Heidi Splete

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

ATLANTA – The meningococcal vaccine MCV4-D (Menactra) is now recommended for use in certain subgroups of high-risk children aged 9-23 months, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted at its June 22 meeting.

Dr. Amanda Cohn of the CDC’s meningitis and vaccine preventable disease branch noted that the recommendations involve a very small subset of the population, and that they do not apply to this age group in general.

ACIP voted that specific groups of children aged 9-23 months at increased risk for meningococcal disease receive a two-dose series of MCV4-D taken 3 months apart:

• Infants needing protection prior to traveling or moving to an area where meningococcal disease is epidemic or highly endemic. Travelers can receive their two doses 2 months apart to accommodate travel schedules.

• Infants with complement component deficiencies such as C3, C5-9, properdin, factor H, and factor D deficiencies.

• Infants in a defined risk group for a community or institutional outbreak.

• Infants with HIV, if another indication for vaccination exists.

The committee, however, opted to postpone voting on whether infants aged 9-23 months with functional or anatomic asplenia, including those with sickle cell anemia, should receive the MCV4-D vaccine.

"This will be on the agenda to consider at a future time when more information becomes available," said Dr. Carol Baker, ACIP chair and professor of pediatrics at Baylor College of Medicine, Houston. "We are not just a rubber stamp for the FDA licensing."

ACIP also voted unanimously to include the recommendations in the Vaccines for Children Program.

The indication for MCV4-D as a two-dose primary series for infants aged 9-23 months was approved by the U.S. Food and Drug Administration in March 2011, Dr. Cohn said.

"This is the first meningococcal vaccine licensed in children under 24 months, but others are likely to be available within the year," she said. Prelicensure safety data met noninferiority criteria, with no serious adverse events, and postlicensure safety surveillance will be conducted for children through age 23 months, Dr. Cohn added.

The recommendations were based on immunogenicity and safety data presented by Dr. David R. Johnson of Sanofi Pasteur, manufacturer of Menactra. He presented several phase-III studies that included immunogenicity data from 1,561 infants and safety data from 3,267 infants.

In one study of 147 children, the protective response rates after two doses of MCV4-D (defined as the percent achieving serum bactericidal assay with human complement [SBA-HC] immune titers of at least a ratio of 1:8) against meningococcal serogroups A, C, Y, and W-135 were 91%, 100%, 95%, and 82%, respectively, Dr. Johnson said.

In the same study, seroprotection rates when MCV4-D was given with MMRV (measles, mumps, rubella, varicella) were higher than when PCV7 was given with MMRV. However, pneumococcal geometric mean concentrations when PVC7 was given with MCV4-D were lower than with PCV7 given with MMRV.

The impact of MCV4-D on the effectiveness of the pneumococcal vaccine was cause for concern.

"We don’t want to do anything to impact the burden of pneumococcal disease in the high-risk patients" Dr. Michael Brady, chair of the American Academy of Pediatrics committee on infectious disease, said during the discussion period prior to voting. He also is chair of the department of pediatrics at Ohio State University in Columbus.

Many ACIP members expressed similar concerns about the risks of interference that could occur with the coadministration of a pneumococcal vaccine and meningococcal vaccine in the specific subset of children with functional or anatomic asplenia, including sickle cell anemia, and the vote was postponed based on these concerns.

The rate of medically significant adverse events from 30 days to 6 months after MCV4-D plus concomitant vaccines was less than 5%. No data were presented on safety or immunogenicity data for MCV4-D and PCV13.

Current immunization schedules are available at the CDC website.

As an employee of the CDC, Dr. Cohn had no relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Approximately one-third of health care providers conduct unnecessary low-risk testing, based on results of a survey of 376 office-based health care providers and 216 outpatient clinics published in the July 2011 issue of Obstetrics & Gynecology.

