As of January 2013, the FDA is pushing to reschedule hydrocodone combination products from Schedule III to Schedule II, and this month plan to submit its formal recommendation package to the U.S. Department of Health & Human Services (HHS) Secretary, Kathleen Sebelius. The FDA is confident that the National Institute on Drug Abuse will stand alongside them on this recommendation, which will in turn help the HHS submit its recommendation to the DEA to make the ultimate decision on rescheduling the prescription drugs. The American Pharmacists Association (APhA) is completely against the proposed recommendation by the FDA.
The Association stated, “The APhA opposes FDA’s recommendation to reschedule hydrocodone to Schedule II because there is clear evidence that this change will reduce patient access to medications and cause harm—largely to patients living with chronic pain. Furthermore, rescheduling these medications will introduce inefficiencies and increase healthcare costs at a time when policymakers are seeking to do precisely the opposite.”
The National Community Pharmacists Association (NCPA) and the National Association of Chain Drug Stores (NACDS) also disagree with the FDA. “The FDA’s reported decision will likely pose significant hardships for many patients and delay relief for vulnerable patients with legitimate chronic pain, especially those in a nursing home and long-term care settings,” NCPA said in a statement. “There are more practical means available to reduce prescription drug abuse. For starters, more effective education of prescribers, electronic prescription drug monitoring programs and tracing systems, and shutting down rogue pain clinics are all steps that can combat abuse without harming patients and the pharmacists caring for them.”
The NACDS believes the proposal is not the best way to deal with prescription drug abuse and would make it very difficult for people who genuinely need the medication to deal with chronic pain to obtain it. They are in mutual agreement with the NCPA that there are more “workable” ways to handle the problem of those addicted to painkillers without causing stress and difficulty obtaining the painkillers for those who are not abusing the drugs.
This is a very debated topic that will surely not come to a close anytime soon.
Contact a CAP Medical Clinic near you for any questions or how this may affect you.