Exposure of consumers to substandard antibiotics from selected authorised and unauthorised medicine sales outlets in Ghana.
antibiotic medicines
antimicrobial resistance
drug quality assessment
liquid chromatography
medicine sales outlets
poor-quality medicines
tandem mass spectrometry method
Journal
Tropical medicine & international health : TM & IH
ISSN: 1365-3156
Titre abrégé: Trop Med Int Health
Pays: England
ID NLM: 9610576
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
pubmed:
18
5
2020
medline:
25
11
2020
entrez:
18
5
2020
Statut:
ppublish
Résumé
To assess the quality of antibiotics sampled from authorised sales outlets (ATs) (i.e. hospitals/health centres, pharmacies and licensed chemical shops) and unauthorised sales outlets (UATs) (mainly street vendors) in Ghana and to explore the health-seeking behaviour of medicine consumers. The contents of 14 active pharmaceutical ingredients (APIs) in 348 sampled products were determined using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) method. Data on health-seeking practices were collected through entry and exit interviews and field observations from ATs and UATs. It was observed that 66.38% of all sampled antibiotic products were substandard; they either contained less (<90%) or more API (>110%) than the label claim. Medicines from UATs recorded substantially less API contents than those from ATs (F Consumers who purchase from UATs are at high risk of receiving substandard medicines. The quality of medicines in the national healthcare system, in the supply chain and in the distribution system needs to be monitored regularly to reduce the incidence of substandard medicines and their impact on antimicrobial resistance. The fight against substandard medicines needs to incorporate a full understanding of socioeconomic factors that drive consumer decisions regarding their health and choice of healthcare providers. Evaluer la qualité des antibiotiques prélevés auprès des vendeurs autorisés (VA) (c'est-à-dire les hôpitaux/centres de santé, les pharmacies et les magasins de produits chimiques agréés) et des vendeurs non autorisés (VNA) (principalement les vendeurs de rue) au Ghana et étudier le comportement des utilisateurs de médicaments en quête de santé. MÉTHODES: Le contenu de 14 principes actifs (PA) pharmaceutiques dans 348 produits échantillonnés a été déterminé à l'aide d'une méthode validée de chromatographie liquide et de spectrométrie de masse en tandem (LC-MS/MS). Les données sur les pratiques de recherche de santé ont été collectées par le biais d'entretiens d'entrée et de sortie, et d'observations sur le terrain des VA et des VNA. RÉSULTATS: Il a été observé que 66,38% de tous les produits antibiotiques échantillonnés étaient inférieurs aux normes; ils contenaient soit moins (<90%), soit plus de PA (>110%) que ce qui était indiqué sur la notice. Les médicaments provenant des VNA ont enregistré une quantité de PA sensiblement inférieure à celle des VA (F Les utilisateurs qui s'approvisionnent auprès des VNA courent un risque élevé de recevoir des médicaments de qualité inférieure. La qualité des médicaments dans le système national de santé, dans la chaîne d'approvisionnement et dans le système de distribution doit être contrôlée régulièrement pour réduire l'incidence des médicaments de qualité inférieure et leur impact sur la résistance aux antimicrobiens. La lutte contre les médicaments de qualité inférieure doit intégrer une compréhension complète des facteurs socioéconomiques qui déterminent les décisions des utilisateurs concernant leur santé et le choix des prestataires de soins de santé.
Autres résumés
Type: Publisher
(fre)
Evaluer la qualité des antibiotiques prélevés auprès des vendeurs autorisés (VA) (c'est-à-dire les hôpitaux/centres de santé, les pharmacies et les magasins de produits chimiques agréés) et des vendeurs non autorisés (VNA) (principalement les vendeurs de rue) au Ghana et étudier le comportement des utilisateurs de médicaments en quête de santé. MÉTHODES: Le contenu de 14 principes actifs (PA) pharmaceutiques dans 348 produits échantillonnés a été déterminé à l'aide d'une méthode validée de chromatographie liquide et de spectrométrie de masse en tandem (LC-MS/MS). Les données sur les pratiques de recherche de santé ont été collectées par le biais d'entretiens d'entrée et de sortie, et d'observations sur le terrain des VA et des VNA. RÉSULTATS: Il a été observé que 66,38% de tous les produits antibiotiques échantillonnés étaient inférieurs aux normes; ils contenaient soit moins (<90%), soit plus de PA (>110%) que ce qui était indiqué sur la notice. Les médicaments provenant des VNA ont enregistré une quantité de PA sensiblement inférieure à celle des VA (F
Substances chimiques
Anti-Bacterial Agents
0
Counterfeit Drugs
0
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
962-975Subventions
Organisme : Ministry of Foreign Affairs
ID : 09-099 SSI
Pays : International
Informations de copyright
© 2020 John Wiley & Sons Ltd.
