Patient, Healthcare Groups Urge FDA to Ensure Patient Access to Prescription Medications amid Hydrocodone Rescheduling Debate

Published Online: Monday, February 4, 2013
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February 4, 2013

Arlington, Va. – In continuing efforts to ensure patient access to much-needed prescription medications, patient and healthcare groups sent a letter urging the Food and Drug Administration (FDA) to reject the rescheduling of combination hydrocodone products from Schedule III to Schedule II. 

In January, the FDA’s Drug Safety and Risk Management Advisory Committee voted in favor of rescheduling combination hydrocodone products into Schedule II.  If enacted, this rescheduling would pose significant challenges for patients to access medications to manage chronic pain and related conditions. 

The following groups signed the letter: American Academy of Pain Management (AAPM), American Association of Nurse Assessment Coordination (AANAC), American Cancer Society Cancer Action Network (ACS CAN), American Society of Consultant Pharmacists (ASCP), Amputee Coalition, CarsonCompany, LLC, Citizen Advocacy Center (CAC), Interstitial Cystitis Association, Long Term Care Pharmacy Alliance (LTCPA), Massachusetts Pain Initiative, NADONA, National Association of Chain Drug Stores (NACDS), National Community Pharmacists Association (NCPA), National Fibromyalgia & Chronic Pain Association, National Hospice and Palliative Care Organization, Pain Treatment Topics, US Pain Foundation and the Wisconsin Pain Initiative.

“No evidence currently exists to show that reclassifying hydrocodone will curb misuse and abuse of pain medications.  In contrast, there is evidence that rescheduling medications to higher classifications can reduce patient access to medications and cause harm,” the groups stated in the letter.

“The Institute of Medicine (IOM) has documented that there are 100 million Americans living with chronic pain.  That number does not count Americans with acute pain annually estimated by the CDC to be 46 million from surgery alone.  Rescheduling these medications is a drastic measure that would have far-reaching consequences; chief among them would be loss of pain control for millions of Americans,” the letter stated. 

The letter also cited patient access challenges and increased costs for patients and the overall healthcare delivery system if this scheduling change is approved.

“Prescriptions for Schedule II medications cannot be transmitted by telephone or fax, nor can they be refilled.  The proposed policy change would require patients to see their doctor for office visits with greater frequency simply to refill a prescription.  [In addition] rescheduling these medications would unnecessarily introduce inefficiencies and increase healthcare costs at a time when policymakers are seeking ways of increasing efficiencies and reducing costs,” the groups stated in the letter.

In the letter, the groups offered solutions to help curb drug abuse and diversion, including targeting illegitimate drug sellers, better educating prescribers and youth, better utilizing prescription drug monitoring programs, and establishing a permanent medication disposal program.   

“The prescription drug abuse problem can be successfully curbed.  However, we urge FDA not to recommend unworkable provisions, such as moving all combination hydrocodone products into Schedule II.  Combating prescription drug abuse must take a holistic approach.  All affected stakeholders must work proactively to tackle and resolve this complex problem,” the letter concluded.

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