Heidi Splete

ATLANTA — The safety profile for Zostavax, the herpes zoster vaccine manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

"Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials," said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1 to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths.

Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available; the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines, sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of Varivax, inasmuch as each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

Merck has agreed to conduct postlicensure studies to further assess the rates of serious adverse events.

ATLANTA — The safety profile for Zostavax, the herpes zoster vaccine manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

"Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials," said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1 to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths.

Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available; the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines, sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of Varivax, inasmuch as each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

Merck has agreed to conduct postlicensure studies to further assess the rates of serious adverse events.

ATLANTA — The safety profile for Zostavax, the herpes zoster vaccine manufactured by Merck & Co., was reinforced during its first year of widespread use, based on adverse event reports collected from clinicians, patients, and others.

"Zostavax seems to have a very good safety profile, which was expected based on data from prelicensure trials," said Dr. Sandra Chaves of the Centers for Disease Control and Prevention's Division of Viral and Rickettsial Disease.

A total of 590 reports related to Zostavax (including 44 classified as serious) had been submitted as of June 1 to the Vaccine Adverse Event Reporting System (VAERS), a vaccine safety surveillance system operated by the CDC and the Food and Drug Administration. The overall reporting rate was 73.3/100,000 doses distributed, and the serious event reporting rate was 5.5/100,000 doses distributed. Two of the 44 serious events reported were deaths.

Most (90%) of the reports referred to the Zostavax vaccine administered alone, and 82 reports involved possible off-label use or medical error.

Serious events were defined as instances of hospitalization, death, life-threatening conditions, disabling illness, or other medically important conditions, said Dr. Chaves, who presented the VAERS postlicensure safety data at the late June meeting of the CDC's Advisory Committee on Immunization Practices (ACIP). The herpes zoster vaccine was first licensed in May 2006 and recommended by ACIP for prevention of herpes zoster in adults aged 60 years and older in October 2006.

An injection site reaction—the most commonly reported adverse event—was reported in 307 cases. The next most frequent events were a rash (177 cases) and herpes zoster (145 cases). Some reports included more than one event.

The rate of serious adverse events was higher among vaccine recipients, compared with those who received a placebo, in an adverse event monitoring substudy of approximately 6,000 patients, but no specific pattern was observed, Dr. Chaves said. More than half (59%) of the 44 serious events occurred in women, and most (43%) occurred in patients aged 70-79 years.

Examples of nonfatal events included three cases of anaphylaxis in patients aged 71, 76, and 79 years, all of whom recovered fully, and one case of a woman who requested vaccination and discovered 10 days later that she was pregnant. No pregnancy outcome data are available; the woman was being followed by the Pregnancy Registry for Varicella Zoster Virus-Containing Vaccines, sponsored by Merck.

The two deaths that occurred within 6 months of vaccination occurred in female patients aged 80 and 83 years, who died from a heart attack and pneumonia with sepsis, respectively.

In addition, administration errors were reported in both adults and children, including 34 reports of Zostavax being given to children instead of Varivax, Merck's childhood varicella vaccine. The adverse event reports suggest that the errors were simply human error and not caused by confusing medication labels, Dr. Chaves said.

One of the committee members expressed concern about the outcomes in children who received Zostavax instead of Varivax, inasmuch as each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson at the meeting said that the company had studied titers as high as 50,000 plaque-forming units in healthy children and found a plateau of response, so an accidental dose of Zostavax should not be dangerous in most cases and should not prevent a second dose of varicella vaccine in children who received Zostavax accidentally as the first dose.

Safety surveillance for the zoster vaccine is challenging because of the many comorbid conditions in the 60-years-and-older population, Dr. Chaves noted.

Merck has agreed to conduct postlicensure studies to further assess the rates of serious adverse events.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

"Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention," said Dr. John Iskander, who presented the postlicensure data at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two surveillance mechanisms supported by the CDC.

"The data encompass the first 11 months of the U.S. experience with Gardasil," said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

"Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine," Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9-26 years (the age range used in prelicensure clinical trials).

"A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination," Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), and fever, nausea, and headache (all 11%). The most common symptoms reported with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13-16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. "Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope," Dr. Iskander noted. Many of the frequently reported adverse events, such as syncope, are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general, he said.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, and no claims alleging injuries as a result of HPV4 had been filed as of June 7, Dr. Iskander said. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006, and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

"Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention," said Dr. John Iskander, who presented the postlicensure data at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two surveillance mechanisms supported by the CDC.

"The data encompass the first 11 months of the U.S. experience with Gardasil," said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

"Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine," Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9-26 years (the age range used in prelicensure clinical trials).

"A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination," Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), and fever, nausea, and headache (all 11%). The most common symptoms reported with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13-16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. "Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope," Dr. Iskander noted. Many of the frequently reported adverse events, such as syncope, are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general, he said.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, and no claims alleging injuries as a result of HPV4 had been filed as of June 7, Dr. Iskander said. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006, and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline.

ATLANTA — Clinicians can be more confident about the safety of Gardasil, the quadrivalent human papillomavirus vaccine, because postlicensure safety data from the first year of widespread use confirm that serious adverse events associated with the vaccine are rare.

"Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention," said Dr. John Iskander, who presented the postlicensure data at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

Dr. Iskander presented safety data from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two surveillance mechanisms supported by the CDC.

"The data encompass the first 11 months of the U.S. experience with Gardasil," said Dr. Iskander, an officer at the CDC's Immunization Safety Office.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine.

"Now [that] the vaccine has been out for about a year, it is beginning to develop a safety record, so it should make the practitioner feel more confident in the safety of the vaccine," Dr. Joseph Bocchini Jr., the American Academy of Pediatrics' liaison to ACIP and chairman of the department of pediatrics at Louisiana State University, Shreveport, said in an interview.

More than 5 million doses of Gardasil have been distributed as of the end of March, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time, Dr. Bocchini added.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event rate is 1.8 per 100,000 doses, based on VAERS data.

A total of 1,763 adverse events related to use of the HPV4 vaccine had been reported to the VAERS as of May 8. Of these, 87% involved the use of HPV4 alone. Nearly 70% of the reports involved girls and women aged 9-26 years (the age range used in prelicensure clinical trials).

"A substantial proportion of vaccine events began on the day of vaccination (39%), or in the days [immediately] following vaccination," Dr. Iskander noted. Similarly, 42% of serious adverse events occurred on the day of vaccination, with an average onset time of 1 day afterward. A total of 857 vaccine events (49%) were reported after a single dose of HPV4.

The most common symptoms in reports of serious adverse events were vomiting (14%), syncope (12%), and fever, nausea, and headache (all 11%). The most common symptoms reported with vaccine use were dizziness (13%), injection site pain (10%), syncope (10%), and nausea (9%).

Although data on associations between HPV4 use and reports of Guillain-Barré syndrome are limited, the VAERS data included 13 reports of GBS in patients who received HPV4. Of these, 11 cases occurred in girls aged 13-16 years; one case occurred in a 50-year-old woman, and the age of the other patient is unknown. More than half of these cases involved coadministration of Menactra and Gardasil.

The VAERS data also included two nonfatal cases of thromboembolism in patients who received the HPV4 vaccine.

In addition, 11 serious event reports from VAERS involved syncope, all of which occurred within 10 minutes of vaccination. "Current recommendations suggest a 15-minute waiting period after vaccination … to avoid syncope," Dr. Iskander noted. Many of the frequently reported adverse events, such as syncope, are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general, he said.

Dr. Iskander also presented details on four cases of death in patients who had been vaccinated with HPV4. The cases included a 12-year-old girl who died of myocarditis after developing ventricular tachycardia, a 19-year-old girl who died from sudden cardiac death and pulmonary embolism (her autopsy showed multiple blood clots), a 14-year-old who died from multiorgan system failure due to influenza B viral sepsis, and a fourth case for whom few data were available except her use of oral contraceptives; her death was associated with blood clots.

