Collaborative health and enforcement operations on the quality of antimalarials and antibiotics in southeast Asia.

Yuk Lin Yong,Chin-Chin Lim,Yen Hui Lau,Aline Plançon,Sourisak Sounvoravong,Ruth Lee Choo Ai,Thitikornkovit Dumrong,Suon Nara,Mam Boravann,Nurjaya Bangsawan,Dana M Hostetler,Min Yong Low,Facundo M Fernández,Paul N Newton,Michael D Green

doi:10.4269/ajtmh.14-0574

Yuk Lin Yong, Chin-Chin Lim + Show 13 more

Open Access

https://doi.org/10.4269/ajtmh.14-0574

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Abstract

Counterfeit (or falsified) and substandard medicines pose a major public health risk. We describe the findings of Operation Storm I and II conducted in 2008–2009 to combat counterfeit medicines through partnership between national customs, Drug Regulatory Agencies (DRAs), and police in Cambodia, Indonesia, Laos, Myanmar, Singapore, Thailand, and Vietnam. Samples were obtained from seizures and market surveillance by national DRAs. Laboratory analysis using spectroscopic and chromatographic techniques and examination of packaging were performed. Ninety-three suspect antibiotics and 95 antimalarial samples were collected. Of the 93 antibiotics, 29 (31%) had % active pharmaceutical ingredient content (%API) < 85% or > 115% (including one counterfeit). Of the 95 antimalarials, 30 (32%) had %API < 85 > 115% API (including one counterfeit). A significant minority of samples, antimalarials (13%) and antibiotics (15%), were collected in plastic bags with minimal or no labeling. Of 20 ampicillin samples, 13 (65%) contained < 85% API (with one counterfeit containing additional amoxicillin). Of 34 oral artesunate samples, 7 (21%) contained %API out of the 85–115% range. Coordinated and synergistic partnership adopted by the participating countries, International Criminal Police Organization (INTERPOL), World Health Organization (WHO), and laboratories facilitated a platform for discussions and intelligence sharing, helping to improve each participating country's capacity to combat poor-quality medicines.

Highlights

IntroductionBuilding on Operation Jupiter,[8] an operation to investigate falsified artesunate in southeast Asia, International Criminal Police Organization (INTERPOL), together with the World Health Organization (WHO) set up Operation Storm in the Greater Mekong region of southeast Asia
Samples were collected by the national Drug Regulatory Agencies (DRAs) inspection staff in the seven participating countries (Cambodia, Indonesia, Lao PDR (Laos), Myanmar (Burma), Singapore, Thailand, and Vietnam) and submitted to the Health Sciences Authority (HSA), Singapore, Center for Disease Control and Prevention (CDC), Atlanta, GA, and the Georgia Institute of Technology (GT), Atlanta, GA for chemical analysis
Fifty-four (58%) antibiotics were classed as having %active pharmaceutical ingredients (APIs) within the 90–110% range and one had %API > 115%, 28 had %API < 85%, and an additional 10 had %API between 85% and < 90%

Summary

Introduction

Building on Operation Jupiter,[8] an operation to investigate falsified artesunate in southeast Asia, International Criminal Police Organization (INTERPOL), together with the World Health Organization (WHO) set up Operation Storm in the Greater Mekong region of southeast Asia. Operation Storm I and II were conducted by seven participating countries (Cambodia, Indonesia, Lao PDR, Myanmar, Singapore, Thailand, and Vietnam) between April 2008 and November 2009. This multi-country operation provided a common platform for coordination meetings and training. The customs, Drug Regulatory Agencies (DRAs), and the police in each participating country conducted joint operations to investigate suspected pharmaceutical crime

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