Implementation of a Cardiac Transitions of Care Pilot Program: A Prospective Study of Inpatient and Outpatient Clinical Pharmacy Services for Patients With Heart Failure Exacerbation or Acute Myocardial Infarction.

BACKGROUND:: Pharmacists may assist with reducing 30-day readmission rates for patients with heart failure (HF) exacerbation or acute myocardial infarction (AMI) by promoting medication adherence. OBJECTIVE:: To determine the change in 30-day readmission rates for patients with HF exacerbation or AMI after implementation of a "high-touch" standard of care. METHODS:: Patients admitted with HF exacerbation, non-ST-segment elevation AMI, or ST-segment elevation AMI from August 1, 2013, to June 30, 2015, were included in this prospective study. Patients were educated while in the inpatient setting and followed up in the outpatient setting through telephone contact and scheduling a medication therapy management (MTM) appointment with a pharmacist. Data were collected by pharmacy personnel involved in the implementation of the intervention. RESULTS:: Within the HF and AMI arms, 100 and 93 patients, respectively, were included in the study. The 30-day readmission rates were 24% and 17.2% for HF and AMI, respectively, which were not statistically significant when compared to historical institutional readmission rates prior to study initiation (18.2% for HF, P = .238; 11.4% for AMI, P = .252). CONCLUSION:: A "high-touch" pharmacist-driven transitions of care program may affect 30-day readmission rates for patients with HF exacerbation or AMI; potential processes for initiating transitions of care programs are provided.

Conversion of calibration curves for accurate estimation of molecular weight averages and distributions of polyether polyols by conventional size exclusion chromatography.

Accurate measurement of molecular weight averages (M¯n,M¯w,M¯z) and molecular weight distributions (MWD) of polyether polyols by conventional SEC (size exclusion chromatography) is not as straightforward as it would appear. Conventional calibration with polystyrene (PS) standards can only provide PS apparent molecular weights which do not provide accurate estimates of polyol molecular weights. Using polyethylene oxide/polyethylene glycol (PEO/PEG) for molecular weight calibration could improve the accuracy, but the retention behavior of PEO/PEG is not stable in THF-based (tetrahydrofuran) SEC systems. In this work, two approaches for calibration curve conversion with narrow PS and polyol molecular weight standards were developed. Equations to convert PS-apparent molecular weight to polyol-apparent molecular weight were developed using both a rigorous mathematical analysis and graphical plot regression method. The conversion equations obtained by the two approaches were in good agreement. Factors influencing the conversion equation were investigated. It was concluded that the separation conditions such as column batch and operating temperature did not have significant impact on the conversion coefficients and a universal conversion equation could be obtained. With this conversion equation, more accurate estimates of molecular weight averages and MWDs for polyether polyols can be achieved from conventional PS-THF SEC calibration. Moreover, no additional experimentation is required to convert historical PS equivalent data to reasonably accurate molecular weight results.

Inhibiting Sterilization-Induced Oxidation of Large Molecule Therapeutics Packaged in Plastic Parenteral Vials.

For many years, glass has been the default material for parenteral packaging, but the development of advanced plastics such as cyclic olefin polymers and the rapidly increasing importance of biologic drugs have provided new choices, as well as more stringent performance requirements. In particular, many biologics must be stored at non-neutral pH, where glass is susceptible to hydrolysis, metal extraction, and delamination. Plastic containers are not susceptible to these problems, but suffer from higher gas permeability and a propensity for sterilization-induced radical generation, heightening the risk of oxidative damage to sensitive drugs. This study evaluates the properties of a hybrid material, SiOPlas™, in which an ultrathin multilayer coating is applied to the interior of cyclic olefin polymer containers via plasma-enhanced chemical vapor deposition. Our results show that the coating decreases oxygen permeation through the vial walls 33-fold compared to uncoated cyclic olefin polymers, which should allow for improved control of oxygen levels in sensitive formulations. We also measured degradation of two biologic drugs that are known to be sensitive to oxidation, teriparatide and erythropoietin, in gamma and electron beam sterilized SiOPlas™, glass, and uncoated cyclic olefin polymer vials. In both cases, solutions stored in SiOPlas™ vials did not show elevated susceptibility to oxidation compared to either glass or unsterilized controls. Taken together, these results suggest that hybrid materials such as SiOPlas™ are attractive choices for storing high-value biologic drugs.LAY ABSTRACT: One of the most important functions of parenteral drug containers is safeguarding their contents from damage, either chemical or physical. Glass has been the container material of choice for many years, but concerns over breakage and vulnerability to chemical attack at non-neutral pH have spurred the rise of advanced plastics as alternatives. Plastics solve many problems associated with glass but introduce several of their own, including increased gas permeation and generation of oxidizing radicals during sterilization. In this article, we evaluate SiOPlas™, a hybrid material consisting of plastic with a thin multilayer coating applied to the interior, for its ability to overcome these two problems. We find that SiOPlas™ is much less permeable to oxygen than uncoated plastic, and that two biologic drugs stored in gamma and electron beam sterilized SiOPlas™ vials do not display elevated levels of oxidation compared to either glass or unsterilized vials. This suggests that hybrid materials such as SiOPlas™ can exhibit the best qualities of both glass and plastic, making them attractive materials for storing high-value parenteral drugs.

