GAO study and consumer polls find conflicting results in limiting pseudoephedrine access


Mixed results parallel similar efforts in controlled-substances regulation

A new study by the Government Accountability Office (GAO), “State Approaches [to control] Methamphetamine” (GAO 13-204) finds that federal and state efforts to make the precursors to methamphetamine (mostly pseudoephedrine, PSE) have generally been effective in reducing the activity of meth labs (where the precursors are “cooked”); however, following a steep decline in the mid-2000s, when these regulations went into place, the tally of DEA meth lab “incidents” has begun rising again, due in part to what is called “smurfing” (having multiple individuals buy small, legal amounts, and then consolidating those quantities). Meanwhile, the Consumer Healthcare Products Assn. (Washington, DC) has sponsored a series of studies showing that consumer acceptance of restrictions is limiting. At issue: whether to make PSE products Rx only. The most recent study, performed by Harris Interactive on behalf of the Asthma and Allergy Foundation of America, finds that 63% of asthma/allergy patients oppose Rx-only restrictions (only patients suffering from breathing conditions or flu were polled. The Foundation says that 45 million Americans suffer from allergies, and an additional 22 million have asthma.)

Starting in the mid-2000s, the US Congress passed laws making PSE products “behind the counter” at pharmacies, and a public-private partnership sponsored the National Precursor Log Exchange (NaPlex) which obliges retailers to report individual data on PSE purchases. The GAO report notes that DEA incidents declined from over 24,000 to just under 7,000 from 2004 to 2007—but were back up to 15,314 in 2010.

Liana Burns, a policy executive at the Foundation, notes that some 20 states have looked at Rx-only legislation since 2006, but only two, Oregon and Mississippi, went the Rx-only route. The group’s report on the Harris poll notes that patients incur substantial costs, including copays for drugs and doctor visits, when Rx-only treatments are the requirement. Moreover, doctor visits to obtain prescriptions could run into the hundreds of thousands annually, adding cost to the healthcare system. The topic is being debated in state legislatures in Kentucky, North Carolina and New York currently. Another advocacy group, Allergy and Asthmatic Network Mothers of Asthmatics (Mclean, VA), supports Rx-only legislation, asserting that “In 28 years, AANMA has never heard from asthma and allergy patients who rely on non-prescription oral decongestants for their condition.”

Although opioids and other controlled substances are a different situation than OTC PSEs, the parallels are striking: the collective response has been to set up patient-identification systems and interstate data-sharing (most states now have PDMPs—Prescription Drug Monitoring Programs—in place for controlled substances). And the same dynamic of trying to restrict access, while confronting patient interests that argue for maintaining access, come into play. At the same time, despite the healthcare-products industry responses, the problem seems to be getting worse rather than better.

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