Heidi Splete

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, 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. “We estimate 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.”

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, who presented 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. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is about $1,200.”

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector for vaccines bought 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 suggested 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.

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.

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 about 40% of the states. The ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they 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 negotiated state contracts with vaccine manufacturers, 9 decreased their purchases of adult vaccines, and 4 designated annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said she was unable to disclose which states had expanded the FQHCs because interviewees' names were kept confidential.

But the study did not address reimbursement, which remains a hot-button issue for physicians. “A bigger issue is reimbursement. Even if a vaccine is covered, you won't necessarily get paid for all your expenses,” said Dr. Jonathan Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP, in a discussion. For more information, visit www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, 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. “We estimate 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.”

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, who presented 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. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is about $1,200.”

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector for vaccines bought 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 suggested 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.

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.

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 about 40% of the states. The ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they 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 negotiated state contracts with vaccine manufacturers, 9 decreased their purchases of adult vaccines, and 4 designated annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said she was unable to disclose which states had expanded the FQHCs because interviewees' names were kept confidential.

But the study did not address reimbursement, which remains a hot-button issue for physicians. “A bigger issue is reimbursement. Even if a vaccine is covered, you won't necessarily get paid for all your expenses,” said Dr. Jonathan Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP, in a discussion. For more information, visit www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The current vaccine financing system in the United States continues to derail vaccinations for underinsured children, 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. “We estimate 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.”

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, who presented 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. “In 1985, it cost $45 to fully vaccinate a child. In 2006, the estimated cost to vaccinate a female child is about $1,200.”

Many underinsured children must pay out of pocket for vaccines. Alternatively, private providers may refer them to the public sector for vaccines bought 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 suggested 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.

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.

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 about 40% of the states. The ACIP recently recommended expanding meningococcal vaccination to include all adolescents aged 11-18 years.

The respondents expressed discomfort at having to turn away children who could not afford to pay for new vaccines, Dr. Lee noted. The respondents cited insufficient state funding as a primary barrier to vaccination, and they 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 negotiated state contracts with vaccine manufacturers, 9 decreased their purchases of adult vaccines, and 4 designated annual health plan appropriations.

Of the 13 states that reported expanding FQHC designations, 9 designated some public VFC providers in their states as FQHCs; 3 designated all public VFC providers as FQHCs; and 1 state manager designated all public and private VFC providers as FQHCs. Dr. Lee said she was unable to disclose which states had expanded the FQHCs because interviewees' names were kept confidential.

But the study did not address reimbursement, which remains a hot-button issue for physicians. “A bigger issue is reimbursement. Even if a vaccine is covered, you won't necessarily get paid for all your expenses,” said Dr. Jonathan Temte, a family physician at the University of Wisconsin, Madison, and the American Academy of Family Physicians' liaison to ACIP, in a discussion. For more information, visit www.cms.hhs.gov/center/fqhc.asp

ELSEVIER GLOBAL MEDICAL NEWS

ATLANTA – The safety profile for herpes zoster vaccine Zostavax, 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, 2007, 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, but 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 the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present 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 that exist in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” he said.

Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA – The safety profile for herpes zoster vaccine Zostavax, 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, 2007, 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, but 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 the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present 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 that exist in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” he said.

Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA – The safety profile for herpes zoster vaccine Zostavax, 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, 2007, 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, but 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 the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present 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 that exist in the 60-years-and-older population, Dr. Chaves noted.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” he said.

Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

WASHINGTON – Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

“The program facilitated our efforts in providing smoking cessation counseling and offering NRT to all these identified patients,” the researchers said. Also, adding smoking status to the EMR helped physicians retrieve information more easily, which may help with long-term studies of patients' smoking status after they leave the hospital.

WASHINGTON – Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

“The program facilitated our efforts in providing smoking cessation counseling and offering NRT to all these identified patients,” the researchers said. Also, adding smoking status to the EMR helped physicians retrieve information more easily, which may help with long-term studies of patients' smoking status after they leave the hospital.

WASHINGTON – Adding a smoking cessation component to electronic medical record systems improves the likelihood that hospitalized individuals with a history of smoking will receive cessation counseling, according to study results presented at a conference sponsored by the National Patient Safety Foundation.

Because hospitalization forces patients to temporarily abstain from smoking, identifying smokers when they are hospitalized with other illnesses may help them to quit, Dr. Vikram Verma wrote in a poster.

Dr. Verma and colleagues at Kings County Hospital Center in Brooklyn, N.Y., reviewed 420 patient charts during the 6-month period prior to adding a smoking cessation component to the electronic medical record (EMR). The researchers identified 62 smokers (15%). Of these, 24 (39%) received nicotine replacement therapy and 29 patients refused NRT. For the other nine, the smoking cessation issue remained unaddressed.

The EMR included a mandatory “tobacco evaluation” field to guarantee that the smoking status was assessed in all patients. In addition, an electronic inpatient admission order with a reminder to prescribe transdermal NRT appears in the records of all patients who smoke, and any patients who are “positive” in the smoking history field are automatically referred to a smoking cessation counselor.

During the 6-month period after adding the smoking cessation field to the EMR, the researchers identified 85 smokers when they reviewed another 420 patient charts. The issue of smoking cessation was addressed in 100% of those patients, although only 20 (24%) were receptive to NRT and 65 (76%) refused NRT.

“The program facilitated our efforts in providing smoking cessation counseling and offering NRT to all these identified patients,” the researchers said. Also, adding smoking status to the EMR helped physicians retrieve information more easily, which may help with long-term studies of patients' smoking status after they leave the hospital.

The Centers for Disease Control and Prevention's updated recommendations for the 2007–2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007–2008 flu season in the July 13 issue of the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1–40).

