Alicia Ault

Medicare will decrease reimbursement by 3%–9% in 2007 for implantation of various neurological devices under a final rule issued in early November.

The cuts are included in the Hospital Outpatient Prospective Payment System rule for 2007. Not much has changed since the Centers for Medicare and Medicaid Services (CMS) first proposed the rule in August, so surprises are few.

Although CMS will increase the overall payments to hospitals—averaging a 3% rise for outpatient services—some procedures are slated for cuts, primarily those involving neurologic devices.

With the 3% increase, Medicare will pay at least $32 billion to hospitals for outpatient procedures in 2007.

The agency has expressed concern that outpatient costs are rising precipitously—an estimated 12% in 2005 and 9% in 2007—mostly because of growth in volume and intensity of services. The increase in costs affects not only Medicare's overall budget but also seniors who, with 25% copayments for outpatient services, will face increasingly larger out-of-pocket burdens, said CMS.

The agency said it will reduce payments for implantation of a neurostimulator by 7% to $11,500 for 2007. CMS has reduced its payments for neurostimulator implantation each of the last 2 years. And, whereas CMS has generally increased payments for implantation of the lead and electrodes that are attached to the stimulators, in 2007, the agency is reducing coverage by 10% from $14,900 to $13,500.

Other procedures will be getting a boost, including implantation of drug infusion reservoirs (60% increase), drug infusion devices (16% increase), and pain management catheters (11% increase).

Finally, hospitals will not have to begin reporting on outpatient quality in 2007. CMS lifted that requirement, which was proposed in the initial rule and would have required reporting on certain measures in order to receive the increase in overall payments. Instead, the agency has postponed that requirement until 2009. In the meantime, CMS will develop outpatient-specific quality measures.

The American Hospital Association applauded the delay. “The AHA is pleased that CMS will develop quality measures specifically for the outpatient setting and has correctly given hospitals ample time to implement a reporting system for hospital outpatient services,” AHA executive vice president Rick Pollack said in a statement.

Medicare will decrease reimbursement by 3%–9% in 2007 for implantation of various neurological devices under a final rule issued in early November.

The cuts are included in the Hospital Outpatient Prospective Payment System rule for 2007. Not much has changed since the Centers for Medicare and Medicaid Services (CMS) first proposed the rule in August, so surprises are few.

Although CMS will increase the overall payments to hospitals—averaging a 3% rise for outpatient services—some procedures are slated for cuts, primarily those involving neurologic devices.

With the 3% increase, Medicare will pay at least $32 billion to hospitals for outpatient procedures in 2007.

The agency has expressed concern that outpatient costs are rising precipitously—an estimated 12% in 2005 and 9% in 2007—mostly because of growth in volume and intensity of services. The increase in costs affects not only Medicare's overall budget but also seniors who, with 25% copayments for outpatient services, will face increasingly larger out-of-pocket burdens, said CMS.

The agency said it will reduce payments for implantation of a neurostimulator by 7% to $11,500 for 2007. CMS has reduced its payments for neurostimulator implantation each of the last 2 years. And, whereas CMS has generally increased payments for implantation of the lead and electrodes that are attached to the stimulators, in 2007, the agency is reducing coverage by 10% from $14,900 to $13,500.

Other procedures will be getting a boost, including implantation of drug infusion reservoirs (60% increase), drug infusion devices (16% increase), and pain management catheters (11% increase).

Finally, hospitals will not have to begin reporting on outpatient quality in 2007. CMS lifted that requirement, which was proposed in the initial rule and would have required reporting on certain measures in order to receive the increase in overall payments. Instead, the agency has postponed that requirement until 2009. In the meantime, CMS will develop outpatient-specific quality measures.

The American Hospital Association applauded the delay. “The AHA is pleased that CMS will develop quality measures specifically for the outpatient setting and has correctly given hospitals ample time to implement a reporting system for hospital outpatient services,” AHA executive vice president Rick Pollack said in a statement.

Medicare will decrease reimbursement by 3%–9% in 2007 for implantation of various neurological devices under a final rule issued in early November.

The cuts are included in the Hospital Outpatient Prospective Payment System rule for 2007. Not much has changed since the Centers for Medicare and Medicaid Services (CMS) first proposed the rule in August, so surprises are few.

Although CMS will increase the overall payments to hospitals—averaging a 3% rise for outpatient services—some procedures are slated for cuts, primarily those involving neurologic devices.

With the 3% increase, Medicare will pay at least $32 billion to hospitals for outpatient procedures in 2007.

The agency has expressed concern that outpatient costs are rising precipitously—an estimated 12% in 2005 and 9% in 2007—mostly because of growth in volume and intensity of services. The increase in costs affects not only Medicare's overall budget but also seniors who, with 25% copayments for outpatient services, will face increasingly larger out-of-pocket burdens, said CMS.

The agency said it will reduce payments for implantation of a neurostimulator by 7% to $11,500 for 2007. CMS has reduced its payments for neurostimulator implantation each of the last 2 years. And, whereas CMS has generally increased payments for implantation of the lead and electrodes that are attached to the stimulators, in 2007, the agency is reducing coverage by 10% from $14,900 to $13,500.

Other procedures will be getting a boost, including implantation of drug infusion reservoirs (60% increase), drug infusion devices (16% increase), and pain management catheters (11% increase).

Finally, hospitals will not have to begin reporting on outpatient quality in 2007. CMS lifted that requirement, which was proposed in the initial rule and would have required reporting on certain measures in order to receive the increase in overall payments. Instead, the agency has postponed that requirement until 2009. In the meantime, CMS will develop outpatient-specific quality measures.

The American Hospital Association applauded the delay. “The AHA is pleased that CMS will develop quality measures specifically for the outpatient setting and has correctly given hospitals ample time to implement a reporting system for hospital outpatient services,” AHA executive vice president Rick Pollack said in a statement.

Depression Guidance Needed

Heart disease patients are often depressed, and at an increased risk of events, and yet cardiologists don't have guidance to help them identify and treat depressed patients, according to a new report by a National Heart, Lung, and Blood Institute task force, “Assessment and Treatment of Depression in Patients With Cardiovascular Disease.” The group outlined treatment options and made recommendations on how to more uniformly assess depression. Most therapies found to be effective in patients without heart disease “will likely also reduce depression in [coronary heart disease] patients,” said the report. The panel also recommended randomized trials to assess whether drug therapy or psychotherapy can reduce the risk of cardiovascular disease events and mortality associated with depression in heart disease patients.

Triglyceride Danger Not Understood

Americans—even those under a physician's care for dyslipidemia or diabetes—are unaware of the dangers posed by triglycerides, according to a Harris Interactive survey conducted for the National Lipid Association. Harris queried 2,089 adults and 510 physicians—205 primary care physicians, 155 cardiologists, and 150 endocrinologists. One in five consumers said they were knowledgeable about lipids, but fewer than one in five knew the safe levels of LDL cholesterol, HDL cholesterol, and triglycerides. One-fifth said they were the ones who initiated a discussion about lipids, and that most physician discussions lasted less than 5 minutes; fewer than one-third said the talks were “clear.” Physicians, however, believed they were the initiators. Triglycerides are discussed less than any other lipid topic, the survey found.

J&J Suit on Guidant Sale

Johnson & Johnson is suing Boston Scientific, seeking $5.5 billion in damages relating to Boston Scientific's acquisition of Guidant. J&J had been a Guidant suitor. The lawsuit was filed in the U.S. District Court for Southern New York and alleges that Guidant leaked confidential information that allowed Boston Scientific to make a superior offer to the J&J bid. The suit also names Abbott Laboratories, which it says was a party to the leak, allowing it to separately purchase Guidant's vascular and endovascular businesses. Boston Scientific completed its $27 billion purchase of the rest of Guidant's business in April. In a statement, Boston Scientific senior vice president Paul Donovan said the suit is without merit, adding, “Throughout this process, we complied with all the terms of the J&J/Guidant merger agreement.”

Reporting on Quality

More than 3,300 hospitals around the country have reported data on quality measures to Medicare and consumers, according to the Centers for Medicare and Medicaid Services. Of the 3,490 acute care hospitals eligible to participate in the federal program that links payments to hospitals to reporting of quality measures, 99% opted to report data. Under the program, hospitals that submit quality information to CMS are eligible to receive the full 2% payment update for inpatient services in 2007 under Medicare, while those who do not report will see a 2% payment reduction next year. “This is more evidence that paying for reporting and improving quality can help patients get better care,” Dr. Mark McClellan, outgoing CMS administrator said in a statement. “Consumers can use this information to evaluate care and doctors and hospitals can use it to help improve their performance.” For 2007, CMS officials have added 11 measures for hospital reporting, bringing the total number of hospital performance measures to 21.

Low Physician E-Mail Use

Physicians are rarely using e-mail to communicate with patients, according to one study, and yet, patients overwhelmingly say they'd like to use the technology to talk with their doctors and receive test results, according to a poll. The Center for Studying Health System Change found that only 24% of physicians used e-mail to discuss a clinical issue with a patient during 2004–2005, a 4% increase from the previous study in 2000–2001. Almost half of physicians in academic and staff or group HMO practices use e-mail for clinical discussions, compared with 20% in practices of 10 or fewer. Physicians in nonmetropolitan areas, or who have large numbers of Medicaid and/or Medicare patients, are less likely to use e-mail because of patients' lack of access to the technology. Reasons for not using e-mail include lack of reimbursement for consultations, cost of implementing a secure system, and fears that e-mail will add to workloads. A recent Wall Street Journal-Harris Interactive poll of 2,624 adults found that 74% want to communicate directly with doctors by e-mail and 67% said they want to receive test results by e-mail.

Depression Guidance Needed

Heart disease patients are often depressed, and at an increased risk of events, and yet cardiologists don't have guidance to help them identify and treat depressed patients, according to a new report by a National Heart, Lung, and Blood Institute task force, “Assessment and Treatment of Depression in Patients With Cardiovascular Disease.” The group outlined treatment options and made recommendations on how to more uniformly assess depression. Most therapies found to be effective in patients without heart disease “will likely also reduce depression in [coronary heart disease] patients,” said the report. The panel also recommended randomized trials to assess whether drug therapy or psychotherapy can reduce the risk of cardiovascular disease events and mortality associated with depression in heart disease patients.

Triglyceride Danger Not Understood

Americans—even those under a physician's care for dyslipidemia or diabetes—are unaware of the dangers posed by triglycerides, according to a Harris Interactive survey conducted for the National Lipid Association. Harris queried 2,089 adults and 510 physicians—205 primary care physicians, 155 cardiologists, and 150 endocrinologists. One in five consumers said they were knowledgeable about lipids, but fewer than one in five knew the safe levels of LDL cholesterol, HDL cholesterol, and triglycerides. One-fifth said they were the ones who initiated a discussion about lipids, and that most physician discussions lasted less than 5 minutes; fewer than one-third said the talks were “clear.” Physicians, however, believed they were the initiators. Triglycerides are discussed less than any other lipid topic, the survey found.

