1. Experience on quality of anti-malarials in Lao PDR by Dr.Somthavy CHANGVISOMMID Deputy Director of Food and Drug Department Ministry of Health, Lao PDR

2. Backgrounds The use of poor quality drugs is one of many factors that be a cause of drug-resistant, especially anti-malarial drug. Although the Ministry of Health has paid attention as well as the support from international organizations (WHO, Wellcome Trust, JICA...) the malaria disease is still a main cause of mortality. Since 2003, Lao PDR has participated in monitoring of drug quality of anti malaria which supported by the coordination of USP DQI and the regional WHO

3. Objectives To obtain evidence-based data from the field on the quality of selected anti-malarial drugs. To improve the quality of drugs used in priority disease programs, especially anti- malarial drugs: –Implementing a strategies approach for early detection of counterfeit and substandard drugs on the market and being used in the national malaria programs.

4. Objectives (cont.) –Enhancing the technical capacity of national laboratory and sentinel site laboratory for drugs quality control. –Strengthening national regulatory authorities. To present recommendation to policy- makers on developing and implementing appropriate strategies to address drug quality problems.

5. Training Training: 1-5/04/2003 –GLP principles –Basic testing: Simple disintegration test, TLC by using GPHF-Mini lab. –Samples collection –Testing and reporting –Data management.

6. Sentinel sites Provinces Districts Sayaboury PhiengBoten SavannakhetKhanthaboury Athsaphang -thong Vilaboury ChampasackPakseBachiangMunlapamok

7. Target drug –Artesunate- Chloroquine –Fansidar- Quinine –Tetracycline- Mefloquine Source of Sampling: –Private pharmacy: 199 samples. –Hospital: 16 samples. –Total:215 samples.

8. Summary of samples collected – Round I Name of sitesNo. of samplesNo. of samples tested that failed (at sentinel site) No. of samples verified and failed (at national laboratory.) Sayaboury9190 Savannakhet5972 Champasack6533 Total215195

9. Testing results by drugs – Round I Name of drugNo. of samples collected No. of samples tested that failed (at sentinel site) No. of samples verified and failed (at national laboratory.) Artesunate0804 Chloroquine651300 Fansida4700 Quinine290201 Tetracycline6600 Total2151905

10. Summary of samples collected – Round II Name of sitesNo. of samples collected No. of samples tested that failed (at sentinel site) No. of samples verified and failed (at National lab.) Sayabuory29 1-doubtful 3-failed In process analysing Savannakhet27-Ditto Champasack26 2-doubtful (chloroquine) Ditto Total82 3-doubtful 3-failed Ditto

11. Strengths Good collaboration between Food and Drug Quality Control Center (FDQCC), Food and Drug Department (FDD) and Center of Malariology, Parasitology and Entomology. Testing methods are not too difficult to perform. Support from MOH, USP DQI and WHO

12. Weakness Lack of experiences in implementation of project: with 3 different parts from 3 levels of Center, Provinces and Districts. The plan of project implementation is not suitable to the actual condition. Knowledge of analysts at sentinel site on technique: still low and limited. Lack of equipment in the lab: Chemical, glassware... Difficulty of sampling: repeated batches, some pharmacies are not regularly opened.

13. Recommendation Awareness campaign on counterfeit drugs to different target groups should be included in the next coming plan of activities. Enforcement to violations should be implemented strictly unanimously in the whole country. National lab. and sentinel sites need more laboratory equipment (HPLC, glassware and chemicals) to be able to perform of drugs analysis. To propose to WHO and USP DQI in supporting technical on GMP, GLP concept and necessary budget.

14. Thank you