Published 1/1/2014

Second Look—Advocacy

FDA requests label changes to OTC topical antiseptics
The U.S. Food and Drug Administration (FDA) is requesting label and packaging changes to enhance the safe use of certain over-the-counter (OTC) topical antiseptic products. The request is the result of an ongoing evaluation of infrequent but continuing reports of infections resulting from antiseptic products labeled for preoperative or preinjection skin preparation. Contamination of topical antiseptics may occur when organisms are introduced into the product by users. To reduce the risk of infection with improper topical antiseptic use and the possibility of such products becoming contaminated with bacteria during use, the agency is requesting that manufacturers package antiseptics indicated for preoperative or preinjection skin preparation in single-use containers. The FDA also recommends that providers follow label directions, not dilute products after opening, and discard applicators and any unused solution.

Drug Quality and Security Act
President Obama has signed the Drug Quality and Security Act, which increases federal oversight of large-scale compounding pharmacies and establishes a national prescription drug track-and-trace system. The legislation was spurred by an outbreak of fungal meningitis linked to contaminated steroid injections produced by New England Compounding Center.

Payments, participation in exchange networks
Although solid information on pay rates for physicians under Affordable Care Act insurance exchanges is difficult to obtain, some insurers appear prepared to pay physicians significantly less for exchange plan patients. In addition, information on the exchange networks themselves is often opaque, with some physicians unclear as to whether they are included in a network or not. Insurers are under significant pressure to keep exchange plans affordable, and suggest that physicians will make up for lower pay by seeing more patients.

These items originally appeared in AAOS Headline News Now, a thrice-weekly enewsletter that keeps AAOS members up to date on clinical, socioeconomic, and political issues, with links to more detailed information. Subscribe at www.aaos.org/news/news.asp (member login required)