J&J Suit on Guidant Sale

Johnson & Johnson is suing Boston Scientific, seeking $5.5 billion in damages relating to Boston Scientific's acquisition of Guidant. J&J had been a Guidant suitor. The lawsuit was filed in the U.S. District Court for Southern New York and alleges that Guidant leaked confidential information that allowed Boston Scientific to make a superior offer to the J&J bid. The suit also names Abbott Laboratories, which it says was a party to the leak, allowing it to separately purchase Guidant's vascular and endovascular businesses. Boston Scientific completed its $27 billion purchase of the rest of Guidant's business in April. In a statement, Boston Scientific senior vice president Paul Donovan said the suit is without merit, adding, “Throughout this process, we complied with all the terms of the J&J/Guidant merger agreement.”

Reporting on Quality

More than 3,300 hospitals around the country have reported data on quality measures to Medicare and consumers, according to the Centers for Medicare and Medicaid Services. Of the 3,490 acute care hospitals eligible to participate in the federal program that links payments to hospitals to reporting of quality measures, 99% opted to report data. Under the program, hospitals that submit quality information to CMS are eligible to receive the full 2% payment update for inpatient services in 2007 under Medicare, while those who do not report will see a 2% payment reduction next year. “This is more evidence that paying for reporting and improving quality can help patients get better care,” Dr. Mark McClellan, outgoing CMS administrator said in a statement. “Consumers can use this information to evaluate care and doctors and hospitals can use it to help improve their performance.” For 2007, CMS officials have added 11 measures for hospital reporting, bringing the total number of hospital performance measures to 21.

Low Physician E-Mail Use

Physicians are rarely using e-mail to communicate with patients, according to one study, and yet, patients overwhelmingly say they'd like to use the technology to talk with their doctors and receive test results, according to a poll. The Center for Studying Health System Change found that only 24% of physicians used e-mail to discuss a clinical issue with a patient during 2004–2005, a 4% increase from the previous study in 2000–2001. Almost half of physicians in academic and staff or group HMO practices use e-mail for clinical discussions, compared with 20% in practices of 10 or fewer. Physicians in nonmetropolitan areas, or who have large numbers of Medicaid and/or Medicare patients, are less likely to use e-mail because of patients' lack of access to the technology. Reasons for not using e-mail include lack of reimbursement for consultations, cost of implementing a secure system, and fears that e-mail will add to workloads. A recent Wall Street Journal-Harris Interactive poll of 2,624 adults found that 74% want to communicate directly with doctors by e-mail and 67% said they want to receive test results by e-mail.

Depression Guidance Needed

Heart disease patients are often depressed, and at an increased risk of events, and yet cardiologists don't have guidance to help them identify and treat depressed patients, according to a new report by a National Heart, Lung, and Blood Institute task force, “Assessment and Treatment of Depression in Patients With Cardiovascular Disease.” The group outlined treatment options and made recommendations on how to more uniformly assess depression. Most therapies found to be effective in patients without heart disease “will likely also reduce depression in [coronary heart disease] patients,” said the report. The panel also recommended randomized trials to assess whether drug therapy or psychotherapy can reduce the risk of cardiovascular disease events and mortality associated with depression in heart disease patients.

Triglyceride Danger Not Understood

Americans—even those under a physician's care for dyslipidemia or diabetes—are unaware of the dangers posed by triglycerides, according to a Harris Interactive survey conducted for the National Lipid Association. Harris queried 2,089 adults and 510 physicians—205 primary care physicians, 155 cardiologists, and 150 endocrinologists. One in five consumers said they were knowledgeable about lipids, but fewer than one in five knew the safe levels of LDL cholesterol, HDL cholesterol, and triglycerides. One-fifth said they were the ones who initiated a discussion about lipids, and that most physician discussions lasted less than 5 minutes; fewer than one-third said the talks were “clear.” Physicians, however, believed they were the initiators. Triglycerides are discussed less than any other lipid topic, the survey found.

J&J Suit on Guidant Sale

Johnson & Johnson is suing Boston Scientific, seeking $5.5 billion in damages relating to Boston Scientific's acquisition of Guidant. J&J had been a Guidant suitor. The lawsuit was filed in the U.S. District Court for Southern New York and alleges that Guidant leaked confidential information that allowed Boston Scientific to make a superior offer to the J&J bid. The suit also names Abbott Laboratories, which it says was a party to the leak, allowing it to separately purchase Guidant's vascular and endovascular businesses. Boston Scientific completed its $27 billion purchase of the rest of Guidant's business in April. In a statement, Boston Scientific senior vice president Paul Donovan said the suit is without merit, adding, “Throughout this process, we complied with all the terms of the J&J/Guidant merger agreement.”

Reporting on Quality

More than 3,300 hospitals around the country have reported data on quality measures to Medicare and consumers, according to the Centers for Medicare and Medicaid Services. Of the 3,490 acute care hospitals eligible to participate in the federal program that links payments to hospitals to reporting of quality measures, 99% opted to report data. Under the program, hospitals that submit quality information to CMS are eligible to receive the full 2% payment update for inpatient services in 2007 under Medicare, while those who do not report will see a 2% payment reduction next year. “This is more evidence that paying for reporting and improving quality can help patients get better care,” Dr. Mark McClellan, outgoing CMS administrator said in a statement. “Consumers can use this information to evaluate care and doctors and hospitals can use it to help improve their performance.” For 2007, CMS officials have added 11 measures for hospital reporting, bringing the total number of hospital performance measures to 21.

Low Physician E-Mail Use

Physicians are rarely using e-mail to communicate with patients, according to one study, and yet, patients overwhelmingly say they'd like to use the technology to talk with their doctors and receive test results, according to a poll. The Center for Studying Health System Change found that only 24% of physicians used e-mail to discuss a clinical issue with a patient during 2004–2005, a 4% increase from the previous study in 2000–2001. Almost half of physicians in academic and staff or group HMO practices use e-mail for clinical discussions, compared with 20% in practices of 10 or fewer. Physicians in nonmetropolitan areas, or who have large numbers of Medicaid and/or Medicare patients, are less likely to use e-mail because of patients' lack of access to the technology. Reasons for not using e-mail include lack of reimbursement for consultations, cost of implementing a secure system, and fears that e-mail will add to workloads. A recent Wall Street Journal-Harris Interactive poll of 2,624 adults found that 74% want to communicate directly with doctors by e-mail and 67% said they want to receive test results by e-mail.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Many safety-related issues in recent years–including the widely publicized struggles over labeling changes for antidepressants and the recall of Vioxx (rofecoxib)–have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to strife and miscues that may have resulted in delays in addressing safety issues, said the panel, made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, the panel said. Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Dr. Janet Woodcock, deputy commissioner for operations, said the Center for Drug Evaluation and Research has long recognized many of these issues and has been addressing them by doing things like establishing a drug safety board. The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Many safety-related issues in recent years–including the widely publicized struggles over labeling changes for antidepressants and the recall of Vioxx (rofecoxib)–have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to strife and miscues that may have resulted in delays in addressing safety issues, said the panel, made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, the panel said. Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Dr. Janet Woodcock, deputy commissioner for operations, said the Center for Drug Evaluation and Research has long recognized many of these issues and has been addressing them by doing things like establishing a drug safety board. The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Many safety-related issues in recent years–including the widely publicized struggles over labeling changes for antidepressants and the recall of Vioxx (rofecoxib)–have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to strife and miscues that may have resulted in delays in addressing safety issues, said the panel, made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. The FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.

After 5 years, the FDA should formally review all the available data on those products and publicize the findings, the panel said. Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov

The FDA should not be given unilateral authority, however, said the panel. “We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Dr. Janet Woodcock, deputy commissioner for operations, said the Center for Drug Evaluation and Research has long recognized many of these issues and has been addressing them by doing things like establishing a drug safety board. The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Many safety-related issues in recent years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.

After 5 years, the FDA should formally review all available data on those products and publicize the findings, the panel said.

Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Most label changes are voluntary and many companies have not conducted requested postmarketing studies, so the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said. But the FDA should not be given unilateral authority, the panel said.

“We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Among the IOM panel's other recommendations:

▸ FDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” acting FDA Commissioner Andrew von Eschenbach said at the briefing.

Dr. Janet Woodcock, deputy commissioner for operations, said that the Center for Drug Evaluation and Research “has recognized a number of these issues for quite some time and has been systematically addressing them,” by doing things like establishing a drug safety board. “We are committed to continuing to address the issues that have been raised after we've fully absorbed this report,” she added.

The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Many safety-related issues in recent years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.

After 5 years, the FDA should formally review all available data on those products and publicize the findings, the panel said.

Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Most label changes are voluntary and many companies have not conducted requested postmarketing studies, so the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said. But the FDA should not be given unilateral authority, the panel said.

“We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Among the IOM panel's other recommendations:

▸ FDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” acting FDA Commissioner Andrew von Eschenbach said at the briefing.

Dr. Janet Woodcock, deputy commissioner for operations, said that the Center for Drug Evaluation and Research “has recognized a number of these issues for quite some time and has been systematically addressing them,” by doing things like establishing a drug safety board. “We are committed to continuing to address the issues that have been raised after we've fully absorbed this report,” she added.

The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

The Food and Drug Administration should shift its emphasis from the preapproval period to postmarketing, when new drugs pose the greatest risk of safety problems, a sweeping report from the Institute of Medicine recommends.

Many safety-related issues in recent years—including the widely publicized recall of Vioxx (rofecoxib), and struggles over labeling changes for antidepressants—have led to a lack of confidence in drug development and regulation, according to the 15 experts impaneled by the IOM.

“The credibility of FDA, the industry, the academic research enterprise, and health care providers has become seriously diminished in recent years,” the committee said in its report.

The FDA, in particular, has floundered, hampered by a lack of funding and mismanagement that has led to internecine strife and miscues that may have resulted in delays in addressing safety issues, said the panel, which was made up of academicians, ethicists, and the head of the U.K. Medicines and Healthcare Products Regulatory Agency.

“FDA's reputation has been hurt by a perceived lack of transparency and accountability to the public, a legacy of organizational changes that have not been completed or sustained, and an apparent slowness in addressing lack of sponsor compliance,” according to the report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public.”

The committee recommended that FDA consider requiring new molecular entities to carry a special caution that the products' true risks and benefits are unknown. FDA also should consider restricting or banning direct-to-consumer advertising of those products during that early marketing period, the committee said.

After 5 years, the FDA should formally review all available data on those products and publicize the findings, the panel said.

