Technologies for detecting falsified and substandard drugs in low and middle-income countries

PLoS ONE

Volumn 9, Issue 3, 2014, Pages

  Kovacs, Stephanie ^a   Hawes, Stephen E ^a   Maley, Stephen N ^a   Mosites, Emily ^a   Wong, Ling ^b   Stergachis, Andy ^a  

^a UNIVERSITY OF WASHINGTON   (United States)

^b BILL AND MELINDA GATES FOUNDATION   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANALYTICAL EQUIPMENT; ANION EXCHANGE CHROMATOGRAPHY; ARTICLE; ATMOSPHERIC PRESSURE SOLID ANALYSIS PROBE; ATOMIC FORCE MICROSCOPY; CALORIMETRY; CAPILLARY ELECTROPHORESIS; COST BENEFIT ANALYSIS; COUNTERFEIT DETECTION DEVICE 3; DESORPTION ELECTROSPRAY IONIZATION; DIRECT ANALYSIS IN REAL TIME; DIRECT ANALYSIS IN REAL TIME WITH SURFACE ACOUSTIC WAVE NEBULIZER; DRIFT TUBE ION MOBILITY SPECTROMETRY; DRUG FORMULATION; DRUG SURVEILLANCE PROGRAM; FEASIBILITY STUDY; FLOW INJECTION GRADIENT RATIO STANDARD ADDITION MASS SPECTROMETRY; GAS CHROMATOGRAPHY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; INDUCTIVELY COUPLED PLASMA; INFRARED SPECTROMETRY; INFRARED SPECTROSCOPY; ION TRAP; ISOTOPE RATIO MASS SPECTROMETRY; LIQUID CHROMATOGRAPHY; LOW INCOME COUNTRY; MASS FRAGMENTOGRAPHY; MASS SPECTROMETRY; MATRIX ASSISTED LASER DESORPTION IONIZATION; MICELLAR ELECTROKINETIC CHROMATOGRAPHY; MIDDLE INCOME COUNTRY; NANOTECHNOLOGY; NUCLEAR MAGNETIC RESONANCE SPECTROSCOPY; ORBITRAP; PAPER CHROMATOGRAPHY; PLASMA PENCIL ATMOSPHERIC MASS SPECTROMETRY; QUADRUPOLE; RAMAN SPECTROMETRY; REFRACTOMETER; SOCIAL STATUS; SURFACE ACOUSTIC WAVE NEBULIZER; SYSTEMATIC REVIEW; TECHNOLOGY; THIN LAYER CHROMATOGRAPHY; TIME OF FLIGHT MASS SPECTROMETRY; TRIPLE QUADRUPOLE; WORKFLOW; X RAY POWDER DIFFRACTION; DEVELOPING COUNTRY; ECONOMICS; FORENSIC SCIENCE; INCOME; LABORATORY; PROCEDURES; REPRODUCIBILITY; STANDARDS;

DRUG;

DEVELOPING COUNTRIES; FORENSIC SCIENCES; INCOME; LABORATORIES; PHARMACEUTICAL PREPARATIONS; REPRODUCIBILITY OF RESULTS; TECHNOLOGY;

EID: 84900336799     PISSN: None     EISSN: 19326203     Source Type: Journal    
DOI: 10.1371/journal.pone.0090601     Document Type: Article

References (45)

