REDS (Respiratory Drugs Survey) Study. Active Surveillance of Respiratory Drugs and in Particular of Inhaled Steroids (IS) in the Paediatric Age

Authors

  • E. Napoleone FP-MCRN (Family Pediatricians-Medicines for Children Research Network), Italy and Pharmacovigilance Molise Center, Italy
  • A. Lavalle Pharmacovigilance Molise Center, Italy
  • C. Scasserra FP-MCRN (Family Pediatricians-Medicines for Children Research Network), Italy and Pharmacovigilance Molise Center, Italy
  • M. Rossi Pharmacovigilance Umbria Center, Italy
  • G. Bucaneve Pharmacovigilance Umbria Center, Italy
  • R. E. Rocchi Pharmacovigilance Umbria Center, Italy
  • M. Ricci Pharmacovigilance Molise Center, Italy

DOI:

https://doi.org/10.12974/2311-8687.2018.06.4

Keywords:

Children, Adverse drug reactions, Inhaled steroids, Pharmacovigilance, Post-marketing clinical studies.

Abstract

Background and aims: Inhaled Steroids (IS) are used inappropriately for children who have been "over prescribed" for conditions such as colds, coughs and sore throats. This practice is not always based on scientific evidence. IS have a modest effectiveness in preventing both recurrent wheezing, viral and bronchiolitis in children.

The aim of the study is to monitor the use of IS with careful analysis of the risk / benefit factor of the treatment, through accuracy of diagnosis, the therapeutic appropriateness and the safe use of these medications.

Methods: In this epidemiological / observational (case-study) and active observational project, the prescribing data for children (0-14 yrs) were collected and processed by Family Pediatricians (FPs). The activities have been divided into four sections:

1) Elaboration of the prescriptive data (year 2015-retrospective)

2) Training / information events for FPs and families on the correct use of IS (year 2016)

3) Elaboration of the prescriptive data of the same FPs after the training year (year 2017-prospective)

4) Comparison of the prescriptive data of IS in the age group of 0 - 14 years in the years 2015 and 2017 (before and after the training phase)

Results: After the training phase: the prevalence of use of IS decreased from 20.71% to 15.15% ; the percentage of the appropriate prescriptions increased from 30.65% to 58.02% ; the percentage of the inappropriate prescriptions decreased from 68.67 % to 38.66%; the prevalence of inappropriate prescriptions decreased : a) in the 0-4 yrs from 70.24% to 39.30%; b) in the 5-10 yrs from 66.31% to 35.95%, and c) in the 11-14 yrs from 69.80% to 35.04%; the percentage of inappropriate expenditure decreased from 67.31% to 37.63%; the percentages of inappropriate prescriptions decreased for Beclomethasone from 71.47% to 38.29%, for Budesonide from 69.82% to 43.29%, for Fluticasone from 53.84% to 19.01% and for Flunisolide from 70.45% to 56.93% ; the total number of pieces prescribed decreased from 4.338 to 3.148.

Conclusions: We have highlighted that through training courses for Family Pediatricians and a correct information to families a significant improvement in the use of Inhaled Steroids can be achieved. 

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Published

2018-05-03

How to Cite

Napoleone, E., Lavalle, A., Scasserra, C., Rossi, M., Bucaneve, G., Rocchi, R. E., & Ricci, M. (2018). REDS (Respiratory Drugs Survey) Study. Active Surveillance of Respiratory Drugs and in Particular of Inhaled Steroids (IS) in the Paediatric Age. International Journal of Pediatrics and Child Health, 6, 27–41. https://doi.org/10.12974/2311-8687.2018.06.4

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