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FDA: Naproxen may pose lower CV risk
The Food and Drug Administration says that the nonsteroidal anti-inflammatory drug naproxen may carry a lower risk of cardiovascular thromboembolic events than that of other selective or nonselective NSAIDs.
The agency presented evidence for that finding in briefing documents that were issued ahead of a Feb. 10-11 joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
At that meeting, the FDA will ask the two advisory committees if the data show that naproxen may have a lower risk for CV thrombotic events. The agency also will ask whether warnings or restrictions should be considered for patients who might be at higher risk for CV events, and whether over-the-counter NSAIDs are acceptable at the currently available doses.
According to the documents, the primary evidence for a better cardiovascular safety profile for naproxen comes from a meta-analysis conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration at Oxford University. The principal investigators gave the FDA a prepublication copy of the study in February 2013. The meta-analysis, which assessed both the gastrointestinal and the cardiovascular risks of nonselective NSAIDs, concluded that naproxen had a lower risk of CV thromboembolic events than did celecoxib and ibuprofen (Lancet 2013;382:769-79).
The FDA has been assessing the safety profile of both cyclooxygenase-2 (COX-2) selective NSAIDs and nonselective NSAIDs for almost a decade. In 2005, the arthritis and drug safety committees pondered the safety of rofecoxib and celecoxib. Based on the panels’ conclusions, the FDA concluded that the risk for CV thromboembolic events was present for both COX-2 selective NSAIDs and nonselective NSAIDs.
The agency subsequently asked Pfizer to voluntarily withdraw valdecoxib (Bextra) from the U.S. market, and all prescription NSAIDs were given a boxed warning on the potential for serious adverse CV events. (Merck had previously withdrawn rofecoxib voluntarily from the U.S. market in 2004.) NSAIDs also carry a warning on the potential for gastrointestinal events. A Medication Guide was developed for patients to inform them of the risk of CV events and gastrointestinal bleeding with all NSAIDs. And companies that made nonselective NSAIDs were asked to conduct comprehensive reviews of their existing controlled clinical trial databases to evaluate CV safety.
The Oxford meta-analysis reinforces the agency’s conclusions from 2005, according to the briefing documents. It also brings into question whether Pfizer should continue its long-term study, Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen (PRECISION), which was begun in the wake of the 2005 panel meeting at the agency’s behest.
The necessity – and wisdom – of continuing that trial is one of the issues that will be discussed at the Feb. 10-11 joint advisory committee meeting.
On Twitter @aliciaault
The Food and Drug Administration says that the nonsteroidal anti-inflammatory drug naproxen may carry a lower risk of cardiovascular thromboembolic events than that of other selective or nonselective NSAIDs.
The agency presented evidence for that finding in briefing documents that were issued ahead of a Feb. 10-11 joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
At that meeting, the FDA will ask the two advisory committees if the data show that naproxen may have a lower risk for CV thrombotic events. The agency also will ask whether warnings or restrictions should be considered for patients who might be at higher risk for CV events, and whether over-the-counter NSAIDs are acceptable at the currently available doses.
According to the documents, the primary evidence for a better cardiovascular safety profile for naproxen comes from a meta-analysis conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration at Oxford University. The principal investigators gave the FDA a prepublication copy of the study in February 2013. The meta-analysis, which assessed both the gastrointestinal and the cardiovascular risks of nonselective NSAIDs, concluded that naproxen had a lower risk of CV thromboembolic events than did celecoxib and ibuprofen (Lancet 2013;382:769-79).
The FDA has been assessing the safety profile of both cyclooxygenase-2 (COX-2) selective NSAIDs and nonselective NSAIDs for almost a decade. In 2005, the arthritis and drug safety committees pondered the safety of rofecoxib and celecoxib. Based on the panels’ conclusions, the FDA concluded that the risk for CV thromboembolic events was present for both COX-2 selective NSAIDs and nonselective NSAIDs.
The agency subsequently asked Pfizer to voluntarily withdraw valdecoxib (Bextra) from the U.S. market, and all prescription NSAIDs were given a boxed warning on the potential for serious adverse CV events. (Merck had previously withdrawn rofecoxib voluntarily from the U.S. market in 2004.) NSAIDs also carry a warning on the potential for gastrointestinal events. A Medication Guide was developed for patients to inform them of the risk of CV events and gastrointestinal bleeding with all NSAIDs. And companies that made nonselective NSAIDs were asked to conduct comprehensive reviews of their existing controlled clinical trial databases to evaluate CV safety.
The Oxford meta-analysis reinforces the agency’s conclusions from 2005, according to the briefing documents. It also brings into question whether Pfizer should continue its long-term study, Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen (PRECISION), which was begun in the wake of the 2005 panel meeting at the agency’s behest.
The necessity – and wisdom – of continuing that trial is one of the issues that will be discussed at the Feb. 10-11 joint advisory committee meeting.
On Twitter @aliciaault
The Food and Drug Administration says that the nonsteroidal anti-inflammatory drug naproxen may carry a lower risk of cardiovascular thromboembolic events than that of other selective or nonselective NSAIDs.
The agency presented evidence for that finding in briefing documents that were issued ahead of a Feb. 10-11 joint meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee.
At that meeting, the FDA will ask the two advisory committees if the data show that naproxen may have a lower risk for CV thrombotic events. The agency also will ask whether warnings or restrictions should be considered for patients who might be at higher risk for CV events, and whether over-the-counter NSAIDs are acceptable at the currently available doses.
According to the documents, the primary evidence for a better cardiovascular safety profile for naproxen comes from a meta-analysis conducted by the Coxib and traditional NSAID Trialists’ (CNT) Collaboration at Oxford University. The principal investigators gave the FDA a prepublication copy of the study in February 2013. The meta-analysis, which assessed both the gastrointestinal and the cardiovascular risks of nonselective NSAIDs, concluded that naproxen had a lower risk of CV thromboembolic events than did celecoxib and ibuprofen (Lancet 2013;382:769-79).
The FDA has been assessing the safety profile of both cyclooxygenase-2 (COX-2) selective NSAIDs and nonselective NSAIDs for almost a decade. In 2005, the arthritis and drug safety committees pondered the safety of rofecoxib and celecoxib. Based on the panels’ conclusions, the FDA concluded that the risk for CV thromboembolic events was present for both COX-2 selective NSAIDs and nonselective NSAIDs.
The agency subsequently asked Pfizer to voluntarily withdraw valdecoxib (Bextra) from the U.S. market, and all prescription NSAIDs were given a boxed warning on the potential for serious adverse CV events. (Merck had previously withdrawn rofecoxib voluntarily from the U.S. market in 2004.) NSAIDs also carry a warning on the potential for gastrointestinal events. A Medication Guide was developed for patients to inform them of the risk of CV events and gastrointestinal bleeding with all NSAIDs. And companies that made nonselective NSAIDs were asked to conduct comprehensive reviews of their existing controlled clinical trial databases to evaluate CV safety.
The Oxford meta-analysis reinforces the agency’s conclusions from 2005, according to the briefing documents. It also brings into question whether Pfizer should continue its long-term study, Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen or Naproxen (PRECISION), which was begun in the wake of the 2005 panel meeting at the agency’s behest.
The necessity – and wisdom – of continuing that trial is one of the issues that will be discussed at the Feb. 10-11 joint advisory committee meeting.
On Twitter @aliciaault
Inpatient safety efforts yield mixed results
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
Adverse events decreased over the last decade for Medicare inpatients with acute myocardial infarction or heart failure but barely changed for those with pneumonia or conditions requiring surgery, according to an analysis of a Medicare database.
The improvements likely translated to 81,000 fewer adverse events for patients with acute MI (AMI) and heart failure (HF) from 2010 to 2011 alone, according to the study published Jan. 22 in the New England Journal of Medicine.
"Although this suggests that national efforts focused on patient safety have made some inroads, the lack of reductions across the board is disappointing," Yun Wang, Ph.D., of the Harvard School of Public Health, Boston, and his colleagues wrote.
The researchers examined whether hospitalized patients are any better off in light of the current focus on patient safety, including the launch of initiatives such as the American College of Surgeons’ National Surgical Quality Improvement Program and the federal government’s Surgical Infection Prevention Project.
They used three composite outcomes measures: the rate of occurrence for adverse events for which patients were at risk (for instance, only patients receiving warfarin were at risk for warfarin-related events); the proportion of patients with one or more adverse events; and the number of adverse events per 1,000 hospitalizations. They analyzed data on 61,523 patients who were discharged from 4,372 hospitals; the data were extracted from the Medicare Patient Safety Monitoring System database (N. Engl. J. Med. 2014:370;341-51).
The 61,523 patients included 11,399 with AMI, 15,374 with HF, 18,269 with pneumonia, and 16,481 with conditions requiring surgery. Postsurgical patients largely were being treated for joint replacement procedures and other osteoarthritis-related conditions, femur fracture, colon cancer, post-AMI procedures, or other forms of chronic ischemic heart disease.
From 2005-2006 to 2010-2011, AMI and HF patients saw a 1.3 percentage point decline in the rate of adverse events, from 5% to 3.7%. The proportion who had one or more such events decreased from 26% to 19%. The number of adverse events per 1,000 hospitalizations declined from 402 to 262 for AMI patients and from 235 to 167 for HF patients.
Infection-related and drug-related adverse events declined significantly in heart attack and HF patients. There was also a substantial improvement in postprocedure events in HF patients.
Postsurgical patients experienced slight increases in all three outcomes measures, in particular, increases in infection-related and postprocedural events such as venous thromboembolism, and cardiac and catheter-related events. The number of events per 1,000 hospitalizations for pneumonia patients increased insignificantly from 216 to 223. For postsurgical patients, the number of events increased insignificantly from 352/1,000 to 368/1,000.
Patients who had adverse events had significantly longer hospital stays and were at higher risk for death. As the number of adverse events increased, so did the risk of death.
