Michael Toscani

A multicenter, randomized, comparative assessment in healthy pediatric volunteers of the palatability of oral antibiotics effective in the therapy of otitis media

Abstract Objective The goal of this study was to evaluate the palatability of antimicrobial suspensions effective against beta-lactamaseproducing bacteria in a US pediatric population. Background Compliance with an antibiotic regimen is a key factor in treatment success. Dosing convenience and palatability are believed to be essential aspects of compliance; however, few studies have evaluated the palatability of antimicrobial suspensions in children. Methods This single-blind, multicenter, randomized, comparative taste test included 4 antimicrobial suspensions: azithromycin (cherry flavored), cefprozil (bubble gum flavored), cefixime (strawberry flavored), and amoxicillin/clavulanate (banana flavored). It was conducted at 3 primary care pediatric centers and involved a volunteer sample of 90 healthy children (5 to 9 years of age). After each antimicrobial test dose, subjects rated its taste on a 10-cm visual analog scale (VAS) incorporating a facial hedonic scale. Assessments of preference for the best- and worst-tasting suspensions were also conducted. Parent surveys regarding the use of antibiotics to treat ear infections were included. Results Using the VAS, the best-tasting suspension was cefixime (7.3 ± 3.3), compared with azithromycin (6.0 ± 3.8; P P P Conclusion Among the pediatric population tested, cefixime was most commonly rated as best tasting.

Sleep Health and Appropriate Use of OTC Sleep Aids in Older Adults—Recommendations of a Gerontological Society of America Workgroup

Getting a good nights sleep can be challenging for older adults with chronic medical conditions, which often interfere with sleep. As a result, many older adults turn to over-the-counter (OTC) sleep aids, that is, products with diphenhydramine or doxylamine. However, these products are indicated only for occasional difficulty with sleep, not for chronic use; and their safety and efficacy has not been well established in general and in older adults specifically. To engage national stakeholders in a discussion of OTC sleep aids in older adults, the Gerontological Society of America (GSA) convened a multidisciplinary workgroup. The Workgroup examined differences between younger and older adults in sleep health and use of OTC sleep aids using data from the National Health and Wellness Survey; assessed the pharmacologic properties and medication effects of OTC sleep aids; and worked with stakeholders to promote strategies for safe and effective use. Older adults are more likely to take diphenhydramine or doxylamine products 15 or more days in a month, an indicator of inappropriate use. The Workgroup recommends research to investigate the ways older people use OTC sleep aids. The goal should be reduction in inappropriate use and associated risks, such as daytime sedation, compromised cognitive function, and falls. In addition, the Workgroup recommends a greater role for community pharmacists in counseling older adults on appropriate use of OTC sleep aids.

Clinical and Economic Impact of Empirical Extended-Infusion Piperacillin-Tazobactam in a Community Medical Center

Background: Current medical center practice allows for the automatic conversion of all piperacillin/tazobactam orders from intermittent to extended infusion (EI). Objective: To compare the clinical and cost impact of empirical extended-infusion piperacillin/tazobactam. Methods: All consecutive patients treated with piperacillin/tazobactam for >48 hours were reviewed for inclusion. Patients were stratified into 2 groups: (1) traditional infusion (TI), preprotocol implementation, and (2) EI, postprotocol implementation. Patient demographics and primary and secondary diagnoses were extracted from the hospital discharge database. All patients were assessed for the primary end point of all cause 14-day in-hospital mortality. Secondary outcomes included length of hospital stay, duration of antibiotic therapy, cost per treatment course, and occurrence of Clostridium difficile infection. Results: A total of 2150 patients were included (EI = 632; TI = 1518). After adjusting for comorbidity, length of stay, and age, 14-day in-hospital mortality was similar between groups (odds ratio = 1.16; 95% CI = 0.85-1.58; P = 0.37). Length of stay was similar between the EI group versus TI (mean ± SD: 12.5 ± 9.58 days vs 11.8 ± 9.58 days, respectively; P = 0.10) after adjusting for age and Chalson-Deyo comorbidity index. Total cost per treatment course was reduced in the EI group by 13% compared with the TI group (

Disease Management: Building a Solid Foundation

565.90 ±

The PharmD/MD Dual-Degree Program and Its Potential Value in the Pharmaceutical Industry

257.70 vs

Current Trends in Personalized Medicine and Companion Diagnostics A Summary From the DIA Meeting on Personalized Medicine and Companion Diagnostics

648.30 ±

Analysis of Social Media Interactions Between Pharmaceutical Companies and Consumers: The Power of the ''Like''

349.20, respectively; P < 0.0001). Conclusion: Automatic substitution of EI for TI piperacillin/tazobactam is safe and associated with significant cost savings. EI piperacillin/tazobactam was not associated with a reduction in mortality or length of stay.

Challenges in the Development of Drug/Device and Biologic/Device Combination Products in the United States and European Union A Summary From the 2013 DIA Meeting on Combination Products

SummaryThis article reviews the early experience of organisations in the US who have attempted to design, develop and implement disease management programmes. A systems approach is recommended and outlined as a solution to the obstacles that have hindered the success of ‘first generation’ disease management programmes. The authors focus on important considerations and specific components needed to build a solid foundation for the successful implementation of disease management systems.

Evaluation of Risk Versus Benefit Information in Direct-To-Consumer (DTC) Prescription Drug Television Advertisements

The first dual-degree program combining both the doctor of pharmacy (PharmD) and the doctor of medicine (MD) degrees was designed and launched by Rutgers, The State University of New Jersey, in academic year 2013-2014. This joint effort was led by the Ernest Mario School of Pharmacy (EMSOP) and the Robert Wood Johnson Medical School (RWJMS) to combine expertise in both diagnostic and treatment facets of health care and to prepare graduates for leadership roles in providing and managing comprehensive patient care in a variety of settings. One area of potential value of these skill sets is the drug development industry. A survey was conducted among pharmaceutical executive stakeholders associated with a postdoctoral training program to assess the perceived value of this new dual-degree skill set and to identify particular functions where the combined training has its best fit. Results indicate that the combined nature of this training is highly valued in this setting, especially in the areas of clinical pharmacology, drug safety and pharmacovigilance, medical affairs/strategy, and medical science liaisons. Future monitoring of graduates will further define the value of this dual degree in this and other health care settings.

Telepharmacy: A New Paradigm for Our Profession:

Personalized medicine has reached the mainstream, accounting for more new drug approvals and a promising pipeline of candidate therapeutics. Recent advances in genomics, computational biology, medical imaging, diagnostic technologies, and translational medicine are creating the possibility for scientists to develop diagnostic tools and new treatments for cancer, genetic disorders, and infectious diseases that may be particularly effective in biomarker-defined subpopulations. Drug development under this model creates new challenges that will require the need for increased regulatory flexibility, novel clinical trial designs, and translational science development. In this review, the authors highlight key developmental and regulatory challenges in the advancement of personalized medicines and their associated companion diagnostics with the need for innovative clinical trial designs to support drug/diagnostic development and registration. Further, the clinical complexities of implementing new technologies are considered, such as high-throughput next-generation sequencing in personalized medicine, and offer a glimpse of the regulatory and policy considerations shaping this methodology in multimarker diagnostic development.