Alicia Ault

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough.

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough.

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough.

Hospital-acquired infections are the leading cause of preventable mortality in pediatric patients, according to an analysis of data from hospitals in 19 states.

Out of 5 million pediatric patient records from the period 2006–2008, there were 25,367 events identified, and of those, 1,465 potentially preventable inpatient deaths, according to HealthGrades, the independent health care ratings organization that conducted the review.

Seventy percent of the deaths were associated with hospital-acquired infections, the Golden, Colo.–based company concluded.

Overall, 1 in 208 pediatric patients experienced a potentially preventable event.

The organization cautioned that while this may seem like a low rate, it is calculated only for 19 states and only for eight safety measures developed by the Agency for Healthcare Research and Quality.

The eight indicators were accidental puncture or laceration; pressure ulcer; avoidance of collapsed lung; postoperative hemorrhage or hematoma; postoperative respiratory failure; postoperative sepsis; postoperative wound dehiscence; and central venous catheter-related infections.

Four incidents that occurred with the most frequency per 1,000 patients were postoperative sepsis (at a rate of 24 per 1,000), postoperative respiratory failure (18), pressure ulcers (3), and central venous catheter-related infections (2).

There was improvement in four of the measures over the study period: selected infections due to medical care, postop hemorrhage or hematoma, postop respiratory failure, and postop wound dehiscence.

But four indicators worsened: accidental puncture, pressure ulcer, iatrogenic pneumothorax, and postop sepsis.

HealthGrades said it decided to undertake its first-ever review of pediatric safety because families and health care providers might not be familiar with the magnitude of errors in the pediatric population.

There are more than 6 million pediatric hospitalizations each year, 40% of which come through the emergency department.

Pediatric hospitals and programs largely have been overlooked or excluded from quality improvement efforts, according to the company.

The states with the best-rated pediatric safety performance were California, Florida, Iowa, Oregon, Utah, and Wisconsin.

Wide variation in quality was noted among the 2,080 hospitals that reported data.

HealthGrades conferred patient safety awards on 97 hospitals that had rates that were statistically lower than those of the other facilities studied.

Children at those hospitals had a 29% lower risk of experiencing one or more of the events compared with patients at the other facilities.

A venture capital company, Vestar Capital Partners, recently agreed to purchase HealthGrades.

Hospital-acquired infections are the leading cause of preventable mortality in pediatric patients, according to an analysis of data from hospitals in 19 states.

Out of 5 million pediatric patient records from the period 2006–2008, there were 25,367 events identified, and of those, 1,465 potentially preventable inpatient deaths, according to HealthGrades, the independent health care ratings organization that conducted the review.

Seventy percent of the deaths were associated with hospital-acquired infections, the Golden, Colo.–based company concluded.

Overall, 1 in 208 pediatric patients experienced a potentially preventable event.

The organization cautioned that while this may seem like a low rate, it is calculated only for 19 states and only for eight safety measures developed by the Agency for Healthcare Research and Quality.

The eight indicators were accidental puncture or laceration; pressure ulcer; avoidance of collapsed lung; postoperative hemorrhage or hematoma; postoperative respiratory failure; postoperative sepsis; postoperative wound dehiscence; and central venous catheter-related infections.

Four incidents that occurred with the most frequency per 1,000 patients were postoperative sepsis (at a rate of 24 per 1,000), postoperative respiratory failure (18), pressure ulcers (3), and central venous catheter-related infections (2).

There was improvement in four of the measures over the study period: selected infections due to medical care, postop hemorrhage or hematoma, postop respiratory failure, and postop wound dehiscence.

But four indicators worsened: accidental puncture, pressure ulcer, iatrogenic pneumothorax, and postop sepsis.

HealthGrades said it decided to undertake its first-ever review of pediatric safety because families and health care providers might not be familiar with the magnitude of errors in the pediatric population.

There are more than 6 million pediatric hospitalizations each year, 40% of which come through the emergency department.

Pediatric hospitals and programs largely have been overlooked or excluded from quality improvement efforts, according to the company.

The states with the best-rated pediatric safety performance were California, Florida, Iowa, Oregon, Utah, and Wisconsin.

Wide variation in quality was noted among the 2,080 hospitals that reported data.

HealthGrades conferred patient safety awards on 97 hospitals that had rates that were statistically lower than those of the other facilities studied.

Children at those hospitals had a 29% lower risk of experiencing one or more of the events compared with patients at the other facilities.

A venture capital company, Vestar Capital Partners, recently agreed to purchase HealthGrades.

Hospital-acquired infections are the leading cause of preventable mortality in pediatric patients, according to an analysis of data from hospitals in 19 states.

Out of 5 million pediatric patient records from the period 2006–2008, there were 25,367 events identified, and of those, 1,465 potentially preventable inpatient deaths, according to HealthGrades, the independent health care ratings organization that conducted the review.

Seventy percent of the deaths were associated with hospital-acquired infections, the Golden, Colo.–based company concluded.

Overall, 1 in 208 pediatric patients experienced a potentially preventable event.

The organization cautioned that while this may seem like a low rate, it is calculated only for 19 states and only for eight safety measures developed by the Agency for Healthcare Research and Quality.

The eight indicators were accidental puncture or laceration; pressure ulcer; avoidance of collapsed lung; postoperative hemorrhage or hematoma; postoperative respiratory failure; postoperative sepsis; postoperative wound dehiscence; and central venous catheter-related infections.

Four incidents that occurred with the most frequency per 1,000 patients were postoperative sepsis (at a rate of 24 per 1,000), postoperative respiratory failure (18), pressure ulcers (3), and central venous catheter-related infections (2).

