ANTICOUNTERFEITING STRATEGIES OF LOCAL DRUG MANUFACTURERS IN LAGOS, NIGERIA: DRUG SAFETY AND IMPLICATIONS FOR PUBLIC HEALTH
Main Article Content
Keywords
Counterfeit Medicines, Anticounterfeiting Strategies, Truscan, National Agency for Food and Drug Administration and Control (NAFDAC), Antimalarials, Antibiotics
Abstract
Background
Nigeria and many countries in the world have been plagued by counterfeit and poor-quality medicines with several studies indicating varying degree of prevalence.
Objectives
The study is aimed at determining the anticounterfeiting strategies employed by local drug manufacturers in Lagos, Nigeria.
Method
The first phase was a descriptive study which involves the use of a self-administered closed ended structured questionnaire to assess the anticounterfeiting strategies employed by local manufacturers in Nigeria. The second phase was an experimental study which selected 2 classes of most frequently faked drugs identified by the respondents in the first phase (antimalarials and antibiotics) and subjected to spot checks using the Truscan analysis deployed by NAFDAC to identify counterfeit medicines. Anticounterfeiting features on the samples were also examined. The data obtained from phase one was analyzed using SPSS while the data obtained from phase 2 was entered into the Truscan data sheet and analyzed using Chi-squared. Results were considered to be significant at P<0.05.
Results
The anticounterfeiting technologies indicated by the respondents as the highest in the first phase were Sequential Batch Numbering 61.1 % (overt) and Bar Codes 29.0 % (covert). While the second phase revealed that 83% and 78% of antimalarials drawn from the manufacturing sources and open market respectively passed the Truscan spot checks. Similarly, 50% of antibiotics drawn from the 2 sampling sites passed the Truscan checks. There was no significant difference (P>0.05) between the sampled antimalarials and antibiotics from the manufacturing sources and open market.
Nigeria and many countries in the world have been plagued by counterfeit and poor-quality medicines with several studies indicating varying degree of prevalence.
Objectives
The study is aimed at determining the anticounterfeiting strategies employed by local drug manufacturers in Lagos, Nigeria.
Method
The first phase was a descriptive study which involves the use of a self-administered closed ended structured questionnaire to assess the anticounterfeiting strategies employed by local manufacturers in Nigeria. The second phase was an experimental study which selected 2 classes of most frequently faked drugs identified by the respondents in the first phase (antimalarials and antibiotics) and subjected to spot checks using the Truscan analysis deployed by NAFDAC to identify counterfeit medicines. Anticounterfeiting features on the samples were also examined. The data obtained from phase one was analyzed using SPSS while the data obtained from phase 2 was entered into the Truscan data sheet and analyzed using Chi-squared. Results were considered to be significant at P<0.05.
Results
The anticounterfeiting technologies indicated by the respondents as the highest in the first phase were Sequential Batch Numbering 61.1 % (overt) and Bar Codes 29.0 % (covert). While the second phase revealed that 83% and 78% of antimalarials drawn from the manufacturing sources and open market respectively passed the Truscan spot checks. Similarly, 50% of antibiotics drawn from the 2 sampling sites passed the Truscan checks. There was no significant difference (P>0.05) between the sampled antimalarials and antibiotics from the manufacturing sources and open market.
References
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29. JDSU. JDSU white paper: pharmaceutical counterfeiting, tampering, and diversion: solutions for addressing a growing threat. Available at: www.jdsu.com/productlit-erature/pharmaceutical_white_paper.pdf.
30. USFDA. Counterfeit drug task report. February 2004 Update TECHNOLOGY. Available at: www.fda.gov/Drugs/DrugSafety/ucm173297.html.
31. Dietrich E. Hologram innovation take on counterfeiting. J Pharm Med Packaging News 2008;16(1).
32. Amuda KI. Knowledge, attitude and perception of community pharmacists in Lagos State on Mobile Authentication Service (MAS) anticounterfeiting technology. West Africa Postgraduate College of Pharmacists’ (WAPCP) Dissertation; 2014.
33. NAFDAC Internal Memo. Compliance directives on mas coding of antibiotics and antimalarial medicines. August 4, 2014.
34. Olubusayo S. Over $44m invested in Nigeria pharmaceutical industry – PMG-MAN Chairman. 2013. Available at: http://venturesafrica.com/44m-investments-made-nigeria-pharmaceutical-industry-pmg-man-chairman/.
35. WHO Technical Report Series 902. WHO Expert Committee on specifications for pharmaceutical preparations. 2002. Thirty Sixth Report. Available at: www.who.int/publications.
36. Mayberry J. The proof is in the packaging. Available at: pharmpro.com/articles/2012/03/proof-packaging
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38. Kaplan W, Lain R. local production of pharmaceuticals: industrial policy and access to medicine - an overview of key concepts, issues and opportunities for future research. World Bank, HNP Discussion Paper, Human Development Network. Available at: www.medeor.de/images/themen/kaplanlocalproductionfinal5b15d.pdf.
