An Exploratory Medicine Quality Survey of Furosemide Tablets in Selected Pharmacies around Hospitals Providing Specialist Cardiovascular Care in Nigeria

Abstract
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 multisite post-marketing screening for medicine quality is needed in Nigeria.

KEYWORDS: furosemide, cardiovascular medicines, children, Nigeria, quality