Also, results of phase II-IV clinical trials submitted to the FDA should be published on the Web site www.clinicaltrials.gov

Most label changes are voluntary and many companies have not conducted requested postmarketing studies, so the FDA needs more power to enforce regulations, including the ability to more quickly and directly levy fines or secure injunctions against companies that do not comply, the committee said. But the FDA should not be given unilateral authority, the panel said.

“We understand that offering discretion does not mean offering dictatorial power,” said R. Alta Charo, a bioethicist at the University of Wisconsin Law School.

Among the IOM panel's other recommendations:

▸ FDA funding and staff should be vastly increased.

▸ FDA commissioners should be appointed to a 6-year term in order to bring stability to the agency's leadership.

▸ Staff from the FDA's Office of Surveillance and Epidemiology should join the teams that review new drugs, to increase the safety focus from the start.

▸ At least 60% of the membership of each FDA advisory committee should have no significant financial involvement with the sponsors of the products being reviewed.

Some of these changes—such as a shift in resources from the preapproval to the postapproval side—could be done administratively. Others, however, such as giving the agency new enforcement authority, would require an act of Congress.

In a press briefing after the report was released, FDA officials acknowledged that there have been some difficulties, but they largely deflected the criticism by instead discussing initiatives the agency has undertaken in the last 2 years to shore up postmarketing safety efforts.

“The FDA has led an aggressive effort, which includes developing new tools for communicating information to patients and new resources for drug safety, to improve the management of the process for how we uncover and communicate important drug safety issues,” acting FDA Commissioner Andrew von Eschenbach said at the briefing.

Dr. Janet Woodcock, deputy commissioner for operations, said that the Center for Drug Evaluation and Research “has recognized a number of these issues for quite some time and has been systematically addressing them,” by doing things like establishing a drug safety board. “We are committed to continuing to address the issues that have been raised after we've fully absorbed this report,” she added.

The Pharmaceutical Research and Manufacturers of America also defended FDA's recent strides and the industry's safety record.

Cosmetics for Calif. Oral Surgeons

California Governor Arnold Schwarzenegger (R) has signed a bill that will grant new privileges to oral and maxillofacial surgeons. The governor vetoed a similar bill in 2005. Board-certified and licensed dentists who have completed an oral and maxillofacial surgery residency will be able to apply for and receive a 2-year, $500 permit to perform elective facial cosmetic surgery. Every 6 years, the permit holder has to submit evidence of competence to a credentialing committee. Procedures such as facial rejuvenation and contouring must be done at licensed and accredited hospitals or outpatient surgical facilities. The privileges do not extend to reconstructive surgery. The bill was supported by the California Association of Oral and Maxillofacial Surgeons, and opposed by the California Medical Association and the American Association of Plastic and Reconstructive Surgery.

Specialty Drug Demand Is Inelastic

Patients who need expensive specialty drugs will keep using the products even if they have to pay more—and that can drive up the cost of health care, said RAND Corp. researchers, who argued against tight restrictions and higher patient cost-sharing for such drugs. The researchers used 2003–2004 data covering 1.5 million beneficiaries from 55 health plans to gauge private coverage for patients with four conditions—cancer, kidney disease, rheumatoid and/or psoriatic arthritis, and multiple sclerosis. They included drugs administered at physicians' offices and other nonhospital health care facilities. Health plan spending ranged from $3,200 per user for Lupron (leuprolide acetate), to $10,000 per user for Enbrel (etanercept), to $100,000 per user for recombinant factor VIII. Patients spent between $3,301 and $8,878 out of pocket on these four conditions. Writing in the September/October issue of Health Affairs, the researchers said their data showed that even if a plan doubled the patient's share, overall spending on specialty drugs by insurers would drop by only 1%–21%, depending on diagnosis. They concluded that increasing patient copays only transfers more of the burden to the patient and will do little to cut overall spending. The study was supported by Amgen, the National Institute on Aging, and United Healthcare.

Psoriatic Arthritis Resources

The National Psoriasis Foundation has partnered with Abbott to provide psoriatic arthritis patients with online tools to manage their symptoms. The Web site, found at

www.psoriasis.org/PATH

Coalition Seeks More FDA Funds

A coalition of strange bedfellows has joined together to call on the White House and Congress to increase funding for the Food and Drug Administration, saying that the agency's mission and responsibilities have expanded hugely while its appropriations have failed to keep up with inflation or with the growing largess going to other agencies like the National Institutes of Health. That NIH investment will likely result in a large number of new products, all of which the FDA will have to regulate, according to the Coalition for a Stronger FDA. The agency also needs help coping with growing pharmaceutical, medical device, and food safety issues, the group said. The Coalition includes the Consumer Federation of America, the Center for Science in the Public Interest, the Grocery Manufacturers Association, the Biotechnology Industry Organization, and the Advanced Medical Technology Association, among others. Serving as cochairs of the Coalition are the last three secretaries of the Department of Health and Human Services: Tommy G. Thompson, Donna E. Shalala, and Louis Sullivan.

Low Physician E-Mail Use

Physicians rarely use e-mail to communicate with patients, according to one study, and yet patients overwhelmingly report that they would like to use e-mail to set appointments, talk with the doctor, and receive test results, according to a separate poll. The Center for Studying Health System Change found that only 24% of physicians said they used e-mail to discuss a clinical issue with a patient in 2004–2005, a 4% increase from the previous study period of 2000–2001. Almost half of physicians in academic settings and staff or group HMO practices use e-mail for clinical discussions, compared with about 20% in practices of 10 or fewer physicians. Physicians in nonmetropolitan areas, or who have large numbers of Medicaid and/or Medicare patients, say they are less likely to use e-mail because of patients' lack of access to the technology. Some other reasons for not using e-mail: lack of reimbursement for consultations, cost of implementing a secure system, and fears that e-mail would add to workload. A recent Wall Street Journal-Harris Interactive poll of 2,624 adults found that 74% want to communicate directly with doctors by e-mail, 67% want to receive test results, and 75% want to schedule appointments via the Internet.

Cosmetics for Calif. Oral Surgeons

California Governor Arnold Schwarzenegger (R) has signed a bill that will grant new privileges to oral and maxillofacial surgeons. The governor vetoed a similar bill in 2005. Board-certified and licensed dentists who have completed an oral and maxillofacial surgery residency will be able to apply for and receive a 2-year, $500 permit to perform elective facial cosmetic surgery. Every 6 years, the permit holder has to submit evidence of competence to a credentialing committee. Procedures such as facial rejuvenation and contouring must be done at licensed and accredited hospitals or outpatient surgical facilities. The privileges do not extend to reconstructive surgery. The bill was supported by the California Association of Oral and Maxillofacial Surgeons, and opposed by the California Medical Association and the American Association of Plastic and Reconstructive Surgery.

Specialty Drug Demand Is Inelastic

Patients who need expensive specialty drugs will keep using the products even if they have to pay more—and that can drive up the cost of health care, said RAND Corp. researchers, who argued against tight restrictions and higher patient cost-sharing for such drugs. The researchers used 2003–2004 data covering 1.5 million beneficiaries from 55 health plans to gauge private coverage for patients with four conditions—cancer, kidney disease, rheumatoid and/or psoriatic arthritis, and multiple sclerosis. They included drugs administered at physicians' offices and other nonhospital health care facilities. Health plan spending ranged from $3,200 per user for Lupron (leuprolide acetate), to $10,000 per user for Enbrel (etanercept), to $100,000 per user for recombinant factor VIII. Patients spent between $3,301 and $8,878 out of pocket on these four conditions. Writing in the September/October issue of Health Affairs, the researchers said their data showed that even if a plan doubled the patient's share, overall spending on specialty drugs by insurers would drop by only 1%–21%, depending on diagnosis. They concluded that increasing patient copays only transfers more of the burden to the patient and will do little to cut overall spending. The study was supported by Amgen, the National Institute on Aging, and United Healthcare.

Psoriatic Arthritis Resources

The National Psoriasis Foundation has partnered with Abbott to provide psoriatic arthritis patients with online tools to manage their symptoms. The Web site, found at

www.psoriasis.org/PATH

Coalition Seeks More FDA Funds

A coalition of strange bedfellows has joined together to call on the White House and Congress to increase funding for the Food and Drug Administration, saying that the agency's mission and responsibilities have expanded hugely while its appropriations have failed to keep up with inflation or with the growing largess going to other agencies like the National Institutes of Health. That NIH investment will likely result in a large number of new products, all of which the FDA will have to regulate, according to the Coalition for a Stronger FDA. The agency also needs help coping with growing pharmaceutical, medical device, and food safety issues, the group said. The Coalition includes the Consumer Federation of America, the Center for Science in the Public Interest, the Grocery Manufacturers Association, the Biotechnology Industry Organization, and the Advanced Medical Technology Association, among others. Serving as cochairs of the Coalition are the last three secretaries of the Department of Health and Human Services: Tommy G. Thompson, Donna E. Shalala, and Louis Sullivan.

Low Physician E-Mail Use

Physicians rarely use e-mail to communicate with patients, according to one study, and yet patients overwhelmingly report that they would like to use e-mail to set appointments, talk with the doctor, and receive test results, according to a separate poll. The Center for Studying Health System Change found that only 24% of physicians said they used e-mail to discuss a clinical issue with a patient in 2004–2005, a 4% increase from the previous study period of 2000–2001. Almost half of physicians in academic settings and staff or group HMO practices use e-mail for clinical discussions, compared with about 20% in practices of 10 or fewer physicians. Physicians in nonmetropolitan areas, or who have large numbers of Medicaid and/or Medicare patients, say they are less likely to use e-mail because of patients' lack of access to the technology. Some other reasons for not using e-mail: lack of reimbursement for consultations, cost of implementing a secure system, and fears that e-mail would add to workload. A recent Wall Street Journal-Harris Interactive poll of 2,624 adults found that 74% want to communicate directly with doctors by e-mail, 67% want to receive test results, and 75% want to schedule appointments via the Internet.

Cosmetics for Calif. Oral Surgeons

California Governor Arnold Schwarzenegger (R) has signed a bill that will grant new privileges to oral and maxillofacial surgeons. The governor vetoed a similar bill in 2005. Board-certified and licensed dentists who have completed an oral and maxillofacial surgery residency will be able to apply for and receive a 2-year, $500 permit to perform elective facial cosmetic surgery. Every 6 years, the permit holder has to submit evidence of competence to a credentialing committee. Procedures such as facial rejuvenation and contouring must be done at licensed and accredited hospitals or outpatient surgical facilities. The privileges do not extend to reconstructive surgery. The bill was supported by the California Association of Oral and Maxillofacial Surgeons, and opposed by the California Medical Association and the American Association of Plastic and Reconstructive Surgery.

