Affiliations: Department of Public Health Sciences, Division of International Health Care Research, Karolinska Institutet, SE‐171 76 Stockholm, Sweden | Medical Products Agency, Box 26, SE‐751 03 Uppsala, Sweden | Food and Drug Department, Ministry of Health, Vientiane, Lao P.D.R.
Note: [] Correspondence to: Bo Stenson, IHCAR, Karolinska Institutet, SE‐171 76 Stockholm, Sweden. Tel.: +46 8 51776542; Fax: +46 8 31 15 90; E‐mail: bo.stenson@ phs.ki.se.
Abstract: Objective: To describe and discuss the quality of a number of sample drugs collected in private pharmacies in Laos (Lao P.D.R.). Design: A stratified random sample was used to select 115 pharmacies and four sample drugs were collected from each. Three tests were used; identity, assay and measurement of weight variation. The identity was confirmed by TLC, UV and colour reactions. Titrimetric, UV and HPLC methods were used for assay. Setting: Savannakhet province in Laos. Study population: The 214 licensed private pharmacies in the province. Main outcome measures: Drug quality as assessed against the standards of the British and US pharmacopoeias. Results: 12 (3.3%) out of the 366 drugs contained no active ingredient, 42 (11.5%) had levels of active ingredient outside acceptable limits in assay, 128 (35.0%) had excessive weight variation, and 4 (1.1%) were managed badly in the pharmacy. Conclusions: The major problem is caused by insufficient attention to Good Manufacturing Practice (GMP). Half of the sample drugs would not be approved according to international standards. There is little difference between the private and public sectors. Serious problems such as counterfeit drugs and mix‐ups are not frequent. The government should focus its efforts on ensuring that all drugs in the pharmacies can be traced to manufacturer.
