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ADRs and Children: Knowledge and Methodological Standard in PASS (Post Authorization Safety Studies)




Author(s)

Ettore Napoleone and Cristiana Scasserra

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DOI:10.17265/2328-2150/2017.06.003

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.

Children, adverse drug reactions, off-label, pharmacovigilance, post-marketing clinical studies.

Napoleone, E., and Scasserra, C. 2017. “ADRs and Children: Knowledge and Methodological Standard in PASS (Post Authorization Safety Studies).” Journal of Pharmacy and Pharmacology 5 (6): 314-322.