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FDA approves GLP-1 receptor agonist albiglutide for type 2 diabetes
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
Albiglutide, a once-weekly subcutaneous injection, has been approved by the Food and Drug Administration to improve glycemic control, in conjunction with diet and exercise in type 2 diabetes.
Albiglutide, which will be marketed as Tanzeum by GlaxoSmithKline, "can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes," said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA Center for Drug Evaluation and Research, in a statement.
The FDA approval is based on the results of the HARMONY program, which had eight trials involving more than 2,000 patients who received albiglutide. The glucagon-like peptide-1 (GLP-1) receptor agonist was compared with commonly used type 2 diabetes therapies, including insulin, metformin, glimepiride, and pioglitazone, in patients at different stages of the disease and in those with renal impairment.
Patients given albiglutide showed an improvement in their hemoglobin A1c levels. However, in HARMONY 7, published recently (Lancet Diabetes Endocrinol. 2014;2:289-97), albiglutide did not reduce HbA1c levels as much as another GLP-1 receptor agonist, once-daily liraglutide.
Albiglutide is the third GLP-1 receptor agonist to reach the U.S. market. Exenatide (Byetta), approved in 2005, gained an expanded indication in 2009, as monotherapy for improving glycemic control in type 2 diabetes. Liraglutide (Victoza) was approved in 2010. This class of biologic drugs promotes glucose-dependent insulin secretion and slows gastric emptying.
Administration of the drug is once weekly, subcutaneously, using an injector pen supplied with a 5-mm, 29-gauge thin-walled needle. It comes in two formulations, 30 mg and 50 mg. The dose can be increased to 50 mg once weekly in patients requiring additional glycemic control.
Albiglutide is not recommended as a first-line therapy and should not be used to treat type 1 diabetes or in patients with diabetic ketoacidosis. The drug has not been studied in patients with preexisting severe gastrointestinal disease or in combination with prandial insulin.
And the drug has a boxed warning on the potential for thyroid C-cell tumors, which have been observed in rodent studies with some GLP-1 receptor agonists. The FDA says that albiglutide should not be used in patients with a personal or family history of medullary thyroid carcinoma or in patients with multiple endocrine neoplasia syndrome type 2. GSK also suggests that alternatives be considered in patients with a history of pancreatitis, and that albiglutide should be discontinued immediately if pancreatitis is suspected.
The most frequent adverse reactions in trials were upper respiratory tract infection, diarrhea, nausea, and injection site reaction.
The FDA is requiring GSK to conduct several postmarketing studies: one to evaluate dosing, efficacy, and safety in pediatric patients, and another to evaluate cardiovascular risk in patients with high baseline risk of cardiovascular disease. GSK will also establish a medullary thyroid carcinoma registry that lasts at least 15 years to identify any increase in incidence that might be related to albiglutide.
The drug was approved with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care providers about the serious risks associated with it.
The company said it expects that albiglutide will be available in the fall. The drug – under the brand name Eperzan – received European approval in March.
On Twitter @aliciaault
FDA approves Grastek, second oral allergy therapy
The Food and Drug Administration has approved Grastek, a sublingual immunotherapy for grass pollen–induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years.
Grastek (Timothy Grass Pollen Allergen Extract), manufactured by Merck, was unanimously supported by an FDA advisory committee in December and is the second sublingual oral therapy to be approved by the agency in a few weeks. On April 1, the FDA approved Greer Laboratories’ Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky blue grass, orchard, perennial rye, sweet vernal, and Timothy. That product is approved for individuals aged 10-65 years.
Like Oralair, Grastek has a black box warning of the potential for severe allergic reactions such as anaphylaxis. Grastek is also contraindicated in patients with severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy grass (Phleum pratense) is a common, widespread, long-stemmed grass that is very hardy. According to Merck, it is cross reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue, and redtop.
Before initiating treatment, a patient’s allergy must be confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Therapy – at a dose of one tablet sublingually daily – is begun 12 weeks before the grass pollen season and should continue through the season. The first dose should be given under a physician’s supervision, according to Merck. Subsequent doses can be taken at home, but patients should also be prescribed injectable epinephrine and given training in how to use the autoinjector.
The company said that Grastek can be taken daily for up to 3 consecutive years.
In trials, the most common adverse reactions for both adult and pediatric patients included oral pruritus, throat irritation, and mouth edema. Adults also experienced ear pruritus.
The FDA approved production of tablets that have a potency of 2,800 Bioequivalent Allergy Units (BAU) of Timothy Grass pollen extract, which will be supplied in 10-tablet blister packs. The agency also said in its approval letter that it will require Merck to create a Medication Guide for distribution to patients because the product "poses a serious and significant public health concern."
Merck also will be required to conduct a 3-year, 10,000-patient postmarketing study to gauge safety, to be completed by about 2017. A second postmarketing study is also required, looking at 10,000 new users who are identified through electronic medical records. That study is also due to be finished by 2017.
Grastek will be available in U.S. pharmacies in late April, according to Merck.
On Twitter @aliciaault
The Food and Drug Administration has approved Grastek, a sublingual immunotherapy for grass pollen–induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years.
Grastek (Timothy Grass Pollen Allergen Extract), manufactured by Merck, was unanimously supported by an FDA advisory committee in December and is the second sublingual oral therapy to be approved by the agency in a few weeks. On April 1, the FDA approved Greer Laboratories’ Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky blue grass, orchard, perennial rye, sweet vernal, and Timothy. That product is approved for individuals aged 10-65 years.
Like Oralair, Grastek has a black box warning of the potential for severe allergic reactions such as anaphylaxis. Grastek is also contraindicated in patients with severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy grass (Phleum pratense) is a common, widespread, long-stemmed grass that is very hardy. According to Merck, it is cross reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue, and redtop.
Before initiating treatment, a patient’s allergy must be confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Therapy – at a dose of one tablet sublingually daily – is begun 12 weeks before the grass pollen season and should continue through the season. The first dose should be given under a physician’s supervision, according to Merck. Subsequent doses can be taken at home, but patients should also be prescribed injectable epinephrine and given training in how to use the autoinjector.
The company said that Grastek can be taken daily for up to 3 consecutive years.
In trials, the most common adverse reactions for both adult and pediatric patients included oral pruritus, throat irritation, and mouth edema. Adults also experienced ear pruritus.
The FDA approved production of tablets that have a potency of 2,800 Bioequivalent Allergy Units (BAU) of Timothy Grass pollen extract, which will be supplied in 10-tablet blister packs. The agency also said in its approval letter that it will require Merck to create a Medication Guide for distribution to patients because the product "poses a serious and significant public health concern."
Merck also will be required to conduct a 3-year, 10,000-patient postmarketing study to gauge safety, to be completed by about 2017. A second postmarketing study is also required, looking at 10,000 new users who are identified through electronic medical records. That study is also due to be finished by 2017.
Grastek will be available in U.S. pharmacies in late April, according to Merck.
On Twitter @aliciaault
The Food and Drug Administration has approved Grastek, a sublingual immunotherapy for grass pollen–induced allergic rhinitis with or without conjunctivitis in individuals aged 5-65 years.
Grastek (Timothy Grass Pollen Allergen Extract), manufactured by Merck, was unanimously supported by an FDA advisory committee in December and is the second sublingual oral therapy to be approved by the agency in a few weeks. On April 1, the FDA approved Greer Laboratories’ Oralair, which contains a mixture of freeze-dried extracts from the pollens of five grasses: Kentucky blue grass, orchard, perennial rye, sweet vernal, and Timothy. That product is approved for individuals aged 10-65 years.
Like Oralair, Grastek has a black box warning of the potential for severe allergic reactions such as anaphylaxis. Grastek is also contraindicated in patients with severe, unstable, or uncontrolled asthma; a history of any severe systemic allergic reaction; a history of any severe local reaction after taking any sublingual allergen immunotherapy; a history of eosinophilic esophagitis; or hypersensitivity to any of the inactive ingredients contained in the product.
Timothy grass (Phleum pratense) is a common, widespread, long-stemmed grass that is very hardy. According to Merck, it is cross reactive with other grasses, including sweet vernal, orchard (also known as cocksfoot), perennial rye, Kentucky blue (also known as June grass), meadow fescue, and redtop.
Before initiating treatment, a patient’s allergy must be confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Therapy – at a dose of one tablet sublingually daily – is begun 12 weeks before the grass pollen season and should continue through the season. The first dose should be given under a physician’s supervision, according to Merck. Subsequent doses can be taken at home, but patients should also be prescribed injectable epinephrine and given training in how to use the autoinjector.
The company said that Grastek can be taken daily for up to 3 consecutive years.
In trials, the most common adverse reactions for both adult and pediatric patients included oral pruritus, throat irritation, and mouth edema. Adults also experienced ear pruritus.
The FDA approved production of tablets that have a potency of 2,800 Bioequivalent Allergy Units (BAU) of Timothy Grass pollen extract, which will be supplied in 10-tablet blister packs. The agency also said in its approval letter that it will require Merck to create a Medication Guide for distribution to patients because the product "poses a serious and significant public health concern."
Merck also will be required to conduct a 3-year, 10,000-patient postmarketing study to gauge safety, to be completed by about 2017. A second postmarketing study is also required, looking at 10,000 new users who are identified through electronic medical records. That study is also due to be finished by 2017.
