A review on drug quality surveillance in West Africa
Main Article Content
Abstract
Background: Comprehensive and concerted drug quality surveillance has been recognised as a panacea towards ensuring that safe and effective drugs are in circulation.
Objectives: This review chronicles the efforts at ensuring good quality drugs within the West African subregion. It also discusses the efforts of International donor agencies and National Drug Regulatory Agencies at combating the menace of substandard, spurious, falsely-labeled, falsified and counterfeit (SSFFC) medicines.
Methods: Literature searches were conducted on all reports detailing efforts within the various countries in the sub-region. The expectations of various donor agencies and international organizations were reviewed from available reports. Efforts by the various National Agencies were also studied using information on their websites. Based on the available records, the recurring challenges were identified and solutions proffered.
Results: Several publications in scientific journals were found addressing the quality of circulating drugs within West Africa. The reports spanned close to fifteen years. Majority of the reports on antibacterial agents focused more on antimicrobial resistance rather than on the quality of the agents. The efforts of the donors are commendable as they have been providing avenues in terms of technical training and provision of reference standards. Several challenges against effective drug quality are still prevalent in the sub-region.
Conclusion: It is imperative to note that the battle against circulation of SSFFCs is far from being won. Every stakeholder in the drug distribution chain must arise to the responsibilities of eliminating them.
Downloads
Article Details
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
How to Cite
Share
References
Management Sciences for Health (2013). Quality assurance of pharmaceuticals Part II, Pharmaceutical Management 19.1 - 19.23.
https://www.msh.org/sites/msh.org/files/mds3-ch19-qualityassurance-mar2012.pdf. Date accessed September 13, 2017.
Drug and Therapeutics Committee. Session 5. Pharmaceutical Quality Assurancehttp://slideplayer.com/slide/2350826/. Date
accessed September 13, 2017.
World Health Organization (2016). Substandard, spurious, falsely-labeled, falsified and counterfeit (SSFFC) medical products.
http://www.who.int/mediacentre/factsheets/fs275/en/, Date accessed September 13, 2017.
World Health Organization (2014). Medicines quality: combating unsafe medical products: outcomes of a survey on testing of suspect
medicines. WHO drug information 28: 317 – 323.
World Health Organization (2011). Report of the working group of Member States on substandard/spurious/falselylabeled/falsified/counterfeit (SSFFC) medical products. Annex to Document A64/16, 24 March 2011.
WHO News (2006). Bulletin of the World Health Organization 84 (9):689-694.
USAID (2016). Promoting the Quality of Medicines (PQM). FY 2016 First Quarter Report, October 1 - December 31, 2015. Agreement Number GHS-A-00-09-00003-00
United States Pharmacopoeia. http://www.usppqm.org/about/history. Date accessed 30 August 2017.
Food and Drug Administration. 2017. https://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/default.htm. Date accessed August 30, 2017.
Food and Drug Administration 2006. Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations. 32 pp.
United States Pharmacopoeia Mission and Vision.http://www.usp.org/about. Date accessed 30 August 2017.
ICH Quality Guidelines. http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html. Date accessed 30
August 2017.
Bate R, Coticelli P, Tren R and Attaran A (2008). Antimalarial Drug Quality in the Most Severely Malarious Parts of Africa – A Six Country Study. PLoS ONE 3(5): e2132 3 pages.
Gomes M, Wayling S and Pang L (1998). Interventions to improve the use of antimalarials in south-east Asia: an overview. Bulletin of the
World Health Organization 76 (1): 9–19.
Minzi OM, Moshi MJ, Hipolite D, Massele AY, Tomson G, Ericsson O, Gustafsson LL. 2003. Evaluation of the quality of amodiaquine and
sulphadoxine/pyrimethamine tablets sold by private wholesale pharmacies in Dar es Salaam Tanzania. Journal of Clinical Pharmacy and
Therapeutics 28:117–122.
