Alicia Ault

WASHINGTON – As a Senate committee held a hearing Dec. 15 on the continuing drug shortage problem, the Food and Drug Administration announced that it would require some manufacturers to give the agency early warning of an imminent shortage.

The agency issued an interim final rule in response to President Obama's Oct. 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said at the Health, Education, Labor and Pensions (HELP) committee hearing that the agency has been busy since that Oct. 31 order, among other things, reminding drug makers of their legal duty to report, in some instances, impending supply problems.

“Our efforts are having an effect,” said Dr. Kweder. She noted that the agency used to receive about 10 notifications a month of a potential shortage, and that since late October it has received 61 notifications. The agency has monitored 220 shortages since January 2011, and has prevented 96, she said.

Dr. Kweder said the agency had averted shortages by helping manufacturers get supplies of critical ingredients, by helping them change manufacturing processes, or by going to competitors and encouraging them to ramp up production of the drug that is in short supply. She noted that the FDA had recently worked with generic drug maker Teva to get its doxorubicin production on line again, and had also approved Pfizer as a new maker of that chemotherapy drug.

The U.S. General Accounting Office issued a new report at the hearing that urged Congress to require all manufacturers to report potential supply issues to the FDA.

“Because FDA usually doesn't know about a shortage until it is well under way, the agency's approach to managing drug shortages is predominately reactive,” said Marcia Crosse, director of health care at the GAO. The agency has been able to prevent shortages when it knows in advance that there will be a problem, she said.

The GAO found that the agency does not maintain a database on shortages. That means it can't track trends or create effective strategies, said Ms. Crosse. The agency does have the power to expedite reviews of generic drug applications, but currently has a backlog of 8,000 applications, said Ms. Crosse.

Several Republican members of the Senate HELP committee questioned whether the agency was doing all it could to ease that backlog. Ms. Crosse said that the FDA had expedited hundreds of applications, but that it could not say whether any were completed in time to help resolve any particular shortage.

Sen. Richard Blumenthal (D-Conn.) suggested that some of the shortages might be due to a lack of competition in the generic injectable industry. Data presented by market research company IMS Health shows that more than 82% of the products in short supply over the last 5 years were generic injectables. “I will be proposing more aggressive measures that are necessary to crack down on what appear to be anticonsumer practices,” said Sen. Blumenthal, a former attorney general of Connecticut.

“The shortages are creating a public health menace,” he said, adding that he's considering whether to direct the Department of Justice or the Federal Trade Commission to investigate what he called “astonishing and appalling markups” for drugs in short supply.

The generic industry responded with a new initiative, which it announced at the hearing. The Accelerated Recovery Initiative includes manufacturers who represent 80% of the generic injectable market. They are proposing to provide more timely assessments of shortages and “establish practices that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage,” according to testimony by Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The initiative does have to be approved by the Federal Trade Commission and the Department of Health and Human Services, said Mr. Neas.

The FDA has monitored 220 drug shortages since January 2011 and has prevented 96, said Dr. Sandra Kweder.

Shortages may result from a lack of competition in generic injectables, said Sen. Richard Blumenthal (D-Conn.).

Source Photos: Alicia Ault/Elsevier Global Medical News

WASHINGTON – As a Senate committee held a hearing Dec. 15 on the continuing drug shortage problem, the Food and Drug Administration announced that it would require some manufacturers to give the agency early warning of an imminent shortage.

The agency issued an interim final rule in response to President Obama's Oct. 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said at the Health, Education, Labor and Pensions (HELP) committee hearing that the agency has been busy since that Oct. 31 order, among other things, reminding drug makers of their legal duty to report, in some instances, impending supply problems.

“Our efforts are having an effect,” said Dr. Kweder. She noted that the agency used to receive about 10 notifications a month of a potential shortage, and that since late October it has received 61 notifications. The agency has monitored 220 shortages since January 2011, and has prevented 96, she said.

Dr. Kweder said the agency had averted shortages by helping manufacturers get supplies of critical ingredients, by helping them change manufacturing processes, or by going to competitors and encouraging them to ramp up production of the drug that is in short supply. She noted that the FDA had recently worked with generic drug maker Teva to get its doxorubicin production on line again, and had also approved Pfizer as a new maker of that chemotherapy drug.

The U.S. General Accounting Office issued a new report at the hearing that urged Congress to require all manufacturers to report potential supply issues to the FDA.

“Because FDA usually doesn't know about a shortage until it is well under way, the agency's approach to managing drug shortages is predominately reactive,” said Marcia Crosse, director of health care at the GAO. The agency has been able to prevent shortages when it knows in advance that there will be a problem, she said.

The GAO found that the agency does not maintain a database on shortages. That means it can't track trends or create effective strategies, said Ms. Crosse. The agency does have the power to expedite reviews of generic drug applications, but currently has a backlog of 8,000 applications, said Ms. Crosse.

Several Republican members of the Senate HELP committee questioned whether the agency was doing all it could to ease that backlog. Ms. Crosse said that the FDA had expedited hundreds of applications, but that it could not say whether any were completed in time to help resolve any particular shortage.

Sen. Richard Blumenthal (D-Conn.) suggested that some of the shortages might be due to a lack of competition in the generic injectable industry. Data presented by market research company IMS Health shows that more than 82% of the products in short supply over the last 5 years were generic injectables. “I will be proposing more aggressive measures that are necessary to crack down on what appear to be anticonsumer practices,” said Sen. Blumenthal, a former attorney general of Connecticut.

“The shortages are creating a public health menace,” he said, adding that he's considering whether to direct the Department of Justice or the Federal Trade Commission to investigate what he called “astonishing and appalling markups” for drugs in short supply.

The generic industry responded with a new initiative, which it announced at the hearing. The Accelerated Recovery Initiative includes manufacturers who represent 80% of the generic injectable market. They are proposing to provide more timely assessments of shortages and “establish practices that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage,” according to testimony by Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The initiative does have to be approved by the Federal Trade Commission and the Department of Health and Human Services, said Mr. Neas.

The FDA has monitored 220 drug shortages since January 2011 and has prevented 96, said Dr. Sandra Kweder.

Shortages may result from a lack of competition in generic injectables, said Sen. Richard Blumenthal (D-Conn.).

Source Photos: Alicia Ault/Elsevier Global Medical News

WASHINGTON – As a Senate committee held a hearing Dec. 15 on the continuing drug shortage problem, the Food and Drug Administration announced that it would require some manufacturers to give the agency early warning of an imminent shortage.

The agency issued an interim final rule in response to President Obama's Oct. 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services.

Dr. Sandra Kweder, deputy director of the FDA's Office of New Drugs, said at the Health, Education, Labor and Pensions (HELP) committee hearing that the agency has been busy since that Oct. 31 order, among other things, reminding drug makers of their legal duty to report, in some instances, impending supply problems.

“Our efforts are having an effect,” said Dr. Kweder. She noted that the agency used to receive about 10 notifications a month of a potential shortage, and that since late October it has received 61 notifications. The agency has monitored 220 shortages since January 2011, and has prevented 96, she said.

Dr. Kweder said the agency had averted shortages by helping manufacturers get supplies of critical ingredients, by helping them change manufacturing processes, or by going to competitors and encouraging them to ramp up production of the drug that is in short supply. She noted that the FDA had recently worked with generic drug maker Teva to get its doxorubicin production on line again, and had also approved Pfizer as a new maker of that chemotherapy drug.

The U.S. General Accounting Office issued a new report at the hearing that urged Congress to require all manufacturers to report potential supply issues to the FDA.

“Because FDA usually doesn't know about a shortage until it is well under way, the agency's approach to managing drug shortages is predominately reactive,” said Marcia Crosse, director of health care at the GAO. The agency has been able to prevent shortages when it knows in advance that there will be a problem, she said.

The GAO found that the agency does not maintain a database on shortages. That means it can't track trends or create effective strategies, said Ms. Crosse. The agency does have the power to expedite reviews of generic drug applications, but currently has a backlog of 8,000 applications, said Ms. Crosse.

Several Republican members of the Senate HELP committee questioned whether the agency was doing all it could to ease that backlog. Ms. Crosse said that the FDA had expedited hundreds of applications, but that it could not say whether any were completed in time to help resolve any particular shortage.

Sen. Richard Blumenthal (D-Conn.) suggested that some of the shortages might be due to a lack of competition in the generic injectable industry. Data presented by market research company IMS Health shows that more than 82% of the products in short supply over the last 5 years were generic injectables. “I will be proposing more aggressive measures that are necessary to crack down on what appear to be anticonsumer practices,” said Sen. Blumenthal, a former attorney general of Connecticut.

“The shortages are creating a public health menace,” he said, adding that he's considering whether to direct the Department of Justice or the Federal Trade Commission to investigate what he called “astonishing and appalling markups” for drugs in short supply.

The generic industry responded with a new initiative, which it announced at the hearing. The Accelerated Recovery Initiative includes manufacturers who represent 80% of the generic injectable market. They are proposing to provide more timely assessments of shortages and “establish practices that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage,” according to testimony by Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The initiative does have to be approved by the Federal Trade Commission and the Department of Health and Human Services, said Mr. Neas.

The FDA has monitored 220 drug shortages since January 2011 and has prevented 96, said Dr. Sandra Kweder.

Shortages may result from a lack of competition in generic injectables, said Sen. Richard Blumenthal (D-Conn.).

Source Photos: Alicia Ault/Elsevier Global Medical News

HOT SPRINGS, VA. – An analysis of a large database of bariatric surgery patients has found that those with metabolic syndrome had dramatic improvements in comorbidities but a slightly higher rate of adverse events after 90 days.

Overall, patients with metabolic syndrome tend to be sicker and to have a greater incidence of adverse outcomes and higher mortality than do obese patients who don't have the syndrome, said Dr. William B. Inabnet III, professor of surgery at Mount Sinai School of Medicine in New York.

He and his colleagues at Mount Sinai also determined that the reduction in weight was procedure dependent. “A careful assessment of risk-benefit ratio is warranted to develop the optimal clinical pathway for treating these patients,” said Dr. Inabnet at the meeting.

The researchers examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone bariatric surgery from June 2007 to November 2010 and had metabolic syndrome.

BOLD is maintained by the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence program, and includes 1,157 surgeons at 884 hospitals. The data are self-reported, but some data are verified by on-site inspections. The surgical interventions covered in the registry include gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.

