Drug Information Journal最新文献

Drug information centers have existed for more than 20 years. Well over 100 centers function across the country, primarily affiliated with hospitals and/or colleges of pharmacy. The centers serve an audience of primarily health professionals but in some settings meet consumer needs. Three general areas of responsibility exist: service, education and research. In the area of service, specific functions such as answering questions, supporting the Pharmacy and Therapeutics Committee, and preparing newsletters are frequent. Educational responsibilities often include teaching pharmacy students drug information skills. Evaluation of the services has focused mostly on answering questions and Pharmacy and Therapeutics (P&T) Committee functions. Commercial information systems used by Drug Information Centers (DICs) are increasingly sophisticated and offer the opportunity to improve efficiency. Funding generally is provided by the institution with which the center is affiliated. Attempts to charge for services have provided only modest revenue. Drug information centers continue to mature and offer a useful service.

The study of a new drug includes the assessment of its pharmacologic effects, benefits (efficacy), and risks (safety). Most recent drug discontinuations in the United States and the United Kingdom have been associated with problems of safety. The assessment of clinical drug safety is difficult. Those assessing drug safety are confronted with the need to make causality assessment judgments of drug-related events. Several procedures for assessing causality of adverse reactions have been proposed; however, none of them is completely satisfactory. Global introspection (the unaided judgment based on knowledge and experience) and the currently available standardized decision aids (questionnaires or algorithms) have serious limitations that hamper their use. There is a need for better procedures.

The free circulation of drugs among the European Economic Community (EEC) member states ensues from the principles stated by the Treaty of Rome. This is possible thanks to a series of legal and technical directives stating the criteria with which the national authorities--who are sovereign in this matter--must comply. These directives are briefly explained. In particular, the procedure by which the initial authorization, granted by one member state, can be extended to at least five others is presented. The content and order of the registration dossier is presented in detail.

As one facet of a larger investigation evaluating the various means by which patients receive information concerning their medications, a telephone-based drug information service was established for selected public use. The purpose was to detail the growth and utilization of the service, characterize the type and importance of the questions asked, and compare the potential utility with that of the USP-DI patient package insert (PPI) in responding to the public's drug information requests. Availability of the toll-free number for the Prescription Drug Information Service (PDIS) was controlled by offering it only to outpatients receiving selected medicines from the pharmacy of a large university-based medical center. The PDIS was operated by clinical pharmacists who participated in completing standardized operational data forms after each drug information call by the public. Of those calls received, 91.7% were not of a serious nature and most commonly dealt with side effects, drug interactions, and drug identification. Fifty percent of first-time calls occurred within two days of the subject's visit to the pharmacy and 23.4% of the total PDIS calls were repeat contacts. Interestingly, 34% of the patients' questions could not have been answered using the standard USP-DI PPI.

A questionnaire was developed to characterize the location, operation, personnel, reference resources, and functions of drug information centers in countries throughout the world other than the United States. The questionnaire was mailed to 100 drug information centers or pharmacy practitioners (primarily faculty) in 65 countries. The majority of drug information centers responding to this questionnaire were located at and funded by university based hospitals. Most were open eight hours per day and engaged in the following activities: answering requests for information, publishing pharmacy bulletins, teaching, continuing education, and providing information directly to pharmacy and therapeutics committees. Additional information gathered from this survey included: common references and journals maintained by drug information centers, user demographics, and a request profile. Although many similarities among the information centers were found, interesting observations regarding their differences may be made. It is important that drug information centers share their experiences so that others may learn about their new and innovative programs.

The consumer's perspective of over-the-counter medication should be one of the most important determinants of strategy for individuals and companies manufacturing and distributing such products. The consumers, buyers, and users have been telling industry for a long time that they are concerned with safety, cost, effectiveness, and availability of choice. The wise producers have begun to heed the signs and the public is responding.