Should the DEA Conduct a “Patient Impact Assessment” When Promulgating New Restrictions on Controlled Substance Distribution?

Abstract

The federal notice and comment rulemaking process is described and illustrated with the recent multiple-copy prescription controversy. Impact assessment, balance in controlled substance regulation, and informing balanced decision making are discussed. Examples of regulations that may warrant patient impact assessment scrutiny are provided and the need for caution in applying these is described.

KEYWORDS:

• controlled substances
• Drug Enforcement Administration
• DEA
• patient impact assessment