August 21st, 2014 by Pat Anson, Editor
The most widely prescribed drug in the U.S. will soon be harder to get.
The Drug Enforcement Administration has announced it is publishing in the Federal Register its Final Rule for the rescheduling of hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II.
“The DEA finds that the scientific, medical, and epidemiological data are robust and support rescheduling HCPs into schedule II of the CSA (Controlled Substances Act). Various drug abuse indicators for HCPs indicate that HCPs are widely diverted and abused at rates largely similar to that of oxycodone products,” the DEA said in the Final Rule.
The rescheduling, which takes effect in 45 days, means that pain patients taking Vicodin, Lortab, Lorcet or other HCP painkillers will be limited to an initial 90-day supply and then will have to see a doctor each time for a prescription when they need a refill. Prescriptions for Schedule II drugs also cannot be phoned or faxed in by physicians.
The rescheduling will affect dozens of pain medications that contain hydrocodone (a complete list is available here). Typically in these products, the hydrocodone is combined with either aspirin or acetaminophen. Over 130 million prescriptions are written annually in the U.S. for HCPs – drugs that the DEA says have a “high abuse potential.”
Oxycodone, codeine and some other opioid painkillers are already classified as Schedule II drugs.
“Almost seven million Americans abuse controlled-substance prescription medications, including opioid painkillers, resulting in more deaths from prescription drug overdoses than auto accidents,” said DEA Administrator Michele Leonhart, “Today’s action recognizes that these products are some of the most addictive and potentially dangerous prescription medications available.”
The DEA first recommended reclassifying HCPs several years ago, a move opposed by the Food and Drug Administration, as well as many physicians, pharmacists, and patients who feared the drugs would become too hard to get.
Last year the FDA changed its position, citing an “epidemic” of overdoses and deaths caused by prescription opioid painkillers. The agency was also under strong political pressure to back the rescheduling.
“I am confident that rescheduling hydrocodone will undoubtedly begin saving hundreds of thousands of lives immediately,” said U.S. Sen. Joe Manchin of West Virginia, a longtime critic of the FDA.
“Family lives are ripped apart because of addiction and overdose deaths. Grandparents, great grandparents and neighbors are raising kids whose parents suffer from addiction. Students are unable to play outside because too many needles blanket their playgrounds. These circumstances are too common and simply unacceptable, which is why I am so grateful that the DEA has finalized the rescheduling process of hydrocodone.”
The DEA received 573 public comments on the rescheduling of HCPs. Over half (52%) supported the rescheduling and 41% opposed it.
“The U.S already loses hundreds of billions of dollars a year in productivity to chronic pain. Rescheduling hydrocodone will make this figure even worse. It will also add stress and undue burden to the people in pain who can’t see a pain specialist for a few weeks because of the doctor being booked,” said Andy, a chronic pain sufferer.
“I firmly believe that hydrocodone should remain a Schedule III medicine. It is a lifesaver for people who are in severe pain and cannot get a pain management specialist appointment soon enough.”
“Rescheduling the products to Schedule II would create significant hardships for all — leading to delayed access for vulnerable patients with legitimate chronic pain,” the National Community Pharmacists Association said in a statement.
But the DEA insists the agency “does not intend for legitimate patients to go without adequate care” and that patients will still be able to get the drugs if their doctor writes a prescription for them.
“There may be some practitioners who are reluctant to prescribe a schedule II controlled substance although authorized by State law to do so. However, the DEA notes that other schedule II controlled substances are widely prescribed. Given that classification has not deterred practitioners from prescribing those drugs, the DEA believes that when a practitioner makes a medical determination that a particular controlled substance is appropriate to treat a patient’s medical condition, the practitioner will prescribe the appropriate controlled substance, regardless of the substance’s schedule,” the DEA said in the Final Rule.