To Curb PSE Diversion, Retailers Lead By Example With Emphasis On Tamper-Resistant Products

An HHS agency’s 2013 drug use survey shows the number of meth users rising by 155,000 after changing little the previous two years. Acura Pharmaceuticals notes the survey and Tennessee data showing that making only tamper-resistant, single-ingredient PSE products available affects the diversion rate.

Acura Pharmaceuticals Inc. says a national survey showing a rise in methamphetamine use should prompt more retailers to offer only tamper-resistant, single-ingredient pseudoephedrine products to help prevent PSE diversion.

Law enforcement officials also expect pharmacies and other stores could have an impact on PSE diversion by stocking only tamper-resistant, single-ingredient PSE, and they see retailers’ voluntary moves are more likely than state lawmakers imposing tighter restrictions on sales of PSE-containing products.

The Department of Health and Human Services’ Substance Abuse and Mental Health Services has published key findings from its 2013 National Survey on Drug Use and Health report, including the number of meth users rising from 440,000 in 2012 to 595,000 in 2013 after the number changed little the previous two years. SAMHSA has yet to publish its full report from the survey.

In addition to the SAMHSA data, Acura notes Tennessee Bureau of Investigation data showing that making only tamper-resistant, single-ingredient PSE products available affects the diversion rate for the meth precursor. Acura markets Nexafed (PSE 30mg) nasal decongestant made with the firm’s Impede tamper-resistant formulation.

According to the TBI’s Methamphetamine & Pharmaceutical Task Force, the number of meth lab seizures for the first three months of 2014 dropped dramatically from the same period in 2013 in two counties in east-central Tennessee bordering Kentucky, where retailers voluntarily are selling only tamper-resistant, single-ingredient PSE products.

The task force reported that meth lab seizures dropped nearly 91% in Scott County, from 11 in the first three months of 2013 to one during January-March this year, and 88% in Campbell County, from 26 to 3.

“You can’t argue with the success that they’ve had,” task force Director Tommy Farmer said of retailers’ voluntary limits on PSE sales.

Farmer added that whether they realize it or not, retailers are the front line of curbing meth diversion.

“They know what’s going on. … They can either voluntarily do that and have an impact on the problem, or the states are going to have to do something,” he said.

The National Narcotic Officers’ Associations’ Coalition, says President Bob Bushman, supports retailers moving to selling only tamper-resistant, single-ingredient PSE products and also recognizes that community support is crucial for curbing PSE diversion.

“This is not just a police issue. It’s a community issue and it’s a private industry issue,” Bushman said.

Palatine, Ill.-based Acura distributes Nexafed to 10,000 drug stores in the U.S., which represents one in six pharmacies nationwide, said marketing VP Brad Rivet.

The Fruth Pharmacy chain in West Virginia and Ohio, Rite Aid stores in West Virginia and some independent pharmacies are selling only Nexafed as a single-ingredient PSE product, he said.

Other chains and retailers including Walmart, Kmart, Kroger, Publix and Meijer are stocking Nexafed and another tamper-resistant PSE brand, [Westport Pharmaceuticals LLC]’s Zephrex-D, as well as conventionally formulated products such as Sudafed and store brands. Walgreens gives its pharmacists the option of stocking tamper-resistant PSE products in stores (Also see "Acura Expects Dominoes To Fall In Retailers Prioritizing Tamper-Resistant PSE" - Pink Sheet, 8 Aug, 2014.).

Acura also is discussing with CVS Health stocking Nexafed. The chain in June began selling only Zephrex-D as a single-ingredient PSE product in more than 90 stores in West Virginia and within 15 miles of the state’s border in Kentucky, Maryland, Ohio, Pennsylvania and Virginia. Like other CVS locations, those stores also sell conventional products that include PSE and other active ingredients.

State Changes Since PSE Went OTC

Farmer noted that state legislatures began eyeing restrictions on nonprescription PSE sales soon after the drug initially became available OTC in 1976.

