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ADA, AAOMS recommend against controlled substance reclassification

October 15, 2012

By Craig Palmer, ADA News staff

Washington—The ADA and American Association of Oral and Maxillofacial Surgeons told federal regulators that reclassification of hydrocodone-containing combination drug products “could cause inconvenience, unnecessary suffering and higher out-of-pocket costs for patients with a legitimate need” for the medications.

“It is unclear how rescheduling HCCs from C-III to C-II would alter dentist prescribing patterns,” the dental organizations told the Food and Drug Administration, which is weighing a Drug Enforcement Administration request for a scientific and medical evaluation and scheduling recommendation for HCCs in response to reports of misuse, abuse and addiction related to these products.

The FDA scheduled an Oct. 29-30 meeting of its drug safety and risk management advisory committee to discuss the public health benefits and risks, including the potential for abuse, of drugs containing hydrocodone either combined with other analgesics or as an antitussive.

The two dental organizations submitted a joint statement Oct. 15 to the advisory panel.

Dr. Frederick A. Curro, representing the American Dental Association, will address the advisory panel on The Clinical Impact of a Proposed Drug Schedule Change for Hydrocodone Combination Analgesic Products. Dr. Curro is director of the PEARL (Practitioners Engaged in Applied Research and Learning) Practice Based Research Network, regulatory affairs director for the Bluestone Center for Clinical Research and New York University College of Dentistry Department of Oral Radiology, Pathology & Medicine clinical professor.

“The ADA and AAOMS prefer education and communication over regulatory changes that are likely to negatively impact dental patients in pain,” said the jointly submitted statement. “As a strategy for keeping prescription drugs from being illegally diverted for non-medical use, we recommend against changing the controlled substance classification of HCCs from C-III to C-II.”

“We appreciate the DEA's concern about how children and teens are unduly accessing prescription opioid medications. Fortunately, the current strategy of expanding prescription drug monitoring programs and educating patients and caregivers about how to properly secure, monitor and dispose of their unused, unwanted or expired prescription medications seems to be working,” officials of the organizations told the FDA in a cover letter.

“As prescribers of opioid pain medications, dentists and oral surgeons are well positioned to counsel patients and caregivers about keeping prescription medications from becoming a source of harm. This is one reason the ADA and AAOMS have been collaborating with public and private stakeholders to educate dental practitioners about judicious opioid prescribing and counseling patients and caregivers about how to safely secure, monitor and dispose of unused, unwanted and expired medications. Information about these activities is available online at RX Abuse.”

Dentists must register with the Drug Enforcement Administration to prescribe controlled substances.