Background:The main objective of the present systematic review is to identify potential risk factors for adverse drug reactions (ADRs) through prospective cohort studies in pediatric inpatients. Methods: The data search was done in the following electronic databases PubMed/MEDLINE; Scopus; LILACS and Web of Science from the earliest record until 31 May 2015. Two reviewers independently screened each study and one of them assessed the methodological quality according to the Newcastle-Ottawa scale for cohort studies. The data extraction was conducted according to Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) initiative for cohort studies. Results:The only risk factor observed in all studies was the increase in the number of prescription drugs. However, other factors were identified, such as the increase in the length of stay or the number of low-or high-risk drugs prescribed, use of general anesthesia and oncological diagnosis. The cumulative incidence of ADR was 16.4% (95% confidence interval: 15.6 to 17.2). The main professional responsible for ADR identification was the pharmacist and the dominant category among the ADRs were gastrointestinal disorders. In addition, analgesics, antibacterial agents and corticosteroids were the drug classes commonly associated with ADRs. The methodology used in this study was tried to homogenize the data extracted; however, this was not sufficient to correct the discrepancies so it was not possible to perform a meta-analysis. Conclusions:The increase in the number of prescription drugs was the main risk factor in this population. However, additional studies are required to identify the risk factors for ADRs in pediatric inpatients.

Objective The aim of the study was to determine the prevalence and main types of harm caused by high-alert medication after medication errors (MEs) in hospitals. Method A literature systematic review was conducted on PubMed, Scopus, Web of Science, and Lilacs. Eligible studies published until June 2017 were included. Result Of 6244 studies identified through searching four electronic databases, five studies meeting the selection criteria of this study were analyzed. There was wide variation in the overall prevalence of harm due to MEs involving HAM, from 3.8% to 100%, whereas the pooled prevalence was 16.3%. Overall, 0.01% of harm caused by MEs involving HAM resulted in death. The severity of errors ranged from 0.1% to 19.2% for moderate errors, 0.2% to 15.4% for serious errors, and 1.9% lethal to the patients. The highest prevalences of harm occurred after errors involving potassium chloride 15%, insulin, and epoprostenol. The lowest prevalence of harm was related to errors of anticoagulants administration. The methodological heterogeneity limited direct comparisons among the studies. Conclusions Of the 15 drugs on the list of Institute for Safe Medication Practices HAMs in the United States and Brazil, nine did not present scientific evidence of the potential for harm. In general, few studies, characterized by methodological and conceptual heterogeneity, were performed to determine the harm prevalence resulting from errors involving these drugs.