Attention California Psychiatrists

Two new laws affecting CA physicians became effective January 1, 2019:

• CA Law AB 2760 (Chapter 324), requires prescribers to offer a prescription for naloxone hydrochloride or another FDA approved drug for the complete or partial reversal of opioid depression to patients meeting the following criteria:
  • The prescription dosage for the patient is 90 or more morphine milligram equivalents of an opioid medication per day;
  • An opioid medication is prescribed concurrently with a prescription for benzodiazepine; and
  • The patient presents with an increased risk for overdose, including a patient with a history of overdose, a patient with a history of substance use disorder, or a patient at risk for returning to a high dose of opioid medication to which the patient is no longer tolerant.

CA Law AB 2760 does not require the prescriber to issue a prescription if the patient declines. Nor does the law limit its requirements to the physician who prescribed the opioid to the patient. Moreover, this law does not limit its requirements to a one-time offer; the requirements must be complied with each time the specified conditions are present.

In addition, CA Law AB 2760 requires prescribers to provide education, consistent with the standard of care, regarding overdose prevention and the use of naloxone hydrochloride or another FDA drug approved for the complete or partial reversal of opioid depression, to:

For more information, see: http://www.mbc.ca.gov/Licensees/Prescribing/OverdosePrevention/AB2760FAQs.pdf

• Effective January 1, 2019, California Law AB 1753 (Chapter 479) requires prescription forms for controlled substances to be printed with a unique, serialized number. There is not a specified transition period to allow for continuous use of previously compliant controlled substance security forms on or after January 1, 2019.

The standardized format for the serialized number is a 15- digit alphanumeric in the following format: AAANNNNNNNNNNNN (A= alpha character and N= a numeral). The United States Department of Justice has approved thirty-eight security printers that are compliant with the new requirement.

The California Medical Board is responsible for enforcing the provisions related to physician prescribers and encourages physician prescribers to obtain and begin using the new controlled substance security forms as soon as possible.

In order to prevent patients being denied access to necessary medications, the Pharmacy Board Enforcement Committee recommended to the Pharmacy Board that prior to July 1, 2019, enforcement staff not take action against pharmacists when they determine that it is in the patient’s best interest to fill a controlled substance prescription written on a security form that was compliant prior to January 1, 2019. Prescribers should expect to receive calls from dispensers regarding such prescriptions. Among other things, dispensers may:

• Request that prescribers substitute an electronic prescription;
• Treat the prescription as an oral prescription and verify the order telephonically with the prescriber;
• Consult with the physician as to whether the patient is terminally ill and eligible for a “11159.2 exemption”; or
• Refuse to fill the prescription.

For more information, see: http://www.mbc.ca.gov/Licensees/Prescribing/AB1753Notice.pdf

Clozapine Risk Evaluation and Mitigation Strategy (REMS) Update

The FDA recently announced modifications to the Clozapine REMS program (REMS) that became effective in February 2019.¹ 

Pursuant to the REMS modifications:

• Prescribers and pharmacies must be certified as of February 28, 2019, in order to prescribe/dispense Clozapine;
• Inpatient prescribers are not required to be certified if they are prescribing for patients already enrolled in the program;
• If a patient’s absolute neutrophil count (ANC) is not current, this will not prevent Clozapine from being dispensed; and
• Pharmacies are no longer allowed to enroll patients in the Clozapine REMS Program after February 28, 2019, since the enrollment of patients must be completed by the prescriber or the prescriber designee.²

In 2015, the FDA approved the REMS program to ensure a centralized system for prescribers and pharmacists to monitor and manage patient risk of Clozapine-induced severe neutropenia.³ For more information related to the recent REMS program modifications, please see the Clozapine Product Manufacturers’ Group update: https://www.clozapinerems.com/CpmgClozapineUI/home.

¹ United States Food and Drug Administration, “The Clozapine Risk Evaluation and Mitigation Strategy (REMS) Program Modification will go live on February 28, 2019,” (https://www.fda.gov/Drugs/DrugSafety/ucm467560.htm).

² Id.

³ In Session with Allied World, Vol. 6, Issue 1, Winter 2016.