The Quality of Medicines in Community Pharmacies in Riyadh, Saudi Arabia: A Lot Quality Assurance Sampling (LQAS)-Based Survey
Hani M. J. Khojah, Henrik Pallos, Naoko Yoshida, Manabu Akazawa, Hirohito Tsuboi, Kazuko Kimura
Department of Drug Management and Policy, Graduate School of Natural Science and Technology, Kanazawa University, Kana-zawa, Japan.
Department of Drug Management and Policy, Graduate School of Natural Science and Technology, Kanazawa University, Kana-zawa, Japan;.
Department of Drug Management and Policy, Graduate School of Natural Science and Technology, Kanazawa University, Kana-zawa, Japan; Department of Clinical and Hospital Pharmacy, College of Pharmacy, Taibah University, Madinah, KSA;.
Department of International Pharmaceutical Sciences, Graduate School of Natural Science and Technology, Kanazawa University, Kanazawa, Japan;.
Department of Public Health and Epidemiology, Meiji Pharmaceutical University, Kiyose, Japan.
DOI: 10.4236/pp.2013.47074   PDF    HTML     4,375 Downloads   7,806 Views   Citations

Abstract

Objectives: To classify community pharmacies (CPs) in Riyadh, Saudi Arabia, in terms of the quality of medicines sold by them, using the lot quality assurance sampling (LQAS) technique with a predefined threshold. Methods: Riyadh CPs were divided into 2 categories (“lots” for the purpose of LQAS), i.e., chain and independent CPs. Upper and lower rate thresholds for CPs that sell low-quality medicines were predefined as 20% and 5%, respectively. Consumer and provider risks were predefined as 0.05 and 0.10, respectively. The calculated number of randomly selected CPs required in each lot was 36; then, sale of low-quality medicines in >3 CPs implies a prevalence of >20% of such CPs according to LQAS. A randomly selected brand of amoxicillin (selected as a quality indicator of medicines because it is both widely counterfeited and heat-sensitive) was purchased from each pharmacy by a “mystery shopper”, checked for authenticity, and analyzed for drug content and content uniformity using a validated HPLC method. Results: Substandard amoxicillin was purchased in 9 pharmacies (4 chains and 5 independent). Both lots were thus rejected as unacceptable, which may indicate that consumers in Riyadh are at risk of purchasing substandard medicines at CPs. Conclusions: The quality of medicines sold in CPs in Riyadh did not meet our acceptability criterion, and appropriate intervention by decision makers is recommended. LQAS proved to be a practical, economical, and statistically valid sampling method for surveying the quality of medicines. It should enable decision makers to allocate resources for improvement more efficiently.

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H. Khojah, H. Pallos, N. Yoshida, M. Akazawa, H. Tsuboi and K. Kimura, "The Quality of Medicines in Community Pharmacies in Riyadh, Saudi Arabia: A Lot Quality Assurance Sampling (LQAS)-Based Survey," Pharmacology & Pharmacy, Vol. 4 No. 7, 2013, pp. 511-519. doi: 10.4236/pp.2013.47074.

Conflicts of Interest

The authors declare no conflicts of interest.

