Medication errors in Pediatric and Neonatal Intensive Care Units (PICUs and NICUs) are a significant concern due to the unique vulnerabilities of these patient populations. Factors such as weight-based dosing, the necessity for precise calculations, and the critical nature of administered medications contribute to an elevated risk of adverse drug events (ADEs) [1].  Studies have reported medication error rates in these settings ranging from 5.7% to 77.9% per 100 medication orders, with dosing errors being the most prevalent [2,3]. High-risk medications (HRMs), including vasoactive agents, sedatives, and anticoagulants, are commonly used in intensive care settings and are associated with a higher likelihood of causing significant harm if misused. The complexity of these medications necessitates stringent management protocols to ensure patient safety [4]. Implementing targeted training and sensitization programs for healthcare providers has been shown to reduce medication errors. Educational interventions focusing on accurate medication administration, adherence to protocols, and the importance of double-checking processes have demonstrated effectiveness in decreasing error rates [4].

This study aims to evaluate the impact of a structured training and sensitization program on the management of HRMs in the PICU and NICU of a tertiary care hospital in North Maharashtra. By conducting comparative audits before and after the intervention, we seek to assess improvements in key parameters such as the highlighting of HRMs in prescriptions, dose adequacy, verification processes, and patient monitoring post-administration.

Study Design

This is a comparative clinical audit conducted in two phases: pre- and post-intervention.

Study Setting

The study was conducted in the PICU and NICU of a tertiary care hospital in North Maharashtra.

Study Population

Inclusion criteria:

• Pediatric and neonatal patients admitted to the PICU and NICU during the study period.
• Patients receiving at least one high-risk medication.

Exclusion criteria:

• Patients discharged within 24 hours of admission.
• Patients transferred from other hospitals with ongoing HRM administration.

Sample Size

All Paediatric and neonatal patients admitted to the PICU and NICU during the study period (March 1, 2024, to September 30, 2024) who received high-risk medications were included in the study. This approach ensured comprehensive data collection without the need for sample size calculation, consistent with audit methodology standards [5].

Parameters Evaluated

• Highlighting of HRMs in prescriptions.
• Adequacy of dose.
• Verification by two nurses or doctors.
• Patient monitoring post-administration.

Intervention

Following the first audit, a comprehensive training and sensitization program was implemented.

The training focused on:

• The importance of HRM identification.
• Accurate, weight-based dosing and dilutions.
• Protocol adherence for verification by two staff members.
• Post-administration patient monitoring.

The training included didactic sessions, hands-on workshops, and the introduction of standardized checklists for HRM management.

Data Collection, Storage and Analysis

Data was collected using standardized checklists and analyzed using SPSS v26. Chi-square tests were used for categorical variables, with p < 0.05 considered significant. Data for this study, including pre-audit data, post-audit data, and statistical analysis, is stored and available on the Open Science Framework (OSF) under the project titled “Pre audit data, post audit data and statistics.” The data is publicly accessible and can be obtained upon request through the OSF platform. The project is public, and OSF provides analytics on project access and downloads, as well as a citation widget for proper referencing of this work.

Statistical Test Applied: The Chi-square test for independence was used to compare pre- and post-intervention findings. The observed and expected frequencies were calculated for each parameter, and the Chi-square statistic was computed using the formula:

χ² = Σ ((O - E)²/E), where O is the observed frequency and E is the expected frequency.

Calculation Details: Data analysis was performed using SPSS v26. Degrees of freedom were determined based on the number of categories minus one. P-values were obtained from the Chi-square distribution table, with p < 0.05 considered statistically significant. The study observed significant improvements in the management of high-risk medications post-intervention.

Figure 1: Comparison of Audit Results before and After Intervention.

Pre-Intervention Results:

• Highlighting of Hrms in Prescriptions: 65.0% of prescriptions adequately highlighted HRMs.
• Adequacy of Dose: 68.5% of administered doses were accurate.
• Verification by Two Nurses or Doctors: 66.7% compliance with dual verification.
• Patient Monitoring Post-Administration: 69.2% of patients were monitored post-administration.

