Follow-up assessment of a faculty peer observation and evaluation program.

OBJECTIVE: To assess a previously described peer observation and evaluation program 2 years after implementation. METHODS: An pre-implementation survey assessed faculty needs and attitudes related to peer evaluation. Two years after implementation, the survey was repeated and additional questions asked regarding adherence to peer observation and evaluation policies and procedures, feedback received, and impact on teaching. RESULTS: Faculty attitudes towards peer evaluation stayed the same or improved post-implementation. Adherence to the initial 3 steps of the process was high (100%, 100%, and 94%, respectively); however, step 4, which required a final discussion after student assessments were finished, was completed by only 47% of the respondents. All faculty members reported receiving a balance of positive and constructive feedback; 78% agreed that peer observation and evaluation gave them concrete suggestions for improving their teaching; and 89% felt that the benefits of peer observation and evaluation outweighed the effort of participating. CONCLUSIONS: Faculty members adhered to the policies and procedures of peer observation and evaluation and found peer feedback was beneficial.

Fidaxomicin: the newest addition to the armamentarium against Clostridium difficile infections.

BACKGROUND: Fidaxomicin, a macrolide antibiotic, was the first medication for the management of Clostridium difficile infections (CDI) to be approved by the US Food and Drug Administration in more than 20 years. OBJECTIVE: This article reviews published literature on fidaxomicin for management of CDI, including its chemistry, spectrum of activity, pharmacokinetic properties, pharmacodynamics, therapeutic efficacy, adverse events, dosing, administration, and pharmacoeconomic considerations. METHODS: Pertinent English-language literature was reviewed through searches of MEDLINE, EMBASE, and BIOSIS from 1975 through September 2011. Reference lists of identified publications and published abstracts from the Interscience Conference on Antimicrobial Agents and Chemotherapy meetings were also reviewed. Search terms included, but were not limited to, fidaxomicin, difimicin, lipiarmycin, tiacumicin B, OPT-80, Clostridium spp, and diarrhea. RESULTS: A total of 79 publications were identified and 10 were excluded; 6 review articles and 4 abstracts that were later published as articles. Fidaxomicin's in vitro profile is favorable compared with oral metronidazole and vancomycin, with minimum inhibitory concentrations against C difficile that are 2 dilutions lower. From the 2 published Phase III trials, fidaxomicin was deemed to be noninferior in the treatment of mild to moderate CDI compared with oral vancomycin. Recurrence rates for all strains of CDI were lower with fidaxomicin than vancomycin. Adverse events associated with fidaxomicin were similar to placebo, with nausea and vomiting being the most common. Although no pharmacoeconomic studies have compared fidaxomicin with metronidazole or vancomycin, the current price exceeds $2500 (US) per treatment course. CONCLUSIONS: Reports suggest that fidaxomicin is noninferior to oral vancomycin in the treatment of mild or moderate CDI, although no published comparisons with metronidazole exist to date. Additionally, fidaxomicin improved outcomes compared with oral vancomycin in terms of rates of relapse and recurrent CDI, and in patients who might require concomitant antibiotics. Prospective, randomized studies comparing fidaxomicin with metronidazole in the treatment of mild or moderate CDI, as well as against vancomycin for severe CDI, should be undertaken to clarify the exact role of fidaxomicin in clinical practice.

Doripenem monohydrate, a broad-spectrum carbapenem antibiotic.

