A retrospective review of paediatric adverse drug reactions reported in Lombardy and Croatia from 2005 to 2013

ABSTRACT

Objective: to characterise the adverse drugs reactions (ADRs) reported in the Lombard and Croatian paediatric population and to compare data to specific paediatric age groups, in terms of trend, pattern and severity of ADRs, increasing understanding of paediatric ADRs.

Research design and methods: We selected and analysed all the spontaneous reports in which children were involved (0 < 18 years old) reported in the Lombardy and in Croatian pharmacovigilance databases from 1^th March 2005 to 31^th December 2013.

Results: 9175 ADR reports were reported in the Lombardy, 2457 were included in the Croatian database. The age groups most involved were 2–11 for both countries. The 13.2% and 40.3% of reports retrieved in Lombardy and Croatia were classified as serious, respectively. Fatalities account for 0.09% and 0.12% in Lombardy and Croatia, respectively.

Conclusion: Data on serious reports reflect a similar scenario in terms of age range; strikingly different therapeutic subgroups were involved in reporting activity likely due to greater self-medication practices with penicillins and anti-inflammatory, analgesic and antipyretics drugs in Lombardy than in Croatia, highlighting the need to closely monitor this paediatric therapeutic area to ensure a safe use of these drugs.

KEYWORDS:

• Adverse drug reaction
• paediatrics
• pharmacovigilance
• children

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This study was supported by the Lombardy Region and Agency for Medical Products and Medical Devices of Croatia (HALMED). This paper is part of a supplemental issue funded by the Second University of Naples