Heidi Splete

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu. The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

“The vaccine clearly has long term benefits, and we'd like to extend those benefits to people over 40,” but more data are needed, he said. For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu. The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

“The vaccine clearly has long term benefits, and we'd like to extend those benefits to people over 40,” but more data are needed, he said. For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu. The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

“The vaccine clearly has long term benefits, and we'd like to extend those benefits to people over 40,” but more data are needed, he said. For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

“Adding technology gives you the opportunity to improve patient safety,” but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA; Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

▸ Medications (17 questions).

▸ Handoffs and transitions (11 questions).

▸ Surgery and invasive procedures, sedation, and anesthesia (6 questions).

▸ Personnel qualifications and competency (10 questions).

▸ Practice management and culture (22 questions).

▸ Patient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from “unaware or aware but no activity to implement” to “fully implemented everywhere.”

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. “Even among practices with EHRs, 30% used paper lab forms,” Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients.

The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

“We are almost paper chartless,” Ms. Schon said. “But what we want to do is make sure that we are managing our patient population effectively.”

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to the size of your practice, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

“Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it,” Ms. Schon said.

“We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient,” she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

“That's an area where you still have to rely on a piece of paper and a conversation,” Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

“We are the health care safety net for our community,” Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

“Adding technology gives you the opportunity to improve patient safety,” but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA; Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

▸ Medications (17 questions).

▸ Handoffs and transitions (11 questions).

▸ Surgery and invasive procedures, sedation, and anesthesia (6 questions).

▸ Personnel qualifications and competency (10 questions).

▸ Practice management and culture (22 questions).

▸ Patient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from “unaware or aware but no activity to implement” to “fully implemented everywhere.”

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. “Even among practices with EHRs, 30% used paper lab forms,” Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients.

The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

“We are almost paper chartless,” Ms. Schon said. “But what we want to do is make sure that we are managing our patient population effectively.”

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to the size of your practice, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

“Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it,” Ms. Schon said.

“We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient,” she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

“That's an area where you still have to rely on a piece of paper and a conversation,” Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

“We are the health care safety net for our community,” Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

“Adding technology gives you the opportunity to improve patient safety,” but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA; Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

▸ Medications (17 questions).

▸ Handoffs and transitions (11 questions).

▸ Surgery and invasive procedures, sedation, and anesthesia (6 questions).

▸ Personnel qualifications and competency (10 questions).

▸ Practice management and culture (22 questions).

▸ Patient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from “unaware or aware but no activity to implement” to “fully implemented everywhere.”

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. “Even among practices with EHRs, 30% used paper lab forms,” Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients.

The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

“We are almost paper chartless,” Ms. Schon said. “But what we want to do is make sure that we are managing our patient population effectively.”

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to the size of your practice, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

“Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it,” Ms. Schon said.

“We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient,” she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

“That's an area where you still have to rely on a piece of paper and a conversation,” Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

“We are the health care safety net for our community,” Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

MINNEAPOLIS — Depression is what keeps breast cancer survivors up at night, according to data from a study of more than 2,000 women.

“Depression is consistently the strongest predictor of insomnia in these breast cancer survivors,” Wayne A. Bardwell, Ph.D., said at the annual meeting of the Associated Professional Sleep Societies.

In general, women who have survived breast cancer report a high rate of insomnia, compared with the general population, he said.

To determine the relative importance of a range of risk factors for insomnia in breast cancer survivors, Dr. Bardwell and his colleagues at the University of California, San Diego, surveyed 2,101 women at four time points: at baseline, at 1 year, at either 2 or 3 years, and at 4 years after they had completed their cancer treatments. The study was supported by several organizations including Susan B. Komen for the Cure (formerly the Susan G. Komen Foundation), the Lance Armstrong Foundation, and the Walton Family Foundation.

The women were classified as having persistent insomnia, remittent insomnia, or normal sleep based on their responses on the Women's Health Initiative Insomnia Rating Scale (WHIIRS).

Overall, 14% of the women met the criteria for persistent insomnia (scores of 9 or higher on the WHIIRS at all time points). Another 45% fell into a pattern of mixed or remitting insomnia (scores of 9 or higher at some, but not all, time points), and 40% were consistently normal sleepers (scores lower than 9 at all time points).

After controlling for multiple variables, including cancer data, personal characteristics, health behaviors (such as diet and exercise), physical health, and emotional health, only depression and night sweats were significantly associated with chronic insomnia.

All the women in the study had early-stage breast cancer (ranging from stage I to stage IIIA), with no metastases. “Most of the women were stage II and they averaged 2 years since their diagnoses,” Dr. Bardwell noted. About 40% of the women had been initially treated with surgery.

Cancer-specific variables were unimportant in predicting whether the women experienced persistent or remittent insomnia, the researchers concluded.