Grastek will be available in U.S. pharmacies in late April, according to Merck.
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. Several researchers were associated with Qualidigm, a consultancy that administers the Medicare database. No other relevant conflicts of interest were disclosed.
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. Several researchers were associated with Qualidigm, a consultancy that administers the Medicare database. No other relevant conflicts of interest were disclosed.
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. Several researchers were associated with Qualidigm, a consultancy that administers the Medicare database. No other relevant conflicts of interest were disclosed.
On Twitter @aliciaault
Block marketing of e-cigs to kids, senators urge FDA
Stating that e-cigarettes are a gateway to tobacco addiction for young people, almost a dozen members of Congress are urging the Food and Drug Administration to immediately begin regulating the sale and marketing of the products to children.
The 11 Democratic lawmakers from the House and the Senate issued a report that they say shows that e-cigarette makers are using the same tactics once used by tobacco manufacturers – but now prohibited – to lure young people into using the nicotine-infused devices.
"E-cigarettes are a candy-flavored addiction, which is dangerous to our young people," said Sen. Dick Durbin (D-Ill.) in a briefing with reporters. He said that the report, which is based on data submitted to Congress by nine e-cigarette manufacturers, contains evidence that the companies are making what he called a "determined effort" to attract young users.
The Democratic members of Congress surveyed the manufacturers in the wake of a report from the Centers for Disease Control and Prevention that showed that, from 2011 to 2012, the percentage of high school students who had used e-cigarettes more than doubled, from 4.7% to 10%.
The marketing practices used by the companies include using social media like Facebook and Twitter to reach youths and adolescents, sponsorships of youth-oriented events like music festivals and handing out free samples at the events, and radio and television ads played during events and programs with significant youth viewership. In 2012 and 2013, six of the companies sponsored or provided free samples at 348 events. Also, six e-cigarette makers market e-cigarettes in flavors that might appeal to young people, including Cherry Crush, Chocolate Treat, Peachy Keen, and Grape Mint.
"It’s time for the FDA to step up and regulate this product," said Sen. Durbin.
He said that the FDA currently has the authority to "deem" e-cigarettes similar to conventional tobacco products, and thus apply the rules that govern marketing of those products to the electronic products. The senator also said that absent FDA action, there was not enough support in the House and Senate to pass a new law specifically aimed at the e-cigarette industry. "I’m a realist, and the likelihood of revisiting this whole issue of FDA authority is not very strong," said Sen. Durbin.
"The report we are issuing today should be the prod to act," Rep. Henry Waxman (D-Calif.) told reporters. Rep. Waxman is one of the lawmakers who have called for tougher regulations.
Both Sen. Durbin and Rep. Waxman said that they believed that e-cigarettes have the potential to be addictive for young people, and called it a gateway to the use of tobacco products. But Rep. Waxman also said he believed that the FDA needs to study e-cigarettes. "We don’t really know the benefit," he said. "All we have are claims of benefits. But we are seeing the risks very clearly," said Rep. Waxman.
The Democratic lawmakers are recommending that:
• The FDA issue regulations that deem e-cigarettes the same as other tobacco products, and prohibit sales to minors under age 18.
• Companies prohibit sales to youth under age 18.
• The FDA should ban sales tactics that may be attractive to children and teens, such as the use of flavors that appeal to them, distributing free samples of e-cigarettes, and product promotion through social media, sponsorship of events, and other activities that are intended for a youth audience. Manufacturers should also agree to stop such activities.
• Manufacturers refrain from the use of television and radio ads.
• The FDA should require strong, uniform labels to inform consumers of health risks and should prohibit misleading product claims.
The Democratic lawmakers requested information from the following e-cigarette makers: NJOY, Lorillard, Reynolds American, Altria Group, LOGIC, EonSmoke, Green Smoke, VMR Products, and Lead By Sales. Of these, only Lead by Sales, which makes White Cloud Cigarettes, did not respond.
Six of the companies said they support some form of regulation, including restrictions on the marketing and sale of e-cigarettes to children and teens.
On Twitter @aliciaault
Stating that e-cigarettes are a gateway to tobacco addiction for young people, almost a dozen members of Congress are urging the Food and Drug Administration to immediately begin regulating the sale and marketing of the products to children.
The 11 Democratic lawmakers from the House and the Senate issued a report that they say shows that e-cigarette makers are using the same tactics once used by tobacco manufacturers – but now prohibited – to lure young people into using the nicotine-infused devices.
"E-cigarettes are a candy-flavored addiction, which is dangerous to our young people," said Sen. Dick Durbin (D-Ill.) in a briefing with reporters. He said that the report, which is based on data submitted to Congress by nine e-cigarette manufacturers, contains evidence that the companies are making what he called a "determined effort" to attract young users.
The Democratic members of Congress surveyed the manufacturers in the wake of a report from the Centers for Disease Control and Prevention that showed that, from 2011 to 2012, the percentage of high school students who had used e-cigarettes more than doubled, from 4.7% to 10%.
The marketing practices used by the companies include using social media like Facebook and Twitter to reach youths and adolescents, sponsorships of youth-oriented events like music festivals and handing out free samples at the events, and radio and television ads played during events and programs with significant youth viewership. In 2012 and 2013, six of the companies sponsored or provided free samples at 348 events. Also, six e-cigarette makers market e-cigarettes in flavors that might appeal to young people, including Cherry Crush, Chocolate Treat, Peachy Keen, and Grape Mint.
"It’s time for the FDA to step up and regulate this product," said Sen. Durbin.
He said that the FDA currently has the authority to "deem" e-cigarettes similar to conventional tobacco products, and thus apply the rules that govern marketing of those products to the electronic products. The senator also said that absent FDA action, there was not enough support in the House and Senate to pass a new law specifically aimed at the e-cigarette industry. "I’m a realist, and the likelihood of revisiting this whole issue of FDA authority is not very strong," said Sen. Durbin.
"The report we are issuing today should be the prod to act," Rep. Henry Waxman (D-Calif.) told reporters. Rep. Waxman is one of the lawmakers who have called for tougher regulations.
Both Sen. Durbin and Rep. Waxman said that they believed that e-cigarettes have the potential to be addictive for young people, and called it a gateway to the use of tobacco products. But Rep. Waxman also said he believed that the FDA needs to study e-cigarettes. "We don’t really know the benefit," he said. "All we have are claims of benefits. But we are seeing the risks very clearly," said Rep. Waxman.
The Democratic lawmakers are recommending that:
• The FDA issue regulations that deem e-cigarettes the same as other tobacco products, and prohibit sales to minors under age 18.
• Companies prohibit sales to youth under age 18.
• The FDA should ban sales tactics that may be attractive to children and teens, such as the use of flavors that appeal to them, distributing free samples of e-cigarettes, and product promotion through social media, sponsorship of events, and other activities that are intended for a youth audience. Manufacturers should also agree to stop such activities.
• Manufacturers refrain from the use of television and radio ads.
• The FDA should require strong, uniform labels to inform consumers of health risks and should prohibit misleading product claims.
The Democratic lawmakers requested information from the following e-cigarette makers: NJOY, Lorillard, Reynolds American, Altria Group, LOGIC, EonSmoke, Green Smoke, VMR Products, and Lead By Sales. Of these, only Lead by Sales, which makes White Cloud Cigarettes, did not respond.
Six of the companies said they support some form of regulation, including restrictions on the marketing and sale of e-cigarettes to children and teens.
On Twitter @aliciaault
Stating that e-cigarettes are a gateway to tobacco addiction for young people, almost a dozen members of Congress are urging the Food and Drug Administration to immediately begin regulating the sale and marketing of the products to children.
The 11 Democratic lawmakers from the House and the Senate issued a report that they say shows that e-cigarette makers are using the same tactics once used by tobacco manufacturers – but now prohibited – to lure young people into using the nicotine-infused devices.
"E-cigarettes are a candy-flavored addiction, which is dangerous to our young people," said Sen. Dick Durbin (D-Ill.) in a briefing with reporters. He said that the report, which is based on data submitted to Congress by nine e-cigarette manufacturers, contains evidence that the companies are making what he called a "determined effort" to attract young users.
The Democratic members of Congress surveyed the manufacturers in the wake of a report from the Centers for Disease Control and Prevention that showed that, from 2011 to 2012, the percentage of high school students who had used e-cigarettes more than doubled, from 4.7% to 10%.
The marketing practices used by the companies include using social media like Facebook and Twitter to reach youths and adolescents, sponsorships of youth-oriented events like music festivals and handing out free samples at the events, and radio and television ads played during events and programs with significant youth viewership. In 2012 and 2013, six of the companies sponsored or provided free samples at 348 events. Also, six e-cigarette makers market e-cigarettes in flavors that might appeal to young people, including Cherry Crush, Chocolate Treat, Peachy Keen, and Grape Mint.
"It’s time for the FDA to step up and regulate this product," said Sen. Durbin.
He said that the FDA currently has the authority to "deem" e-cigarettes similar to conventional tobacco products, and thus apply the rules that govern marketing of those products to the electronic products. The senator also said that absent FDA action, there was not enough support in the House and Senate to pass a new law specifically aimed at the e-cigarette industry. "I’m a realist, and the likelihood of revisiting this whole issue of FDA authority is not very strong," said Sen. Durbin.
