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drugs in order to have meaningful pharmacy outcomes that com-US FDA Drug Classification pare ‘apples-with-apples’. The AMA has expressed concerns re-garding United States Pharmacopeia Draft Model Guidelines forSystemDrug Classes and Categories for drug formularies under MedicarePart D Prescription Drug Benefit.[2] The other classification stan-We would like to draw attention and a cautionary note regard-dards include the American Hospital Formulary System, the De-ing the US FDA drug classification system. The FDA drug classi-partment of Veterans Affairs National Formulary, and First Datafication system is a national therapeutic system for drugs. TheBank. The classification system that is selected must permit thetherapeutic evaluation assigned at the time of the product’s ap-National Drug Code for a specific drug to reside in multipleproval may not be relevant to agents within a class at a later date.therapeutic classes, be comprehensive, and be reevaluated on aFor example, an ACE inhibitor may be used for treatment ofperiodic basis. In addition, there will need to be an evaluation ofhypertension, heart failure, or in diabetic nephropathy. The FDAthe application of the classification system to pharmacy claimswebsite states that “the Major and Minor Drug codes are no longerdata to insure clinical correlation. For example, pharmacy claimsavailable at this site. FDA plans to review the use of the Americandata will need to provide insight into the use of an ACE inhibitorMedical Association (AMA) DRUG Evaluation Subscription clas-for multiple therapeutic indications.sification scheme. This review is necessary because this classifica-

Alan J. Johnson,1 Edward Fleegler2 and Gregory D. Berg1 tion scheme had not been updated since 1976 and therefore many

1 McKesson Corporation, Broomfield, Colorado, USAnew molecular entities are not included.”[1] The issue of a stan-

2 Independence Blue Cross, Philadelphia, Pennsylvania, USAdardized accepted drug classification system is relevant to thedisease management community and Centers for Medicare and

ReferencesMedicaid Services (CMS). The nine CMS demonstration projects1. U.S. Food and Drug Administration. The national drug code directory [online].

awarded as a result of the Medicare Modernization Act of 2003 Available from URL: http://www.fda.gov/cder/index.htm [Accessed 2005 Jul28]will require a careful prospective evaluation of pharmacy utiliza-

2. Covington & Burling. Medicare Part D: USP draft model guidelines and publiction. The disease management community and CMS should agree comment session [online]. Available from URL: http://www.cov.com/publica-upon a national standardized therapeutic classification system for tions/download/oid6075/487.pdf [Accessed 2005 Jul 28]