New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6–10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is currently approved only for healthy, nonpregnant individuals aged 5–49 years. The influenza vaccine for the 2007–2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for influenza complications.

▸ Individuals in nursing homes or chronic care facilities.

Updates to the 2007–2008 flu vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007–2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007–2008 flu season in the July 13 issue of the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1–40).

New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6–10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is currently approved only for healthy, nonpregnant individuals aged 5–49 years. The influenza vaccine for the 2007–2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for influenza complications.

▸ Individuals in nursing homes or chronic care facilities.

Updates to the 2007–2008 flu vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

The Centers for Disease Control and Prevention's updated recommendations for the 2007–2008 flu season emphasize vaccinating health care personnel and catching up previously unvaccinated children aged 6 months to 8 years with two doses of vaccine.

The CDC's Advisory Committee on Immunization Practices (ACIP) published its updated flu vaccination recommendations for the 2007–2008 flu season in the July 13 issue of the Morbidity and Mortality Weekly Report (2007;56 [RR-6]:1–40).

New recommendations for the upcoming flu season include the following:

▸ For health care administrators. Treat the vaccination of health care personnel as a patient safety issue and implement ways to encourage all health care providers to get flu shots. For example, require signed statements from health care providers who decline flu vaccination.

▸ For clinicians. In addition to those who were not previously vaccinated, those children aged 6 months to 8 years who received only one dose of flu vaccine in earlier years should receive two doses this year. Administer a second dose of the trivalent inactivated influenza vaccine (TIV) at least 4 weeks after the first dose. Clinicians who are using the live, attenuated influenza vaccine (LAIV) for these children should give a second dose at least 6–10 weeks after the first dose.

The TIV may be used for any person aged 6 months and older, including those with high-risk conditions. The LAIV is currently approved only for healthy, nonpregnant individuals aged 5–49 years. The influenza vaccine for the 2007–2008 season contains a new strain called A/Solomon Islands/3/2006 (H1N1)-like, along with two strains that have been used in previous vaccines: A/Wisconsin/67/2005 (H3N2)-like and B/Malaysia/2506/2004-like viruses.

Vaccination coverage continues to fall short of the CDC's recommendations, and the CDC encourages clinicians to be proactive about vaccinating their patients and to offer vaccination throughout the flu season.

As in recent years, the CDC recommends annual vaccination for the following groups:

▸ Anyone (including school-aged children) who wants to reduce the risk of getting or transmitting the flu.

▸ All children aged 6 months to 4 years.

▸ All adults aged 50 years and older.

▸ Children and teens aged 6 months to 18 years who receive long-term aspirin therapy.

▸ Pregnant women or women who plan to be pregnant during the flu season.

▸ All persons with chronic pulmonary, cardiovascular, liver, kidney, or metabolic disorders, including diabetes but excluding hypertension.

▸ All persons with conditions that could impede respiratory function (such as cognitive dysfunction, spinal cord injuries, or other neuromuscular problems).

▸ All immunosuppressed persons.

▸ Health care personnel.

▸ Healthy household contacts and caregivers of children younger than 5 years or of adults aged 50 years and older.

▸ Healthy household contacts and caregivers of anyone with a medical condition that increases the risk for influenza complications.

▸ Individuals in nursing homes or chronic care facilities.

Updates to the 2007–2008 flu vaccination recommendations will be posted on the CDC's Web site at www.cdc.gov/flu

ATLANTA — The safety profile for herpes zoster vaccine Zostavax, 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, 2007, 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, but 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 the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present 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.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” Dr. Chaves said. Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA — The safety profile for herpes zoster vaccine Zostavax, 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, 2007, 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, but 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 the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present 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.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” Dr. Chaves said. Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

ATLANTA — The safety profile for herpes zoster vaccine Zostavax, 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, 2007, 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, but 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 the children's varicella vaccine. Each dose of Zostavax contains 14 times the amount of varicella zoster virus as Varivax.

A Merck spokesperson who was present 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.

“More data are needed and postlicensure safety studies are expected, which will add to the information on the safety profile of this vaccine,” Dr. Chaves said. Merck has agreed to conduct postlicensure studies including a randomized, placebo-controlled safety study with up to 6 months' follow-up to assess the rates of serious adverse events further.

WASHINGTON — Clinicians ignored more than half of drug allergy warnings generated by computerized physician order entry programs, based on a review of nearly 30,000 medication orders for 2,732 hospitalized patients.

To determine how often computerized allergy warnings for medications were overridden and why, Philip J. Schneider of the Ohio State University, Columbus, and his colleagues analyzed data from four 1-week intervals and one 16-week interval between August 2003 and February 2005. They presented their findings in a poster at a conference sponsored by the National Patient Safety Foundation.

Computerized physician order entry (CPOE) programs allow physicians and other qualified clinicians to enter medication orders directly into a database in order to reduce the ambiguity of handwritten prescriptions. Once a prescription has been entered into the database, the system generates alerts regarding patient allergies and potential drug-drug interactions.

Clinicians overrode warnings about potential drug allergies in 56% of the orders, and changed the medication in 44% of the orders.

When the data were broken down by provider type, physicians were the least likely to override warnings, although more than half of them did so. A total of 54% of physician medication decisions overrode the warnings, compared with decisions by pharmacists (55%) and nurses (61%).

The most commonly cited reason for overriding the warnings was that the patient had tolerated the drug in the past. Other reasons included “not a true allergy,” “medical reason outweighed risk,” and “physician/pharmacist approved.”

CPOEs are not yet widely used, but they have the potential to improve patient safety, the researchers noted.

WASHINGTON — Clinicians ignored more than half of drug allergy warnings generated by computerized physician order entry programs, based on a review of nearly 30,000 medication orders for 2,732 hospitalized patients.

