 facilities.

According to Dr. Clancy, the Diffusion of Excellence Initiative uses an internal VA social media platform to identify promising practices that align with strategic priorities, offer efficient resource use, can be implemented in diverse care environments, and can be implemented within 6 to 12 months. The initiative also sought to identify local champions or early adopters who can begin to implement the best practice locally. Once it is proven practice, the initiative seeks to find additional locations to further test the practice in a different setting. Best practices are chosen for national standardization if they have had relative success with an initial implementation and similar outcomes when replicated elsewhere.

So far 50 best practices have been replicated and are ready for widespread dissemination. “Identifying and spreading best practices can be a major driver of consistent, high-quality health care for veterans,” Dr. Clancy told the Senate panel. “This is restoring trust in the system. It offers a model for other health systems.”

Examples of best practices include the following:

Improving Same-Day Access Using Registered Nurse (RN) Care Manager “Chair” Visits: At the Boise VAMC in Idaho, the primary care team created a process where same-day appointment requests are triaged and scribed by RN Care Managers, saving primary care providers’ time when they see patients between appointments to assess and confirm the care plan.

Access Data Dashboard to Improve Clinic Management: The data analysis team at Harry S. Truman Memorial Veterans’ Hospital (Columbia, Missouri) implemented a dashboard for clinic access metrics (no-shows, completed appointment wait times, clinic utilization, etc). These metrics are posted monthly on an accessible dashboard that can be used by staff to solve problems and make key decisions that help veterans get timely access to care.

Planning for Future Medical Decision via Group Visits: This initiative presents advance care directives and other care planning for future medical decisions in interactive and patient-centered group visits.

Increasing Access to Primary Care With Pharmacists: The William S. Middleton Memorial Veterans’ Hospital (Madison, Wisconsin) matched clinical pharmacy specialists with multiple patient aligned care teams to conduct new patient intake calls 1 week before a new patient has his or her first appointment with a provider, collecting medications, noting any formulary conversions, and orienting the patient to VA.

eScreening: The eScreening Program is a mobile technology developed to facilitate the screening process and improve care coordination and measurement-based care for veterans. It offers veteran-directed screening, real-time scoring, individualized patient feedback, instantaneous medical record clinical documentation, immediate alerts to clinicians for evaluation and triage, and monitoring of treatment outcomes.

Regional Liver Tumor Board: The hepatology team at the Philadelphia VAMC combined a regional telehealth-supported liver cancer tumor board model, a web-based submission process, and a consolidated database to manage and track communications for patients with liver cancer. This practice has shortened the time for veterans with liver cancer to receive their evaluation and first treatment as well as reduced unnecessary biopsies—easing the minds and experiences of patients and their families in an incredibly stressful time.

In a rare turn, the Senate Veterans Affairs Committee recently focused on what the VA is doing right. “We are changing culture and doing so by celebrating the people who have dedicated their careers to serving veterans,” testified Carolyn Clancy, MD, deputy under secretary for health for organizational excellence. “We are breaking down cultural barriers, like competition, by creating systematic incentives to share what has worked with others in the system.”

Dr. Clancy outlined some of the successes from the VA’s newly developed Diffusion of Excellence Initiative. The goal of the initiative has been to “identify clinical and administrative best practices, disseminate these practices to other sites of care, and encourage standardization of practices that deliver positive outcomes for veterans and their families,” Dr. Clancy reported. So far the initiative has generated more than 260 ongoing innovations at 70 facilities.

According to Dr. Clancy, the Diffusion of Excellence Initiative uses an internal VA social media platform to identify promising practices that align with strategic priorities, offer efficient resource use, can be implemented in diverse care environments, and can be implemented within 6 to 12 months. The initiative also sought to identify local champions or early adopters who can begin to implement the best practice locally. Once it is proven practice, the initiative seeks to find additional locations to further test the practice in a different setting. Best practices are chosen for national standardization if they have had relative success with an initial implementation and similar outcomes when replicated elsewhere.

So far 50 best practices have been replicated and are ready for widespread dissemination. “Identifying and spreading best practices can be a major driver of consistent, high-quality health care for veterans,” Dr. Clancy told the Senate panel. “This is restoring trust in the system. It offers a model for other health systems.”

Examples of best practices include the following:

Improving Same-Day Access Using Registered Nurse (RN) Care Manager “Chair” Visits: At the Boise VAMC in Idaho, the primary care team created a process where same-day appointment requests are triaged and scribed by RN Care Managers, saving primary care providers’ time when they see patients between appointments to assess and confirm the care plan.

Access Data Dashboard to Improve Clinic Management: The data analysis team at Harry S. Truman Memorial Veterans’ Hospital (Columbia, Missouri) implemented a dashboard for clinic access metrics (no-shows, completed appointment wait times, clinic utilization, etc). These metrics are posted monthly on an accessible dashboard that can be used by staff to solve problems and make key decisions that help veterans get timely access to care.

