FDA Approves OTC Emergency Contraception for Women 18 and Older
The U.S. Food and Drug Administration (FDA) has approved over-the-counter (OTC) sale of levonorgestrel (Plan B) for emergency contraception in women 18 years and older. The drug has been available by prescription since 1999 and still will be available for women 17 years and younger as a prescription-only option. It will be kept behind the counter, with proof of age required for purchase. The FDA’s announcement follows a lengthy process of advice, public comment, and negotiation to resolve various issues surrounding the marketing of the drug as an OTC product. The manufacturer sought approval of the drug as a nonprescription option for women 16 years and older in 2004, following which the FDA asked for public input on issues associated with a switch from prescription to OTC status. In August 2006, the FDA met with the manufacturer to discuss amendments to the application, including the raising of the minimum age to 18 years. The manufacturer committed to provide labeling and education about appropriate use of the drug, to ensure that it is not available from convenience stores or other retail outlets where it could be purchased without a prescription by women younger than 18, and to monitor the effectiveness of age-restriction methods. More information is available from the FDA Web site athttp://www.fda.gov/cder/drug/infopage/planB/default.htm.
Researchers Study Physician Perspectives on Testing Process Problems
In a recent study of the American Academy of Family Physicians’ National Research Network assessing the range of errors occurring in primary care testing processes, family physicians and their staffs identified problems at all stages, from ordering a test to taking follow-up action with a patient. A total of 139 physicians and staff members at eight practices participated in focus groups to discuss process problems, potential solutions, and perceived barriers to these solutions. The researchers found that although family physicians are aware of problems and understand the contributing factors and barriers to improvement, they still desire quick fixes that may not adequately address the errors. The most commonly cited contributing factors—not following procedures, inadequate systems, lack of standardization, and communication flaws—were closely related to commonly mentioned barriers—lack of leadership support and resistance to change. However, the desired improvements most often mentioned were technology improvement and increased staffing. The authors note that cultural barriers for organizational change are harder to overcome than process barriers. They state that practices wanting to decrease errors should solicit input from all staff, and that future research should assess solutions accounting for barriers to change. For more information and access to the study abstract, visithttps://www.aafp.org/news-now/clinical-care-research/20060823errorsstudy.html.
New Microchip-Based Test May Improve Diagnosis of Influenza Strains
A new microchip-based test may allow more laboratories to diagnose and determine critical information about influenza infections. Developed by scientists from the University of Colorado, Boulder, and the Centers for Disease Control and Prevention (CDC), the test distinguished among 72 influenza strains, including avian influenza A (H5N1), within 12 hours. The researchers hope to refine the test, enabling it to determine the type and subtype of a virus within one hour. Although many U.S. laboratories can perform basic tests to ascertain the type and subtype of a virus, further details can be determined only through specialized testing at laboratories with high-level biosafety facilities. The new test can be used in lower-level biosafety facilities and could allow more laboratories to determine a virus’s origin, whether its source is human, how closely it relates to previous viruses, and whether it is becoming more virulent. For more information, visithttp://www.cdc.gov/od/oc/media/pressrel/r060828.htm.
Number of Physicians Taking New Medicaid Patients Decreases
According to an analysis of data from the Center for Studying Health System Change, the proportion of U.S. physicians who accept new Medicaid patients has shown a slight decrease in the past 10 years. About 27 percent of family physicians accepted no new Medicaid patients in 2004–2005, compared with about 25 percent in 1996–1997. Across specialties, 21 percent of physicians accepted no new Medicaid patients in 2004–2005 compared with 19 percent in 1996–1997. The report states that the care of Medicaid patients is increasingly concentrated among a smaller group of physicians who practice in large groups, hospitals, academic medical centers, and community health centers. Small and single-physician practices accounted for 52 percent of total Medicaid physician revenue in 1996–1997 but only 42 percent in 2004–2005, whereas the proportion of revenue taken by medium and large practices and institutions increased. The decreased involvement with Medicaid among physicians in small practices could be a result of the relatively low payment rates and high administrative costs, the authors suggest. For more information and to access the full report, visithttps://www.aafp.org/news-now/professional-issues/20060824medicaiddocs.html.
CMS Administrator Announces His Resignation as of October 2006
The Centers for Medicare and Medicaid Services (CMS) Administrator Mark McClellan, M.D., Ph.D., announced in September that he will resign. McClellan will leave the post in October. As CMS Administrator from March 2004, McClellan oversaw the Medicare and Medicaid programs, which provide benefits to more than 80 million Americans and have an annual budget of $570 billion. Some of his primary responsibilities were the implementation of the Medicare Modernization Act and the Medicare prescription drug benefit, which began in January 2006. For more information, visithttps://www.aafp.org/news-now/government-medicine/20060906mcclellan.html.
CDC Projects Availability of 100 Million Influenza Vaccine Doses
Manufacturers of influenza vaccine expect to distribute more than 100 million doses in the United States by January 2007, the CDC announced. Most of the vaccine will be distributed in October and November, and all providers who ordered it should receive some vaccine by the end of October. The total doses expected to be available exceed last year’s total by almost 20 million, with about 15 million more doses being distributed by the end of October 2006 than were distributed by the end of October 2005. How much vaccine each provider receives depends on the manufacturer. The viruses in the 2006–2007 influenza vaccine are an A/New Caledonia/20/99 (H1N1)–like virus; an A/Wisconsin/67/2005 (H3N2)–like virus (A/Wisconsin/67/2005 and A/Hiroshima/52/2005 strains); and a B/Malaysia/2506/2004–like virus (B/Malaysia/2506/2004 and B/Ohio/1/2005 strains). Although October and November are the best months for vaccination, the CDC said, vaccinations administered in December or later still provide protection. It recommends that influenza vaccine be offered throughout the influenza season, even after infection in a community has begun. For more information, visithttp://www.cdc.gov/flu.
Conference on Electronic Patient Education to be Held in November
The Conference on Practice Improvement: Health Information and Patient Education (formerly the Conference on Patient Education) will be held in Denver, Colo., on November 9–12, 2006. This year the conference will focus on use of electronic health systems to enhance communication with patients, provide patient education, or improve quality of care in the management of chronic illness. More information about the conference and registration forms are available athttps://www.aafp.org/online/en/home/cme/aafpcourses/clinicalcourses/pec.html.
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