The importance of visual inspection in national quality assurance systems for medicines
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(2020) 13:52
LETTER TO THE EDITOR
Open Access
The importance of visual inspection in national quality assurance systems for medicines Gamal Khalafalla Mohamed Ali1, Raffaella Ravinetto2*
and Abubakr Abdelraouf Alfadl3
Dear Editor, In their short report, Schiavetti and colleagues presented a visual inspection checklist, designed to guide health workers at the point of care to rapidly identify suspect poor-quality medicines [1]. We would like to emphasize the importance of this tool, by discussing three cases reported at different time points in Sudan. Since 1998, a simple checklist was implemented by the Revolving Drug Fund (RDF) in Khartoum State, Sudan, and later by the Sudanese National Medical Supplies Fund (NMSF), to monitor the quality of medicines at health facilities in Khartoum State and in Sudan respectively. In 1999, the national lay press widely publicized an incident of contaminated intravenous fluids purchased from an Indian manufacturer [2] and imported by the central medical public corporation (CMS), i.e., the national public procurement agency, which was further transformed into the nonprofit NMSF in 2015 [3]. A fungal growth was clearly visible on different bottles from different batches, but those in charge of acting upon the non-conform product disagreed on actions to be undertaken. The “proponents,” mainly at the CMS, argued that findings of the visual inspection should not be generalized to other bottles or other batches that did not show (yet) fungal growth [2], while the “opponents,” mainly at the Chamber of Medicine’s Importers, argued that information from the lay press must be taken seriously, and that batch recalls were urgently needed, as not acting would cause health damage and perhaps claim lives [2]. Eventually, all intravenous fluids * Correspondence: [email protected] 2 Department of Public Health, Institute of Tropical Medicine, Nationalestraat 155, 2000 Antwerp, Belgium Full list of author information is available at the end of the article
imported by CMS from this company were withdrawn from the market, regardless of contamination status, by a ministerial decree in 2001. Remarkably, findings from a simple visual inspection allowed to identify a non-reliable supplier and to prevent future harm. A similar scenario was repeated in 2005 [3]. At that time, the General Directorate of Pharmacy (G-DOP) was acting as a secretariat of the National Medicines and Poisons Board (NMPB) that is the national medicine regulatory authority (an autonomous secretariat of NMPB, under direct supervision of the Minister of Health, was formally established in November 2007). The G-DOP revoked the marketing authorization of a cough syrup manufactured by a United Arab Emiratesbased drug company, and imported by the CMS. The decision was taken because the visual inspection revealed leaked bottles from different batches. Again, decision-makers divided. “Proponents”complained that the G-DOP had not tested the product chemically and based its decision on visual inspection only. The G-DOP argued that whe
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