The findings supported Dr. Bardwell's recent study of baseline insomnia (rather than chronic insomnia) in the same group of women, which also showed that only depressive and vasomotor symptoms in the form of night sweats were significantly associated with insomnia immediately after the completion of treatment for early-stage breast cancer (Psychooncology 2007 Apr. 11 [Epub doi:10.1002/pon.1192]).

Dr. Bardwell's study did not address how or whether the women were treated for their insomnia and depression. The use of low-dose sedating antidepressants is becoming more common as a way to manage chronic insomnia, but more dose-related studies of safety and effectiveness are needed in a range of patient populations.

MINNEAPOLIS — Depression is what keeps breast cancer survivors up at night, according to data from a study of more than 2,000 women.

“Depression is consistently the strongest predictor of insomnia in these breast cancer survivors,” Wayne A. Bardwell, Ph.D., said at the annual meeting of the Associated Professional Sleep Societies.

In general, women who have survived breast cancer report a high rate of insomnia, compared with the general population, he said.

To determine the relative importance of a range of risk factors for insomnia in breast cancer survivors, Dr. Bardwell and his colleagues at the University of California, San Diego, surveyed 2,101 women at four time points: at baseline, at 1 year, at either 2 or 3 years, and at 4 years after they had completed their cancer treatments. The study was supported by several organizations including Susan B. Komen for the Cure (formerly the Susan G. Komen Foundation), the Lance Armstrong Foundation, and the Walton Family Foundation.

The women were classified as having persistent insomnia, remittent insomnia, or normal sleep based on their responses on the Women's Health Initiative Insomnia Rating Scale (WHIIRS).

Overall, 14% of the women met the criteria for persistent insomnia (scores of 9 or higher on the WHIIRS at all time points). Another 45% fell into a pattern of mixed or remitting insomnia (scores of 9 or higher at some, but not all, time points), and 40% were consistently normal sleepers (scores lower than 9 at all time points).

After controlling for multiple variables, including cancer data, personal characteristics, health behaviors (such as diet and exercise), physical health, and emotional health, only depression and night sweats were significantly associated with chronic insomnia.

All the women in the study had early-stage breast cancer (ranging from stage I to stage IIIA), with no metastases. “Most of the women were stage II and they averaged 2 years since their diagnoses,” Dr. Bardwell noted. About 40% of the women had been initially treated with surgery.

Cancer-specific variables were unimportant in predicting whether the women experienced persistent or remittent insomnia, the researchers concluded.

The findings supported Dr. Bardwell's recent study of baseline insomnia (rather than chronic insomnia) in the same group of women, which also showed that only depressive and vasomotor symptoms in the form of night sweats were significantly associated with insomnia immediately after the completion of treatment for early-stage breast cancer (Psychooncology 2007 Apr. 11 [Epub doi:10.1002/pon.1192]).

Dr. Bardwell's study did not address how or whether the women were treated for their insomnia and depression. The use of low-dose sedating antidepressants is becoming more common as a way to manage chronic insomnia, but more dose-related studies of safety and effectiveness are needed in a range of patient populations.

MINNEAPOLIS — Depression is what keeps breast cancer survivors up at night, according to data from a study of more than 2,000 women.

“Depression is consistently the strongest predictor of insomnia in these breast cancer survivors,” Wayne A. Bardwell, Ph.D., said at the annual meeting of the Associated Professional Sleep Societies.

In general, women who have survived breast cancer report a high rate of insomnia, compared with the general population, he said.

To determine the relative importance of a range of risk factors for insomnia in breast cancer survivors, Dr. Bardwell and his colleagues at the University of California, San Diego, surveyed 2,101 women at four time points: at baseline, at 1 year, at either 2 or 3 years, and at 4 years after they had completed their cancer treatments. The study was supported by several organizations including Susan B. Komen for the Cure (formerly the Susan G. Komen Foundation), the Lance Armstrong Foundation, and the Walton Family Foundation.

The women were classified as having persistent insomnia, remittent insomnia, or normal sleep based on their responses on the Women's Health Initiative Insomnia Rating Scale (WHIIRS).

Overall, 14% of the women met the criteria for persistent insomnia (scores of 9 or higher on the WHIIRS at all time points). Another 45% fell into a pattern of mixed or remitting insomnia (scores of 9 or higher at some, but not all, time points), and 40% were consistently normal sleepers (scores lower than 9 at all time points).

After controlling for multiple variables, including cancer data, personal characteristics, health behaviors (such as diet and exercise), physical health, and emotional health, only depression and night sweats were significantly associated with chronic insomnia.

