Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Malaria Journal
Published in: Malaria Journal 1/2015

Open Access 01-12-2015 | Research

Assessing the quality of anti-malarial drugs from Gabonese pharmacies using the MiniLab®: a field study

Authors: Benjamin J Visser, Janneke Meerveld-Gerrits, Daniëlle Kroon, Judith Mougoula, Rieke Vingerling, Emmanuel Bache, Jimmy Boersma, Michèle van Vugt, Selidji T Agnandji, Harparkash Kaur, Martin P Grobusch

Published in: Malaria Journal | Issue 1/2015

Login to get access

Abstract

Background

Recent studies alluded to the alarming scale of poor anti-malarial drug quality in malaria-endemic countries, but also illustrated the major geographical gaps in data on anti-malarial drug quality from endemic countries. Data are particularly scarce from Central Africa, although it carries the highest burden of malaria. The aim of this medicine quality field survey was to determine the prevalence of poor-quality anti-malarial drugs in Gabon.

Methods

A field survey of the quality of anti-malarial drugs in Gabonese pharmacies was conducted using the Global Pharma Health Fund Minilab® tests, following the Medicine Quality Assessment Reporting Guidelines. Anti-malarial drugs were purchased randomly from selected pharmacies in Gabon. Semi-quantitative thin-layer chromatography (TLC) and disintegration testing were carried out to measure the concentration of active pharmaceutical ingredients (APIs). The samples failing the TLC test were analysed by high-performance liquid chromatography. Following the collection of anti-malarial drugs, a street survey was conducted to understand where people purchase their anti-malarial drugs.

Results

A total of 432 samples were purchased from 41 pharmacies in 11 cities/towns in Gabon. The prevalence of poor-quality anti-malarial drugs was 0.5% (95% CI 0.08–1.84%). Two out of 432 samples failed the MiniLab® semi-quantitative TLC test, of which a suspected artemether-lumefantrine (AL) sample was classified as falsified and one sulfadoxine-pyrimethamine (SP) sample as substandard. High performance liquid chromatography with ultraviolet photo diode array detection analysis confirmed the absence of APIs in the AL sample, and showed that the SP sample did contain the stated APIs but the amount was half the stated dose. Of the people interviewed, 92% (187/203) purchased their anti-malarial drugs at a pharmacy.

