Diana Mahoney

BOSTON — “E-prescribing saves lives, it saves money, and it's time we implement it,” according to Health and Human Services Secretary Mike Leavitt.

However, streamlining the bloated health care system “is an economic imperative for our country. We have to get down to making the system better, and [e-prescribing] is one piece of a large puzzle,” Secretary Leavitt commented at a conference on e-prescribing sponsored by the Centers for Medicare and Medicaid Services.

After acknowledging that “change is hard,” especially change that requires substantial time and money, Secretary Leavitt assured meeting attendees that the benefits of implementing an electronic prescribing system would quickly exceed the costs, thanks in large part to the incentive program provided under the Medicare Improvements for Patients and Providers Act of 2008.

Under MIPPA, physicians who use a qualified e-prescribing system for their Medicare patients will be eligible to receive a bonus of 2% of their Medicare revenue in 2009 and 2010.

The bonus amount will decrease to 1% of total Medicare revenue in 2011 and 2012, and to 0.5% in 2013. Beginning in 2014, physicians who are not prescribing electronically will see their Medicare payments reduced by as much as 2%.

From the government's perspective, the business case for e-prescribing is a “no-brainer,” according to acting CMS administrator Kerry Weems, as widespread implementation of the technology could save Medicare $13 million-$146 million between 2009 and 2013.

The savings, he said, will be achieved through averted medication errors and the substitution of less-expensive prescription drug alternatives.

Specifically, “errors associated with illegible handwriting are eliminated and those linked to oral miscommunications are substantially reduced because the process is automated,” he said.

Additionally, e-prescribing software provides secure electronic access to each patient's prescription history and automatically alerts physicians to dangerous drug interactions and allergies, thereby minimizing the potential for both.

E-prescribing also promises advantages that will have a positive impact on physician bottom lines, Mr. Weems said.

Automating the prescribing process reduces time spent on phone calls and faxes to pharmacies, speeds the prescription renewal request and authorization process, increases medication compliance, improves formulary adherence, allows greater prescriber mobility, and improves drug surveillance.

Together with the promised bonuses (and future penalties) for e-prescribing, the argument in favor of technology is gaining steam.

“With MIPPA, Congress has helped us solve the business equation side of e-prescribing,” he said.

Without question, the financial incentives improve the case for converting from traditional to electronic prescribing, Mr. Weems said, noting that the average e-prescribing primary care doctor stands to collect between $2,000 and $3,000 in bonuses in 2009 and the cost of an e-prescribing system ranges from $2,500 to $3,000.

The psychological obstacles, on the other hand, may be tougher to knock down, according to Secretary Leavitt.

“There's always going to be resistance to change, and in this case, some of it is well thought out: 'I've got training costs; there's likely to be a productivity dip; do I really want my business to go through this?' Those are the kinds of things that are part of any sort of business process change, and such change doesn't happen overnight,” he said.

To help facilitate the change, the eHealth Initiative, in collaboration with physicians groups like the American Medical Association, the American Academy of Family Physicians, the Medical Group Management Association, as well as the Center for Improving Medication Management, has published “A Clinician's Guide to Electronic Prescribing.”

The guide offers practical information on planning, selecting, and implementing an e-prescribing system.

The guide “is an invaluable resource provides substantial detail not only on how to get started but what challenges to expect and how to overcome them,” said Dr. Steven E. Waldren, who is the director of the American Academy of Family Physician's Center for Health Information Technology.

Other challenges that are currently hindering the widespread adoption of e-prescribing by physicians, according to the guide, include work flow changes, the continued need for improved connectivity and technology, state regulatory restrictions (for example, the New York State Medicaid requirement that the “dispense as written” instruction be handwritten), and the need for reconciled medication histories.

For a copy of “A Clinician's Guide to Electronic Prescribing,” visit www.ehealthinitiative.org

ELSEVIER GLOBAL MEDICAL NEWS

This Month's Talk Back Question

What is your strategy for implementing e-prescribing in your practice?

Basic Requirement for E-Prescribing Bonus: A 'Qualified' Prescribing System

A list of vendors of compliant e-prescribing systems is available online at

http://www.surescripts.com

Integrating an electronic prescribing system into a medical practice and qualifying for the promised Medicare bonus for doing so “isn't as straightforward as it sounds,” an audience member observed at the conference.

While panel member Dr. Michael Rapp, director of the Centers for Medicare and Medicaid Services Quality Measurement and Health Assessment Group, agreed that the process does require careful consideration, he assured attendees that “most office-based doctors would meet the basic eligibility requirements.”

Chief among these basic requirements are the use of an e-prescribing system that meets the 2009 Medicare Part D standards, which go into effect in April 2009, and properly reporting e-prescribing activity, according to Dr. Rapp.

Under the Physician Quality Reporting Initiative (PQRI) measure No. 125, “qualified” e-prescribing systems must be able to generate a medication list; provide information on lower-cost alternative medications; transmit prescriptions directly to the pharmacy; generate automated alerts offering information on the drug, potential inappropriate dose of route of administration, drug-drug interactions, allergy concerns, and warnings; and provide information on tiered formulary medications, he said.

Whether these criteria are met by a stand-alone e-prescribing system or a full-blown electronic health record (EHR) system with an e-prescribing module does not affect eligibility, said Dr. Rapp. “It is important to think long term when choosing what type of system to buy. Although a full EHR system is not necessary now, it very likely will be a requirement in the future, so think about buying something that will enable the eventual transition to an EHR.”

With respect to documenting e-prescribing activity, physicians must report on the Medicare claim form that they have and use a qualified e-prescribing system, and they must report an encounter with one of several CPT or G-codes specified in the measure (

www.cms.hhs.gov/eprescribing

“Successful reporting,” according to Dr. Rapp, “is defined as reporting the measure on at least 50% of eligible patients.”

Additionally, physicians must receive at least 10% of their total allowed charges for Medicare Part B covered services from these codes, he explained.

The details of the 2009 e-prescribing incentive program were still being tweaked at press time, Dr. Rapp stated.

BOSTON — “E-prescribing saves lives, it saves money, and it's time we implement it,” according to Health and Human Services Secretary Mike Leavitt.

However, streamlining the bloated health care system “is an economic imperative for our country. We have to get down to making the system better, and [e-prescribing] is one piece of a large puzzle,” Secretary Leavitt commented at a conference on e-prescribing sponsored by the Centers for Medicare and Medicaid Services.

After acknowledging that “change is hard,” especially change that requires substantial time and money, Secretary Leavitt assured meeting attendees that the benefits of implementing an electronic prescribing system would quickly exceed the costs, thanks in large part to the incentive program provided under the Medicare Improvements for Patients and Providers Act of 2008.

Under MIPPA, physicians who use a qualified e-prescribing system for their Medicare patients will be eligible to receive a bonus of 2% of their Medicare revenue in 2009 and 2010.

The bonus amount will decrease to 1% of total Medicare revenue in 2011 and 2012, and to 0.5% in 2013. Beginning in 2014, physicians who are not prescribing electronically will see their Medicare payments reduced by as much as 2%.

From the government's perspective, the business case for e-prescribing is a “no-brainer,” according to acting CMS administrator Kerry Weems, as widespread implementation of the technology could save Medicare $13 million-$146 million between 2009 and 2013.

The savings, he said, will be achieved through averted medication errors and the substitution of less-expensive prescription drug alternatives.

Specifically, “errors associated with illegible handwriting are eliminated and those linked to oral miscommunications are substantially reduced because the process is automated,” he said.

Additionally, e-prescribing software provides secure electronic access to each patient's prescription history and automatically alerts physicians to dangerous drug interactions and allergies, thereby minimizing the potential for both.

E-prescribing also promises advantages that will have a positive impact on physician bottom lines, Mr. Weems said.

Automating the prescribing process reduces time spent on phone calls and faxes to pharmacies, speeds the prescription renewal request and authorization process, increases medication compliance, improves formulary adherence, allows greater prescriber mobility, and improves drug surveillance.

Together with the promised bonuses (and future penalties) for e-prescribing, the argument in favor of technology is gaining steam.

“With MIPPA, Congress has helped us solve the business equation side of e-prescribing,” he said.

Without question, the financial incentives improve the case for converting from traditional to electronic prescribing, Mr. Weems said, noting that the average e-prescribing primary care doctor stands to collect between $2,000 and $3,000 in bonuses in 2009 and the cost of an e-prescribing system ranges from $2,500 to $3,000.

The psychological obstacles, on the other hand, may be tougher to knock down, according to Secretary Leavitt.

“There's always going to be resistance to change, and in this case, some of it is well thought out: 'I've got training costs; there's likely to be a productivity dip; do I really want my business to go through this?' Those are the kinds of things that are part of any sort of business process change, and such change doesn't happen overnight,” he said.

To help facilitate the change, the eHealth Initiative, in collaboration with physicians groups like the American Medical Association, the American Academy of Family Physicians, the Medical Group Management Association, as well as the Center for Improving Medication Management, has published “A Clinician's Guide to Electronic Prescribing.”

The guide offers practical information on planning, selecting, and implementing an e-prescribing system.

The guide “is an invaluable resource provides substantial detail not only on how to get started but what challenges to expect and how to overcome them,” said Dr. Steven E. Waldren, who is the director of the American Academy of Family Physician's Center for Health Information Technology.

Other challenges that are currently hindering the widespread adoption of e-prescribing by physicians, according to the guide, include work flow changes, the continued need for improved connectivity and technology, state regulatory restrictions (for example, the New York State Medicaid requirement that the “dispense as written” instruction be handwritten), and the need for reconciled medication histories.

For a copy of “A Clinician's Guide to Electronic Prescribing,” visit www.ehealthinitiative.org

ELSEVIER GLOBAL MEDICAL NEWS

This Month's Talk Back Question

What is your strategy for implementing e-prescribing in your practice?

Basic Requirement for E-Prescribing Bonus: A 'Qualified' Prescribing System

A list of vendors of compliant e-prescribing systems is available online at

http://www.surescripts.com

Integrating an electronic prescribing system into a medical practice and qualifying for the promised Medicare bonus for doing so “isn't as straightforward as it sounds,” an audience member observed at the conference.

While panel member Dr. Michael Rapp, director of the Centers for Medicare and Medicaid Services Quality Measurement and Health Assessment Group, agreed that the process does require careful consideration, he assured attendees that “most office-based doctors would meet the basic eligibility requirements.”

Chief among these basic requirements are the use of an e-prescribing system that meets the 2009 Medicare Part D standards, which go into effect in April 2009, and properly reporting e-prescribing activity, according to Dr. Rapp.

Under the Physician Quality Reporting Initiative (PQRI) measure No. 125, “qualified” e-prescribing systems must be able to generate a medication list; provide information on lower-cost alternative medications; transmit prescriptions directly to the pharmacy; generate automated alerts offering information on the drug, potential inappropriate dose of route of administration, drug-drug interactions, allergy concerns, and warnings; and provide information on tiered formulary medications, he said.

Whether these criteria are met by a stand-alone e-prescribing system or a full-blown electronic health record (EHR) system with an e-prescribing module does not affect eligibility, said Dr. Rapp. “It is important to think long term when choosing what type of system to buy. Although a full EHR system is not necessary now, it very likely will be a requirement in the future, so think about buying something that will enable the eventual transition to an EHR.”

With respect to documenting e-prescribing activity, physicians must report on the Medicare claim form that they have and use a qualified e-prescribing system, and they must report an encounter with one of several CPT or G-codes specified in the measure (

www.cms.hhs.gov/eprescribing

“Successful reporting,” according to Dr. Rapp, “is defined as reporting the measure on at least 50% of eligible patients.”

Additionally, physicians must receive at least 10% of their total allowed charges for Medicare Part B covered services from these codes, he explained.

The details of the 2009 e-prescribing incentive program were still being tweaked at press time, Dr. Rapp stated.

BOSTON — “E-prescribing saves lives, it saves money, and it's time we implement it,” according to Health and Human Services Secretary Mike Leavitt.

However, streamlining the bloated health care system “is an economic imperative for our country. We have to get down to making the system better, and [e-prescribing] is one piece of a large puzzle,” Secretary Leavitt commented at a conference on e-prescribing sponsored by the Centers for Medicare and Medicaid Services.

After acknowledging that “change is hard,” especially change that requires substantial time and money, Secretary Leavitt assured meeting attendees that the benefits of implementing an electronic prescribing system would quickly exceed the costs, thanks in large part to the incentive program provided under the Medicare Improvements for Patients and Providers Act of 2008.

Under MIPPA, physicians who use a qualified e-prescribing system for their Medicare patients will be eligible to receive a bonus of 2% of their Medicare revenue in 2009 and 2010.

The bonus amount will decrease to 1% of total Medicare revenue in 2011 and 2012, and to 0.5% in 2013. Beginning in 2014, physicians who are not prescribing electronically will see their Medicare payments reduced by as much as 2%.

From the government's perspective, the business case for e-prescribing is a “no-brainer,” according to acting CMS administrator Kerry Weems, as widespread implementation of the technology could save Medicare $13 million-$146 million between 2009 and 2013.

The savings, he said, will be achieved through averted medication errors and the substitution of less-expensive prescription drug alternatives.

Specifically, “errors associated with illegible handwriting are eliminated and those linked to oral miscommunications are substantially reduced because the process is automated,” he said.

Additionally, e-prescribing software provides secure electronic access to each patient's prescription history and automatically alerts physicians to dangerous drug interactions and allergies, thereby minimizing the potential for both.

E-prescribing also promises advantages that will have a positive impact on physician bottom lines, Mr. Weems said.

Automating the prescribing process reduces time spent on phone calls and faxes to pharmacies, speeds the prescription renewal request and authorization process, increases medication compliance, improves formulary adherence, allows greater prescriber mobility, and improves drug surveillance.

Together with the promised bonuses (and future penalties) for e-prescribing, the argument in favor of technology is gaining steam.

“With MIPPA, Congress has helped us solve the business equation side of e-prescribing,” he said.

Without question, the financial incentives improve the case for converting from traditional to electronic prescribing, Mr. Weems said, noting that the average e-prescribing primary care doctor stands to collect between $2,000 and $3,000 in bonuses in 2009 and the cost of an e-prescribing system ranges from $2,500 to $3,000.

The psychological obstacles, on the other hand, may be tougher to knock down, according to Secretary Leavitt.

“There's always going to be resistance to change, and in this case, some of it is well thought out: 'I've got training costs; there's likely to be a productivity dip; do I really want my business to go through this?' Those are the kinds of things that are part of any sort of business process change, and such change doesn't happen overnight,” he said.

To help facilitate the change, the eHealth Initiative, in collaboration with physicians groups like the American Medical Association, the American Academy of Family Physicians, the Medical Group Management Association, as well as the Center for Improving Medication Management, has published “A Clinician's Guide to Electronic Prescribing.”

The guide offers practical information on planning, selecting, and implementing an e-prescribing system.

The guide “is an invaluable resource provides substantial detail not only on how to get started but what challenges to expect and how to overcome them,” said Dr. Steven E. Waldren, who is the director of the American Academy of Family Physician's Center for Health Information Technology.

Other challenges that are currently hindering the widespread adoption of e-prescribing by physicians, according to the guide, include work flow changes, the continued need for improved connectivity and technology, state regulatory restrictions (for example, the New York State Medicaid requirement that the “dispense as written” instruction be handwritten), and the need for reconciled medication histories.

For a copy of “A Clinician's Guide to Electronic Prescribing,” visit www.ehealthinitiative.org

ELSEVIER GLOBAL MEDICAL NEWS

This Month's Talk Back Question

What is your strategy for implementing e-prescribing in your practice?

