ISSN: 2642-6315
Authors: Mwamwitwa K, Fimbo A, Mziray S, Nandonde M, Hipolite D, Kijo AS, Njau B, and Kaale E*
Background: Globally, cardiovascular diseases (CDVs) are amongst of the life threatening non- communicable diseases. The World Health Organization (WHO) reports indicate that CDVs is number one cause of deaths worldwide, largely in developing countries. Hypertension is a major risk factor for CVDs accounting for 9.4 million deaths worldwide every year. The prevalence of hypertension amongst Tanzanian is reported to be as high as 17%. Early detection and appropriate management of hypertension with quality and effective medicines is of clinical importance. The growing market of substandard and/or falsified medicines is a threat as it can result in treatment failure and unnecessary increase of healthcare cost. Objective: The surveillance was done by Tanzania Food and Drugs Authority with the aim of monitoring the quality of anti-hypertensive medicines circulating on the Tanzania mainland market. Methodology: Selected antihypertensive medicines were sampled from Medical Store Department, private and public healthcare facilities and pharmaceutical outlets from eleven (11) selected regions. All samples were subjected to product information review. All nifedipine samples were subjected to tier I quality screening test using the Global Pharma Health Fund® Mini-Lab kits. All samples which were not screened and about 10% of those passed the screening test were subjected to tier II confirmatory testing at Tanzania Food and Drugs Authority –WHO prequalified laboratory. Results: A total of 170 samples of antihypertensive were collected of which 63.5% (108/170) failed to comply with product information requirements. All 69 samples of nifedipine subjected to tier I screening test, passed disintegration and identification test by thin layer chromatography. A total of 90 samples were subjected to tier II confirmatory test ofwhich included (7) nifedipine, (32) atenolol, (27) captopril and (24) furosemide, all passed identification, disintegration, weight variation and appearance tests. Also all samples of atenolol, captopril and furosemide passed assay test. However, of the tested samples of nifedipine, 45.4% (5/11) failed assay test by having low contents of active ingredients with results ranged between 69.4% and 79.5% (Limit 90-110%). All batches of failed nifidipine tables were recalled from the market. Conclusion: Majority of the surveyed antihypertensive medicines were found to meet quality standards. However, the observed failure in assay of some nifedipine samples from a single manufacturer is a sign of availability of substandard medicines on the market and thus, calls for further vigilance of this product on the market.
Keywords: Medicines quality; Substandard; Antihypertensive; Post market surveillance