39. Bate R. Local production in developing countries. Campaign for Fighting Disease Discussion Paper No 1; 2008. Available at: http://thefacts2014.ipa.org.au/document_root/library/Local%20Pharmaceutical%20Production%20web.pdf.
40. Mackintosh M, et al. Global Health. 2014 Mar 10;10:12 doi 10:1186/1744-8603-10-12. Available at: www.ncbi.nlm.nih.gov/pubmed/24612518.
41. Organisation for Economic Co-operation and Development. The economic impact of counterfeiting and piracy. www.oecd.org/sti/ind/2090589.pdf. 2008; Available at: and https://books.google.com.ng/books?id=Se7V.
42. Brand News. Pharmaceutical company trials DNA labels. Vol.3, (26 January 2006). Available at: www.oecd.org/sti/ind/2090589.pdf. 2006.
43. Halling C. Improving packaging security. Pharmaceut Tech Eur 2011;23(5). Available at: http://www.pharmtech.com/ptedigital0511.
44. Pharmaceutical Technology Europe. Improving Packaging security. 2011. Available at: http://pharmtech.findpharma.com/pharmtech/articledetail.jsp?id=718108.
45. Guido R. Designing a brand protection organization in life sciences. 2013. Available at: https://www.google.com.ng/search?q=DESIGNING+A+BRAND+PROTECTION+ORGANIZATION+IN+LIFE+SCIENCES+-+.
46. Onwuka J. “The situation of medicine counterfeiting in Africa. 2010. Available at: www.whpa.org/back-ground_medicine_counterfeiting_in_africa.html.
2. World Health Organization. WHO IMPACT Publication. “Counterfeit Drugs Kill.” Geneva: Author; 2006. Available at: www.who.int/impact.
3. Charatan F. Fake prescription drugs are flooding the United States. Br Med J 2001;16;322(7300):1446.
4. Khan AY, Ghilzai NM. Counterfeit and substandard quality of drugs: the need for an effective and stringent regulatory control in India and other developing countries. Ind J Pharmacol 2007;1;39(4):206.
5. SCRIP World Pharmaceutical News. Nigeria Fights Corruption; 2001. Available at: www.scripnews.com/home/news/Nigeria.fights corruption-77125.
6. Taylor RB, Shakoor O, Behrens RH, et al. Pharmacopoeial quality of drugs supplied by Nigerian pharmacies. The Lancet 2001;16;357(9272):1933–6.
7. Yankus W. Counterfeit drugs: coming to a pharmacy near you. American Council on Science and Health; 2006. Available at: www.acsh.org/publications/pubID.1379/pub_detail asp.
8. The Economist. Bad Medicine. Available at: www.economist.com/mode/21564546; 2012.
9. World Health Organization. Survey of selected antimalarial medicine circulating in 6 countries of sub-Sahara Africa. Geneva: Author; 2011. Available at: www.who.int.
10. WHO/QAMSA Report. Survey of the quality of selected antimalarial medicines circulating in 6 countries of sub-Saharan Africa. Geneva: Author; 2011. Available at: WHO/EMP/QSM/2011.1
11. Iwokwagh NS. Assessment of new media use in the fight against counterfeit medicine in Nigeria. Available at: https://scholar.google.com/scholar?q=Iwokwagh+NS
12. Thermo Scientific TruscanRM Next generation handheld Raman for raw material identification; 2011. Available at: www.thermoscientific.com/Truscan 2011.
13. Orhii PB. An Overview of NAFDAC. Presentation at the First Regulatory Forum, Lagos; 2013.
14. GPHF. Showcasing the innovators: a practical presentation at NAFDAC in-house training for regulatory officers. Lagos, Nigeria; 2014.
15. Sproxil Fight Against Counterfeit Drugs. Available at” www.sproxil.com/Nigeria.html.
16. Obinna C, Olawole G. Nigeria: NAFDAC introduces new anticounterfeiting technologies; 2010. Available at: all Africa.com/stories/201006141446.html?mstac=0.
17. World Health Organization/IMPACT. Anticounterfeiting technologies for the protection of medicines. Geneva: Author; 2010. Available at: www.who.int/impact.
18. Berman B. Strategies to detect and reduce anticounter-feiting activity. business horizons. (May-June 2008, Vol 51(3) 191–99. Available at: http://www.sciencedirect.com/science/article/pii/S0007681308000037. 2008.
19. International Federation of Pharmaceutical Manufacturers Association. The IFPMA 10 principles on counterfeit medicine; 2010. Available at: www.ifpma.org.
20. Peterson K. How fake and substandard drugs get to Nigeria; 2015. Available at: premiumtimesng.com/features-and-interviews/189328-interview. 2015.
21. Onyebuchi OB. National drug distribution in Nigeria; implications for the goals of national drug policy. Eur J Pharm Med Res 2016;3(1):1–4.
22. Obinna C, Udemba K, Amusat M. fg bans sale of drugs in open markets. Vanguard Newpaper; 2013. Available at: vanguard.com/2013/08/fg-bans-sale-of-drugs-in-open-market.
