Investigation on the current situation : Pediatric off-label drug use in Chinese Hospitals

Investigation on the current situation : Pediatric off-label drug use in Chinese Hospitals | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Investigation on the current situation : Pediatric off-label drug use in Chinese Hospitals Yueqin Zhang, Xuelin Sun, Dong Wang, Yiming Hua, Gang Wang, Nelson Ramalho This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7351063/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 29 Oct, 2025 Read the published version in International Journal of Clinical Pharmacy → Version 1 posted 9 You are reading this latest preprint version Abstract Introduction Off-label prescribing, use of medications outside approved indications, dosages, administration routes, or age groups is common in pediatric clinical practice, largely because of the lack of high-quality clinical trials in children. Although such prescriptions can meet urgent therapeutic needs, particularly in complex or rare pediatric conditions, they also raise significant concerns regarding safety, effectiveness, and medicolegal liability. Limited research has examined the behavioral factors that influence pediatricians’ decisions to prescribe off-label drugs. Aim This study aimed to identify the behavioral determinants of pediatricians’ off-label drug use in Chinese hospitals by applying the Theory of Planned Behavior (TPB) to assess how attitudes, subjective norms, and perceived behavioral control influence prescribing intentions and behaviors. Methods A cross-sectional survey was conducted among pediatricians from 40 hospitals across seven provinces and municipalities in China. A TPB-based questionnaire was developed and refined through expert panel review and pilot testing. Psychometric properties were evaluated using reliability testing and confirmatory factor analysis (CFA). Structural equation modeling (SEM) was used to test the hypothesized relationships among the TPB constructs. Results Most pediatricians acknowledged the necessity (82.4%) and risks (78.9%) of off-label use. Attitudes reflecting perceived benefits, safety concerns, and cost implications significantly predicted behavioral intention (β = 0.32, p < 0.01). Perceived behavioral control, including barriers such as outdated labeling, lack of pediatric formulations, and limited data, also predicted intention (β = 0.30, p < 0.01), but not behavior directly (β = 0.08, p = 0.12). Subjective norms such as institutional expectations and peer influence were positively associated with intention (β = 0.28, p < 0.01). Behavioral intention was the strongest predictor of actual off-label prescription behaviors (β = 0.41, p < 0.001). Most pediatricians (85.2%) supported pharmacists’ involvement in evidence reviews, documentation, and prescription oversight. The SEM demonstrated a good model fit (CFI = 0.94, RMSEA = 0.065, SRMR = 0.045). Conclusion Pediatric off-label prescribing in China is largely intention-driven and shaped by attitudes, perceived control, and professional norms. Interventions targeting these behavioral domains, along with institutional policies and pharmacist collaboration, may enhance the safety, consistency, and regulatory oversight of off-label use in pediatric care. Off-Label Use Pediatrics Drug Prescriptions Physician Practice Patterns Pharmacists Behavioral Medicine Cross-Sectional Studies Theory of Planned Behavior Figures Figure 1 Impacts on practice This study validated the application of the Theory of Planned Behavior (TPB) to understand and influence pediatricians’ off-label prescriptions, supporting its use in designing targeted behavior-change interventions. The findings emphasize the significance of institutional norms and peer expectations, suggesting that hospitals should implement standardized protocols and internal review mechanisms to promote safe and consistent off-label use. These results highlight the essential role of pharmacists in supporting off-label prescription through evidence appraisal, documentation, and prescription oversight, reinforcing the need for interdisciplinary collaboration in pediatric medication management. Introduction Off-label drug use, also referred to as unlabeled or out-of-label use, describes the prescription of pharmaceutical agents for indications, dosages, routes of administration, or age groups not approved by regulatory authorities or specified in product labeling [ 1 ]. Off-label prescribing in children is widespread globally and is particularly prevalent in high-risk settings such as intensive care units and oncology wards. Reported rates of adverse drug reactions (ADRs) associated with off-label use range from 23–60% [ 2 , 3 ], largely because of the limited availability of clinical trials involving pediatric populations [ 4 ]. In the absence of age-specific evidence, pediatricians often rely on clinical experience, expert consensus, or extrapolated data to make prescription decisions. Multiple studies have documented both the high prevalence and potential safety risks associated with off-label pediatric use. For example, a review of 158 medication errors in British children’s hospitals from 2004 to 2006 found that 20 were classified as moderately harmful, 60% of which were associated with off-label prescription [ 5 , 6 ]. Inappropriate or unsupported off-label use can increase the likelihood of ADRs, therapeutic failure, or medicolegal complications [ 7 , 8 ]. Conversely, when guided by clinical rationale and supported by available evidence, off-label prescriptions may fulfill critical therapeutic needs and improve pediatric outcomes [ 7 , 9 ]. Despite its prevalence, pediatric off-label prescriptions remain under-regulated and inconsistently monitored in many healthcare systems, including China. Although some policy initiatives have emerged to promote rational prescribing, limited attention has been paid to the psychological and contextual factors that influence physicians’ prescribing decisions. The Theory of Planned Behavior (TPB) offers a well-established framework for understanding and predicting health professionals’ actions [ 10 ]. TPB posits that behavioral intention is the immediate antecedent of behavior, shaped by three core constructs: attitude (e.g., perceived benefit vs. risk), subjective norms (e.g., perceived expectations from peers or institutions), and perceived behavioral control (e.g., perceived ease or difficulty of performing the behavior due to external or internal factors) [ 11 ]. These constructs are underpinned by the corresponding behavioral, normative, and control beliefs, which ultimately influence intention and behavior. The TPB has been widely applied in healthcare settings to assess behavioral drivers among health professionals, for example, in evaluating pharmacists’ use of prescription drug monitoring programs [ 12 , 13 ] and physicians’ adherence to clinical guidelines [ 14 , 15 ]. Few studies have systematically applied TPB to understand how regulatory, institutional, and patient-related factors interact with psychological drivers in shaping off-label prescribing behavior among pediatricians. Aim This study aimed to identify the behavioral determinants of pediatricians’ off-label drug use in Chinese hospitals by applying the Theory of Planned Behavior to assess how attitudes, subjective norms, and perceived behavioral control influence prescribing intentions and behaviors. Method Study Design and Participants This cross-sectional, questionnaire-based study was guided by TPB, which provides a framework for understanding how behavioral attitudes (BA), subjective norms (SN), and perceived behavioral control (PBC) influence prescribing intentions and behavior. This study targeted pediatricians using stratified purposive sampling to ensure geographic and institutional diversity. Questionnaires were distributed to pediatricians with at least one year of prescribing experience, who provided informed consent. Questionnaire Development The questionnaire was developed in alignment with the four core constructs of TPB: BA, SN, PBC, and behavioral intention (BI) [ 12 , 16 ]. Items were generated based on previous TPB studies in healthcare settings [ 17 – 19 ] and adapted to reflect the common challenges in pediatric off-label prescribing in China. Content validity was ensured through an expert panel review of pediatricians, clinical pharmacists, pharmacologists, and epidemiologists of the Pediatric Society of the Chinese Medical Association. Two rounds of expert consultation and pilot testing with 15 pediatricians were conducted to assess item clarity and relevance, leading to refinement of the survey instrument. The final questionnaire comprised four sections: (1) demographics and professional background (five items); (2) experiences, perceived causes, and risks of off-label prescription (nine items); (3) legal and regulatory awareness (five items); and (4) TPB-based items assessing BA, SN, PBC, and BI (13 items). A standardized definition of off-label use was provided at the beginning to ensure consistent interpretation across respondents. The full questionnaire is provided in Supplemental Material . Supplemental Table 1 links the item codes used in the text and analyses (e.g., 29c, 8d) to the corresponding questionnaire items and response scales. Operationalization of Theory of Planned Behavior Constructs Each domain of the TPB was operationalized using a multi-item questionnaire tailored to the context of pediatric off-label drug use in China. The standard TPB model ( Supplemental Fig. 1 ) includes three core psychological constructs: BA, SN, and PBC, which collectively shape BI and ultimately predict Actual Behavior (TBODU). An extended TPB model (Fig. 1) was adopted to incorporate contextual factors such as national regulations, hospital policies, and patient-level influences, which may indirectly shape pediatricians’ cognitive, normative, and control-related beliefs. The constructs were measured as follows ( Supplemental Fig. 2, Supplemental Table 1, Supplemental Material ). BA: Pediatricians’ cognitive and emotional evaluations of off-label prescribing were captured by items assessing use in rare or refractory conditions (29c), reference to foreign pharmacopoeias and unupdated local guidelines (29b), classification of general vs. high-risk drugs (29a), responsibility for contraindicated use (17c), and financial burden on patients (9c). SN: Assessed social and institutional expectations through items on reporting high-risk drug use (34f), reliance on clinical experience (34c), emphasis on pharmacological expertise (34b), and strengthening professional self-discipline (34a). PBC: Captured perceived prescribing barriers, such as lack of pediatric-specific evidence and guidance (6a), outdated labeling (6h), and formulation limitations (6 g). BI: Measured by the likelihood of prescribing off-label drugs under certain conditions, including alignment with national treatment standards (8b), inclusion in international guidelines (8c), support from expert consensus or clinical evidence (8d), lack of organizational oversight (19c), and cost to the healthcare system (9d). Behavior (TBODU): Captured