Drug use and adverse event monitoring in German children
M A Lewis1, D Kühl-Habich, J von Rosen
1EPES Epidemiology, Pharmacoepidemiology and Systems Research, Berlin, Germany.
Insights
Adverse drug effects (AE) in children are generally mild, with about 1% of treatments causing mild to moderate AE. Direct practice recording yielded more AE reports than a sentinel system.
Area of Science:
- Pediatric Pharmacology
- Drug Safety Monitoring
- Real-World Evidence in Pediatrics
Background:
- Assessing drug use and adverse drug effects (AE) in pediatric populations is crucial for patient safety.
- Previous studies have highlighted challenges in AE detection and reporting in children.
- Understanding the incidence and nature of AE in children is essential for optimizing pharmacovigilance.
Purpose of the Study:
- To evaluate drug utilization and the incidence of mild to moderate adverse drug effects (AE) in children aged 0-16 years.
- To compare two different approaches for AE assessment in pediatric practice.
- To determine the real-world incidence of AE in a large pediatric cohort.
Main Methods:
- A drug utilization component (DUC) was implemented in 20 pediatric practices in Brandenburg, Germany, documenting diagnoses, prescriptions, and AE over 3 months for 14,000 children.
- A sentinel physician system involving 50 practices (36,000 children) also reported AE.
- Data analysis focused on diagnoses, drug prescriptions, and documented AE, with a specific focus on AE incidence and characteristics.
Main Results:
- The DUC involved 12,628 children, with 85% receiving 33,140 drug prescriptions. Common diagnoses included respiratory ailments, skin conditions, and infections.
- The incidence of mild to moderate adverse drug effects (AE) was estimated at approximately 1% of treatments (1,200 per 100,000 children over 3 months).
- AE were predominantly mild (83%), often occurred within 3 days of treatment initiation, and were frequently linked to antibiotics and immunizations. AE incidence decreased with age.
Conclusions:
- Underreporting of AE remains a significant challenge in pediatric pharmacovigilance, even with structured monitoring.
- While most AE in children are non-serious, approximately 1% of treatments may lead to mild AE requiring medical consultation.
- Direct recording of AE within pediatric practices proved more effective in generating reports compared to a sentinel physician system.
Objective:
To assess drug use and the incidence of mild to moderate adverse drug effects (AE) in children aged 0 - 16 years, with 2 different approaches.
Methods:
All 185 pediatric practices in the State of Brandenburg, Germany, were surveyed (95% positive response). A random sample of 50 practices servicing 36,000 children participated in the study as sentinel physicians reporting any AE among their patients. Twenty practices servicing 14,000 children were included in a drug utilization component (DUC) which documented diagnoses, prescribing and AE in all children seen in a 3-month period.
Results:
The results on the DUC are based on 12,628 children with 26,168 physician contacts, 34,465 diagnoses and 33,140 drug prescriptions given to 85% of the children seen (average age: 6.7 years). Practice size ranged from 94 to 1,473 children seen in a 3-month period. The average number of physician contacts per child was 2. 1, with 10% seeing a physician 5 times and more. The diagnoses were respiratory ailments (30%), skin- (12%), injection- (11%) and trauma- (10%) related diagnoses. Major drug uses were respiratory (34% of prescriptions), anti-infective (22%), dermatological (13%), gastrointestinal (9%) and psychotropic agents (8%). One hundred and fifty-two AE affecting 150 children were documented in the DUC, 60% of these occurring within 3 days after treatment initiation. 83% of AE were mild (up to 4 on a scale from I -6), and 85% were considered by physicians to be attributable. Only 4 reports of very severe events were received. 47% of reports were related to antibiotic uses, 31% to immunizations, 11% to respiratory, and 4% to gastrointestinal agents. While there are no differences in the occurrence of AE by gender, AE decreases significantly by age, maintaining the same patterns of AE type and causative medication. Over a 3-month period, the incidence of mild to moderate ADR in children given medications is estimated as 1,200 per 100,000, or about 1%.
Conclusions:
Underreporting of AE remains an issue even when a monitoring scheme suggests compliance. The results of this study show that while AE in children are generally non-serious, 1% of treatments might elicit mild AE leading to a consultation. Direct practice recording produces more reports than a sentinel system.
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