A critical analysis of labeling errors of high-alert medications – Safety assessment and remedial measures through case based approach

Abstract

Background and objective: Wrong labeling of the drugs is one of the critical issues that can end up in serious health issues among patients. Labeling errors of high-risk medications can lead to permanent disability or death of patients in critical settings. This article aims in identifying and analyzing the critical labeling error of the parenteral products and draws a comprehensive outline of its remediations and unintended consequences with respect to patient safety. Materials and methods: The pharmaceutical supply chain department of high-end Tertiary hospitals and community pharmacies located in Udupi and Dakshina Kannada districts in Karnataka, India were visually inspected using a validated checklist for labeling errors in parenteral products. Defective products with labeling errors were identified and procured. Results: Two defective samples with labeling errors were identified. A small volume parenteral (infusion) bottle having both 50% Dextrose and Atropine sulphate injection (100 mg) mentioned on the same label and a Biphasic Isophane Insulin Injection (a × b mL) cartridge with missing batch code was procured from the Hospital Pharmacies. Conclusion: Streamlining the process of labeling errors, development of strategies, providing effective training to manufacturing personnel, dispensing pharmacists and all other healthcare professionals and improving regulatory compliance by adhering to current Good Manufacturing Practices can contribute to the reduction of labeling errors. This study will create sound awareness among the healthcare care professionals, pharmaceutical manufacturers, and stakeholders/policy makers by the in-depth exploration of real-life problems and help them in the initiation of necessary measures to avoid such problems in future.

Keywords

• Clinical competence
• Drug labeling
• Medication error
• Prevention and control
• Risk management