FACTORS CONTRIBUTING TO SUBSTANDARD MEDICAL PRODUCTS IN KENYA
Abstract
The medical supplies sector is key to functional health care systems worldwide. This sector is currently facing numerous challenges in its mandate to provide quality and efficacious products. Statistics estimate that over 25% of the medical products consumed developing countries are substandard. The study evaluated factors contributing to proliferation of substandard medical products in Kenya. The factors examined include regulation, supply chain, handling and storage, demand and workmanship. It was carried out in Kiambu and Ruiru Districts. A descriptive survey research design was applied on a target population of 44 assorted medical outlets. Respondents were conveniently sampled using a questionnaire and data analyzed using SPSS. Findings were presented in form of frequency distribution tables, charts and percentages. The study revealed absence of industry policy and guiding documents in majority of operators and that cooperation between stakeholders was loose. Demand was rated as ‘very important’ motivation fueling circulation of substandard medical products. On workmanship, it was confirmed that quality variation between manufacturers is significant. On ICT use, only about half of the respondents employed ICT tools in service and majority was satisfied with how authorities were employing technology to confront the problem of substandard products.
Key words: Functional Healthcare, Efficacious Products, Quality Variation
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Ahmad, K. (2004). Anti-depressants Sold as Anti-Retrovirals in DR Congo. [Web og science Medicine]: Lancet.
Alliance for Safe Online Pharmacies [ ASOP]. (2010). 36 Million Americans have Bought Medications Online WithoutDoctor’s Prescription. Washington: PRNewswire- US Newswire.
Andreas, W. R. (2002). A concise Quality Control Guide on Essential Drugs vol. II. Frankfurt, Germany: (GPHF).
Angelos, W.(2005).Health News: US Authorities Seize Shipments of Substadard GSK Drugs. Health News: http://health.dailynewscentral.com/content/view/471/0.
EPZ Authority.(2005).Kenya's Pharmaceutical Industry. Nairobi: EPZ Authority.
Bekett,A.H, &Stenlake, J.B (1988). Practical Pharmaceutical Chemisty 4th edition. London: AthlonePress.
Basheer, S. (2008).The Rhetoric of Patent Busting. Mumbai: Spicyindia.blogspot.com.
Boateng, R. (2007). Bad Medicine in the Market. New York: American Enterprise Institute for Public Policy Research.
Bougie, U. S. (2010). Research Methods for Business:A Skill Building Approach (5th edition). Delhi: JohnWilley& Sons Ltd.
Borg, W. R., & Gall, M. D. (1989). Educational Research (5th edition). White Plains, New York: Longman Inc.
Carpenter, J. (2006, July 26). A Matrix of drug quality reports on USAID assisted countries by the USP DQ&IP. Drug Quality Matrix , pp. 4-9.
Caudron, J. (2008). Substandard Medicines in Resource Poor Settings.
CEHURD. (2010). Anti-counterfeiting Law and Access to Essential Medicines in Eastern and Southern Africa, Policy brief 22. Harare: CEHURD, Equinet, Tarsc.
Commission of The USP. (2006). Ensuring the Quality of Medicines in Low Income Countries: an Operational Guide. New York: USP Commision.
DasMaimi, A. (2009). Quality Concepts. Nepal: Nepal Engineering College.
Derek, M.J .(2010). Drug Patents in India. Mumbai: In the Pipeline.
DeStefano.(2009). Good Storage and Shipping Practices for Drug Products. New York: USP Commission.
Donalt,B., James,S.,Laura,B.,Joan,L. (2004). Why We Pay So Much For Drugs. New York: Time Magazine.
Dondorp,A.M., Newton, P.N., Mayxay,M., VanDamme, W., Smithuis F.M, Yeung S, Petit A, Lynam AJ, Johnson A, Hien TT, McGready R, Farrar JJ, Looareesuwan S, Day NP, Green MD, White NJ: 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 2004, 9:1241-1246.
Enserink, M. (2010).Facing Inquiry, WHO Strikes Back at Fake Pandemic Swine Flu Criticism. http//News.sciencemag.org: Science Insider.
EPZ Authority.(2005). Kenya's Pharmaceutical Industry. Nairobi: Kenya EPZ Authority.
FDA.(June 1998). "Draft Guidance for Industry: Stability Testing of Drug Substances and Drug Products".Rockville,MD.: FDA,.
FDA: Facts and Myths About Generic Drugs, available at HYPERLINK "http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm"http://www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/understandinggenericdrugs/ucm167991.htm, accessed on 15/11/2011 at 556pm.
Franklin, H. (2003). WHO Steps up Campaign on Counterfeit Drugs. [Web of science]-[ Medicine]: Lancet.
Gathura, G. (2010). Malaria "Drug" Endangers Kenyan Lives. Nairobi: Daily Nation.
Gatonye, G.(2009 ). Substandard drugs Fast Becoming a Threat to Kenyans. Nairobi: Nation Newspaper.
Gennaro, A. (2000). Remington: The Science and Practice of Pharmacy, 20th Edition. Baltimore: Lippincott Williams & Wilkins.
