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

Billy Chabalenge; Elimas Jere; Namuchindo Nanyangwe; Christabel Hikaambo; Steward Mudenda; Michelo Banda; Aubrey Kalungia; Scott Matafwali

doi:10.1177/27550834221141767

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

J Med Access. 2022 Dec 25:6:27550834221141767. doi: 10.1177/27550834221141767. eCollection 2022 Jan-Dec.

Authors

Billy Chabalenge¹, Elimas Jere¹, Namuchindo Nanyangwe¹, Christabel Hikaambo², Steward Mudenda³, Michelo Banda³, Aubrey Kalungia³, Scott Matafwali⁴

Affiliations

¹ Department of Medicines Control, Zambia Medicines Regulatory Authority, Lusaka, Zambia.
² Department of Chemistry, Faculty of Science, University of Cape Town, Cape Town, South Africa.
³ Department of Pharmacy, University of Zambia, Lusaka, Zambia.
⁴ Department of Clinical Research, Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK.

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.

Keywords: Pharmacovigilance; ZAMRA; Zambia; falsified; medical products; recall; substandard.