To determine how often computerized allergy warnings for medications were overridden and why, Philip J. Schneider of the Ohio State University, Columbus, and his colleagues analyzed data from four 1-week intervals and one 16-week interval between August 2003 and February 2005. They presented their findings in a poster at a conference sponsored by the National Patient Safety Foundation.

Computerized physician order entry (CPOE) programs allow physicians and other qualified clinicians to enter medication orders directly into a database in order to reduce the ambiguity of handwritten prescriptions. Once a prescription has been entered into the database, the system generates alerts regarding patient allergies and potential drug-drug interactions.

Clinicians overrode warnings about potential drug allergies in 56% of the orders, and changed the medication in 44% of the orders.

When the data were broken down by provider type, physicians were the least likely to override warnings, although more than half of them did so. A total of 54% of physician medication decisions overrode the warnings, compared with decisions by pharmacists (55%) and nurses (61%).

The most commonly cited reason for overriding the warnings was that the patient had tolerated the drug in the past. Other reasons included “not a true allergy,” “medical reason outweighed risk,” and “physician/pharmacist approved.”

CPOEs are not yet widely used, but they have the potential to improve patient safety, the researchers noted.

WASHINGTON — Clinicians ignored more than half of drug allergy warnings generated by computerized physician order entry programs, based on a review of nearly 30,000 medication orders for 2,732 hospitalized patients.

To determine how often computerized allergy warnings for medications were overridden and why, Philip J. Schneider of the Ohio State University, Columbus, and his colleagues analyzed data from four 1-week intervals and one 16-week interval between August 2003 and February 2005. They presented their findings in a poster at a conference sponsored by the National Patient Safety Foundation.

Computerized physician order entry (CPOE) programs allow physicians and other qualified clinicians to enter medication orders directly into a database in order to reduce the ambiguity of handwritten prescriptions. Once a prescription has been entered into the database, the system generates alerts regarding patient allergies and potential drug-drug interactions.

Clinicians overrode warnings about potential drug allergies in 56% of the orders, and changed the medication in 44% of the orders.

When the data were broken down by provider type, physicians were the least likely to override warnings, although more than half of them did so. A total of 54% of physician medication decisions overrode the warnings, compared with decisions by pharmacists (55%) and nurses (61%).

The most commonly cited reason for overriding the warnings was that the patient had tolerated the drug in the past. Other reasons included “not a true allergy,” “medical reason outweighed risk,” and “physician/pharmacist approved.”

CPOEs are not yet widely used, but they have the potential to improve patient safety, the researchers noted.

WASHINGTON — Patient safety problems in hospitals often stem from a lack of teamwork and poor communication, James Battles, Ph.D., said at a conference sponsored by the National Patient Safety Foundation.

“In health care, if we don't have good teamwork, patients die,” said Dr. Battles, the senior service fellow for patient safety at the Agency for Healthcare Research and Quality (AHRQ).

“Teamwork is not unique to health care, and what we know about teamwork research comes from a number of disciplines, namely the military,” he said.

In the wake of “To Err Is Human,” the 1999 Institute of Medicine report that raised awareness of medical errors and called for better teamwork among physicians, AHRQ partnered with the Department of Defense to develop a teamwork training program. The resulting Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program was designed to help doctors and hospitals integrate teamwork principles into their daily activities as a way to reduce clinical errors and to improve patient outcomes, patient satisfaction, and hospital staff satisfaction.

Poor communication and other teamwork issues usually are to blame when a serious medical error occurs in a hospital, case studies have shown. “There is a growing scientific body of literature that indicates that medical teamwork can improve the quality of the clinical process,” Dr. Battles said.

One key characteristic of successful teams is a shared mental model, which means that members of the team are “on the same page” and have a mutual sense of trust and a sense of being part of a team working toward a common goal. Each member of a successful team knows his or her role. And the most successful teams have supportive leadership.

Physicians can download materials from the AHRQ Web site and customize them to suit their practices. TeamSTEPPS became widely available in November 2006, and about 50 medical centers across the United States have used the program to improve teamwork and patient safety in their facilities, Dr. Battles said.

TeamSTEPPS offers ways to transform hospital culture by addressing the root causes of serious safety problems, particularly failures of communication.

“The program offers an excellent model and thorough instruction on how an institution can alter [its] culture and support enhanced teamwork,” Dr. Mark V. Williams, professor of medicine at Emory University in Atlanta and director of the Emory Hospital Medicine Unit, said in an interview.

“It especially empowers nurses and other health care staff to speak up and alert their colleagues and physicians when patient safety is at risk,” said Dr. Williams, who is evaluating the TeamSTEPPS program for possible use at Emory.

Key team events that make up the TeamSTEPPS program include briefs, huddles, debriefs, and conflict resolution, Heidi King, director of DOD's Healthcare Team Coordination Program, said at the meeting. A brief is a short gathering of caregivers to review what is scheduled for the day. Topics include assignments, a review of relevant patient data, plans for specific patients, staff availability and workload, and resources.

“The idea is that we are creating words that people can use, when we say 'get together for a brief or a huddle,' everyone knows what is meant,” Ms. King said. “What we call the 'huddle' is for problem solving and to reestablish situation awareness. An example of a huddle: When a core care team, such as a surgical team or ob.gyn. team, meets for a quick review prior to a specific procedure.”

The debriefing is the step in which quality improvement occurs. Team members meet after the procedure or the next day to review events, even if everything went well the previous day. “This is where patient safety needs to take place, on the front lines of patient care,” Ms. King said.

A debriefing may include conflict resolution. The TeamSTEPPS material offers a constructive approach to resolving conflicts among team members in a four-step process called the DESC:

▸ Describe the specific situation or behavior that caused conflict.

