American journal of hospital pharmacy
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The purpose and use of the FDA's classification system for new drug products are described. Investigational new drug applications (INDs) and new drug applications (NDAs) are submitted to the FDA's Center for Drug Evaluation and Research. To establish the priority of the product in the review process, expert reviewers classify each product according to chemical type and therapeutic potential. ⋯ Because this system is the only national therapeutic rating system for drug products, it has been used in legislation, in clinical evaluation of new drug products as they are approved, and in formulary decisions. However, caution is needed because the therapeutic rating assigned at the time of the product's approval may not reflect its importance relative to all agents available at a later date. The FDA classification system was designed to guide new drug products through the application process and should be used only with caution for other purposes.
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The process of nociception, the anatomy of the epidural space, and the placement of the epidural catheter are reviewed, and the pharmacology and pharmacokinetics, analgesic efficacy, and potential adverse effects of epidurally administered narcotics and local anesthetics are discussed, as well as patient monitoring standards and solution preparation guidelines for these agents. The epidural space is located between the dura mater (the outer-most membrane surrounding the spinal cord) and the vertebral canal. The site of catheter placement is determined by the dermatomes corresponding to the site of desired analgesia. ⋯ The most bothersome adverse effect encountered with analgesic doses of local anesthetics is paresthesia. Solutions for epidural administration must be sterile and preservative free. Epidural administration of narcotics and local anesthetics seems to provide better pain relief than conventional methods but may be associated with more bothersome adverse effects.
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Some of the newer high-technology infusion devices commercially available or under development are described. The range of infusion devices includes both controllers and pumps; pumps can be classified by mechanism of operation (peristaltic, syringe, cassette, elastomeric reservoir), frequency or type of drug delivery (continuous or intermittent infusion, bolus dosing, single- or multiple-solution delivery), or therapeutic application (such as the patient-controlled analgesia, or PCA, pump). ⋯ Current research in infusion-device technology is focusing on implantable pumps, pumps with chronobiological applications, osmotic-pressure devices, and open- and closed-loop systems. Pharmacists need to keep abreast of the rapidly changing intravenous device marketplace to provide clinical expertise and leadership in the review and evaluation of high-technology drug delivery systems.
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Societal forces behind the increased use of outcomes to measure the quality of health care are described, and continuous improvement of outcomes as a goal for pharmacy is discussed. Consumerism, the demands of the aging American population, and problems of access to care for many Americans have helped to bring about an examination of quality. The effectiveness of clinical decision-making methods has been challenged. ⋯ Documentation of quality assurance efforts will be required. Drug-use evaluations should include assessment for therapeutic failure. Pharmacy quality improvement efforts can improve patient care and expand the pharmacist's role on the health-care team.