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
-
Omid Moharrami
,
Akbar Abdollhiasl
,
Abbas Kebriaeezadeh
,
Shekoufeh Nikfar
,
Bita Mesgarpour
,
Mojtaba Salarifar
Abstract
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.
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32. Fitch K, Bernstein SJ, Aguilar MD, Burnand B, LaCalle JR. The RAND/UCLA appropriateness method user's manual. 2001.
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34. Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Research in nursing & health. 2006;29(5):489-97.
35. Martilla JA, James JC. Importance-performance analysis. Journal of marketing. 1977;41(1):77-9.
36. Incerti D, Thom H, Baio G, Jansen JP. R you still using excel? The advantages of modern software tools for health technology assessment. Value in Health. 2019;22(5):575-9.
37. Godman B, Fadare J, Kwon H-Y, Dias CZ, Kurdi A, Dias Godoi IP, et al. Evidence-based public policy making for medicines across countries: findings and implications for the future. Journal of comparative effectiveness research. 2021;10(12):1019-52.
38. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, et al. Essential medicines for universal health coverage. The Lancet. 2017;389(10067):403-76.
39. Ewen M, Zweekhorst M, Regeer B, Laing R. Baseline assessment of WHO’s target for both availability and affordability of essential medicines to treat non-communicable diseases. PloS one. 2017;12(2):e0171284.
40. Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane database of systematic reviews. 2014(11).
41. Organization WH. Global report on effective access to assistive technology. who https://apps? who. int/iris/handle/10665/341978; 2021.
42. Bigdeli M, Peters DH, Wagner AK, Organization WH. Medicines in health systems: advancing access, affordability and appropriate use. Medicines in health systems: advancing access, affordability and appropriate use2014.
43. Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, et al. A new taxonomy for describing and defining adherence to medications. British journal of clinical pharmacology. 2012;73(5):691-705.
44. Ma Z, Augustijn K, de Esch IJ, Bossink B. Collaborative university–industry R&D practices supporting the pharmaceutical innovation process: Insights from a bibliometric review. Drug Discovery Today. 2022;27(8):2333-41.
45. Davari M, Walley T, Haycox A. Pharmaceutical policy and market in Iran: past experiences and future challenges. Journal of Pharmaceutical Health Services Research. 2011;2(1):47-52.
46. Indicators AHO. Monitoring the building blocks of health systems. Geneva, Switzerland: WHO Document Production Services. 2010.
47. Cheraghali AM. Impacts of international sanctions on Iranian pharmaceutical market. DARU Journal of Pharmaceutical Sciences. 2013;21(1):64.
48. Kheirandish M, Rashidian A, Kebriaeezade A, Cheraghali AM, Soleymani F. A review of pharmaceutical policies in response to economic crises and sanctions. Journal of Research in Pharmacy Practice. 2015;4(3):115-22.
49. Godman B, Hill A, Simoens S, Kurdi A, Gulbinovič J, Martin A, et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal. 2019;8(2):49-70.
50. Karakurt P, Kaşikçi M. Factors affecting medication adherence in patients with hypertension. Journal of vascular nursing. 2012;30(4):118-26.
51. Bana A, Sharma KK, Guptha S, Gupta R. Adherence to pharmacotherapy for secondary prevention of coronary heart disease: A registry-based prospective study. Indian Heart Journal. 2025.
52. Systems EOoH, Policies. State of Health in the EU Austria: Country Health Profile 2021: OECD Publishing; 2021.
53. Gerybadze A, Reger G. Globalization of R&D: recent changes in the management of innovation in transnational corporations. Research policy. 1999;28(2-3):251-74.
54. AKHMAD AD, KRISTINA SA, Endarti D. A Systematic review of pharmaceutical situation on access, quality, and rational drug use. International Journal of Pharmaceutical Research (09752366). 2021;13(2).
55. Luiza VL, Chaves LA, Campos MR, Bertoldi AD, Silva RM, Bigdeli M, et al. Applying a health system perspective to the evolving Farmácia Popular medicines access programme in Brazil. BMJ Global Health. 2018;2.
2. Buse K, Mays N, Walt G. Making health policy: McGraw-hill education (UK); 2012.
3. Shahri S, Tabibi SJ, Nasiripour AA, Ghaffari F. Effect functions on goals of health system in Iran. Payavard salamat. 2017;11(3):247-58.
4. McCarthy S, O’Raghallaigh P, Woodworth S, Lim YL, Kenny LC, Adam F. An integrated patient journey mapping tool for embedding quality in healthcare service reform. Journal of Decision Systems. 2016;25(sup1):354-68.
5. Lam WY, Fresco P. Medication adherence measures: an overview. BioMed research international. 2015;2015.
6. Brown MT, Bussell JK, editors. Medication adherence: WHO cares? Mayo clinic proceedings; 2011: Elsevier.
7. Ferdinand KC, Senatore FF, Clayton-Jeter H, Cryer DR, Lewin JC, Nasser SA, et al. Improving medication adherence in cardiometabolic disease: practical and regulatory implications. Journal of the American College of Cardiology. 2017;69(4):437-51.