A modified scoring system (0-5) was used to assess comorbidities. For the purposes of the study, metabolic syndrome was defined as a hypertension score greater than 3, a diabetes score greater than 2, a dyslipidemia score greater than 2, and a sleep apnea score greater than 3. (Sleep apnea is not usually included in the definition of metabolic syndrome, but the researchers were interested in the condition as a comorbidity, said Dr. Inabnet.)

Overall, there were 186,567 patients in BOLD, including 23,106 patients who had metabolic syndrome. Those with metabolic syndrome were more likely than other obese patients to be male, older, and white, and to have sleep apnea and an ASA (American Society of Anesthesiologists) classification of 3 or greater. Body mass index was similar for both groups at 47 kg/m

Gastric bypass was the most commonly performed procedure, and was the preferred method in patients with metabolic syndrome, followed by gastric banding, sleeve gastrectomy, and duodenal switch. And, said Dr. Inabnet, the researchers “were truly amazed to see that the vast majority of these cases were performed with laparoscopic approaches.”

At 30 days, those with metabolic syndrome had increases in mortality, serious complications, readmissions, and reoperations, compared with other obese patients. The increases continued as time went on, and became more pronounced at 90 days post surgery, said Dr. Inabnet.

Overall mortality was very low (0.1%) for the entire cohort of 186,567 patients.

Mortality rates differed by procedure, however. The gastric band patients had the lowest rate (0.1%), followed by 1.2% for duodenal switch, 0.3% for sleeve gastrectomy, and 0.4% for gastric bypass. The serious complications, readmissions, and reoperations at 90 days were also lowest for gastric band patients, followed by duodenal switch, sleeve gastrectomy, and gastric bypass patients.

Metabolic syndrome was associated with the greatest risk for serious complications, according to the authors' regression model. Those who received the gastric band had a 2.79-fold increase in risk at 90 days, compared with bypass patients, who had a 1.34-fold increased risk.

Follow-up data at 1 year were available for a little more than half of those with metabolic syndrome (12,144 patients). The data show that the decrease in BMI was procedure dependent. The greatest decrease in mean BMI (from 51 to 32) was seen in those who had a biliopancreatic diversion. Mean BMI dropped from 46 to 39 in gastric band patients, from 49 to 36 in those who had a sleeve gastrectomy, and from 48 to 32 in those who had the bypass.

Reduction of comorbidities was also greatest in the duodenal switch group, followed by the bypass, sleeve, and gastric band procedures. For instance, diabetes resolved in 74% of patients who had the duodenal switch, compared with only 28% of those who received the band. There were big reductions in hyperlipidemia and sleep apnea for all the procedures.

The data are limited in that they are self-reported, noted Dr. Inabnet. Even so, the “study confirms the previously held hypothesis that metabolic syndrome confers increased morbidity,” said Dr. Bruce Schirmer, vice-chair of the department of surgery at the University of Virginia, Charlottesville. In discussing the paper, Dr. Schirmer noted that BOLD also seemed to show lower overall weight loss and resolution of comorbidities than was previously reported by individual institutions.

The database, however, has its advantages, said another discussant, Dr. William O. Richards, chair of the department of surgery and director of the surgical weight loss center at the University of South Alabama, Mobile. “This paper is important because it's another one of the studies emanating from prospective [collections of data across the United States] from hundreds of surgeons, and convinces me we are ever more confident in reporting results not just from a single surgeon but from actual practice,” said Dr. Richards.

He questioned whether the low mortality rate was a reflection of surgeons' opting to avoid procedures in high-risk, older obese patients, or whether it was a reflection of the success of the centers of excellence system.

Dr. Inabnet said that there were 200 patients older than age 75, and although the data are currently too young to allow the measurement of any trends, it does not seem that older patients are being operated on less often than are younger patients.

“What is the best operation? That really is the million dollar question,” he said. The data show that the Roux-en-Y procedure provides the best overall risk profile, but he added that the sleeve gastrectomy is increasing in prevalence and may eventually prove to be a good choice.

Dr. Inabnet, Dr. Schirmer, and Dr. Richards reported no conflicts.

Roux-en-Y has the best risk profile, but sleeve gastrectomy may prove to be a good choice.

Source DR. INABNET

HOT SPRINGS, VA. – An analysis of a large database of bariatric surgery patients has found that those with metabolic syndrome had dramatic improvements in comorbidities but a slightly higher rate of adverse events after 90 days.

Overall, patients with metabolic syndrome tend to be sicker and to have a greater incidence of adverse outcomes and higher mortality than do obese patients who don't have the syndrome, said Dr. William B. Inabnet III, professor of surgery at Mount Sinai School of Medicine in New York.

He and his colleagues at Mount Sinai also determined that the reduction in weight was procedure dependent. “A careful assessment of risk-benefit ratio is warranted to develop the optimal clinical pathway for treating these patients,” said Dr. Inabnet at the meeting.

The researchers examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone bariatric surgery from June 2007 to November 2010 and had metabolic syndrome.

BOLD is maintained by the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence program, and includes 1,157 surgeons at 884 hospitals. The data are self-reported, but some data are verified by on-site inspections. The surgical interventions covered in the registry include gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.

A modified scoring system (0-5) was used to assess comorbidities. For the purposes of the study, metabolic syndrome was defined as a hypertension score greater than 3, a diabetes score greater than 2, a dyslipidemia score greater than 2, and a sleep apnea score greater than 3. (Sleep apnea is not usually included in the definition of metabolic syndrome, but the researchers were interested in the condition as a comorbidity, said Dr. Inabnet.)

Overall, there were 186,567 patients in BOLD, including 23,106 patients who had metabolic syndrome. Those with metabolic syndrome were more likely than other obese patients to be male, older, and white, and to have sleep apnea and an ASA (American Society of Anesthesiologists) classification of 3 or greater. Body mass index was similar for both groups at 47 kg/m

Gastric bypass was the most commonly performed procedure, and was the preferred method in patients with metabolic syndrome, followed by gastric banding, sleeve gastrectomy, and duodenal switch. And, said Dr. Inabnet, the researchers “were truly amazed to see that the vast majority of these cases were performed with laparoscopic approaches.”

At 30 days, those with metabolic syndrome had increases in mortality, serious complications, readmissions, and reoperations, compared with other obese patients. The increases continued as time went on, and became more pronounced at 90 days post surgery, said Dr. Inabnet.

Overall mortality was very low (0.1%) for the entire cohort of 186,567 patients.

Mortality rates differed by procedure, however. The gastric band patients had the lowest rate (0.1%), followed by 1.2% for duodenal switch, 0.3% for sleeve gastrectomy, and 0.4% for gastric bypass. The serious complications, readmissions, and reoperations at 90 days were also lowest for gastric band patients, followed by duodenal switch, sleeve gastrectomy, and gastric bypass patients.

Metabolic syndrome was associated with the greatest risk for serious complications, according to the authors' regression model. Those who received the gastric band had a 2.79-fold increase in risk at 90 days, compared with bypass patients, who had a 1.34-fold increased risk.

Follow-up data at 1 year were available for a little more than half of those with metabolic syndrome (12,144 patients). The data show that the decrease in BMI was procedure dependent. The greatest decrease in mean BMI (from 51 to 32) was seen in those who had a biliopancreatic diversion. Mean BMI dropped from 46 to 39 in gastric band patients, from 49 to 36 in those who had a sleeve gastrectomy, and from 48 to 32 in those who had the bypass.

Reduction of comorbidities was also greatest in the duodenal switch group, followed by the bypass, sleeve, and gastric band procedures. For instance, diabetes resolved in 74% of patients who had the duodenal switch, compared with only 28% of those who received the band. There were big reductions in hyperlipidemia and sleep apnea for all the procedures.

The data are limited in that they are self-reported, noted Dr. Inabnet. Even so, the “study confirms the previously held hypothesis that metabolic syndrome confers increased morbidity,” said Dr. Bruce Schirmer, vice-chair of the department of surgery at the University of Virginia, Charlottesville. In discussing the paper, Dr. Schirmer noted that BOLD also seemed to show lower overall weight loss and resolution of comorbidities than was previously reported by individual institutions.

The database, however, has its advantages, said another discussant, Dr. William O. Richards, chair of the department of surgery and director of the surgical weight loss center at the University of South Alabama, Mobile. “This paper is important because it's another one of the studies emanating from prospective [collections of data across the United States] from hundreds of surgeons, and convinces me we are ever more confident in reporting results not just from a single surgeon but from actual practice,” said Dr. Richards.

He questioned whether the low mortality rate was a reflection of surgeons' opting to avoid procedures in high-risk, older obese patients, or whether it was a reflection of the success of the centers of excellence system.

Dr. Inabnet said that there were 200 patients older than age 75, and although the data are currently too young to allow the measurement of any trends, it does not seem that older patients are being operated on less often than are younger patients.

“What is the best operation? That really is the million dollar question,” he said. The data show that the Roux-en-Y procedure provides the best overall risk profile, but he added that the sleeve gastrectomy is increasing in prevalence and may eventually prove to be a good choice.

Dr. Inabnet, Dr. Schirmer, and Dr. Richards reported no conflicts.

Roux-en-Y has the best risk profile, but sleeve gastrectomy may prove to be a good choice.

Source DR. INABNET

HOT SPRINGS, VA. – An analysis of a large database of bariatric surgery patients has found that those with metabolic syndrome had dramatic improvements in comorbidities but a slightly higher rate of adverse events after 90 days.

Overall, patients with metabolic syndrome tend to be sicker and to have a greater incidence of adverse outcomes and higher mortality than do obese patients who don't have the syndrome, said Dr. William B. Inabnet III, professor of surgery at Mount Sinai School of Medicine in New York.

He and his colleagues at Mount Sinai also determined that the reduction in weight was procedure dependent. “A careful assessment of risk-benefit ratio is warranted to develop the optimal clinical pathway for treating these patients,” said Dr. Inabnet at the meeting.

The researchers examined BOLD (Bariatric Outcomes Longitudinal Database) to identify patients who had undergone bariatric surgery from June 2007 to November 2010 and had metabolic syndrome.

BOLD is maintained by the American Society for Metabolic and Bariatric Surgery (ASMBS) Bariatric Surgery Center of Excellence program, and includes 1,157 surgeons at 884 hospitals. The data are self-reported, but some data are verified by on-site inspections. The surgical interventions covered in the registry include gastric banding, Roux-en-Y gastric bypass, sleeve gastrectomy, and biliopancreatic diversion with duodenal switch.

