Industry Goes On Offensive Against Prescription Pseudoephedrine Trend

Drug firms hope to dissuade states from moving drugs that contain methamphetamine precursors to prescription status by funding electronic systems to track nonprescription sales of the products.

The National Precursor Log Exchange system funded by Consumer Healthcare Products Association members will track all purchases of nonprescription ephedrine- or pseudoephedrine-containing products in states that require e-tracking. The information will be available to law enforcement agencies and retailers within a state and to other states linked into the network.

Law enforcement agencies and retailers will not have to pay to implement or access NPLEx.

"What we recognized is that states, especially at this time, are strapped for funds," said Andy Fish, CHPA's senior VP for legal and government affairs.

The group is in a race to show that e-tracking and existing federal law is effective enough at preventing PSE diversion to meth before state and national efforts to follow Oregon's lead and make the ingredients prescription-only gain unstoppable momentum.

"We in the industry have a great interest in seeing PSE sales limits work," Fish said.

NPLEx is "designed to fund electronic tracking systems in states with critical meth lab problems and essentially ensure that enforcement of the federal Combat Meth Act and state laws is actually effective," he added.

The Combat Methamphetamine Act of 2006 moved nonprescription PSE drugs behind store counters and set daily and monthly limits on consumers' purchases. The law requires retailers to ask for customers' identification at point of sale and to maintain transaction logs in order to prevent consumers from exceeding the limits.

However, law enforcement officials - particularly in states with large meth problems - say retailers' records do little to curtail illegal purchases of PSE products.

Even in Missouri, which enacted a statewide e-tracking law in 2008, a narcotics investigator said Rx status for meth precursors may still be needed (¹ (Also see "Database Funding Needed To Sell Investigators On Combat Meth Enforcement" - Pink Sheet, 25 Aug, 2008.)).

In 2006, prior to the federal Combat Meth Act, Oregon imposed a state law requiring prescriptions for all PSE drugs. The federal law stipulated that more restrictive state measures would remain in effect or could be imposed later.

With continuing difficulties in enforcing the retail provisions of the Combat Meth Act, more states are looking at the Oregon model.

Oregon Sen. Ron Wyden this year drafted legislation for nationwide Rx status for all meth precursors, but the Democrat has not introduced a bill (² (Also see "Wyden To Propose Prescription-Only Status For Pseudoephedrine" - Pink Sheet, 23 Feb, 2009.)).

The possible spread of state prescription laws for all PSE drugs "is a concern," said Fish, who also is CHPA's general counsel and secretary. "We support e-tracking and we're working to support those states implementing these systems."

CHPA realizes state legislators may be likely to dismiss requiring an e-tracking network that must be funded in favor of an Rx-only law. However, Fish said, Rx status drives up consumers' costs and leads to increased spending in Medicaid and other state health care programs.

"Imposing prescription-only access on these widely used medicines is a significant consumer burden and a burden to the health case system as well."

CHPA also wants lawmakers to scrutinize law enforcement data. Limits imposed earlier, such as behind-the-counter sale, created the bulk of the reduction of meth-related crime in Oregon before the Rx-only law was passed, the group says.

According to law enforcement data CHPA compiled, meth lab incidents in Oregon reached 472 in 2004. But after the state moved nonprescription PSE drugs behind store counters in November that year and then to pharmacy-only sales in 2005, the number dropped by 283 to 189.

In 2006, when the state's Rx law took effect in July, the year-on-year decrease in incidents slowed to 134, with the total at 55. The totals were 22 in 2007 and 21 in 2008.

"Proponents of Rx status sell it as a magic bullet, but it's not," Fish said.

NPLEx "actually offers a more robust system than a prescription system because it provides for real-time checking, and maintains a database fully accessible at point of sale and by law enforcement," he added.

Based on retailers' Combat Meth Act data, Oregon consumers are going to neighboring states to buy PSE products without prescriptions.

Further, someone intent on exceeding PSE retail purchase limits can obtain enough prescriptions to do that, CHPA says.

"There's ample opportunity for people to get prescriptions, and a lot of them," said Virginia Cox, CHPA's senior VP for communications and strategic initiatives.

E-tracking And Rx Bills Both Grow

Some chains have implemented e-tracking systems, but those networks are not always accessible by other chains or law enforcement agencies (³ (Also see "Rite Aid Joins Fragmented Electronic Effort Against “Smurfing”" - Pink Sheet, 2 Feb, 2009.)).

While some states require e-tracking, not all are appropriating funding for the systems. For instance, like Missouri, four other states -Illinois, Iowa, Kansas and Louisiana - enacted e-tracking legislation without funding for the projects.

While Iowa has received federal funding to pay for its statewide e-tracking system and is soliciting bids for the project, CHPA is working with the other four states to implement NPLEx. Iowa is soliciting bids for its network.

CHPA contracted with the information technology vendor that developed Kentucky's statewide electronic tracking of meth precursor purchases, Appriss Inc., to build out the system so it could be offered to other states that require e-tracking.

Two other states also previously implemented statewide e-tracking - Arkansas worked with a separate IT vendor and Oklahoma developed its own system. Neither is linked with NPLEx.

NPLEx "is simply a more effective way to enforce the Combat Meth Act than under the current sort of hodge-podge of paper and electronic records that are broken down state by state and chain by chain," said Fish.

When states pass laws requiring electronic tracking for PSE sales, CHPA will contact those states about memoranda of understanding mandating NPLEx as the network, including linking to all retailers affected by the requirement.

Fish said CHPA is "pushing hard" for statewide e-tracking legislation in California, where a bill to make all PSE drugs prescription-only this year passed the Senate before being voted down in the Assembly (⁴ 'The Tan Sheet' June 8, 2009, In Brief).

Similar bills also were introduced and failed this year in Georgia, Indiana, Missouri and Washington. CHPA says it is not aware of any bills proposing this change already introduced for the 2010 sessions of state legislatures.

Retail Perspectives

The National Association of Chain Drug Stores opposes turning nonprescription PSE products into Rx drugs, the group, which represents major retail chains, said in an e-mail.

Members of the National Community Pharmacists Association, which represents small retailers including many single stores, are split.

"Many of their patients like to be able to get all their drugs from pharmacists," said John Coster, NCPA's senior VP of government affairs

While NCPA supports linking to e-tracking networks for PSE sales data, the group has concerns about potential costs for business owners.

"We want to be part of the solution, but it's not as simple as turning on a switch," Coster said in an interview.

Retail chains are more likely to have point-of-sale systems that need little to no modifications for compatibility with NPLEx, and the variety of technologies that individual stores use is significant.

"There could be dozens of different systems within a state," Coster said.

There's also possible danger when employees refuse to sell products to customers flagged by e-tracking networks. "Pharmacists don't want to be put in a position of being law enforcement agents," he said.

- Malcolm Spicer ( ⁵ [email protected] )