Oster G, Huse D M, Delea T E, Colditz G A, Richter J M
Policy Analysis Inc., Brookline, MA 02146.
Med Care. 1990 Sep;28(9):834-52. doi: 10.1097/00005650-199009000-00012.
In recent years, many new over-the-counter (OTC) medications have resulted from the granting of OTC status by the U.S. Food and Drug Administration to drug entities that previously were available only by prescription (Rx). While the benefits to consumers of Rx-to-OTC switches may be substantial, they also involve some degree of risk, as usage typically expands and physician supervision diminishes. This study explores the potential utility of techniques of decision analysis in evaluating the balance of these benefits and risks. Histamine H2 receptor antagonists (H2-blockers), which are currently available only by prescription, are presented as a case study and were examined to determine how OTC availability of these agents would alter the patterns, effectiveness, and risks of self-treatment for acid-peptic disorders. Currently, about 5.7 million persons experience an episode of dyspepsia during any given quarter, of whom 3.5 million self-medicate with antacids. Study results indicate that OTC availability of H2-blockers would: 1) increase the proportion of persons with dyspepsia who self-medicate from 61.8% currently to 64.1%; 2) increase the proportion of persons who experience complete relief of their symptoms while self-medicating from 37.9% currently to 43.2%; 3) result in 14 additional cases of serious hematologic disorders and an additional 22,000 instances of minor side effects per quarter, but cause the overall rate of side effects among persons who self-medicate to decline; 4) cause an additional 300 persons per quarter with gastric cancer to self-medicate before seeking professional care, but cause no change in the median time between onset of symptoms and the decision to seek such care; and 5) decrease by 277,000 the number of persons per quarter who seek professional care for dyspepsia. On balance, results suggest that OTC H2-blockers may be a relatively safe and effective means of self-care for acid-peptic disorders, and may substantially reduce the number of patient encounters with the medical care system for minor gastrointestinal complaints. This study also illustrates the potential utility of the techniques of decision analysis to the formulation of drug regulatory policy.
近年来，许多新的非处方（OTC）药物是由美国食品药品监督管理局将以前只能凭处方（Rx）获取的药物实体批准为非处方药而产生的。虽然处方药转换为非处方药给消费者带来的益处可能很大，但也存在一定程度的风险，因为用药量通常会增加而医生的监督会减少。本研究探讨了决策分析技术在评估这些益处和风险平衡方面的潜在效用。组胺H2受体拮抗剂（H2阻滞剂）目前只能凭处方获取，本文将其作为案例研究进行分析，以确定这些药物非处方可用会如何改变酸相关性疾病自我治疗的模式、有效性和风险。目前，每季度约有570万人出现消化不良症状，其中350万人自行服用抗酸剂。研究结果表明，H2阻滞剂非处方可用将：1）使自行用药的消化不良患者比例从目前的61.8%增至64.1%；2）使自行用药时症状完全缓解的患者比例从目前的37.9%增至43.2%；3）每季度导致额外14例严重血液系统疾病病例和额外22000例轻微副作用，但会使自行用药者的总体副作用发生率下降；4）每季度导致额外300例胃癌患者在寻求专业治疗前自行用药，但症状出现到决定寻求此类治疗的中位时间没有变化；5）每季度因消化不良寻求专业治疗的人数减少27.7万。总体而言，结果表明非处方H2阻滞剂可能是酸相关性疾病相对安全有效的自我护理手段，并可能大幅减少因轻微胃肠道不适而就医的患者数量。本研究还说明了决策分析技术在制定药品监管政策方面的潜在效用。
