Bruce K. Dixon

CHICAGO – Clear parental expectations about adolescents' cell phone use can support family relationships, a survey of 196 parent-adolescent dyads shows.

Helping parents realize this can assist them in launching their adolescents toward adulthood, said Robert S. Weisskirch, Ph.D., of California State University Monterey Bay, Seaside.

It's estimated that more than half of adolescents now carry cell phones. The few studies that have been done suggest that they identify security or safety as the primary reason for using the technology, Dr. Weisskirch said in a poster presentation at a meeting sponsored by the Society for Research on Adolescence.

For this study, parent-adolescent dyads from across the United States completed separate questionnaires. Of these, 83% were white, and 80% of the parents indicated they were currently married or in a domestic partnership.

The dyads were identified as 13% father-son, 11% father-daughter, 30% mother-son, and 46% mother-daughter. All the adolescents were of high school age and included all four grades.

The teenagers rated 18 items on a variety of typical situations and circumstances in which they would have to call their parents, including “to ask permission to do something,” “to ask for a ride somewhere or to be picked up,” and “argue by phone.” Parents answered the same questions, though they were reworded to reflect their perspectives.

Also, the adolescents rated 23 items on how often the parents call them for specific reasons or situations. Examples included, “to make sure you are where you said you would be,” “to see how your day went,” and “to ask what you want to eat.” The same questions were given to parents.

Parents and their children also completed a 22-item measure of parental self-efficacy by rating their degree of confidence in doing each of the items. Additionally, the participants rated six dimensions of parenting: closeness, monitoring, support, communication, conflict, and peer approval.

For adolescents, calling their parents for social support and in response to monitoring was associated with support, communication, peer approval, family closeness, and successful monitoring, Dr. Weisskirch said.

From the parents' perspective, adolescents calling for social support increased parent ratings of communication and closeness in the relationship, while teen-initiated calls in response to monitoring increased parental ratings of support, closeness, and monitoring.

However, arrangements were likely to sour when parents initiated calls perceived by their children to constitute overmonitoring. Calls made to track schoolwork or calling when upset were associated with increased conflict, he said.

“For parents, it's a warning that, while you want to call your kids, you don't want to do it too often because that's going to create more problems,” Dr. Weisskirch said in an interview.

He posited that adolescents want the autonomy to respond without the feeling of being monitored. However, adolescents who perceived an obligation to inform parents of their whereabouts have parents who have more parental self-efficacy.

“It's all about setting expectations about how the adolescent is supposed to use the cell phone,” the researcher said in an interview. “If those guidelines are given as instructions and not an order, and the child understands them, the parent-child relationship will be strengthened.”

Giving children instructions that they understand strengthens the parent-child relationship. DR. WEISSKIRCH

CHICAGO – Clear parental expectations about adolescents' cell phone use can support family relationships, a survey of 196 parent-adolescent dyads shows.

Helping parents realize this can assist them in launching their adolescents toward adulthood, said Robert S. Weisskirch, Ph.D., of California State University Monterey Bay, Seaside.

It's estimated that more than half of adolescents now carry cell phones. The few studies that have been done suggest that they identify security or safety as the primary reason for using the technology, Dr. Weisskirch said in a poster presentation at a meeting sponsored by the Society for Research on Adolescence.

For this study, parent-adolescent dyads from across the United States completed separate questionnaires. Of these, 83% were white, and 80% of the parents indicated they were currently married or in a domestic partnership.

The dyads were identified as 13% father-son, 11% father-daughter, 30% mother-son, and 46% mother-daughter. All the adolescents were of high school age and included all four grades.

The teenagers rated 18 items on a variety of typical situations and circumstances in which they would have to call their parents, including “to ask permission to do something,” “to ask for a ride somewhere or to be picked up,” and “argue by phone.” Parents answered the same questions, though they were reworded to reflect their perspectives.

Also, the adolescents rated 23 items on how often the parents call them for specific reasons or situations. Examples included, “to make sure you are where you said you would be,” “to see how your day went,” and “to ask what you want to eat.” The same questions were given to parents.

Parents and their children also completed a 22-item measure of parental self-efficacy by rating their degree of confidence in doing each of the items. Additionally, the participants rated six dimensions of parenting: closeness, monitoring, support, communication, conflict, and peer approval.

For adolescents, calling their parents for social support and in response to monitoring was associated with support, communication, peer approval, family closeness, and successful monitoring, Dr. Weisskirch said.

From the parents' perspective, adolescents calling for social support increased parent ratings of communication and closeness in the relationship, while teen-initiated calls in response to monitoring increased parental ratings of support, closeness, and monitoring.

However, arrangements were likely to sour when parents initiated calls perceived by their children to constitute overmonitoring. Calls made to track schoolwork or calling when upset were associated with increased conflict, he said.

“For parents, it's a warning that, while you want to call your kids, you don't want to do it too often because that's going to create more problems,” Dr. Weisskirch said in an interview.

He posited that adolescents want the autonomy to respond without the feeling of being monitored. However, adolescents who perceived an obligation to inform parents of their whereabouts have parents who have more parental self-efficacy.

“It's all about setting expectations about how the adolescent is supposed to use the cell phone,” the researcher said in an interview. “If those guidelines are given as instructions and not an order, and the child understands them, the parent-child relationship will be strengthened.”

Giving children instructions that they understand strengthens the parent-child relationship. DR. WEISSKIRCH

CHICAGO – Clear parental expectations about adolescents' cell phone use can support family relationships, a survey of 196 parent-adolescent dyads shows.

Helping parents realize this can assist them in launching their adolescents toward adulthood, said Robert S. Weisskirch, Ph.D., of California State University Monterey Bay, Seaside.

It's estimated that more than half of adolescents now carry cell phones. The few studies that have been done suggest that they identify security or safety as the primary reason for using the technology, Dr. Weisskirch said in a poster presentation at a meeting sponsored by the Society for Research on Adolescence.

For this study, parent-adolescent dyads from across the United States completed separate questionnaires. Of these, 83% were white, and 80% of the parents indicated they were currently married or in a domestic partnership.

The dyads were identified as 13% father-son, 11% father-daughter, 30% mother-son, and 46% mother-daughter. All the adolescents were of high school age and included all four grades.

The teenagers rated 18 items on a variety of typical situations and circumstances in which they would have to call their parents, including “to ask permission to do something,” “to ask for a ride somewhere or to be picked up,” and “argue by phone.” Parents answered the same questions, though they were reworded to reflect their perspectives.

Also, the adolescents rated 23 items on how often the parents call them for specific reasons or situations. Examples included, “to make sure you are where you said you would be,” “to see how your day went,” and “to ask what you want to eat.” The same questions were given to parents.

Parents and their children also completed a 22-item measure of parental self-efficacy by rating their degree of confidence in doing each of the items. Additionally, the participants rated six dimensions of parenting: closeness, monitoring, support, communication, conflict, and peer approval.

For adolescents, calling their parents for social support and in response to monitoring was associated with support, communication, peer approval, family closeness, and successful monitoring, Dr. Weisskirch said.

From the parents' perspective, adolescents calling for social support increased parent ratings of communication and closeness in the relationship, while teen-initiated calls in response to monitoring increased parental ratings of support, closeness, and monitoring.

However, arrangements were likely to sour when parents initiated calls perceived by their children to constitute overmonitoring. Calls made to track schoolwork or calling when upset were associated with increased conflict, he said.

“For parents, it's a warning that, while you want to call your kids, you don't want to do it too often because that's going to create more problems,” Dr. Weisskirch said in an interview.

He posited that adolescents want the autonomy to respond without the feeling of being monitored. However, adolescents who perceived an obligation to inform parents of their whereabouts have parents who have more parental self-efficacy.

“It's all about setting expectations about how the adolescent is supposed to use the cell phone,” the researcher said in an interview. “If those guidelines are given as instructions and not an order, and the child understands them, the parent-child relationship will be strengthened.”

Giving children instructions that they understand strengthens the parent-child relationship. DR. WEISSKIRCH

CHICAGO — Dual-source computed tomography significantly reduces radiation exposure to patients undergoing heart scans, and eliminates the need for heart-slowing medications, according to a study presented at the annual meeting of the Radiological Society of North America.

Improved temporal resolution with dual-source CT (DSCT) improves diagnostic quality by significantly reducing cardiac motion artifacts, obviating the need for β-blockade, Dr. U. Joseph Schoepf said.

In addition, more effective ECG pulsing techniques and faster scan times available with DSCT significantly decrease radiation dose by an average of 10%, compared with conventional 64-slice CT, Dr. Schoepf said in an interview.

“Dual-source CT has built-in features that allow the operator to accurately tailor radiation dose to each patient,” said Dr. Schoepf, of the Medical University of South Carolina (MUSC) in Charleston.

In this study, the first 30 patients who underwent CT angiography with a DSCT scanner (SOMATOM Definition, Siemens Medical Solutions) were compared with the most recent 30 patients to undergo 64-slice CT angiography at MUSC.

A fixed temporal resolution of 83 msec, heart-rate adaptive pitch, and ECG pulsing were used with the DSCT in all cases. Temporal resolution at 64-slice CT was 165 msec at a fixed pitch of 0.2. With both scanners, the gantry rotation time was 330 msec, collimation was 0.6 mm, and the injection protocol was triphasic.

A radiologist and a cardiologist who were blinded to the scanner type evaluated the coronary arteries for motion artifact using the American Heart Association segment model. Patient heart rate, radiation dose, and use of β-blockers were recorded.

“With the previous generation scanner, we still had to use β-blockers to slow heart rate to achieve good images,” Dr. Schoepf said in an interview. “We quickly learned that medications were not necessary with the DS scanner because of the faster shutter speed and better temporal resolution.”

The abandonment of β-blockade simplifies procedural logistics, he said, explaining that the typical intravenous protocol requires having a nurse available and increases scan time because the drug is administered while the patient occupies the scanner table. “And it's always better to avoid giving drugs when you can,” he added.

The average computed tomography dose index (fundamental radiation dose parameter used in CT) volumes were 61 mGy for patients aged 35–72 years and 53 mGy for patients aged 21–89 years, respectively.

The average heart rates were 64 beats per minute among the control group and 73 beats per minute among those imaged with the dual scanner. β-Blockers were used in 12 of the 30 patients scanned with 64-slice CT; none were used in the DSCT group.

Cardiac motion artifacts were observed in 24% of coronary segments in 64-slice CT patients, compared with 9% of segments in the DSCT arm. In each group, data sets were completely void of motion artifacts in 3 of 30 and 12 of 30 patients, respectively.

“Overall, the diagnostic quality was better in the DSCT group despite the faster heart rates,” said Dr. Schoepf, who disclosed that he is a consultant to and has received research support from Siemens Medical Solutions and the imaging contrast divisions of Bayer, GE Healthcare, and Bracco Diagnostics. However, no outside funding was used for the current study or the scanners used in it, he said.

“With another step in the evolution of medical imaging, we're closing the gap from invasive to noninvasive diagnostic catheterization and getting to the point of being able to get the same diagnostic information, particularly for excluding coronary artery disease,” Dr. Schoepf said.