"The report we are issuing today should be the prod to act," Rep. Henry Waxman (D-Calif.) told reporters. Rep. Waxman is one of the lawmakers who have called for tougher regulations.
Both Sen. Durbin and Rep. Waxman said that they believed that e-cigarettes have the potential to be addictive for young people, and called it a gateway to the use of tobacco products. But Rep. Waxman also said he believed that the FDA needs to study e-cigarettes. "We don’t really know the benefit," he said. "All we have are claims of benefits. But we are seeing the risks very clearly," said Rep. Waxman.
The Democratic lawmakers are recommending that:
• The FDA issue regulations that deem e-cigarettes the same as other tobacco products, and prohibit sales to minors under age 18.
• Companies prohibit sales to youth under age 18.
• The FDA should ban sales tactics that may be attractive to children and teens, such as the use of flavors that appeal to them, distributing free samples of e-cigarettes, and product promotion through social media, sponsorship of events, and other activities that are intended for a youth audience. Manufacturers should also agree to stop such activities.
• Manufacturers refrain from the use of television and radio ads.
• The FDA should require strong, uniform labels to inform consumers of health risks and should prohibit misleading product claims.
The Democratic lawmakers requested information from the following e-cigarette makers: NJOY, Lorillard, Reynolds American, Altria Group, LOGIC, EonSmoke, Green Smoke, VMR Products, and Lead By Sales. Of these, only Lead by Sales, which makes White Cloud Cigarettes, did not respond.
Six of the companies said they support some form of regulation, including restrictions on the marketing and sale of e-cigarettes to children and teens.
On Twitter @aliciaault
ACP gives primary care and specialists tools for better referrals
ORLANDO – The American College of Physicians has unveiled a toolkit to improve referrals and care coordination between primary care physicians and specialists.
The High Value Care Coordination Toolkit also aims to eliminate waste and duplicative care and create more efficiency in care delivery.
The toolkit is available on the ACP’s website and was developed by the group’s Council of Subspecialty Societies and patient advocacy groups. The ACP also received input from a number of specialty societies, including the American Academy of Neurology, the American College of Cardiology, the American College of Rheumatology, the American Gastroenterological Association, the American Society of Hematology, the Endocrine Society, and the Society of Hospital Medicine.
"Physicians need specific information to do their jobs effectively," said Dr. Molly Cooke, the outgoing president of the ACP, in a statement. "The High Value Care Coordination Toolkit facilitates clear communication between primary care and subspecialist practices so that doctors can provide seamless, coordinated, and quality care to their patients."
Dr. Charles Cutler, immediate past chair of the ACP Board of Regents, said that he frequently heard from frustrated specialists who felt that referring primary care doctors had not given them enough information about the patient who was being referred.
"This is not a trivial problem, it’s something that drives both the medical subspecialists crazy and the primary care doctor like myself," said Dr. Cutler. "Because, on both sides, the information isn’t moving back and forth."
The toolkit creates a roadmap, he said. It includes five components:
• A checklist of information to include in a generic referral to a subspecialist practice.
• A checklist of information to include in a subspecialist’s response to a referral request.
• Pertinent data sets reflecting specific information – in addition to that found on a generic referral request – to include in a referral for a number of specific common conditions to help ensure an effective and high-value engagement.
• Model care coordination agreement templates between primary care and subspecialty practices, and between a primary care practice and hospital care team.
• An outline of recommendations to physicians on preparing a patient for a referral in a patient- and family-centered manner.
The data sets were developed with the medical specialty societies and can come in very useful, said Dr. Cooke, who has been using the toolkit in her practice at the University of California, San Francisco.
Dr. Carol Greenlee, vice chair of the ACP’s Council of Subspecialty Societies and an endocrinologist in Grand Junction, Colo., also said that she had been using the toolkit with physicians who were in her independent practice association (IPA).
"It’s easy when we’re integrated," said Dr. Greenlee, who helped develop the toolkit. For physicians who work outside her IPA, she said she sent letters outlining what she would like from doctors who made referrals to her. She said the vast majority responded, and now she gets great clinical questions and data on the patients who come in. And the patients come in prepared, Dr. Greenlee added.
She recommended that primary care physicians ask specialists who they work with what they’d like to see. "It doesn’t have to be a contract," she said.
Care coordination would be more crucial as health care moved to accountable care organizations and payment arrangements that were either true capitation or something similar, noted Dr. Bruce Leff, chair of the ACP’s Council of Subspecialty Societies. "There will be very strong positive incentives to be more efficient," said Dr. Leff, a geriatrician at Johns Hopkins University, Baltimore. "Efficiency is not just dollars. It’s physician time and patient time."
The documents offered in the toolkit "are really well thought–through guides," said Dr. Leff, adding that he believed that they could "save medical systems a lot of time and effort."
On Twitter @aliciaault
Dr. Molly Cooke,
ORLANDO – The American College of Physicians has unveiled a toolkit to improve referrals and care coordination between primary care physicians and specialists.
The High Value Care Coordination Toolkit also aims to eliminate waste and duplicative care and create more efficiency in care delivery.
The toolkit is available on the ACP’s website and was developed by the group’s Council of Subspecialty Societies and patient advocacy groups. The ACP also received input from a number of specialty societies, including the American Academy of Neurology, the American College of Cardiology, the American College of Rheumatology, the American Gastroenterological Association, the American Society of Hematology, the Endocrine Society, and the Society of Hospital Medicine.
"Physicians need specific information to do their jobs effectively," said Dr. Molly Cooke, the outgoing president of the ACP, in a statement. "The High Value Care Coordination Toolkit facilitates clear communication between primary care and subspecialist practices so that doctors can provide seamless, coordinated, and quality care to their patients."
Dr. Charles Cutler, immediate past chair of the ACP Board of Regents, said that he frequently heard from frustrated specialists who felt that referring primary care doctors had not given them enough information about the patient who was being referred.
"This is not a trivial problem, it’s something that drives both the medical subspecialists crazy and the primary care doctor like myself," said Dr. Cutler. "Because, on both sides, the information isn’t moving back and forth."
The toolkit creates a roadmap, he said. It includes five components:
• A checklist of information to include in a generic referral to a subspecialist practice.
• A checklist of information to include in a subspecialist’s response to a referral request.
• Pertinent data sets reflecting specific information – in addition to that found on a generic referral request – to include in a referral for a number of specific common conditions to help ensure an effective and high-value engagement.
• Model care coordination agreement templates between primary care and subspecialty practices, and between a primary care practice and hospital care team.
• An outline of recommendations to physicians on preparing a patient for a referral in a patient- and family-centered manner.
The data sets were developed with the medical specialty societies and can come in very useful, said Dr. Cooke, who has been using the toolkit in her practice at the University of California, San Francisco.
Dr. Carol Greenlee, vice chair of the ACP’s Council of Subspecialty Societies and an endocrinologist in Grand Junction, Colo., also said that she had been using the toolkit with physicians who were in her independent practice association (IPA).
"It’s easy when we’re integrated," said Dr. Greenlee, who helped develop the toolkit. For physicians who work outside her IPA, she said she sent letters outlining what she would like from doctors who made referrals to her. She said the vast majority responded, and now she gets great clinical questions and data on the patients who come in. And the patients come in prepared, Dr. Greenlee added.
She recommended that primary care physicians ask specialists who they work with what they’d like to see. "It doesn’t have to be a contract," she said.
Care coordination would be more crucial as health care moved to accountable care organizations and payment arrangements that were either true capitation or something similar, noted Dr. Bruce Leff, chair of the ACP’s Council of Subspecialty Societies. "There will be very strong positive incentives to be more efficient," said Dr. Leff, a geriatrician at Johns Hopkins University, Baltimore. "Efficiency is not just dollars. It’s physician time and patient time."
The documents offered in the toolkit "are really well thought–through guides," said Dr. Leff, adding that he believed that they could "save medical systems a lot of time and effort."
On Twitter @aliciaault
ORLANDO – The American College of Physicians has unveiled a toolkit to improve referrals and care coordination between primary care physicians and specialists.
The High Value Care Coordination Toolkit also aims to eliminate waste and duplicative care and create more efficiency in care delivery.
The toolkit is available on the ACP’s website and was developed by the group’s Council of Subspecialty Societies and patient advocacy groups. The ACP also received input from a number of specialty societies, including the American Academy of Neurology, the American College of Cardiology, the American College of Rheumatology, the American Gastroenterological Association, the American Society of Hematology, the Endocrine Society, and the Society of Hospital Medicine.
"Physicians need specific information to do their jobs effectively," said Dr. Molly Cooke, the outgoing president of the ACP, in a statement. "The High Value Care Coordination Toolkit facilitates clear communication between primary care and subspecialist practices so that doctors can provide seamless, coordinated, and quality care to their patients."
Dr. Charles Cutler, immediate past chair of the ACP Board of Regents, said that he frequently heard from frustrated specialists who felt that referring primary care doctors had not given them enough information about the patient who was being referred.
"This is not a trivial problem, it’s something that drives both the medical subspecialists crazy and the primary care doctor like myself," said Dr. Cutler. "Because, on both sides, the information isn’t moving back and forth."