perceived risks associated with off-label prescriptions, including ADRs (14a), medical disputes (14b), and cost-related disputes (14c). Confirmatory factor analysis (CFA) and structural equation modeling (SEM) were used to evaluate construct validity and test the hypothesized relationships between the TPB domains ( Supplemental Fig. 2 ). Data Collection Data were collected between February 2025, and April 2025. Questionnaires were distributed either on-site or electronically through designated contacts at the participating hospitals. Completed responses were collected and only fully completed questionnaires that met the inclusion criteria were retained for analysis. No personally identifiable information was collected and all responses were anonymized to ensure confidentiality. Data Analysis Data were entered into Epidata 3.1, using double-entry verification, and analyzed using SPSS version 18.0. Descriptive statistics were used to summarize respondent characteristics and item responses. Internal consistency reliability for each TPB construct was assessed using Cronbach’s alpha. Exploratory factor analysis was conducted to assess the construct validity and underlying structure of the TPB domains. SEM was developed using AMOS software to test the theoretical pathways among the TPB constructs. Model fit was evaluated using standard indices, including chi-square, comparative fit index (CFI > 0.90), Root Mean Square Error of Approximation (RMSEA < 0.08), and Standardized Root Mean Square Residual (SRMR < 0.08). Ethics approval This study was reviewed and confirmed by the Ethics Committee of Beijing Aerospace General Hospital to meet the criteria for exemption from a full ethics review (filing no. 2025-40). Results Participant Characteristics A total of 350 questionnaires were distributed, of which 320 were returned (response rate: 91.4%). After excluding two incomplete responses, 318 valid questionnaires were included in the final analysis. The respondents were pediatricians from 40 hospitals across seven provinces and municipalities in China ( Supplemental Fig. 3 ). Among them, 39.9% held junior professional titles, 29.3% held intermediate titles, and 30.8% held senior titles. Participants were evenly distributed across tertiary children’s hospitals, general hospitals, and other healthcare institutions ( Supplemental Fig. 4 ). Internal Consistency and Construct Validity The TPB constructs demonstrated good internal consistency, with Cronbach’s alpha coefficients ranging from 0.78 to 0.89 across BA, SN, PBC, and BI. The CFA, as shown in Supplemental Fig. 2 , supported the hypothesized four-factor structure. The Kaiser-Meyer-Olkin (KMO) measure was 0.84, and Bartlett’s test of sphericity was significant (χ² = 2663.91, p 0.60) on their respective latent factors with minimal cross-loadings. These results confirmed the construct validity of the TPB-based instrument and its suitability for SEM. Structural Equation Model Based on the Extended TPB Framework The extended TPB model (Fig. 1) demonstrated a good fit (CFI = 0.94, RMSEA = 0.065, SRMR = 0.045) and explained the key pathways between psychological constructs and behavior. As illustrated in Supplemental Fig. 2 , BA (β = 0.51), PBC (β = 0.26), and SN (β = 0.07) positively influenced BI, which in turn significantly predicted off-label prescribing behavior (TBODU) (β = 0.44). The direct path from PBC to behavior was not statistically significant (β = 0.16), suggesting a mediating effect through BI. Validated questionnaire items (e.g., 29c, 8d, 6a, 14a) were used to measure each construct. Behavioral Attitude: Perceptions of Off-Label Prescribing Most pediatricians regarded both patient- and system-level costs as important considerations when prescribing off-label medications, with 87.7% rating patient cost and 95.5% rating health system cost as “somewhat important” or “very important.” Ethical responsibility was strongly emphasized; 86.0% agreed that off-label drugs should not be used if contraindicated, even when informed consent was obtained. Regarding context-specific perspectives, 90.8% supported distinguishing between general and high-risk drugs, 93.1% agreed to consider foreign pharmacopoeias and guidelines not yet updated in China, and 87.0% endorsed differentiated use of rare or refractory diseases ( Table 1 ). These findings reflect a predominantly cautious and ethically grounded approach to off-label prescription, balancing clinical necessity with safety and regulatory considerations. Subjective Norms: Social Pressures Influencing Prescribing Most pediatricians reported a strong normative support for rational and cautious off-label prescriptions. Nearly all respondents (98.7%) agreed that enhancing professional knowledge, including pharmacology, efficacy, toxicity, and adverse effects, was essential, and 86.5% strongly agreed. Similarly, 98.7% endorsed improving self-discipline to prevent drug misuse and 82.7% strongly agreed. The need to report high-risk drug use to superiors was supported by 98.7% of the participants, while 98.1% emphasized the importance of sufficient clinical experience before engaging in off-label prescribing ( Table 2 ). These findings highlight the substantial influence of institutional expectations, peer norms, and professional self-regulation on pediatricians’ prescription behaviors. Behavioral Intention: Willingness to Prescribe Off-Label Most pediatricians expressed a willingness to prescribe off-label medications when supported by authoritative guidance or credible evidence. Specifically, 75.3% agreed that inclusion in Chinese diagnostic and treatment standards justified off-label prescription, with nearly half (48.7%) strongly agreeing. Foreign diagnostic and treatment norms were viewed more cautiously, with only 52.4% agreeing and 13.9% strongly agreeing. When off-label use was supported by expert consensus or clinical trial evidence, 72.5% expressed willingness, including 55.4%, who moderately agreed. In contrast, a strong majority (76.5%) disagreed with prescribing without informed consent because of a lack of organizational oversight ( Table 3 ). These findings indicate that pediatricians’ intentions are firmly grounded in formal guidelines and evidence-based recommendations, while ethical safeguards such as informed consent remain decisive factors. Perceived Behavioral Control and Associated Barriers Pediatricians have identified multiple structural and regulatory barriers influencing their ability to prescribe off-label medications. The most frequently cited limitation was the delay in updating drug instructions despite the inclusion of new indications in the pharmacopoeia and disease guidelines, with 80.2% agreeing and 31.9% strongly agreeing. Another closely related concern, older drugs with new indications not included in pharmacopoeia or guidelines and not reflected in updated instructions, yielded nearly identical results, with 81.1% agreement and 36.1% strong agreement. In addition, 71.5% of the participants agreed that limitations in pharmaceutical preparations restricted the availability of suitable pediatric dosage forms ( Table 4 ). These findings highlight systemic constraints, particularly regulatory delays in revising instructions and formulation shortages, as key determinants of perceived behavioral control in pediatric off-label prescribing. Perceived Risks and Off-Label Prescribing Behavior (TBODU) Pediatricians perceived ADRs as the most likely hazard associated with off-label prescribing, with 92.7% rating this outcome as moderately or very probable, including 69.8% who selected “very probable.” Medical disputes were also viewed as a substantial risk, with 87.9% considering them moderately or very probable. Cost-related disputes were perceived as somewhat less likely, but still notable, with 79.1% rating them as moderately or very probable ( Table 5 ). These findings suggest that pediatricians are acutely aware of the medicolegal and financial implications of off-label prescriptions, with safety concerns and potential conflicts representing key behavioral deterrents. Pharmacists’ Role in Off-Label Drug Use The majority (85.2%) affirmed the pharmacists’ essential role in promoting safe off-label prescriptions. The most supported roles were documentation and feedback (74.2%), synthesizing clinical evidence (72.0%), conducting prescription reviews (57.6%) and facilitating co-signatures (56.0%). These findings support the integration of pharmacists into interdisciplinary decision making to ensure evidence-based and rational drug use. Discussion This study investigated the behavioral determinants of pediatric off-label drug use in Chinese hospitals using the TPB framework. The structural equation model provided empirical support for the TPB, confirming that behavioral intention mediates the effects of attitude, subjective norms, and perceived behavioral control on prescribing behavior. These findings advance the understanding of prescribing decision-making in resource-limited and guideline-constrained pediatric settings. Major Findings The results demonstrated that positive behavioral attitudes and greater perceived behavioral control significantly increased pediatricians’ intentions to prescribe off-label medications. Behavioral intention emerged as the strongest predictor of actual prescribing behavior, whereas perceived control had no direct effect, reinforcing intention as the central mediating construct in the TPB framework. Most pediatricians considered off-label use necessary in certain clinical contexts but approached it with caution due to perceived risks. Willingness to prescribe off-label increased when supported by clinical guidelines, expert consensus, or trial-based evidence. In contrast, physicians were reluctant to prescribe off-label drugs in the absence of informed consent or institutional supervision. These findings align with international research highlighting the complexities of pediatric pharmacotherapy and clinicians' cautious balancing of benefits, evidence, and risks [ 20 , 21 ]. The study also revealed strong support for pharmacist involvement in the off-label prescription process. Pediatricians emphasized the importance of pharmacists in documentation, evidence synthesis, and prescription reviews, highlighting the value of interprofessional collaboration. These findings are consistent with global initiatives advocating for increased pharmacist engagement in pediatric prescriptions to reduce medication errors and optimize outcomes. Hospital-based studies have shown that clinical pharmacists intercept a substantial proportion of medication errors, further validating this recommendation [ 22 ]. Interpretation in Context This study extends the existing literature by applying a validated behavioral model to explore the cognitive, normative, and control-related drivers of off-label prescriptions. Although off-label use in children has been widely reported, primarily because of the lack of pediatric-specific formulations or clinical data [ 23 , 24 ], few studies have systematically examined the behavioral mechanisms guiding such decisions. Our results are consistent with Ajzen’s proposition that behavioral intention is