{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T07:11:25Z","timestamp":1785222685223,"version":"3.55.0"},"reference-count":47,"publisher":"American Society of Tropical Medicine and Hygiene","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2017,5,3]]},"abstract":"<jats:p>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.<\/jats:p>","DOI":"10.4269\/ajtmh.16-1008","type":"journal-article","created":{"date-parts":[[2017,2,21]],"date-time":"2017-02-21T01:40:35Z","timestamp":1487641235000},"page":"1124-1135","source":"Crossref","is-referenced-by-count":29,"title":["Low Prevalence of Substandard and Falsified Antimalarial and Antibiotic Medicines in Public and Faith-Based Health Facilities of Southern Malawi"],"prefix":"10.4269","volume":"96","author":[{"given":"Felix","family":"Khuluza","sequence":"first","affiliation":[{"name":"Pharmacy Department, College of Medicine, University of Malawi, Blantyre, Malawi."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Kigera","sequence":"additional","affiliation":[{"name":"Mission for Essential Drugs and Supplies (MEDS), Nairobi, Kenya."}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lutz","family":"Heide","sequence":"additional","affiliation":[{"name":"Pharmacy Department, College of Medicine, University of Malawi, Blantyre, Malawi."},{"name":"Pharmaceutical Institute, Eberhard-Karls-University Tuebingen, Tuebingen, Germany."}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2795","reference":[{"key":"ref1","series-title":"Transforming Our World: The 2030 Agenda for Sustainable Development, A\/RES\/70\/1 (25 September 2015)","author":"United Nations, General Assembly resolution 70\/1"},{"key":"ref2","series-title":"The Lancet","first-page":"403","article-title":"Essential medicines for universal health coverage","volume":"389","author":"Wirtz","year":"2017"},{"key":"ref3","series-title":"Am J Trop Med Hyg","first-page":"2","article-title":"The global pandemic of falsified medicines: laboratory and field innovations and policy perspectives","volume":"92","author":"Nayyar","year":"2015"},{"key":"ref4","series-title":"Lancet Infect Dis","first-page":"488","article-title":"Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa","volume":"12","author":"Nayyar","year":"2012"},{"key":"ref5","series-title":"Am J Trop Med Hyg","first-page":"119","article-title":"Estimated under-five deaths associated with poor-quality antimalarials in sub-Saharan Africa","volume":"92","author":"Renschler","year":"2015"},{"key":"ref6","series-title":"Clin Microbiol Rev","first-page":"443","article-title":"Substandard\/counterfeit antimicrobial drugs","volume":"28","author":"Kelesidis","year":"2015"},{"key":"ref7","series-title":"Lancet","first-page":"1884","article-title":"Global health security: the wider lessons from the west African Ebola virus disease epidemic","volume":"385","author":"Heymann","year":"2015"},{"key":"ref8","series-title":"BMJ Open","first-page":"e002923","article-title":"Substandard and counterfeit medicines: a systematic review of the literature","volume":"3","author":"Almuzaini","year":"2013"},{"key":"ref9","series-title":"BMJ","first-page":"e7381","article-title":"How to achieve international action on falsified and substandard medicines","volume":"345","author":"Attaran","year":"2012"},{"key":"ref10","series-title":"Essential Medicines and Health Products. Definitions of SSFFC Medical Products","author":"World Health Organization (WHO)","year":"2016"},{"key":"ref11","series-title":"Substandard, Spurious, Falsely Labelled, Falsified and Counterfeit (SSFFC) Medical Products","author":"WHO Media Centre","year":"2016"},{"key":"ref12","series-title":"Am J Trop Med Hyg","first-page":"68","article-title":"Monitoring the quality of medicines: results from Africa, Asia, and South America","volume":"92","author":"Hajjou","year":"2015"},{"key":"ref13","series-title":"Malar