Parental reporting of adverse drug events and other drug-related problems in children in Finland
Lindell-Osuagwu, Leena; Sepponen, Kati; Farooqui, S; Kokki, Hannu; Hämeen-Anttila, Katri; Vainio, Kirsti (2013)
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Lindell-Osuagwu, Leena
Sepponen, Kati
Farooqui, S
Kokki, Hannu
Hämeen-Anttila, Katri
Vainio, Kirsti
2013
European Journal of Clinical Pharmacology : 4
Tiivistelmä
Purpose Drug-related problems (DRPs) are common in
paediatric pharmacotherapy, but few studies describe them
from the parents’ perspective. In the present survey, we have
investigated the lifetime prevalence and type of DRPs in
children in Finland.
Methods This was a population-based survey of a random
sample of 6,000 children below 12 years of age in 2007. A
questionnaire was sent to their parents. The final response
rate was 67% with a study population of 4,032. The main
outcome measure was the lifetime prevalence and type of
DRPs.
Results The lifetime prevalence of DRPs was 21% (95% CI
20–22). The most common (82%) of the 1,346 reported
DRPs were adverse drug events (ADEs). The prevalence
of ADEs was 17% (95% CI 16–19), that of other DRPs
5.2% (95% CI 4.5–5.9). The prevalence of serious ADEs
was 0.4% and that of unexpected ADEs was 0.8%. The most
common system involved in the ADEs was the gastrointestinal
tract, comprising 34% of the 1,106 ADEs. The most
common of the 240 other DRPs were problems with the
administration and dosing of medicine (86%). Overall, 64%
of DRPs were related to anti-infectives.
Conclusions One fifth of the Finnish children below
12 years of age had experienced DRPs. Appropriate
counselling, including possible adverse drug reactions and
dosing directions, is important for parents and children at
both the prescribing and dispensing of medicines for paediatric
patients. Reporting of any suspected serious or unexpected
ADEs is an essential part of efficient pharmacovigilance in
paediatrics.
paediatric pharmacotherapy, but few studies describe them
from the parents’ perspective. In the present survey, we have
investigated the lifetime prevalence and type of DRPs in
children in Finland.
Methods This was a population-based survey of a random
sample of 6,000 children below 12 years of age in 2007. A
questionnaire was sent to their parents. The final response
rate was 67% with a study population of 4,032. The main
outcome measure was the lifetime prevalence and type of
DRPs.
Results The lifetime prevalence of DRPs was 21% (95% CI
20–22). The most common (82%) of the 1,346 reported
DRPs were adverse drug events (ADEs). The prevalence
of ADEs was 17% (95% CI 16–19), that of other DRPs
5.2% (95% CI 4.5–5.9). The prevalence of serious ADEs
was 0.4% and that of unexpected ADEs was 0.8%. The most
common system involved in the ADEs was the gastrointestinal
tract, comprising 34% of the 1,106 ADEs. The most
common of the 240 other DRPs were problems with the
administration and dosing of medicine (86%). Overall, 64%
of DRPs were related to anti-infectives.
Conclusions One fifth of the Finnish children below
12 years of age had experienced DRPs. Appropriate
counselling, including possible adverse drug reactions and
dosing directions, is important for parents and children at
both the prescribing and dispensing of medicines for paediatric
patients. Reporting of any suspected serious or unexpected
ADEs is an essential part of efficient pharmacovigilance in
paediatrics.
Kokoelmat
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