▸ Express how the situation made you feel and what your concerns are.

▸ Suggest alternatives and seek agreement.

▸ Consequences should be stated in terms of the impact on team goals.

The outcomes of the training can be measured by improvements in four core skill areas: leadership, situation monitoring, mutual support, and communication. (See box at left.)

Program participants develop a combination of knowledge (of the shared goals), attitudes (of mutual trust and support), and skills (related to accuracy, efficiency, and safety) that ultimately improve patient safety, Ms. King said.

“The big thing is sustaining the changes in attitude,” Ms. King said. “Implement the training in one section of the hospital, start monitoring what is going on, and communicate about what is working and not working, and then expand the training to other areas of the hospital,” she advised.

In order to change a hospital culture with teamwork training, create opportunities for team members to practice what they learn, then celebrate success as a way to promote progress, she added.

Barriers to good teamwork include inconsistency in team activity, lack of information sharing, hierarchy, defensiveness, varying communication styles, overwork, misinterpretation of cues, and confusion about one's role. The TeamSTEPPS strategies of better communication through briefs and huddles, as well as through feedback, patient advocacy, and mutual support, can combat these problems, Ms. King said, and result in mutual trust, improved performance, and patient safety.

Developing a team mentality is easier said than done. “We all train separately, and we come together and are expected to work together,” she acknowledged.

But physicians can learn the concept of better teamwork as a way to improve patient safety, said Dr. Alison Clay, who participates in TeamSTEPPS at Duke University in Durham, N. C.

TeamSTEPPS at Duke began in the pediatric ICU and it has spread to the operating room. “We are taking it to different parts of the hospital,” said Dr. Clay, an internist with appointments to the departments of surgery, and of internal medicine and pulmonary critical care at Duke. The program is likely to move next to the hospital wards and hospitalists and attending physicians, and then to clinics, she said.

The program starts with lectures and conversation and then proceeds to use of simulations and a debriefing to assess how the participants worked as a team.

Dr. Clay has participated in the TeamSTEPPS curriculum, and she has trained to coach others in teamwork building in her role as the capstone course director for fourth-year medical students. “We are committed to teamwork training for all the medical and nursing students,” she said.

Dr. Clay has a unique perspective on patient safety: She was a victim of a medical error at Duke when she arrived at the emergency department as a patient and went into respiratory arrest after being given a medication meant for the patient across the hall.

For more information about TeamSTEPPS or to review and order materials, visit www.ahrq.gov/qual/teamstepps

Key Skills for Team Effectiveness

The TeamSTEPPS approach is an evidence-based framework that is designed to improve team performance in all areas of health care.

According to AHRQ, the framework integrates four key skill areas:

▸ Leadership. This means the ability to coordinate team activities by ensuring that the team's action are understood, that new information is shared, and that team members have the resources needed to do their jobs.

▸ Situation monitoring. This involves actively scanning and assessing the elements of a situation to get more information, gain a deeper understanding, or maintain awareness to support the function of the medical care team as a cohesive unit.

▸ Mutual support. Team members must be able to anticipate and support team members through knowledge of common goals and recognition of the team members' responsibilities and workload, and being willing to help where needed to improve patient care.

▸ Communication. Team members must exchange information clearly and accurately.

The TeamSTEPPS materials incorporate specific strategies to ensure clear and accurate communication, including the SBAR (Situation, Background, Assessment, and Recommendation) technique for communicating critical information that requires immediate attention, and the use of “call outs” and “check backs” as techniques for team members to stay informed, especially in critical care settings.

WASHINGTON — Patient safety problems in hospitals often stem from a lack of teamwork and poor communication, James Battles, Ph.D., said at a conference sponsored by the National Patient Safety Foundation.

“In health care, if we don't have good teamwork, patients die,” said Dr. Battles, the senior service fellow for patient safety at the Agency for Healthcare Research and Quality (AHRQ).

“Teamwork is not unique to health care, and what we know about teamwork research comes from a number of disciplines, namely the military,” he said.

In the wake of “To Err Is Human,” the 1999 Institute of Medicine report that raised awareness of medical errors and called for better teamwork among physicians, AHRQ partnered with the Department of Defense to develop a teamwork training program. The resulting Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program was designed to help doctors and hospitals integrate teamwork principles into their daily activities as a way to reduce clinical errors and to improve patient outcomes, patient satisfaction, and hospital staff satisfaction.

Poor communication and other teamwork issues usually are to blame when a serious medical error occurs in a hospital, case studies have shown. “There is a growing scientific body of literature that indicates that medical teamwork can improve the quality of the clinical process,” Dr. Battles said.

One key characteristic of successful teams is a shared mental model, which means that members of the team are “on the same page” and have a mutual sense of trust and a sense of being part of a team working toward a common goal. Each member of a successful team knows his or her role. And the most successful teams have supportive leadership.

Physicians can download materials from the AHRQ Web site and customize them to suit their practices. TeamSTEPPS became widely available in November 2006, and about 50 medical centers across the United States have used the program to improve teamwork and patient safety in their facilities, Dr. Battles said.

TeamSTEPPS offers ways to transform hospital culture by addressing the root causes of serious safety problems, particularly failures of communication.

“The program offers an excellent model and thorough instruction on how an institution can alter [its] culture and support enhanced teamwork,” Dr. Mark V. Williams, professor of medicine at Emory University in Atlanta and director of the Emory Hospital Medicine Unit, said in an interview.

“It especially empowers nurses and other health care staff to speak up and alert their colleagues and physicians when patient safety is at risk,” said Dr. Williams, who is evaluating the TeamSTEPPS program for possible use at Emory.

