Brian L Erstad

PMID: 22950987;Abstract:

Purpose: To categorize and synthesize medication safety event detection methods in the critically ill in order to provide clinicians and administrators with approaches to event detection that are intended to expand and complement traditional voluntary reporting systems. Methods: A literature search of OvidMEDLINE was performed to identify articles related to medication safety involving critically ill patients in the intensive care unit setting. The inclusion of articles was restricted to comparative studies. The bibliographies of all retrieved articles were reviewed to obtain additional articles of relevance. The various event detection methods were compared by: evidence supporting their use; number, type and severity of events detected; phase of the medication use process in which events were detected; and ease and cost of implementation. Major limitations of each method were also collated. Results: There are a number of methods that can be used to identify medication safety events in the critically ill. These can broadly be categorized as: 1) voluntary reporting, 2) record review, 3) rules/triggers and 4) direct observation and 5) interviews/surveys. Relatively few studies have directly compared these assessment methods in the ICU setting, although the limitations of the traditional voluntary reporting system as the sole method of event detection are well established. Although not truly dichotomous, these methods can be broken down into more proactive and reactive approaches. Rules/triggers and direct observation of the medication use process in the ICU are examples of proactive approaches to event detection, while the traditional unsolicited voluntary reporting is typically reactive. However, each of the event detection methods has advantages and disadvantages, so the methods should not be considered mutually exclusive with respect to obtaining information about medication safety. Conclusions: Given the limitations of traditional voluntary reporting systems, a multimodal approach used to identify medication safety events is most likely to capture the largest number and type of events. We would advise not trying to implement additional approaches beyond voluntary reporting systems all at once. This would be difficult and costly. Rather, we suggest a systematic implementation of additional event detection approaches that takes into account hospitalspecific considerations. © 2012 Bentham Science Publishers.

PMID: 8947970;Abstract:

Original research, reviews, anti case reports discussing viral infectivity of blood- and plasma-derived products were reviewed to determine the potential viral infectivity of human serum albumin (HSA) and plasma protein fraction (PPF). Data concerning vital infectivity, vital screening anti inactivation procedures, and viral outbreaks associated with blood and plasma products were extracted and evaluated for pertinence to HSA and PPF. The starting material used for fractionation, the manufacturing process, postmanufacturing handling, and immunocompetence of HSA or PPF recipients were assessed to determine risk of symptomatic viral disease after transfusion. Both HSA and PPF are manufactured with pasteurization procedures that have led to an excellent viral safety record based on 50 years of clinical use. One outbreak of hepatitis B was associated with PPF as a result of an unreliable manufacturing process that has been corrected. The pasteurization process is effective in eradicating known viral pathogens when good manufacturing practices are followed. Continued surveillance of such products is warranted for viruses not included in routine screening procedures and for those that are resistant to current inactivation methods.

PMID: 10119446;Abstract:

Objective: To identify patients receiving albumin, develop guidelines for albumin use, and examine distribution and billing procedures. Design: Case series. Setting: Tertiary care center. Patients: All patients received albumin in a four-week period. Patients were identified concurrently using intensive care unit surveys and the pharmacy computer system, and retrospectively using billing statements. Data were analyzed from 73 of 79 patients (92.4 percent); 6 (7.6 percent) had no record of albumin being ordered or administered. Pediatric patient data were used only in the financial calculations. Data Collection: Demographics and albumin dosages were recorded for all patients. Prescribing service and indications for use were recorded in adults. Albumin administered was compared with the amount billed to each patient. Main Results: Sixty adult patients aged 14-91 y (median 62) received 1-69 units (median 4 units [1 unit=12.5 g albumin]) and 470 total units. Surgical services prescribed albumin in 73 percent and medical services in 27 percent of the patients. Common indications for albumin included volume expansion (65 percent), as intraoperative fluid (13 percent), and to increase urine output (10 percent). The pharmacy computer system identified 63 percent of the patients. Of these, 13 percent were not billed for albumin they received. Examinations of patient billing statements found that up to $17,740 a year (15 percent) of albumin administered is not billed. The floor-stock distribution system used in the intensive care units contributed to most errors. Conclusions: Recommendations addressing the problems identified in this audit were made to the pharmacy, medical, nursing, and billing departments. Guidelines for albumin use were formulated and approved by the hospital's pharmacy and therapeutics committee.