Specialty Drug Demand Is Inelastic

Patients who need expensive specialty drugs will keep using the products even if they have to pay more—and that can drive up the cost of health care, said RAND Corp. researchers, who argued against tight restrictions and higher patient cost-sharing for such drugs. The researchers used 2003–2004 data covering 1.5 million beneficiaries from 55 health plans to gauge private coverage for patients with four conditions—cancer, kidney disease, rheumatoid and/or psoriatic arthritis, and multiple sclerosis. They included drugs administered at physicians' offices and other nonhospital health care facilities. Health plan spending ranged from $3,200 per user for Lupron (leuprolide acetate), to $10,000 per user for Enbrel (etanercept), to $100,000 per user for recombinant factor VIII. Patients spent between $3,301 and $8,878 out of pocket on these four conditions. Writing in the September/October issue of Health Affairs, the researchers said their data showed that even if a plan doubled the patient's share, overall spending on specialty drugs by insurers would drop by only 1%–21%, depending on diagnosis. They concluded that increasing patient copays only transfers more of the burden to the patient and will do little to cut overall spending. The study was supported by Amgen, the National Institute on Aging, and United Healthcare.

Psoriatic Arthritis Resources

The National Psoriasis Foundation has partnered with Abbott to provide psoriatic arthritis patients with online tools to manage their symptoms. The Web site, found at

www.psoriasis.org/PATH

Coalition Seeks More FDA Funds

A coalition of strange bedfellows has joined together to call on the White House and Congress to increase funding for the Food and Drug Administration, saying that the agency's mission and responsibilities have expanded hugely while its appropriations have failed to keep up with inflation or with the growing largess going to other agencies like the National Institutes of Health. That NIH investment will likely result in a large number of new products, all of which the FDA will have to regulate, according to the Coalition for a Stronger FDA. The agency also needs help coping with growing pharmaceutical, medical device, and food safety issues, the group said. The Coalition includes the Consumer Federation of America, the Center for Science in the Public Interest, the Grocery Manufacturers Association, the Biotechnology Industry Organization, and the Advanced Medical Technology Association, among others. Serving as cochairs of the Coalition are the last three secretaries of the Department of Health and Human Services: Tommy G. Thompson, Donna E. Shalala, and Louis Sullivan.

Low Physician E-Mail Use

Physicians rarely use e-mail to communicate with patients, according to one study, and yet patients overwhelmingly report that they would like to use e-mail to set appointments, talk with the doctor, and receive test results, according to a separate poll. The Center for Studying Health System Change found that only 24% of physicians said they used e-mail to discuss a clinical issue with a patient in 2004–2005, a 4% increase from the previous study period of 2000–2001. Almost half of physicians in academic settings and staff or group HMO practices use e-mail for clinical discussions, compared with about 20% in practices of 10 or fewer physicians. Physicians in nonmetropolitan areas, or who have large numbers of Medicaid and/or Medicare patients, say they are less likely to use e-mail because of patients' lack of access to the technology. Some other reasons for not using e-mail: lack of reimbursement for consultations, cost of implementing a secure system, and fears that e-mail would add to workload. A recent Wall Street Journal-Harris Interactive poll of 2,624 adults found that 74% want to communicate directly with doctors by e-mail, 67% want to receive test results, and 75% want to schedule appointments via the Internet.

ASHEVILLE, N.C. — Six years after its manufacturer, G.D. Searle, warned against using the drug in pregnancy due to litigation and political concerns, misoprostol is finding off-label use throughout pregnancy, Dr. Wendy Hansen said at the Southern Obstetric and Gynecologic Seminar.

Dr. Hansen, of the University of Kentucky, Lexington, said misoprostol is being used as an abortifacient in first- and second-trimester pregnancy failures, as an induction agent in the third trimester, and to manage postpartum hemorrhage.

The drug's pharmacokinetics are dependent on its route of administration. Orally, it is rapidly absorbed with a peak concentration in 12 minutes and a half-life of 21 minutes. The drug has the shortest onset of action and greatest bioavailability when given sublingually. There is also great bioavailability when misoprostol is given vaginally or rectally, but the absorption is not as consistent, said Dr. Hansen. Peak concentration with vaginal administration is 1 hour, with a slow decline over the 4 hours post administration.

However, vaginal dosing has been shown to be superior to oral regimens in hastening delivery time and reducing the need for oxytocin (Obstet. Gynecol. 1997;89:392–7; Am. J. Obstet. Gynecol. 1999;180:1155–60). That route also decreases side effects, which include nausea, vomiting, diarrhea, abdominal pain, chills, shivering, and fever.

Misoprostol is usually given in 25-mcg doses vaginally, though it comes in a 100-mcg tablet. Dr. Hansen says she has her pharmacy cut the 100-mcg tablets into quarters and then weigh each to be sure of providing the right dose. Doses should be reduced for women with hepatic disease.

The drug fell out of favor in the late 1990s after Searle issued its warning, but the American College of Obstetricians and Gynecologists countered with a letter to members stating that the evidence backed use of misoprostol in pregnancy. Use picked up, but it was tempered with caution after there were many sporadic reports of uterine rupture in the presence of a uterine scar, said Dr. Hansen. A retrospective study of 20,000 women with a prior cesarean delivery found that prostaglandins such as misoprostol did increase the rupture risk (N. Engl. J. Med. 2001;345:3–8).

Dr. Hansen recommends considering a repeat cesarean if induction is necessary in a woman with a uterine scar.

A relatively new use of misoprostol is in the first trimester for women who have missed a therapeutic abortion or have a pregnancy failure. Expectant management has been the customary approach, but the interval to spontaneous expulsion is unpredictable, which leads to sadness and uncertainty, noted Dr. Hansen. Misoprostol gives more control over timing and provides prompter evacuation, she said. A large randomized, controlled trial found that success rates for misoprostol ranged from 71% at day 3 to 85% at day 15, compared with nearly 100% success for surgical management (N. Engl. J. Med. 2005;353:761–9).

Patients who had an incomplete or inevitable abortion were administered 800 mcg of misoprostol vaginally on day 1 and again on day 3 if expulsion was incomplete (491 patients) or given electric or manual vacuum aspiration (161 patients). The pain was worse in the group given misoprostol, as was nausea, vomiting, and diarrhea. But the acceptability was the same, and 78% of women said they'd try misoprostol again, compared with 75% of the surgical group.

Women considering misoprostol for first-trimester failure should be told that success diminishes with parity, and that success can't be predicted by the biometry of the sac or the gestational age of the fetal pole, said Dr. Hansen. And, misoprostol does not seem to affect long-term fertility (Hum. Reprod. 2005;20:3355–9).

Misoprostol has become a standard treatment for second-trimester terminations or induction for intrauterine fetal demise, Dr. Hansen said. Two regimens are used, but it is not clear which is better: 400 mcg vaginally every 4 hours up to a maximum of five doses, or 800 mcg every 6, 8, or 12 hours for 24 hours. Oral routes are sometimes used also: 400 mcg every 2 hours for 24 hours or 200 mcg every hour for 8 hours. Several studies have now shown that it is safe to use in the second trimester, even in women who have had previous cesareans or uterine ruptures, said Dr. Hansen.

The drug has a history of being used successfully to manage postpartum hemorrhage, she said, adding that the rectal route is best for this purpose. Patients are given 600–800 mcg rectally, 200 mcg orally, or 400 mcg sublingually.

Dr. Hansen was asked if there had been any reports of infections with Clostridium sordellii. There have been at least five deaths attributable to that pathogen in women who took misoprostol in combination with mifepristone. But Dr. Hansen said she had not heard any such reports with misoprostol alone or outside the setting of elective medical abortion.

Another meeting attendee said that her clinic provides patients with a consent form stating that misoprostol for induction is an off-label use. But Dr. Hansen said she does not feel that it's necessary to discuss the off-label aspect because ACOG endorses its use throughout pregnancy.

ASHEVILLE, N.C. — Six years after its manufacturer, G.D. Searle, warned against using the drug in pregnancy due to litigation and political concerns, misoprostol is finding off-label use throughout pregnancy, Dr. Wendy Hansen said at the Southern Obstetric and Gynecologic Seminar.

Dr. Hansen, of the University of Kentucky, Lexington, said misoprostol is being used as an abortifacient in first- and second-trimester pregnancy failures, as an induction agent in the third trimester, and to manage postpartum hemorrhage.

The drug's pharmacokinetics are dependent on its route of administration. Orally, it is rapidly absorbed with a peak concentration in 12 minutes and a half-life of 21 minutes. The drug has the shortest onset of action and greatest bioavailability when given sublingually. There is also great bioavailability when misoprostol is given vaginally or rectally, but the absorption is not as consistent, said Dr. Hansen. Peak concentration with vaginal administration is 1 hour, with a slow decline over the 4 hours post administration.

However, vaginal dosing has been shown to be superior to oral regimens in hastening delivery time and reducing the need for oxytocin (Obstet. Gynecol. 1997;89:392–7; Am. J. Obstet. Gynecol. 1999;180:1155–60). That route also decreases side effects, which include nausea, vomiting, diarrhea, abdominal pain, chills, shivering, and fever.

Misoprostol is usually given in 25-mcg doses vaginally, though it comes in a 100-mcg tablet. Dr. Hansen says she has her pharmacy cut the 100-mcg tablets into quarters and then weigh each to be sure of providing the right dose. Doses should be reduced for women with hepatic disease.

The drug fell out of favor in the late 1990s after Searle issued its warning, but the American College of Obstetricians and Gynecologists countered with a letter to members stating that the evidence backed use of misoprostol in pregnancy. Use picked up, but it was tempered with caution after there were many sporadic reports of uterine rupture in the presence of a uterine scar, said Dr. Hansen. A retrospective study of 20,000 women with a prior cesarean delivery found that prostaglandins such as misoprostol did increase the rupture risk (N. Engl. J. Med. 2001;345:3–8).

Dr. Hansen recommends considering a repeat cesarean if induction is necessary in a woman with a uterine scar.

A relatively new use of misoprostol is in the first trimester for women who have missed a therapeutic abortion or have a pregnancy failure. Expectant management has been the customary approach, but the interval to spontaneous expulsion is unpredictable, which leads to sadness and uncertainty, noted Dr. Hansen. Misoprostol gives more control over timing and provides prompter evacuation, she said. A large randomized, controlled trial found that success rates for misoprostol ranged from 71% at day 3 to 85% at day 15, compared with nearly 100% success for surgical management (N. Engl. J. Med. 2005;353:761–9).

Patients who had an incomplete or inevitable abortion were administered 800 mcg of misoprostol vaginally on day 1 and again on day 3 if expulsion was incomplete (491 patients) or given electric or manual vacuum aspiration (161 patients). The pain was worse in the group given misoprostol, as was nausea, vomiting, and diarrhea. But the acceptability was the same, and 78% of women said they'd try misoprostol again, compared with 75% of the surgical group.

Women considering misoprostol for first-trimester failure should be told that success diminishes with parity, and that success can't be predicted by the biometry of the sac or the gestational age of the fetal pole, said Dr. Hansen. And, misoprostol does not seem to affect long-term fertility (Hum. Reprod. 2005;20:3355–9).