Basic Requirement for E-Prescribing Bonus: A 'Qualified' Prescribing System

A list of vendors of compliant e-prescribing systems is available online at

http://www.surescripts.com

Integrating an electronic prescribing system into a medical practice and qualifying for the promised Medicare bonus for doing so “isn't as straightforward as it sounds,” an audience member observed at the conference.

While panel member Dr. Michael Rapp, director of the Centers for Medicare and Medicaid Services Quality Measurement and Health Assessment Group, agreed that the process does require careful consideration, he assured attendees that “most office-based doctors would meet the basic eligibility requirements.”

Chief among these basic requirements are the use of an e-prescribing system that meets the 2009 Medicare Part D standards, which go into effect in April 2009, and properly reporting e-prescribing activity, according to Dr. Rapp.

Under the Physician Quality Reporting Initiative (PQRI) measure No. 125, “qualified” e-prescribing systems must be able to generate a medication list; provide information on lower-cost alternative medications; transmit prescriptions directly to the pharmacy; generate automated alerts offering information on the drug, potential inappropriate dose of route of administration, drug-drug interactions, allergy concerns, and warnings; and provide information on tiered formulary medications, he said.

Whether these criteria are met by a stand-alone e-prescribing system or a full-blown electronic health record (EHR) system with an e-prescribing module does not affect eligibility, said Dr. Rapp. “It is important to think long term when choosing what type of system to buy. Although a full EHR system is not necessary now, it very likely will be a requirement in the future, so think about buying something that will enable the eventual transition to an EHR.”

With respect to documenting e-prescribing activity, physicians must report on the Medicare claim form that they have and use a qualified e-prescribing system, and they must report an encounter with one of several CPT or G-codes specified in the measure (

www.cms.hhs.gov/eprescribing

“Successful reporting,” according to Dr. Rapp, “is defined as reporting the measure on at least 50% of eligible patients.”

Additionally, physicians must receive at least 10% of their total allowed charges for Medicare Part B covered services from these codes, he explained.

The details of the 2009 e-prescribing incentive program were still being tweaked at press time, Dr. Rapp stated.

Residual soft tissue and bone edema associated with diagnostic or surgical intervention for suspected osteomyelitis or septic arthritis do not diminish the value of subsequent magnetic resonance imaging in children with persistent signs of infection, a study has shown.

The issue under investigation was whether iatrogenic injury to soft tissue or marrow before an MRI study interferes with the clinician's ability to exclude infection or diagnose alternative causes for symptoms that remain despite a negative result after intervention.

Dr. J. Herman Kan of Vanderbilt Children's Hospital, Nashville, Tenn., and his colleagues conducted a retrospective case-control study using data from patients who underwent emergent contrast-enhanced MRI examinations that were performed for suspected osteomyelitis or septic arthritis at the hospital from March 2002 through September 2007.

Of the initial 136 MRI examinations, the analysis included only the 34 performed within 10 days after an initial diagnostic or surgical intervention, such as joint, marrow, or soft-tissue aspiration; arthrotomy; or incision and drainage of bone or soft tissue. The study control group consisted of 96 patients who underwent MRI for suspected osteomyelitis or septic arthritis during the same period but who did not have a prior intervention.

Pediatric radiologists with additional training in pediatric musculoskeletal radiology performed consensus reviews of the images to assess whether objective MRI criteria could still be applied to those patients who had undergone recent intervention. They also evaluated the presence or absence of specific MRI features of osteomyelitis that could neither be attributed to the recent intervention nor were suggestive of a noninfectious alternative diagnosis. Such features included intraosseous abscess, cortical breach, subperiosteal abscess, and soft-tissue or bone edema, the authors wrote in the November 2008 issue of the American Journal of Roentgenology.

The reviewing radiologists had knowledge of the location of the prior intervention and the final discharge diagnosis, they noted (Am. J. Roentgenol. 2008;191: 1595–600).

In 10 of the 34 study group patients (29%), the MRI findings led to a need for additional intervention, which was similar to the control group, in which the MRI findings pointed to further intervention for 26 of the 96 control group patients (27%), the authors reported. The groups did not differ significantly in the number of patients with a final diagnosis of osteomyelitis, osteomyelitis or septic arthritis, cellulitis or pyomyositis, and noninfectious conditions, they stated.

A total of nine patients had a final diagnosis of osteomyelitis, and “objective MRI criteria were present in all nine patients,” the authors wrote, while none of the remaining 25 patients had characteristic imaging features of osteomyelitis. Among the patients with an osteomyelitis diagnosis, “eight of nine had one or more imaging criteria of osteomyelitis, including intraosseous abscess, cortical breach, or subperiosteal abscess,” they said. The ninth subject was diagnosed with acetabular osteomyelitis based on evidence of marrow and soft-tissue edema in the obturator internus muscle, away from the intervention site.

The findings suggest that musculoskeletal MRI “plays an important role in the management of these patients because of its ability to evaluate underlying osteomyelitis despite recent intervention,” according to the authors. With correct clinical and surgical history, they wrote, “patterns of soft-tissue and marrow edema can be explained.”

Though intervention-related iatrogenic changes do not affect MRI's diagnostic efficacy in suspected osteomyelitis or septic arthritis, “MRI before intervention adds efficacy to patient management, guides the surgical procedure, and prevents additional surgery in children with suspected pelvic or appendicular osteomyelitis or septic arthritis,” the authors concluded.

Right foot after IV administration of gadolinium shows large soft-tissue abscess (arrows) and intraosseous calcaneal abscess (arrowhead).

T2-weighted humerus, intramedullary, and subperiosteal abscess (arrows).

Corresponding T1-weighted image of the distal humerus, shown above. Images courtesy Dr. J. Herman Kan

Residual soft tissue and bone edema associated with diagnostic or surgical intervention for suspected osteomyelitis or septic arthritis do not diminish the value of subsequent magnetic resonance imaging in children with persistent signs of infection, a study has shown.

The issue under investigation was whether iatrogenic injury to soft tissue or marrow before an MRI study interferes with the clinician's ability to exclude infection or diagnose alternative causes for symptoms that remain despite a negative result after intervention.

Dr. J. Herman Kan of Vanderbilt Children's Hospital, Nashville, Tenn., and his colleagues conducted a retrospective case-control study using data from patients who underwent emergent contrast-enhanced MRI examinations that were performed for suspected osteomyelitis or septic arthritis at the hospital from March 2002 through September 2007.

Of the initial 136 MRI examinations, the analysis included only the 34 performed within 10 days after an initial diagnostic or surgical intervention, such as joint, marrow, or soft-tissue aspiration; arthrotomy; or incision and drainage of bone or soft tissue. The study control group consisted of 96 patients who underwent MRI for suspected osteomyelitis or septic arthritis during the same period but who did not have a prior intervention.

Pediatric radiologists with additional training in pediatric musculoskeletal radiology performed consensus reviews of the images to assess whether objective MRI criteria could still be applied to those patients who had undergone recent intervention. They also evaluated the presence or absence of specific MRI features of osteomyelitis that could neither be attributed to the recent intervention nor were suggestive of a noninfectious alternative diagnosis. Such features included intraosseous abscess, cortical breach, subperiosteal abscess, and soft-tissue or bone edema, the authors wrote in the November 2008 issue of the American Journal of Roentgenology.

The reviewing radiologists had knowledge of the location of the prior intervention and the final discharge diagnosis, they noted (Am. J. Roentgenol. 2008;191: 1595–600).

In 10 of the 34 study group patients (29%), the MRI findings led to a need for additional intervention, which was similar to the control group, in which the MRI findings pointed to further intervention for 26 of the 96 control group patients (27%), the authors reported. The groups did not differ significantly in the number of patients with a final diagnosis of osteomyelitis, osteomyelitis or septic arthritis, cellulitis or pyomyositis, and noninfectious conditions, they stated.

A total of nine patients had a final diagnosis of osteomyelitis, and “objective MRI criteria were present in all nine patients,” the authors wrote, while none of the remaining 25 patients had characteristic imaging features of osteomyelitis. Among the patients with an osteomyelitis diagnosis, “eight of nine had one or more imaging criteria of osteomyelitis, including intraosseous abscess, cortical breach, or subperiosteal abscess,” they said. The ninth subject was diagnosed with acetabular osteomyelitis based on evidence of marrow and soft-tissue edema in the obturator internus muscle, away from the intervention site.

The findings suggest that musculoskeletal MRI “plays an important role in the management of these patients because of its ability to evaluate underlying osteomyelitis despite recent intervention,” according to the authors. With correct clinical and surgical history, they wrote, “patterns of soft-tissue and marrow edema can be explained.”

Though intervention-related iatrogenic changes do not affect MRI's diagnostic efficacy in suspected osteomyelitis or septic arthritis, “MRI before intervention adds efficacy to patient management, guides the surgical procedure, and prevents additional surgery in children with suspected pelvic or appendicular osteomyelitis or septic arthritis,” the authors concluded.

Right foot after IV administration of gadolinium shows large soft-tissue abscess (arrows) and intraosseous calcaneal abscess (arrowhead).

T2-weighted humerus, intramedullary, and subperiosteal abscess (arrows).

Corresponding T1-weighted image of the distal humerus, shown above. Images courtesy Dr. J. Herman Kan

Residual soft tissue and bone edema associated with diagnostic or surgical intervention for suspected osteomyelitis or septic arthritis do not diminish the value of subsequent magnetic resonance imaging in children with persistent signs of infection, a study has shown.

The issue under investigation was whether iatrogenic injury to soft tissue or marrow before an MRI study interferes with the clinician's ability to exclude infection or diagnose alternative causes for symptoms that remain despite a negative result after intervention.

Dr. J. Herman Kan of Vanderbilt Children's Hospital, Nashville, Tenn., and his colleagues conducted a retrospective case-control study using data from patients who underwent emergent contrast-enhanced MRI examinations that were performed for suspected osteomyelitis or septic arthritis at the hospital from March 2002 through September 2007.

Of the initial 136 MRI examinations, the analysis included only the 34 performed within 10 days after an initial diagnostic or surgical intervention, such as joint, marrow, or soft-tissue aspiration; arthrotomy; or incision and drainage of bone or soft tissue. The study control group consisted of 96 patients who underwent MRI for suspected osteomyelitis or septic arthritis during the same period but who did not have a prior intervention.

Pediatric radiologists with additional training in pediatric musculoskeletal radiology performed consensus reviews of the images to assess whether objective MRI criteria could still be applied to those patients who had undergone recent intervention. They also evaluated the presence or absence of specific MRI features of osteomyelitis that could neither be attributed to the recent intervention nor were suggestive of a noninfectious alternative diagnosis. Such features included intraosseous abscess, cortical breach, subperiosteal abscess, and soft-tissue or bone edema, the authors wrote in the November 2008 issue of the American Journal of Roentgenology.

The reviewing radiologists had knowledge of the location of the prior intervention and the final discharge diagnosis, they noted (Am. J. Roentgenol. 2008;191: 1595–600).

In 10 of the 34 study group patients (29%), the MRI findings led to a need for additional intervention, which was similar to the control group, in which the MRI findings pointed to further intervention for 26 of the 96 control group patients (27%), the authors reported. The groups did not differ significantly in the number of patients with a final diagnosis of osteomyelitis, osteomyelitis or septic arthritis, cellulitis or pyomyositis, and noninfectious conditions, they stated.

A total of nine patients had a final diagnosis of osteomyelitis, and “objective MRI criteria were present in all nine patients,” the authors wrote, while none of the remaining 25 patients had characteristic imaging features of osteomyelitis. Among the patients with an osteomyelitis diagnosis, “eight of nine had one or more imaging criteria of osteomyelitis, including intraosseous abscess, cortical breach, or subperiosteal abscess,” they said. The ninth subject was diagnosed with acetabular osteomyelitis based on evidence of marrow and soft-tissue edema in the obturator internus muscle, away from the intervention site.

The findings suggest that musculoskeletal MRI “plays an important role in the management of these patients because of its ability to evaluate underlying osteomyelitis despite recent intervention,” according to the authors. With correct clinical and surgical history, they wrote, “patterns of soft-tissue and marrow edema can be explained.”

Though intervention-related iatrogenic changes do not affect MRI's diagnostic efficacy in suspected osteomyelitis or septic arthritis, “MRI before intervention adds efficacy to patient management, guides the surgical procedure, and prevents additional surgery in children with suspected pelvic or appendicular osteomyelitis or septic arthritis,” the authors concluded.

Right foot after IV administration of gadolinium shows large soft-tissue abscess (arrows) and intraosseous calcaneal abscess (arrowhead).

T2-weighted humerus, intramedullary, and subperiosteal abscess (arrows).

Corresponding T1-weighted image of the distal humerus, shown above. Images courtesy Dr. J. Herman Kan

BOSTON — Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors, including the Framingham risk score.

However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy, said Dr. Benjamin Chow at the annual meeting of the American Society of Nuclear Cardiology.

Dr. Chow and associates conducted an imaging study that was designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors, as well as to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden using computed tomographic angiography (CTA).

The study revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores (FRS).

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Chow reported.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy. Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the FRS using age, sex, total cholesterol, high-density lipoprotein cholesterol, smoking history, and blood pressure.

Based on the FRS, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%–19%) and 53 were considered high risk (20% or greater), said Dr. Chow. Of the patients in the very-low- and low-risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, he said. Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the FRS] and plaque was fair,” Dr. Chow reported. The findings suggest that, although the FRS is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CTA has yet to be established in clinical trials, said Dr. Chow of the institute. “Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate.”

Currently, the main suggested indication for CTA is for symptomatic patients or those with equivocal stress tests, Dr. Chow noted. CTA “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved].”

Dr. Chow reported no conflicts of interest with respect to his presentation.

BOSTON — Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors, including the Framingham risk score.

However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy, said Dr. Benjamin Chow at the annual meeting of the American Society of Nuclear Cardiology.

Dr. Chow and associates conducted an imaging study that was designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors, as well as to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden using computed tomographic angiography (CTA).

The study revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores (FRS).

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Chow reported.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy. Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the FRS using age, sex, total cholesterol, high-density lipoprotein cholesterol, smoking history, and blood pressure.

Based on the FRS, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%–19%) and 53 were considered high risk (20% or greater), said Dr. Chow. Of the patients in the very-low- and low-risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, he said. Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the FRS] and plaque was fair,” Dr. Chow reported. The findings suggest that, although the FRS is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CTA has yet to be established in clinical trials, said Dr. Chow of the institute. “Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate.”

Currently, the main suggested indication for CTA is for symptomatic patients or those with equivocal stress tests, Dr. Chow noted. CTA “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved].”

Dr. Chow reported no conflicts of interest with respect to his presentation.

BOSTON — Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors, including the Framingham risk score.

However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy, said Dr. Benjamin Chow at the annual meeting of the American Society of Nuclear Cardiology.

Dr. Chow and associates conducted an imaging study that was designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors, as well as to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden using computed tomographic angiography (CTA).

The study revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores (FRS).

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Chow reported.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy. Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the FRS using age, sex, total cholesterol, high-density lipoprotein cholesterol, smoking history, and blood pressure.

Based on the FRS, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%–19%) and 53 were considered high risk (20% or greater), said Dr. Chow. Of the patients in the very-low- and low-risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, he said. Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the FRS] and plaque was fair,” Dr. Chow reported. The findings suggest that, although the FRS is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CTA has yet to be established in clinical trials, said Dr. Chow of the institute. “Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate.”

Currently, the main suggested indication for CTA is for symptomatic patients or those with equivocal stress tests, Dr. Chow noted. CTA “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved].”

Dr. Chow reported no conflicts of interest with respect to his presentation.

BOSTON — The recent finding that adverse reactions to antimicrobial agents cause more than 142,000 emergency department visits per year in the United States, and that the highest rate occurs in children under 1 year of age should be a wake-up call to pediatric health care providers to exercise caution when pulling out the prescription pad.