Gardasil has been covered under the national Vaccine Injury Compensation Program since Feb. 1, and no claims alleging injuries as a result of HPV4 had been filed as of June 7, Dr. Iskander said. Complete vaccination coverage data are not yet available, but vaccine uptake is being followed using the VSD. The VSD sites are monitoring 68,266 doses of Gardasil given between Aug. 6, 2006, and May 13, 2007, for a variety of safety outcomes including Guillain-Barré syndrome, seizure, syncope, stroke, thrombosis, and pulmonary embolism.

Serious adverse events involving HPV4 have rarely been reported; the reported deaths in vaccine recipients don't appear to be causally related to vaccination, Dr. Iskander said. But the CDC will continue to collaborate with the Food and Drug Administration, the World Health Organization, and other organizations to monitor postlicensure surveillance and other communication related to HPV4.

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline.

WASHINGTON – A 99% majority of emergency department staff said that a clinical emergency pharmacist in the ED improved the quality of patient care, based on data presented at a conference sponsored by the National Patient Safety Foundation.

Drug-related adverse events in the ED remain a significant public health problem. Reports of the success of clinical pharmacists in other hospital areas suggest that the ED-based clinical pharmacists could improve the quality of patient care; however, ED-based pharmacy programs are relatively rare, and their impact has not been well studied.

To assess the ED staff's perception of their facility's emergency clinical pharmacists, Dr. Roger J. Fairbanks and colleagues at the University of Rochester (N.Y.) surveyed a random sample of ED staff members in a tertiary care academic medical center and trauma center that included an emergency medicine residency program.

Anecdotal reports suggest that ED staff members value clinical pharmacists, but no previous studies had addressed the question, the researchers said in a poster.

They collected responses from 33 doctors and other health care providers and 42 nurses as part of a research program supported by the Agency for Healthcare Research and Quality.

A total of 96% of the respondents said that the emergency pharmacist was an integral part of the ED team. In addition, 93% of the respondents said that they regularly consulted the emergency pharmacist, and 93% reported using the pharmacist more in the ED location than in the pharmacist's previous location.

Overall, 47% of the ED staff (55% of physicians and other providers and 40% of nurses) said that immediate availability for consultation was the most valuable role of a clinical pharmacist. By contrast, slightly more nurses than doctors or other providers reported that attending medical and trauma resuscitations was the most valuable role of an emergency pharmacist (38% vs. 22%, 36% overall). Another 7% of the respondents said that the emergency pharmacist's most important role was reviewing orders, and 8% said that the emergency pharmacist's most important role was staff education.

A Web site hosted by the University of Rochester (www.emergencypharmacist.org

WASHINGTON – A 99% majority of emergency department staff said that a clinical emergency pharmacist in the ED improved the quality of patient care, based on data presented at a conference sponsored by the National Patient Safety Foundation.

Drug-related adverse events in the ED remain a significant public health problem. Reports of the success of clinical pharmacists in other hospital areas suggest that the ED-based clinical pharmacists could improve the quality of patient care; however, ED-based pharmacy programs are relatively rare, and their impact has not been well studied.

To assess the ED staff's perception of their facility's emergency clinical pharmacists, Dr. Roger J. Fairbanks and colleagues at the University of Rochester (N.Y.) surveyed a random sample of ED staff members in a tertiary care academic medical center and trauma center that included an emergency medicine residency program.

Anecdotal reports suggest that ED staff members value clinical pharmacists, but no previous studies had addressed the question, the researchers said in a poster.

They collected responses from 33 doctors and other health care providers and 42 nurses as part of a research program supported by the Agency for Healthcare Research and Quality.

A total of 96% of the respondents said that the emergency pharmacist was an integral part of the ED team. In addition, 93% of the respondents said that they regularly consulted the emergency pharmacist, and 93% reported using the pharmacist more in the ED location than in the pharmacist's previous location.

Overall, 47% of the ED staff (55% of physicians and other providers and 40% of nurses) said that immediate availability for consultation was the most valuable role of a clinical pharmacist. By contrast, slightly more nurses than doctors or other providers reported that attending medical and trauma resuscitations was the most valuable role of an emergency pharmacist (38% vs. 22%, 36% overall). Another 7% of the respondents said that the emergency pharmacist's most important role was reviewing orders, and 8% said that the emergency pharmacist's most important role was staff education.

A Web site hosted by the University of Rochester (www.emergencypharmacist.org

WASHINGTON – A 99% majority of emergency department staff said that a clinical emergency pharmacist in the ED improved the quality of patient care, based on data presented at a conference sponsored by the National Patient Safety Foundation.

Drug-related adverse events in the ED remain a significant public health problem. Reports of the success of clinical pharmacists in other hospital areas suggest that the ED-based clinical pharmacists could improve the quality of patient care; however, ED-based pharmacy programs are relatively rare, and their impact has not been well studied.

To assess the ED staff's perception of their facility's emergency clinical pharmacists, Dr. Roger J. Fairbanks and colleagues at the University of Rochester (N.Y.) surveyed a random sample of ED staff members in a tertiary care academic medical center and trauma center that included an emergency medicine residency program.

Anecdotal reports suggest that ED staff members value clinical pharmacists, but no previous studies had addressed the question, the researchers said in a poster.

They collected responses from 33 doctors and other health care providers and 42 nurses as part of a research program supported by the Agency for Healthcare Research and Quality.

A total of 96% of the respondents said that the emergency pharmacist was an integral part of the ED team. In addition, 93% of the respondents said that they regularly consulted the emergency pharmacist, and 93% reported using the pharmacist more in the ED location than in the pharmacist's previous location.

Overall, 47% of the ED staff (55% of physicians and other providers and 40% of nurses) said that immediate availability for consultation was the most valuable role of a clinical pharmacist. By contrast, slightly more nurses than doctors or other providers reported that attending medical and trauma resuscitations was the most valuable role of an emergency pharmacist (38% vs. 22%, 36% overall). Another 7% of the respondents said that the emergency pharmacist's most important role was reviewing orders, and 8% said that the emergency pharmacist's most important role was staff education.

A Web site hosted by the University of Rochester (www.emergencypharmacist.org

MINNEAPOLIS – Women with no history of sleep disorders often report sleep problems–especially difficulty falling asleep–as they undergo menopause. Their complaints were validated by a sleep study of more than 700 women presented at the annual meeting of the Associated Professional Sleep Societies.

“These data provide, for the first time, objective findings to support this common sleep complaint in postmenopausal women,” said Edward O. Bixler, Ph.D., vice chair of the sleep research division at Pennsylvania State University, Hershey.

To confirm the association between menopause and poor sleep and to seek a possible mechanism for this connection, Dr. Bixler and his colleagues conducted single-night polysomnographies on 715 women with a mean age of 49 years. Of these, 400 women were premenopausal, 120 were postmenopausal and using hormone therapy (HT), and 195 were postmenopausal but not using HT.

Women sleep as well as or better than men until they reach menopause, but sleep needs change with age, Dr. Bixler noted. With this fact in mind, the researchers used a group of 609 men who were at least 45 years old (with an average age of 49 years) as controls for the study. The average body mass index for both genders was 26.9 kg/m

The results of the single-night sleep test showed that the postmenopausal women who were not on hormone therapy took an average of 15 minutes longer to fall asleep compared with women on HT, and an average of 10 minutes longer to fall asleep compared with the men. These differences were statistically significant. The average time it took for the male controls to fall asleep was not significantly different from that of premenopausal women (a difference of 1.6 minutes) or of postmenopausal women who were taking hormone therapy (a difference of 5.6 minutes).

