Guest Post From Julie G. Pilitsis, MD, PhD
Chair of the AANS/CNS Section on Pain
Albany, New York
Last week, the AANS and CNS issued a position statement on Hydrocodone Prescribing Policy, which was developed by the AANS/CNS Section on Pain to address action taken earlier this year by the FDA’s Drug Safety and Risk Management Advisory Committee imposing significantly stricter prescribing rules on drugs containing hydrocodone.
Neurosurgeons believe that patient safety considerations need to be balanced with the need for patients to have appropriate and ready access to pain relief medications. Reclassifying hydrocodone combination drugs would create an unreasonable burden on providers and patient care.
In our statement, organized neurosurgery emphasized the following points:
- Reclassifying hydrocodone combination drugs 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. It should be appreciated as well that plain hydrocodone is already classified in Schedule II. This change would move combination drugs into that category as well.
- This change would have significant implications with regard to hydrocodone combination drug 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. Moreover, the direct involvement of mid-level practitioners, relied on more frequently than ever to assist with the significant burdens of everyday medical practice, would become strained as the ability of nurse practitioners and physician assistants to prescribe Schedule II drugs varies state by state.
Classifying hydrocodone combination drugs is a laborious and insufficient solution. It would require more frequent office and emergency room visits, unnecessarily increasing the time and resources allocated to refilling these medication prescriptions, which are often used in modest amounts for peri-operative pain management.
As practitioners in a surgical subspecialty who also interact with a significant number of patients in chronic pain as well as peri-operative pain, neurosurgeons strongly believe that this schedule change will result in reduced quality of care and likely increased illicit narcotic abuse, some of the very goals the FDA seeks to avoid.