Dr. Barbara W. Stechenberg gave this warning at the annual meeting of the American Academy of Pediatrics.

The study used nationally representative surveillance data to estimate the rates of adverse events associated with systemic antibiotics and compared the results by antibiotic class, specific drug, and type of adverse event (Clin. Infect. Dis. 2008;47:735–43).

Approximately half of the emergency department visits attributable to antimicrobial adverse events were for reactions to penicillins and half were for reactions to multiple other agents, according to researchers Dr. Nadine Shehab and her associates at the Centers for Disease Control and Prevention.

Although infants younger than 1 year accounted for only 6% of the emergency department visits, after controlling for prescription frequency, “the rate of visits [for antimicrobial-related adverse events] was highest in this age group,” said Dr. Stechenberg, director of pediatric infectious diseases at Baystate Medical Center in Springfield, Mass.

“Clearly, adverse reactions to antimicrobials are a huge issue. [These findings] remind us to consider certain underlying principles before we prescribe antibiotics to our patients.”

First, ask yourself whether the patient really needs the therapy, “because no therapy is often safer than any therapy,” she said.

“Next, name the bug before you choose the drug, so you can use the narrowest spectrum, least toxic drug possible,” Dr. Stechenberg advised.

The majority of adverse reactions seen in the above study—approximately 80%—were allergic reactions, ranging from rash to anaphylaxis, and the rest were toxicity related.

With respect to allergic reactions, said Dr. Stechenberg, “the ones we worry about the most, particularly with penicillins and cephalosporins, are the IgE-mediated reactions which occur fairly early in the course of antibiotic therapy, but a lot of what we see—most of the maculopapular and morbilliform rashes—are non-IgE mediated.”

With respect to toxic reactions, “most toxicity that we see is related to giving a dose of antibiotic that is above what the particular host can manage. Sometimes it's the wrong dose or the decimal is in the wrong place, but a lot of times it's related to impaired metabolism: The host child has renal dysfunction or liver dysfunction and is not able to metabolize the drug appropriately.”

Other adverse reactions are side effects. “Many patients report stomachaches with erythromycin, for example. Side effects are not IgE mediated or related to toxic levels. They just happen,” said Dr. Stechenberg. “This is a reason why taking a thorough history is very important.”

Adverse reactions associated with genetic issues occasionally arise. In HIV patients, for example, “we know that people metabolize INH [isoniazid] differently. People who are slow metabolizers may accumulate INH and develop neuropathy,” she said.

Finally, underlying diseases also can contribute to antibiotic adverse reactions, Dr. Stechenberg noted.

“Cystic fibrosis patients are more likely to have allergic reactions than other patients, which may be related to the hyperactivity of their immune system. The same is true with HIV patients.”

An awareness of the types of adverse reactions that can occur with different antimicrobial agents is critical to management of them, Dr. Stechenberg stressed.

The following are some of the important points to consider with respect to different drug classes and specific drug reactions.

▸ Penicillins. “Penicillins are generally very safe. There is very little dose-related toxicity because of the wide dose range,” said Dr. Stechenberg.

Regarding allergies, “studies have shown that the true incidence of penicillin allergies among patients who report them is only about 10% [as determined by skin testing]. This doesn't mean that they're not going to have a nonimmediate reaction to penicillin, but it does make you feel more comfortable about the risk of anaphylaxis, which is very uncommon,” she commented.

When immediate reactions to β-lactams, especially penicillins, do occur, they are often IgE mediated and typically present as urticaria. The more severe reactions include bronchospasm or hypertension, she said.

“Most [IgE-mediated reactions] occur within the first 15–20 minutes, the vast majority in the first hour, but about 5% occur after the first hour, which is important to remember as you think about rechallenging someone with penicillin.”

Among the late reactions to penicillins—which usually occur after 72 hours, often 5–10 days into the course of therapy—are maculopapular rashes and morbilliform rashes, often on the extremities, she said.

More severe reactions include hemolytic anemia, neutropenia, and thrombocytopenia. “For a lot of these, we don't know what the mechanism is. They may be antibody mediated, and certainly these reactions demand our attention.

In terms of management, the timing and character of previous reactions is important.

“Reactions late in the course are less likely to be IgE mediated. If the child previously had an idiopathic, nonpruritic late rash, you can consider giving the drug in the future,” said Dr. Stechenberg.

In patients with a history of immediate reactions or more severe late reactions, such as Stevens-Johnson syndrome, you wouldn't rechallenge with the same drug, she said.

▸ Vancomycin. Most families think vancomycin hypersensitivity is an allergy. It's really a rate-dependent infusion reaction, said Dr. Stechenberg. It often happens on the first dose, which is different from anaphylaxis, and the rash is more likely to be a diffuse erythema, often on the upper trunk, face, and neck.

The package insert states that the drug infusion shouldn't exceed 1 g over an hour. “Sometimes we have to modify that, but if there's a mild reaction, the best thing is to just stop the infusion and wait a short period, then restart at a slower rate,” she said.

“If there's a moderate reaction, one might want to treat with diphenhydramine and allow the symptoms to subside, then use a much longer rate.”

In patients with severe reactions, “you might have to use an alternate drug,” she said.

▸ Clindamycin. “The biggest issue with this drug is diarrhea. It's often mild and self-limited, which you can treat through.

“When it persists and is more severe, we worry about Clostridium difficile, which can have a wide range of presentations,” Dr. Stechenberg said. The diagnosis of C. difficile can be made by enzyme immunoassays in most hospital labs, she said, noting, however, that “the fly in the ointment with C. difficile is that kids up to 1 year of age will often have asymptomatic C. difficile, so they will test positive by toxin assay.

“The occurrence of diarrheal disease [with antibiotic treatment] may be unrelated.”

The first line of treatment for C. difficile is to stop the drug. “In 20%–25% of patients, this is all you need to do,” Dr. Stechenberg said.

If symptoms persist, “try oral metronidazole. We try not to use oral vancomycin because of concerns about vancomycin-resistant enterococcus, but for patients who can't tolerate or fail metronidazole, oral vancomycin is an option,” she said.

Another option is linezolid, but it is expensive and has been associated with thrombocytopenia in adults.

▸ Trim/sulfa. This broad-spectrum antibiotic “has been around for a long time, but it has new life in the therapy of methicillin-resistant staph aureus,” said Dr. Stechenberg.

It has a reputation as a drug that can cause a rash because a lot of HIV patients who took it developed rashes. In the general population, however, the incidence of rash is fairly low, she said.

“In kids with HIV, we do see fixed drug eruptions in the same area of the body, and [so] we do talk to families about the possibility of rash.”

Trim/sulfa (trimethoprim/sulfamethoxazole) is not recommended for use in infants younger than 2 months because it displaces bilirubin from albumin binding sites, she said.

▸ Azithromycin. The most common reaction with this drug is gastrointestinal upset. “These are side effects, not allergy. Some people just cannot tolerate macrolides,” Dr. Stechenberg noted.

Although rash is uncommon with azithromycin, “when it does occur, it lasts for a long time.

One of the nice things about this drug is that treatment is only for 5 days because it stays in the body for a long time, but that means when there's rash, it will persist,” she said.

▸ Doxycycline. Concerns about tooth staining “have led to a magic cutoff age of 8–9 years old for doxycycline, after the eruption of maxillary central incisors,” said Dr. Stechenberg.

“In reality, tooth staining results from multiple courses of the drug over long periods. When we're using it as a drug of choice for children younger than 8 years, we're treating for 5–7 days for specific indications.”

Photosensitivity dermatitis also is a concern with doxycycline, but this can be prevented with anticipatory guidance regarding the use of broad-spectrum sunscreen and sun avoidance, she said.

▸ Fluoroquinolones. Pediatricians have been reluctant to use these in children, because they have been linked with cartilage damage in animal and adult studies and because of resistance concerns, especially in pneumococcus, said Dr. Stechenberg.

Small studies have shown that fluoroquinolones are reasonably safe in children, “but they should be reserved for patients who have no other reasonable options,” she said.

“Also, advise patients to report any joint pain so the medication can be stopped before the possibility of tendon rupture.”

▸ Acyclovir. “This is a fairly safe drug to use in children. We're used to using it in patients with genital herpes and immunocompromised patients with zoster,” said Dr. Stechenberg.

However, because it is excreted in the kidney almost unchanged, it can cause renal tubular dysfunction, crystalline nephropathy, and interstitial nephritis, she said. For this reason, “it's important not to have rapid infusions and to make sure patients are well hydrated before treatment starts, to give enough hydration along with treatment, and to look for underlying renal disease.”

Dr. Stechenberg reported having no disclosures related to her presentation.

BOSTON — The recent finding that adverse reactions to antimicrobial agents cause more than 142,000 emergency department visits per year in the United States, and that the highest rate occurs in children under 1 year of age should be a wake-up call to pediatric health care providers to exercise caution when pulling out the prescription pad.

Dr. Barbara W. Stechenberg gave this warning at the annual meeting of the American Academy of Pediatrics.

The study used nationally representative surveillance data to estimate the rates of adverse events associated with systemic antibiotics and compared the results by antibiotic class, specific drug, and type of adverse event (Clin. Infect. Dis. 2008;47:735–43).

Approximately half of the emergency department visits attributable to antimicrobial adverse events were for reactions to penicillins and half were for reactions to multiple other agents, according to researchers Dr. Nadine Shehab and her associates at the Centers for Disease Control and Prevention.

Although infants younger than 1 year accounted for only 6% of the emergency department visits, after controlling for prescription frequency, “the rate of visits [for antimicrobial-related adverse events] was highest in this age group,” said Dr. Stechenberg, director of pediatric infectious diseases at Baystate Medical Center in Springfield, Mass.

“Clearly, adverse reactions to antimicrobials are a huge issue. [These findings] remind us to consider certain underlying principles before we prescribe antibiotics to our patients.”

First, ask yourself whether the patient really needs the therapy, “because no therapy is often safer than any therapy,” she said.

“Next, name the bug before you choose the drug, so you can use the narrowest spectrum, least toxic drug possible,” Dr. Stechenberg advised.

The majority of adverse reactions seen in the above study—approximately 80%—were allergic reactions, ranging from rash to anaphylaxis, and the rest were toxicity related.

With respect to allergic reactions, said Dr. Stechenberg, “the ones we worry about the most, particularly with penicillins and cephalosporins, are the IgE-mediated reactions which occur fairly early in the course of antibiotic therapy, but a lot of what we see—most of the maculopapular and morbilliform rashes—are non-IgE mediated.”

With respect to toxic reactions, “most toxicity that we see is related to giving a dose of antibiotic that is above what the particular host can manage. Sometimes it's the wrong dose or the decimal is in the wrong place, but a lot of times it's related to impaired metabolism: The host child has renal dysfunction or liver dysfunction and is not able to metabolize the drug appropriately.”

Other adverse reactions are side effects. “Many patients report stomachaches with erythromycin, for example. Side effects are not IgE mediated or related to toxic levels. They just happen,” said Dr. Stechenberg. “This is a reason why taking a thorough history is very important.”

Adverse reactions associated with genetic issues occasionally arise. In HIV patients, for example, “we know that people metabolize INH [isoniazid] differently. People who are slow metabolizers may accumulate INH and develop neuropathy,” she said.

Finally, underlying diseases also can contribute to antibiotic adverse reactions, Dr. Stechenberg noted.

“Cystic fibrosis patients are more likely to have allergic reactions than other patients, which may be related to the hyperactivity of their immune system. The same is true with HIV patients.”

An awareness of the types of adverse reactions that can occur with different antimicrobial agents is critical to management of them, Dr. Stechenberg stressed.

The following are some of the important points to consider with respect to different drug classes and specific drug reactions.

▸ Penicillins. “Penicillins are generally very safe. There is very little dose-related toxicity because of the wide dose range,” said Dr. Stechenberg.

Regarding allergies, “studies have shown that the true incidence of penicillin allergies among patients who report them is only about 10% [as determined by skin testing]. This doesn't mean that they're not going to have a nonimmediate reaction to penicillin, but it does make you feel more comfortable about the risk of anaphylaxis, which is very uncommon,” she commented.

When immediate reactions to β-lactams, especially penicillins, do occur, they are often IgE mediated and typically present as urticaria. The more severe reactions include bronchospasm or hypertension, she said.

“Most [IgE-mediated reactions] occur within the first 15–20 minutes, the vast majority in the first hour, but about 5% occur after the first hour, which is important to remember as you think about rechallenging someone with penicillin.”

Among the late reactions to penicillins—which usually occur after 72 hours, often 5–10 days into the course of therapy—are maculopapular rashes and morbilliform rashes, often on the extremities, she said.

More severe reactions include hemolytic anemia, neutropenia, and thrombocytopenia. “For a lot of these, we don't know what the mechanism is. They may be antibody mediated, and certainly these reactions demand our attention.

In terms of management, the timing and character of previous reactions is important.

“Reactions late in the course are less likely to be IgE mediated. If the child previously had an idiopathic, nonpruritic late rash, you can consider giving the drug in the future,” said Dr. Stechenberg.

In patients with a history of immediate reactions or more severe late reactions, such as Stevens-Johnson syndrome, you wouldn't rechallenge with the same drug, she said.

▸ Vancomycin. Most families think vancomycin hypersensitivity is an allergy. It's really a rate-dependent infusion reaction, said Dr. Stechenberg. It often happens on the first dose, which is different from anaphylaxis, and the rash is more likely to be a diffuse erythema, often on the upper trunk, face, and neck.

The package insert states that the drug infusion shouldn't exceed 1 g over an hour. “Sometimes we have to modify that, but if there's a mild reaction, the best thing is to just stop the infusion and wait a short period, then restart at a slower rate,” she said.

“If there's a moderate reaction, one might want to treat with diphenhydramine and allow the symptoms to subside, then use a much longer rate.”

In patients with severe reactions, “you might have to use an alternate drug,” she said.

▸ Clindamycin. “The biggest issue with this drug is diarrhea. It's often mild and self-limited, which you can treat through.

“When it persists and is more severe, we worry about Clostridium difficile, which can have a wide range of presentations,” Dr. Stechenberg said. The diagnosis of C. difficile can be made by enzyme immunoassays in most hospital labs, she said, noting, however, that “the fly in the ointment with C. difficile is that kids up to 1 year of age will often have asymptomatic C. difficile, so they will test positive by toxin assay.

“The occurrence of diarrheal disease [with antibiotic treatment] may be unrelated.”

The first line of treatment for C. difficile is to stop the drug. “In 20%–25% of patients, this is all you need to do,” Dr. Stechenberg said.

If symptoms persist, “try oral metronidazole. We try not to use oral vancomycin because of concerns about vancomycin-resistant enterococcus, but for patients who can't tolerate or fail metronidazole, oral vancomycin is an option,” she said.

Another option is linezolid, but it is expensive and has been associated with thrombocytopenia in adults.

▸ Trim/sulfa. This broad-spectrum antibiotic “has been around for a long time, but it has new life in the therapy of methicillin-resistant staph aureus,” said Dr. Stechenberg.

It has a reputation as a drug that can cause a rash because a lot of HIV patients who took it developed rashes. In the general population, however, the incidence of rash is fairly low, she said.

“In kids with HIV, we do see fixed drug eruptions in the same area of the body, and [so] we do talk to families about the possibility of rash.”

Trim/sulfa (trimethoprim/sulfamethoxazole) is not recommended for use in infants younger than 2 months because it displaces bilirubin from albumin binding sites, she said.

▸ Azithromycin. The most common reaction with this drug is gastrointestinal upset. “These are side effects, not allergy. Some people just cannot tolerate macrolides,” Dr. Stechenberg noted.