All the women in the study had early-stage breast cancer (ranging from stage I to stage IIIA), with no metastases. “Most of the women were stage II and they averaged 2 years since their diagnoses,” Dr. Bardwell noted. About 40% of the women had been initially treated with surgery.

Cancer-specific variables were unimportant in predicting whether the women experienced persistent or remittent insomnia, the researchers concluded.

The findings supported Dr. Bardwell's recent study of baseline insomnia (rather than chronic insomnia) in the same group of women, which also showed that only depressive and vasomotor symptoms in the form of night sweats were significantly associated with insomnia immediately after the completion of treatment for early-stage breast cancer (Psychooncology 2007 Apr. 11 [Epub doi:10.1002/pon.1192]).

Dr. Bardwell's study did not address how or whether the women were treated for their insomnia and depression. The use of low-dose sedating antidepressants is becoming more common as a way to manage chronic insomnia, but more dose-related studies of safety and effectiveness are needed in a range of patient populations.

Low bone mineral density in children and teens with systemic lupus erythematosus was more closely linked to longer disease duration than to the cumulative use of corticosteroids, reported Dr. Sandrine Compeyrot-Lacassagne and colleagues at the Hospital for Sick Children in Toronto.

The common practice of using high-dose corticosteroids to treat chronic inflammation may place at risk the bone health of children who have systemic lupus erythematosus (SLE), the study's researchers noted.

To determine the prevalence of and risk factors for low bone mineral density in juvenile SLE patients, Dr. Compeyrot-Lacassagne and colleagues reviewed 64 consecutive patients younger than 18 years who met the American College of Rheumatology criteria for SLE and had undergone dual x-ray absorptiometry (DXA) scanning between January 2001 and July 2004. The DXA scans were performed an average of 3 years after SLE diagnosis in all but five patients who underwent scans when they were first diagnosed (Arthritis Rheum. 2007;56;1966–73).

Overall, osteopenia at the lumbar spine appeared in 24 (38%) of the patients; osteoporosis at the lumbar spine appeared in 13 (20%); and decreased bone mineral density (BMD) at the hip (a BMD less than 80%) appeared in 12 patients (19%). Because these findings were similar to the prevalence rates in studies of adults with SLE, the researchers recommended using the same definitions of osteopenia (BMD less than −1 and greater than or equal to −2.5) and osteoporosis (BMD less than −2.5) that are used in adults.

Cumulative corticosteroid use was the only significant predictor of lumbar spine osteopenia, but disease duration was the only significant predictor of both lumbar spine osteoporosis and a hip BMD less than 80% in a multivariate analysis.

The lower odds ratio of cumulative corticosteroid use compared with disease duration suggests a lesser contribution of corticosteroids to BMD, the researchers noted. In addition, lupus nephritis was associated with lumbar spine osteoporosis, but the association fell short of statistical significance in the multivariate analysis.

Osteoporosis was significantly associated with disease duration, cumulative corticosteroid dose, duration of corticosteroid use, and lupus nephritis, according to the findings of a univariate analysis. Similarly, both osteopenia and decreased hip BMD were significantly associated with disease duration, cumulative corticosteroid dose, and duration of corticosteroid use.

Additional studies are needed to confirm a lack of association between corticosteroid use and osteoporosis, the researchers said.

Low bone mineral density in children and teens with systemic lupus erythematosus was more closely linked to longer disease duration than to the cumulative use of corticosteroids, reported Dr. Sandrine Compeyrot-Lacassagne and colleagues at the Hospital for Sick Children in Toronto.

The common practice of using high-dose corticosteroids to treat chronic inflammation may place at risk the bone health of children who have systemic lupus erythematosus (SLE), the study's researchers noted.

To determine the prevalence of and risk factors for low bone mineral density in juvenile SLE patients, Dr. Compeyrot-Lacassagne and colleagues reviewed 64 consecutive patients younger than 18 years who met the American College of Rheumatology criteria for SLE and had undergone dual x-ray absorptiometry (DXA) scanning between January 2001 and July 2004. The DXA scans were performed an average of 3 years after SLE diagnosis in all but five patients who underwent scans when they were first diagnosed (Arthritis Rheum. 2007;56;1966–73).

Overall, osteopenia at the lumbar spine appeared in 24 (38%) of the patients; osteoporosis at the lumbar spine appeared in 13 (20%); and decreased bone mineral density (BMD) at the hip (a BMD less than 80%) appeared in 12 patients (19%). Because these findings were similar to the prevalence rates in studies of adults with SLE, the researchers recommended using the same definitions of osteopenia (BMD less than −1 and greater than or equal to −2.5) and osteoporosis (BMD less than −2.5) that are used in adults.

Cumulative corticosteroid use was the only significant predictor of lumbar spine osteopenia, but disease duration was the only significant predictor of both lumbar spine osteoporosis and a hip BMD less than 80% in a multivariate analysis.