A modified scoring system (0-5) was used to assess comorbidities. For the purposes of the study, metabolic syndrome was defined as a hypertension score greater than 3, a diabetes score greater than 2, a dyslipidemia score greater than 2, and a sleep apnea score greater than 3. (Sleep apnea is not usually included in the definition of metabolic syndrome, but the researchers were interested in the condition as a comorbidity, said Dr. Inabnet.)

Overall, there were 186,567 patients in BOLD, including 23,106 patients who had metabolic syndrome. Those with metabolic syndrome were more likely than other obese patients to be male, older, and white, and to have sleep apnea and an ASA (American Society of Anesthesiologists) classification of 3 or greater. Body mass index was similar for both groups at 47 kg/m

Gastric bypass was the most commonly performed procedure, and was the preferred method in patients with metabolic syndrome, followed by gastric banding, sleeve gastrectomy, and duodenal switch. And, said Dr. Inabnet, the researchers “were truly amazed to see that the vast majority of these cases were performed with laparoscopic approaches.”

At 30 days, those with metabolic syndrome had increases in mortality, serious complications, readmissions, and reoperations, compared with other obese patients. The increases continued as time went on, and became more pronounced at 90 days post surgery, said Dr. Inabnet.

Overall mortality was very low (0.1%) for the entire cohort of 186,567 patients.

Mortality rates differed by procedure, however. The gastric band patients had the lowest rate (0.1%), followed by 1.2% for duodenal switch, 0.3% for sleeve gastrectomy, and 0.4% for gastric bypass. The serious complications, readmissions, and reoperations at 90 days were also lowest for gastric band patients, followed by duodenal switch, sleeve gastrectomy, and gastric bypass patients.

Metabolic syndrome was associated with the greatest risk for serious complications, according to the authors' regression model. Those who received the gastric band had a 2.79-fold increase in risk at 90 days, compared with bypass patients, who had a 1.34-fold increased risk.

Follow-up data at 1 year were available for a little more than half of those with metabolic syndrome (12,144 patients). The data show that the decrease in BMI was procedure dependent. The greatest decrease in mean BMI (from 51 to 32) was seen in those who had a biliopancreatic diversion. Mean BMI dropped from 46 to 39 in gastric band patients, from 49 to 36 in those who had a sleeve gastrectomy, and from 48 to 32 in those who had the bypass.

Reduction of comorbidities was also greatest in the duodenal switch group, followed by the bypass, sleeve, and gastric band procedures. For instance, diabetes resolved in 74% of patients who had the duodenal switch, compared with only 28% of those who received the band. There were big reductions in hyperlipidemia and sleep apnea for all the procedures.

The data are limited in that they are self-reported, noted Dr. Inabnet. Even so, the “study confirms the previously held hypothesis that metabolic syndrome confers increased morbidity,” said Dr. Bruce Schirmer, vice-chair of the department of surgery at the University of Virginia, Charlottesville. In discussing the paper, Dr. Schirmer noted that BOLD also seemed to show lower overall weight loss and resolution of comorbidities than was previously reported by individual institutions.

The database, however, has its advantages, said another discussant, Dr. William O. Richards, chair of the department of surgery and director of the surgical weight loss center at the University of South Alabama, Mobile. “This paper is important because it's another one of the studies emanating from prospective [collections of data across the United States] from hundreds of surgeons, and convinces me we are ever more confident in reporting results not just from a single surgeon but from actual practice,” said Dr. Richards.

He questioned whether the low mortality rate was a reflection of surgeons' opting to avoid procedures in high-risk, older obese patients, or whether it was a reflection of the success of the centers of excellence system.

Dr. Inabnet said that there were 200 patients older than age 75, and although the data are currently too young to allow the measurement of any trends, it does not seem that older patients are being operated on less often than are younger patients.

“What is the best operation? That really is the million dollar question,” he said. The data show that the Roux-en-Y procedure provides the best overall risk profile, but he added that the sleeve gastrectomy is increasing in prevalence and may eventually prove to be a good choice.

Dr. Inabnet, Dr. Schirmer, and Dr. Richards reported no conflicts.

Roux-en-Y has the best risk profile, but sleeve gastrectomy may prove to be a good choice.

Source DR. INABNET

The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...

*For a PDF of the full article, click in the link to the left of this introduction.

The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...

*For a PDF of the full article, click in the link to the left of this introduction.

The Food and Drug Administration (FDA) has announced that it would require some manufacturers to give the agency early warning of an imminent drug shortage. The agency made the announcement on December 15, 2011, as a Senate committee held a hearing the continuing drug shortage problem. It issued an interim final rule in response to President Obama’s October 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product “to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition,” according to a press release from the Department of Health and Human Services...

*For a PDF of the full article, click in the link to the left of this introduction.

The Food and Drug Administration on Dec. 28 approved a class-wide risk management program for all transmucosal immediate-release fentanyl formulations.

The TIRF REMS [transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy] Access program is the agency’s first class-wide REMS for opioids. It replaces the individual REMS that exists for each product in the class now.

It will likely be the model for a REMS that the agency is developing for long-acting and extended-release opioids.

The REMS program is designed to reduce the risk of misuse, abuse, addiction, and overdose. REMS only applies to outpatient prescriptions. Hospitals, hospices and long-term care providers do not have to participate.

The TIRF REMS covers Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal soluble film.

The FDA said that it developed a single risk management program for all the drugs to make management of these druigs easier for prescribers, pharmacists, distributors and outpatients. They all need to enroll only once to prescribe, dispense, or receive any of the products.

The program will start in March 2012. At that time, physicians will be able to enroll, after having completed an education program and assessment. Patients and health providers will also have to complete and sign an agreement form with the first prescription. And prescribers will have to give patients a Medication Guide that explains the risks, benefits, and proper use of the drug.

Health care providers who are already enrolled in an individual REMS program for at least one transmucosal immediate-release fentanyl medicine will not need to re-enroll because they will be automatically transitioned to the shared TIRF REMS Access program. Prescribers will be required to re-enroll in the TIRF REMS program every 2 years from the date of enrollment into either the individual REMS or TIRF REMS program, whichever was earlier.

The Food and Drug Administration on Dec. 28 approved a class-wide risk management program for all transmucosal immediate-release fentanyl formulations.

The TIRF REMS [transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy] Access program is the agency’s first class-wide REMS for opioids. It replaces the individual REMS that exists for each product in the class now.

It will likely be the model for a REMS that the agency is developing for long-acting and extended-release opioids.

The REMS program is designed to reduce the risk of misuse, abuse, addiction, and overdose. REMS only applies to outpatient prescriptions. Hospitals, hospices and long-term care providers do not have to participate.

The TIRF REMS covers Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal soluble film.

The FDA said that it developed a single risk management program for all the drugs to make management of these druigs easier for prescribers, pharmacists, distributors and outpatients. They all need to enroll only once to prescribe, dispense, or receive any of the products.

The program will start in March 2012. At that time, physicians will be able to enroll, after having completed an education program and assessment. Patients and health providers will also have to complete and sign an agreement form with the first prescription. And prescribers will have to give patients a Medication Guide that explains the risks, benefits, and proper use of the drug.

Health care providers who are already enrolled in an individual REMS program for at least one transmucosal immediate-release fentanyl medicine will not need to re-enroll because they will be automatically transitioned to the shared TIRF REMS Access program. Prescribers will be required to re-enroll in the TIRF REMS program every 2 years from the date of enrollment into either the individual REMS or TIRF REMS program, whichever was earlier.

The Food and Drug Administration on Dec. 28 approved a class-wide risk management program for all transmucosal immediate-release fentanyl formulations.

The TIRF REMS [transmucosal immediate-release fentanyl Risk Evaluation and Mitigation Strategy] Access program is the agency’s first class-wide REMS for opioids. It replaces the individual REMS that exists for each product in the class now.

It will likely be the model for a REMS that the agency is developing for long-acting and extended-release opioids.

The REMS program is designed to reduce the risk of misuse, abuse, addiction, and overdose. REMS only applies to outpatient prescriptions. Hospitals, hospices and long-term care providers do not have to participate.

The TIRF REMS covers Abstral (fentanyl) sublingual tablet, Actiq (fentanyl citrate) oral transmucosal lozenge and its generic equivalents, Fentora (fentanyl citrate) buccal tablet, Lazanda (fentanyl) nasal spray, and Onsolis (fentanyl) buccal soluble film.

The FDA said that it developed a single risk management program for all the drugs to make management of these druigs easier for prescribers, pharmacists, distributors and outpatients. They all need to enroll only once to prescribe, dispense, or receive any of the products.

The program will start in March 2012. At that time, physicians will be able to enroll, after having completed an education program and assessment. Patients and health providers will also have to complete and sign an agreement form with the first prescription. And prescribers will have to give patients a Medication Guide that explains the risks, benefits, and proper use of the drug.

Health care providers who are already enrolled in an individual REMS program for at least one transmucosal immediate-release fentanyl medicine will not need to re-enroll because they will be automatically transitioned to the shared TIRF REMS Access program. Prescribers will be required to re-enroll in the TIRF REMS program every 2 years from the date of enrollment into either the individual REMS or TIRF REMS program, whichever was earlier.

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the meeting.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

Photo (c) -Oxford-/iStock.com

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart, chairman of the department of surgery.

Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared to open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led to an increase in enforcement.

"It appears that tort reform in Texas has done what it was intended to do," increased the activity of the Texas Medical Board, and decreased the activity of the medical liability tort system, said Dr. Russell Postier, chairman of the surgery department at the University of Oklahoma, Oklahoma City, in discussing the paper.

Further, it appears to have increased the number of physicians practicing in the state, which could "make other states take notice and potentially enact tort reform," Dr. Postier said.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts.

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the meeting.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

Photo (c) -Oxford-/iStock.com

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart, chairman of the department of surgery.

Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared to open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led to an increase in enforcement.

"It appears that tort reform in Texas has done what it was intended to do," increased the activity of the Texas Medical Board, and decreased the activity of the medical liability tort system, said Dr. Russell Postier, chairman of the surgery department at the University of Oklahoma, Oklahoma City, in discussing the paper.

Further, it appears to have increased the number of physicians practicing in the state, which could "make other states take notice and potentially enact tort reform," Dr. Postier said.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts.

HOT SPRINGS, VA. – Since tort reform in Texas, the number of lawsuits and associated costs have decreased, but patient complaints to the state medical board and board investigations of physicians have risen, according to an analysis presented at the meeting.

