When it comes to the use of hydrocodone-combination products in the treatment of chronic pain, federal regulators think patients need to be protected from themselves—and the physicians who treat them.
At least that’s what some in the health care community have accused the FDA and Drug Enforcement Administration (DEA) of thinking after the agencies’ joint proposal to reclassify combination products that include the opioid analgesic from Schedule III to Schedule II controlled substances. Combination products such as hydrocodone-acetaminophen are among the most prescribed medications in the United States, despite concerns regarding the potential for abuse, misuse and addiction of opioids. Pure hydrocodone is already a Schedule II substance, as are methadone and oxycodone.
The DEA and FDA first proposed the change in October 2013, and their recommendation was endorsed by the Department of Health and Human Services in December. According to DEA spokesperson Barbara Carreno, at press time, the agency was “in the process of drafting the notice of proposed rulemaking,” which is the first step in making a schedule change for a drug under the Controlled Substances Act. The notice will then have to be published in the Federal Register, at which time the DEA will begin to collect public comments on the matter.
“DEA is concerned about the safety of how hydrocodone is used,” Ms. Carreno said. She would not “speculate on how long [the process] will take,” but the schedule change will likely not take effect for several months, if at all. In other words, those opposed still have the opportunity to have their voices heard; however, they may be swimming against the tide, given that opinion among the relevant government agencies is unified.
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