Although rash is uncommon with azithromycin, “when it does occur, it lasts for a long time.

One of the nice things about this drug is that treatment is only for 5 days because it stays in the body for a long time, but that means when there's rash, it will persist,” she said.

▸ Doxycycline. Concerns about tooth staining “have led to a magic cutoff age of 8–9 years old for doxycycline, after the eruption of maxillary central incisors,” said Dr. Stechenberg.

“In reality, tooth staining results from multiple courses of the drug over long periods. When we're using it as a drug of choice for children younger than 8 years, we're treating for 5–7 days for specific indications.”

Photosensitivity dermatitis also is a concern with doxycycline, but this can be prevented with anticipatory guidance regarding the use of broad-spectrum sunscreen and sun avoidance, she said.

▸ Fluoroquinolones. Pediatricians have been reluctant to use these in children, because they have been linked with cartilage damage in animal and adult studies and because of resistance concerns, especially in pneumococcus, said Dr. Stechenberg.

Small studies have shown that fluoroquinolones are reasonably safe in children, “but they should be reserved for patients who have no other reasonable options,” she said.

“Also, advise patients to report any joint pain so the medication can be stopped before the possibility of tendon rupture.”

▸ Acyclovir. “This is a fairly safe drug to use in children. We're used to using it in patients with genital herpes and immunocompromised patients with zoster,” said Dr. Stechenberg.

However, because it is excreted in the kidney almost unchanged, it can cause renal tubular dysfunction, crystalline nephropathy, and interstitial nephritis, she said. For this reason, “it's important not to have rapid infusions and to make sure patients are well hydrated before treatment starts, to give enough hydration along with treatment, and to look for underlying renal disease.”

Dr. Stechenberg reported having no disclosures related to her presentation.

BOSTON — The recent finding that adverse reactions to antimicrobial agents cause more than 142,000 emergency department visits per year in the United States, and that the highest rate occurs in children under 1 year of age should be a wake-up call to pediatric health care providers to exercise caution when pulling out the prescription pad.

Dr. Barbara W. Stechenberg gave this warning at the annual meeting of the American Academy of Pediatrics.

The study used nationally representative surveillance data to estimate the rates of adverse events associated with systemic antibiotics and compared the results by antibiotic class, specific drug, and type of adverse event (Clin. Infect. Dis. 2008;47:735–43).

Approximately half of the emergency department visits attributable to antimicrobial adverse events were for reactions to penicillins and half were for reactions to multiple other agents, according to researchers Dr. Nadine Shehab and her associates at the Centers for Disease Control and Prevention.

Although infants younger than 1 year accounted for only 6% of the emergency department visits, after controlling for prescription frequency, “the rate of visits [for antimicrobial-related adverse events] was highest in this age group,” said Dr. Stechenberg, director of pediatric infectious diseases at Baystate Medical Center in Springfield, Mass.

“Clearly, adverse reactions to antimicrobials are a huge issue. [These findings] remind us to consider certain underlying principles before we prescribe antibiotics to our patients.”

First, ask yourself whether the patient really needs the therapy, “because no therapy is often safer than any therapy,” she said.

“Next, name the bug before you choose the drug, so you can use the narrowest spectrum, least toxic drug possible,” Dr. Stechenberg advised.

The majority of adverse reactions seen in the above study—approximately 80%—were allergic reactions, ranging from rash to anaphylaxis, and the rest were toxicity related.

With respect to allergic reactions, said Dr. Stechenberg, “the ones we worry about the most, particularly with penicillins and cephalosporins, are the IgE-mediated reactions which occur fairly early in the course of antibiotic therapy, but a lot of what we see—most of the maculopapular and morbilliform rashes—are non-IgE mediated.”

With respect to toxic reactions, “most toxicity that we see is related to giving a dose of antibiotic that is above what the particular host can manage. Sometimes it's the wrong dose or the decimal is in the wrong place, but a lot of times it's related to impaired metabolism: The host child has renal dysfunction or liver dysfunction and is not able to metabolize the drug appropriately.”

Other adverse reactions are side effects. “Many patients report stomachaches with erythromycin, for example. Side effects are not IgE mediated or related to toxic levels. They just happen,” said Dr. Stechenberg. “This is a reason why taking a thorough history is very important.”

Adverse reactions associated with genetic issues occasionally arise. In HIV patients, for example, “we know that people metabolize INH [isoniazid] differently. People who are slow metabolizers may accumulate INH and develop neuropathy,” she said.

Finally, underlying diseases also can contribute to antibiotic adverse reactions, Dr. Stechenberg noted.

“Cystic fibrosis patients are more likely to have allergic reactions than other patients, which may be related to the hyperactivity of their immune system. The same is true with HIV patients.”

An awareness of the types of adverse reactions that can occur with different antimicrobial agents is critical to management of them, Dr. Stechenberg stressed.

The following are some of the important points to consider with respect to different drug classes and specific drug reactions.

▸ Penicillins. “Penicillins are generally very safe. There is very little dose-related toxicity because of the wide dose range,” said Dr. Stechenberg.

Regarding allergies, “studies have shown that the true incidence of penicillin allergies among patients who report them is only about 10% [as determined by skin testing]. This doesn't mean that they're not going to have a nonimmediate reaction to penicillin, but it does make you feel more comfortable about the risk of anaphylaxis, which is very uncommon,” she commented.

When immediate reactions to β-lactams, especially penicillins, do occur, they are often IgE mediated and typically present as urticaria. The more severe reactions include bronchospasm or hypertension, she said.

“Most [IgE-mediated reactions] occur within the first 15–20 minutes, the vast majority in the first hour, but about 5% occur after the first hour, which is important to remember as you think about rechallenging someone with penicillin.”

Among the late reactions to penicillins—which usually occur after 72 hours, often 5–10 days into the course of therapy—are maculopapular rashes and morbilliform rashes, often on the extremities, she said.

More severe reactions include hemolytic anemia, neutropenia, and thrombocytopenia. “For a lot of these, we don't know what the mechanism is. They may be antibody mediated, and certainly these reactions demand our attention.

In terms of management, the timing and character of previous reactions is important.

“Reactions late in the course are less likely to be IgE mediated. If the child previously had an idiopathic, nonpruritic late rash, you can consider giving the drug in the future,” said Dr. Stechenberg.

In patients with a history of immediate reactions or more severe late reactions, such as Stevens-Johnson syndrome, you wouldn't rechallenge with the same drug, she said.

▸ Vancomycin. Most families think vancomycin hypersensitivity is an allergy. It's really a rate-dependent infusion reaction, said Dr. Stechenberg. It often happens on the first dose, which is different from anaphylaxis, and the rash is more likely to be a diffuse erythema, often on the upper trunk, face, and neck.

The package insert states that the drug infusion shouldn't exceed 1 g over an hour. “Sometimes we have to modify that, but if there's a mild reaction, the best thing is to just stop the infusion and wait a short period, then restart at a slower rate,” she said.

“If there's a moderate reaction, one might want to treat with diphenhydramine and allow the symptoms to subside, then use a much longer rate.”

In patients with severe reactions, “you might have to use an alternate drug,” she said.

▸ Clindamycin. “The biggest issue with this drug is diarrhea. It's often mild and self-limited, which you can treat through.

“When it persists and is more severe, we worry about Clostridium difficile, which can have a wide range of presentations,” Dr. Stechenberg said. The diagnosis of C. difficile can be made by enzyme immunoassays in most hospital labs, she said, noting, however, that “the fly in the ointment with C. difficile is that kids up to 1 year of age will often have asymptomatic C. difficile, so they will test positive by toxin assay.

“The occurrence of diarrheal disease [with antibiotic treatment] may be unrelated.”

The first line of treatment for C. difficile is to stop the drug. “In 20%–25% of patients, this is all you need to do,” Dr. Stechenberg said.

If symptoms persist, “try oral metronidazole. We try not to use oral vancomycin because of concerns about vancomycin-resistant enterococcus, but for patients who can't tolerate or fail metronidazole, oral vancomycin is an option,” she said.

Another option is linezolid, but it is expensive and has been associated with thrombocytopenia in adults.

▸ Trim/sulfa. This broad-spectrum antibiotic “has been around for a long time, but it has new life in the therapy of methicillin-resistant staph aureus,” said Dr. Stechenberg.

It has a reputation as a drug that can cause a rash because a lot of HIV patients who took it developed rashes. In the general population, however, the incidence of rash is fairly low, she said.

“In kids with HIV, we do see fixed drug eruptions in the same area of the body, and [so] we do talk to families about the possibility of rash.”

Trim/sulfa (trimethoprim/sulfamethoxazole) is not recommended for use in infants younger than 2 months because it displaces bilirubin from albumin binding sites, she said.

▸ Azithromycin. The most common reaction with this drug is gastrointestinal upset. “These are side effects, not allergy. Some people just cannot tolerate macrolides,” Dr. Stechenberg noted.

Although rash is uncommon with azithromycin, “when it does occur, it lasts for a long time.

One of the nice things about this drug is that treatment is only for 5 days because it stays in the body for a long time, but that means when there's rash, it will persist,” she said.

▸ Doxycycline. Concerns about tooth staining “have led to a magic cutoff age of 8–9 years old for doxycycline, after the eruption of maxillary central incisors,” said Dr. Stechenberg.

“In reality, tooth staining results from multiple courses of the drug over long periods. When we're using it as a drug of choice for children younger than 8 years, we're treating for 5–7 days for specific indications.”

Photosensitivity dermatitis also is a concern with doxycycline, but this can be prevented with anticipatory guidance regarding the use of broad-spectrum sunscreen and sun avoidance, she said.

▸ Fluoroquinolones. Pediatricians have been reluctant to use these in children, because they have been linked with cartilage damage in animal and adult studies and because of resistance concerns, especially in pneumococcus, said Dr. Stechenberg.

Small studies have shown that fluoroquinolones are reasonably safe in children, “but they should be reserved for patients who have no other reasonable options,” she said.

“Also, advise patients to report any joint pain so the medication can be stopped before the possibility of tendon rupture.”

▸ Acyclovir. “This is a fairly safe drug to use in children. We're used to using it in patients with genital herpes and immunocompromised patients with zoster,” said Dr. Stechenberg.

However, because it is excreted in the kidney almost unchanged, it can cause renal tubular dysfunction, crystalline nephropathy, and interstitial nephritis, she said. For this reason, “it's important not to have rapid infusions and to make sure patients are well hydrated before treatment starts, to give enough hydration along with treatment, and to look for underlying renal disease.”

Dr. Stechenberg reported having no disclosures related to her presentation.

Exposure to acetaminophen may be an important risk factor for the development of asthma later in childhood, according to new data from an international asthma study.

In a sample of more than 200,000 children from 31 countries, those children given acetaminophen—known outside the United States as paracetamol—for fever during their first year of life were approximately 50% more likely to have experienced asthma symptoms at age 6–7 years than were unexposed children. Dr. Richard Beasley of the Medical Research Institute of New Zealand, Wellington, and his colleagues reported that in phase III of the International Study of Asthma and Allergies in Childhood (ISAAC), exposure to acetaminophen in the first year of life was associated with significantly increased risk of severe asthma symptoms, as well as rhinoconjunctivitis and eczema at 6–7 years (Lancet 2008;372:1039–48).

The prevalence of asthma has increased substantially over the past 50 years, as has the use of acetaminophen in children, the authors wrote. Previous studies have reported associations between asthma risk and exposure to acetaminophen in utero, during infancy, and in late childhood and adulthood in populations from developed and developing countries. Additionally, phase I of ISAAC identified positive associations between per-person acetaminophen consumption and asthma prevalence in children, they stated.

The current analysis was designed to evaluate the consistency of the association between acetaminophen and asthma and to investigate one of the proposed biological mechanisms for the link—specifically, that acetaminophen exposure contributes to the development of oxidant-induced airway inflammation caused by reduced concentrations of the antioxidant glutathione in the lung and stimulation of the T helper cell 2 response.

Toward this end, parents and guardians of 205,487 children aged 6–7 years from 73 centers were asked to complete two standardized questionnaires, including a prevalence questionnaire about symptoms of asthma, rhinoconjunctivitis, and eczema, and an environmental questionnaire about possible protective and risk factors for asthma and allergic disorders including the use of acetaminophen in the first year of life and now.

The primary outcome measure for the analysis was the association between acetaminophen use for fever in the first year of life and asthma symptoms at 6–7 years as measured by multivariate analysis.

A total of 194,555 children were included in the analysis of acetaminophen use for fever during the first year of life. Of these, 105,041 had complete covariate data and were included in the multivariate analysis. In this group, the association between asthma symptoms and acetaminophen use in the first year of life was significant (odds ratio 1.46). Similarly, the association between first year acetaminophen use and rhinoconjunctivitis and eczema were significant (OR 1.48 and 1.35, respectively).

Despite the study's power, size, and multinational nature, the findings do not establish causality because of its design, the authors stressed. In the absence of an adequately powered, population-based randomized control trial, “evidence is insufficient to advise parents and health care workers of the risk benefit of taking [acetaminophen] in childhood, or its comparative efficacy and safety with other approaches,” they wrote.

In an accompanying editorial, Dr. R. Graham Barr of Columbia University Medical Center, New York, agreed. “The studies to date are suggestive but not definitive enough to recommend a wholesale change in antipyretic use in children. Acetaminophen has known benefits for pediatric febrile illness as well as known toxicities,” he wrote. “The drug might contribute to asthma incidence and it might be prudent to minimize casual use of this—and all—drugs in otherwise healthy children. However, we need to take the guesswork out of recommending and prescribing antipyretic drugs for children.” What is needed, he wrote, are randomized trials that examine the incidence of childhood asthma, comparing acetaminophen use with an active control such as ibuprofen or placebo (Lancet 2008;372:1011–2). Dr. Beasley reported having received grant support and honoraria for lectures from GlaxoSmithKline Inc., the maker of acetaminophen.

Exposure to acetaminophen may be an important risk factor for the development of asthma later in childhood, according to new data from an international asthma study.

In a sample of more than 200,000 children from 31 countries, those children given acetaminophen—known outside the United States as paracetamol—for fever during their first year of life were approximately 50% more likely to have experienced asthma symptoms at age 6–7 years than were unexposed children. Dr. Richard Beasley of the Medical Research Institute of New Zealand, Wellington, and his colleagues reported that in phase III of the International Study of Asthma and Allergies in Childhood (ISAAC), exposure to acetaminophen in the first year of life was associated with significantly increased risk of severe asthma symptoms, as well as rhinoconjunctivitis and eczema at 6–7 years (Lancet 2008;372:1039–48).

The prevalence of asthma has increased substantially over the past 50 years, as has the use of acetaminophen in children, the authors wrote. Previous studies have reported associations between asthma risk and exposure to acetaminophen in utero, during infancy, and in late childhood and adulthood in populations from developed and developing countries. Additionally, phase I of ISAAC identified positive associations between per-person acetaminophen consumption and asthma prevalence in children, they stated.

The current analysis was designed to evaluate the consistency of the association between acetaminophen and asthma and to investigate one of the proposed biological mechanisms for the link—specifically, that acetaminophen exposure contributes to the development of oxidant-induced airway inflammation caused by reduced concentrations of the antioxidant glutathione in the lung and stimulation of the T helper cell 2 response.

Toward this end, parents and guardians of 205,487 children aged 6–7 years from 73 centers were asked to complete two standardized questionnaires, including a prevalence questionnaire about symptoms of asthma, rhinoconjunctivitis, and eczema, and an environmental questionnaire about possible protective and risk factors for asthma and allergic disorders including the use of acetaminophen in the first year of life and now.