The authors noted that declines in events for AMI and HF patients might be a reflection of the numerous efforts and initiatives to improve care in those two conditions.
But they also found that concerted efforts to improve safety did not necessarily work. There was an increase in pressure ulcers in postsurgical patients, and no decline in ventilator-associated pneumonia in most patients, even though there have been initiatives focused on those conditions.
"Our finding of an increased adverse-event rate among surgical patients indicates a continuing challenge and identifies an important target for patient-safety initiatives," the researchers said.
The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
On Twitter @aliciaault
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Major finding: At least 81,000 adverse events were avoided in a single year in patients hospitalized for acute MI and heart failure.
Data source: A retrospective analysis of data from 61,523 patients in the Medicare Patient Safety Monitoring System.
Disclosures: The study was supported by the Agency for Healthcare Research and Quality as well as academic and federal grants. Dr. Wang was a consultant to and other researchers were employees of the research firm Qualidigm and participated in the analysis. One of the researchers, Dr. Harlan M. Krumholz, disclosed being on a scientific advisory board for UnitedHealthcare and receiving grant money from Medtronic.
Will 100% coverage spur more use of breast cancer chemopreventives?
Breast cancer chemopreventive drugs such as tamoxifen should be covered as a preventive service with no out-of-pocket cost for high-risk women, according to the Health and Human Services department. But it’s not clear if the HHS clarification of covered preventive benefits under the Affordable Care Act will encourage more primary care physicians to prescribe the medications and more women to take the drugs.
Dr. Jeffery Ward, an oncologist at the Swedish Cancer Institute, Edmonds, Wash., said that he did not think cost was a big obstacle, as tamoxifen is available generically. Concern about side effects and a lack of knowledge among primary care physicians are larger issues, said Dr. Ward, who is the immediate past chairman of the American Society of Clinical Oncology’s clinical practice committee.
The policy – clarified by HHS on Jan. 9 – would apply to group and individual health insurance policies that went into effect after the March 2010 enactment of the Affordable Care Act, as well as those that have been substantially changed since then.
The ACA mandates that services or therapies given an "A" or "B" rating by the U.S. Preventive Services Task Force be covered as preventive care by individual and group health plans and Medicare. States have the option to cover these benefits for Medicaid recipients.
Preventive benefits must be covered with no copayments, deductibles, or other out-of-pocket costs.
The breast cancer prevention coverage must start on or after Sept. 24, 2014, 1 year after the USPSTF first issued a "B" rating also, for use of the selective estrogen receptor modulators, tamoxifen, or raloxifene for women at high-risk for breast cancer and low risk for side effects. ASCO urged use of tamoxifen and raloxifene for breast cancer prevention in guidelines issued in July (J. Clin. Onc. 2013;31:2942-62).
Currently, tamoxifen and raloxifene are the only Food and Drug Administration–approved drugs for breast cancer prevention in high-risk women. Tamoxifen is approved for women aged 35 years and older; and raloxifene for postmenopausal women. The USPSTF backed the use of the FDA-approved therapies only. Likewise, the HHS policy applies to only FDA-approved drugs.
As many of 5% of U.S. women may be eligible for breast cancer chemoprevention, according to Dr. Mark H. Ebell, a USPSTF member and epidemiologist with the University of Georgia, Athens, who spoke with Frontline Medical News after the guidelines were issued. Few seem to be currently taking any of these prevention drugs, however, according to data compiled by the USPSTF. The task force cited surveys showing that, after being told of the risks and benefits, 50%-75% of high-risk women declined to accept a prescription for tamoxifen or raloxifene. Concerns about side effects seemed to be the main concern.
There is also a lag in prescribing. Only 96 of 350 primary care physicians – including ob.gyns – who responded to a survey, said that they had prescribed tamoxifen as a preventive, according to a study.
Dr. Ward said that primary care physicians may not understand who is an appropriate candidate or may be reluctant to refer healthy women to an oncologist. They also might not be comfortable prescribing a medication they regard as a cancer drug, he said. Many of the high-risk women referred to him ultimately end up taking a chemopreventive, he said, adding that for every patient who refuses, there are probably 4 who agree to try the therapy, but "15 after that who never hear about it," because of gaps in knowledge in the primary care setting.
While the HHS clarification will likely help many of his patients, he also sees it leading to some confusion. For instance, patients who already have breast cancer might think that their medications will now be covered without any out-of-pocket costs. "The consequences have not been well thought out," said Dr. Ward, of the coverage policy.
The coverage requirement also gave insurers pause. "We are concerned about the precedent of expanding the definition of prevention to now include some treatments that must be covered with no cost-sharing," said Robert Zirkelbach, a spokesman for America’s Health Insurance Plans (AHIP). He said that while, "helping women with breast cancer get the care they need has long been a top priority for health plans," the cost of therapies that appear to be "free" are actually "reflected in the premiums consumers pay for coverage."
Dr. Ward noted, however, that it might be less expensive for insurers to cover the cost of chemopreventives than for the treatment of a woman with breast cancer.
On Twitter @aliciaault
Breast cancer chemopreventive drugs such as tamoxifen should be covered as a preventive service with no out-of-pocket cost for high-risk women, according to the Health and Human Services department. But it’s not clear if the HHS clarification of covered preventive benefits under the Affordable Care Act will encourage more primary care physicians to prescribe the medications and more women to take the drugs.
Dr. Jeffery Ward, an oncologist at the Swedish Cancer Institute, Edmonds, Wash., said that he did not think cost was a big obstacle, as tamoxifen is available generically. Concern about side effects and a lack of knowledge among primary care physicians are larger issues, said Dr. Ward, who is the immediate past chairman of the American Society of Clinical Oncology’s clinical practice committee.
The policy – clarified by HHS on Jan. 9 – would apply to group and individual health insurance policies that went into effect after the March 2010 enactment of the Affordable Care Act, as well as those that have been substantially changed since then.
The ACA mandates that services or therapies given an "A" or "B" rating by the U.S. Preventive Services Task Force be covered as preventive care by individual and group health plans and Medicare. States have the option to cover these benefits for Medicaid recipients.
Preventive benefits must be covered with no copayments, deductibles, or other out-of-pocket costs.
The breast cancer prevention coverage must start on or after Sept. 24, 2014, 1 year after the USPSTF first issued a "B" rating also, for use of the selective estrogen receptor modulators, tamoxifen, or raloxifene for women at high-risk for breast cancer and low risk for side effects. ASCO urged use of tamoxifen and raloxifene for breast cancer prevention in guidelines issued in July (J. Clin. Onc. 2013;31:2942-62).
Currently, tamoxifen and raloxifene are the only Food and Drug Administration–approved drugs for breast cancer prevention in high-risk women. Tamoxifen is approved for women aged 35 years and older; and raloxifene for postmenopausal women. The USPSTF backed the use of the FDA-approved therapies only. Likewise, the HHS policy applies to only FDA-approved drugs.
As many of 5% of U.S. women may be eligible for breast cancer chemoprevention, according to Dr. Mark H. Ebell, a USPSTF member and epidemiologist with the University of Georgia, Athens, who spoke with Frontline Medical News after the guidelines were issued. Few seem to be currently taking any of these prevention drugs, however, according to data compiled by the USPSTF. The task force cited surveys showing that, after being told of the risks and benefits, 50%-75% of high-risk women declined to accept a prescription for tamoxifen or raloxifene. Concerns about side effects seemed to be the main concern.
There is also a lag in prescribing. Only 96 of 350 primary care physicians – including ob.gyns – who responded to a survey, said that they had prescribed tamoxifen as a preventive, according to a study.
Dr. Ward said that primary care physicians may not understand who is an appropriate candidate or may be reluctant to refer healthy women to an oncologist. They also might not be comfortable prescribing a medication they regard as a cancer drug, he said. Many of the high-risk women referred to him ultimately end up taking a chemopreventive, he said, adding that for every patient who refuses, there are probably 4 who agree to try the therapy, but "15 after that who never hear about it," because of gaps in knowledge in the primary care setting.
While the HHS clarification will likely help many of his patients, he also sees it leading to some confusion. For instance, patients who already have breast cancer might think that their medications will now be covered without any out-of-pocket costs. "The consequences have not been well thought out," said Dr. Ward, of the coverage policy.
The coverage requirement also gave insurers pause. "We are concerned about the precedent of expanding the definition of prevention to now include some treatments that must be covered with no cost-sharing," said Robert Zirkelbach, a spokesman for America’s Health Insurance Plans (AHIP). He said that while, "helping women with breast cancer get the care they need has long been a top priority for health plans," the cost of therapies that appear to be "free" are actually "reflected in the premiums consumers pay for coverage."
Dr. Ward noted, however, that it might be less expensive for insurers to cover the cost of chemopreventives than for the treatment of a woman with breast cancer.
On Twitter @aliciaault
Breast cancer chemopreventive drugs such as tamoxifen should be covered as a preventive service with no out-of-pocket cost for high-risk women, according to the Health and Human Services department. But it’s not clear if the HHS clarification of covered preventive benefits under the Affordable Care Act will encourage more primary care physicians to prescribe the medications and more women to take the drugs.
Dr. Jeffery Ward, an oncologist at the Swedish Cancer Institute, Edmonds, Wash., said that he did not think cost was a big obstacle, as tamoxifen is available generically. Concern about side effects and a lack of knowledge among primary care physicians are larger issues, said Dr. Ward, who is the immediate past chairman of the American Society of Clinical Oncology’s clinical practice committee.
The policy – clarified by HHS on Jan. 9 – would apply to group and individual health insurance policies that went into effect after the March 2010 enactment of the Affordable Care Act, as well as those that have been substantially changed since then.
The ACA mandates that services or therapies given an "A" or "B" rating by the U.S. Preventive Services Task Force be covered as preventive care by individual and group health plans and Medicare. States have the option to cover these benefits for Medicaid recipients.
Preventive benefits must be covered with no copayments, deductibles, or other out-of-pocket costs.