There was improvement in four of the measures over the study period: selected infections due to medical care, postop hemorrhage or hematoma, postop respiratory failure, and postop wound dehiscence.

But four indicators worsened: accidental puncture, pressure ulcer, iatrogenic pneumothorax, and postop sepsis.

HealthGrades said it decided to undertake its first-ever review of pediatric safety because families and health care providers might not be familiar with the magnitude of errors in the pediatric population.

There are more than 6 million pediatric hospitalizations each year, 40% of which come through the emergency department.

Pediatric hospitals and programs largely have been overlooked or excluded from quality improvement efforts, according to the company.

The states with the best-rated pediatric safety performance were California, Florida, Iowa, Oregon, Utah, and Wisconsin.

Wide variation in quality was noted among the 2,080 hospitals that reported data.

HealthGrades conferred patient safety awards on 97 hospitals that had rates that were statistically lower than those of the other facilities studied.

Children at those hospitals had a 29% lower risk of experiencing one or more of the events compared with patients at the other facilities.

A venture capital company, Vestar Capital Partners, recently agreed to purchase HealthGrades.

The American Medical Association is calling on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved out of a resolution put forward and unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting.

The New York delegation called on the AMA to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has already been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

The last time the insurance industry issued any kind of internal standards was 15 years ago, according to the AMA, which added in a statement that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to re-commit to patients' best interests and the fair business practices necessary to re-establish trust with the patient and physician communities.”

Americas Health Insurance Plans, the industry trade organization, did not directly address the code, but spokesman Robert Zirkelbach said many of the principles are covered under the health reform law—formally, the Affordable Care Act.

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” Mr. Zirkelbach said.

“We will continue to work with policymakers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system,” he added.

The code's principles address topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

Physicians should also have more opportunity to challenge ratings in those systems, according to the principles. The AMA said that it has written to the eight largest health insurers seeking their pledge to comply with the code.

For more information, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'It's time for insurers to re-commit to … the fair business practices necessary to re-establish trust.'

Source Dr. ROHACK

The American Medical Association is calling on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved out of a resolution put forward and unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting.

The New York delegation called on the AMA to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has already been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

The last time the insurance industry issued any kind of internal standards was 15 years ago, according to the AMA, which added in a statement that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to re-commit to patients' best interests and the fair business practices necessary to re-establish trust with the patient and physician communities.”

Americas Health Insurance Plans, the industry trade organization, did not directly address the code, but spokesman Robert Zirkelbach said many of the principles are covered under the health reform law—formally, the Affordable Care Act.

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” Mr. Zirkelbach said.

“We will continue to work with policymakers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system,” he added.

The code's principles address topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

Physicians should also have more opportunity to challenge ratings in those systems, according to the principles. The AMA said that it has written to the eight largest health insurers seeking their pledge to comply with the code.

For more information, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'It's time for insurers to re-commit to … the fair business practices necessary to re-establish trust.'

Source Dr. ROHACK

The American Medical Association is calling on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved out of a resolution put forward and unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting.

The New York delegation called on the AMA to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has already been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

The last time the insurance industry issued any kind of internal standards was 15 years ago, according to the AMA, which added in a statement that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to re-commit to patients' best interests and the fair business practices necessary to re-establish trust with the patient and physician communities.”

Americas Health Insurance Plans, the industry trade organization, did not directly address the code, but spokesman Robert Zirkelbach said many of the principles are covered under the health reform law—formally, the Affordable Care Act.

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” Mr. Zirkelbach said.

“We will continue to work with policymakers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system,” he added.

The code's principles address topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems.

Physicians should also have more opportunity to challenge ratings in those systems, according to the principles. The AMA said that it has written to the eight largest health insurers seeking their pledge to comply with the code.

For more information, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'It's time for insurers to re-commit to … the fair business practices necessary to re-establish trust.'

Source Dr. ROHACK

The American Medical Association has called on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved from a resolution that was unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting. The New York Delegation called on the association to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

The last time the insurance industry issued any kind of internal standards was 15 years ago, said the AMA, which added that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to re-commit to patients' best interests and the fair business practices necessary to re-establish trust with the patient and physician communities.”

Americas Health Insurance Plans, the industry trade organization, did not directly address the AMA code. But spokesman Robert Zirkelbach said many of the principles are covered under the health reform law (Affordable Care Act).

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” he said. “We will continue to work with policy makers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system.”

The code's principles address topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems. Physicians should also have more opportunity to review and challenge their ratings in those systems, according to the principles.

The AMA said it has written to the eight largest health insurers seeking their pledge to comply with the code.

For more information, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'It's time for health insurers to re-commit to patients' best interests.'

Source DR. ROHACK

The American Medical Association has called on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved from a resolution that was unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting. The New York Delegation called on the association to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

The last time the insurance industry issued any kind of internal standards was 15 years ago, said the AMA, which added that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to re-commit to patients' best interests and the fair business practices necessary to re-establish trust with the patient and physician communities.”

Americas Health Insurance Plans, the industry trade organization, did not directly address the AMA code. But spokesman Robert Zirkelbach said many of the principles are covered under the health reform law (Affordable Care Act).

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” he said. “We will continue to work with policy makers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system.”

The code's principles address topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems. Physicians should also have more opportunity to review and challenge their ratings in those systems, according to the principles.

The AMA said it has written to the eight largest health insurers seeking their pledge to comply with the code.

For more information, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'It's time for health insurers to re-commit to patients' best interests.'

Source DR. ROHACK

The American Medical Association has called on U.S. health insurance companies to adopt its just-issued code of conduct.

