Drug Information Journal最新文献

A strategy is proposed for estimating the average cost of answering drug information requests, comparing the factors that influence cost and controlling that cost. The cost for answering a request is based on the time it takes to answer the request, the salary of the person who answers the request, the cost of the information sources used to find the answer, and, indirectly, the frequency of requests of the same type. Request types have been defined by scope of search and formal of answer required, as textbook search/verbal answer, literature search/verbal answer, and literature search/written answer request. An empirical formula was used to calculate average costs for each request type at the Oregon Poison Control and Drug Information Center. A simple computer program was then used to generate costs over a range of changes that could be considered reasonable for each factor. The effect of modifying any of the factors in this formula demonstrated that a low volume of requests brings about the most critical change. Cost changes abruptly and may become unjustifiably high. If, for example, the volume of requests requiring literature search and verbal answer is 30 per month, the average cost for a request is $29.13; at a volume of 10 per month, the cost is $35.93; and at a volume of one per month the cost is $127.65. It is suggested that hospital pharmacy departments experiencing small frequencies of certain types of request analyze the cost in this manner and, if necessary, adopt a method for controlling the cost.

A review of the philosophy, strategies, and methods for the collection of medical event (ME) information in clinical trials sponsored by the Research and Development Division of THe Upjohn Company is presented. Goals for collection of ME information for Phase I, II, and III trials are reviewed. Case report form and terminology issues are discussed, with particular emphasis placed on procedures that avoid premature decisions on ME causality and incomplete reporting of events. Procedures for separating the seriousness from the intensity of the MEs are reviewed. Analysis issues are considered insofar as they impact on data collection procedures and goals. Recommendations are made with respect to protocol content, data collection forms, and related analysis issues.

This article describes procedures used to prepare and maintain prescription drug labeling beginning with a brief overview of the statutory and regulatory requirements. Discussed is the labeling format prescribed by FDA regulation and the type of information needed for the key labeling components. The article provides a description of typical company approaches for developing and approving the labeling text. Discussed are the multi-disciplinary groups responsible for preparing and approving the copy with comparison to an analogous multi-disciplinary group at the FDA which has responsibility for review and approval of labeling submitted with regulatory documents. Discussed also is the need for international labeling consistency for drugs which are marketed in countries other than the U.S. Reference is made to security considerations regarding the approved copy.

Summary displays of data should illustrate narrative points made about the clinical experiment. Documentation of the source of the information selected for the critical displays should be assembled based on the data reduction steps that have occurred. Understanding and systematizing the presentation of the data reduction steps will facilitate the review of complex adverse experience data bases and allow well-informed decisions about the safety information.

This review of the Food and Drug Administration's Bioresearch Monitoring Program focuses on the inspection of clinical investigators who study investigational drugs. The differences between routine, "for-cause," and bioequivalency/bioavailability inspections are examined, with emphasis on the responsibilities of the clinical investigator, reasons for conducting the inspections, and problems found. Important aspects of the inspection report, such as protocol adherence, records maintenance, informed consent, institutional review board approval, and drug accountability, are outlined. The disqualification and consent agreement processes for investigators with serious problems are explained. FDA policies on third-party notification and remote data entry are noted.