TMA opposes schedule change for hydrocodone
In February, the Drug Enforcement Ad- ministration (DEA) announced its pro- posal to reschedule hydrocodone com- bination products from schedule III to schedule II controlled substances. Sched- ule II substances carry a higher risk for physical and psychological dependence than drugs in schedules III through V. DEA says it bases its proposal on a
recommendation from the Assistant Secretary for Health for the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). If finalized, the schedule change would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II con- trolled substances to those who manu- facture, distribute, dispense, import, export, engage in research of, conduct instructional activities on, or possess hy- drocodone. The Texas Medical Association Coun- cil on Science and Public Health spoke out against DEA’s proposed schedule change in May at TexMed 2014, TMA’s annual conference.
Angelina County Medical Society sub- mitted a resolution to the TMA House of Delegates, asking them to write a formal letter to DEA opposing the change.
According to the resolution, the schedule change would negatively af- fect patients in rural areas who live more than 90 miles from their treating physician because schedule II controlled substances can’t be renewed via tele- phone or fax. The resolution also states the change could incline physicians to prescribe a patient more hydrocodone in the initial prescription to avoid the has- sle of getting the patient a refill, thereby creating a greater opportunity for abuse. The TMA House of Delegates voted
to reaffirm TMA’s 2004 opposition to the schedule change for hydrocodone and write a letter to DEA expressing its policy.
In April, HHS released a draft FDA-
SIA report proposing a strategy for HIT that would promote product innovation, protect patient safety, and avoid regula- tory duplication. In particular, the report,
http://1.usa.gov/1ja6tl8, recommends clarifying oversight of HIT products based on a product’s function and its po- tential risk to patients. Products with medical device HIT functions pose greater risks to patients and require more oversight than do products with administrative or health management functions, the report says. Products with medical device HIT
HIT report aims to protect patients
The Department of Health and Human Services (HHS) recommends more over- sight of health information technology (HIT) products that deal with medical devices designed for patient care. In 2012, Congress passed the Food and Drug Administration Safety and In- novation Act (FDASIA), which required FDA to work with the Office of the Na- tional Coordinator (ONC) and the Fed- eral Communications Commission (FCC) to develop regulatory HIT framework.
functions include computer-aided detec- tion software, software for bedside moni- tor alarms, and radiation treatment soft- ware. If these types of products do not perform as intended, they pose a risk to patient safety, the report says. The report found products with ad-
ministrative HIT functions, including software for billing and claims process- ing, scheduling, and practice and inven- tory management, pose little or no risk to patient safety. Likewise, products with health management HIT functions, including software for health informa- tion and data management, medica- tion management, provider order entry, knowledge management, electronic ac- cess to clinical results, and most clinical decision support software, pose little risk to patients, and FDA does not intend to focus its oversight on those products. The report also proposes ONC create a public-private HIT Safety Center in collaboration with FDA, FCC, and the HHS Agency for Healthcare Research and Quality. The center would develop best practices and provide a forum for the exchange of ideas and information focused on patient safety. HIT products present many potential benefits to physicians, but can pose a safety risk to patients. The safety of HIT relies not only on a product’s design and development but also on its customiza- tion, implementation, integration, and use, the report says. n
Kara Nuzback is a reporter for Texas Medicine. You can reach her by telephone at (800) 880-1300, ext. 1393, or (512) 370-1393; by fax at (512) 370-1629; or by email at
kara.nuzback@
texmed.org.
60 TEXAS MEDICINE July 2014
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