The breast cancer prevention coverage must start on or after Sept. 24, 2014, 1 year after the USPSTF first issued a "B" rating also, for use of the selective estrogen receptor modulators, tamoxifen, or raloxifene for women at high-risk for breast cancer and low risk for side effects. ASCO urged use of tamoxifen and raloxifene for breast cancer prevention in guidelines issued in July (J. Clin. Onc. 2013;31:2942-62).
Currently, tamoxifen and raloxifene are the only Food and Drug Administration–approved drugs for breast cancer prevention in high-risk women. Tamoxifen is approved for women aged 35 years and older; and raloxifene for postmenopausal women. The USPSTF backed the use of the FDA-approved therapies only. Likewise, the HHS policy applies to only FDA-approved drugs.
As many of 5% of U.S. women may be eligible for breast cancer chemoprevention, according to Dr. Mark H. Ebell, a USPSTF member and epidemiologist with the University of Georgia, Athens, who spoke with Frontline Medical News after the guidelines were issued. Few seem to be currently taking any of these prevention drugs, however, according to data compiled by the USPSTF. The task force cited surveys showing that, after being told of the risks and benefits, 50%-75% of high-risk women declined to accept a prescription for tamoxifen or raloxifene. Concerns about side effects seemed to be the main concern.
There is also a lag in prescribing. Only 96 of 350 primary care physicians – including ob.gyns – who responded to a survey, said that they had prescribed tamoxifen as a preventive, according to a study.
Dr. Ward said that primary care physicians may not understand who is an appropriate candidate or may be reluctant to refer healthy women to an oncologist. They also might not be comfortable prescribing a medication they regard as a cancer drug, he said. Many of the high-risk women referred to him ultimately end up taking a chemopreventive, he said, adding that for every patient who refuses, there are probably 4 who agree to try the therapy, but "15 after that who never hear about it," because of gaps in knowledge in the primary care setting.
While the HHS clarification will likely help many of his patients, he also sees it leading to some confusion. For instance, patients who already have breast cancer might think that their medications will now be covered without any out-of-pocket costs. "The consequences have not been well thought out," said Dr. Ward, of the coverage policy.
The coverage requirement also gave insurers pause. "We are concerned about the precedent of expanding the definition of prevention to now include some treatments that must be covered with no cost-sharing," said Robert Zirkelbach, a spokesman for America’s Health Insurance Plans (AHIP). He said that while, "helping women with breast cancer get the care they need has long been a top priority for health plans," the cost of therapies that appear to be "free" are actually "reflected in the premiums consumers pay for coverage."
Dr. Ward noted, however, that it might be less expensive for insurers to cover the cost of chemopreventives than for the treatment of a woman with breast cancer.
On Twitter @aliciaault
Budget, short-term SGR fix signed
Physicians will get a 0.5% raise in Medicare pay on Jan. 1, thanks to a last-minute legislative fix to the Sustainable Growth Rate formula signed into law by President Obama on Dec. 26.
The Pathway for SGR Reform Act of 2013 was attached as an amendment to the Bipartisan Budget Agreement of 2013. The budget deal, brokered by Sen. Patty Murray (D-Wash.) and Rep. Paul Ryan (R-Wis.), passed the House on Dec. 12 and the Senate on Dec. 18. The Congressional Budget Office estimated that the temporary fix would cost $3.3 billion in 2014 and a total of $7.3 billion through 2023. It would be paid for by cutting Medicaid payments for hospital-based charity care and to long-term care hospitals.
The law also extends the 2% sequestration cut to Medicare payments by 2 years, to 2023.
It encourages the CMS to simplify physicians’ administrative burden by more closely coordinating quality measure requirements and giving doctors timely feedback.
The law extends funding for a variety of other health-related federal programs for an additional 3 months, including for Area Agencies on Aging. Finally, the law delays enforcement of the "two-midnight rule" until October 2014. The goal of the rule is to cut down on hospitals using observation status to keep from admitting patients. Hospitals have until Oct. 1, 2014, to adjust to the new policy, which requires admission if a physician thinks a patient will need a stay longer than 48 hours.
Congress was expected to consider a permanent replacement for the SGR when it returned on Jan. 6.
Physicians will get a 0.5% raise in Medicare pay on Jan. 1, thanks to a last-minute legislative fix to the Sustainable Growth Rate formula signed into law by President Obama on Dec. 26.
The Pathway for SGR Reform Act of 2013 was attached as an amendment to the Bipartisan Budget Agreement of 2013. The budget deal, brokered by Sen. Patty Murray (D-Wash.) and Rep. Paul Ryan (R-Wis.), passed the House on Dec. 12 and the Senate on Dec. 18. The Congressional Budget Office estimated that the temporary fix would cost $3.3 billion in 2014 and a total of $7.3 billion through 2023. It would be paid for by cutting Medicaid payments for hospital-based charity care and to long-term care hospitals.
The law also extends the 2% sequestration cut to Medicare payments by 2 years, to 2023.
It encourages the CMS to simplify physicians’ administrative burden by more closely coordinating quality measure requirements and giving doctors timely feedback.
The law extends funding for a variety of other health-related federal programs for an additional 3 months, including for Area Agencies on Aging. Finally, the law delays enforcement of the "two-midnight rule" until October 2014. The goal of the rule is to cut down on hospitals using observation status to keep from admitting patients. Hospitals have until Oct. 1, 2014, to adjust to the new policy, which requires admission if a physician thinks a patient will need a stay longer than 48 hours.
Congress was expected to consider a permanent replacement for the SGR when it returned on Jan. 6.
Physicians will get a 0.5% raise in Medicare pay on Jan. 1, thanks to a last-minute legislative fix to the Sustainable Growth Rate formula signed into law by President Obama on Dec. 26.
The Pathway for SGR Reform Act of 2013 was attached as an amendment to the Bipartisan Budget Agreement of 2013. The budget deal, brokered by Sen. Patty Murray (D-Wash.) and Rep. Paul Ryan (R-Wis.), passed the House on Dec. 12 and the Senate on Dec. 18. The Congressional Budget Office estimated that the temporary fix would cost $3.3 billion in 2014 and a total of $7.3 billion through 2023. It would be paid for by cutting Medicaid payments for hospital-based charity care and to long-term care hospitals.
The law also extends the 2% sequestration cut to Medicare payments by 2 years, to 2023.
It encourages the CMS to simplify physicians’ administrative burden by more closely coordinating quality measure requirements and giving doctors timely feedback.
The law extends funding for a variety of other health-related federal programs for an additional 3 months, including for Area Agencies on Aging. Finally, the law delays enforcement of the "two-midnight rule" until October 2014. The goal of the rule is to cut down on hospitals using observation status to keep from admitting patients. Hospitals have until Oct. 1, 2014, to adjust to the new policy, which requires admission if a physician thinks a patient will need a stay longer than 48 hours.
Congress was expected to consider a permanent replacement for the SGR when it returned on Jan. 6.
2014 budget reduces spending for ACA, IPAB
A $1 trillion spending bill that funds the government through Sept. 30 restores money for some health programs but delivers a blow to the Affordable Care Act.
Even so, President Obama is expected to sign it.
The House approved the Consolidated Appropriations Act for FY 2014 (H.R. 3547) on Jan. 15 by a vote of 359-67, and the Senate approved it a day later 72-26.
Republican members of the House Appropriations Committee added language to the bill that puts a hold on any new funding for the ACA in fiscal 2014 and takes $1 billion out of the law’s Prevention and Public Health Fund. The fund is hotly contested and has been labeled a "slush fund," by opponents.
The House Appropriations panel also succeeded in cutting $10 million in funding for the Independent Payment Advisory Board (IPAB). The IPAB was due to make its first recommendations by mid-January; however, the Obama administration has yet to appoint any members.
The spending bill continues to ban the use federal funds for needle exchanges; for research that creates or uses embryos; and for abortion, except in the case of rape, incest, or endangerment of the life of the mother.
The bill includes a $3.7 billion budget for the Centers for Medicare and Medicaid Services – almost $200 million less than it received in fiscal year 2013 but equal to what it would receive under sequestration. Some $305 million is earmarked for the timely processing and payment of benefits.
The bill increases funding for other federal health-related agencies. The National Institutes of Health budget was increased $1 billion, which should allow it to begin 385 clinical trials, according to the Senate Appropriations Committee.
There is new funding for the Brain Research through Advancing of Innovative Neurotechnologies (BRAIN) Initiative, and funding for an initiative to study prevention and treatments for Alzheimer’s disease.
Mental health programs at various labor, health, and education agencies will receive $1.13 billion, an increase of $213 million, according to the Senate panel. Those programs include violence prevention and grants to schools to help train teachers and to help build a mental health workforce. The Senate Committee estimates that new training will help add 4,375 social workers, psychologists, therapists and other mental health professionals to the behavioral health workforce. The Substance Abuse and Mental Health Services Administration received a $144 million increase in its budget, bringing it to $3.6 billion.
Funding for the Centers for Disease Control and Prevention was increased $567 million to $6.9 billion. That budget includes $30 million to support the Advanced Molecular Detection initiative, which helps the agency detect and stop infectious disease outbreaks and $160 million for the Preventive Health & Health Services Block Grant.
The legislation also includes $3.6 billion to improve the quantity and quality of health care services in medically underserved areas and populations. As part of that, $350 million is appropriated to create more than 450 new community health centers and expand services at existing ones.
On Twitter @aliciaault
A $1 trillion spending bill that funds the government through Sept. 30 restores money for some health programs but delivers a blow to the Affordable Care Act.
Even so, President Obama is expected to sign it.
The House approved the Consolidated Appropriations Act for FY 2014 (H.R. 3547) on Jan. 15 by a vote of 359-67, and the Senate approved it a day later 72-26.
Republican members of the House Appropriations Committee added language to the bill that puts a hold on any new funding for the ACA in fiscal 2014 and takes $1 billion out of the law’s Prevention and Public Health Fund. The fund is hotly contested and has been labeled a "slush fund," by opponents.
