An Exploratory Medicine Quality Survey of Furosemide Tablets in Selected Pharmacies around Hospitals Providing Specialist Cardiovascular Care in Nigeria
Keywords:
quality, Nigeria, children, cardiovascular medicines, furosemideAbstract
Introduction: Poor-quality medicines remain a public health challenge in Nigeria, despite the efforts of the National Agency for Food and Drug Administration and Control (NAFDAC). The quality of medicines intended for use in children is not known, as there are no studies on this area. The pharmacological management of cardiovascular disease in children is also an understudied research area. The aim of this study was to explore the quality of furosemide tablets intended for the extemporaneous preparation (compounding) of children's cardiovascular medicine in Nigeria.
Methods: The study used the mystery shopper approach to obtain samples of furosemide tablets from pharmacies purposively and conveniently selected in Bayelsa State, Lagos State and Abuja, Nigeria. Rationale for locations included states with public healthcare facilities providing paediatric cardiovascular care. At these locations, the major pharmacies within one-hour's drive from these
facilities were surveyed. Furosemide samples were assessed for quality by packaging inspection using registration by NAFDAC and chemical analysis for potency using the British Pharmacopoeia (BP) specification for Percent Label Claim (PLC). Samples that met the specified PLC of 95-105% were defined as being of quality, for compounding purposes.
Results: The majority, 90% (9/10) of the four brands of furosemide tablets samples were not registered by NAFDAC. The PLC of all samples was 100.2 ± 1.6% (mean ± SD).
Conclusion: Samples met official potency standards for quality (while other pharmacopoeial specifications were not checked), but the majority were not registered by NAFDAC. Regular multi- site post-marketing screening for medicine quality is needed in Nigeria.
Downloads
References
1. WHO. WHO Global Surveillance and Moonitoring System for Substandard and Falsified Medical Products [Internet]. 2017 [cited 2019 Dec 25]. Available from: https://apps.who.int/iris/bitstream/handle/10665/326708/9789241513425-eng.pdf?ua=1
2. Makgetla I. Innovations for Successful Societies. Oral history program: Governance Traps, Interview no H1. 2009;1-8.
3. Muanya C, Onyenucheya A. NAFDAC raises alarm over fake COVID-19 vaccine in Nigeria. The Guardian Nigeria News - Nigeria and World News [Internet]. 2021[cited 2021 Jan 29]; Available from: https://guardian.ng/news/nafdac-raises-alarm-over-fake-covid-19-vaccine-in-nigeria/
4. WHO. WHO Model List of Essential Medicines for Children - 7th list, 2019 [Internet]. 2019 [cited 2021 Feb 11]. Available from: https://www.who.int/publications-detail-redirect/WHOMVPEMPIAU201907
5. WHO. Non communicable diseases [Internet]. 2020. [cited 2020 Dec 27]. Available from: https://www.who.int/news-room/fact-sheets/detail/noncommunicable-diseases
6. Zühlke L, Mirabel M, Marijon E. Congenital heart disease and rheumatic heart disease in Africa: recent advances and current priorities. Heart 2013;99(21):155461.
7. Bowles A, Keane J, Ernest T, Clapham D, Tuleu C. Specific aspects of gastro- intestinal transit in children for drug delivery design. Int J Pharm 2010;395(12):3743.
8. Orubu ESF, Okwelogu C, Opanuga O, Nunn T, Tuleu C. Access to age-appropriate essential medicines: a retrospective survey of compounding of medicines for children in hospitals in Nigeria and implications for policy development. Health Policy Plan 2016;32(2):22535.
9. Ankrah DNA, Turkson JT, Boateng EB, Amegavie FTT, Bruce E. Insufficient access to oral paediatric medicines in Ghana: A descriptive study. BMC Health Serv Res 2016;16(1):15.
10. Bilakhia NA, Tirop LJ, Menge TB, Kuria KAM. A retrospective study of oral medications compounded for pediatric patients at Kenyatta National Hospital. East Cent Afr J Pharm Sci2014;17(3):649.
