Joint Statement from the California Department of Justice, California State Board of Pharmacy, and the Medical Board of California Regarding Secure Prescription Forms
January 10, 2019
As of January 1, 2019, California law requires prescription forms for controlled substances to be printed with a uniquely serialized number. Notices explaining the serial number format and reporting requirements have been released by the Department of Justice (DOJ). Additionally, notices to prescribers and pharmacists were issued by the California State Board of Pharmacy (Pharmacy Board), and by the Medical Board of California (Medical Board), yet questions remain about implementation. This joint statement by DOJ, the Pharmacy Board, and the Medical Board is therefore being issued to provide further clarification and guidance on implementation.
As explained in previous notices from the Pharmacy Board and Medical Board, because of the absence of a grandfathering or transition period in Assembly Bill (AB) 1753 (Low), which enacted this change, as of January 1, 2019, only security forms with unique serialized numbers may lawfully be used to write paper controlled substance prescriptions.
As of that date, any paper controlled substance prescription written on a controlled substance security prescription form that does not bear all of the 15 security features will be presumptively invalid.
DOJ has issued guidance to the Security Printers and the pharmacy and direct dispense data reporters regarding the approved serialized number format and reporting requirements. The DOJ has approved 38 security printers that are compliant with the new requirement. However, the signatories to this joint statement recognize that it may take some time for all prescribers to begin using the new, fully-compliant security forms. And that there may be a period of weeks or months during which prescribers continue to use outdated security forms, and those outdated forms are presented to dispensers.
Prescribers are encouraged to procure compliant security forms at their earliest opportunity. In the interim, however, none of the signatory agencies want to see patients denied access to necessary medications during this transition period. With that in mind, the Enforcement Committee of the Pharmacy Board has recommended to the Pharmacy Board and the Executive Officer that, prior to July 1, 2019, enforcement staff not make an enforcement priority of actions against and/or investigations of pharmacists (or their employing pharmacies) who, in the exercise of his or her best professional judgment, determine that it is in the best interest of patient or public health or safety to fill a controlled substance prescription written on a security form that would have been compliant prior to January 1, 2019. Further, to assist pharmacists, pharmacies, and other dispensers with implementation challenges, the Pharmacy Board has told its licensees to consider the following responses to presentation of an outdated form:
(a) Communicating with the prescriber about the need for a compliant security prescription;
(b) Advising the prescriber to substitute an electronic prescription;
(c) Consulting with the prescriber about whether the patient might be terminally ill and eligible for a "11159.2 exemption" prescription under Health and Safety Code section 11159.2;
(d) Treating prescription orders written on the outdated forms for Schedule III, IV and V medications as oral prescriptions, and verifying the order telephonically with the prescriber’s office, pursuant to Health and Safety Code section 11164, subdivision (b);
(e) Schedule II prescriptions on non-compliant security prescription forms present unique challenges, because of the inability to substitute an oral prescription. It is therefore especially important that pharmacists use their best professional judgment to get needed Schedule II medications to their patients, and the same lack of enforcement priority will be applied to these dispensing decisions until July 1, 2019.
(f) If failure to dispense may result in loss of life or intense suffering, dispensing pursuant to the emergency situation requirements of Health and Safety Code section 11167, and curing with a compliant controlled substance security prescription form within seven (7) days; or
(g) Refusing to fill the prescription.
Prescribers should expect to receive calls from dispensers seeking to validate such prescriptions.
More and FAQ's here: https://www.pharmacy.ca.gov/licensees/joint_advisory.pdf
Update: Proposed extension for compliant prescription forms
The CVMA has reported on the California Medical Association (Physicians) effort for extension in the implementation of the new requirement
Since the implementation of AB 1753 (Low) on January 1, which requires all controlled substance prescription pads to have a unique serial number and reduces the number of printing companies, the health care industry has reported huge challenges with compliance. This has resulted, in some cases, with patients not being able to obtain medications.
The California Medical Association, recognizing that a quick legislative remedy was essential, reached out to Assemblyman Jim Cooper who introduced AB 149 that will allow for a grace period for the new law. CVMA lobbyist, Mike Dillon, voiced the CVMA’s support at the Assembly Business and Professions Committee hearing on January 29, 2019.
AB 149 would add an “urgency clause” – meaning that the bill would be able to take effect soon after it is signed; remove Department of Justice rulemaking language that would hold the bill up; and indicate that existing controlled substance prescription pads could be used until January 1, 2021. The CVMA has taken a support position on this bill.
Current Security Prescription Printer list:
https://www.pharmacy.ca.gov/licensees/joint_advisory.pdf
Watch for more updates on this topic at www.VMB.CA.GOV
UPDATE 3/31/19 — January 1, 2021 is the revised implementation date for compliance.