Dr. Ronald M. Stewart and his colleagues from the University of Texas Health Science Center at San Antonio obtained publicly available data from the Texas Medical Board and compared the 7-year period before tort reform (1996-2002) and the 6 years after the law was enacted (2004-2010).

Photo (c) -Oxford-/iStock.com

The data were adjusted for the increase in the physician population; before reform there were about 170 physicians per 100,000 residents. After the law went into effect, the number rose to 195 physicians per 100,000, said Dr. Stewart, chairman of the department of surgery.

Before reform, about 125 complaints per 1,000 physicians were made to the medical board. That number increased by 13% after reform, to around 140 complaints per 1,000 physicians, said Dr. Stewart.

The rate of investigations increased from 38 per 1,000 to 52 per 1,000, with 5% of physicians the subject of a medical board inquiry. Postreform, there were more disciplinary actions when compared to open investigations, at about 8 per 1,000 in the latter period. Before reform, 0.5 per 1,000 physicians were ordered to revoke or to voluntarily surrender their licenses; after reform, that value rose to 0.8 per 1,000, a significant increase, noted Dr. Stewart.

The most striking change before and after reform was the decline in financial penalties. The state collected a total of $4.7 million in the postreform period. To put that figure into context, the San Antonio department of surgery alone spent $4.8 million on liability settlements in the prereform period, said Dr. Stewart.

It’s not clear why complaints and disciplinary actions went up, Dr. Stewart said. Having access to electronic information and greater awareness of the ability to complain to the medical board probably spurred more patient reporting.

The increases in investigations and disciplinary actions were mainly driven by the legislature, according to Dr. Stewart. The lawmakers mandated greater oversight by the medical board, so that undoubtedly led to an increase in enforcement.

"It appears that tort reform in Texas has done what it was intended to do," increased the activity of the Texas Medical Board, and decreased the activity of the medical liability tort system, said Dr. Russell Postier, chairman of the surgery department at the University of Oklahoma, Oklahoma City, in discussing the paper.

Further, it appears to have increased the number of physicians practicing in the state, which could "make other states take notice and potentially enact tort reform," Dr. Postier said.

Dr. Stewart said that putting malpractice in the hands of the medical board had decreased costs and been generally positive. For instance, he said, the medical board process is transparent and allows more input from stakeholders like physicians.

"There’s no question that the benefits of tort reform in my opinion outweigh the potential negative consequences to physicians," he said.

Dr. Stewart and Dr. Postier reported no financial conflicts.

HOT SPRINGS, VA. – A collaboration among 10 hospitals in Tennessee has produced a boost in quality of care while also saving millions of dollars.

The collaboration first got started in 2005, when the three initial participants – Erlanger Medical Center in Chattanooga, Vanderbilt University Medical Center in Nashville, and St. Francis Hospital–Memphis – took inspiration from the rollout of the American College of Surgeons’ National Surgical Quality Improvement Project (NSQIP), said Dr. Joseph B. Cofer, a professor of surgery at the University of Tennessee, Chattanooga.

A successful run so far has led BlueCross Blue Shield of Tennessee (which has bankrolled the operation) to extend its funding through 2012 for the 10 hospitals that are currently participating, said Dr. Cofer. And it made funds available for an additional 11 hospitals to join, which would bring the total to 21.

With data now complete for 2009 and 2010, the Tennessee Surgical Quality Collaborative reported that postoperative mortality was not statistically significantly different from the first year (2.32%, or 232/10,000) to the second year (2.38%, or 237/10,000).

However, significant declines in postoperative complications in five areas – acute renal failure (25% drop), graft/flap failure (60% drop), ventilation for more than 48 hours (15% drop), superficial incisional surgical-site infection (19% drop), and wound disruption (34% drop) – resulted in total savings of $4.47 million.

At the same time, increases in postoperative complications in three areas – urinary tract infection (42% rise), pneumonia (23% rise), and deep vein thrombosis (35% rise) – cost $2.1 million.

Overall, the savings were at least $2 million for the 10 participating hospitals, said Dr. Cofer. But that number reflects only a sampling of cases from the 10 hospitals; if all the cases had been included, "we can reliably say we probably avoided about $8 million in costs over this year," Dr. Cofer said.

"Why this happened, we don’t know," he added. It’s possible that just being part of the NSQIP process improves monitoring and outcomes.

The Tennessee collaborative is now identifying exemplar hospitals and "sending out teams to dissect how they did it so well," Dr. Cofer said. Then, those best practices will be disseminated to other hospitals in the collaborative.

The collaboration would not likely have been possible without the participation of BlueCross BlueShield of Tennessee. Dr. Cofer spearheaded the talks with the insurer, which began in 2006 and culminated in a three-way partnership among the Blues, the Tennessee chapter of the ACS, and the Tennessee Hospital Association. In 2008, the Blues announced that it was giving the collaboration $2.5 million over the next 3 years to fund the collaborative.

Another crucial element was the leadership committee, said Dr. Cofer. Of the seven committee members, four are surgeons, two are hospital CEOs, and one is a staff person from the Tennessee Hospital Association. Data cannot be released without permission of the committee, and, so far, specific data are not being shared.

Dr. J. David Richardson, a discussant and chairman of the NSQIP committee at ACS, said, "it takes a tremendous effort to put a group like this together," adding that "within the ACS, I think we’ve all been heartened by the initiative taken by the Tennessee chapter in developing this program." The ACS is looking to expand the program, particularly beyond Veterans Affairs hospitals, said Dr. Richardson, professor and vice chairman of surgery at the University of Louisville (Ky.). The collaborative model is a way to spread the cost, so it may entice more participants, he said.

"This is a provocative paper because it should provoke us to follow suit," Dr. Joseph J. Tepas III, professor of surgery at the University of Florida, Jacksonville, said in his discussion of the paper. "This report demonstrates that this engine of quality, fueled by real-time clinical data, produces results that are understandable to the nonphysician public."

He added that just participating in NSQIP likely improved the hospitals’ quality. "The power of NSQIP is, first, in its surveillance, and this is what’s so well demonstrated here," he said.

Dr. Tepas, Dr. Richardson, and several other discussants asked why there had been improvement in some clinical areas but not in others. Was this perhaps a change in surgical leadership, or – as Dr. Cofer suggested – the Hawthorne effect (that is, the tendency of outcomes to improve when participants – in this case, hospitals and surgeons – know they are being monitored)?

Lead author Dr. Oscar Guillamondegui had an answer: "There have been no real changes in leadership at any of these hospitals, but if you think about the cost of putting together a NSQIP program – other than for the large hospitals – for many of these hospitals, it’s a bottom-line item that’s not insubstantial," he said. "Most hospitals will push to have improvement of care just based on the fact they’re putting that kind of funding into a system," said Dr. Guillamondegui of the division of trauma and surgical critical care at Vanderbilt University Medical Center. He also surmised that the Hawthorne effect may have played a part.

Some outcomes got worse, likely because of natural variations, but also because NSQIP definitions are strict and include a 30-day window, he said. For instance, more than half of urinary tract infections happen outside the hospital, but if they occur within 30 days of admission, they fall within the NSQIP 30-day morbidity outcome window.

Going forward, sustaining such collaboratives could be difficult, said Dr. Guillamondegui. "If you have a weak surgeon champion, then the program does nothing," especially if data are not being shared with other surgeons or the hospital administration. "If your culture isn’t capable of sustaining this, it will fail."

Dr. Cofer, Dr. Tepas, and Dr. Guillamondegui reported no conflicts. Dr. Richardson chairs the ACS NSQIP committee.

HOT SPRINGS, VA. – A collaboration among 10 hospitals in Tennessee has produced a boost in quality of care while also saving millions of dollars.

The collaboration first got started in 2005, when the three initial participants – Erlanger Medical Center in Chattanooga, Vanderbilt University Medical Center in Nashville, and St. Francis Hospital–Memphis – took inspiration from the rollout of the American College of Surgeons’ National Surgical Quality Improvement Project (NSQIP), said Dr. Joseph B. Cofer, a professor of surgery at the University of Tennessee, Chattanooga.

A successful run so far has led BlueCross Blue Shield of Tennessee (which has bankrolled the operation) to extend its funding through 2012 for the 10 hospitals that are currently participating, said Dr. Cofer. And it made funds available for an additional 11 hospitals to join, which would bring the total to 21.

With data now complete for 2009 and 2010, the Tennessee Surgical Quality Collaborative reported that postoperative mortality was not statistically significantly different from the first year (2.32%, or 232/10,000) to the second year (2.38%, or 237/10,000).

However, significant declines in postoperative complications in five areas – acute renal failure (25% drop), graft/flap failure (60% drop), ventilation for more than 48 hours (15% drop), superficial incisional surgical-site infection (19% drop), and wound disruption (34% drop) – resulted in total savings of $4.47 million.

At the same time, increases in postoperative complications in three areas – urinary tract infection (42% rise), pneumonia (23% rise), and deep vein thrombosis (35% rise) – cost $2.1 million.

Overall, the savings were at least $2 million for the 10 participating hospitals, said Dr. Cofer. But that number reflects only a sampling of cases from the 10 hospitals; if all the cases had been included, "we can reliably say we probably avoided about $8 million in costs over this year," Dr. Cofer said.

"Why this happened, we don’t know," he added. It’s possible that just being part of the NSQIP process improves monitoring and outcomes.

The Tennessee collaborative is now identifying exemplar hospitals and "sending out teams to dissect how they did it so well," Dr. Cofer said. Then, those best practices will be disseminated to other hospitals in the collaborative.

The collaboration would not likely have been possible without the participation of BlueCross BlueShield of Tennessee. Dr. Cofer spearheaded the talks with the insurer, which began in 2006 and culminated in a three-way partnership among the Blues, the Tennessee chapter of the ACS, and the Tennessee Hospital Association. In 2008, the Blues announced that it was giving the collaboration $2.5 million over the next 3 years to fund the collaborative.

Another crucial element was the leadership committee, said Dr. Cofer. Of the seven committee members, four are surgeons, two are hospital CEOs, and one is a staff person from the Tennessee Hospital Association. Data cannot be released without permission of the committee, and, so far, specific data are not being shared.

Dr. J. David Richardson, a discussant and chairman of the NSQIP committee at ACS, said, "it takes a tremendous effort to put a group like this together," adding that "within the ACS, I think we’ve all been heartened by the initiative taken by the Tennessee chapter in developing this program." The ACS is looking to expand the program, particularly beyond Veterans Affairs hospitals, said Dr. Richardson, professor and vice chairman of surgery at the University of Louisville (Ky.). The collaborative model is a way to spread the cost, so it may entice more participants, he said.

