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PubMedDate not supplied

Historical overview of generic medication policy.

OBJECTIVE: To provide a historical perspective on controversies surrounding the use of generic drugs. DATA SOURCES: Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION: Performed by the authors, with preference given to events from 1951 to the present. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: The history of generic drug use is a history of conflict from a variety of perspectives. The primary conflict is economic, in which manufacturers of brandname pharmaceuticals aggressively seek to protect their patents from a variety of groups (e.g., the federal government, managed care organizations, consumer groups) that want access to less expensive medications. Another conflict is professional, especially for the members of the pharmacy profession who view drug product selection as an important opportunity for pharmacists to use their professional judgment. The most confusing conflict is the scientific discussion of bioequivalence and product quality. The brand manufacturers suggest that not all products are bioequivalent and of the same quality. This position has been opposed by the pharmacy profession, generic drug manufacturers, health care institutions, and the Food and Drug Administration. CONCLUSION: Generic drug use has increased dramatically during the past 50 years and is an accepted part of health care. However, the economic consequences of generic drug use are sufficiently high for this activity to continue as a source of controversy in the future.

Drugs, Generic↗
PubMedDate not supplied

Economics and structure of the generic pharmaceutical industry.

OBJECTIVE: To review key economic trends of the generic medication market and analyze the changing structure of the generic medication industry. DATA SOURCES: Articles were indexed initially using terms such as generic medications, generic drugs, multisource medications, and multisource drugs. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), Science Citation Index, Psychological Abstracts, and Wilson Indexes to Journal Articles. STUDY SELECTION: Performed by the authors. DATA EXTRACTION: Not applicable. DATA SYNTHESIS: The generic pharmaceutical market has the potential to play an important role in containing drug costs, although the amount that could be saved through the use of generic medications is not easy to measure. If estimates for the future growth in the use of generic products prove correct, the proportion of pharmaceutical sales attributable to generic products will remain in the 9% to 10% range through the first decade of the 21st century. The generic pharmaceutical industry includes several categories of companies based on business strategies. Further consolidation is expected as more resources are needed to address patent challenges stimulated by the Drug Price Competition and Patent Restoration Act. Companies are also entering into partnerships with research manufacturers to share profits from proprietary products. Future growth of the generic market will require more than increased use of generic products. Therapeutic interchange, involving switching from single-source, patent-protected products to products within the therapeutic class for which there are generic equivalents, represents a major growth opportunity for generic drug manufacturers because the savings potential is more significant than that for straightforward substitution of generic for brandname products. CONCLUSION: As it responds to challenges and opportunities, the generic pharmaceutical industry will continue to be a major force shaping the economics of medication use.

Drug Industry↗
PubMed2006

Febuxostat: a selective xanthine oxidase inhibitor for the treatment of hyperuricemia and gout.

OBJECTIVE: To review the pharmacology, pharmacokinetics, clinical trial data, safety profile, precautions, and place in therapy of febuxostat, a novel nonpurine xanthine oxidase inhibitor in development for the treatment of hyperuricemia and gout. DATA SOURCES: Available studies and abstracts were identified through MEDLINE (1990-November 2006), Science Citation Index, International Pharmaceutical Abstracts, Cochrane Databases, and the American College of Rheumatology and European League Against Rheumatism Web sites. Key search terms were febuxostat, TMX-67, TEI-6720, hyperuricemia, and gout. STUDY SELECTION AND DATA EXTRACTION: All available studies describing the pharmacology of febuxostat were included. Human studies formed the basis for discussion of clinical parameters, including pharmacokinetics, pharmacodynamics, efficacy, and safety of febuxostat. DATA SYNTHESIS: Febuxostat significantly reduces uric acid levels within 2 weeks after initiation of therapy and up to 48% by the end of 104 weeks of therapy. Approximately 60% of patients achieved the primary goal of serum uric acid less than 6 mg/dL during the last 3 months following once-daily administration of febuxostat 80 mg or 120 mg for at least 52 weeks. The most common adverse reactions to febuxostat were abnormal results from liver function tests, diarrhea, headache, arthralgias, and musculoskeletal symptoms. Due to its potency, patients are at an increased risk of experiencing gout flares for at least the first year of therapy. Up to 70% of patients in clinical trials experienced gout flares despite concomitant prophylactic treatment with colchicine or naproxen. Additional clinical trial evidence supports the efficacy and safety of febuxostat in the treatment of hyperuricemia and gout. CONCLUSIONS: Febuxostat is a promising alternative to allopurinol for the treatment of gout and hyperuricemia. The optimal length of prophylactic therapy, clinical significance of abnormal liver function tests results during therapy, and safety in patients with moderate or severe renal insufficiency warrant further investigation.

