Four H1N1 Vaccines Demonstrate Safety and Effectiveness, Receive FDA Approval

The U.S. Food and Drug Administration (FDA) has approved four vaccines against the novel influenza A (H1N1) virus, and initial lots are expected to be distributed by mid-October 2009. Preliminary data from clinical trials showed a robust immune response in most healthy adults eight to 10 days after a single dose of unadjuvanted vaccine with 15 micrograms of antigen. Medicare and several of the nation's largest private health insurers have issued coding instructions for physicians to bill for H1N1 vaccine administration. Despite achieving FDA approval, uptake for the new vaccine is expected to be similar to that of seasonal influenza, which is relatively low. Although seasonal influenza vaccine is recommended for more than 80 percent of the U.S. population, less than 40 percent of Americans receive the vaccine each year. Moreover, less than one half of health care workers get immunized against seasonal influenza each year. Preliminary data from the clinical trials indicate that health care workers who are immunized with the new H1N1 vaccine will help protect themselves, their patients, and their coworkers. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20090923h1n1-uptake.html or https://www.aafp.org/news-now/practice-management/20090916h1n1-paymt.html.

CDC and IOM Update Recommendations for Influenza Treatment and Protection

In its updated guidelines for the 2009–2010 flu season, the Centers for Disease Control and Prevention (CDC) did not change its recommendations for who should receive antiviral medication. However, to avoid medication shortages and the development of antiviral resistance, the CDC is reminding physicians that most persons with influenza-like illness do not need antiviral medication. The updated guidelines suggest that physicians provide prescriptions to patients in high-risk groups to be filled at the onset of symptoms, after a telephone consultation with the physician. The updates also recommend that physicians educate high-risk patients about influenza symptoms and the importance of early treatment, as well as the potential for viral shedding after the initiation of treatment. Additionally, the Institute of Medicine (IOM) has endorsed the CDC's recommendation that health care workers who interact with patients with novel H1N1 infection or influenza-like illnesses should use fit-tested N95 respirators. When properly fitted, the respirators are designed to filter out at least 95 percent of particles as small as 0.3 micrometers, which is smaller than influenza viruses. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20090911cdc-antivir-upd.html or https://www.aafp.org/news-now/clinical-care-research/20090911n95-masks.html.

Study Shows Retail Clinics Provide Care Comparable with Other Settings

The cost and quality of health care provided by retail health clinics may be comparable with that of traditional health care settings, according to a study in the September 1, 2009, issue of Annals of Internal Medicine. The RAND Corp. study compared the care patients received at retail clinics with the care received in physician offices, urgent care centers, and emergency departments for three acute conditions: otitis media, pharyngitis, and urinary tract infection. Researchers found that retail clinics provided services at a lower cost than alternative settings, with similar quality of care and no adverse effect on the delivery of preventive care. However, the study did not address how the expansion of retail health clinics might affect the fragmentation of health care or the communication between physicians and patients. In response to the study findings, American Academy of Family Physicians (AAFP) President Ted Epperly, MD, of Boise, Idaho, said that although retail clinics may be convenient for patients who do not have a primary care physician, or for patients with a symptom-limited urgent problem, they are not a replacement for the patient-centered medical home. For more information, visit https://www.aafp.org/news-now/professional-issues/20090916rand-retail.html or the Annals of Internal Medicine Web site at http://www.annals.org/cgi/content/full/151/5/321.

Physician Groups Call on Congress to Replace Sustainable Growth Rate Formula

The AAFP has joined with several physician groups to remind lawmakers that Congress needs to replace the sustainable growth rate (SGR) formula as part of any comprehensive health care reform plan. In a September 18, 2009, letter to the Senate, the groups note that physicians will face a payment cut of about 21 percent in 2010 if lawmakers do not act. The letter is in response to a recently introduced bill from the Senate Finance Committee that proposes a one-year SGR patch, but does not replace the formula. AAFP Board Chair Jim King, MD, of Selmer, Tenn., reiterated the need for a replacement Medicare physician payment system to avoid further substantial cuts over the next several years. In the House, the three committees responsible for drafting health care reform legislation have approved a tricommittee bill that would eliminate the SGR. However, according to King, the Senate Finance Committee is having trouble finding the money needed to offset a repeal of the SGR. For more information, visit https://www.aafp.org/news-now/government-medicine/20090923joint-ltr.html.

