Upscheduling of Hydrocodone: Convenience and Access vs Patient Safety Measures

Abstract

The Controlled Substance Act of 1970 designates drugs into one of five schedules, based upon medicinal value, harmfulness, and potential for abuse and addiction [1]. Schedule I drugs are those considered to have a high potential for abuse with no medicinal value, Schedule II drugs have a high potential for abuse with medicinal value, Schedule III designates drugs that have a lower potential for abuse than Schedule I and II drugs, Schedule IV drugs have a low potential for abuse, and Schedule V drugs are thought to have an abuse potential even lower than those designated as Schedule IV. A controversial decision by the US Food and Drug Administration (FDA) in 1971 permitted hydrocodone to have a split Schedule, with pure hydrocodone designated as a Schedule II drug and hydrocodone combined with acetaminophen designated as Schedule III [2]. However, at present, hydrocodone is not sold commercially in the United States in its pure form, but rather always in combination with another medication. In January of 2013, an FDA advisory committee determined that hydrocodone required tighter regulation owing to its high abuse potential. Accordingly the recommendation was to upschedule hydrocodone combination products from Schedule III to Schedule II. Currently, the FDA is deciding whether it will enact the advisory committee’s recommendation. The issue, the committee recommendation, and the history of FDAs stance have generated significant controvery. In this month’s Ethics Forum, Dr. Andrew Kolodny, the President of Physicians for Responsible Opioid Prescribing (PROP) elucidates the position that the upscheduling of hydrocodone is an imperative based upon its potential for abuse and lethality. The opposing viewpoint is presented by Dr. Anna Lee and Dr. Jeffrey Gudin, a nationally renowned pain management specialist; both physicians are concerned with the potential negative consequences associated with reclassification; namely, the undertreatment of pain.