The primary outcome measure for the analysis was the association between acetaminophen use for fever in the first year of life and asthma symptoms at 6–7 years as measured by multivariate analysis.

A total of 194,555 children were included in the analysis of acetaminophen use for fever during the first year of life. Of these, 105,041 had complete covariate data and were included in the multivariate analysis. In this group, the association between asthma symptoms and acetaminophen use in the first year of life was significant (odds ratio 1.46). Similarly, the association between first year acetaminophen use and rhinoconjunctivitis and eczema were significant (OR 1.48 and 1.35, respectively).

Despite the study's power, size, and multinational nature, the findings do not establish causality because of its design, the authors stressed. In the absence of an adequately powered, population-based randomized control trial, “evidence is insufficient to advise parents and health care workers of the risk benefit of taking [acetaminophen] in childhood, or its comparative efficacy and safety with other approaches,” they wrote.

In an accompanying editorial, Dr. R. Graham Barr of Columbia University Medical Center, New York, agreed. “The studies to date are suggestive but not definitive enough to recommend a wholesale change in antipyretic use in children. Acetaminophen has known benefits for pediatric febrile illness as well as known toxicities,” he wrote. “The drug might contribute to asthma incidence and it might be prudent to minimize casual use of this—and all—drugs in otherwise healthy children. However, we need to take the guesswork out of recommending and prescribing antipyretic drugs for children.” What is needed, he wrote, are randomized trials that examine the incidence of childhood asthma, comparing acetaminophen use with an active control such as ibuprofen or placebo (Lancet 2008;372:1011–2). Dr. Beasley reported having received grant support and honoraria for lectures from GlaxoSmithKline Inc., the maker of acetaminophen.

Exposure to acetaminophen may be an important risk factor for the development of asthma later in childhood, according to new data from an international asthma study.

In a sample of more than 200,000 children from 31 countries, those children given acetaminophen—known outside the United States as paracetamol—for fever during their first year of life were approximately 50% more likely to have experienced asthma symptoms at age 6–7 years than were unexposed children. Dr. Richard Beasley of the Medical Research Institute of New Zealand, Wellington, and his colleagues reported that in phase III of the International Study of Asthma and Allergies in Childhood (ISAAC), exposure to acetaminophen in the first year of life was associated with significantly increased risk of severe asthma symptoms, as well as rhinoconjunctivitis and eczema at 6–7 years (Lancet 2008;372:1039–48).

The prevalence of asthma has increased substantially over the past 50 years, as has the use of acetaminophen in children, the authors wrote. Previous studies have reported associations between asthma risk and exposure to acetaminophen in utero, during infancy, and in late childhood and adulthood in populations from developed and developing countries. Additionally, phase I of ISAAC identified positive associations between per-person acetaminophen consumption and asthma prevalence in children, they stated.

The current analysis was designed to evaluate the consistency of the association between acetaminophen and asthma and to investigate one of the proposed biological mechanisms for the link—specifically, that acetaminophen exposure contributes to the development of oxidant-induced airway inflammation caused by reduced concentrations of the antioxidant glutathione in the lung and stimulation of the T helper cell 2 response.

Toward this end, parents and guardians of 205,487 children aged 6–7 years from 73 centers were asked to complete two standardized questionnaires, including a prevalence questionnaire about symptoms of asthma, rhinoconjunctivitis, and eczema, and an environmental questionnaire about possible protective and risk factors for asthma and allergic disorders including the use of acetaminophen in the first year of life and now.

The primary outcome measure for the analysis was the association between acetaminophen use for fever in the first year of life and asthma symptoms at 6–7 years as measured by multivariate analysis.

A total of 194,555 children were included in the analysis of acetaminophen use for fever during the first year of life. Of these, 105,041 had complete covariate data and were included in the multivariate analysis. In this group, the association between asthma symptoms and acetaminophen use in the first year of life was significant (odds ratio 1.46). Similarly, the association between first year acetaminophen use and rhinoconjunctivitis and eczema were significant (OR 1.48 and 1.35, respectively).

Despite the study's power, size, and multinational nature, the findings do not establish causality because of its design, the authors stressed. In the absence of an adequately powered, population-based randomized control trial, “evidence is insufficient to advise parents and health care workers of the risk benefit of taking [acetaminophen] in childhood, or its comparative efficacy and safety with other approaches,” they wrote.

In an accompanying editorial, Dr. R. Graham Barr of Columbia University Medical Center, New York, agreed. “The studies to date are suggestive but not definitive enough to recommend a wholesale change in antipyretic use in children. Acetaminophen has known benefits for pediatric febrile illness as well as known toxicities,” he wrote. “The drug might contribute to asthma incidence and it might be prudent to minimize casual use of this—and all—drugs in otherwise healthy children. However, we need to take the guesswork out of recommending and prescribing antipyretic drugs for children.” What is needed, he wrote, are randomized trials that examine the incidence of childhood asthma, comparing acetaminophen use with an active control such as ibuprofen or placebo (Lancet 2008;372:1011–2). Dr. Beasley reported having received grant support and honoraria for lectures from GlaxoSmithKline Inc., the maker of acetaminophen.

The unique lifetime care needs of adults with congenital heart disease—particularly young adults who are making the transition out of pediatric cardiology care—are the focus of new practice guidelines released jointly by the American College of Cardiology and the American Heart Association.

The adult congenital heart disease (CHD) guidelines, the first of their kind in the United States, are designed to help physicians make routine clinical decisions for the ever-increasing number of patients who, because of the advances in the treatment of CHD, are now surviving into adulthood but are doing so with complex cardiac anatomy and physiology that are related to the repaired heart defects, according to Dr. Carole A. Warnes and her colleagues on the American College of Cardiology/American Heart Association guidelines writing committee.

“In particular, there are a substantial number of young adults with single-ventricle physiology, systemic right ventricles, or complex intracardiac baffles who are now entering adult life,” the authors wrote in the executive summary of the guidelines, which will be published in the Dec. 2, 2008, issues of both the Journal of the American College of Cardiology and Circulation and which are available in the online editions of each issue (doi:10.1016/j.jacc.2008.10.001).

Altough the infrastructure of most pediatric cardiology centers supports the multiple unique needs of children with CHD through, for example, comprehensive case management by advanced practice nurses and social workers, the adult health care system is not similarly structured, the authors noted.

In addition, “young adults have many psychological, social, and financial issues that present barriers to proactive health management,” they wrote. In an effort to minimize “the compound effects of a complex and unfamiliar disease with an unprepared patient and healthcare system,” the practice guidelines outline the most important diagnostic and management strategies and indicate when to refer patients to a highly specialized center.

Improving the delivery of care and ensuring access to care figure prominently in the recommendations. Specifically, the guidelines call for the development and strengthening of transition clinics for adolescents and young adults with CHD, as well as outreach and education programs for patients, families, and caregivers and enhanced education of adult and pediatric cardiovascular specialists to ensure optimal management of adult CHD.

The guidelines recommend that:

▸ The care of adult CHD patients should be coordinated by regional centers of excellence.

▸ Adult CHD patients carry a complete “medical passport” containing their medical histories as well as contact information for the regional centers of excellence to facilitate access to data and counsel.

▸ Designated health care guardians be included in the medical decision-making process for patients whose care is complicated by additional special needs.

▸ Patients have a primary care physician and a local cardiovascular specialist, each of whom has copies of current clinical records on file.

▸ Patients establish a relationship with a regional adult CHD center to ensure the availability of geographically accessible care when needed.

The guidelines specify that, in the absence of specific training or experience in adult CHD, primary caregivers and cardiologists of patients with CHD should work in collaboration with trained specialists, and patients should have access to specialized follow-up care. For example, the guidelines state that patients with low-risk, simple CHD should have at least one follow-up at a regional adult CHD center, while more frequent follow-up (every 12–24 months minimum) is advised for “adults with complex and moderate CHD.”

In addition, certain clinical scenarios warrant consultation with, treatment at, or transfer to, a regional adult CHD center. Such scenarios include hospital admission for urgent or acute care in most cases; the performance of diagnostic or interventional procedures; surgical procedures requiring general anesthesia or conscious sedation; urgent or acute care of cardiac problems; and urgent or acute care of noncardiac problems in high-risk patients.

The guidelines also address the psychosocial needs of adult CHD patients with the recommendation that the comprehensive care of these patients should incorporate individual and family psychosocial screening, counseling, and education regarding the possible social, emotional, and vocational impact of the conditon.

Because CHD patients are at increased risk for infectious endocarditis, it is important that patients and their families be educated about the signs and symptoms of infectious complications, as well as how to prevent them, according to the authors.

In particular, the guidelines recommend antibiotic prophylaxis in high-risk CHD patients “before dental procedures that involved manipulation of the gingival tissue or the periapical region of teeth or perforation of the oral mucosa.” Antibiotic prophylaxis also should be considered before vaginal delivery at the time of membrane rupture in patients with a prosthetic cardiac valve or in whom prosthetic material was used for valve repair and patients with unrepaired and palliated cyanotic CHD.

However, antibiotic prophylaxis against infectious endocarditis “is not recommended for nondental procedures [such as esophagogastroduodenoscopy or colonoscopy] in the absence of active infection,” the authors wrote in the guidelines.

Pregnancy and contraception require special consideration in women with CHD. With respect to contraception, oral estrogen-containing drugs are not recommended for patients at risk of thromboembolism, including those with pulmonary arterial hypertension or cyanosis related to an intracardiac shunt, according to the guidelines. Regarding pregnancy, patients are advised to consult with an adult CHD expert to determine a labor and delivery management plan prior to becoming pregnant.

In addition to the general recommendations for the care of adult CHD patients, the guidelines also include comprehensive information on the clinical features, diagnosis, treatment options, activity limitations, pregnancy risks, and preventive strategies related to specific lesions, such as atrial, ventricular, or atrioventricular septal defects; patent ductus arteriosus; left-sided heart obstructive lesions; right ventricular outflow tract obstruction; pulmonary artery hypertension/Eisenmenger physiology; and tetralogy of Fallot.

The adult CHD guidelines were developed in collaboration with the American Society of Echocardiography, the Canadian Cardiovascular Society, the Heart Rhythm Society, the International Society for Adult Congenital Cardiac Disease, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

While the recommendations are evidence based wherever possible, “unlike other ACC/AHA practice guidelines, there is not a large body of peer-reviewed published evidence to support most recommendations,” the authors wrote. For this reason, the evidence supporting many of the recommendations comes from the consensus of experts.

An increasing number of patients are now surviving into adulthood with complex cardiac anatomy and physiology. DR. WARNES

The unique lifetime care needs of adults with congenital heart disease—particularly young adults who are making the transition out of pediatric cardiology care—are the focus of new practice guidelines released jointly by the American College of Cardiology and the American Heart Association.

The adult congenital heart disease (CHD) guidelines, the first of their kind in the United States, are designed to help physicians make routine clinical decisions for the ever-increasing number of patients who, because of the advances in the treatment of CHD, are now surviving into adulthood but are doing so with complex cardiac anatomy and physiology that are related to the repaired heart defects, according to Dr. Carole A. Warnes and her colleagues on the American College of Cardiology/American Heart Association guidelines writing committee.

“In particular, there are a substantial number of young adults with single-ventricle physiology, systemic right ventricles, or complex intracardiac baffles who are now entering adult life,” the authors wrote in the executive summary of the guidelines, which will be published in the Dec. 2, 2008, issues of both the Journal of the American College of Cardiology and Circulation and which are available in the online editions of each issue (doi:10.1016/j.jacc.2008.10.001).

Altough the infrastructure of most pediatric cardiology centers supports the multiple unique needs of children with CHD through, for example, comprehensive case management by advanced practice nurses and social workers, the adult health care system is not similarly structured, the authors noted.

In addition, “young adults have many psychological, social, and financial issues that present barriers to proactive health management,” they wrote. In an effort to minimize “the compound effects of a complex and unfamiliar disease with an unprepared patient and healthcare system,” the practice guidelines outline the most important diagnostic and management strategies and indicate when to refer patients to a highly specialized center.

Improving the delivery of care and ensuring access to care figure prominently in the recommendations. Specifically, the guidelines call for the development and strengthening of transition clinics for adolescents and young adults with CHD, as well as outreach and education programs for patients, families, and caregivers and enhanced education of adult and pediatric cardiovascular specialists to ensure optimal management of adult CHD.

The guidelines recommend that:

▸ The care of adult CHD patients should be coordinated by regional centers of excellence.

▸ Adult CHD patients carry a complete “medical passport” containing their medical histories as well as contact information for the regional centers of excellence to facilitate access to data and counsel.

▸ Designated health care guardians be included in the medical decision-making process for patients whose care is complicated by additional special needs.

▸ Patients have a primary care physician and a local cardiovascular specialist, each of whom has copies of current clinical records on file.

▸ Patients establish a relationship with a regional adult CHD center to ensure the availability of geographically accessible care when needed.

The guidelines specify that, in the absence of specific training or experience in adult CHD, primary caregivers and cardiologists of patients with CHD should work in collaboration with trained specialists, and patients should have access to specialized follow-up care. For example, the guidelines state that patients with low-risk, simple CHD should have at least one follow-up at a regional adult CHD center, while more frequent follow-up (every 12–24 months minimum) is advised for “adults with complex and moderate CHD.”

In addition, certain clinical scenarios warrant consultation with, treatment at, or transfer to, a regional adult CHD center. Such scenarios include hospital admission for urgent or acute care in most cases; the performance of diagnostic or interventional procedures; surgical procedures requiring general anesthesia or conscious sedation; urgent or acute care of cardiac problems; and urgent or acute care of noncardiac problems in high-risk patients.

The guidelines also address the psychosocial needs of adult CHD patients with the recommendation that the comprehensive care of these patients should incorporate individual and family psychosocial screening, counseling, and education regarding the possible social, emotional, and vocational impact of the conditon.

Because CHD patients are at increased risk for infectious endocarditis, it is important that patients and their families be educated about the signs and symptoms of infectious complications, as well as how to prevent them, according to the authors.

In particular, the guidelines recommend antibiotic prophylaxis in high-risk CHD patients “before dental procedures that involved manipulation of the gingival tissue or the periapical region of teeth or perforation of the oral mucosa.” Antibiotic prophylaxis also should be considered before vaginal delivery at the time of membrane rupture in patients with a prosthetic cardiac valve or in whom prosthetic material was used for valve repair and patients with unrepaired and palliated cyanotic CHD.

However, antibiotic prophylaxis against infectious endocarditis “is not recommended for nondental procedures [such as esophagogastroduodenoscopy or colonoscopy] in the absence of active infection,” the authors wrote in the guidelines.

Pregnancy and contraception require special consideration in women with CHD. With respect to contraception, oral estrogen-containing drugs are not recommended for patients at risk of thromboembolism, including those with pulmonary arterial hypertension or cyanosis related to an intracardiac shunt, according to the guidelines. Regarding pregnancy, patients are advised to consult with an adult CHD expert to determine a labor and delivery management plan prior to becoming pregnant.

In addition to the general recommendations for the care of adult CHD patients, the guidelines also include comprehensive information on the clinical features, diagnosis, treatment options, activity limitations, pregnancy risks, and preventive strategies related to specific lesions, such as atrial, ventricular, or atrioventricular septal defects; patent ductus arteriosus; left-sided heart obstructive lesions; right ventricular outflow tract obstruction; pulmonary artery hypertension/Eisenmenger physiology; and tetralogy of Fallot.

The adult CHD guidelines were developed in collaboration with the American Society of Echocardiography, the Canadian Cardiovascular Society, the Heart Rhythm Society, the International Society for Adult Congenital Cardiac Disease, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

While the recommendations are evidence based wherever possible, “unlike other ACC/AHA practice guidelines, there is not a large body of peer-reviewed published evidence to support most recommendations,” the authors wrote. For this reason, the evidence supporting many of the recommendations comes from the consensus of experts.

