R.Ph.s tag psuedoephedrine rules as a burden

January 14, 2008

Some pharmacists feel that record-keeping is unduly burdensome and the process has not reduced the production of methamphetamines.

A survey of 193 pharmacists in Albany and other parts of New York State found that 67% felt there has been a dramatic decrease in pseudoephedrine product sales, with 20 or fewer of the products sold each week per pharmacy. Nevertheless, they are averaging 30-38 minutes a week logging the information, with almost 77% finding it burdensome. The study, done by School of Public Health students and faculty at the State University of New York (SUNY) at Albany, was presented at the recent annual meeting of the American Public Health Association in Washington, D.C.

The federal law that came into effect in September 2006 requires pharmacies to put all pseudoephedrine products behind the counter. Sellers must document the purchasers' names and addresses, the time of sale, and the amount of product. All employees involved in the sale of pseudoephedrine products must be trained.

Although 80% of responding pharmacists spent less than one hour per week documenting sales, Nadeau said, "Pharmacists may just be too busy within the pharmacy area to deal with this increased time burden." She also noted that the study asked only about the time in documenting the sales, and not about maintaining the stock of products behind the counter or training employees on the procedures. Pharmacists hand in their logs to drug enforcement agencies who check them for multiple purchases by one person. Nadeau commented, however, that many pharmacists believe the law is ineffective because people can still make purchases at a variety of pharmacies. The researchers suggested that perhaps a computerized system of log entry would help the process.

Because there are indications that the rules have cut domestic methamphetamine production, the doubts that many pharmacists have may mean they need more feedback on this issue, Nadeau speculated.

An October 2006 National Drug Threat Assessment from the U.S. Drug Enforcement Administration (DEA) said recent controls of precursor chemicals have contributed to a sharp decrease in domestic methamphetamine production. Although the federal rules for sales became effective only in September of 2006, DEA said that since April 2004, 44 states have restricted retail sales of ephedrine and pseudoephedrine products to varying degrees. But DEA also said the drop in domestic manufacture has been offset by increased production in Mexico for U.S. distribution by Mexican drug organizations.

Because many pharmacists feel pseudoephedrine sales have dropped and because a number of cold-remedy makers have switched to phenylephrine-containing products, Nadeau theorized that consumers may be buying more phenylephrine-based products to avoid taking the time for the documentation process. Some studies have found no difference in effect between phenylephrine and placebo. "No one has currently looked at whether consumers understand the difference between the two active ingredients," Nadeau said.

Meanwhile, Sen. Joseph Biden Jr. (D, Del.), chair of the Senate Judiciary Subcommittee on Crime and Drugs, cited what he indicated is the success of the pseudoephedrine law. Adding to that law, he introduced a bill Oct. 31 to require customers to be at least 18 years old to purchase dextromethorphan-containing products such as Robitussin and Coricidin Cough and Cold-something many grocery stores and pharmacies have already done, he said.

THE AUTHOR is a writer based in the Washington, D.C., area.