The lower odds ratio of cumulative corticosteroid use compared with disease duration suggests a lesser contribution of corticosteroids to BMD, the researchers noted. In addition, lupus nephritis was associated with lumbar spine osteoporosis, but the association fell short of statistical significance in the multivariate analysis.

Osteoporosis was significantly associated with disease duration, cumulative corticosteroid dose, duration of corticosteroid use, and lupus nephritis, according to the findings of a univariate analysis. Similarly, both osteopenia and decreased hip BMD were significantly associated with disease duration, cumulative corticosteroid dose, and duration of corticosteroid use.

Additional studies are needed to confirm a lack of association between corticosteroid use and osteoporosis, the researchers said.

Low bone mineral density in children and teens with systemic lupus erythematosus was more closely linked to longer disease duration than to the cumulative use of corticosteroids, reported Dr. Sandrine Compeyrot-Lacassagne and colleagues at the Hospital for Sick Children in Toronto.

The common practice of using high-dose corticosteroids to treat chronic inflammation may place at risk the bone health of children who have systemic lupus erythematosus (SLE), the study's researchers noted.

To determine the prevalence of and risk factors for low bone mineral density in juvenile SLE patients, Dr. Compeyrot-Lacassagne and colleagues reviewed 64 consecutive patients younger than 18 years who met the American College of Rheumatology criteria for SLE and had undergone dual x-ray absorptiometry (DXA) scanning between January 2001 and July 2004. The DXA scans were performed an average of 3 years after SLE diagnosis in all but five patients who underwent scans when they were first diagnosed (Arthritis Rheum. 2007;56;1966–73).

Overall, osteopenia at the lumbar spine appeared in 24 (38%) of the patients; osteoporosis at the lumbar spine appeared in 13 (20%); and decreased bone mineral density (BMD) at the hip (a BMD less than 80%) appeared in 12 patients (19%). Because these findings were similar to the prevalence rates in studies of adults with SLE, the researchers recommended using the same definitions of osteopenia (BMD less than −1 and greater than or equal to −2.5) and osteoporosis (BMD less than −2.5) that are used in adults.

Cumulative corticosteroid use was the only significant predictor of lumbar spine osteopenia, but disease duration was the only significant predictor of both lumbar spine osteoporosis and a hip BMD less than 80% in a multivariate analysis.

The lower odds ratio of cumulative corticosteroid use compared with disease duration suggests a lesser contribution of corticosteroids to BMD, the researchers noted. In addition, lupus nephritis was associated with lumbar spine osteoporosis, but the association fell short of statistical significance in the multivariate analysis.

Osteoporosis was significantly associated with disease duration, cumulative corticosteroid dose, duration of corticosteroid use, and lupus nephritis, according to the findings of a univariate analysis. Similarly, both osteopenia and decreased hip BMD were significantly associated with disease duration, cumulative corticosteroid dose, and duration of corticosteroid use.

Additional studies are needed to confirm a lack of association between corticosteroid use and osteoporosis, the researchers said.

Drinking multiple cups of coffee each day may reduce the risk of gout in men, according to data from a prospective study of nearly 50,000 men.

Studies of coffee's effects on the body are important for public health, because so many people drink so much of it, wrote Dr. Hyon K. Choi of the University of British Columbia, Vancouver, and colleagues. “More than 50% of Americans drink coffee,” they noted, and the average per capita intake is approximately two cups per day.

Coffee is a major source of the phenol known as chlorogenic acid, which is a very powerful antioxidant (Arthritis Rheum. 2007;56:2049–55). Data from previous studies suggest that chlorogenic acid may reduce plasma glucose concentrations and interact with other antioxidants that are present in coffee to reduce oxidative stress and, consequently, reduce the risk of developing gout.

Other components of coffee may also play a role in reducing gout risk by affecting insulin resistance.

To determine the relationship between coffee consumption and gout, the investigators studied 45,869 adult men with no baseline history of gout. The men's coffee consumption was assessed at 4-year intervals over a 12-year follow-up period using a validated questionnaire. An additional questionnaire was used to determine whether the men met the American College of Rheumatology's criteria for gout.

The researchers identified 757 confirmed incident cases of gout, and found that the risk for gout was 59% lower in men who drank six or more cups of coffee per day and 40% lower among men who drank four to five cups of coffee per day.

The risk reduction was 8% among men who drank one to three cups of coffee per day, and 3% among men who drank less than one cup of coffee per day.

The association between increased coffee intake and reduced risk of gout was independent of dietary factors and other variables including body mass index, age, hypertension, alcohol consumption, diuretic use, and chronic renal failure. No significant associations were found between total caffeine intake and risk for gout, and there was no apparent effect on gout risk for men who consumed caffeine from noncoffee sources, the researchers noted.

