Experience on quality of anti-malarials Experience on quality of anti-malarials in Lao PDRin Lao PDR

by by Dr.Somthavy CHANGVISOMMIDDr.Somthavy CHANGVISOMMIDDeputy Director of Food and Drug DepartmentDeputy Director of Food and Drug Department

Ministry of Health, Lao PDRMinistry of Health, Lao PDR

BackgroundsBackgrounds

• 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

ObjectivesObjectives

• 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.

Objectives (cont.)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.

TrainingTraining

• 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.

Sentinel sites

ProvincesDistricts

Sayaboury Sayaboury Phieng Boten

Savannakhet KhanthabouryAthsaphang-thong

Vilaboury

Champasack Pakse Bachiang Munlapamok

• Target drug–Artesunate - Chloroquine–Fansidar - Quinine–Tetracycline - Mefloquine

• Source of Sampling: – Private pharmacy: 199 samples. – Hospital: 16 samples. – Total: 215 samples.

Summary of samples collected – Round I

Name of sites No. of samples No. of samples tested that failed (at sentinel site)

No. of samples verified and failed (at national laboratory.)

Sayaboury 91 9 0

Savannakhet 59 7 2

Champasack 65 3 3

Total 215 19 5

Testing results by drugs – Round IName of drug No. of samples

collected No. of samples tested that failed (at sentinel site)

No. of samples verified and failed (at national laboratory.)

Artesunate 08 04 04

Chloroquine 65 13 00

Fansida 47 00 00

Quinine 29 02 01

Tetracycline 66 00 00

Total 215 19 05

Summary of samples collected – Round II

Name of sites No. of samples collected

No. of samples tested that failed (at sentinel site)

No. of samples verified and failed (at National lab.)

Sayabuory 291-doubtful

3-failedIn process analysing

Savannakhet 27 - Ditto

Champasack 262-doubtful

(chloroquine)Ditto

Total 823-doubtful

3-failedDitto

StrengthsStrengths

• 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

WeaknessWeakness

• 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.

RecommendationRecommendation

• 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.

Thank you