The House Appropriations panel also succeeded in cutting $10 million in funding for the Independent Payment Advisory Board (IPAB). The IPAB was due to make its first recommendations by mid-January; however, the Obama administration has yet to appoint any members.
The spending bill continues to ban the use federal funds for needle exchanges; for research that creates or uses embryos; and for abortion, except in the case of rape, incest, or endangerment of the life of the mother.
The bill includes a $3.7 billion budget for the Centers for Medicare and Medicaid Services – almost $200 million less than it received in fiscal year 2013 but equal to what it would receive under sequestration. Some $305 million is earmarked for the timely processing and payment of benefits.
The bill increases funding for other federal health-related agencies. The National Institutes of Health budget was increased $1 billion, which should allow it to begin 385 clinical trials, according to the Senate Appropriations Committee.
There is new funding for the Brain Research through Advancing of Innovative Neurotechnologies (BRAIN) Initiative, and funding for an initiative to study prevention and treatments for Alzheimer’s disease.
Mental health programs at various labor, health, and education agencies will receive $1.13 billion, an increase of $213 million, according to the Senate panel. Those programs include violence prevention and grants to schools to help train teachers and to help build a mental health workforce. The Senate Committee estimates that new training will help add 4,375 social workers, psychologists, therapists and other mental health professionals to the behavioral health workforce. The Substance Abuse and Mental Health Services Administration received a $144 million increase in its budget, bringing it to $3.6 billion.
Funding for the Centers for Disease Control and Prevention was increased $567 million to $6.9 billion. That budget includes $30 million to support the Advanced Molecular Detection initiative, which helps the agency detect and stop infectious disease outbreaks and $160 million for the Preventive Health & Health Services Block Grant.
The legislation also includes $3.6 billion to improve the quantity and quality of health care services in medically underserved areas and populations. As part of that, $350 million is appropriated to create more than 450 new community health centers and expand services at existing ones.
On Twitter @aliciaault
A $1 trillion spending bill that funds the government through Sept. 30 restores money for some health programs but delivers a blow to the Affordable Care Act.
Even so, President Obama is expected to sign it.
The House approved the Consolidated Appropriations Act for FY 2014 (H.R. 3547) on Jan. 15 by a vote of 359-67, and the Senate approved it a day later 72-26.
Republican members of the House Appropriations Committee added language to the bill that puts a hold on any new funding for the ACA in fiscal 2014 and takes $1 billion out of the law’s Prevention and Public Health Fund. The fund is hotly contested and has been labeled a "slush fund," by opponents.
The House Appropriations panel also succeeded in cutting $10 million in funding for the Independent Payment Advisory Board (IPAB). The IPAB was due to make its first recommendations by mid-January; however, the Obama administration has yet to appoint any members.
The spending bill continues to ban the use federal funds for needle exchanges; for research that creates or uses embryos; and for abortion, except in the case of rape, incest, or endangerment of the life of the mother.
The bill includes a $3.7 billion budget for the Centers for Medicare and Medicaid Services – almost $200 million less than it received in fiscal year 2013 but equal to what it would receive under sequestration. Some $305 million is earmarked for the timely processing and payment of benefits.
The bill increases funding for other federal health-related agencies. The National Institutes of Health budget was increased $1 billion, which should allow it to begin 385 clinical trials, according to the Senate Appropriations Committee.
There is new funding for the Brain Research through Advancing of Innovative Neurotechnologies (BRAIN) Initiative, and funding for an initiative to study prevention and treatments for Alzheimer’s disease.
Mental health programs at various labor, health, and education agencies will receive $1.13 billion, an increase of $213 million, according to the Senate panel. Those programs include violence prevention and grants to schools to help train teachers and to help build a mental health workforce. The Senate Committee estimates that new training will help add 4,375 social workers, psychologists, therapists and other mental health professionals to the behavioral health workforce. The Substance Abuse and Mental Health Services Administration received a $144 million increase in its budget, bringing it to $3.6 billion.
Funding for the Centers for Disease Control and Prevention was increased $567 million to $6.9 billion. That budget includes $30 million to support the Advanced Molecular Detection initiative, which helps the agency detect and stop infectious disease outbreaks and $160 million for the Preventive Health & Health Services Block Grant.
The legislation also includes $3.6 billion to improve the quantity and quality of health care services in medically underserved areas and populations. As part of that, $350 million is appropriated to create more than 450 new community health centers and expand services at existing ones.
On Twitter @aliciaault
Surgeon General report links smoking to diseases beyond cancer
While smoking rates have dropped precipitously since the landmark 1964 Surgeon General’s report, "Smoking and Health," smoking is still the leading cause of preventable disease and death in the United States and is now causally linked to additional diseases and conditions across most organ systems.
A new Surgeon General's report, "The Health Consequences of Smoking – 50 Years of Progress," released at a White House event Jan. 17, synthesizes original and review evidence in an effort to further federal antismoking efforts.
The report causally links cigarette smoking to type 2 diabetes, rheumatoid arthritis, ectopic pregnancy, and erectile dysfunction. Secondhand smoke is now causally linked to cancers, respiratory diseases, and cardiovascular diseases, as well as adverse effects on the health of children, the authors wrote.
In addition, the 980-page report establishes that secondhand smoke is a cause of stroke, and that smoking increases the risk of dying in cancer patients and cancer survivors.
Another finding: Cigarette smokers today have a higher risk of lung cancer than did those who smoked in 1964, because of the higher number of chemical additives now used.
Women smokers now have the same risk of death from lung cancer as that of men and a higher relative risk of dying from coronary heart disease than that of men. Because of smoking, the number of women dying from chronic obstructive pulmonary disease (COPD) is now higher than in men.
With this report, the federal government is launching a new effort to prevent children from using tobacco.
"Today, we’re asking Americans to join a sustained effort to make the next generation a tobacco-free generation," Health and Human Services Secretary Kathleen Sebelius said in a statement. "This is not something the federal government can do alone. We need to partner with the business community, local elected officials, schools and universities, the medical community, the faith community, and committed citizens in communities across the country to make the next generation tobacco free."
The report finds that youth smoking rates declined by 50% between 1997 and 2011, but 3,200 children under age 18 still start smoking each day, and an additional 2,100 youth and young adults become daily smokers. The report places most of the blame for continued interest in smoking on the tobacco industry, saying it has used "aggressive strategies" to deliberately mislead the public about the harms of smoking.
Acting Surgeon General Boris Lushniak noted that smoking rates are disproportionately higher among people with less education and lower incomes, among the mentally ill, and among gay, lesbian, bisexual, and transgender individuals.
Dr. Lushniak and other officials at the White House event called for greater tobacco control efforts, including stricter regulation. The Food and Drug Administration was given the power to regulate tobacco through the 2009 Family Smoking Prevention and Tobacco Control Act.
FDA Commissioner Margaret Hamburg said that the agency is ready to take action.
"The FDA is funding and conducting regulatory science research on tobacco products, enforcing the laws that reduce the access and attractiveness of tobacco products to young people, and preparing to launch an unprecedented national public education campaign to prevent youth tobacco use," Dr. Hamburg said in a statement.
Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, noted that while states collect some $80 per person a year in tobacco taxes and payments from the 1998 tobacco industry master settlement agreement, they spend an average of $1.50 per person on control.
The CDC has urged states to spend $12 per person on control, Dr. Frieden said.
Dr. Lushniak noted that for current and about-to-start smokers, "the clock is ticking – they can’t wait for slow and steady progress to end the epidemic. Enough is enough."
On Twitter @aliciaault
While smoking rates have dropped precipitously since the landmark 1964 Surgeon General’s report, "Smoking and Health," smoking is still the leading cause of preventable disease and death in the United States and is now causally linked to additional diseases and conditions across most organ systems.
A new Surgeon General's report, "The Health Consequences of Smoking – 50 Years of Progress," released at a White House event Jan. 17, synthesizes original and review evidence in an effort to further federal antismoking efforts.
The report causally links cigarette smoking to type 2 diabetes, rheumatoid arthritis, ectopic pregnancy, and erectile dysfunction. Secondhand smoke is now causally linked to cancers, respiratory diseases, and cardiovascular diseases, as well as adverse effects on the health of children, the authors wrote.
In addition, the 980-page report establishes that secondhand smoke is a cause of stroke, and that smoking increases the risk of dying in cancer patients and cancer survivors.
Another finding: Cigarette smokers today have a higher risk of lung cancer than did those who smoked in 1964, because of the higher number of chemical additives now used.
Women smokers now have the same risk of death from lung cancer as that of men and a higher relative risk of dying from coronary heart disease than that of men. Because of smoking, the number of women dying from chronic obstructive pulmonary disease (COPD) is now higher than in men.
With this report, the federal government is launching a new effort to prevent children from using tobacco.
"Today, we’re asking Americans to join a sustained effort to make the next generation a tobacco-free generation," Health and Human Services Secretary Kathleen Sebelius said in a statement. "This is not something the federal government can do alone. We need to partner with the business community, local elected officials, schools and universities, the medical community, the faith community, and committed citizens in communities across the country to make the next generation tobacco free."
The report finds that youth smoking rates declined by 50% between 1997 and 2011, but 3,200 children under age 18 still start smoking each day, and an additional 2,100 youth and young adults become daily smokers. The report places most of the blame for continued interest in smoking on the tobacco industry, saying it has used "aggressive strategies" to deliberately mislead the public about the harms of smoking.
Acting Surgeon General Boris Lushniak noted that smoking rates are disproportionately higher among people with less education and lower incomes, among the mentally ill, and among gay, lesbian, bisexual, and transgender individuals.
Dr. Lushniak and other officials at the White House event called for greater tobacco control efforts, including stricter regulation. The Food and Drug Administration was given the power to regulate tobacco through the 2009 Family Smoking Prevention and Tobacco Control Act.
