No abstract

PhV (pharmacovigilance) knowledge has the outcome of being inadequate in particular due to the lack of instruction. Pediatricians have to face the realization that over-the-counter medicines increments the peril of ADRs (adverse drug reactions) has become a public health concern. The purpose of this article is to disseminate knowledge of the PhV and to highlight the cultural and organizational difficulties for its implementation. The objectives of promoting the organization of specific training courses and research projects aimed at: (1) to foster the culture of iatrogenic disease in pediatrics; (2) to improve the appropriateness of prescribing drugs in children; (3) to encourage spontaneous reporting of ADRs in children; (4) to involve Pediatricians in PASS (post-authorization safety studies) according to GCP, GVP and ENCEPP Code of Conduct. An up to date proposal of PhV, a procedure of preparation improves the productivity of creating novel informative reports which can be utilized for a benefit/risk scrutiny making strides in medicine prescription. In this context, FP-MCRN (family paediatricians-medicines for children research network) established with the aim of developing competence, infrastructure and education for paediatric clinical trials, plays a crucial role in paediatric PhV, through an improvement of PhV training, a correct research methodology and very strong relationship with the families. The initial necessity is cultural, implementing culture of iatrogenic illnesses and a watchful evaluation of the importance of PASS by FPs (family pediatricians). Participation in clinical trials that generates a precise database administered by FPs together with follow-up outcomes becomes relevant and vital for a scrupulous and accurate assessment of ADRs. PASS can foresee on one hand training and information regarding the proper use of drugs in children and possible iatrogenic pathologies caused by their improper use, the other to constitute a territorial survey in the prescriptive appropriateness and safety of pediatric drugs aimed at evaluating the risk-benefit balance on usage.

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.