The Health Insurer Code of Conduct Principles evolved from a resolution that was unanimously adopted by the AMA House of Delegates at its 2008 Interim Meeting. The New York Delegation called on the association to develop such a code, get insurers to sign on, and come up with a way to monitor compliance. The code has been endorsed by nearly every state medical society as well as 19 specialty societies, according to the AMA.

The last time the insurance industry issued any kind of internal standards was 15 years ago, said the AMA, which added that the industry has had a “questionable” record of compliance with those standards, known as the Philosophy of Care.

“The health insurance industry has a crisis of credibility,” Dr. J. James Rohack, AMA president, said in the statement. “With the enactment of federal health reform legislation, it's time for insurers to re-commit to patients' best interests and the fair business practices necessary to re-establish trust with the patient and physician communities.”

Americas Health Insurance Plans, the industry trade organization, did not directly address the AMA code. But spokesman Robert Zirkelbach said many of the principles are covered under the health reform law (Affordable Care Act).

“Health plans have pioneered innovative programs to reward quality, promote prevention and wellness, coordinate care for patients with chronic conditions, streamline administrative processes, and provide policyholders with greater peace of mind,” he said. “We will continue to work with policy makers and other health care stakeholders to improve the quality, safety, and efficiency of our health care system.”

The code's principles address topics including cancellations and recissions; medical loss ratios and calculating fair premiums; open access to care, including transparent rules on provider networks and benefit limitations; fairness in contract negotiations with physicians; medical necessity and who can define it; and a call for more administrative simplification, fewer restrictions on benefits, and better risk adjustment mechanisms for “physician profiling” systems. Physicians should also have more opportunity to review and challenge their ratings in those systems, according to the principles.

The AMA said it has written to the eight largest health insurers seeking their pledge to comply with the code.

For more information, visit www.ama-assn.org/ama/pub/advocacy/current-topics-advocacy/private-sector-advocacy/code-of-conduct-principles.shtml

'It's time for health insurers to re-commit to patients' best interests.'

Source DR. ROHACK

The Food and Drug Administration has notified Roche that it will not accept the company’s application for an accelerated approval of trastuzumab-DM1 in advanced HER2-positive breast cancer.

Roche had filed for a fast-track review of T-DM1 in July, after meeting with the FDA in March to discuss such an application. The drug combines the anti-HER2 activity of trastuzumab (Herceptin) with the targeted intracellular delivery of DM1, a potent antimicrotubule agent. The DM1 component is licensed by ImmunoGen Inc.

In seeking the approval, Roche submitted results from a 110-patient single-arm phase II study. In that trial, one-third of women with advanced HER2-positive breast cancer had a tumor response. Results were presented at the 2009 San Antonio Breast Cancer Symposium.

Even though the women had received on average seven prior therapies, including HER2-targeted agents, the FDA told Roche that the trial did not meet the standard for accelerated approval because the patients had not exhausted all approved treatment options for metastatic breast cancer.

Roche said in a statement that it will continue with its phase III study, EMILIA, which compares T-DM1 to lapatinib (Tykerb) in combination with capecitabine (Xeloda) in advanced HER2-positive breast cancer. The study will evaluate overall survival and progression-free survival. Roche said it anticipated filing for approval in various nations, including the United States, in mid-2012.

“We firmly believe in the potential of T-DM1 as a novel HER2-targeted option and remain fully committed to its ongoing development,” said Dr. Hal Barron, Roche’s head of global development and chief medical officer, in a statement.

T-DM1 is being compared to trastuzumab in a phase II study in previously untreated advanced HER2-positive breast cancer as well. It is also in a phase III study, MARIANNE, where it is being compared with trastuzumab as a single agent or in combination with pertuzumab (Omnitarg) in previously untreated advanced HER2-positive breast cancer.

The Food and Drug Administration has notified Roche that it will not accept the company’s application for an accelerated approval of trastuzumab-DM1 in advanced HER2-positive breast cancer.

Roche had filed for a fast-track review of T-DM1 in July, after meeting with the FDA in March to discuss such an application. The drug combines the anti-HER2 activity of trastuzumab (Herceptin) with the targeted intracellular delivery of DM1, a potent antimicrotubule agent. The DM1 component is licensed by ImmunoGen Inc.

In seeking the approval, Roche submitted results from a 110-patient single-arm phase II study. In that trial, one-third of women with advanced HER2-positive breast cancer had a tumor response. Results were presented at the 2009 San Antonio Breast Cancer Symposium.

Even though the women had received on average seven prior therapies, including HER2-targeted agents, the FDA told Roche that the trial did not meet the standard for accelerated approval because the patients had not exhausted all approved treatment options for metastatic breast cancer.

Roche said in a statement that it will continue with its phase III study, EMILIA, which compares T-DM1 to lapatinib (Tykerb) in combination with capecitabine (Xeloda) in advanced HER2-positive breast cancer. The study will evaluate overall survival and progression-free survival. Roche said it anticipated filing for approval in various nations, including the United States, in mid-2012.

“We firmly believe in the potential of T-DM1 as a novel HER2-targeted option and remain fully committed to its ongoing development,” said Dr. Hal Barron, Roche’s head of global development and chief medical officer, in a statement.

T-DM1 is being compared to trastuzumab in a phase II study in previously untreated advanced HER2-positive breast cancer as well. It is also in a phase III study, MARIANNE, where it is being compared with trastuzumab as a single agent or in combination with pertuzumab (Omnitarg) in previously untreated advanced HER2-positive breast cancer.

The Food and Drug Administration has notified Roche that it will not accept the company’s application for an accelerated approval of trastuzumab-DM1 in advanced HER2-positive breast cancer.