A high-risk human papillomavirus (HPV) DNA test, which detects cancer-causing HPV types, is generally used for screening and managing women with abnormal Pap test results, but there are no clinical recommendations for use of a low-risk HPV DNA test that detects five nononcogenic HPV types, said Jennifer Wai-Yin Lee, R.N., and her colleagues at the Centers for Disease Control and Prevention (Obstet. Gynecol. 2011;118:4-13).

To assess the use of different types of HPV testing, the researchers reviewed data from the 2006 Cervical Cancer Screening Supplement, a survey conducted by the CDC. Overall, 76% of the office-based providers and 77% of the outpatient clinics reported ever ordering an HPV test, and 35% of health care providers and 32% of clinics said they used low-risk HPV testing.

The finding on the use of low-risk HPV testing "is surprising," the researchers wrote. "The low-risk HPV DNA test screens for infection with nononcogenic HPV types and thus serves no purpose in the context of cervical cancer screening," they noted.

The use of low-risk HPV testing in the Unites States may be driven by a combination of factors including financial gain, test marketing, and health care provider confusion on the difference between the low-risk and high-risk tests, the researchers said.

"We discovered that the low-risk HPV test – which has no clinical indications and is not recommended by any guidelines – was actually part of an older version of the HPV test, which tested for both low- and high-risk HPV types," lead author Dr. Mona Saraiya, also of the CDC, said in an interview. "Despite newer HPV tests that screen only for high-risk types, the combined test remains in active use. Over one-third of providers in our study who used HPV testing reported using the low-risk HPV test, which is a large number and sheds light on a practice that we didn’t know much about before," she said.

Overall, office-based providers and clinics were more likely to use HPV testing to manage an abnormal Pap test (reflex or recall testing) than to augment routine cervical cancer screening (cotesting). Of the office-based providers who ordered any HPV test, 89% said they used it for managing an abnormal test result, while 47% said that they used it with the Pap test for routine cervical cancer screening. Clinics also were more likely to perform reflex or recall testing than HPV cotesting.

However, approximately 60% of the respondents (60% of office-based providers and 66% of clinics) also said they used HPV cotesting with a Pap test for routine cervical cancer screening in women younger than 30 years, although such testing is recommended only for women aged 30 years and older. And more than half of health care providers (56% of office-based providers and 55% of clinics) reported doing reflex HPV testing in women younger than 30 years.

"The concern over testing in this age group arises from the follow-up colposcopies and excisional treatments, which carry their own risks and side effects that may occur as a result of HPV testing that should not have been performed to begin with," Dr. Saraiya said.

"Clinicians may need to explain to a patient under 30 years old who is requesting the HPV test with her Pap smear why HPV testing is at best, not useful in her situation, and potentially harmful at worst," she said.

The frequent use of HPV tests in younger women in both health care settings is cause for concern, because most HPV infections in women younger than 30 years are transient, and these infections will resolve without further intervention and health care costs, the researchers noted. "Avoiding unnecessary work-up or treatment of transient HPV infections in younger women is an important goal ... because studies have found associations between certain procedures used to treat cervical dysplasia and adverse birth outcomes," including preterm delivery and perinatal mortality, the investigators noted.

In addition, 71% of office-based providers and 63% of clinics performed reflex HPV testing after Pap test results of ASC-H(atypical squamous cells, cannot rule out high-grade squamous intraepithelial lesions), although HPV testing is not recommended in these instances.

Guidelines from the American Cancer Society, the American College of Obstetricians and Gynecologists, and the American Society for Colposcopy and Cervical Pathology state that HPV DNA testing is not recommended for certain situations, including low-risk HPV types, routine cervical cancer screening in women younger than 30 years, routine screening more often than 3 years in women older than 30 years, routine sexually transmitted disease screenings, sexual assault work-ups, and initial triage of women with Pap test results of high-grade squamous epithelial lesions (HSILs) or of ASC-H, the researchers said.

The unnecessary and improper use of HPV testing suggests that actions such as limiting test reimbursement and educating health care providers are needed to eliminate unnecessary low-risk testing, the researchers said.

