01/12/2015

Handling emergency Schedule II prescriptions


Following the October 2014 reclassification under federal law of hydrocodone combination products (HCPs) such as Vicodin and Norco from federal Schedule III to federal Schedule II, some dentists report pharmacies refusing to fill emergency prescriptions telephoned in for HCPs, under circumstances in which they may traditionally have been accepted. This article is intended to clarify the state of the law with regard to such HCPs and help dentists understand the requirements and limitations on oral prescriptions for a Schedule II drug.

Under both federal* and California law,** the requirements for Schedule II drugs specify that prescribers may only telephone in prescriptions for Schedule II drugs in very limited emergency situations. However, as some differences between federal and California law may be a source of confusion, to ensure a patient’s need for pain medication is met appropriately, dentists should be aware of the following information:

With regard to emergency prescriptions, federal law limits its definition of an “emergency situation” authorizing the issuance of an oral prescription for a Schedule II to those situations in which the prescriber determines:

  • Immediate administration of the controlled substance is necessary for proper treatment of the intended ultimate user.
  • No appropriate alternative treatment is available, including administration of a non-Schedule II drug.
  • It is not reasonably possible for the prescribing practitioner to provide a written prescription to be presented to the dispenser, prior to dispensing. 

Further, federal law permits a pharmacist to dispense a Schedule II drug based on an oral authorization from a prescriber only when:

  • The quantity prescribed and dispensed is limited to an amount adequate to treat the patient during the emergency period.
  • The prescription is immediately reduced to writing by the pharmacist and contains all the legally required information.  
  • The prescriber is either already known to the pharmacist or the pharmacist makes a reasonable effort to determine that the oral authorization came from an authorized prescriber, which may include calling back the prescriber or other efforts to verify identity.
  • Within seven days after authorizing an emergency oral prescription, the prescriber delivers (or mails) a paper or electronic prescription for the emergency quantity prescribed to the dispensing pharmacist that, in addition to conforming to the other requirements, must have written on its face “Authorization for Emergency Dispensing” and the date of the oral order.

The pharmacist must notify the Drug Enforcement Administration (DEA) if the prescriber fails to deliver the paper or electronic prescription in a timely manner, and failure by the pharmacist to do so renders the prescription invalid.

California law on emergency dispensing for Schedule II drugs is similar to the federal requirements, and dentists should also be aware of the emergency dispensing limits that apply under state law. For instance, California law defines an emergency justifying dispensing pursuant to an emergency oral prescription for a Schedule II drug only “… where failure to issue a prescription may result in loss of life or intense suffering …”

With the increasing scrutiny of opioid abuse, the pharmacy profession, which is regulated by the California Board of Pharmacy, has been charged with enforcing its responsibility to reduce the use of addictive substances, and interprets narrowly the circumstances where “intense suffering” may require a Schedule II prescription; this has historically been primarily limited to patients in hospice care and in skilled nursing and long-term care facilities. This may result in the pharmacist who receives a call from a dentist for an emergency Schedule II prescription counseling the prescriber on other options for pain relief that are not Schedule II.

When an emergency prescription is accepted by the pharmacist, it is similarly subject to several stringent requirements under California law, including that the pharmacy reduces any oral order to hard copy form prior to dispensing the controlled substance and that the prescriber provides a written prescription on a controlled substance prescription form that meets state requirements, by the seventh day following the oral order. California law also requires the pharmacy to notify the Department of Justice in writing within 144 hours of a prescriber’s failure to supply the required follow-up written prescription. 

Dentists should anticipate these new barriers to prescribing emergency pain relief to patients using Schedule II drugs and should make every attempt possible to provide the patient with a written prescription. As a last resort, if a dentist must telephone in a prescription for a Schedule II drug, the prescriber should provide only the number of pills required to address the emergency, be prepared to explain to the pharmacist how the failure to provide a patient with the drug is medically necessary and/or may result in intense suffering, why a written prescription is not possible, and assure the pharmacist that a written prescription that complies with all requirements will follow within seven days. 

A dentist should also consider the effectiveness of prescribing a Schedule III drug instead and is encouraged to talk with pharmacist colleagues about any new contemporary pain relief medications that may fit the patient’s circumstance.

If a pharmacy refuses to fill a prescription for what you believe is an emergency that meets the standards as outlined in state law, please report the incident to CDA Practice Support at 800.232.7645. CDA continues to discuss the situation with the California Board of Pharmacy and California Pharmacists Association.

*21 CFR § 290.10, and 21 CFR § 1306.11(d)
** California Health and Safety Code section 11167



Topics
Top