Patient Awareness and Expectations of Pharmacist Services During Hospital Stay.

BACKGROUND: There are insufficient data in the United States regarding patient awareness and expectations of hospital pharmacist availability and services. OBJECTIVE: The objective of this research is to assess patient awareness and expectations of hospital pharmacist services and to determine whether a marketing campaign for pharmacist services increases patient awareness and expectations. METHODS: Eligible inpatients were surveyed before and after implementation of a hospital-wide pharmacist services marketing campaign (12 items; Likert scale of 1 [strongly disagree] to 4 [strongly agree]; maximum total score of 48) regarding awareness of pharmacist services. The primary outcome was the change in median total survey scores from baseline. Other outcomes included the frequency of patient requests for pharmacists. RESULTS: Similar numbers of patients completed the survey before and after the campaign (intervention, n = 140, vs control, n = 147). Awareness of pharmacist availability and services was increased (41 [interquartile ranges, IQRs: 36-46] vs 37 [IQR 31-43]; P < .001). Patients were 7 times more likely to request a pharmacist following the marketing campaign implementation. CONCLUSION: Awareness among inpatients of pharmacist services is low. Marketing pharmacist availability and services to patients in the hospital improves awareness and expectations for pharmacist-provided care and increases the frequency of patient-initiated interaction between pharmacists and patients. This could improve patient outcomes as pharmacists become more integrally involved in direct patient care.

"Tech-check-tech": a review of the evidence on its safety and benefits.

OBJECTIVE: The published evidence on state-authorized programs permitting final verification of medication orders by pharmacy technicians, including the programs' impact on pharmacist work hours and clinical activities, is reviewed. SUMMARY: Some form of "tech-check-tech" (TCT)--the checking of a technician's order-filling accuracy by another technician rather than a pharmacist--is authorized for use by pharmacies in at least nine states. The results of 11 studies published since 1978 indicate that technicians' accuracy in performing final dispensing checks is very comparable to pharmacists' accuracy (mean ± S.D., 99.6% ± 0.55% versus 99.3% ± 0.68%, respectively). In 6 of those studies, significant differences in accuracy or error detection rates favoring TCT were reported (p < 0.05), although published TCT studies to date have had important limitations. In states with active or pilot TCT programs, pharmacists surveyed have reported that the practice has yielded time savings (estimates range from 10 hours per month to 1 hour per day), enabling them to spend more time providing clinical services. States permitting TCT programs require technicians to complete special training before assuming TCT duties, which are generally limited to restocking automated dispensing machines and filling unit dose batches of refills in hospitals and other institutional settings. CONCLUSION: The published evidence demonstrates that pharmacy technicians can perform as accurately as pharmacists, perhaps more accurately, in the final verification of unit dose orders in institutional settings. Current TCT programs have fairly consistent elements, including the limitation of TCT to institutional settings, advanced education and training requirements for pharmacy technicians, and ongoing quality assurance.

Infectious diseases in the critically ill patients.

