American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
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Am J Health Syst Pharm · Jan 2001
ReviewRegulation of the compounding of positron emission tomography drugs.
Controversial aspects of the regulatory framework for compounding drug products used in positron emission tomography (PET) are discussed. The Food and Drug Administration Modernization Act of 1997 (FDAMA), which amends the Federal Food, Drug, and Cosmetic Act (FFDCA), required that FDA establish approval (new drug application [NDA] and abbreviated new drug application [ANDA]) procedures and current good manufacturing practice (CGMP) requirements for PET drugs; this seems to conflict with differentiation between manufacturing and compounding in FFDCA. Compounding by pharmacists is implied in the FDAMA section on PET, but specific mention of "pharmacist" needs to be included. ⋯ Without relief from the current regulations, many academic PET centers are likely to close; this would violate FDAMA's stated intent of making PET available to patients at reasonable cost. Also problematic is FDAMA's prohibition of compounding "regularly or in inordinate amounts" a product that is commercially available; the common PET radiopharmaceutical fludeoxyglucose F 18 injection, for example, is commercially available. A sensible alternative to NDA or ANDA and CGMP requirements would be the enforcement of USP standards for PET drugs by state boards of pharmacy.
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Am J Health Syst Pharm · Dec 2000
Re-engineering the medication error-reporting process: removing the blame and improving the system.
A hospital's change from a traditional, multitiered incident-reporting system for medication errors to a standardized, nonpunitive medication-use variance process is described. After weaknesses were identified in the hospital's system for reporting and evaluating medication errors, a multidisciplinary task force was formed to redesign the hospital's medication error-reporting system. Its guiding principles were as follows: anonymity and freedom from punitive action are essential for increasing the number of reports, rating medication errors facilitates identification of areas for system improvement, potential errors provide valuable insight into the system's vulnerabilities, and timely review of reports enables rapid systematic correction. ⋯ In the first six months following hospitalwide implementation, the number of events captured increased more than fivefold; it continues to increase. The resulting database serves as a trigger for quality improvement efforts and a measure of their effectiveness. The redesign of the medication error-reporting process served as the impetus for a change in the organizational culture surrounding medication errors.
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Am J Health Syst Pharm · Dec 2000
Improving the quality of the order-writing process for inpatient orders and outpatient prescriptions.
Because many preventable medication errors occur at the ordering stage, a program for improving the quality of writing inpatient orders and outpatient prescriptions at one institution was developed. To determine whether potential problems existed in the order-writing process for inpatients, all physician orders for a seven-day period in 1997 were reviewed (n = 3740). More than 10% of all orders had illegible handwriting or were written with a felt-tip pen, which makes NCR copies difficult to read. ⋯ Follow-up reviews of outpatient prescriptions indicate improvements in handwriting and completeness, but continuing educational efforts are needed. The quality of order writing for inpatients and outpatients continues to be monitored on a regular basis. Ongoing educational programs, follow-up reminders, and feedback to physicians have greatly improved the prescription-writing habits of physicians.
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Am J Health Syst Pharm · Nov 2000
Comparative StudyExperiences at a large teaching hospital with levofloxacin for the treatment of community-acquired pneumonia.
Costs, patient outcomes, and susceptibility patterns of selected organisms after the implementation of guidelines for the treatment of community-acquired pneumonia (CAP) at a large community teaching hospital were analyzed to assess the benefit of the guidelines. The guidelines, implemented in September 1998, included recommendations for the use of levofloxacin as the preferred antimicrobial, with rapid intravenous (i.v.) to oral (p.o.) conversion. Purchase data for levofloxacin, ceftriaxone, and azithromycin were analyzed, as well as susceptibilities and demographic and outcome data for patients admitted in 1999 in diagnosis-related groups (DRGs) 89 and 90 (simple pneumonia with and without comorbidities, respectively). ⋯ The average costs in the AOT groups suggest that total hospital costs for 1999 in the LUO group were $241,516 less than costs would have been before guideline implementation. Combined drug acquisition cost savings in 1999 for levofloxacin, ceftriaxone, and azithromycin were $21,115. The use of CAP treatment guidelines was associated with reductions in antimicrobial costs, total hospitalization costs, LOS, and death rate, without a detrimental effect on organism susceptibility.