“But the investment of around $2.6 million for a dual-source CT probably is only worth it if you want to exploit the particular capabilities of this device, which include the dedicated cardiac, vascular, and dual-energy applications,” he added.

Single-source 64-slice CT (left) has good diagnostic quality, but DSCT (right) results in even clearer delineation of all vessel segments. Photos courtesy Dr. U. Joseph Schoepf

CHICAGO — Dual-source computed tomography significantly reduces radiation exposure to patients undergoing heart scans, and eliminates the need for heart-slowing medications, according to a study presented at the annual meeting of the Radiological Society of North America.

Improved temporal resolution with dual-source CT (DSCT) improves diagnostic quality by significantly reducing cardiac motion artifacts, obviating the need for β-blockade, Dr. U. Joseph Schoepf said.

In addition, more effective ECG pulsing techniques and faster scan times available with DSCT significantly decrease radiation dose by an average of 10%, compared with conventional 64-slice CT, Dr. Schoepf said in an interview.

“Dual-source CT has built-in features that allow the operator to accurately tailor radiation dose to each patient,” said Dr. Schoepf, of the Medical University of South Carolina (MUSC) in Charleston.

In this study, the first 30 patients who underwent CT angiography with a DSCT scanner (SOMATOM Definition, Siemens Medical Solutions) were compared with the most recent 30 patients to undergo 64-slice CT angiography at MUSC.

A fixed temporal resolution of 83 msec, heart-rate adaptive pitch, and ECG pulsing were used with the DSCT in all cases. Temporal resolution at 64-slice CT was 165 msec at a fixed pitch of 0.2. With both scanners, the gantry rotation time was 330 msec, collimation was 0.6 mm, and the injection protocol was triphasic.

A radiologist and a cardiologist who were blinded to the scanner type evaluated the coronary arteries for motion artifact using the American Heart Association segment model. Patient heart rate, radiation dose, and use of β-blockers were recorded.

“With the previous generation scanner, we still had to use β-blockers to slow heart rate to achieve good images,” Dr. Schoepf said in an interview. “We quickly learned that medications were not necessary with the DS scanner because of the faster shutter speed and better temporal resolution.”

The abandonment of β-blockade simplifies procedural logistics, he said, explaining that the typical intravenous protocol requires having a nurse available and increases scan time because the drug is administered while the patient occupies the scanner table. “And it's always better to avoid giving drugs when you can,” he added.

The average computed tomography dose index (fundamental radiation dose parameter used in CT) volumes were 61 mGy for patients aged 35–72 years and 53 mGy for patients aged 21–89 years, respectively.

The average heart rates were 64 beats per minute among the control group and 73 beats per minute among those imaged with the dual scanner. β-Blockers were used in 12 of the 30 patients scanned with 64-slice CT; none were used in the DSCT group.

Cardiac motion artifacts were observed in 24% of coronary segments in 64-slice CT patients, compared with 9% of segments in the DSCT arm. In each group, data sets were completely void of motion artifacts in 3 of 30 and 12 of 30 patients, respectively.

“Overall, the diagnostic quality was better in the DSCT group despite the faster heart rates,” said Dr. Schoepf, who disclosed that he is a consultant to and has received research support from Siemens Medical Solutions and the imaging contrast divisions of Bayer, GE Healthcare, and Bracco Diagnostics. However, no outside funding was used for the current study or the scanners used in it, he said.

“With another step in the evolution of medical imaging, we're closing the gap from invasive to noninvasive diagnostic catheterization and getting to the point of being able to get the same diagnostic information, particularly for excluding coronary artery disease,” Dr. Schoepf said.

“But the investment of around $2.6 million for a dual-source CT probably is only worth it if you want to exploit the particular capabilities of this device, which include the dedicated cardiac, vascular, and dual-energy applications,” he added.

Single-source 64-slice CT (left) has good diagnostic quality, but DSCT (right) results in even clearer delineation of all vessel segments. Photos courtesy Dr. U. Joseph Schoepf

CHICAGO — Dual-source computed tomography significantly reduces radiation exposure to patients undergoing heart scans, and eliminates the need for heart-slowing medications, according to a study presented at the annual meeting of the Radiological Society of North America.

Improved temporal resolution with dual-source CT (DSCT) improves diagnostic quality by significantly reducing cardiac motion artifacts, obviating the need for β-blockade, Dr. U. Joseph Schoepf said.

In addition, more effective ECG pulsing techniques and faster scan times available with DSCT significantly decrease radiation dose by an average of 10%, compared with conventional 64-slice CT, Dr. Schoepf said in an interview.

“Dual-source CT has built-in features that allow the operator to accurately tailor radiation dose to each patient,” said Dr. Schoepf, of the Medical University of South Carolina (MUSC) in Charleston.

In this study, the first 30 patients who underwent CT angiography with a DSCT scanner (SOMATOM Definition, Siemens Medical Solutions) were compared with the most recent 30 patients to undergo 64-slice CT angiography at MUSC.

A fixed temporal resolution of 83 msec, heart-rate adaptive pitch, and ECG pulsing were used with the DSCT in all cases. Temporal resolution at 64-slice CT was 165 msec at a fixed pitch of 0.2. With both scanners, the gantry rotation time was 330 msec, collimation was 0.6 mm, and the injection protocol was triphasic.

A radiologist and a cardiologist who were blinded to the scanner type evaluated the coronary arteries for motion artifact using the American Heart Association segment model. Patient heart rate, radiation dose, and use of β-blockers were recorded.

“With the previous generation scanner, we still had to use β-blockers to slow heart rate to achieve good images,” Dr. Schoepf said in an interview. “We quickly learned that medications were not necessary with the DS scanner because of the faster shutter speed and better temporal resolution.”

The abandonment of β-blockade simplifies procedural logistics, he said, explaining that the typical intravenous protocol requires having a nurse available and increases scan time because the drug is administered while the patient occupies the scanner table. “And it's always better to avoid giving drugs when you can,” he added.

The average computed tomography dose index (fundamental radiation dose parameter used in CT) volumes were 61 mGy for patients aged 35–72 years and 53 mGy for patients aged 21–89 years, respectively.

The average heart rates were 64 beats per minute among the control group and 73 beats per minute among those imaged with the dual scanner. β-Blockers were used in 12 of the 30 patients scanned with 64-slice CT; none were used in the DSCT group.

Cardiac motion artifacts were observed in 24% of coronary segments in 64-slice CT patients, compared with 9% of segments in the DSCT arm. In each group, data sets were completely void of motion artifacts in 3 of 30 and 12 of 30 patients, respectively.

“Overall, the diagnostic quality was better in the DSCT group despite the faster heart rates,” said Dr. Schoepf, who disclosed that he is a consultant to and has received research support from Siemens Medical Solutions and the imaging contrast divisions of Bayer, GE Healthcare, and Bracco Diagnostics. However, no outside funding was used for the current study or the scanners used in it, he said.

“With another step in the evolution of medical imaging, we're closing the gap from invasive to noninvasive diagnostic catheterization and getting to the point of being able to get the same diagnostic information, particularly for excluding coronary artery disease,” Dr. Schoepf said.

“But the investment of around $2.6 million for a dual-source CT probably is only worth it if you want to exploit the particular capabilities of this device, which include the dedicated cardiac, vascular, and dual-energy applications,” he added.

Single-source 64-slice CT (left) has good diagnostic quality, but DSCT (right) results in even clearer delineation of all vessel segments. Photos courtesy Dr. U. Joseph Schoepf

The soaring numbers of commonly used drugs with soundalike and look-alike names have prompted the U.S. Pharmacopeia to ask physicians and pharmacists to include an "indication for use" on prescriptions.

This and other recommendations are contained in U.S. Pharmacopeia's 8th annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, a figure that is nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

"We were surprised to see that much of an increase in such a short time, and the concern is that this increase in products in the marketplace further raises the opportunity for error," said Ms. Cousins, USP's vice president of health care quality and information.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professionals to confidentially report potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or soundalike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the 400-page report.

"We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list," Ms. Cousins said in an interview.

An important finding of this year's report is the role of pharmacy staff in LASA-related errors, she said. "Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff."

The report also identifies an emerging trend of look-alike drug names in computerized direct order entry systems as a source of confusion. "This trend will likely continue as these systems become a standard of practice," she said, adding that the LASA-related error problem is further compounded by the indiscriminate use of suffixes, as well as look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was cefazolin, a first-generation cephalosporin antibiotic. "We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications," said Ms. Cousins.

Among other major paired LASAs were cardiovascular medications, such as lisinopril and enalapril, and central nervous system agents, such as trazodone and chlorpromazine.

Drug mix-ups led to seven reported fatalities, including two deaths attributed to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl.

In another case, an autistic pediatric patient was given the wrong product when disodium EDTA (a hypercalcemia treatment) was administered instead of the chelation therapy calcium disodium EDTA, which is approved by the Food and Drug Administration for the treatment of lead poisoning and was prescribed in an attempt to help treat the patient's autism.

In another case, an emergency department physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead. The patient received a large amount of the wrong agent, which led to a fatal heart arrhythmia.

The remaining three reported deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many, such as the primidone-prednisone incident, are due to confusion over the prescribing physician's handwriting, which lead the pharmacist to issue the wrong drug.

"Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine," she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors. "Anything that takes handwriting out of the equation is a help."

It would also be helpful if the FDA were given more authority to force name changes during the drug review process, as has been suggested by the Institute of Medicine. It's much more difficult to correct a name confusion issue once the products are on the market.

The recommendation that physicians include indications for use in their prescriptions is not an attempt by USP to impose on privacy, Ms. Cousins emphasized. "All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or, 'for cough,'" she said, explaining that this also would help patients avoid confusion if they forget which vial is for which condition.

USP also recommends that "tall man lettering" be implemented in pharmacy software, labeling, and order writing to say, for example, "acetaZOLamide" (glaucoma) and "acetoHEXamide" (diabetes).

Where risk exists, take action to reduce the chance for error. USP recommends the following:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for soundalikes that have been mixed up at your facility.

Physicians' offices should always require a read-back from pharmacists, making sure "they both say and spell the drug name, especially for these often confusing drug pairs," Ms. Cousins concluded.

The drug with the most mix-ups was cefazolin, which was confused with 15 other drugs, primarily antimicrobials. MS. COUSINS

The soaring numbers of commonly used drugs with soundalike and look-alike names have prompted the U.S. Pharmacopeia to ask physicians and pharmacists to include an "indication for use" on prescriptions.

This and other recommendations are contained in U.S. Pharmacopeia's 8th annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, a figure that is nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

"We were surprised to see that much of an increase in such a short time, and the concern is that this increase in products in the marketplace further raises the opportunity for error," said Ms. Cousins, USP's vice president of health care quality and information.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professionals to confidentially report potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or soundalike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the 400-page report.

"We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list," Ms. Cousins said in an interview.

An important finding of this year's report is the role of pharmacy staff in LASA-related errors, she said. "Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff."

