By James M. Stanford, JD, Partner, ByrdAdatto

In 2018, California made several changes to try to curb unauthorized access to controlled substances as part of a national trend in combating opioid abuse. One of the major changes went into effect this past October, when it became mandatory for medical professionals who write prescriptions to first run a search of the patient on the CURES system before issuing a prescription. CURES is the name of California's prescription monitoring program, a statewide database that documents all prescriptions issued to a person. CURES allows prescribers to check that they aren't prescribing conflicting drugs or duplicating prescriptions the patient may have received from a different prescriber.

Another major change takes effect January 1, 2019. In its continuing efforts to make the prescribing process more secure and accurate, California will require paper prescriptions be issued only on specially approved prescription pads with certain security features ("Secured Pads"). The mandatory security features for Secured Pads were enacted in the bill known as AB 1753. Among the features are a number of identifying marks including a watermark, lot number, printer identification number, unique serial number, and latent repeating "void" pattern that becomes visible on photocopies. The Secure Pads can be obtained from any printer who has been approved by the California Department of Justice as having implemented the necessary security features. The Attorney General's website maintains a list of approved printers where the Secured Pads can be ordered; however, ordering them prior to AB 1753 taking effect would have been difficult as the list did not appear until 1/1/19.

As AB 1753 was passed in mid-September, there may be other issues with enacting the secure printing requirements in time. In fact the California Medical Board just released a memo on Friday, December 28th alerting physicians to the new requirements. Questions about approved printers or the Secured Pad program can be emailed to SecurityPrinter@doj.ca.gov.

As the California Medical Board memo notes, there is no transition period phasing in the use of the Secured Pads, meaning pharmacists are only permitted to accept Secure Pads beginning January 1, 2019. In the event a prescriber is unable to obtain Secure Pads immediately, there are a few alternatives. Given that the law only affects paper prescriptions, prescribers may continue with existing electronic prescriptions. If electronic prescriptions are not a viable option, a prescriber may call the pharmacy and make a verbal prescription for Schedule III – V drugs. If the prescription is for a terminally ill patient, the prescription can be made on a noncompliant prescription pad under the Section 11159.2 exemption. In certain emergency situations, a prescription can be issued on a noncompliant prescription pad as long as a prescription from a Secured Pad is issued within 7 days to cure the noncompliance. The California Medical Board also maintains a page of their website with additional information and procedures to follow when reporting a lost or stolen prescription pad.

If you are an AmSpa member and you have any questions about California's new prescription pad requirements or your medical practice's compliance in general, please contact Morgan Gire at morgan@americanmedspa.org to set up your yearly complimentary consultation with a lawyer at ByrdAdatto.

James M. Stanford is an attorney and partner at the ByrdAdatto law firm. From transitions, mergers, and acquisitions to structuring complex ownership arrangements, James enjoys the personal reward that comes from bringing parties together and making deals happen. James practices primarily in the areas of health care and corporate law with a focus on intellectual property. A proud father, Jim served in the U.S. Army and is fluent in Russian. In his spare time, he enjoys hunting, fishing, and spending time outdoors.