DEA Reclassifies Hydrocodone Combination Products to Schedule II
On August 22, 2014, the U. S. Drug Enforcement Administration (DEA) published the Final Rule moving hydrocodone combination products (HCPs) from Schedule III to the more-restrictive Schedule II classification. The Final Rule in effective October 6, 2014.
The Controlled Substances Act (CSA) places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V. Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use. Hydrocodone combination products (HCPs) are drugs that contain both hydrocodone, which by itself is a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin.
Hydrocodone combination products include Vicodin, Norco, Lortab, Lorcet, and Vicoprofen.
The Final Rule was made to address concerns about the abuse potential of HCPs. The Centers for Disease Control report that drug overdose is the leading cause of injury death. More than 16,000 people die each year from pharmaceutical related death in the U.S. Hydrocodone is the most prescribed drug in the U.S. Americans consume 80 percent of the world’s supply of narcotics but only account for 4.6% of the world’s population.
What does this mean to patients who are prescribed hydrocodone? Doctors can no longer call in or fax prescriptions for HCPs. Prescribers will need to prepare HCP prescriptions on hard-copy, tamper-resistant prescription forms, for patients to bring to their pharmacy. Only a 30 day supply can be written. Refills are not allowed unless the patient is evaluated by a health care provider and then written by the provider.