“What was unexpected was that we didn't find an increase in daytime sleepiness,” Dr. Bixler noted. He proposed that the lack of daytime sleepiness might be a result of the reduced need for sleep that is a natural part of aging. “As you age, you are less likely to be sleepy during the day even though you are sleeping less at night,” he said.

When the researchers looked at short-wave sleep, which is associated with the brain's ability to recharge, think, and remember, they found no differences between premenopausal women and male controls.

But postmenopausal women who didn't use HT were twice as likely to have slow-wave sleep as were male controls, and postmenopausal women who used HT were four times as likely to have slow-wave sleep as were male controls. Therefore, postmenopausal women who used HT were twice as likely to have short-wave sleep as were women who didn't use HT.

The data suggest that sleep latency is a valid symptom among menopausal women without a history of sleep disorders, especially among those who are not using HT. Based on these findings, menopausal women may be at increased risk for developing chronic insomnia that may require treatment, Dr. Bixler added.

“We would speculate that [menopausal changes] may be triggers for the onset of primary insomnia in vulnerable women,” he said.

MINNEAPOLIS – Women with no history of sleep disorders often report sleep problems–especially difficulty falling asleep–as they undergo menopause. Their complaints were validated by a sleep study of more than 700 women presented at the annual meeting of the Associated Professional Sleep Societies.

“These data provide, for the first time, objective findings to support this common sleep complaint in postmenopausal women,” said Edward O. Bixler, Ph.D., vice chair of the sleep research division at Pennsylvania State University, Hershey.

To confirm the association between menopause and poor sleep and to seek a possible mechanism for this connection, Dr. Bixler and his colleagues conducted single-night polysomnographies on 715 women with a mean age of 49 years. Of these, 400 women were premenopausal, 120 were postmenopausal and using hormone therapy (HT), and 195 were postmenopausal but not using HT.

Women sleep as well as or better than men until they reach menopause, but sleep needs change with age, Dr. Bixler noted. With this fact in mind, the researchers used a group of 609 men who were at least 45 years old (with an average age of 49 years) as controls for the study. The average body mass index for both genders was 26.9 kg/m

The results of the single-night sleep test showed that the postmenopausal women who were not on hormone therapy took an average of 15 minutes longer to fall asleep compared with women on HT, and an average of 10 minutes longer to fall asleep compared with the men. These differences were statistically significant. The average time it took for the male controls to fall asleep was not significantly different from that of premenopausal women (a difference of 1.6 minutes) or of postmenopausal women who were taking hormone therapy (a difference of 5.6 minutes).

“What was unexpected was that we didn't find an increase in daytime sleepiness,” Dr. Bixler noted. He proposed that the lack of daytime sleepiness might be a result of the reduced need for sleep that is a natural part of aging. “As you age, you are less likely to be sleepy during the day even though you are sleeping less at night,” he said.

When the researchers looked at short-wave sleep, which is associated with the brain's ability to recharge, think, and remember, they found no differences between premenopausal women and male controls.

But postmenopausal women who didn't use HT were twice as likely to have slow-wave sleep as were male controls, and postmenopausal women who used HT were four times as likely to have slow-wave sleep as were male controls. Therefore, postmenopausal women who used HT were twice as likely to have short-wave sleep as were women who didn't use HT.

The data suggest that sleep latency is a valid symptom among menopausal women without a history of sleep disorders, especially among those who are not using HT. Based on these findings, menopausal women may be at increased risk for developing chronic insomnia that may require treatment, Dr. Bixler added.

“We would speculate that [menopausal changes] may be triggers for the onset of primary insomnia in vulnerable women,” he said.

MINNEAPOLIS – Women with no history of sleep disorders often report sleep problems–especially difficulty falling asleep–as they undergo menopause. Their complaints were validated by a sleep study of more than 700 women presented at the annual meeting of the Associated Professional Sleep Societies.

“These data provide, for the first time, objective findings to support this common sleep complaint in postmenopausal women,” said Edward O. Bixler, Ph.D., vice chair of the sleep research division at Pennsylvania State University, Hershey.

To confirm the association between menopause and poor sleep and to seek a possible mechanism for this connection, Dr. Bixler and his colleagues conducted single-night polysomnographies on 715 women with a mean age of 49 years. Of these, 400 women were premenopausal, 120 were postmenopausal and using hormone therapy (HT), and 195 were postmenopausal but not using HT.

Women sleep as well as or better than men until they reach menopause, but sleep needs change with age, Dr. Bixler noted. With this fact in mind, the researchers used a group of 609 men who were at least 45 years old (with an average age of 49 years) as controls for the study. The average body mass index for both genders was 26.9 kg/m

The results of the single-night sleep test showed that the postmenopausal women who were not on hormone therapy took an average of 15 minutes longer to fall asleep compared with women on HT, and an average of 10 minutes longer to fall asleep compared with the men. These differences were statistically significant. The average time it took for the male controls to fall asleep was not significantly different from that of premenopausal women (a difference of 1.6 minutes) or of postmenopausal women who were taking hormone therapy (a difference of 5.6 minutes).

“What was unexpected was that we didn't find an increase in daytime sleepiness,” Dr. Bixler noted. He proposed that the lack of daytime sleepiness might be a result of the reduced need for sleep that is a natural part of aging. “As you age, you are less likely to be sleepy during the day even though you are sleeping less at night,” he said.

When the researchers looked at short-wave sleep, which is associated with the brain's ability to recharge, think, and remember, they found no differences between premenopausal women and male controls.

But postmenopausal women who didn't use HT were twice as likely to have slow-wave sleep as were male controls, and postmenopausal women who used HT were four times as likely to have slow-wave sleep as were male controls. Therefore, postmenopausal women who used HT were twice as likely to have short-wave sleep as were women who didn't use HT.

The data suggest that sleep latency is a valid symptom among menopausal women without a history of sleep disorders, especially among those who are not using HT. Based on these findings, menopausal women may be at increased risk for developing chronic insomnia that may require treatment, Dr. Bixler added.

“We would speculate that [menopausal changes] may be triggers for the onset of primary insomnia in vulnerable women,” he said.

CHICAGO — Assume noncompliance when treating atopic dermatitis in teenage patients, said Dr. Jon M. Hanifin, a dermatologist at Oregon Health and Science University in Portland.

“Managing atopic dermatitis in teenagers is not for the faint of heart,” said Dr. Hanifin, a specialist in atopic dermatitis who has served as a consultant for multiple pharmaceutical companies.

Dr. Hanifin shared some tips on treating atopic dermatitis (AD) in teenagers at the annual meeting of the Society for Pediatric Dermatology. His advice included the following:

▸ Keep the parents out of the room except for the start and end of the visit. “You have to get the parents out of the room to find out what's going on,” he said.

▸ Ask the teens to call the office if the treatment isn't going well and encourage them to schedule their appointments.

▸ Offer psychiatric consultation. Some of these teens genuinely want help other than their parents yelling at them.

▸ Don't shy away from systemic medications. Try methotrexate for moderate to severe cases of AD in adolescents because it is less expensive than cyclosporin, Dr. Hanifin said.

He said he often starts teen atopic dermatitis patients with 2.5 mg of methotrexate for 4 of 7 days each week, which has been more effective than a once weekly dose of 15 mg in many of his teen patients. “For the really severe cases, I'll increase the dose [of methotrexate] to 5 mg, and when remission occurs we'll go through the same pattern of tapering that we would with cyclosporin.”

But clinicians should remember that teenagers are prone to rebellion, and they will try everything else they think might work except what parents and doctors advise them to do, he warned.

For a busy teenager, making time for consistent AD care is rarely a priority, he noted.