Amin AA, Snow RW, Kokwaro GO (2005). The quality of sulphadoxine-pyrimethamine and amodiaquine products in the Kenyan retail sector. Journal of Clinical Pharmacy and Therapeutics 30:559–565.
Basco LK (2004). Molecular epidemiology of malaria in Cameroon. XIX. Quality of antimalarial drugs used for self-medication. American Journal of Tropical Medicine and Hygiene 70: 245–250.
Attaran A, Barnes KI, Curtis C, d'Alessandro U, Fanello CI, Galinski MR, Kokwaro G, Looareesuwan S, Makanga M, Mutabingwa TK, et al. (2004). WHO, the Global Fund and medical malpractice in malaria treatment. The Lancet 363(9404): 237–240.
Odeniyi M.A., Adegoke O. A., Adereti R.B., Odeku O.A. and Itiola O.A (2003). Comparative Analysis of Eight Brands of Sulphadoxine-Pyrimethamine Tablets. Tropical Journal of Pharmaceutical Research 2 (1):161-167.
WHO malaria report (2013). http://www.who.int/malaria/publications/world_malaria_report_2013/en/. Date accessed September 4, 2017.
Chaccour CJ, Kaur H, Mabey D, Del Pozo JL (2012). Travel and fake artesunate: a risky business. The Lancet Sep 22; 380 (9847).
Newton PN1, Amin AA, Bird C, Passmore P, Dukes G, Tomson G, Simons B, Bate R, Guerin PJ, White NJ. (2011).The primacy of public health considerations in defining poor quality medicines. PLoS—One 8, e1001139.
Kaur H, Allan EL, Hall Z, Ibe O, El Sherbiny M, van Wyk A, Yeung S, Swamidoss I, Green MD, Dwivedi P, Culzoni MJ, 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 DOI:10.1371/journal.pone.0125577. 13 pages.
Newton PN, Green MD, Mildenhall DC, Plançon A, Nettey H, Nyadong L, Hostetler DM, Swamidoss I, Harris GA, Powell K, et al. (2011).
Poor quality vital anti-malarials in Africa—an urgent neglected public health priority. Malaria Journal Dec 13; 10:352.
Onwujekwe O, Kaur H, Dike N, Shu E, Uzochukwu B, Hanson K, Okoye V, Okonkwo P (2009). Quality of anti-malarial drugs provided by public and private healthcare providers in southeast Nigeria. Malaria
Journal 8(1):22.
Odunfa GO, Adegoke OA and Onaga IC (2009). Pharmaceutical equivalence study of some commercial samples of artesunate and
amodiaquine tablets sold in Southwest Nigeria. Tropical Journal of Pharmaceutical Research 8: 491-499.
Amin AA and Kokwaro GO (2007). Antimalarial drug quality in Africa. Journal of Clinical Pharmacy Therapeutics 32: 429–440.
Bassat Q, Tanner M, Guerin PJ, Stricker K and Hamed K (2016). Combating poor-quality anti-malarial medicines: a call to action. Malaria
Journal 15:302, 12 pages
WHO (2011). Prequalification of quality control laboratories. Procedure for assessing the acceptability, in principle, of quality control
laboratories for use by United Nations agencies (Technical report series, no. 961). Geneva: World Health Organization.
Osei-Safo D, Agbonon A, Konadu DY, Harrison JJ, Edoh M, Gordon A, Gbeassor M, et al. (2014). Evaluation of the quality of artemisinin-based antimalarial medicines distributed in Ghana and Togo. Malaria Research and Treatment 2014:806416.
Hajjou M, Krech L, Lane-Barlow C, Roth L, Pribluda VS, Phanouvong S, El-Hadri L, Evans III L, Raymond C, Yuan E, et al. (2015). Monitoring the Quality of Medicines: Results from Africa, Asia, and South America. American Journal of Tropical Medicine and Hygiene 92 (Suppl 6): 68–74.