8. Kini V, Ho PM. Interventions to improve medication adherence: a review. Jama. 2018;320(23):2461-73.
9. Baur C. The national action plan to improve health literacy. US Department of Health and Human Services, Office of Disease Prevention and Health Promotion. 2010.
10. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/labeling-policy-team. https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/labeling-policy-team 2022.
11. Carvalho M, Almeida IF. The role of pharmaceutical compounding in promoting medication adherence. Pharmaceuticals. 2022;15(9):1091.
12. Kardas P, Lewek P, Matyjaszczyk M. Determinants of patient adherence: a review of systematic reviews. Frontiers in pharmacology. 2013;4:91.
13. Zeković M, Krajnović D, Marinković V, Tasić L. The Complexity of Adherence Issue: A Review of its scope and determinants. Acta Medica Medianae. 2016;55(1):51-8.
14. Kılıç H, Güneş ED. Patient adherence in healthcare operations: A narrative review. Socio-Economic Planning Sciences. 2023:101795.
15. Baroletti S, Dell'Orfano H. Medication adherence in cardiovascular disease. Circulation. 2010;121(12):1455-8.
16. Pietrzykowski Ł, Michalski P, Kosobucka A, Kasprzak M, Fabiszak T, Stolarek W, et al. Medication adherence and its determinants in patients after myocardial infarction. Scientific reports. 2020;10(1):12028.
17. Pettinati HM, Volpicelli JR, Pierce Jr JD, O'brien CP. Improving naltrexone response: an intervention for medical practitioners to enhance medication compliance in alcohol dependent patients. Journal of Addictive Diseases. 2000;19(1):71-83.
18. Rb H. Can simple clinical measurements detect patient noncompliance? Hypertension. 1980;2:757-64.
19. Walsh JC, Mandalia S, Gazzard BG. Responses to a 1-month self-report on adherence to antiretroviral therapy are consistent with electronic data and virological treatment outcome. Aids. 2002;16(2):269-77.
20. Tasavon Gholamhoseini M, Arjomand Kermani S, Yazdi-Feyzabadi V, Goudarzi R. Economic burden of cardiovascular diseases among elderly patients in Iran: a case from a developing country. BMC Health Services Research. 2024;24(1):1355.
21. Rezaei S, Vaezi F, Afzal G, Naderi N, Mehralian G. Medication adherence and health literacy in patients with heart failure: a cross-sectional survey in Iran. HLRP: Health Literacy Research and Practice. 2022;6(3):e191-e9.
22. Saki N, Karandish M, Cheraghian B, Heybar H, Hashemi SJ, Azhdari M. Prevalence of cardiovascular diseases and associated factors among adults from southwest Iran: Baseline data from Hoveyzeh Cohort Study. BMC cardiovascular disorders. 2022;22(1):309.
23. Behnoush AH, Younesian S, Mousavi SM, Khanmohammadi S, Golestani A, Rashidi M-M, et al. Temporal trends in cardiovascular disease risk factors attributed burden in Iran, 1990–2021. Scientific Reports. 2025;15(1):14279.
24. Piña IL, Di Palo KE, Brown MT, Choudhry NK, Cvengros J, Whalen D, et al. Medication adherence: importance, issues and policy: a policy statement from the American Heart Association. Progress in cardiovascular diseases. 2021;64:111-20.
25. Adams J, Hillier-Brown FC, Moore HJ, Lake AA, Araujo-Soares V, White M, Summerbell C. Searching and synthesising ‘grey literature’and ‘grey information’in public health: critical reflections on three case studies. Systematic reviews. 2016;5(1):164.
26. Noy C. Sampling knowledge: The hermeneutics of snowball sampling in qualitative research. International Journal of social research methodology. 2008;11(4):327-44.
27. Sabaté E. Adherence to long-term therapies: evidence for action: World health organization; 2003.
28. Chenail RJ. Interviewing the investigator: Strategies for addressing instrumentation and researcher bias concerns in qualitative research. Qualitative report. 2011;16(1):255-62.
29. VERBI Software. MAXQDA 2020. Berlin, Germany 2020.
30. Guest G, Bunce A, Johnson L. How many interviews are enough? An experiment with data saturation and variability. Field methods. 2006;18(1):59-82.
31. Limotai C, Boonyapisit K, Suwanpakdee P, Jirasakuldej S, Wangponpattanasiri K, Wongwiangiunt S, et al. From international guidelines to real-world practice consensus on investigations and management of status epilepticus in adults: a modified Delphi approach. Journal of Clinical Neuroscience. 2020;72:84-92.