an immediate antecedent of behavior [ 18 ]. Interventions that cultivate favorable attitudes or enhance perceived control, such as clear institutional policies, peer support, and pharmacist involvement, may increase intentions and improve prescription practices. Furthermore, the cautious approach observed among pediatricians reflects heightened awareness of medicolegal risks, which may vary depending on national regulations and institutional safeguards. The model fit indices (CFI = 0.94, RMSEA = 0.065, SRMR = 0.045) supported the robustness of the structural model and confirmed that the extended TPB framework was appropriate for assessing prescribing behavior in this context. Moreover, the inclusion of pediatricians from 40 hospitals across seven provinces enhances the generalizability of our findings and provides insight into prescribing behavior across diverse institutional and geographic settings within China. These findings are consistent with recent international guidelines recommending multidisciplinary evidence-based approaches to off-label pediatric prescriptions. The inclusion of contextual variables, such as legal frameworks and hospital-level procedures, adds nuance to the TPB model and reflects the complex real-world environment in which pediatricians operate. Policy and Practice Implications This study has several implications for both clinical governance and medication safety. Given the ongoing gaps in drug labeling and scarcity of pediatric formulations, healthcare institutions should consider developing internal protocols or formularies to support evidence-based off-label prescriptions. Embedding pharmacists in a prescription workflow can further promote safety through real-time documentation, literature appraisal, and risk mitigation. Training programs grounded in TPB may also be effective in shifting clinician behavior by targeting attitudes, normative influences, and control beliefs. National policy frameworks should incorporate structured decision-making tools such as standardized prescribing checklists or off-label justification templates to ensure consistency and accountability. Finally, integrating electronic prescribing systems with clinical decision support features may help address medicolegal concerns and enhance transparency in prescribing practices. Strengths A key strength of this study is its theory-driven design, which enabled the systematic evaluation of both the psychological and contextual determinants of off-label prescriptions. The use of SEM allowed for a nuanced analysis of the interrelationships among TPB constructs. Additionally, the geographically diverse and institutionally representative sample increases the relevance of the findings across China's varied healthcare landscapes. Limitations This study had several limitations. First, reliance on self-reported data may introduce a response bias, especially given the legal and ethical sensitivity of off-label prescriptions. Second, although the questionnaire underwent expert review and pilot testing, its test-retest reliability and external validation were not assessed, which may have affected its reproducibility. Third, the cross-sectional nature of the study limits causal inferences. Future longitudinal or interventional research is warranted to assess the temporal dynamics and impact of targeted interventions. Lastly, the perspectives of other stakeholders, such as pharmacists, nurses, and administrators, were not captured and should be included in future studies to gain a more comprehensive understanding of off-label medication use in pediatric settings. Conclusion Using the Theory of Planned Behavior, this study identified behavioral intention as the primary driver of pediatric off-label prescribing, shaped by attitudes, subjective norms, and perceived control. These findings highlight the need for institutional policies, pharmacist collaboration, and decision-support tools to promote safe, consistent, and evidence-based off-label drug use in pediatric care. Declarations Acknowledgments The authors thank all participating pediatricians across China for their valuable time and contribution to completing the questionnaire, which made this study possible. Funding None. Competing Interests The authors declare no conflicts of interest. Author contributions Conceptualization: YZ, NR; Methodology: NR, YZ; Investigation: GW, YH; Formal analysis: DW, XS; Writing – Original Draft: YZ, YH; Writing – Review and Editing: YZ, NR, GW; Supervision: YZ, NR; Project administration: DW, XS. All authors have read and approved the final manuscript. Data Availability The datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request. Ethics Approval This study was reviewed and confirmed by the Ethics Committee of Beijing Aerospace General Hospital to meet the criteria for exemption from a full ethics review (filing no. 2025-40, filing date: May 25, 2024). References Si W, Ma P. Judicial and legislative practice and related suggestions on off-label drug use in China. BMC Health Serv Res. 2023;23(1):312. Cuzzolin L, Atzei A, Fanos V. 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Behavioral attitudes of pediatricians toward off-label prescribing (n = 318) Questionnaire Item Response Category Score n % Importance of cost to patient Not important at all 1 0 0.0 Somewhat unimportant 2 1 0.3 Neither important nor unimportant 3 38 12.0 Somewhat important 4 211 66.6 Very important 5 67 21.1 Importance of cost to health system Not important at all 1 0 0.0 Somewhat unimportant 2 0 0.0 Neither important nor unimportant 3 14 4.5 Somewhat important 4 260 82.8 Very important 5 40 12.7 Responsibility when contraindicated despite informed consent Strongly disagree 1 18 5.7 Moderately disagree 2 25 7.9 Neutral 3 1 0.3 Moderately agree 4 146 46.4 Strongly agree 5 125 39.7 View off-label use differently: general vs. high-risk drugs Strongly disagree 1 29 9.2 Moderately disagree 2 0 0.0 Neutral 3 0 0.0 Moderately agree 4 65 20.7 Strongly agree 5 220 70.1 View off-label use differently: foreign pharmacopoeia & guidelines not updated in China Strongly disagree 1 21 6.6 Moderately disagree 2 1 0.3 Neutral 3 0 0.0 Moderately agree 4 108 34.0 Strongly agree 5 188 59.1 View off-label use differently: rare/refractory vs. common diseases Strongly disagree 1 24 7.6 Moderately disagree 2 5 1.6 Neutral 3 12 3.8 Moderately agree 4 101 32.1 Strongly agree 5 173 54.9 Table 2. Subjective norms of pediatricians toward off-label prescribing (n = 318) Questionnaire Item Response Category Score n % Raise the level of professional knowledge, including pharmacology, efficacy, toxicity, and side effects Strongly disagree 1 0 0.0 Moderately disagree 2 4 1.26 Neutral 3 0 0.0 Moderately agree 4 39 12.26 Strongly agree 5 275 86.48 Increase self-discipline to avoid drug abuse Strongly disagree 1 0 0.0 Moderately disagree 2 4 1.26 Neutral 3 0 0.0 Moderately agree 4 51 16.04 Strongly agree 5 263 82.70 Report the use of high-risk drugs to superiors for record-keeping Strongly disagree 1 0 0.0 Moderately disagree 2 4 1.26 Neutral 3 0 0.0 Moderately agree 4 55 17.29 Strongly agree 5 259 81.45 Have sufficient clinical experience before off-label drug use to avoid random prescribing Strongly disagree 1 0 0.0 Moderately disagree 2 4 1.26 Neutral 3 0 0.0 Moderately agree 4 63 19.81 Strongly agree 5 251 78.93 Table 3. Behavioral intention of pediatricians toward off-label prescribing (n = 318) Questionnaire Item Response Category Score n % Prescribing basis: included in Chinese diagnostic and treatment standards Strongly disagree 1 52 16.46 Moderately disagree 2 26 8.23 Neutral 3 0 0.0 Moderately agree 4 84 26.58 Strongly agree 5 154 48.73 Prescribing basis: included in foreign diagnostic and treatment norms Strongly disagree 1 50 15.77 Moderately disagree 2 70 22.08 Neutral 3 31 9.78 Moderately agree 4 122 38.49 Strongly agree 5 44 13.88 Prescribing basis: not regulated but supported by expert advice or clinical trial evidence Strongly disagree 1 52 16.45 Moderately disagree 2 35 11.08 Neutral 3 0 0.0 Moderately agree 4 175 55.38 Strongly agree 5 54 17.09 Reason to prescribe without informed consent: lack of organizational concern Strongly disagree 1 178 57.24 Moderately disagree 2 60 19.29 Neutral 3 11 3.54 Moderately agree 4 61 19.61 Strongly agree 5 1 0.32 Table 4. Perceived behavioral control of pediatricians toward off-label prescribing (n = 318) Questionnaire Item Response Category Score n % Older drugs with new indications already included in pharmacopoeia and disease guidelines, but not yet reflected in updated drug instructions Strongly disagree 1 40 12.6 Moderately disagree 2 13 4.10 Neutral 3 10 3.2 Moderately agree 4 153 48.3 Strongly agree 5 101 31.9 Limitations in pharmaceutical preparations leading to fewer pediatric dosage forms Strongly disagree 1 33 10.6 Moderately disagree 2 39 12.5 Neutral 3 17 5.5 Moderately agree 4 142 45.51 Strongly agree 5 81 25.96 Older drugs with new indications not included in pharmacopoeia and disease guidelines, and not yet reflected in updated drug instructions Strongly disagree 1 38 12.14 Moderately disagree 2 11 3.51 Neutral 3 10 3.20 Moderately agree 4 141 45.05 Strongly agree 5 113 36.10 Table 5. Perceived risks and off-label prescribing behavior (TBODU) of pediatricians (n = 318) Questionnaire Item Response Category Score n % Risk of adverse drug reactions Very improbable 1 8 2.5 Moderately improbable 2 1 0.3 50/50 probability 3 14 4.4 Moderately probable 4 72 22.9 Very probable 5 220 69.8 Increase in medical disputes Very improbable 1 8 2.5 Moderately improbable 2 0 0.0 50/50 probability 3 30 9.5 Moderately probable 4 64 20.3 Very probable 5 214 67.7 Disputes over increased drug costs Very improbable 1 8 2.5 Moderately improbable 2 2 0.6 50/50 probability 3 56 17.7 Moderately probable 4 90 28.5 Very probable 5 160 50.6 Additional Declarations No competing interests reported. Supplementary Files SupplementalMaterial.zip Cite Share Download PDF Status: Published Journal Publication published 29 Oct, 2025 Read the published version in International Journal of Clinical Pharmacy → Version 1 posted Editorial decision: Revision requested 28 Aug, 2025 Reviews received at journal 27 Aug, 2025 Reviews received at journal 25 Aug, 2025 Reviewers agreed at journal 18 Aug, 2025 Reviewers agreed at journal 17 Aug, 2025 Reviewers invited by journal 15 Aug, 2025 Editor assigned by journal 12 Aug, 2025 Submission checks completed at journal 12 Aug, 2025 First submitted to journal 11 Aug, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-7351063","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":501671314,"identity":"3ef969f1-17bb-4b49-9a02-0ef1eb4da7b3","order_by":0,"name":"Yueqin Zhang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA0klEQVRIiWNgGAWjYDACCQiVwNje2PjgA2laeg43G84gSQuDRHqbNAcxOuRnNz97+LXNOo955sMGaQYGOzndBgJaGOccMzeWbUsvZpyd2GBcwJBsbHaAgBZmiQQzacm2w4mNQC3JMxgOJG4jpIVNIv0bRMvMgw2HeYjRwiORYyb5EaRlBmNjM1FaJCRyyqQZzgH90pPYzDjDgAi/yM9I3yb5o8w6z7D9+PMfHyrs5AhqAQFmXjZmBsMGENOACOUgwPjjDzODPJGKR8EoGAWjYAQCAB66RQHDsZGoAAAAAElFTkSuQmCC","orcid":"","institution":"Beijing Aerospace General