11. Ndichu ET, Ohiri K, Sekoni O, Makinde O, Schulman K. Evaluating the quality of antihypertensive drugs in Lagos State, Nigeria. Musinguzi G, editor. PLOS ONE2019;14(2):e0211567.
12. Redfern J, Kaur H, Adedoyin RA, Ofori S, Anchala R, Vamadevan AS, et al. Equivalence in Active Pharmaceutical Ingredient of Generic Antihypertensive Medicines Available in Nigeria (EQUIMEDS): A Case for Further Surveillance. Glob Heart 2019;14(3):327.
13. Chinaka CN, Nwachukwu N. Comparative in vitro quality assessment of five brands of furosemide tablets marketed in Port Harcourt, Nigeria. Niger J Pharm Res 2017;13(2):97104.
14. Orubu ESF, Robert FO, Samuel M, Megbule D. Access to essential cardiovascular medicines for children: a pilot study of availability, price and affordability in Nigeria. Health Policy Plan 2019;34(3):iii20iii26.
15. Newton PN, Lee SJ, Goodman C, Fernández
FM, Yeung S, Phanouvong S, et al.
Guidelines for Field Surveys of the
Quality of Medicines: A Proposal.
PLoS Med 2009;6(3):e1000052.
16. Ekure E, Sadoh W, Bode-Thomas F, Orogade A, Animasahun A, Ogunkunle O, et al. Audit of availability and distribution of paediatric cardiology services and facilities in Nigeria. Cardiovasc J Afr 2017;28(1):549.
17. Anyakora C, Oni Y, Ezedinachi U, Adekoya A, Ali I, Nwachukwu C, et al. Quality medicines in maternal health: results of oxytocin, misoprostol, magnesium sulfate and calcium gluconate quality audits. BMC Pregnancy Childbirth2018;18(1):44.
18. British Pharmacopoeia Commission. British pharmacopoeia: Furosemide. Vol. 1. London, United Kingdom: TSO2020.
19. Antignac M, Diop BI, Do B, NGuetta R, Toure IA, Zabsonre P, et al. Quality Assessment of 7 Cardiovascular Drugs in 10 Sub-Saharan Countries: The SEVEN Study. JAMA Cardiol 2017;2(2):223.
20. Abebe S, Ketema G, Kassahun H. In vitro Comparative Quality Assessment of Different Brands of Furosemide Tablets Marketed in Northwest Ethiopia. Drug Des Devel Ther 2020;14:511928.
21. Pribluda VS, Barojas A, Coignez V, Bradby S, Dijiba Y, El-Hadri L, et al. The Three- Level Approach: A Framework for Ensuring Medicines Quality in Limited - Resource Countries. Pharmaceut Reg Affairs 2014;3:117.
22. Mukhtar MD, Bashir M, Arzai AH. Comparative in-vitro studies on antiplasmodial quality of some Nigerian and foreign brands of
chloroquine oral formulations marketed in kano. Afr J Biotechnol 2006;5(24):2464-68.
23. Okhuelegbe ES, Dennis ICA, Amara IM. Pharmaceutical quality assessment of brands of metformin hydrochloride tablets available in south-east nigeria. Afr J Pharm Res Dev 2020;12(3):333- 341.
24. Nnamdi JA, Arhewoh IM, Okhamafe AO, Enato EFO. Evaluation of the Pharmaceutical Quality of Some Quinine Preparations Sold in Nigeria. Med Princ Pract2009;18(3):1937.
25. Akunyili D. The challenges faced by NAFDAC in the national regulatory process as it relates to essential drugs for prevention of maternal and newborn deaths in Nigeria. Trop J Obstet Gynaecol 2010;27(1):817.
Downloads
Published
Issue
Section
License
All articles published in the journal are licensed under a Creative Commons Attribution (CC BY) license(i.e CC Attribution-NonCommercial-ShareAlike 4.0), allowing others to share, distribute, and build upon the work, provided the original author(s) and source are properly cited. Authors retain the copyright of their work.