"When it comes to low-risk HPV testing, the take-home message to clinicians is simple: Women should stop being tested for low-risk HPV," Ms. Lee said in an interview. "We already know that low-risk HPV types are nononcogenic, so testing for low-risk HPV is not useful in determining a woman’s risk for developing cervical cancer. We also want to make clear that although low-risk HPV types are associated with genital warts, having a positive low-risk HPV test does not mean a woman will develop genital warts, nor does it provide any prognosis for women who have genital warts," she said.

"By knowing this information, clinicians will hopefully feel empowered to request their laboratories to provide high-risk-HPV-only testing, instead of a combined low- and high-risk HPV test," she added.

More work is needed to improve the clinical value of HPV testing, the researchers said. "Eliminating the low-risk HPV test and making the high-risk HPV test the only option would help minimize confusion for providers when ordering the HPV test. Removing incentives for this practice like insurance reimbursement is another method that may be effective," Ms. Lee said.

"Interventions that can help providers use HPV tests appropriately include changing laboratory requisition forms to reflect guideline-consistent HPV testing and point-of-care decision support algorithms that are designed to give patient-specific recommendations," she said.

In an accompanying editorial, Philip E. Castle, Ph.D., of the American Society for Clinical Pathology in Chicago, noted that the overuse and improper use of HPV testing has negative effects on patients: "A patient who tests HPV positive has a wide range of negative psychosocial and psychosexual outcomes, including anxiety, distress, and a decreased sense of sexual well-being."

He also emphasized the impact of unnecessary HPV testing on the health care system: "With an estimated $4 billion spent on cervical cancer prevention alone in 2004, we can no longer afford to perform tests that do not benefit our patients" (Obstet. Gynecol. 2011;118:1-3).

Dr. Castle supported the study authors’ call for better education of clinicians, for they have the final responsibility for the use of HPV testing. He said it also would be helpful if payers stopped reimbursing for these unnecessary HPV tests, for that would quickly put a halt to such practices. He emphasized, "Overuse of HPV testing not only seriously wastes government, payer, and patient dollars, but also potentially harms patients, therefore violating the first tenet of the Hippocratic Oath: Do no harm."

Neither the study authors nor Dr. Castle said they had any relevant financial disclosures.

Pregnant women do not need to be routinely screened for vitamin D deficiency, according to a new policy from the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, published online June 20 in Obstetrics & Gynecology.

There is no consensus on the optimal vitamin D level for pregnant women, Dr. George A. Macones, chair of the committee, said in a statement. Instead, the college recommends vitamin D testing only in pregnant women who are at increased risk for vitamin D deficiency.

© Kaspri/Fotolia.com

High-risk groups include women who are vegetarians, those who have limited sun exposure because they live in northern locations or wear protective clothing, and women who are ethnic minorities, especially those with darker skin, according to ACOG committee opinion No. 495 (Obstet. Gynecol. 2011;118:) For these at-risk women, 1,000-2,000 IU of vitamin D supplementation daily is safe, but the safety of higher levels of supplementation has not been well studied, the committee wrote.

Women who are not at increased risk for vitamin D deficiency will get adequate vitamin D during pregnancy if they take a prenatal vitamin, the committee noted. The Institute of Medicine determined in 2010 that 600 IU of vitamin D daily was adequate for pregnant and lactating women, and most prenatal vitamins contain at least 400 IU per pill.

"I think first patients need to understand that most prenatal vitamins have vitamin D in them. If a patient is concerned beyond this, drinking fortified milk or fruit juices will help," Dr. Macones said in an interview.

Current evidence is insufficient to recommend screening all pregnant women for vitamin D deficiency, the committee wrote. "Recommendations concerning routine vitamin D. supplementation during pregnancy beyond that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials," they noted.

Dr. Macones emphasized that additional research is needed to improve understanding of the role of vitamin D during pregnancy. "I think this is really the key: We need to understand whether or not screening and supplementing with vitamin D in pregnancy improves the health of mother or baby. As of yet, we don’t know the answer to this, and that is why routine screening cannot be recommended," he said.

