Interrater reliability and ease of use of the High-Alert Medication Stratification Tool‒Revised Prospective (HAMST-R PRO): A prospective, multisite study.

OBJECTIVE: The High-Alert Medication Stratification Tool‒Revised (HAMST-R) was originally designed to standardize the identification of high-alert medications (HAMs) according to safety risk. The primary objective of this multisite study was to assess interrater reliability of the HAMST-R PRO, a version of the tool designed to prospectively evaluate safety risk of medications during evaluation for formulary addition. METHODS: HAMST-R was designed as an objective tool to evaluate HAMs at a single site during the HAMST-R phase I study. Phase II of the study demonstrated the validity of the tool in a multisite, national study. In this third study, 11 medication safety experts from 8 health systems across the United States and 1 in Canada facilitated evaluation of medications prospectively with the HAMST-R PRO during the formulary review process for 27 medications. At each site, at least 5 individuals were asked to review each medication. Interrater reliability was evaluated using Kendall's coefficient of concordance. Ease of use was determined by participant interviews. RESULTS: Overall interrater reliability for HAMST-R PRO was found to be 0.76 (P < 0.001) across all sites, indicating substantial agreement between users. Interrater reliability among individual sites ranged from 0.52 to 0.82 (P < 0.05 for all sites). CONCLUSION: Interrater reliability of HAMST-R PRO is substantial, indicating consistency and agreement among pharmacists utilizing this tool to evaluate safety risk of medications before their addition to a health-system formulary. This information can be used to identify potential interventions for each step of the medication-use process that institutions may implement to decrease a medication's potential safety risk.

Assessment of Oral Anticoagulant Adverse Drug Events Before and After Implementation of a Real-Time Clinical Surveillance Tool.

OBJECTIVE: The aim of the study was to determine the effect on occurrence of oral anticoagulant adverse drug events (ADEs) after implementation of a real-time clinical surveillance tool in a large health system. METHODS: Records of patients receiving an oral anticoagulant during a 6-month period before and after implementation of a real-time clinical surveillance tool were reviewed for 31 hospitals within a nationwide health system. The real-time clinical surveillance tool analyzed clinical data from the electronic medical record and alerted the pharmacist of potential opportunities for patient clinical intervention. Oral anticoagulant administration data, International Classification of Diseases, Ninth Edition code documentation of ADEs caused by oral anticoagulants, and alert notification data from the real-time clinical surveillance tool were evaluated. RESULTS: A total of 56,761 patients were included in the study. The oral anticoagulant ADE ratio decreased from 0.69% during the period before implementation of the real-time clinical surveillance tool to 0.41% during the period after implementation (P < 0.001). Most alert notifications and greatest impact on ADE ratio occurred in patients administered a single oral anticoagulant during hospitalization. CONCLUSIONS: Implementation of a real-time clinical surveillance tool prompting pharmacist intervention reduced the oral anticoagulant ADE ratio for the health system.

Preparation of porcine carotid arteries for vascular tissue engineering applications.

Biomaterials derived from tissue continue to offer viable alternatives to synthetic materials when autologous materials are unavailable for transplantation due to their unique chemical and mechanical properties. Tissue processing aims to stabilize the material against host degradation and render it immunologically inert by removing cellular material and crosslinking the structural proteins. It is clear that different approaches taken to achieve these goals have very different chemical and mechanical effects on the material. We describe herein the development of a tissue processing methodology to generate acellular scaffolds for tissue engineering small-diameter vascular grafts. Carotid arteries were isolated from Great White pigs and exposed to various solvent treatments, xylene, butanol, and ethanol to determine optimal parameters for the extraction of host lipids. The tissue was then exposed to a limited proteolysis with trypsin to disrupt cellular protein. This resulted in a controlled digestion that disrupted porcine nuclear DNA and cleared bulk cellular protein, leaving the more resistant structural proteins largely intact and retaining the bulk mechanical properties of the matrix. Histological analysis and scanning electron microscopy illustrated the complete removal of intact cells and nuclear material. The decellularized graft was stabilized by crosslinking with the photooxidative dye methylene green in the presence of 30,000 LUX of broad-band light energy. High-performance liquid chromatography analysis showed that the crosslinked tissue yielded 78.6% less hydroxyproline, compared with control tissue, after 20 h incubation with pepsin. Analysis of the crosslinked vessels' burst-pressure and stress-strain characteristics have shown comparable mechanical properties to those of control vessels. Assessment of in vitro cell adhesion and compatibility was conducted by seeding primary human umbilical vein endothelial cells and adult human vascular smooth muscle cells onto the lumenal and ablumenal surfaces, respectively; these cells were shown to adhere and proliferate under traditional static culture conditions.