An industry-funded study finds that requiring prescriptions for all pseudoephedrine-containing drugs will “force high social and economic costs on consumers” and likely will not stop diversion to meth production.

The Consumer Healthcare Products Association funded the study, an argument against the movement to require prescriptions for PSE.

“PSE diversion to meth production remains a demonstrable problem” despite the 2006 Combat Methamphetamine Act that moved pseudoephedrine cold and allergy products behind the counter and limited retail purchase amounts, Matrix Global Advisors states in the study released March 4.

However, Matrix CEO Alex Brill maintained that requiring a prescription for PSE-containing products as advocated by law enforcement agencies and lawmakers such as Sen. Dianne Feinstein, D-Calif., and Sen. Ron Wyden, D-Ore., is “shortsighted” and not the answer Also see "GAO Backs Prescription Pseudoephedrine Approach" - Pink Sheet, 18 February, 2013..

“Given some lawmakers’ interest in pursuing prescription-only policies at the state and possibly the federal level, it is important to understand any foreseeable unintended effects this policy would produce,” Brill said.

“While motivated by good intentions, such a move is not without appreciable costs,” he added.

PSE Use Could Fall 83%

For example, many of the 18 million families who currently use PSE products for relief from allergies and colds would not bother to seek a prescription if a nonprescription option disappeared, the study found. Roughly 60 million people simply would not seek treatment, reducing PSE use by 83%, it added.

This would hit manufacturers’ revenues and cost states an estimated $219.2 million in lost tax revenues over 10 years, Brill said. A nationwide Rx-only PSE law also would increase absenteeism and lost work productivity, which already costs the U.S. $25 billion annually due to the common cold, according to the study.

Point/Counterpoint: Switching PSE

According to a CHPA-funded study, if PSE was Rx-only:

60 million people likely would not seek treatment
PSE use would drop by 83%
Consumers and insurers would pay $59 million more for doctors’ visits to obtain Rx

Advocates for switching PSE to Rx-only say:

NPLEx does not stop smurfers or significantly help find labs
Meth lab clean-up and enforcement costs in Kentucky outweigh potential lost revenue from state taxes 2 to 1
Meth labs are down 89% in Oregon and 65% in Mississippi since each state required Rx for PSE

Those who choose to obtain prescriptions and buy PSE products also would face higher costs. Within the first year of the implementation of a prescription-only policy, consumers and insurers would pay an extra $59 million to cover additional doctor visits to obtain a prescription, Brill said.

This includes an estimated $32.4 million in additional costs for private and public payers, and $26.6 million in consumers’ out-of-pocket costs to cover an estimated 579,315 additional doctor visits, based on analysis Avalere Health conducted in 2011, Brill notes.

Extra doctor visits also could drive up health insurance premiums, as could price hikes for PSE medicines to cover the cost difference between making, shipping and marketing prescription versus OTC drugs.

Kentucky’s Narcotic Officers’ Association is not buying these arguments, however. It notes on its website that money gathered through state taxes on PSE products does not outweigh the cost of cleaning up meth labs. In 2009, Kentucky spent $1.5 million cleaning up labs and “if you add in the cost of arrest, one day jail stay, public defender cost, the total goes up to $4 million,” substantially more than the estimated $750,000 in lost sales tax.

The association also notes that if PSE products became schedule III drugs consumers would not need to visit a doctor to obtain a prescription. Rather the doctor simply could call in the prescription.

Would Diversion Persist?

Requiring prescriptions “would not be 100% effective at eliminating PSE diversion,” Brill argues.

He notes meth lab operators still could access the ingredients with fraudulent prescriptions or through theft from pharmacies, warehouses or cargo during transit.

Likewise, the fact that prescription drug abuse is considered a “public health epidemic” by the Centers for Disease Control and Prevention shows that requiring an extra step for a consumer to access a drug does not stop abuse, Brill writes. He added that the 2011 National Drug Threat Assessment showed that “deaths from prescription drug overdose outnumber deaths due to cocaine, heroin and meth combined.”

In addition, requiring a prescription would not stop the importation of meth from Mexico, which accounts for 80% of the meth sold in the U.S., Brill says.

The GAO Perspective

However, requiring a prescription for PSE products dramatically reduced meth lab incidents in Oregon 89% between 2004 and 2006, and 65% in Mississippi from 2010 to 2011, according to a recent Government Accountability Office report.

“Given some lawmakers’ interest in pursuing prescription-only policies at the state and possibly the federal level, it is important to understand any foreseeable unintended effects this policy would produce.” – Matrix CEO Alex Brill

Those results prompted other states, including Tennessee, to consider requiring prescriptions for the ingredient, too, and fueled GAO’s support for a national prescription requirement (Also see "Rx-Only Pseudoephedrine Legislation Spreads To More States" - Pink Sheet, 31 January, 2011. and Also see "Tennessee Emerges As PSE Battleground With Rx, NPLEx Proposals" - Pink Sheet, 7 February, 2011.).

Still, Brill argues, “the benefits of a prescription-only policy for PSE medicines do not seem worth the costs, especially when there are other policy options at hand.”

The NPLEx Debate

For example, Brill touts the National Precursor Log Exchange, an electronic sales blocking technology funded by CHPA and member companies, which is in 25 states. CHPA has long said that the more states that participate in NPLEx, the more effectively the system will block sales that are over the limit and over state lines.

The former governor of Mississippi said years after he signed the state law requiring a prescription for PSE products that the drug industry should try to repeal the law now that NPLEx had grown to include so many more states than the three participating when the law became effective Also see "Electronic Tracking Success Could End Rx-Only Pseudoephedrine In Mississippi" - Pink Sheet, 19 March, 2012..

But not everyone is happy with NPLEx’s results. Kentucky’s Narcotic Officers’ Association notes tracking PSE buyers is not the same as stopping meth cooks, who often rely on a network of people to buy PSE products at levels under the legal limit. The group’s website says that NPLEx helped Kentucky law enforcement find only 54 of the 716 meth labs uncovered in 2009. The rest were directly tracked.

The Alternatives

The CHPA-funded study cites a number of alternatives to a prescription approach that states are using to curb diversion “without unduly compromising” consumer access.

Ten states have lowered the threshold for the volume of PSE medicines individuals can purchase below the nationally allowed level, the study notes. And a bill is moving through Indiana’s congress that would reduce the amount of PSE consumers could buy to 61 grams a year, about 56% of the current national cap.

A lower limit is designed to make it more difficult to obtain sufficient PSE to make meth. However, some might argue that meth labs would simply expand their network of purchasers. In addition, a one-pot method allows labs to make meth with less PSE than other methods.

With this in mind, the Indiana bill also would increase the penalty for smurfing, or buying PSE products for someone else to make meth, as a way to discourage the practice.

Likewise, eight states prohibit the sale of PSE to anyone convicted of meth-related crimes, which likely aims at reducing recidivism, and 16 states sell PSE medicines only through pharmacies, which reduces the number of stores selling the drug and ostensibly would make finding noncompliant stores easier.

Prescription PSE Law Would Cripple Sales, Push Costs – Industry Study

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