Improved quality of reporting safety data of medication in paediatric randomised controlled trials.

OBJECTIVE: Evaluating the reporting of safety data of medication in paediatric randomised controlled trials (RCTs) in 2017-2018 compared with our earlier study. DESIGN: Literature search with a systemic appraisal of adverse drug event reporting. MAIN OUTCOME MEASURES: Quality of reporting of safety data using Consolidated Standards of Reporting Trials (CONSORT) and Ioannidis scores in paediatric drug RCTs. The CONSORT score consists of nine recommendations of the CONSORT Group issued to improve the quality of reporting adverse events. The Ioannidis score is based on these advices. We considered a CONSORT score of at least 6 and an Ioannidis score of at least 3 as sufficient. RESULTS: We reviewed 100 RCTs published in 2017 and 2018. Ninety-four (94%) articles mentioned adverse events compared with 78% in the earlier study. Fifty-seven per cent used a standardised method for reporting adverse events compared with 34% in our earlier study. In 26 of the articles, the expected adverse events were defined, and 27 articles had a preset standardised scale for adverse events. Of these, 62 articles (62%) had a CONSORT score of 6 or higher compared with 18% in 2010. In the present study, 67% had an Ioannidis score of 3 or higher, whereas in the earlier study this was 29%. Both differences are statistically significant (p<0.05). CONCLUSIONS: Reporting safety data in paediatric RCTs has improved over the past 10 years. However, there is still room for improvement and for further improvement. Authors and editors should give more attention to methods for collecting, reporting and presenting safety data of RCTs in studies and manuscripts.

An age-adjusted instruction video enhances the correct use of nasal corticosteroid sprays in children

INTRODUCTION AND OBJECTIVES: Allergic rhinitis is a common disorder. Intranasal corticosteroid sprays are used to control symptoms. However, incorrect use of these sprays can decrease efficacy and lead to side effects such as nose bleeding. We studied if watching an age-adjusted instruction video is effective to improve administration technique. MATERIALS AND METHODS: We invited children who used intranasal corticosteroid sprays. We examined their administration technique before, directly after, and one month after showing them an age-adjusted instruction video. We compared their administration technique with the instructions in the patient information leaflet. We assessed whether the children performed the seventeen maneuvers mentioned in the patient information leaflet and the eight we considered essential. RESULTS: Of the 99 eligible children, 23 (15 boys, median age nine years) participated. Before watching the instruction video none of them administered according to all maneuvers in the patient information leaflet or showed all essential maneuvers. One month after seeing the instruction video, three children demonstrated correct inhalation as per the patient information leaflet. Three performed the essential maneuvers. When a 75% threshold level for carrying out all 17 maneuvers was used, still none showed 75% of all or of the essential maneuvers before watching the video. Yet, after one month 12 children showed sufficient administration technique (52%, 95% confidence interval (CI) 31%-73%, p = 0.004). Nine showed all essential manoeuvres (47%, 95%CI 24%-71%, p = 0.004). CONCLUSIONS: An age-adjusted instruction video is a useful and easy method to teach children to administer nasal intranasal corticosteroid sprays correctly

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Observational study of administering intranasal steroid sprays by healthcare workers.

OBJECTIVES: Patients with allergic rhinitis receive their information about administering intranasal corticosteroid sprays (INCS) from healthcare workers. Since the majority of patients does not administer these sprays correctly, we investigated whether healthcare workers know how to administer INCS. SETTINGS: We studied participants at their working place: pharmacy, outpatient clinic or general practitioner centre for emergencies. PARTICIPANTS: Pharmacist assistants, general practitioners, paediatricians and ear nose throat doctors. DESIGN: Observational study. All the participants demonstrated the administration technique with a spray device filled with water. PRIMARY OUTCOME: Number of steps of administration of INCS based on the established INCS protocol. SECONDARY OUTCOME: Number of five steps are labelled essential to obtain optimal distribution of the medication. RESULTS: Among the 75 participants, none performed all the steps correctly. The median of correctly performed steps in the protocol was 14 out of 29. A significantly better result was found among the pharmacist assistants. The essential steps were performed by 27 out of the 75 participants (36%). CONCLUSION: The majority of healthcare workers does not know how to administer INCS correctly. Patients could, therefore, receive incorrect and non-uniform instructions. The education of healthcare workers on how to administer INCS correctly may be an option for improvement.

Psychiatric adverse drug reactions in the paediatric population.

OBJECTIVE: Due to lack of information on drug use in children, many drugs are used off-label in paediatrics. Increased knowledge of adverse drug reactions (ADRs) would enable a better risk-benefit analysis. Our aim was to characterise drugs causing psychiatric ADRs in children by conducting a descriptive study based on pharmacovigilance reports. DESIGN: Reports submitted to the Netherlands Pharmacovigilance Centre Lareb from 2003 to 2016 were used to investigate drugs causing psychiatric ADRs in the Dutch paediatric population. These data were corrected for drug utilisation in order to correct the number of reports for the number of users of a drug. MAIN OUTCOME MEASURES: ORs were calculated as a measure of disproportionality for drug-ADR associations for three different age groups. Significant drug-ADR associations were checked if it was labelled in the product information. RESULTS: Lareb received 918 reports of psychiatric ADRs, which constitute 15% of the reports of ADRs in children. Drugs used for the treatment of ADHD (methylphenidate and atomoxetine) and drugs used for the treatment of asthma (montelukast and fluticasone) were the most frequently reported. However, psychiatric ADRs were also reported for less often prescribed medications such as oxybutynin and isotretinoin. CONCLUSIONS: Real-world data on psychiatric ADRs in the Dutch paediatric population show a consistent pattern with what is known from drug labels and the literature. Reports of psychiatric ADRs should be taken seriously because of the impact on medication adherence and the well-being of the child and its family.