Références
Byarugaba DK. Antimicrobial resistance in developing countries and responsible risk factors. Int J Antimicrob Agents 2004: 24: 105-110.
Coates ARM, Halls G. Antibiotics in phase II and III clinical trials. Handb Exp Pharmacol 2012: (211): 167-83.
WHO. World Health Organization. Global Strategy for Containment of Antimicrobial Resistance. World Health Organization [Internet]. 2001;WHO/CDS/CS:105 (Available from: http://scholar.google.com/scholar?hl=en&btnG=Search&q=intitle:WHO+Global+Strategy+for+Containment+of+Antimicrobial+Resistance#0).
Baxerres C, Le Hesran JY. Where do pharmaceuticals on the market originate? An analysis of the informal drug supply in Cotonou, Benin. Soc Sci Med 2011: 73: 1249-1256.
Whyte SR, Van Der Geest S, Hardon A. Social Lives of Medicines. Cambridge University Press; 2002. 1-24 p. (Available from: http://www.cambridge.org) [19 January 2020].
Laing R, Waning B, Gray A, Ford N, T Hoen E. 25 Years of the WHO essential medicines lists: progress and challenges. Lancet 2003: 361: 1723-1729.
Gullberg E, Cao S, Berg OG et al. Selection of resistant bacteria at very low antibiotic concentrations. PLoS Pathog 2011: 7: e1002158.
Petralanda I. Quality of antimalarial drugs and resistance to Plasmodium vivax in Amazonian region. Lancet 1995: 345: 1433.
Nwokike J, Clark A, Nguyen PP. Medicines quality assurance to fight antimicrobial resistance. Bull World Health Org 2018: 96: 135-137.
Kelesidis T, Kelesidis I, Rafailidis PI, Falagas ME. Counterfeit or substandard antimicrobial drugs: a review of the scientific evidence. J Antimicrob Chemother 2007: 60: 214-236.
Namboodiri SS, Opintan JA, Lijek RS, Newman MJ, Okeke IN. Quinolone resistance in Escherichia coli from Accra, Ghana. BMC Microbiol 2011: 11: 44.
Forson A, Kudzawu S, Kwara A, Flanigan T. High frequency of first-line anti-tuberculosis drug resistance among persons with chronic pulmonary tuberculosis at a teaching hospital chest clinic. Ghana Med J 2011: 44: 42-46.
Donkor E, Nartey E. Nasal colonisation of drug resistant bacteria in Ghanaian children less than five years. J Microbiol 2007: 5.
Mills-Robertson F, Addy ME, Mensah P, Crupper SS. Molecular characterization of antibiotic resistance in clinical Salmonella typhi isolated in Ghana. FEMS Microbiol Lett 2002: 215: 249-253.
Mills-Robertson F, Crupper SS, Addy ME, Mensah P. Antibiotic resistance and genotyping of clinical group B Salmonella isolated in Accra. Ghana. J Appl Microbiol 2003: 94: 289-294.
Sackey BA, Mensah P, Collison E, Sakyi-Dawson E. Campylobacter, Salmonella, Shigella and Escherichia coli in live and dressed poultry from metropolitan Accra. Int J Food Microbiol 2001: 71: 21-28.
Taylor RB, Shakoor O, Behrens RH et al. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. Lancet 2001: 357: 1933-1936.
Bate R, Tren R, Mooney L et al. Pilot study of essential drug quality in two major cities in India. PLoS One 2009: 4: e6003.
