The State of Medicine Quality in the Mekong Sub-Region

The State of Medicine Quality in the Mekong Sub-Region

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English
88 Pages

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This study aims to increase awareness and interest on the pharmaceutical quality and counterfeit medicines issues in the Mekong Subregion. It provides a review of existing empirical findings regarding the state of medicine quality in the region. It also analyzes data on quality testing of drug samples from the five countries (Cambodia, China, Lao PDR, Thailand and Vietnam) in the region, in order to develop a conceptual framework for addressing the issue at the regional level, and to suggest areas for further study.


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Published 03 July 2018
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Tne State of MediciNe Quality iN tne MekoNg Sub-RegioN
Sauwakon Ratanawijitrasin and Souly Phanouvong
DOI: 10.4000/books.irasec.1192 Publisher: Institut de recherche sur l’Asie du Sud-Est contemporaine Year of publication: 2014 Published on OpenEdition Books: 3 July 2018 Serie: Observatoire des trafics Electronic ISBN: 9782355960277
http://books.openedition.org
Printed version ISBN: 9786167571195 Number of pages: 88
Electronic reference RATANAWIJITRASIN, Sauwakon ; PHANOUVONG, Souly.The State of Medicine Quality in the Mekong Sub-Region.New edition [online]. Bangkok: Institut de recherche sur l’Asie du Sud-Est contemporaine, 2014 (generated 05 juillet 2018). Available on the Internet: . ISBN: 9782355960277. DOI: 10.4000/books.irasec.1192.
This text was automatically generated on 5 July 2018.
© Institut de recherche sur l’Asie du Sud-Est contemporaine, 2014 Terms of use: http://www.openedition.org/6540
Tnaceutical quality andthe pharm s to increase awareness and interest on is study aim counterfeit m edicines issues in the Mekong Subreg ion. It provides a review of existing em pirical finding s reg arding the state of m edicine quality in the reg ion. It also analyzes data on quality tes ting of drug sam ples from the five countries (Cam bodia, China, Lao PDR, Thailand and V ietnam ) in the reg ion, in order to develop a conceptual fram ework for addressing the i ssue at the reg ional level, and to sug g est areas for further study.
SAUWAKON RATANAWIJITRASIN
Dr. Sauwakon Ratanawijitrasin is an expert in health and pharm aceutical policies, and system desig n. She has conducted research and published in the areas of drug policy, drug reg ulation, supply, quality, utilization, inform ation, health insurance, and health services, in institutional, national and international contexts. She has also advised g overnm ents and international org anizations, such as WHO, MSH, USP. Dr. Sauwakon currently teaches at Mahidol University.
SOULY PHANOUVONG
Souly Phanouvong is currently the Manag er for Asia Prog ram s of the United States Pharm acopeia’s Prom oting the Quality of Medicines prog ram , funded by the United States Ag ency for International Developm ent. In early 2000, he worked for WHO in Geneva as a technical officer for prom oting access to hig h-quality anti-tuberculosis m edicines. He has over 25 years of international experiences in the areas of m edicines quality assurance and policy from both advanced and less advanced reg ulatory setting s. He holds a B.Sc. (Pharm ), a Pharm .D and two PhDs.
TABLE OF CONTENTS
List of figures
List of tables
Introduction
1 - The Mekong Subregion and Medicine Quality 1.1 - Leg al Framework for Medicine Quality in the Five Countries 1.2 - Assessing the Quality of Medicines in the Mekong Subreg ion: a Brief Review of Existing Empirical Studies
2 - The Mekong Subregion Medicine Quality Study 2.1 - Methodolog ies 2.2 - Medicine Quality Database and Analysis of Test Results
3 - Medicine Quality as Reflected in the Five Country Study 3.1 - Medicine Quality: the Overall Picture 3.2 - Medicine Quality Trends at Country Level 3.3 - Quality of Medicines by Therapeutic Group 3.4 - Counterfeit Medicines 3.5 - Quality of Medicines and Consumer’ Risk
4 - The Multiple Requirements of Medicine Quality
5 - Regulating medicine: regulatory spheres and gap
6 - The ‘demand’ for poor quality medicines
7 - Improving the state of medicine quality in the mekong subregion
Références
Annex I. Legal Definitions of Medicines from the Quality Perspective-by country
Annex II. Additional Data on Medicine Quality
Annex III. Research Project Team
List of figures
Figure 1:Example of counterfeit chloroquine phosphate tablets found in Cambodia in 2004
Figure 2: Example of counterfeit artesunate found in the Mekong Subreg ion in 2004
Figure 3: Example of counterfeit amoxicillin capsules found in Cambodia, 2009
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Figure 4: Multi-colour medicine sachets of cocktail pills repacked by retail drug outlets are still available in some parts of the countries in the Mekong Subreg ion. This photo was 22 taken in Cambodia in 2011
