2013: Year in Review

FPs Flooded With Recommendations on What to Do -- and Not Do -- in the Clinic

January 02, 2014 08:01 pm News Staff

Family physicians and the AAFP played a key role in developing or otherwise contributing to a slew of new clinical recommendations that guided family medicine and primary care practices in 2013. The Academy also distinguished itself by guiding national immunization policy and addressing other public health issues.

Speaking during a Feb. 21 press event in Washington, AAFP Board Chair Glen Stream, M.D., M.B.I., center, describes the Choosing Wisely campaign as being part of a "many-faceted journey to reform our health care system -- to make it higher quality, more cost-effective and more equitable, as well." Stream is flanked by Gail Wilensky, Ph.D., senior fellow with Project HOPE, and Jim Knutson, risk manager and human resources director for Aircraft Gear Corp.

In January, a study in JAMA Internal Medicine found significant improvement in the delivery of underused care from 1999 to 2009, but researchers said there were limited changes in the reduction of inappropriate care during the same time. Given the high cost of health care, researchers said the results were concerning.

Just a few weeks later, the AAFP released its second list of recommendations that aim to help physicians curtail the practice of ordering unnecessary tests and procedures. The Academy's second set of Choosing Wisely recommendations -- which was created by family physician volunteers via the AAFP's Commission on Health of the Public and Science -- offered the following recommendations to improve quality and lower costs:

  • Don't screen for carotid artery stenosis in asymptomatic adult patients.
  • Don't screen women older than 65 years of age for cervical cancer who have had adequate prior screening and are not otherwise at high risk for cervical cancer.
  • Don't screen women younger than 30 years of age for cervical cancer with human papillomavirus (HPV) testing, alone or in combination with cytology.
  • Don't schedule elective, nonmedically indicated inductions of labor or Cesarean deliveries before 39 weeks, 0 days gestational age.
  • Avoid elective, nonmedically indicated inductions of labor between 39 weeks, 0 days and 41 weeks, 0 days unless the cervix is deemed favorable.

"It has been estimated that nearly one-third of health care delivered in the United States is unnecessary," said (then) AAFP Board Chair Glen Stream, M.D., M.B.I., of Spokane, Wash. "Tests and procedures that lack evidence of their effectiveness put our patients at risk and drive up the cost of care."

The AAFP followed up on the recommendations regarding labor and delivery in May when it joined more than a dozen other organizations in sending a letter to 3,100 hospitals, urging them to help eliminate nonmedically indicated deliveries before 39 weeks' gestation.

In addition, the Academy is in the process of reviewing a number of guidelines issued by other health care organizations.

In May, the American Urological Association (AUA) recommended against performing all routine prostate-specific antigen (PSA)-based screening for prostate cancer, as well as all such screening in men older than 70, men younger than 40 and in average-risk men ages 40-54.

Doug Campos-Outcalt, M.D., M.P.A., of Phoenix, the AAFP liaison to the U.S. Preventive Services Task Force (USPSTF), said the move brought the AUA in line with AAFP and USPSTF recommendations against performing PSA screening in asymptomatic men regardless of age.

"This is pretty big," Campos-Outcalt said at the time. "The AUA was very much against the official USPSTF/AAFP universal recommendation against PSA screening when it was released. I think their guideline committee deserves a lot of praise. It is not easy to buck common practice within your own specialty."

In addition, the American College of Physicians called for physicians to discuss "the limited potential benefits and substantial harms of screening for prostate cancer" with patients between the ages of 50 and 69. The guidance also encourages physicians to perform screening only if a patient expresses a clear preference to do so.

Throughout the year, family physicians like Campos-Outcalt helped shape important health recommendations through their work with groups like the USPSTF and the CDC's Advisory Committee on Immunization Practices.