Gillman &Goodman.(2006). ThePharmacoligical Basis of Therapeutics. New York: McGraw Hill.
Givering, J. M. ( 2007). Chinese Gangs behind Fake Drugs. London: BBC News.
Golafshani, N. (2003). Understanding Reliability and Validity in Qualitative Research.The Qualitative Report, 8(4), 597-607. Retrieved 16/11/2011 from HYPERLINK "http://www.nova.edu/ssss/QR8-4/golafshani.pdf"http://www.nova.edu/ssss/QR8-4/golafshani.pdf
Gopakumar, S. (2010).Unpacking the Issue of Counterfeit Medicines. New Delhi: Third World Network.
Gottelieb, S.(2002).Drug Companies Maintain"Astounding Profits". New York: Aids Coalition to Unleash Power(ACTUP).
Hendeles L, Hochhaus G, Kazerounian,S.(1993). Generic and Alternative Brand-name Pharmaceutical Equivalents: Select with Caution, Am J Hosp Pharm,; 50:2, 323-329.
Hill, J. (2007). International Business, 7th edition. New York: McGraw Hill.
Horwitz, J. (2005). Making Profits and Providing Care: Comparing Non-Profit, for profit and Government Hospitals. New York: Health Affairs.
Howard J.,Rosa,O. &David,L.(2005). Quality Management. New York: McGraw-Hill Irwin.
Julian, Stevens & Phillip.(2009).Keeping It Real: Combating the Spread of Fake Drugs in Poor Countries. London: Internationa Policy Net Work (IPN).
Kealey, F.W.(2000). Principals and Practice of Analytical Chemistry. Tokyo: Blackwell Science Ltd.
Kenya National Assembly Official Report (Hansard): Supply of Fake Drugs to the Ministry of Health, July 2004, available at books.google.co.ke/books?, accessed on 16/11/2011 at 755pm.
Keuffel, P. D. (2005). Regulation of the pharmaceutical industry.Conference on Regulation.New York: NEBR conference on regulation.
Kibwage, I.O (1999). The East and Central African Journal of Pharmaceutical Sciences. Nairobi: Nairobi University Press.
Kivumba, P.C.(2004). The Quality of Essential Anti-microbial and Anti Malarial Drugs in Rwanda and Tanzania: Influence of Tropical Storage Conditions on In-vitro Dissolution,29,331-8.
Knightley, P. (1979). Suffer The Children: The Story of Thalidomide. London: Viking Press.
Kothari, C.R (2004). Reasearch Methodology: Methods and Techniques (2nd edition). New Delhi: New Age International (P) Limited.
Mango, C. (2009).Ministry Orders Sh800m Fake Medicine Destroyed. Nairobi: The star News paper.
Maskus, K. (2001). Parallel Imports in Pharmaceuticals: Implications for Competition and Prices in Developing Countries. Boulder: University of Colorado at Boulder.
Martin ,K, &Acuna,C.(2002). SPSS for Institutional Researchers.Bucknell Lewisburg, Pennsylvania: University Press.
Mbogo, S. (2008).Why we areLosing the War Against Fake Drugs. Nairobi: Business Daily.
Menkes.(1997). Hazardous Drugs in Developing Countries. [web science] [ Medicine]: BMJ.
Mikati, M., Bassett, N., Schachter, S. (1992).Double-blind Randomized Study Comparing Brand-name and Generic Phenytoin Monotherapy, Epilepsia ; 33:2, 359-364.
Ministry of Medical Services.(2008). Kenya National Pharmaceutical Policy. Nairobi: Ministry of Health.
Mugenda, A.G &Mugenda,O.(2003). Research Methods:Qualitative and Quantitative Approaches. Nairobi: ACTS.
Nachmias, D.&Nachmias, C. (1976).Research Methods in the Social Sciences. New York: St. Martins Press.
Nasr, M. (2005).Implementation of Quality by Design: Status,Challenges and Next Steps. New York: FDA Advisory Committee for Pharmaceutical Sciences.
Newton,P.,Proux,S& Green, L.: Counterfeit Anti Infective Medicines. Lancet Inf .Dis.2006;6: 602-613. [PubMed]
Newton,P.(2001).Fake Artesunate in South East Asia. [Web science] [ Medicine]: Lancet.
Obina, C. (2008). Killer Paracetamol - Dealer In Contaminated Chemical Arrested. Lagos: VANGUARD.
Okwemba, A. (2010). Deseases become more Resistant as Fake Medicines Flood the Market. Nairobi: Daily Nation.
Olem,K., Rolland,S.,Esther, G., Walter,G. & Mark, P.(2005). Vaccine Derived Poliovirus and the Endgame Strategy for Global Polio Eradication. Atlanta: National Center for Infectious Deseases- Center for Desease Control& Prevention.
Oles,K., Penry, J.,Smith, L., Anderson, R., Dean, J., Riela, A.(1992).Therapeutic Bioequivalency Study of Brand name versus Generic Carbamazepine.Neurology.
