Linda Kimble - Comment

Document ID: FDA-2012-N-0548-0004
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: August 29 2012, at 12:00 AM Eastern Daylight Time
Date Posted: September 5 2012, at 12:00 AM Eastern Standard Time
Comment Start Date: June 8 2012, at 12:00 AM Eastern Standard Time
Comment Due Date: November 6 2012, at 11:59 PM Eastern Standard Time
Tracking Number: 810fa796
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[Docket No. FDA-2012-N-0548] It has come to my attention that the Drug Safety and Risk Management Advisory Committee is considering the changing of hydrocodone from schedule III to a schedule II drug. I believe that this will lead to many provider issues and promote patient sufferring. As a schedule III drug, Hydrocodone is within the scope of the nonphsician provider in most states. Many patients with acute and chronic pain are dependent on the ability of the APN or PA to order them medicines that will relieve their pain. All scheduled medicaitons have the potential for abuse of some kind, but to put more and more restrictions on the providers who are prescribing treatment, puts the patient in jeopardy. I have personally had both acute and chronic pain, and know what it is to be denied needed treatment, spending over four months on schedule III drugs, and, eventually, spinal surgery. My patients with chronic and acute pain are in need of appropriate treatment. Prior to 2012, as an APN in Ohio, if hydrocodone was a schedule II drug, I would not have been able to prescribe the appropriate drug for the patient. Please do not change hydrocodone to a schedule III and tie the hands of APN's and PA's who are limited to schedule III - V drugs across the states. Consider those patients who are dependent on access to appropriate pain management and keep hydrocodone as a schedule III. Patients who are legitimately on hydrocodone on a specific dose and interval, who have been on it for chronic illness, do not see the tolerance that develops in true addiction. Many chronic pain patients may receive dosing of one, two, or three times daily for years without having to have their dose or the interval changed. I believe that this drug is safe and effective for patients with chronic and acute pain. Changing it to a schedule II will limit access for those patients who have nonphysician providers who do not have schedule II prescriptive authority.

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