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The Safety of Drug Therapy in Children
Stefan Wimmer1, Antje Neubert, Wolfgang Rascher
1Department of Paediatrics and Adolescent Medicine, Universitätsklinikum Erlangen.
Insights
Adverse drug reactions (ADRs) affect 1.7% of outpatient and 10% of hospitalized children in Germany. Improving drug administration processes and pediatric clinical trials is crucial for enhancing medication safety.
Area of Science:
- Pediatric pharmacology
- Drug safety and pharmacovigilance
- Healthcare quality improvement
Background:
- Adverse drug reactions (ADRs) affect a significant percentage of children in Germany, with an estimated 1.7% of outpatients and 10% of hospitalized children experiencing at least one ADR.
- The incidence of ADRs in pediatric populations highlights a critical area for medical intervention and research.
Purpose of the Study:
- To review the causes and prevention strategies for adverse drug reactions in pediatric patients.
- To identify areas for improvement in drug administration and clinical trial practices for children.
Main Methods:
- A selective literature search was conducted using PubMed to identify pertinent studies on pediatric adverse drug reactions.
- Analysis of reported cases submitted to the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ).
Main Results:
- Serious ADRs in children can result from overdoses, administration despite contraindications, inadequate monitoring, and medication errors (communication, labeling, administration).
- Off-label drug use significantly increases the risk of ADRs.
- Specific medications like dimenhydrinate, α-adrenergic nose drops, phosphate enemas, ACE inhibitors, sartans, and methylphenidate have been associated with serious ADRs.
- Preventive measures include computerized physician order entry systems, individual dose packaging, and barcode identification.
Conclusions:
- Optimizing drug administration through interventions and electronic support, tailored to local contexts, is essential for pediatric patient safety.
- Encouraging clinical trials in children, especially for off-patent drugs, and providing financial incentives are vital for improving drug safety.
- Physicians and pharmacists must adhere to reporting requirements for adverse reactions, particularly for new drugs, off-label use, and medication errors.
- A standardized national dosing system for computerized physician order entry is needed to facilitate evidence-based pediatric dosage calculations.
Background:
1.7% of children taking medication on an outpatient basis in Germany have at least one adverse drug reaction (ADR). The corresponding figure for hospitalized children is estimated at 10% .
Methods:
This review is based on pertinent literature retrieved by a selective search in PubMed.
Results:
According to reports submitted to the Drug Commission of the German Medical Association (Arzneimittelkommission der deutschen Ärzteschaft, AkdÄ), serious ADRs can arise, for example, after the administration of dimenhydrinate, α-adrenergic nose drops, enemas containing phosphate, ACE inhibitors, angiotensin-2-receptor antagonists (sartans), and methylphenidate. The causes of ADRs include overdoses, drug administration despite contraindications, and inadequate monitoring of long-term treatment. Errors can also be made in communication, labeling, and drug administration. The risk of ADRs is especially high in off-label use. Computerized physician order entry systems, individual packaging and labeling of single doses, and the use of bar codes for patient and drug identification can help prevent such errors.
Conclusion:
The process of drug administration should be optimized through suitable interventions and electronic support, with due consideration of local circumstances. Clinical trials on children should be encouraged as a means of improving drug safety, and additional financial incentives should be created for trials concerning drugs that are off-patent. Physicians and pharmacists should take care to report adverse reactions as they are required to do by professional code, particularly in the case of new drugs, off-label use, or medication errors. A recognized national standard for dosing that can be implemented in computerized physician order entry systems is needed so that evidence-based pediatric dosages can be calculated.
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