The report also identifies an emerging trend of look-alike drug names in computerized direct order entry systems as a source of confusion. "This trend will likely continue as these systems become a standard of practice," she said, adding that the LASA-related error problem is further compounded by the indiscriminate use of suffixes, as well as look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was cefazolin, a first-generation cephalosporin antibiotic. "We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications," said Ms. Cousins.

Among other major paired LASAs were cardiovascular medications, such as lisinopril and enalapril, and central nervous system agents, such as trazodone and chlorpromazine.

Drug mix-ups led to seven reported fatalities, including two deaths attributed to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl.

In another case, an autistic pediatric patient was given the wrong product when disodium EDTA (a hypercalcemia treatment) was administered instead of the chelation therapy calcium disodium EDTA, which is approved by the Food and Drug Administration for the treatment of lead poisoning and was prescribed in an attempt to help treat the patient's autism.

In another case, an emergency department physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead. The patient received a large amount of the wrong agent, which led to a fatal heart arrhythmia.

The remaining three reported deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many, such as the primidone-prednisone incident, are due to confusion over the prescribing physician's handwriting, which lead the pharmacist to issue the wrong drug.

"Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine," she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors. "Anything that takes handwriting out of the equation is a help."

It would also be helpful if the FDA were given more authority to force name changes during the drug review process, as has been suggested by the Institute of Medicine. It's much more difficult to correct a name confusion issue once the products are on the market.

The recommendation that physicians include indications for use in their prescriptions is not an attempt by USP to impose on privacy, Ms. Cousins emphasized. "All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or, 'for cough,'" she said, explaining that this also would help patients avoid confusion if they forget which vial is for which condition.

USP also recommends that "tall man lettering" be implemented in pharmacy software, labeling, and order writing to say, for example, "acetaZOLamide" (glaucoma) and "acetoHEXamide" (diabetes).

Where risk exists, take action to reduce the chance for error. USP recommends the following:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for soundalikes that have been mixed up at your facility.

Physicians' offices should always require a read-back from pharmacists, making sure "they both say and spell the drug name, especially for these often confusing drug pairs," Ms. Cousins concluded.

The drug with the most mix-ups was cefazolin, which was confused with 15 other drugs, primarily antimicrobials. MS. COUSINS

The soaring numbers of commonly used drugs with soundalike and look-alike names have prompted the U.S. Pharmacopeia to ask physicians and pharmacists to include an "indication for use" on prescriptions.

This and other recommendations are contained in U.S. Pharmacopeia's 8th annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, a figure that is nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

"We were surprised to see that much of an increase in such a short time, and the concern is that this increase in products in the marketplace further raises the opportunity for error," said Ms. Cousins, USP's vice president of health care quality and information.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professionals to confidentially report potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or soundalike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the 400-page report.

"We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list," Ms. Cousins said in an interview.

An important finding of this year's report is the role of pharmacy staff in LASA-related errors, she said. "Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff."

The report also identifies an emerging trend of look-alike drug names in computerized direct order entry systems as a source of confusion. "This trend will likely continue as these systems become a standard of practice," she said, adding that the LASA-related error problem is further compounded by the indiscriminate use of suffixes, as well as look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was cefazolin, a first-generation cephalosporin antibiotic. "We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications," said Ms. Cousins.

Among other major paired LASAs were cardiovascular medications, such as lisinopril and enalapril, and central nervous system agents, such as trazodone and chlorpromazine.

Drug mix-ups led to seven reported fatalities, including two deaths attributed to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl.

In another case, an autistic pediatric patient was given the wrong product when disodium EDTA (a hypercalcemia treatment) was administered instead of the chelation therapy calcium disodium EDTA, which is approved by the Food and Drug Administration for the treatment of lead poisoning and was prescribed in an attempt to help treat the patient's autism.

In another case, an emergency department physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead. The patient received a large amount of the wrong agent, which led to a fatal heart arrhythmia.

The remaining three reported deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many, such as the primidone-prednisone incident, are due to confusion over the prescribing physician's handwriting, which lead the pharmacist to issue the wrong drug.

"Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine," she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors. "Anything that takes handwriting out of the equation is a help."

It would also be helpful if the FDA were given more authority to force name changes during the drug review process, as has been suggested by the Institute of Medicine. It's much more difficult to correct a name confusion issue once the products are on the market.

The recommendation that physicians include indications for use in their prescriptions is not an attempt by USP to impose on privacy, Ms. Cousins emphasized. "All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or, 'for cough,'" she said, explaining that this also would help patients avoid confusion if they forget which vial is for which condition.

USP also recommends that "tall man lettering" be implemented in pharmacy software, labeling, and order writing to say, for example, "acetaZOLamide" (glaucoma) and "acetoHEXamide" (diabetes).

Where risk exists, take action to reduce the chance for error. USP recommends the following:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for soundalikes that have been mixed up at your facility.

Physicians' offices should always require a read-back from pharmacists, making sure "they both say and spell the drug name, especially for these often confusing drug pairs," Ms. Cousins concluded.

The drug with the most mix-ups was cefazolin, which was confused with 15 other drugs, primarily antimicrobials. MS. COUSINS

Researchers in Montreal have reported new evidence supporting a strong causal association between human papillomavirus infection and tonsil-related oral cancers.

The study also found that human papillomavirus (HPV) 16 seropositivity contributes substantial independent risk prediction. "HPV 16 seropositivity may thus serve as a surrogate marker for the totality of HPV exposure that is relevant in oral carcinogenesis," wrote Dr. Javier Pintos and his associates from the division of cancer epidemiology at McGill University.

Additionally, while some researchers have reported a positive correlation between markers of sexual activity and oral cancers, this study found no such association (Oral Oncol. 2008;44:242–50).

The investigation, as part of a multicenter study coordinated by the International Agency for Research on Cancer, followed a hospital-based case-control design.

A total of 72 patients with newly diagnosed squamous cell carcinoma of the mouth and 129 controls were recruited. Among patients, the most common cancer site was the tongue (21 patients), followed by the floor of the mouth (12) and palatine tonsil (12), "other" and "unspecified" parts of the mouth (18), the palate (4), the gums (2), the oropharynx (2), and the inner lip (1), Dr. Pintos and his coinvestigators said.

Patients ranged in age from 25 to 84 years, though most were between 55 and 74; men accounted for more than 70%.

As expected, tobacco smoking and alcohol consumption were higher among patients, compared with controls. Controls were selected from the same hospitals where patients had been recruited but did not have personal histories of cancer nor admitting conditions related to tobacco or alcohol. Heavy smokers (more than 49 pack-years) represented 39% of patients and 16% of controls, and more than half of patients and 17% of controls were categorized as heavy drinkers.

HPV DNA was detected in 6 of 129 controls (5%) and 14 of 72 patients (19%). Most viral infections among patients harbored high-risk HPV types (13 of 14 samples), compared with 4 of the 6 HPV-positive controls, the investigators said, adding that HPV 16, which was not detected among controls, was found in 13 of the 14 positive samples from the oral cancer arm.

Other studies have found that, in the oral cavity, the tonsils appear to be preferentially infected by HPV, the authors said. "In addition to the epidemiological evidence, there is consistent biological evidence that HPV-positive cancers arising from the palatine and lingual tonsils are a distinct entity etiologically linked to infection by high-risk HPV types, especially HPV 16."

On the other hand, there is scant biologic evidence linking HPV infection and cancers of the oral cavity not related to the lingual and palatine tonsils, and the proportion of nontonsillar cancers of the mouth attributable to HPV infection is likely to be small, they wrote.

"The association found in this investigation between HPV and cancers of the palatine tonsils and base of tongue seem to be genuine," the authors said, noting that the association is independent from the influence of smoking and alcohol, the two established causal factors for oral cancers.

The validity of the association was further supported through the consistent use of both polymerase chain reaction and serologic techniques, Dr. Pintos and his associates wrote.

The study was funded by the National Cancer Institute of Canada. The authors had no conflicts of interest to declare.

ELSEVIER GLOBAL MEDICAL NEWS

Researchers in Montreal have reported new evidence supporting a strong causal association between human papillomavirus infection and tonsil-related oral cancers.

The study also found that human papillomavirus (HPV) 16 seropositivity contributes substantial independent risk prediction. "HPV 16 seropositivity may thus serve as a surrogate marker for the totality of HPV exposure that is relevant in oral carcinogenesis," wrote Dr. Javier Pintos and his associates from the division of cancer epidemiology at McGill University.

Additionally, while some researchers have reported a positive correlation between markers of sexual activity and oral cancers, this study found no such association (Oral Oncol. 2008;44:242–50).

The investigation, as part of a multicenter study coordinated by the International Agency for Research on Cancer, followed a hospital-based case-control design.

A total of 72 patients with newly diagnosed squamous cell carcinoma of the mouth and 129 controls were recruited. Among patients, the most common cancer site was the tongue (21 patients), followed by the floor of the mouth (12) and palatine tonsil (12), "other" and "unspecified" parts of the mouth (18), the palate (4), the gums (2), the oropharynx (2), and the inner lip (1), Dr. Pintos and his coinvestigators said.

Patients ranged in age from 25 to 84 years, though most were between 55 and 74; men accounted for more than 70%.

As expected, tobacco smoking and alcohol consumption were higher among patients, compared with controls. Controls were selected from the same hospitals where patients had been recruited but did not have personal histories of cancer nor admitting conditions related to tobacco or alcohol. Heavy smokers (more than 49 pack-years) represented 39% of patients and 16% of controls, and more than half of patients and 17% of controls were categorized as heavy drinkers.

HPV DNA was detected in 6 of 129 controls (5%) and 14 of 72 patients (19%). Most viral infections among patients harbored high-risk HPV types (13 of 14 samples), compared with 4 of the 6 HPV-positive controls, the investigators said, adding that HPV 16, which was not detected among controls, was found in 13 of the 14 positive samples from the oral cancer arm.

Other studies have found that, in the oral cavity, the tonsils appear to be preferentially infected by HPV, the authors said. "In addition to the epidemiological evidence, there is consistent biological evidence that HPV-positive cancers arising from the palatine and lingual tonsils are a distinct entity etiologically linked to infection by high-risk HPV types, especially HPV 16."

On the other hand, there is scant biologic evidence linking HPV infection and cancers of the oral cavity not related to the lingual and palatine tonsils, and the proportion of nontonsillar cancers of the mouth attributable to HPV infection is likely to be small, they wrote.

"The association found in this investigation between HPV and cancers of the palatine tonsils and base of tongue seem to be genuine," the authors said, noting that the association is independent from the influence of smoking and alcohol, the two established causal factors for oral cancers.

The validity of the association was further supported through the consistent use of both polymerase chain reaction and serologic techniques, Dr. Pintos and his associates wrote.

The study was funded by the National Cancer Institute of Canada. The authors had no conflicts of interest to declare.

ELSEVIER GLOBAL MEDICAL NEWS

Researchers in Montreal have reported new evidence supporting a strong causal association between human papillomavirus infection and tonsil-related oral cancers.

The study also found that human papillomavirus (HPV) 16 seropositivity contributes substantial independent risk prediction. "HPV 16 seropositivity may thus serve as a surrogate marker for the totality of HPV exposure that is relevant in oral carcinogenesis," wrote Dr. Javier Pintos and his associates from the division of cancer epidemiology at McGill University.