Hospital","correspondingAuthor":true,"prefix":"","firstName":"Yueqin","middleName":"","lastName":"Zhang","suffix":""},{"id":501671315,"identity":"64008357-9695-4ae1-a41f-d553b05b2256","order_by":1,"name":"Xuelin Sun","email":"","orcid":"","institution":"Beijing Hospital","correspondingAuthor":false,"prefix":"","firstName":"Xuelin","middleName":"","lastName":"Sun","suffix":""},{"id":501671316,"identity":"b7d1caf7-ef00-4737-9d9d-a891680cace6","order_by":2,"name":"Dong Wang","email":"","orcid":"","institution":"Southern Medical University","correspondingAuthor":false,"prefix":"","firstName":"Dong","middleName":"","lastName":"Wang","suffix":""},{"id":501671317,"identity":"88dc8827-84b3-4977-bfaf-a735a32d7fb6","order_by":3,"name":"Yiming Hua","email":"","orcid":"","institution":"Xuanwu Hospital Capital Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yiming","middleName":"","lastName":"Hua","suffix":""},{"id":501671318,"identity":"ccc5e299-87a4-4b05-9a0b-b6e285f8e893","order_by":4,"name":"Gang Wang","email":"","orcid":"","institution":"Beijing Aerospace General Hospital","correspondingAuthor":false,"prefix":"","firstName":"Gang","middleName":"","lastName":"Wang","suffix":""},{"id":501671319,"identity":"9f50f0a1-2abd-4166-a286-a357f6d408ff","order_by":5,"name":"Nelson Ramalho","email":"","orcid":"","institution":"Southern Medical University","correspondingAuthor":false,"prefix":"","firstName":"Nelson","middleName":"","lastName":"Ramalho","suffix":""}],"badges":[],"createdAt":"2025-08-12 04:08:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7351063/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7351063/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1007/s11096-025-02032-9","type":"published","date":"2025-10-29T15:58:10+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":89972160,"identity":"4a982a59-a57d-4cc1-b931-cbf19f862b74","added_by":"auto","created_at":"2025-08-27 05:39:27","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":229173,"visible":true,"origin":"","legend":"\u003cp\u003eContextualized Theory of Planned Behavior (TPB) Model of Pediatricians’ Off-Label Prescribing.\u003c/p\u003e\n\u003cp\u003eThe model illustrates how behavioral beliefs (e.g., efficacy and therapeutic outcomes), normative influences (e.g., peer and institutional expectations), and control beliefs (e.g., regulatory and hospital constraints) shape pediatricians’ attitudes, subjective norms, and perceived behavioral control, which in turn influence behavioral intention and actual off-label prescribing behavior.\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7351063/v1/8c60cd91a887274e6facc75b.png"},{"id":95040022,"identity":"a6d5f414-e10a-4332-83c1-916d6971d4a5","added_by":"auto","created_at":"2025-11-03 16:07:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1411256,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7351063/v1/eb2987c6-939f-48e0-81a3-1ae733ad1ca9.pdf"},{"id":89972164,"identity":"0ae78bbc-4013-4bdb-ba0b-93e66a626606","added_by":"auto","created_at":"2025-08-27 05:39:27","extension":"zip","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":256392,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementalMaterial.zip","url":"https://assets-eu.researchsquare.com/files/rs-7351063/v1/24f79d9217f04f216363d51f.zip"}],"financialInterests":"No competing interests reported.","formattedTitle":"Investigation on the current situation : Pediatric off-label drug use in Chinese Hospitals","fulltext":[{"header":"Impacts on practice","content":"\u003cul\u003e\n \u003cli\u003eThis study validated the application of the Theory of Planned Behavior (TPB) to understand and influence pediatricians\u0026rsquo; off-label prescriptions, supporting its use in designing targeted behavior-change interventions.\u003c/li\u003e\n \u003cli\u003eThe findings emphasize the significance of institutional norms and peer expectations, suggesting that hospitals should implement standardized protocols and internal review mechanisms to promote safe and consistent off-label use.\u003c/li\u003e\n \u003cli\u003eThese results highlight the essential role of pharmacists in supporting off-label prescription through evidence appraisal, documentation, and prescription oversight, reinforcing the need for interdisciplinary collaboration in pediatric medication management.\u003c/li\u003e\n\u003c/ul\u003e"},{"header":"Introduction","content":"\u003cp\u003eOff-label drug use, also referred to as unlabeled or out-of-label use, describes the prescription of pharmaceutical agents for indications, dosages, routes of administration, or age groups not approved by regulatory authorities or specified in product labeling [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]. Off-label prescribing in children is widespread globally and is particularly prevalent in high-risk settings such as intensive care units and oncology wards. Reported rates of adverse drug reactions (ADRs) associated with off-label use range from 23–60% [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e], largely because of the limited availability of clinical trials involving pediatric populations [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. In the absence of age-specific evidence, pediatricians often rely on clinical experience, expert consensus, or extrapolated data to make prescription decisions.\u003c/p\u003e\u003cp\u003eMultiple studies have documented both the high prevalence and potential safety risks associated with off-label pediatric use. For example, a review of 158 medication errors in British children’s hospitals from 2004 to 2006 found that 20 were classified as moderately harmful, 60% of which were associated with off-label prescription [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]. Inappropriate or unsupported off-label use can increase the likelihood of ADRs, therapeutic failure, or medicolegal complications [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Conversely, when guided by clinical rationale and supported by available evidence, off-label prescriptions may fulfill critical therapeutic needs and improve pediatric outcomes [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eDespite its prevalence, pediatric off-label prescriptions remain under-regulated and inconsistently monitored in many healthcare systems, including China. Although some policy initiatives have emerged to promote rational prescribing, limited attention has been paid to the psychological and contextual factors that influence physicians’ prescribing decisions. The Theory of Planned Behavior (TPB) offers a well-established framework for understanding and predicting health professionals’ actions [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]. TPB posits that behavioral intention is the immediate antecedent of behavior, shaped by three core constructs: attitude (e.g., perceived benefit vs. risk), subjective norms (e.g., perceived expectations from peers or institutions), and perceived behavioral control (e.g., perceived ease or difficulty of performing the behavior due to external or internal factors) [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]. These constructs are underpinned by the corresponding behavioral, normative, and control beliefs, which ultimately influence intention and behavior.\u003c/p\u003e\u003cp\u003eThe TPB has been widely applied in healthcare settings to assess behavioral drivers among health professionals, for example, in evaluating pharmacists’ use of prescription drug monitoring programs [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e] and physicians’ adherence to clinical guidelines [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]. Few studies have systematically applied TPB to understand how regulatory, institutional, and patient-related factors interact with psychological drivers in shaping off-label prescribing behavior among pediatricians.\u003c/p\u003e\n\u003ch3\u003eAim\u003c/h3\u003e\n\u003cp\u003eThis study aimed to identify the behavioral determinants of pediatricians’ off-label drug use in Chinese hospitals by applying the Theory of Planned Behavior to assess how attitudes, subjective norms, and perceived behavioral control influence prescribing intentions and behaviors.\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003cdiv id=\"Sec4\" class=\"Section3\"\u003e\u003c/div\u003e\u003c/div\u003e\n\n\n\n\n\n\n\n"},{"header":"Method","content":"\u003ch2\u003eStudy Design and Participants\u003c/h2\u003e\u003cp\u003eThis cross-sectional, questionnaire-based study was guided by TPB, which provides a framework for understanding how behavioral attitudes (BA), subjective norms (SN), and perceived behavioral control (PBC) influence prescribing intentions and behavior. This study targeted pediatricians using stratified purposive sampling to ensure geographic and institutional diversity. Questionnaires were distributed to pediatricians with at least one year of prescribing experience, who provided informed consent.\u003c/p\u003e\u003ch3\u003eQuestionnaire Development\u003c/h3\u003e\u003cp\u003eThe questionnaire was developed in alignment with the four core constructs of TPB: BA, SN, PBC, and behavioral intention (BI) [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e, \u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]. Items were generated based on previous TPB studies in healthcare settings [\u003cspan additionalcitationids=\"CR18\" citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e–\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] and adapted to reflect the common challenges in pediatric off-label prescribing in China. Content validity was ensured through an expert panel review of pediatricians, clinical pharmacists, pharmacologists, and epidemiologists of the Pediatric Society of the Chinese Medical Association. Two rounds of expert consultation and pilot testing with 15 pediatricians were conducted to assess item clarity and relevance, leading to refinement of the survey instrument.\u003c/p\u003e\u003cp\u003eThe final questionnaire comprised four sections: (1) demographics and professional background (five items); (2) experiences, perceived causes, and risks of off-label prescription (nine items); (3) legal and regulatory awareness (five items); and (4) TPB-based items assessing BA, SN, PBC, and BI (13 items). A standardized definition of off-label use was provided at the beginning to ensure consistent interpretation across respondents. The full questionnaire is provided in \u003cb\u003eSupplemental Material\u003c/b\u003e. \u003cb\u003eSupplemental Table\u0026nbsp;1\u003c/b\u003e links the item codes used in the text and analyses (e.g., 29c, 8d) to the corresponding questionnaire items and response scales.\u003c/p\u003e\u003ch3\u003eOperationalization of Theory of Planned Behavior Constructs\u003c/h3\u003e\u003cp\u003eEach domain of the TPB was operationalized using a multi-item questionnaire tailored to the context of pediatric off-label drug use in China. The standard TPB model (\u003cb\u003eSupplemental Fig.\u0026nbsp;1\u003c/b\u003e) includes three core psychological constructs: BA, SN, and PBC, which collectively shape BI and ultimately predict Actual Behavior (TBODU). An extended TPB model (Fig.