Misoprostol has become a standard treatment for second-trimester terminations or induction for intrauterine fetal demise, Dr. Hansen said. Two regimens are used, but it is not clear which is better: 400 mcg vaginally every 4 hours up to a maximum of five doses, or 800 mcg every 6, 8, or 12 hours for 24 hours. Oral routes are sometimes used also: 400 mcg every 2 hours for 24 hours or 200 mcg every hour for 8 hours. Several studies have now shown that it is safe to use in the second trimester, even in women who have had previous cesareans or uterine ruptures, said Dr. Hansen.

The drug has a history of being used successfully to manage postpartum hemorrhage, she said, adding that the rectal route is best for this purpose. Patients are given 600–800 mcg rectally, 200 mcg orally, or 400 mcg sublingually.

Dr. Hansen was asked if there had been any reports of infections with Clostridium sordellii. There have been at least five deaths attributable to that pathogen in women who took misoprostol in combination with mifepristone. But Dr. Hansen said she had not heard any such reports with misoprostol alone or outside the setting of elective medical abortion.

Another meeting attendee said that her clinic provides patients with a consent form stating that misoprostol for induction is an off-label use. But Dr. Hansen said she does not feel that it's necessary to discuss the off-label aspect because ACOG endorses its use throughout pregnancy.

ASHEVILLE, N.C. — Six years after its manufacturer, G.D. Searle, warned against using the drug in pregnancy due to litigation and political concerns, misoprostol is finding off-label use throughout pregnancy, Dr. Wendy Hansen said at the Southern Obstetric and Gynecologic Seminar.

Dr. Hansen, of the University of Kentucky, Lexington, said misoprostol is being used as an abortifacient in first- and second-trimester pregnancy failures, as an induction agent in the third trimester, and to manage postpartum hemorrhage.

The drug's pharmacokinetics are dependent on its route of administration. Orally, it is rapidly absorbed with a peak concentration in 12 minutes and a half-life of 21 minutes. The drug has the shortest onset of action and greatest bioavailability when given sublingually. There is also great bioavailability when misoprostol is given vaginally or rectally, but the absorption is not as consistent, said Dr. Hansen. Peak concentration with vaginal administration is 1 hour, with a slow decline over the 4 hours post administration.

However, vaginal dosing has been shown to be superior to oral regimens in hastening delivery time and reducing the need for oxytocin (Obstet. Gynecol. 1997;89:392–7; Am. J. Obstet. Gynecol. 1999;180:1155–60). That route also decreases side effects, which include nausea, vomiting, diarrhea, abdominal pain, chills, shivering, and fever.

Misoprostol is usually given in 25-mcg doses vaginally, though it comes in a 100-mcg tablet. Dr. Hansen says she has her pharmacy cut the 100-mcg tablets into quarters and then weigh each to be sure of providing the right dose. Doses should be reduced for women with hepatic disease.

The drug fell out of favor in the late 1990s after Searle issued its warning, but the American College of Obstetricians and Gynecologists countered with a letter to members stating that the evidence backed use of misoprostol in pregnancy. Use picked up, but it was tempered with caution after there were many sporadic reports of uterine rupture in the presence of a uterine scar, said Dr. Hansen. A retrospective study of 20,000 women with a prior cesarean delivery found that prostaglandins such as misoprostol did increase the rupture risk (N. Engl. J. Med. 2001;345:3–8).

Dr. Hansen recommends considering a repeat cesarean if induction is necessary in a woman with a uterine scar.

A relatively new use of misoprostol is in the first trimester for women who have missed a therapeutic abortion or have a pregnancy failure. Expectant management has been the customary approach, but the interval to spontaneous expulsion is unpredictable, which leads to sadness and uncertainty, noted Dr. Hansen. Misoprostol gives more control over timing and provides prompter evacuation, she said. A large randomized, controlled trial found that success rates for misoprostol ranged from 71% at day 3 to 85% at day 15, compared with nearly 100% success for surgical management (N. Engl. J. Med. 2005;353:761–9).

Patients who had an incomplete or inevitable abortion were administered 800 mcg of misoprostol vaginally on day 1 and again on day 3 if expulsion was incomplete (491 patients) or given electric or manual vacuum aspiration (161 patients). The pain was worse in the group given misoprostol, as was nausea, vomiting, and diarrhea. But the acceptability was the same, and 78% of women said they'd try misoprostol again, compared with 75% of the surgical group.

Women considering misoprostol for first-trimester failure should be told that success diminishes with parity, and that success can't be predicted by the biometry of the sac or the gestational age of the fetal pole, said Dr. Hansen. And, misoprostol does not seem to affect long-term fertility (Hum. Reprod. 2005;20:3355–9).

Misoprostol has become a standard treatment for second-trimester terminations or induction for intrauterine fetal demise, Dr. Hansen said. Two regimens are used, but it is not clear which is better: 400 mcg vaginally every 4 hours up to a maximum of five doses, or 800 mcg every 6, 8, or 12 hours for 24 hours. Oral routes are sometimes used also: 400 mcg every 2 hours for 24 hours or 200 mcg every hour for 8 hours. Several studies have now shown that it is safe to use in the second trimester, even in women who have had previous cesareans or uterine ruptures, said Dr. Hansen.

The drug has a history of being used successfully to manage postpartum hemorrhage, she said, adding that the rectal route is best for this purpose. Patients are given 600–800 mcg rectally, 200 mcg orally, or 400 mcg sublingually.

Dr. Hansen was asked if there had been any reports of infections with Clostridium sordellii. There have been at least five deaths attributable to that pathogen in women who took misoprostol in combination with mifepristone. But Dr. Hansen said she had not heard any such reports with misoprostol alone or outside the setting of elective medical abortion.

Another meeting attendee said that her clinic provides patients with a consent form stating that misoprostol for induction is an off-label use. But Dr. Hansen said she does not feel that it's necessary to discuss the off-label aspect because ACOG endorses its use throughout pregnancy.

ASHEVILLE, N.C. — Ultrasound can be an important tool in classifying suspicious ovarian masses, Dr. Angela Gantt said at the Southern Obstetric and Gynecologic Seminar.

Because of the burgeoning problem with obesity, it has become more difficult to determine which masses may be dangerous by feel alone, said Dr. Gantt of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. “If you feel something abnormal, ultrasound helps you determine what course to take.”

According to Dr. Gantt, 13%–21% of women who have a suspicious mass end up having surgery, so it's important to determine the nature of the mass. Ultrasound can be used to rule out a malignancy because it offers high sensitivity. Unfortunately, it is not very specific.

It takes a skilled technician to properly interpret an exam, but even so, the technology offers many advantages: It is ubiquitous, offers information quickly, and can distinguish physiologic from pathologic processes, Dr. Gantt said.

Among the pearls offered by Dr. Gantt: If an ovary is surrounding a mass, it is probably not a cancer; solid masses should be the subject of more imaging or surgical intervention; a simple cyst of less than 4 cm can be managed conservatively; a larger cyst puts the ovary at risk; pay particular attention to a solid mass in a woman over age 50, as 80% of cancers are diagnosed in this group; and never rule out a pregnancy in women aged 13–65.

The most common finding is a simple cyst, which is almost always benign and includes follicular cysts, corpus luteal cysts, ovarian surface inclusion cysts, and para- ovarian/paratubal cysts. On ultrasound, these are generally thin-walled (less than 3 mm), have oval-shaped or circular walls, no solid components, no septations, and no internal vascular activity, Dr. Gantt said. Generally, these cysts are observed.

For premenopausal women, if cysts are less than 4 cm, a follow-up ultrasound is not generally recommended; at 4–7 cm, a follow-up scan can be done in 10–12 weeks. Surgical evaluation is recommended in cysts larger than 7 cm.

Recommendations are slightly different for postmenopausal women, she said. Cysts of less than 3 cm should receive a repeat ultrasound in 10–12 weeks and again in 6 months and every year if they are stable. At 3–5 cm, a follow-up scan should be done at 10–12 weeks; if stable, the physician should weigh a follow-up ultrasound or surgical evaluation. Surgery is recommended for cysts larger than 5 cm in these women.

Ultrasound can be an especially good tool for more complex masses, which can be classified with Timor's scoring system, which assigns a numerical score based on the inner wall features, wall thickness, septa, and echogenicity. Often, a peritoneal pseudocyst can mimic complex multicystic ovaries. The pseudocysts are common in patients with a history of pelvic inflammatory disease or abdominal surgery.

Hemorrhagic corpus luteum can be difficult to distinguish from malignancy. Typically, it presents as a spiderweb-like pattern, Dr. Gantt said. With Doppler, it becomes clear there is no vascular activity within the cyst, and the contents tend to morph with any probing. Repeat ultrasounds should be conducted, as the condition tends to resolve within two cycles.

Endometriosis is often confused with hemorrhagic corpus luteum. Ultrasound can be used to support a clinician's diagnosis, but it's not as good at confirming the condition until it is at a later stage, Dr. Gantt said. The test will show a cyst with thickened walls and echogenic foci in the walls, along with no vascular activity.

Similarly, the technology is not as accurate in diagnosing pelvic inflammatory disease in its early stages, she said.

Ultrasound is helpful for distinguishing adnexal myomas, which also can be confused with solid tumors. Doppler can be used to identify vasculature to the uterine cavity. The most common benign ovarian mass is a mature teratoma. Its size generally makes it symptomatic, though symptoms are variable, Dr. Gantt said. As it gets larger, there is a risk of ovarian torsion. On ultrasound, it may be dense, so the key is to look for the “tip of the iceberg” sign, which will be hyperechoic with posterior shadowing. It may also show as hyperechoic speckling or as diffuse dots and lines within the cyst.

Finally, malignancies will be solid, though extremely variable, with irregular outlines or walls, and thickened cyst walls and septations of greater than 3 mm. There may be papillary projections into the cyst from the cyst wall. And the vascular pattern and flow, as shown by Doppler, is very abnormal and irregular.

Normal ovarian tissue (crescent sign) is a marker for a nonmalignant process.

Cystic and solid components with hypervascularity may mean malignancy. Photos courtesy Dr. Angela Gantt

ASHEVILLE, N.C. — Ultrasound can be an important tool in classifying suspicious ovarian masses, Dr. Angela Gantt said at the Southern Obstetric and Gynecologic Seminar.

Because of the burgeoning problem with obesity, it has become more difficult to determine which masses may be dangerous by feel alone, said Dr. Gantt of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. “If you feel something abnormal, ultrasound helps you determine what course to take.”

According to Dr. Gantt, 13%–21% of women who have a suspicious mass end up having surgery, so it's important to determine the nature of the mass. Ultrasound can be used to rule out a malignancy because it offers high sensitivity. Unfortunately, it is not very specific.

