Today I heard that the FDA approved moving hydrocodone products (e.g. Vicodin, Norco, Lortab) to ‘schedule II’ status. The final decision has to go through the DEA, and they are expected to support the change.
The change has been argued back and forth for years, with a push more recently from PROP, Physicians for Responsible Opioid Prescribing. The FDA has been taking comments from the public through an internet portal for a number of months, and appears to have given the decision considerable thought. I’ll weigh in, not because I think the FDA will hold an emergency meeting over my comments, but rather because I think that people on both sides of the issue should at least understand each others’ arguments. Too often, discussions over this type of issue– i.e. issues that don’t have a clear answer–degenerate into sound-bite comments accusing the opposite side of cruelty or stupidity. One reason I find opioids so ‘blog-worthy’ is because there are so many issues that deserve thoughtful discussion, that have no correct or incorrect position.
Proponents of the schedule change point out that hydrocodone is a gateway drug if there ever was one. Most of the people I treat for opioid dependence first discovered their love for opioids after taking Vicodin or Norco prescribed for surgery or minor injury, or shared by a coworker. Hydrocodone is only available in combination medications, i.e. packaged with acetaminophen, aspirin, or antihistamines, although I seem to remember a new product announcement a while back that consisted of hydrocodone alone (correct me if I’m wrong). The theory, I suppose, is that the additional agent provides some counter-incentive to abuse hydrocodone. I doubt though that someone needing 30 Vicodin tablets to avoid withdrawal is deterred by the risk of liver toxicity from acetaminophen!
Schedule II medications are regulated more closely than schedule III, where hydrocodone is currently classified. Schedule II meds include oxycodone and other potent opioids like oxymorphone (Opana), hydromorphone (Dilaudid), and fentanyl. Most CNS stimulants are also classified as schedule II. Prescriptions for medications in that schedule cannot be phoned or faxed to pharmacies (although emergency 5-day supplies can be called in, providing a written script is provided within a few days). Doctors can prescribe only 90 days of medication at one time, and have to do so by writing three, 30-day prescriptions, each with identical amounts of medication. The prescriptions expire after 60 days, making it difficult for patients to fill the third script in the series, since the third script expires on the date that it can be filled. The policy creates a conflict that makes calls about expired schedule II scripts some of the most common exchanges between patients and doctors’ offices.
Schedule II medications have other restrictions; they are counted more often in pharmacies and hospitals for example, and criminal penalties for their abuse are steeper than for lower-scheduled medications.
From a neurochemical standpoint, the separation of hydrocodone from other opioids makes little sense. The effects of opioids are dose-related, and so a large dose of hydrocodone has the exact same effects as a somewhat lower dose of oxycodone. The dangers of addiction, overdose, and impairment are as significant with hydrocodone as with other opioids.
One of the main arguments for maintaining hydrocodone as schedule III also serves as the basis for arguments to change hydrocodone to schedule II, and relates to access to pain medications. Right now, hydrocodone products can be ordered by on-call doctors who are unable to physically meet with the patient. If a dentist extracts wisdom teeth and the patient, two days later, develops ‘dry sockets’, the dentist can call in a few Vicodin to hold the patient over until the next day. On the other hand, schedule III status allows a physician to call in hydrocodone for patients with abdominal pain or headaches who perhaps should be evaluated more thoroughly before being told to ‘call me in the morning.’ The ability to call in orders for hydrocodone is the reason that Vicodin-based products are among the most-prescribed medications each year.
The argument over the change in schedule comes down, in my opinion, to one discussion: Should doctors and patients have available an opioid pain medication that can be ordered by telephone. The need for written prescriptions can be a significant hurdle for rural patients who drive hours to see their doctor. And while schedule II opioids have a provision for emergency prescribing, many doctors are either not aware of the provision or choose not to exercise the emergency option when contacted after hours– causing significant delay before patients in pain have access to opioids. The counter argument is that anyone who develops pain after hours that is severe enough to warrant treatment with opioid medications should be seen and evaluated before medications are given to mask the symptoms of a potentially-serious condition.
The attention to diversion of potent opioids over the past few years has had a dramatic effect on physician attitudes about the routine prescribing of opioids. Many doctors now refuse to prescribe opioids altogether, or provide amounts intended to last for 24-48 hours, rather than the 30-day supplies that used to be given out fairly routinely for patients with painful conditions. I expect the change in schedule of hydrocodone to have a similar impact on the use of opioids.
But as readers know, my favorite topics relate to unforeseen consequences; the things that ALWAYS occur that nobody saw coming. The change in formulation of Oxycontin had the desired effect of reducing nasal insufflation of oxycodone, but likely fueled the increase in heroin use over the past few years— which increased the use of needles. Was reducing the snorting of oxycodone worth the increase in IV drug abuse?
I’ll try to remember to do a ‘look-back’ in a year or so, to see whether they got it right this time.