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New rules on prescribing hydrocodone combo products take effect October 6



Physicians are reminded that effective October 6, 2014, medicines containing hydrocodone will be reclassified as Schedule II substances, in line with oxycodone and morphine.

This reclassification will apply to all drugs that contain both hydrocodone, which by itself was already classified a Schedule II drug, and specified amounts of other substances, such as acetaminophen or aspirin. As Schedule II drugs, patients will be limited to up to a 90-day supply of medication and will have to see a provider to get a refill. (Under the Schedule III classification, a prescription could be refilled five times before the patient had to see a physician.) Physicians will not generally be allowed to call, fax or e-mail in a prescription to a pharmacy; instead, patients will have to present a written prescription.

Prescriptions that have been filled at least once before October 6, 2014, and have authorized refills remaining, are allowed to be dispensed during a transition period, until April 8, 2015, in accordance with federal rules. However, pharmacies are not required to honor such refills during the transition period, and indications are that many California pharmacies may choose not to. Physicians should be prepared for patient requests for new prescriptions.

California exceptions for emergencies and that apply to skilled nursing facilities, intermediate care facilities and hospice care remains in effect. (For more information see CMA On-Call document #3201, "Controlled Substances Prescribing.")

Under the new rule, physician assistants and nurse practitioners may administer, provide or issue a drug order for Schedule II controlled substances if they have advance approval by a supervising physician and if they have completed an approved education course that explicitly covers prescribing of Schedule II controlled substances. Physician assistants and nurse practitioners should consult their respective boards for more information on the required trainings.

In addition, current law requires that physicians must within seven days countersign and date the medical record of any patient cared for by a physician assistant under their supervision who is issuing a Schedule II drug order for that patient. Physicians are not required by law to countersign medical records for Schedule II drug orders written by nurse practitioners. However, standardized protocols and requirements from third parties may contain counter signature requirements related to Schedule II drug orders.

The Controlled Substances Act places substances with accepted medical uses into one of four schedules, with the substances with the highest potential for harm and abuse being placed in Schedule II, and substances with progressively less potential for harm and abuse being placed in Schedules III through V. (Schedule I is reserved for those controlled substances with no currently accepted medical use and lack of accepted safety for use.)

Contact: CMA Legal Information Line, (800) 786-4262 or legalinfo@cmanet.org.

 


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