Drug safety
-
Review
Benefits and risks of using smart pumps to reduce medication error rates: a systematic review.
Smart infusion pumps have been introduced to prevent medication errors and have been widely adopted nationally in the USA, though they are not always used in Europe or other regions. Despite widespread usage of smart pumps, intravenous medication errors have not been fully eliminated. ⋯ The literature suggests that smart pumps reduce but do not eliminate programming errors. Although the hard limits of a drug library play a main role in intercepting medication errors, soft limits were still not as effective as hard limits because of high override rates. Compliance in using smart pumps is key towards effectively preventing errors. Opportunities for improvement include upgrading drug libraries, developing standardized drug libraries, decreasing the number of unnecessary warnings, and developing stronger approaches to minimize workarounds. Also, as with other clinical information systems, smart pumps should be implemented with the idea of using continuous quality improvement processes to iteratively improve their use.
-
New pharmacovigilance legislation in the European Union has underlined the importance of signal management, giving the European Medicines Agency's newly established Pharmacovigilance Risk Assessment Committee (PRAC) the mandate to oversee all aspects of the use of medicinal products including detection, assessment, minimization, and communication relating to the risk of adverse reactions. In this study, we describe the signals as brought to the PRAC during the first 18 months of its operation and the ensuing regulatory actions. ⋯ The importance of spontaneous reporting in signal detection and monitoring of safety issues throughout the entire life cycle of a medicinal product is confirmed in this study. The amount of time a drug has been on the market is correlated with the number of signals detected. The PRAC decision-making process seems efficient particularly with respect to serious concerns; its role in improving signal prioritization and real-time signal management will be further clarified in its subsequent years of operation.