The toolkit creates a roadmap, he said. It includes five components:
• A checklist of information to include in a generic referral to a subspecialist practice.
• A checklist of information to include in a subspecialist’s response to a referral request.
• Pertinent data sets reflecting specific information – in addition to that found on a generic referral request – to include in a referral for a number of specific common conditions to help ensure an effective and high-value engagement.
• Model care coordination agreement templates between primary care and subspecialty practices, and between a primary care practice and hospital care team.
• An outline of recommendations to physicians on preparing a patient for a referral in a patient- and family-centered manner.
The data sets were developed with the medical specialty societies and can come in very useful, said Dr. Cooke, who has been using the toolkit in her practice at the University of California, San Francisco.
Dr. Carol Greenlee, vice chair of the ACP’s Council of Subspecialty Societies and an endocrinologist in Grand Junction, Colo., also said that she had been using the toolkit with physicians who were in her independent practice association (IPA).
"It’s easy when we’re integrated," said Dr. Greenlee, who helped develop the toolkit. For physicians who work outside her IPA, she said she sent letters outlining what she would like from doctors who made referrals to her. She said the vast majority responded, and now she gets great clinical questions and data on the patients who come in. And the patients come in prepared, Dr. Greenlee added.
She recommended that primary care physicians ask specialists who they work with what they’d like to see. "It doesn’t have to be a contract," she said.
Care coordination would be more crucial as health care moved to accountable care organizations and payment arrangements that were either true capitation or something similar, noted Dr. Bruce Leff, chair of the ACP’s Council of Subspecialty Societies. "There will be very strong positive incentives to be more efficient," said Dr. Leff, a geriatrician at Johns Hopkins University, Baltimore. "Efficiency is not just dollars. It’s physician time and patient time."
The documents offered in the toolkit "are really well thought–through guides," said Dr. Leff, adding that he believed that they could "save medical systems a lot of time and effort."
On Twitter @aliciaault
Dr. Molly Cooke,
Dr. Molly Cooke,
AT ACP INTERNAL MEDICINE 2014
ACP: Physicians must address gun violence
ORLANDO – Gun violence is a public health threat that needs to be addressed with the best scientific evidence to help reduce injuries and deaths, a new policy from the American College of Physicians proclaims.
"Access to firearms, especially firearms in the home, increases the likelihood that a person will be a victim of gun violence by homicide or suicide," Bob Doherty, ACP senior vice president of governmental affairs and public policy, said April 10 at the annual meeting of the American College of Physicians. "The evidence is very clear – the risk is higher.
The policy, published simultaneously in Annals of Internal Medicine (2014 April 10 [doi: 10.7326/M14-0216]), calls for universal criminal background checks and favors a prohibition on assault and semiautomatic weapons and large-capacity magazines. It updates the ACP’s 1996 policy.
"As an organization representing physicians who have firsthand experience with the devastating impact of firearm-related violence, ACP has a responsibility to participate in efforts to mitigate needless tragedies," Dr. Thomas Tape, chairman of the ACP health and public policy committee, said.
The ACP sought to balance its recommendations on gun violence and mental illness, Dr. Tape said, adding that any restrictions on gun ownership should not broadly target people with mental illness. Only a small portion of those who are mentally ill may be at risk for harming themselves or others, he said.
Of the 32,000 gun-related deaths in the United States each year, 11,000 are homicides, 19,000 are suicides, and the rest are unintentional, according to evidence from the 120 studies reviewed for the policy paper.
Determining who’s at the greatest risk for harming themselves or others "clearly begs for more research," said Dr. Tape. "We need better predictors."
Dr. Molly Cooke, ACP president, agreed, and noted that 30% of patients in primary care practices have a mental health diagnosis. With a high prevalence of illness and a low proportion of those who might actually do harm, "you’d be prohibiting lots of people from owning guns who would never harm anyone," Dr. Cooke said.
Dr. Tape also said the ACP believes that "the physician’s judgment is critically important." He said that often, patients will disclose their state of mind, allowing the physician to determine whether it is appropriate to alert the authorities or offer follow-up care.
Physicians are required by law to inform authorities when they believe a patient poses an imminent threat. "But the question is whether physicians should be required to more broadly report on individuals with mental illness who may pose a threat," Dr. Tape said.
Reporting requirements should not act as a disincentive to seek care, or interfere with the patient-physician relationship, according to the policy paper.
"The ACP strongly believes the patient-physician relationship should be protected from laws that prevent physicians from initiating a discussion about guns," Dr. Cooke said.
The policy paper also voices the ACP’s support for devices such as trigger locks, as well as efforts to keep guns out of the hands of children, adolescents, people with dementia, and those with substance use disorders.
According to a 2013 survey of ACP members, the vast majority agree that firearm injury is a public health issue. Close to 90% also said they supported mandatory background checks, mandatory registration, and a ban on assault weapons (Ann. Intern. Med. 2014 April 10 [doi: 10.7326/M13-1960]).
Of the 573 respondents, 64% reported having had patients who were injured or killed by a gun, and 14% said that they or someone in their family had been threatened or injured by someone with a gun.
However, more than half (58%) said they had never asked patients whether they had guns in the home, and 80% reported never discussing gun use with patients. More than three-quarters said they had never discussed ways to reduce the risk for gun-related injury or death, and 62% had never talked about keeping guns away from children. Gun-owning physicians were more likely to ask about guns in the home.
Three-quarters of the physician respondents said there was a need for an educational program to help physicians counsel patients in firearm injury prevention.
[email protected] On Twitter @aliciaault
Listen to audio from the press briefing here:
And here:ORLANDO – Gun violence is a public health threat that needs to be addressed with the best scientific evidence to help reduce injuries and deaths, a new policy from the American College of Physicians proclaims.
"Access to firearms, especially firearms in the home, increases the likelihood that a person will be a victim of gun violence by homicide or suicide," Bob Doherty, ACP senior vice president of governmental affairs and public policy, said April 10 at the annual meeting of the American College of Physicians. "The evidence is very clear – the risk is higher.
The policy, published simultaneously in Annals of Internal Medicine (2014 April 10 [doi: 10.7326/M14-0216]), calls for universal criminal background checks and favors a prohibition on assault and semiautomatic weapons and large-capacity magazines. It updates the ACP’s 1996 policy.
"As an organization representing physicians who have firsthand experience with the devastating impact of firearm-related violence, ACP has a responsibility to participate in efforts to mitigate needless tragedies," Dr. Thomas Tape, chairman of the ACP health and public policy committee, said.
The ACP sought to balance its recommendations on gun violence and mental illness, Dr. Tape said, adding that any restrictions on gun ownership should not broadly target people with mental illness. Only a small portion of those who are mentally ill may be at risk for harming themselves or others, he said.
Of the 32,000 gun-related deaths in the United States each year, 11,000 are homicides, 19,000 are suicides, and the rest are unintentional, according to evidence from the 120 studies reviewed for the policy paper.
Determining who’s at the greatest risk for harming themselves or others "clearly begs for more research," said Dr. Tape. "We need better predictors."
Dr. Molly Cooke, ACP president, agreed, and noted that 30% of patients in primary care practices have a mental health diagnosis. With a high prevalence of illness and a low proportion of those who might actually do harm, "you’d be prohibiting lots of people from owning guns who would never harm anyone," Dr. Cooke said.
Dr. Tape also said the ACP believes that "the physician’s judgment is critically important." He said that often, patients will disclose their state of mind, allowing the physician to determine whether it is appropriate to alert the authorities or offer follow-up care.
Physicians are required by law to inform authorities when they believe a patient poses an imminent threat. "But the question is whether physicians should be required to more broadly report on individuals with mental illness who may pose a threat," Dr. Tape said.
Reporting requirements should not act as a disincentive to seek care, or interfere with the patient-physician relationship, according to the policy paper.
"The ACP strongly believes the patient-physician relationship should be protected from laws that prevent physicians from initiating a discussion about guns," Dr. Cooke said.
The policy paper also voices the ACP’s support for devices such as trigger locks, as well as efforts to keep guns out of the hands of children, adolescents, people with dementia, and those with substance use disorders.
According to a 2013 survey of ACP members, the vast majority agree that firearm injury is a public health issue. Close to 90% also said they supported mandatory background checks, mandatory registration, and a ban on assault weapons (Ann. Intern. Med. 2014 April 10 [doi: 10.7326/M13-1960]).
Of the 573 respondents, 64% reported having had patients who were injured or killed by a gun, and 14% said that they or someone in their family had been threatened or injured by someone with a gun.
However, more than half (58%) said they had never asked patients whether they had guns in the home, and 80% reported never discussing gun use with patients. More than three-quarters said they had never discussed ways to reduce the risk for gun-related injury or death, and 62% had never talked about keeping guns away from children. Gun-owning physicians were more likely to ask about guns in the home.
Three-quarters of the physician respondents said there was a need for an educational program to help physicians counsel patients in firearm injury prevention.
[email protected] On Twitter @aliciaault
Listen to audio from the press briefing here:
And here:ORLANDO – Gun violence is a public health threat that needs to be addressed with the best scientific evidence to help reduce injuries and deaths, a new policy from the American College of Physicians proclaims.