"I think there is lots of information and misinformation about vitamin D in the lay press, and patients are certainly asking about this," added Dr. Macones, the Mitchell and Elaine Yanow Professor and chair of obstetrics and gynecology at Washington University in St. Louis. "The goal of the opinion was really to tell ob.gyns. that you shouldn’t universally screen pregnant women for vitamin D deficiency."

Dr. Macones said he had no relevant financial disclosures.

Pregnant women do not need to be routinely screened for vitamin D deficiency, according to a new policy from the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, published online June 20 in Obstetrics & Gynecology.

There is no consensus on the optimal vitamin D level for pregnant women, Dr. George A. Macones, chair of the committee, said in a statement. Instead, the college recommends vitamin D testing only in pregnant women who are at increased risk for vitamin D deficiency.

© Kaspri/Fotolia.com

High-risk groups include women who are vegetarians, those who have limited sun exposure because they live in northern locations or wear protective clothing, and women who are ethnic minorities, especially those with darker skin, according to ACOG committee opinion No. 495 (Obstet. Gynecol. 2011;118:) For these at-risk women, 1,000-2,000 IU of vitamin D supplementation daily is safe, but the safety of higher levels of supplementation has not been well studied, the committee wrote.

Women who are not at increased risk for vitamin D deficiency will get adequate vitamin D during pregnancy if they take a prenatal vitamin, the committee noted. The Institute of Medicine determined in 2010 that 600 IU of vitamin D daily was adequate for pregnant and lactating women, and most prenatal vitamins contain at least 400 IU per pill.

"I think first patients need to understand that most prenatal vitamins have vitamin D in them. If a patient is concerned beyond this, drinking fortified milk or fruit juices will help," Dr. Macones said in an interview.

Current evidence is insufficient to recommend screening all pregnant women for vitamin D deficiency, the committee wrote. "Recommendations concerning routine vitamin D. supplementation during pregnancy beyond that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials," they noted.

Dr. Macones emphasized that additional research is needed to improve understanding of the role of vitamin D during pregnancy. "I think this is really the key: We need to understand whether or not screening and supplementing with vitamin D in pregnancy improves the health of mother or baby. As of yet, we don’t know the answer to this, and that is why routine screening cannot be recommended," he said.

"I think there is lots of information and misinformation about vitamin D in the lay press, and patients are certainly asking about this," added Dr. Macones, the Mitchell and Elaine Yanow Professor and chair of obstetrics and gynecology at Washington University in St. Louis. "The goal of the opinion was really to tell ob.gyns. that you shouldn’t universally screen pregnant women for vitamin D deficiency."

Dr. Macones said he had no relevant financial disclosures.

Pregnant women do not need to be routinely screened for vitamin D deficiency, according to a new policy from the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, published online June 20 in Obstetrics & Gynecology.

There is no consensus on the optimal vitamin D level for pregnant women, Dr. George A. Macones, chair of the committee, said in a statement. Instead, the college recommends vitamin D testing only in pregnant women who are at increased risk for vitamin D deficiency.

© Kaspri/Fotolia.com

High-risk groups include women who are vegetarians, those who have limited sun exposure because they live in northern locations or wear protective clothing, and women who are ethnic minorities, especially those with darker skin, according to ACOG committee opinion No. 495 (Obstet. Gynecol. 2011;118:) For these at-risk women, 1,000-2,000 IU of vitamin D supplementation daily is safe, but the safety of higher levels of supplementation has not been well studied, the committee wrote.

Women who are not at increased risk for vitamin D deficiency will get adequate vitamin D during pregnancy if they take a prenatal vitamin, the committee noted. The Institute of Medicine determined in 2010 that 600 IU of vitamin D daily was adequate for pregnant and lactating women, and most prenatal vitamins contain at least 400 IU per pill.

"I think first patients need to understand that most prenatal vitamins have vitamin D in them. If a patient is concerned beyond this, drinking fortified milk or fruit juices will help," Dr. Macones said in an interview.