Roche had filed for a fast-track review of T-DM1 in July, after meeting with the FDA in March to discuss such an application. The drug combines the anti-HER2 activity of trastuzumab (Herceptin) with the targeted intracellular delivery of DM1, a potent antimicrotubule agent. The DM1 component is licensed by ImmunoGen Inc.

In seeking the approval, Roche submitted results from a 110-patient single-arm phase II study. In that trial, one-third of women with advanced HER2-positive breast cancer had a tumor response. Results were presented at the 2009 San Antonio Breast Cancer Symposium.

Even though the women had received on average seven prior therapies, including HER2-targeted agents, the FDA told Roche that the trial did not meet the standard for accelerated approval because the patients had not exhausted all approved treatment options for metastatic breast cancer.

Roche said in a statement that it will continue with its phase III study, EMILIA, which compares T-DM1 to lapatinib (Tykerb) in combination with capecitabine (Xeloda) in advanced HER2-positive breast cancer. The study will evaluate overall survival and progression-free survival. Roche said it anticipated filing for approval in various nations, including the United States, in mid-2012.

“We firmly believe in the potential of T-DM1 as a novel HER2-targeted option and remain fully committed to its ongoing development,” said Dr. Hal Barron, Roche’s head of global development and chief medical officer, in a statement.

T-DM1 is being compared to trastuzumab in a phase II study in previously untreated advanced HER2-positive breast cancer as well. It is also in a phase III study, MARIANNE, where it is being compared with trastuzumab as a single agent or in combination with pertuzumab (Omnitarg) in previously untreated advanced HER2-positive breast cancer.

Hospitals that have been lagging on prevention of venous thromboembolism (VTE) might find themselves increasingly at risk for lower reimbursement or downgrades in quality ratings, but a new Society of Hospital Medicine (SHM) program may help some facilities start measuring up.

The Joint Commission is close to implementing a set of VTE measures looking at whether prophylaxis is in place within 24 hours of admission. The Centers for Medicare and Medicaid Services already refuses to pay for any VTE incurred as a complication of hip or knee replacement.

But these sticks have not been huge motivating factors for facilities when it comes to VTE, said Dr. Gregory A. Maynard, chief of the division of hospital medicine at the University of California, San Diego.

The biggest hurdle still seems to be the lack of physician awareness about which populations are vulnerable, said Dr. Maynard, who has been involved in collaboratives backed by the Institute for Healthcare Improvement (IHI) and the Agency for Healthcare Research and Quality (AHRQ). That’s partly because while these events are common, an individual physician might not have many VTEs in his or her own practice, he said.

Dr. Maynard has been a key architect of the SHM’s efforts to help hospitalists improve VTE prevention. The VTE Prevention Collaborative, which launches in September, is supported in part by Sanofi-Aventis U.S. Participants will have access to a toolkit, resources, and individualized mentoring and support, as part of the program developed by Dr. Maynard and Dr. Jason Stein, director of the Clinical Research Program for the section of hospital medicine at Emory University, Atlanta.

According to Dr. Maynard, nearly every hospitalized patient is at risk for VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Most patients have four to six risk factors, he said. The three big risk categories are stasis (related to age greater than 40 years, immobility, anesthesia, obesity, stroke, or heart failure), hypercoagulability (associated with cancer, sepsis, smoking, and pregnancy), and endothelial damage (surgery, central lines, trauma, or prior VTE).

PE is the cause of death in more than 100,000 hospitalized patients each year, and a contributing factor in the death of 100,000 additional inpatients annually, the SHM estimates.

And yet, studies have found that only about 30%-50% of inpatients are given appropriate prophylaxis – this, despite the availability of guidelines and protocols that make the process more efficient, and of effective pharmacologic agents. The ENDORSE trial, for instance, found that among 70,000 inpatients, only 59% of surgical patients and 40% of medical patients were given appropriate prophylaxis (Lancet 2008;371:387-94).

At UCSD, Dr. Maynard and Dr. Stein (who was previously at UCSD) leveraged an AHRQ grant to build a protocol for VTE prevention. It was designed with the aim that it would be universally applicable to any and all hospitalist programs, he said. The protocol increased prophylaxis rates from 50% of patients in 2005 to 98% in 2007 at UCSD (J. Hospital Medicine 2010;5:10-8).

Essentially, it was a simple model that stratified patients into low-, moderate- and high-risk categories. Almost no patients fall into the low-risk category; most are classified as moderate risk, Dr. Maynard said.

The risk assessment can be completed by a physician in seconds and can be done either on paper or as part of an electronic health record. Once determined, the risk level is linked to a menu of prophylaxis options, either in chart form, on paper, or electronically. Importantly, these options very specifically say which pharmacologic agents, and at what dose, are most appropriate for the patient, given their risk and taking into account other factors. The protocol also recommends that mechanical prophylaxis only be used as an adjunct, not as a first-line therapy.

To ensure the protocol was followed, Dr. Maynard and Dr. Stein created a method they dubbed “Measure-vention” – that is, the prophylaxis is monitored on a real-time basis and the intervention is done in real time, as well. The program also automatically collects data that can be used for quality improvement.

If a patient is indicated to need prophylaxis but is not identified as having received it on the medication record, the nurse or pharmacist receives an automated note. They in turn notify the physician via text message or page. About half the time, the physician changes the order, and the rest of the time, there is a valid reason for no prevention – or the physician simply does not want to be told what to do, Dr. Maynard observed.

At Emory, the Measure-vention strategy was adopted in 2009 as the final piece of the VTE prevention program, which started in 2006. Patients are color coded on a “dashboard” that is refreshed hourly. Red means no prophylaxis ordered, yellow means mechanical only has been ordered, and green means the patient is receiving a pharmacologic agent.