BACKGROUND: Doripenem monohydrate, a broad-spectrum carbapenem antibiotic, has been approved by the US Food and Drug Administration for the treatment of complicated intra-abdominal infections (cIAIs) and complicated urinary tract infections (cUTIs). OBJECTIVE: This article reviews available information on doripenem in the management of patients with complicated bacterial infections, including its chemistry, spectrum of activity, resistance mechanisms, pharmacokinetics, pharmacodynamics, drug interactions, therapeutic efficacy, tolerability, and dosing and administration. Also discussed are pharmacoeconomic considerations associated with doripenem. METHODS: Pertinent English-language literature was identified from searches of MEDLINE (1996-October 2008) and BIOSIS (1993-October 2008). Search terms included, but were not limited to, doripenem, S-4661, spectrum of activity, resistance, pharmacology, pharmacokinetics, pharmacodynamics, adverse events, and therapeutic use. Additional publications were found by searching the reference lists of identified articles and reviewing abstracts from meetings of the Interscience Conference on Antimicrobial Agents and Chemotherapy (2003-2007). RESULTS: Doripenem is a parenteral carbapenem antibiotic with in vitro activity against gram-positive, gram-negative, and anaerobic organisms. It is stable against a wide variety of beta-lactamases, including extended-spectrum and AmpC beta-lactamases; it is, however, inactivated by organisms that produce class A enzymes, KPC enzymes, class B metallo-beta-lactamases, and class D enzymes. Doripenem is eliminated primarily in the urine (68%-80% unchanged). It should be used cautiously in patients receiving valproic acid, as combined use may lead to a precipitous decline in serum concentrations of valproic acid. A large Phase III study in the treatment of cIAIs found doripenem noninferior to meropenem (clinical cure rates, 83.9% and 85.9%, respectively; difference, -2.1; 95% CI, -9.8 to 5.6). A Phase III study in the treatment of cIAIs, including pyelonephritis, found doripenem non-inferior to levofloxacin (clinical cure rates, 95.1% and 90.2%, respectively; 95% CI, 0.2 to 9.6). With respect to the treatment of nosocomial pneumonia, one Phase III study found doripenem noninferior to imipenem (clinical cure rates, 68.3% and 64.8%, respectively; difference, 3.5%; 95% CI, -9.1 to 16.1), and another found it noninferior to piperacillin/tazobactam (clinical cure rates, 81.3% and 79.8%, respectively; difference, 1.5%; 95% CI, -9.1 to 12.1). Adverse events with doripenem were similar to those of other antibiotics with which it has been compared. Adverse events in clinical trials of doripenem have included anaphylaxis and rash (l%-5%), gastrointestinal effects (25%-32%, including nausea [1.1%-12.0%], diarrhea [1.9%-11.0%], and vomiting [1.5%-6.6%]), and central nervous system effects (headache [2.1%-16.0%], insomnia [3.7%], anxiety [2.9%], and, rarely, seizures). CONCLUSIONS: In Phase III studies, doripenem was noninferior to meropenem in the treatment of cIAIs; noninferior to levofloxacin in the treatment of cUTIs; and noninferior to imipenem and piperacillin/tazobactam in the treatment of nosocomial pneumonia. As with all new antibiotics, because of the risk of selecting for resistant organisms, use of doripenem should be reserved for infections in which a multidrug-resistant gram-negative organism, polymicrobial infection, or Pseudomonas aeruginosa is suspected.

Development of a peer teaching-assessment program and a peer observation and evaluation tool.

OBJECTIVES: To develop a formalized, comprehensive, peer-driven teaching assessment program and a valid and reliable assessment tool. METHODS: A volunteer taskforce was formed and a peer-assessment program was developed using a multistep, sequential approach and the Peer Observation and Evaluation Tool (POET). A pilot study was conducted to evaluate the efficiency and practicality of the process and to establish interrater reliability of the tool. Intra-class correlation coefficients (ICC) were calculated. RESULTS: ICCs for 8 separate lectures evaluated by 2-3 observers ranged from 0.66 to 0.97, indicating good interrater reliability of the tool. CONCLUSION: Our peer assessment program for large classroom teaching, which includes a valid and reliable evaluation tool, is comprehensive, feasible, and can be adopted by other schools of pharmacy.

Peginterferon alfa-2a: a review of approved and investigational uses.

BACKGROUND: In October 2002, the US Food and Drug Administration approved peginterferon alfa-2a for the management of chronic hepatitis C virus (HCV) infection. The addition of polyethylene glycol (PEG) moiety to the interferon (IFN) molecule results in a product with altered pharmacokinetic properties. OBJECTIVE: The aim of this article is to review the pharmacology, medications interactions, adverse events (AEs), and approved or investigational uses of PEG-IFN alfa-2a for viral hepatitis and oncologic conditions. METHODS: Relevant articles were identified through searches of MEDLINE (1980-July 2003) and EMBASE (1980-July 2003). Search terms included, but were not limited to, peginterferon alfa-2a, pharmacokinetics, pharmacology, pharmacodynamics, and therapeutic use, as well as terms for specific disease states and AEs. Further publications were identified from citations of resulting papers. RESULTS: Pegylation of IFN alfa-2a results in major changes in the pharmacokinetics of the product. Absorption is prolonged and serum concentrations are sustained over the dosing regimen. PEG-IFN alfa-2a has been shown to be more effective with or without ribavirin (RBV), in the management of treatment-naive patients with chronic HCV infection, than unmodified IFN alfa-2a with or without RBV. Results in other disease states are still preliminary. AEs are similar, in incidence and severity, to those occurring with unmodified IFN. They include earlier hematologic symptoms and fewer influenza-like symptoms. Drug-drug interactions are the same as those occurring with the unmodified IFN product. CONCLUSIONS: The pharmacokinetic profile of IFN alfa-2a is improved by pegylation, which enables less frequent administration and results in improved efficacy with a similar side-effect profile. Combination of PEG-IFN alfa-2a with RBV is associated with a greater chance of achieving a sustained virologic response in treatment-naive patients with chronic HCV, compared with unmodified IFN alfa-2a/RBV combinations. Documentation of efficacy in other conditions awaits results of controlled clinical trials.