2013 legislation aims to protect patients

               

By Bruce Brod, MD
Chair, AADA State Policy Committee

Dermatology patients nationwide will be better served should numerous pieces of state legislation designed to improve patient safety become enacted. Anticipating the U.S. Food and Drug Administration’s approval of biosimilars in the next few years, legislation has been introduced in 16 states that would specify the circumstances under which a biologic can be substituted with a biosimilar. Mirroring the AADA’s position statement, adopted November 2013, the AADA and state dermatology societies have sought amendments that would require the pharmacist to notify a physician 24 hours prior to substitution. To date, Governor Herbert of Utah, Governor McDonnell of Virginia, and Governor Dalrymple of North Dakota signed legislation that would provide for physician notification after dispensing. The laws vary with respect to the notification piece, ranging from within 24 hours of the substitution (North Dakota) to three business days (Utah) to five business days (Virginia). The AADA’s position statement provides for physician notification 24 hours prior to dispensing.

Multiple states are turning their attention toward compounding pharmacies after last year’s meningitis outbreak was caused by contaminated compounded injectable medication mixed at a large compounding pharmacy in Massachusetts. The issues that have emerged as a result of the outbreak include: inspection of pharmacies, differences between manufacturing and compounding, enforcement and funding of enforcement, and single-use injectables. Approximately 11 states have introduced legislation addressing some of the issues above. For example, legislation in Massachusetts would prohibit a pharmacy from compounding sterile compound drug products unless the pharmacy has obtained a Sterile Products specialty license from the pharmacy board.

Several states are addressing patient safety issues in cosmetic surgical facilities. Multiple pieces of legislation have been introduced in Maryland after the death of a woman at a medical spa, allegedly resulting from non-sterile practices. The bill, which has passed the House, would authorize the health department to establish standards under which procedures are deemed cosmetic surgical procedures based on findings that such procedures raise substantial health and safety concerns. The department would also establish standards for cosmetic surgical facilities and retain the existing law that sets the threshold for obtaining accreditation for liposuction at 1000 ccs or higher of aspirate.

Lastly, 2013 has seen an increase in states that seek to protect minors from indoor tanning. To date, 28 states have introduced legislation that would increase protection of minors. The protections range from under 18 bans to requiring written parental consent. The AADA has been working closely with state dermatology societies, state medical societies, the American Society of Dermatologic Surgery Association, patient survivor groups, and other stakeholders to advance such legislation.

Dr. Brod is chair of the AADA’s State Policy Committee, and he also serves as advisor to the AADA's State Society Development Task Force. He is a clinical associate professor of dermatology at the University of Pennsylvania Perelman School of Medicine.