Controlled substances can now be ordered electronically

June 20, 2005

Until now, all distributions of Schedules I and II controlled substances required the completion of the Drug Enforcement Administration's Form 222. As of May 31, DEA came out with an electronic alternative to the paper form. DEA says the system will "go live" soon, although it has not released a specific date.

Until now, all distributions of Schedules I and II controlled substances required the completion of the Drug Enforcement Administration's Form 222. As of May 31, DEA came out with an electronic alternative to the paper form. DEA says the system will "go live" soon, although it has not released a specific date.

More than five years in development, the Controlled Substance Ordering System (CSOS) can be used by pharmacists and other DEA registrants in place of the paper DEA 222 forms. DEA hopes the system will cut down on errors, reduce turnaround time for orders, and allow pharmacists to maintain smaller inventories of these substances, agency officials said at an open meeting held outside Washington, D.C., in mid-May. The CSOS system is optional, but very likely more of the industry will find that it is effectively mandatory, given the efficiencies that it offers, said Andrew McFaul, chief of the regulatory drafting unit of the Office of Diversion Control. However, DEA registrants may continue using the paper forms if they wish.

The system is made possible, said DEA, by the maturation of "Public Key Infrastructure" (PKI) technology, providing for the creation of a highly secure "digital signature." The electronic format follows the paper DEA 222 requirements closely, McFaul noted. Both are simply the means by which DEA registrants can satisfy the requirements of ordering and supplying controlled substances. Despite the recognized advantages of the system, widespread adoption by pharmacists at the community level may take four or five years, according to industry representatives.

On the other hand, Nicholson and Kenneth Riddle, Pharm.D., assistant director of professional affairs at the National Community Pharmacists Association, said large suppliers are quickly preparing to adopt the system. There's likely to be extensive near-term use of it between suppliers and manufacturers and between suppliers themselves, they said. A number of large chain drugstores are focusing resources on getting CSOS systems working, they reported.

"For pharmacists, particularly for community R.Ph.s, it's positive," helping to bring the rest of health care into the electronic age. Most pharmacists are equipped now to handle electronic Rxs and are waiting for other professions to catch up.

DEA will not endorse any particular software for CSOS transactions, but the final rule spells out what the software must accomplish, including limiting access to the individual owners of personal keys.

DEA will require a one-time, independent, third-party audit of any vendor's software for CSOS purchaser or supplier functions to certify that it performs the necessary PKI functions. McFaul said the agency would not routinely be checking purchasers' and suppliers' systems, but that it might check a system if a concern exists about it.

Beyond inventory and turnaround advantages, the electronic format will also accommodate the Schedules I, II, III, IV, and V drug orders. (The paper form can be used only for Schedules I and II drugs.) The electronic version will also allow drugs from the different schedules to be ordered on the same form. The electronic form can hold any number of orders, in contrast to the paper form's limit of 10.

Under the rules, while the software packages may allow the purchaser simply to enter the NDC number rather than the entire product description, the software must be able to automatically retrieve the product description.

The final rules for the system appeared in the April 1 Federal Register, available at http://www.gpoaccess.gov/. Other information on the new system is at: http://www.deadiversion.usdoj.gov/ecomm/. DEA said that it would be posting a CSOS subscriber manual and compliance policy guide shortly.

Kathryn Foxhall is a writer based in the Washington, D.C., area.