CHICAGO — Assume noncompliance when treating atopic dermatitis in teenage patients, said Dr. Jon M. Hanifin, a dermatologist at Oregon Health and Science University in Portland.

“Managing atopic dermatitis in teenagers is not for the faint of heart,” said Dr. Hanifin, a specialist in atopic dermatitis who has served as a consultant for multiple pharmaceutical companies.

Dr. Hanifin shared some tips on treating atopic dermatitis (AD) in teenagers at the annual meeting of the Society for Pediatric Dermatology. His advice included the following:

▸ Keep the parents out of the room except for the start and end of the visit. “You have to get the parents out of the room to find out what's going on,” he said.

▸ Ask the teens to call the office if the treatment isn't going well and encourage them to schedule their appointments.

▸ Offer psychiatric consultation. Some of these teens genuinely want help other than their parents yelling at them.

▸ Don't shy away from systemic medications. Try methotrexate for moderate to severe cases of AD in adolescents because it is less expensive than cyclosporin, Dr. Hanifin said.

He said he often starts teen atopic dermatitis patients with 2.5 mg of methotrexate for 4 of 7 days each week, which has been more effective than a once weekly dose of 15 mg in many of his teen patients. “For the really severe cases, I'll increase the dose [of methotrexate] to 5 mg, and when remission occurs we'll go through the same pattern of tapering that we would with cyclosporin.”

But clinicians should remember that teenagers are prone to rebellion, and they will try everything else they think might work except what parents and doctors advise them to do, he warned.

For a busy teenager, making time for consistent AD care is rarely a priority, he noted.

CHICAGO — Assume noncompliance when treating atopic dermatitis in teenage patients, said Dr. Jon M. Hanifin, a dermatologist at Oregon Health and Science University in Portland.

“Managing atopic dermatitis in teenagers is not for the faint of heart,” said Dr. Hanifin, a specialist in atopic dermatitis who has served as a consultant for multiple pharmaceutical companies.

Dr. Hanifin shared some tips on treating atopic dermatitis (AD) in teenagers at the annual meeting of the Society for Pediatric Dermatology. His advice included the following:

▸ Keep the parents out of the room except for the start and end of the visit. “You have to get the parents out of the room to find out what's going on,” he said.

▸ Ask the teens to call the office if the treatment isn't going well and encourage them to schedule their appointments.

▸ Offer psychiatric consultation. Some of these teens genuinely want help other than their parents yelling at them.

▸ Don't shy away from systemic medications. Try methotrexate for moderate to severe cases of AD in adolescents because it is less expensive than cyclosporin, Dr. Hanifin said.

He said he often starts teen atopic dermatitis patients with 2.5 mg of methotrexate for 4 of 7 days each week, which has been more effective than a once weekly dose of 15 mg in many of his teen patients. “For the really severe cases, I'll increase the dose [of methotrexate] to 5 mg, and when remission occurs we'll go through the same pattern of tapering that we would with cyclosporin.”

But clinicians should remember that teenagers are prone to rebellion, and they will try everything else they think might work except what parents and doctors advise them to do, he warned.

For a busy teenager, making time for consistent AD care is rarely a priority, he noted.

MIAMI – A few changes can make a practice more welcoming to lesbian patients, Dr. Christy Isler said at the annual meeting of the American College of Preventive Medicine.

Being mindful and inclusive in words and actions (as well as reminding your staff to do likewise) can go a long way toward helping patients feel comfortable, while also boosting the likelihood that they'll return for regular visits, said Dr. Isler, who is an ob.gyn. and maternal-fetal medicine specialist at East Carolina University in Greenville, N.C.

Dr. Isler offered the following advice:

▸ Don't presume a person's sexuality based on appearance, demeanor, or profession. Revise forms to include options for “partnered” in addition to the usual choices of single, married, divorced, or widowed. Use terms such as “partner's name” rather than “spouse's name.”

Make sure the partner's name is on the patient's information form, because that partner may be the emergency contact for that patient.

▸ Post a nondiscrimination policy where all patients can see it. But also note that patients' confidentiality on all health issues is respected and protected.

▸ Ask patients whether they are sexually active with men, with women, or with both.

▸ Ask an individual about her partner the same way you would ask any woman how her family is doing. Remember that for many lesbian patients, their partners are their chosen families, and they may have little or no relationship with their biological families.

▸ Remember that a regular visit for a lesbian patient includes the same preventive medicine issues as for any other female patient: diet, exercise, alcohol use, smoking, reproductive issues, and domestic violence.

▸ Be aware of a possible increased risk of psychological problems among lesbians. Ask about stress levels and refer for additional help as needed to address mental and emotional health issues.

MIAMI – A few changes can make a practice more welcoming to lesbian patients, Dr. Christy Isler said at the annual meeting of the American College of Preventive Medicine.

Being mindful and inclusive in words and actions (as well as reminding your staff to do likewise) can go a long way toward helping patients feel comfortable, while also boosting the likelihood that they'll return for regular visits, said Dr. Isler, who is an ob.gyn. and maternal-fetal medicine specialist at East Carolina University in Greenville, N.C.

Dr. Isler offered the following advice:

▸ Don't presume a person's sexuality based on appearance, demeanor, or profession. Revise forms to include options for “partnered” in addition to the usual choices of single, married, divorced, or widowed. Use terms such as “partner's name” rather than “spouse's name.”

Make sure the partner's name is on the patient's information form, because that partner may be the emergency contact for that patient.

▸ Post a nondiscrimination policy where all patients can see it. But also note that patients' confidentiality on all health issues is respected and protected.

▸ Ask patients whether they are sexually active with men, with women, or with both.

▸ Ask an individual about her partner the same way you would ask any woman how her family is doing. Remember that for many lesbian patients, their partners are their chosen families, and they may have little or no relationship with their biological families.

▸ Remember that a regular visit for a lesbian patient includes the same preventive medicine issues as for any other female patient: diet, exercise, alcohol use, smoking, reproductive issues, and domestic violence.

▸ Be aware of a possible increased risk of psychological problems among lesbians. Ask about stress levels and refer for additional help as needed to address mental and emotional health issues.

MIAMI – A few changes can make a practice more welcoming to lesbian patients, Dr. Christy Isler said at the annual meeting of the American College of Preventive Medicine.

Being mindful and inclusive in words and actions (as well as reminding your staff to do likewise) can go a long way toward helping patients feel comfortable, while also boosting the likelihood that they'll return for regular visits, said Dr. Isler, who is an ob.gyn. and maternal-fetal medicine specialist at East Carolina University in Greenville, N.C.

Dr. Isler offered the following advice:

▸ Don't presume a person's sexuality based on appearance, demeanor, or profession. Revise forms to include options for “partnered” in addition to the usual choices of single, married, divorced, or widowed. Use terms such as “partner's name” rather than “spouse's name.”

Make sure the partner's name is on the patient's information form, because that partner may be the emergency contact for that patient.

▸ Post a nondiscrimination policy where all patients can see it. But also note that patients' confidentiality on all health issues is respected and protected.

▸ Ask patients whether they are sexually active with men, with women, or with both.

▸ Ask an individual about her partner the same way you would ask any woman how her family is doing. Remember that for many lesbian patients, their partners are their chosen families, and they may have little or no relationship with their biological families.

▸ Remember that a regular visit for a lesbian patient includes the same preventive medicine issues as for any other female patient: diet, exercise, alcohol use, smoking, reproductive issues, and domestic violence.

▸ Be aware of a possible increased risk of psychological problems among lesbians. Ask about stress levels and refer for additional help as needed to address mental and emotional health issues.

ATLANTA – The vaccine financing system in the United States continues to derail vaccinations for underinsured children and adolescents, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass.

“For example, we estimate that about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector,” said Dr. Lee, who gave results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is approximately $1,200,” she said.