\u0026nbsp;1) was adopted to incorporate contextual factors such as national regulations, hospital policies, and patient-level influences, which may indirectly shape pediatricians’ cognitive, normative, and control-related beliefs.\u003c/p\u003e\u003cp\u003eThe constructs were measured as follows (\u003cb\u003eSupplemental Fig.\u0026nbsp;2, Supplemental Table\u0026nbsp;1, Supplemental Material\u003c/b\u003e). BA: Pediatricians’ cognitive and emotional evaluations of off-label prescribing were captured by items assessing use in rare or refractory conditions (29c), reference to foreign pharmacopoeias and unupdated local guidelines (29b), classification of general vs. high-risk drugs (29a), responsibility for contraindicated use (17c), and financial burden on patients (9c). SN: Assessed social and institutional expectations through items on reporting high-risk drug use (34f), reliance on clinical experience (34c), emphasis on pharmacological expertise (34b), and strengthening professional self-discipline (34a). PBC: Captured perceived prescribing barriers, such as lack of pediatric-specific evidence and guidance (6a), outdated labeling (6h), and formulation limitations (6 g). BI: Measured by the likelihood of prescribing off-label drugs under certain conditions, including alignment with national treatment standards (8b), inclusion in international guidelines (8c), support from expert consensus or clinical evidence (8d), lack of organizational oversight (19c), and cost to the healthcare system (9d). Behavior (TBODU): Captured perceived risks associated with off-label prescriptions, including ADRs (14a), medical disputes (14b), and cost-related disputes (14c).\u003c/p\u003e\u003cp\u003eConfirmatory factor analysis (CFA) and structural equation modeling (SEM) were used to evaluate construct validity and test the hypothesized relationships between the TPB domains (\u003cb\u003eSupplemental Fig.\u0026nbsp;2\u003c/b\u003e).\u003c/p\u003e\u003ch3\u003eData Collection\u003c/h3\u003e\u003cp\u003eData were collected between February 2025, and April 2025. Questionnaires were distributed either on-site or electronically through designated contacts at the participating hospitals. Completed responses were collected and only fully completed questionnaires that met the inclusion criteria were retained for analysis. No personally identifiable information was collected and all responses were anonymized to ensure confidentiality.\u003c/p\u003e\u003ch2\u003eData Analysis\u003c/h2\u003e\u003cp\u003eData were entered into Epidata 3.1, using double-entry verification, and analyzed using SPSS version 18.0. Descriptive statistics were used to summarize respondent characteristics and item responses. Internal consistency reliability for each TPB construct was assessed using Cronbach’s alpha. Exploratory factor analysis was conducted to assess the construct validity and underlying structure of the TPB domains. SEM was developed using AMOS software to test the theoretical pathways among the TPB constructs. Model fit was evaluated using standard indices, including chi-square, comparative fit index (CFI \u0026gt; 0.90), Root Mean Square Error of Approximation (RMSEA \u0026lt; 0.08), and Standardized Root Mean Square Residual (SRMR \u0026lt; 0.08).\u003c/p\u003e\u003ch3\u003eEthics approval\u003c/h3\u003e\u003cp\u003eThis study was reviewed and confirmed by the Ethics Committee of Beijing Aerospace General Hospital to meet the criteria for exemption from a full ethics review (filing no. 2025-40).\u003c/p\u003e"},{"header":"Results","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003eParticipant Characteristics\u003c/h2\u003e\u003cp\u003eA total of 350 questionnaires were distributed, of which 320 were returned (response rate: 91.4%). After excluding two incomplete responses, 318 valid questionnaires were included in the final analysis. The respondents were pediatricians from 40 hospitals across seven provinces and municipalities in China (\u003cb\u003eSupplemental Fig.\u0026nbsp;3\u003c/b\u003e). Among them, 39.9% held junior professional titles, 29.3% held intermediate titles, and 30.8% held senior titles. Participants were evenly distributed across tertiary children\u0026rsquo;s hospitals, general hospitals, and other healthcare institutions (\u003cb\u003eSupplemental Fig.\u0026nbsp;4\u003c/b\u003e).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003eInternal Consistency and Construct Validity\u003c/h2\u003e\u003cp\u003eThe TPB constructs demonstrated good internal consistency, with Cronbach\u0026rsquo;s alpha coefficients ranging from 0.78 to 0.89 across BA, SN, PBC, and BI. The CFA, as shown in \u003cb\u003eSupplemental Fig.\u0026nbsp;2\u003c/b\u003e, supported the hypothesized four-factor structure. The Kaiser-Meyer-Olkin (KMO) measure was 0.84, and Bartlett\u0026rsquo;s test of sphericity was significant (χ\u0026sup2; = 2663.91, p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), indicating sampling adequacy. All observed items loaded strongly (\u0026gt;\u0026thinsp;0.60) on their respective latent factors with minimal cross-loadings. These results confirmed the construct validity of the TPB-based instrument and its suitability for SEM.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec13\" class=\"Section2\"\u003e\u003ch2\u003eStructural Equation Model Based on the Extended TPB Framework\u003c/h2\u003e\u003cp\u003eThe extended TPB model (Fig.\u0026nbsp;1) demonstrated a good fit (CFI\u0026thinsp;=\u0026thinsp;0.94, RMSEA\u0026thinsp;=\u0026thinsp;0.065, SRMR\u0026thinsp;=\u0026thinsp;0.045) and explained the key pathways between psychological constructs and behavior. As illustrated in \u003cb\u003eSupplemental Fig.\u0026nbsp;2\u003c/b\u003e, BA (β\u0026thinsp;=\u0026thinsp;0.51), PBC (β\u0026thinsp;=\u0026thinsp;0.26), and SN (β\u0026thinsp;=\u0026thinsp;0.07) positively influenced BI, which in turn significantly predicted off-label prescribing behavior (TBODU) (β\u0026thinsp;=\u0026thinsp;0.44). The direct path from PBC to behavior was not statistically significant (β\u0026thinsp;=\u0026thinsp;0.16), suggesting a mediating effect through BI. Validated questionnaire items (e.g., 29c, 8d, 6a, 14a) were used to measure each construct.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec14\" class=\"Section2\"\u003e\u003ch2\u003eBehavioral Attitude: Perceptions of Off-Label Prescribing\u003c/h2\u003e\u003cp\u003eMost pediatricians regarded both patient- and system-level costs as important considerations when prescribing off-label medications, with 87.7% rating patient cost and 95.5% rating health system cost as \u0026ldquo;somewhat important\u0026rdquo; or \u0026ldquo;very important.\u0026rdquo; Ethical responsibility was strongly emphasized; 86.0% agreed that off-label drugs should not be used if contraindicated, even when informed consent was obtained. Regarding context-specific perspectives, 90.8% supported distinguishing between general and high-risk drugs, 93.1% agreed to consider foreign pharmacopoeias and guidelines not yet updated in China, and 87.0% endorsed differentiated use of rare or refractory diseases (\u003cb\u003eTable\u0026nbsp;1\u003c/b\u003e). These findings reflect a predominantly cautious and ethically grounded approach to off-label prescription, balancing clinical necessity with safety and regulatory considerations.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec15\" class=\"Section2\"\u003e\u003ch2\u003eSubjective Norms: Social Pressures Influencing Prescribing\u003c/h2\u003e\u003cp\u003eMost pediatricians reported a strong normative support for rational and cautious off-label prescriptions. Nearly all respondents (98.7%) agreed that enhancing professional knowledge, including pharmacology, efficacy, toxicity, and adverse effects, was essential, and 86.5% strongly agreed. Similarly, 98.7% endorsed improving self-discipline to prevent drug misuse and 82.7% strongly agreed. The need to report high-risk drug use to superiors was supported by 98.7% of the participants, while 98.1% emphasized the importance of sufficient clinical experience before engaging in off-label prescribing (\u003cb\u003eTable\u0026nbsp;2\u003c/b\u003e). These findings highlight the substantial influence of institutional expectations, peer norms, and professional self-regulation on pediatricians\u0026rsquo; prescription behaviors.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec16\" class=\"Section2\"\u003e\u003ch2\u003eBehavioral Intention: Willingness to Prescribe Off-Label\u003c/h2\u003e\u003cp\u003eMost pediatricians expressed a willingness to prescribe off-label medications when supported by authoritative guidance or credible evidence. Specifically, 75.3% agreed that inclusion in Chinese diagnostic and treatment standards justified off-label prescription, with nearly half (48.7%) strongly agreeing. Foreign diagnostic and treatment norms were viewed more cautiously, with only 52.4% agreeing and 13.9% strongly agreeing. When off-label use was supported by expert consensus or clinical trial evidence, 72.5% expressed willingness, including 55.4%, who moderately agreed. In contrast, a strong majority (76.5%) disagreed with prescribing without informed consent because of a lack of organizational oversight (\u003cb\u003eTable\u0026nbsp;3\u003c/b\u003e). These findings indicate that pediatricians\u0026rsquo; intentions are firmly grounded in formal guidelines and evidence-based recommendations, while ethical safeguards such as informed consent remain decisive factors.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec17\" class=\"Section2\"\u003e\u003ch2\u003ePerceived Behavioral Control and Associated Barriers\u003c/h2\u003e\u003cp\u003ePediatricians have identified multiple structural and regulatory barriers influencing their ability to prescribe off-label medications. The most frequently cited limitation was the delay in updating drug instructions despite the inclusion of new indications in the pharmacopoeia and disease guidelines, with 80.2% agreeing and 31.9% strongly agreeing. Another closely related concern, older drugs with new indications not included in pharmacopoeia or guidelines and not reflected in updated instructions, yielded nearly identical results, with 81.1% agreement and 36.1% strong agreement. In addition, 71.5% of the participants agreed that limitations in pharmaceutical preparations restricted the availability of suitable pediatric dosage forms (\u003cb\u003eTable\u0026nbsp;4\u003c/b\u003e). These findings highlight systemic constraints, particularly regulatory delays in revising instructions and formulation shortages, as key determinants of perceived behavioral control in pediatric off-label prescribing.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec18\" class=\"Section2\"\u003e\u003ch2\u003ePerceived Risks and Off-Label Prescribing Behavior (TBODU)\u003c/h2\u003e\u003cp\u003ePediatricians perceived ADRs as the most likely hazard associated with off-label prescribing, with 92.7% rating this outcome as moderately or very probable, including 69.8% who selected \u0026ldquo;very probable.