"This is a provocative paper because it should provoke us to follow suit," Dr. Joseph J. Tepas III, professor of surgery at the University of Florida, Jacksonville, said in his discussion of the paper. "This report demonstrates that this engine of quality, fueled by real-time clinical data, produces results that are understandable to the nonphysician public."

He added that just participating in NSQIP likely improved the hospitals’ quality. "The power of NSQIP is, first, in its surveillance, and this is what’s so well demonstrated here," he said.

Dr. Tepas, Dr. Richardson, and several other discussants asked why there had been improvement in some clinical areas but not in others. Was this perhaps a change in surgical leadership, or – as Dr. Cofer suggested – the Hawthorne effect (that is, the tendency of outcomes to improve when participants – in this case, hospitals and surgeons – know they are being monitored)?

Lead author Dr. Oscar Guillamondegui had an answer: "There have been no real changes in leadership at any of these hospitals, but if you think about the cost of putting together a NSQIP program – other than for the large hospitals – for many of these hospitals, it’s a bottom-line item that’s not insubstantial," he said. "Most hospitals will push to have improvement of care just based on the fact they’re putting that kind of funding into a system," said Dr. Guillamondegui of the division of trauma and surgical critical care at Vanderbilt University Medical Center. He also surmised that the Hawthorne effect may have played a part.

Some outcomes got worse, likely because of natural variations, but also because NSQIP definitions are strict and include a 30-day window, he said. For instance, more than half of urinary tract infections happen outside the hospital, but if they occur within 30 days of admission, they fall within the NSQIP 30-day morbidity outcome window.

Going forward, sustaining such collaboratives could be difficult, said Dr. Guillamondegui. "If you have a weak surgeon champion, then the program does nothing," especially if data are not being shared with other surgeons or the hospital administration. "If your culture isn’t capable of sustaining this, it will fail."

Dr. Cofer, Dr. Tepas, and Dr. Guillamondegui reported no conflicts. Dr. Richardson chairs the ACS NSQIP committee.

HOT SPRINGS, VA. – A collaboration among 10 hospitals in Tennessee has produced a boost in quality of care while also saving millions of dollars.

The collaboration first got started in 2005, when the three initial participants – Erlanger Medical Center in Chattanooga, Vanderbilt University Medical Center in Nashville, and St. Francis Hospital–Memphis – took inspiration from the rollout of the American College of Surgeons’ National Surgical Quality Improvement Project (NSQIP), said Dr. Joseph B. Cofer, a professor of surgery at the University of Tennessee, Chattanooga.

A successful run so far has led BlueCross Blue Shield of Tennessee (which has bankrolled the operation) to extend its funding through 2012 for the 10 hospitals that are currently participating, said Dr. Cofer. And it made funds available for an additional 11 hospitals to join, which would bring the total to 21.

With data now complete for 2009 and 2010, the Tennessee Surgical Quality Collaborative reported that postoperative mortality was not statistically significantly different from the first year (2.32%, or 232/10,000) to the second year (2.38%, or 237/10,000).

However, significant declines in postoperative complications in five areas – acute renal failure (25% drop), graft/flap failure (60% drop), ventilation for more than 48 hours (15% drop), superficial incisional surgical-site infection (19% drop), and wound disruption (34% drop) – resulted in total savings of $4.47 million.

At the same time, increases in postoperative complications in three areas – urinary tract infection (42% rise), pneumonia (23% rise), and deep vein thrombosis (35% rise) – cost $2.1 million.

Overall, the savings were at least $2 million for the 10 participating hospitals, said Dr. Cofer. But that number reflects only a sampling of cases from the 10 hospitals; if all the cases had been included, "we can reliably say we probably avoided about $8 million in costs over this year," Dr. Cofer said.

"Why this happened, we don’t know," he added. It’s possible that just being part of the NSQIP process improves monitoring and outcomes.

The Tennessee collaborative is now identifying exemplar hospitals and "sending out teams to dissect how they did it so well," Dr. Cofer said. Then, those best practices will be disseminated to other hospitals in the collaborative.

The collaboration would not likely have been possible without the participation of BlueCross BlueShield of Tennessee. Dr. Cofer spearheaded the talks with the insurer, which began in 2006 and culminated in a three-way partnership among the Blues, the Tennessee chapter of the ACS, and the Tennessee Hospital Association. In 2008, the Blues announced that it was giving the collaboration $2.5 million over the next 3 years to fund the collaborative.

Another crucial element was the leadership committee, said Dr. Cofer. Of the seven committee members, four are surgeons, two are hospital CEOs, and one is a staff person from the Tennessee Hospital Association. Data cannot be released without permission of the committee, and, so far, specific data are not being shared.

Dr. J. David Richardson, a discussant and chairman of the NSQIP committee at ACS, said, "it takes a tremendous effort to put a group like this together," adding that "within the ACS, I think we’ve all been heartened by the initiative taken by the Tennessee chapter in developing this program." The ACS is looking to expand the program, particularly beyond Veterans Affairs hospitals, said Dr. Richardson, professor and vice chairman of surgery at the University of Louisville (Ky.). The collaborative model is a way to spread the cost, so it may entice more participants, he said.

"This is a provocative paper because it should provoke us to follow suit," Dr. Joseph J. Tepas III, professor of surgery at the University of Florida, Jacksonville, said in his discussion of the paper. "This report demonstrates that this engine of quality, fueled by real-time clinical data, produces results that are understandable to the nonphysician public."

He added that just participating in NSQIP likely improved the hospitals’ quality. "The power of NSQIP is, first, in its surveillance, and this is what’s so well demonstrated here," he said.

Dr. Tepas, Dr. Richardson, and several other discussants asked why there had been improvement in some clinical areas but not in others. Was this perhaps a change in surgical leadership, or – as Dr. Cofer suggested – the Hawthorne effect (that is, the tendency of outcomes to improve when participants – in this case, hospitals and surgeons – know they are being monitored)?

Lead author Dr. Oscar Guillamondegui had an answer: "There have been no real changes in leadership at any of these hospitals, but if you think about the cost of putting together a NSQIP program – other than for the large hospitals – for many of these hospitals, it’s a bottom-line item that’s not insubstantial," he said. "Most hospitals will push to have improvement of care just based on the fact they’re putting that kind of funding into a system," said Dr. Guillamondegui of the division of trauma and surgical critical care at Vanderbilt University Medical Center. He also surmised that the Hawthorne effect may have played a part.

Some outcomes got worse, likely because of natural variations, but also because NSQIP definitions are strict and include a 30-day window, he said. For instance, more than half of urinary tract infections happen outside the hospital, but if they occur within 30 days of admission, they fall within the NSQIP 30-day morbidity outcome window.

Going forward, sustaining such collaboratives could be difficult, said Dr. Guillamondegui. "If you have a weak surgeon champion, then the program does nothing," especially if data are not being shared with other surgeons or the hospital administration. "If your culture isn’t capable of sustaining this, it will fail."

Dr. Cofer, Dr. Tepas, and Dr. Guillamondegui reported no conflicts. Dr. Richardson chairs the ACS NSQIP committee.

HOT SPRINGS, VA. – An analysis of a prospectively collected database indicates that breast cancer patients with multiple nodal disease need a metastatic work-up only if they have tumor grade 3 or 4.

Current NCCN (National Comprehensive Cancer Network) guidelines recommend that patients with stage III and node-positive disease receive a work-up if they are N1. But the NCCN guidelines are less clear about what to do about N2 and N3 patients, said Dr. Quyen Chu at the annual meeting of the Southern Surgical Association.

About 20% of patients with stage III disease will have distant metastases, said Dr. Chu, chief of the surgical oncology division at Louisiana State University Health Sciences Center, Shreveport.

He and his colleagues at LSU extracted data from an ongoing, prospective breast cancer database, which was created in 1998 and comprises patient experience primarily from the LSU center but also from E.A. Conway Hospital in Monroe, La. They analyzed 256 patients with N2 or N3 disease who began treatment in 2010.

There was little difference between the two groups. The mean age of the 158 N2 patients was 58 years; it was 57 for the 68 N3 patients. The mean tumor grade was 2.5, and the mean tumor size was 4.6 cm. The tumor stage was similar between the two groups, with about 40% overall staged at T2.

"Are we risking an observation based on the play of chance?"

About half of the tumors were estrogen receptor positive overall. There was no difference in estrogen receptor status between the two groups. But more of the N3 patients had HER2-positive tumors, at 43% (31 of 72 patients), compared with 26% (27 of 103 patients) for the N2 group.

The primary end point for the study was the incidence of stage IV disease, either at the time of diagnosis or within 30 days of surgery. Patients underwent bone scans, CT, and/or PET to detect metastases.

Unexpectedly, the researchers found two T0 patients and 35 T1 patients who had stage III metastatic disease. The overall risk of stage IV disease was 16%. In all, 6% of T2 patients had stage IV disease, compared with 22% of T3 patients and 36% of T3 patients.

By N stage, about 83% of N2 and N3 patients had stage III disease, whereas 15% of each group had stage IV disease.

There was no difference in overall survival between the N2 and N3 groups, but those with stage IV disease had a predictably and statistically significant lower overall survival. Using a Cox proportional hazard model, the researchers determined that the only significant predictors of survival were T stage and grade.

Commenting on the paper, Dr. William C. Wood said that Dr. Chu’s observations were "unique," and that the data might help clinicians to more accurately judge tumor progression. "The rate of progression is very important to prognosis," said Dr. Wood, professor of surgery at Emory University in Atlanta. He cautioned, however, that the data set was small. Given that there was no difference in prognosis among the N2 and N3 groups, he asked, "Are we risking an observation based on the play of chance?"

Dr. Wood also suggested that there might not be any utility to identifying patients who had asymptomatic stage IV disease. Staging studies could be avoided, along with potential false positives, and the decision to not identify such patients "could avoid a longer period [of] awareness of stage IV disease in a person who could otherwise be blissfully unaware," he said.

Dr. Chu agreed that this was a valid question. But he suggested that newer agents and aggressive surgical intervention have been shown recently to potentially extend survival in stage IV disease.

Several other commentators wondered if the findings had prompted any change at LSU. "This paper by no means suggests we should change our standard of care," said Dr. Chu. It might prompt some review of the role of different imaging modalities used, he noted. And he added that the study should cause clinicians to question the biology of breast cancer.

