Research Refutes Rx-Only Pseudoephedrine Requirements

Research shows Rx requirements “do not effectively reduce methamphetamine’s overall impact on a given state,” CHPA President Scott Melville says. One study found Oregon’s Rx-only law has not dramatically reduced meth lab incidents compared to other states and the second showed the requirement would cost Oklahoma $59 million annually.

Two recent studies funded by the Consumer Healthcare Products Association support drug manufacturers’ argument that states should not require a prescription for pseudoephedrine-containing OTC drugs.

One study found that Oregon’s Rx-only law for PSE products has not dramatically reduced meth lab incidents there compared to other states, while the other research showed that an Rx-only law in Oklahoma would cost the state $59 million annually.

CHPA President Scott Melville pointed out that other states look to Oregon to decide whether to replicate the prescription mandate. But research shows that in addition to increased costs, lost productivity and restricted access, “prescription requirements do not effectively reduce methamphetamine’s overall impact on a given state,” Melville said in a Feb. 22 release.

In PSE-related legislative activity in states this year, Oklahoma and West Virginia lawmakers voted down Rx-only bills and a Kentucky Senate committee narrowly passed one, which has not been voted on by the entire chamber (Also see "States Make PSE Sales A Common Legislative Issue" - Pink Sheet, 27 Feb, 2012.).

Oregon’s Experience “Does Not Stand Out”

Since Oregon’s requirement of a prescription for all PSE products took effect in 2006, the state’s experience with meth manufacturing and abuse “does not stand out from its neighbors or other parts of the United States,” according to a CHPA-funded report authored by consulting firm Bates White and released by Oregon public policy research firm Cascade Policy Institute.

While the number of meth lab incidents in Oregon declined from 467 in 2004 to 12 in 2010, the report says the Rx-only law is not the reason. “Most of this decline occurred before the Rx-only law became effective in 2006, by which time the number of incidents already had fallen to 50,” Bates White wrote.

A similar trend is evident in the neighboring states of California and Washington, which do not have Rx-only requirements. While incidents related to meth manufacturing have declined in Oregon and regionally, the drug continues to be available widely. Law enforcement officials believe finished product made in Mexico and other states has replaced locally manufactured meth in Oregon, the report says.

Most of Oregon’s decline in meth lab incidents “occurred before the Rx-only law became effective.”

–Cascade Policy Institute report

Finally, the report notes, the decline in meth treatment episodes in Oregon – about 23% – is similar to the rate of decline in the western U.S. and across the country.

Oregon became the first state with an Rx-only law for PSE after lawmakers there passed legislation in 2005, and Mississippi in 2010 became the second and so far only other state to follow suit (Also see "Mississippi PSE Prescription Switch Will Not Start An Avalanche - CHPA" - Pink Sheet, 8 Feb, 2010.).

Rob Bovett, a district attorney in Oregon and one of the authors of the state’s Rx-only law, said the federal data Bates White used to calculate meth lab incidents are “notoriously unreliable.”

“The timing of the flawed study was perfect for the pharmaceutical industry, who have already used it throughout the nation to help kill legislation in states plagued with meth labs,” Bovett added in an email.

Costs In Oklahoma “May Be Significant”

Although requiring a prescription for OTC PSE products appears to cause “only modest inconveniences” for consumers, the costs actually “may be significant,” according to a study by the Economic Impact Group.

The group conducted its CHPA-funded study in Oklahoma, which became the first state to require behind-the-counter sales of nonprescription PSE products in 2004, two years before Congress passed the Combat Methamphetamine Epidemic Act requiring BTC sales while also allowing states to impose more stringent limits (Also see "State Pseudoephedrine Proposals Go Above, Beyond Combat Meth Act" - Pink Sheet, 19 Mar, 2007.).

Costs linked to requiring prescriptions for all PSE include co-pays for doctors’ visits and prescriptions, premium increases and productivity losses, among others. Extrapolating U.S. data on doctors’ visits and medication costs for viral respiratory tract infections, the researchers estimate direct-to-consumer costs of $17.7 million for physician visits in Oklahoma. The costs of medicine across the state would go down about $3.9 million for a net direct cost increase of $13.8 million for out-of-pocket expenses.

The other costs in the state will be in federal Medicare and Medicaid spending ($16.5 million), state Medicaid and children’s health insurance programs ($1.77 million) and private health insurers ($27.7 million).

“Given the more adverse-claims environment facing private insurance, it is likely that a portion of these costs gets passed on to enrollees in the form of higher premiums or reduction in benefit generosity,” the study says.

In addition to the direct costs on individual consumers in Oklahoma and the health care system, the state would lose productivity. Employees currently are absent 0.2 to 0.4 workdays on average per viral respiratory infection at a cost of $227.8 million to $414.2 million per year, the study authors say.

“Under a policy shift, it is likely that the average number of workdays missed per episode would increase as employees take leave to procure PSE products via prescription or complement a less effective substitute with additional rest and recovery,” they note.

Problems With Other Changes, Too

The Oklahoma study also notes that an “exhaustive and determinative” cost-benefit study of moving PSE products to Rx-only status is “very likely impossible given the complexity of the markets involved and the unknowable data hidden in black market activity.”

Although pharmacologically similar, phenylephrine is not a perfect substitute for PSE, the authors note. Phenylephrine is metabolized faster than PSE and is not available in 12- or 24-hour delayed release formulas.

“A segment of the consumer population views the products differently and is willing to endure the additional costs, including the opportunity costs of their time,” associated with purchasing PSE through the pharmacy, they add.

Some OTC manufacturers began marketing allergy products with phenylephrine after Congress sent all pseudoephedrine sales behind the counter, but some experts do not consider PHE to be as effective and sales of those products have trailed PSE-containing drugs. Additionally, phenylephrine is among the ingredients being reviewed in FDA’s monograph update process.

Limiting meth producers’ access to tablet PSE will not stop the manufacturing of meth, they note. Meth production from liquid and gel capsule PSE products is “only marginally more difficult” than production from tablets, but “yields a less pure product.”

Meth produced abroad also will fill the void. The authors note although 90% of labs are small-scale operations, super labs – those capable of producing at least 10 lbs. of meth in a single production cycle – account for 80% of all the meth produced. The majority of meth consumed in America originates from super labs run by drug traffickers in Mexico, they assert.

Legislation that attempts to restrict the sale of meth precursors can “if only temporarily, impact local production patterns; it is less effective at legislating reduced demand for the product,” according to the Oklahoma study.