Because of the complexities associated with anticoagulation in temporary percutaneous ventricular assist device (pVAD) recipients, a lack of standardization exists in their management. This retrospective analysis evaluates current anticoagulation practices at a single center with the aim of identifying an optimal anticoagulation strategy and protocol. Patients were divided into two cohorts based on pVAD implanted (CentriMag (Thoratec; Pleasanton, CA) / TandemHeart (CardiacAssist; Pittsburgh, PA) or Impella (Abiomed, Danvers, MA)), with each group individually analyzed for bleeding and thrombotic complications. Patients in the CentriMag/TandemHeart cohort were subdivided based on the anticoagulation monitoring strategy (activated partial thromboplastin time (aPTT) or antifactor Xa unfractionated heparin (anti-Xa) values). In the CentriMag/TandemHeart cohort, there were five patients with anticoagulation titrated based on anti-Xa values; one patient developed a device thrombosis and a major bleed, whereas another patient experienced major bleeding. Eight patients received an Impella pVAD. Seven total major bleeds in three patients and no thrombotic events were detected. Based on distinct differences between the devices, anti-Xa values, and outcomes, two protocols were created to guide anticoagulation adjustments. However, anticoagulation in patients who require pVAD support is complex with constantly evolving anticoagulation goals. The ideal level of anticoagulation should be individually determined using several coagulation laboratory parameters in concert with hemodynamic changes in the patient's clinical status, the device, and the device cannulation.
Objective. To evaluate the advanced clinical track, a curricular track designed to prepare doctor of pharmacy (PharmD) students for residency training and institutional practice. Design. The advanced clinical track required completion of elective coursework, an additional advanced practice experience, 8 clinical experiences, and a skills checklist, and participation in a clinical skills competition. Assessment. Thirty-two graduates of the advanced clinical track were surveyed. Of the 23 respondents, 95% of those who pursued residency training were successfully matched with a residency program. Ninety-one percent of respondents felt that the advanced clinical track increased their confidence and 74% felt it was definitely an advantage when applying to a residency program. All participants agreed that the advanced clinical track met their expectations or goals and would recommend it to other students. Conclusion. Completion of an advanced clinical track was viewed by PharmD graduates as valuable preparation for residency training and institutional practice and would be recommended to other students.
Antidepressant drug development first began in the mid-twentieth century with the discovery of monoamine oxidase inhibitors and tricyclic antidepressants. Soon after, additional molecular targets and drug entities were created, eventually leading to the development of selective serotonin reuptake inhibitors. Today, antidepressants now rank among the top 10 most commonly used medications in the United States (US) and account for over $11 billion in annual sales. To help ensure the safety and efficacy of these commonly used products, in 1977 the US Food and Drug Administration (FDA) created guidelines to standardize antidepressant studies and the approval process. Although many of the recommendations outlined by FDA are still relevant, the document remains vague when describing key aspects of antidepressant trial design and much of the clinical information is outdated by today's standards. This paper will provide a general overview of the FDA-approval process, summarize FDA's position related to antidepressant trial design, and discuss the need for updates in the approval process.
Purpose A project was undertaken at an academic medical center to assess use of available dosing buttons within the computerized provider-order-entry (CPOE) system in order to identify opportunities for optimization of medication builds. Methods A retrospective observational study was conducted to identify medication records within a CPOE system meeting prespecified inclusion and exclusion criteria. A report capturing all inpatient adult medication orders associated with the identified medication records over a 6-month period was generated. The primary endpoint was percent dosing-button compliance, calculated as the number of orders with doses consistent with existing dosing-button options divided by the total number of orders during the study period. Secondary study objectives included a comparison of high- and low-performing medication record samples and identification of potential reasons for lack of dosing-button use. Results A total of 2,506 CPOE medication records associated with a total of 694,877 medication orders entered during the study period were analyzed. Median percent dosing-button compliance was 99.92% (interquartile range, 83.33–100%). High-performing records (n = 1243) were more likely to be associated with anti-infective medications (p = 0.041) and medications not on formulary at the study institution (p < 0.001). Medications in the sample of poor-performing CPOE records (n = 614) were more likely to be agents delivered via the i.v. route (p < 0.001). There were 45 records for which poor dosing-button compliance was attributed to lack of a clinically reasonable dosing option. Conclusion A high level of dosing-button compliance was demonstrated despite the lack of routine revalidation of dosing buttons after initial medication builds. Some opportunity for optimization was identified during the project, which established a quality assurance method to facilitate future auditing of medication builds.
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