Fixed dose drug combinations – are they pharmacoeconomically sound? Findings and implications especially for lower- and middle-income countries

Author:

Godman Brian1234ORCID,McCabe Holly5,D Leong Trudy6ORCID,Mueller Debjani78,Martin Antony P.910ORCID,Hoxha Iris11,Mwita Julius C.12ORCID,Rwegerera Godfrey Mutashambara13ORCID,Massele Amos14,Costa Juliana de Oliveira151617ORCID,do Nascimento Renata Cristina Rezende Macedo118ORCID,Lemos Livia Lovato Pires de1516ORCID,Tachkov Konstantin19ORCID,Milushewa Petya19,Patrick Okwen2021,Niba Loveline Lum2022,Laius Ott23,Sefah Israel24ORCID,Abdulsalim Suhaj25ORCID,Soleymani Fatemeh2627ORCID,Guantai Anastasia N28,Achieng Loice29ORCID,Oluka Margaret28,Jakupi Arianit30,Logviss Konstantīns31,Hassali Mohamed Azmi4ORCID,Kibuule Dan32ORCID,Kalemeera Francis32ORCID,Mubita Mwangana32,Fadare Joseph3334ORCID,Ogunleye Olayinka O.3536ORCID,Saleem Zikria37ORCID,Hussain Shazhad38,Bochenek Tomasz39ORCID,Mardare Ileana40ORCID,Alrasheedy Alian A.41ORCID,Furst Jurij42,Tomek Dominik43,Markovic-Pekovic Vanda44ORCID,Rampamba Enos M.245ORCID,Alfadl Abubakr4146ORCID,Amu Adefolarin A47,Matsebula Zinhle48,Phuong Thuy Nguyen Thi49ORCID,Thanh Binh Nguyen49,Chichonyi Kalungia Aubrey50ORCID,Zaranyika Trust51ORCID,Masuka Nyasha52ORCID,Olaru Ioana D.5354ORCID,Wale Janney55,Hill Ruaraidh56ORCID,Kurdi Amanj157ORCID,Timoney Angela158,Campbell Stephen5960ORCID,Meyer Johanna C.2ORCID

Affiliation:

1. Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, UK

2. Division of Public Health Pharmacy and Management, School of Pharmacy, Sefako Makgatho Health Sciences University, Pretoria, South Africa

3. Division of Clinical Pharmacology, Karolinska Institute, Karolinska University Hospital Huddinge, Stockholm, Sweden

4. School of Pharmaceutical Sciences, Universiti Sains Malaysia, Penang, Malaysia

5. Department of Management Science, Strathclyde Business School, University of Strathclyde, Glasgow, UK

6. Essential Drugs Programme, Affordable Medicines Directorate, South African National Department of Health, Pretoria, South Africa

7. Department of Public Health Medicine, Steve Biko Academic Hospital and University of Pretoria, Pretoria, South Africa

8. Charlotte Maxeke Medical Research Cluster, Johannesburg, South Africa

9. Health Economics Centre, University of Liverpool Management School, Liverpool, UK

10. HCD Economics, The Innovation Centre, Daresbury, UK

11. Department of Pharmacy, Faculty of Medicine, University of Medicine Tirana, Tirana, Albania

12. Department of Internal Medicine, Faculty of Medicine, University of Botswana, Gaborone, Botswana

13. Faculty of Medicine, Department of Internal Medicine, University of Botswana and Department of Medicine, Princess Marina Hospital, Gaborone, Botswana

14. Department of Biomedical Sciences, Faculty of Medicine, University of Botswana, Gaborone, Botswana

15. SUS Collaborating Centre for Technology Assessment & Excellence in Health, Universidade Federal De Minas Gerais, Belo Horizonte, Brazil

16. Programa De Pós-Graduação Em Saúde Pública, Faculdade De Medicina, Universidade Federal De Minas Gerais, Belo Horizonte, Minas Gerais, Brazil

17. Centre for Big Data Research in Health, UNSW Sydney, Sydney, NSW, Australia

18. Departament of Pharmacy, School of Pharmacy, Federal University of Ouro Preto (UFOP), Ouro Preto, Brazil

19. Faculty of Pharmacy, Department of Social Pharmacy and Pharmacoeconomics, Medical University of Sofia, Sofia, Bulgaria