Infection is common in the critically ill and often results due to the severity of the patient's illness. Recent data suggest 51% of intensive care unit (ICU) patients are infected, and 71% receive antimicrobial therapy. Bacterial infection is the primary concern, although some fungal infections are opportunistic. Infection more than doubles the ICU mortality rate, and the costs associated with infection may be as high as 40% of total ICU expenditures. There are many contemporary antimicrobial resistance concerns that the critical care clinician must consider in managing the pharmacotherapy of infection. Methicillin resistance in Staphylococcus aureus, vancomycin resistance in Enterococci, beta-lactamase resistance in Enterobacteriaceae, multidrug resistance in Pseudomonas aeruginosa and Acinetobacter species, fluoroquinolone resistance in Escherichia coli, and fungal resistance are among the most common issues ICU clinician's must face in managing infection. Critical illness causes changes in pharmacokinetics that influence drug and dosing considerations. Absorption, distribution, metabolism, and excretion may all be affected by the various disease states that define critical illness. Several specific diseases are discussed, including ventilator-associated pneumonia, various fungal infections, gastrointestinal infections due to Clostridium difficile, urinary tract infections, and bloodstream infections. Within each disease section, discussion includes causes and prevention strategies, microbiology, evidence-based guidelines, and important caveats.

Intravenous to oral conversion of antihypertensives: a toolkit for guideline development.

OBJECTIVE: To provide a toolkit of information for hospitals to use in developing intravenous to oral conversion protocols for antihypertensives. DATA SOURCES: Articles describing intravenous to oral conversion protocols for any therapeutic category were identified in an English-language MEDLINE search (1990-April 2010) using a wide variety of MeSH terms. References from selected articles were reviewed for additional material. STUDY SELECTION AND DATA EXTRACTION: Experimental and observational English-language studies and review articles that focused on oral transition of intravenous drugs were selected. DATA SYNTHESIS: Most of the literature on conversion from intravenous to oral formulations involves antimicrobials. There is considerable evidence documenting reduced costs and improved patient flow through the health-care system following implementing these protocols with drugs like antimicrobials, histamine-2 receptor antagonists, and proton pump inhibitors. Although antihypertensives have not been studied, principles and implementation strategies used for other drug classes can be applied to antihypertensives. Guidance is provided on framing the problem, issues surrounding oral absorption principles, information pertaining to oral conversion in specific disease states, and implementation and documentation strategies. Detailed tables of oral and intravenous antihypertensives are provided. CONCLUSIONS: We recommend that hospitals consider developing protocols on conversion of intravenous to oral antihypertensives in an attempt to reduce unnecessarily prolonged intravenous therapy. Information contained in this article can be used as a toolkit to select information specific to the characteristics of individual health-care systems.

Antimicrobial resistance: consideration as an adverse drug event.

Antimicrobial resistance has increased dramatically in the past 15 to 20 yrs and presents a patient safety concern unlike any other in the intensive care unit. Antimicrobial resistance in critically ill patients increases morbidity, mortality, length of hospital stay, and healthcare costs. Some organisms may have intrinsically high levels of resistance or may be spread between patients by poor infection control practices. However, a major driver of antimicrobial resistance is antibiotic use. As such, the development of antimicrobial resistance can often be thought of as an adverse drug event. This article explores the link between drug use, drug dosing, other selective pressures and resistance, and describes concepts to minimize the negative impact of antimicrobial therapy. Two broad themes of these concepts are minimizing the use of antibiotics whenever possible and optimizing antibiotic usage when they are needed. Strategies for minimizing the use of antimicrobials include using optimal diagnostic procedures to ensure the need for antimicrobials, streamlining or discontinuing therapy when possible based on culture results, and using the shortest duration of therapy needed for documented infections. Strategies for optimizing antimicrobial use include using optimal dosing based on the manufacturer's instructions and current pharmacodynamic data, guiding better prescribing based on local susceptibility patterns and formulary restriction, and avoiding drugs with more propensity to foster resistance.

Implementation of a $4 generic drug program in a 340B pharmacy.

PURPOSE: The implementation of a $4 generic drug program in a 340B pharmacy is described. SUMMARY: The Cordelia Martin Health Center (CMHC) pharmacy operates as part of the Neighborhood Health Association, a federally qualified health center in Toledo, Ohio. Clinic patients have prescription coverage through Medicaid or do not have prescription coverage, and 89% of prescriptions without any form of prescription coverage are for patients whose income is at or below 200% of the federal poverty line. Financial transaction data at CMHC were analyzed to determine the financial viability of a program for $4 generic medications. Once this was determined to be a financially viable option, the $4 lists of mass-merchant pharmacies were obtained, and the drugs from the CMHC formulary that appeared on any of these lists were included on the $4 list of the CMHC pharmacy. A total of 93 medications were included on CMHC's list. The new pricing structure became effective in January 2009. The total number of prescriptions filled at the CMHC pharmacy from January to March 2009 was 7134. For the same three-month period in 2008, 6166 prescriptions were filled. In January-March 2009, the average prescription volume increased by 9 prescriptions per day in January, by 19 prescriptions per day in February, and by 23 prescriptions per day in March, compared with those months in 2008. CONCLUSION: A $4 generic drug program implemented at a 340B pharmacy increased patients' access to medication and increased the pharmacy's prescription volume while contributing to an increase in the pharmacy's net revenue.