"Access to firearms, especially firearms in the home, increases the likelihood that a person will be a victim of gun violence by homicide or suicide," Bob Doherty, ACP senior vice president of governmental affairs and public policy, said April 10 at the annual meeting of the American College of Physicians. "The evidence is very clear – the risk is higher.
The policy, published simultaneously in Annals of Internal Medicine (2014 April 10 [doi: 10.7326/M14-0216]), calls for universal criminal background checks and favors a prohibition on assault and semiautomatic weapons and large-capacity magazines. It updates the ACP’s 1996 policy.
"As an organization representing physicians who have firsthand experience with the devastating impact of firearm-related violence, ACP has a responsibility to participate in efforts to mitigate needless tragedies," Dr. Thomas Tape, chairman of the ACP health and public policy committee, said.
The ACP sought to balance its recommendations on gun violence and mental illness, Dr. Tape said, adding that any restrictions on gun ownership should not broadly target people with mental illness. Only a small portion of those who are mentally ill may be at risk for harming themselves or others, he said.
Of the 32,000 gun-related deaths in the United States each year, 11,000 are homicides, 19,000 are suicides, and the rest are unintentional, according to evidence from the 120 studies reviewed for the policy paper.
Determining who’s at the greatest risk for harming themselves or others "clearly begs for more research," said Dr. Tape. "We need better predictors."
Dr. Molly Cooke, ACP president, agreed, and noted that 30% of patients in primary care practices have a mental health diagnosis. With a high prevalence of illness and a low proportion of those who might actually do harm, "you’d be prohibiting lots of people from owning guns who would never harm anyone," Dr. Cooke said.
Dr. Tape also said the ACP believes that "the physician’s judgment is critically important." He said that often, patients will disclose their state of mind, allowing the physician to determine whether it is appropriate to alert the authorities or offer follow-up care.
Physicians are required by law to inform authorities when they believe a patient poses an imminent threat. "But the question is whether physicians should be required to more broadly report on individuals with mental illness who may pose a threat," Dr. Tape said.
Reporting requirements should not act as a disincentive to seek care, or interfere with the patient-physician relationship, according to the policy paper.
"The ACP strongly believes the patient-physician relationship should be protected from laws that prevent physicians from initiating a discussion about guns," Dr. Cooke said.
The policy paper also voices the ACP’s support for devices such as trigger locks, as well as efforts to keep guns out of the hands of children, adolescents, people with dementia, and those with substance use disorders.
According to a 2013 survey of ACP members, the vast majority agree that firearm injury is a public health issue. Close to 90% also said they supported mandatory background checks, mandatory registration, and a ban on assault weapons (Ann. Intern. Med. 2014 April 10 [doi: 10.7326/M13-1960]).
Of the 573 respondents, 64% reported having had patients who were injured or killed by a gun, and 14% said that they or someone in their family had been threatened or injured by someone with a gun.
However, more than half (58%) said they had never asked patients whether they had guns in the home, and 80% reported never discussing gun use with patients. More than three-quarters said they had never discussed ways to reduce the risk for gun-related injury or death, and 62% had never talked about keeping guns away from children. Gun-owning physicians were more likely to ask about guns in the home.
Three-quarters of the physician respondents said there was a need for an educational program to help physicians counsel patients in firearm injury prevention.
[email protected] On Twitter @aliciaault
Listen to audio from the press briefing here:
And here:AT ACP INTERNAL MEDICINE 2014
Physicians could get squeezed by Open Payments delay
Website delays may curtail physicians’ ability to review data on payments they received from drug and device makers before the federal government publishes it Sept. 30.
"There is a compelling need to ensure that physicians have an adequate amount of time to register with the Open Payments Program system, to review their consolidated reports, to dispute errors, and obtain corrections," Dr. James L. Madara, AMA executive vice president, wrote in a letter to the Centers for Medicare & Medicaid Services.
CMS got a late start in launching its online system for data collection, created as part of the Affordable Care Act.
The Open Payments Program – colloquially known as the Sunshine Act program – requires manufacturers of drugs, devices, biologicals, and medical supplies to report the honoraria, fees, and other payments that they make to doctors. The information will be published in a searchable database.
Manufacturers began tabulating data in August 2013 and were supposed to start reporting to the CMS through a website on Jan. 1. The program called for doctors to be able to register for the website at the same time so they could begin reviewing data.
CMS launched the website 6 weeks late on Feb. 18 and made it available only to manufacturers and group purchasing organizations. The first registration and reporting phase ended March 31. The agency has not begun the second phase yet.
Registration and review for physicians and teaching hospitals will begin no later than Aug. 1, according to CMS.
The AMA is urging the CMS "to adjust the public reporting date until the agency can ensure that physician due process rights are protected, and the agency has in place a process and system that will produce accurate reports."
The AMA said that it is concerned that the agency might not be able to ensure timeliness or accuracy because "the CMS is building a new system that reportedly has not been beta tested."
The ACA requires the CMS to give physicians 60 days to review data and settle any disputes, according to Neil Kirschner, senior associate for health policy and regulatory affairs at the American College of Physicians. He said that the ACP will continue to monitor the CMS’s progress and advocate for a minimum of a 60-day review period.
Officials at the American College of Cardiology also are wary of the situation.
"Given the difficulties that physicians have had in obtaining access to their Physician Quality Reporting System reports and other similar documents that require authentication of identity, the College is concerned that there will not be sufficient time to both communicate to them the need to register and for the registration and authentication to occur before the reports are available," said Lisa Goldstein, ACC associate director of regulatory affairs.
"Instead, many will likely be scrambling to register and authenticate their identities during the limited review period before the information is made public, reducing the amount of time the physicians have to review their reports and file disputes as appropriate," she said.
Dr. Brett Coldiron, president of the American Academy of Dermatology, said that the academy "wants to ensure that the information that is shared through Open Payments is as accurate as possible, and that implementation of the program is seamless and does not create undue administrative burdens on physicians."
On Twitter @aliciaault
Website delays may curtail physicians’ ability to review data on payments they received from drug and device makers before the federal government publishes it Sept. 30.
"There is a compelling need to ensure that physicians have an adequate amount of time to register with the Open Payments Program system, to review their consolidated reports, to dispute errors, and obtain corrections," Dr. James L. Madara, AMA executive vice president, wrote in a letter to the Centers for Medicare & Medicaid Services.
CMS got a late start in launching its online system for data collection, created as part of the Affordable Care Act.
The Open Payments Program – colloquially known as the Sunshine Act program – requires manufacturers of drugs, devices, biologicals, and medical supplies to report the honoraria, fees, and other payments that they make to doctors. The information will be published in a searchable database.
Manufacturers began tabulating data in August 2013 and were supposed to start reporting to the CMS through a website on Jan. 1. The program called for doctors to be able to register for the website at the same time so they could begin reviewing data.
CMS launched the website 6 weeks late on Feb. 18 and made it available only to manufacturers and group purchasing organizations. The first registration and reporting phase ended March 31. The agency has not begun the second phase yet.
Registration and review for physicians and teaching hospitals will begin no later than Aug. 1, according to CMS.
The AMA is urging the CMS "to adjust the public reporting date until the agency can ensure that physician due process rights are protected, and the agency has in place a process and system that will produce accurate reports."
The AMA said that it is concerned that the agency might not be able to ensure timeliness or accuracy because "the CMS is building a new system that reportedly has not been beta tested."
The ACA requires the CMS to give physicians 60 days to review data and settle any disputes, according to Neil Kirschner, senior associate for health policy and regulatory affairs at the American College of Physicians. He said that the ACP will continue to monitor the CMS’s progress and advocate for a minimum of a 60-day review period.
Officials at the American College of Cardiology also are wary of the situation.
"Given the difficulties that physicians have had in obtaining access to their Physician Quality Reporting System reports and other similar documents that require authentication of identity, the College is concerned that there will not be sufficient time to both communicate to them the need to register and for the registration and authentication to occur before the reports are available," said Lisa Goldstein, ACC associate director of regulatory affairs.
"Instead, many will likely be scrambling to register and authenticate their identities during the limited review period before the information is made public, reducing the amount of time the physicians have to review their reports and file disputes as appropriate," she said.
Dr. Brett Coldiron, president of the American Academy of Dermatology, said that the academy "wants to ensure that the information that is shared through Open Payments is as accurate as possible, and that implementation of the program is seamless and does not create undue administrative burdens on physicians."
On Twitter @aliciaault
Website delays may curtail physicians’ ability to review data on payments they received from drug and device makers before the federal government publishes it Sept. 30.
"There is a compelling need to ensure that physicians have an adequate amount of time to register with the Open Payments Program system, to review their consolidated reports, to dispute errors, and obtain corrections," Dr. James L. Madara, AMA executive vice president, wrote in a letter to the Centers for Medicare & Medicaid Services.
CMS got a late start in launching its online system for data collection, created as part of the Affordable Care Act.
The Open Payments Program – colloquially known as the Sunshine Act program – requires manufacturers of drugs, devices, biologicals, and medical supplies to report the honoraria, fees, and other payments that they make to doctors. The information will be published in a searchable database.
Manufacturers began tabulating data in August 2013 and were supposed to start reporting to the CMS through a website on Jan. 1. The program called for doctors to be able to register for the website at the same time so they could begin reviewing data.
