A Pharmacotherapy Scholars Program to Provide Intensive Training to Enhance Pharmacy Students' Postgraduate Readiness.

Objective. To design, integrate the curriculum for, and evaluate an innovative program to facilitate placement of students into postgraduate pharmacy residency training programs involving direct patient care. Methods. The Pharmacotherapy Scholars Program (PSP) was designed to prepare fourth-professional year students to become highly proficient in a direct patient care role and to successfully match with postgraduate residency training programs. The following elements were included in the year-long curriculum: integrated synchronous advanced pharmacy practice experiences with personal advising, team-based mentoring, peer-to-peer learning, longitudinal research, and professional development. Program goals were modeled after the accreditation standards for postgraduate year one (PGY1) pharmacy residency programs. Program faculty members ensured that the PSP had a broad scope, included rigorous student assessments, had a strong research focus, and provided scholarship opportunities. Results. Sixty-eight students completed the program from fall 2013 through spring 2019. The overall residency match rate was 93%. Students' performance on both knowledge and clinical skills assessments significantly improved after completing the program. There was an approximately 15% increase in knowledge and a 30% improvement in clinical skills based on comprehensive readiness assessments and an intermittent clinical examination that used patient simulation, respectively. Conclusion. The Pharmacotherapy Scholars Program is an innovative training program designed to enhance PharmD students' preparation for advanced clinical training. Students who completed the PSP achieved a high PGY1 residency placement rate while demonstrating significant improvements in pharmacotherapy knowledge and clinical skills in direct patient care activities.

Pharmacodynamics and clinical efficacy of fentanyl iontophoretic transdermal system for post-operative pain in hospitalized patients.

INTRODUCTION: The fentanyl iontophoretic transdermal system (ITS) is a patient-controlled transdermal system allowing needle-free administration of on-demand doses of Fentanyl of 40 µg over a 10-min period up to 80 doses or over a 24-h period. It is indicated in opioid naïve patients for the treatment of acute postoperative pain in the hospitalized patients for up to 72 h. AREAS COVERED: It has been demonstrated to be effective and safe in randomized trials and to provide comparable analgesia versus morphine intravenous (i.v.) patient-controlled analgesia (PCA) with adverse events similar between groups. EXPERT OPINION: Fentanyl ITS has shown high patient satisfaction rates, and was described by patients and investigators as easy and convenient to use. These properties make this technology interesting when considering perioperative pain management. In the present health care environment additional data are required to establish the cost-benefit ratio of this technology in optimizing patient's recovery from surgery.

Addressing innovative off-label medication use at an academic medical center.

PURPOSE: A large hospital's systematic and evidence-based approach to adjudicating, monitoring, and ensuring the safety of off-label medication use is described. SUMMARY: In 2003 the University of Pittsburgh Medical Center (UPMC)-Presbyterian implemented a policy that created a formal process for the systematic evaluation of formulary requests and drug-utilization patterns indicating or suggesting off-label use. Explicit criteria were developed for differentiating "innovative off-label use" (i.e., use based on a reasonable rationale yet lacking definitive scientific support in the form of fully published randomized controlled trials) from medication use more appropriately classified as clinical research. The UPMC-Presbyterian policy also outlined a process for the development, implementation, and evaluation of guidelines on innovative off-label use, including the collection of efficacy and safety outcomes. As of October 2012, 31 proposals for off-label medication use had been evaluated by the medical center's pharmacy and therapeutics committee and formulary subcommittee. Thirteen requests resulted in a determination of innovative off-label use and the development of prescribing guidelines, and 10 prompted the extension of an agent's current formulary status; in 6 cases, proposed off-label uses were determined to constitute clinical research. In some instances, innovative off-label medication use generated safety and outcomes data that led to changes in local standards of care. An algorithm to guide decision-making with regard to requests and proposals for off-label medication use is provided. CONCLUSION: The UPMC-Presbyterian experience indicates that off-label medication use can be effectively managed using evidence-based principles and peer review mechanisms.

Building an outpatient cancer center pharmacy program across a tristate region.