MED WATCH: FDA Advises Physicians to Use Caution When Prescribing Tamiflu

The FDA has issued a public health alert to warn physicians about potential dosing errors with oseltamivir (Tamiflu) oral suspension, one of the medications used to treat the novel H1N1 virus. According to the agency, U.S. physicians typically write prescriptions for liquid medications in milliliters or teaspoons. However, dose recommendations on the Tamiflu package insert are provided in milligrams, and the dosing dispenser included with the drug is marked at 30, 45, and 60 milligrams. The FDA has received reports of dosing errors, which could lead to a patient receiving an inadequate dose or an overdose. Physicians are encouraged to make sure that prescriptions match the units of measure on provided dosing dispensers. The FDA also said physicians should not prescribe Tamiflu oral suspension in teaspoons, and instructed pharmacists to convert such prescriptions to milliliters and to provide an appropriate dosing dispenser. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20090928tamifludosing.html.

Primary Care Physician Shortages Linked to Challenges in Graduate Medical Education

Primary care physician residency programs are plagued by a lack of interest, support, and funding, all of which contribute to a shortage of primary care physicians, according to Russell Robertson, MD, chair of the Council on Graduate Medical Education. Robertson, a family physician, spoke before the Medicare Payment Advisory Committee in Washington, DC, to address factors undermining primary care residency programs, such as medical school admission policies. Robertson noted that although students from medically underserved communities continue to apply to medical schools in steady numbers, they are also more likely to be rejected. However, if accepted, these students are more likely to return to rural areas and practice primary care. Robertson also decried the lack of funding for Title VII of the Public Health Service Act, which provides funds to academic departments and programs to increase the number of primary care health professionals. Title VII funding in 2008 was less than one half of the 2002 funding level. For more information, visit https://www.aafp.org/news-now/professional-issues/20090923medpac-pcps.html.

U.S. Immunization Rates Remain High, but Fall Short of Healthy People 2010 Goal

Childhood immunization rates in the United States remained stable in 2008, according to a CDC report published in the August 28, 2009, Morbidity and Mortality Weekly Report. The report estimated vaccination coverage among children 19 to 35 months of age at the time of the survey. The U.S. Department of Health and Human Services' Healthy People 2010 initiative set vaccination coverage goals of 90 percent for each vaccine in the 4:3:1:3:3:1 series, and a goal of 80 percent for the entire series. The series includes four or more doses of diphtheria, tetanus, and pertussis vaccine; three or more doses of polio vaccine; one or more doses of measles, mumps, and rubella vaccine; three or more doses of Haemophilus influenzae type b vaccine; three or more doses of hepatitis B vaccine; and one or more doses of varicella vaccine. In 2008, coverage for the entire series was 76.1 percent, down slightly from 77.4 percent in 2007. Although immunization rates were relatively high, rates among children in families living below the poverty line were about 5 percent lower than rates among children whose families were at or above the line. For more information, visit https://www.aafp.org/news-now/health-of-the-public/20090916kid-vacc-rates.html.

Alternative Ointments Available for Ophthalmia Neonatorum Prophylaxis

The CDC has updated its recommendations on prophylaxis against ophthalmia neonatorum, or neonatal conjunctivitis. The recommendations were updated in light of the current shortage of erythromycin 0.5% ophthalmic ointment, which is the only FDA-approved product for this indication. Azithromycin 1% ophthalmic solution, which is marketed as Azasite, is an acceptable substitute if erythromycin ophthalmic ointment is unavailable. However, there are no clinical data on the effectiveness of azithromycin ophthalmic solution for this indication. The recommendation was made on the basis of available data on pharmacology and gonococcal micro-biologic sensitivity. According to the FDA, the shortage of erythromycin ophthalmic ointment was caused by a change in manufacturers, and the agency is working with drug makers to increase the supply. For more information, visit https://www.aafp.org/news-now/clinical-care-research/20090909neonatoph-tx-updt.html.

— AFP and AAFP NEWS NOW staff