It takes a skilled technician to properly interpret an exam, but even so, the technology offers many advantages: It is ubiquitous, offers information quickly, and can distinguish physiologic from pathologic processes, Dr. Gantt said.

Among the pearls offered by Dr. Gantt: If an ovary is surrounding a mass, it is probably not a cancer; solid masses should be the subject of more imaging or surgical intervention; a simple cyst of less than 4 cm can be managed conservatively; a larger cyst puts the ovary at risk; pay particular attention to a solid mass in a woman over age 50, as 80% of cancers are diagnosed in this group; and never rule out a pregnancy in women aged 13–65.

The most common finding is a simple cyst, which is almost always benign and includes follicular cysts, corpus luteal cysts, ovarian surface inclusion cysts, and para- ovarian/paratubal cysts. On ultrasound, these are generally thin-walled (less than 3 mm), have oval-shaped or circular walls, no solid components, no septations, and no internal vascular activity, Dr. Gantt said. Generally, these cysts are observed.

For premenopausal women, if cysts are less than 4 cm, a follow-up ultrasound is not generally recommended; at 4–7 cm, a follow-up scan can be done in 10–12 weeks. Surgical evaluation is recommended in cysts larger than 7 cm.

Recommendations are slightly different for postmenopausal women, she said. Cysts of less than 3 cm should receive a repeat ultrasound in 10–12 weeks and again in 6 months and every year if they are stable. At 3–5 cm, a follow-up scan should be done at 10–12 weeks; if stable, the physician should weigh a follow-up ultrasound or surgical evaluation. Surgery is recommended for cysts larger than 5 cm in these women.

Ultrasound can be an especially good tool for more complex masses, which can be classified with Timor's scoring system, which assigns a numerical score based on the inner wall features, wall thickness, septa, and echogenicity. Often, a peritoneal pseudocyst can mimic complex multicystic ovaries. The pseudocysts are common in patients with a history of pelvic inflammatory disease or abdominal surgery.

Hemorrhagic corpus luteum can be difficult to distinguish from malignancy. Typically, it presents as a spiderweb-like pattern, Dr. Gantt said. With Doppler, it becomes clear there is no vascular activity within the cyst, and the contents tend to morph with any probing. Repeat ultrasounds should be conducted, as the condition tends to resolve within two cycles.

Endometriosis is often confused with hemorrhagic corpus luteum. Ultrasound can be used to support a clinician's diagnosis, but it's not as good at confirming the condition until it is at a later stage, Dr. Gantt said. The test will show a cyst with thickened walls and echogenic foci in the walls, along with no vascular activity.

Similarly, the technology is not as accurate in diagnosing pelvic inflammatory disease in its early stages, she said.

Ultrasound is helpful for distinguishing adnexal myomas, which also can be confused with solid tumors. Doppler can be used to identify vasculature to the uterine cavity. The most common benign ovarian mass is a mature teratoma. Its size generally makes it symptomatic, though symptoms are variable, Dr. Gantt said. As it gets larger, there is a risk of ovarian torsion. On ultrasound, it may be dense, so the key is to look for the “tip of the iceberg” sign, which will be hyperechoic with posterior shadowing. It may also show as hyperechoic speckling or as diffuse dots and lines within the cyst.

Finally, malignancies will be solid, though extremely variable, with irregular outlines or walls, and thickened cyst walls and septations of greater than 3 mm. There may be papillary projections into the cyst from the cyst wall. And the vascular pattern and flow, as shown by Doppler, is very abnormal and irregular.

Normal ovarian tissue (crescent sign) is a marker for a nonmalignant process.

Cystic and solid components with hypervascularity may mean malignancy. Photos courtesy Dr. Angela Gantt

ASHEVILLE, N.C. — Ultrasound can be an important tool in classifying suspicious ovarian masses, Dr. Angela Gantt said at the Southern Obstetric and Gynecologic Seminar.

Because of the burgeoning problem with obesity, it has become more difficult to determine which masses may be dangerous by feel alone, said Dr. Gantt of the department of obstetrics and gynecology at the University of North Carolina at Chapel Hill. “If you feel something abnormal, ultrasound helps you determine what course to take.”

According to Dr. Gantt, 13%–21% of women who have a suspicious mass end up having surgery, so it's important to determine the nature of the mass. Ultrasound can be used to rule out a malignancy because it offers high sensitivity. Unfortunately, it is not very specific.

It takes a skilled technician to properly interpret an exam, but even so, the technology offers many advantages: It is ubiquitous, offers information quickly, and can distinguish physiologic from pathologic processes, Dr. Gantt said.

Among the pearls offered by Dr. Gantt: If an ovary is surrounding a mass, it is probably not a cancer; solid masses should be the subject of more imaging or surgical intervention; a simple cyst of less than 4 cm can be managed conservatively; a larger cyst puts the ovary at risk; pay particular attention to a solid mass in a woman over age 50, as 80% of cancers are diagnosed in this group; and never rule out a pregnancy in women aged 13–65.

The most common finding is a simple cyst, which is almost always benign and includes follicular cysts, corpus luteal cysts, ovarian surface inclusion cysts, and para- ovarian/paratubal cysts. On ultrasound, these are generally thin-walled (less than 3 mm), have oval-shaped or circular walls, no solid components, no septations, and no internal vascular activity, Dr. Gantt said. Generally, these cysts are observed.

For premenopausal women, if cysts are less than 4 cm, a follow-up ultrasound is not generally recommended; at 4–7 cm, a follow-up scan can be done in 10–12 weeks. Surgical evaluation is recommended in cysts larger than 7 cm.

Recommendations are slightly different for postmenopausal women, she said. Cysts of less than 3 cm should receive a repeat ultrasound in 10–12 weeks and again in 6 months and every year if they are stable. At 3–5 cm, a follow-up scan should be done at 10–12 weeks; if stable, the physician should weigh a follow-up ultrasound or surgical evaluation. Surgery is recommended for cysts larger than 5 cm in these women.

Ultrasound can be an especially good tool for more complex masses, which can be classified with Timor's scoring system, which assigns a numerical score based on the inner wall features, wall thickness, septa, and echogenicity. Often, a peritoneal pseudocyst can mimic complex multicystic ovaries. The pseudocysts are common in patients with a history of pelvic inflammatory disease or abdominal surgery.

Hemorrhagic corpus luteum can be difficult to distinguish from malignancy. Typically, it presents as a spiderweb-like pattern, Dr. Gantt said. With Doppler, it becomes clear there is no vascular activity within the cyst, and the contents tend to morph with any probing. Repeat ultrasounds should be conducted, as the condition tends to resolve within two cycles.

Endometriosis is often confused with hemorrhagic corpus luteum. Ultrasound can be used to support a clinician's diagnosis, but it's not as good at confirming the condition until it is at a later stage, Dr. Gantt said. The test will show a cyst with thickened walls and echogenic foci in the walls, along with no vascular activity.

Similarly, the technology is not as accurate in diagnosing pelvic inflammatory disease in its early stages, she said.

Ultrasound is helpful for distinguishing adnexal myomas, which also can be confused with solid tumors. Doppler can be used to identify vasculature to the uterine cavity. The most common benign ovarian mass is a mature teratoma. Its size generally makes it symptomatic, though symptoms are variable, Dr. Gantt said. As it gets larger, there is a risk of ovarian torsion. On ultrasound, it may be dense, so the key is to look for the “tip of the iceberg” sign, which will be hyperechoic with posterior shadowing. It may also show as hyperechoic speckling or as diffuse dots and lines within the cyst.

Finally, malignancies will be solid, though extremely variable, with irregular outlines or walls, and thickened cyst walls and septations of greater than 3 mm. There may be papillary projections into the cyst from the cyst wall. And the vascular pattern and flow, as shown by Doppler, is very abnormal and irregular.

Normal ovarian tissue (crescent sign) is a marker for a nonmalignant process.

Cystic and solid components with hypervascularity may mean malignancy. Photos courtesy Dr. Angela Gantt

At least 80% of children aged 19–35 months received three or more of the four required doses of pneumococcal vaccine in 2005—a big jump from 40% coverage 3 years ago, according to results of the National Immunization Survey released in a Centers for Disease Control and Prevention press briefing.

CDC officials also reported that, for the first time in a decade, there was no significant difference in coverage among ethnic groups. “We have immunization coverage rates that are at or near record highs,” Dr. Anne Schuchat said in the briefing, adding, “We are very close to closing the gap in coverage between racial and ethnic minority groups and others.”

Overall, 76% of children received all the required doses of six vaccines: diphtheria, pertussis, and tetanus; polio; measles-mumps-rubella; Haemophilus influenzae type b; hepatitis B; and varicella. This was the first year that varicella was added into the report, said Dr. Schuchat, director of the National Center for Immunization and Respiratory Diseases, Atlanta. Results are reported in the Morbidity and Mortality Weekly Report (MMWR 2006;55:988–93).

The most striking figure was the increase in coverage for the six-vaccine series from 2002 to 2005 for African American children—from 62% to 77%—said Dr. Schuchat. During the same time period, coverage increased for Hispanics from 66% to 76%, and for whites from 66% to 76%.

There were some differences in uptake for specific vaccines. Blacks and Hispanics had lower coverage for the DTP/DT/ DTaP and pneumococcal vaccines, compared with whites, but they had more coverage for varicella. In the MMWR report, the authors suggest that monitoring coverage for blacks and Hispanics for DTP and pneumococcal vaccine especially is important, given that there is a higher incidence of pneumococcal disease in black children.

There still are significant differences in coverage among the states. It is highest in Massachusetts, at 91% coverage overall, and lowest in Vermont, at 63%. Dr. Schuchat said differences in coverage might be caused by varying rates of commitment by localities and pediatricians, and strength of immunization programs.

Uptake of vaccines is tracked, but generally not reported in the first few years a product has been added to the vaccination schedule, said Dr. Schuchat. The varicella vaccine was added to the recommended list in 2000, so its uptake has been recorded but not reported until this year.

Pneumococcal vaccine use is being tracked but is not included as part of the formal overall coverage target for 2005, said Dr. Schuchat. There were concerns that uptake would be slowed by both expense and a shortage during February to September 2004, but that has not proven to be the case, she said. In 2005, more than 50% of children received four doses, and more than 80% had three or more doses.

The annual NIS is compiled from quarterly random-digit dialing to sample parents of children aged 19–35 months. Immunization coverage is confirmed with providers' records. In 2005, records were obtained for 17,563 children.

At least 80% of children aged 19–35 months received three or more of the four required doses of pneumococcal vaccine in 2005—a big jump from 40% coverage 3 years ago, according to results of the National Immunization Survey released in a Centers for Disease Control and Prevention press briefing.

CDC officials also reported that, for the first time in a decade, there was no significant difference in coverage among ethnic groups. “We have immunization coverage rates that are at or near record highs,” Dr. Anne Schuchat said in the briefing, adding, “We are very close to closing the gap in coverage between racial and ethnic minority groups and others.”

