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“Hydrocodone Rescheduling: Yesterday’s Solutions for Today’s Problem”

DEA Chronicles By D. Linden Barber

FDA recently announced that it was recommending that hydrocodone combination products be moved from Schedule III to Schedule II under the Controlled Substances Act. The placement of hydrocodone combination products in Schedule II is a great idea — for 2003. But FDA’s belated action is unlikely to have a significant impact on prescription drug abuse. Moving hydrocodone combination products to Schedule II means that prescriptions for these products cannot be faxed to a pharmacy or phoned in by the prescriber. In the heyday of Internet pharmacies, this would have brought the computer-generated faxing of hydrocodone prescriptions to a screeching halt. But DEA succeeded in doing that with a multi-pronged enforcement strategy from 2005-2009. Then the Ryan Haight Act closed the door on any remaining domestic pharmacies engaged in questionable Internet pharmacy practices. All of this was accomplished while hydrocodone combination products were in Schedule III.

Some commentators have claimed that rescheduling hydrocodone will reduce prescription drug abuse because of the social stigma attached to Schedule II drugs and because prescribers cannot authorize refills on prescriptions for Schedule II drugs. Although not technically “refills,” DEA allows prescribers to issue multiple post-dated prescriptions for Schedule II drugs. The net effect of this rule is similar to permitting two refills for a Schedule II drug. Rescheduling hydrocodone will have only a limited effect on the ability to authorize multiple prescriptions based on a single visit to a physician. More to the point, there has been no evidence that the ability to authorize refills increases illicit prescribing or misuse of controlled substances. As for the social stigma of Schedule II drugs, we should remember the reported drug abuse issues involving Oxycontin, a Schedule II drug, prior to its more tamper-resistant reformulation. And what about the widespread abuse of oxycodone, a Schedule II drug, over the last 7 years? DEA continues to warn registrants about the growing abuse of hydromorphone and oxymorphone, both Schedule II drugs.

Then there are the unintended consequences of moving the most prescribed pain reliever to Schedule II. If hydrocodone 5 milligram combinations products have the same restrictions and purported stigma as other Schedule II drugs, perhaps prescribers will forego prescribing low-strength hydrocodone in favor higher strength single-entity oxycodone, methadone, and hydrocodone products. The timing of FDA’s recent approval of a high strength single-entity hydrocodone product — the first of its kind — provides a touch of irony when considering this possibility. Given the widespread abuse of oxycodone single-entity products, it is easy to imagine that single-entity hydrocodone products will also be subject to abuse. If there is any incentive to prescribe lower-strength hydrocodone products because they are in Schedule III, that incentive will disappear with rescheduling. Rescheduling hydrocodone combination products might lead to a decrease in the prescribing of those products, but it may also lead to an increase in the prescribing of higher-strength narcotics — an unintended consequence that would exacerbate the prescription drug abuse problem.

Prescription drug abuse, including the abuse of hydrocodone, is a serious problem that calls for serious solutions. Rescheduling hydrocodone combination products might help at the margins, but it does not address the real issues that drive prescription drug abuse like illicit demand and the existence of an illicit market for the products, lack of education for prescribers and patients, and the ever-growing supply of narcotics as revealed in the annual quotas established by DEA.

I hope that rescheduling hydrocodone combination products reduces prescription drug abuse, but I doubt it will have a significant impact. What do you think the impact of rescheduling hydrocodone will be?