Evaluating the Role of the Strategic Level of the National Drug Regulatory Authority in Enhancing Medication Adherence in Cardiovascular Patients: An Importance-Performance Analysis Approach.

Abstract

Highlights: Eight strategic tasks (28.6%) fell into the "Concentrate Here" quadrant, with 50.7% of the weight and a gap of 2.69.The largest gaps were in research and innovation (3.54), production/import planning (2.88), and quality monitoring (2.79).Drug supply and distribution performed well, but innovation, financial planning, quality monitoring, and patient education were deficient.

Introduction: Medication adherence in patients with cardiovascular disease remains a significant challenge and directly affects treatment success, morbidity, and healthcare costs. Although many studies have examined clinical and individual factors that influence adherence, the role of regulatory agencies has received less attention. The Iranian Food and Drug Administration (IFDA) is the leading authority responsible for regulating drugs, Understanding the strategic functions of this agency, and aligning them with adherence factors can be crucial for improving patient outcomes and maintaining the sustainability of the healthcare system.

Methods: This study was conducted in 3 stages. First, regulatory activities of the IFDA were gathered from regulations, policy documents, organizational reports, and semistructured interviews. Second, the identified factors were validated by clinical and pharmaceutical experts, and monitoring activities were matched with medication adherence through a mapping matrix approach. Third, the importance-performance analysis (IPA) method was applied to evaluate systematic strengths and weaknesses, and the performance gap and normal weight were calculated.

Results: Twenty-eight strategic-level tasks of the organization were classified into 4 IPA quadrants. The "Immediate Focus" quadrant consisted of 8 tasks (28.6%) with the highest normal weight (50.7%) and an average performance gap of 2.69, indicating serious weaknesses in the areas of innovation and research, strategic planning of production/imports, quality monitoring, and currency policies. The "Continuing the Good" quadrant encompassed 6 tasks (21.4%, 25.1% weight) reflecting strengths in drug supply, continuous access, equitable distribution, drug information systems, and communications. The "Low Priority" (5 tasks, 17.9%) and "Overfocus" (9 tasks, 32.1%) quadrants reflected administrative or ineffective activities that allocated disproportionate resources.

Conclusion: The findings of this study suggest that the strategic-level tasks of the IFDA play a crucial role in promoting adherence to cardiovascular medication for patients. While good performance was observed in the areas of drug supply and access, significant deficiencies were identified in innovation, financial planning, quality monitoring, and patient education.