Figure 5the locations ofion with dots illustrating : Map of countries of the Mekong Subreg pharmaceutical sample collection sites
Figure 6: Methodolog ical framework on medicine quality monitoring applied in the GMS by the United States Pharmacopeia Promoting the Quality of Medicines Prog ram
Figure 7: Three levels of testing for checking the quality of the samples
Figure 8: Basic tests used in the medicines quality monitoring prog ramme in the Mekong Subreg ion
Figure 9ration test of oseltamivir tablets in Cambodia: Officers conduct a simple disinteg
Figure 10: Training on basic testing for field monitoring of anti-infective medicines in Thailand, 2009
Figure 11: Training on quality control technique and procedures to detect counterfeit and substandard medicines to central and field laboratory staff in Vietnam
Figure 12quality testing by country: Percentag e of samples failing
Figure 13: Quality of medicine samples collected in Cambodia between 2002-2008 showing the proportion of products that passed and failed quality testing
Figure 14: Quality of medicine samples collected in Lao PDR between 2003-2008 showing the proportion of products that passed and failed quality testing
Figure 15: Quality of medicine samples collected in Vietnam between 2004-2008 showing the proportion of products that passed and failed quality testing
Figure 16: Quality of four categ ories of anti-microbial medicine samples collected and
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tested in the reg ion (2003-2008)
Figure 17: Quality of anti-malarials collected by country
Figure 18: Inspectors of the Food and Drug Department of Lao PDR inspect retail pharmacy outlets as part of the monotherapies ban policy implementation in Lao PDR
Figure 19: Quality of antibiotics collected and tested by country
Figure 20: Quality of anti-TB medicines collected and tested by country
Figure 21: Quality of ARVs collected and tested by country
Figure 22: Counterfeit medicines by country
Figure 23: Counterfeit medicines found in Cambodia between 2005-2008
Figure 24: Percentag e of counterfeit medicines from each distribution channel out of total counterfeit samples found in the countries surveyed
Figure 25: Consumers’ risk of receiving bad medicines from pharmacies at the border provinces in each of the countries
Figure 26: Consumers’ risk of receiving bad medicines from hospitals in the border provinces in each of the countries
Figure 27: Consumers’ risk of receiving bad medicines from clinics in the border provinces in each of the countries
Figure 28: Consumers’ risk of receiving bad medicines from malaria clinics in the border provinces in each of the countries
Figure 29: Consumers’ risk of receiving poor quality medicines from various distribution channels in the border provinces of Cambodia
Figure 30: Consumers’ risk of receiving poor quality medicines from various distribution channels in the border counties of Yunnan Province
Figure 31: Consumers’ risk of receiving poor quality medicines from various distribution channels in the border provinces of Lao PDR
Figure 32: Consumers’ risk of receiving poor quality medicines from various distribution channels in the border provinces of Thailand
Figure 33: Consumers’ risk of receiving poor quality medicines from various distribution channels in the border provinces of Vietnam
Figure 34rammatic depiction of the factors in the medicine process – critical to: Diag quality
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Figure 35ulatory control: Conceptual spheres of reg
Figure 36: Conceptual spheres of the four main reg ulatory functions
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List of tables
Table 1: Types of medicine samples in USP-PhaReD database
Table 2: Number of Samples Collected by Country by Year
Table 3: Counterfeit medicines identified in the five countries during 2002-2008
Table 4: Counterfeit medicines identified in Cambodia
Table 5: Examples of counterfeit quinine identified in Cambodia with information reg arding active ing redients, trade-name and manufacturer as stated on the packag ing
Table 6: Examples of counterfeit artesunate identified in Cambodia with information reg arding active ing redients, trade name and manufacturer as stated on the packag ing
Table 7: Examples of counterfeit mefloquine identified in Cambodia with information reg arding active ing redients, trade name and manufacturer as stated on the packag ing
Table 8: Examples of counterfeit tetracycline identified in Cambodia with information reg arding active ing redients, trade name and manufacturer as stated on the packag ing
Table 9: Number and percentag e of counterfeit medicines in Cambodia identified by province and year
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