Drug Information Journal最新文献

Formal auditing of clinical research data has become a standard contemporary practice within the pharmaceutical industry. Its basic purpose is to provide documentation relevant to an assessment of the quality and integrity of data collected in the course of a clinical trial. This paper outlines the audit procedures developed within one major pharmaceutical firm. These procedures require an intensive investigation of internal and external aspects of study management, records management, data entry, data analysis and statistical report preparation. A qualitative evaluation of the results achieved by this auditing procedure are presented.

CAS ONLINE, the chemical substance search and display system available directly from Chemical Abstracts Service, is a new service which is particularly useful in drug design studies. In CAS ONLINE chemists search by structures to identify chemical substances, for example, derivatives or analogs of a drug or its pharmacologically active fragment, which share user-defined features. Search questions are phrased in terms of one or more structure diagrams, each of which can include variable atoms, bonds, or positions of substitution as required by the searcher. CAS ONLINE provides access to the world's largest (more than 6 million substance records) and most current chemical structure information data base. CAS ONLINE is updated weekly with 7,000-10,000 new substance records. Substance information available from searches in CAS ONLINE include structure diagrams, systematic and common names (including trade names) for substances, molecular formulas, and the widely cited CAS Registry Numbers. The searcher may optionally request for each substance bibliographic information for the ten most recent literature references which have been cited in Chemical Abstracts since 1967.

The pharmaceutical industry sponsor bears the ultimate responsibility for the verification of all clinical data submitted to the FDA in support of a New Drug Application (NDA). The author provides an overview of a systematic approach to providing quality assurance for all clinical data collected in the course of human trials with research compounds. This systemic approach includes such features as: Standard Operating Procedures Manuals, the development of a quality assurance function within the organization, detailed documentation for all monitoring activities, careful assessment of all clinical research data collected, and an emphasis on preventive measures that can be introduced to assure the quality of subsequent research data.

To ensure that drugs are available in adequate quantity and quality for the health needs of the population and properly used, Asian governments in the past decades have exercised their sovereign rights quite independently and differently. A high number of patients per prescribing physician has consequences for drug information, in regard to both prescribers and consumers needing to self-medicate. To reliably inform patients through physicians, pharmacists, or medical auxiliary personnel is of great importance in the face of an illiteracy problem. Self- medication and illiteracy place emphasis on communication by word of mouth or by pictures. Word of mouth is the most important route, because even with a steady increase in literacy, the increase in transistor radios has been even more pronounced. For specific health information, instructional posters, with emphasis on pictures, have been very effective. Billboards do not allow adequate information disclosure needed for drugs. The opportunity to expand the coverage of consumer drug information, in that labelling for consumers gives additional relevant general health information, seems appropriate.

The United Kingdom Drug Information Network has been developed in recent years to form an effective service. The structure of the health service is discussed and the organization of drug information services within this framework is outlined. A number of collaborative and work sharing exercises have been undertaken between regional services and thus are reviewed together with future trends for the service.

FDA allowance of comparative claims as part of the approved labeling for new prescription drugs creates special problems. Claims contained in prescription drug labeling are viewed by physicians as embodying not just the normal puffery of the manufacturer, but the considered views of government agency charged with protecting public health. Thus, labeling claims for prescription drugs have an impact and significance that promotional claims for other products do not. In the Moxam case--a dispute between Upjohn and Lilly over the FDA's approval of a comparative claim for a new Lilly antibiotic--the agency recognized this fundamental reality. Faced with the prospect of having to provide a procedure to permit competitors to challenge approval of comparative claims, the FDA has moved toward a policy of not permitting such claims in labeling, while allowing them in advertising.

In order to select important journals to be monitored for efficient collection of literature information on drug safety, a retrospective search was made of the safety information in the Excerpta Medica (EM) database between 1979 and 1981. The search provided 54,005 references to drug safety, which were found in a total of 2,536 journals. Fifty percent of the references appeared in only 148 journals, or 6% of all journals surveyed. A similar search, carried out using the Japicdoc (JD) database, provided 9,268 references in 172 journals. To cover all the necessary information appearing in overseas journals, however, a retrospective search of a bibliographic database is required as a cost-effective means to improve the comprehensiveness of the collection of information. In domestic journals, because JD includes fewer journals than EM, all of the 172 journals can be monitored for the collection of drug safety information.

Pharmacists are continually faced with drug product selection decisions. When is a generic drug product equivalent to the innovator product and, thus, a suitable candidate for generic substitution? The FDA policy has been that only drug products that are therapeutic equivalents are candidates for product selection decisions. This paper outlines the regulatory and scientific framework for the FDA's policies and requirements for generic drug products. The history and current status of the Drug Efficacy Study Implementation (DESI) project is described. Originally begun in 1966 as a review of about 3,400 drug products, the review in mid-1983 is more than 90% complete, but its impact has already affected more than 7,000 marketed drug products. The therapeutic equivalence policy and the manner in which decisions on therapeutic equivalence are communicated are reviewed. Regulatory policies for the approval of generic drug products are reviewed and specific litigation challenging the rights of generic drug manufacturers to produce generic "look-alikes" and challenging the FDA's policy that a generic drug product is a new drug requiring an approved New Drug Application for marketing is discussed. The conclusion reached is that the evaluation of regulatory requirements and science is leading to a point where all generic drug products will be known to be safe, effective and therapeutically equivalent, and pharmacists can be optimistic about the quality of products in the generic drug market.

Drug Interactions are a clearly defined problem that we as health professionals must deal with on a day-by-day basis. It is by far the area of health care that demands more attention today and tomorrow than was possible in the past. The amount of reference sources and text material of drug interactions is growing at such a rate that it is almost impossible to recall essential information in a reasonable time frame. If the practitioner is to continue with an uninterrupted work flow and still maintain the best possible service for the patient, an immediate and accurate method is needed in the hands of the user ... a computerized drug interaction database. The community health care standards would be ultimately raised to a level never before attainable and efficiency would continue with full utilization of professional practice. Combine then, drug interaction data with ancillary benefits such as cost containment, third party accounting, inventory control, and a multitude of other operational functions into a computerized database and the end product results in an enhanced, controlled, professional operation.

The ultimate responsibility and social contribution of the innovation-based pharmaceutical industry is to discover, develop, and provide products that contribute to improved health care. Achievement of this objective is dependent upon effective communication of accurate and comprehensive information about our products. This is a unique role which the research-based segment of the industry performs well and must be allowed to continue to perform. Although the ultimate objective of improved health care is a constant, the effective communication of product information is affected by a variety of factors which represent change or evolution. The discussion of drug information will review: the various forms that such information takes; the effects of differences in national health systems and objectives; and the implications of the fact that product data bases continue to develop after introductions. The systems and experience at the Upjohn Company, while not necessarily applicable for all companies, will be discussed briefly as useful examples of a working, effective process.