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Biomedical subjects

Colleen M Culley

Publications and source records attributed to Colleen M Culley.

6 recordsLinked to original sources

Evaluation of conflicting literature and application to formulary decisions.

PURPOSE: Guidelines were developed for grading the quality, quantity, and consistency of drug literature in support of formulary recommendations. METHODS: Four developmental steps were taken to create a comprehensive literature evaluation system. The first step identified the attributes of a body of literature that were most reflective of its applicability to patient care. The next step defined each domain (quality, quantity, consistency), as determined by the Agency of Healthcare Research and Quality (AHRQ), in terms of the specific qualities to be assessed; a value was assigned to those qualities. Also, a literature search was conducted to identify strategies for evaluating bodies of literature employed in published assessment tools. Following the analysis of previously published systems, which were evaluated with respect to their inclusion of the AHRQ-identified domains, the next step was the development of specific domains and definitions to get a composite grade (with "better" evidence earning more points) for formulary recommendations. The final step was the creation of a system that aggregated the final score for the recommendation. The recommendation was categorized according to quality, quantity, and consistency of supporting evidence, and the total number of points was calculated and the recommendation given letter and numerical grades. RESULTS: The guidelines that were developed allow the user to accurately, consistently, and easily determine the strength of recommendations for a body of literature that may be conflicting. The addition of criteria for quantity and consistency to previously-published grading systems has made the guidelines more objective. CONCLUSION: A system that accounts for the quality, quantity, and consistency of drug literature was developed to assist in making formulary decisions.

Contrast Media↗

Advanced practice internship: experiential learning in a drug use and disease state management program.

OBJECTIVE: Establish a 3-year hospital internship within a drug use and disease state management program that would provide doctor of pharmacy students with experiential learning while still completing their classroom studies. DESIGN: As paid interns, students engaged in group and individual activities that assessed clinical practice guidelines. Patient monitoring and clinical intervention techniques were learned through prospective evaluation of drug therapy. Students designed evidence-based treatment guidelines and participated in all phases of development, including multidisciplinary approval, implementation, and evaluation stages. ASSESSMENT: Student competency was continually monitored through direct observation by a preceptor and written examinations. Patient case studies, group discussions, and poster presentations allowed assessment of student growth in knowledge and communication skills. CONCLUSION: The comprehensive structure of this internship provides a broad perspective for understanding the role of the hospital pharmacist in providing pharmaceutical care. Close supervision maximizes student learning potential and fosters a mentoring relationship for both personal and professional growth.

Accreditation↗

Challenge and rechallenge: drotrecogin alfa (activated)-induced prolongation of activated partial thromboplastin time in a patient with severe sepsis.

An 81-year-old woman with ischemic bowel underwent laparotomy with small-bowel resection and developed septic shock. She required broadspectrum antibiotics, norepinephrine, and mechanical ventilation. The patient received drotrecogin alfa (activated) 24 microg/kg/hour for a total of 67.5 hours. Coagulation parameters were monitored during her therapy. Significant increases in activated partial thromboplastin time (aPTT) during infusion led to two temporary discontinuations of the drug. Coagulation parameters decreased when the drug was held and increased with each rechallenge. The patient survived the episode and was discharged on postoperative day 27. Medical records of 26 other patients who received drotrecogin alfa (activated) at our institution from November 2001-August 2003 were reviewed retrospectively for coagulation parameters and bleeding rate. Of the 26 patients, nine (35%) were treatment compliant (>90% of the 96-hr course). Coagulopathy and bleeding resulted in early discontinuation in four (15%) and six (23%) patients, respectively. An increase in aPTT from baseline to during infusion of drotrecogin alfa (activated) was noted in 14 patients with complete data (p=0.56). A decrease in median platelet count from baseline to during infusion was noted in the six patients who bled during therapy (p=0.01). Two of these patients had platelet counts less than 30x10(3)/mm3 during administration. Drotrecogin alfa (activated) should be considered an anticoagulant. In postmarketing reports, clinically significant bleeding occurred more frequently than was noted in a large, randomized, multicenter trial. Patients receiving drotrecogin alfa (activated) should be closely monitored for prolongation of coagulation parameters. Temporary discontinuation of the drug should be considered when international normalized ratio is greater than 3.0, platelet count is less than 15x10(3)/mm3, and aPTT is greater than 100 seconds.

