Kentucky FPs Join Fight to Make Pseudoephedrine Prescription-only

Sixteen state legislatures considered bills this year that would have made pseudoephedrine -- the key ingredient in methamphetamine -- a prescription drug. But, despite the escalating number of meth lab incidence nationwide and an estimated $23 billion a year spent on issues related to meth abuse, the measures failed in all 16 states.

For one of those states, however, the battle is just beginning.

In Kentucky, which ranks among the top five states in meth lab incidence, the Kentucky AFP and the Kentucky Medical Association have partnered with the state police and the state's narcotics officers association to lobby in favor of a bill to make pseudoephedrine a prescription drug.

"This was our No. 1 priority this year for both physician groups," said family physician William Thornbury, M.D., of Glasgow, a Kentucky chapter member closely involved in the effort. "If it's not the single most important piece of legislation regarding public health, I don't know what is."

That's why Kentucky's family physicians are ready to try again when a new legislative session starts in January. Sen. Tom Jensen, R-London, and Rep. Linda Belcher, D-Shepherdsville, who sponsored the prescription bill that failed during the 2011 legislative session, have said they plan to file a new bill regarding pseudoephedrine during the 2012 session.

Meanwhile, Rep. Brent Yonts, D-Greenville, already has filed a bill supported by the Consumer Healthcare Products Association, or CHPA, that would prevent convicted meth offenders in Kentucky from buying pseudoephedrine products.

Pseudoephedrine became an OTC drug in 1976. Faced with a growing problem of diversion, the U.S. Congress forced the product behind the pharmacy counter in 2006 and set daily and monthly limits on the amount of pseudoephedrine an individual can purchase.

But, according to Tony Loya, director of the National Methamphetamine and Pharmaceuticals Initiative, an initiative of the High Intensity Drug Trafficking Area program of the National Office of Drug Control Policy, meth cooks easily adjusted to the tracking programs for pseudoephedrine purchases. Many use fake identification or co-conspirators to buy large quantities of pseudoephedrine through multiple small purchases, a practice known as "smurfing," said Loya.

Although CHPA data from earlier this year indicate that four states with fully implemented electronic tracking systems were able to block nearly 40,000 grams of pseudoephedrine sales per month, that's just a drop in the bucket, according to Loya.

"The system does block some sales," he said. "The problem is that those are the dumb smurfers who go out and get caught. The secret isn't in what they block but in what the tracking systems allow because they can't stop smurfing and fake IDs. The fact that they block so many sales, and there's still a significant number of lab incidence around the country, tells you the system doesn't work."

Currently, only two states -- Oregon and Mississippi -- require a prescription for pseudoephedrine products. After Oregon made pseudoephedrine a prescription drug in 2006, meth lab incidence fell (1-page PDF; About PDFs) by more than 90 percent.

Mississippi instituted a similar law in 2010. In the 12-month period ending Aug. 5, meth lab incidence fell 65 percent in that state, and there was a 77 percent reduction in the number of children placed into protective custody because of meth labs.

"The reason Mississippi hasn't gone any lower is because people cross to other states and bring the precursor back," Loya said. "All of Mississippi's border states have tracking systems, but tracking systems haven't stopped sales."

Oklahoma is one state that already has tried, and failed, to stop diversion of pseudoephedrine by implementing a meth offender registry similar to the one proposed in Kentucky, said Stan Salyards, past president and a board member of the Kentucky Narcotics Officers Association.

The association approached the Kentucky AFP about working together before the 2011 legislative session, and, despite the setback with the failed bill, Salyards still thinks physicians can make a difference in 2012.

"You have to educate the community," Salyards said. "We need support from doctors and pharmacists saying, 'This isn't an access issue, and it isn't a health care issue.'"

CHPA, which represents manufacturers who make more than $600 million in annual sales of pseudoephedrine products, has argued that requiring a prescription for the decongestant would put a burden on law-abiding consumers and increase health care costs. Opponents have estimated that legislation would lead to 17,000 more physician office visits each year in Kentucky.

Salyards isn't buying it.

"Walk into a pharmacy and look at all the over-the-counter products that take care of the sniffles," he said. "There are about 120 products. Oregon and Mississippi have proven that when pseudoephedrine goes prescription, people go with what's still on the shelf. They don't run to the doctor and pay for an office visit just so they can get a prescription for pseudoephedrine."