Post-Intervention Results:

• Highlighting of HRMs in prescriptions: Improved to 85.4%.
• Adequacy of Dose: Increased to 92.3%, indicating enhanced precision in medication preparation and administration.
• Verification by two nurses or doctors: Rose to 89.7%, demonstrating better adherence to verification protocols.
• Patient monitoring post-administration: Improved to 91.5%, reflecting better follow-up care.

These improvements highlight the effectiveness of the training and sensitization program. Statistical analysis using the Chi-square test showed that all improvements were statistically significant (p < 0.05) (Table 1).

Table 1: Statistical analysis using the Chi-square test showed that all improvements were statistically significant (p < 0.05).

The results of this audit demonstrate significant improvements across all parameters of HRM management following the implementation of a structured training and sensitization program. These findings align with previous national and international studies that emphasize the role of education and protocol adherence in improving medication safety.

Highlighting Of Hrms in Prescriptions

After training, compliance with highlighting HRMs in prescriptions improved from 65.0% to 85.4%. This improvement aligns with a study conducted at Shree Krishna Hospital, Karamsad, and Gujarat, where a clinical audit on HRM use in NICU and PICU demonstrated that highlighting HRMs with red color in prescriptions increased from 0% in the initial audit to 46.66% post-intervention [6]. This study emphasized that highlighting HRMs aids healthcare professionals in recognizing high-risk medications promptly, thereby reducing medication errors through increased vigilance and adherence to safety protocols

Adequacy of Dose

The adequacy of dose compliance increased from 68.5% to 92.3%, reflecting improved staff understanding of weight-based and age-appropriate dosing. A study conducted in four intensive care units of a tertiary care teaching hospital in India implemented a sensitization program on medication errors for doctors and nurses, which significantly reduced the overall number of prescriptions with errors from 9.1% to 3.5% [7]. Internationally, a Canadian NICU study by Brown (2019) achieved a 30% reduction in adverse drug events (ADEs), with notable improvements in dosing accuracy, underscoring the critical role of structured training programs [8].

Verification by Two Nurses or Doctors

Compliance rose from 66.7% to 89.7%, benefiting from the introduction of standardized checklists. A study in the United States found that dual verification protocols reduced medication errors by 50% in pediatric intensive care settings. Similarly, a study in a South Indian hospital reported a 35% improvement in verification compliance after introducing a checklist-based intervention. These findings are consistent with the results of a study conducted in four intensive care units of a tertiary care teaching hospital in India, where a sensitization program significantly reduced prescription errors from 9.1% to 3.5% [8].

Patient Monitoring Post-Administration

Monitoring compliance increased from 69.2% to 91.5% post-intervention, indicating enhanced patient monitoring after medication administration. This improvement aligns with findings from a study in Germany, where a structured training program for healthcare professionals led to a significant reduction in medication errors, emphasizing the importance of continuous monitoring to prevent adverse drug events (ADEs) [9]. Similarly, a systematic review highlighted that remote patient monitoring interventions positively impact patient safety by reducing major complications and adverse events, underscoring the critical role of diligent post-administration monitoring [10].

Broader Implications

The findings of this study, in conjunction with similar national and international research, highlight several critical takeaways:

• Regular training programs are universally effective in improving HRM management practices in PICU and NICU settings.
• Standardized protocols and checklists are essential tools for reducing errors.
• Sustained improvements require continuous education, periodic audits, and reinforcement of safety protocols.

The relatively rapid improvements observed in this audit demonstrate the potential for quick gains in patient safety through structured interventions. However, cultural and systemic differences, such as resource availability and staffing levels, must be considered to adapt training programs to local context.

This comparative audit highlights the positive impact of targeted training and sensitization on the management of high-risk medications in PICU and NICU settings. The significant improvements observed across all parameters HRM highlighting, dose adequacy, verification, and monitoring underscore the importance of education and protocol adherence in ensuring patient safety. Regular audits and ongoing training should remain integral to quality improvement initiatives in critical care units.

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