Current evidence is insufficient to recommend screening all pregnant women for vitamin D deficiency, the committee wrote. "Recommendations concerning routine vitamin D. supplementation during pregnancy beyond that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials," they noted.

Dr. Macones emphasized that additional research is needed to improve understanding of the role of vitamin D during pregnancy. "I think this is really the key: We need to understand whether or not screening and supplementing with vitamin D in pregnancy improves the health of mother or baby. As of yet, we don’t know the answer to this, and that is why routine screening cannot be recommended," he said.

"I think there is lots of information and misinformation about vitamin D in the lay press, and patients are certainly asking about this," added Dr. Macones, the Mitchell and Elaine Yanow Professor and chair of obstetrics and gynecology at Washington University in St. Louis. "The goal of the opinion was really to tell ob.gyns. that you shouldn’t universally screen pregnant women for vitamin D deficiency."

Dr. Macones said he had no relevant financial disclosures.

Pregnant women do not need to be routinely screened for vitamin D deficiency, according to a new policy from the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, published online June 20 in Obstetrics & Gynecology.

There is no consensus on the optimal vitamin D level for pregnant women, Dr. George A. Macones, chair of the committee, said in a statement. Instead, the college recommends vitamin D testing only in pregnant women who are at increased risk for vitamin D deficiency.

© Kaspri/Fotolia.com

High-risk groups include women who are vegetarians, those who have limited sun exposure because they live in northern locations or wear protective clothing, and women who are ethnic minorities, especially those with darker skin, according to ACOG committee opinion No. 495 (Obstet. Gynecol. 2011;118:) For these at-risk women, 1,000-2,000 IU of vitamin D supplementation daily is safe, but the safety of higher levels of supplementation has not been well studied, the committee wrote.

Women who are not at increased risk for vitamin D deficiency will get adequate vitamin D during pregnancy if they take a prenatal vitamin, the committee noted. The Institute of Medicine determined in 2010 that 600 IU of vitamin D daily was adequate for pregnant and lactating women, and most prenatal vitamins contain at least 400 IU per pill.

"I think first patients need to understand that most prenatal vitamins have vitamin D in them. If a patient is concerned beyond this, drinking fortified milk or fruit juices will help," Dr. Macones said in an interview.

Current evidence is insufficient to recommend screening all pregnant women for vitamin D deficiency, the committee wrote. "Recommendations concerning routine vitamin D. supplementation during pregnancy beyond that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials," they noted.

Dr. Macones emphasized that additional research is needed to improve understanding of the role of vitamin D during pregnancy. "I think this is really the key: We need to understand whether or not screening and supplementing with vitamin D in pregnancy improves the health of mother or baby. As of yet, we don’t know the answer to this, and that is why routine screening cannot be recommended," he said.

"I think there is lots of information and misinformation about vitamin D in the lay press, and patients are certainly asking about this," added Dr. Macones, the Mitchell and Elaine Yanow Professor and chair of obstetrics and gynecology at Washington University in St. Louis. "The goal of the opinion was really to tell ob.gyns. that you shouldn’t universally screen pregnant women for vitamin D deficiency."

Dr. Macones said he had no relevant financial disclosures.

Pregnant women do not need to be routinely screened for vitamin D deficiency, according to a new policy from the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, published online June 20 in Obstetrics & Gynecology.

There is no consensus on the optimal vitamin D level for pregnant women, Dr. George A. Macones, chair of the committee, said in a statement. Instead, the college recommends vitamin D testing only in pregnant women who are at increased risk for vitamin D deficiency.

© Kaspri/Fotolia.com

High-risk groups include women who are vegetarians, those who have limited sun exposure because they live in northern locations or wear protective clothing, and women who are ethnic minorities, especially those with darker skin, according to ACOG committee opinion No. 495 (Obstet. Gynecol. 2011;118:) For these at-risk women, 1,000-2,000 IU of vitamin D supplementation daily is safe, but the safety of higher levels of supplementation has not been well studied, the committee wrote.