\u0026rdquo; Medical disputes were also viewed as a substantial risk, with 87.9% considering them moderately or very probable. Cost-related disputes were perceived as somewhat less likely, but still notable, with 79.1% rating them as moderately or very probable (\u003cb\u003eTable\u0026nbsp;5\u003c/b\u003e). These findings suggest that pediatricians are acutely aware of the medicolegal and financial implications of off-label prescriptions, with safety concerns and potential conflicts representing key behavioral deterrents.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec19\" class=\"Section2\"\u003e\u003ch2\u003ePharmacists\u0026rsquo; Role in Off-Label Drug Use\u003c/h2\u003e\u003cp\u003eThe majority (85.2%) affirmed the pharmacists\u0026rsquo; essential role in promoting safe off-label prescriptions. The most supported roles were documentation and feedback (74.2%), synthesizing clinical evidence (72.0%), conducting prescription reviews (57.6%) and facilitating co-signatures (56.0%). These findings support the integration of pharmacists into interdisciplinary decision making to ensure evidence-based and rational drug use.\u003c/p\u003e\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study investigated the behavioral determinants of pediatric off-label drug use in Chinese hospitals using the TPB framework. The structural equation model provided empirical support for the TPB, confirming that behavioral intention mediates the effects of attitude, subjective norms, and perceived behavioral control on prescribing behavior. These findings advance the understanding of prescribing decision-making in resource-limited and guideline-constrained pediatric settings.\u003c/p\u003e\u003cdiv id=\"Sec21\" class=\"Section2\"\u003e\u003ch2\u003eMajor Findings\u003c/h2\u003e\u003cp\u003eThe results demonstrated that positive behavioral attitudes and greater perceived behavioral control significantly increased pediatricians\u0026rsquo; intentions to prescribe off-label medications. Behavioral intention emerged as the strongest predictor of actual prescribing behavior, whereas perceived control had no direct effect, reinforcing intention as the central mediating construct in the TPB framework.\u003c/p\u003e\u003cp\u003eMost pediatricians considered off-label use necessary in certain clinical contexts but approached it with caution due to perceived risks. Willingness to prescribe off-label increased when supported by clinical guidelines, expert consensus, or trial-based evidence. In contrast, physicians were reluctant to prescribe off-label drugs in the absence of informed consent or institutional supervision. These findings align with international research highlighting the complexities of pediatric pharmacotherapy and clinicians' cautious balancing of benefits, evidence, and risks [\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e, \u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e].\u003c/p\u003e\u003cp\u003eThe study also revealed strong support for pharmacist involvement in the off-label prescription process. Pediatricians emphasized the importance of pharmacists in documentation, evidence synthesis, and prescription reviews, highlighting the value of interprofessional collaboration. These findings are consistent with global initiatives advocating for increased pharmacist engagement in pediatric prescriptions to reduce medication errors and optimize outcomes. Hospital-based studies have shown that clinical pharmacists intercept a substantial proportion of medication errors, further validating this recommendation [\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e].\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec22\" class=\"Section2\"\u003e\u003ch2\u003eInterpretation in Context\u003c/h2\u003e\u003cp\u003eThis study extends the existing literature by applying a validated behavioral model to explore the cognitive, normative, and control-related drivers of off-label prescriptions. Although off-label use in children has been widely reported, primarily because of the lack of pediatric-specific formulations or clinical data [\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e, \u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e], few studies have systematically examined the behavioral mechanisms guiding such decisions.\u003c/p\u003e\u003cp\u003eOur results are consistent with Ajzen\u0026rsquo;s proposition that behavioral intention is an immediate antecedent of behavior [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. Interventions that cultivate favorable attitudes or enhance perceived control, such as clear institutional policies, peer support, and pharmacist involvement, may increase intentions and improve prescription practices. Furthermore, the cautious approach observed among pediatricians reflects heightened awareness of medicolegal risks, which may vary depending on national regulations and institutional safeguards.\u003c/p\u003e\u003cp\u003eThe model fit indices (CFI\u0026thinsp;=\u0026thinsp;0.94, RMSEA\u0026thinsp;=\u0026thinsp;0.065, SRMR\u0026thinsp;=\u0026thinsp;0.045) supported the robustness of the structural model and confirmed that the extended TPB framework was appropriate for assessing prescribing behavior in this context. Moreover, the inclusion of pediatricians from 40 hospitals across seven provinces enhances the generalizability of our findings and provides insight into prescribing behavior across diverse institutional and geographic settings within China.\u003c/p\u003e\u003cp\u003e These findings are consistent with recent international guidelines recommending multidisciplinary evidence-based approaches to off-label pediatric prescriptions. The inclusion of contextual variables, such as legal frameworks and hospital-level procedures, adds nuance to the TPB model and reflects the complex real-world environment in which pediatricians operate.\u003c/p\u003e\u003cdiv id=\"Sec23\" class=\"Section3\"\u003e\u003ch2\u003ePolicy and Practice Implications\u003c/h2\u003e\u003cp\u003eThis study has several implications for both clinical governance and medication safety. Given the ongoing gaps in drug labeling and scarcity of pediatric formulations, healthcare institutions should consider developing internal protocols or formularies to support evidence-based off-label prescriptions. Embedding pharmacists in a prescription workflow can further promote safety through real-time documentation, literature appraisal, and risk mitigation.\u003c/p\u003e\u003cp\u003eTraining programs grounded in TPB may also be effective in shifting clinician behavior by targeting attitudes, normative influences, and control beliefs. National policy frameworks should incorporate structured decision-making tools such as standardized prescribing checklists or off-label justification templates to ensure consistency and accountability. Finally, integrating electronic prescribing systems with clinical decision support features may help address medicolegal concerns and enhance transparency in prescribing practices.\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\u003cdiv id=\"Sec24\" class=\"Section2\"\u003e\u003ch2\u003eStrengths\u003c/h2\u003e\u003cp\u003eA key strength of this study is its theory-driven design, which enabled the systematic evaluation of both the psychological and contextual determinants of off-label prescriptions. The use of SEM allowed for a nuanced analysis of the interrelationships among TPB constructs. Additionally, the geographically diverse and institutionally representative sample increases the relevance of the findings across China's varied healthcare landscapes.\u003c/p\u003e\u003cdiv id=\"Sec25\" class=\"Section3\"\u003e\u003ch2\u003eLimitations\u003c/h2\u003e\u003cp\u003eThis study had several limitations. First, reliance on self-reported data may introduce a response bias, especially given the legal and ethical sensitivity of off-label prescriptions. Second, although the questionnaire underwent expert review and pilot testing, its test-retest reliability and external validation were not assessed, which may have affected its reproducibility. Third, the cross-sectional nature of the study limits causal inferences. Future longitudinal or interventional research is warranted to assess the temporal dynamics and impact of targeted interventions. Lastly, the perspectives of other stakeholders, such as pharmacists, nurses, and administrators, were not captured and should be included in future studies to gain a more comprehensive understanding of off-label medication use in pediatric settings.\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eUsing the Theory of Planned Behavior, this study identified behavioral intention as the primary driver of pediatric off-label prescribing, shaped by attitudes, subjective norms, and perceived control. These findings highlight the need for institutional policies, pharmacist collaboration, and decision-support tools to promote safe, consistent, and evidence-based off-label drug use in pediatric care.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank all participating pediatricians across China for their valuable time and contribution to completing the questionnaire, which made this study possible.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNone.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eAuthor contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eConceptualization: YZ, NR; Methodology: NR, YZ; Investigation: GW, YH; Formal analysis: DW, XS; Writing \u0026ndash; Original Draft: YZ, YH; Writing \u0026ndash; Review and Editing: YZ, NR, GW; Supervision: YZ, NR; Project administration: DW, XS. All authors have read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets generated and/or analyzed during the current study are available from the corresponding author upon reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eEthics Approval\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was reviewed and confirmed by the Ethics Committee of Beijing Aerospace General Hospital to meet the criteria for exemption from a full ethics review (filing no. 2025-40, filing date: May 25, 2024).\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSi W, Ma P. Judicial and legislative practice and related suggestions on off-label drug use in China. BMC Health Serv Res. 2023;23(1):312.\u003c/li\u003e\n\u003cli\u003eCuzzolin L, Atzei A, Fanos V. Off-label and unlicensed prescribing for newborns and children in different settings: a review of the literature and a consideration about drug safety. Expert opinion on drug safety. 2006;5(5):703-18.\u003c/li\u003e\n\u003cli\u003eLee S, Yang MH, Kim JS, et al. Evaluation of off-label medication use and drug safety in a pediatric intensive care unit. Saudi Pharm J. 2023;31(9):101704.\u003c/li\u003e\n\u003cli\u003eVieira JML, de Matos GC, da Silva FAB, et al. Serious Adverse Drug Reactions and Safety Signals in Children: A Nationwide Database Study. Front Pharmacol. 2020;11:964.\u003c/li\u003e\n\u003cli\u003eGhaleb MA, Barber N, Franklin BD, et al. The incidence and nature of prescribing and medication administration errors in paediatric inpatients. Archives of disease in childhood. 2010;95(2):113-8.\u003c/li\u003e\n\u003cli\u003eSutherland A, Phipps DL, Tomlin S, et al. Mapping the prevalence and nature of drug related problems among hospitalised children in the United Kingdom: a systematic review. BMC Pediatr. 