J","first-page":"86","article-title":"Fake anti-malarials: start with the facts","volume":"15","author":"Kaur","year":"2016"},{"key":"ref14","series-title":"Report of the Informal Technical Working Group on Draft Working Definitions of Substandard\/Spurious\/Falsely-Labelled\/Falsified\/Counterfeit (SSFFC) Medical Products. Fifth Meeting of the Member State Mechanism on Substandard\/Spurious\/Falsely-Labelled\/Falsified\/Counterfeit Medical Products, 23\u201325 November 2016. A\/MSM\/5\/7","author":"World Health Organization (WHO)","year":"2016"},{"key":"ref15","series-title":"Malar J","first-page":"139","article-title":"Mind the gaps\u2014the epidemiology of poor-quality anti-malarials in the malarious world\u2014analysis of the WorldWide Antimalarial Resistance Network database","volume":"13","author":"Tabernero","year":"2014"},{"key":"ref16","series-title":"The Daily Times of Malawi","first-page":"1","article-title":"Market awash with counterfeit medicine","author":"Chinele","year":"2015"},{"key":"ref17","series-title":"Malawi Med J","first-page":"38","article-title":"In-vitro evaluation of the quality of paracetamol and co-trimoxazole tablets used in Malawi based on pharmacopoeial standards","volume":"26","author":"Khuluza","year":"2014"},{"key":"ref18","series-title":"BMC Health Serv Res","first-page":"234","article-title":"Gaps in universal health coverage in Malawi: a qualitative study in rural communities","volume":"14","author":"Abiiro","year":"2014"},{"key":"ref19","series-title":"BMJ","first-page":"i3618","article-title":"The threat of poor quality antibiotics in increasing antimicrobial resistance","volume":"354","author":"Ravinetto","year":"2016"},{"key":"ref20","series-title":"Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa","author":"World Health Organization (WHO)","year":"2011"},{"key":"ref21","series-title":"Pharm Regul Aff","first-page":"1000117","article-title":"The three-level approach: a framework for ensuring medicines quality in limited-resource countries","volume":"3","author":"Pribluda","year":"2014"},{"key":"ref22","series-title":"Guidelines on the conduct of surveys of the quality of medicines. WHO Expert Committee on specifications for pharmaceutical preparations (Fiftieth report)","author":"World Health Organization (WHO)","year":"2016"},{"key":"ref23","series-title":"PLoS Med","first-page":"e52","article-title":"Guidelines for field surveys of the quality of medicines: a proposal","volume":"6","author":"Newton","year":"2009"},{"key":"ref24","series-title":"Malar J","first-page":"215","article-title":"Use of thin-layer chromatography to detect counterfeit sulfadoxine\/pyrimethamine tablets with the wrong active ingredient in Malawi","volume":"15","author":"Khuluza","year":"2016"},{"key":"ref25","series-title":"Malawi: Introduction to Country Context","author":"WHO Regional Office Africa","year":"2016"},{"key":"ref26","series-title":"WHO Country Cooperation Strategy 2008\u20132013. Malawi","author":"WHO Regional Office for Africa","year":"2009"},{"key":"ref27","series-title":"Development of Country Profiles and Monitoring of the Pharmaceutical Situation in Countries. Country Profile Data Malawi","author":"World Health Organization (WHO)","year":"2016"},{"key":"ref28","series-title":"Trop Med Int Health","first-page":"799","article-title":"Ethical challenges in designing and conducting medicine quality surveys","volume":"21","author":"Tabernero","year":"2016"},{"key":"ref29","series-title":"List of Prequalifed Quality Control Laboratories","author":"World Health Organization (WHO)","year":"2016"},{"key":"ref30","series-title":"Manual Accompanying the GPHF Minilab\u2122. Volume II. Thin-Layer Chromatographic Tests","author":"Global Pharma Health Fund","year":"2008"},{"key":"ref31","series-title":"Malawi Standard Treatment Guidelines (MSTG), 5th Edition. Incorporating Malawi Essential Medicines List (MEML) 2015","author":"Ministry