FDA Commissioner Margaret Hamburg said that the agency is ready to take action.
"The FDA is funding and conducting regulatory science research on tobacco products, enforcing the laws that reduce the access and attractiveness of tobacco products to young people, and preparing to launch an unprecedented national public education campaign to prevent youth tobacco use," Dr. Hamburg said in a statement.
Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, noted that while states collect some $80 per person a year in tobacco taxes and payments from the 1998 tobacco industry master settlement agreement, they spend an average of $1.50 per person on control.
The CDC has urged states to spend $12 per person on control, Dr. Frieden said.
Dr. Lushniak noted that for current and about-to-start smokers, "the clock is ticking – they can’t wait for slow and steady progress to end the epidemic. Enough is enough."
On Twitter @aliciaault
While smoking rates have dropped precipitously since the landmark 1964 Surgeon General’s report, "Smoking and Health," smoking is still the leading cause of preventable disease and death in the United States and is now causally linked to additional diseases and conditions across most organ systems.
A new Surgeon General's report, "The Health Consequences of Smoking – 50 Years of Progress," released at a White House event Jan. 17, synthesizes original and review evidence in an effort to further federal antismoking efforts.
The report causally links cigarette smoking to type 2 diabetes, rheumatoid arthritis, ectopic pregnancy, and erectile dysfunction. Secondhand smoke is now causally linked to cancers, respiratory diseases, and cardiovascular diseases, as well as adverse effects on the health of children, the authors wrote.
In addition, the 980-page report establishes that secondhand smoke is a cause of stroke, and that smoking increases the risk of dying in cancer patients and cancer survivors.
Another finding: Cigarette smokers today have a higher risk of lung cancer than did those who smoked in 1964, because of the higher number of chemical additives now used.
Women smokers now have the same risk of death from lung cancer as that of men and a higher relative risk of dying from coronary heart disease than that of men. Because of smoking, the number of women dying from chronic obstructive pulmonary disease (COPD) is now higher than in men.
With this report, the federal government is launching a new effort to prevent children from using tobacco.
"Today, we’re asking Americans to join a sustained effort to make the next generation a tobacco-free generation," Health and Human Services Secretary Kathleen Sebelius said in a statement. "This is not something the federal government can do alone. We need to partner with the business community, local elected officials, schools and universities, the medical community, the faith community, and committed citizens in communities across the country to make the next generation tobacco free."
The report finds that youth smoking rates declined by 50% between 1997 and 2011, but 3,200 children under age 18 still start smoking each day, and an additional 2,100 youth and young adults become daily smokers. The report places most of the blame for continued interest in smoking on the tobacco industry, saying it has used "aggressive strategies" to deliberately mislead the public about the harms of smoking.
Acting Surgeon General Boris Lushniak noted that smoking rates are disproportionately higher among people with less education and lower incomes, among the mentally ill, and among gay, lesbian, bisexual, and transgender individuals.
Dr. Lushniak and other officials at the White House event called for greater tobacco control efforts, including stricter regulation. The Food and Drug Administration was given the power to regulate tobacco through the 2009 Family Smoking Prevention and Tobacco Control Act.
FDA Commissioner Margaret Hamburg said that the agency is ready to take action.
"The FDA is funding and conducting regulatory science research on tobacco products, enforcing the laws that reduce the access and attractiveness of tobacco products to young people, and preparing to launch an unprecedented national public education campaign to prevent youth tobacco use," Dr. Hamburg said in a statement.
Dr. Thomas R. Frieden, director of the Centers for Disease Control and Prevention, noted that while states collect some $80 per person a year in tobacco taxes and payments from the 1998 tobacco industry master settlement agreement, they spend an average of $1.50 per person on control.
The CDC has urged states to spend $12 per person on control, Dr. Frieden said.
Dr. Lushniak noted that for current and about-to-start smokers, "the clock is ticking – they can’t wait for slow and steady progress to end the epidemic. Enough is enough."
On Twitter @aliciaault
FDA: Stop prescribing combo drugs with high-dose acetaminophen
The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.
In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.
Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.
"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.
In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.
Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.
The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.
The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.
Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.
On Twitter @aliciaault
The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.
In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.
Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.
"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.
In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.
Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.
The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.
The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.
Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.
On Twitter @aliciaault
The Food and Drug Administration is turning to doctors, dentists, and pharmacists to accomplish what some drug manufacturers won’t help it do.
In 2011, the agency recommended manufacturers cease marketing of acetaminophen/opioid combination products with more than 325 mg of acetaminophen per dose, in an effort to reduce the risk of severe liver injury. Not all manufacturers complied.
Now, the agency on Jan. 14 issued a MedWatch recommendation that health care providers refrain from prescribing combinations with larger acetaminophen doses. The recommendation goes further, urging pharmacists to contact prescribers when they receive a prescription for a combination product with more than 325 mg of acetaminophen per dose to discuss a substitute product with a lower acetaminophen dose.
"Inadvertent overdose from prescription combination drugs containing acetaminophen accounts for nearly half of all cases of acetaminophen-related liver failure in the United States, some of which result in liver transplant or death," the agency said, in a statement.
In the same 2011 notice, the FDA is requiring prescription acetaminophen combinations to carry a boxed warning on the potential for liver damage.
Acetaminophen-containing prescription combinations are among the most-prescribed pharmaceuticals in the United States, and include products such as Vicodin (acetaminophen/hydrocodone), Percocet (acetaminophen/oxycodone), and Tylenol with codeine.
The FDA has been examining acetaminophen since at least 2002. The recommendations of a joint meeting of several advisory committees in 2009 resulted in the 2011 policy changes and recommendations.
The agency now has sent letters to manufacturers that have not lowered the acetaminophen dose warning them that the FDA will withdraw approval of those products.
Physicians can report adverse events or side effects related to the use of acetaminophen products to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program either online or at 800-332-1088.
On Twitter @aliciaault
Rural Coverage a Key to Meeting Primary Care Demand
WASHINGTON – Rural family medicine residency programs are doing what they can to attract more primary care physicians to underserved areas and keep them there, but they are faced with an ever-larger task. Rural communities will be the most hard-pressed to meet growing demand for physicians as more Americans gain health insurance and seek a regular medical care provider, said several experts at a forum on Capitol Hill sponsored by the American Academy of Family Physicians.
The majority of the nation’s rural areas are underserved by physicians, and in particular by primary care.
The problem is exacerbated by the fact that the number of medical school students choosing primary care residencies still lags far behind those electing to pursue other specialties, said Dr. Ted Epperly, president and chief executive officer of the Family Medicine Residency of Idaho in Boise.
"It all starts with making sure we have a pipeline developed of training broad, well-trained, comprehensivists," said Dr. Epperly. Generalism is the most important attribute needed for primary care, but "what we’ve created is a system of subspecialization, so at a time when we need a complex skill set to be able to handle problems, we’ve micro-detailed our physicians into looking at the left kidney," Dr. Epperly said.
Some 62 million Americans, or 20% of the nation’s population, live in a rural area, said Amy Elizondo, vice president of program services at the National Rural Health Association. Only 9% of the nation’s physicians practice in rural areas, and 77% of the 2,050 rural counties in America are designated as Health Professional Shortage Areas by the Health Resources and Services Administration (HRSA). A shortage area is one in which there is one or fewer primary care physicians per 3,500 people, according to HRSA. The agency estimates that, as of Nov. 14, there were 5,800 total primary care shortage areas in the United States, which can be located in urban or rural areas. It would take an additional 7,500 primary care physicians to end the shortages in all of those areas, said HRSA.
Physician organizations and HRSA, among others, have been trying to figure out how to draw more primary care doctors to those areas. The Affordable Care Act established a grant program for states looking to study their workforce issues, but so far HRSA has not been given any money by Congress to fund any grants. When the State Health Workforce Development Grants were announced in 2010, the Department of Health and Human Services said that almost $6 million would be made available to 26 states.
The ACA also established a National Health Care Workforce Commission, but that, too, has never been funded, although members were appointed in 2010 by the head of the Government Accountability Office. The GAO was given the authority under the health law to appoint the commission’s members.
"Right now we don’t have a unified policy or approach to addressing our workforce," said Dr. Stan Kozakowski, director of medical education at the American Academy of Family Physicians.
Dr. Kozakowski said that another way to boost the numbers of rural physicians was to increase training slots devoted to family medicine and, more specifically, residents trained in delivering medicine in rural areas.
A number of family medicine residency programs have developed a rural training track, which requires residents to spend 1 year in the larger academic medical center, followed by 2 years in the rural area, which may or may not have a hospital. Currently, there are 26 active rural training track programs. All are strapped for funding because fewer than half are eligible to receive traditional graduate medical education funding from the Centers for Medicare and Medicaid Services (CMS), said Dr. Randall Longenecker, professor of family medicine and assistant dean for rural and underserved programsat the Ohio University Heritage College of Osteopathic Medicine in Athens.
But the programs have proven to be effective, said Dr. Longenecker, who is also the executive director of the new nonprofit RTT Collaborative. He cited data showing that, 3 years after graduation, almost half of recent rural training track participants had continued to practice in rural areas and about a third were serving in professional shortage areas.
"The biggest challenge for retention is getting people to live in a rural place," said Dr. Longenecker, adding that, by living and training in the area for 2 years, physicians learn how to live there.
"The longer they stay, the longer they stay," agreed Dr. Epperly. He said that 85% of the physicians trained through the rural sites of the Family Medicine Residency of Idaho end up practicing in those areas. Another key is to help spouses become acclimated, which his program does through group outreach, Dr. Epperly said.
He noted that 35 of the nation’s 165 medical schools have started to look at training for rural areas in "a more serious way."
In addition, 13 states are contemplating developing rural track training, said Dr. Longenecker.
On Twitter @aliciaault
WASHINGTON – Rural family medicine residency programs are doing what they can to attract more primary care physicians to underserved areas and keep them there, but they are faced with an ever-larger task. Rural communities will be the most hard-pressed to meet growing demand for physicians as more Americans gain health insurance and seek a regular medical care provider, said several experts at a forum on Capitol Hill sponsored by the American Academy of Family Physicians.