"A lot of us have the preconceived notion that if you have N2 or N3 disease, [the] outcome is very bad. But in actuality, it may not be the case," he said. "You may have a subset [of patients] who do quite well, who are true stage III rather than stage IV."

Dr. Chu reported no conflicts.

HOT SPRINGS, VA. – An analysis of a prospectively collected database indicates that breast cancer patients with multiple nodal disease need a metastatic work-up only if they have tumor grade 3 or 4.

Current NCCN (National Comprehensive Cancer Network) guidelines recommend that patients with stage III and node-positive disease receive a work-up if they are N1. But the NCCN guidelines are less clear about what to do about N2 and N3 patients, said Dr. Quyen Chu at the annual meeting of the Southern Surgical Association.

About 20% of patients with stage III disease will have distant metastases, said Dr. Chu, chief of the surgical oncology division at Louisiana State University Health Sciences Center, Shreveport.

He and his colleagues at LSU extracted data from an ongoing, prospective breast cancer database, which was created in 1998 and comprises patient experience primarily from the LSU center but also from E.A. Conway Hospital in Monroe, La. They analyzed 256 patients with N2 or N3 disease who began treatment in 2010.

There was little difference between the two groups. The mean age of the 158 N2 patients was 58 years; it was 57 for the 68 N3 patients. The mean tumor grade was 2.5, and the mean tumor size was 4.6 cm. The tumor stage was similar between the two groups, with about 40% overall staged at T2.

"Are we risking an observation based on the play of chance?"

About half of the tumors were estrogen receptor positive overall. There was no difference in estrogen receptor status between the two groups. But more of the N3 patients had HER2-positive tumors, at 43% (31 of 72 patients), compared with 26% (27 of 103 patients) for the N2 group.

The primary end point for the study was the incidence of stage IV disease, either at the time of diagnosis or within 30 days of surgery. Patients underwent bone scans, CT, and/or PET to detect metastases.

Unexpectedly, the researchers found two T0 patients and 35 T1 patients who had stage III metastatic disease. The overall risk of stage IV disease was 16%. In all, 6% of T2 patients had stage IV disease, compared with 22% of T3 patients and 36% of T3 patients.

By N stage, about 83% of N2 and N3 patients had stage III disease, whereas 15% of each group had stage IV disease.

There was no difference in overall survival between the N2 and N3 groups, but those with stage IV disease had a predictably and statistically significant lower overall survival. Using a Cox proportional hazard model, the researchers determined that the only significant predictors of survival were T stage and grade.

Commenting on the paper, Dr. William C. Wood said that Dr. Chu’s observations were "unique," and that the data might help clinicians to more accurately judge tumor progression. "The rate of progression is very important to prognosis," said Dr. Wood, professor of surgery at Emory University in Atlanta. He cautioned, however, that the data set was small. Given that there was no difference in prognosis among the N2 and N3 groups, he asked, "Are we risking an observation based on the play of chance?"

Dr. Wood also suggested that there might not be any utility to identifying patients who had asymptomatic stage IV disease. Staging studies could be avoided, along with potential false positives, and the decision to not identify such patients "could avoid a longer period [of] awareness of stage IV disease in a person who could otherwise be blissfully unaware," he said.

Dr. Chu agreed that this was a valid question. But he suggested that newer agents and aggressive surgical intervention have been shown recently to potentially extend survival in stage IV disease.

Several other commentators wondered if the findings had prompted any change at LSU. "This paper by no means suggests we should change our standard of care," said Dr. Chu. It might prompt some review of the role of different imaging modalities used, he noted. And he added that the study should cause clinicians to question the biology of breast cancer.

"A lot of us have the preconceived notion that if you have N2 or N3 disease, [the] outcome is very bad. But in actuality, it may not be the case," he said. "You may have a subset [of patients] who do quite well, who are true stage III rather than stage IV."

Dr. Chu reported no conflicts.

HOT SPRINGS, VA. – An analysis of a prospectively collected database indicates that breast cancer patients with multiple nodal disease need a metastatic work-up only if they have tumor grade 3 or 4.

Current NCCN (National Comprehensive Cancer Network) guidelines recommend that patients with stage III and node-positive disease receive a work-up if they are N1. But the NCCN guidelines are less clear about what to do about N2 and N3 patients, said Dr. Quyen Chu at the annual meeting of the Southern Surgical Association.

About 20% of patients with stage III disease will have distant metastases, said Dr. Chu, chief of the surgical oncology division at Louisiana State University Health Sciences Center, Shreveport.

He and his colleagues at LSU extracted data from an ongoing, prospective breast cancer database, which was created in 1998 and comprises patient experience primarily from the LSU center but also from E.A. Conway Hospital in Monroe, La. They analyzed 256 patients with N2 or N3 disease who began treatment in 2010.

There was little difference between the two groups. The mean age of the 158 N2 patients was 58 years; it was 57 for the 68 N3 patients. The mean tumor grade was 2.5, and the mean tumor size was 4.6 cm. The tumor stage was similar between the two groups, with about 40% overall staged at T2.

"Are we risking an observation based on the play of chance?"

About half of the tumors were estrogen receptor positive overall. There was no difference in estrogen receptor status between the two groups. But more of the N3 patients had HER2-positive tumors, at 43% (31 of 72 patients), compared with 26% (27 of 103 patients) for the N2 group.

The primary end point for the study was the incidence of stage IV disease, either at the time of diagnosis or within 30 days of surgery. Patients underwent bone scans, CT, and/or PET to detect metastases.

Unexpectedly, the researchers found two T0 patients and 35 T1 patients who had stage III metastatic disease. The overall risk of stage IV disease was 16%. In all, 6% of T2 patients had stage IV disease, compared with 22% of T3 patients and 36% of T3 patients.

By N stage, about 83% of N2 and N3 patients had stage III disease, whereas 15% of each group had stage IV disease.

There was no difference in overall survival between the N2 and N3 groups, but those with stage IV disease had a predictably and statistically significant lower overall survival. Using a Cox proportional hazard model, the researchers determined that the only significant predictors of survival were T stage and grade.

Commenting on the paper, Dr. William C. Wood said that Dr. Chu’s observations were "unique," and that the data might help clinicians to more accurately judge tumor progression. "The rate of progression is very important to prognosis," said Dr. Wood, professor of surgery at Emory University in Atlanta. He cautioned, however, that the data set was small. Given that there was no difference in prognosis among the N2 and N3 groups, he asked, "Are we risking an observation based on the play of chance?"

Dr. Wood also suggested that there might not be any utility to identifying patients who had asymptomatic stage IV disease. Staging studies could be avoided, along with potential false positives, and the decision to not identify such patients "could avoid a longer period [of] awareness of stage IV disease in a person who could otherwise be blissfully unaware," he said.

Dr. Chu agreed that this was a valid question. But he suggested that newer agents and aggressive surgical intervention have been shown recently to potentially extend survival in stage IV disease.

Several other commentators wondered if the findings had prompted any change at LSU. "This paper by no means suggests we should change our standard of care," said Dr. Chu. It might prompt some review of the role of different imaging modalities used, he noted. And he added that the study should cause clinicians to question the biology of breast cancer.

"A lot of us have the preconceived notion that if you have N2 or N3 disease, [the] outcome is very bad. But in actuality, it may not be the case," he said. "You may have a subset [of patients] who do quite well, who are true stage III rather than stage IV."

Dr. Chu reported no conflicts.

NEW ORLEANS – Patient navigators are increasingly becoming a part of the medical landscape, especially in oncology, but their exact role needs to be better defined, delegates said at the American Medical Association’s interim meeting.

The delegates approved a report that outlines the organization’s current opinions on how navigators should be trained, how they should work with physicians and other providers, and where their responsibilities should begin and end.

The report from the AMA Council on Medical Service will essentially be a starting point for creating the organization’s policy on patient navigators.

Overall, the delegates approved a call for action for the AMA to work with the American College of Surgeons and other physician organizations "to ensure that patient navigators are free of bias, do not have any role in directing referrals, do not usurp the physician’s role in and responsibility for patient education or treatment planning, and act under the direction of the physician or physicians primarily responsible for each patient’s care."

The Council on Medical Service report found that patient navigator programs fall into four categories:

• Those focused on reducing health care disparities and increasing access to care.

• Those aimed at improving outcomes for a specific chronic condition.

• Those that try to make care more efficient and less costly.

• Those that help patients make their way through a complex health care system.

The programs are being adopted in many different clinical areas, and soon will get official government backing. In 2014, state health insurance exchanges – established as part of the Affordable Care Act – will start up. The exchanges have been directed to set up navigator programs that will give purchasers details on how to buy a health plan, as well as help with enrollment and dispute resolutions.

Training programs for patient navigators do exist, but are not widespread. The Society for Healthcare Consumer Advocacy, an offshoot of the American Hospital Association, offers a web-based certificate program. And some universities offer certificate programs or degrees in health advocacy.

The Council on Medical Service generally endorsed navigator programs, saying that they could enhance patient care. But it also recommended a set of principles to ensure that navigators stay in communication with the medical team; that they disclose training, experience, and potential conflicts; and that they refrain from making any clinical decisions or judgments.

Patient navigators can be a big help, especially when patients are overwhelmed by the system, said Dr. Mark V. Williams, chief of hospital medicine at Northwestern University, Chicago. Although hospitalists generally do not interact much with navigators, they are likely to in the future, he said. He added that he would like to see navigators integrated into primary care practices or medical homes to ensure that there is full coordination among all members of a health care team.

AMA delegates expressed concern that navigators could somehow undermine the physician’s role. And there was some worry that navigators might steer patients away from a particular physician, as well as discussion over whether navigators should act under the "direction" or the "supervision" of physicians in the clinical environment.

Dr. Chris Nunnink, a delegate representing the American Society of Clinical Oncology, said that the organization supported navigators because they helped underserved patients better access the system. But, the process needs to be "fair and transparent," said Dr. Nunnink, an oncologist at the Vermont Cancer Center, Colchester. He said he’d also had experiences where long-time patients had been steered to other systems or physicians by navigators.

That argues for better communication and the transparent process, he said.

Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, and a delegate from the American College of Physicians, said that the cancer society is "acutely aware of the issues raised here."

The goal of the ACS navigator program, however, was to help underserved patients get access, not steer them away from particular physicians, he said. "They need our help to get through this system, otherwise they fall through the cracks, they don’t get the care in a timely fashion, and they suffer as a result," he told the delegates.

