P13 Serious adverse reactions and off label and unlicensed drug use in children – decade of pharmacovigilance study in Serbia

• Published in: Archives of disease in childhood Vol. 104; no. 6; p. e22
• Main Authors: Bajcetic, M, Joksimovic, J
• Format: Journal Article
• Language: English
• Published: London BMJ Publishing Group LTD 01.06.2019
• Subjects: Age; Age groups; Antimicrobial agents; Children; Drug use; Medical equipment; Narcotics; Pediatrics; Pharmacovigilance; Safety; Side effects; Vaccines; Serbia
• ISSN: 0003-9888; 1468-2044
• DOI: 10.1136/archdischild-2019-esdppp.52

BackgroundOff label (OL) and unlicensed (UL) drug use in children is a widespread global problem. Previous study showed that only 66% of all available drugs for children is with licence in Serbia.1 Data on safety of medicines in children remain lacking, so the key intervention for the effective use of medicine is safety monitoring. Therefore, the aim of this study is to evaluate safety implication of OL and UL drug use in children up to 12 years old.MethodWe conducted a retrospective study based on reports of suspected adverse reactions (ADRs) collected from 2008. to 2018. by Medicines and Medical Devices Agency of Serbia, using the Medical Dictionary for Regulatory Activities and organized by System Organ Class. Sources of information about medicines including vaccines (license, drug formulation, etc.) are the Summary of Product Characteristics and Serbia´s official drug registry.ResultsWithin 10 years, we observed 1595 ADRs. Vaccines, antineoplastic and antimicrobial drugs were the most frequently pharmacotherapeutic subgroups involved. Out of total number of observed ADRs, 433 (28%) were serious; 189 of them led to hospitalization, 31 to life threatening conditions and 7 were fatal. More than a half (63%) of serious ADRs were detected in children for the age group of 28 days - 23 months, followed by the age group of 2 to 11 years (34%) and finally by age group of 0 to 27 days (3%). Serious ADRs were detected in boys (55%) as well as in girls (45%). Out of total number of registered only 3% (46) of ADRs were associated with off-label use; 18 of them were serious, 7 led to life threatening conditions and 3 were fatal.ConclusionThis research provided new insight on the factors such as OL and UL use, that might increase the risk of serious ADRs in children.ReferencesBo i B, Stupar S, Stupar D, Babi U, Bajčeti M. Availability of pediatric-evaluated formulations in Serbia. Indian J Pharmacol 2017 Mar-Apr;49(2):189–193Disclosure(s)Nothing to disclose