Key articles and guidelines relative to intensive care unit pharmacotherapy: 2009 update.

Compilations of key articles and guidelines in a particular clinical practice area are useful not only to clinicians who practice in that area, but also to all clinicians. We compiled pertinent articles and guidelines pertaining to drug therapy in the intensive care setting from the perspective of experienced critical care pharmacists. A broad assembly of practitioners with expertise in various areas of intensive care unit pharmacology were involved in the compilation of this update.

Interprofessional education in six US colleges of pharmacy.

OBJECTIVE: To present and describe interprofessional education (IPE) in 6 US colleges of pharmacy including benefits, barriers, and strategies for implementation. METHODS: A focus group with campus faculty IPE leaders and administrators was conducted at each of the 6 colleges. External facilitators used a structured script with open-ended questions to guide each session. A qualitative approach was used and content analysis of transcripts was conducted. RESULTS: On a 10-point scale, mean participant interest in IPE was 8.8 +/- 1.7. Incentives included enhanced student education, instructional economies of scale, improved communication among disciplines, and promotion of teamwork to improve quality of care. Curricular logistics, limited resources, lack of conceptual support, and cultural issues were the major barriers to IPE. Institutions were at various stages of IPE implementation. Participants emphasized that full institutional support was critical in maintaining IPE programs. CONCLUSION: Interest in IPE was high and opportunities were numerous as described by faculty members at the institutions; however, numerous challenges to implementation were identified.

Clinical and economic outcomes of involving pharmacists in the direct care of critically ill patients with infections.

OBJECTIVE: To determine whether the absence or presence of clinical pharmacists in intensive care units (ICUs) results in differences in mortality rates, length of ICU stay, and ICU charges for Medicare patients with nosocomial-acquired infections, community-acquired infections, and sepsis. DESIGN, SETTING, AND PATIENTS: The type and level of pharmacy services provided to ICUs were obtained from a 2004 national survey. Clinical pharmacy services were defined as having at least a partial pharmacist full-time equivalent specifically devoted to the ICU for the purpose of direct involvement in patient care. Infections were defined using International Classification of Diseases, Ninth Revision, Clinical Modification codes. ICU outcome data were drawn from the 2004 modified Medicare provider analysis and review. Depending on the infection studied, the involvement of clinical pharmacists was evaluated in 8,927-54,042 patients from 265 to 276 hospitals. INTERVENTIONS: None. MEASUREMENTS AND MAIN OUTCOMES: Mortality rates, length of ICU stay, Medicare charges, drug charges, and laboratory charges for each of the infections categorized according to the absence or presence of clinical pharmacists. Compared to ICUs with clinical pharmacists, mortality rates in ICUs that did not have clinical pharmacists were higher by 23.6% (p < 0.001, 386 extra deaths), 16.2% (p = 0.008, 74 extra deaths), and 4.8% (p = 0.008, 211 extra deaths) for nosocomial-acquired infections, community-acquired infections, and sepsis, respectively. Similarly, ICU length of stay was longer by 7.9% (p < 0.001, 14,248 extra days), 5.9% (p = 0.03, 2855 extra days), and 8.1% (p < 0.001, 19,215 extra days) for nosocomial-acquired infections, community-acquired infections, and sepsis, respectively. ICUs that did not have clinical pharmacists had greater total Medicare billings of 12% (p < 0.001, $132,978,807 extra billing charges), 11.9% (p < 0.001, $32,240,378 extra billing charges), and 12.9% (p < 0.001, $224,694,784 extra billing charges) for nosocomial-acquired infections, community-acquired infections, and sepsis, respectively. Similar findings were observed for Medicare drug charges and laboratory charges. CONCLUSION: The involvement of clinical pharmacists in the care of critically ill Medicare patients with infections is associated with improved clinical and economic outcomes. Hospitals should consider employing clinical ICU pharmacists.