23. City Mayors. World’s fastest growing cities and urban areas from 2006 to 2020; 2006. Available at: http://www.citymayors.com/statistics/urban_growth1.html. 2006.
24. DER. List of registered pharmaceutical companies in Nigeria as at March 2014. Available at: Drug Evaluation and Research Directorate (DER), NAFDAC. 2014.
25. Shahverdi S, Hajimiri M, Pourmalek F, et al. Iranian pharmacists’ knowledge, attitude and practice regarding counterfeit drugs. Ir J Pharm Res 2012;11(3);963–68.
26. Harocopos A, Hough M. Drug dealing in open-air markets. Problem-oriented guides for police. Problem Specific Guides Series No. 31; 2005. Available at: http://www.popcenter.org/problems/drugdealing_openair/
27. Business Day. “Open drug markets, major threat to Nigeria’s health sector. Business Day Dec. 20, 2013; Available at: http://businessdayonline.com/2013/12/open-drug-market-major-threaten-to-nigerias-health-sector/#.VZ-2hVFkb1U.
28. American Enterprise Institute (AEI), Initiative for Public Policy Analysis (IPPA) and African Fighting Malaria (AFM). Drug use in Nigeria. An informal survey of doctors, pharmacists, healthcare workers in Lagos, Ondo, and Ogun, and a pilot quality assessment of essential drugs from Lagos pharmacies. Available at: www.ippanigeria.org/nigeria_drug_project_august2009.pdf 2009.
29. JDSU. JDSU white paper: pharmaceutical counterfeiting, tampering, and diversion: solutions for addressing a growing threat. Available at: www.jdsu.com/productlit-erature/pharmaceutical_white_paper.pdf.
30. USFDA. Counterfeit drug task report. February 2004 Update TECHNOLOGY. Available at: www.fda.gov/Drugs/DrugSafety/ucm173297.html.
31. Dietrich E. Hologram innovation take on counterfeiting. J Pharm Med Packaging News 2008;16(1).
32. Amuda KI. Knowledge, attitude and perception of community pharmacists in Lagos State on Mobile Authentication Service (MAS) anticounterfeiting technology. West Africa Postgraduate College of Pharmacists’ (WAPCP) Dissertation; 2014.
33. NAFDAC Internal Memo. Compliance directives on mas coding of antibiotics and antimalarial medicines. August 4, 2014.
34. Olubusayo S. Over $44m invested in Nigeria pharmaceutical industry – PMG-MAN Chairman. 2013. Available at: http://venturesafrica.com/44m-investments-made-nigeria-pharmaceutical-industry-pmg-man-chairman/.
35. WHO Technical Report Series 902. WHO Expert Committee on specifications for pharmaceutical preparations. 2002. Thirty Sixth Report. Available at: www.who.int/publications.
36. Mayberry J. The proof is in the packaging. Available at: pharmpro.com/articles/2012/03/proof-packaging
37. Bansal D, Malla S, Gudala K, et al. Anti-counterfeit technologies: A pharmaceutical industry perspective. Sci Pharm 2013;81(1):1–3.
38. Kaplan W, Lain R. local production of pharmaceuticals: industrial policy and access to medicine - an overview of key concepts, issues and opportunities for future research. World Bank, HNP Discussion Paper, Human Development Network. Available at: www.medeor.de/images/themen/kaplanlocalproductionfinal5b15d.pdf.
39. Bate R. Local production in developing countries. Campaign for Fighting Disease Discussion Paper No 1; 2008. Available at: http://thefacts2014.ipa.org.au/document_root/library/Local%20Pharmaceutical%20Production%20web.pdf.
40. Mackintosh M, et al. Global Health. 2014 Mar 10;10:12 doi 10:1186/1744-8603-10-12. Available at: www.ncbi.nlm.nih.gov/pubmed/24612518.
41. Organisation for Economic Co-operation and Development. The economic impact of counterfeiting and piracy. www.oecd.org/sti/ind/2090589.pdf. 2008; Available at: and https://books.google.com.ng/books?id=Se7V.
42. Brand News. Pharmaceutical company trials DNA labels. Vol.3, (26 January 2006). Available at: www.oecd.org/sti/ind/2090589.pdf. 2006.
43. Halling C. Improving packaging security. Pharmaceut Tech Eur 2011;23(5). Available at: http://www.pharmtech.com/ptedigital0511.
44. Pharmaceutical Technology Europe. Improving Packaging security. 2011. Available at: http://pharmtech.findpharma.com/pharmtech/articledetail.jsp?id=718108.
45. Guido R. Designing a brand protection organization in life sciences. 2013. Available at: https://www.google.com.ng/search?q=DESIGNING+A+BRAND+PROTECTION+ORGANIZATION+IN+LIFE+SCIENCES+-+.
46. Onwuka J. “The situation of medicine counterfeiting in Africa. 2010. Available at: www.whpa.org/back-ground_medicine_counterfeiting_in_africa.html.