One issue that comes up for many of the underserved patients is that they come into the system without a supervising physician, said Dr. Richard B. Reiling, medical director of the Presbyterian Cancer Center, Charlotte, N.C., and a delegate from the American College of Surgeons.

Dr. Reiling argued that the AMA should alter its report language to state that patients should be under the "direction," not the "supervision," of a physician. The delegates ultimately approved that change.

NEW ORLEANS – Patient navigators are increasingly becoming a part of the medical landscape, especially in oncology, but their exact role needs to be better defined, delegates said at the American Medical Association’s interim meeting.

The delegates approved a report that outlines the organization’s current opinions on how navigators should be trained, how they should work with physicians and other providers, and where their responsibilities should begin and end.

The report from the AMA Council on Medical Service will essentially be a starting point for creating the organization’s policy on patient navigators.

Overall, the delegates approved a call for action for the AMA to work with the American College of Surgeons and other physician organizations "to ensure that patient navigators are free of bias, do not have any role in directing referrals, do not usurp the physician’s role in and responsibility for patient education or treatment planning, and act under the direction of the physician or physicians primarily responsible for each patient’s care."

The Council on Medical Service report found that patient navigator programs fall into four categories:

• Those focused on reducing health care disparities and increasing access to care.

• Those aimed at improving outcomes for a specific chronic condition.

• Those that try to make care more efficient and less costly.

• Those that help patients make their way through a complex health care system.

The programs are being adopted in many different clinical areas, and soon will get official government backing. In 2014, state health insurance exchanges – established as part of the Affordable Care Act – will start up. The exchanges have been directed to set up navigator programs that will give purchasers details on how to buy a health plan, as well as help with enrollment and dispute resolutions.

Training programs for patient navigators do exist, but are not widespread. The Society for Healthcare Consumer Advocacy, an offshoot of the American Hospital Association, offers a web-based certificate program. And some universities offer certificate programs or degrees in health advocacy.

The Council on Medical Service generally endorsed navigator programs, saying that they could enhance patient care. But it also recommended a set of principles to ensure that navigators stay in communication with the medical team; that they disclose training, experience, and potential conflicts; and that they refrain from making any clinical decisions or judgments.

Patient navigators can be a big help, especially when patients are overwhelmed by the system, said Dr. Mark V. Williams, chief of hospital medicine at Northwestern University, Chicago. Although hospitalists generally do not interact much with navigators, they are likely to in the future, he said. He added that he would like to see navigators integrated into primary care practices or medical homes to ensure that there is full coordination among all members of a health care team.

AMA delegates expressed concern that navigators could somehow undermine the physician’s role. And there was some worry that navigators might steer patients away from a particular physician, as well as discussion over whether navigators should act under the "direction" or the "supervision" of physicians in the clinical environment.

Dr. Chris Nunnink, a delegate representing the American Society of Clinical Oncology, said that the organization supported navigators because they helped underserved patients better access the system. But, the process needs to be "fair and transparent," said Dr. Nunnink, an oncologist at the Vermont Cancer Center, Colchester. He said he’d also had experiences where long-time patients had been steered to other systems or physicians by navigators.

That argues for better communication and the transparent process, he said.

Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, and a delegate from the American College of Physicians, said that the cancer society is "acutely aware of the issues raised here."

The goal of the ACS navigator program, however, was to help underserved patients get access, not steer them away from particular physicians, he said. "They need our help to get through this system, otherwise they fall through the cracks, they don’t get the care in a timely fashion, and they suffer as a result," he told the delegates.

One issue that comes up for many of the underserved patients is that they come into the system without a supervising physician, said Dr. Richard B. Reiling, medical director of the Presbyterian Cancer Center, Charlotte, N.C., and a delegate from the American College of Surgeons.

Dr. Reiling argued that the AMA should alter its report language to state that patients should be under the "direction," not the "supervision," of a physician. The delegates ultimately approved that change.

NEW ORLEANS – Patient navigators are increasingly becoming a part of the medical landscape, especially in oncology, but their exact role needs to be better defined, delegates said at the American Medical Association’s interim meeting.

The delegates approved a report that outlines the organization’s current opinions on how navigators should be trained, how they should work with physicians and other providers, and where their responsibilities should begin and end.

The report from the AMA Council on Medical Service will essentially be a starting point for creating the organization’s policy on patient navigators.

Overall, the delegates approved a call for action for the AMA to work with the American College of Surgeons and other physician organizations "to ensure that patient navigators are free of bias, do not have any role in directing referrals, do not usurp the physician’s role in and responsibility for patient education or treatment planning, and act under the direction of the physician or physicians primarily responsible for each patient’s care."

The Council on Medical Service report found that patient navigator programs fall into four categories:

• Those focused on reducing health care disparities and increasing access to care.

• Those aimed at improving outcomes for a specific chronic condition.

• Those that try to make care more efficient and less costly.

• Those that help patients make their way through a complex health care system.

The programs are being adopted in many different clinical areas, and soon will get official government backing. In 2014, state health insurance exchanges – established as part of the Affordable Care Act – will start up. The exchanges have been directed to set up navigator programs that will give purchasers details on how to buy a health plan, as well as help with enrollment and dispute resolutions.

Training programs for patient navigators do exist, but are not widespread. The Society for Healthcare Consumer Advocacy, an offshoot of the American Hospital Association, offers a web-based certificate program. And some universities offer certificate programs or degrees in health advocacy.

The Council on Medical Service generally endorsed navigator programs, saying that they could enhance patient care. But it also recommended a set of principles to ensure that navigators stay in communication with the medical team; that they disclose training, experience, and potential conflicts; and that they refrain from making any clinical decisions or judgments.

Patient navigators can be a big help, especially when patients are overwhelmed by the system, said Dr. Mark V. Williams, chief of hospital medicine at Northwestern University, Chicago. Although hospitalists generally do not interact much with navigators, they are likely to in the future, he said. He added that he would like to see navigators integrated into primary care practices or medical homes to ensure that there is full coordination among all members of a health care team.

AMA delegates expressed concern that navigators could somehow undermine the physician’s role. And there was some worry that navigators might steer patients away from a particular physician, as well as discussion over whether navigators should act under the "direction" or the "supervision" of physicians in the clinical environment.

Dr. Chris Nunnink, a delegate representing the American Society of Clinical Oncology, said that the organization supported navigators because they helped underserved patients better access the system. But, the process needs to be "fair and transparent," said Dr. Nunnink, an oncologist at the Vermont Cancer Center, Colchester. He said he’d also had experiences where long-time patients had been steered to other systems or physicians by navigators.

That argues for better communication and the transparent process, he said.

Dr. Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, and a delegate from the American College of Physicians, said that the cancer society is "acutely aware of the issues raised here."

The goal of the ACS navigator program, however, was to help underserved patients get access, not steer them away from particular physicians, he said. "They need our help to get through this system, otherwise they fall through the cracks, they don’t get the care in a timely fashion, and they suffer as a result," he told the delegates.

One issue that comes up for many of the underserved patients is that they come into the system without a supervising physician, said Dr. Richard B. Reiling, medical director of the Presbyterian Cancer Center, Charlotte, N.C., and a delegate from the American College of Surgeons.

Dr. Reiling argued that the AMA should alter its report language to state that patients should be under the "direction," not the "supervision," of a physician. The delegates ultimately approved that change.

The U.S. Senate voted on Dec. 17 to put off by 2 months a Medicare physician pay cut due to take effect on Jan. 1.

The pay cut provision was included in a larger package that would extend unemployment benefits and a payroll tax cut. The Senate voted 89-19 to approve the package, just before it left Washington for a holiday recess.

But on Dec. 19, as the House came back into session, many congressmen said they would not support the package, mainly because it only provided 2 months of relief, rather than a year or longer. The House was scheduled to vote on the bill late on Dec. 19.

Similar legislation passed the House Dec. 13, but with a longer horizon: If enacted, that bill would replace the 27% cut with a 1% increase for 2 years.

If the House votes against approving the Senate bill, and the two houses cannot compromise before Jan. 1, physicians will see a 27% reduction in fees, as dictated by the Medicare Sustainable Growth Rate (SGR) formula.

The American Medical Association expressed disgust in a statement issued after the Senate vote.

"Waiting until the last week of the legislative session to address a problem that Congress knew was looming all year is not the way to conduct our nation’s business," AMA President Peter Carmel said in the statement.

The AMA called on Congress to stop instituting stop-gap fixes and to instead replace the SGR formula. "The 12 temporary patches that Congress has applied have raised the cost of solving the problem by more than 500% over the last few years and eroded patients’ access to care," said Dr. Carmel. "A permanent solution is the long overdue, fiscally responsible approach."

The U.S. Senate voted on Dec. 17 to put off by 2 months a Medicare physician pay cut due to take effect on Jan. 1.

The pay cut provision was included in a larger package that would extend unemployment benefits and a payroll tax cut. The Senate voted 89-19 to approve the package, just before it left Washington for a holiday recess.

But on Dec. 19, as the House came back into session, many congressmen said they would not support the package, mainly because it only provided 2 months of relief, rather than a year or longer. The House was scheduled to vote on the bill late on Dec. 19.

Similar legislation passed the House Dec. 13, but with a longer horizon: If enacted, that bill would replace the 27% cut with a 1% increase for 2 years.

If the House votes against approving the Senate bill, and the two houses cannot compromise before Jan. 1, physicians will see a 27% reduction in fees, as dictated by the Medicare Sustainable Growth Rate (SGR) formula.

The American Medical Association expressed disgust in a statement issued after the Senate vote.

"Waiting until the last week of the legislative session to address a problem that Congress knew was looming all year is not the way to conduct our nation’s business," AMA President Peter Carmel said in the statement.

The AMA called on Congress to stop instituting stop-gap fixes and to instead replace the SGR formula. "The 12 temporary patches that Congress has applied have raised the cost of solving the problem by more than 500% over the last few years and eroded patients’ access to care," said Dr. Carmel. "A permanent solution is the long overdue, fiscally responsible approach."

The U.S. Senate voted on Dec. 17 to put off by 2 months a Medicare physician pay cut due to take effect on Jan. 1.

The pay cut provision was included in a larger package that would extend unemployment benefits and a payroll tax cut. The Senate voted 89-19 to approve the package, just before it left Washington for a holiday recess.

