Burden of and factors associated with poor quality antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi

Abstract

Objective To assess the prevalence and factors associated with substandard and falsified (SF) medicines among antibiotic, antimalarial, antihypertensive and antidiabetic medicines in Malawi. Methods We conducted a cross-sectional study in 23 public, faith-based and private health facilities in Zomba, Machinga and Nsanje districts. We analyzed oral medicine samples of commonly used medicines among antibiotics, antimalarial, antihypertensive and antidiabetics in accordance with Malawi Essential Medicines List and local treatment guidelines. These medicines were subjected to visual inspection for any defects and screening for the content of active pharmaceutical ingredient and disintegration of dosage units. Samples that failed during screening and at least 10% of those that passed were subjected to pharmacopeia assay and dissolution test for confirmation. We used thin layer chromatography and disintegration test methods provided in the Global Pharma Health Fund minilab® for the screening purposes. We conducted confirmatory test using High-Performance Liquid Chromatography (HPLC) or ultra-violet/visible spectrophotometer and dissolution. Results Of the 293 medicine samples collected, 14.3% were SF medicines. Among the SF medicines were 12.5% of Amlodipine (1/8), 19.2% of Amoxicillin (5/26), 72.2% of Atenolol (8/11), 21.2% of Ciprofloxacin (7/33), 14.3% of Enalapril (1/7), 44.4% of Flucloxacillin (4/9), and 35.7% of sulfadoxine/ pyrimethamine (10/28). Medicine quality was associated with therapeutic medicine class, stated origin of manufacturer, primary packaging material and geographical location. Antimalarial and antidiabetic medicines were of better quality as compared to antibiotics, odds ratio OR 4.2 (95% CI 1.7–9.49), p < 0.002 and OR 5.6 (95% CI 1.21–26.09), p < 0.028 respectively. In terms of stated country of origin, the prevalence of SF medicines was 30% (15/50), 33% (9/27), 26.7% (4/15) and 6.6% (8/122) for medicines stated to be manufactured in Malawi, China, Kenya and India respectively. Conclusion This study presents the first findings on the assessment of quality of medicines since the establishment of the national pharmacovigilance center in 2019 in Malawi. It is revealed that the problem of SF medicines is not improving and hence the need for further strengthening of quality assurance systems in Malawi.

Temperature variations in pharmaceutical storage facilities and knowledge, attitudes, and practices of personnel on proper storage conditions for medicines in southern Malawi

“…We placed the Tempmate data loggers in public, faith-based and private pharmacies and drugstores. Details on the how the sites were selected have been described in another publication ( 19 ). In summary, we installed Tempmate® in 11 faith-based not for profit, 16 public and two private health facilities.…”

Uncovering the Quality Deficiencies with Potentially Harmful Effects in Substandard and Falsified PDE-5 Inhibitors Seized by Belgian Controlling Agencies

“…Based on the scientific literature, one of the major health risks associated with the use of SF medicinal products is the fact that they might contain an improper amount of the active pharmaceutical ingredient (API) or the wrong ingredients [5][6][7][8][9][10][11][12][13][14][16][17][18][19][20][21][22]26]. A serious incident with counterfeit PDE-5 inhibitors occurred in Singapore in 2008, where 150 non-diabetic patients suffered from drug-induced hypoglycemia due to four brands of sexual-enhancement drugs that were contaminated with glyburide [13].…”

“…For several decades, the falsifications of blockbuster drugs have been encountered on a worldwide scale but with regional differences in the products targeted by criminals and criminal organizations. Examples of these are the high occurrence of lifesaving medicines like antibiotics and antimalarial products in African and Asian countries [1,[4][5][6][7][8][9][10][11]. Meanwhile, in Western countries, although there is prevalence of substandard and falsified lifesaving medicines, they are encountered less frequently.…”

The impact of anti-malarial markets on artemisinin resistance: perspectives from Burkina Faso

“…Socio-economic factors and (un)availability of therapies have also been related to resistance along with health system weaknesses and supply chain deficiencies [26,27]. Anti-malarial market characteristics, including supply chain processes, quality control systems, distribution procedures and storage conditions, have previously been analysed, showing their impact on the quality, price and/ or the availability of anti-malarial drugs [6,[28][29][30][31][32].…”