Women who are not at increased risk for vitamin D deficiency will get adequate vitamin D during pregnancy if they take a prenatal vitamin, the committee noted. The Institute of Medicine determined in 2010 that 600 IU of vitamin D daily was adequate for pregnant and lactating women, and most prenatal vitamins contain at least 400 IU per pill.

"I think first patients need to understand that most prenatal vitamins have vitamin D in them. If a patient is concerned beyond this, drinking fortified milk or fruit juices will help," Dr. Macones said in an interview.

Current evidence is insufficient to recommend screening all pregnant women for vitamin D deficiency, the committee wrote. "Recommendations concerning routine vitamin D. supplementation during pregnancy beyond that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials," they noted.

Dr. Macones emphasized that additional research is needed to improve understanding of the role of vitamin D during pregnancy. "I think this is really the key: We need to understand whether or not screening and supplementing with vitamin D in pregnancy improves the health of mother or baby. As of yet, we don’t know the answer to this, and that is why routine screening cannot be recommended," he said.

"I think there is lots of information and misinformation about vitamin D in the lay press, and patients are certainly asking about this," added Dr. Macones, the Mitchell and Elaine Yanow Professor and chair of obstetrics and gynecology at Washington University in St. Louis. "The goal of the opinion was really to tell ob.gyns. that you shouldn’t universally screen pregnant women for vitamin D deficiency."

Dr. Macones said he had no relevant financial disclosures.

Pregnant women do not need to be routinely screened for vitamin D deficiency, according to a new policy from the American College of Obstetricians and Gynecologists’ Committee on Obstetric Practice, published online June 20 in Obstetrics & Gynecology.

There is no consensus on the optimal vitamin D level for pregnant women, Dr. George A. Macones, chair of the committee, said in a statement. Instead, the college recommends vitamin D testing only in pregnant women who are at increased risk for vitamin D deficiency.

© Kaspri/Fotolia.com

High-risk groups include women who are vegetarians, those who have limited sun exposure because they live in northern locations or wear protective clothing, and women who are ethnic minorities, especially those with darker skin, according to ACOG committee opinion No. 495 (Obstet. Gynecol. 2011;118:) For these at-risk women, 1,000-2,000 IU of vitamin D supplementation daily is safe, but the safety of higher levels of supplementation has not been well studied, the committee wrote.

Women who are not at increased risk for vitamin D deficiency will get adequate vitamin D during pregnancy if they take a prenatal vitamin, the committee noted. The Institute of Medicine determined in 2010 that 600 IU of vitamin D daily was adequate for pregnant and lactating women, and most prenatal vitamins contain at least 400 IU per pill.

"I think first patients need to understand that most prenatal vitamins have vitamin D in them. If a patient is concerned beyond this, drinking fortified milk or fruit juices will help," Dr. Macones said in an interview.

Current evidence is insufficient to recommend screening all pregnant women for vitamin D deficiency, the committee wrote. "Recommendations concerning routine vitamin D. supplementation during pregnancy beyond that contained in a prenatal vitamin should await the completion of ongoing randomized clinical trials," they noted.

Dr. Macones emphasized that additional research is needed to improve understanding of the role of vitamin D during pregnancy. "I think this is really the key: We need to understand whether or not screening and supplementing with vitamin D in pregnancy improves the health of mother or baby. As of yet, we don’t know the answer to this, and that is why routine screening cannot be recommended," he said.

"I think there is lots of information and misinformation about vitamin D in the lay press, and patients are certainly asking about this," added Dr. Macones, the Mitchell and Elaine Yanow Professor and chair of obstetrics and gynecology at Washington University in St. Louis. "The goal of the opinion was really to tell ob.gyns. that you shouldn’t universally screen pregnant women for vitamin D deficiency."

Dr. Macones said he had no relevant financial disclosures.

LONDON – Among patients with giant cell arteritis, those in the lowest socioeconomic quarter of the population were more than three times as likely to have ischemic complications, based on data from 271 patients in England. The results were presented today.

