IOM Report Finds Few Causal Relationships Between Vaccines and Adverse Events

The Institute of Medicine (IOM) has released a comprehensive review of evidence on vaccines and adverse events. To conclude whether vaccines could cause specific adverse events, an IOM committee reviewed more than 1,000 peer-reviewed articles, and weighed epidemiologic and clinical evidence. The committee examined adverse event reports related to vaccines for hepatitis A; hepatitis B; human papillomavirus (HPV); influenza; measles, mumps, and rubella (MMR); meningococcal disease; tetanus; and varicella. Based on the evidence, 158 vaccine and adverse event relationships were assigned to one of the following categories: evidence convincingly supports causal relationship; evidence favors acceptance of causal relationship; evidence favors rejection of causal relationship; and evidence is inadequate to accept or reject causal relationship. More than 100 of the vaccine and adverse event pairings were in the category of inadequate evidence because the event in question was so rare it was difficult to study. The pairings that favored rejection of a causal relationship included MMR vaccine and autism; MMR vaccine and type 1 diabetes mellitus; diphtheria and tetanus toxoids and acellular pertussis vaccine and type 1 diabetes; inactivated influenza vaccine and Bell palsy; and inactivated influenza vaccine and exacerbation of asthma or reactive airway disease episodes in children and adults. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20110912iomreview.html.

CDC Survey Shows Little Improvement in HPV Vaccination Rates in Adolescents

Increases in vaccination rates for HPV vaccine are lagging behind the two other vaccines specifically recommended for teens and preteens (i.e., tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis [Tdap] vaccine; and meningococcal vaccine [MCV4]). The HPV vaccine is recommended for girls beginning at 11 years of age to help prevent common types of HPV that cause cervical cancer. A survey in the August 26, 2011, issue of Morbidity and Mortality Weekly Report found that the proportion of adolescent girls 13 to 17 years of age who had received at least one dose of the HPV vaccine increased from 44.3 percent in 2009 to 48.7 percent in 2010. The proportion of those who had completed the series increased from 26.7 to 32.0 percent. By comparison, coverage with at least one dose of Tdap increased from 55.6 to 68.7 percent during the same period, and MCV4 coverage increased from 53.6 to 62.7 percent. According to Melinda Wharton, MD, deputy director of the Centers for Disease Control and Prevention's (CDC's) National Center for Immunization and Respiratory Diseases, one reason for the disparity is that some young patients and their parents are not getting a strong recommendation for HPV vaccination from their physicians. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20110907teenvax.html, and http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6033a1.htm.

HHS Proposes Rules to Expand Patients' Rights to Access Health Information

At the first-ever U.S. Department of Health and Human Services (HHS) Consumer Health Information Technology Summit, HHS Secretary Kathleen Sebelius proposed new rules that would expand patients' rights to use health information technology to access their personal health information. The rules would allow laboratories covered by the Health Insurance Portability and Accountability Act to provide information directly to patients or their personal representatives. According to Sebelius, patients who have access to their own test results can make more informed decisions about their health care. Sebelius also announced the voluntary Personal Health Record Model Privacy Notice, which provides Web-based personal health record companies with an easy-to-read, standardized template to inform patients about their privacy and security policies. For more information, visit http://www.hhs.gov/news/press/2011pres/09/20110912a.html.

CMS Extends Deadline for Hardship Exemptions from E-Prescribing Program

Physicians have an extra month to submit a request for hardship exemptions from the 2011 Medicare electronic prescribing (e-prescribing) incentive program known as Medicare eRX. The new deadline is November 1, 2011. However, there still will be a penalty in 2012 for physicians who do not successfully e-prescribe in 2011. The Centers for Medicare and Medicaid Services (CMS) released the final rule on the program and an accompanying agency fact sheet on August 31, 2011. The final rule clarifies language on “qualified” e-prescribing systems, and explains how physicians can use a Web-based tool to request a hardship exemption. The rule also finalized additional hardship categories that offer exemptions to physicians who are unable to e-prescribe because of local, state, or federal regulations; who have limited prescribing activity; or who have insufficient opportunity in their practice to use the required codes. For more information, visit https://www.aafp.org/news-now/practice-professional-issues/20110907eprescribedeadline.html, and http://www.gpo.gov/fdsys/pkg/FR-2011-09-06/pdf/2011-22629.pdf.

