Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi

Abstract

Substandard and falsified antimalarial and antibiotic medicines represent a serious problem for public health, especially in low- and middle-income countries. However, information on the prevalence of poor-quality medicines is limited. In the present study, samples of six antimalarial and six antibiotic medicines were collected from 31 health facilities and drug outlets in southern Malawi. Random sampling was used in the selection of health facilities. For sample collection, an overt approach was used in licensed facilities, and a mystery shopper approach in nonlicensed outlets. One hundred and fifty-five samples were analyzed by visual and physical examination and by rapid prescreening tests, that is, disintegration testing and thin-layer chromatography using the GPHF-Minilab. Fifty-six of the samples were analyzed according to pharmacopeial monographs in a World Health Organization-prequalified quality control laboratory. Seven out-of-specification medicines were identified. One sample was classified as falsified, lacking the declared active ingredients, and containing other active ingredients instead. Three samples were classified as substandard with extreme deviations from the pharmacopeial standards, and three further samples as substandard with nonextreme deviations. Of the substandard medicines, three failed in dissolution testing, two in the assay for the content of the active pharmaceutical ingredient, and one failed in both dissolution testing and assay. Six of the seven out-of-specification medicines were from private facilities. Only one out-of-specification medicine was found within the samples from public and faith-based health facilities. Although the observed presence of substandard and falsified medicines in Malawi requires action, their low prevalence in public and faith-based health facilities is encouraging.

Availability and affordability of antimalarial and antibiotic medicines in Malawi

“…Prices of medicine samples which were found not comply with pharmacopeial specifications [22] are underlined . 1 Not included in calculations, see Methods. 2 Prices of artemether/lumefantrine were not included in the calculation of the overall median price ratio for CHAM and private facilities.…”

“…Prices of medicine samples which were found not comply with pharmacopeial specifications [22] are underlined .…”

“…The sampling strategy is explained in detail in the report on the quality analysis [22]. The study included the urban centre of Blantyre with its surrounding district, as well as three rural districts of southern Malawi.…”

Assessment of the quality of anti-tuberculosis medicines in Almaty, Kazakhstan, 2014

“…Given that ±10%variations in TLC readings can be seen with the naked eye, medicines with 70–80% of the API that otherwise meet quality standards could be acceptable. 21,23,24 However, as TLC may mistakenly identify a form as having too little or sufficient API, reader experience is important for accurate interpretation. 24 Conversely, the detection of breakdown products of the API by TLC due to, for example, incorrect storage, can lend confidence to an interpretation of too little drug.…”

Quality of the antimalarial medicine artemether – lumefantrine in 8 cities of the Democratic Republic of the Congo

“…A study conducted in Tanzania has reported a failure rate of only 4.8% for antimalarial drugs collected between 2012 and 2015 . A likewise low prevalence of substandard and falsified antimalarial medicines (and also in the case of antibiotic pharmaceutical preparations) has recently been found in Southern Malawi …”