An increasing number of patients are now surviving into adulthood with complex cardiac anatomy and physiology. DR. WARNES

The unique lifetime care needs of adults with congenital heart disease—particularly young adults who are making the transition out of pediatric cardiology care—are the focus of new practice guidelines released jointly by the American College of Cardiology and the American Heart Association.

The adult congenital heart disease (CHD) guidelines, the first of their kind in the United States, are designed to help physicians make routine clinical decisions for the ever-increasing number of patients who, because of the advances in the treatment of CHD, are now surviving into adulthood but are doing so with complex cardiac anatomy and physiology that are related to the repaired heart defects, according to Dr. Carole A. Warnes and her colleagues on the American College of Cardiology/American Heart Association guidelines writing committee.

“In particular, there are a substantial number of young adults with single-ventricle physiology, systemic right ventricles, or complex intracardiac baffles who are now entering adult life,” the authors wrote in the executive summary of the guidelines, which will be published in the Dec. 2, 2008, issues of both the Journal of the American College of Cardiology and Circulation and which are available in the online editions of each issue (doi:10.1016/j.jacc.2008.10.001).

Altough the infrastructure of most pediatric cardiology centers supports the multiple unique needs of children with CHD through, for example, comprehensive case management by advanced practice nurses and social workers, the adult health care system is not similarly structured, the authors noted.

In addition, “young adults have many psychological, social, and financial issues that present barriers to proactive health management,” they wrote. In an effort to minimize “the compound effects of a complex and unfamiliar disease with an unprepared patient and healthcare system,” the practice guidelines outline the most important diagnostic and management strategies and indicate when to refer patients to a highly specialized center.

Improving the delivery of care and ensuring access to care figure prominently in the recommendations. Specifically, the guidelines call for the development and strengthening of transition clinics for adolescents and young adults with CHD, as well as outreach and education programs for patients, families, and caregivers and enhanced education of adult and pediatric cardiovascular specialists to ensure optimal management of adult CHD.

The guidelines recommend that:

▸ The care of adult CHD patients should be coordinated by regional centers of excellence.

▸ Adult CHD patients carry a complete “medical passport” containing their medical histories as well as contact information for the regional centers of excellence to facilitate access to data and counsel.

▸ Designated health care guardians be included in the medical decision-making process for patients whose care is complicated by additional special needs.

▸ Patients have a primary care physician and a local cardiovascular specialist, each of whom has copies of current clinical records on file.

▸ Patients establish a relationship with a regional adult CHD center to ensure the availability of geographically accessible care when needed.

The guidelines specify that, in the absence of specific training or experience in adult CHD, primary caregivers and cardiologists of patients with CHD should work in collaboration with trained specialists, and patients should have access to specialized follow-up care. For example, the guidelines state that patients with low-risk, simple CHD should have at least one follow-up at a regional adult CHD center, while more frequent follow-up (every 12–24 months minimum) is advised for “adults with complex and moderate CHD.”

In addition, certain clinical scenarios warrant consultation with, treatment at, or transfer to, a regional adult CHD center. Such scenarios include hospital admission for urgent or acute care in most cases; the performance of diagnostic or interventional procedures; surgical procedures requiring general anesthesia or conscious sedation; urgent or acute care of cardiac problems; and urgent or acute care of noncardiac problems in high-risk patients.

The guidelines also address the psychosocial needs of adult CHD patients with the recommendation that the comprehensive care of these patients should incorporate individual and family psychosocial screening, counseling, and education regarding the possible social, emotional, and vocational impact of the conditon.

Because CHD patients are at increased risk for infectious endocarditis, it is important that patients and their families be educated about the signs and symptoms of infectious complications, as well as how to prevent them, according to the authors.

In particular, the guidelines recommend antibiotic prophylaxis in high-risk CHD patients “before dental procedures that involved manipulation of the gingival tissue or the periapical region of teeth or perforation of the oral mucosa.” Antibiotic prophylaxis also should be considered before vaginal delivery at the time of membrane rupture in patients with a prosthetic cardiac valve or in whom prosthetic material was used for valve repair and patients with unrepaired and palliated cyanotic CHD.

However, antibiotic prophylaxis against infectious endocarditis “is not recommended for nondental procedures [such as esophagogastroduodenoscopy or colonoscopy] in the absence of active infection,” the authors wrote in the guidelines.

Pregnancy and contraception require special consideration in women with CHD. With respect to contraception, oral estrogen-containing drugs are not recommended for patients at risk of thromboembolism, including those with pulmonary arterial hypertension or cyanosis related to an intracardiac shunt, according to the guidelines. Regarding pregnancy, patients are advised to consult with an adult CHD expert to determine a labor and delivery management plan prior to becoming pregnant.

In addition to the general recommendations for the care of adult CHD patients, the guidelines also include comprehensive information on the clinical features, diagnosis, treatment options, activity limitations, pregnancy risks, and preventive strategies related to specific lesions, such as atrial, ventricular, or atrioventricular septal defects; patent ductus arteriosus; left-sided heart obstructive lesions; right ventricular outflow tract obstruction; pulmonary artery hypertension/Eisenmenger physiology; and tetralogy of Fallot.

The adult CHD guidelines were developed in collaboration with the American Society of Echocardiography, the Canadian Cardiovascular Society, the Heart Rhythm Society, the International Society for Adult Congenital Cardiac Disease, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons.

While the recommendations are evidence based wherever possible, “unlike other ACC/AHA practice guidelines, there is not a large body of peer-reviewed published evidence to support most recommendations,” the authors wrote. For this reason, the evidence supporting many of the recommendations comes from the consensus of experts.

An increasing number of patients are now surviving into adulthood with complex cardiac anatomy and physiology. DR. WARNES

BOSTON—Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors. However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy.

In a study that was designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors and to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden, computed tomographic angiography (CTA) revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores (FRS).

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Benjamin Chow reported at the annual meeting of the American Society of Nuclear Cardiology.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy.

Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

The mean pretest probability for obstructive coronary artery disease was 24.4%, he said.

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the FRS using age, sex, total cholesterol level, HDL cholesterol level, smoking history, and blood pressure.

Based on the FRS, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%−19%) and 53 were considered high risk (20% or greater), Dr. Chow said. Of the patients in the very-low- and low- risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, he said.

Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the FRS] and plaque was fair,” Dr. Chow reported.

The findings suggest that, although the FRS is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CTA has yet to be established in clinical trials, said Dr. Chow of the University of Ottawa Heart Institute.

“Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate,” he said.

Currently, the main suggested indication for CTA is for symptomatic patients or those with equivocal stress tests, Dr. Chow noted.

CT angiography “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved],” he said.

Dr. Chow reported no conflicts of interest with respect to his presentation.

BOSTON—Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors. However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy.

In a study that was designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors and to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden, computed tomographic angiography (CTA) revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores (FRS).

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Benjamin Chow reported at the annual meeting of the American Society of Nuclear Cardiology.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy.

Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

The mean pretest probability for obstructive coronary artery disease was 24.4%, he said.

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the FRS using age, sex, total cholesterol level, HDL cholesterol level, smoking history, and blood pressure.

Based on the FRS, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%−19%) and 53 were considered high risk (20% or greater), Dr. Chow said. Of the patients in the very-low- and low- risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, he said.

Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the FRS] and plaque was fair,” Dr. Chow reported.

The findings suggest that, although the FRS is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CTA has yet to be established in clinical trials, said Dr. Chow of the University of Ottawa Heart Institute.

“Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate,” he said.

Currently, the main suggested indication for CTA is for symptomatic patients or those with equivocal stress tests, Dr. Chow noted.

CT angiography “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved],” he said.

Dr. Chow reported no conflicts of interest with respect to his presentation.

BOSTON—Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors. However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy.

In a study that was designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors and to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden, computed tomographic angiography (CTA) revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores (FRS).

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Benjamin Chow reported at the annual meeting of the American Society of Nuclear Cardiology.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy.

Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

The mean pretest probability for obstructive coronary artery disease was 24.4%, he said.

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the FRS using age, sex, total cholesterol level, HDL cholesterol level, smoking history, and blood pressure.

Based on the FRS, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%−19%) and 53 were considered high risk (20% or greater), Dr. Chow said. Of the patients in the very-low- and low- risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, he said.

Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the FRS] and plaque was fair,” Dr. Chow reported.

The findings suggest that, although the FRS is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CTA has yet to be established in clinical trials, said Dr. Chow of the University of Ottawa Heart Institute.

“Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate,” he said.

Currently, the main suggested indication for CTA is for symptomatic patients or those with equivocal stress tests, Dr. Chow noted.

CT angiography “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved],” he said.

Dr. Chow reported no conflicts of interest with respect to his presentation.

BOSTON—In the ongoing debate over whether patients with chronic, stable angina are better served by revascularization with percutaneous coronary intervention in addition to drug treatment or optimal medical therapy alone, the key variable appears to be ischemic burden, Dr. Daniel S. Berman reported at the annual meeting of the American Society of Nuclear Cardiology.

Last year, investigators in the Clinical Outcomes Using Revascularization and Aggressive Drug Evaluation (COURAGE) trial reported that adding percutaneous coronary intervention (PCI) to optimal medical therapy in patients with stable coronary artery disease did not improve clinical end points, compared with optimal medical therapy alone (N. Engl. J. Med. 2007;356:1503–16).

More recently, however, a substudy of the COURAGE trial comprising 314 patients equally distributed between groups treated with PCI plus optical medical therapy and optimal medical therapy alone showed that the PCI strategy produced a greater ischemia reduction than the optimal medical therapy-only (OMT-only) intervention—particularly among patients with moderate to severe ischemia at baseline, said Dr. Berman, chief of cardiac imaging and nuclear cardiology at Cedars-Sinai Heart Center in Los Angeles. “Importantly, patients in both groups who experienced ischemia reduction had a significantly lower risk for death or myocardial infarction than patients without ischemia reduction, and the magnitude of residual ischemia was proportional to the overall risk of subsequent cardiac event,” he said.

The main COURAGE trial included 2,287 patients, with a history of angina or documented myocardial ischemia and at least one significant coronary lesion, who were stable on medical therapy. Participants were randomized to continue their medication alone or with PCI, and the study's combined end points were death or nonfatal myocardial infarction. The composite rates of death or nonfatal MI over 4.6 years of follow-up were statistically similar in both groups, at 19.0% and 18.5%, respectively, for PCI and OMT-only.

In the nuclear imaging substudy, the 314 patients were equally distributed between the PCI and OMT groups and they were well matched with respect to demographics and risk factors, said Dr. Berman. All of the patients were on medication for a mean 374 days from baseline and all underwent serial myocardial perfusion single-photon emission computed tomography (MPI SPECT) studies 6–18 months following the baseline examination to assess the extent and severity of the perfusion defect in the global myocardium, he said.

With myocardial ischemia defined as the total perfusion deficit at stress minus the perfusion deficit at rest, 33% of patients in the PCI group and 20% in the OMT-only group showed a 5% or greater reduction in ischemia. Among patients with moderate to severe pretreatment ischemia, defined as a perfusion defect involving 10% or more of myocardium, “78% of the PCI patients demonstrated 5% improvement or greater, compared to 52% of the [OMT-only] patients,” Dr. Berman reported.

In considering these changes in terms of their relationship to subsequent outcomes, “we looked at the myocardial infarction rates in patients with and without ischemia reduction and determined that patients in both groups with 5% improvement in ischemia had approximately 50% lower cardiac event rate,” Dr. Berman said. A similarly reduced cardiac event rate was observed in the 105 patients from both groups with moderate to severe ischemia and a greater than 5% reduction post treatment, he said.

Although the substudy was not sufficiently powered to generalize that reducing ischemia will prevent later cardiac events, “we did see a striking relationship between amount of residual ischemia and the subsequent death or myocardial infarction rate,” Dr. Berman said. This observation is “definitely a hypothesis generator,” warranting a controlled trial comparing the PCI-based strategy with OMT alone in patients with chronic stable angina who would be randomized based on the presence of moderate to severe ischemia, he said. “We should be studying patients with 10% or more ischemia to determine if there is a subset of patients who would have improved angina and quality-of-life outcomes with revascularization.” The findings would be especially important to those patients with documented large amounts of jeopardized myocardia in whom medical therapy does not provide adequate relief, he concluded.

The COURAGE nuclear imaging substudy was supported by Bristol-Myers Squibb Medical Imaging and Astellas Healthcare.

COURAGE patients with moderate to severe ischemia showed greater improvement after PCI than after medical therapy. DR. BERMAN

MPI-SPECT image shows the first and second stress myocardial perfusion in a patient who received optimal medical therapy only. Total perfusion deficit was reduced from 16% to 6%. Images courtesy Dr. Daniel S. Berman

BOSTON—In the ongoing debate over whether patients with chronic, stable angina are better served by revascularization with percutaneous coronary intervention in addition to drug treatment or optimal medical therapy alone, the key variable appears to be ischemic burden, Dr. Daniel S. Berman reported at the annual meeting of the American Society of Nuclear Cardiology.

Last year, investigators in the Clinical Outcomes Using Revascularization and Aggressive Drug Evaluation (COURAGE) trial reported that adding percutaneous coronary intervention (PCI) to optimal medical therapy in patients with stable coronary artery disease did not improve clinical end points, compared with optimal medical therapy alone (N. Engl. J. Med. 2007;356:1503–16).

More recently, however, a substudy of the COURAGE trial comprising 314 patients equally distributed between groups treated with PCI plus optical medical therapy and optimal medical therapy alone showed that the PCI strategy produced a greater ischemia reduction than the optimal medical therapy-only (OMT-only) intervention—particularly among patients with moderate to severe ischemia at baseline, said Dr. Berman, chief of cardiac imaging and nuclear cardiology at Cedars-Sinai Heart Center in Los Angeles. “Importantly, patients in both groups who experienced ischemia reduction had a significantly lower risk for death or myocardial infarction than patients without ischemia reduction, and the magnitude of residual ischemia was proportional to the overall risk of subsequent cardiac event,” he said.

The main COURAGE trial included 2,287 patients, with a history of angina or documented myocardial ischemia and at least one significant coronary lesion, who were stable on medical therapy. Participants were randomized to continue their medication alone or with PCI, and the study's combined end points were death or nonfatal myocardial infarction. The composite rates of death or nonfatal MI over 4.6 years of follow-up were statistically similar in both groups, at 19.0% and 18.5%, respectively, for PCI and OMT-only.

In the nuclear imaging substudy, the 314 patients were equally distributed between the PCI and OMT groups and they were well matched with respect to demographics and risk factors, said Dr. Berman. All of the patients were on medication for a mean 374 days from baseline and all underwent serial myocardial perfusion single-photon emission computed tomography (MPI SPECT) studies 6–18 months following the baseline examination to assess the extent and severity of the perfusion defect in the global myocardium, he said.

With myocardial ischemia defined as the total perfusion deficit at stress minus the perfusion deficit at rest, 33% of patients in the PCI group and 20% in the OMT-only group showed a 5% or greater reduction in ischemia. Among patients with moderate to severe pretreatment ischemia, defined as a perfusion defect involving 10% or more of myocardium, “78% of the PCI patients demonstrated 5% improvement or greater, compared to 52% of the [OMT-only] patients,” Dr. Berman reported.

In considering these changes in terms of their relationship to subsequent outcomes, “we looked at the myocardial infarction rates in patients with and without ischemia reduction and determined that patients in both groups with 5% improvement in ischemia had approximately 50% lower cardiac event rate,” Dr. Berman said. A similarly reduced cardiac event rate was observed in the 105 patients from both groups with moderate to severe ischemia and a greater than 5% reduction post treatment, he said.