Additionally, while some researchers have reported a positive correlation between markers of sexual activity and oral cancers, this study found no such association (Oral Oncol. 2008;44:242–50).

The investigation, as part of a multicenter study coordinated by the International Agency for Research on Cancer, followed a hospital-based case-control design.

A total of 72 patients with newly diagnosed squamous cell carcinoma of the mouth and 129 controls were recruited. Among patients, the most common cancer site was the tongue (21 patients), followed by the floor of the mouth (12) and palatine tonsil (12), "other" and "unspecified" parts of the mouth (18), the palate (4), the gums (2), the oropharynx (2), and the inner lip (1), Dr. Pintos and his coinvestigators said.

Patients ranged in age from 25 to 84 years, though most were between 55 and 74; men accounted for more than 70%.

As expected, tobacco smoking and alcohol consumption were higher among patients, compared with controls. Controls were selected from the same hospitals where patients had been recruited but did not have personal histories of cancer nor admitting conditions related to tobacco or alcohol. Heavy smokers (more than 49 pack-years) represented 39% of patients and 16% of controls, and more than half of patients and 17% of controls were categorized as heavy drinkers.

HPV DNA was detected in 6 of 129 controls (5%) and 14 of 72 patients (19%). Most viral infections among patients harbored high-risk HPV types (13 of 14 samples), compared with 4 of the 6 HPV-positive controls, the investigators said, adding that HPV 16, which was not detected among controls, was found in 13 of the 14 positive samples from the oral cancer arm.

Other studies have found that, in the oral cavity, the tonsils appear to be preferentially infected by HPV, the authors said. "In addition to the epidemiological evidence, there is consistent biological evidence that HPV-positive cancers arising from the palatine and lingual tonsils are a distinct entity etiologically linked to infection by high-risk HPV types, especially HPV 16."

On the other hand, there is scant biologic evidence linking HPV infection and cancers of the oral cavity not related to the lingual and palatine tonsils, and the proportion of nontonsillar cancers of the mouth attributable to HPV infection is likely to be small, they wrote.

"The association found in this investigation between HPV and cancers of the palatine tonsils and base of tongue seem to be genuine," the authors said, noting that the association is independent from the influence of smoking and alcohol, the two established causal factors for oral cancers.

The validity of the association was further supported through the consistent use of both polymerase chain reaction and serologic techniques, Dr. Pintos and his associates wrote.

The study was funded by the National Cancer Institute of Canada. The authors had no conflicts of interest to declare.

ELSEVIER GLOBAL MEDICAL NEWS

Children with multiple prescriptions and those whose parents lack English skills are at increased risk of having preventable adverse drug events, according to a Boston study.

"Further attention should be directed toward improved communication among health care providers and patients," said Dr. Stephanie O. Zandieh of Cornell University, New York, and the Komansky Center for Children's Health at New York-Presbyterian Hospital and associates.

In the prospective cohort of patients aged under 21 years who were seen from July 2002 to April 2003 at six urban and suburban practice sites in Boston, Mass. The primary outcome measure was the presence of a preventable adverse drug event (ADE), defined as actual harm from medication use (J. Pediatr. 2008;152:225–31). Telephone surveys were used to gather information about race, ethnicity, reported annual family income, parental educational attainment, and parental self-reported English proficiency.

Independent variables, such as socio-economic characteristics, poverty status, health care access, and medication regimen complexity, were determined by both telephone interviews and chart reviews.

The study logged more than 21,000 visits by 14,000 patients, 3,838 of whom received a prescription. Of those, the researchers studied 1,689 who completed the 10-day survey and had a chart review; they received 2,155 prescriptions.

The study population was about 49% white, 15% black, 21% Hispanic, and 14% "other," the investigators said. Two-thirds of Hispanics had limited English proficiency, compared with 16% of blacks, 3% of whites, and 23% of the "other" group of Native Americans, Asians, and Native Pacific Islanders. "We found 283 ADEs occurred in 242 children (14% [of total 1,689 patients]), of which 57 were preventable in 56 children and 226 were nonpreventable ADEs in 186 children," the investigators said, adding that about 10% of the children who had a preventable ADE also experienced a nonpreventable event. None of the preventable ADEs were life threatening or fatal, 14% were serious, and 86% were considered significant.

A total of 40 preventable ADEs (70%) occurred during parental administration of medication, and 15 (26%) occurred during ordering, they said, adding that the most common drugs involved in preventable ADEs were amoxicillin or amoxicillin-clavulanate (26%), inhaled steroids (11%), topical antifungals (7%), antihistamines (7%), and inhaled bronchodilators (5%).

In the univariate analysis of the data, the researchers found that children of parents who said they spoke English poorly were twice as likely to have a preventable ADE, compared with children of parents who spoke English very well. Similarly, children with less than a year of continuous care were more likely to have a preventable ADE. In multivariate anaylsis, children with chronic illnesses had more medications prescribed, increasing their risk of a preventable adverse event. Also, most preventable ADEs occurred during home administration, the researchers wrote.

The investigators derived two key policy implications from their findings. First, identification of parents' health literacy and appropriate tailoring of medication-related information are required. "It is imperative that parents clearly understand medication-related instructions and have their questions answered," Dr. Zandieh said. Secondly, for policy makers and providers who are interested in improving patient safety, better methods are needed to identify preventable ADEs.

Children with multiple prescriptions and those whose parents lack English skills are at increased risk of having preventable adverse drug events, according to a Boston study.

"Further attention should be directed toward improved communication among health care providers and patients," said Dr. Stephanie O. Zandieh of Cornell University, New York, and the Komansky Center for Children's Health at New York-Presbyterian Hospital and associates.

In the prospective cohort of patients aged under 21 years who were seen from July 2002 to April 2003 at six urban and suburban practice sites in Boston, Mass. The primary outcome measure was the presence of a preventable adverse drug event (ADE), defined as actual harm from medication use (J. Pediatr. 2008;152:225–31). Telephone surveys were used to gather information about race, ethnicity, reported annual family income, parental educational attainment, and parental self-reported English proficiency.

Independent variables, such as socio-economic characteristics, poverty status, health care access, and medication regimen complexity, were determined by both telephone interviews and chart reviews.

The study logged more than 21,000 visits by 14,000 patients, 3,838 of whom received a prescription. Of those, the researchers studied 1,689 who completed the 10-day survey and had a chart review; they received 2,155 prescriptions.

The study population was about 49% white, 15% black, 21% Hispanic, and 14% "other," the investigators said. Two-thirds of Hispanics had limited English proficiency, compared with 16% of blacks, 3% of whites, and 23% of the "other" group of Native Americans, Asians, and Native Pacific Islanders. "We found 283 ADEs occurred in 242 children (14% [of total 1,689 patients]), of which 57 were preventable in 56 children and 226 were nonpreventable ADEs in 186 children," the investigators said, adding that about 10% of the children who had a preventable ADE also experienced a nonpreventable event. None of the preventable ADEs were life threatening or fatal, 14% were serious, and 86% were considered significant.

A total of 40 preventable ADEs (70%) occurred during parental administration of medication, and 15 (26%) occurred during ordering, they said, adding that the most common drugs involved in preventable ADEs were amoxicillin or amoxicillin-clavulanate (26%), inhaled steroids (11%), topical antifungals (7%), antihistamines (7%), and inhaled bronchodilators (5%).

In the univariate analysis of the data, the researchers found that children of parents who said they spoke English poorly were twice as likely to have a preventable ADE, compared with children of parents who spoke English very well. Similarly, children with less than a year of continuous care were more likely to have a preventable ADE. In multivariate anaylsis, children with chronic illnesses had more medications prescribed, increasing their risk of a preventable adverse event. Also, most preventable ADEs occurred during home administration, the researchers wrote.

The investigators derived two key policy implications from their findings. First, identification of parents' health literacy and appropriate tailoring of medication-related information are required. "It is imperative that parents clearly understand medication-related instructions and have their questions answered," Dr. Zandieh said. Secondly, for policy makers and providers who are interested in improving patient safety, better methods are needed to identify preventable ADEs.

Children with multiple prescriptions and those whose parents lack English skills are at increased risk of having preventable adverse drug events, according to a Boston study.

"Further attention should be directed toward improved communication among health care providers and patients," said Dr. Stephanie O. Zandieh of Cornell University, New York, and the Komansky Center for Children's Health at New York-Presbyterian Hospital and associates.

In the prospective cohort of patients aged under 21 years who were seen from July 2002 to April 2003 at six urban and suburban practice sites in Boston, Mass. The primary outcome measure was the presence of a preventable adverse drug event (ADE), defined as actual harm from medication use (J. Pediatr. 2008;152:225–31). Telephone surveys were used to gather information about race, ethnicity, reported annual family income, parental educational attainment, and parental self-reported English proficiency.

Independent variables, such as socio-economic characteristics, poverty status, health care access, and medication regimen complexity, were determined by both telephone interviews and chart reviews.

The study logged more than 21,000 visits by 14,000 patients, 3,838 of whom received a prescription. Of those, the researchers studied 1,689 who completed the 10-day survey and had a chart review; they received 2,155 prescriptions.

The study population was about 49% white, 15% black, 21% Hispanic, and 14% "other," the investigators said. Two-thirds of Hispanics had limited English proficiency, compared with 16% of blacks, 3% of whites, and 23% of the "other" group of Native Americans, Asians, and Native Pacific Islanders. "We found 283 ADEs occurred in 242 children (14% [of total 1,689 patients]), of which 57 were preventable in 56 children and 226 were nonpreventable ADEs in 186 children," the investigators said, adding that about 10% of the children who had a preventable ADE also experienced a nonpreventable event. None of the preventable ADEs were life threatening or fatal, 14% were serious, and 86% were considered significant.

A total of 40 preventable ADEs (70%) occurred during parental administration of medication, and 15 (26%) occurred during ordering, they said, adding that the most common drugs involved in preventable ADEs were amoxicillin or amoxicillin-clavulanate (26%), inhaled steroids (11%), topical antifungals (7%), antihistamines (7%), and inhaled bronchodilators (5%).

In the univariate analysis of the data, the researchers found that children of parents who said they spoke English poorly were twice as likely to have a preventable ADE, compared with children of parents who spoke English very well. Similarly, children with less than a year of continuous care were more likely to have a preventable ADE. In multivariate anaylsis, children with chronic illnesses had more medications prescribed, increasing their risk of a preventable adverse event. Also, most preventable ADEs occurred during home administration, the researchers wrote.

The investigators derived two key policy implications from their findings. First, identification of parents' health literacy and appropriate tailoring of medication-related information are required. "It is imperative that parents clearly understand medication-related instructions and have their questions answered," Dr. Zandieh said. Secondly, for policy makers and providers who are interested in improving patient safety, better methods are needed to identify preventable ADEs.

Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.

The Food and Drug Administration granted ceftobiprole fast-track status for the treatment of complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia. Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International, a Johnson & Johnson company.

The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).

Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) in 123 patients and methicillin-susceptible S. aureus (MSSA) in 250 patients.

The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime. Respectively, the two study arms consisted of 63% and 64% men and had mean ages of 53 years and 52 years. The proportion of patients completing the trial was 92% in the ceftobiprole arm and 90% in the comparator arm.

Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours. In the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours. The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.

At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted.

Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.

The Food and Drug Administration granted ceftobiprole fast-track status for the treatment of complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia. Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International, a Johnson & Johnson company.

The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).

Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) in 123 patients and methicillin-susceptible S. aureus (MSSA) in 250 patients.

The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime. Respectively, the two study arms consisted of 63% and 64% men and had mean ages of 53 years and 52 years. The proportion of patients completing the trial was 92% in the ceftobiprole arm and 90% in the comparator arm.

Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours. In the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours. The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.

At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted.

Monotherapy with ceftobiprole was found to be as effective as vancomycin plus ceftazidime for treating patients with a broad range of complicated skin and skin-structure infections caused by gram-positive and gram-negative bacteria.

The Food and Drug Administration granted ceftobiprole fast-track status for the treatment of complicated skin and skin-structure infections caused by methicillin-resistant staphylococci and hospital-acquired pneumonia. Ceftobiprole is a novel, broad-spectrum cephalosporin developed jointly by Basilea Pharmaceutica AG and Cilag AG International, a Johnson & Johnson company.

The randomized, double-blind, multicenter trial included 828 patients with diabetic foot infections, abscess, cellulitis, and wound infection, reported Gary J. Noel and his fellow researchers, all full-time employees of Johnson & Johnson Pharmaceutical Research and Development, Raritan, N.J., which funded the study (Clin. Infect. Dis. 2008;46:647–55).

Infecting pathogen types—identified in at least 10 patients at baseline—included coagulase-negative and coagulase-positive staphylococci, Pseudomonas aeruginosa, β-hemolytic streptococci, and enterobacteriaceae. The most prevalent pathogens were gram-positive bacteria, specifically methicillin-resistant Staphylococcus aureus (MRSA) in 123 patients and methicillin-susceptible S. aureus (MSSA) in 250 patients.

The patient cohort, accumulated over 129 international sites, was divided into two arms, with 547 patients receiving ceftobiprole and 281 receiving the glycopeptide antibiotic vancomycin plus the third-generation cephalosporin ceftazidime. Respectively, the two study arms consisted of 63% and 64% men and had mean ages of 53 years and 52 years. The proportion of patients completing the trial was 92% in the ceftobiprole arm and 90% in the comparator arm.

Patients in the ceftobiprole arm received 500 mg for 120 minutes every 8 hours. In the comparator group, the starting dose was 1,000 mg vancomycin infused over 60 minutes every 12 hours plus 1,000 mg ceftazidime infused over 120 minutes every 8 hours. The mean duration of treatment in the clinically evaluable population was about 9 days in both arms, the authors noted.

At the test-of-cure (TOC) visit (after 6–17 days of treatment) for the evaluable patients, clinical cure occurred for 439 of 485 (91%) ceftobiprole-treated patients and for 220 of 244 (90%) comparator-treated patients, the researchers noted.

Women with type 1 diabetes who take less insulin than prescribed may be raising their risk of complications and shortening their life spans.

Because of various psychosocial variables, more than half of adult patients do not achieve the American Diabetes Association's glycemic targets, said Ann E. Goebel-Fabbri, Ph.D., of the Joslin Diabetes Center and Harvard Medical School, both in Boston, and her associates. Chief among the implicated variables are general psychological distress, diabetes-specific distress, fear of hypoglycemia, concern about weight gain, and related eating-disorder behaviors.

In this 11-year study, the largest to examine the long-term effect of insulin restriction on the morbidity and mortality of women with type 1 diabetes, insulin restriction at baseline conveyed more than a threefold increase in the relative risk of death, said the authors (Diabetes Care 2008;31:1–5).

At baseline, the cohort included 234 women aged 13–60 years who had had a diagnosis of type 1 diabetes for at least 1 year and who agreed to be followed up. Of those, 26 died during the study period. Mean age at follow-up was 45 years (range, 24–72 years).

Women reporting insulin restriction showed distinct clinical differences from those reporting appropriate insulin use.

At baseline, insulin restricters were significantly younger (aged 32 vs. 36 years) and had higher hemoglobin A_1c values (9.6% vs. 8.3%). However, there were no differences between the two groups with regard to baseline body mass index (BMI) or diabetes duration, the authors said.

Predictably, insulin restricters reported significantly lower scores on the baseline measure of diabetes self-care behaviors, and they scored higher on baseline measures of diabetes distress; fear of hypoglycemia; general psychological symptoms; eating disorder symptoms, such as bulimia; and the Eating Disorders Inventory.

In addition, women who said at baseline that they restricted insulin were significantly more likely to report nephropathy and foot problems at follow-up, the researchers said, adding that self-reported rates of retinopathy, neuropathy, and cardiovascular complications at follow-up did not differ between groups.

Causes of death for 10 of 71 women reporting insulin restriction included perforated bowel with gastroparesis (1), cancer (1), cardiac events (3), hypoglycemia (1), renal failure (2), sepsis (1), and suicide in the context of retinopathy-related blindness (1).

Causes of death for 16 of 163 women reporting appropriate insulin use included cancer (1), cardiac events (11), diabetic ketoacidosis (1), sepsis (2), and unknown causes (1), Dr. Goebel-Fabbri noted in an interview.

Comparisons of both groups of deceased women found that those who had restricted insulin died at a significantly younger age, and had higher baseline hemoglobin A_1c values, poorer diabetes self-care behaviors, increased levels of diabetes-specific distress, and higher scores on measures of bulimia and other eating disorder symptoms.

Compared with their living counterparts, deceased insulin restricters at baseline had higher BMI and hemoglobin A_1c values and reported more symptoms of bulimia and higher levels of diabetes-specific distress.

“These data suggest that mortality associated with insulin restriction occurred in the context of eating disorder symptoms, rather than other psychological distress,” the authors said. They added that these patients require careful monitoring and would benefit from in-depth evaluations by a mental health professional, ideally one with specialized training in diabetes.

The researchers suggested physicians screen type 1 diabetes patients by routinely asking them if they follow their insulin prescriptions. “The health and wellness of women with type 1 diabetes is likely to be promoted by greater attention to the problem of insulin restriction in future research and clinical practice,” they concluded.

ELSEVIER GLOBAL MEDICAL NEWS

Women with type 1 diabetes who take less insulin than prescribed may be raising their risk of complications and shortening their life spans.

Because of various psychosocial variables, more than half of adult patients do not achieve the American Diabetes Association's glycemic targets, said Ann E. Goebel-Fabbri, Ph.D., of the Joslin Diabetes Center and Harvard Medical School, both in Boston, and her associates. Chief among the implicated variables are general psychological distress, diabetes-specific distress, fear of hypoglycemia, concern about weight gain, and related eating-disorder behaviors.

In this 11-year study, the largest to examine the long-term effect of insulin restriction on the morbidity and mortality of women with type 1 diabetes, insulin restriction at baseline conveyed more than a threefold increase in the relative risk of death, said the authors (Diabetes Care 2008;31:1–5).

At baseline, the cohort included 234 women aged 13–60 years who had had a diagnosis of type 1 diabetes for at least 1 year and who agreed to be followed up. Of those, 26 died during the study period. Mean age at follow-up was 45 years (range, 24–72 years).

Women reporting insulin restriction showed distinct clinical differences from those reporting appropriate insulin use.

At baseline, insulin restricters were significantly younger (aged 32 vs. 36 years) and had higher hemoglobin A_1c values (9.6% vs. 8.3%). However, there were no differences between the two groups with regard to baseline body mass index (BMI) or diabetes duration, the authors said.

Predictably, insulin restricters reported significantly lower scores on the baseline measure of diabetes self-care behaviors, and they scored higher on baseline measures of diabetes distress; fear of hypoglycemia; general psychological symptoms; eating disorder symptoms, such as bulimia; and the Eating Disorders Inventory.

In addition, women who said at baseline that they restricted insulin were significantly more likely to report nephropathy and foot problems at follow-up, the researchers said, adding that self-reported rates of retinopathy, neuropathy, and cardiovascular complications at follow-up did not differ between groups.

Causes of death for 10 of 71 women reporting insulin restriction included perforated bowel with gastroparesis (1), cancer (1), cardiac events (3), hypoglycemia (1), renal failure (2), sepsis (1), and suicide in the context of retinopathy-related blindness (1).

Causes of death for 16 of 163 women reporting appropriate insulin use included cancer (1), cardiac events (11), diabetic ketoacidosis (1), sepsis (2), and unknown causes (1), Dr. Goebel-Fabbri noted in an interview.

Comparisons of both groups of deceased women found that those who had restricted insulin died at a significantly younger age, and had higher baseline hemoglobin A_1c values, poorer diabetes self-care behaviors, increased levels of diabetes-specific distress, and higher scores on measures of bulimia and other eating disorder symptoms.

Compared with their living counterparts, deceased insulin restricters at baseline had higher BMI and hemoglobin A_1c values and reported more symptoms of bulimia and higher levels of diabetes-specific distress.

“These data suggest that mortality associated with insulin restriction occurred in the context of eating disorder symptoms, rather than other psychological distress,” the authors said. They added that these patients require careful monitoring and would benefit from in-depth evaluations by a mental health professional, ideally one with specialized training in diabetes.

The researchers suggested physicians screen type 1 diabetes patients by routinely asking them if they follow their insulin prescriptions. “The health and wellness of women with type 1 diabetes is likely to be promoted by greater attention to the problem of insulin restriction in future research and clinical practice,” they concluded.

ELSEVIER GLOBAL MEDICAL NEWS

Women with type 1 diabetes who take less insulin than prescribed may be raising their risk of complications and shortening their life spans.

Because of various psychosocial variables, more than half of adult patients do not achieve the American Diabetes Association's glycemic targets, said Ann E. Goebel-Fabbri, Ph.D., of the Joslin Diabetes Center and Harvard Medical School, both in Boston, and her associates. Chief among the implicated variables are general psychological distress, diabetes-specific distress, fear of hypoglycemia, concern about weight gain, and related eating-disorder behaviors.

In this 11-year study, the largest to examine the long-term effect of insulin restriction on the morbidity and mortality of women with type 1 diabetes, insulin restriction at baseline conveyed more than a threefold increase in the relative risk of death, said the authors (Diabetes Care 2008;31:1–5).

At baseline, the cohort included 234 women aged 13–60 years who had had a diagnosis of type 1 diabetes for at least 1 year and who agreed to be followed up. Of those, 26 died during the study period. Mean age at follow-up was 45 years (range, 24–72 years).

Women reporting insulin restriction showed distinct clinical differences from those reporting appropriate insulin use.

At baseline, insulin restricters were significantly younger (aged 32 vs. 36 years) and had higher hemoglobin A_1c values (9.6% vs. 8.3%). However, there were no differences between the two groups with regard to baseline body mass index (BMI) or diabetes duration, the authors said.