CMS launched the website 6 weeks late on Feb. 18 and made it available only to manufacturers and group purchasing organizations. The first registration and reporting phase ended March 31. The agency has not begun the second phase yet.
Registration and review for physicians and teaching hospitals will begin no later than Aug. 1, according to CMS.
The AMA is urging the CMS "to adjust the public reporting date until the agency can ensure that physician due process rights are protected, and the agency has in place a process and system that will produce accurate reports."
The AMA said that it is concerned that the agency might not be able to ensure timeliness or accuracy because "the CMS is building a new system that reportedly has not been beta tested."
The ACA requires the CMS to give physicians 60 days to review data and settle any disputes, according to Neil Kirschner, senior associate for health policy and regulatory affairs at the American College of Physicians. He said that the ACP will continue to monitor the CMS’s progress and advocate for a minimum of a 60-day review period.
Officials at the American College of Cardiology also are wary of the situation.
"Given the difficulties that physicians have had in obtaining access to their Physician Quality Reporting System reports and other similar documents that require authentication of identity, the College is concerned that there will not be sufficient time to both communicate to them the need to register and for the registration and authentication to occur before the reports are available," said Lisa Goldstein, ACC associate director of regulatory affairs.
"Instead, many will likely be scrambling to register and authenticate their identities during the limited review period before the information is made public, reducing the amount of time the physicians have to review their reports and file disputes as appropriate," she said.
Dr. Brett Coldiron, president of the American Academy of Dermatology, said that the academy "wants to ensure that the information that is shared through Open Payments is as accurate as possible, and that implementation of the program is seamless and does not create undue administrative burdens on physicians."
On Twitter @aliciaault
House panel chides FDA for inaction on sunscreens
WASHINGTON – The Food and Drug Administration has taken too long to review and approve new sunscreen ingredients and should be required to clear its current backlog within 8 months and review new products within 11 months, members of Congress said at a hearing April 7.
"Everyone seems to agree that the current system for approving sunscreen ingredients is broken," Rep. Fred Upton (R-Mich.), chairman of the House Energy & Commerce Committee, said at a hearing of his committee’s Subcommittee on Health. H.R. 4250, the Sunscreen Innovation Act, "would help provide a solution to the current backlog of sunscreen ingredients pending at the FDA."
Currently, eight sunscreen ingredients are under review by the FDA, many of which have been approved for use in other countries; some reviews have been ongoing for 3-11 years.
H.R. 4250 was introduced March 13 in the House by Rep. Ed Whitfield (R-Ky.) and Rep. John Dingell (D-Mich.) and as S. 2141 the same day in the Senate by Sen. Jack Reed (D-R.I.) and Sen. Johnny Isakson (R-Ga.).
In addition to eliminating the backlog, the bill would align the sunscreen review process more closely with the new-drug and device approval process. Under the legislation, the FDA Nonprescription Drugs Advisory Committee would review the safety and efficacy of the ingredient and make a recommendation on approval. The FDA would have 45 days to make the final decision for approval.
Rep. Henry Waxman (D-Calif.) said that he worried this would essentially give an advisory committee the power to make an approval decision if the FDA did not act. That would set a bad precedent, said Rep. Waxman, who added that he otherwise supported the Sunscreen Innovation Act.
The American Academy of Dermatology Association supported the legislation.
"A more timely review process has the potential to reduce Americans’ risk for skin cancer by ensuring that they have access to the safest, most effective sunscreens available," Dr. Brett M. Coldiron, AAD president, said in a statement.
Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said that she agreed that the process should be modernized and that it was no longer serving consumers, manufacturers, or the agency itself.
As Americans have gone from occasional and limited use of sunscreen products to year-round and heavier use of them, new questions have been raised about the short- and long-term effects of these products, Dr. Woodcock said. The FDA "has been actively examining the important scientific questions," such as whether there is systemic exposure to an ingredient, or if an ingredient might be an endocrine disrupter.
The FDA recently sent letters to the makers of two sunscreen ingredients – amiloxate and diethylhexyl butamido triazone – noting that the evidence is not sufficient to establish safety and efficacy, Dr. Woodcock said. The agency is still reviewing six other sunscreen ingredients.
The FDA will hold a public hearing later this year to clarify what information it is seeking to establish the safety and efficacy of sunscreen ingredients, she added.
[email protected] On Twitter @aliciaault
WASHINGTON – The Food and Drug Administration has taken too long to review and approve new sunscreen ingredients and should be required to clear its current backlog within 8 months and review new products within 11 months, members of Congress said at a hearing April 7.
"Everyone seems to agree that the current system for approving sunscreen ingredients is broken," Rep. Fred Upton (R-Mich.), chairman of the House Energy & Commerce Committee, said at a hearing of his committee’s Subcommittee on Health. H.R. 4250, the Sunscreen Innovation Act, "would help provide a solution to the current backlog of sunscreen ingredients pending at the FDA."
Currently, eight sunscreen ingredients are under review by the FDA, many of which have been approved for use in other countries; some reviews have been ongoing for 3-11 years.
H.R. 4250 was introduced March 13 in the House by Rep. Ed Whitfield (R-Ky.) and Rep. John Dingell (D-Mich.) and as S. 2141 the same day in the Senate by Sen. Jack Reed (D-R.I.) and Sen. Johnny Isakson (R-Ga.).
In addition to eliminating the backlog, the bill would align the sunscreen review process more closely with the new-drug and device approval process. Under the legislation, the FDA Nonprescription Drugs Advisory Committee would review the safety and efficacy of the ingredient and make a recommendation on approval. The FDA would have 45 days to make the final decision for approval.
Rep. Henry Waxman (D-Calif.) said that he worried this would essentially give an advisory committee the power to make an approval decision if the FDA did not act. That would set a bad precedent, said Rep. Waxman, who added that he otherwise supported the Sunscreen Innovation Act.
The American Academy of Dermatology Association supported the legislation.
"A more timely review process has the potential to reduce Americans’ risk for skin cancer by ensuring that they have access to the safest, most effective sunscreens available," Dr. Brett M. Coldiron, AAD president, said in a statement.
Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said that she agreed that the process should be modernized and that it was no longer serving consumers, manufacturers, or the agency itself.
As Americans have gone from occasional and limited use of sunscreen products to year-round and heavier use of them, new questions have been raised about the short- and long-term effects of these products, Dr. Woodcock said. The FDA "has been actively examining the important scientific questions," such as whether there is systemic exposure to an ingredient, or if an ingredient might be an endocrine disrupter.
The FDA recently sent letters to the makers of two sunscreen ingredients – amiloxate and diethylhexyl butamido triazone – noting that the evidence is not sufficient to establish safety and efficacy, Dr. Woodcock said. The agency is still reviewing six other sunscreen ingredients.
The FDA will hold a public hearing later this year to clarify what information it is seeking to establish the safety and efficacy of sunscreen ingredients, she added.
[email protected] On Twitter @aliciaault
WASHINGTON – The Food and Drug Administration has taken too long to review and approve new sunscreen ingredients and should be required to clear its current backlog within 8 months and review new products within 11 months, members of Congress said at a hearing April 7.
"Everyone seems to agree that the current system for approving sunscreen ingredients is broken," Rep. Fred Upton (R-Mich.), chairman of the House Energy & Commerce Committee, said at a hearing of his committee’s Subcommittee on Health. H.R. 4250, the Sunscreen Innovation Act, "would help provide a solution to the current backlog of sunscreen ingredients pending at the FDA."
Currently, eight sunscreen ingredients are under review by the FDA, many of which have been approved for use in other countries; some reviews have been ongoing for 3-11 years.
H.R. 4250 was introduced March 13 in the House by Rep. Ed Whitfield (R-Ky.) and Rep. John Dingell (D-Mich.) and as S. 2141 the same day in the Senate by Sen. Jack Reed (D-R.I.) and Sen. Johnny Isakson (R-Ga.).
In addition to eliminating the backlog, the bill would align the sunscreen review process more closely with the new-drug and device approval process. Under the legislation, the FDA Nonprescription Drugs Advisory Committee would review the safety and efficacy of the ingredient and make a recommendation on approval. The FDA would have 45 days to make the final decision for approval.
Rep. Henry Waxman (D-Calif.) said that he worried this would essentially give an advisory committee the power to make an approval decision if the FDA did not act. That would set a bad precedent, said Rep. Waxman, who added that he otherwise supported the Sunscreen Innovation Act.
The American Academy of Dermatology Association supported the legislation.
"A more timely review process has the potential to reduce Americans’ risk for skin cancer by ensuring that they have access to the safest, most effective sunscreens available," Dr. Brett M. Coldiron, AAD president, said in a statement.
Dr. Janet Woodcock, director of the FDA Center for Drug Evaluation and Research, said that she agreed that the process should be modernized and that it was no longer serving consumers, manufacturers, or the agency itself.
As Americans have gone from occasional and limited use of sunscreen products to year-round and heavier use of them, new questions have been raised about the short- and long-term effects of these products, Dr. Woodcock said. The FDA "has been actively examining the important scientific questions," such as whether there is systemic exposure to an ingredient, or if an ingredient might be an endocrine disrupter.