Overall, 76% of children received all the required doses of six vaccines: diphtheria, pertussis, and tetanus; polio; measles-mumps-rubella; Haemophilus influenzae type b; hepatitis B; and varicella. This was the first year that varicella was added into the report, said Dr. Schuchat, director of the National Center for Immunization and Respiratory Diseases, Atlanta. Results are reported in the Morbidity and Mortality Weekly Report (MMWR 2006;55:988–93).

The most striking figure was the increase in coverage for the six-vaccine series from 2002 to 2005 for African American children—from 62% to 77%—said Dr. Schuchat. During the same time period, coverage increased for Hispanics from 66% to 76%, and for whites from 66% to 76%.

There were some differences in uptake for specific vaccines. Blacks and Hispanics had lower coverage for the DTP/DT/ DTaP and pneumococcal vaccines, compared with whites, but they had more coverage for varicella. In the MMWR report, the authors suggest that monitoring coverage for blacks and Hispanics for DTP and pneumococcal vaccine especially is important, given that there is a higher incidence of pneumococcal disease in black children.

There still are significant differences in coverage among the states. It is highest in Massachusetts, at 91% coverage overall, and lowest in Vermont, at 63%. Dr. Schuchat said differences in coverage might be caused by varying rates of commitment by localities and pediatricians, and strength of immunization programs.

Uptake of vaccines is tracked, but generally not reported in the first few years a product has been added to the vaccination schedule, said Dr. Schuchat. The varicella vaccine was added to the recommended list in 2000, so its uptake has been recorded but not reported until this year.

Pneumococcal vaccine use is being tracked but is not included as part of the formal overall coverage target for 2005, said Dr. Schuchat. There were concerns that uptake would be slowed by both expense and a shortage during February to September 2004, but that has not proven to be the case, she said. In 2005, more than 50% of children received four doses, and more than 80% had three or more doses.

The annual NIS is compiled from quarterly random-digit dialing to sample parents of children aged 19–35 months. Immunization coverage is confirmed with providers' records. In 2005, records were obtained for 17,563 children.

At least 80% of children aged 19–35 months received three or more of the four required doses of pneumococcal vaccine in 2005—a big jump from 40% coverage 3 years ago, according to results of the National Immunization Survey released in a Centers for Disease Control and Prevention press briefing.

CDC officials also reported that, for the first time in a decade, there was no significant difference in coverage among ethnic groups. “We have immunization coverage rates that are at or near record highs,” Dr. Anne Schuchat said in the briefing, adding, “We are very close to closing the gap in coverage between racial and ethnic minority groups and others.”

Overall, 76% of children received all the required doses of six vaccines: diphtheria, pertussis, and tetanus; polio; measles-mumps-rubella; Haemophilus influenzae type b; hepatitis B; and varicella. This was the first year that varicella was added into the report, said Dr. Schuchat, director of the National Center for Immunization and Respiratory Diseases, Atlanta. Results are reported in the Morbidity and Mortality Weekly Report (MMWR 2006;55:988–93).

The most striking figure was the increase in coverage for the six-vaccine series from 2002 to 2005 for African American children—from 62% to 77%—said Dr. Schuchat. During the same time period, coverage increased for Hispanics from 66% to 76%, and for whites from 66% to 76%.

There were some differences in uptake for specific vaccines. Blacks and Hispanics had lower coverage for the DTP/DT/ DTaP and pneumococcal vaccines, compared with whites, but they had more coverage for varicella. In the MMWR report, the authors suggest that monitoring coverage for blacks and Hispanics for DTP and pneumococcal vaccine especially is important, given that there is a higher incidence of pneumococcal disease in black children.

There still are significant differences in coverage among the states. It is highest in Massachusetts, at 91% coverage overall, and lowest in Vermont, at 63%. Dr. Schuchat said differences in coverage might be caused by varying rates of commitment by localities and pediatricians, and strength of immunization programs.

Uptake of vaccines is tracked, but generally not reported in the first few years a product has been added to the vaccination schedule, said Dr. Schuchat. The varicella vaccine was added to the recommended list in 2000, so its uptake has been recorded but not reported until this year.

Pneumococcal vaccine use is being tracked but is not included as part of the formal overall coverage target for 2005, said Dr. Schuchat. There were concerns that uptake would be slowed by both expense and a shortage during February to September 2004, but that has not proven to be the case, she said. In 2005, more than 50% of children received four doses, and more than 80% had three or more doses.

The annual NIS is compiled from quarterly random-digit dialing to sample parents of children aged 19–35 months. Immunization coverage is confirmed with providers' records. In 2005, records were obtained for 17,563 children.

In an attempt to pull together all the relevant data into one consensus reference guide, several prominent American and European cardiology professional organizations have issued guidelines for the diagnosis and treatment of ventricular arrhythmias and the prevention of sudden cardiac death.

The guidelines were issued by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology, and were developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

The joint statement consolidates at least 24 guidelines, papers, and statements, and incorporates evidence accumulated since publication of those various reports. It addresses acute and chronic therapies, including pharmacologic interventions, surgery and revascularization, ablation, and implantation of implantable cardioverter defibrillators (ICDs), and other devices.

“We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias,” Dr. A. John Camm, European cochair of the guideline writing committee, said in a statement. “We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S.”

The guidelines are “an attempt to summarize the state of knowledge and put it into usable recommendations for the practicing clinician,” Dr. Robert J. Myerburg, a spokesman for the ACC and a professor of medicine and physiology at the University of Miami, said in an interview.

“There will be new information coming out which will modify the approaches recommended in this document,” he said, but he added that it is unlikely that the guidelines will be updated soon as it took 3 years to pull them together. “So much effort went into it in terms of getting consensus and smoothing out the points where there were various viewpoints.”

One area where varying viewpoints were brought together: recommendations for prophylactic implantable defibrillator implantation.

“The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut-off value for enrollment, and subgroup analyses of clinical trial populations based on ejection fraction have not been consistent in their implications,” said Dr. Douglas P. Zipes, cochair of the guideline writing committee. “The result was substantial differences among guidelines.”

The joint guidelines make recommendations for ejection fractions less than or equal to a range of values.

For instance, in various guidelines issued over the last few years, European and American cardiology societies had each reached somewhat different conclusions on the levels of evidence supporting ICDs as primary prevention for patients with left ventricular dysfunction due to a prior myocardial infarction, New York Heart Association class II or III heart failure, and ejection fractions of 30% or less, or of 30%–35%.

The ACC/AHA/ESC guidelines reached the consensus that for all patients with left ventricular dysfunction as a result of a previous MI, there is class I, level A evidence that ICD implantation is an appropriate preventive therapy.

These are recommendations—not standards, said Dr. Myerburg, adding that cultural, financial, and societal considerations may affect how the guidelines are applied. The guidelines “take into consideration that not all therapies and recommendations are available in all segments of society” or everywhere in the world.

The guidelines' executive summary is published in the societies' journals and can be viewed online at the ACC, AHA, and ESC Web sites.

In an attempt to pull together all the relevant data into one consensus reference guide, several prominent American and European cardiology professional organizations have issued guidelines for the diagnosis and treatment of ventricular arrhythmias and the prevention of sudden cardiac death.

The guidelines were issued by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology, and were developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

The joint statement consolidates at least 24 guidelines, papers, and statements, and incorporates evidence accumulated since publication of those various reports. It addresses acute and chronic therapies, including pharmacologic interventions, surgery and revascularization, ablation, and implantation of implantable cardioverter defibrillators (ICDs), and other devices.

“We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias,” Dr. A. John Camm, European cochair of the guideline writing committee, said in a statement. “We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S.”

The guidelines are “an attempt to summarize the state of knowledge and put it into usable recommendations for the practicing clinician,” Dr. Robert J. Myerburg, a spokesman for the ACC and a professor of medicine and physiology at the University of Miami, said in an interview.

“There will be new information coming out which will modify the approaches recommended in this document,” he said, but he added that it is unlikely that the guidelines will be updated soon as it took 3 years to pull them together. “So much effort went into it in terms of getting consensus and smoothing out the points where there were various viewpoints.”

One area where varying viewpoints were brought together: recommendations for prophylactic implantable defibrillator implantation.

“The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut-off value for enrollment, and subgroup analyses of clinical trial populations based on ejection fraction have not been consistent in their implications,” said Dr. Douglas P. Zipes, cochair of the guideline writing committee. “The result was substantial differences among guidelines.”

The joint guidelines make recommendations for ejection fractions less than or equal to a range of values.

For instance, in various guidelines issued over the last few years, European and American cardiology societies had each reached somewhat different conclusions on the levels of evidence supporting ICDs as primary prevention for patients with left ventricular dysfunction due to a prior myocardial infarction, New York Heart Association class II or III heart failure, and ejection fractions of 30% or less, or of 30%–35%.

The ACC/AHA/ESC guidelines reached the consensus that for all patients with left ventricular dysfunction as a result of a previous MI, there is class I, level A evidence that ICD implantation is an appropriate preventive therapy.

These are recommendations—not standards, said Dr. Myerburg, adding that cultural, financial, and societal considerations may affect how the guidelines are applied. The guidelines “take into consideration that not all therapies and recommendations are available in all segments of society” or everywhere in the world.

The guidelines' executive summary is published in the societies' journals and can be viewed online at the ACC, AHA, and ESC Web sites.

In an attempt to pull together all the relevant data into one consensus reference guide, several prominent American and European cardiology professional organizations have issued guidelines for the diagnosis and treatment of ventricular arrhythmias and the prevention of sudden cardiac death.

The guidelines were issued by the American College of Cardiology, the American Heart Association, and the European Society of Cardiology, and were developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society.

The joint statement consolidates at least 24 guidelines, papers, and statements, and incorporates evidence accumulated since publication of those various reports. It addresses acute and chronic therapies, including pharmacologic interventions, surgery and revascularization, ablation, and implantation of implantable cardioverter defibrillators (ICDs), and other devices.

“We have consciously attempted to create a streamlined document that would be useful specifically to locate recommendations on the evaluation and treatment of patients who have or may be at risk for ventricular arrhythmias,” Dr. A. John Camm, European cochair of the guideline writing committee, said in a statement. “We are pleased that this consensus document has the support of all the major cardiovascular societies in Europe and the U.S.”

The guidelines are “an attempt to summarize the state of knowledge and put it into usable recommendations for the practicing clinician,” Dr. Robert J. Myerburg, a spokesman for the ACC and a professor of medicine and physiology at the University of Miami, said in an interview.

“There will be new information coming out which will modify the approaches recommended in this document,” he said, but he added that it is unlikely that the guidelines will be updated soon as it took 3 years to pull them together. “So much effort went into it in terms of getting consensus and smoothing out the points where there were various viewpoints.”