USPSTF

The USPSTF, with input from the Academy, issued numerous recommendations to guide primary care practices in 2013. Perhaps most notably, the task force overturned decades' worth of routine practice in February, when it recommended against daily supplementation with 400 IU or less of vitamin D3 and 1,000 mg of calcium carbonate for the primary prevention of fractures in noninstitutionalized postmenopausal women.

"What we're saying is that a practice that we have commonly used for years -- literally, years -- routinely in postmenopausal women just doesn't work," said family physician and USPSTF Co-vice Chair Michael LeFevre, M.D., M.S.P.H., of Columbia, Mo.

The USPSTF also made the following recommendations:

  • In January, the AAFP and the USPSTF called for physicians to screen all women of childbearing age for intimate partner violence regardless of whether symptoms are present. For women who screen positive, physicians should provide or refer them to intervention services.
  • In April, the AAFP and the USPSTF issued new recommendations calling for routine screening of normal-risk adolescents and adults for HIV infection. However, the two organizations differed regarding the recommended age at which routine screening should begin. The task force called for screening beginning at age 15, while the Academy recommended screening at 18. The CDC, meanwhile, calls for such screening to begin at age 13.
  • Also in April, the task force proposed a reaffirmation of its position on screening for oral cancer in asymptomatic adults, issuing a draft recommendation statement that indicates current evidence remains insufficient to assess the balance of benefits and harms of testing.
  • The task force also issued a draft recommendation encouraging primary care physicians to screen women with a family history of breast or ovarian cancer using a screening tool specifically designed to pinpoint whether that family history may be associated with an increased risk for potentially harmful mutations in breast cancer susceptibility genes BRCA1 or BRCA2. In addition, the task force recommended that women with a positive screening result should receive genetic counseling and, if indicated after counseling, BRCA testing. However, the task force recommended against routine genetic counseling or testing for the majority of women outside this high-risk group.
  • The task force issued final recommendations on screening for hepatitis C virus infection, proposing routine screening of high-risk adults, as well as a one-time screen for all adults born between 1945 and 1965.
  • The USPSTF issued a draft recommendation in July proposing that physicians screen high-risk, 55- to 79-year-olds for lung cancer annually using low-dose CT scans. High-risk adults in this age group include those who have accumulated 30 cigarette pack-years and are still smoking or who quit within the past 15 years.
  • The task force released a draft recommendation in November recommending against using beta-carotene or vitamin E supplements to prevent cardiovascular disease or cancer.
  • The AAFP and USPSTF issued final recommendations that physicians provide interventions, including education or brief counseling, to prevent the initiation of tobacco use by school-aged children and adolescents. LeFevre said evidence shows there are intervention programs, including the AAFP's Tar Wars initiative, that family physicians can implement to reduce the number of adolescents who become regular smokers.

On the subject of tobacco, the AAFP continued its efforts to curtail its use, including sending an Aug. 7 letter urging the FDA to ban the use of menthol in cigarettes and other tobacco products.

Vaccines and Immunizations

The CDC -- with input from the AAFP and other primary care organizations -- made several changes to its immunization recommendations, including a move to combine its previously separate child and adolescent schedules into a single 0- to 18-year schedule. Among other changes to the schedule was a recommendation that infants ages 6 months through 11 months who are traveling anywhere outside the United States should receive measles, mumps and rubella (MMR) vaccine.

Lack of MMR immunization generated news in August when the CDC noted that 159 measles cases had been reported, marking the second-largest number since U.S.-originated cases of the viral infection were eliminated in the United States in 2000. Unvaccinated individuals accounted for 131 cases, and 79 percent of those patients had philosophical objections to the vaccine.

"These diseases are still out there," said Anne Schuchat, M.D., director of the CDC's National Center for Immunization and Respiratory Diseases. "They are literally a plane ride away, and every day, about 11,000 babies are born in the United States completely vulnerable to all of these diseases."