The FDA recently sent letters to the makers of two sunscreen ingredients – amiloxate and diethylhexyl butamido triazone – noting that the evidence is not sufficient to establish safety and efficacy, Dr. Woodcock said. The agency is still reviewing six other sunscreen ingredients.
The FDA will hold a public hearing later this year to clarify what information it is seeking to establish the safety and efficacy of sunscreen ingredients, she added.
[email protected] On Twitter @aliciaault
AT AN ENERGY AND COMMERCE SUBCOMMITTEE HEARING
Psychiatrists call for more coordination with primary care
WASHINGTON – The American Psychiatric Association is putting out a call for much tighter integration of primary care and mental health care, saying that it will lead to better services for patients and a reduction in costs to the health system.
"Studies have shown that concurrently treating behavioral and physical conditions leads to better control of the illness itself, but also better patient satisfaction, quality of life, and reduced costs," Dr. Jeffrey Lieberman, president of the APA, said at a briefing, sponsored by the American Psychiatric Association.
The APA released a report that shows that effective integration could save $26 billion to $48 billion a year in general medical care. The report was written by the consulting firm Milliman, which the APA commissioned to take a look at integrated care models and the potential to improve care.
Dr. Lieberman, who is also chairman of the psychiatry department at Columbia University Medical Center, New York, said the Milliman report was only the latest in a series of studies that have shown that addressing medical conditions and behavioral issues simultaneously is more effective and more cost-effective than creating silos to address each. A recent review by the Cochrane Collaboration of 79 randomized controlled trials, including more than 24,000 patients worldwide, compared collaborative care with routine care for depression and anxiety (Cochrane Database Syst. Rev. 2012;10:CD006525). The review found that collaborative care is more effective, increasing patient satisfaction and quality of life.
"The jury is now in, that integrated care is effective," said Michael F. Hogan, Ph.D., the former commissioner of the New York State Office of Mental Health, at the briefing. He said the specialty mental health system is not the solution to helping people with mental illness and comorbid conditions improve.
Almost half of people with a mental disorder first consult with a primary care physician. On average, it takes 9 years after the first symptoms for a patient to receive a diagnosis, Dr. Hogan said. Given that the average age at which those symptoms appear is age 14 years, that means a lot of individuals are struggling without a diagnosis during adolescence, he said, calling that a "bad approach."
And, about 50% of the 38,000 people who commit suicide each year have seen a primary care physician within a month of the completed attempt, he added. Dr. Hogan said that not only do primary care physicians need the tools and education to help them do a better job in diagnosing and treating patients with mental disorders, but that they also need a team that includes a psychiatrist or behavioral health specialist.
Dr. Frank V. deGruy III, the Woodward-Chisholm Professor and chair of the department of family medicine at the University of Colorado Denver, agreed that primary care physicians needed a psychiatrist as a team member for the roughly 20% of patients seen in primary care practices who have mental disorders co-occurring with chronic health problems.
The "relative neglect of behavioral care" has been a major reason for the lack of comprehensiveness in collaborative care, said Dr. deGruy, who is also a past president of the North American Primary Care Research Group. He added that the Milliman report helps provide a missing piece and made him feel that "comprehensive, effective, coordinated care is right at our threshold."
The Milliman report – which drew on claims data for 20 million people enrolled in commercial insurance, Medicare, or Medicaid – found that only 14% of those who had a mental disorder were receiving treatment but that they accounted for 30% of the spending by those insurers. That totaled about $525 billion for 1 year, according to the report.
Even though they are insured and are being treated for their mental illnesses, the lack of coordinated care represents lost opportunities, said Dr. Paul Summergrad, president-elect of the APA. The Milliman report found that general health care costs were two to three times higher for people with a mental disorder and a chronic condition, compared with those without a mental condition.
The higher costs were mostly attributable to patients falling through the cracks or not getting proper care – which showed up in more emergency room visits, more hospitalizations, and hospital readmissions, said Dr. Summergard, who is also chair of the psychiatry department of Tufts University and psychiatrist in chief at Tufts Medical Center, Boston.
"There’s no way we’re really going to deal with the total issues around health care and health care costs unless we reach out to everyone," he said, adding that "we need to make sure we’re all working together to provide that care."
On Twitter @aliciaault
WASHINGTON – The American Psychiatric Association is putting out a call for much tighter integration of primary care and mental health care, saying that it will lead to better services for patients and a reduction in costs to the health system.
"Studies have shown that concurrently treating behavioral and physical conditions leads to better control of the illness itself, but also better patient satisfaction, quality of life, and reduced costs," Dr. Jeffrey Lieberman, president of the APA, said at a briefing, sponsored by the American Psychiatric Association.
The APA released a report that shows that effective integration could save $26 billion to $48 billion a year in general medical care. The report was written by the consulting firm Milliman, which the APA commissioned to take a look at integrated care models and the potential to improve care.
Dr. Lieberman, who is also chairman of the psychiatry department at Columbia University Medical Center, New York, said the Milliman report was only the latest in a series of studies that have shown that addressing medical conditions and behavioral issues simultaneously is more effective and more cost-effective than creating silos to address each. A recent review by the Cochrane Collaboration of 79 randomized controlled trials, including more than 24,000 patients worldwide, compared collaborative care with routine care for depression and anxiety (Cochrane Database Syst. Rev. 2012;10:CD006525). The review found that collaborative care is more effective, increasing patient satisfaction and quality of life.
"The jury is now in, that integrated care is effective," said Michael F. Hogan, Ph.D., the former commissioner of the New York State Office of Mental Health, at the briefing. He said the specialty mental health system is not the solution to helping people with mental illness and comorbid conditions improve.
Almost half of people with a mental disorder first consult with a primary care physician. On average, it takes 9 years after the first symptoms for a patient to receive a diagnosis, Dr. Hogan said. Given that the average age at which those symptoms appear is age 14 years, that means a lot of individuals are struggling without a diagnosis during adolescence, he said, calling that a "bad approach."
And, about 50% of the 38,000 people who commit suicide each year have seen a primary care physician within a month of the completed attempt, he added. Dr. Hogan said that not only do primary care physicians need the tools and education to help them do a better job in diagnosing and treating patients with mental disorders, but that they also need a team that includes a psychiatrist or behavioral health specialist.
Dr. Frank V. deGruy III, the Woodward-Chisholm Professor and chair of the department of family medicine at the University of Colorado Denver, agreed that primary care physicians needed a psychiatrist as a team member for the roughly 20% of patients seen in primary care practices who have mental disorders co-occurring with chronic health problems.
The "relative neglect of behavioral care" has been a major reason for the lack of comprehensiveness in collaborative care, said Dr. deGruy, who is also a past president of the North American Primary Care Research Group. He added that the Milliman report helps provide a missing piece and made him feel that "comprehensive, effective, coordinated care is right at our threshold."
The Milliman report – which drew on claims data for 20 million people enrolled in commercial insurance, Medicare, or Medicaid – found that only 14% of those who had a mental disorder were receiving treatment but that they accounted for 30% of the spending by those insurers. That totaled about $525 billion for 1 year, according to the report.
Even though they are insured and are being treated for their mental illnesses, the lack of coordinated care represents lost opportunities, said Dr. Paul Summergrad, president-elect of the APA. The Milliman report found that general health care costs were two to three times higher for people with a mental disorder and a chronic condition, compared with those without a mental condition.
The higher costs were mostly attributable to patients falling through the cracks or not getting proper care – which showed up in more emergency room visits, more hospitalizations, and hospital readmissions, said Dr. Summergard, who is also chair of the psychiatry department of Tufts University and psychiatrist in chief at Tufts Medical Center, Boston.
"There’s no way we’re really going to deal with the total issues around health care and health care costs unless we reach out to everyone," he said, adding that "we need to make sure we’re all working together to provide that care."
On Twitter @aliciaault
WASHINGTON – The American Psychiatric Association is putting out a call for much tighter integration of primary care and mental health care, saying that it will lead to better services for patients and a reduction in costs to the health system.
"Studies have shown that concurrently treating behavioral and physical conditions leads to better control of the illness itself, but also better patient satisfaction, quality of life, and reduced costs," Dr. Jeffrey Lieberman, president of the APA, said at a briefing, sponsored by the American Psychiatric Association.
The APA released a report that shows that effective integration could save $26 billion to $48 billion a year in general medical care. The report was written by the consulting firm Milliman, which the APA commissioned to take a look at integrated care models and the potential to improve care.
Dr. Lieberman, who is also chairman of the psychiatry department at Columbia University Medical Center, New York, said the Milliman report was only the latest in a series of studies that have shown that addressing medical conditions and behavioral issues simultaneously is more effective and more cost-effective than creating silos to address each. A recent review by the Cochrane Collaboration of 79 randomized controlled trials, including more than 24,000 patients worldwide, compared collaborative care with routine care for depression and anxiety (Cochrane Database Syst. Rev. 2012;10:CD006525). The review found that collaborative care is more effective, increasing patient satisfaction and quality of life.
"The jury is now in, that integrated care is effective," said Michael F. Hogan, Ph.D., the former commissioner of the New York State Office of Mental Health, at the briefing. He said the specialty mental health system is not the solution to helping people with mental illness and comorbid conditions improve.