Previous studies have shown a link between low socioeconomic status and carotid atherosclerosis. Studies of giant cell arteritis (GCA) have not controlled for socioeconomic status as a possible confounder, said Dr. Sarah Louise Mackie of the University of Leeds (England).

In an observational study of patients from eight recruitment centers in England, Dr. Mackie and her colleagues identified 271 confirmed cases of GCA.

Overall, 222 of 271 patients had ischemic complications. "The most striking finding was an association of ischemic complications with increasing Index of Deprivation 2007 (IMD2007) scores," with an odds ratio of 4.2 for the most-deprived quartile compared with the least-deprived quartile, Dr. Mackie noted. After controlling for a 30-day median duration of symptoms, the odds ratio for ischemic complications was 3.2 for the most-deprived quartile compared with the least-deprived quartile.

Ischemic complications were defined as lost or blurred vision; visual aura; diplopia; claudication of the jaw, tongue, or limb; scalp necrosis; or cerebral or myocardial ischemia.

Smoking was not associated with an increased risk of ischemic complications. Falling into the most socioeconomically deprived quartile was associated with a higher lifetime tobacco exposure and a lower prevalence of previously diagnosed polymyalgia rheumatica. However, neither of these factors appeared to affect the impact of socioeconomic deprivation on complications.

The adjusted odds ratio for the influence of hypertension was 1.6, and the adjusted odds ratio for the influence of atherosclerosis was 1.5. Neither of these conditions appeared to mediate the effect of socioeconomic deprivation on ischemic complications.

"This is a novel finding that requires replication," Dr. Mackie noted. Meanwhile, any public awareness campaign for GCA "should attempt to engage individuals in more deprived areas to encourage early presentation and prompt treatment," she said.

Dr. Mackie said she had no financial conflicts to disclose.

LONDON – Among patients with giant cell arteritis, those in the lowest socioeconomic quarter of the population were more than three times as likely to have ischemic complications, based on data from 271 patients in England. The results were presented today.

Previous studies have shown a link between low socioeconomic status and carotid atherosclerosis. Studies of giant cell arteritis (GCA) have not controlled for socioeconomic status as a possible confounder, said Dr. Sarah Louise Mackie of the University of Leeds (England).

In an observational study of patients from eight recruitment centers in England, Dr. Mackie and her colleagues identified 271 confirmed cases of GCA.

Overall, 222 of 271 patients had ischemic complications. "The most striking finding was an association of ischemic complications with increasing Index of Deprivation 2007 (IMD2007) scores," with an odds ratio of 4.2 for the most-deprived quartile compared with the least-deprived quartile, Dr. Mackie noted. After controlling for a 30-day median duration of symptoms, the odds ratio for ischemic complications was 3.2 for the most-deprived quartile compared with the least-deprived quartile.

Ischemic complications were defined as lost or blurred vision; visual aura; diplopia; claudication of the jaw, tongue, or limb; scalp necrosis; or cerebral or myocardial ischemia.

Smoking was not associated with an increased risk of ischemic complications. Falling into the most socioeconomically deprived quartile was associated with a higher lifetime tobacco exposure and a lower prevalence of previously diagnosed polymyalgia rheumatica. However, neither of these factors appeared to affect the impact of socioeconomic deprivation on complications.

The adjusted odds ratio for the influence of hypertension was 1.6, and the adjusted odds ratio for the influence of atherosclerosis was 1.5. Neither of these conditions appeared to mediate the effect of socioeconomic deprivation on ischemic complications.

"This is a novel finding that requires replication," Dr. Mackie noted. Meanwhile, any public awareness campaign for GCA "should attempt to engage individuals in more deprived areas to encourage early presentation and prompt treatment," she said.

Dr. Mackie said she had no financial conflicts to disclose.

LONDON – Among patients with giant cell arteritis, those in the lowest socioeconomic quarter of the population were more than three times as likely to have ischemic complications, based on data from 271 patients in England. The results were presented today.