References

[1] M. ten Ham, “Health Risks of Counterfeit Pharmaceuticals,” Drug Safety, Vol. 26, No. 14, 2003, pp. 991-997 http://dx.doi.org/10.2165/00002018-200326140-00001
[2] S. E. Nsimba, “Problems Associated with Substandard and Counterfeit Drugs in Developing Countries: A Review Article on Global Implications of Counterfeit Drugs in the Era of Antiretroviral (ARVs) Drugs in a Free Market Economy,” East African Journal of Public Health, Vol. 5, No. 3, 2008, pp. 205-210.
[3] T. Kelesidis, I. Kelesidis, P. I. Rafailidis and M. E. Falagas, “Counterfeit or Substandard Antimicrobial Drugs: A Review of the Scientific Evidence,” Journal of Antimicrobial Chemotherapy, Vol. 60, No. 2, 2007, pp. 214-236. http://dx.doi.org/10.1093/jac/dkm109
[4] R. Watson, “European Union Prepares to Tackle Counterfeit Drugs,” British Medical Journal, Vol. 340, 2010, p. c2425. http://dx.doi.org/10.1136/bmj.c2425
[5] E. Wondemagegnehu, “Counterfeit and Substandard Drugs in Myanmar and Viet Nam—Report of a Study Carried out in Cooperation with the Governments of Myanmar and Viet Nam,” 2011. http://apps.who.int/medicinedocs/pdf/s2276e/s2276e.pdf
[6] M. H. Khan, J. Okumura, T. Sovannarith, N. Nivanna, M. Akazawa and K. Kimura, “Prevalence of Counterfeit Anthelminthic Medicines: A Cross-Sectional Survey in Cambodia,” Tropical Medicine and International Health, Vol. 15, No. 5, 2010, pp. 639-644. http://dx.doi.org/10.1111/j.1365-3156.2010.02494.x
[7] P. N. Newton, M. D. Green, D. C. Mildenhall, A. Plancon, H. Nettey, L. Nyadong, D. M. Hostetler, I. Swamidoss, G. A. Harris, K. Powell, A. E. Timmermans, A. A. Amin, S. K. Opuni, S. Barbereau, C. Faurant, R. C. W. Soong, K. Faure, J. Thevanayagam, P. Fernandes, H. Kaur, B. Angus, K. Stepniewska, P. J. Guerin and F. M. Fernández, “Poor Quality Vital Anti-Malarials in Africa—An Urgent Neglected Public Health Priority,” Malaria Journal, Vol. 10, 2011, p. 352. http://dx.doi.org/10.1186/1475-2875-10-352
[8] S. Kyriacos, M. Mroueh, R. P. Chahine and O. Khouzam, “Quality of Amoxicillin Formulations in Some Arab Countries,” Journal of Clinical Pharmacy and Therapeutics, Vol. 33, No. 4, 2008, pp. 375-379. http://dx.doi.org/10.1111/j.1365-2710.2008.00926.x
[9] World Health Organization, “Counterfeit Drugs. Guidelines for the Development of Measures to Combat Counterfeit Drugs,” 2011. http://whqlibdoc.who.int/hq/1999/WHO_EDM_QSM_99.1.pdf
[10] World Health Organization, “Counterfeit Medicines: Some Frequently Asked Questions,” 2011. http://www.wpro.who.int/mediacentre/factsheets/fs_20050506/en/index.html
[11] P. N. Newton, S. J. Lee, C. Goodman, F. M. Fernández, S. Yeung, S. Phanouvong, H. Kaur, A. A. Amin, C. J. M. Whitty, G. O. Kokwaro, N. Lindegardh, P. Lukulay, L. J. White, N. P. J. Day, M. D. Green and N. J. White, “Guidelines for Field Surveys of the Quality of Medicines: A Proposal,” PLoS Medicine, Vol. 6, No. 3, 2009, Article ID: e1000052. http://dx.doi.org/10.1371/journal.pmed.1000052
[12] W. A. Reinke, “Applicability of Industrial Sampling Techniques to Epidemiologic Investigations: Examination of an Underutilized Resource,” American Journal of Epidemiology, Vol. 134, No. 10, 1991, pp. 1222-1232.
[13] S. E. Robertson and J. J. Valadez, “Global Review of Health Care Surveys Using Lot Quality Assurance Sampling (LQAS), 1984-2004,” Social Science & Medicine, Vol. 63, No. 6, 2006, pp. 1648-1660. http://dx.doi.org/10.1016/j.socscimed.2006.04.011
[14] A. Bhuiya, S. M. A. Hanifi, N. Roy and P. K. Streatfield, “Performance of the Lot Quality Assurance Sampling Method Compared to Surveillance for Identifying Inadequately-Performing Areas in Matlab, Bangladesh,” Journal of Health, Population, and Nutrition, Vol. 25, No. 1, 2007, pp. 37-46.
[15] S. A. Bawazir, “Prescribing Pattern at Community Pharmacies in Saudi Arabia,” International Pharmacy Journal, Vol. 6, No. 5, 1992, pp. 222-224.
[16] A. A. Bin Abdulhak, M. A. Altannir, M. A. Almansor, M. S. Almohaya, A. S. Onazi, M. A. Marei, O. F. Aldossary, S. A. Obeidat, M. A. Obeidat, M. S. Riaz and I. M. Tleyjeh, “Non Prescribed Sale of Antibiotics in Riyadh, Saudi Arabia: A Cross Sectional Study,” BMC Public Health, Vol. 11, No. 1, 2011, p. 538. http://www.biomedcentral.com/1471-2458/11/538 http://dx.doi.org/10.1186/1471-2458-11-538
