From Policy to Practice: Weak Enforcement of Antibiotic Dispensing Regulations as a Patient Safety Threat in Nepal

Effective pharmacy regulation is essential for ensuring patient safety, rational medicine use, and the responsible management of antimicrobial resistance. Although Nepal has established regulatory frameworks, including the Drug Act 1978 and policies restricting non-prescription antibiotic sales, enforcement remains weak and inconsistent. Evidence from multiple studies indicates that antibiotics are frequently dispensed without valid prescriptions in community pharmacies, often by personnel lacking appropriate pharmaceutical qualifications. These practices reflect broader systemic challenges, including limited regulatory capacity, shortages of qualified pharmacists, commercially driven dispensing behaviors, and inadequate public awareness of appropriate medicine use. Consequently, unsafe pharmaceutical practices persist, undermining patient safety, pharmacovigilance, and national antimicrobial stewardship efforts. Addressing these challenges requires viewing regulatory enforcement as a health-system and patient-safety priority rather than solely a regulatory responsibility. Key interventions include ensuring the mandatory presence of qualified pharmacists, strengthening inspection and compliance mechanisms, integrating community pharmacies into antimicrobial stewardship initiatives, and promoting public education on the rational use of medicines. Weak implementation of antibiotic dispensing regulations in Nepal represents a significant yet underrecognized threat to public health. Translating existing policies into effective practice through coordinated systemic reforms is critical to reducing medication-related harm and preserving the effectiveness of antibiotics for future generations.