A modest association was noted between decaffeinated coffee consumption and a reduced risk for gout (a 27% reduction in men who drank at least four cups per day), but tea consumption was not associated with a reduced risk.

Because individuals can develop a tolerance for caffeine over time with respect to variables such as blood pressure and heart rate, long-term caffeine intake alone may not have a significant effect on the risk for gout, the researchers noted.

The investigation was limited by its observational nature, and the findings may not be generalizable to women, they added.

The study was sponsored in part by TAP Pharmaceutical Products Inc.

Dr. Choi has served on the advisory boards of Savient Pharmaceuticals Inc. and TAP.

ELSEVIER GLOBAL MEDICAL NEWS

Men who drank one to three cups per day cut their gout risk by 8%. Lynda Banzi/Elsevier Global Medical News

Drinking multiple cups of coffee each day may reduce the risk of gout in men, according to data from a prospective study of nearly 50,000 men.

Studies of coffee's effects on the body are important for public health, because so many people drink so much of it, wrote Dr. Hyon K. Choi of the University of British Columbia, Vancouver, and colleagues. “More than 50% of Americans drink coffee,” they noted, and the average per capita intake is approximately two cups per day.

Coffee is a major source of the phenol known as chlorogenic acid, which is a very powerful antioxidant (Arthritis Rheum. 2007;56:2049–55). Data from previous studies suggest that chlorogenic acid may reduce plasma glucose concentrations and interact with other antioxidants that are present in coffee to reduce oxidative stress and, consequently, reduce the risk of developing gout.

Other components of coffee may also play a role in reducing gout risk by affecting insulin resistance.

To determine the relationship between coffee consumption and gout, the investigators studied 45,869 adult men with no baseline history of gout. The men's coffee consumption was assessed at 4-year intervals over a 12-year follow-up period using a validated questionnaire. An additional questionnaire was used to determine whether the men met the American College of Rheumatology's criteria for gout.

The researchers identified 757 confirmed incident cases of gout, and found that the risk for gout was 59% lower in men who drank six or more cups of coffee per day and 40% lower among men who drank four to five cups of coffee per day.

The risk reduction was 8% among men who drank one to three cups of coffee per day, and 3% among men who drank less than one cup of coffee per day.

The association between increased coffee intake and reduced risk of gout was independent of dietary factors and other variables including body mass index, age, hypertension, alcohol consumption, diuretic use, and chronic renal failure. No significant associations were found between total caffeine intake and risk for gout, and there was no apparent effect on gout risk for men who consumed caffeine from noncoffee sources, the researchers noted.

A modest association was noted between decaffeinated coffee consumption and a reduced risk for gout (a 27% reduction in men who drank at least four cups per day), but tea consumption was not associated with a reduced risk.

Because individuals can develop a tolerance for caffeine over time with respect to variables such as blood pressure and heart rate, long-term caffeine intake alone may not have a significant effect on the risk for gout, the researchers noted.

The investigation was limited by its observational nature, and the findings may not be generalizable to women, they added.

The study was sponsored in part by TAP Pharmaceutical Products Inc.

Dr. Choi has served on the advisory boards of Savient Pharmaceuticals Inc. and TAP.

ELSEVIER GLOBAL MEDICAL NEWS

Men who drank one to three cups per day cut their gout risk by 8%. Lynda Banzi/Elsevier Global Medical News

Drinking multiple cups of coffee each day may reduce the risk of gout in men, according to data from a prospective study of nearly 50,000 men.

Studies of coffee's effects on the body are important for public health, because so many people drink so much of it, wrote Dr. Hyon K. Choi of the University of British Columbia, Vancouver, and colleagues. “More than 50% of Americans drink coffee,” they noted, and the average per capita intake is approximately two cups per day.

Coffee is a major source of the phenol known as chlorogenic acid, which is a very powerful antioxidant (Arthritis Rheum. 2007;56:2049–55). Data from previous studies suggest that chlorogenic acid may reduce plasma glucose concentrations and interact with other antioxidants that are present in coffee to reduce oxidative stress and, consequently, reduce the risk of developing gout.

Other components of coffee may also play a role in reducing gout risk by affecting insulin resistance.

To determine the relationship between coffee consumption and gout, the investigators studied 45,869 adult men with no baseline history of gout. The men's coffee consumption was assessed at 4-year intervals over a 12-year follow-up period using a validated questionnaire. An additional questionnaire was used to determine whether the men met the American College of Rheumatology's criteria for gout.

The researchers identified 757 confirmed incident cases of gout, and found that the risk for gout was 59% lower in men who drank six or more cups of coffee per day and 40% lower among men who drank four to five cups of coffee per day.