Onyango, J. (2009). Government Tightens Noose on Counterfeits. Nairobi: Nation News paper.
Orodho, J. A. (2008). Techniqiesof Writing Research Projects and Reports in Education and Social Sciences. Nairobi: Kanezja HP Enterpprises.
Parsons,Talcot and Shills.(1976).Toward a General Theory of Action.Cambridge:Havard University Press.
Phanouyong, S. R. (2005).Why be concerned about the Quality of Anti-malarials and ARVs.Kobe,Japan: Poster presented at the 7th International congress on AIDS in Asia and Pacific.
Plus News. (2011). Government Grapples with Counterfeit ARVs.Accessed on 31st October 2011: Plus News:
PlusNews. (2008). South Africa; Alarm over Drug Recalls. Accessed on 20/11/2011 at 431pm: Available at http://www.irinnews.org/fr/ReportFrench.aspx?ReportId=79777.
PPB. (2011). The Life Saver: Kenya National Information and Pharmacovigilance Newsletter. Nairobi: The Pharmacy and Poisons Board.
Prafull, Narayana&Madhulika.(2006). Extentof Spurious Medicines in India . New Delhi: SEARPharm Forum Secretariat.
Rago, L. (2006). Counterfeit Drugs. Geneva: Global forum for pharmaceutical anti-counterfeiting.
Rhodes, C. (2008). Drug Stability.Kingstone: University of Rhode Island.
Ronald, T. N. (1991). Improving Quality through Planned Experimentation. New York: McGraw Hill.
Sai, M. (2011).FDA Finding Fuels Indian Crackdown on Substandatd Drugs. New Delhi: PharmExecBrog:
Salinsky, E., Warble, C. "The Vaccine Industry: Does it need a Shot in the Arm?" National Health Policy Forum. 25(January 2006): 12. Available at http://www.nhpf.org/pdfs_bp/BP_Vaccine Industry_01-25-06.pdf.
Sanofi-Aventis. (2010). Countefeiting : Sanofi-Aventis Takes Action. Paris: Sanofi Aventis.
Schinder, D. C. (2006).Business Research Methods, 9thedition.New Delhi, India: McgRaw Hill.
Sekaran,U&Bougie, R. (2010).Research Methods for Business: A Skill Building Approach 5th Edition. New Delhi: John Willey & Sons limited.
Senior, K. (2008). Global Health Implications of Substandard Medicines. London: The Lancet.
Sinha, K. (May 2008). 20% of Drugs Sold in India Fake, fear Experts. New Delhi: Times of India.
Stevenson, W. J. (2005). Operations Management-5th edition. New York: McGraw-Hill/ Irwin.
Teresa, I.,Rafik, B. & Robert H.(2004).A Stability Program for Distribution of Drug Products. New York: Novastar Communications.
The Food and Drug Adminstration.(2010). Information for Consumer Drugs. New York: The Food and Drugs Adminstration.
Tromp, N., Donald, K., &Delno.(2006).Project and Thesis Writing. Nairobi: Paulines Publications Africa.
UNIDO, U. N. (2010).Pharmaceutical Sector Profile: Kenya.Viena: UNIDO.
USDQIPandCollaborators. (2007). Ensuring Quality of Medicines in Resource-Limited Countries: An Operational Guide. Rockville, Md: Available online: www.usp.org/worldwide/dqi/resources/technicalReports.
USPconvention.(2006). United States Pharmacopoeia & National Formulary. Washington: USP Board of Trustees.
WHO. (2005). Counterfeit and Substandard Drugs: Frequently Asked Questions. http://www.who.int/medicines/services/counterfeit/faqs/en/ , Accessed on 14th September 2011.: World Health Organization.
WHO.(1999). Counterfeit and Substandatddrugs in Myanmar and Vietnam. Geneva: WHO.
WHO.(1999). Counterfeit Drugs. Geneva: WHO.
WHO.(2009). Model List of Essential Medicines, 16th list. Geneva: WHO:Available at http://www.who.int/medicines/publications/essentialmedicines/en/index.html, accessed on 28th October 2011.
WHO. (2003). Quality of Anti-Malarials: A study in selected African Countries, 1-67.
WHO. (2006). What Encourages Counterfeit Drugs. Geneva: WHO.
WHO), W. H. (2011).Survey of the Quality of Selected Anti-malarial Medicines Circulating in six Countries of Sub-Saharan Africa. Geneva: WHO.
Wilson, G. D. (1971). Text Book of Organic Medicinal and Pharmaceutical Chemisty-10thedition.Oxford: JP Lippincott Publications.
Yates, D. M. (1996).The Practice of Statistics. New York: Freeman. Oxford: JP Lippincott publications
Zax, D. (2010).Fighting Counterfeit Drugs with Mobile Technology. Abuja: Fast Company.
Zumdahl, S. S. (2006). Chemical Principals 2nd edition. New York: Health Publishing inc.
DOI: http://dx.doi.org/10.61426/sjbcm.v2i1.109
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