Key team events that make up the TeamSTEPPS program include briefs, huddles, debriefs, and conflict resolution, Heidi King, director of DOD's Healthcare Team Coordination Program, said at the meeting. A brief is a short gathering of caregivers to review what is scheduled for the day. Topics include assignments, a review of relevant patient data, plans for specific patients, staff availability and workload, and resources.

“The idea is that we are creating words that people can use, when we say 'get together for a brief or a huddle,' everyone knows what is meant,” Ms. King said. “What we call the 'huddle' is for problem solving and to reestablish situation awareness. An example of a huddle: When a core care team, such as a surgical team or ob.gyn. team, meets for a quick review prior to a specific procedure.”

The debriefing is the step in which quality improvement occurs. Team members meet after the procedure or the next day to review events, even if everything went well the previous day. “This is where patient safety needs to take place, on the front lines of patient care,” Ms. King said.

A debriefing may include conflict resolution. The TeamSTEPPS material offers a constructive approach to resolving conflicts among team members in a four-step process called the DESC:

▸ Describe the specific situation or behavior that caused conflict.

▸ Express how the situation made you feel and what your concerns are.

▸ Suggest alternatives and seek agreement.

▸ Consequences should be stated in terms of the impact on team goals.

The outcomes of the training can be measured by improvements in four core skill areas: leadership, situation monitoring, mutual support, and communication. (See box at left.)

Program participants develop a combination of knowledge (of the shared goals), attitudes (of mutual trust and support), and skills (related to accuracy, efficiency, and safety) that ultimately improve patient safety, Ms. King said.

“The big thing is sustaining the changes in attitude,” Ms. King said. “Implement the training in one section of the hospital, start monitoring what is going on, and communicate about what is working and not working, and then expand the training to other areas of the hospital,” she advised.

In order to change a hospital culture with teamwork training, create opportunities for team members to practice what they learn, then celebrate success as a way to promote progress, she added.

Barriers to good teamwork include inconsistency in team activity, lack of information sharing, hierarchy, defensiveness, varying communication styles, overwork, misinterpretation of cues, and confusion about one's role. The TeamSTEPPS strategies of better communication through briefs and huddles, as well as through feedback, patient advocacy, and mutual support, can combat these problems, Ms. King said, and result in mutual trust, improved performance, and patient safety.

Developing a team mentality is easier said than done. “We all train separately, and we come together and are expected to work together,” she acknowledged.

But physicians can learn the concept of better teamwork as a way to improve patient safety, said Dr. Alison Clay, who participates in TeamSTEPPS at Duke University in Durham, N. C.

TeamSTEPPS at Duke began in the pediatric ICU and it has spread to the operating room. “We are taking it to different parts of the hospital,” said Dr. Clay, an internist with appointments to the departments of surgery, and of internal medicine and pulmonary critical care at Duke. The program is likely to move next to the hospital wards and hospitalists and attending physicians, and then to clinics, she said.

The program starts with lectures and conversation and then proceeds to use of simulations and a debriefing to assess how the participants worked as a team.

Dr. Clay has participated in the TeamSTEPPS curriculum, and she has trained to coach others in teamwork building in her role as the capstone course director for fourth-year medical students. “We are committed to teamwork training for all the medical and nursing students,” she said.

Dr. Clay has a unique perspective on patient safety: She was a victim of a medical error at Duke when she arrived at the emergency department as a patient and went into respiratory arrest after being given a medication meant for the patient across the hall.

For more information about TeamSTEPPS or to review and order materials, visit www.ahrq.gov/qual/teamstepps

Key Skills for Team Effectiveness

The TeamSTEPPS approach is an evidence-based framework that is designed to improve team performance in all areas of health care.

According to AHRQ, the framework integrates four key skill areas:

▸ Leadership. This means the ability to coordinate team activities by ensuring that the team's action are understood, that new information is shared, and that team members have the resources needed to do their jobs.

▸ Situation monitoring. This involves actively scanning and assessing the elements of a situation to get more information, gain a deeper understanding, or maintain awareness to support the function of the medical care team as a cohesive unit.

▸ Mutual support. Team members must be able to anticipate and support team members through knowledge of common goals and recognition of the team members' responsibilities and workload, and being willing to help where needed to improve patient care.

▸ Communication. Team members must exchange information clearly and accurately.

The TeamSTEPPS materials incorporate specific strategies to ensure clear and accurate communication, including the SBAR (Situation, Background, Assessment, and Recommendation) technique for communicating critical information that requires immediate attention, and the use of “call outs” and “check backs” as techniques for team members to stay informed, especially in critical care settings.

WASHINGTON — Patient safety problems in hospitals often stem from a lack of teamwork and poor communication, James Battles, Ph.D., said at a conference sponsored by the National Patient Safety Foundation.

“In health care, if we don't have good teamwork, patients die,” said Dr. Battles, the senior service fellow for patient safety at the Agency for Healthcare Research and Quality (AHRQ).

“Teamwork is not unique to health care, and what we know about teamwork research comes from a number of disciplines, namely the military,” he said.

In the wake of “To Err Is Human,” the 1999 Institute of Medicine report that raised awareness of medical errors and called for better teamwork among physicians, AHRQ partnered with the Department of Defense to develop a teamwork training program. The resulting Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) program was designed to help doctors and hospitals integrate teamwork principles into their daily activities as a way to reduce clinical errors and to improve patient outcomes, patient satisfaction, and hospital staff satisfaction.

Poor communication and other teamwork issues usually are to blame when a serious medical error occurs in a hospital, case studies have shown. “There is a growing scientific body of literature that indicates that medical teamwork can improve the quality of the clinical process,” Dr. Battles said.

One key characteristic of successful teams is a shared mental model, which means that members of the team are “on the same page” and have a mutual sense of trust and a sense of being part of a team working toward a common goal. Each member of a successful team knows his or her role. And the most successful teams have supportive leadership.