PURPOSE: The transition to a hybrid model of oncology pharmacy services including remote order verification across a regional network of cancer centers is described. SUMMARY: Five years ago the University of Pittsburgh Medical Center (UPMC) began a major expansion of its cancer care services, gradually integrating 19 community-based physician practice sites into its tristate oncology network as affiliated hospital-based clinics (HBCs). The network expansion was achieved through a stepwise process including (1) development of oncology medication protocols, (2) interdisciplinary efforts to modify oncology care workflows, (3) implementation of a hybrid practice model to optimize the use of clinical pharmacy resources, and (4) focused staff training programs. Under the hybrid practice model, first checks of antineoplastic medication orders, premedication orders, and laboratory values are performed by either onsite or remote pharmacists, with all second checks performed remotely. In 2013, network pharmacists implemented large numbers of medication therapy interventions to improve chemotherapy and biological response modifier dosing (n = 641) and nonchemotherapy medication use (n = 1082); other documented interventions included patient counseling to help optimize the use of erythropoietin-stimulating agents and other medications (n = 441) and anticoagulation-related dosing adjustments and patient education (n = 102). CONCLUSION: Nineteen ambulatory care centers were successfully integrated into the UPMC oncology network as affiliated HBCs through a stepwise process that included workflow modifications, staff training, and a hybrid pharmacy services model that ensures a two-pharmacist check of antineoplastic orders in accordance with regulatory and quality standards.

Extrapyramidal symptoms following administration of oral perphenazine 4 or 8 mg: an 11-year retrospective analysis.

BACKGROUND: Perphenazine is a treatment option in postoperative nausea and vomiting (PONV) prophylaxis. Chronic administration and high dose are known to cause extrapyramidal system (EPS) dysfunction at a frequency of 8%, but the incidence of acute EPS after a single 4 or 8 mg dose is unknown. OBJECTIVE: A retrospective analysis of patient medication billing data and departmental quality records was performed (January 2001 to 10 July 2012) to identify patients who experienced EPS dysfunction after oral perphenazine. DESIGN: A retrospective analysis. SETTING: Surgical outpatients presenting to any one of 10 hospitals in the area of Pittsburgh, Pennsylvania, USA. PATIENTS: Overall, 45 766 patients received 4 or 8 mg of perphenazine before same-day surgery. MAIN OUTCOME MEASURES: EPS dysfunction was defined as acute dystonia, akathisia or pseudoparkinsonism. Records were reviewed to determine the likely number of reactions to perphenazine, the nature of these reactions and impact on patient care. RESULTS: There were four 'likely' cases of EPS dysfunction, and two 'possible' cases. Five reported events were consistent with akathisia, with the sixth being a dystonic reaction. All six patients had resolution of symptoms, with five receiving intravenous diphenhydramine for treatment. The incidence of EPS dysfunction was 1.3 events per 10 000 patients (95% confidence interval (CI) 0.4 to 3.0, based on six events). All patients who experienced reactions pre-operatively were able to proceed to surgery without complications or delay. One patient required unplanned admission and 3-h observation owing to sedation from diphenhydramine. The incidence of EPS dysfunction after oral perphenazine is low. Reactions that did occur were mild and easily treated. CONCLUSION: Given the infrequent side effects, this single, low dose of perphenazine should be encouraged as a low-risk adjunct to any multimodal PONV prophylaxis regimen, based on the selection criteria described.

Quality-improvement analytics for intravenous infusion pumps.

PURPOSE: The implementation of a smart-pump continuous quality-improvement (CQI) program across a large health system is described, with an emphasis on key metrics for outcomes analyses and program refinement. SUMMARY: Three years ago, the University of Pittsburgh Medical Center health system launched a CQI initiative to help ensure the safe use of 6000 smart pumps in its 14 inpatient facilities. A centralized team led by pharmacists is responsible for the retrieval and interpretation of smart-pump data, which is continuously transmitted to a main server. CQI findings are regularly posted on the health system's interdisciplinary intranet. Monitored metrics include rates of compliance with preprogrammed infusion limits, the top 20 drugs involved in alerts, drugs associated with alert-override rates of ≥90%, numbers of alerts by infusion type, nurse responses to alerts, and alert rate per drug library update. Based on the collected CQI data and site-specific requests, four systemwide updates of the smart-pump drug library were performed during the first 18 months of the program, reducing "nuisance alerts" by about 10% per update cycle and enabling targeted interventions to reduce rapid-infusion errors, other adverse drug events (ADEs), and pump-programming workarounds. Over one 12-month period, bedside alerts prompted nurses to reprogram or cancel continuous infusions an average of 400 times per month, potentially averting i.v. medication ADEs. CONCLUSION: A smart-pump CQI program is an effective tool for enhancing the safety of i.v. medication administration. The ongoing refinement of the drug library through the development and implementation of key interventions promotes the growth and sustainability of the smart-pump initiative systemwide.

