BETHESDA, MD 29 Apr 2011—In the battle to cut off the supply of pseudoephedrine to illicit methamphetamine manufacturers, one state is turning to pharmacists to keep the nasal decongestant available without a prescription to persons with a legitimate need.
Arkansas Governor Mike Beebe on March 23 signed into law a bill requiring pharmacists in pharmacies selling nonprescription pseudoephedrine-containing products to determine whether potential purchasers have a "medical and pharmaceutical need."
An alternative piece of legislation would have put pseudoephedrine in Schedule III of the state's list of controlled substances and made the drug available only by prescription.
The new law requires pharmacists to "make a professional determination, based on a pharmacist-patient relationship."
Nothing in the new law explicitly forbids pharmacists and pharmacy technicians from selling nonprescription pseudoephedrine to persons lacking a legitimate need. But the law empowers the state board of pharmacy to review pharmacists' professional determinations regarding purchasers' need for pseudoephedrine and take "appropriate disciplinary action as required."
Attorney and pharmacist Scott Pace, associate executive vice president of the Arkansas Pharmacists Association, said his group worked with state senator Percy Malone on the bill's language.
Malone, a pharmacist and pharmacy owner, chairs the state senate's public health, welfare, and labor committee.
Pace called purchases of pseudoephedrine for "nonmedical" purposes an "epidemic problem" despite statewide use of a real-time electronic logbook.
Since 2008, the state has required pharmacies to use a logbook to record sales of pseudoephedrine. The Arkansas Crime Information Center, which selected LeadsOnline's MethMonitor for pharmacies' use, said the logbook instantly displays to pharmacy personnel a color-coded response indicating whether to complete a sale.
Pace said even with the electronic logbook, his organization received telephone calls from pharmacists who "felt pressure from management" to sell pseudoephedrine against their better judgment.
In June 2010, the state board of pharmacy unanimously voted to support a legislative initiative that would convert pseudoephedrine to a Schedule III controlled-substance prescription item. Solid oral dosage forms of the drug were already Schedule V nonprescription products.
Pace's organization sought a change that did not alter the drug's nonprescription status.
"We wanted patients to still have access to a very effective nasal decongestant without having to go to the expense" of a physician office visit, Pace said.
The Arkansas Society of Health-System Pharmacists, said Susan Newton, executive director, did not work on the legislation.
"Most of us do not have a retail pharmacy permit," she said.
Only five or six health systems in the state, Pace estimated, have such a permit.
Jan K. Hastings, clinical coordinator for community pharmacy experiential education at the University of Arkansas for Medical Sciences in Little Rock, said the decision-making process under the law rests on the pharmacist–patient relationship.
"There has to be a pharmacist–patient relationship before you make the recommendation, just like there would be for any other medication that you would recommend for a patient," she said.
The law lists three factors on which the determination of legitimate need may be based: (1) the prescription profile at that pharmacy, (2) patient screening, and (3) "[o]ther tools that provide professional reassurance to the pharmacist."
Regarding the screening, Hastings recommended pharmacists use the same process they would for any other patient needing assistance with a nonprescription product.
"I use a system called QuEST/SCHOLAR, where you talk about their symptoms, the characteristics, the history, . . . onset, location, aggravating factors, [and] remitting factors," said Hastings, who also works as a "relief pharmacist" in several central Arkansas pharmacies.
The QuEST/SCHOLAR self-care counseling process was developed by Ken Leibowitz of the University of the Sciences in Philadelphia and Diane B. Ginsburg of the University of Texas at Austin.
"You're going to be able to tell with some of them by the way they look that they're obviously in pain" above or below the eyes, Hastings said. "Or . . . you can hear by the way they talk that they can't breathe" through their nose.
Those patients, she said, obviously need a decongestant.
As for which decongestant, Hastings said she would recommend pseudoephedrine over phenylephrine because the latter has not worked well for her.
Pace said the law purposely defers to the professional judgment of the pharmacist for determining the legitimacy of a person's need for pseudoephedrine and deciding whether to sell the drug product to that person.
"This is not a unique model in Arkansas," he said.
A state regulation requires pharmacists conduct a consultation with patients who want to buy a nonprescription narcotic-containing product in Schedule V.
The new law restricts sales of nonprescription pseudoephedrine-containing products to persons with an Arkansas-issued driver's license or ID card and active duty military personnel with an ID card from the U.S. Department of Defense. This driver's license or ID card must have a functioning magnetic stripe or bar code.
Residents of neighboring Mississippi, Hastings said, have been pseudoephedrine "smurfing" in Arkansas.
Pseudoephedrine became a prescription-only drug in July 2010 in Mississippi.
The director of the Mississippi Bureau of Narcotics told the Associated Press that his personnel seized 203 methamphetamine laboratories from July 2010 through February 2011; as many as 98% percent of those laboratories had been using pseudoephedrine purchased from another state.
Pace said Arkansas' law goes into effect 90 days after the legislature adjourns its current session.