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector to receive vaccines purchased by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in recommended vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults. “Historically, vaccines weren't so expensive, but now it is getting harder to vaccinate all children with everything due to a lack of increase in 317 funding,” Dr. Lee commented.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers. The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children, Dr. Lee said.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in approximately 40% of the states. Of note, the ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The survey respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. Respondents cited insufficient state funding as a primary barrier to vaccination and reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers reported negotiating state contracts with vaccine manufacturers, 9 reported decreasing their purchases of adult vaccines, and 4 reported designating annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states, 3 designated all public VFC providers, and 1 state manager designated all public and private VFC providers as FQHCs.

Dr. Lee said in an interview that she was unable to disclose which states had expanded the FQHCs because the interviewees' names were kept confidential.

In particular, the strategy of expanding FQHC designations to improve access for VFC patients could help relieve the increased stress of paying for vaccines for children, Dr. Lee said. But the study did not address the other side of vaccine financing–reimbursement–which remains a hot-button issue for physicians.

“All is not well in the realm of private providers,” Dr. Jonathan Temte said during the discussion period following the presentation. “A bigger issue is reimbursement. Even if a vaccine is covered you won't necessarily get paid for all your expenses,” said Dr. Temte of the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP.

For up-to-date information on FQHCcoverage, billing, and policies, visit www.cms.hhs.gov/center/fqhc.asp

ATLANTA – The vaccine financing system in the United States continues to derail vaccinations for underinsured children and adolescents, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass.

“For example, we estimate that about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector,” said Dr. Lee, who gave results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is approximately $1,200,” she said.

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector to receive vaccines purchased by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in recommended vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults. “Historically, vaccines weren't so expensive, but now it is getting harder to vaccinate all children with everything due to a lack of increase in 317 funding,” Dr. Lee commented.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers. The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children, Dr. Lee said.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in approximately 40% of the states. Of note, the ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The survey respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. Respondents cited insufficient state funding as a primary barrier to vaccination and reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers reported negotiating state contracts with vaccine manufacturers, 9 reported decreasing their purchases of adult vaccines, and 4 reported designating annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states, 3 designated all public VFC providers, and 1 state manager designated all public and private VFC providers as FQHCs.

Dr. Lee said in an interview that she was unable to disclose which states had expanded the FQHCs because the interviewees' names were kept confidential.

In particular, the strategy of expanding FQHC designations to improve access for VFC patients could help relieve the increased stress of paying for vaccines for children, Dr. Lee said. But the study did not address the other side of vaccine financing–reimbursement–which remains a hot-button issue for physicians.

“All is not well in the realm of private providers,” Dr. Jonathan Temte said during the discussion period following the presentation. “A bigger issue is reimbursement. Even if a vaccine is covered you won't necessarily get paid for all your expenses,” said Dr. Temte of the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP.

For up-to-date information on FQHCcoverage, billing, and policies, visit www.cms.hhs.gov/center/fqhc.asp

ATLANTA – The vaccine financing system in the United States continues to derail vaccinations for underinsured children and adolescents, based on new survey data from state immunization program managers.

“Limitations in 317 funding and state funding are clearly contributing to this gap,” said Dr. Grace M. Lee of Harvard University, Cambridge, Mass.

“For example, we estimate that about 3.9 billion children are unable to receive Menactra in the private sector and 1.1 billion are also unable to receive Menactra in the public sector,” said Dr. Lee, who gave results from a study of states' vaccine financing activities at a meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The explosion in the number and cost of vaccines for children and adolescents in recent years prompted the study. In 1985, there were 7 vaccines in the routine childhood and adolescent immunization schedule; in 1995, there were 10; and in 2006, there were 16, said Dr. Lee. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is approximately $1,200,” she said.

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector to receive vaccines purchased by the state government with 317 funds or through the federally funded Vaccines for Children (VFC) program. But neither of these sources has kept up with the growth in recommended vaccinations.

The Section 317 program is a discretionary federal grant given to each state (plus all U.S. protectorates, territories, and six cities) to be used for vaccines for underinsured children and adolescents who do not meet the criteria for the VFC program or whose parents or guardians can't afford the out-of-pocket costs for full vaccination. Most of the Section 317 funds are used for routine childhood and adolescent vaccinations, although any remaining funds can be used to pay for vaccinations for underinsured adults. “Historically, vaccines weren't so expensive, but now it is getting harder to vaccinate all children with everything due to a lack of increase in 317 funding,” Dr. Lee commented.

Dr. Lee and her colleagues conducted a two-phase study that included qualitative interviews with 48 state immunization program managers followed by a national survey and interviews with the state managers plus two city immunization program managers. The survey and interview questions asked how and whether the cities and states provided vaccines to underinsured children, Dr. Lee said.

Overall, about 50% of underinsured children could not be vaccinated in their medical homes unless they could pay out of pocket, according to the survey results. The meningococcal vaccine (Menactra) was the least-covered vaccine. Menactra was not covered by private providers in nearly 70% of states in the study and it was not covered in public clinics in approximately 40% of the states. Of note, the ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The survey respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. Respondents cited insufficient state funding as a primary barrier to vaccination and reported using several strategies to address the lack of funds.

A total of 27 states' managers reported limiting provider vaccine choice, and 25 used annual state appropriations to address financing limitations. A total of 13 managers reported expanding their definitions of federally qualified health care centers (FQHCs) so more underinsured children would be eligible for the VFC program. In addition, 11 managers reported negotiating state contracts with vaccine manufacturers, 9 reported decreasing their purchases of adult vaccines, and 4 reported designating annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states, 3 designated all public VFC providers, and 1 state manager designated all public and private VFC providers as FQHCs.

Dr. Lee said in an interview that she was unable to disclose which states had expanded the FQHCs because the interviewees' names were kept confidential.

In particular, the strategy of expanding FQHC designations to improve access for VFC patients could help relieve the increased stress of paying for vaccines for children, Dr. Lee said. But the study did not address the other side of vaccine financing–reimbursement–which remains a hot-button issue for physicians.

“All is not well in the realm of private providers,” Dr. Jonathan Temte said during the discussion period following the presentation. “A bigger issue is reimbursement. Even if a vaccine is covered you won't necessarily get paid for all your expenses,” said Dr. Temte of the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP.

For up-to-date information on FQHCcoverage, billing, and policies, visit www.cms.hhs.gov/center/fqhc.asp

MINNEAPOLIS — Adults with Arnold-Chiari type I malformations are at greater risk for sleep-disordered breathing, compared with healthy controls, based on data presented at the annual meeting of the Associated Professional Sleep Societies.

In light of this finding, “We should be screening all Arnold-Chiari I patients for sleep-disordered breathing,” said Dr. Nate Watson, a neurologist at the University of Washington, Seattle.

The displaced brain structures that characterize Arnold-Chiari I (AC-1), a benign developmental brain anomaly, can compress the brainstem, impeding breathing, he said.

To better assess the risk of sleep-disordered breathing in AC-1 patients, Dr. Watson and his colleagues compared 18 women with AC-1 (mean age 36 years) with 35 age- and sex-matched controls.

The researchers used several subjective questionnaires, including the Epworth Sleepiness Scale, to assess sleep-disordered breathing and sleepiness. Based on these results, the AC-1 patients were at significantly greater risk for sleep-disordered breathing, compared with controls (69% vs. 20%). Specifically, the results from the questionnaires showed that three factors—snoring, sleepiness, and obesity/hypertension—were significantly more common among AC-1 patients vs. controls, and occurred in 44% vs. 6%, 78% vs. 46%, and 64% vs. 34%, respectively.