Although the substudy was not sufficiently powered to generalize that reducing ischemia will prevent later cardiac events, “we did see a striking relationship between amount of residual ischemia and the subsequent death or myocardial infarction rate,” Dr. Berman said. This observation is “definitely a hypothesis generator,” warranting a controlled trial comparing the PCI-based strategy with OMT alone in patients with chronic stable angina who would be randomized based on the presence of moderate to severe ischemia, he said. “We should be studying patients with 10% or more ischemia to determine if there is a subset of patients who would have improved angina and quality-of-life outcomes with revascularization.” The findings would be especially important to those patients with documented large amounts of jeopardized myocardia in whom medical therapy does not provide adequate relief, he concluded.

The COURAGE nuclear imaging substudy was supported by Bristol-Myers Squibb Medical Imaging and Astellas Healthcare.

COURAGE patients with moderate to severe ischemia showed greater improvement after PCI than after medical therapy. DR. BERMAN

MPI-SPECT image shows the first and second stress myocardial perfusion in a patient who received optimal medical therapy only. Total perfusion deficit was reduced from 16% to 6%. Images courtesy Dr. Daniel S. Berman

BOSTON—In the ongoing debate over whether patients with chronic, stable angina are better served by revascularization with percutaneous coronary intervention in addition to drug treatment or optimal medical therapy alone, the key variable appears to be ischemic burden, Dr. Daniel S. Berman reported at the annual meeting of the American Society of Nuclear Cardiology.

Last year, investigators in the Clinical Outcomes Using Revascularization and Aggressive Drug Evaluation (COURAGE) trial reported that adding percutaneous coronary intervention (PCI) to optimal medical therapy in patients with stable coronary artery disease did not improve clinical end points, compared with optimal medical therapy alone (N. Engl. J. Med. 2007;356:1503–16).

More recently, however, a substudy of the COURAGE trial comprising 314 patients equally distributed between groups treated with PCI plus optical medical therapy and optimal medical therapy alone showed that the PCI strategy produced a greater ischemia reduction than the optimal medical therapy-only (OMT-only) intervention—particularly among patients with moderate to severe ischemia at baseline, said Dr. Berman, chief of cardiac imaging and nuclear cardiology at Cedars-Sinai Heart Center in Los Angeles. “Importantly, patients in both groups who experienced ischemia reduction had a significantly lower risk for death or myocardial infarction than patients without ischemia reduction, and the magnitude of residual ischemia was proportional to the overall risk of subsequent cardiac event,” he said.

The main COURAGE trial included 2,287 patients, with a history of angina or documented myocardial ischemia and at least one significant coronary lesion, who were stable on medical therapy. Participants were randomized to continue their medication alone or with PCI, and the study's combined end points were death or nonfatal myocardial infarction. The composite rates of death or nonfatal MI over 4.6 years of follow-up were statistically similar in both groups, at 19.0% and 18.5%, respectively, for PCI and OMT-only.

In the nuclear imaging substudy, the 314 patients were equally distributed between the PCI and OMT groups and they were well matched with respect to demographics and risk factors, said Dr. Berman. All of the patients were on medication for a mean 374 days from baseline and all underwent serial myocardial perfusion single-photon emission computed tomography (MPI SPECT) studies 6–18 months following the baseline examination to assess the extent and severity of the perfusion defect in the global myocardium, he said.

With myocardial ischemia defined as the total perfusion deficit at stress minus the perfusion deficit at rest, 33% of patients in the PCI group and 20% in the OMT-only group showed a 5% or greater reduction in ischemia. Among patients with moderate to severe pretreatment ischemia, defined as a perfusion defect involving 10% or more of myocardium, “78% of the PCI patients demonstrated 5% improvement or greater, compared to 52% of the [OMT-only] patients,” Dr. Berman reported.

In considering these changes in terms of their relationship to subsequent outcomes, “we looked at the myocardial infarction rates in patients with and without ischemia reduction and determined that patients in both groups with 5% improvement in ischemia had approximately 50% lower cardiac event rate,” Dr. Berman said. A similarly reduced cardiac event rate was observed in the 105 patients from both groups with moderate to severe ischemia and a greater than 5% reduction post treatment, he said.

Although the substudy was not sufficiently powered to generalize that reducing ischemia will prevent later cardiac events, “we did see a striking relationship between amount of residual ischemia and the subsequent death or myocardial infarction rate,” Dr. Berman said. This observation is “definitely a hypothesis generator,” warranting a controlled trial comparing the PCI-based strategy with OMT alone in patients with chronic stable angina who would be randomized based on the presence of moderate to severe ischemia, he said. “We should be studying patients with 10% or more ischemia to determine if there is a subset of patients who would have improved angina and quality-of-life outcomes with revascularization.” The findings would be especially important to those patients with documented large amounts of jeopardized myocardia in whom medical therapy does not provide adequate relief, he concluded.

The COURAGE nuclear imaging substudy was supported by Bristol-Myers Squibb Medical Imaging and Astellas Healthcare.

COURAGE patients with moderate to severe ischemia showed greater improvement after PCI than after medical therapy. DR. BERMAN

MPI-SPECT image shows the first and second stress myocardial perfusion in a patient who received optimal medical therapy only. Total perfusion deficit was reduced from 16% to 6%. Images courtesy Dr. Daniel S. Berman

For a copy of “A Clinician's Guide to Electronic Prescribing”' visit www.ehealthinitiative.orghttps://www.epsilonregistration.com/er/EventHomePage/CustomPage.jsp?ActivityID=378&ItemID=1133

BOSTON—“E-prescribing saves lives, it saves money, and it's time we implement it,” according to Health and Human Services Secretary Mike Leavitt. Streamlining the bloated health care system “is an economic imperative for our country. We have to get down to making the system better, and [e-prescribing] is one piece of a large puzzle,” he stressed at a conference on e-prescribing sponsored by the Centers for Medicare and Medicaid Services.

After acknowledging that “change is hard,” especially change that requires substantial time and money, Secretary Leavitt assured attendees that the benefits of implementing an electronic prescribing system would quickly exceed the costs, thanks in large part to the incentive program provided by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

Under MIPPA, physicians who use a qualified e-prescribing system for their Medicare patients will be eligible to receive a bonus of 2% of their Medicare revenue in 2009 and 2010. The bonus amount will decrease to 1% of total Medicare revenue in 2011 and 2012, and to 0.5% in 2013. Beginning in 2014, physicians who are not prescribing electronically will see their Medicare payments reduced by as much as 2%.

From the government's perspective, the business case for e-prescribing is a “no-brainer,” according to acting CMS administrator Kerry Weems, as widespread implementation of the technology could save Medicare $13 million-$146 million between 2009 and 2013. The savings, he said, will be achieved through averted medication errors and the substitution of less-expensive prescription drug alternatives. Specifically, “errors associated with illegible handwriting are eliminated and those linked to oral miscommunications are substantially reduced because the process is automated,” he said.

Additionally, e-prescribing software provides secure electronic access to each patient's prescription history and automatically alerts physicians to dangerous drug interactions and allergies, thereby minimizing the potential for both.

E-prescribing also promises advantages that will have a positive impact on physician bottom line, Mr. Weems said. Automating the prescribing process reduces time spent on phone calls and faxes to pharmacies, speeds the prescription renewal request and authorization process, increases medication compliance, improves formulary adherence, allows greater prescriber mobility, and improves drug surveillance.

Together with the promised bonuses (and future penalties) for e-prescribing, the argument in favor of technology is gaining steam. “With MIPPA, Congress has helped us solve the business equation side of e-prescribing,” he said.

Without question, the financial incentives improve the case for converting from traditional to electronic prescribing, Mr. Weems said, noting that the average e-prescribing primary care doctor stands to collect between $2,000 and $3,000 in bonuses in 2009 and the cost of an e-prescribing system ranges from $2,500 to $3,000.

The psychological obstacles, on the other hand, may be tougher to knock down, according to Secretary Leavitt. “There's always going to be resistance to change, and in this case, some of it is well thought out: 'I've got training costs; there's likely to be a productivity dip; do I really want my business to go through this?' Those are the kinds of things that are part of any sort of business process change, and such change doesn't happen overnight,” he said.

To help facilitate the change, the eHealth Initiative, in collaboration with the American Medical Association, the American Academy of Family Physicians, the Medical Group Management Association, and the Center for Improving Medication Management has published “A Clinician's Guide to Electronic Prescribing,” which offers practical information on planning, selecting, and implementing an e-prescribing system.

The guide “is an invaluable resource that provides substantial detail not only on how to get started but what challenges to expect and how to overcome them,” said Dr. Steven E. Waldren, director of the AAFP's Center for Health Information Technology.”

Other challenges hindering widespread adoption of e-prescribing, according to the guide, include workflow changes, continued need for improved connectivity and technology, state regulatory restrictions (such as the New York State Medicaid requirement that the “dispense as written” instruction be handwritten), and the need for reconciled medication histories.

Elsevier Global Medical News

Transitioning to E-Prescribing: Careful Planning Can Smooth the Way

Moving from paper prescribing to electronic prescribing can dramatically improve the workflow in a busy practice setting, but the transition can be difficult, according to AAFP's Dr. Waldren.

Technology-averse staff may resist the new processes; productivity may temporarily dip as users become accustomed to the new system; and frustrations may mount as a result of the inevitable impact on established roles and responsibilities, he said at the conference.

Dr. Waldren identified the following predictors of a successful transition:

▸ Commitment to the technology. “Everyone has to be on board with [the transition],” Dr. Waldren stressed. “You don't want a dual system where some doctors are still using a prescription pad and others use a computer. There needs to be a blanket adoption.”

▸ Vision of a paperless prescribing process. “If you dabble in the technology, or do it only some of the time,” the transition will be more difficult, he said.

▸ Good intraoffice communication.

▸ Strong leadership and management in the practice.

▸ Proactive outreach to pharmacies and patients.

When planning the switch to e-prescribing, it's important to set realistic, measurable goals, said Dr. Waldren.

“Maybe you want the 2% bonus from Medicare, or maybe it's reducing the number of phone calls from pharmacists by 75%, or getting by with one less front desk person.” Whatever goal you adopt, he said, “stay focused [on it].”

Next, evaluate your practice's long-term goals and short-term needs in order to identify the e-prescribing system that will best meet both, said Dr. Waldren.

One of the first considerations when shopping for a system is deciding whether to purchase stand-alone software, which can be acquired for, on average, $2000–$3000 per physician, or a full-function electronic health record (EHR) system with an e-prescribing component, which can cost up to $50,000.

“Each has its pros and cons,” said Dr. Waldren. Stand-alone systems are relatively inexpensive and easier to implement than a full EHR, “but you're still stuck with paper charts,” he said. “EHRs automate your entire practice,” but they're relatively expensive.

Because full-blown EHRs will likely be a requirement down the line, “if you're looking at a stand-alone system, think of it as one of the first modules to deploy in an electronic health record,” said Dr. Waldren. For this reason, system interoperability should top the list of requisite features, he said.

Other considerations with respect to system selection include making sure the solutions being considered meet the Medicare definition of e-prescribing and that they connect to the pharmacy industry's SureScripts RxHub, Dr. Waldren advised.

Additionally, evaluate the user friendliness of the various systems, and try to visit other practices that have implemented the systems you're interested in “to see the products in real-world action,” he said. “A salesman's demo is not enough.”

After selecting a system and negotiating pricing with the vendor, create a team within the practice to lead and manage the transition and develop a reasonable “go-live” strategy that clearly specifies the nature and timing the transition, advised Dr. David Allard, physician director of the Henry Ford Health System's Royal Oak (Mich.) Medical Center.

Training needs and expectations should also be well defined, he said. “In our practice, [software] trainers remained on site for 3–5 days and training was done in groups organized by function [doctors, nurses, front desk].”

Hands-on training should take place close to the “go-live” date to keep the information fresh, Dr. Allard said.

Also, “training should be revisited a few weeks later to address advanced functionality and address any issues that have come up,” he advised.

Finally, in anticipation of the transition, “contact local pharmacies and notify them that you are moving toward e-prescribing,” said Dr. Waldren.

Additionally, inform patients that the prescribing and renewal processes will be changing and let them know how it will affect them, he said.

For a copy of “A Clinician's Guide to Electronic Prescribing”' visit www.ehealthinitiative.orghttps://www.epsilonregistration.com/er/EventHomePage/CustomPage.jsp?ActivityID=378&ItemID=1133

BOSTON—“E-prescribing saves lives, it saves money, and it's time we implement it,” according to Health and Human Services Secretary Mike Leavitt. Streamlining the bloated health care system “is an economic imperative for our country. We have to get down to making the system better, and [e-prescribing] is one piece of a large puzzle,” he stressed at a conference on e-prescribing sponsored by the Centers for Medicare and Medicaid Services.

After acknowledging that “change is hard,” especially change that requires substantial time and money, Secretary Leavitt assured attendees that the benefits of implementing an electronic prescribing system would quickly exceed the costs, thanks in large part to the incentive program provided by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

Under MIPPA, physicians who use a qualified e-prescribing system for their Medicare patients will be eligible to receive a bonus of 2% of their Medicare revenue in 2009 and 2010. The bonus amount will decrease to 1% of total Medicare revenue in 2011 and 2012, and to 0.5% in 2013. Beginning in 2014, physicians who are not prescribing electronically will see their Medicare payments reduced by as much as 2%.

From the government's perspective, the business case for e-prescribing is a “no-brainer,” according to acting CMS administrator Kerry Weems, as widespread implementation of the technology could save Medicare $13 million-$146 million between 2009 and 2013. The savings, he said, will be achieved through averted medication errors and the substitution of less-expensive prescription drug alternatives. Specifically, “errors associated with illegible handwriting are eliminated and those linked to oral miscommunications are substantially reduced because the process is automated,” he said.

Additionally, e-prescribing software provides secure electronic access to each patient's prescription history and automatically alerts physicians to dangerous drug interactions and allergies, thereby minimizing the potential for both.

E-prescribing also promises advantages that will have a positive impact on physician bottom line, Mr. Weems said. Automating the prescribing process reduces time spent on phone calls and faxes to pharmacies, speeds the prescription renewal request and authorization process, increases medication compliance, improves formulary adherence, allows greater prescriber mobility, and improves drug surveillance.

Together with the promised bonuses (and future penalties) for e-prescribing, the argument in favor of technology is gaining steam. “With MIPPA, Congress has helped us solve the business equation side of e-prescribing,” he said.

Without question, the financial incentives improve the case for converting from traditional to electronic prescribing, Mr. Weems said, noting that the average e-prescribing primary care doctor stands to collect between $2,000 and $3,000 in bonuses in 2009 and the cost of an e-prescribing system ranges from $2,500 to $3,000.

The psychological obstacles, on the other hand, may be tougher to knock down, according to Secretary Leavitt. “There's always going to be resistance to change, and in this case, some of it is well thought out: 'I've got training costs; there's likely to be a productivity dip; do I really want my business to go through this?' Those are the kinds of things that are part of any sort of business process change, and such change doesn't happen overnight,” he said.

To help facilitate the change, the eHealth Initiative, in collaboration with the American Medical Association, the American Academy of Family Physicians, the Medical Group Management Association, and the Center for Improving Medication Management has published “A Clinician's Guide to Electronic Prescribing,” which offers practical information on planning, selecting, and implementing an e-prescribing system.

The guide “is an invaluable resource that provides substantial detail not only on how to get started but what challenges to expect and how to overcome them,” said Dr. Steven E. Waldren, director of the AAFP's Center for Health Information Technology.”