Six months after it was implemented, the dashboard helped pull prophylaxis rates above 90% in the 15 inpatient units at Emory University Hospital that were using the strategy, triple the rate before the dashboard, Dr. Stein said.

A year after starting the real-time monitoring in 2008, one 20-bed intensive care unit had a 75% reduction in potentially preventable hospital-acquired VTE, “attributable to a similarly significant rise in VTE prophylaxis from 73% to 94%,” he said.

There were nine fewer clots in that unit, which “represents real morbidity prevention and real cost savings, and very possibly represents preventable deaths from pulmonary embolism,” he said.

The implementation of the dashboard – which is now available to nurses and physicians at five Emory hospitals – has created new channels of communication between clinical and information services and contributed to an increased sense of pride in frontline nurses and clinicians, Dr. Stein observed.

“Ultimately, we’ve developed a new mindset for how performance is measured and improved at Emory,” he said.

Emory was recognized at the SHM annual meeting in April with an Excellence in Teamwork in Quality Improvement Award.

SHM hopes that other facilities can replicate the Emory experience. It has enrolled 80 facilities in the Prevention Collaborative.

Dr. Maynard said that awareness may also increase throughout the Department of Veterans Affairs, which initially had six hospitals take part in a pilot that he and Dr. Stein helped launch. Now, “many, many sites in the VA” are using the VTE prevention toolkit, he said.

The IHI and AHRQ also have enrolled dozens of hospitals in collaborations to reduce VTE.

VTE prophylaxis has been “suboptimal for a long time,” said Dr. Maynard. But, “it’s getting there.”

Hospitals that have been lagging on prevention of venous thromboembolism (VTE) might find themselves increasingly at risk for lower reimbursement or downgrades in quality ratings, but a new Society of Hospital Medicine (SHM) program may help some facilities start measuring up.

The Joint Commission is close to implementing a set of VTE measures looking at whether prophylaxis is in place within 24 hours of admission. The Centers for Medicare and Medicaid Services already refuses to pay for any VTE incurred as a complication of hip or knee replacement.

But these sticks have not been huge motivating factors for facilities when it comes to VTE, said Dr. Gregory A. Maynard, chief of the division of hospital medicine at the University of California, San Diego.

The biggest hurdle still seems to be the lack of physician awareness about which populations are vulnerable, said Dr. Maynard, who has been involved in collaboratives backed by the Institute for Healthcare Improvement (IHI) and the Agency for Healthcare Research and Quality (AHRQ). That’s partly because while these events are common, an individual physician might not have many VTEs in his or her own practice, he said.

Dr. Maynard has been a key architect of the SHM’s efforts to help hospitalists improve VTE prevention. The VTE Prevention Collaborative, which launches in September, is supported in part by Sanofi-Aventis U.S. Participants will have access to a toolkit, resources, and individualized mentoring and support, as part of the program developed by Dr. Maynard and Dr. Jason Stein, director of the Clinical Research Program for the section of hospital medicine at Emory University, Atlanta.

According to Dr. Maynard, nearly every hospitalized patient is at risk for VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Most patients have four to six risk factors, he said. The three big risk categories are stasis (related to age greater than 40 years, immobility, anesthesia, obesity, stroke, or heart failure), hypercoagulability (associated with cancer, sepsis, smoking, and pregnancy), and endothelial damage (surgery, central lines, trauma, or prior VTE).

PE is the cause of death in more than 100,000 hospitalized patients each year, and a contributing factor in the death of 100,000 additional inpatients annually, the SHM estimates.

And yet, studies have found that only about 30%-50% of inpatients are given appropriate prophylaxis – this, despite the availability of guidelines and protocols that make the process more efficient, and of effective pharmacologic agents. The ENDORSE trial, for instance, found that among 70,000 inpatients, only 59% of surgical patients and 40% of medical patients were given appropriate prophylaxis (Lancet 2008;371:387-94).

At UCSD, Dr. Maynard and Dr. Stein (who was previously at UCSD) leveraged an AHRQ grant to build a protocol for VTE prevention. It was designed with the aim that it would be universally applicable to any and all hospitalist programs, he said. The protocol increased prophylaxis rates from 50% of patients in 2005 to 98% in 2007 at UCSD (J. Hospital Medicine 2010;5:10-8).

Essentially, it was a simple model that stratified patients into low-, moderate- and high-risk categories. Almost no patients fall into the low-risk category; most are classified as moderate risk, Dr. Maynard said.

The risk assessment can be completed by a physician in seconds and can be done either on paper or as part of an electronic health record. Once determined, the risk level is linked to a menu of prophylaxis options, either in chart form, on paper, or electronically. Importantly, these options very specifically say which pharmacologic agents, and at what dose, are most appropriate for the patient, given their risk and taking into account other factors. The protocol also recommends that mechanical prophylaxis only be used as an adjunct, not as a first-line therapy.

To ensure the protocol was followed, Dr. Maynard and Dr. Stein created a method they dubbed “Measure-vention” – that is, the prophylaxis is monitored on a real-time basis and the intervention is done in real time, as well. The program also automatically collects data that can be used for quality improvement.

If a patient is indicated to need prophylaxis but is not identified as having received it on the medication record, the nurse or pharmacist receives an automated note. They in turn notify the physician via text message or page. About half the time, the physician changes the order, and the rest of the time, there is a valid reason for no prevention – or the physician simply does not want to be told what to do, Dr. Maynard observed.

At Emory, the Measure-vention strategy was adopted in 2009 as the final piece of the VTE prevention program, which started in 2006. Patients are color coded on a “dashboard” that is refreshed hourly. Red means no prophylaxis ordered, yellow means mechanical only has been ordered, and green means the patient is receiving a pharmacologic agent.

