
Editorial
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These medication errors have occurred in health care facilities at least once. They will happen again—perhaps where you work. Through education and alertness of personnel and procedural safeguards, they can be avoided. You should consider publishing accounts of errors in your newsletters and/or presenting them in your inservice training programs.
Your assistance is required to continue this feature. The reports described here were received through the USP Medication Errors Reporting Program, which is presented in cooperation with the Institute for Safe Medication Practices. If you have encountered medication errors and would like to report them, you may call USP toll-free, 24 hours a day, at 800–233–7767 (800–23-ERROR).
Any reports published by ISMP will be anonymous. Comments are also invited; the writers' names will be published if desired. ISMP may be contacted at the address shown below.
The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), to discuss methods of prevention, and to promote reporting of ADRs to the FDA's medWatch program (800-FDA-1088). If you have reported an interesting preventable ADR to medWatch, please consider sharing the account with our readers.
The increasing complexity of cancer chemotherapy makes it mandatory that pharmacists be familiar with these highly toxic agents. This column focuses on the commercially available and investigational agents used to treat malignant diseases, reviewing issues related to the preparation, dispensing, and administration of cancer chemotherapy.
This Hospital Pharmacy feature is extracted from Off-Label DrugFacts, a quarterly publication available from Facts and Comparisons. Off-Label DrugFacts is a practitioner-oriented resource for information about specific FDA-unapproved drug uses. This new guide to the literature will enable the health care professional/clinician to quickly identify published studies on off-label uses and to determine if a specific use is rational in a patient care scenario. The most relevant data are provided in tabular form so that the reader can easily identify the scope of information available. A summary of the data-including, background, study design, patient population, dosage information, therapy duration, results, safety, and therapeutic considerations-precedes each table of published studies. References direct the reader to the full literature for more comprehensive information prior to patient care decisions. Direct questions or comments on “Off-Label Drug Uses” to
The objective of this study was to evaluate the physical and chemical stability of imipenem-cilastatin sodium 250 mg/100 mL and 500 mg/100 mL (of each drug component) admixed in 0.9% sodium chloride injection packaged in AutoDose Infusion System bags.
Triplicate test samples were prepared by bringing the required amount of imipenem-cilastatin sodium injection to volume with 0.9% sodium chloride injection. A total of 100 mL of each of the test solutions was packaged in each of three ethylene vinyl acetate (EVA) AutoDose bags designed for use in the AutoDose Infusion System for each storage condition. Samples were protected from light and evaluated at appropriate intervals for up to three days at 23°C and 14 days at 4°C.
Physical stability was assessed using a multistep evaluation procedure that included turbidimetric and particulate measurement in addition to visual inspection. Chemical stability was assessed with stability-indicating high performance liquid chromatography (HPLC) analytical techniques, based on initial drug concentrations and concentrations at appropriate intervals over the study periods. The admixtures were clear throughout the study when viewed in normal fluorescent room light and with a Tyndall beam. Measured turbidity and particulate content were low initially and exhibited little change throughout the study. HPLC analysis revealed extensive decomposition in the samples, with imipenem being the less stable component.
The instability of the imipenem-cilastatin sodium admixtures is consistent with previous studies. Admixtures stored under refrigeration should be used immediately upon warming to room temperature due to the rapid rate of imipenem decomposition. The AutoDose Infusion System bags were not found to affect adversely or improve the physical and chemical stability of this drug.
Many procedures involved in the preparation and administration of hazardous drugs put health care workers at risk of exposure to these agents through leakage or accidental spills. The first objective of this study was to determine if the conventional needle/syringe technique has the potential to allow drugs to escape into the environment. The second objective was to evaluate if a closed system, PhaSeal, prevents inadvertent release of hazardous drugs. Fluorescein, a fluorescent indicator, was prepared as a dry powder and a 0.05% solution in empty drug vials. Each phase of the manipulation was photographed using UV light to visualize fluorescein leaks and spills. The procedures included reconstitution of a dry powder, drug transfer from the vial to an IV bag, simulated drug administration, and IV push administrations through an IV port. With the conventional needle/syringe technique, each phase of the manipulations resulted in visible fluorescein leakage into the environment. Fluorescein leakage ranged in size from less than 1 to 50 mm in diameter. The syringes, work surfaces, gloves, manifold ports, and IV bag ports exhibited fluorescein contamination. With PhaSeal, no leakage was observed during any phase of the manipulations. Using the conventional needle/syringe technique during preparation of a hazardous drug may lead to release of the agent into the work environment, posing a health risk to the worker. A closed system such as PhaSeal has the ability to confine hazardous drugs, substantially reducing or possibly eliminating drug exposures.