The CDC's adult immunization schedule was updated with two new recommendations for tetanus, diphtheria and acellular pertussis (Tdap) vaccine. Specifically, all adults ages 65 and older should be offered the vaccine, and all pregnant women should receive a dose of Tdap in the late second or early third trimester of each pregnancy, regardless of their Tdap immunization history.

A July report from the CDC showed that HPV vaccination coverage among adolescent girls flattened out in 2012, and rates actually decreased for completion of the three-dose series despite the availability of safe and effective vaccines.

In November, the agency announced it had identified a cluster of late vitamin K deficiency bleeding involving four Tennessee newborns whose parents had declined vitamin K prophylaxis. Three infants had bleeding within the brain, and the fourth presented with gastrointestinal bleeding.

In other vaccine news, Merck & Co. Inc. recalled 743,360 vials of its quadrivalent HPV vaccine Gardasil in December because some of the vials may be contaminated with minute glass particles resulting from breakage during the manufacturing process.

Diseases and Outbreaks

An outbreak of infection caused by Cyclospora cayetanensis affected more than a dozen states. In August, epidemiologic investigations by health departments in Nebraska and Iowa linked the outbreaks to prepackaged salads from Mexico.

A novel tick-borne illness that presents with undifferentiated flu-like symptoms similar to those seen in patients with Lyme disease made news in July when it was detected in the Northeastern United States.

Obesity continued to make news, with the AAFP's delegation to the AMA House of Delegates supporting a measure that declared obesity to be a disease. The declaration dominated headlines and sparked discussion by stakeholders across the country.

Meanwhile, researchers at Boston Medical Center and Boston University School of Medicine found evidence that obesity may be an independent risk factor for Clostridium difficile infection.

A study about the AAFP's Americans in Motion-Healthy Interventions (AIM-HI) program showed clinically significant before and after improvements in outcomes for patients in 21 U.S. family medicine practices using the AIM-HI program, which defines fitness as a combination of physical activity, healthy eating, and emotional well-being. Researchers found that 16.2 percent of patients who completed a 10-month postintervention visit and 10 percent of all patients enrolled lost 5 percent or more of their body weight.

Another study that compared aerobic training and resistance training found that aerobic training led to more weight loss than resistance training.

In November, the CDC issued a health advisory in response to reports of eight cases of serogroup B meningococcal disease in students at Princeton University and three cases in students at the University of California, Santa Barbara.

FDA Actions

Throughout the year, the FDA announced numerous actions that were designed to protect public health, many of which affected family physicians and their patients.

  • In January, the FDA issued a drug safety warning regarding a possible risk of "significant" liver injury associated with the use of the selective vasopressin V2-receptor antagonist tolvaptan. The agency is urging clinicians to conduct liver tests promptly in patients who report symptoms that may indicate liver injury.
  • In March, the FDA said use of the antibiotic azithromycin (Zithromax or Zmax) can lead to a potentially fatal irregular heart rhythm in people with certain risk factors.
  • In May, the agency issued a drug safety communication that said administering magnesium sulfate injection to stop preterm labor in pregnant women -- an off-label use of the drug -- for longer than five to seven days may lead to low calcium levels and bone problems in a developing fetus, including osteopenia and fractures.
  • In September, FDA officials proposed mandating class-wide label changes to extended-release and long-acting (ER/LA) opioids, including a new boxed warning for pregnant women, as well as imposing a postmarketing research directive on manufacturers of these drugs. The agency said ER/LA opioids should be prescribed only to manage pain severe enough to require daily, around-the-clock, long-term treatment and are not indicated for as-needed pain relief.
  • In November, the FDA lifted restrictions the agency had placed on the diabetes medication rosiglitazone (Avandia) based on research findings that failed to confirm a link between use of the drug and an increased risk for cardiovascular events.
  • Finally, in December, the FDA issued a proposed rule that would require manufacturers of OTC antibacterial products to submit research showing they are "generally recognized as safe and effective." Manufacturers that fail to submit such data would be required to reformulate or relabel their products.


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