of Health, Malawi","year":"2015"},{"key":"ref32","series-title":"Guidelines for the Treatment of Malaria","author":"World Health Organization (WHO)","year":"2015"},{"key":"ref33","series-title":"Malawi Standard Treatment Guidelines (MSTG), 4th Edition. Incorporating Malawi Essential Medicines List (MEML) 2009","author":"Ministry of Health, Malawi","year":"2009"},{"key":"ref34","series-title":"WHO Model Formulary","author":"World Health Organization (WHO)","year":"2008"},{"key":"ref35","series-title":"Arzneiverordnungs-Report 2015","author":"Schwabe","year":"2015"},{"key":"ref36","series-title":"J Public Health Policy","first-page":"137","article-title":"A quiet revolution in global public health: the World Health Organization, Prequalification of Medicines Programme","volume":"35","author":"'t Hoen","year":"2014"},{"key":"ref37","series-title":"List of Prequalified Medicinal Products","author":"World Health Organization (WHO)","year":"2016"},{"key":"ref38","series-title":"Pharm Ind","first-page":"1187","article-title":"Counterfeit medicines and the GPHF-Minilab for rapid drug quality verification","volume":"66","author":"J\u00e4hnke","year":"2004"},{"key":"ref39","series-title":"Test for One Proportion","article-title":"MedCalc easy-to-use statistical software"},{"key":"ref40","series-title":"Comparison of Proportions","article-title":"MedCalc easy-to-use statistical software"},{"key":"ref41","series-title":"Pan Afr Med J","first-page":"318","article-title":"Survey of counterfeit oral antiinfectives medecine sold in Lubumbashi","volume":"22","author":"Tshilumba","year":"2015"},{"key":"ref42","series-title":"Malar J","first-page":"95","article-title":"Substandard anti-malarial drugs in Burkina Faso","volume":"7","author":"Tipke","year":"2008"},{"key":"ref43","series-title":"PLoS One","first-page":"e0125577","article-title":"Quality of artemisinin-based combination formulations for malaria treatment: prevalence and risk factors for poor quality medicines in public facilities and private sector drug outlets in Enugu, Nigeria","volume":"10","author":"Kaur","year":"2015"},{"key":"ref44","series-title":"Malar J","first-page":"127","article-title":"Post-marketing surveillance of anti-malarial medicines used in Malawi","volume":"14","author":"Chikowe","year":"2015"},{"key":"ref45","series-title":"J Pharm Biomed Anal","first-page":"85","article-title":"Characterization of drug authenticity using thin-layer chromatography imaging with a mobile phone","volume":"125","author":"Yu","year":"2016"},{"key":"ref46","series-title":"The International Drug Price Indicator Guide","author":"Freye","year":"2014"},{"key":"ref47","series-title":"Am J Trop Med Hyg","first-page":"39","article-title":"Quality of antimalarials at the epicenter of antimalarial drug resistance: results from an overt and mystery client survey in Cambodia","volume":"92","author":"Yeung","year":"2015"}],"container-title":["The American Society of Tropical Medicine and Hygiene"],"original-title":[],"link":[{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/96\/5\/article-p1124.xml","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/96\/5\/article-p1124.xml","content-type":"text\/html","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/www.ajtmh.org\/downloadpdf\/journals\/tpmd\/96\/5\/article-p1124.xml","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2024,8,7]],"date-time":"2024-08-07T22:30:59Z","timestamp":1723069859000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.ajtmh.org\/view\/journals\/tpmd\/96\/5\/article-p1124.xml"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,5,3]]},"references-count":47,"journal-issue":{"issue":"5"},"URL":"https:\/\/doi.org\/10.4269\/ajtmh.16-1008","relation":{},"ISSN":["0002-9637","1476-1645"],"issn-type":[{"value":"0002-9637","type":"print"},{"value":"1476-1645","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,5,3]]}}}