Physicians can download materials from the AHRQ Web site and customize them to suit their practices. TeamSTEPPS became widely available in November 2006, and about 50 medical centers across the United States have used the program to improve teamwork and patient safety in their facilities, Dr. Battles said.

TeamSTEPPS offers ways to transform hospital culture by addressing the root causes of serious safety problems, particularly failures of communication.

“The program offers an excellent model and thorough instruction on how an institution can alter [its] culture and support enhanced teamwork,” Dr. Mark V. Williams, professor of medicine at Emory University in Atlanta and director of the Emory Hospital Medicine Unit, said in an interview.

“It especially empowers nurses and other health care staff to speak up and alert their colleagues and physicians when patient safety is at risk,” said Dr. Williams, who is evaluating the TeamSTEPPS program for possible use at Emory.

Key team events that make up the TeamSTEPPS program include briefs, huddles, debriefs, and conflict resolution, Heidi King, director of DOD's Healthcare Team Coordination Program, said at the meeting. A brief is a short gathering of caregivers to review what is scheduled for the day. Topics include assignments, a review of relevant patient data, plans for specific patients, staff availability and workload, and resources.

“The idea is that we are creating words that people can use, when we say 'get together for a brief or a huddle,' everyone knows what is meant,” Ms. King said. “What we call the 'huddle' is for problem solving and to reestablish situation awareness. An example of a huddle: When a core care team, such as a surgical team or ob.gyn. team, meets for a quick review prior to a specific procedure.”

The debriefing is the step in which quality improvement occurs. Team members meet after the procedure or the next day to review events, even if everything went well the previous day. “This is where patient safety needs to take place, on the front lines of patient care,” Ms. King said.

A debriefing may include conflict resolution. The TeamSTEPPS material offers a constructive approach to resolving conflicts among team members in a four-step process called the DESC:

▸ Describe the specific situation or behavior that caused conflict.

▸ Express how the situation made you feel and what your concerns are.

▸ Suggest alternatives and seek agreement.

▸ Consequences should be stated in terms of the impact on team goals.

The outcomes of the training can be measured by improvements in four core skill areas: leadership, situation monitoring, mutual support, and communication. (See box at left.)

Program participants develop a combination of knowledge (of the shared goals), attitudes (of mutual trust and support), and skills (related to accuracy, efficiency, and safety) that ultimately improve patient safety, Ms. King said.

“The big thing is sustaining the changes in attitude,” Ms. King said. “Implement the training in one section of the hospital, start monitoring what is going on, and communicate about what is working and not working, and then expand the training to other areas of the hospital,” she advised.

In order to change a hospital culture with teamwork training, create opportunities for team members to practice what they learn, then celebrate success as a way to promote progress, she added.

Barriers to good teamwork include inconsistency in team activity, lack of information sharing, hierarchy, defensiveness, varying communication styles, overwork, misinterpretation of cues, and confusion about one's role. The TeamSTEPPS strategies of better communication through briefs and huddles, as well as through feedback, patient advocacy, and mutual support, can combat these problems, Ms. King said, and result in mutual trust, improved performance, and patient safety.

Developing a team mentality is easier said than done. “We all train separately, and we come together and are expected to work together,” she acknowledged.

But physicians can learn the concept of better teamwork as a way to improve patient safety, said Dr. Alison Clay, who participates in TeamSTEPPS at Duke University in Durham, N. C.

TeamSTEPPS at Duke began in the pediatric ICU and it has spread to the operating room. “We are taking it to different parts of the hospital,” said Dr. Clay, an internist with appointments to the departments of surgery, and of internal medicine and pulmonary critical care at Duke. The program is likely to move next to the hospital wards and hospitalists and attending physicians, and then to clinics, she said.

The program starts with lectures and conversation and then proceeds to use of simulations and a debriefing to assess how the participants worked as a team.

Dr. Clay has participated in the TeamSTEPPS curriculum, and she has trained to coach others in teamwork building in her role as the capstone course director for fourth-year medical students. “We are committed to teamwork training for all the medical and nursing students,” she said.

Dr. Clay has a unique perspective on patient safety: She was a victim of a medical error at Duke when she arrived at the emergency department as a patient and went into respiratory arrest after being given a medication meant for the patient across the hall.

For more information about TeamSTEPPS or to review and order materials, visit www.ahrq.gov/qual/teamstepps

Key Skills for Team Effectiveness

The TeamSTEPPS approach is an evidence-based framework that is designed to improve team performance in all areas of health care.

According to AHRQ, the framework integrates four key skill areas:

▸ Leadership. This means the ability to coordinate team activities by ensuring that the team's action are understood, that new information is shared, and that team members have the resources needed to do their jobs.

▸ Situation monitoring. This involves actively scanning and assessing the elements of a situation to get more information, gain a deeper understanding, or maintain awareness to support the function of the medical care team as a cohesive unit.

▸ Mutual support. Team members must be able to anticipate and support team members through knowledge of common goals and recognition of the team members' responsibilities and workload, and being willing to help where needed to improve patient care.

▸ Communication. Team members must exchange information clearly and accurately.

The TeamSTEPPS materials incorporate specific strategies to ensure clear and accurate communication, including the SBAR (Situation, Background, Assessment, and Recommendation) technique for communicating critical information that requires immediate attention, and the use of “call outs” and “check backs” as techniques for team members to stay informed, especially in critical care settings.

MINNEAPOLIS — A single 6-mg dose of doxepin significantly cut the time needed for adults with transient insomnia to fall soundly asleep, based on data presented at the annual meeting of the Associated Professional Sleep Societies.

