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NCPA to FDA: Rescheduling hydrocodone combo products to create headache for legitimate pain patients

ALEXANDRIA, Va. — The National Community Pharmacists Association on Monday submitted comments to the Food and Drug Administration urging the agency to preserve access to hydrocodone-containing pain relief products, as FDA considers moving the medications from the Drug Enforcement Administration’s Schedule III list of controlled substances to the more restrictive Schedule II list.

“NCPA understands the concerns about diversion and abuse of these products and shares these concerns,” stated Ronna Hauser, NCPA VP policy and regulatory affairs. “Nevertheless, moving all of these hydrocodone products to Schedule II will result in significant barriers for patients who have a legitimate need for these products and it will result in adding to the nation’s health care costs with no assurance of a reduction in diversion and abuse.”

NCPA advised the proposed change would create an inordinate amount of hurdles in prescribing the prescription-strength pain reliever such as preventing prescribers from phoning in prescriptions to pharmacies, stopping prescription refills, limiting who can prescribe, and in some instances, prohibiting electronic prescribing. NCPA also suggested that rescheduling would likely increase the value of illicit hydrocodone products, which may prompt more crimes against pharmacies.

NCPA identified for the FDA a range of alternative solutions to reduce drug abuse without the harm to patients that rescheduling hydrocodone would cause. These included more effective education of prescribers, linking their DEA registration to such training; prescription drug monitoring databases and programs; shutting down rogue pain clinics; offering more disposal options for excess medications; greater use of electronic prescribing; and more scrutiny of controlled substances delivered by mail order pharmacies.


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