The AC-1 patients were significantly more likely to report other symptoms associated with sleep-disordered breathing, including nighttime choking or gasping and nighttime shortness of breath, compared with controls. And when they woke up, the AC-1 patients also reported sore throats, heartburn, and headaches significantly more often than did controls.

In addition, the AC-1 patients reported sleeping significantly fewer hours (6.3 hours vs. 7.6 hours) and taking significantly longer to fall asleep (61.4 minutes vs. 18.6 minutes), compared with controls

Consider decompressive surgery for patients if respiration is their main complaint, but remember that they need to be followed, said Dr. Watson during the discussion after his presentation. Previous studies indicate that decompression surgery makes a difference. Data from 16 consecutive patients with AC-1 malformations showed a significant improvement in the central apnea index from 14.9 to 1.3 based on full-night polysomnography conducted approximately 200 days after decompression surgery (Neurology 2006;66:136–8).

Future studies of AC-1 patients need to continue to focus on objective measures and comparison of patients before and after decompressive surgery, Dr. Watson said.

MINNEAPOLIS — Adults with Arnold-Chiari type I malformations are at greater risk for sleep-disordered breathing, compared with healthy controls, based on data presented at the annual meeting of the Associated Professional Sleep Societies.

In light of this finding, “We should be screening all Arnold-Chiari I patients for sleep-disordered breathing,” said Dr. Nate Watson, a neurologist at the University of Washington, Seattle.

The displaced brain structures that characterize Arnold-Chiari I (AC-1), a benign developmental brain anomaly, can compress the brainstem, impeding breathing, he said.

To better assess the risk of sleep-disordered breathing in AC-1 patients, Dr. Watson and his colleagues compared 18 women with AC-1 (mean age 36 years) with 35 age- and sex-matched controls.

The researchers used several subjective questionnaires, including the Epworth Sleepiness Scale, to assess sleep-disordered breathing and sleepiness. Based on these results, the AC-1 patients were at significantly greater risk for sleep-disordered breathing, compared with controls (69% vs. 20%). Specifically, the results from the questionnaires showed that three factors—snoring, sleepiness, and obesity/hypertension—were significantly more common among AC-1 patients vs. controls, and occurred in 44% vs. 6%, 78% vs. 46%, and 64% vs. 34%, respectively.

The AC-1 patients were significantly more likely to report other symptoms associated with sleep-disordered breathing, including nighttime choking or gasping and nighttime shortness of breath, compared with controls. And when they woke up, the AC-1 patients also reported sore throats, heartburn, and headaches significantly more often than did controls.

In addition, the AC-1 patients reported sleeping significantly fewer hours (6.3 hours vs. 7.6 hours) and taking significantly longer to fall asleep (61.4 minutes vs. 18.6 minutes), compared with controls

Consider decompressive surgery for patients if respiration is their main complaint, but remember that they need to be followed, said Dr. Watson during the discussion after his presentation. Previous studies indicate that decompression surgery makes a difference. Data from 16 consecutive patients with AC-1 malformations showed a significant improvement in the central apnea index from 14.9 to 1.3 based on full-night polysomnography conducted approximately 200 days after decompression surgery (Neurology 2006;66:136–8).

Future studies of AC-1 patients need to continue to focus on objective measures and comparison of patients before and after decompressive surgery, Dr. Watson said.

MINNEAPOLIS — Adults with Arnold-Chiari type I malformations are at greater risk for sleep-disordered breathing, compared with healthy controls, based on data presented at the annual meeting of the Associated Professional Sleep Societies.

In light of this finding, “We should be screening all Arnold-Chiari I patients for sleep-disordered breathing,” said Dr. Nate Watson, a neurologist at the University of Washington, Seattle.

The displaced brain structures that characterize Arnold-Chiari I (AC-1), a benign developmental brain anomaly, can compress the brainstem, impeding breathing, he said.

To better assess the risk of sleep-disordered breathing in AC-1 patients, Dr. Watson and his colleagues compared 18 women with AC-1 (mean age 36 years) with 35 age- and sex-matched controls.

The researchers used several subjective questionnaires, including the Epworth Sleepiness Scale, to assess sleep-disordered breathing and sleepiness. Based on these results, the AC-1 patients were at significantly greater risk for sleep-disordered breathing, compared with controls (69% vs. 20%). Specifically, the results from the questionnaires showed that three factors—snoring, sleepiness, and obesity/hypertension—were significantly more common among AC-1 patients vs. controls, and occurred in 44% vs. 6%, 78% vs. 46%, and 64% vs. 34%, respectively.

The AC-1 patients were significantly more likely to report other symptoms associated with sleep-disordered breathing, including nighttime choking or gasping and nighttime shortness of breath, compared with controls. And when they woke up, the AC-1 patients also reported sore throats, heartburn, and headaches significantly more often than did controls.

In addition, the AC-1 patients reported sleeping significantly fewer hours (6.3 hours vs. 7.6 hours) and taking significantly longer to fall asleep (61.4 minutes vs. 18.6 minutes), compared with controls

Consider decompressive surgery for patients if respiration is their main complaint, but remember that they need to be followed, said Dr. Watson during the discussion after his presentation. Previous studies indicate that decompression surgery makes a difference. Data from 16 consecutive patients with AC-1 malformations showed a significant improvement in the central apnea index from 14.9 to 1.3 based on full-night polysomnography conducted approximately 200 days after decompression surgery (Neurology 2006;66:136–8).

Future studies of AC-1 patients need to continue to focus on objective measures and comparison of patients before and after decompressive surgery, Dr. Watson said.

MINNEAPOLIS — Two dopamine agonists—pramipexole and ropinirole—each improved symptoms and quality of life in adults with restless legs syndrome, based on data from studies presented at the annual meeting of the Associated Professional Sleep Societies. Both drugs are approved by the Food and Drug Administration for the treatment of restless legs syndrome.

Patients with restless legs syndrome (RLS) often report uncomfortable sensations deep in their legs accompanied by irresistible urges to move their legs. The symptoms worsen at night and tend to disrupt sleep, which has a negative impact on patients' quality of life.

Data from three randomized, double-blind, placebo-controlled studies of pramipexole showed that those who received the drug reported significant improvements in quality of life and in RLS symptoms, compared with placebo patients. The dosage used in the three studies ranged from 0.125 mg/day to 0.75 mg/day. The studies included a total of 784 adults (aged 18–79 years; average age 51 years); all patients met the diagnosis for RLS and had at least one postbaseline evaluation. All three studies were supported by Boehringer Ingelheim Pharmaceuticals Inc.

In the largest of the three studies, the 258 patients randomized to receive pramipexole for 12 weeks reported significant improvements in sleep quality, shorter time to fall asleep, and improved daytime symptoms, compared with 86 patients who received a placebo. Based on visual analog scale scores, daytime symptom severity improved by 49% in the pramipexole group, compared with 32% in the placebo group, and pramipexole patients reported an average of 57% improvement in sleep satisfaction, vs. 38% in the placebo group. The study was conducted by Dr. Robert D. Ballard of the University of Colorado Health Sciences Center in Denver.

Pramipexole did not increase daytime sleepiness, compared with placebo, across these three studies. In fact, the pramipexole patients who reported abnormal daytime sleepiness at baseline reported significant improvement in daytime sleepiness, compared with placebo patients, based on the Epworth Sleepiness Scale. No significant differences appeared in daytime sleepiness among patients in the two groups that reported normal levels of daytime sleepiness at baseline.

In a pair of similar studies of ropinirole, presented by Dr. Markus H. Schmidt of the Ohio Sleep Medicine Institute in Dublin, Ohio, the drug significantly improved the symptoms of restless legs syndrome and improved patients' quality of life in a randomized trial with an intent-to-treat population of 382 adults with RLS. The daily dose ranged from 0.5 to 6.0 mg, titrated as needed. Dr. Schmidt has received financial support from and has served as a speaker for GlaxoSmithKline, the company that supported the research.