Six months after it was implemented, the dashboard helped pull prophylaxis rates above 90% in the 15 inpatient units at Emory University Hospital that were using the strategy, triple the rate before the dashboard, Dr. Stein said.

A year after starting the real-time monitoring in 2008, one 20-bed intensive care unit had a 75% reduction in potentially preventable hospital-acquired VTE, “attributable to a similarly significant rise in VTE prophylaxis from 73% to 94%,” he said.

There were nine fewer clots in that unit, which “represents real morbidity prevention and real cost savings, and very possibly represents preventable deaths from pulmonary embolism,” he said.

The implementation of the dashboard – which is now available to nurses and physicians at five Emory hospitals – has created new channels of communication between clinical and information services and contributed to an increased sense of pride in frontline nurses and clinicians, Dr. Stein observed.

“Ultimately, we’ve developed a new mindset for how performance is measured and improved at Emory,” he said.

Emory was recognized at the SHM annual meeting in April with an Excellence in Teamwork in Quality Improvement Award.

SHM hopes that other facilities can replicate the Emory experience. It has enrolled 80 facilities in the Prevention Collaborative.

Dr. Maynard said that awareness may also increase throughout the Department of Veterans Affairs, which initially had six hospitals take part in a pilot that he and Dr. Stein helped launch. Now, “many, many sites in the VA” are using the VTE prevention toolkit, he said.

The IHI and AHRQ also have enrolled dozens of hospitals in collaborations to reduce VTE.

VTE prophylaxis has been “suboptimal for a long time,” said Dr. Maynard. But, “it’s getting there.”

Hospitals that have been lagging on prevention of venous thromboembolism (VTE) might find themselves increasingly at risk for lower reimbursement or downgrades in quality ratings, but a new Society of Hospital Medicine (SHM) program may help some facilities start measuring up.

The Joint Commission is close to implementing a set of VTE measures looking at whether prophylaxis is in place within 24 hours of admission. The Centers for Medicare and Medicaid Services already refuses to pay for any VTE incurred as a complication of hip or knee replacement.

But these sticks have not been huge motivating factors for facilities when it comes to VTE, said Dr. Gregory A. Maynard, chief of the division of hospital medicine at the University of California, San Diego.

The biggest hurdle still seems to be the lack of physician awareness about which populations are vulnerable, said Dr. Maynard, who has been involved in collaboratives backed by the Institute for Healthcare Improvement (IHI) and the Agency for Healthcare Research and Quality (AHRQ). That’s partly because while these events are common, an individual physician might not have many VTEs in his or her own practice, he said.

Dr. Maynard has been a key architect of the SHM’s efforts to help hospitalists improve VTE prevention. The VTE Prevention Collaborative, which launches in September, is supported in part by Sanofi-Aventis U.S. Participants will have access to a toolkit, resources, and individualized mentoring and support, as part of the program developed by Dr. Maynard and Dr. Jason Stein, director of the Clinical Research Program for the section of hospital medicine at Emory University, Atlanta.

According to Dr. Maynard, nearly every hospitalized patient is at risk for VTE, which includes deep vein thrombosis (DVT) and pulmonary embolism (PE). Most patients have four to six risk factors, he said. The three big risk categories are stasis (related to age greater than 40 years, immobility, anesthesia, obesity, stroke, or heart failure), hypercoagulability (associated with cancer, sepsis, smoking, and pregnancy), and endothelial damage (surgery, central lines, trauma, or prior VTE).

PE is the cause of death in more than 100,000 hospitalized patients each year, and a contributing factor in the death of 100,000 additional inpatients annually, the SHM estimates.

And yet, studies have found that only about 30%-50% of inpatients are given appropriate prophylaxis – this, despite the availability of guidelines and protocols that make the process more efficient, and of effective pharmacologic agents. The ENDORSE trial, for instance, found that among 70,000 inpatients, only 59% of surgical patients and 40% of medical patients were given appropriate prophylaxis (Lancet 2008;371:387-94).

At UCSD, Dr. Maynard and Dr. Stein (who was previously at UCSD) leveraged an AHRQ grant to build a protocol for VTE prevention. It was designed with the aim that it would be universally applicable to any and all hospitalist programs, he said. The protocol increased prophylaxis rates from 50% of patients in 2005 to 98% in 2007 at UCSD (J. Hospital Medicine 2010;5:10-8).

Essentially, it was a simple model that stratified patients into low-, moderate- and high-risk categories. Almost no patients fall into the low-risk category; most are classified as moderate risk, Dr. Maynard said.

The risk assessment can be completed by a physician in seconds and can be done either on paper or as part of an electronic health record. Once determined, the risk level is linked to a menu of prophylaxis options, either in chart form, on paper, or electronically. Importantly, these options very specifically say which pharmacologic agents, and at what dose, are most appropriate for the patient, given their risk and taking into account other factors. The protocol also recommends that mechanical prophylaxis only be used as an adjunct, not as a first-line therapy.

To ensure the protocol was followed, Dr. Maynard and Dr. Stein created a method they dubbed “Measure-vention” – that is, the prophylaxis is monitored on a real-time basis and the intervention is done in real time, as well. The program also automatically collects data that can be used for quality improvement.

If a patient is indicated to need prophylaxis but is not identified as having received it on the medication record, the nurse or pharmacist receives an automated note. They in turn notify the physician via text message or page. About half the time, the physician changes the order, and the rest of the time, there is a valid reason for no prevention – or the physician simply does not want to be told what to do, Dr. Maynard observed.

