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.

PurposeThe present study aims to identify the risk factors for adverse drug reactions (ADR) in pediatric inpatients.MethodsA prospective cohort study in one general pediatric ward in a hospital in Northeast Brazil was conducted in two stages: the first stage was conducted between August 17th and November 6th, 2015, and the second one between March 1st and August 25th, 2016. We included children aged 0–14 years 11 months hospitalized with a minimum stay of 48 hours. Observed outcomes were the ADR occurrence and the time until the first ADR observed. In the univariate analysis, the time to the first ADR was compared among groups using a log-rank test. For the multivariate analysis, the Cox regression model was used.ResultsA total of 173 children (208 admissions) and 66 ADR classified as “definite” and “probable” were identified. The incidence rate was 3/100 patient days. The gastro-intestinal system disorders were the main ADR observed (28.8%). In addition, 22.7% of the ADR were related to antibacterials for systemic use and 15.2% to general anesthesia. Prior history of ADR of the child [hazard ratio (HR) 2.44; 95% confidence interval (CI) 1.19–5.00], the use of meglumine antimonate (HR 4.98; 95% CI 1.21–20.54), antibacterial for systemic use (HR 2.75; 95% CI 1.08–6.98) and antiepileptic drugs (HR 3.84; 95% CI 1.40–10.56) were identified risk factors for ADR.ConclusionsWe identified as risk factors the prior history of ADR of the child and the use of meglumine antimonate, antibacterial for systemic use and antiepileptic drugs.

Objective To evaluate unlicensed and off‐label prescription and use of drugs to children in primary health care. Methods This is a systematic review that was written based on Preferred Reporting Items for Systematic Reviews and Meta‐Analysis (PRISMA). The studies were extracted from the databases: LILACS, PubMed/MEDLINE, and Scopus. Studies in English, Spanish or Portuguese with abstract available regarding the use and prescription of off‐label and unlicensed drugs to children aged 0‐18 years in primary health care were included. The evaluation of the titles, abstracts and Full‐text were performed independently by two reviewers, and the divergences were resolved by a third reviewer. Results Six studies were included. The incidence of off‐label prescription varied from 29.5% to 51.7% in relation to the total number of drugs prescribed. The prevalence of off‐label drugs ranged from 31.7% to 93.5% in relation to the total number of drugs prescribed. It was observed a higher proportion of off‐label prescription related to age and dose. For unlicensed drugs, there was a small variation in incidence between 2.4% and 3.9%, relative to the total number of prescriptions, or between 2.4% and 10.0%, relative to the sample size. It was observed a higher proportion of unlicensed prescription related to children under 2 years of age. Conclusions The unlicensed and off‐label prescription of drugs is recurring in the pediatric population of primary health care. It is necessary to have better information on these drugs by the regulatory agencies and the pharmaceutical industries for rational use of drugs in children.

Aims: The aim of this study was to present the needs of hospital pharmacists in pharmacovigilance practices. Methods: This study has a cross-sectional design and was carried out with hospital pharmacists in Brazil. The sample was obtained by voluntary recruitment. Pharmacists who worked at Brazilian hospitals and were registered in their respective regulatory councils were invited to participate in the present study. A personalized questionnaire was developed by the authors and was electronically filled out by the respondents on the platform ‘Google forms’. The questionnaire was nationally available on the digital platform of the Pharmacy Federal Council, the Brazilian Society of Hospital Pharmacy and Health Services, four Pharmacy regional councils and the social network farmacêuticoclínico®. Quantitative variables were analyzed by mean and standard deviation. The qualitative variables were analyzed by means of absolute and relative frequency. Difficulties related to pharmacovigilance activities are presented in an Ishikawa diagram in the Supplemental Material online. Results: Of the 27 federative units of Brazil, we obtained answers from pharmacists located in 85.2% ( n = 23) of them. Among the pharmacovigilance practices developed by Brazilian pharmacists, the adverse drug reaction investigation (55.4%) and notification activities (47.0%) were worthy of note. Numerous difficulties were reported by the pharmacists, highlighting the difficulty in monitoring the medication and imputation of causality (27.7%). After categorizing the difficulties reported, it was observed that the category ‘people involved’ (45.1%) stood out from the others. Conclusion: This study pointed out numerous challenges to pharmacovigilance practices involving pharmacists in Brazil. It is believed that the correction of certain difficulties may impact on the better consolidation of pharmacovigilance activities in the country. However, regulatory agencies at all hierarchical levels of pharmacovigilance must work together to make it possible. Plain language Summary Challenges to the consolidation of pharmacovigilance This is a study that seeks to present the needs of Brazilian hospital pharmacists in relation to pharmacovigilance activities. Through online interviews, pharmacists answered a questionnaire, presented the pharmacovigilance activities they develop and expressed their anxieties and difficulties for the development of these activities. With this study, it was concluded that numerous activities of active search, investigation and notification of adverse drug reaction are developed by Brazilian pharmacists. However, each pharmacist performs a different method of pharmacovigilance. In addition, it was observed that among the interviewees there was a perception of insufficient professional training and a shortage of professionals to assist in pharmacovigilance activities. These were the main difficulties reported. Therefore, the search for models or agile solutions to solve problems involving adverse drug reactions seems necessary for a better consolidation of pharmacovigilance services in Brazil.

the modeling platform of the National Agency for Protection of the Environment. ResultsThe year 2010 was marked by the occurrence of the highest number of cases (23.5%). A statistically significant increase in SCD risk of 29.2% was observed during the winter (p=0.017; OR 1.45 IC95% [1.07-1.96]), compared with other seasons. The comparison of the mean concentrations of PM10 and TSP between the days with and without SCD as well as one day before the onset of SCD had note significantly lower concentrations. No statistically significant difference in mean temperature, relative humidity, atmospheric pressure and others pollutants between days with and without SCD was found. Conclusion Some environmental parameters may predispose to the onset of SCD. Understanding their accurate influence may have preventive and curative implications