Critical care pharmacy services in United States hospitals.

BACKGROUND: Critical care pharmacy activities have been described as fundamental, desirable, and optimal, but actual services provided have not been evaluated. OBJECTIVE: To characterize the type and level of pharmacy services provided to intensive care units (ICUs). METHODS: A 38 question survey was sent in 2 consecutive mailings to all US institutions (N = 3238) with an ICU. Questions were categorized according to clinical, educational, administrative, and scholarly activities, with levels of services stratified as fundamental, desirable, or optimal. RESULTS: Completed surveys were received from 382 (11.8%) institutions encompassing 1034 ICUs. Direct clinical pharmacy activities were provided at 62.2% of ICUs. The pharmacists in those programs attended rounds 4.4 +/- 1.5 days/wk, mean +/- SD, and had a workweek that consisted of patient care (43% of hours worked), drug distribution (26.2%), administration (12.6%), education (10.9%), and scholarly activities (7.3%). Fundamental clinical activities performed during at least 75% of patient ICU days were providing drug information, drug therapy evaluation, drug therapy intervention, and pharmacokinetic monitoring. Conducting in-services (92.8%), a fundamental service, was the only educational activity frequently provided. Most respondents were involved with at least one multidisciplinary committee, and 45.5% conducted scholarly activities. Desirable or optimal activities were not frequently provided across all service categories. CONCLUSIONS: Clinical pharmacists are directly involved as caregivers in nearly two-thirds of ICUs in the US. Although they provide a range of clinical and administrative services, involvement in educational and scholarly activities is variable. The level of services provided is consistent with the criteria deemed fundamental for improving patient care. Higher-order services are far less likely to be provided.

Key articles and guidelines relative to intensive care unit pharmacology--2004.

Compilations of key articles and guidelines in a particular clinical practice area are useful not only to clinicians who practice in that area, but to all clinicians. We compiled pertinent articles and guidelines pertaining to drug therapy in the intensive care setting from the perspective of actively practicing critical care pharmacists. This document differs from the original 2002 version in that a broader assembly of intensive care practitioners was involved in the compilation.

A nationwide survey of physician office visits found that inappropriate antibiotic prescriptions were issued for bacterial respiratory tract infections in ambulatory patients.

OBJECTIVE: Correlations between probabilities of resistance and the frequencies with which antibiotics were prescribed for treating bacterial respiratory infections were examined in a nationwide ambulatory population. STUDY DESIGN AND SETTING: The data of a nationwide probability sample survey of visits to physician offices in the United States in 1999 were used to conduct this study of drug use. A clinical pharmacologist identified antibiotics prescribed during those visits using a large online database. The participating physicians diagnosed the bacterial respiratory infections. An infectious disease expert determined the probabilities of bacterial resistance from a nationwide antibiotic surveillance database. RESULTS: Various bacterial respiratory infections were diagnosed during 6.5% of physician office visits in 1999. One or more antibiotics were prescribed during 51.0% of those visits. The probabilities of resistance to the most frequently prescribed antibiotics varied from 20% to 40% and showed a weak positive correlation with the frequencies of antibiotic prescriptions. CONCLUSION: A significant number of inappropriate antibiotic prescriptions were issued for infections with a high probability of bacterial resistance to the prescribed antibiotics.

The use of fluoroquinolones in the treatment of skin infections.

Fluoroquinolones have been studied for both uncomplicated and complicated skin and skin structure infections. Their broad spectrum, rapid bactericidal activity, extensive tissue penetration, excellent bioavailability and ease of administration have made these drugs a common choice for many infectious diseases, including skin infections. Extensive research has shown the fluoroquinolones to be as effective as beta-lactam antibiotics in managing a spectrum of diseases including erysipelas, cellulitis, impetigo, surgical wounds and diabetic foot infections. However, resistance to the fluoroquinolones has increased among the staphylococci, streptococci, Enterobacteriaceae and other important Gram-negative bacilli. Resistance has been linked directly to the widespread use of these compounds. Despite their appeal in the treatment of both uncomplicated and complicated skin infections, the fluoroquinolones should be reserved as alternatives to beta-lactams and other antibiotics or as empirical therapy in complicated infections until pathogens have been identified and drug regimens can be focused.