High-Alert Medication Stratification Tool-Revised Phase II: A Multisite Study Examining the Validity, Interrater Reliability, and Ease of Use of the High-Alert Medication Stratification Tool-Revised.

OBJECTIVES: The primary objective of this multisite study, High-Alert Medication Stratification Tool-Revised (HAMST-R) phase II, was to assess the content validity of HAMST-R. Secondary outcomes included interrater reliability and ease of use. METHODS: HAMST-R was designed as an objective tool to evaluate high-alert medications (HAMs) at a single site during HAMST-R Phase I. Medication safety experts from 7 health systems across the United States volunteered to participate in this phase II study. Participants completed a demographic survey, oversaw evaluation of 47 HAMs and 35 non-HAMs using HAMST-R, and submitted scores for each medication evaluated. In addition, participants rated each question of HAMST-R on its relevance to assess a medication's safety risk, measured as scale-content validity index. Positive and negative predictive values were evaluated in a post hoc analysis. Interrater reliability was evaluated using the Kendall coefficient of concordance (K), and ease of use was assessed using a mixed-methods approach. RESULTS: Scale-content validity index was 0.80, indicating that the tool was valid. Positive predictive value was 90.5% (95% confidence interval, 87.2%-93.0%), and negative predictive value was 98.2% (95% confidence interval, 95.4%-99.3%). A score of 4 or more differentiated between HAMs and non-HAMs, confirming phase I findings. K was 0.56, indicating moderate agreement. Participants confirmed that the tool was easy to use and plan to incorporate the tool into HAM policies and procedures, formulary review, and safety strategy implementation. CONCLUSIONS: HAMST-R is a valid, objective, and easy to use method that institutions may implement to evaluate a medication's potential safety risk.

Early onset probable linezolid-induced encephalopathy.

Linezolid is increasingly being utilized for the treatment of gram-positive pathogens. While neurological complications with linezolid are rare, long-term exposure can be associated with neurotoxic effects. Patients with pre-existing neurologic sequelae or risk factors, such as alcohol abuse, diabetes, or concomitant administration of chemotherapeutic agents and/or antiretroviral therapy, may be more susceptible to the development of linezolid-induced neurotoxicity. We describe a 41-year-old male who developed early onset encephalopathy after a day and a half of linezolid therapy. Our patient had at least one significant risk factor (alcoholism), making linezolid-induced encephalopathy probable based upon the Naranjo probability scale. Clinicians should be aware of the potential for early onset linezolid-induced neurotoxicity, particularly in patients with concomitant risk factors.

Acute renal failure after placement of tobramycin-impregnated bone cement in an infected total knee arthroplasty.

Tobramycin-impregnated bone cement is frequently used in revision procedures of infected total hip and knee arthroplasties. Aminoglycoside-impregnated cement is typically fashioned into beads or block spacers, which are temporarily placed in infected joint spaces. The use of aminoglycoside-impregnated bone cement has allowed the local concentration to exceed the minimum inhibitory concentration breakpoint of susceptible organisms while serum concentrations after 48 hours were usually not detected. Nephrotoxic complications are rarely encountered with this type of antibiotic delivery method. However, we report the case of an 85-year-old man with a history of renal insufficiency who experienced acute renal failure after undergoing revision treatment of an infected knee arthroplasty with the combined use of tobramycin-cefazolin bone cement and a block spacer. Clinicians should be aware of the potential for aminoglycoside-induced nephrotoxicity from the use of this combination.

Silicone gel breast implant rupture rates: research issues.

Documenting the rate of rupture of silicone breast implants appears to be deceptively easy. Largely because of the phenomenon of "silent rupture," it isn't. The authors explore the various technical biases (selection, misclassification, and confounding) and methodological problems that have plagued much of the research conducted to date. By means of a series of illustrations, they argue that explantation has limited utility. Noninvasive techniques have to be used to gather the proper type of data on the timing and frequency of these events. Only with the proper incidence data will researchers be able to identify better the different mechanisms underlying implant rupture and the relative importance of each. The authors recommend that better and standardized definitions of implant rupture be developed, that greater recognition be given to the technical biases and a greater effort be made to eliminate them from investigations of implant rupture, and that more research be conducted by multidisciplinary teams. Because of the growing awareness of the complexity of this issue, the authors also recommend that properly constituted advisory teams be used to provide comprehensive oversight of future research projects from beginning to end.