The use of fidaxomicin for treatment of relapsed Clostridium difficile infections in patients with cancer.

OBJECTIVES: To report our experience with the use of fidaxomicin (FDX), an oral macrocyclic antibiotic, in cancer patients with Clostridium difficile infection (CDI). METHODS: A single-center retrospective case series was conducted at The University of Texas MD Anderson Cancer Center. Patients with CDI treated with FDX from May 2011 to January 2013 were identified via the pharmacy database. Clinical response and recurrence after FDX initiation were evaluated. RESULTS: Twenty-two patients were included, most of whom were male (55%) with a mean age of 58 years (range: 20-83 yrs). The most common underlying malignancies were nine patients with lymphoma (41%), seven with leukemia (32%), and six with solid tumors (27%). Indications for FDX included recurrent CDI in 16 patients (72%) and failure of both metronidazole and oral vancomycin in 6 patients (28%). Nineteen patients (86%) were on concomitant antimicrobials during CDI treatment. Clinical response to FDX was 91%, and overall sustained clinical response was 82%. FDX was well tolerated with no major adverse events that were FDX related or discontinuations due to drug-related adverse events. CONCLUSION: In cancer patients, FDX is effective treatment for the first episode of CDI after failure of standard therapies and treatment of recurrent CDI. This was interesting given the large number of high-risk patients who continued to receive concomitant antimicrobial therapy, which is common in this immunocompromised patient population.

A clinician's guide to systematic reviews.

The purpose of this article is to discuss systematic reviews, how they are performed, and their associated strengths and limitations. A systematic review is an assessment of evidence involving exact methods to systematically identify, select, and critically evaluate all available literature on a particular topic. Unlike most narrative reviews, systematic reviews have defined methods established a priori for searching, evaluating, extracting, synthesizing, and reporting available evidence. Key characteristics differentiating systematic reviews from most narrative reviews include: clearly stated objectives, pre-defined inclusion/exclusion criteria, an explicit reproducible methodology, systematic exhaustive searches to identify all sources of evidence, an assessment of the validity for each included study, and a systematic presentation of the study characteristics/results. Though there are significant advantages to systematic reviews, there are also clear limitations such as: the quality of included evidence; heterogeneity and homogeneity of included studies; and publication bias. Even with these limitations, systematic reviews are beneficial to front line clinicians when the quantity of evidence is so substantial that reviewing and synthesizing it is not feasible, available evidence is conflicting, or when the robustness of available evidence is unknown.

Improving Pediatric Adverse Drug Event Reporting through Clinical Pharmacy Services.

OBJECTIVES: The purpose of this study was to summarize adverse drug event (ADE) reporting and to characterize the type of healthcare practitioners involved in reporting over a 10-year period at a 120-bed university-affiliated children's hospital. METHODS: The University of Virginia Children's Hospital ADE database was analyzed for records involving pediatric patients. Data from patients <18 years of age who were admitted to the University of Virginia Children's Hospital between January 1, 2000, and December 31, 2009, were analyzed. Data collected included drug name and therapeutic class of the suspected causative agent, description of the event, severity, causality, outcome, and the type of healthcare practitioner reporting the event. RESULTS: A total of 863 ADEs were reported over the 10-year period. The 5 most common types reported were extravasation injury (10%), rash (8%), hypotension (5%), pruritus (5%), and renal failure (3%). A total of 196 (21%) cases were categorized as mild, 436 (47%) cases as moderate, and 296 (32%) cases as severe. Further characterization of extravasations was performed to identify trends relating to potential causes. In 45 (57%) reports, parenteral nutrition was identified as the causative agent. Full recovery was documented in 21 (47%) extravasations. Of the total events reported, 83% were reported by pharmacists, 16% by nurses, and <1% by other healthcare practitioners. CONCLUSIONS: Results of this study are consistent with those of previous studies involving ADE reporting in children's hospitals. This consistency is due in part to system design and use of unit-based pharmacists as the primary reporters.