Conclusion

Using the GPHF Minilab®, the prevalence of poor-quality anti-malarial drugs is far lower than anticipated. The findings emphasize the need for randomized and robust sampling methods in order to collect representative data on anti-malarial drug quality.
Trial registration: NTR4341 (Dutch Trial Registry)
Appendix
Available only for authorised users
Literature
1.
2.
Visser BJ, van Vugt M, Grobusch MP (2014) Malaria: an update on current chemotherapy. Expert Opin Pharmacother 15:2219–2254PubMedCrossRef
3.
Visser BJ, Wieten RW, Kroon D, Nagel IM, Belard S, van Vugt M et al (2014) Efficacy and safety of artemisinin combination therapy (ACT) for non-falciparum malaria: a systematic review. Malar J 13:463PubMedCentralPubMedCrossRef
4.
van Vugt M, van Beest A, Sicuri E, van Tulder M, Grobusch MP (2011) Malaria treatment and prophylaxis in endemic and nonendemic countries: evidence on strategies and their cost-effectiveness. Future Microbiol 6:1485–1500PubMedCrossRef
5.
Newton PN, Green MD, Mildenhall DC, Plancon A, Nettey H, Nyadong L et al (2011) Poor quality vital anti-malarials in Africa—an urgent neglected public health priority. Malar J 10:352PubMedCentralPubMedCrossRef
6.
Newton PN, Amin AA, Bird C, Passmore P, Dukes G, Tomson G et al (2011) The primacy of public health considerations in defining poor quality medicines. PLoS Med 8:e1001139PubMedCentralPubMedCrossRef
7.
Almuzaini T, Choonara I, Sammons H (2013) Substandard and counterfeit medicines: a systematic review of the literature. BMJ Open 3:e002923PubMedCentralPubMed
8.
Kelesidis T, Falagas ME (2015) Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev 28:443–464PubMedCrossRef
9.
White NJ, Pongtavornpinyo W, Maude RJ, Saralamba S, Aguas R, Stepniewska K et al (2009) Hyperparasitaemia and low dosing are an important source of anti-malarial drug resistance. Malar J 8:253PubMedCentralPubMedCrossRef
10.
11.
Chaccour C, Kaur H, Del Pozo JL (2015) Falsified antimalarials: a minireview. Expert Rev Anti Infect Ther 13:505–509PubMed
12.
Tabernero P, Fernandez FM, Green M, Guerin PJ, Newton PN (2014) Mind the gaps–the epidemiology of poor-quality anti-malarials in the malarious world–analysis of the WorldWide Antimalarial Resistance Network database. Malar J 13:139PubMedCentralPubMedCrossRef
13.
14.
Assele V, Ndoh G, Nkoghe D, Fandeur T (2015) No evidence of decline in malaria burden from 2006 to 2013 in a rural Province of Gabon: implications for public health policy. BMC Public Health 15:81PubMedCentralPubMedCrossRef
15.
Bouyou-Akotet MK, Offouga CL, Mawili-Mboumba DP, Essola L, Madoungou B, Kombila M (2014) Falciparum malaria as an emerging cause of Fever in adults living in Gabon, Central Africa. Biomed Res Int 2014:351281PubMedCentralPubMedCrossRef
16.
Mawili-Mboumba DP, Bouyou Akotet MK, Kendjo E, Nzamba J, Medang MO, Mbina JR et al (2013) Increase in malaria prevalence and age of at risk population in different areas of Gabon. Malar J 12:3PubMedCentralPubMedCrossRef
17.
Sawadogo CW, Amood Al-Kamarany M, Al-Mekhlafi HM, Elkarbane M, Al-Adhroey AH, Cherrah Y et al (2011) Quality of chloroquine tablets available in Africa. Ann Trop Med Parasitol 105:447–453PubMedCentralPubMedCrossRef
18.
Basco LK (2004) Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. Am J Trop Med Hyg 70:245–250PubMed
19.
Basco LK, Ringwald P, Manene AB, Chandenier J (1997) False chloroquine resistance in Africa. Lancet 350:224PubMedCrossRef
20.
Newton PN, McGready R, Fernandez F, Green MD, Sunjio M, Bruneton C et al (2006) Manslaughter by fake artesunate in Asia–will Africa be next? PLoS Med 3:e197PubMedCentralPubMedCrossRef
21.
22.
23.
Chaccour CJ, Kaur H, Mabey D, Del Pozo JL (2012) Travel and fake artesunate: a risky business. Lancet 380:1120PubMedCrossRef
24.
Dondorp AM, Newton PN, Mayxay M, Van Damme W, Smithuis FM, Yeung S et al (2004) Fake antimalarials in Southeast Asia are a major impediment to malaria control: multinational cross-sectional survey on the prevalence of fake antimalarials. Trop Med Int Health 9:1241–1246PubMedCrossRef
25.
Onwujekwe O, Kaur H, Dike N, Shu E, Uzochukwu B, Hanson K et al (2009) Quality of anti-malarial drugs provided by public and private healthcare providers in south-east Nigeria. Malar J 8:22PubMedCentralPubMedCrossRef
26.
27.
Newton PN, Lee SJ, Goodman C, Fernandez FM, Yeung S, Phanouvong S et al (2009) Guidelines for field surveys of the quality of medicines: a proposal. PLoS Med 6:e52PubMedCrossRef
28.
Newton PN, Schellenberg D, Ashley EA, Ravinetto R, Green MD, Kuile FO et al (2015) Quality assurance of drugs used in clinical trials: proposal for adapting guidelines. BMJ 25:350
29.
Visser BJ, Buijink AW, Grobusch MP (2014) Reporting of medical research costs. Improving transparency and reproducibility of medical research. Methods Inf Med 53:329–331PubMedCrossRef
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
Kaur H, Allan EL, Mamadu I, Hall Z, Ibe O, El Sherbiny M et al (2015) 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. PLoS One 10:e0125577PubMedCentralPubMedCrossRef
42.
Viera AJ, Garrett JM (2005) Understanding interobserver agreement: the kappa statistic. Fam Med 37:360–363PubMed
43.
Verbeken M, Suleman S, Baert B, Vangheluwe E, Van Dorpe S, Burvenich C et al (2011) Stability-indicating HPLC-DAD/UV-ESI/MS impurity profiling of the anti-malarial drug lumefantrine. Malar J 10:51PubMedCentralPubMedCrossRef
44.
45.
46.
Newton PN, Tabernero P, Dwivedi P, Culzoni MJ, Monge ME, Swamidoss I et al (2014) Falsified medicines in Africa: all talk, no action. Lancet Glob Health 2:e509–e510PubMedCrossRef
47.
Miller KW, Wilder LB, Stillman FA, Becker DM (1997) The feasibility of a street-intercept survey method in an African-American community. Am J Public Health 87:655–658PubMedCentralPubMedCrossRef
48.
Agnandji ST, Kurth F, Belard S, Mombo-Ngoma G, Basra A, Fernandes JF et al (2011) Current status of the clinical development and implementation of paediatric artemisinin combination therapies in Sub-Saharan Africa. Wien Klin Wochenschr 123(Suppl 1):7–9PubMedCrossRef
49.
Agnandji ST, Kurth F, Fernandes JF, Soulanoudjingar SS, Abossolo BP, Mombo-Ngoma G et al (2011) The use of paediatric artemisinin combinations in sub-Saharan Africa: a snapshot questionnaire survey of health care personnel. Malar J 10:365PubMedCentralPubMedCrossRef
50.
O’Connell KA, Poyer S, Solomon T, Munroe E, Patouillard E, Njogu J et al (2013) Methods for implementing a medicine outlet survey: lessons from the anti-malarial market. Malar J 12:52PubMedCentralPubMedCrossRef
51.
52.
Risha PG, Msuya Z, Clark M, Johnson K, Ndomondo-Sigonda M, Layloff T (2008) The use of Minilabs to improve the testing capacity of regulatory authorities in resource limited settings: Tanzanian experience. Health Policy 87:217–222PubMedCrossRef
53.
Odaga J, Sinclair D, Lokong JA, Donegan S, Hopkins H, Garner P (2014) Rapid diagnostic tests versus clinical diagnosis for managing people with fever in malaria endemic settings. Cochrane Database Syst Rev 4:Cd008998
54.
Phanouvong S, Dijiba Y, Vijaykadga S, Raymond C, Krech L, Lukulay P et al (2013) The quality of antimalarial medicines in eastern Thailand: a case study along the Thai-Cambodian border. Southeast Asian J Trop Med Public Health 44:363–373PubMed
55.
Phanouvong S, Raymond C, Krech L, Dijiba Y, Mam B, Lukulay P et al (2013) The quality of antimalarial medicines in western Cambodia: a case study along the Thai-Cambodian border. Southeast Asian J Trop Med Public Health 44:349–362PubMed
56.
57.
Hoellein L, Holzgrabe U (2014) Development of simplified HPLC methods for the detection of counterfeit antimalarials in resource-restraint environments. J Pharm Biomed Anal 98:434–445PubMedCrossRef
Metadata
Title
Assessing the quality of anti-malarial drugs from Gabonese pharmacies using the MiniLab®: a field study
Authors
Benjamin J Visser
Janneke Meerveld-Gerrits
Daniëlle Kroon
Judith Mougoula
Rieke Vingerling
Emmanuel Bache
Jimmy Boersma
Michèle van Vugt
Selidji T Agnandji
Harparkash Kaur
Martin P Grobusch
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Malaria Journal / Issue 1/2015
Electronic ISSN: 1475-2875
DOI
https://doi.org/10.1186/s12936-015-0795-z