Predictably, insulin restricters reported significantly lower scores on the baseline measure of diabetes self-care behaviors, and they scored higher on baseline measures of diabetes distress; fear of hypoglycemia; general psychological symptoms; eating disorder symptoms, such as bulimia; and the Eating Disorders Inventory.

In addition, women who said at baseline that they restricted insulin were significantly more likely to report nephropathy and foot problems at follow-up, the researchers said, adding that self-reported rates of retinopathy, neuropathy, and cardiovascular complications at follow-up did not differ between groups.

Causes of death for 10 of 71 women reporting insulin restriction included perforated bowel with gastroparesis (1), cancer (1), cardiac events (3), hypoglycemia (1), renal failure (2), sepsis (1), and suicide in the context of retinopathy-related blindness (1).

Causes of death for 16 of 163 women reporting appropriate insulin use included cancer (1), cardiac events (11), diabetic ketoacidosis (1), sepsis (2), and unknown causes (1), Dr. Goebel-Fabbri noted in an interview.

Comparisons of both groups of deceased women found that those who had restricted insulin died at a significantly younger age, and had higher baseline hemoglobin A_1c values, poorer diabetes self-care behaviors, increased levels of diabetes-specific distress, and higher scores on measures of bulimia and other eating disorder symptoms.

Compared with their living counterparts, deceased insulin restricters at baseline had higher BMI and hemoglobin A_1c values and reported more symptoms of bulimia and higher levels of diabetes-specific distress.

“These data suggest that mortality associated with insulin restriction occurred in the context of eating disorder symptoms, rather than other psychological distress,” the authors said. They added that these patients require careful monitoring and would benefit from in-depth evaluations by a mental health professional, ideally one with specialized training in diabetes.

The researchers suggested physicians screen type 1 diabetes patients by routinely asking them if they follow their insulin prescriptions. “The health and wellness of women with type 1 diabetes is likely to be promoted by greater attention to the problem of insulin restriction in future research and clinical practice,” they concluded.

ELSEVIER GLOBAL MEDICAL NEWS

The soaring numbers of commonly used drugs with sound-alike and look-alike names have prompted the U.S. Pharmacopeia to ask physicians and pharmacists to include an “indication for use” on prescriptions.

This and other recommendations are contained in U.S. Pharmacopeia's 8th annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, a figure that is nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

“We were surprised to see that much of an increase in such a short time, and the concern is that this increase in products in the marketplace further raises the opportunity for error,” said Ms. Cousins, USP's vice president of health care quality and information.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professionals to confidentially report potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or sound-alike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the 400-page report. “We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list,” Ms. Cousins said in an interview.

An important finding of this year's report is the role of pharmacy staff in LASA-related errors, she said. “Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff.”

The report identifies an emerging trend of look-alike drug names in computerized systems as a source of confusion. “This trend will likely continue as these systems become a standard of practice,” she said, adding the LASA-related error problem is compounded by the indiscriminate use of suffixes and look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was Cefazolin, a first-generation cephalosporin antibiotic. “We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications,” Ms. Cousins said.

Drug mix-ups led to seven reported fatalities, including two deaths attributed to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl.

In another case, an autistic pediatric patient was given the wrong product when disodium EDTA (a hypercalcemia treatment) was administered instead of the chelation therapy calcium disodium EDTA, which is approved by the Food and Drug Administration for the treatment of lead poisoning and was prescribed in an attempt to help treat the patient's autism.

In yet another case, an emergency department physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead. The patient received a large amount of the wrong agent, which led to a fatal heart arrhythmia.

The remaining three reported deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many, such as the primidone-prednisone incident, are due to confusion over the prescribing physician's handwriting, which leads the pharmacist to issue the wrong drug.

“Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine,” she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors. “Anything that takes handwriting out of the equation is a help.”

It would also be helpful if the FDA were given more authority to force name changes during the drug review process, as has been suggested by the Institute of Medicine. It becomes much more difficult to correct a name confusion issue once the products are on the market.

The recommendation that physicians include indications for use in their prescriptions is not an attempt by USP to impose on privacy, Ms. Cousins emphasized. “All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or 'for cough,'” she said, explaining that this also would help patients avoid confusion if they forget which vial is for which condition.

USP also recommends that “tall man lettering” be implemented in pharmacy software, labeling, and order writing to say, for example, “acetaZOLamide” (glaucoma) and “acetoHEXamide” (diabetes).

Where risk exists, take action to reduce the chance for error. USP recommends the following:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for sound-alikes that have been mixed up at your facility.

“Physicians' offices should always require a read-back from pharmacists, making sure that they both say and spell the drug name, especially for these often confusing drug pairs,” Ms. Cousins concluded.

USP has compiled a list of more than 3,000 drug pairs that look or sound alike, double the number of pairs identified in 2004. MS. COUSINS

The soaring numbers of commonly used drugs with sound-alike and look-alike names have prompted the U.S. Pharmacopeia to ask physicians and pharmacists to include an “indication for use” on prescriptions.

This and other recommendations are contained in U.S. Pharmacopeia's 8th annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, a figure that is nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

“We were surprised to see that much of an increase in such a short time, and the concern is that this increase in products in the marketplace further raises the opportunity for error,” said Ms. Cousins, USP's vice president of health care quality and information.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professionals to confidentially report potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or sound-alike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the 400-page report. “We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list,” Ms. Cousins said in an interview.

An important finding of this year's report is the role of pharmacy staff in LASA-related errors, she said. “Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff.”

The report identifies an emerging trend of look-alike drug names in computerized systems as a source of confusion. “This trend will likely continue as these systems become a standard of practice,” she said, adding the LASA-related error problem is compounded by the indiscriminate use of suffixes and look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was Cefazolin, a first-generation cephalosporin antibiotic. “We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications,” Ms. Cousins said.

Drug mix-ups led to seven reported fatalities, including two deaths attributed to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl.

In another case, an autistic pediatric patient was given the wrong product when disodium EDTA (a hypercalcemia treatment) was administered instead of the chelation therapy calcium disodium EDTA, which is approved by the Food and Drug Administration for the treatment of lead poisoning and was prescribed in an attempt to help treat the patient's autism.

In yet another case, an emergency department physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead. The patient received a large amount of the wrong agent, which led to a fatal heart arrhythmia.

The remaining three reported deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many, such as the primidone-prednisone incident, are due to confusion over the prescribing physician's handwriting, which leads the pharmacist to issue the wrong drug.

“Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine,” she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors. “Anything that takes handwriting out of the equation is a help.”

It would also be helpful if the FDA were given more authority to force name changes during the drug review process, as has been suggested by the Institute of Medicine. It becomes much more difficult to correct a name confusion issue once the products are on the market.

The recommendation that physicians include indications for use in their prescriptions is not an attempt by USP to impose on privacy, Ms. Cousins emphasized. “All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or 'for cough,'” she said, explaining that this also would help patients avoid confusion if they forget which vial is for which condition.

USP also recommends that “tall man lettering” be implemented in pharmacy software, labeling, and order writing to say, for example, “acetaZOLamide” (glaucoma) and “acetoHEXamide” (diabetes).

Where risk exists, take action to reduce the chance for error. USP recommends the following:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for sound-alikes that have been mixed up at your facility.

“Physicians' offices should always require a read-back from pharmacists, making sure that they both say and spell the drug name, especially for these often confusing drug pairs,” Ms. Cousins concluded.

USP has compiled a list of more than 3,000 drug pairs that look or sound alike, double the number of pairs identified in 2004. MS. COUSINS

The soaring numbers of commonly used drugs with sound-alike and look-alike names have prompted the U.S. Pharmacopeia to ask physicians and pharmacists to include an “indication for use” on prescriptions.

This and other recommendations are contained in U.S. Pharmacopeia's 8th annual MEDMARX report, which is based on a review of more than 26,000 records submitted to the MEDMARX database from 2003 to 2006.

The records implicate nearly 1,500 drugs in medication errors due to brand or generic names that could be confused. From these data, U.S. Pharmacopeia (USP) compiled a list of more than 3,000 drug pairs that look or sound alike, a figure that is nearly double the number of pairs identified in USP's 2004 report, said Diane Cousins, R.Ph.

“We were surprised to see that much of an increase in such a short time, and the concern is that this increase in products in the marketplace further raises the opportunity for error,” said Ms. Cousins, USP's vice president of health care quality and information.

USP also operates, in conjunction with the Institute for Safe Medication Practices, the Medication Errors Reporting Program (MER), which allows health care professionals to confidentially report potential and actual medication errors directly to USP.

USP reviewed both MEDMARX and MER to summarize the variables associated with more than 26,000 look-alike and/or sound-alike (LASA) errors, of which 1.4% (384) resulted in harm or death. More than 670 health care facilities contributed 26,000 records, according to the 400-page report. “We looked at lists of the top 200 drugs prescribed and used in hospitals, and virtually every time, all of the top 10 appeared within the USP similar names list,” Ms. Cousins said in an interview.

An important finding of this year's report is the role of pharmacy staff in LASA-related errors, she said. “Although pharmacy personnel, who are generally technicians, made the majority of errors, pharmacists as a group identified, prevented, and reported more than any other staff.”

The report identifies an emerging trend of look-alike drug names in computerized systems as a source of confusion. “This trend will likely continue as these systems become a standard of practice,” she said, adding the LASA-related error problem is compounded by the indiscriminate use of suffixes and look-alike packaging and labeling.

Over the 3-year period, the drug most commonly confused with others was Cefazolin, a first-generation cephalosporin antibiotic. “We found it to be confused with 15 other drugs, primarily antimicrobials, which might be explained by the fact that this is the most frequently used class of medications,” Ms. Cousins said.

Drug mix-ups led to seven reported fatalities, including two deaths attributed to confusion over the Alzheimer's drug Reminyl (galantamine) and the antidiabetes drug Amaryl (glimepiride).

In 2005, recognizing the high risk of confusion and subsequent fatal hypoglycemia, Ortho-McNeil Neurologics Inc. announced that the name Reminyl had been changed to Razadyne to avoid confusion with Amaryl.

In another case, an autistic pediatric patient was given the wrong product when disodium EDTA (a hypercalcemia treatment) was administered instead of the chelation therapy calcium disodium EDTA, which is approved by the Food and Drug Administration for the treatment of lead poisoning and was prescribed in an attempt to help treat the patient's autism.

In yet another case, an emergency department physician was preparing to intubate a patient and calculated the dose for rocuronium (Zemuron), a preintubation agent used to assist with the procedure. The physician gave orders for the nurse to obtain the medication and indicated the volume to administer to the patient. The nurse obtained and administered the neuromuscular blocking agent vecuronium (Norcuron) instead. The patient received a large amount of the wrong agent, which led to a fatal heart arrhythmia.

The remaining three reported deaths involved mix-ups between the anticonvulsant primidone and prednisone; the antiepileptic drug phenytoin sodium and the barbiturate phenobarbital; and Norcuron and the heart failure treatment Natrecor (nesiritide recombinant).