But on Dec. 19, as the House came back into session, many congressmen said they would not support the package, mainly because it only provided 2 months of relief, rather than a year or longer. The House was scheduled to vote on the bill late on Dec. 19.

Similar legislation passed the House Dec. 13, but with a longer horizon: If enacted, that bill would replace the 27% cut with a 1% increase for 2 years.

If the House votes against approving the Senate bill, and the two houses cannot compromise before Jan. 1, physicians will see a 27% reduction in fees, as dictated by the Medicare Sustainable Growth Rate (SGR) formula.

The American Medical Association expressed disgust in a statement issued after the Senate vote.

"Waiting until the last week of the legislative session to address a problem that Congress knew was looming all year is not the way to conduct our nation’s business," AMA President Peter Carmel said in the statement.

The AMA called on Congress to stop instituting stop-gap fixes and to instead replace the SGR formula. "The 12 temporary patches that Congress has applied have raised the cost of solving the problem by more than 500% over the last few years and eroded patients’ access to care," said Dr. Carmel. "A permanent solution is the long overdue, fiscally responsible approach."

WASHINGTON – As a Senate committee held a hearing Dec. 15 on the continuing drug shortage problem, the Food and Drug Administration announced that it would require some manufacturers to give the agency early warning of an imminent shortage.

The agency issued an interim final rule in response to President Obama’s Oct. 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product "to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition," according to a press release from the Department of Health and Human Services.

Alicia Ault/Elsevier Global Medical News

Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, said at the Health, Education, Labor and Pensions (HELP) committee hearing that the agency has been busy since that Oct. 31 order, among other things, reminding drug makers of their legal duty to report, in some instances, impending supply problems.

"Our efforts are having an effect," said Dr. Kweder. She noted that the agency used to receive about 10 notifications a month of a potential shortage, and that since late October it has received 61 notifications. The agency has monitored 220 shortages since January 2011, and has prevented 96, she said.

Dr. Kweder said the agency had averted shortages by helping manufacturers get supplies of critical ingredients, by helping them change manufacturing processes, or by going to competitors and encouraging them to ramp up production of the drug that is in short supply. She noted that the FDA had recently worked with generic drug maker Teva to get its doxorubicin production on-line again, and had also approved Pfizer as a new maker of that chemotherapy drug.

The U.S. General Accounting Office issued a new report at the hearing that urged Congress to require all manufacturers to report potential supply issues to the FDA.

"Because FDA usually doesn’t know about a shortage until it is well under way, the agency’s approach to managing drug shortages is predominately reactive," said Marcia Crosse, director of health care at the GAO. The agency has been able to prevent shortages when it knows in advance that there will be a problem, she said.

The GAO found that the agency does not maintain a database on shortages. That means it can’t track trends or create effective strategies, said Ms. Crosse. The agency does have the power to expedite reviews of generic drug applications, but currently has a backlog of 8,000 applications, said Ms. Crosse.

Several Republican members of the Senate HELP committee questioned whether the agency was doing all it could to ease that backlog. Ms. Crosse said that the FDA had expedited hundreds of applications, but that it could not say whether any were completed in time to help resolve any particular shortage.

Alicia Ault/Elsevier Global Medical News

Sen. Richard Blumenthal (D-Conn.) suggested that some of the shortages might be due to a lack of competition in the generic injectable industry. Data presented by market research company IMS Health shows that more than 82% of the products in short supply over the last 5 years were generic injectables. "I will be proposing more aggressive measures that are necessary to crack down on what appear to be anticonsumer practices," said Sen. Blumenthal, a former attorney general of Connecticut.

"The shortages are creating a public health menace," he said, adding that he’s considering whether to direct the Department of Justice or the Federal Trade Commission to investigate what he called "astonishing and appalling markups" for drugs in short supply.

The generic industry responded with a new initiative, which it announced at the hearing. The Accelerated Recovery Initiative includes manufacturers who represent 80% of the generic injectable market. They are proposing to provide more timely assessments of shortages and "establish practices that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage," according to testimony by Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The initiative does have to be approved by the Federal Trade Commission and the Department of Health and Human Services, said Mr. Neas.

WASHINGTON – As a Senate committee held a hearing Dec. 15 on the continuing drug shortage problem, the Food and Drug Administration announced that it would require some manufacturers to give the agency early warning of an imminent shortage.

The agency issued an interim final rule in response to President Obama’s Oct. 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product "to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition," according to a press release from the Department of Health and Human Services.

Alicia Ault/Elsevier Global Medical News

Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, said at the Health, Education, Labor and Pensions (HELP) committee hearing that the agency has been busy since that Oct. 31 order, among other things, reminding drug makers of their legal duty to report, in some instances, impending supply problems.

"Our efforts are having an effect," said Dr. Kweder. She noted that the agency used to receive about 10 notifications a month of a potential shortage, and that since late October it has received 61 notifications. The agency has monitored 220 shortages since January 2011, and has prevented 96, she said.

Dr. Kweder said the agency had averted shortages by helping manufacturers get supplies of critical ingredients, by helping them change manufacturing processes, or by going to competitors and encouraging them to ramp up production of the drug that is in short supply. She noted that the FDA had recently worked with generic drug maker Teva to get its doxorubicin production on-line again, and had also approved Pfizer as a new maker of that chemotherapy drug.

The U.S. General Accounting Office issued a new report at the hearing that urged Congress to require all manufacturers to report potential supply issues to the FDA.

"Because FDA usually doesn’t know about a shortage until it is well under way, the agency’s approach to managing drug shortages is predominately reactive," said Marcia Crosse, director of health care at the GAO. The agency has been able to prevent shortages when it knows in advance that there will be a problem, she said.

The GAO found that the agency does not maintain a database on shortages. That means it can’t track trends or create effective strategies, said Ms. Crosse. The agency does have the power to expedite reviews of generic drug applications, but currently has a backlog of 8,000 applications, said Ms. Crosse.

Several Republican members of the Senate HELP committee questioned whether the agency was doing all it could to ease that backlog. Ms. Crosse said that the FDA had expedited hundreds of applications, but that it could not say whether any were completed in time to help resolve any particular shortage.

Alicia Ault/Elsevier Global Medical News

Sen. Richard Blumenthal (D-Conn.) suggested that some of the shortages might be due to a lack of competition in the generic injectable industry. Data presented by market research company IMS Health shows that more than 82% of the products in short supply over the last 5 years were generic injectables. "I will be proposing more aggressive measures that are necessary to crack down on what appear to be anticonsumer practices," said Sen. Blumenthal, a former attorney general of Connecticut.

"The shortages are creating a public health menace," he said, adding that he’s considering whether to direct the Department of Justice or the Federal Trade Commission to investigate what he called "astonishing and appalling markups" for drugs in short supply.

The generic industry responded with a new initiative, which it announced at the hearing. The Accelerated Recovery Initiative includes manufacturers who represent 80% of the generic injectable market. They are proposing to provide more timely assessments of shortages and "establish practices that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage," according to testimony by Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The initiative does have to be approved by the Federal Trade Commission and the Department of Health and Human Services, said Mr. Neas.

WASHINGTON – As a Senate committee held a hearing Dec. 15 on the continuing drug shortage problem, the Food and Drug Administration announced that it would require some manufacturers to give the agency early warning of an imminent shortage.

The agency issued an interim final rule in response to President Obama’s Oct. 31 Executive Order asking the agency to use its existing authority to address the shortage issue. The rule would require manufacturers who are the only suppliers of a product "to report to the FDA all interruptions in manufacturing of products that are life supporting, life sustaining, or intended for use in the prevention of a debilitating disease or condition," according to a press release from the Department of Health and Human Services.

Alicia Ault/Elsevier Global Medical News

Dr. Sandra Kweder, deputy director of the FDA’s Office of New Drugs, said at the Health, Education, Labor and Pensions (HELP) committee hearing that the agency has been busy since that Oct. 31 order, among other things, reminding drug makers of their legal duty to report, in some instances, impending supply problems.

"Our efforts are having an effect," said Dr. Kweder. She noted that the agency used to receive about 10 notifications a month of a potential shortage, and that since late October it has received 61 notifications. The agency has monitored 220 shortages since January 2011, and has prevented 96, she said.

Dr. Kweder said the agency had averted shortages by helping manufacturers get supplies of critical ingredients, by helping them change manufacturing processes, or by going to competitors and encouraging them to ramp up production of the drug that is in short supply. She noted that the FDA had recently worked with generic drug maker Teva to get its doxorubicin production on-line again, and had also approved Pfizer as a new maker of that chemotherapy drug.

The U.S. General Accounting Office issued a new report at the hearing that urged Congress to require all manufacturers to report potential supply issues to the FDA.

"Because FDA usually doesn’t know about a shortage until it is well under way, the agency’s approach to managing drug shortages is predominately reactive," said Marcia Crosse, director of health care at the GAO. The agency has been able to prevent shortages when it knows in advance that there will be a problem, she said.

The GAO found that the agency does not maintain a database on shortages. That means it can’t track trends or create effective strategies, said Ms. Crosse. The agency does have the power to expedite reviews of generic drug applications, but currently has a backlog of 8,000 applications, said Ms. Crosse.

Several Republican members of the Senate HELP committee questioned whether the agency was doing all it could to ease that backlog. Ms. Crosse said that the FDA had expedited hundreds of applications, but that it could not say whether any were completed in time to help resolve any particular shortage.

Alicia Ault/Elsevier Global Medical News

Sen. Richard Blumenthal (D-Conn.) suggested that some of the shortages might be due to a lack of competition in the generic injectable industry. Data presented by market research company IMS Health shows that more than 82% of the products in short supply over the last 5 years were generic injectables. "I will be proposing more aggressive measures that are necessary to crack down on what appear to be anticonsumer practices," said Sen. Blumenthal, a former attorney general of Connecticut.

"The shortages are creating a public health menace," he said, adding that he’s considering whether to direct the Department of Justice or the Federal Trade Commission to investigate what he called "astonishing and appalling markups" for drugs in short supply.

The generic industry responded with a new initiative, which it announced at the hearing. The Accelerated Recovery Initiative includes manufacturers who represent 80% of the generic injectable market. They are proposing to provide more timely assessments of shortages and "establish practices that allow for potential, voluntary production adjustments to lessen or eliminate the impact of a current shortage," according to testimony by Ralph Neas, president and CEO of the Generic Pharmaceutical Association.

The initiative does have to be approved by the Federal Trade Commission and the Department of Health and Human Services, said Mr. Neas.