GOVERNMENT and LAW

California adopts hybrid Rx for scheduled drugs

Triplicate prescriptions for controlled substances will soon be history. California, the only state still requiring three-part scripts for Schedule II drugs, is going electronic.

"The whole triplicate program has been a significant barrier to the treatment of pain," said Michael Negrete associate VP for clinical affairs at the California Pharmacists Association. "It was a real hurdle for providers, pharmacists, and patients."

Gov. Gray Davis signed California's new program, the Treatment & Drug Diversion Act of 2003, before he was recalled in October. The act formalizes California's Controlled Substance Utilization Review & Evaluation System, or CURES, which combines a single tamper-resistant Rx blank with an electronic database. The state rolled out a pilot version of CURES in 1997. The permanent system will go live on July 1, 2004. Triplicates will still be allowed during a six-month transition period. CURES will take over on Jan. 1, 2005.

Under CURES, providers must write all controlled-substance scripts on a new tamper-resistant Rx pad approved by the board of pharmacy. Pharmacies must report Schedule II and Schedule III fills to a statewide database. Individual pharmacists and prescribers as well as state regulatory boards and law enforcement will be able to search the CURES database by patient, product, provider, and pharmacy to track Rx abuse. According to the board of pharmacy, about a dozen states have some form of electronic tracking system for controlled substance scripts.

"Writing all scheduled products on the same Rx blank will remove the stigma associated with Schedule II drugs that has impeded appropriate prescribing," explained board executive officer Patricia Harris. "We want to make it as efficient as possible to track abusive prescribers and pharmacies as well as patients who have become doctor shoppers."

The triplicate system was designed in the 1940s to track controlled substances. The prescriber keeps one copy, the filling pharmacy keeps a copy, and the third is filed with law enforcement. Triplicates have been required only for Schedule II drugs. But the additional paperwork discouraged providers from writing Schedule II scripts, noted Sandra Bauer, executive director of the Campaign for Patient Safety and former state board of pharmacy member. Bauer has been advocating an electronic tracking system for more than a decade.

According to the Southern California Cancer Pain Initiative, an early backer of CURES, only 61% of California physicians with Schedule II prescribing privileges have triplicate Rx pads. Most pain-control scripts are filled with less effective Schedule III products to avoid administrative burdens, the group said.

Singling out Schedule IIs for special treatment also cast a pall of suspicion over prescribers and patients, Bauer said. And law enforcement was never able to use the system to track Rx drug abuse.

Pharmacists are waiting to be convinced. "I like the idea of killing triplicates," said Gary Avnet, president of Sayre Medical Pharmacy in the Los Angeles area. "It will make diverters think twice, but I'm not sure it will stop everything. There is still confusion on the part of pharmacists on just how the program is going to work."

The biggest hurdle may be the new tamper-resistant Rx pads. According to Bauer, the forms will be similar to safety forms used for checks, currency, and other sensitive documents. The final design has not been approved and the board of pharmacy has not yet cleared any printers to manufacture the new documents.

Safety features will include a latent VOID pattern that appears if the script is photocopied or scanned; watermarks; inks that change color when exposed to high temperatures; inks that disappear if the blank is erased or washed; and surface treatments resistant to washing. In addition, every lot of Rx blanks must be numbered, and each blank within the lot must be sequentially numbered. Scripts will be void if more than one controlled substance is written on each form or if the total number of scripts is not entered.

One question that is still open: Will prescribers end up carrying two Rx pads—one for Schedule II to Schedule V drugs and one for everything else? Maybe not. Safety pads will be the same size and bulk as conventional Rx pads, Negrete said. The new forms will be more expensive, but nothing bars the use of safety pads for non-Schedule scripts. If prescribers value convenience more than cost, plain paper Rx pads could disappear.

"Prescribers aren't going to want to carry two Rx pads around," Negrete noted. "They just might end up using the secure pad for all drugs, which would be a deterrent to all prescription forgeries. It's an unintended consequence that could be very positive."

Fred Gebhart

 

Fred Gebhart. California adopts hybrid Rx for scheduled drugs. Drug Topics Nov. 3, 2003;147:81.