Kyriacos S, Mroueh M, Chahine RP, Khouzam O. Quality of amoxicillin formulations in some Arab countries. J Clin Pharm Ther 2008: 33: 375-379.
Hadi Usman, Van den Broek Peterhans, Kolopaking Erni P, Zairina Nun, Gardjito Widjoseno, Gyssens Inge C. Cross-sectional study of availability and pharmaceutical quality of antibiotics requested with or without prescription (Over The Counter) in Surabaya, Indonesia. BMC Infect Dis 2010: 10: 203.
Nayyar GML, Breman JG, Newton PN, Herrington J. Poor-quality antimalarial drugs in Southeast Asia and sub-Saharan Africa. Lancet Infect Dis 2012: 12: 488-496.
Shakoor O, Taylor RB, Behrens RH. Assessment of the incidence of substandard drugs in developing countries. Trop Med Int Heal 1997: 2: 839-845.
Martey J. Study on the quality of antibiotics in Ghana. Accra, 2010.
Nayyar GML, Breman JG, Mackey TK et al. Falsified and substandard drugs: Stopping the pandemic. Am J Trop Med Hyg 2019: 100: 1058-1065.
Agotis SA, Rose W. Factors contributing to substandard medical products in Kenya. Strateg J Bus Chang Manag 2015: 2: 747-766.
Olliaro E, Olliaro P, Ho CWL, Ravinetto R. Legal uncertainty - the gray area around substandard medicines: where public health meets law. Am J Trop Med Hyg 2020: 102: 262-267.
Seiter A, Gyansa-Lutterodt M. Policy note: The Pharmaceutical Sector in Ghana. 2009. (Available from: http://apps.who.int/medicinedocs/en/m/abstract/Js16765e/). [19 Jan 2020].
van der Geest S, Whyte SR, Hardon A. The anthropology of pharmaceuticals: a biographical approach. Annu Rev Anthropol 1996: 25: 153-178.
Adu-Sarkodie YA. Antimicrobial self medication in patients attending a sexually transmitted diseases clinic. Int J STD AIDS 1997: 8: 456-458.
Salako LA, Brieger WR, Afolabi BM et al. Treatment of childhood fevers and other illnesses in three rural Nigerian communities. J Trop Pediatr 2001: 47: 230-238.
Abdulraheem IS, Parakoyi DB. Factors affecting mothers’ healthcare-seeking behaviour for childhood illnesses in a rural Nigerian setting. Early Child Dev Care 2009: 179: 671-683.
Afari-Asiedu S, Kinsman J, Boamah-Kaali E et al. To sell or not to sell; the differences between regulatory and community demands regarding access to antibiotics in rural Ghana. J Pharm Policy Pract 2018: 11: 1-10.
Istúriz RE, Carbon C. Antibiotic use in developing countries. Infect Control Hosp Epidemiol 2000: 21: 394-397.
Okeke IN, Lamikanra A. Quality and bioavailability of tetracycline capsules in a Nigerian semi-urban community. Int J Antimicrob Agents 1995: 5: 245-250.
Nazerali H, Hogerzeil HV. The quality and stability of essential drugs in rural Zimbabwe: controlled longitudinal study. Br Med J 1998: 317: 512-513.
Dodoo ANO, Fogg C, Asiimwe A et al. Pattern of drug utilization for treatment of uncomplicated malaria in urban Ghana following national treatment policy change to artemisinin-combination therapy. Malar J. 2009: 8: 2.
Bosu WK, Ofori-Adjei D. An audit of prescribing practices in health care facilities of the Wassa West district of Ghana. West Afr J Med 2000: 19: 298-303.
Das V, Das RK. Urban health and pharmaceutical consumption in Delhi, India. J Biosoc Sci 2006: 38: 69-82.
Ivankova NV, Creswell JW, Stick SL. Using mixed-methods sequential explanatory design: from theory to practice. Field Methods 2006: 18: 3-20.
WHO. Guidelines on the conduct of surveys of the quality of medicines. In: WHO Expert Committee on Specifications for Pharmaceutical Preparations - No 996. 15th Repor. Geneva: World Health Organization, 20, avenue Appia, 1211 Geneva 27, Switzerland; 2016. p. 228-261. Available from: www.who.int.
