Transcript Lao PDR Presentation - World Health Organization

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
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
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 antimalarial 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.)
– Enhancing the technical capacity of national
laboratory and sentinel site laboratory for
drugs quality control.
– Strengthening national regulatory authorities.
• To present recommendation to policymakers on developing and implementing
appropriate strategies to address drug
quality problems.
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.
Sentinel sites
Districts
Provinces
Sayaboury
Sayaboury
Phieng
Boten
Savannakhet Khanthaboury
Athsaphang
Vilaboury
-thong
Champasack Pakse
Bachiang
Munlapamok
• Target drug
–Artesunate
–Fansidar
–Tetracycline
- Chloroquine
- Quinine
- Mefloquine
• Source of Sampling:
– Private pharmacy:
– Hospital:
– Total:
199 samples.
16 samples.
215 samples.
Summary of samples collected –
Round I
Name of sites
No. of samples No. of samples No. of samples
tested that failed verified and failed
(at sentinel site) (at national
laboratory.)
Sayaboury
91
9
0
Savannakhet
59
7
2
Champasack
65
3
3
Total
215
19
5
Testing results by drugs – Round I
Name of drug
No. of samples No. of samples
collected
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 No. of samples
tested that failed verified and
(at sentinel site) failed (at
National lab.)
Sayabuory
29
1-doubtful
3-failed
Savannakhet
27
-
Ditto
26
2-doubtful
(chloroquine)
Ditto
82
3-doubtful
3-failed
Ditto
Champasack
Total
In process
analysing
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
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.
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.
Thank
you