One area where varying viewpoints were brought together: recommendations for prophylactic implantable defibrillator implantation.

“The inconsistencies occurred because clinical investigators chose different ejection fractions for enrollment in trials of therapy, average values of the ejection fraction have been substantially lower than the cut-off value for enrollment, and subgroup analyses of clinical trial populations based on ejection fraction have not been consistent in their implications,” said Dr. Douglas P. Zipes, cochair of the guideline writing committee. “The result was substantial differences among guidelines.”

The joint guidelines make recommendations for ejection fractions less than or equal to a range of values.

For instance, in various guidelines issued over the last few years, European and American cardiology societies had each reached somewhat different conclusions on the levels of evidence supporting ICDs as primary prevention for patients with left ventricular dysfunction due to a prior myocardial infarction, New York Heart Association class II or III heart failure, and ejection fractions of 30% or less, or of 30%–35%.

The ACC/AHA/ESC guidelines reached the consensus that for all patients with left ventricular dysfunction as a result of a previous MI, there is class I, level A evidence that ICD implantation is an appropriate preventive therapy.

These are recommendations—not standards, said Dr. Myerburg, adding that cultural, financial, and societal considerations may affect how the guidelines are applied. The guidelines “take into consideration that not all therapies and recommendations are available in all segments of society” or everywhere in the world.

The guidelines' executive summary is published in the societies' journals and can be viewed online at the ACC, AHA, and ESC Web sites.

After reviewing nursing homes' emergency plans and outcomes of evacuations and sheltering for the last two hurricane seasons, the Health and Human Services Department's Office of Inspector General has suggested that the Centers for Medicare and Medicaid Services strengthen federal emergency management standards for long-term care facilities.

Of the 16,125 nursing homes inspected nationwide in 2004 and 2005, 94% met federal standards for emergency plans, and 80% met those standards for emergency training, the OIG said.

The rates were similar for the 2,526 facilities in the Gulf states of Alabama, Florida, Louisiana, Mississippi, and Texas, according to the OIG's report. But it found in many cases that nursing home administrators and staff did not follow their own plans, or lacked transportation or other resources to effect those plans in a crisis.

The office reviewed state survey data for emergency preparedness and interviewed nursing home staff and administrators and local authorities in nine counties across the five affected states. The OIG took an in-depth look at plans from 20 nursing homes caught in hurricanes Ivan in September 2004, Katrina in August 2005, Rita in September 2005, and Wilma in October 2005, and compared those plans to provisions required by state law.

All 20 homes ran into challenges, whether they evacuated or not. All administrators said evacuation was not necessarily the best course of action as it could cause physical and mental stress. They also cited transportation contracts that weren't honored, complicated medication needs, and host facilities that were not available or prepared to receive evacuees.

Homes where patients were sheltered in place did not have as many problems overall but still had staffing and supplies issues.

At 5 of the 20 homes, administrators said they deviated from the prepared plan because the plan wasn't up to date or did not address their situation.

Six of the homes did not have instructions on how to evacuate to an alternative site, 9 did not have any guidance on how to determine whether to evacuate or shelter in place, and 11 did not have any instructions on how to return to the homes after an evacuation.

Still, Dr. John Morley, director of the division of geriatric medicine for St. Louis University, said there is a need for an additional plan, saying this is an issue that “goes beyond a local plan and expecting nursing homes to do everything themselves.” He said “local police, emergency units, and everyone needs to be involved.”

The reality is that evacuation plans have to go beyond the facility because “if something goes wrong, it will affect” the entire area, Dr. Morley said. A facility may plan to use local buildings in an extended outage, but if there is a major disaster, “you probably have to move to another county.” Dr. Morley said the issue is not only having a plan and following it but “knowing when to evacuate,” given the risks of moving such a vulnerable population.

Indeed, during Katrina, facilities that did not evacuate were criticized, and others that tried to move to Houston had tragic deaths, Dr. Morley noted. He said emergency planning falls apart in older populations, including those in home care and hospice care, because “no one is very interested. We're an ageist society—we don't like old people so we don't plan for them. Then, we get all upset when things go wrong.”

Dr. Morley also stressed the need for an “electronic database” to help track patients as part of disaster preparedness.

The challenge of evacuations was underscored in the Sept. 21 grand jury indictments against two nursing home owners in New Orleans' St. Bernard Parish. The Katrina surge flooded the one-story facility to the ceiling in 20 minutes. The owners, Mabel and Salvador Mangano, were charged with negligent homicide in the drowning of 35 residents. However, they have maintained their innocence, saying they were worried that frail residents wouldn't survive the ordeal of an evacuation.

After reviewing nursing homes' emergency plans and outcomes of evacuations and sheltering for the last two hurricane seasons, the Health and Human Services Department's Office of Inspector General has suggested that the Centers for Medicare and Medicaid Services strengthen federal emergency management standards for long-term care facilities.

Of the 16,125 nursing homes inspected nationwide in 2004 and 2005, 94% met federal standards for emergency plans, and 80% met those standards for emergency training, the OIG said.

The rates were similar for the 2,526 facilities in the Gulf states of Alabama, Florida, Louisiana, Mississippi, and Texas, according to the OIG's report. But it found in many cases that nursing home administrators and staff did not follow their own plans, or lacked transportation or other resources to effect those plans in a crisis.

The office reviewed state survey data for emergency preparedness and interviewed nursing home staff and administrators and local authorities in nine counties across the five affected states. The OIG took an in-depth look at plans from 20 nursing homes caught in hurricanes Ivan in September 2004, Katrina in August 2005, Rita in September 2005, and Wilma in October 2005, and compared those plans to provisions required by state law.

All 20 homes ran into challenges, whether they evacuated or not. All administrators said evacuation was not necessarily the best course of action as it could cause physical and mental stress. They also cited transportation contracts that weren't honored, complicated medication needs, and host facilities that were not available or prepared to receive evacuees.

Homes where patients were sheltered in place did not have as many problems overall but still had staffing and supplies issues.

At 5 of the 20 homes, administrators said they deviated from the prepared plan because the plan wasn't up to date or did not address their situation.

Six of the homes did not have instructions on how to evacuate to an alternative site, 9 did not have any guidance on how to determine whether to evacuate or shelter in place, and 11 did not have any instructions on how to return to the homes after an evacuation.

Still, Dr. John Morley, director of the division of geriatric medicine for St. Louis University, said there is a need for an additional plan, saying this is an issue that “goes beyond a local plan and expecting nursing homes to do everything themselves.” He said “local police, emergency units, and everyone needs to be involved.”

The reality is that evacuation plans have to go beyond the facility because “if something goes wrong, it will affect” the entire area, Dr. Morley said. A facility may plan to use local buildings in an extended outage, but if there is a major disaster, “you probably have to move to another county.” Dr. Morley said the issue is not only having a plan and following it but “knowing when to evacuate,” given the risks of moving such a vulnerable population.

Indeed, during Katrina, facilities that did not evacuate were criticized, and others that tried to move to Houston had tragic deaths, Dr. Morley noted. He said emergency planning falls apart in older populations, including those in home care and hospice care, because “no one is very interested. We're an ageist society—we don't like old people so we don't plan for them. Then, we get all upset when things go wrong.”

Dr. Morley also stressed the need for an “electronic database” to help track patients as part of disaster preparedness.

The challenge of evacuations was underscored in the Sept. 21 grand jury indictments against two nursing home owners in New Orleans' St. Bernard Parish. The Katrina surge flooded the one-story facility to the ceiling in 20 minutes. The owners, Mabel and Salvador Mangano, were charged with negligent homicide in the drowning of 35 residents. However, they have maintained their innocence, saying they were worried that frail residents wouldn't survive the ordeal of an evacuation.

After reviewing nursing homes' emergency plans and outcomes of evacuations and sheltering for the last two hurricane seasons, the Health and Human Services Department's Office of Inspector General has suggested that the Centers for Medicare and Medicaid Services strengthen federal emergency management standards for long-term care facilities.

Of the 16,125 nursing homes inspected nationwide in 2004 and 2005, 94% met federal standards for emergency plans, and 80% met those standards for emergency training, the OIG said.

The rates were similar for the 2,526 facilities in the Gulf states of Alabama, Florida, Louisiana, Mississippi, and Texas, according to the OIG's report. But it found in many cases that nursing home administrators and staff did not follow their own plans, or lacked transportation or other resources to effect those plans in a crisis.

The office reviewed state survey data for emergency preparedness and interviewed nursing home staff and administrators and local authorities in nine counties across the five affected states. The OIG took an in-depth look at plans from 20 nursing homes caught in hurricanes Ivan in September 2004, Katrina in August 2005, Rita in September 2005, and Wilma in October 2005, and compared those plans to provisions required by state law.

All 20 homes ran into challenges, whether they evacuated or not. All administrators said evacuation was not necessarily the best course of action as it could cause physical and mental stress. They also cited transportation contracts that weren't honored, complicated medication needs, and host facilities that were not available or prepared to receive evacuees.

Homes where patients were sheltered in place did not have as many problems overall but still had staffing and supplies issues.

At 5 of the 20 homes, administrators said they deviated from the prepared plan because the plan wasn't up to date or did not address their situation.

Six of the homes did not have instructions on how to evacuate to an alternative site, 9 did not have any guidance on how to determine whether to evacuate or shelter in place, and 11 did not have any instructions on how to return to the homes after an evacuation.

Still, Dr. John Morley, director of the division of geriatric medicine for St. Louis University, said there is a need for an additional plan, saying this is an issue that “goes beyond a local plan and expecting nursing homes to do everything themselves.” He said “local police, emergency units, and everyone needs to be involved.”

The reality is that evacuation plans have to go beyond the facility because “if something goes wrong, it will affect” the entire area, Dr. Morley said. A facility may plan to use local buildings in an extended outage, but if there is a major disaster, “you probably have to move to another county.” Dr. Morley said the issue is not only having a plan and following it but “knowing when to evacuate,” given the risks of moving such a vulnerable population.

Indeed, during Katrina, facilities that did not evacuate were criticized, and others that tried to move to Houston had tragic deaths, Dr. Morley noted. He said emergency planning falls apart in older populations, including those in home care and hospice care, because “no one is very interested. We're an ageist society—we don't like old people so we don't plan for them. Then, we get all upset when things go wrong.”

Dr. Morley also stressed the need for an “electronic database” to help track patients as part of disaster preparedness.

The challenge of evacuations was underscored in the Sept. 21 grand jury indictments against two nursing home owners in New Orleans' St. Bernard Parish. The Katrina surge flooded the one-story facility to the ceiling in 20 minutes. The owners, Mabel and Salvador Mangano, were charged with negligent homicide in the drowning of 35 residents. However, they have maintained their innocence, saying they were worried that frail residents wouldn't survive the ordeal of an evacuation.