After 12 weeks, the 187 patients who received ropinirole reported significantly greater improvements in symptoms, compared with the 195 placebo patients, in four areas of the Medical Outcomes Study Sleep Scale (reduction in sleep disturbance, reduction in daytime sleepiness, increased sleep adequacy, and increased sleep quantity). Adverse events were mild to moderate, and only 4% of the ropinirole patients and 3% of the placebo patients discontinued the medications because of adverse events. The most often reported adverse events in the ropinirole group vs. the placebo group were nausea (28% vs. 7%), headache (20% vs. 18%), and sleepiness (9% vs. 6%).

After treatment, nearly half (49%) of the ropinirole patients were classified as “not ill” or “borderline ill,” compared with 31% of placebo patients, based on a clinician-rated scale. In addition, significantly more patients showed improvement in illness based on a patient-rated scale at 2 days, 3 days, and 4 days after starting treatment. On day 4, 42% of the ropinirole patients were classified as responders, compared with 24% of the placebo patients.

MINNEAPOLIS — Two dopamine agonists—pramipexole and ropinirole—each improved symptoms and quality of life in adults with restless legs syndrome, based on data from studies presented at the annual meeting of the Associated Professional Sleep Societies. Both drugs are approved by the Food and Drug Administration for the treatment of restless legs syndrome.

Patients with restless legs syndrome (RLS) often report uncomfortable sensations deep in their legs accompanied by irresistible urges to move their legs. The symptoms worsen at night and tend to disrupt sleep, which has a negative impact on patients' quality of life.

Data from three randomized, double-blind, placebo-controlled studies of pramipexole showed that those who received the drug reported significant improvements in quality of life and in RLS symptoms, compared with placebo patients. The dosage used in the three studies ranged from 0.125 mg/day to 0.75 mg/day. The studies included a total of 784 adults (aged 18–79 years; average age 51 years); all patients met the diagnosis for RLS and had at least one postbaseline evaluation. All three studies were supported by Boehringer Ingelheim Pharmaceuticals Inc.

In the largest of the three studies, the 258 patients randomized to receive pramipexole for 12 weeks reported significant improvements in sleep quality, shorter time to fall asleep, and improved daytime symptoms, compared with 86 patients who received a placebo. Based on visual analog scale scores, daytime symptom severity improved by 49% in the pramipexole group, compared with 32% in the placebo group, and pramipexole patients reported an average of 57% improvement in sleep satisfaction, vs. 38% in the placebo group. The study was conducted by Dr. Robert D. Ballard of the University of Colorado Health Sciences Center in Denver.

Pramipexole did not increase daytime sleepiness, compared with placebo, across these three studies. In fact, the pramipexole patients who reported abnormal daytime sleepiness at baseline reported significant improvement in daytime sleepiness, compared with placebo patients, based on the Epworth Sleepiness Scale. No significant differences appeared in daytime sleepiness among patients in the two groups that reported normal levels of daytime sleepiness at baseline.

In a pair of similar studies of ropinirole, presented by Dr. Markus H. Schmidt of the Ohio Sleep Medicine Institute in Dublin, Ohio, the drug significantly improved the symptoms of restless legs syndrome and improved patients' quality of life in a randomized trial with an intent-to-treat population of 382 adults with RLS. The daily dose ranged from 0.5 to 6.0 mg, titrated as needed. Dr. Schmidt has received financial support from and has served as a speaker for GlaxoSmithKline, the company that supported the research.

After 12 weeks, the 187 patients who received ropinirole reported significantly greater improvements in symptoms, compared with the 195 placebo patients, in four areas of the Medical Outcomes Study Sleep Scale (reduction in sleep disturbance, reduction in daytime sleepiness, increased sleep adequacy, and increased sleep quantity). Adverse events were mild to moderate, and only 4% of the ropinirole patients and 3% of the placebo patients discontinued the medications because of adverse events. The most often reported adverse events in the ropinirole group vs. the placebo group were nausea (28% vs. 7%), headache (20% vs. 18%), and sleepiness (9% vs. 6%).

After treatment, nearly half (49%) of the ropinirole patients were classified as “not ill” or “borderline ill,” compared with 31% of placebo patients, based on a clinician-rated scale. In addition, significantly more patients showed improvement in illness based on a patient-rated scale at 2 days, 3 days, and 4 days after starting treatment. On day 4, 42% of the ropinirole patients were classified as responders, compared with 24% of the placebo patients.

MINNEAPOLIS — Two dopamine agonists—pramipexole and ropinirole—each improved symptoms and quality of life in adults with restless legs syndrome, based on data from studies presented at the annual meeting of the Associated Professional Sleep Societies. Both drugs are approved by the Food and Drug Administration for the treatment of restless legs syndrome.

Patients with restless legs syndrome (RLS) often report uncomfortable sensations deep in their legs accompanied by irresistible urges to move their legs. The symptoms worsen at night and tend to disrupt sleep, which has a negative impact on patients' quality of life.

Data from three randomized, double-blind, placebo-controlled studies of pramipexole showed that those who received the drug reported significant improvements in quality of life and in RLS symptoms, compared with placebo patients. The dosage used in the three studies ranged from 0.125 mg/day to 0.75 mg/day. The studies included a total of 784 adults (aged 18–79 years; average age 51 years); all patients met the diagnosis for RLS and had at least one postbaseline evaluation. All three studies were supported by Boehringer Ingelheim Pharmaceuticals Inc.

In the largest of the three studies, the 258 patients randomized to receive pramipexole for 12 weeks reported significant improvements in sleep quality, shorter time to fall asleep, and improved daytime symptoms, compared with 86 patients who received a placebo. Based on visual analog scale scores, daytime symptom severity improved by 49% in the pramipexole group, compared with 32% in the placebo group, and pramipexole patients reported an average of 57% improvement in sleep satisfaction, vs. 38% in the placebo group. The study was conducted by Dr. Robert D. Ballard of the University of Colorado Health Sciences Center in Denver.

Pramipexole did not increase daytime sleepiness, compared with placebo, across these three studies. In fact, the pramipexole patients who reported abnormal daytime sleepiness at baseline reported significant improvement in daytime sleepiness, compared with placebo patients, based on the Epworth Sleepiness Scale. No significant differences appeared in daytime sleepiness among patients in the two groups that reported normal levels of daytime sleepiness at baseline.

In a pair of similar studies of ropinirole, presented by Dr. Markus H. Schmidt of the Ohio Sleep Medicine Institute in Dublin, Ohio, the drug significantly improved the symptoms of restless legs syndrome and improved patients' quality of life in a randomized trial with an intent-to-treat population of 382 adults with RLS. The daily dose ranged from 0.5 to 6.0 mg, titrated as needed. Dr. Schmidt has received financial support from and has served as a speaker for GlaxoSmithKline, the company that supported the research.

After 12 weeks, the 187 patients who received ropinirole reported significantly greater improvements in symptoms, compared with the 195 placebo patients, in four areas of the Medical Outcomes Study Sleep Scale (reduction in sleep disturbance, reduction in daytime sleepiness, increased sleep adequacy, and increased sleep quantity). Adverse events were mild to moderate, and only 4% of the ropinirole patients and 3% of the placebo patients discontinued the medications because of adverse events. The most often reported adverse events in the ropinirole group vs. the placebo group were nausea (28% vs. 7%), headache (20% vs. 18%), and sleepiness (9% vs. 6%).

After treatment, nearly half (49%) of the ropinirole patients were classified as “not ill” or “borderline ill,” compared with 31% of placebo patients, based on a clinician-rated scale. In addition, significantly more patients showed improvement in illness based on a patient-rated scale at 2 days, 3 days, and 4 days after starting treatment. On day 4, 42% of the ropinirole patients were classified as responders, compared with 24% of the placebo patients.

