Majercik P L, May J R, Longe R L, Johnson M H
Am J Hosp Pharm. 1985 May;42(5):1073-6.
Pharmacy and therapeutics (P & T) committee drug evaluation reports prepared by pharmacies and drug information centers (DICs) and product package inserts were compared with standard guidelines to evaluate their quality. Letters were sent to 143 hospital pharmacies asking them to submit a previously prepared drug evaluation report on temazepam, moxalactam disodium, or atenolol. The reports and package inserts for these three drugs were evaluated by the presence of 40 elements derived from the published ASHP guidelines for drug evaluation report preparation. Responses were obtained from 124 (87%) pharmacies; however, only 80 reports (60 DIC-prepared and 20 pharmacy-prepared) were received. The reports contained a mean of 28 of the 40 (70%) possible elements. The most frequently omitted elements were AHFS number, potential unlabeled uses, drug-drug interactions, drug-disease-laboratory test interactions, risk and benefit data, prevention and treatment of side effects, comparisons with established treatment, and disadvantages of the drug under consideration. Although the reports prepared by the DICs and pharmacies contained the same amount of information, the DIC-prepared reports included data more frequently on supply sources, therapeutic indications, approved labeling, comparison with established treatment, bioavailability and pharmacokinetics, and recommendations. Most of the reports contained more elements than the corresponding package inserts. The product package inserts did not contain the comparative elements required for P & T committee decisions. Both the pharmacy- and DIC-prepared reports failed to contain all 40 elements recommended in the standard guidelines, suggesting the need for more thorough reports.
将药房和药物信息中心(DIC)编写的药房与治疗学(P&T)委员会药物评估报告以及产品包装说明书与标准指南进行比较,以评估其质量。向143家医院药房发送信函,要求它们提交一份先前编写的关于替马西泮、二氯马嗪钠或阿替洛尔的药物评估报告。根据已发布的美国卫生系统药师协会(ASHP)药物评估报告编写指南中的40项要素,对这三种药物的报告和包装说明书进行评估。从124家(87%)药房获得了回复;然而,仅收到80份报告(60份由DIC编写,20份由药房编写)。这些报告平均包含40项可能要素中的28项(70%)。最常遗漏的要素是美国医院处方集服务处(AHFS)编号、潜在的未标明用途、药物相互作用、药物-疾病-实验室检查相互作用、风险和获益数据、副作用的预防和治疗、与既定治疗方法的比较以及所考虑药物的缺点。尽管由DIC和药房编写的报告包含的信息量相同,但由DIC编写的报告更频繁地包含有关供应来源的数据、治疗适应症、批准的标签、与既定治疗方法的比较、生物利用度和药代动力学以及建议。大多数报告包含的要素比相应的产品包装说明书更多。产品包装说明书不包含P&T委员会决策所需的比较要素。由药房和DIC编写的报告均未包含标准指南中推荐的所有40项要素,这表明需要编写更全面的报告。