The single dose of doxepin also significantly improved the overall duration and quality of the participants' sleep. “These data suggest that doxepin 6 mg may improve all aspects of sleep impairment in adults with transient insomnia,” reported Dr. Howard Schwartz medical director of Miami Research Associates, a research facility and sleep lab.

The 283 subjects who received one 6-mg dose of doxepin reached persistent sleep an average of 13 minutes earlier than the 282 subjects who received a placebo. The reduced time to sleep was the primary end point of the study, which was sponsored by Somaxon Pharmaceuticals, a manufacturer of doxepin.

The 565 participants were otherwise healthy adults who underwent a prestudy phase advance (a technique conducted in a sleep lab to induce transient insomnia). The subjects then received either the drug or a placebo, and their sleep was evaluated using single-night polysomnography data and a patient questionnaire that they completed the next morning.

The polysomnography data also showed that, compared with the placebo group, the doxepin group had a significantly longer total sleep time (51 minutes), woke up significantly later (39 minutes), and reported significantly improved sleep efficiency, compared with the placebo group. In addition, sleep efficiency improved by an average of 10% in the doxepin group, compared with the placebo group, during each of 8 hours and during each third of the night's measurements.

MINNEAPOLIS — A single 6-mg dose of doxepin significantly cut the time needed for adults with transient insomnia to fall soundly asleep, based on data presented at the annual meeting of the Associated Professional Sleep Societies.

The single dose of doxepin also significantly improved the overall duration and quality of the participants' sleep. “These data suggest that doxepin 6 mg may improve all aspects of sleep impairment in adults with transient insomnia,” reported Dr. Howard Schwartz medical director of Miami Research Associates, a research facility and sleep lab.

The 283 subjects who received one 6-mg dose of doxepin reached persistent sleep an average of 13 minutes earlier than the 282 subjects who received a placebo. The reduced time to sleep was the primary end point of the study, which was sponsored by Somaxon Pharmaceuticals, a manufacturer of doxepin.

The 565 participants were otherwise healthy adults who underwent a prestudy phase advance (a technique conducted in a sleep lab to induce transient insomnia). The subjects then received either the drug or a placebo, and their sleep was evaluated using single-night polysomnography data and a patient questionnaire that they completed the next morning.

The polysomnography data also showed that, compared with the placebo group, the doxepin group had a significantly longer total sleep time (51 minutes), woke up significantly later (39 minutes), and reported significantly improved sleep efficiency, compared with the placebo group. In addition, sleep efficiency improved by an average of 10% in the doxepin group, compared with the placebo group, during each of 8 hours and during each third of the night's measurements.

MINNEAPOLIS — A single 6-mg dose of doxepin significantly cut the time needed for adults with transient insomnia to fall soundly asleep, based on data presented at the annual meeting of the Associated Professional Sleep Societies.

The single dose of doxepin also significantly improved the overall duration and quality of the participants' sleep. “These data suggest that doxepin 6 mg may improve all aspects of sleep impairment in adults with transient insomnia,” reported Dr. Howard Schwartz medical director of Miami Research Associates, a research facility and sleep lab.

The 283 subjects who received one 6-mg dose of doxepin reached persistent sleep an average of 13 minutes earlier than the 282 subjects who received a placebo. The reduced time to sleep was the primary end point of the study, which was sponsored by Somaxon Pharmaceuticals, a manufacturer of doxepin.

The 565 participants were otherwise healthy adults who underwent a prestudy phase advance (a technique conducted in a sleep lab to induce transient insomnia). The subjects then received either the drug or a placebo, and their sleep was evaluated using single-night polysomnography data and a patient questionnaire that they completed the next morning.

The polysomnography data also showed that, compared with the placebo group, the doxepin group had a significantly longer total sleep time (51 minutes), woke up significantly later (39 minutes), and reported significantly improved sleep efficiency, compared with the placebo group. In addition, sleep efficiency improved by an average of 10% in the doxepin group, compared with the placebo group, during each of 8 hours and during each third of the night's measurements.

WASHINGTON — Insomnia is a disorder of hyperarousal rather than one of sleep deprivation, Thomas Roth, Ph.D., said at the annual meeting of the American Academy of Clinical Psychiatrists.

Because 90% of people with insomnia have other comorbid conditions, insomnia was seen as a symptom rather than an independent disorder until 2005. That's when the National Institute of Mental Health declared that insomnia met the criteria for a disorder, which include impairment in function and quality of life that is associated with specific symptoms and rooted in physiology.

When treating a patient who complains of chronic sleep problems, be sure to ask these key questions, Dr. Roth said in an interview:

▸ What is the nature of the nighttime sleep problems (difficulty falling asleep, difficulty staying asleep)?

▸ What is the nature of daytime consequences (daytime sleepiness, impaired function)?

▸ What is the frequency and duration of symptoms?

▸ Does the patient have any comorbid medical or psychiatric conditions?

Prevalence data are limited, but about 30% of the general population has some type of disturbed sleep, said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

Many patients with insomnia report that the daytime impairment and distress resulting from insomnia are more frustrating for them than their difficulty sleeping at night. Psychiatrists may be able to address these complaints.

Chronic pain is a common comorbidity in insomnia patients. “The less you sleep, the more sensitive you are to pain,” Dr. Roth said. Sleep loss increases the body's inflammatory response and heightens pain sensitivity, and several studies have shown that increasing total sleep time can decrease pain sensitivity.

Treatment of insomnia remains a challenge, but recognition of the role of hyperarousal and the frequency of comorbidities allows for new therapeutic targets, including some sedating antidepressants.

Depending on the nature and severity of the sleep impairment, many patients can benefit from sleep aids immediately, Dr. Roth said.

WASHINGTON — Insomnia is a disorder of hyperarousal rather than one of sleep deprivation, Thomas Roth, Ph.D., said at the annual meeting of the American Academy of Clinical Psychiatrists.