The risk reduction was 8% among men who drank one to three cups of coffee per day, and 3% among men who drank less than one cup of coffee per day.

The association between increased coffee intake and reduced risk of gout was independent of dietary factors and other variables including body mass index, age, hypertension, alcohol consumption, diuretic use, and chronic renal failure. No significant associations were found between total caffeine intake and risk for gout, and there was no apparent effect on gout risk for men who consumed caffeine from noncoffee sources, the researchers noted.

A modest association was noted between decaffeinated coffee consumption and a reduced risk for gout (a 27% reduction in men who drank at least four cups per day), but tea consumption was not associated with a reduced risk.

Because individuals can develop a tolerance for caffeine over time with respect to variables such as blood pressure and heart rate, long-term caffeine intake alone may not have a significant effect on the risk for gout, the researchers noted.

The investigation was limited by its observational nature, and the findings may not be generalizable to women, they added.

The study was sponsored in part by TAP Pharmaceutical Products Inc.

Dr. Choi has served on the advisory boards of Savient Pharmaceuticals Inc. and TAP.

ELSEVIER GLOBAL MEDICAL NEWS

Men who drank one to three cups per day cut their gout risk by 8%. Lynda Banzi/Elsevier Global Medical News

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

“Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention,” said Dr. John Iskander, who presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

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

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

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

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

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

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event 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 are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general.

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

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

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

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

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

“Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention,” said Dr. John Iskander, who presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

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

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

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

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

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

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event 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 are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general.

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

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

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

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

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

“Postlicensure safety reporting for HPV4 has occurred at relatively high levels, as is expected for a newly licensed product that has garnered significant public attention,” said Dr. John Iskander, who presented the postlicensure data at the June 2007 meeting of the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices.

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

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

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

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

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

So far, the HPV4 overall vaccine adverse event reporting rate is 33 per 100,000 doses, and the serious adverse event 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 are common in the general population and do not have a specific relationship to this vaccine or to vaccinations in general.

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

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

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

At future ACIP meetings, the postlicensure safety data for Gardasil may be considered in conjunction with safety data on the bivalent HPV vaccine recently submitted to the FDA by GlaxoSmithKline, said Dr. Lauri Markowitz, a member of ACIP's HPV working group. If the GSK vaccine, HPV-008 (Cervarix), is approved by FDA, the working group will review data and discuss including vaccine preference, and whether doses of the two could be interchangeable.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu.

The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination do include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

The committee also voted to include the new hepatitis A recommendations for prophylaxis and for travel in the CDC's Vaccines for Children program.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu.

The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination do include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

The committee also voted to include the new hepatitis A recommendations for prophylaxis and for travel in the CDC's Vaccines for Children program.

ATLANTA — The hepatitis A vaccine should now be the first choice for postexposure prevention of hepatitis A infection in otherwise healthy people aged 12 months to 40 years.

The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) reached that conclusion based on postexposure data from a study that included 4,524 people. The hepatitis A vaccine was as effective as immunoglobulin in preventing hepatitis A in children and adults aged 12 months to 40 years who had been exposed to the viral infection.

ACIP's hepatitis A working group therefore recommended use of the hepatitis A vaccine for postexposure prophylaxis for anyone aged 12 months to 40 years, said ACIP member Dr. Tracy Lieu.

The postexposure study did not include persons older than 40 years, so immunoglobulin is preferred for individuals older than age 40, but the hepatitis A vaccine can be used if immunoglobulin is not available, Dr. Lieu said. Only immunoglobulin should be used in special cases, such as in persons who are immunocompromised or in children younger than 12 months.

“These recommendations are pretty solid, and they are straightforward and simple for practitioners to follow,” said Dr. Lieu, who introduced the revised hepatitis A recommendations during ACIP's meeting. The panel voted to accept the recommendations.

Ryan Novak, Ph.D., a CDC epidemiologist, noted that the potential benefits of using hepatitis A instead of immunoglobulin include long-term protection, easier administration, and lower cost.

He presented results from a postexposure study that compared the effectiveness of the hepatitis A vaccine and of immunoglobulin for disease prevention after exposure to hepatitis A. In a randomized noninferiority study conducted in Almaty, a large city in Kazakhstan, the investigators enrolled 4,524 individuals aged 2–40 years with no history of hepatitis A, chronic liver disease, or allergy to the vaccine or to immunoglobulin. Ultimately, 1,414 individuals or their household or day care contacts were exposed to hepatitis A; 740 received the hepatitis A vaccine and 674 received immunoglobulin.

Overall, the hepatitis A vaccine was similar in effectiveness to immunoglobulin. The risk of developing hepatitis A was 4.7% in the vaccine group and 4.0% in the immunoglobulin group. “Putting this in context, the risk of hepatitis A among vaccine recipients was never more than 1.5% greater than among [immunoglobulin] recipients,” Dr. Novak said.

