Perspectives in Biology and Medicine

POUCY ISSUES CONCERNING ANTIMICROBIALS: CONTROLS ON ANTIMICROBIAL USAGE HAROLDJ. SIMON* The progressively worsening problems of microbial resistance to commonly used antimicrobials have led to continuous demands from clinicians for new ones. The pharmaceutical industry has responded with enthusiasm and imagination. In fact, by meeting design specifications, the newest agents expose our limited understanding of underlying biological principles [1-3]. As a consequence, the problem of resistance to antimicrobials, which has steadily worsened over the past three decades , may soon become insurmountable. Thus, unless drastic steps are taken in time, antimicrobial therapy as it has been practiced for the past 40 years may no longer be effective by the end of this decade [4-7]. If that comes about, the world will actually be worse off than before the advent of the antimicrobials because (1) there is now a much greater population of aged, infirm, and immunocompromised patients, (2) numerous advanced medical and surgical procedures depend for success on the appropriate use of effective antimicrobials, and (3) many other aspects of our daily lives—from food production, processing , and storage through the manufacture of vaccines—depend on antimicrobials. The problems of increasing resistance to antimicrobials are so urgent —and the traditional approaches of education and peer pressure are so ineffective in terms of limiting the promiscuous use of antimicrobials —that drastic measures are required to avert unprecedented misfortune . The far-reaching implications of resistance to the newer and newest agents necessitate a very hard look at (1) current antimicrobial treatment practices, (2) the policies and practices pertaining to the inThis paper was presented at the First International Symposium on Antimicrobial Therapy , heid in Rio de Janeiro, Brazil, in May 1983. ?Professor of international health policy and director of International Health Programs, University of California, San Diego, School of Medicine, La Jolla, California 92093.© 1985 bv The University of Chicago. All rights reserved. 003 1-5982/85/2802-0426$01 .00 Perspectives in Biology and Medicine, 28, 2 · Winter 1985 | 223 troduction and use of new drugs, (3) the education of medical students and physicians regarding the principles of antimicrobial therapy, (4) the kinds of information about antimicrobials provided to the general public, and (5) the possible need for professional and/or governmentally imposed controls on antimicrobial usage. These issues are clearly interrelated . The situation appears so urgent, however, that unusual and unusually drastic measures seem indicated to avoid the most serious consequences. Accordingly, this paper will focus on the issue of controls on antimicrobial use. A need for controls on antimicrobial use has always existed. That need has now become more urgent because abuse ofantimicrobials continues, educational efforts and governmental attempts to limit their use have largely failed, costs of antimicrobial therapy are escalating, and recently introduced antimicrobials pose entirely new threats. To a medical educator, the idea of controls on the use of antimicrobial therapy is abhorrent, as is the imposition of any external (i.e., extraprofessional ) controls on medical education or medical treatment; such measures appear to be the antithesis of education. Thus, mandatory requirements for clearance ofan antimicrobial prescription by a hospital pharmacist, or by a particular medical specialist who is not directly responsible for a patient's welfare, seem directly opposed to the tenets of professional responsibility and the objectives ofeducation. In the past 40 years, however, a period that comprises the era of modern antimicrobial therapy, the effectiveness of one antimicrobial after another has first been compromised and then destroyed within a few years after these drugs have been introduced into general use. In the industrialized countries, the selection pressures exerted by these agents have resulted in the accumulation of multiply resistant bacterial populations in hospitals. As a result, an infectious complication of a medical or surgical procedure can today be a matter of the greatest moment, causing much morbidity and significant mortality. Increasingly , community-acquired infections are also due to microorganisms resistant to those antibiotics which, until the relatively recent past, could be employed with a very high degree of assurance that the infecting agents would prove susceptible. This is especially true in the developing countries [7, 8], where the combination ofwidespread promiscuous prescribing of antimicrobials by physicians, unauthorized dispensing of these agents by pharmacists...