Substandard and falsified medical product recalls in Zambia from 2018 to 2021 and implications on the quality surveillance systems

Abstract

Background: Substandard and falsified (SF) medical products are removed from circulation through a process called ‘product recall’ by medicines regulatory agencies. In Zambia, the Zambia Medicines Regulatory Authority (ZAMRA) is responsible for recalling SF medical products from the Zambian market through passive and active surveillance methods. This study aimed to describe the prevalence of recalls of SF medical products and to analyse the frequently recalled therapeutic categories, dosage forms, categories of defects that led to the recalls and their sources with respect to the country of the marketing authorisation holder (MAH) or manufacturer. Methods: We conducted a descriptive cross-sectional review of the product recalls issued by ZAMRA between January 2018 and December 2021. A search for all medical product alerts and recalls issued by ZAMRA was carried out by reviewing the internal post-marketing surveillance database kept at ZAMRA headquarters. Data were extracted using a structured Excel database and analysed using Microsoft Excel. Results: A total of 119 alerts were received during the review period, of which 83 (69.7%) were product recalls. Oral solid dosage forms were the most recalled dosage form (53%). Furthermore, the number of recalls increased in 2020 (44.6%) and 2021 (22.9%), with the majority (20.5%) of the recalled products being substandard products classified as antiseptics and disinfectants and were attributed to the high demand during the COVID-19 pandemic. Manufacturing laboratory control issues were the reason for product recall in almost half (47.4%) of the cases. Most of the products recalled originated from India (38.6%), followed by Zambia (25.3%). Only one suspected falsified product was recalled between 2018 and 2021. A total of 66 recalls of the 83 products were initiated by ZAMRA, with only 17 voluntarily by foreign MAHs. No product recall was initiated by the local representatives of foreign manufacturers or MAH. Conclusion: The majority of the pharmaceutical product recalls in Zambia were substandard products. Manufacturing laboratory control issues lead to most recalls and require investigation of the root causes, preventive action, and strict compliance with the good manufacturing practices guidelines by manufacturers.

A four-year assessment of the characteristics of Rwandan FDA drug recalls

“…In a specific case involving ranitidine, a nitrosamine impurity classified as a probable human carcinogen was detected, prompting a voluntary recall by the manufacturer. The pattern of contamination as a significant factor in product recall is evident not only in Rwanda but also in the United States, Nepal and Zambia [ 4 , 28 , 29 ]. The prevalence of contamination as a leading cause emphasizes the critical importance of rigorous quality control protocols throughout the production and distribution chain.…”

“…India emerged as a predominant source of recalled products, accounting for 29.2% of the total recall but, many Indian products fell into Class II recalls (80.6%). India was also found to be the leading manufacturing country for the recalled product in Zambia, Nepal and Sri Lanka [ 28 , 29 , 31 ]. This highlights the need for heightened vigilance in quality control, within its pharmaceutical industry and underlines the importance of vigilance for products imported from India.…”

Quality of medicines in Sri Lanka: a retrospective review of safety alerts

“…This result is consistent with findings from other studies conducted internationally examining medicine recalls. Different numbers of defective medicines, such as 653, 280, 195, 84, and 83, have been reported in Canada [ 9 ], the UK [ 8 ], the USA [ 19 ], Saudi Arabia [ 21 ] and Zambia [ 22 ], respectively. However, it should be noted that it is not possible to compare the compatibility of findings from this study with other international studies due to the difference in study duration.…”

“…Such problems are usually detected when patients, consumers or healthcare providers report issues on medicines to relevant authorities [ 19 , 20 ]. Medicine recalls have been reported all around the world, including the West [ 8 , 9 , 19 , 21 , 22 ]. SM and FM can be recalled due to several factors, and to provide accurate information, they can be classified into multiple defect categories, as reported in the literature [ 8 , 9 , 19 , 21 , 22 ].…”

“…Medicine recalls have been reported all around the world, including the West [ 8 , 9 , 19 , 21 , 22 ]. SM and FM can be recalled due to several factors, and to provide accurate information, they can be classified into multiple defect categories, as reported in the literature [ 8 , 9 , 19 , 21 , 22 ]. Furthermore, the European Medicines Agency (EMA), an agency of the European Union in charge of the evaluation and supervision of pharmaceutical products, classifies SM and FM in five high-level terms.…”