At Emory, the Measure-vention strategy was adopted in 2009 as the final piece of the VTE prevention program, which started in 2006. Patients are color coded on a “dashboard” that is refreshed hourly. Red means no prophylaxis ordered, yellow means mechanical only has been ordered, and green means the patient is receiving a pharmacologic agent.

Six months after it was implemented, the dashboard helped pull prophylaxis rates above 90% in the 15 inpatient units at Emory University Hospital that were using the strategy, triple the rate before the dashboard, Dr. Stein said.

A year after starting the real-time monitoring in 2008, one 20-bed intensive care unit had a 75% reduction in potentially preventable hospital-acquired VTE, “attributable to a similarly significant rise in VTE prophylaxis from 73% to 94%,” he said.

There were nine fewer clots in that unit, which “represents real morbidity prevention and real cost savings, and very possibly represents preventable deaths from pulmonary embolism,” he said.

The implementation of the dashboard – which is now available to nurses and physicians at five Emory hospitals – has created new channels of communication between clinical and information services and contributed to an increased sense of pride in frontline nurses and clinicians, Dr. Stein observed.

“Ultimately, we’ve developed a new mindset for how performance is measured and improved at Emory,” he said.

Emory was recognized at the SHM annual meeting in April with an Excellence in Teamwork in Quality Improvement Award.

SHM hopes that other facilities can replicate the Emory experience. It has enrolled 80 facilities in the Prevention Collaborative.

Dr. Maynard said that awareness may also increase throughout the Department of Veterans Affairs, which initially had six hospitals take part in a pilot that he and Dr. Stein helped launch. Now, “many, many sites in the VA” are using the VTE prevention toolkit, he said.

The IHI and AHRQ also have enrolled dozens of hospitals in collaborations to reduce VTE.

VTE prophylaxis has been “suboptimal for a long time,” said Dr. Maynard. But, “it’s getting there.”

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug’s label about the increased potential for developing eosinophilic pneumonia.  The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing.  The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug’s label about the increased potential for developing eosinophilic pneumonia.  The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing.  The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug’s label about the increased potential for developing eosinophilic pneumonia.  The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing.  The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician

COLLEGE PARK, Md. –The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor’s maker, AstraZeneca, including use in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) trial showing that patients in the United States did not fare as well as those in overseas sites. “That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a post-approval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels’ advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said that they also found a higher rate of bleeding after CABG.

But the main concern – and the primary reason for the panel meeting – was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion.

The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, Md. –The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor’s maker, AstraZeneca, including use in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) trial showing that patients in the United States did not fare as well as those in overseas sites. “That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a post-approval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels’ advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said that they also found a higher rate of bleeding after CABG.

But the main concern – and the primary reason for the panel meeting – was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion.

The agency is due to make a decision on the application for approval by Sept. 18.

COLLEGE PARK, Md. –The Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee voted 7-1 to recommend approval of the platelet inhibitor ticagrelor to treat non–ST elevation myocardial infarction and ST-elevation myocardial infarction in patients intended to receive primary coronary intervention or who would be managed medically.

The panel did not directly address other indications being sought by ticagrelor’s maker, AstraZeneca, including use in unstable angina and after a coronary artery bypass graft (CABG). But in an interview after the meeting, FDA official Robert Temple said that the panel had basically covered all the populations that would be considered under the rubric of acute coronary syndrome. As the agency weighs approval, it will decide whether to grant specific indications, said Dr. Temple, who is head of the office reviewing ticagrelor (Brilinta).

According to the company, ticagrelor is the first reversibly binding oral adenosine diphosphate receptor antagonist. It selectively inhibits P2Y12, a key target receptor for ADP.

FDA committee member Mori J. Krantz was the lone panelist who voted against approval. He said that he was concerned about data from the pivotal PLATO (A Study of Platelet Inhibition and Patient Outcomes) trial showing that patients in the United States did not fare as well as those in overseas sites. “That it went in the opposite direction is a little discomforting,” said Dr. Krantz of the University of Colorado, Denver.

Committee chairman Sanjay Kaul voted in favor of approval, but said, “I am concerned, however, about the data going in the wrong direction in the United States.” He urged the FDA to require a post-approval study that would include a substantial number of Americans and look in particular at unstable angina.

The FDA generally follows its panels’ advice.

The PLATO data was first presented at the European Society of Cardiology in 2009 and published online in the New England Journal of Medicine in August 2009. The randomized, double-blind trial compared ticagrelor to clopidogrel in all-comer ACS patients. The study enrolled 18,624 patients at 862 centers in 43 countries.

AstraZeneca said that PLATO proved that ticagrelor was superior to clopidogrel, with a 16% reduction in relative risk for the primary composite end point of cardiovascular death, myocardial infarction, or stroke. The company claimed there was no difference in major bleeding as defined by the trial, but acknowledged that there was a slightly higher number of patients with intracranial hemorrhage, including fatal hemorrhage.

The FDA reviewers said that they also found a higher rate of bleeding after CABG.

But the main concern – and the primary reason for the panel meeting – was why there were more cardiovascular events in Americans. AstraZeneca said that a post hoc analysis determined that Americans were taking higher doses of aspirin, which led to more heart attacks, strokes, and deaths.

After lengthy debate, the committee said the difference could not be attributed to chance alone or to the aspirin dosages. Differences in clinical practice in the United States were the more likely explanation, said a number of panelists.

Members of FDA advisory panels have been cleared of conflicts related to the topic under discussion.

The agency is due to make a decision on the application for approval by Sept. 18.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug’s label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug’s label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Food and Drug Administration is warning physicians and patients that the intravenous antibiotic daptomycin has been associated with an increased risk of eosinophilic pneumonia.