Most of the cases occurred in children, but the risk of developing hepatitis A was similar for adults in both groups. Of the 35 suspected cases of hepatis A in the vaccine group, 28 occurred in children and 7 occurred in adults aged 19–40 years. Of the 27 suspected cases in the immunoglobulin group, 20 occurred in children and 7 occurred in adults.

Questions remain about who can receive the hepatitis A vaccine for postexposure disease prevention, Dr. Novak acknowledged during the committee's discussion prior to voting.

For people older than 40 years, immunoglobulin is preferred because of a lack of data regarding vaccine performance, he emphasized.

Also, children aged 12–24 months were not included in the study. Current preexposure recommendations for hepatitis A vaccination do include 12- to 24-month-olds, but the committee agreed to leave the current immunoglobulin recommendations in place for children younger than 12 months.

Based on the new postexposure data, the panel also recommended these adjustments to the current CDC hepatitis A travel vaccination recommendations:

▸ The first dose of hepatitis A vaccine that is given at any time before travel should protect most healthy persons.

▸ In addition to the hepatitis A vaccine, anyone at increased risk of infection who will travel to places where hepatitis A is more common should receive immunoglobulin within 2 weeks before traveling.

▸ Infants younger than 12 months should receive immunoglobulin for preexposure protection from hepatitis A if they are traveling to a high-risk area.

The committee also voted to include the new hepatitis A recommendations for prophylaxis and for travel in the CDC's Vaccines for Children program.

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.

“Mothers of newborn babies don't have insomnia; they simply don't have adequate opportunities for sleep,” said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

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.

To meet the diagnostic criteria for insomnia, a person must report one or more of the following symptoms: difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep.

When treating a patient who complains of chronic sleep problems, be sure to ask these several 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 are 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, Dr. Roth said.

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.

Chronic pain is a common comorbidity in insomnia patients. In addition, people with insomnia are significantly more likely to develop comorbid psychiatric disorders.

Dr. Roth cited a recent study from his laboratory in which the researchers evaluated 1,000 people who had never had a psychiatric disease and found that 240 met criteria for insomnia. At a follow-up 3.5 years later, the people with insomnia had 4.5 times the risk of developing a psychiatric disorder.

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.

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.

“Mothers of newborn babies don't have insomnia; they simply don't have adequate opportunities for sleep,” said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

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.

To meet the diagnostic criteria for insomnia, a person must report one or more of the following symptoms: difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep.

When treating a patient who complains of chronic sleep problems, be sure to ask these several 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 are 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, Dr. Roth said.

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.

Chronic pain is a common comorbidity in insomnia patients. In addition, people with insomnia are significantly more likely to develop comorbid psychiatric disorders.

Dr. Roth cited a recent study from his laboratory in which the researchers evaluated 1,000 people who had never had a psychiatric disease and found that 240 met criteria for insomnia. At a follow-up 3.5 years later, the people with insomnia had 4.5 times the risk of developing a psychiatric disorder.

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.

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.

“Mothers of newborn babies don't have insomnia; they simply don't have adequate opportunities for sleep,” said Dr. Roth, director of research and chief of sleep medicine at the Henry Ford Hospital in Detroit.

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.

To meet the diagnostic criteria for insomnia, a person must report one or more of the following symptoms: difficulty falling asleep, difficulty staying asleep, or nonrestorative sleep.

When treating a patient who complains of chronic sleep problems, be sure to ask these several 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 are 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, Dr. Roth said.

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.

Chronic pain is a common comorbidity in insomnia patients. In addition, people with insomnia are significantly more likely to develop comorbid psychiatric disorders.

Dr. Roth cited a recent study from his laboratory in which the researchers evaluated 1,000 people who had never had a psychiatric disease and found that 240 met criteria for insomnia. At a follow-up 3.5 years later, the people with insomnia had 4.5 times the risk of developing a psychiatric disorder.

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.

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

"Adding technology gives you the opportunity to improve patient safety," but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA) (Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

PIMedications (17 questions).

PIHandoffs and transitions (11 questions).

PISurgery and invasive procedures, sedation, and anesthesia (6 questions).

PIPersonnel qualifications and competency (10 questions).

PIPractice management and culture (22 questions).

PIPatient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from "unaware or aware but no activity to implement" to "fully implemented everywhere."

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. "Even among practices with EHRs, 30% used paper lab forms," Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients. The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

"We are almost paper chartless," Ms. Schon said. "But what we want to do is make sure that we are managing our patient population effectively."

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to practice size, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

"Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it," Ms. Schon said.