2019;19(1):486.\u003c/li\u003e\n\u003cli\u003eYuan X, Gao J, Yang L, et al. Off‑label and unapproved pediatric drug utilization: A meta‑analysis. Experimental and Therapeutic Medicine. 2024;28(5):412.\u003c/li\u003e\n\u003cli\u003eDudhal KS, Kadhe NG, Pawar S. Evaluation of adverse drug reactions to off-label use of drugs in children from spontaneously reported cases at a tertiary care hospital. National Journal of Physiology, Pharmacy and Pharmacology. 2024;14(8):1640-.\u003c/li\u003e\n\u003cli\u003eJi Z, Wang X, Wang J. Analysis of off-label drug use and its influencing factors in pediatric patients undergoing otolaryngology, head, and neck surgery. Front Pharmacol. 2025;16:1553221.\u003c/li\u003e\n\u003cli\u003eBlankart KE, Lichtenberg FR. Prevalence and relationship with health of off-label and contraindicated drug use in the United States: a cross-sectional study. J Pharm Policy Pract. 2025;18(1):2472221.\u003c/li\u003e\n\u003cli\u003eAlsulami FT, Alqarni YS, Alruqayb WS, et al. Understanding community pharmacists\u0026rsquo; intentions to report adverse drug reactions in Saudi Arabia: a theory of planned behavior analysis. Frontiers in Pharmacology. 2025;16:1574412.\u003c/li\u003e\n\u003cli\u003eGuraya SS, Clarke E, Sadeq A, et al. Validating a theory of planned behavior questionnaire for assessing changes in professional behaviors of medical students. Frontiers in Medicine. 2024;11:1382903.\u003c/li\u003e\n\u003cli\u003eNaughton BD. Planned Behavior in the United Kingdom and Ireland Online Medicine Purchasing Context: Mixed Methods Survey Study. JMIR Formative Research. 2025;9(1):e55391.\u003c/li\u003e\n\u003cli\u003eStewart D, Al Hail M, Al-Shaibi S, et al. A scoping review of theories used to investigate clinician adherence to clinical practice guidelines. Int J Clin Pharm. 2023;45(1):52-63.\u003c/li\u003e\n\u003cli\u003eKamyab A, Bijani M, Jormand H, et al. Education based on the theory of planned behavior to improve medication regimen adherence, hope and marital quality in patients with substance use disorder. BMC public health. 2024;24(1):3173.\u003c/li\u003e\n\u003cli\u003eLiao YH, Tang KP, Chou CY, et al. Assessment of factors influencing physicians\u0026apos; intention to prescribe transfusion using the theory of planned behavior. BMC Health Serv Res. 2023;23(1):973.\u003c/li\u003e\n\u003cli\u003eRich A, Brandes K, Mullan B, et al. Theory of planned behavior and adherence in chronic illness: a meta-analysis. J Behav Med. 2015;38(4):673-88.\u003c/li\u003e\n\u003cli\u003eAjzen I. The theory of planned behavior: Frequently asked questions. Human behavior and emerging technologies. 2020;2(4):314-24.\u003c/li\u003e\n\u003cli\u003eMeng M, Hu J, Lei W, et al. The implementation of the guideline for the management of pediatric off-label use of drugs in China: a cross-sectional study. Translational Pediatrics. 2024;13(8):1425.\u003c/li\u003e\n\u003cli\u003eBosch I, Siebel H, Heiser M, et al. Decision-making for children and adolescents: a scoping review of interventions increasing participation in decision-making. Pediatr Res. 2025;97(6):1840-54.\u003c/li\u003e\n\u003cli\u003eBarrett JS, Turner MA. Consideration for Assessing Data/Models/Tools Expiration Supporting Drug Development and Clinical Decision Making. Ther Innov Regul Sci. 2025;59(4):707-17.\u003c/li\u003e\n\u003cli\u003eWang JK, Herzog NS, Kaushal R, et al. Prevention of pediatric medication errors by hospital pharmacists and the potential benefit of computerized physician order entry. Pediatrics. 2007;119(1):e77-e85.\u003c/li\u003e\n\u003cli\u003eConroy S, Choonara I, Impicciatore P, et al. Survey of unlicensed and off label drug use in paediatric wards in European countries. bmj. 2000;320(7227):79-82.\u003c/li\u003e\n\u003cli\u003eGazarian M, Kelly M, McPhee JR, et al. Off‐label use of medicines: consensus recommendations for evaluating appropriateness. Medical Journal of Australia. 2006;185(10):544-8.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 1. Behavioral attitudes of pediatricians toward off-label prescribing (n = 318)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQuestionnaire Item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponse Category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScore\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eImportance of cost to patient\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNot important at all\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eSomewhat unimportant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeither important nor unimportant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e38\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eSomewhat important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e211\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e66.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e67\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e21.1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eImportance of cost to health system\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNot important at all\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eSomewhat unimportant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeither important nor unimportant\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eSomewhat important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e260\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e82.8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery important\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eResponsibility when contraindicated despite informed consent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e7.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e146\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e46.4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e125\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e39.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eView off-label use differently: general vs. high-risk drugs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e9.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e65\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e20.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e220\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e70.1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eView off-label use differently: foreign pharmacopoeia \u0026amp; guidelines not updated in China\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e21\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e6.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e108\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e34.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e188\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e59.1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eView off-label use differently: rare/refractory vs. common diseases\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e7.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3.8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e101\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e32.1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e173\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e54.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;Table 2. Subjective norms of pediatricians toward off-label prescribing (n = 318)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQuestionnaire Item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponse Category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScore\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eRaise the level of professional knowledge, including pharmacology, efficacy, toxicity, and side effects\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e39\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e275\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e86.48\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eIncrease self-discipline to avoid drug abuse\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e16.04\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e263\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e82.70\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eReport the use of high-risk drugs to superiors for record-keeping\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e55\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e17.29\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e259\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e81.45\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eHave sufficient clinical experience before off-label drug use to avoid random prescribing\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1.26\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e63\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e19.81\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e251\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e78.93\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;Table 3. Behavioral intention of pediatricians toward off-label prescribing (n = 318)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQuestionnaire Item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponse Category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScore\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003ePrescribing basis: included in Chinese diagnostic and treatment standards\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e16.46\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e8.23\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e84\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e26.58\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e154\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e48.73\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003ePrescribing basis: included in foreign diagnostic and treatment norms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e50\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e15.77\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e22.08\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e31\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e9.78\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e122\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e38.49\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e44\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e13.88\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003ePrescribing basis: not regulated but supported by expert advice or clinical trial evidence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e52\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e16.45\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e35\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e11.08\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e175\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e55.38\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e54\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e17.09\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eReason to prescribe without informed consent: lack of organizational concern\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e178\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e57.24\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e19.29\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3.54\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e61\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e19.61\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.32\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTable 4. Perceived behavioral control of pediatricians toward off-label prescribing (n = 318)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQuestionnaire Item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponse Category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScore\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eOlder drugs with new indications already included in pharmacopoeia and disease guidelines, but not yet reflected in updated drug instructions\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e40\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4.10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3.2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e153\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e48.