Other challenges hindering widespread adoption of e-prescribing, according to the guide, include workflow changes, continued need for improved connectivity and technology, state regulatory restrictions (such as the New York State Medicaid requirement that the “dispense as written” instruction be handwritten), and the need for reconciled medication histories.

Elsevier Global Medical News

Transitioning to E-Prescribing: Careful Planning Can Smooth the Way

Moving from paper prescribing to electronic prescribing can dramatically improve the workflow in a busy practice setting, but the transition can be difficult, according to AAFP's Dr. Waldren.

Technology-averse staff may resist the new processes; productivity may temporarily dip as users become accustomed to the new system; and frustrations may mount as a result of the inevitable impact on established roles and responsibilities, he said at the conference.

Dr. Waldren identified the following predictors of a successful transition:

▸ Commitment to the technology. “Everyone has to be on board with [the transition],” Dr. Waldren stressed. “You don't want a dual system where some doctors are still using a prescription pad and others use a computer. There needs to be a blanket adoption.”

▸ Vision of a paperless prescribing process. “If you dabble in the technology, or do it only some of the time,” the transition will be more difficult, he said.

▸ Good intraoffice communication.

▸ Strong leadership and management in the practice.

▸ Proactive outreach to pharmacies and patients.

When planning the switch to e-prescribing, it's important to set realistic, measurable goals, said Dr. Waldren.

“Maybe you want the 2% bonus from Medicare, or maybe it's reducing the number of phone calls from pharmacists by 75%, or getting by with one less front desk person.” Whatever goal you adopt, he said, “stay focused [on it].”

Next, evaluate your practice's long-term goals and short-term needs in order to identify the e-prescribing system that will best meet both, said Dr. Waldren.

One of the first considerations when shopping for a system is deciding whether to purchase stand-alone software, which can be acquired for, on average, $2000–$3000 per physician, or a full-function electronic health record (EHR) system with an e-prescribing component, which can cost up to $50,000.

“Each has its pros and cons,” said Dr. Waldren. Stand-alone systems are relatively inexpensive and easier to implement than a full EHR, “but you're still stuck with paper charts,” he said. “EHRs automate your entire practice,” but they're relatively expensive.

Because full-blown EHRs will likely be a requirement down the line, “if you're looking at a stand-alone system, think of it as one of the first modules to deploy in an electronic health record,” said Dr. Waldren. For this reason, system interoperability should top the list of requisite features, he said.

Other considerations with respect to system selection include making sure the solutions being considered meet the Medicare definition of e-prescribing and that they connect to the pharmacy industry's SureScripts RxHub, Dr. Waldren advised.

Additionally, evaluate the user friendliness of the various systems, and try to visit other practices that have implemented the systems you're interested in “to see the products in real-world action,” he said. “A salesman's demo is not enough.”

After selecting a system and negotiating pricing with the vendor, create a team within the practice to lead and manage the transition and develop a reasonable “go-live” strategy that clearly specifies the nature and timing the transition, advised Dr. David Allard, physician director of the Henry Ford Health System's Royal Oak (Mich.) Medical Center.

Training needs and expectations should also be well defined, he said. “In our practice, [software] trainers remained on site for 3–5 days and training was done in groups organized by function [doctors, nurses, front desk].”

Hands-on training should take place close to the “go-live” date to keep the information fresh, Dr. Allard said.

Also, “training should be revisited a few weeks later to address advanced functionality and address any issues that have come up,” he advised.

Finally, in anticipation of the transition, “contact local pharmacies and notify them that you are moving toward e-prescribing,” said Dr. Waldren.

Additionally, inform patients that the prescribing and renewal processes will be changing and let them know how it will affect them, he said.

For a copy of “A Clinician's Guide to Electronic Prescribing”' visit www.ehealthinitiative.orghttps://www.epsilonregistration.com/er/EventHomePage/CustomPage.jsp?ActivityID=378&ItemID=1133

BOSTON—“E-prescribing saves lives, it saves money, and it's time we implement it,” according to Health and Human Services Secretary Mike Leavitt. Streamlining the bloated health care system “is an economic imperative for our country. We have to get down to making the system better, and [e-prescribing] is one piece of a large puzzle,” he stressed at a conference on e-prescribing sponsored by the Centers for Medicare and Medicaid Services.

After acknowledging that “change is hard,” especially change that requires substantial time and money, Secretary Leavitt assured attendees that the benefits of implementing an electronic prescribing system would quickly exceed the costs, thanks in large part to the incentive program provided by the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA).

Under MIPPA, physicians who use a qualified e-prescribing system for their Medicare patients will be eligible to receive a bonus of 2% of their Medicare revenue in 2009 and 2010. The bonus amount will decrease to 1% of total Medicare revenue in 2011 and 2012, and to 0.5% in 2013. Beginning in 2014, physicians who are not prescribing electronically will see their Medicare payments reduced by as much as 2%.

From the government's perspective, the business case for e-prescribing is a “no-brainer,” according to acting CMS administrator Kerry Weems, as widespread implementation of the technology could save Medicare $13 million-$146 million between 2009 and 2013. The savings, he said, will be achieved through averted medication errors and the substitution of less-expensive prescription drug alternatives. Specifically, “errors associated with illegible handwriting are eliminated and those linked to oral miscommunications are substantially reduced because the process is automated,” he said.

Additionally, e-prescribing software provides secure electronic access to each patient's prescription history and automatically alerts physicians to dangerous drug interactions and allergies, thereby minimizing the potential for both.

E-prescribing also promises advantages that will have a positive impact on physician bottom line, Mr. Weems said. Automating the prescribing process reduces time spent on phone calls and faxes to pharmacies, speeds the prescription renewal request and authorization process, increases medication compliance, improves formulary adherence, allows greater prescriber mobility, and improves drug surveillance.

Together with the promised bonuses (and future penalties) for e-prescribing, the argument in favor of technology is gaining steam. “With MIPPA, Congress has helped us solve the business equation side of e-prescribing,” he said.

Without question, the financial incentives improve the case for converting from traditional to electronic prescribing, Mr. Weems said, noting that the average e-prescribing primary care doctor stands to collect between $2,000 and $3,000 in bonuses in 2009 and the cost of an e-prescribing system ranges from $2,500 to $3,000.

The psychological obstacles, on the other hand, may be tougher to knock down, according to Secretary Leavitt. “There's always going to be resistance to change, and in this case, some of it is well thought out: 'I've got training costs; there's likely to be a productivity dip; do I really want my business to go through this?' Those are the kinds of things that are part of any sort of business process change, and such change doesn't happen overnight,” he said.

To help facilitate the change, the eHealth Initiative, in collaboration with the American Medical Association, the American Academy of Family Physicians, the Medical Group Management Association, and the Center for Improving Medication Management has published “A Clinician's Guide to Electronic Prescribing,” which offers practical information on planning, selecting, and implementing an e-prescribing system.

The guide “is an invaluable resource that provides substantial detail not only on how to get started but what challenges to expect and how to overcome them,” said Dr. Steven E. Waldren, director of the AAFP's Center for Health Information Technology.”

Other challenges hindering widespread adoption of e-prescribing, according to the guide, include workflow changes, continued need for improved connectivity and technology, state regulatory restrictions (such as the New York State Medicaid requirement that the “dispense as written” instruction be handwritten), and the need for reconciled medication histories.

Elsevier Global Medical News

Transitioning to E-Prescribing: Careful Planning Can Smooth the Way

Moving from paper prescribing to electronic prescribing can dramatically improve the workflow in a busy practice setting, but the transition can be difficult, according to AAFP's Dr. Waldren.

Technology-averse staff may resist the new processes; productivity may temporarily dip as users become accustomed to the new system; and frustrations may mount as a result of the inevitable impact on established roles and responsibilities, he said at the conference.

Dr. Waldren identified the following predictors of a successful transition:

▸ Commitment to the technology. “Everyone has to be on board with [the transition],” Dr. Waldren stressed. “You don't want a dual system where some doctors are still using a prescription pad and others use a computer. There needs to be a blanket adoption.”

▸ Vision of a paperless prescribing process. “If you dabble in the technology, or do it only some of the time,” the transition will be more difficult, he said.

▸ Good intraoffice communication.

▸ Strong leadership and management in the practice.

▸ Proactive outreach to pharmacies and patients.

When planning the switch to e-prescribing, it's important to set realistic, measurable goals, said Dr. Waldren.

“Maybe you want the 2% bonus from Medicare, or maybe it's reducing the number of phone calls from pharmacists by 75%, or getting by with one less front desk person.” Whatever goal you adopt, he said, “stay focused [on it].”

Next, evaluate your practice's long-term goals and short-term needs in order to identify the e-prescribing system that will best meet both, said Dr. Waldren.

One of the first considerations when shopping for a system is deciding whether to purchase stand-alone software, which can be acquired for, on average, $2000–$3000 per physician, or a full-function electronic health record (EHR) system with an e-prescribing component, which can cost up to $50,000.

“Each has its pros and cons,” said Dr. Waldren. Stand-alone systems are relatively inexpensive and easier to implement than a full EHR, “but you're still stuck with paper charts,” he said. “EHRs automate your entire practice,” but they're relatively expensive.

Because full-blown EHRs will likely be a requirement down the line, “if you're looking at a stand-alone system, think of it as one of the first modules to deploy in an electronic health record,” said Dr. Waldren. For this reason, system interoperability should top the list of requisite features, he said.

Other considerations with respect to system selection include making sure the solutions being considered meet the Medicare definition of e-prescribing and that they connect to the pharmacy industry's SureScripts RxHub, Dr. Waldren advised.

Additionally, evaluate the user friendliness of the various systems, and try to visit other practices that have implemented the systems you're interested in “to see the products in real-world action,” he said. “A salesman's demo is not enough.”

After selecting a system and negotiating pricing with the vendor, create a team within the practice to lead and manage the transition and develop a reasonable “go-live” strategy that clearly specifies the nature and timing the transition, advised Dr. David Allard, physician director of the Henry Ford Health System's Royal Oak (Mich.) Medical Center.

Training needs and expectations should also be well defined, he said. “In our practice, [software] trainers remained on site for 3–5 days and training was done in groups organized by function [doctors, nurses, front desk].”

Hands-on training should take place close to the “go-live” date to keep the information fresh, Dr. Allard said.

Also, “training should be revisited a few weeks later to address advanced functionality and address any issues that have come up,” he advised.

Finally, in anticipation of the transition, “contact local pharmacies and notify them that you are moving toward e-prescribing,” said Dr. Waldren.

Additionally, inform patients that the prescribing and renewal processes will be changing and let them know how it will affect them, he said.

BOSTON — Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors. However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy.

In a study designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors and to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden, computed tomographic angiography (CTA) revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores.

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Benjamin Chow reported at the annual meeting of the American Society of Nuclear Cardiology.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy. Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

The mean pretest probability for obstructive coronary artery disease was 24.4%, he said.

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the Framingham risk scores using age, sex, total cholesterol, HDL cholesterol, smoking history, and blood pressure.

Based on the Framingham risk score, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%–19%) and 53 were considered high risk (20% or greater), said Dr. Chow.

Of the patients who were found to be in the very-low- and low-risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, Dr. Chow said.

Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the Framingham risk score] and plaque was fair,” Dr. Chow reported.

The findings suggest that, although the Framingham risk score is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CT angiography has yet to be established in clinical trials, noted Dr. Chow of the University of Ottawa Heart Institute.

“Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate.”

Currently, the main suggested indication for CT angiography is for symptomatic individuals or those patients who have equivocal stress test findings, Dr. Chow noted.

CTA “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved],” he said.

Dr. Chow reported no conflicts of interest with respect to his presentation at the meeting.

BOSTON — Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors. However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy.

In a study designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors and to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden, computed tomographic angiography (CTA) revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores.

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Benjamin Chow reported at the annual meeting of the American Society of Nuclear Cardiology.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy. Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

The mean pretest probability for obstructive coronary artery disease was 24.4%, he said.

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the Framingham risk scores using age, sex, total cholesterol, HDL cholesterol, smoking history, and blood pressure.

Based on the Framingham risk score, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%–19%) and 53 were considered high risk (20% or greater), said Dr. Chow.

Of the patients who were found to be in the very-low- and low-risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, Dr. Chow said.

Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the Framingham risk score] and plaque was fair,” Dr. Chow reported.

The findings suggest that, although the Framingham risk score is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CT angiography has yet to be established in clinical trials, noted Dr. Chow of the University of Ottawa Heart Institute.

“Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate.”

Currently, the main suggested indication for CT angiography is for symptomatic individuals or those patients who have equivocal stress test findings, Dr. Chow noted.

CTA “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved],” he said.

Dr. Chow reported no conflicts of interest with respect to his presentation at the meeting.

BOSTON — Direct screening for atherosclerosis using CT coronary angiography may provide a more accurate cardiovascular risk picture than do routine clinical predictors. However, the value of the imaging method in asymptomatic patients must be demonstrated in clinical trials before it can be used to modify therapy.

In a study designed to determine the prevalence of coronary atherosclerosis in patients with varying clinical predictors and to identify the limitations of traditional cardiac risk factors for predicting individual atherosclerotic burden, computed tomographic angiography (CTA) revealed evidence of calcific and noncalcific coronary atherosclerosis in a cohort of consecutive patients with low to intermediate Framingham risk scores.

This finding, together with the absence of atherosclerotic plaques in some patients with high FRS, suggests that the use of routine clinical predictors may be insufficient for identifying patients who might benefit from aggressive risk factor modification, Dr. Benjamin Chow reported at the annual meeting of the American Society of Nuclear Cardiology.

Of 1,247 consecutive patients who underwent CTA at the University of Ottawa (Ont.) Heart Institute between February 2006 and March 2008, Dr. Chow and his coinvestigators identified 554 patients (mean age, 55 years) who did not have a history of myocardial infarction, revascularization, or diabetes mellitus, and who were not on current statin therapy. Approximately half of the patients were men, and the mean body mass index was 28.5 kg/m

The mean pretest probability for obstructive coronary artery disease was 24.4%, he said.

Using a 17-segment model of the coronary arteries to assess for the presence of calcific or noncalcific plaque, the investigators calculated a total plaque score by summing the number of coronary segments with visible atherosclerotic plaque. They calculated the Framingham risk scores using age, sex, total cholesterol, HDL cholesterol, smoking history, and blood pressure.

Based on the Framingham risk score, 408 of the patients were considered to have a very low (5% or less) or low (10% or less) 10-year risk for cardiac events, whereas 93 patients had an intermediate risk (11%–19%) and 53 were considered high risk (20% or greater), said Dr. Chow.

Of the patients who were found to be in the very-low- and low-risk groups, more than half had visible evidence of atherosclerotic plaque on CTA, Dr. Chow said.

Additionally, about 9% of patients in the high-risk category had no evidence of calcific or noncalcific plaques.

“Although the mean atherosclerotic plaque burden did increase with the 10-year Framingham risk, the correlation between [the Framingham risk score] and plaque was fair,” Dr. Chow reported.

The findings suggest that, although the Framingham risk score is moderately predictive of plaque burden in this patient population, “it may underestimate total plaque burden,” he said.

The value of identifying subclinical coronary atherosclerosis through CT angiography has yet to be established in clinical trials, noted Dr. Chow of the University of Ottawa Heart Institute.

“Although many would argue that more aggressive risk-factor modification is warranted for patients with evidence of coronary atherosclerosis, prospective studies are needed to determine whether modifying therapy [based on imaging evidence] is appropriate.”

Currently, the main suggested indication for CT angiography is for symptomatic individuals or those patients who have equivocal stress test findings, Dr. Chow noted.

CTA “is not currently indicated to screen for coronary atherosclerosis because the benefit of doing so has yet to be [proved],” he said.

Dr. Chow reported no conflicts of interest with respect to his presentation at the meeting.