PHARMACIST STEVE

New California Pharmacy Law 11162.1 subdivision (a)(15) goes into effect January 1, 2019.

Written, para-phrased and abbreviated by Kevin Lasick, Pharm.D.

In the most recent legislative session, Assembly Bill (AB) 1753 (Low, Chapter 479, Statutes of 2018) was enacted to require an additional improvement to controlled substance security prescription forms, that being a unique alpha numeric serialized number to each form in a format approved by the Department of Justice (DOJ). Consequently, AB 1753 will likely further reduce the number of approved security printer vendors for controlled substance forms, causing additional delays for prescribers to obtain compliant security prescription forms, compounding pressure on pharmacies and inconvenience associated with pain and/or suffering for patients.  

Under the new statutes, absence of any transition or grandfathering period, the new security forms will be the exclusive means to write paper controlled substance prescriptions as of January 1, 2019. Any prescription written on a controlled substance security prescription form that does not bear all of the 15 security features will be presumptively invalid. 

Due to the uncomfortable position of having to decide between providing needed medications to patients, and compliance with the law, the Enforcement Committee has recommended to the California State Board of Pharmacy and to the executive officer that prior to July 1, 2019 the board shall not make an enforcement priority any investigation or action against a pharmacist who, in the exercise of his or her professional judgement, determines that it is in the best interest of the patient or public health or safety to nonetheless fill such prescription.

Physicians were notified mid-December that the updated forms were available for purchase from some of the currently approved vendors, with less than two weeks to go before Health & Safety Code 11162.1, subdivision (a) (15) goes into effect January 1, 2019. The California Medical Association is very concerned that this does not provide enough time for prescribers to re-order forms and integrate the use of the new forms beginning January 1, 2019. The very short window of planning and opportunity for prescribers to be compliant could be a serious barrier to patients who must access necessary medications in a timely manner.

Though the new law is effective immediately, yet the Board of Pharmacy has set a “make no enforcement” ruling of compliance until July 1, 2019, pharmacists need to communicate with prescribers that the law is already in effect and they need to provide an electronic prescription for controlled substances or supply a properly formatted “written paper hard-copy” prescription utilizing a unique serialized number in a format approved by the DOJ.

Below includes an abbreviated list of the original 14 security features as outlined by 11162.1 and the new 15th security feature with an example of an approved unique serialized number. 

The prescription forms for controlled substances shall be printed with the following 15 features: 

(1) A latent, repetitive “void” pattern shall be printed across the entire front of the prescription.

(2) A watermark of “California Security Prescription.” Shall be on the backside or each Rx.

(3) A chemical void protection that prevents alteration by chemical washing.

(4) A feature printed in thermochromic ink.

(5) An area of opaque writing so that the writing disappears if the prescription is lightened. 

(6) A description of the security features included on each prescription form. 

(7) Six quantity check off boxes shall be printed on the form. 

(8) Prescription is void if the number of drugs prescribed is not noted statement at the bottom.

(9) Name, category of licensure, license#, DEA number, and address of the prescriber.

(10) Check boxes shall be printed on the form to indicate the number of refills ordered. 

(11) The date of origin of the prescription.

(12) A check box indicating the prescriber’s order not to substitute. 

(13) An identifying number assigned to the approved security printer by the Dept. of Justice. 

(14) A check box for each prescriber when a prescription form lists multiple prescribers. 

(15) A uniquely serialized number, in a manner prescribed by the Department of Justice. 

Example of the new 15 digit alpha numeric “unique serialized number” in approved format:

|AAA|000000|A|00000|

3 alpha, 6 numeric, 1 alpha, 5 numeric sequence

DOJ190326A05500

Department of Justice, March 26, 2019 production date, sequential prescription blank number (SPB#) = 05500

This new law is very important aid in combating the ongoing fraud associated with theft, tampering, and misuse of the California controlled substance security prescription form.

I have already received a email where a pharmacist decided to “play games” with the pt over a C-II Rx.. the pt brought in a Rx on Dec 30th or 31st and the Pharmacist said that the pt couldn’t have the Rx until Jan 2nd… even though the Rx was in fact due on the day presented.

The pt showed up on Jan 3rd to get his Rx and was told by the pharmacist that the Rx was “NOT ON THE PROPER FORMATTED FORM” so the Rx was NULL/VOID and according to the pt … his prescriber was not expecting the new Rx forms in until the end of the first week of Jan.

There are two issues here… first of all the pharmacist could have filled the Rx on the day presented on the then legal Rx blank and put it on will call for the pt to pick it up on Jan 2nd.

Was the pharmacist NOT AWARE of the 6 month “grace period” on using the old forms before enforcement was going to commence and he could have really have filled the C-II on Jan 2nd/3rd ?

What moron at the state board of pharmacy or the legislature in Sacramento believes that adding a 15th security feature to their Rx blanks are going to even make a dent in the fraudulent Rx blanks trying to be passed/filed by substance abuser/diverters ?