Because 90% of people with insomnia have other comorbid conditions, insomnia was seen as a symptom rather than an independent disorder until 2005. That's when the National Institute of Mental Health declared that insomnia met the criteria for a disorder, which include impairment in function and quality of life that is associated with specific symptoms and rooted in physiology.

When treating a patient who complains of chronic sleep problems, be sure to ask these key questions, Dr. Roth said in an interview:

▸ What is the nature of the nighttime sleep problems (difficulty falling asleep, difficulty staying asleep)?

▸ What is the nature of daytime consequences (daytime sleepiness, impaired function)?

▸ What is the frequency and duration of symptoms?

▸ Does the patient have any comorbid medical or psychiatric conditions?

Prevalence data are limited, but about 30% of the general population has some type of disturbed sleep, said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

Many patients with insomnia report that the daytime impairment and distress resulting from insomnia are more frustrating for them than their difficulty sleeping at night. Psychiatrists may be able to address these complaints.

Chronic pain is a common comorbidity in insomnia patients. “The less you sleep, the more sensitive you are to pain,” Dr. Roth said. Sleep loss increases the body's inflammatory response and heightens pain sensitivity, and several studies have shown that increasing total sleep time can decrease pain sensitivity.

Treatment of insomnia remains a challenge, but recognition of the role of hyperarousal and the frequency of comorbidities allows for new therapeutic targets, including some sedating antidepressants.

Depending on the nature and severity of the sleep impairment, many patients can benefit from sleep aids immediately, Dr. Roth said.

WASHINGTON — Insomnia is a disorder of hyperarousal rather than one of sleep deprivation, Thomas Roth, Ph.D., said at the annual meeting of the American Academy of Clinical Psychiatrists.

Because 90% of people with insomnia have other comorbid conditions, insomnia was seen as a symptom rather than an independent disorder until 2005. That's when the National Institute of Mental Health declared that insomnia met the criteria for a disorder, which include impairment in function and quality of life that is associated with specific symptoms and rooted in physiology.

When treating a patient who complains of chronic sleep problems, be sure to ask these key questions, Dr. Roth said in an interview:

▸ What is the nature of the nighttime sleep problems (difficulty falling asleep, difficulty staying asleep)?

▸ What is the nature of daytime consequences (daytime sleepiness, impaired function)?

▸ What is the frequency and duration of symptoms?

▸ Does the patient have any comorbid medical or psychiatric conditions?

Prevalence data are limited, but about 30% of the general population has some type of disturbed sleep, said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

Many patients with insomnia report that the daytime impairment and distress resulting from insomnia are more frustrating for them than their difficulty sleeping at night. Psychiatrists may be able to address these complaints.

Chronic pain is a common comorbidity in insomnia patients. “The less you sleep, the more sensitive you are to pain,” Dr. Roth said. Sleep loss increases the body's inflammatory response and heightens pain sensitivity, and several studies have shown that increasing total sleep time can decrease pain sensitivity.

Treatment of insomnia remains a challenge, but recognition of the role of hyperarousal and the frequency of comorbidities allows for new therapeutic targets, including some sedating antidepressants.

Depending on the nature and severity of the sleep impairment, many patients can benefit from sleep aids immediately, Dr. Roth said.

ATLANTA — Postlicensure safety data from the first year of widespread use of Gardasil show that serious adverse events from the quadrivalent human papillomavirus vaccine are rare.

Dr. John Iskander presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The safety data, which encompass the first 11 months of the U.S. experience with Gardasil, were from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two vaccine surveillance mechanisms supported by the CDC.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine, said Dr. Iskander of the CDC's Immunization Safety Office.

More than 5 million doses of Gardasil have been distributed as of the end of March 2007, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event reporting 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, 2007. 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%), fever (11%), nausea (11%), and headache (11%). Similarly, the most commonly reported symptoms associated 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 presented details on four cases of death in patients who had been vaccinated with HPV4. None of the deaths 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.

ATLANTA — Postlicensure safety data from the first year of widespread use of Gardasil show that serious adverse events from the quadrivalent human papillomavirus vaccine are rare.

Dr. John Iskander presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The safety data, which encompass the first 11 months of the U.S. experience with Gardasil, were from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two vaccine surveillance mechanisms supported by the CDC.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine, said Dr. Iskander of the CDC's Immunization Safety Office.

More than 5 million doses of Gardasil have been distributed as of the end of March 2007, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event reporting 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, 2007. 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%), fever (11%), nausea (11%), and headache (11%). Similarly, the most commonly reported symptoms associated 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 presented details on four cases of death in patients who had been vaccinated with HPV4. None of the deaths 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.

ATLANTA — Postlicensure safety data from the first year of widespread use of Gardasil show that serious adverse events from the quadrivalent human papillomavirus vaccine are rare.

Dr. John Iskander presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

The safety data, which encompass the first 11 months of the U.S. experience with Gardasil, were from the United States Vaccine Adverse Event Reporting System (VAERS) and the Vaccine Safety Datalink (VSD), two vaccine surveillance mechanisms supported by the CDC.

The postlicensure data are likely to increase comfort levels for doctors when they talk to patients about the HPV4 vaccine, said Dr. Iskander of the CDC's Immunization Safety Office.

More than 5 million doses of Gardasil have been distributed as of the end of March 2007, according to the vaccine's manufacturer (Merck), although the exact number of doses that have been administered is uncertain at this time.

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event reporting 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, 2007. 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%), fever (11%), nausea (11%), and headache (11%). Similarly, the most commonly reported symptoms associated 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 presented details on four cases of death in patients who had been vaccinated with HPV4. None of the deaths 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.