Core competencies for research training in the clinical pharmaceutical sciences.

OBJECTIVE: To identify and apply core competencies for training students enrolled in the clinical pharmaceutical scientist PhD training program at the University of Pittsburgh School of Pharmacy. DESIGN: Faculty members reached consensus on the required core competencies for the program and mapped them to curricular and experiential requirements. ASSESSMENT: A rubric was created based on core competencies spanning 8 major categories of proficiency, and competencies of clinical versus traditional PhD training were delineated. A retrospective evaluation of the written comprehensive examinations of 12 former students was conducted using the rubric. Students scored above satisfactory in 11 out of 14 comprehensive examination metrics, with a mean score greater than 3.8 on a 5-point scale. CONCLUSIONS: The core competencies identified will provide an essential foundation for informed decision-making and assessment of PhD training in the clinical pharmaceutical sciences.

Educational program for pharmacists at a multifacility academic medical center.

PURPOSE: An educational program for pharmacists in a multifacility health care setting is described. SUMMARY: The expansion of pharmacy services at a university medical center from a centralized to a decentralized, unit-based model created the need for enhanced education of staff pharmacists. A steering committee with pharmacy department and school of pharmacy representation surveyed educational and professional needs related to the expanded services. Pharmacists indicated that they needed an educational program that was comprehensive, interactive, and accessible to all shifts. Pharmacy school clinical faculty members provided most of the initial educational sessions, which combined didactic presentations and case-based discussion. The needs survey was used in selecting topics that were most relevant to the pharmacists' expanded practice. Each major topic was covered in a series of one-hour sessions held at two-week intervals and scheduled at a time convenient for afternoon-shift pharmacists. Incentives were offered to encourage participation. The live presentations were recorded with video-streaming technology and made available via the Internet to pharmacists on all shifts in all facilities of the health system as well as to faculty members. Since program implementation in 2005, attendance at the live sessions has averaged 25. In postimplementation surveys, pharmacists indicated that the program was meeting their needs and improving patient care. Since 2008, pharmacists have been able to earn continuing-education (CE) credit for the sessions. CONCLUSION: A collaborative educational series with online access, clinical content, and CE credit has been effective in meeting pharmacists' needs in a multifacility health care setting.

Coagulation factor VIIa (recombinant) in nonhemophilic patients requiring neurosurgery.

PURPOSE: The clinical outcomes, safety, and use of resources associated with the administration of factor VIIa (recombinant) to nonhemophilic patients requiring neurosurgery were evaluated. METHODS: An interdisciplinary group created guidelines for the pharmacy and therapeutics committee for the unlabeled use of factor VIIa (recombinant). Nonhemophilic patients were eligible to receive the agent without approval from the hematology-coagulation service if they had an intracranial hemorrhage (ICH), were undergoing an emergency neurosurgical procedure, and had coagulopathy. A standard single dose of 40 microg/kg was recommended for these patients. Data were prospectively collected between March 2004 and March 2006 for all neurological surgery patients receiving factor VIIa (recombinant). RESULTS: A total of 92 nonhemophilic patients received single doses of factor VIIa (recombinant) under the guidelines during the two-year study period. The majority of patients had a baseline International Normalized Ratio (INR) of >2, underwent emergency neurosurgical procedures, and had an intracranial hemorrhage. All guideline criteria for indication and approval were followed for 48 patients. Eighty-seven patients received concomitant treatment for reversal of anticoagulation. A significant correction in the baseline INR after administration of factor VIIa (recombinant) was noted (p < 0.0001). Five patients experienced adverse events. Implementation of the guidelines decreased the annual cost of factor VIIa (recombinant) by 46%. CONCLUSION: A protocol calling for administration of factor VIIa (recombinant) 40 microg/kg in nonhemophilic patients with coagulopathy and ICH led to a rapid and significant decrease in the INR, allowing for emergency surgical intervention. Few adverse events were detected in these patients, and none were deemed to be directly related to factor VIIa (recombinant).

Training and recruiting future pharmacists through a hospital-based student internship program.