APACHE↗

A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective.

Paracetamol (acetaminophen) poisoning remains the most common exposure reported to US poison information centres and the leading cause of poisoning-related fatalities, despite the availability of an effective antidote, acetylcysteine. Oral acetylcysteine solution has been approved for the management of acetaminophen poisoning in the US for four decades. Until the recent approval of intravenous acetylcysteine in the US, it was necessary to compound the oral solution for intravenous administration. The effectiveness and tolerability of oral and intravenous acetylcysteine for the prevention of hepatotoxicity induced by paracetamol poisoning are well established in the literature. Intravenous acetylcysteine may be preferred over oral administration based on improved tolerability, ease of administration and the shortened course of therapy (20 hours intravenous vs 72 hours oral). The two intravenous acetylcysteine regimens documented in the literature, 48 hours and 20 hours, have similar efficacy when started within 8-10 hours of ingestion. Although there are no legal concerns with continuing the routine compounding of the oral solution to an intravenous product, new standards for pharmacy compounding of sterile preparations set forth by the US Pharmacopoeia highlight that the risk of compounding products for intravenous use must be assessed carefully. Changing the route of administration of a sterile oral solution to an intravenous preparation, when a commercial sterile and pyrogen-free product is available, may not be advisable. The best cost-containment strategies must be used for introduction of the more costly sterile, pyrogen-free intravenous acetylcysteine formulation by hospitals and healthcare systems. The intravenous acetylcysteine product is more cost effective when given for 20 hours than other treatment protocols based on the costs of acetylcysteine and hospitalisation. If used per protocol, the 20-hour intravenous acetylcysteine regimen may decrease hospital length of stay, thereby, offsetting the increased drug cost. Data conflict on the efficacy and administration of intravenous acetylcysteine for off-label uses, such as radiographic contrast media-induced nephropathy prevention and reperfusion in orthotopic liver transplantation. The costs for the intravenous formulation for these indications is significantly higher than use of the oral formulation for oral administration in radiographic contrast media-induced nephropathy prevention and compounded for intravenous use in orthotopic liver transplantation. The oral solution should be retained by healthcare systems for oral and inhalation applications, such as respiratory conditions, oral administration for radiographic contrast media nephropathy prevention, or the use of the 72-hour oral protocol to treat paracetamol poisoning, when the intravenous preparation cannot be used.

Acetaminophen↗

Meeting the modified drug information requirements of ASHP-accredited pharmacy practice residency programs.

The current standards for meeting drug information (DI) requirements in American Society of Health-System Pharmacists (ASHP)-accredited pharmacy practice residency (PPR) programs and the impact of changes in ASHP standards for the DI requirements were studied. In September 2002 a nine-question survey was e-mailed to the directors of all ASHP-accredited PPR programs listed with an available e-mail address on ASHP's residency directory Web page as of August 2002. The program directors were asked to provide information on the demographics of their practice settings, the current methods of completing the DI requirements of their programs, whether the DI requirements had changed between the 2001-02 and 2002-03 residency years, and whether any changes in the DI requirements were anticipated. A total of 178 (49%) of 365 PPR programs responded. Of the respondents, 87% were located in a hospital setting, 33% were affiliated with a school of pharmacy, and 40% had a formal onsite DI center. Half of the respondents fulfilled DI requirements through a longitudinal rotation, 20% through a block rotation, and 27% through both. Eighty-two percent of the respondents were familiar with the revised ASHP DI requirements, and 26% had modified their DI requirements between the 2001-02 and 2002-03 residency years. Seventeen percent anticipated changing their DI requirements in the future. Influences for modifications to the programs' DI requirements were mainly ASHP revisions and feedback from preceptors and residents. A national survey suggested that DI requirements in PPR programs are primarily achieved through a longitudinal rotation design.

Drug Information Services↗