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Objective: To review the potential legal liability of the pharmacist in the drug product selection process., Data Sources: Published articles identified through MEDLINE, published law reviews identified through InfoTrac, and appellate court decisions. Search terms used included pharmacist liability, drug product selection, and generic substitution. Additional articles, books, and appellate court decisions were identified from the bibliographies of retrieved articles and citations in appellate court decisions., Data Synthesis: Pharmacists engaging in drug product selection are civilly liable under three legal theories: negligence, express or implied warranties, and strict product liability. Potential criminal liability includes prosecution for insurance fraud, deceptive business practices, and violation of state drug product selection laws and regulation., Conclusion: Pharmacists increase their liability when engaging in drug product selection, but the increase is small. Still, the law continues to evolve as pharmacists seek expanded roles and responsibilities. When courts give closer examination to pharmacists' expanded role, it is likely that pharmacists' liability will increase.

Objective: To review the major scientific issues embedded in the generic drug approval process., Data Sources: Articles indexed initially under terms such as generic medications, generic drugs, bioequivalence, and bioinequivalence. These terms were used to search indexing services such as MEDLINE, International Pharmaceutical Abstracts, CINAHL (a database of nursing and allied health literature), and Science Citation Index. Additional data sources included the Code of Federal Regulations and regulatory guidances from the Food and Drug Administration (FDA) Center for Drug Evaluation and Research., Study Selection: Performed by the authors., Data Extraction: Not applicable., Data Synthesis: Despite the fact that regulations regarding bioequivalence have been in place for more than 20 years, controversies over bioequivalence continue to arise. Consensus on many of these issues is driving the development of new FDA guidances regarding bioequivalence. Still, despite the issuance of new guidance and consensus building among scientists, many clinicians and consumers remain uninformed regarding the scientific basis for establishing bioequivalence and the generic drug approval process in general. Although some have suggested that the generic drug approval process is flawed, overall, it appears that the process works., Conclusion: Understanding the generic drug approval process and the issues surrounding bioequivalence is of paramount importance to both clinicians and scientists.

Objective: To develop and test a tool for evaluating the performance of working groups in the institutional health care setting and to discuss its utility for pharmacists and other health care providers., Design: A model for understanding how groups make decisions in health care settings was developed based on theories derived from organizational research. Our general group decision-making model was based on data collected from a national survey of members of hospital pharmacy and therapeutics (P&T) committees. Members were asked to describe how they interacted when making decisions regarding whether to add or delete drugs from their hospital's formulary. The relationships were examined using structural equation modeling., Setting: Large teaching hospitals., Participants: Key members of P&T committees., Main Outcome Measures: Committee members' responses about committee structure, organizational environment, quality of their interactions with each other, and the committee's decision-making abilities. Individual responses were aggregated into group measures to improve reliability and validity., Results: Responses were received from 114 of the 222 hospitals surveyed (51.3%), and analysis was conducted on 95 hospitals (42.8%) for which three or more group members responded. Positive interactions among group members had the greatest influence on the group's decision-making abilities (beta = 0.92). These interactions were facilitated by a well-designed group (gamma = 0.71) and the support of the environment within which the committee operates (gamma = 0.29)., Conclusion: The general group decision-making model tested in this study may be useful in understanding how the internal processes of health care groups such as P&T committees influence group performance and, hence, group outputs. Health care providers who apply a systematic approach to assessing group performance will find this model useful because it provides a starting point for examining the process, a way to show interrelationships among various group activities, and a guide to which strategies may be most effective for improving the decision-making process.

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.

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.