This article describes the process and results of employing an Investigational Drug Service Pharmacist (IDSP) to coordinate pharmacy support for clinical drug studies. In 1998, a Clinical Research Center (CRC) was established to coordinate all research at a 407-bed Baltimore teaching hospital, resulting in an increase in studies requiring pharmacy support. By the end of 1998, there was a backlog of nine studies awaiting review for feasibility and impact on pharmacy resources. A lack of communication between departments further impeded the process. In March 1999, a part-time pharmacist was hired to coordinate all drug studies; the pharmacist's salary was paid by the CRC. Primary responsibilities of the position were protocol review, staff education, and drug accountability. Dispensing was still handled by staff pharmacists. After three years, results were as follows: 72 studies were reviewed, 41 were opened for enrollment, 8 were in preparation, 16 were completed. Two studies alone have saved the pharmacy department over $80,000 in drug acquisition costs. The efforts of the IDSP have helped the CRC to more than double its growth, with gross income from studies of $533,712 in 2001 compared with only $237,663 in 1998. The IDSP has improved communication between the CRC and pharmacy and expedited study initiation. It has also made the CRC more attractive to prospective sponsors, since one pharmacist works directly with study coordinators. With more physicians interested in carrying out research and hospital budgets becoming tighter, the part-time IDSP position represents an important means of supporting these endeavors without increasing fiscal burdens.
Each month, subscribers to The Formulary Monograph Service receive five to six well-documented monographs on drugs that are newly released or are in late Phase III trials. The monographs are targeted to your Pharmacy and Therapeutics Committee. Subscribers also receive monthly one-page summary monographs on the agents that are useful for agendas and pharmacy/nursing in-services. A comprehensive target drug utilization evaluation (DUE) is also provided each month. The monographs are published in printed form and on diskettes that allow customization. Subscribers to the The Formulary Monograph Service also receive access to a pharmacy bulletin board, The Formulary Information Exchange (The F.I.X.). All topics pertinent to clinical and hospital pharmacy are discussed on The F.I.X.
Through the cooperation of The Formulary, Hospital Pharmacy publishes selected reviews in this column. If you would like information about The Formulary Monograph Service or The F.I.X., call The Formulary at 800–322–4349. The January 2003 monograph topics are ezetimibe, enfurvitide, aripiprazole, atomoxetine, and amoxicillin/clavulanate potassium extended-release tablets. The DUE is on ezetimibe.
This monthly feature will help readers keep current on new drugs, new indications and dosage forms, and safety-related changes in labeling or use. Each month, new information will be added to the table (shown in bold type) and older information will be removed. Efforts have been made to ensure the accuracy of the information; however, if there are any questions, let us know at
This column addresses questions from readers about any issue, process, standard, or future direction of the Joint Commission, whether it relates to home care, the hospital, or other practice environment. The objective is to give you a better insight into the Joint Commission accreditation process in your own practice site. Any question is fair game.
This continuing feature will inform readers about the process of implementing, maintaining, and supporting computerized prescriber order entry (CPOE) at the Ohio State University Medical Center. (By “prescribers,” we refer to health care professionals authorized to prescribe medications by their states.) Practical information on what worked and what failed will be provided, along with current updates on the status of CPOE at the Medical Center. Questions or suggestions should be addressed to Alicia S. Miller, Department of Pharmacy, The Ohio State University Medical Center, 368 Doan Hall, 410 West 10th Avenue, Columbus, OH 43210. E-mail:
To help readers monitor the most important developments in specialized areas of pharmacy practice in organized health systems, Hospital Pharmacy commissions Basic Bibliographies by guest editors, who have expertise in their respective fields. These guest editors survey the relevant literature and rank approximately 15 to 20 references that represent the most significant research and practice contributions in their areas. The more fundamental are listed first so that persons with limited time can select reading appropriate to their needs. A cumulative index to Basic Bibliography topics will be published semi-annually in June and December. Readers are urged to forward reactions or challenges to: Joyce A. Generali, Director, Drug Information Center, University of Kansas Medical Center, 3901 Rainbow Boulevard, Kansas City, KS 66160 or