20. Effective Basic Services (Ebase) Africa, Bamenda, Cameroon, Africa

21. Adelaide University, Adelaide, Australia

22. Department of Public Health, University of Bamenda, Bambili, Cameroon

23. State Agency of Medicines, Tartu, Estonia

24. Department of Pharmacy, Keta Municipal Hospital, Ghana Health Service, Ghana

25. Department of Pharmacy Practice, Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia

26. Pharmaceutical Management & Economic Research Center, Tehran University of Medical Sciences, Tehran, Iran

27. Department of Pharmacoeconomics and Pharmaceutical Management, Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran

28. Department of Pharmacology and Pharmacognosy, School of Pharmacy, University of Nairobi, Nairobi, Kenya

29. Department of Clinical Medicine and Therapeutics, School of Medicine, University of Nairobi, Nairobi, Kenya

30. UBT– Higher Education Institution, Prishtina, Kosovo

31. Institute of Public Health & Department of Dosage Form Technology, Faculty of Pharmacy, Riga Stradins University, Latvia

32. Department of Pharmacy Practice and Policy, Faculty of Health Sciences, University of Namibia, Windhoek, Namibia

33. Department of Pharmacology and Therapeutics, Ekiti State University, Ado-Ekiti, Nigeria

34. Department of Medicine, Ekiti State University Teaching Hospital, Ado-Ekiti, Nigeria

35. Department of Pharmacology, Therapeutics and Toxicology, Lagos State University College of Medicine, Ikeja, Lagos, Nigeria

36. Department of Medicine, Lagos State University Teaching Hospital, Ikeja, Lagos, Nigeria

37. Faculty of Pharmacy, The University of Lahore, Lahore, Pakistan

38. National Institute of Health, Islamabad, Pakistan

39. Department of Nutrition and Drug Research, Faculty of Health Sciences, Jagiellonian University Medical College, Krakow, Poland

40. Faculty of Medicine, Public Health and Management Department, “Carol Davila” University of Medicine and Pharmacy Bucharest, Bucharest, Romania

41. Unaizah College of Pharmacy, Qassim University, Qassim, Saudi Arabia

42. Health Insurance Institute, Ljubljana, Slovenia

43. Faculty of Medicine, Slovak Medical University in Bratislava, Bratislava, Slovakia

44. Department of Social Pharmacy, Faculty of Medicine, University of Banja Luka, Republic of Srpska, Bosnia and Herzegovina

45. Department of Pharmacy, Tshilidzini Hospital, Limpopo Department of Health, Limpopo Province, South Africa

46. Medicines and Poison Board, Federal Ministry of Health, Khartoum, Sudan

47. Eswatini Medical Christian University, Mbabane, Kingdom of Eswatini

48. Raleigh Fitkin Memorial Hospital, Manzini, Kingdom of Eswatini

49. Pharmaceutical Administration & PharmacoEconomics, Hanoi University of Pharmacy, Vietnam

50. Department of Pharmacy, University of Zambia, Lusaka, Zambia

51. Department Of Medicine, University of Zimbabwe College of Health Sciences, Harare, Zimbabwe

52. Independent Health Systems Consultant, Harare, Zimbabwe

53. Clinical Research Department, London School of Hygiene and Tropical Medicine, London, UK

54. Biomedical Research and Training Institute, Harare, Zimbabwe

55. Independent Consumer Advocate, Brunswick, Victoria, Australia

56. Liverpool Reviews and Implementation Group, Whelan Building, Liverpool University, Liverpool, UK

57. Department of Pharmacology, College of Pharmacy, Hawler Medical University, Erbil, Iraq

58. NHS Lothian Director of Pharmacy, NHS Lothian, Edinburgh, UK

59. Centre for Primary Care, Division of Population Health, Health Services Research and Primary Care, University of Manchester, Manchester, UK

60. NIHR Greater Manchester Patient Safety Translational Research Centre, School of Health Sciences, University of Manchester, Manchester, UK

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Health Policy,General Medicine

Reference333 articles.

1. Fixed dose drug combinations (FDCs): rational or irrational: a view point

2. EMA. Guideline on clinical development of fixed combination medicinal products. 2017 [cited 2019 Oct 10]. Available from https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-clinical-development-fixed-combination-medicinal-products-revision-2_en.pdf

3. Availability and rationality of fixed dose combinations available in Kaduna, Nigeria

4. An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009–2014: A Focus on Benefit-Risk and Clinical Development Conditions

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