Brent Wright, M.D., co-chair of the Kentucky AFP's advocacy committee, said patients shouldn't take pseudoephedrine without consulting their physicians anyway because of a long list of side effects, potential drug interactions and contraindications, including hypertension.

Wright, associate professor and director of the family medicine residency program at the University of Louisville-Glasgow, said phenylephrine -- another nasal decongestant -- has fewer drawbacks, is effective and can't be used to make meth.

"This doesn't have to be a burden to patients," he said. "If they work with their physician and they need to take Sudafed, it can be arranged through their doctor's office. The benefit of discouraging the illegal manufacturing of methamphetamine far outweighs any inconvenience to patients."

Although Kentucky introduced an electronic sales tracking system for pseudoephedrine in 2008, meth lab incidence increased from 743 in 2009 to more than 1,000 last year. The figure is expected to top 1,400 this year, Thornbury said.

Cost to law enforcement -- including cleanup, arrest, prosecution, and jail and prison expenses -- have increased as well, climbing from $26 million in 2008 to $34.5 million last year.

"There are roughly 4 million people residing within the Commonwealth," said Thornbury. "That's more than $8 per person from tax revenue -- and that doesn't include the additional costs of burn care, emergency room visits, child protective services and secondary crime related to supporting meth abuse. It's now become a fiscal problem" for the state.

Salyards said that based on the success experienced by Oregon and Mississippi, prescription requirements for pseudoephedrine should be a "no-brainer."

That doesn't mean that all physicians are embracing the issue, however. The Kentucky AFP submitted a resolution to the AAFP Congress of Delegates in September, calling for the Academy to adopt a policy in favor of a prescription requirement for pseudoephedrine. It was not adopted.

"I think the delegates viewed it as a law enforcement issue," Thornbury said. "But it's our issue. We're the family physicians of America, and we're the guardians of public health. These chemicals are toxic that people are putting in their bodies. There are children and families that are broken up. It's very expensive for our communities and states.

"Pseudoephedrine has risen to the position that it's a controlled substance. There was a time when it wasn't. It was just a treatment for congestion. But now, most of it is being diverted for misuse."

Just how much pseudoephedrine is being diverted is unclear, and estimates vary widely.

"We monitor meth labs and where they get the precursor," Loya said. "It's not coming from Mexico, Canada, or the Internet. It all comes from the corner drug store. The domestic methamphetamine production problem is squarely on the shoulders of industry. They make a lot of money on sales. The question is how much of those sales are legitimate and how much of it is going to meth. Industry has used a figure as low as 4 percent, but that's nuts."

Law enforcement groups offer much different estimates. Salyards estimates that 45 percent of all pseudoephedrine products sold in Kentucky are diverted to meth production.

In Missouri, Kentucky's neighbor to the west, 60 counties and cities have passed laws that make pseudoephedrine a schedule drug.

Jason Grellner, task force commander for the Franklin County, Mo., narcotics unit and past president of the Missouri Narcotics Officers Association, estimates that as much as 90 percent of pseudoephedrine sold in Missouri ends up in meth production.

Grellner said that he reviewed the pseudoephedrine sales from the five pharmacies in Washington, Mo., in the 90-day period before the small town instituted a prescription requirement and the 90-day period after the law took effect. In that town of 13,500 people, 4,400 boxes of pseudoephedrine products were sold in the 90 days before the law took effect. The number fell to 268 boxes in the 90 days after the law was implemented, he said.

And, according to Grellner, who also is regional director of the National Narcotics Officers Coalition, the new city and county laws have not created problems for physicians or pharmacists.

"There were no complaints from local doctors of offices being overrun, and I was hugged and literally kissed by pharmacists," he said. "In fact, in the 60 communities around the state, there've been no complaints from doctors or pharmacists. I have yet to hear stories about citizens with pitchforks and torches walking around government centers wanting their pseudoephedrine back."

Loya said physician and community support for prescription requirements will be critical in the coming legislative session.

"That's where the answer lies," he said. "If it's just law enforcement, we're not going to win. We're just not strong enough. It's the voting public that's going to have an effect on the situation."

Wright said he is ready for the challenge.

"I feel very passionate about this issue," he said. "I went into medicine to make a difference, not only with the patients I serve but in the community I serve. I feel like this is one of those issues that is ready-made for what we do as physicians, and we need to be there speaking to it."