A good pill is hard to find. The reclassification of hydrocodone may make some EPs reluctant to prescribe it. What you need to know about the Fed’s recent clamp down on this front line ED pain med.
What you need to know about the Fed’s recent clamp down on this front line ED pain med.
A good pill is hard to find: The reclassificaiton of hydrocodone may make some EPs relunctant to prescribe it.
The August 22 edition of the Federal Register contained a notice from the Drug Enforcement Agency and the Department of Justice explaining the final rule rescheduling all hydrocodone products from Schedule III to Schedule II under the Controlled Substances Act. See here. While most hydrocodone products are already listed as Schedule II drugs, some combination products such as Vicodin, Norco, and Tussionex were previously listed on Schedule III.
As part of this rulemaking process, there was a public comment period during which any interested parties were permitted to submit comments to the DEA regarding this proposed change. More than half of all commenters to the proposed law supported rescheduling hydrocodone to a Schedule II drug. Of those, 74% of the general public and 56% of physicians supported rescheduling. Sixty percent of pharmacists and 91% of hydrocodone users were opposed to rescheduling.
In determining whether rescheduling hydrocodone was necessary, the DEA considered multiple factors. Most of those factors centered around the potential for abuse, the likelihood of dependence, the current patterns and scope of abuse, and the threat to public health posed by the drug. Many of the public comments encouraged the DEA to consider how the increased regulatory burdens would make physicians less willing to prescribe hydrocodone to patients with severe pain. The DEA responded that those were “not relevant” concerns when determining how hydrocodone should be scheduled. Similarly, pharmacists’ concerns that they would need to devote more time to regulatory burdens associated with Schedule II hydrocodone prescriptions rather than focusing on patient counseling and safety were also met with a “this is not relevant” response.
With the intended and unintended consequences of rescheduling hydrocodone products, we’re probably going to have to adjust our practices in some ways.
How the reclassification of hydrocodone may affect your practice
Prescribing limitations for Schedule II drugs will not affect a practitioner’s ability to prescribe hydrocodone if that practitioner has a personal DEA registration number, but it may affect midlevel providers and residents who operate under collaborative agreements or hospital DEA numbers.
The DEA differentiates between “orders” which are written for medications dispensed immediately to patients within a hospital setting and “prescriptions” which are medication orders given to the ultimate user to have filled. Hospital “orders” for medications are written using the hospital DEA number and are not considered “prescriptions” by the DEA.
With hydrocodone’s change in Schedule, medical residents using a hospital DEA number in some states may no longer be permitted to write outpatient prescriptions for hydrocodone-containing products. The legal limitations in this regard are state-specific and practitioners should be familiar with the laws of the states in which they practice. Some states don’t allow a hospital DEA number to be used for any controlled substance prescriptions, while some state laws may limit prescription of only certain schedules of controlled substances using a hospital DEA number. In general, if a resident is currently permitted to prescribe other Schedule II medications such as dilaudid, oxycodone, or fentanyl, then the resident’s prescribing practices for hydrocodone should parallel the prescribing practices for other Schedule II medications. Because in-hospital medication orders are not considered “prescriptions,” the change should have no bearing on a resident’s in-hospital orders for hydrocodone.
State laws may also limit a midlevel provider’s ability to prescribe certain Schedules of medications, so the transition of hydrocodone from Schedule III to II may mean that in some states, midlevel practitioners will no longer be able to prescribe hydrocodone-containing products. This change would mean that physicians working with midlevel providers would either have to personally sign prescriptions for hydrocodone-containing products or that the midlevel providers would have to prescribe a pain medication that is not Schedule II such as acetaminophen/codeine or tramadol.
Verbal and facsimile orders for hydrocodone-containing products will generally no longer be allowed. Some commenters to the proposed rescheduling noted that the requirement of a written prescription for hydrocodone would cause problems for patients over weekends when no primary physicians were available and would likely overburden emergency departments even further. The DEA noted that oral prescriptions for Schedule II drugs are permissible if there is an “emergency situation” which, under 21 CFR 290.10, means that “immediate administration of the controlled substance is necessary for proper treatment of the patient, that no appropriate alternative treatment is available and that it is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the person dispensing the substance, prior to the dispensing.” There are multiple other requirements for such an “emergency situation” under 21 CFR 1306.11(d), including that the prescriber must forward a written prescription to the pharmacy by mail within 7 days. However, since emergency physicians don’t typically call in prescriptions for medications, those requirements would likely not apply to emergency physicians. Also of note is that the DEA still permits electronic prescriptions of controlled substances Scheduled II through V. See 21 CFR 1311.
Prescriptions for all Schedule II drugs may only be given for a maximum 30 day supply. Commenters to the DEA stated that the rescheduling would require more trips to the doctor in order to receive appropriate pain control. The DEA noted that while Schedule II prescriptions cannot be refilled, practitioners are permitted to write multiple prescriptions authorizing a patient to receive up to a 90 day supply of Schedule II medications provided that each prescription indicates the earliest date on which the prescription may be filled, that the prescriptions are written for a legitimate medical purpose, and that the other requirements in 21 CFR 1306.12 are fulfilled. There will also be a transition period in which prescriptions with refill authorizations written before October 6, 2014 are allowed to be filled until April 8, 2015. No prescriptions written on or after October 6, 2014 may authorize refills. However, even during this transition period, some pharmacies may choose not to dispense hydrocodone refills after the effective date of the Schedule change.
For more information about the DEA’s requirements for valid controlled substance prescriptions, check out the DEA’s Office of Diversion Control web site.
William Sullivan, DO, JD is a senior editor for Emergency Physicians Monthly