Evaluation of pharmacy and therapeutics committee drug evaluation reports.
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.
D001262:Atenolol / Q000627:therapeutic use; D003625:Data Collection; D004348:Drug Labeling / Q000592:standards; D005069:Evaluation Studies as Topic; D006801:Humans; D009070:Moxalactam / Q000627:therapeutic use; D010607:Pharmacy Service, Hospital / Q000458:organization & administration; D010606:Pharmacy and Therapeutics Committee / Q000592:standards*; D013693:Temazepam / Q000627:therapeutic use
D001262:Atenolol; D013693:Temazepam; D009070:Moxalactam