PURPOSE: A hospital-based pharmacy internship program is described. SUMMARY: The University of Pittsburgh Medical Center (UPMC) is a 19-hospital partnership affiliated with the University of Pittsburgh Schools of the Health Sciences, serving over 4 million patients per year through its community and teaching hospitals, community care programs, and managed care insurance product. UPMC created a structured pharmacy internship program that provides students with the skills to prepare them for future employment in a hospital or institutional pharmacy setting and creates a hiring and benefits infrastructure focused on student retention after graduation. During the first year of the internship, the training for the student pharmacist focuses on hands-on learning in hospital pharmacy operations. Subsequent years provide the opportunity to learn from pharmacists in a variety of practice sites, training side by side and working on a project with a pharmacist in a specialty area of the student's choice. A pathway of sequential job classifications with increasing salary and the advantage of accruing years of service with UPMC was established through administrative approval. Additional financial incentives offer encouragement for students to accept pharmacist positions at UPMC after graduation. Since the internship's inception in 2004, eight interns have completed the program. Of these, four are employed by UPMC as hospital pharmacists, and another is completing a postgraduate year 1 residency at UPMC. CONCLUSION: A four-year, structured pharmacy internship program at UPMC provided students with early experience in hospital pharmacy practice and resulted in successful training and retention of the interns as pharmacists at UPMC.

Formulary decisions for pre-1938 medications.

PURPOSE: A process is described for formulary revisions consistent with the Food and Drug Administration (FDA)'s current initiative to ensure that all drugs marketed in the United States have been approved for safety and efficacy. SUMMARY: A list of pre-1938 drugs (i.e., formulations marketed before the Federal Food, Drug, and Cosmetic Act established safety requirements) was compiled from USP DI Volume III and International Journal of Pharmaceutical Compounding lists. Products on the resulting list were reviewed for current marketing and FDA approval status and for availability. The project team recommended formulary addition or retention if a product had been used and been purchased more than once at the hospital in the past year, if no formulary alternative was available, or if the product had been approved by FDA. Nonformulary status was recommended if none of these criteria applied or the product was no longer available. Of 88 pre-1938 formulations of 59 drugs, only 3 had been approved by FDA before 1962 (when evidence of efficacy was first required) and 14 thereafter. Of the 88 formulations, 47 were on the hospital's formulary. The team recommended that 37 formulations be retained on or added to the formulary and that 51 be maintained or designated as nonformulary. The hospital's pharmacy and therapeutics (P&T) committee accepted the recommendations, provided that the 30 nonapproved formulations recommended for formulary status be reviewed as FDA continues its effort to have manufacturers either apply for approval of their products or remove them from the market. The recommendations were also accepted by the health system's P&T committee. CONCLUSION: A systematic approach to reviewing pre-1938 medications for the purpose of formulary revision was successful in addressing safety concerns about these older drug formulations.

Use of lipid emulsion to reverse local anesthetic-induced toxicity.

OBJECTIVE: To evaluate the use of lipid emulsion for reversal of local anesthetic-induced toxicity. DATA SOURCES: Literature was accessed through PubMed and OVID (1966-May 2007) using the search terms lipid emulsion and local anesthetic. Reference lists were consulted to identify additional publications. STUDY SELECTION AND DATA EXTRACTION: All articles published in English were evaluated for inclusion. Publications describing the use of lipid emulsion for reversal of local anesthetic in either humans or animals were included. DATA SYNTHESIS: It has been suggested that lipid emulsion (Intralipid) may reverse local anesthetic toxicity by extracting lipophilic local anesthetics from aqueous plasma or tissues or by counteracting local anesthetic inhibition of myocardial fatty acid oxygenation. Studies in rats and dogs have shown that lipid emulsion is effective in resuscitating animals who are asystolic after the administration of intravenous bupivacaine. Three case reports support the use of lipid emulsion to reverse systemic toxicity, including seizures, electrocardiogram abnormalities, and cardiac arrest, resulting from the administration of levobupivacaine, ropivacaine, bupivacaine, or mepivacaine. The regimens used in these cases consisted of bolus doses of 1.2-2 mL/kg followed by continuous infusions of 0.25-0.5 mL/kg/min. All of the patients recovered fully with no neurologic sequelae. CONCLUSIONS: Literature describing animal studies and human case reports suggests that lipid emulsion is effective in the reversal of local anesthetic toxicity. The potential risks of administering the relatively high doses of this agent are uncertain, and the optimal dose has not been established. In light of these uncertainties, it is appropriate to administer lipid emulsion only after advanced cardiac life support has failed and prior to cardiopulmonary bypass.

Eliminating postoperative nausea and vomiting in outpatient surgery with multimodal strategies including low doses of nonsedating, off-patent antiemetics: is "zero tolerance" achievable?