Febuxostat↗
PubMed1983

Online searching of the pharmaceutical literature.

Online databases that cover pharmaceutical topics are described and then illustrated with four sample searches. The online databases useful for searching pharmaceutical topics can be grouped into three categories: (1) databases devoted exclusively to drugs and the pharmacy profession, such as International Pharmaceutical Abstracts, Pharmaceutical News Index, and Ringdoc; (2) databases covering the clinical medicine literature, such as MEDLINE and its related files and Excerpta Medica; and (3) other scientific databases that include coverage of the pharmaceutical literature, such as BIOSIS Previews, Chem, Scisearch, and NTIS. Databases from each of these groups are discussed. The fields, which are categories of information contained in each record (e.g., author, article title, journal reference, abstract, and assigned indexing terms), are delineated, along with descriptions of how these fields function during the searching operation. The implications of the indexing policies of the various databases on search strategy are also explained. Sample search strategies are illustrated to compare file retrievals on specific subjects.

Drug Information Services↗
PubMed1982

DSH abstract: coverage of the world communicative disorders literature.

The percentage of journal articles covered by dsh Abstracts and the time it took these articles to appear as abstracts in this secondary publication were analyzed. Articles were obtained from nineteen communicative disorders journals every other year for the years from 1968 to 1976. Then the author index of dsh Abstracts was searched each year for up to five years following journal publication to determine whether each article was included in this abstracting service's coverage of the world literature. Of the 5548 articles included in the study, 3270 (59%) were covered by this abstracting service within a mean time of 9 months; however, time lag and coverage varied considerably for individual journals on a year by year basis. It was concluded that for historical searches and current awareness needs this secondary publication may not be meeting the information needs of communicative disorders specialists.

Abstracting and Indexing↗
PubMed1999

Questions on validity of International Classification of Diseases-coded diagnoses.

International Classification of Diseases (ICD) codes are used for indexing medical diagnoses for various purposes and in various contexts. According to the literature and our personal experience, the validity of the coded information is unsatisfactory in general, however the 'correctness' is purpose and environment dependent. For detecting potential error sources, this paper gives a general framework of the coding process. The key elements of this framework are: (1) the formulation of the established diagnoses in medical language; (2) the induction from diagnoses to diseases; (3) indexing the diseases to ICD categories; (4) labelling of the coded entries (e.g. principal disease, complications, etc.). Each step is a potential source of errors. The most typical types of error are: (1) overlooking of diagnoses; (2) incorrect or skipped induction; (3) indexing errors; (4) violation of ICD rules and external regulations. The main reasons of the errors are the physician's errors in the primary documentation, the insufficient knowledge of the encoders (different steps of the coding process require different kind of knowledge), the internal inconsistency of the ICD, and some psychological factors. Computer systems can facilitate the coding process, but attention has to be paid to the entire coding process, not only to the indexing phase.

Abstracting and Indexing↗
PubMed1989

Compatible information systems a key to merger success.

Information systems compatibility can directly affect the benefits an organization receives from a merger or acquisition. At the macro level, the degree of compatibility determines whether consolidating systems is feasible and cost effective. At the micro level, information systems compatibility is closely tied to every benefit a merger or acquisition brings. Potential merger partners can assess whether their systems will mesh with an information systems compatibility index.

Abstracting and Indexing↗