1. World Health Organization (2012) Spurious/Falsely-labelled/falseified/ counterfeit (SFFC) medicines. Available: http://www.who.int/medicines/services/ counterfeit/en/. Accessed 2013 Jul 25.
2. Bate R, Mooney L, Hess M, Milligan J, Attaran M (2012) Anti-infective medicine quality: Analysis of basic product quality by approval status and country of manufacture. Res Reports iin Trop Med 2: 57-61.
3. Kaur H, Goodman C, Thompson K, Thompson I, Masania S, et al. (2008) A nationwide survey of the quality of antimalarials in retail outlets in Tanzania. PLoS One 3: e3403.
4. Stanton C, Koski C, Cofie E, Mirzabagi B, Grady I, et al.(2012) Uterotonic drug quality: An assessment of the potency of injectable uterotonic drugs purchased by simulated clients in three districts in Ghana. BMJ Open 2: 1-7.
5. World Health Organization (2011) Survey of the quality of selected antimalarial medicines circulating in six countries of Sub-Saharan Africa. Geneva, Switzerland.
6. Almuzaini T, Choonara I, Sammons H (2013) Substandard and counterfeit medicines : a systematic review of the literature. BMJ Open 3: 1-7. doi:10.1136/bmjopen-2013-002923.
7. Institute of Medicine (2013) Countering the problem of falsified and substandard drugs. Washington, DC.
8. Roll Back Malaria (2012) Global Malaria Action Plan. Available: http://rbm.who.int/gmap/. Accessed 2013 Jul 25.
9. Nayyar GML, Breman JG, Newton PN, Herrington J (2012) Poor-quality antimalarial drugs in southeast Asia and sub-Saharan Africa. Lancet Infect Dis 12: 488-496. doi:10.1016/S1473-3099(12)70064-6.
10. Maponga C, Ondari C (2003) The quality of antimalarials A study in selected African countries. Available: http://apps.who.int/medicinedocs/en/d/ Js4901e/. Accessed 2013 Jul 25.
11. USP (2013) PQM: Promoting the Quality Medicines in Developing Countries. Available: http://www.usp.org/global-health-impact-programs/promoting-quality- medicines-pqmusaid. Accessed 2013 Jul 25.
12. Liberati A, Altman DG, Tetzlaff J, Mulrow C, Gøtzsche PC, et al. (2009) The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions : explanation and elaboration. BMJ 339. doi:10.1136/bmj.b2700.
13. Fernandez FM, Hostetler D, Powell K, Kaur H, Green MD, et al. (2011) Poor quality drugs: grand challenges in high throughput detection, countrywide sampling, and forensics in developing countries. Analyst 136: 3073-3082. doi:10.1039/c0an00627k.
14. Counterfeit Drug Forensic Investigation Network (CODFIN) (n.d.). Available: http://codfin.org/. Accessed 2013 Jul 25.
15. World Health Organization (n.d.) Tool for visual inspection. Available: http://www.whpa.org/Toolkit-BeAware-Inspection.pdf. Accessed 2013 Jul 25.
16. Lal R, Ramachandran S, Arnsdorf MF (2010) Multidimensional atomic force microscopy: a versatile novel technology for nanopharmacology research. AAPS J 12: 716-728. doi:10.1208/s12248-010-9232-y.
17. Weaver A a, Reiser H, Barstis TL, Benvenuti M, Ghosh D, et al. (2013) Paper analytical devices for fast field screening of beta lactam antibiotics and anti-tuberculosis pharmaceuticals. Anal Chem. doi:10.1021/ac400989p.
18. Deconinck E, Sacré P-Y, Courselle P, De Beer JO (2013) Chromatography in the Detection and Characterization of Illegal Pharmaceutical Preparations. J Chromatogr Sci. doi:10.1093/chromsci/bmt006.
19. FDA's Anti-Counterfeit Device (2013). Available: http://www.hhs.gov/open/ initiatives/hhsinnovates/round6/fda-anti-counterfeit-device.html. Accessed 2013 Jul 25.
20. Kenyon A, Flinn E, Layloff T (1995) Rapid screening of pharmacueticals by thin layer chromatography: analysis of essential drugs by visual methods. J AOAC Int 28: 41-49.
21. Hu C, Zou WB, Hu WS, Ma XK, Yang MZ, et al. (2006) Establishment of a fast chemical identification system for screening of counterfeit drugs of macrolide antibiotics. J Pharm Biomed Anal 40: 68-74. (Pubitemid 43061218)
22. Bate R, Tren R, Hess K, Mooney L, Porter K (2009) Pilot study comparing technologies to test for substandard drugs in field settings. 3: 165-170.
23. Davison M (2011) Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs. First. John Wiley & Sons, Inc.
24. Wilkinson N (2012) Briefcase encounter: an invention to detect fake drugs. Welcome Trust Blog. Available: http://blog.wellcome.ac.uk/2012/11/12/ briefcase-encounter-an-invention-to-detect-fake-drugs/. Accessed 2013 Jul 25.
25. Storme-Paris I, Rebiere H, Matoga M, Civade C, Bonnet P, et al. (2010) Challenging Near InfraRed Spectoscopy discriminating ability for counterfeit pharmaceuticals detection. Anal Chim Acta 658: 163-174.