Vernet G, Mary C, Altmann DM, Doumbo O, Morpeth S, Bhutta ZA, Klugman KP (2014). Surveillance for Antimicrobial Drug Resistance in
Under-Resourced Countries. Emerging Infectious Diseases 20: 434 - 441.
Opintan JA, Newman MJ, Arhin RE, Donkor ES, Gyansa-Lutterodt M, Mills-Pappoe W (2015). Laboratory-based nationwide surveillance of
antimicrobial resistance in Ghana. Infection and Drug Resistance 8: 379–389.
Gehre F, Out J, Kendall L, Forson A, Kwara A, Kudzawu S, Kehinde AO, Adebiyi O, Salako K, Baldeh I, et al. (2016). The emerging threat of preextensively drug-resistant tuberculosis in West Africa: preparing for large-scale tuberculosis research and drug resistance surveillance. BMC Medicine 14:160, 12 pages.
Adegoke OA and Orokotan OA (2013). Evaluation of Directly Observed Treatment Short courses (DOTS) at a Secondary Health Institution in Ibadan, Oyo State, Southwestern Nigeria. Asian Pacific Journal of Tropical Medicine 6 (12): 952-959.
Smine A (2012). Surveillance of pharmaceutical product quality and safety. African Pharmacovigilance meeting; Ensuring Quality and Safety of Medicines in Sub-Saharan Africa. April 18-20, 2012, Nairobi, Kenya.
Akunyili D.N. (2005). Counterfeit and substandard drugs, Nigeria's experience: implications, challenges, actions and recommendations.
https://www.google.com/urlsa=t&rct=j&q=&esrc=s&source=web&cd=15&cad=rja&uact=8&ved=0ahUKEwjv0cmbo4HWAhUGrxoKHVq7Dg04ChAWCDowBA&url=http%3A%2F%2Fsiteresources.worldbank.org%2FINTAFRREGTOPHIVAIDS%2FResources%2F7170891113520923653%2FDora_Akunyili-Good_Intentions-Bad_Drug MAR_10_05.doc&usg=AFQjCNEiPe7i6iVXZpNTFq CUZ1Tx1xxS9w. Date accessed August 17, 2017.
Bidin A (2009). Counterfeit Medicine: A threat to the public health and pharmaceutical industry. International Conference on Corporate Law 1-3 June 2009, Surabaya, Indonesia
National Agency for Food and Drugs Administration and Control (NAFDAC) . http://www.nafdac.gov.ng/. Date accessedSeptember 12, 2017.
Pharmacy Board of SierraLe one. http://www.pharmacyboard.gov.sl/. Date accessed September 12, 2017.
Food and Drug Authority, Ghana. http://fdaghana.gov.gh/. Date accessed August 31, 2017.
Food Safety and Quality Authority of The Gambia. http://www.fsqa.gm/about-us. Date accessed September 12, 2017.
Ministry of Health and Social Welfare, The Gambia. http://www.moh.gov.gm/. Date accessed September 12, 2017.
The Point, Banjul (2015). Gambia: A Medicine Regulatory Authority Is Long Over Due. http://allafrica.com/stories/201501262598.html.
Date accessed September 12, 2017.
Gambia Regulations. https://www.cmacgm.com/static/eCommerce/Attachments/Gambia%20111115.pdf. Date accessed September 12,
West African Drug Regulatory Authority Network (WADRAN)http://healthmarketinnovations.org/program/west-africa-drug-regulatory-authoritynetwork-wadran. Date accessed September 13, 2017.
Attaran A, Bate R, Jin G and Mathur A (2014): Drug quality and global trade. http://voxeu.org/article/drug-quality-and-globaltrade. Date accessed September 11, 2017.
The United States Pharmacopoeial Convention (2015). Quality Matters. http://qualitymatters.usp.org/usp-programshelp-tighten-africa-s-public-health-safety-net. Date accessed September 13, 2017.