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e101\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e31.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eLimitations in pharmaceutical preparations leading to fewer pediatric dosage forms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e33\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e10.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e39\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e17\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e142\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e45.51\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e81\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e25.96\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eOlder drugs with new indications not included in pharmacopoeia and disease guidelines, and not yet reflected in updated drug instructions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e38\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e12.14\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately disagree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3.51\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eNeutral\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3.20\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e141\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e45.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eStrongly agree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e113\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e36.10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;Table 5. Perceived risks and off-label prescribing behavior (TBODU) of pediatricians (n = 318)\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eQuestionnaire Item\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResponse Category\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eScore\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003en\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eRisk of adverse drug reactions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery improbable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately improbable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e50/50 probability\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4.4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e72\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e22.9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e220\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e69.8\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eIncrease in medical disputes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery improbable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately improbable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e50/50 probability\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e9.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e64\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e20.3\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e214\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e67.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"5\" valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eDisputes over increased drug costs\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery improbable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately improbable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e0.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e50/50 probability\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e56\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e17.7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eModerately probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e90\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e28.5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003eVery probable\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e160\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 115px;\"\u003e\n \u003cp\u003e50.6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"international-journal-of-clinical-pharmacy","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ijcp","sideBox":"Learn more about [International Journal of Clinical Pharmacy](https://www.springer.com/journal/11096)","snPcode":"11096","submissionUrl":"https://submission.nature.com/new-submission/11096/3","title":"International Journal of Clinical Pharmacy","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Off-Label Use, Pediatrics, Drug Prescriptions, Physician Practice Patterns, Pharmacists, Behavioral Medicine, Cross-Sectional Studies, Theory of Planned Behavior","lastPublishedDoi":"10.21203/rs.3.rs-7351063/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7351063/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOff-label prescribing, use of medications outside approved indications, dosages, administration routes, or age groups is common in pediatric clinical practice, largely because of the lack of high-quality clinical trials in children. Although such prescriptions can meet urgent therapeutic needs, particularly in complex or rare pediatric conditions, they also raise significant concerns regarding safety, effectiveness, and medicolegal liability. Limited research has examined the behavioral factors that influence pediatricians’ decisions to prescribe off-label drugs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAim\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study aimed to identify the behavioral determinants of pediatricians’ off-label drug use in Chinese hospitals by applying the Theory of Planned Behavior (TPB) to assess how attitudes, subjective norms, and perceived behavioral control influence prescribing intentions and behaviors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA cross-sectional survey was conducted among pediatricians from 40 hospitals across seven provinces and municipalities in China. A TPB-based questionnaire was developed and refined through expert panel review and pilot testing. Psychometric properties were evaluated using reliability testing and confirmatory factor analysis (CFA). Structural equation modeling (SEM) was used to test the hypothesized relationships among the TPB constructs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMost pediatricians acknowledged the necessity (82.4%) and risks (78.9%) of off-label use. Attitudes reflecting perceived benefits, safety concerns, and cost implications significantly predicted behavioral intention (β = 0.32, p \u0026lt; 0.01). Perceived behavioral control, including barriers such as outdated labeling, lack of pediatric formulations, and limited data, also predicted intention (β = 0.30, p \u0026lt; 0.01), but not behavior directly (β = 0.08, p = 0.12). Subjective norms such as institutional expectations and peer influence were positively associated with intention (β = 0.28, p \u0026lt; 0.01). Behavioral intention was the strongest predictor of actual off-label prescription behaviors (β = 0.41, p \u0026lt; 0.001). Most pediatricians (85.2%) supported pharmacists’ involvement in evidence reviews, documentation, and prescription oversight. The SEM demonstrated a good model fit (CFI = 0.94, RMSEA = 0.065, SRMR = 0.045).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePediatric off-label prescribing in China is largely intention-driven and shaped by attitudes, perceived control, and professional norms. Interventions targeting these behavioral domains, along with institutional policies and pharmacist collaboration, may enhance the safety, consistency, and regulatory oversight of off-label use in pediatric care.\u003c/p\u003e","manuscriptTitle":"Investigation on the current situation : Pediatric off-label drug use in Chinese Hospitals","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-27 05:39:22","doi":"10.21203/rs.3.rs-7351063/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-08-29T01:25:53+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-27T10:04:21+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-25T08:12:53+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"177962457827820627602910021260975283058","date":"2025-08-18T04:21:12+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"330987931209394226946427579241806481310","date":"2025-08-18T00:18:14+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-15T08:27:36+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-08-12T11:44:10+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-08-12T11:41:42+00:00","index":"","fulltext":""},{"type":"submitted","content":"International Journal of Clinical Pharmacy","date":"2025-08-12T03:52:37+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"international-journal-of-clinical-pharmacy","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"ijcp","sideBox":"Learn more about [International Journal of Clinical Pharmacy](https://www.springer.com/journal/11096)","snPcode":"11096","submissionUrl":"https://submission.nature.com/new-submission/11096/3","title":"International Journal of Clinical Pharmacy","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"d939486f-afce-46d6-b5b9-843ad6dc58e8","owner":[],"postedDate":"August 27th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-11-03T16:02:30+00:00","versionOfRecord":{"articleIdentity":"rs-7351063","link":"https://doi.org/10.1007/s11096-025-02032-9","journal":{"identity":"international-journal-of-clinical-pharmacy","isVorOnly":false,"title":"International Journal of Clinical Pharmacy"},"publishedOn":"2025-10-29 15:58:10","publishedOnDateReadable":"October 29th, 2025"},"versionCreatedAt":"2025-08-27 05:39:22","video":"","vorDoi":"10.1007/s11096-025-02032-9","vorDoiUrl":"https://doi.org/10.1007/s11096-025-02032-9","workflowStages":[]},"version":"v1","identity":"rs-7351063","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7351063","identity":"rs-7351063","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}