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The State of Medicine Quality in the Mekong Sub-Region

 | 
Sauwakon Ratanawijitrasin
, 
Souly Phanouvong

Introduction

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1As waves of emerging and re-emerging diseases send repercussions around the world time and again, the global community has come to realize the interconnectedness of our world, of its countries, peoples, and activities. Today, what happens in one place can have an impact far beyond the boundary of a geographical locale. The world community pulls together to examine the many interrelated factors causing epidemics that are difficult to contain, and to re-examine old issues in a new light. Medicine quality is one of such issues. Efficacy, safety, and quality are three essential attributes of a medicine. Without these, effective prevention, treatment and care cannot be achieved, and patient safety may be at risk. When a poor quality medicine is used to treat an infectious disease, the impacts of its use can be wide and serious, as ineffective anti-infectives may fail to help stop the spread of an epidemic, engender drug resistance, and erode public confidence in health care systems. Patients contribute to their own and their children’s vulnerability to expensive-to-treat or even incurable infectious diseases if their over-use of anti-infectives leads to resistance (Eggleston et al. 2010). The potential societal ramifications of poor quality anti-infective medicines in the current rapidly globalized world have brought new focus and new urgency to the raising of awareness and the seeking of solutions to stem the spread of bad medicines, as nations and the global community work together to combat emerging and re-emerging diseases.

2The Mekong Subregion has long been a key geographical area of global interest in regards to medicine quality and its implications on global health. The Mekong River originates in the highlands of China’s Yunnan Province, crossing five countries – China, Myanmar, Lao PDR, Thailand, Cambodia – then opening to the sea in southern Vietnam. These riparian states linked by the Mekong form the Greater Mekong Subregion (GMS). After the Indochina War ended in the late 1970s, the countries in this region forged close ties – economically, politically, and culturally – and brought rapid development to the region. Social transformation and economic development are both evident in the boom in trade, tourism and transportation links. With such ties and new demands for goods and services arising from development, the flow of people and goods has increased. One of the trades enhanced by these closer relations is that of medicine, genuine as well as counterfeit. The more rapid and frequent exchanges not only brought increased flows of people and goods, they also, inevitably, heightened the spread of infectious diseases (WHO 2009).

3Malaria epitomizes the interactions among the many dynamics in population movement, trade, and infectious disease epidemiology in this region. The spread of malaria has long been a problem in the Mekong Region, especially along borders. Many of the border areas are characterized by forest and forest fringe areas with high malaria transmission, poor geographical accessibility, high population mobility, and low population density. Large-scale population movement from highly endemic areas to low endemic zones has contributed substantially to the spread of P. falciparum – a virulent species of protozoa causing malaria in humans – within and beyond the region. An example of extensive migration leading to the spread of malaria is the return of 100,000 to 200,000 gem miners from Borai Province in Cambodia to their home provinces in western Thailand following the Ruby Rush from 1988 to 1992, and the subsequent increase in P. falciparum cases. Estimates from clinics in Mae Sot District in Tak Province in western Thailand on the Thai-Myanmar border indicated that 80% of malaria infections were acquired in eastern Thailand on the Thai-Cambodian border (Delacollette et al. 2009).

4These movements intensified the problem of multi-drug resistance historically found in the Mekong Region. Since the 1970s, the Thai-Cambodian border has been the global epicentre of emerging resistance to anti-malarial medicines. It is in this region that parasite resistance to chloroquine was first documented, followed by resistance to sulfadoxine-pyrimethamine, and finally to mefloquine. These resistance strains were later shown by molecular markers to have spread far outside the GMS. Concerns about anti-malarial drug resistance have increased with recent results from surveillance sites on the Thai-Cambodian border, which have shown prolonged parasite clearance of P. falciparum to artemisinin-combination therapies (Noedl et al. 2008, Delacollette et al. 2009, Phyo et al. 2012). The improved road, rail and other transportation facilities accelerate the movement of populations across the borders, leading to conditions that can promote disease transmission. Yet, this greater interconnectedness in transportation and trade coexists with a difficult access to health facilities for people living in remote areas. Availability and affordability of good quality medicines remains a problem, especially for hill-tribe people and ethnic minorities living in remote areas, as well as for migrant populations. These disadvantaged groups are most likely to suffer from poor quality medicines.

  • 1 The term “poor-quality medicines” in this document refers to pharmaceutical products that do not m (...)

5Pharmaceutical products play an important role in the prevention and treatment of diseases, and thus help improve health. In order for a pharmaceutical product to achieve its therapeutic effects, it must meet three pre-requisite criteria, namely, efficacy, safety and quality. It must also be appropriately used. Almost all countries – developed as well as developing – have, with varying degrees, a system of pharmaceutical regulation, depending, in part, on their pharmaceutical industry and legal development status. However, in many developing countries, the quality of pharmaceutical products has often been found to be a problem. Reports, as reviewed below, indicate that substandard and counterfeit medicines are available in different distribution channels in the Mekong Subregion. The use of poor quality medicines1 can produce serious health implications, including treatment failure, prolonged treatment duration, and hospitalization, even death, wasted resources, and some cases may lead to drug-resistance.

6With the looming threat of epidemics in recent years, the quality of pharmaceuticals has been an increasing concern worldwide, and particularly within the Mekong Subregion. This region is a key area where avian influenza outbreaks took place, and where many resistant strains of malaria parasites were initially identified. The issue of medicine quality is in the interest of many parties as all have a stake in ensuring that patients have access to good quality medicines. Consumers/patients need quality drugs to alleviate their illness conditions. The use of substandard or counterfeit drugs not only fails intended treatment and prevention, but might also causes harm. Health care providers need to enhance health outcomes to earn patient trust and confidence. Pharmaceutical companies’ reputation and profits mainly depend on the trust in their products’ quality, safety, and efficacy. Governments have a responsibility to protect and promote public health; they also have to spend public resources on effective care.

  • 2 The USP DQI is a predecessor of Promoting the Quality of Medicines (PQM), a programme that is base (...)

7This study tries to discuss and provide some insightful information, with supporting data, on the quality of essential medicines in the Mekong Subregion. The majority of data discussed in this paper is derived from a United States Pharmacopeia (USP) Drug Quality and Information Program (DQI) project that took place between 2003 and 20062, funded by the United States Agency for International Development (USAID) with some contribution from the World Health Organization (WHO), on selected anti-malarials, anti-tuberculosis agents, anti-retrovirals and antibiotics collected and tested from the Mekong Subregion countries through a regional medicine quality monitoring (MQM) mechanism.

8This paper aims to contribute to increasing 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 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.

9This study employs two main methodologies:

  1. Archival study: Literature review of existing studies – both qualitative and quantitative – and reports on drug quality issues in the Mekong Subregion, including incidents and cases where information is publicly available.
  2. Analysis of test results data from an international database – USP-PhaReD database. The database analysis will produce descriptive statistics of pass/fail test results by generic (International Nonproprietary Names – INN), drug group, country, province, distribution channel, etc., as well as counterfeit identified.

Notes

1 The term “poor-quality medicines” in this document refers to pharmaceutical products that do not meet quality standard specifications. They may be classified as counterfeit or substandard. Their definitions vary slightly from country to country depending on their legal framework. See ANNEX I for details.

2 The USP DQI is a predecessor of Promoting the Quality of Medicines (PQM), a programme that is based on a cooperative agreement between the USP and USAID.

© Institut de recherche sur l’Asie du Sud-Est contemporaine, 2014

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