Planning for Future Medical Decision via Group Visits: This initiative presents advance care directives and other care planning for future medical decisions in interactive and patient-centered group visits.

Increasing Access to Primary Care With Pharmacists: The William S. Middleton Memorial Veterans’ Hospital (Madison, Wisconsin) matched clinical pharmacy specialists with multiple patient aligned care teams to conduct new patient intake calls 1 week before a new patient has his or her first appointment with a provider, collecting medications, noting any formulary conversions, and orienting the patient to VA.

eScreening: The eScreening Program is a mobile technology developed to facilitate the screening process and improve care coordination and measurement-based care for veterans. It offers veteran-directed screening, real-time scoring, individualized patient feedback, instantaneous medical record clinical documentation, immediate alerts to clinicians for evaluation and triage, and monitoring of treatment outcomes.

Regional Liver Tumor Board: The hepatology team at the Philadelphia VAMC combined a regional telehealth-supported liver cancer tumor board model, a web-based submission process, and a consolidated database to manage and track communications for patients with liver cancer. This practice has shortened the time for veterans with liver cancer to receive their evaluation and first treatment as well as reduced unnecessary biopsies—easing the minds and experiences of patients and their families in an incredibly stressful time.

In a rare turn, the Senate Veterans Affairs Committee recently focused on what the VA is doing right. “We are changing culture and doing so by celebrating the people who have dedicated their careers to serving veterans,” testified Carolyn Clancy, MD, deputy under secretary for health for organizational excellence. “We are breaking down cultural barriers, like competition, by creating systematic incentives to share what has worked with others in the system.”

Dr. Clancy outlined some of the successes from the VA’s newly developed Diffusion of Excellence Initiative. The goal of the initiative has been to “identify clinical and administrative best practices, disseminate these practices to other sites of care, and encourage standardization of practices that deliver positive outcomes for veterans and their families,” Dr. Clancy reported. So far the initiative has generated more than 260 ongoing innovations at 70 facilities.

According to Dr. Clancy, the Diffusion of Excellence Initiative uses an internal VA social media platform to identify promising practices that align with strategic priorities, offer efficient resource use, can be implemented in diverse care environments, and can be implemented within 6 to 12 months. The initiative also sought to identify local champions or early adopters who can begin to implement the best practice locally. Once it is proven practice, the initiative seeks to find additional locations to further test the practice in a different setting. Best practices are chosen for national standardization if they have had relative success with an initial implementation and similar outcomes when replicated elsewhere.

So far 50 best practices have been replicated and are ready for widespread dissemination. “Identifying and spreading best practices can be a major driver of consistent, high-quality health care for veterans,” Dr. Clancy told the Senate panel. “This is restoring trust in the system. It offers a model for other health systems.”

Examples of best practices include the following:

Improving Same-Day Access Using Registered Nurse (RN) Care Manager “Chair” Visits: At the Boise VAMC in Idaho, the primary care team created a process where same-day appointment requests are triaged and scribed by RN Care Managers, saving primary care providers’ time when they see patients between appointments to assess and confirm the care plan.

Access Data Dashboard to Improve Clinic Management: The data analysis team at Harry S. Truman Memorial Veterans’ Hospital (Columbia, Missouri) implemented a dashboard for clinic access metrics (no-shows, completed appointment wait times, clinic utilization, etc). These metrics are posted monthly on an accessible dashboard that can be used by staff to solve problems and make key decisions that help veterans get timely access to care.

Planning for Future Medical Decision via Group Visits: This initiative presents advance care directives and other care planning for future medical decisions in interactive and patient-centered group visits.

Increasing Access to Primary Care With Pharmacists: The William S. Middleton Memorial Veterans’ Hospital (Madison, Wisconsin) matched clinical pharmacy specialists with multiple patient aligned care teams to conduct new patient intake calls 1 week before a new patient has his or her first appointment with a provider, collecting medications, noting any formulary conversions, and orienting the patient to VA.

eScreening: The eScreening Program is a mobile technology developed to facilitate the screening process and improve care coordination and measurement-based care for veterans. It offers veteran-directed screening, real-time scoring, individualized patient feedback, instantaneous medical record clinical documentation, immediate alerts to clinicians for evaluation and triage, and monitoring of treatment outcomes.

Regional Liver Tumor Board: The hepatology team at the Philadelphia VAMC combined a regional telehealth-supported liver cancer tumor board model, a web-based submission process, and a consolidated database to manage and track communications for patients with liver cancer. This practice has shortened the time for veterans with liver cancer to receive their evaluation and first treatment as well as reduced unnecessary biopsies—easing the minds and experiences of patients and their families in an incredibly stressful time.