26. Food and Drug Administration (1995) Guidance for Industry: immediate release solid oral dosage forms, scall up and postapproval changes: chemistry, manufacturing, and controls, in vitro dissolution testing, and in vivo bioequivalence documentation. Available: http://www.fda.gov/downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/UCM070636. pdf. Accessed 2013 Aug 10.
27. Green MD, Nettey H, Villalva R, Pamanivong C, Khounsaknalath L, et al. (2007) Use of refractometry and colorimetry as field methods to rapidly assess antimalarial drug quality. J Pharm Biomed Anal 43: 105-110. (Pubitemid 44873183)
28. Green MD, Mount DL, Wirtz RA (2001) Short communication : Authentication of artemether, artesunate and dihydroartemisinin antimalarial tablets using a simple colorimetric method. Trop Med Int Heal 6: 980-982. (Pubitemid 34008765)
29. Sherma J (2007) Analysis of counterfiet drugs by thin layer chromatography. Acta Chromatogr 19: 5-20.
30. GPHF (n.d.) The GPHF Minilab -Protection against counterfeit medicines. Available: http://www.gphf.org/web/en/minilab. Accessed 2013 Jul 25.
31. Martino R, Malet-Martino M, Gilard V, Balayssac S (2010) Counterfeit drugs: analytical techniques for their identification. Anal Bioanal Chem 398: 77-92. doi:10.1007/s00216-010-3748-y.
32. Santamaria-Fernandez R, Hearn R, Wolff J-C (2009) Detection of counterfeit antiviral drug Heptodin and classification of counterfeits using isotope amount ratio measurements by multicollector inductively coupled plasma mass spectrometry (MC-ICPMS) and isotope ratio mass spectrometry (IRMS). Sci Justice 49: 102-106. doi:10.1016/j.scijus.2008.12.003.
33. Marini R, Rozet E, Montes ML, Rohrbasser C, Roht S, et al. (2010) Reliable low-cost capillary electrophoresis device for drug quality control and counterfeit medicines. J Pharm Biomed Anal 53: 1278-1287.
34. Newton PN, Amin A, Bird C, Passmore P, Dukes G, et al. (2011) The primacy of public health considerations in defining poor quality medicines. PLoS Med 8: e1001139. doi:10.1371/journal.pmed.1001139.
35. Poole C (2012) Gas Chromatography. Google e-book: Elsevier.
36. Kaine L, Wolnik K (1994) Forensic investiagtion of gentamicin sulfates by anion-exchange ion chromatography with pulsed electrochemical detection. J Chromatogr A 674: 255-261. (Pubitemid 24244782)
37. Da Silva Fernandes R, da Costa FSL, Valderrama P, Março PH, de Lima KMG (2012) Non-destructive detection of adulterated tablets of glibenclamide using NIR and solid-phase fluorescence spectroscopy and chemometric methods. J Pharm Biomed Anal 66: 85-90. doi:10.1016/j.jpba.2012.03. 004.
38. Holzgrabe U, Malet-Martino M (2011) Analytical challenges in drug counterfeiting and falsification-The NMR approach. J Pharm Biomed Anal 55: 679-687. doi:10.1016/j.jpba.2010.12.017.
39. Maurin JK, Pluciński F, Mazurek AP, Fijałek Z (2007) The usefulness of simple X-ray powder diffraction analysis for counterfeit control-the Viagra example. J Pharm Biomed Anal 43: 1514-1518. doi:10.1016/j.jpba.2006.10.033. (Pubitemid 46282371)
40. Stein MJ, Lo E, Castner DG, Ratner BD (2012) Plasma pencil atmospheric mass spectrometry detection of positive ions from micronutrients emitted from surfaces. Anal Chem 84: 1572-1578. doi:10.1021/ac2028134.
41. Hostetler DM, Dwivedi P, Green MD, Fernández FM (2012) High throughput quantitation of artesunate and its degradation products by flow injection gradient ratio standard addition mass spectrometry (FI-GRSA-MS). Anal Methods 4: 3392. doi:10.1039/c2ay25443c.
42. Harris GA, Graf S, Knochenmuss R, Fernández FM (2012) Coupling laser ablation/desorption electrospray ionization to atmospheric pressure drift tube ion mobility spectrometry for the screening of antimalarial drug quality. Analyst 137: 3039-3044. doi:10.1039/c2an35431d.
43. Harris GA, Kwasnik M, Fernández FM (2011) Direct analysis in real time coupled to multiplexed drift tube ion mobility spectrometry for detecting toxic chemicals. Anal Chem 83: 1908-1915. doi:10.1021/ac102246h.
44. Twohig M, Skilton SJ, Fujimoto G, Ellor N, Plumb RS (2010) Rapid detection and identification of counterfeit and [corrected] adulterated products of synthetic phosphodiesterase type-5 inhibitors with an atmospheric solids analysis probe. Drug Test Anal 2: 45-50. doi:10.1002/dta.115.
45. Felton LA, Shah PP, Sharp Z, Atudorei V, Timmins GS (2011) Stable isotope-labeled excipients for drug product identification and counterfeit detection. Drug Dev Ind Pharm 37: 88-92. doi:10.3109/03639045.2010.492397.