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Parental Perspectives and Acceptance Rates Regarding Off-Label Medication Use in Pediatric PatientsParents Show Mixed Views on Off-Label Drug Use for Children

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Key Takeaway
Clinicians should prioritize trust-centered communication to improve parental understanding and acceptance of off-label use.

This meta-analysis examines the perspectives of parents regarding the off-label use of medications in pediatric patients. The study identifies a notable gap in awareness, with only 20.2% of parents reporting awareness of off-label usage. This suggests a significant opportunity for clinicians to improve transparency during the informed consent process.

Data on acceptance rates show substantial variability, with conditional acceptance ranging from 20.6% to 85.1%. Conversely, unconditional acceptance was notably lower, and refusal rates were recorded at 36.5%. These figures indicate that while many parents are open to off-label options, their willingness is often contingent on specific clinical discussions and provider trust.

To improve patient outcomes, the study suggests shifting from procedural notification to trust-centered communication. Clinicians should focus on clear, transparent dialogue regarding the rationale for off-label prescriptions. Additionally, optimizing prescription and drug supply processes can reduce the administrative burden on parents, fostering a more collaborative and supportive care environment.

This review looked at how parents feel about using medications for their children that are not specifically approved for that age group or condition. The researchers analyzed several studies to understand how much parents know about these drugs and how they react when a doctor suggests them.

The results showed that only about 20.2% of parents were aware that a drug was being used off-label. While many parents might accept these medications under certain conditions, the rate of unconditional acceptance was much lower, at around 18.2% to 22.7%. Additionally, about 36.5% of parents reported refusing off-label options.

Because the data comes from a variety of different studies, the results are not definitive. The study highlights that communication between doctors and parents is very important. It suggests that doctors should focus on building trust and providing clear information to help parents make informed decisions about their child's care.

What this means for you:
Parents show varying levels of awareness and acceptance regarding off-label medications for their children.

Common questions

What percentage of parents know their child's medicine is off-label?

The study found that the awareness rate among parents regarding the off-label use of medications for their children was 20.2%. This means many parents may not realize a drug is being used outside of its standard approved purpose.

Do most parents accept off-label drugs for their children?

Acceptance rates varied. While conditional acceptance was reported between 20.6% and 85.1%, the rate of unconditional acceptance was much lower, ranging from 18.2% to 22.7%. About 36.5% of parents reported refusing off-label options.

How does this affect how doctors talk to parents?

The findings suggest that doctors should move toward trust-centered communication. Instead of just giving a procedural notice, doctors can work to build trust and simplify the process of getting and managing medications to reduce the burden on parents.

Study Details

Study typeMeta analysis
EvidenceLevel 1
PublishedSep 2026
View Original Abstract ↓
OBJECTIVE: To systematically evaluate parental awareness, acceptance, refusal rate and influencing factors of off-label use in children, aiming to provide evidence for optimising informed consent and physician-parent communication. METHODS: We searched PubMed, Web of Science, Elsevier ScienceDirect, CNKI, Wanfang and VIP from inception to March 2026 for observational, mixed-methods and qualitative studies on parental awareness, attitudes and decision-making about off-label use in children. A random-effects single-group rate meta-analysis pooled awareness and refusal rates; conditional acceptance rates were summarised narratively due to extreme heterogeneity in operational definitions; unconditional acceptance rates were reported as individual study estimates. Influencing factors and psychological experiences were synthesised thematically. RESULTS: Seven studies were included. The pooled parental awareness rate was 20.2% (95% CI: 10.6% to 31.9%), conditional acceptance ranged from 20.6% to 85.1% due to inconsistent operational definitions, unconditional acceptance was reported in two studies with individual estimates of 18.2% and 22.7%, and refusal was 36.5% (95% CI: 14.6% to 61.8%). Influencing factors fell into three themes: child clinical characteristics, parental cognition and emotion, and physician communication and qualification. CONCLUSION: Parental awareness of off-label use in children is low. Part of parents accept conditionally; unconditional acceptance is limited, and refusal rates are relatively high. These three themes interact throughout the decision-making process. Postdecision caregiving experiences may lead to long-term scepticism and influence future attitudes. In clinical practice, informed consent should shift from procedural notification to trust-centred communication. Prescription and drug supply processes should be optimised to reduce parental care burden.
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