Errors occur with over-the-counter medications, too. Ms. Cousins described the aural confusion when an order for Ferro-Sequel 500 mg—an iron replacement—was transcribed as Serrosequel 500 mg and the order was misread as Seroquel 500 mg—an antipsychotic.

The rate of mix-ups involving brand name versus generic drugs was about evenly split, 57% and 43%, respectively, Ms. Cousins said, adding that while most errors were made in pharmacies, many, such as the primidone-prednisone incident, are due to confusion over the prescribing physician's handwriting, which leads the pharmacist to issue the wrong drug.

“Errors also are due to physicians using short codes for medications, such as 'clon,' for clonazepam or clonapine,” she said, adding that electronically written prescriptions using a computer or label machine would eliminate many errors. “Anything that takes handwriting out of the equation is a help.”

It would also be helpful if the FDA were given more authority to force name changes during the drug review process, as has been suggested by the Institute of Medicine. It becomes much more difficult to correct a name confusion issue once the products are on the market.

The recommendation that physicians include indications for use in their prescriptions is not an attempt by USP to impose on privacy, Ms. Cousins emphasized. “All that is needed are simple inclusions, such as 'for sinus,' 'for heart,' or 'for cough,'” she said, explaining that this also would help patients avoid confusion if they forget which vial is for which condition.

USP also recommends that “tall man lettering” be implemented in pharmacy software, labeling, and order writing to say, for example, “acetaZOLamide” (glaucoma) and “acetoHEXamide” (diabetes).

Where risk exists, take action to reduce the chance for error. USP recommends the following:

▸ Consider the potential for mix-ups before adding a drug to your formulary.

▸ Physically separate or differentiate products with similar names while they are being stored on the shelf.

▸ Disseminate information about products that have been confused at your facility, to build awareness among staff.

▸ Prohibit verbal orders for sound-alikes that have been mixed up at your facility.

“Physicians' offices should always require a read-back from pharmacists, making sure that they both say and spell the drug name, especially for these often confusing drug pairs,” Ms. Cousins concluded.

USP has compiled a list of more than 3,000 drug pairs that look or sound alike, double the number of pairs identified in 2004. MS. COUSINS

Patients with diabetes can take more active roles in their care, and improve glycemic control, by using a personal digital assistant preinstalled with special software, according to Dr. Samuel N. Forjuoh.

Dr. Forjuoh is leading a team of central Texas researchers to determine the potential benefits of personal digital assistant (PDA) use with outpatients, with the ultimate goal of leveling the self-care playing field across socioeconomic groups.

Their recently-published pilot study revealed that the incorporation of PDA use in diabetes self-care, while feasible, poses significant challenges, said Dr. Forjuoh, professor of family and community medicine and director of research at the Scott and White Memorial Hospital in Temple, Texas.

An initial cohort of 43 subjects was provided with Diabetes Pilot software for Palm handhelds (J. Am. Board Fam. Med. 2007:20:375–84). Diabetes Pilot is made by Digital Altitudes LLC, Arlington Heights, Ill.

The PDA system enables users to record glucose measurements, insulin, and other medicines; meals; exercise; blood pressure; test results; and other notes, according to the Diabetes Pilot Web site. Among other things, the software tracks the intake of carbohydrate, calories, fat, protein, fiber, sodium, cholesterol, and other nutrients, and allows users to see trends in blood sugars with various reports and graphs.

A total of 19 participants dropped out of the study and 6 more participants did not return and/or could not be reached after making several attempts.

The 18 people who completed the PDA intervention had a mean drop in hemoglobin A_1c (HbA_1c) of 18%, from 9.7% at baseline to 8% after 6 months, Dr. Forjuoh said in an interview. He added that further updated results of the study, including data on exercise, foot care, and diet, are contained in a manuscript which has been accepted for online publication this May in Telemedicine and e-Health.

“We saw that the more a patient used the PDA, the greater the drop in HbA_1c,” he said, noting that comparable reductions in blood glucose associated with PDAs or similar technology have been documented by other investigators.

The 18 finishers had an average age of 58 years. The group comprised 56% women, 56% Caucasians, and 38% college graduates. Also, 72% had annual family incomes of $30,000 or more, said Dr. Forjuoh, noting the difficulty of expanding PDA use across a diverse population.

“The majority of patients in this pilot study were at the upper end of computer literacy, and it's apparent that only those who are comfortable using a PDA will benefit,” he said, adding that many patients who could benefit from the technology are strangers to it.

The researchers are about to launch a larger study of 400 patients drawn from 14 Scott and White Health System clinics. The cohort will be assigned to four arms: a PDA-only group, PDA plus chronic disease self-management classes, self-management classes alone, and a usual-care group. In addition, the participants will be representative of the Central Texas population with respect to race, ethnic group, income, location, and insurance status, said coinvestigator Jane N. Bolin, Ph.D.

“We want to see if we can use PDAs to reduce health disparities among the population, and we'll also do a cost analysis that will determine how many health care dollars can be saved for every unit reduction of HbA_1c,” said Dr. Bolin, director of the Southwest Rural Health Research Center, a branch of the Texas A&M University System Health Science Center, School of Rural Public Health in College Station.

In the pilot study, it was found that many patients were discouraged by the tedious task of tracking dietary effects on glucose by entering into the PDA all the foods they had eaten. The complaints and potential for further loss of participants led the investigators to relax the rules on data entry. To make data entry easier and help more patients feel comfortable using the PDA, the vendor has been asked to fine-tune the software in time for the upcoming trial, Dr. Forjuoh said.

The cost per participant in the pilot study was $650, but because that included expenses that patients would not normally bear, Dr. Forjuoh estimates the actual cost per patient at around $300; the larger study with comparison groups is expected to settle that point, he said.

The spotty availability of reimbursement for such programs places a cloud over widespread adoption of self-management technology, according to Dr. Forjuoh. “Many states don't require insurance companies to provide reimbursement for nutritional education and diabetes self-management education; that causes patients to become dependent upon clinics, and eventually they end up in the emergency room,” he concluded.

Neither Dr. Forjuoh nor Dr. Bolin reported financial conflicts.

Personal digital assistants enable users to record test results and medicine use. Courtesy Dr. Samuel N. Forjuoh

Patients with diabetes can take more active roles in their care, and improve glycemic control, by using a personal digital assistant preinstalled with special software, according to Dr. Samuel N. Forjuoh.

Dr. Forjuoh is leading a team of central Texas researchers to determine the potential benefits of personal digital assistant (PDA) use with outpatients, with the ultimate goal of leveling the self-care playing field across socioeconomic groups.

Their recently-published pilot study revealed that the incorporation of PDA use in diabetes self-care, while feasible, poses significant challenges, said Dr. Forjuoh, professor of family and community medicine and director of research at the Scott and White Memorial Hospital in Temple, Texas.

An initial cohort of 43 subjects was provided with Diabetes Pilot software for Palm handhelds (J. Am. Board Fam. Med. 2007:20:375–84). Diabetes Pilot is made by Digital Altitudes LLC, Arlington Heights, Ill.

The PDA system enables users to record glucose measurements, insulin, and other medicines; meals; exercise; blood pressure; test results; and other notes, according to the Diabetes Pilot Web site. Among other things, the software tracks the intake of carbohydrate, calories, fat, protein, fiber, sodium, cholesterol, and other nutrients, and allows users to see trends in blood sugars with various reports and graphs.

A total of 19 participants dropped out of the study and 6 more participants did not return and/or could not be reached after making several attempts.

The 18 people who completed the PDA intervention had a mean drop in hemoglobin A_1c (HbA_1c) of 18%, from 9.7% at baseline to 8% after 6 months, Dr. Forjuoh said in an interview. He added that further updated results of the study, including data on exercise, foot care, and diet, are contained in a manuscript which has been accepted for online publication this May in Telemedicine and e-Health.

“We saw that the more a patient used the PDA, the greater the drop in HbA_1c,” he said, noting that comparable reductions in blood glucose associated with PDAs or similar technology have been documented by other investigators.

The 18 finishers had an average age of 58 years. The group comprised 56% women, 56% Caucasians, and 38% college graduates. Also, 72% had annual family incomes of $30,000 or more, said Dr. Forjuoh, noting the difficulty of expanding PDA use across a diverse population.

“The majority of patients in this pilot study were at the upper end of computer literacy, and it's apparent that only those who are comfortable using a PDA will benefit,” he said, adding that many patients who could benefit from the technology are strangers to it.

The researchers are about to launch a larger study of 400 patients drawn from 14 Scott and White Health System clinics. The cohort will be assigned to four arms: a PDA-only group, PDA plus chronic disease self-management classes, self-management classes alone, and a usual-care group. In addition, the participants will be representative of the Central Texas population with respect to race, ethnic group, income, location, and insurance status, said coinvestigator Jane N. Bolin, Ph.D.

“We want to see if we can use PDAs to reduce health disparities among the population, and we'll also do a cost analysis that will determine how many health care dollars can be saved for every unit reduction of HbA_1c,” said Dr. Bolin, director of the Southwest Rural Health Research Center, a branch of the Texas A&M University System Health Science Center, School of Rural Public Health in College Station.

In the pilot study, it was found that many patients were discouraged by the tedious task of tracking dietary effects on glucose by entering into the PDA all the foods they had eaten. The complaints and potential for further loss of participants led the investigators to relax the rules on data entry. To make data entry easier and help more patients feel comfortable using the PDA, the vendor has been asked to fine-tune the software in time for the upcoming trial, Dr. Forjuoh said.

The cost per participant in the pilot study was $650, but because that included expenses that patients would not normally bear, Dr. Forjuoh estimates the actual cost per patient at around $300; the larger study with comparison groups is expected to settle that point, he said.

The spotty availability of reimbursement for such programs places a cloud over widespread adoption of self-management technology, according to Dr. Forjuoh. “Many states don't require insurance companies to provide reimbursement for nutritional education and diabetes self-management education; that causes patients to become dependent upon clinics, and eventually they end up in the emergency room,” he concluded.

Neither Dr. Forjuoh nor Dr. Bolin reported financial conflicts.

Personal digital assistants enable users to record test results and medicine use. Courtesy Dr. Samuel N. Forjuoh

Patients with diabetes can take more active roles in their care, and improve glycemic control, by using a personal digital assistant preinstalled with special software, according to Dr. Samuel N. Forjuoh.

Dr. Forjuoh is leading a team of central Texas researchers to determine the potential benefits of personal digital assistant (PDA) use with outpatients, with the ultimate goal of leveling the self-care playing field across socioeconomic groups.

Their recently-published pilot study revealed that the incorporation of PDA use in diabetes self-care, while feasible, poses significant challenges, said Dr. Forjuoh, professor of family and community medicine and director of research at the Scott and White Memorial Hospital in Temple, Texas.

An initial cohort of 43 subjects was provided with Diabetes Pilot software for Palm handhelds (J. Am. Board Fam. Med. 2007:20:375–84). Diabetes Pilot is made by Digital Altitudes LLC, Arlington Heights, Ill.