Previous studies have shown a link between low socioeconomic status and carotid atherosclerosis. Studies of giant cell arteritis (GCA) have not controlled for socioeconomic status as a possible confounder, said Dr. Sarah Louise Mackie of the University of Leeds (England).

In an observational study of patients from eight recruitment centers in England, Dr. Mackie and her colleagues identified 271 confirmed cases of GCA.

Overall, 222 of 271 patients had ischemic complications. "The most striking finding was an association of ischemic complications with increasing Index of Deprivation 2007 (IMD2007) scores," with an odds ratio of 4.2 for the most-deprived quartile compared with the least-deprived quartile, Dr. Mackie noted. After controlling for a 30-day median duration of symptoms, the odds ratio for ischemic complications was 3.2 for the most-deprived quartile compared with the least-deprived quartile.

Ischemic complications were defined as lost or blurred vision; visual aura; diplopia; claudication of the jaw, tongue, or limb; scalp necrosis; or cerebral or myocardial ischemia.

Smoking was not associated with an increased risk of ischemic complications. Falling into the most socioeconomically deprived quartile was associated with a higher lifetime tobacco exposure and a lower prevalence of previously diagnosed polymyalgia rheumatica. However, neither of these factors appeared to affect the impact of socioeconomic deprivation on complications.

The adjusted odds ratio for the influence of hypertension was 1.6, and the adjusted odds ratio for the influence of atherosclerosis was 1.5. Neither of these conditions appeared to mediate the effect of socioeconomic deprivation on ischemic complications.

"This is a novel finding that requires replication," Dr. Mackie noted. Meanwhile, any public awareness campaign for GCA "should attempt to engage individuals in more deprived areas to encourage early presentation and prompt treatment," she said.

Dr. Mackie said she had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for dermatologists to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for dermatologists to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for dermatologists to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for physicians to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for physicians to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for physicians to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for dermatologists to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for dermatologists to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.

WHITE OAK, MD – The new sunscreen labeling regulations from the Food and Drug Administration should make it easier for dermatologists to spread the skin protection message and for consumers to select effective products, according to Dr. Ronald L. Moy.

"The FDA has now defined broad spectrum protection so consumers will better understand how to select a sunscreen that protects against skin cancer," said Dr. Moy, president of the American Academy of Dermatology. "We are encouraged that there are now simple, consistent labeling requirements."

He spoke at a press conference that was held to announce the new regulations and emphasized that skin cancer is a serious disease, and the number of cases in the United States are rising. "There are a few easy things you can do to protect your skin from ultraviolet radiation. And today the FDA’s new sunscreen labeling requirements make it even easier for us," he said. Current estimates are that one in five Americans will develop skin cancer in their lifetimes.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, presented the new labeling information at the press conference on June 14. After many years of deliberation and evaluation, the FDA defined the testing that a sunscreen product must undergo before it can make a claim of "broad-spectrum protection" on its label, meaning protection from both UVA and UVB radiation.

"These changes are part of an ongoing effort at the FDA to make sure that sunscreens meet standards for safety and efficacy," Dr. Woodcock said. "It wasn’t until recently that the FDA was able to establish an accurate and reliable broad-spectrum test," Dr. Woodcock said.

Based on the FDA test, the labels of broad-spectrum sunscreens with an SPF of at least 15 can state that, when used properly and with other protective measures, the products can help reduce the risk of skin cancer and the signs of premature aging.

"Only those products that pass the FDA test will be able to be labeled broad spectrum," Dr. Woodcock said. Some sunscreens with SPF in the 2 to 14 range that pass the FDA’s broad-spectrum test can be labeled as such, she said, but they will not be able to make claims related to skin cancer protection or anti-aging protection, according to the FDA rules.

As for concerns about nanoparticles in sunscreens, "the FDA does not currently have reason to warn consumers about their safety," Dr. Woodcock said. "We have performed testing and found that nanoparticles do not penetrate the skin. If we determine that any of the active ingredients do not meet the safety standards, the FDA will notify the public."

Dr. Woodcock and Dr. Moy had no financial conflicts to disclose.