“Ever since then you’ve had states that have produced some legislation trying to wrangle this meth lab monster,” he said.

Acura anticipates that lawmakers in states with PSE-diversion problems will continue proposing tighter limits on sales of nonprescription PSE products than required by the Combat Methamphetamine Act, which took effect in 2006.

“There are a diverse number of activities happening across a number of meth-plagued states, but it’s still too early to tell where legislation is being generated that requires sales of tamper-resistant, single-ingredient PSE products,” Rivet said.

“We can say that local counties in Tennessee, like Scott and Campbell counties, have shown real-world results with the voluntary adoption of single-ingredient PSE products for their stores.”

The Combat Meth Act set purchase limits of 3.6 grams per day and 9 grams a month, and imposed behind-the-counter sales for all nonprescription products containing PSE, ephedrine or phenylpropanolamine, and required retailers to keep records of purchases of those products and obtain identification prior to sales.

Oregon already enacted a prescription requirement for all PSE product sales in the state before Congress passed the Combat Meth Act, Mississippi moved to an Rx-only requirement in 2010 and other state and local governments have imposed other restrictions on sales more stringent than the federal law (Also see "Rx-Only Pseudoephedrine Stalls As Meth Solution In Tennessee, Indiana" - Pink Sheet, 1 Apr, 2013.).

Some states also require retailers to link into electronic tracking networks, including one operated by the Consumer Healthcare Products Association, to satisfy the federal requirement to track PSE purchases and provide real-time monitoring (Also see "NPLEx Pays Dividends In Stopping Multi-State PSE Purchases" - Pink Sheet, 23 Jul, 2012.).

In some states with electronic tracking systems, meth offender registries are maintained to prevent a person convicted of a meth-related crime from purchasing any medicine containing PSE for certain numbers of years following their convictions.

Alabama, Illinois, Kentucky, Oklahoma and Tennessee have implemented meth offender registries as part of their efforts to curb PSE diversion and Michigan this year enacted legislation for a registry.

However, legislatures in additional states have voted down proposals to make all PSE drugs Rx-only and state bills to require sales of only tamper-resistant, single-ingredient PSE products also have failed to gain traction (Also see "State Officials Urging Rx Pseudoephedrine Face Strong Lobby" - Pink Sheet, 30 Jul, 2012.).

From the perspective of Farmer and other officials in states with meth problems, the Rx-only path Mississippi and Oregon chose is the only solution for eliminating PSE diversion.

The Combat Meth Act was intended as a “fix-all, but it hasn’t done what it was designed to do,” Farmer said.

CHPA says limiting the selection of products retailers can offer punishes consumers who have legitimate needs for the products and who prefer to buy certain brands.

NNOAC expects continued activity in state legislatures about limiting PSE product sales, but the group also acknowledges opposition to the changes from the drug industry and from some consumers. Voluntary restrictions by retailers, such as stocking only tamper-resistant, single-ingredient PSE, could be more likely, said Bushman, who joined the group after 33 years in narcotics enforcement in Minnesota.

State proposals for tighter limits on nonprescription PSE sales “have caused quite a lot of discussion, he said. “There’s some pushback there.”

NNOAC also realizes that although the Combat Meth Act allows the Drug Enforcement Administration to grant front-of-counter waivers to nonprescription PSE products determined to be extraction-proof, no PSE product is likely to move from behind-the-counter sales.

As firms like Acura and Westport continue to develop formulations to prevent extraction of PSE, meth cooks continue to find ways to remove some PSE from their products.

“When you close the door on one way, somebody opens another door to do it another way,” Bushman said.

Both Bushman and Farmer pointed out that even as state, regional and local law enforcement agencies make some headway against meth production fueled by PSE diversion, more and more of the drug is being smuggled into the country from Mexico.

Drug cartels in Mexico, Farmer said, “are mass-producing it.”