ATLANTA – Children who had received two doses of varicella vaccine comprised nearly a third of the cases in a varicella outbreak among elementary school children in Arkansas.

“This was one of the largest varicella outbreaks investigated in recent years, and it was the first U.S. outbreak reported with a significant number of two-dose vaccines,” said Adriana Lopez, an epidemiologist with the Centers for Disease Control and Prevention's division of viral diseases.

A total of 85 cases were identified during the outbreak, which occurred among children in prekindergarten through sixth grade in the fall of 2006. Of these, 25 (29%) had received two doses of varicella vaccine, 54 (64%) had received one dose, and 6 (7%) had not received any varicella vaccination. “The moderate level of two-dose coverage was insufficient to prevent the outbreak,” said Ms. Lopez, who presented the results at a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP).

Overall, the school's varicella vaccination coverage was 97% among 758 children and 41% of the vaccinated children had received two doses. The CDC was invited to investigate the outbreak in order to confirm varicella in the children who had received two doses of the vaccine and to characterize the vaccine's effectiveness among one- and two-dose recipients. “Disease in vaccinated persons is generally mild, with fewer than 50 lesions and a shorter duration of illness,” noted Ms. Lopez.

For purposes of the investigation, a varicella case was defined as an acute macular papular vesicular rash without another apparent cause. Because of the frequency of insect bites in the region of the outbreak, a child needed at least three lesions to be considered a case.

A total of 27 cases were sampled for testing. Six of these were confirmed as positive using five polymerase chain reaction tests on lesion samples and one using an IgM serum spot test. The positive results for the PCR tests included one child who had received two doses of vaccine, three children who had each received single doses, and one unvaccinated child who had a history of varicella. The positive IgM serum spot test was used for a child who had received one dose of vaccine.

In June 2006, ACIP recommended a routine two-dose varicella vaccination plan for children, with the first dose given at age 12-15 months, the second dose given at age 4-6 years, and catch-up doses given to anyone older than 6 years.

Varicella cases associated with the outbreak were identified by local health data, the school nurse, and through school surveys on vaccination status and disease history. Parents of the children who were identified as cases were contacted and asked for additional information about medical history and vaccination status. Vaccination history was verified using the state's immunization registry, local health records, and the parents' surveys. Children were considered unvaccinated if they had received their first dose of vaccine 42 days or less before they became ill.

“As next steps, additional vaccine effectiveness studies for two doses are needed,” said Ms. Lopez. Data from more than 30 postlicensure studies show effectiveness estimates for a single dose of varicella vaccine ranging from 44% to 100%.

ATLANTA – Children who had received two doses of varicella vaccine comprised nearly a third of the cases in a varicella outbreak among elementary school children in Arkansas.

“This was one of the largest varicella outbreaks investigated in recent years, and it was the first U.S. outbreak reported with a significant number of two-dose vaccines,” said Adriana Lopez, an epidemiologist with the Centers for Disease Control and Prevention's division of viral diseases.

A total of 85 cases were identified during the outbreak, which occurred among children in prekindergarten through sixth grade in the fall of 2006. Of these, 25 (29%) had received two doses of varicella vaccine, 54 (64%) had received one dose, and 6 (7%) had not received any varicella vaccination. “The moderate level of two-dose coverage was insufficient to prevent the outbreak,” said Ms. Lopez, who presented the results at a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP).

Overall, the school's varicella vaccination coverage was 97% among 758 children and 41% of the vaccinated children had received two doses. The CDC was invited to investigate the outbreak in order to confirm varicella in the children who had received two doses of the vaccine and to characterize the vaccine's effectiveness among one- and two-dose recipients. “Disease in vaccinated persons is generally mild, with fewer than 50 lesions and a shorter duration of illness,” noted Ms. Lopez.

For purposes of the investigation, a varicella case was defined as an acute macular papular vesicular rash without another apparent cause. Because of the frequency of insect bites in the region of the outbreak, a child needed at least three lesions to be considered a case.

A total of 27 cases were sampled for testing. Six of these were confirmed as positive using five polymerase chain reaction tests on lesion samples and one using an IgM serum spot test. The positive results for the PCR tests included one child who had received two doses of vaccine, three children who had each received single doses, and one unvaccinated child who had a history of varicella. The positive IgM serum spot test was used for a child who had received one dose of vaccine.

In June 2006, ACIP recommended a routine two-dose varicella vaccination plan for children, with the first dose given at age 12-15 months, the second dose given at age 4-6 years, and catch-up doses given to anyone older than 6 years.

Varicella cases associated with the outbreak were identified by local health data, the school nurse, and through school surveys on vaccination status and disease history. Parents of the children who were identified as cases were contacted and asked for additional information about medical history and vaccination status. Vaccination history was verified using the state's immunization registry, local health records, and the parents' surveys. Children were considered unvaccinated if they had received their first dose of vaccine 42 days or less before they became ill.

“As next steps, additional vaccine effectiveness studies for two doses are needed,” said Ms. Lopez. Data from more than 30 postlicensure studies show effectiveness estimates for a single dose of varicella vaccine ranging from 44% to 100%.

ATLANTA – Children who had received two doses of varicella vaccine comprised nearly a third of the cases in a varicella outbreak among elementary school children in Arkansas.

“This was one of the largest varicella outbreaks investigated in recent years, and it was the first U.S. outbreak reported with a significant number of two-dose vaccines,” said Adriana Lopez, an epidemiologist with the Centers for Disease Control and Prevention's division of viral diseases.

A total of 85 cases were identified during the outbreak, which occurred among children in prekindergarten through sixth grade in the fall of 2006. Of these, 25 (29%) had received two doses of varicella vaccine, 54 (64%) had received one dose, and 6 (7%) had not received any varicella vaccination. “The moderate level of two-dose coverage was insufficient to prevent the outbreak,” said Ms. Lopez, who presented the results at a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP).

Overall, the school's varicella vaccination coverage was 97% among 758 children and 41% of the vaccinated children had received two doses. The CDC was invited to investigate the outbreak in order to confirm varicella in the children who had received two doses of the vaccine and to characterize the vaccine's effectiveness among one- and two-dose recipients. “Disease in vaccinated persons is generally mild, with fewer than 50 lesions and a shorter duration of illness,” noted Ms. Lopez.

For purposes of the investigation, a varicella case was defined as an acute macular papular vesicular rash without another apparent cause. Because of the frequency of insect bites in the region of the outbreak, a child needed at least three lesions to be considered a case.

A total of 27 cases were sampled for testing. Six of these were confirmed as positive using five polymerase chain reaction tests on lesion samples and one using an IgM serum spot test. The positive results for the PCR tests included one child who had received two doses of vaccine, three children who had each received single doses, and one unvaccinated child who had a history of varicella. The positive IgM serum spot test was used for a child who had received one dose of vaccine.

In June 2006, ACIP recommended a routine two-dose varicella vaccination plan for children, with the first dose given at age 12-15 months, the second dose given at age 4-6 years, and catch-up doses given to anyone older than 6 years.

Varicella cases associated with the outbreak were identified by local health data, the school nurse, and through school surveys on vaccination status and disease history. Parents of the children who were identified as cases were contacted and asked for additional information about medical history and vaccination status. Vaccination history was verified using the state's immunization registry, local health records, and the parents' surveys. Children were considered unvaccinated if they had received their first dose of vaccine 42 days or less before they became ill.

“As next steps, additional vaccine effectiveness studies for two doses are needed,” said Ms. Lopez. Data from more than 30 postlicensure studies show effectiveness estimates for a single dose of varicella vaccine ranging from 44% to 100%.