For ondansetron, dexamethasone, and droperidol (when used for prophylaxis), each is estimated to reduce risk of postoperative nausea and/or vomiting (PONV) by approximately 25%. Current consensus guidelines denote that patients with 0-1 risk factors still have a 10-20% risk of encountering PONV, but do not yet advocate routine prophylaxis for all patients with 10-20% risk. In ambulatory surgery, however, multimodal prophylaxis has gained favor, and our previously published experience with routine prophylaxis has yielded PONV rates below 10%. We now propose a "zero-tolerance" antiemetic algorithm for outpatients that involves routine prophylaxis by first avoiding volatile agents and opioids to the extent possible, using locoregional anesthesia, multimodal analgesia, and low doses of three nonsedating off-patent antiemetics. Routine oral administration (immediately on arrival to the ambulatory surgery suite) of perphenazine 8 mg (antidopaminergic) or cyclizine 50 mg (antihistamine), is followed by dexamethasone 4 mg i.v. after anesthesia induction (dexamethasone is avoided in diabetic patients). At the end of surgery, ondansetron (4 mg i.v., now off-patent) is added. Rescue therapy consists of avoiding unnecessary repeat doses of drugs acting by the same mechanism: haloperidol 2 mg i.v. (antidopaminergic) is prescribed for patients pretreated with cyclizine or promethazine 6.25 mg i.v. (antihistamine) for patients having been pretreated with perphenazine. If available, a consultation for therapeutic acupuncture procedure is ordered. Our approach toward "zero tolerance" of PONV emphasizes liberal identification of and prophylaxis against common risks.

Routine multimodal antiemesis including low-dose perphenazine in an ambulatory surgery unit of a university hospital: a 10-year history. Supplement to: Eliminating postoperative nausea and vomiting in outpatient surgery with multimodal strategies including low doses of nonsedating, off-patent antiemetics: is "zero tolerance" achievable?

For 10 years, we have used intravenous and oral perphenazine as part of a multimodal antiemetic prophylaxis care plan for at least 10,000 outpatients. We have never encountered an adverse event, to our knowledge, when the intravenous dose was less than or equal to 2 mg, or when the single preoperative oral dose did not exceed 8 mg (with no repeated dosing). As a single-dose component of multimodal antiemetic prophylaxis therapy, we believe that this track record of anecdotal safety in adults who meet certain criteria (age 14-70, no less than 45 kg, no history of extrapyramidal reactions or of Parkinson disease, and no Class III antidysrhythmic coadministered for coexisting disease) constitutes a sufficient patient safety basis for formal prospective study. We believe that future perphenazine studies should include routine coadministration with prospectively established multimodal antiemetics (i.e., dexamethasone and a 5-HT3 antagonist). In settings where droperidol is still routinely used and deemed acceptable by local scientific ethics committees, we believe that oral perphenazine 8 mg should be compared head to head with droperidol 0.625-1.25 mg in patients receiving coadministered dexamethasone and 5-HT3 antagonists in order to determine differences in synergistic efficacy, if any. Similar trials should be performed, individually evaluating cyclizine, transdermal scopolamine, and aprepitant in combination with coadministered dexamethasone and a 5-HT3 antagonist. Such studies should also quantify efficacy in preventing nausea and vomiting after discharge home, and also quantify the extent to which the prophylaxis plans reduce postanesthesia care unit (PACU) requirements (i.e., increase PACU bypass), reduce the need for any nursing interventions for postoperative nausea and/or vomiting (PONV), and influence the extent to which any variable costs of postoperative nursing care are reduced.

A model for supporting and training clinical pharmaceutical scientist PhD students.

OBJECTIVES: To enhance the clinical training and financial support of graduate students in a Clinical Pharmaceutical Scientist PhD Program at the University of Pittsburgh School of Pharmacy. DESIGN: The School of Pharmacy and University of Pittsburgh Medical Center entered into a collaborative agreement to develop the Clinical Scientist Associate (CSA) program, as well as financially support students enrolled in a Pharmaceutical Sciences PhD program. These clinical training experiences are in addition to the didactic and laboratory experiences in the pharmaceutical sciences graduate program. ASSESSMENT: Since 2002, three students have participated as CSAs, simultaneously working on their graduate research and meeting the requirements of the CSA program. CONCLUSIONS: The CSA program is a novel model for clinical training and support of post-PharmD graduate students enrolled in a PhD clinical pharmaceutical scientist program.

Designing and implementing a hospital-based vaccine standing orders program.