32. Fitch K, Bernstein SJ, Aguilar MD, Burnand B, LaCalle JR. The RAND/UCLA appropriateness method user's manual. 2001.
33. Walt G, Shiffman J, Schneider H, Murray SF, Brugha R, Gilson L. ‘Doing’health policy analysis: methodological and conceptual reflections and challenges. Health policy and planning. 2008;23(5):308-17.
34. Polit DF, Beck CT. The content validity index: are you sure you know what's being reported? Critique and recommendations. Research in nursing & health. 2006;29(5):489-97.
35. Martilla JA, James JC. Importance-performance analysis. Journal of marketing. 1977;41(1):77-9.
36. Incerti D, Thom H, Baio G, Jansen JP. R you still using excel? The advantages of modern software tools for health technology assessment. Value in Health. 2019;22(5):575-9.
37. Godman B, Fadare J, Kwon H-Y, Dias CZ, Kurdi A, Dias Godoi IP, et al. Evidence-based public policy making for medicines across countries: findings and implications for the future. Journal of comparative effectiveness research. 2021;10(12):1019-52.
38. Wirtz VJ, Hogerzeil HV, Gray AL, Bigdeli M, de Joncheere CP, Ewen MA, et al. Essential medicines for universal health coverage. The Lancet. 2017;389(10067):403-76.
39. Ewen M, Zweekhorst M, Regeer B, Laing R. Baseline assessment of WHO’s target for both availability and affordability of essential medicines to treat non-communicable diseases. PloS one. 2017;12(2):e0171284.
40. Nieuwlaat R, Wilczynski N, Navarro T, Hobson N, Jeffery R, Keepanasseril A, et al. Interventions for enhancing medication adherence. Cochrane database of systematic reviews. 2014(11).
41. Organization WH. Global report on effective access to assistive technology. who https://apps? who. int/iris/handle/10665/341978; 2021.
42. Bigdeli M, Peters DH, Wagner AK, Organization WH. Medicines in health systems: advancing access, affordability and appropriate use. Medicines in health systems: advancing access, affordability and appropriate use2014.
43. Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, et al. A new taxonomy for describing and defining adherence to medications. British journal of clinical pharmacology. 2012;73(5):691-705.
44. Ma Z, Augustijn K, de Esch IJ, Bossink B. Collaborative university–industry R&D practices supporting the pharmaceutical innovation process: Insights from a bibliometric review. Drug Discovery Today. 2022;27(8):2333-41.
45. Davari M, Walley T, Haycox A. Pharmaceutical policy and market in Iran: past experiences and future challenges. Journal of Pharmaceutical Health Services Research. 2011;2(1):47-52.
46. Indicators AHO. Monitoring the building blocks of health systems. Geneva, Switzerland: WHO Document Production Services. 2010.
47. Cheraghali AM. Impacts of international sanctions on Iranian pharmaceutical market. DARU Journal of Pharmaceutical Sciences. 2013;21(1):64.
48. Kheirandish M, Rashidian A, Kebriaeezade A, Cheraghali AM, Soleymani F. A review of pharmaceutical policies in response to economic crises and sanctions. Journal of Research in Pharmacy Practice. 2015;4(3):115-22.
49. Godman B, Hill A, Simoens S, Kurdi A, Gulbinovič J, Martin A, et al. Pricing of oral generic cancer medicines in 25 European countries; findings and implications. Generics and Biosimilars Initiative Journal. 2019;8(2):49-70.
50. Karakurt P, Kaşikçi M. Factors affecting medication adherence in patients with hypertension. Journal of vascular nursing. 2012;30(4):118-26.
51. Bana A, Sharma KK, Guptha S, Gupta R. Adherence to pharmacotherapy for secondary prevention of coronary heart disease: A registry-based prospective study. Indian Heart Journal. 2025.
52. Systems EOoH, Policies. State of Health in the EU Austria: Country Health Profile 2021: OECD Publishing; 2021.
53. Gerybadze A, Reger G. Globalization of R&D: recent changes in the management of innovation in transnational corporations. Research policy. 1999;28(2-3):251-74.
54. AKHMAD AD, KRISTINA SA, Endarti D. A Systematic review of pharmaceutical situation on access, quality, and rational drug use. International Journal of Pharmaceutical Research (09752366). 2021;13(2).
55. Luiza VL, Chaves LA, Campos MR, Bertoldi AD, Silva RM, Bigdeli M, et al. Applying a health system perspective to the evolving Farmácia Popular medicines access programme in Brazil. BMJ Global Health. 2018;2.
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| Issue | Vol 21 No 2 (2026) | |
| Section | Original Article(s) | |
| Keywords | ||
| Medication Adherence Cardiovascular Disease Iranian Food and Drug Administration (IFDA) Health Policy Importance-Performance Analysis | ||
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How to Cite
1.
Moharrami O, Abdollhiasl A, Kebriaeezadeh A, Nikfar S, Mesgarpour B, Salarifar M. 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. Res Heart Yield Transl Med. 2026;21(2):126-140.
