DEA ends year with a flurry of activity

January 14, 2008

DEA issues new rules governing schedule II narcotics prescriptions and forms and suspends the license for two Cardinal Healthcare distrubtion centers.

Seeking to improve security and to update a form that is more than 30 years old, the DEA announced that it has developed a new order form for Schedule I and II controlled substances. DEA proposed a rule that would eliminate the three-sheet carbon copy format and replace it with a single form. Designed to frustrate counterfeiters, the new form will have an embedded watermark of the DEA emblem. Pharmacies will now be required to make a photocopy of the form for their records, which will then display the word "copy" as another security feature. Under the proposed rule, once the new single-sheet form is in use, the current three-part form will be phased out and will no longer be issued by DEA.

Most pharmacy organizations are still examining the proposed rule to determine its potential impact. The DEA is accepting comments through January 28, 2008.

The American Medical Association lobbied hard for the rule and was clearly pleased with it in its final form. "The final rule will allow physicians to continue this well-established clinical practice and decrease the likelihood that patients will run out of drugs that provide critical relief from moderate to severe chronic pain," explained Rebecca Patchin, AMA board member in a written statement. Pharmacists also supported the rule, which should not add any additional burdens to pharmacists, according to Stacey Schwartz, senior director of pharmacy affairs at NCPA.

The DEA also took steps to curb drug diversion, revoking the licenses of two Cardinal Health distribution centers and a pharmacy in Burlington, Wash. The DEA announced that it had suspended the license of Cardinal's Auburn, Wash., distribution facility after uncovering significant diversion by the Burlington-based Horen's Drug Store. According to the DEA, Horen's Drug purchased 605,000 dosage units of hydrocodone from Cardinal Health's Auburn facility between March 1 and September 30, 2007.

Less than a week later, the DEA suspended the license of a second Cardinal distribution center. According to a DEA statement, the Lakeland center distributed over eight million dosage units of hydrocodone products between August 2005 and October 2007 to suspected Internet pharmacies. The DEA also signaled that it will be paying increased attention to the role distributors play in supplying Internet pharmacies. "The Internet is now the main conduit in Florida through which prescription drugs are diverted for abuse," Mark R. Trouville, Special Agent in Charge of the DEA's Miami Field Division, said. "DEA is not only holding doctors and pharmacies accountable, but pharmaceutical distributors as well."

Another wholesaler also got into trouble. In April the DEA suspended the license of an AmerisourceBergen Distribution Center in Orlando, Fla. The license was reinstated in August following the implementation of a new order monitoring system at the center.

Cardinal Health insisted that it would utilize its network of 25 distribution centers nationwide to ensure that pharmacies do not experience an interruption of service while it works to meet DEA demands. The company insists that it is implementing near-and long-term changes to guard against distribution to pharmacies engaged in diversion.

"Anything less than best-in-class controls for the pharmaceutical supply chain is unacceptable," insisted R. Kerry Clark, Cardinal chairman and CEO. "We will do what it takes to address this execution issue with changes to our processes and systems. The security of the pharmaceutical supply chain is core to our business and we are committed to the highest standards as we work with the DEA to resolve this matter."