The majority of the nation’s rural areas are underserved by physicians, and in particular by primary care.
The problem is exacerbated by the fact that the number of medical school students choosing primary care residencies still lags far behind those electing to pursue other specialties, said Dr. Ted Epperly, president and chief executive officer of the Family Medicine Residency of Idaho in Boise.
"It all starts with making sure we have a pipeline developed of training broad, well-trained, comprehensivists," said Dr. Epperly. Generalism is the most important attribute needed for primary care, but "what we’ve created is a system of subspecialization, so at a time when we need a complex skill set to be able to handle problems, we’ve micro-detailed our physicians into looking at the left kidney," Dr. Epperly said.
Some 62 million Americans, or 20% of the nation’s population, live in a rural area, said Amy Elizondo, vice president of program services at the National Rural Health Association. Only 9% of the nation’s physicians practice in rural areas, and 77% of the 2,050 rural counties in America are designated as Health Professional Shortage Areas by the Health Resources and Services Administration (HRSA). A shortage area is one in which there is one or fewer primary care physicians per 3,500 people, according to HRSA. The agency estimates that, as of Nov. 14, there were 5,800 total primary care shortage areas in the United States, which can be located in urban or rural areas. It would take an additional 7,500 primary care physicians to end the shortages in all of those areas, said HRSA.
Physician organizations and HRSA, among others, have been trying to figure out how to draw more primary care doctors to those areas. The Affordable Care Act established a grant program for states looking to study their workforce issues, but so far HRSA has not been given any money by Congress to fund any grants. When the State Health Workforce Development Grants were announced in 2010, the Department of Health and Human Services said that almost $6 million would be made available to 26 states.
The ACA also established a National Health Care Workforce Commission, but that, too, has never been funded, although members were appointed in 2010 by the head of the Government Accountability Office. The GAO was given the authority under the health law to appoint the commission’s members.
"Right now we don’t have a unified policy or approach to addressing our workforce," said Dr. Stan Kozakowski, director of medical education at the American Academy of Family Physicians.
Dr. Kozakowski said that another way to boost the numbers of rural physicians was to increase training slots devoted to family medicine and, more specifically, residents trained in delivering medicine in rural areas.
A number of family medicine residency programs have developed a rural training track, which requires residents to spend 1 year in the larger academic medical center, followed by 2 years in the rural area, which may or may not have a hospital. Currently, there are 26 active rural training track programs. All are strapped for funding because fewer than half are eligible to receive traditional graduate medical education funding from the Centers for Medicare and Medicaid Services (CMS), said Dr. Randall Longenecker, professor of family medicine and assistant dean for rural and underserved programsat the Ohio University Heritage College of Osteopathic Medicine in Athens.
But the programs have proven to be effective, said Dr. Longenecker, who is also the executive director of the new nonprofit RTT Collaborative. He cited data showing that, 3 years after graduation, almost half of recent rural training track participants had continued to practice in rural areas and about a third were serving in professional shortage areas.
"The biggest challenge for retention is getting people to live in a rural place," said Dr. Longenecker, adding that, by living and training in the area for 2 years, physicians learn how to live there.
"The longer they stay, the longer they stay," agreed Dr. Epperly. He said that 85% of the physicians trained through the rural sites of the Family Medicine Residency of Idaho end up practicing in those areas. Another key is to help spouses become acclimated, which his program does through group outreach, Dr. Epperly said.
He noted that 35 of the nation’s 165 medical schools have started to look at training for rural areas in "a more serious way."
In addition, 13 states are contemplating developing rural track training, said Dr. Longenecker.
On Twitter @aliciaault
WASHINGTON – Rural family medicine residency programs are doing what they can to attract more primary care physicians to underserved areas and keep them there, but they are faced with an ever-larger task. Rural communities will be the most hard-pressed to meet growing demand for physicians as more Americans gain health insurance and seek a regular medical care provider, said several experts at a forum on Capitol Hill sponsored by the American Academy of Family Physicians.
The majority of the nation’s rural areas are underserved by physicians, and in particular by primary care.
The problem is exacerbated by the fact that the number of medical school students choosing primary care residencies still lags far behind those electing to pursue other specialties, said Dr. Ted Epperly, president and chief executive officer of the Family Medicine Residency of Idaho in Boise.
"It all starts with making sure we have a pipeline developed of training broad, well-trained, comprehensivists," said Dr. Epperly. Generalism is the most important attribute needed for primary care, but "what we’ve created is a system of subspecialization, so at a time when we need a complex skill set to be able to handle problems, we’ve micro-detailed our physicians into looking at the left kidney," Dr. Epperly said.
Some 62 million Americans, or 20% of the nation’s population, live in a rural area, said Amy Elizondo, vice president of program services at the National Rural Health Association. Only 9% of the nation’s physicians practice in rural areas, and 77% of the 2,050 rural counties in America are designated as Health Professional Shortage Areas by the Health Resources and Services Administration (HRSA). A shortage area is one in which there is one or fewer primary care physicians per 3,500 people, according to HRSA. The agency estimates that, as of Nov. 14, there were 5,800 total primary care shortage areas in the United States, which can be located in urban or rural areas. It would take an additional 7,500 primary care physicians to end the shortages in all of those areas, said HRSA.
Physician organizations and HRSA, among others, have been trying to figure out how to draw more primary care doctors to those areas. The Affordable Care Act established a grant program for states looking to study their workforce issues, but so far HRSA has not been given any money by Congress to fund any grants. When the State Health Workforce Development Grants were announced in 2010, the Department of Health and Human Services said that almost $6 million would be made available to 26 states.
The ACA also established a National Health Care Workforce Commission, but that, too, has never been funded, although members were appointed in 2010 by the head of the Government Accountability Office. The GAO was given the authority under the health law to appoint the commission’s members.
"Right now we don’t have a unified policy or approach to addressing our workforce," said Dr. Stan Kozakowski, director of medical education at the American Academy of Family Physicians.
Dr. Kozakowski said that another way to boost the numbers of rural physicians was to increase training slots devoted to family medicine and, more specifically, residents trained in delivering medicine in rural areas.
A number of family medicine residency programs have developed a rural training track, which requires residents to spend 1 year in the larger academic medical center, followed by 2 years in the rural area, which may or may not have a hospital. Currently, there are 26 active rural training track programs. All are strapped for funding because fewer than half are eligible to receive traditional graduate medical education funding from the Centers for Medicare and Medicaid Services (CMS), said Dr. Randall Longenecker, professor of family medicine and assistant dean for rural and underserved programsat the Ohio University Heritage College of Osteopathic Medicine in Athens.
But the programs have proven to be effective, said Dr. Longenecker, who is also the executive director of the new nonprofit RTT Collaborative. He cited data showing that, 3 years after graduation, almost half of recent rural training track participants had continued to practice in rural areas and about a third were serving in professional shortage areas.
"The biggest challenge for retention is getting people to live in a rural place," said Dr. Longenecker, adding that, by living and training in the area for 2 years, physicians learn how to live there.
"The longer they stay, the longer they stay," agreed Dr. Epperly. He said that 85% of the physicians trained through the rural sites of the Family Medicine Residency of Idaho end up practicing in those areas. Another key is to help spouses become acclimated, which his program does through group outreach, Dr. Epperly said.
He noted that 35 of the nation’s 165 medical schools have started to look at training for rural areas in "a more serious way."
In addition, 13 states are contemplating developing rural track training, said Dr. Longenecker.
On Twitter @aliciaault
FROM AN AAFP BRIEFING
Rural coverage a key to meeting primary care demand
WASHINGTON – Rural family medicine residency programs are doing what they can to attract more primary care physicians to underserved areas and keep them there, but they are faced with an ever-larger task. Rural communities will be the most hard-pressed to meet growing demand for physicians as more Americans gain health insurance and seek a regular medical care provider, said several experts at a forum on Capitol Hill sponsored by the American Academy of Family Physicians.
The majority of the nation’s rural areas are underserved by physicians, and in particular by primary care.
The problem is exacerbated by the fact that the number of medical school students choosing primary care residencies still lags far behind those electing to pursue other specialties, said Dr. Ted Epperly, president and chief executive officer of the Family Medicine Residency of Idaho in Boise.
"It all starts with making sure we have a pipeline developed of training broad, well-trained, comprehensivists," said Dr. Epperly. Generalism is the most important attribute needed for primary care, but "what we’ve created is a system of subspecialization, so at a time when we need a complex skill set to be able to handle problems, we’ve micro-detailed our physicians into looking at the left kidney," Dr. Epperly said.
Some 62 million Americans, or 20% of the nation’s population, live in a rural area, said Amy Elizondo, vice president of program services at the National Rural Health Association. Only 9% of the nation’s physicians practice in rural areas, and 77% of the 2,050 rural counties in America are designated as Health Professional Shortage Areas by the Health Resources and Services Administration (HRSA). A shortage area is one in which there is one or fewer primary care physicians per 3,500 people, according to HRSA. The agency estimates that, as of Nov. 14, there were 5,800 total primary care shortage areas in the United States, which can be located in urban or rural areas. It would take an additional 7,500 primary care physicians to end the shortages in all of those areas, said HRSA.
Physician organizations and HRSA, among others, have been trying to figure out how to draw more primary care doctors to those areas. The Affordable Care Act established a grant program for states looking to study their workforce issues, but so far HRSA has not been given any money by Congress to fund any grants. When the State Health Workforce Development Grants were announced in 2010, the Department of Health and Human Services said that almost $6 million would be made available to 26 states.
The ACA also established a National Health Care Workforce Commission, but that, too, has never been funded, although members were appointed in 2010 by the head of the Government Accountability Office. The GAO was given the authority under the health law to appoint the commission’s members.
