Meeting the information needs of drug purchasers: the evolution of formulary submission guidelines

The emergence of formulary submission guidelines in the 1990s has been seen by many as an attempt to come to grips with the issue of drug management within health systems and to provide, for the first time, a coherent and methodologically rigorous approach to formulary selection. Judging from the available evidence, however, guidelines have fallen far short of their potential. The purpose of this paper is to consider what role guidelines have played in health system management and whether they play a useful role in providing a methodologically sound basis for drug-impact assessment. Two polar cases in guideline development are examined: the Australian guidelines first published in 1992 and now undergoing a second major revision and the guidelines recently published by Blue Cross and Blue Shield of Colorado and Nevada. The former guidelines represent what can be described as the traditional, clinical paradigm of drug-impact assessment; the latter represent what can be called the system-impact paradigm. The argument put forward is that the Australian guidelines are essentially an anachronism, offering little to those whose principal concern is with the management of health systems. In their emphasis on a hierarchy of evidence and a clinical trial-focused, cost-effectiveness evaluation perspective, they represent a methodologic dead end in a number of important respects. The systems-based approach, on the other hand, with its emphasis on validation of claims and the need to consider a range of drug-impact and risk-management scenarios, offers an analytic framework that, while possibly less rigorous, is likely to contribute significantly to the management of health care systems.