MOH. Essential Medicines List (6th edn ). Ministry of Health: Accra, 2010.
NHIA. National Health Insurance Scheme: Medicines List [Internet]. 2011. (Available from: http://www.nhis.gov.gh/?CategoryID=158&ArticleID=1214). [19 Jan 2020].
GSS. 2010 Population and Housing Census Provisional Results: Summary of Findings [Internet]. 2011. (Available from: www.ghana.gov.gh/census/phc2010.pdf). [25 April 2013].
Bekoe SO, Bak SA, Björklund E et al. Determination of thirteen antibiotics in drug products-A new LC-MS/MS tool for screening drug product quality. Anal Methods 2014: 6: 5847-5855.
Clark T. `We're over-researched here!'. Sociology 2008: 42: 953-970.
Roethlisberger FJ, Dickson WJ. Management and the Worker. 5th edn. Thompson K, editor. Routledge Publishers: London, 11 New Fetter Lane, London EC4P 4EE; 2003. 279-378 p.
King N. Using templates in the thematic analysis of text. In: Cassell C Symon G (eds). Essential Guide to Qualitative Methods in Organizational Research. Sage Publications: London, 2004.256-269.
Welsh E. Dealing with data: using NVivo in the qualitative data analysis process. Forum Qual Sozialforsch 2002: 3.
Miles MB, Huberman A. An Expanded Sourcebook: Qualitative Data Analysis, 2nd edn. Miles MB, Huberman AM eds. Sage Publications: London; 1994. 1-354.
BPC. British Pharmacopoeia (Vol 1&2) [Internet]. 2013th ed. The Stationery Office on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA): London; 2012. (Available from: http://www.mhra.gov.uk/pharmacopoeia).
Bate R, Mooney L, Hess K, Milligan J. Anti-infective medicine quality: analysis of basic product quality by approval status and country of manufacture. Res Rep Trop Med 2012: 3: 57-61.
Tivura M, Asante I, van Wyk A et al. Quality of Artemisinin-based Combination Therapy for malaria found in Ghanaian markets and public health implications of their use. BMC Pharmacol Toxicol 2016: 17: 48.
Osei-Safo D, Egbo HA, Nettey H, Konadu DY. Addae-Mensah I. Evaluation of the quality of some antibiotics distributed in Accra and Lagos. Int J Pharm Sci Res. 2016: 7: 1991.
USP. Global Health - Medicines Quality Database | USP [Internet]. The United States Pharmacopeia Convention. (Available from: https://www.usp.org/global-public-health/medicines-quality-database) [18 January 2020].
Kelesidis T, Falagas ME. Substandard/counterfeit antimicrobial drugs. Clin Microbiol Rev 2015: 28: 443-464.
Harper J, Gyansa-Lutterodt M. The viability of pharmaceutical manufacturing in Ghana to address priority endemic diseases in the West Africa sub-region 2007. Trade Matters. 2007.
MOH, GNDP. Assessment of Medicines Procurement and Supply Management Systems in the Public Health Sector :A Country Report 2009. 2009.
Pincock S. WHO tries to tackle problem of counterfeit medicines in Asia. BMJ 2003: 327: 1126.
Ezealisiji K, Pepple A, Stanley C. Effect of sunlight, moisture, temperature and ultraviolet radiation on the quality control parameters of ciprofloxacin tablet formulation. Int J Drug Deliv 2016: 8: 99.
MOH, MOFA, MESTI, MOFAD. Ghana National Action Plan for Antimicrobial Use and Resistance: 2017-2021 [Internet]. 1st edn. 2017. 1-62. (Available from: http://www.moh.gov.gh/wp-content/uploads/2018/04/NAP_FINAL_PDF_A4_19.03.2018-SIGNED-1.pdf) [22 January 2020].
Van Der Geest S, Petryna A, Lakoff A, Kleinman A. Anthropology and the pharmaceutical nexus. Anthropolog Quart 2006: 79: 303-314.
Newton PN, Lee SJ, Goodman C et al. Guidelines for field surveys of the quality of medicines: a proposal. PLoS Medicine 2009: 6: e1000052.