"Right now we don’t have a unified policy or approach to addressing our workforce," said Dr. Stan Kozakowski, director of medical education at the American Academy of Family Physicians.
Dr. Kozakowski said that another way to boost the numbers of rural physicians was to increase training slots devoted to family medicine and, more specifically, residents trained in delivering medicine in rural areas.
A number of family medicine residency programs have developed a rural training track, which requires residents to spend 1 year in the larger academic medical center, followed by 2 years in the rural area, which may or may not have a hospital. Currently, there are 26 active rural training track programs. All are strapped for funding because fewer than half are eligible to receive traditional graduate medical education funding from the Centers for Medicare and Medicaid Services (CMS), said Dr. Randall Longenecker, professor of family medicine and assistant dean for rural and underserved programsat the Ohio University Heritage College of Osteopathic Medicine in Athens.
But the programs have proven to be effective, said Dr. Longenecker, who is also the executive director of the new nonprofit RTT Collaborative. He cited data showing that, 3 years after graduation, almost half of recent rural training track participants had continued to practice in rural areas and about a third were serving in professional shortage areas.
"The biggest challenge for retention is getting people to live in a rural place," said Dr. Longenecker, adding that, by living and training in the area for 2 years, physicians learn how to live there.
"The longer they stay, the longer they stay," agreed Dr. Epperly. He said that 85% of the physicians trained through the rural sites of the Family Medicine Residency of Idaho end up practicing in those areas. Another key is to help spouses become acclimated, which his program does through group outreach, Dr. Epperly said.
He noted that 35 of the nation’s 165 medical schools have started to look at training for rural areas in "a more serious way."
In addition, 13 states are contemplating developing rural track training, said Dr. Longenecker.
On Twitter @aliciaault
WASHINGTON – Rural family medicine residency programs are doing what they can to attract more primary care physicians to underserved areas and keep them there, but they are faced with an ever-larger task. Rural communities will be the most hard-pressed to meet growing demand for physicians as more Americans gain health insurance and seek a regular medical care provider, said several experts at a forum on Capitol Hill sponsored by the American Academy of Family Physicians.
The majority of the nation’s rural areas are underserved by physicians, and in particular by primary care.
The problem is exacerbated by the fact that the number of medical school students choosing primary care residencies still lags far behind those electing to pursue other specialties, said Dr. Ted Epperly, president and chief executive officer of the Family Medicine Residency of Idaho in Boise.
"It all starts with making sure we have a pipeline developed of training broad, well-trained, comprehensivists," said Dr. Epperly. Generalism is the most important attribute needed for primary care, but "what we’ve created is a system of subspecialization, so at a time when we need a complex skill set to be able to handle problems, we’ve micro-detailed our physicians into looking at the left kidney," Dr. Epperly said.
Some 62 million Americans, or 20% of the nation’s population, live in a rural area, said Amy Elizondo, vice president of program services at the National Rural Health Association. Only 9% of the nation’s physicians practice in rural areas, and 77% of the 2,050 rural counties in America are designated as Health Professional Shortage Areas by the Health Resources and Services Administration (HRSA). A shortage area is one in which there is one or fewer primary care physicians per 3,500 people, according to HRSA. The agency estimates that, as of Nov. 14, there were 5,800 total primary care shortage areas in the United States, which can be located in urban or rural areas. It would take an additional 7,500 primary care physicians to end the shortages in all of those areas, said HRSA.
Physician organizations and HRSA, among others, have been trying to figure out how to draw more primary care doctors to those areas. The Affordable Care Act established a grant program for states looking to study their workforce issues, but so far HRSA has not been given any money by Congress to fund any grants. When the State Health Workforce Development Grants were announced in 2010, the Department of Health and Human Services said that almost $6 million would be made available to 26 states.
The ACA also established a National Health Care Workforce Commission, but that, too, has never been funded, although members were appointed in 2010 by the head of the Government Accountability Office. The GAO was given the authority under the health law to appoint the commission’s members.
"Right now we don’t have a unified policy or approach to addressing our workforce," said Dr. Stan Kozakowski, director of medical education at the American Academy of Family Physicians.
Dr. Kozakowski said that another way to boost the numbers of rural physicians was to increase training slots devoted to family medicine and, more specifically, residents trained in delivering medicine in rural areas.
A number of family medicine residency programs have developed a rural training track, which requires residents to spend 1 year in the larger academic medical center, followed by 2 years in the rural area, which may or may not have a hospital. Currently, there are 26 active rural training track programs. All are strapped for funding because fewer than half are eligible to receive traditional graduate medical education funding from the Centers for Medicare and Medicaid Services (CMS), said Dr. Randall Longenecker, professor of family medicine and assistant dean for rural and underserved programsat the Ohio University Heritage College of Osteopathic Medicine in Athens.
But the programs have proven to be effective, said Dr. Longenecker, who is also the executive director of the new nonprofit RTT Collaborative. He cited data showing that, 3 years after graduation, almost half of recent rural training track participants had continued to practice in rural areas and about a third were serving in professional shortage areas.
"The biggest challenge for retention is getting people to live in a rural place," said Dr. Longenecker, adding that, by living and training in the area for 2 years, physicians learn how to live there.
"The longer they stay, the longer they stay," agreed Dr. Epperly. He said that 85% of the physicians trained through the rural sites of the Family Medicine Residency of Idaho end up practicing in those areas. Another key is to help spouses become acclimated, which his program does through group outreach, Dr. Epperly said.
He noted that 35 of the nation’s 165 medical schools have started to look at training for rural areas in "a more serious way."
In addition, 13 states are contemplating developing rural track training, said Dr. Longenecker.
On Twitter @aliciaault
WASHINGTON – Rural family medicine residency programs are doing what they can to attract more primary care physicians to underserved areas and keep them there, but they are faced with an ever-larger task. Rural communities will be the most hard-pressed to meet growing demand for physicians as more Americans gain health insurance and seek a regular medical care provider, said several experts at a forum on Capitol Hill sponsored by the American Academy of Family Physicians.
The majority of the nation’s rural areas are underserved by physicians, and in particular by primary care.
The problem is exacerbated by the fact that the number of medical school students choosing primary care residencies still lags far behind those electing to pursue other specialties, said Dr. Ted Epperly, president and chief executive officer of the Family Medicine Residency of Idaho in Boise.
"It all starts with making sure we have a pipeline developed of training broad, well-trained, comprehensivists," said Dr. Epperly. Generalism is the most important attribute needed for primary care, but "what we’ve created is a system of subspecialization, so at a time when we need a complex skill set to be able to handle problems, we’ve micro-detailed our physicians into looking at the left kidney," Dr. Epperly said.
Some 62 million Americans, or 20% of the nation’s population, live in a rural area, said Amy Elizondo, vice president of program services at the National Rural Health Association. Only 9% of the nation’s physicians practice in rural areas, and 77% of the 2,050 rural counties in America are designated as Health Professional Shortage Areas by the Health Resources and Services Administration (HRSA). A shortage area is one in which there is one or fewer primary care physicians per 3,500 people, according to HRSA. The agency estimates that, as of Nov. 14, there were 5,800 total primary care shortage areas in the United States, which can be located in urban or rural areas. It would take an additional 7,500 primary care physicians to end the shortages in all of those areas, said HRSA.
Physician organizations and HRSA, among others, have been trying to figure out how to draw more primary care doctors to those areas. The Affordable Care Act established a grant program for states looking to study their workforce issues, but so far HRSA has not been given any money by Congress to fund any grants. When the State Health Workforce Development Grants were announced in 2010, the Department of Health and Human Services said that almost $6 million would be made available to 26 states.
The ACA also established a National Health Care Workforce Commission, but that, too, has never been funded, although members were appointed in 2010 by the head of the Government Accountability Office. The GAO was given the authority under the health law to appoint the commission’s members.
"Right now we don’t have a unified policy or approach to addressing our workforce," said Dr. Stan Kozakowski, director of medical education at the American Academy of Family Physicians.
Dr. Kozakowski said that another way to boost the numbers of rural physicians was to increase training slots devoted to family medicine and, more specifically, residents trained in delivering medicine in rural areas.
A number of family medicine residency programs have developed a rural training track, which requires residents to spend 1 year in the larger academic medical center, followed by 2 years in the rural area, which may or may not have a hospital. Currently, there are 26 active rural training track programs. All are strapped for funding because fewer than half are eligible to receive traditional graduate medical education funding from the Centers for Medicare and Medicaid Services (CMS), said Dr. Randall Longenecker, professor of family medicine and assistant dean for rural and underserved programsat the Ohio University Heritage College of Osteopathic Medicine in Athens.
But the programs have proven to be effective, said Dr. Longenecker, who is also the executive director of the new nonprofit RTT Collaborative. He cited data showing that, 3 years after graduation, almost half of recent rural training track participants had continued to practice in rural areas and about a third were serving in professional shortage areas.
"The biggest challenge for retention is getting people to live in a rural place," said Dr. Longenecker, adding that, by living and training in the area for 2 years, physicians learn how to live there.
"The longer they stay, the longer they stay," agreed Dr. Epperly. He said that 85% of the physicians trained through the rural sites of the Family Medicine Residency of Idaho end up practicing in those areas. Another key is to help spouses become acclimated, which his program does through group outreach, Dr. Epperly said.
He noted that 35 of the nation’s 165 medical schools have started to look at training for rural areas in "a more serious way."
In addition, 13 states are contemplating developing rural track training, said Dr. Longenecker.
On Twitter @aliciaault
FROM AN AAFP BRIEFING
Pediatricians, cancer groups ask regulators to help cut tobacco use
WASHINGTON – A coalition of health groups including the American Academy of Pediatrics, the American Heart Association, and the American Cancer Society Cancer Action Network are urging regulators to help the nation achieve at least an 8% reduction in adult smoking rates by 2024.
Smoking kills 440,000 Americans a year and leads to $193 billion in health costs, according to the coalition, which also includes the American Lung Association, the Campaign for Tobacco-Free Kids, the Legacy Foundation, and Americans for Nonsmokers’ Rights. The groups noted that tobacco is the leading cause of preventable death in the United States.