Other articles of this Issue 1/2015

Malaria Journal 1/2015 Go to the issue

Research

Patient adherence to prescribed artemisinin-based combination therapy in Garissa County, Kenya, after three years of health care in a conflict setting

Research

Mosquito host preferences affect their response to synthetic and natural odour blends

Research

Evaluation of antiplasmodial activity of medicinal plants from North Indian Buchpora and South Indian Eastern Ghats

Research

Upstream AUGs and upstream ORFs can regulate the downstream ORF in Plasmodium falciparum

Research

Genetic evidence for contribution of human dispersal to the genetic diversity of EBA-175 in Plasmodium falciparum

Research

Malaria rapid diagnostic test as point-of-care test: study protocol for evaluating the VIKIA® Malaria Ag Pf/Pan

ACC 2024 Congress Coverage

Heart Failure Video

Year in Review: Heart failure and cardiomyopathies

Watch now

Watch this official video from ACC.24. Dr. Biykem Bozkurt discuss last year's major advances in heart failure and cardiomyopathies.

Semaglutide benefits people with type 2 diabetes and obesity-related heart failure

16-04-2024 Type 2 Diabetes News

Incentivised to exercise

11-04-2024 Lifestyle Modifications News

New intervention for STEMI-related cardiogenic shock

10-04-2024 Myocardial Infarction News

» View more highlights on the ACC 2024 congress hub page

Image Credits