Almost half of people with a mental disorder first consult with a primary care physician. On average, it takes 9 years after the first symptoms for a patient to receive a diagnosis, Dr. Hogan said. Given that the average age at which those symptoms appear is age 14 years, that means a lot of individuals are struggling without a diagnosis during adolescence, he said, calling that a "bad approach."
And, about 50% of the 38,000 people who commit suicide each year have seen a primary care physician within a month of the completed attempt, he added. Dr. Hogan said that not only do primary care physicians need the tools and education to help them do a better job in diagnosing and treating patients with mental disorders, but that they also need a team that includes a psychiatrist or behavioral health specialist.
Dr. Frank V. deGruy III, the Woodward-Chisholm Professor and chair of the department of family medicine at the University of Colorado Denver, agreed that primary care physicians needed a psychiatrist as a team member for the roughly 20% of patients seen in primary care practices who have mental disorders co-occurring with chronic health problems.
The "relative neglect of behavioral care" has been a major reason for the lack of comprehensiveness in collaborative care, said Dr. deGruy, who is also a past president of the North American Primary Care Research Group. He added that the Milliman report helps provide a missing piece and made him feel that "comprehensive, effective, coordinated care is right at our threshold."
The Milliman report – which drew on claims data for 20 million people enrolled in commercial insurance, Medicare, or Medicaid – found that only 14% of those who had a mental disorder were receiving treatment but that they accounted for 30% of the spending by those insurers. That totaled about $525 billion for 1 year, according to the report.
Even though they are insured and are being treated for their mental illnesses, the lack of coordinated care represents lost opportunities, said Dr. Paul Summergrad, president-elect of the APA. The Milliman report found that general health care costs were two to three times higher for people with a mental disorder and a chronic condition, compared with those without a mental condition.
The higher costs were mostly attributable to patients falling through the cracks or not getting proper care – which showed up in more emergency room visits, more hospitalizations, and hospital readmissions, said Dr. Summergard, who is also chair of the psychiatry department of Tufts University and psychiatrist in chief at Tufts Medical Center, Boston.
"There’s no way we’re really going to deal with the total issues around health care and health care costs unless we reach out to everyone," he said, adding that "we need to make sure we’re all working together to provide that care."
On Twitter @aliciaault
EXPERT ANALYSIS AT A BRIEFING SPONSORED BY THE APA
Exchanges reaching previously uninsured, say health system execs
The Affordable Care Act’s health insurance exchanges have provided coverage for the previously uninsured, two health system executives said April 7 at the ninth World Health Care Congress.
About 30,000-40,000 new enrollees to Kaiser Permanente’s California health plans were previously uninsured, said Dr. Robert Pearl, executive director and CEO of the Permanente Medical Group.
"When you get coverage, you start to get health care, which from my perspective is a good thing," he said. Although delivering more care may drive costs up initially, in the long run, it will help create a more cost-effective and higher-quality system.
Kaiser has begun reaching out to those newly insured and found that many need immediate care for chronic conditions, Dr. Pearl said. But having more patients covered by insurance also aligns with Kaiser’s mission of focusing on preventive care, he said.
The exchanges will drive many changes in the health care system, he said. Among them is making health care more integrated, both vertically and horizontally.
The ACA is forcing a realignment of health care, according to Scott E. Streator, vice president for the health insurance marketplace with CareSource – a nonprofit provider of Medicare and Medicaid managed care plans and low-cost insurance plans – based in Dayton, Ohio. He described it as at least a 3-year process. Costs will likely go up in the first year because so many previously uninsured patients will use new benefits. In the second year, skeptics are likely to sign up through the exchanges, bringing more patients, but also potentially higher costs. Savings from coverage likely will not materialize until 2017 – a few years after the first enrollees initially received benefits, he said.
CareSource has gained about 30,000 new enrollees since Oct. 1, Mr. Streator said, adding that about 80% have paid their premiums and about 80% have received a subsidy of some sort.
About 60% were previously uninsured, Mr. Streator said.
Other organizations have recently issued data showing that the number of uninsured seems to be declining. The Robert Wood Johnson Foundation estimated that of the 7 million Americans who have supposedly signed up for a plan through the federal or state exchanges, 5.4 million were previously uninsured. The foundation said that there had been an almost 3% drop in the rate of uninsured since September.
And a Gallup poll released April 7 showed that the rate of uninsured Americans is at its lowest point since late 2008. The data are based on interviews with more than 43,500 adults from early January through late March.
The Gallup poll noted that just under 15% of Americans were uninsured in late March, down from 18% in August 2013. The rate has fallen consistently since open enrollment for the exchanges began in October, with a big drop from early March (15.8%) to the end of the month when enrollment closed (14.7%).
On Twitter @aliciaault
The Affordable Care Act’s health insurance exchanges have provided coverage for the previously uninsured, two health system executives said April 7 at the ninth World Health Care Congress.
About 30,000-40,000 new enrollees to Kaiser Permanente’s California health plans were previously uninsured, said Dr. Robert Pearl, executive director and CEO of the Permanente Medical Group.
"When you get coverage, you start to get health care, which from my perspective is a good thing," he said. Although delivering more care may drive costs up initially, in the long run, it will help create a more cost-effective and higher-quality system.
Kaiser has begun reaching out to those newly insured and found that many need immediate care for chronic conditions, Dr. Pearl said. But having more patients covered by insurance also aligns with Kaiser’s mission of focusing on preventive care, he said.
The exchanges will drive many changes in the health care system, he said. Among them is making health care more integrated, both vertically and horizontally.
The ACA is forcing a realignment of health care, according to Scott E. Streator, vice president for the health insurance marketplace with CareSource – a nonprofit provider of Medicare and Medicaid managed care plans and low-cost insurance plans – based in Dayton, Ohio. He described it as at least a 3-year process. Costs will likely go up in the first year because so many previously uninsured patients will use new benefits. In the second year, skeptics are likely to sign up through the exchanges, bringing more patients, but also potentially higher costs. Savings from coverage likely will not materialize until 2017 – a few years after the first enrollees initially received benefits, he said.
CareSource has gained about 30,000 new enrollees since Oct. 1, Mr. Streator said, adding that about 80% have paid their premiums and about 80% have received a subsidy of some sort.
About 60% were previously uninsured, Mr. Streator said.
Other organizations have recently issued data showing that the number of uninsured seems to be declining. The Robert Wood Johnson Foundation estimated that of the 7 million Americans who have supposedly signed up for a plan through the federal or state exchanges, 5.4 million were previously uninsured. The foundation said that there had been an almost 3% drop in the rate of uninsured since September.
And a Gallup poll released April 7 showed that the rate of uninsured Americans is at its lowest point since late 2008. The data are based on interviews with more than 43,500 adults from early January through late March.
The Gallup poll noted that just under 15% of Americans were uninsured in late March, down from 18% in August 2013. The rate has fallen consistently since open enrollment for the exchanges began in October, with a big drop from early March (15.8%) to the end of the month when enrollment closed (14.7%).
On Twitter @aliciaault
The Affordable Care Act’s health insurance exchanges have provided coverage for the previously uninsured, two health system executives said April 7 at the ninth World Health Care Congress.
About 30,000-40,000 new enrollees to Kaiser Permanente’s California health plans were previously uninsured, said Dr. Robert Pearl, executive director and CEO of the Permanente Medical Group.
"When you get coverage, you start to get health care, which from my perspective is a good thing," he said. Although delivering more care may drive costs up initially, in the long run, it will help create a more cost-effective and higher-quality system.
Kaiser has begun reaching out to those newly insured and found that many need immediate care for chronic conditions, Dr. Pearl said. But having more patients covered by insurance also aligns with Kaiser’s mission of focusing on preventive care, he said.
The exchanges will drive many changes in the health care system, he said. Among them is making health care more integrated, both vertically and horizontally.
The ACA is forcing a realignment of health care, according to Scott E. Streator, vice president for the health insurance marketplace with CareSource – a nonprofit provider of Medicare and Medicaid managed care plans and low-cost insurance plans – based in Dayton, Ohio. He described it as at least a 3-year process. Costs will likely go up in the first year because so many previously uninsured patients will use new benefits. In the second year, skeptics are likely to sign up through the exchanges, bringing more patients, but also potentially higher costs. Savings from coverage likely will not materialize until 2017 – a few years after the first enrollees initially received benefits, he said.
CareSource has gained about 30,000 new enrollees since Oct. 1, Mr. Streator said, adding that about 80% have paid their premiums and about 80% have received a subsidy of some sort.
About 60% were previously uninsured, Mr. Streator said.
Other organizations have recently issued data showing that the number of uninsured seems to be declining. The Robert Wood Johnson Foundation estimated that of the 7 million Americans who have supposedly signed up for a plan through the federal or state exchanges, 5.4 million were previously uninsured. The foundation said that there had been an almost 3% drop in the rate of uninsured since September.
And a Gallup poll released April 7 showed that the rate of uninsured Americans is at its lowest point since late 2008. The data are based on interviews with more than 43,500 adults from early January through late March.
The Gallup poll noted that just under 15% of Americans were uninsured in late March, down from 18% in August 2013. The rate has fallen consistently since open enrollment for the exchanges began in October, with a big drop from early March (15.8%) to the end of the month when enrollment closed (14.7%).
On Twitter @aliciaault
FROM THE WORLD HEALTH CARE CONGRESS