"We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient," she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

"That's an area where you still have to rely on a piece of paper and a conversation," Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

"We are the health care safety net for our community," Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

"Adding technology gives you the opportunity to improve patient safety," but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA) (Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

PIMedications (17 questions).

PIHandoffs and transitions (11 questions).

PISurgery and invasive procedures, sedation, and anesthesia (6 questions).

PIPersonnel qualifications and competency (10 questions).

PIPractice management and culture (22 questions).

PIPatient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from "unaware or aware but no activity to implement" to "fully implemented everywhere."

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. "Even among practices with EHRs, 30% used paper lab forms," Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients. The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

"We are almost paper chartless," Ms. Schon said. "But what we want to do is make sure that we are managing our patient population effectively."

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to practice size, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

"Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it," Ms. Schon said.

"We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient," she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

"That's an area where you still have to rely on a piece of paper and a conversation," Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

"We are the health care safety net for our community," Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

WASHINGTON — Health information technology's greatest potential contribution to patient safety lies in areas related to record keeping and record retrieval, David N. Gans said at a conference sponsored by the National Patient Safety Foundation.

"Adding technology gives you the opportunity to improve patient safety," but the technology must be used properly for there to be an impact, said Mr. Gans of the Medical Group Management Association.

Medical groups that reorganize their work flow will see the greatest benefits from health information technology. Ideally, hospitals, pharmacies, and insurers will be able to integrate information and coordinate their systems, he said.

But many medical practices have not fully embraced electronic health records (EHRs) or other types of health information technology as a way to improve patient safety.

To find the extent to which medical groups implement safety practices with and without technology, Mr. Gans and his colleagues surveyed 3,629 medical groups that had completed the Physician Practice Patient Safety Assessment (PPPSA) (Health Affairs 2005;24:1323–33).

The goal of the PPPSA is to provide information that medical groups can incorporate into procedures that will improve patient safety.

The PPPSA was developed by the Medical Group Management Association's center for research, the Health Research and Educational Trust, and the Institute for Safe Medication Practices.

The assessment consists of 79 questions related to patient safety in six areas:

PIMedications (17 questions).

PIHandoffs and transitions (11 questions).

PISurgery and invasive procedures, sedation, and anesthesia (6 questions).

PIPersonnel qualifications and competency (10 questions).

PIPractice management and culture (22 questions).

PIPatient education and communication (13 questions).

For each question in these six domains, respondents can choose from among five answer choices ranging from "unaware or aware but no activity to implement" to "fully implemented everywhere."

Overall, more than 70% of the groups surveyed used paper medical records, while the others used a scanned-image system, a relational database, or other methods.

But practices that have electronic health records still use paper forms for certain functions, primarily for lab orders. "Even among practices with EHRs, 30% used paper lab forms," Mr. Gans said. In addition, 16% of the practices with EHRs used manual methods to order prescriptions and 13% used manual methods to assess drug interactions.

To illustrate one practice's experience with patient safety self-assessment, Christine A. Schon of the Dartmouth-Hitchcock Medical Center in New Hampshire shared her group's experience with the PPPSA.

The data came from the Nashua branch of the medical center and included 62 providers in five locations that serve about 250,000 patients. The medical director of the Nashua division initiated the group's assessment as part of an ongoing goal to improve patient safety.

"We are almost paper chartless," Ms. Schon said. "But what we want to do is make sure that we are managing our patient population effectively."

The Dartmouth-Hitchcock group used the PPPSA as a tool to evaluate how well the group was meeting the National Patient Safety Goals. The PPPSA took about 3 hours to complete, although the time will vary according to practice size, she noted.

As a result of taking the PPPSA, the Dartmouth-Hitchcock group learned that technology isn't everything.

"Our biggest 'aha' moment, as I called it, was [when we realized] that we have a tendency to rely very heavily on electronic medical records, and so we found that if we can't do it electronically, we aren't thinking about doing it," Ms. Schon said.

"We predominantly had good electronic systems in place to make sure that we were doing safe practices and engaged with the patient," she said.

But the group did find that, although physicians were focused on entering information into the EHR and checking for interactions, they weren't really making sure that patients understood their medications.

"That's an area where you still have to rely on a piece of paper and a conversation," Ms. Schon noted.

Patients themselves are not always reliable if doctors ask what medications the patients are taking, she added.

As a result of the assessment process, Ms. Schon's group is considering the use of a checklist to review with patients before they leave the hospital. The sheet would explain what medications the patients are taking and why.

In addition, the group plans to stop using medication samples because they can confuse patients who take generic versions of the brands.

"We are the health care safety net for our community," Ms. Schon said.

For more information about the PPPSA or to order PPPSA materials, visit www.physiciansafetytool.org

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.

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.

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.