FDA Backs New Restrictions on Hydrocodone Painkillers

In an attempt to stem the abuse of hydrocodone combination products, the agency will recommend that they be reclassified as Schedule II drugs from their current status as Schedule III drugs.

The FDA has announced that it will recommend tighter restrictions on commonly prescribed painkillers that include hydrocodone in combination with other drugs such as acetaminophen or aspirin. The announcement, made on October 24, 2013, calls for reclassifying hydrocodone combination painkillers such as Vicodin and Lortab as Schedule II drugs from their current status as Schedule III drugs. It follows a recommendation from an expert advisory panel earlier this year, although the FDA has rejected similar advice in the past.

The new classification would reduce the length of time that patients can get refills of the medications without a new prescription to 90 days from the current limit of 180 days. Patients would also have to take prescriptions for the drugs to their pharmacy rather than having a doctor call them in. The classification change would require pharmacists to meet new storage and record-keeping requirements for the drugs. And, in some states, nurse practitioners and other health care providers who can currently prescribe the drugs would no longer be able to do so.

Drugs containing hydrocodone represent about 70% of all opioid prescriptions, and those in favor of tighter restrictions have argued that the relatively loose rules covering their prescription has led to increased levels of abuse. Opponents of tighter regulations have argued that the restrictions would prevent patients from getting the pain relief they need.

“While the value of and access to these drugs has been a consistent source of public debate, the FDA has been challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse,” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in a statement explaining the recommendation.

B. Douglas Hoey, RPh, MBA, CEO of the National Community Pharmacists Association, criticized the FDA’s move in a statement: “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 nursing home and long-term care settings.”

The National Association of Chain Drug Stores also criticized the decision, with a statement that read in part: “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.”

Dr. Woodcock announced that the FDA plans to submit a formal recommendation regarding the reclassification to the Department of Health and Human Services (HHS) by early December. The change would need to be approved by both HHS and the Drug Enforcement Administration. Schedule II drugs are considered to have the highest potential for abuse of drugs that can legally be prescribed. Other drugs classified as Schedule II include the painkillers oxycodone, methadone, and fentanyl.

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