Tobacco control is effective, Dr. Kenneth E. Warner, a distinguished university professor of public health at the University of Michigan, Ann Arbor, said at a briefing with reporters. He cited just-published data from a JAMA study he conducted with colleagues showing that control efforts had resulted in 8 million saved lives since 1964 and a 30% gain in life expectancy during the same time period (JAMA 2014;311:164-71).
The group said it wants regulators at all levels of government to help reduce smoking from about 18% of adults to less than 10% by 2024, protect all Americans from second-hand smoke within 5 years, and eventually eliminate death and disease caused by tobacco use.
The call to action was issued a week before the release of a new report from the U.S. Surgeon General’s Office on smoking and health that will tabulate the progress in the 50 years since the first Surgeon General’s report on smoking and also lay out the challenges still ahead.
"What has been accomplished in the last 50 years is nothing short of astounding," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a briefing with reporters. He noted that the adult smoking rate has dropped by more than half, from 42% in 1964 to 18%. Among high school seniors, smoking rates have dropped from 36% in 1997 to 16%. Half of the U.S. population is protected from second-hand smoke by laws that bar smoking in public places.
But 44 million adults and almost 4 million children are still current smokers, and each day, 3,000 children start what usually becomes a lifetime habit. Mr. Myers called smoking a "pediatric epidemic."
Mr. Myers and other speakers decried what they said are continued efforts by tobacco makers to target children. Dr. James M. Perrin, president of the American Academy of Pediatrics, noted that although the Food and Drug Administration halted sales of candy-flavored cigarettes in 2010, other candy-like products have emerged, including dissolvables, cigars, and e-cigarettes that have flavors like cotton candy and grape.
"Strong tobacco regulation by the Food and Drug Administration is essential," said Dr. Perrin.
The coalition said that local, state, and federal governments could also help deter tobacco use by increasing excise taxes on tobacco products and raising the age of purchase. New York City and the big island of Hawaii both have banned sales to anyone under age 21 years. High school students may be friends with 18- and 19-year olds, but they aren’t as likely to have peers older than age 20, said Dr. Perrin. Raising the purchase age thus "limits the exposure of younger children ... to tobacco," he said.
E-cigarettes are also a growing concern, even though they are being pitched as a potential smoking cessation tool by their manufacturers, coalition members said. The products also are being marketed to children in a similar way that tobacco has been, said Mr. Myers. The coalition wants FDA regulation of those products "to ensure that the potential for their use to get people to quit is realized, but the danger of their becoming the next generation’s nicotine addiction is avoided," he said.
The Obama Administration may be poised to give the FDA more power to regulate e-cigarettes, said Paul Billings, senior vice president for advocacy at the Lung Association. "There are no e-cigarette products that have been demonstrated to be safe and effective to the Food and Drug Administration," said Mr. Billings.
The rules have been under review for more than 90 days, said Mr. Billings, adding "it’s time for action."
On Twitter @aliciaault
WASHINGTON – A coalition of health groups including the American Academy of Pediatrics, the American Heart Association, and the American Cancer Society Cancer Action Network are urging regulators to help the nation achieve at least an 8% reduction in adult smoking rates by 2024.
Smoking kills 440,000 Americans a year and leads to $193 billion in health costs, according to the coalition, which also includes the American Lung Association, the Campaign for Tobacco-Free Kids, the Legacy Foundation, and Americans for Nonsmokers’ Rights. The groups noted that tobacco is the leading cause of preventable death in the United States.
Tobacco control is effective, Dr. Kenneth E. Warner, a distinguished university professor of public health at the University of Michigan, Ann Arbor, said at a briefing with reporters. He cited just-published data from a JAMA study he conducted with colleagues showing that control efforts had resulted in 8 million saved lives since 1964 and a 30% gain in life expectancy during the same time period (JAMA 2014;311:164-71).
The group said it wants regulators at all levels of government to help reduce smoking from about 18% of adults to less than 10% by 2024, protect all Americans from second-hand smoke within 5 years, and eventually eliminate death and disease caused by tobacco use.
The call to action was issued a week before the release of a new report from the U.S. Surgeon General’s Office on smoking and health that will tabulate the progress in the 50 years since the first Surgeon General’s report on smoking and also lay out the challenges still ahead.
"What has been accomplished in the last 50 years is nothing short of astounding," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a briefing with reporters. He noted that the adult smoking rate has dropped by more than half, from 42% in 1964 to 18%. Among high school seniors, smoking rates have dropped from 36% in 1997 to 16%. Half of the U.S. population is protected from second-hand smoke by laws that bar smoking in public places.
But 44 million adults and almost 4 million children are still current smokers, and each day, 3,000 children start what usually becomes a lifetime habit. Mr. Myers called smoking a "pediatric epidemic."
Mr. Myers and other speakers decried what they said are continued efforts by tobacco makers to target children. Dr. James M. Perrin, president of the American Academy of Pediatrics, noted that although the Food and Drug Administration halted sales of candy-flavored cigarettes in 2010, other candy-like products have emerged, including dissolvables, cigars, and e-cigarettes that have flavors like cotton candy and grape.
"Strong tobacco regulation by the Food and Drug Administration is essential," said Dr. Perrin.
The coalition said that local, state, and federal governments could also help deter tobacco use by increasing excise taxes on tobacco products and raising the age of purchase. New York City and the big island of Hawaii both have banned sales to anyone under age 21 years. High school students may be friends with 18- and 19-year olds, but they aren’t as likely to have peers older than age 20, said Dr. Perrin. Raising the purchase age thus "limits the exposure of younger children ... to tobacco," he said.
E-cigarettes are also a growing concern, even though they are being pitched as a potential smoking cessation tool by their manufacturers, coalition members said. The products also are being marketed to children in a similar way that tobacco has been, said Mr. Myers. The coalition wants FDA regulation of those products "to ensure that the potential for their use to get people to quit is realized, but the danger of their becoming the next generation’s nicotine addiction is avoided," he said.
The Obama Administration may be poised to give the FDA more power to regulate e-cigarettes, said Paul Billings, senior vice president for advocacy at the Lung Association. "There are no e-cigarette products that have been demonstrated to be safe and effective to the Food and Drug Administration," said Mr. Billings.
The rules have been under review for more than 90 days, said Mr. Billings, adding "it’s time for action."
On Twitter @aliciaault
WASHINGTON – A coalition of health groups including the American Academy of Pediatrics, the American Heart Association, and the American Cancer Society Cancer Action Network are urging regulators to help the nation achieve at least an 8% reduction in adult smoking rates by 2024.
Smoking kills 440,000 Americans a year and leads to $193 billion in health costs, according to the coalition, which also includes the American Lung Association, the Campaign for Tobacco-Free Kids, the Legacy Foundation, and Americans for Nonsmokers’ Rights. The groups noted that tobacco is the leading cause of preventable death in the United States.
Tobacco control is effective, Dr. Kenneth E. Warner, a distinguished university professor of public health at the University of Michigan, Ann Arbor, said at a briefing with reporters. He cited just-published data from a JAMA study he conducted with colleagues showing that control efforts had resulted in 8 million saved lives since 1964 and a 30% gain in life expectancy during the same time period (JAMA 2014;311:164-71).
The group said it wants regulators at all levels of government to help reduce smoking from about 18% of adults to less than 10% by 2024, protect all Americans from second-hand smoke within 5 years, and eventually eliminate death and disease caused by tobacco use.
The call to action was issued a week before the release of a new report from the U.S. Surgeon General’s Office on smoking and health that will tabulate the progress in the 50 years since the first Surgeon General’s report on smoking and also lay out the challenges still ahead.
"What has been accomplished in the last 50 years is nothing short of astounding," Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said in a briefing with reporters. He noted that the adult smoking rate has dropped by more than half, from 42% in 1964 to 18%. Among high school seniors, smoking rates have dropped from 36% in 1997 to 16%. Half of the U.S. population is protected from second-hand smoke by laws that bar smoking in public places.
But 44 million adults and almost 4 million children are still current smokers, and each day, 3,000 children start what usually becomes a lifetime habit. Mr. Myers called smoking a "pediatric epidemic."
Mr. Myers and other speakers decried what they said are continued efforts by tobacco makers to target children. Dr. James M. Perrin, president of the American Academy of Pediatrics, noted that although the Food and Drug Administration halted sales of candy-flavored cigarettes in 2010, other candy-like products have emerged, including dissolvables, cigars, and e-cigarettes that have flavors like cotton candy and grape.
"Strong tobacco regulation by the Food and Drug Administration is essential," said Dr. Perrin.
The coalition said that local, state, and federal governments could also help deter tobacco use by increasing excise taxes on tobacco products and raising the age of purchase. New York City and the big island of Hawaii both have banned sales to anyone under age 21 years. High school students may be friends with 18- and 19-year olds, but they aren’t as likely to have peers older than age 20, said Dr. Perrin. Raising the purchase age thus "limits the exposure of younger children ... to tobacco," he said.
E-cigarettes are also a growing concern, even though they are being pitched as a potential smoking cessation tool by their manufacturers, coalition members said. The products also are being marketed to children in a similar way that tobacco has been, said Mr. Myers. The coalition wants FDA regulation of those products "to ensure that the potential for their use to get people to quit is realized, but the danger of their becoming the next generation’s nicotine addiction is avoided," he said.
The Obama Administration may be poised to give the FDA more power to regulate e-cigarettes, said Paul Billings, senior vice president for advocacy at the Lung Association. "There are no e-cigarette products that have been demonstrated to be safe and effective to the Food and Drug Administration," said Mr. Billings.
The rules have been under review for more than 90 days, said Mr. Billings, adding "it’s time for action."
On Twitter @aliciaault
AT A BRIEFING SPONSORED BY THE CAMPAIGN FOR TOBACCO-FREE KIDS