[17] Saudi Food and Drug Authority, “About SFDA,” 2012. http://old.sfda.gov.sa/En/Home/Topics/about/ http://www.sfda.gov.sa/en/about/Pages/overview.aspx
[18] World Health Organization, “17th Model List of Essential Medicines,” 2012.
http://whqlibdoc.who.int/hq/2011/a95053_eng.pdf
[19] Saudi Ministry of Health, “Formulary: Drug List,” 2012.
http://www.moh.gov.sa/Portal/WhatsNew/Documents/MOHF_DRUG_LIST_CD.pdf
[20] K. K. Naidoo, P. Nompuku, S. N. Mkalali, K. Shabangu, L. Nkabinde and V. Singh, “Post-Marketing Stability Surveillance: Amoxicillin,” South African Family Practice, Vol. 48, No. 6, 2006, pp. 14-14d. http://www.safpj.co.za/index.php/safpj/article/view/609/541
[21] R. B. Taylor, O. Shakoor, R. H. Behrens, M. Everard, A. S. Low, J. Wangboonskul, R. G. Reid and J. A. Kolawole, “Pharmacopeial Quality of Drugs Supplied by Nigerian Pharmacies,” The Lancet, Vol. 357, No. 9272, 2011, pp. 1933-1936. http://dx.doi.org/10.1016/S0140-6736(00)05065-0
[22] U. Hadi, P. van den Broek, E. P. Kolopaking, N. Zairina, W. Gardjito and I. C. Gyssens, “Cross-Sectional Study of Availability and Pharmaceutical Quality of Antibiotics Requested with or without Prescription (over the Counter) in Surabaya, Indonesia,” BMC Infectious Diseases, Vol. 10, No. 1, 2010, p. 203. http://dx.doi.org/10.1186/1471-2334-10-203
[23] T. A. O. Najjar, “A Survey on Community Pharmacies in Riyadh, Saudi Arabia,” Saudi Pharmaceutical Journal, Vol. 9, No. 2, 2001, pp. 113-118.
[24] B. L. Hedt, C. Olives, M. Pagano and J. Valadez, “Large Country-Lot Quality Assurance Sampling: A New Method for Rapid Monitoring and Evaluation of Health, Nutrition and Population Programs at Sub-National Levels,” The International Bank for Reconstruction and Development/The World Bank, Washington DC, 2008, pp. 31-32.
[25] S. Lemeshowand and S. Taber, “Lot Quality Assurance Sampling: Single and Double-Sampling Plans,” World Health Statistics Quarterly, Vol. 44, No. 3, 1991, pp. 115-132.
[26] J. J. Valadez, R. Transgrud, M. Mbugua and T. Smith, “Assessing Family Planning Service-Delivery Skills in Kenya,” Studies in Family Planning, Vol. 28, No. 2, 1997, pp. 143-150. http://dx.doi.org/10.2307/2138116
[27] Food and Nutrition Technical Assistance III Project, “LQAS Sample Size Calculator,” 2012. http://www.fantaproject.org/calculators/samplesize_calculator.shtml
[28] P. T. Norris, “Purchasing Restricted Medicines in New Zealand Pharmacies: Results from a ‘Mystery Shopper Study’,” Pharmacy World and Science, Vol. 24, No. 4, 2002, pp. 149-153. http://dx.doi.org/10.1023/A:1019506120713
[29] J. M. Madden, J. D. Quick, D. Ross-Degnan and K. K. Kafle, “Undercover Careseekers: Simulated Clients in the Study of Health Provider Behavior in Developing Countries,” Social Science & Medicine, Vol. 45, No. 10, 1997, pp. 1465-1482. http://dx.doi.org/10.1016/S0277-9536(97)00076-2
[30] United States Pharmacopeial Convention, “United States Pharmacopeia and National Formulary (USP 34/NF 29),” United States Pharmacopeial Convention, Vol. 1, 2011, pp. 403-406.
[31] United States Pharmacopeial Convention, “United States Pharmacopeia and National Formulary (USP 34/NF 29),” United States Pharmacopeial Convention, Vol. 2, 2011, pp. 1882-1888.
[32] The Stationary Office, “British Pharmacopeia,” The Stationary Office, Vol. 1, 2012, pp. 154-156.
[33] P. De Pourcq, J. Hoebus, E. Roets, J. Hoogmartens and H. Vanderhaeghe, “Quantitative Determination of Amoxicillin and Its Decomposition Products by High-Performance Liquid Chromatography,” Journal of Chromatography, Vol. 321, No. 2, 1985, pp. 441-449. http://dx.doi.org/10.1016/S0021-9673(01)90462-5
[34] G. W. Fong, D. T. Martin, R. N. Johnson and B. T. Kho, “Determination of Degradation Products and Impurities of Amoxicillin Capsules Using Ternary Gradient Elution High-Performance Liquid Chromatography,” Journal of Chromatography, Vol. 298, No. 3, 1984, pp. 459-472.
http://dx.doi.org/10.1016/S0021-9673(01)92743-8

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