Update – 2013 – Reclassifying Combination Medications

Submitted by Joshua M. Rosenow, MD

In January, The FDA’s Drug Safety and Risk Management Advisory Committee voted 19 to 10 in favor of reclassifying combination medications containing hydrocodone from Schedule III drugs under the Controlled Substances Act to Schedule II. This would impose significantly stricter prescribing rules on drugs containing hydrocodone, such as popular narcotic combination analgesic medications Vicodin, Lortab, Norco, and Vicoprofen. This would also affect anti-tussive medications containing hydrocodone.

The US Senate initially included this recommendation in an amendment to an FDA reauthorization bill passed in May 2012. That amendment was backed by Sen. Joe Manchin (D-WV). The vote was prompted by increasing implication of hydrocodone in deaths related to narcotic overdoses. The death rate from hydrocodone combination drug overdoses has tripled in the last 20 years. Over 130 million prescriptions for hydrocodone were written in the United States in 2011, making it the most prescribed narcotic analgesic. The United States is responsible for 99% of the world’s use of hydrocodone, per the International Narcotics Control Board.

This change would move hydrocodone combinations from schedule III, which contains medications such as Tylenol with codeine and buprenorphine to schedule II where it would be placed in the same class as hydromorphone, methadone, morphine, oxycodone, fentanyl, methylphenidate, and barbiturates. Schedule II drugs are described as having a high potential for abuse which may lead to severe psychological or physical dependence.” Plain hydrocodone is already classified in schedule II and this move would move combination drugs into that category as well.

Practically, this change would have significant implications with regards to hydrocodone combination prescribing practices. Schedule III drugs are eligible for up to 5 refills on a single prescription while schedule II drugs cannot be refilled without a new prescription. At most a single 90-day supply could be prescribed at once. The ability for nurse practitioners and physician assistants to prescribe schedule II drugs varies state by state. The rules for each state may be found at

The change is being driven not only by the increase in hydrocodone-related mortality, but also by the increasing number of DEA interventions due to skyrocketing narcotic distribution by select retail pharmacies. It was recently reported that several Walgreens pharmacies in Florida had seen the number of oxycodone doses they distribute increase astronomically over several years. One single Walgreens location saw their purchases grow to over 2.2 million doses per year from just 95,000 doses per year 2 years earlier. The average retail pharmacy handles 73,000 doses of oxycodone per year, according to Pain Medicine News. Given that similar numbers were seen at several other Walgreens locations in Florida, it is not surprising that the DEA took steps to investigate these sites, as well as the Walgreens distribution center in Jupiter, Florida.

While many groups, such the American Society of Addiction Medicine, Physicians for Responsible Opioid Prescribing, and Public Citizen’s Health Research Group have hailed the vote as a major move to prevent hydrocodone abuse, others point to the increased burden that will be faced by patients who suffer from chronic pain. Some have also stated that the increased burden will cause some patients to obtain hydrocodone products illegally rather than going through legitimate channels.
The issue now goes to the full FDA for consideration of the panel’s recommendation. There is no timetable for their decision on whether to implement this plan.