WASHINGTON — The Food and Drug Administration has recommended that Vicodin and other pain medications containing hydrocodone be reclassified as Schedule II drugs.
The recommendation now goes to the Department of Health and Human Services and the Drug Enforcement Administration for a final decision.
If implemented, the rescheduling will require drug stores to implement more stringent (and costly) storage and record-keeping requirements for the painkillers, which are among the most widely prescribed medications in the United States.
The federal government estimates that 131 million prescriptions for hydrocodone-containing medications were written for about 47 million patients in 2011.
Patients will face more restrictions as well. Currently patients can get refills for a Schedule III drug such as Vicodin for six months before they have to see a doctor again — twice as long as for a Schedule II drug such as OxyContin.
Pharmacy groups, and organizations such as the American Medical Association and the American Cancer Society, oppose the FDA-recommended change, arguing that it will make it more difficult and costly for chronic pain sufferers to get the medications they need.
“Pharmacies have zero tolerance for prescription drug abuse and a 100% commitment to patient care,” a statement by the National Association of Chain Drug Stores says. “This proposal is not the best avenue to address abuse, and would negatively impact access to needed medications for those who suffer from chronic pain. In the interest of patient care, we have worked with patient advocacy groups in opposition to this recommendation as we support and advance workable solutions.”
NACDS has backed legislation, introduced by Sen. Barbara Boxer (D., Callif.) that would create a commission of federal and state governmental agencies, law enforcement and health care professionals to collaborate on solutions for drug abuse and drug access alike.
Like NACDS, the National Community Pharmacists Association (NCPA) also opposes the change.
“There are more practical means available to reduce prescription drug abuse. ” NCPA chief executive officer B. Douglas Hoey said. “More effective education of prescribers, electronic prescription drug monitoring programs and tracking systems, and shutting down rogue pain clinics are all steps that can combat abuse without harming patients and the pharmacists caring for them.”