The quality of drugs in private pharmacies in Lao PDR: a repeat study in 1997 and 1999
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Objective: To present a repeated test of the quality of ampicillin, tetracycline, chloroquine and ASA from private pharmacies in Laos in 1997 and 1999, and to discuss the quality in relation to the National Drug Policy Programme.
Method: A total of 115 of 214 licensed private pharmacies were selected in Savannakhet province, a pilot province in the Lao National Drug Policy Programme. The four drugs, if available, were collected at each pharmacy. Thirty tablets of each drug were taken from a selected container. In 1997, 366 samples were analysed and three hundred in 1999. Identity, assay (content of active component) and measurement of weight variation tests were performed. Drug quality was compared mainly according to the standards of the British and United States’ pharmacopoeias.
Results: The percentage of substandard drugs decreased significantly from 46% to 22% between 1997 and 1999 (P < 0.001). Substandard ampicillin and tetracycline were reduced significantly from 67% to 9% and from 38% to 12%, respectively (P < 0.001). In total, 3% vs 1% contained no active ingredient, 12% vs 4% had too little or too much active ingredient, and 35% vs 14% had weight variation outside pharmacopoeial limits.
Conclusion: Drug quality was improved. However, the prevalence of substandard drugs was still unacceptably high, which may result in adverse clinical effect or treatment failure for individual patients.
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- 1.World Health Organization. Counterfeit and substandard drugs in Myanmar and Vietnam. Report of a study carried out in cooperation with the governments of Myanmar and Vietnam. Geneva: WHO/EDM/QSM/99.3, 1999.Google Scholar
- 4.Menkes DB. Hazardous drugs in developing countries. The market may be healthier than the people. BMJ 1997; 315: 1557.Google Scholar
- 5.Roy J. The menace of substandard drugs. World Health Forum 1994; 15: 406–7.Google Scholar
- 6.Hanif M, Mobarack MR, Ronan A, Rahman D, Donovan JJJ, Bennish ML. Fatal renal failure caused by diethylene glycol in paracetamol elixir: the Bangladesh epidemic. BMJ 1995; 311: 88–91.Google Scholar
- 10.Okeke IN, Lamikanra A, Edelman R. Socioeconomic and behavioral factors leading to acquired bacterial resistance to antibiotics in developing countries. Emerg Infect Dis 1999; 5: 18–27.Google Scholar
- 11.James EF. Martindale: The Extra Pharmacopoeia, 30th edition. London: The Pharmaceutical Press, 1993.Google Scholar
- 12.World Health Organization. Quality assurance of pharmaceuticals. A compendium of guidelines and related materials, Volume I. Geneva: World Health Organization, 1997.Google Scholar
- 13.Ministry of Health. National health survey, health status of the people in Lao PDR. Vientiane: Ministry of Health, 2001.Google Scholar
- 16.Syhakhang L. The quality of private pharmacy services in a province of Lao PDR: perceptions, practices and regulatory enforcements [Academic thesis]. Stockholm: Department of Public Health Sciences, Karolinska Institutet, 2002.Google Scholar
- 18.Stenson B, Lindgren BH, Syhakhang L, Tomson G. The quality of drugs in private pharmacies in the Lao People’s Democratic Republic. Int J Risk Safety Med 1998; 11: 243–9.Google Scholar
- 19.Stenson B, Syhakhang L, Lundborg CS, Eriksson B, Tomson G. Private pharmacy practice and regulation – a randomized trial in Lao PDR. Int J Technol Assess Health Care 2001; 17: 579–89.Google Scholar
- 20.World Health Organization. Accelerated stability studies of widely used pharmaceutical substances under simulated tropical conditions. Geneva: WHO/Pharm/86.529, 1986.Google Scholar
- 21.Zak AF, Loseva GI, Ermolova OB, Navolotskaya TI, Yakobson LM. Properties of tetracycline hydrochloride and their changes under various storage conditions. Antibiotiki (Moscow) 1974; 19: 1095–8.Google Scholar
- 22.Sandell E. Galenisk farmaci [Galenical Pharmacy.] Stockholm: Svensk, Farmaceutisk Tidskrifts Förlag, 1982 [in Swedish].Google Scholar
- 23.Kenyon TA, Kenyon AS, Sibiya T. Drug quality screening in developing countries: establishment of an appropriate laboratory in Swaziland. Bull World Health Organ 1994; 72: 615–20Google Scholar
- 25.Ballereau F, Prazuck T, Schrive I, Lafleuriel MT, Rozec D, Fisch A et al. Stability of essential drugs in the field: results of a study conducted over a two-year period in Burkina Faso. Am J Trop Med Hyg 1997; 57: 31–6.Google Scholar
- 26.Nazerali H, Hogerzeil HV. The quality and stability of essential drugs in rural Zimbabwe: controlled longitudinal study. BMJ 1998; 317: 512–3.Google Scholar