FDA Considers Reclassification of Controlled Substances
The U.S. Food and Drug Administration (FDA) is proposing recommendations regarding a more restrictive classification of hydrocodone-containing combination drug products (HCCs). These recommendations are the result of an increasing concern related to the abuse and misuse of opioid products, which over the years has become a prevalent issue in certain parts of the United States, especially among teens and adults. After a thorough analysis of scientific literature, review of public comments, and several public meetings, the FDA is proposing to change the Schedule of HCCs, such as Vicodin, from Schedule III to Schedule II, which would increase the controls on these products, and alter the prescribing abilities of physicians and dentists. By early December, the FDA plans to submit a formal recommendation to Department of Health and Human Services (HHS) to reclassify HCCs into Schedule II; the FDA anticipates receiving support on their recommendation from the National Institute on Drug Abuse. The final decision regarding the scheduling of HCCs will be made by the U.S. Drug Enforcement Administration (DEA), which sought a recommendation from the HHS regarding the change in schedule for HCCs in 2009.
In a joint response to the FDA’s recommendation, the American Dental Association (ADA) and the American Association of Oral Maxillofacial (AAOMS) stated that the classification of HCCs from Schedule III to Schedule II could “cause inconvenience, unnecessary suffering and higher out-of-pocket costs for patients with a legitimate need” for the medications. Although both the ADA and AAOMS appreciate the FDA’s concerns regarding the abuse of HCCs, both organizations believe their current drug monitoring programs and education of patients and caregivers regarding the disposal of unused, unwanted or expired prescription medications appear to be working. The ADA and AAOMS feel it is unclear how the rescheduling of HCCs will alter dentist prescribing patterns.
There are concerns that as a result of the increased restrictions of HCCs, dentists would be more likely to prescribe more doses of Schedule II drugs to help patients avoid the inconveniences of additional office visits and pharmacy copays, which could potentially increase the amount of unused medication in the household. Both organizations question whether heightened restrictions on HCCs would effectively address the underlying problem of drug abuse, as it is likely that such restrictions could lead to increased emergency room visits or self-medicating with alcohol or the medication of others when prescription refills are not readily available. The ADA and AAOMS state that the reclassification of HCCs will significantly impact patients with acute pain and restrict the ability of prescribers to effectively manage pre-operative and post-operative pain. The ADA and AAOMS consider dentists and oral surgeons, who prescribe opioid pain medications, to be well positioned to counsel patients about preventing prescription medication abuse and recommend against changing the classification of HCCs as they deem education and communication to be more effective than regulatory changes.
To view the full November 12, 2013 ADA article “FDA to Propose Pain Med Restrictions" and Statement on Proposed Hydrocodone Reclassification from Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research click here.