PURPOSE: An inpatient pneumococcal polysaccharide vaccine (PPV) vaccination program was designed and implemented to meet federal and state regulatory requirements and national vaccination goals. SUMMARY: In 2002, the Centers for Medicare and Medicaid Services published a final rule removing the federal requirement for an individual patient physician-signed order for the pneumococcal and influenza vaccines in Medicare- and Medicaid- participating hospitals. This statute authorized implementation of standing orders programs (SOPs) in health care institutions. At the University of Pittsburgh Medical Center-Presbyterian (UPMC-P), institutional vaccination rates and the existing mechanism for providing adult vaccinations were evaluated. At the peak of the program's effectiveness in 2000, in-hospital total vaccination rates were 31%; those rates fell to 15% by the end of 2003. To rectify this poor rate of vaccination, a multidisciplinary team convened to evaluate the existing program and to design the tools and processes for a conversion to a vaccine SOP. A standing order form was designed, and it was determined that the SOP should be pharmacy driven. As a result of the SOP, the PPV vaccination rate increased dramatically; in 2005, the average rate was 69%, with the highest rate occurring in March 2005 (87%). CONCLUSION: The cooperative effort of a multidisciplinary work group including physicians, nursing staff, and pharmacy personnel led to the creation of a successful inpatient PPV SOP. Analysis of the previous vaccination program and careful planning were instrumental in designing the SOP. Defined responsibilities for daily performance and user-friendly tools with clear instructions were also crucial to the success of the program.

Role of student pharmacist interns in hospital-based standing orders pneumococcal vaccination program.

OBJECTIVE: To describe the role of student pharmacist interns in supporting a standing orders program (SOP) for pneumococcal polysaccharide vaccination in hospitalized patients. SETTING: University of Pittsburgh Medical Center (UPMC) Presbyterian, an academic teaching hospital in Pittsburgh. PRACTICE DESCRIPTION: The hospital-based Drug Use and Disease State Management (DUDSM) program designs, implements, and promotes evidence-based practice guidelines to ensure safe and cost-effective drug therapy. PRACTICE INNOVATION/INTERVENTIONS: Paid student pharmacist interns provide manpower for screening and maintaining the vaccination SOP. Student preparation includes classroom learning about immunization concepts, on-site SOP workflow training, and direct patient care activities. Students participate in the vaccination SOP by (1) screening daily admissions through computerized information systems, (2) reviewing databases for documented prior vaccination, (3) completing preprinted orders for pharmacists, (4) inserting orders into patient charts, (5) checking vaccine administration, (6) educating nurses, and (7) managing the databases. Pharmacists verify and sign vaccine orders. Nurses obtain patient history and consent and administer vaccines. MAIN OUTCOME MEASURES: Hospital vaccination rates as determined monthly for quality improvement reporting, and student time required to complete SOP functions. RESULTS: In 2005, an average monthly vaccination rate of 70% for hospitalized elderly was achieved by this inpatient SOP, with the highest rate (89%) occurring in March. On average, 800 patients were screened each month, with 480 vaccine orders placed into patient charts. CONCLUSION: A vaccination SOP is resource-intensive and requires a diligent effort from qualified personnel. In our institution, trained student interns in the DUDSM program perform the necessary daily functions, such as patient screening, that are instrumental in maintaining the SOP.

Clinical outcomes of intravenous immune globulin in severe clostridium difficile-associated diarrhea.

OBJECTIVES: Our objective was to determine if use of intravenous immune globulin (IVIG) decreases the incidence of mortality, colectomies, and length of stay in the hospital in patients presenting with severe Clostridium difficile-associated diarrhea (CDAD). METHODS: A retrospective analysis was undertaken of 79 patients who had a positive C. difficile toxin titer and severe disease admitted to the University of Pittsburgh Medical Center Presbyterian between July 2001 and July 2003. Standard therapy for severe CDAD including intravenous metronidazole, oral vancomycin, or vancomycin enema was administered to all patients. Eighteen patients also received IVIG treatment (200-300 mg/kg); these were pair matched by propensity scoring with 18 patients who had the most similar characteristics and severity of CDAD from the available pool of 61 subjects who did not receive IVIG treatment. RESULTS: No significant difference was observed in the baseline characteristics between the two groups. There were no statistical differences in clinical outcomes as measured by all cause mortality, colectomies, and length of stay. CONCLUSIONS: These data demonstrate that the use of IVIG in severe CDAD remains unsubstantiated. This study, although limited by a small sample size, does not support the use of IVIG at this dose for severe CDAD outside of a controlled trial.