CMS Releases Data on Annual Wellness Visits and Prescription Drug Discounts

According to data from CMS, more than 17 million Medicare beneficiaries have accessed free preventive services so far this year, and 1 million beneficiaries have participated in the new annual wellness visit, both of which are covered under the Patient Protection and Affordable Care Act. Also, nearly 900,000 Medicare beneficiaries who fell into the Medicare prescription drug coverage gap received prescription drug discounts, resulting in a savings of $517 per person. For more information, visit https://www.aafp.org/news-now/news-in-brief/20110831wklynewsbrfs.html.

AHRQ Guides on Obstructive Sleep Apnea Now Available for Physicians and Patients

The Effective Health Care Program of the Agency for Healthcare Research and Quality (AHRQ) has released guides on obstructive sleep apnea for physicians and adult patients. The guides are based on a comparative effectiveness review conducted by researchers at Tufts Medical Center Evidence-based Practice Center in Boston, Mass. An estimated 12 million Americans have been diagnosed with sleep apnea. Millions more are likely to have the condition, but have not been diagnosed, according to AHRQ. The guides address the accuracy of various screening and diagnostic tools, and offer evidence-based assessments of several treatment approaches, including continuous positive airway pressure, mandibular advancement devices, and weight loss. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20110824sleepapneaguides.html.

Med Watch: FDA Issues Announcements About Two Drug Label Changes

The U.S. Food and Drug Administration (FDA) has issued safety announcements for the osteoporosis agent zoledronic acid marketed as Reclast and the antidepressant citalopram (Celexa). The label for Reclast was updated after use of the drug was linked to 16 deaths from acute renal failure in persons with a history of or risk factors for renal impairment. No changes were made to the label of the zoledronic acid product Zometa because its label already addresses renal toxicity. The FDA also has revised the label of citalopram to include a warning that a dosage greater than 40 mg per day has been linked to QT interval prolongation, which can lead to torsades de pointes. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20110907reclastlabel.html, and https://www.aafp.org/news-now/health-of-the-public/20110825citalopram.html.

HHS Awards Grants for Tobacco Cessation Services and Public Health Laboratories

HHS has awarded $137 million to states to strengthen health care infrastructure and to provide jobs in core areas of public health. The grants, which are partly supported by the Patient Protection and Affordable Care Act, will provide tobacco cessation services and strengthen public health laboratory and immunization services. The grants also are intended to prevent health care– associated infections, and provide comprehensive substance abuse prevention and treatment. The awards include nearly $5 million to help states and territories enhance and expand the national network of tobacco cessation quitlines; $1 million to further enhance the nation's public health laboratories; and $2.6 million to the Emerging Infections Programs around the country. For more information, visit https://www.aafp.org/news-now/news-in-brief/20110831wklynewsbrfs.html.

Data Show Midlevel Providers More Likely to Work with Primary Care Physicians

The National Center for Health Statistics has issued a data brief that explores trends in employment of nurse practitioners, certified nurse midwives, and physician assistants among office-based physicians. The brief relies on data from the 2009 National Ambulatory Medical Care Survey. The authors cite a forecasted shortage of primary care physicians in the future, and note the call for more midlevel providers as a solution to this shortage. The authors found that primary care physicians were more likely to work with each of the three midlevel groups compared with physicians in other specialties. Midlevel providers also were more likely to be employed in large and multispecialty group practices, by middle-aged rather than older physicians, and in practices with a higher proportion of revenue from Medicaid and a lower proportion from Medicare. For more information, visit https://www.aafp.org/news-now/news-in-brief/20110831wklynewsbrfs.html.

— AFP and AAFP NEWS NOW staff