The PDA system enables users to record glucose measurements, insulin, and other medicines; meals; exercise; blood pressure; test results; and other notes, according to the Diabetes Pilot Web site. Among other things, the software tracks the intake of carbohydrate, calories, fat, protein, fiber, sodium, cholesterol, and other nutrients, and allows users to see trends in blood sugars with various reports and graphs.

A total of 19 participants dropped out of the study and 6 more participants did not return and/or could not be reached after making several attempts.

The 18 people who completed the PDA intervention had a mean drop in hemoglobin A_1c (HbA_1c) of 18%, from 9.7% at baseline to 8% after 6 months, Dr. Forjuoh said in an interview. He added that further updated results of the study, including data on exercise, foot care, and diet, are contained in a manuscript which has been accepted for online publication this May in Telemedicine and e-Health.

“We saw that the more a patient used the PDA, the greater the drop in HbA_1c,” he said, noting that comparable reductions in blood glucose associated with PDAs or similar technology have been documented by other investigators.

The 18 finishers had an average age of 58 years. The group comprised 56% women, 56% Caucasians, and 38% college graduates. Also, 72% had annual family incomes of $30,000 or more, said Dr. Forjuoh, noting the difficulty of expanding PDA use across a diverse population.

“The majority of patients in this pilot study were at the upper end of computer literacy, and it's apparent that only those who are comfortable using a PDA will benefit,” he said, adding that many patients who could benefit from the technology are strangers to it.

The researchers are about to launch a larger study of 400 patients drawn from 14 Scott and White Health System clinics. The cohort will be assigned to four arms: a PDA-only group, PDA plus chronic disease self-management classes, self-management classes alone, and a usual-care group. In addition, the participants will be representative of the Central Texas population with respect to race, ethnic group, income, location, and insurance status, said coinvestigator Jane N. Bolin, Ph.D.

“We want to see if we can use PDAs to reduce health disparities among the population, and we'll also do a cost analysis that will determine how many health care dollars can be saved for every unit reduction of HbA_1c,” said Dr. Bolin, director of the Southwest Rural Health Research Center, a branch of the Texas A&M University System Health Science Center, School of Rural Public Health in College Station.

In the pilot study, it was found that many patients were discouraged by the tedious task of tracking dietary effects on glucose by entering into the PDA all the foods they had eaten. The complaints and potential for further loss of participants led the investigators to relax the rules on data entry. To make data entry easier and help more patients feel comfortable using the PDA, the vendor has been asked to fine-tune the software in time for the upcoming trial, Dr. Forjuoh said.

The cost per participant in the pilot study was $650, but because that included expenses that patients would not normally bear, Dr. Forjuoh estimates the actual cost per patient at around $300; the larger study with comparison groups is expected to settle that point, he said.

The spotty availability of reimbursement for such programs places a cloud over widespread adoption of self-management technology, according to Dr. Forjuoh. “Many states don't require insurance companies to provide reimbursement for nutritional education and diabetes self-management education; that causes patients to become dependent upon clinics, and eventually they end up in the emergency room,” he concluded.

Neither Dr. Forjuoh nor Dr. Bolin reported financial conflicts.

Personal digital assistants enable users to record test results and medicine use. Courtesy Dr. Samuel N. Forjuoh

Physicians advising women on nutritional options related to allergies during pregnancy, lactation, and the first year of life can be less restrictive than they have been up to now, according to a revised policy statement of the American Academy of Pediatrics.

“Pediatricians and obstetricians need to reconsider the entire issue of how they feed babies with the intention of preventing allergies,” said Dr. Frank R. Greer.

“We've been too strict and too dogmatic,” said Dr. Greer, chairman of the American Academy of Pediatrics (AAP) Committee on Nutrition, which developed the statement in cooperation with the academy's Section on Allergy and Immunology.

The new document replaces a 2000 policy statement from the AAP that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease (Pediatrics 2008;?21:183–91).

According to this new report, the documented benefits of nutritional intervention that might prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy because a parent or sibling has allergic disease.

“Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation,” according to the report.

“The idea that egg, fish, and foods containing peanut protein should not be introduced before 1 year of age is not based on good science,” Dr. Greer said in an interview. “I suppose that if I had a baby with severe eczema, I would not recommend those foods, but the problem is these restrictions have been applied to all babies.”

There is evidence that breast-feeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood, according to the reviewers.

In studies of infants at high risk of atopy and who are not exclusively breast-fed for 4–6 months or are formula fed, there is modest evidence that the onset of atopic dermatitis might be delayed or prevented in early childhood by the use of extensively or partially hydrolyzed formulas, compared with cow milk formula, they said.

However, not all hydrolyzed formula might have the same effect, and more research is needed to determine if the benefits extend to later childhood and adolescence.

Dr. Greer and his colleagues also concluded that there is scant evidence that delaying the introduction of complementary foods beyond 4–6 months of age prevents atopic disease.

Other major statements summarizing the current evidence included the following:

▸ Maternal dietary restrictions during pregnancy do not appear to play a significant role in the prevention of atopic disease in infants.

▸ There is no convincing evidence for the use of soy-based infant formula for the purpose of allergy prevention.

▸ For infants beyond 4–6 months of age, there is insufficient data to support a protective effect of any dietary intervention for the development of atopic disease.

▸ In infants at risk of developing atopic disease, the current evidence does not support the hypothesis that exclusive breast-feeding protects against allergic asthma occurring beyond 6 years of age.

▸ For a child who has developed an atopic disease that might be precipitated or exacerbated by ingested proteins (via human milk, infant formula, or specific complementary foods), treatment could require specific identification and restriction of causal food proteins. This topic was not reviewed in this document.

“If the child is not at risk, the lactating mother can eat what she wants, and it really doesn't matter when you introduce a child to fish or eggs,” said Dr. Greer.

Physicians advising women on nutritional options related to allergies during pregnancy, lactation, and the first year of life can be less restrictive than they have been up to now, according to a revised policy statement of the American Academy of Pediatrics.

“Pediatricians and obstetricians need to reconsider the entire issue of how they feed babies with the intention of preventing allergies,” said Dr. Frank R. Greer.

“We've been too strict and too dogmatic,” said Dr. Greer, chairman of the American Academy of Pediatrics (AAP) Committee on Nutrition, which developed the statement in cooperation with the academy's Section on Allergy and Immunology.

The new document replaces a 2000 policy statement from the AAP that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease (Pediatrics 2008;?21:183–91).

According to this new report, the documented benefits of nutritional intervention that might prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy because a parent or sibling has allergic disease.

“Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation,” according to the report.

“The idea that egg, fish, and foods containing peanut protein should not be introduced before 1 year of age is not based on good science,” Dr. Greer said in an interview. “I suppose that if I had a baby with severe eczema, I would not recommend those foods, but the problem is these restrictions have been applied to all babies.”

There is evidence that breast-feeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood, according to the reviewers.

In studies of infants at high risk of atopy and who are not exclusively breast-fed for 4–6 months or are formula fed, there is modest evidence that the onset of atopic dermatitis might be delayed or prevented in early childhood by the use of extensively or partially hydrolyzed formulas, compared with cow milk formula, they said.

However, not all hydrolyzed formula might have the same effect, and more research is needed to determine if the benefits extend to later childhood and adolescence.

Dr. Greer and his colleagues also concluded that there is scant evidence that delaying the introduction of complementary foods beyond 4–6 months of age prevents atopic disease.

Other major statements summarizing the current evidence included the following:

▸ Maternal dietary restrictions during pregnancy do not appear to play a significant role in the prevention of atopic disease in infants.

▸ There is no convincing evidence for the use of soy-based infant formula for the purpose of allergy prevention.

▸ For infants beyond 4–6 months of age, there is insufficient data to support a protective effect of any dietary intervention for the development of atopic disease.

▸ In infants at risk of developing atopic disease, the current evidence does not support the hypothesis that exclusive breast-feeding protects against allergic asthma occurring beyond 6 years of age.

▸ For a child who has developed an atopic disease that might be precipitated or exacerbated by ingested proteins (via human milk, infant formula, or specific complementary foods), treatment could require specific identification and restriction of causal food proteins. This topic was not reviewed in this document.

“If the child is not at risk, the lactating mother can eat what she wants, and it really doesn't matter when you introduce a child to fish or eggs,” said Dr. Greer.

Physicians advising women on nutritional options related to allergies during pregnancy, lactation, and the first year of life can be less restrictive than they have been up to now, according to a revised policy statement of the American Academy of Pediatrics.

“Pediatricians and obstetricians need to reconsider the entire issue of how they feed babies with the intention of preventing allergies,” said Dr. Frank R. Greer.

“We've been too strict and too dogmatic,” said Dr. Greer, chairman of the American Academy of Pediatrics (AAP) Committee on Nutrition, which developed the statement in cooperation with the academy's Section on Allergy and Immunology.

The new document replaces a 2000 policy statement from the AAP that addressed the use of hypoallergenic infant formulas and included provisional recommendations for dietary management for the prevention of atopic disease (Pediatrics 2008;?21:183–91).

According to this new report, the documented benefits of nutritional intervention that might prevent or delay the onset of atopic disease are largely limited to infants at high risk of developing allergy because a parent or sibling has allergic disease.

“Current evidence does not support a major role for maternal dietary restrictions during pregnancy or lactation,” according to the report.

“The idea that egg, fish, and foods containing peanut protein should not be introduced before 1 year of age is not based on good science,” Dr. Greer said in an interview. “I suppose that if I had a baby with severe eczema, I would not recommend those foods, but the problem is these restrictions have been applied to all babies.”

There is evidence that breast-feeding for at least 4 months, compared with feeding formula made with intact cow milk protein, prevents or delays the occurrence of atopic dermatitis, cow milk allergy, and wheezing in early childhood, according to the reviewers.

In studies of infants at high risk of atopy and who are not exclusively breast-fed for 4–6 months or are formula fed, there is modest evidence that the onset of atopic dermatitis might be delayed or prevented in early childhood by the use of extensively or partially hydrolyzed formulas, compared with cow milk formula, they said.

However, not all hydrolyzed formula might have the same effect, and more research is needed to determine if the benefits extend to later childhood and adolescence.

Dr. Greer and his colleagues also concluded that there is scant evidence that delaying the introduction of complementary foods beyond 4–6 months of age prevents atopic disease.

Other major statements summarizing the current evidence included the following:

▸ Maternal dietary restrictions during pregnancy do not appear to play a significant role in the prevention of atopic disease in infants.

▸ There is no convincing evidence for the use of soy-based infant formula for the purpose of allergy prevention.

▸ For infants beyond 4–6 months of age, there is insufficient data to support a protective effect of any dietary intervention for the development of atopic disease.

▸ In infants at risk of developing atopic disease, the current evidence does not support the hypothesis that exclusive breast-feeding protects against allergic asthma occurring beyond 6 years of age.

▸ For a child who has developed an atopic disease that might be precipitated or exacerbated by ingested proteins (via human milk, infant formula, or specific complementary foods), treatment could require specific identification and restriction of causal food proteins. This topic was not reviewed in this document.

“If the child is not at risk, the lactating mother can eat what she wants, and it really doesn't matter when you introduce a child to fish or eggs,” said Dr. Greer.