Sangeeta Sharma

Medication safety is a critical component of patient care, yet fragmented regulations, under-reporting of adverse events, and resource constraints continue to pose risks in India and Southeast Asia. Addressing these challenges requires system-level interventions supported by robust policies and technology-driven solutions. This review analyzes medication safety frameworks in India and World Health Organization South-East Asia Region countries using a Strengths, Weaknesses, Opportunities, and Threats (SWOT) approach, identifying internal strengths and weaknesses alongside external opportunities and threats. The goal is to propose strategic actions that enhance regulatory oversight, capacity building, health-system resilience, and hospital-level practices. A comparative narrative review of national regulations, World Health Organization and Association of Southeast Asian Nations frameworks, policy documents, and published literature was conducted. Recurring themes were consolidated into four domains such as regulatory systems, health-system strengthening, workforce capacity building, and hospital-level strategies and synthesized using a SWOT-based analytical approach to identify shared gaps, contextual differences, and strategic priorities across India and South-East Asia Region countries. The SWOT analysis across four domains revealed shared patterns between India and World Health Organization South-East Asia Region countries. Regulatory frameworks show strong institutional structures in India and Association of Southeast Asian Nations Good Manufacturing Practices harmonization, but both lack centralized drug registries and face under-reporting of adverse events. Capacity building benefits from professional networks, yet rural workforce shortages and inconsistent training persist region wide. Health systems leverage multi-tiered structures and national programs, but fragmentation and weak digital infrastructure hinder medication error reporting. At the hospital level, limited resources, staff resistance, and complex policies restrict adoption of electronic health records and safety technologies. Opportunities include harmonizing Good Manufacturing Practice standards, scaling accreditation, and deploying digital tools, while threats such as counterfeit medicines, antimicrobial resistance, and punitive reporting cultures remain significant. Strategic priorities include establishing centralized drug registries, enforcing prescription-only rules, implementing QR codes for high-risk medicines, and promoting blame-free reporting. Medium-term actions involve expanding digital health solutions, integrating medication safety into curricula, and scaling accreditation. Long-term goals focus on regional harmonization, collaborative research, and cultural transformation toward safety. Leveraging India’s regulatory strengths and lessons learned can accelerate medication safety improvements across Southeast

Background: Medication errors remain a leading cause of preventable harm worldwide. Existing safety assessments rely mainly on audits and staff reports, which often overlook patients’ perspectives. Patient-Reported Experience Measures (PREMs) offer a structured way to capture patients’ views on medication administration safety. However, no PREM tool has been developed in India. Objective: To develop, validate, and apply a patient-centred PREM tool for assessing medication administration safety in Indian hospitals. Methods: This prospective, multicentre study was conducted across 16 hospitals (September 2023–April 2024). Tool development followed standard questionnaire design processes, including expert focus groups, face/content validation, and piloting. The final 15-item checklist used binary (yes/no) responses. Reliability was assessed using Kuder–Richardson Formula 20 (KR-20). A total of 614 adult inpatients (>24 h stay) completed the questionnaire. Results: Content validity indices showed excellent agreement (S-CVI/Ave = 0.96). Internal consistency was acceptable for an early-phase validation study (KR-20 = 0.66). High adherence was reported for safety practices such as identity verification (95.0%) and allergy history documentation (94.8%). Areas for improvement included cost communication (68.6%) and disclosure of side effects (67.4%). Missed or skipped doses were reported by 17.3% (95% CI, 14.5%–20.5%) of patients. Conclusion: To our knowledge, this is the first multicentre study in India to develop and undertake early-phase validation of a Patient-Reported Experience Measures (PREMs) tool for medication administration safety. The tool demonstrated feasibility and patient acceptability, while highlighting key safety gaps. Future work will focus on psychometric refinement and wider application, including integration into national quality assurance frameworks.

Health outcomes in Low- and Middle-Income Countries (LMICs) have improved, but poor-quality care, driven by inconsistent clinical practices due to differen

Antimicrobial resistance is a pressing global health threat fueled by a complex interplay of biological, social, and economic factors. Despite widespread recognition of its impact, the antimicrobial resistance crisis continues to deepen because of inadequate innovation, poor access to effective treatments, and irrational antimicrobial use. Effectively combating antimicrobial resistance requires a multisectoral, multistakeholder, and multidimensional approach, with the pharmaceutical industry playing a pivotal role in new antimicrobial discovery along with diagnostic and other stakeholders. This review critically examines the central role of the pharmaceutical industry in addressing antimicrobial resistance, focusing on drug discovery, manufacturing practices, and stewardship efforts. While the industry has made notable contributions through the development of new antimicrobials and alternative approaches such as drug repurposing, artificial intelligence-driven discovery, and improved diagnostics, major challenges persist—including a declining antibiotic pipeline, limited access in low- and middle-income countries, antimicrobial pollution, irrational fixed-dose combinations, and the prevalence of substandard or falsified drugs. To overcome these barriers, this review explores strategic directions, including public-private partnerships, delinked incentive models, small-molecule innovation, ethical marketing, and equitable access strategies. It also underscores the industry’s responsibility in promoting antimicrobial stewardship, participating in global surveillance systems, and educating prescribers and the public on responsible use. Future directions highlight the need for diversified funding, global collaboration, and the adoption of the “triple shield” approach—integrating infection prevention and control, antimicrobial stewardship, and robust surveillance to combat antimicrobial resistance. This review presents an integrated analysis of pharmaceutical accountability, highlighting actionable pathways that align innovation with equitable access, environmental safety, and ethical governance. By bridging gaps between discovery and delivery, the pharmaceutical sector can become a driving force in the global response to antimicrobial resistance.