Quality indicators on medicines packaging as guide to routine quality assurance for procured generic medicines: A community pharmacy survey in Nigeria

Introduction While medicines quality assurance is best performed by a Stringent Regulatory Authority (SRA), many countries still lack this capacity. In these contexts, brand manufacturers take additional steps to signal authenticity to their consumers through the use of overt authentication technologies on medicines packaging. The aim of this study was to use quality indicators on the secondary packaging of medicines to identify, and, thus, risk rank, therapeutic groups most prone to being substandard or falsified. Method This study profiled medicines in the inventory of a conveniently selected pharmacy in Nigeria by three common packaging quality indicators: (i) National Agency for Food and Drug Administration, NAFDAC, registration number, (ii) a mobile authentication service, MAS, number, and (iii) a hologram. Results The inventory contained 66 medicines available as 380 oral, parenteral, or topical products. Of these, 92% had a NAFDAC number, 20% had a MAS number, and 10% bore a hologram – either exclusively, or simultaneously. Antimicrobials – mostly antibiotics and antimalarials – were the most common therapeutic group containing one or all three quality indications. Antibiotic medicines for children formulated as suspensions and drops had the most quality assurance indicators on their packaging. Conclusion This result suggests that antimicrobials, especially those formulated for use in children, may be the medicine group at the greatest risk of being substandard or falsified (SF) in Nigeria. The implication of this finding is the need for healthcare facilities to implement strict medicines quality assurance procurement practices especially for antimicrobials . Continued vigilance by the public would also be necessary.