Darren M. Triller

Gemifloxacin: A New Fluoroquinolone Approved for Treatment of Respiratory Infections

OBJECTIVE: To evaluate the microbiology, pharmacokinetic parameters, drug interactions, and results of the available clinical trials of gemifloxacin for the treatment of community-acquired pneumonia (CAP) and acute exacerbation of chronic bronchitis (AECB). DATA SOURCES: MEDLINE (1966–September 2003) was searched for primary and review articles. Data from the manufacturer were also included. Key words included adverse effects, clinical trials, drug interactions, gemifloxacin, and pharmacokinetic parameters. STUDY SELECTION AND DATA EXTRACTION: All articles and product labeling concerning gemifloxacin, a fluoroquinolone antibiotic recently approved by the Food and Drug Administration for treatment of CAP and AECB, were included for review. DATA SYNTHESIS: Compared with currently available fluoroquinolones, gemifloxacin demonstrated improved in vitro activity against Streptococcus pneumoniae (minimum inhibitory concentration for 90% eradication 0.03 μg/mL) and similar activity against gram-negative respiratory pathogens (Haemophilus influenzae, Moraxella catarrhalis) and atypical pathogens such as Chlamydia pneumoniae, Legionella pneumophila, and Mycoplasma pneumoniae. Gemifloxacin, consistent with other available fluoroquinolones, has insufficient activity against methicillin-resistant Staphylococcus aureus to allow clinical use for such infections. Gemifloxacin has adequate bioavailability and a favorable drug interaction profile. Gemifloxacin was comparable to commonly employed nonfluoroquinolone regimens for treatment of CAP and AECB, although the studies were designed to demonstrate equivalence. Gemifloxacin once daily for 5–7 days was well tolerated in controlled and uncontrolled clinical studies. Available clinical data, however, are insufficient to draw clinical or toxicologic distinctions between gemifloxacin and other fluoroquinolones. CONCLUSIONS: Gemifloxacin may be a suitable choice for empiric treatment of CAP or AECB. However, due to the significant history of fluoroquinolone-induced hepatic failure and dermatologic complications, the use of this drug should be closely monitored.

Survey of Herbal Retailers

The use of alternative medical therapies has increased greatly over recent years. We conducted a survey of over one hundred local pharmacists and non-pharmacist retailers of health food products (NPRs) to assess pharmacy and pharmacist involvement in the sale of herbal products. Nearly all pharmacies sold herbal products, but only 2.1% of pharmacists reported training specific to herbal therapy. Pharmacists were more likely to recommend an herbal preparation to a customer than to actually use the product, and few pharmacists routinely informed their customers of potential adverse effects. Pharmacies are dedicated to the sale of herbal preparations, but pharmacists lack significant training in the area, raising questions about their ability to provide adequate patient service.

Features of Electronic Health Records Necessary for the Delivery of Optimized Anticoagulant Therapy Consensus of the EHR Task Force of the New York State Anticoagulation Coalition

Background: Oral anticoagulants are prescribed to millions of Americans, and consequently are among the medications most likely to contribute to emergency department visits and hospitalizations. Although guidelines and consensus statements promote systematic approaches to therapy, anticoagulation (AC) management is often suboptimal. Electronic health records (EHRs) have the potential to improve safety and quality but have not yet incorporated specialized features necessary to optimize therapy. Objective: To generate a comprehensive, consensus-based list of EHR features clinically necessary to deliver optimized AC management, provide a “language bridge” to accelerate incorporation of features into EHR systems, and suggest mechanisms for the objective evaluation of available EHRs. Methods: A multidisciplinary panel of AC specialists utilized the framework of a previously published consensus statement to map outpatient AC management and developed a comprehensive array of sequential computer logic steps using a restricted language scheme. Logic steps were then translated into narrative descriptions of potential EHR features, which were refined through multiple group evaluations. A finalized list of proposed features was ranked according to perceived clinical necessity by physician, pharmacist, and nurse panelists in a blinded manner using a 5-point Likert scale. Features receiving no more than 1 dissenting opinion were included in a finalized list of clinically necessary features. Results: The task force generated 78 recommended EHR features across 20 key discrete areas and 425 individual logic steps. All recommended features received Strongly Agree or Agree rankings regarding their perceived clinical necessity, and no feature received more than a single Disagree response. Conclusion: The incorporation of key AC-related features into existing EHRs or specialized AC management systems has the potential to systematize the delivery of optimal AC care by health care professionals at the point of care. Optimized AC management has the potential to reduce adverse drug events associated with anticoagulant therapy in the outpatient setting.

Medication management model as experiential education tool for students of pharmacy.

SUMMARY A visiting nurse association (VNA) and a college of pharmacy sought cost-effective models by which consultant pharmacy services could be offered at a rural branch office to improve medication management for high-risk patients. Through a collaborative relationship with the Albany College of Pharmacy, the Eddy VNA used the structure and support of the Partners in Care Foundation (The Model) Medication Management Model to simultaneously provide patient services and train Doctor of Pharmacy candidates. The Model brings the pharmacist into the homecare team to provide pharmaceutical care and can provide the framework by which pharmacist preceptors and interns can effectively provide services to high-risk patients identified through the agencys CQI process. Results from program implementation with 100 Medicaid waiver patients indicate positive staff response and an overall 43% acceptance rate with prescribers and suggest that this is a cost-effective medication management service with implications for adaptation by other HHAs.

Defining Minimum Necessary Anticoagulation-Related Communication at Discharge: Consensus of the Care Transitions Task Force of the New York State Anticoagulation Coalition

BACKGROUND Anticoagulated patients are particularly vulnerable to ADEs when they experience changes in medical acuity, pharmacotherapy, or care setting, and resources guiding care transitions are lacking. The New York State Anticoagulation Coalition convened a task force to develop a consensus list of requisite data elements (RDEs) that should accompany all anticoagulated patients undergoing care transitions. METHODS A multidisciplinary panel of 15 anticoagulation experts voluntarily completed an iterative Delphi process. Resources were disseminated and deliberated via remote technology, with consensus achieved via blinded electronic polling. RESULTS The panel reached consensus on a list of 15 RDEs for anticoagulation communication at discharge (the ACDC List). Consensus was rapidly achieved by the full panel on 13 elements, while 3 (2 of which were combined into 1 element) required multiple iterations and achieved consensus with votes from 8 available panelists. The elements encompassed a range of factors, including drug use and indications, previous exposure and duration of therapy, recent drug exposure and laboratory results and expectations for subsequent administration, therapy goals, patient education and comprehension, and expectations for clinical management. Twelve of the elements are applicable to any anticoagulant, and 3 are specific to warfarin. CONCLUSION The ACDC List identifies specific pieces of clinical information that a panel of anticoagulant experts agree should be communicated to downstream providers for all anticoagulated patients undergoing care transitions. Additional study is needed to objectively evaluate the ability of existing care systems to communicate the elements and to assess possible relationships between communication of the elements and clinical outcomes.