Daptomycin (Cubicin), a once-daily drug, is approved for complicated skin and skin structure infections caused by Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant strains) and for treatment of S. aureus bloodstream infections, including infective endocarditis.

The FDA said a review of published case reports and post-marketing adverse event reports turned up seven cases of eosinophilic pneumonia between 2004 and 2010 that seemed to be associated with use of daptomycin.

The agency is asking daptomycin manufacturer Cubist Pharmaceuticals, based in Lexington, Mass., to add new warnings to the drug’s label about the increased potential for developing eosinophilic pneumonia. The condition is rare but can lead to progressive respiratory failure and death if not recognized and treated, according to the FDA.

Symptoms to watch for include fever, cough, shortness of breath or difficulty breathing. The FDA urged patients taking daptomycin who have those symptoms to immediately talk with their physician.

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online in the New England Journal of Medicine.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The American College of Surgeons Task Force on Resident Duty Hours has analyzed the recommendations and submitted its comments to the ACGME, said Dr. L.D. Britt, chairman of the task force and chairman of the Dept. of Surgery at the Eastern Virginia Medical School, Norfolk, Va. The 34-member task force represented a variety of organizations and specialties. Dr. Britt said that the task force would discuss its comments after the ACGME had a chance to review them.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, said in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online in the New England Journal of Medicine.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The American College of Surgeons Task Force on Resident Duty Hours has analyzed the recommendations and submitted its comments to the ACGME, said Dr. L.D. Britt, chairman of the task force and chairman of the Dept. of Surgery at the Eastern Virginia Medical School, Norfolk, Va. The 34-member task force represented a variety of organizations and specialties. Dr. Britt said that the task force would discuss its comments after the ACGME had a chance to review them.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, said in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”

The Accreditation Council for Graduate Medical Education has revisited its standards for resident duty hours and determined that some modifications should be made, mostly for first-year residents. All other residents should still be subject to an 80-hour work week and up to 24 hours of continuous duty, according to an article published online in the New England Journal of Medicine.

The 16-member ACGME task force that wrote the standards will review public comments and make any modifications considered necessary before July 2011, when the new standards will go into effect.

The American College of Surgeons Task Force on Resident Duty Hours has analyzed the recommendations and submitted its comments to the ACGME, said Dr. L.D. Britt, chairman of the task force and chairman of the Dept. of Surgery at the Eastern Virginia Medical School, Norfolk, Va. The 34-member task force represented a variety of organizations and specialties. Dr. Britt said that the task force would discuss its comments after the ACGME had a chance to review them.

The original ACGME standards, established in 2003, have been the subject of much consternation in the medical community, with opinions differing over whether they have been too restrictive or too loose to properly protect patients and ensure a good quality of life for residents.

According to the latest report, written by Dr. Thomas J. Nasca, Dr. Susan H. Day, and Dr. E. Stephen Amis Jr. on behalf of the ACGME task force, the 2003 standards had the following three “problematic” elements, as identified by the educational community and the public:

▸ The limits on duty hours may have created a shift mentality among residents, which tends to conflict with the duty to serve patients.

▸ Many academic programs began focusing on meeting the duty hour restrictions, perhaps at the expense of education.

▸ The 80-hour work week, with up to 24 hours of continuous duty, was seen by many as compromising patient safety.

In 2008, the Institute of Medicine took a hard look at the ACGME standards and, among other things, recommended that no residents should exceed 16 hours of continuous duty.

The ACGME convened the task force to consider the IOM recommendations. One of the biggest challenges, according to the authors, was to reconcile the IOM's suggestion for an across-the-board restriction on duty hours with the continuing plea from academic programs that duty hours needed to be tailored to each specialty (N. Engl. J. Med. 2010 [doi:10.1056/NEJMsb1005800]).

For surgery, in particular, it would be difficult—and contrary to learning—to have a resident leave in the midst of a procedure because his or her duty hours had been reached.

The ACGME panel also had to weigh whether there was sufficient evidence to show that working more than 16 hours or up to 30 hours continuously led to more medical errors, as has been suggested by many critics of the duty hour standards.

According to the ACGME panel, the data thus far indicate only that first-year residents are more prone to mistakes as a result of sleep deprivation. Therefore, the task force urged a new paradigm for the first year of residency, whereby residents cannot be on duty for longer than 16 hours continuously and should have 10 hours off and 8 hours free of duty between their scheduled duty periods. First-year residents are not allowed to moonlight, and they must have direct, in-house, attending-level supervision.

All residents are allowed to work up to an additional 4 hours to facilitate patient handoffs—an area of concern for patient safety.

The panel decided not to tailor duty hours to specialties “because studies have not shown that the safety effect of current standards varies with specialty,” said the authors.

The IOM had also criticized the ACGME for not properly enforcing the duty hours. The task force said that enforcement is an “inherent” challenge, partly because there are some 9,000 accredited programs.

However, the ACGME is now undertaking annual site visits and analyzing whether institutions can comply. Eventually, the organization will give each institution a report on its compliance status and recommendations for resolving problems. The reports will be made available to the public, said the authors.

Wake Up Doctor, a coalition of public interest and patient safety groups that has been pushing the ACGME to further restrict resident hours, said that the new standards don't go far enough. The group gave the ACGME an “F” for failing to comply with the IOM recommendation that continuous duty be restricted to 16 hours for all residents.

The coalition also gave a failing grade to the ACGME's plans for better monitoring compliance with the standards. However, the recommendation for greater supervision of first-year residents got higher marks.

The revised standards represent an important step, but “I think the acid test will be in the details,” Helen Haskell, founder and president of Mothers Against Medical Error, and a coalition member, said in a statement. “We need to be sure that residents of all levels have sufficient backup and reasonable limits on their workloads.”