PQM in Asia: Activities by Country

Cambodia is also plagued by substandard and counterfeit medicines circulating in its markets. PQM provided evidence-based data in 2003 that pointed to the widespread availability of poor quality medicines, after which PQM began working with the Cambodian government to establish medicine quality monitoring. Initially PQM focused medicine quality monitoring activities in Cambodia on antimalarial medicines, but later expanded activities to include medicines that treat TB, HIV/AIDS, and other infectious diseases.

Recently, Cambodia has been recognized as the epicenter of resistant strains of malaria in the region, with particularly high levels in the provinces along the Thai-Cambodian border. PQM took part in a study with the World Health Organization (WHO) and the Bill and Melinda Gates Foundation to determine what role medicine quality might play in the increase of drug-resistant malaria cases.

The Cambodian government has taken action against fake medicines and counterfeiters, closing illegal pharmacies, confiscating illegal medicines, and spreading information to its citizens. The newly established Center of Pharmacovigilance collects reports on adverse reactions to medicines once they reach the markets. Health professionals were alerted to the growing problem in bulletins and journals, and posters and leaflets of recently found counterfeit and substandard medicines are distributed throughout the country. PQM and its partners in Cambodia have also produced an educational video, dramatizing the potential dangers of using poor quality medicines and illustrating how medicines are collected and tested in the field for use in training, educating the general public, and engaging stakeholders.

The problem of tuberculosis (TB), a global concern for decades, has been further complicated by development of multidrug-resistant tuberculosis (MDR-TB) and the emergence of extensively drug resistant tuberculosis (XDR-TB). These forms are resistant to first-line treatments and require more expensive, less available medicines. PQM is assisting the Global Drug Facility and the Green Light Committee to increase the number of manufacturers of good quality second-line anti-TB drugs that have been prequalified by the World Health Organization, including several in India.

Another rampant problem, particularly for children under the age of five, is acute diarrheal disease, which robs them of the precious few nutrients they consume. In 2004, PQM and USP worked together to produce pharmacopeial monographs for two oral forms of medicinal-quality zinc acceptable for children and, in 2007, developed guidelines for their quality manufacture. Now PQM is working with companies in India to develop a compendial monograph for zinc syrups and test medicines for quality.

Although Laos has a relatively low level of HIV/AIDS, it is bordered by Cambodia, Thailand, and Vietnam—all of which have higher rates of HIV infection. If current levels of international migration remain high, HIV/AIDS could spread in Laos if appropriate interventions are not in place. Yet the staffs of community pharmacies, where most patients go first for medicines and medical advice, are not usually trained to provide information on the safety and quality of medications to people living with HIV/AIDS. To address the problem, PQM helped train selected community and hospital pharmacists in HIV/AIDS hot-spot areas of Laos in the many different ways that medication errors can occur and how they can prevent them.

PQM has helped strengthen medicine quality assurance and quality control systems in the Mekong region, contributing to the regional effort of improving access to high quality medicines. Having begun with just antimalarials in 2003, Laos now monitors for antimalarial, antibiotic, anti-tuberculosis, and antiretroviral (HIV/AIDS) medicines and is expanding coverage to the more remote areas so that by 2012, all 17 provinces across the country will have sentinel sites.

Among the leading health conditions in Nepal is diarrheal disease. An estimated three million children die each year in developing countries from diarrhea and it contributes substantially to malnutrition in surviving children. One of the leading causes is zinc deficiency, thought to be prevalent in children in developing countries. To ensure that available zinc products are of high quality, PQM performs Good Manufacturing Practices (GMP) assessments and audits of zinc sulfate manufacturers and assists them in the process of achieving World Health Organization (WHO) prequalification status.

Because maternal mortality is also high in the region, PQM is also working to improve the capacity of local manufacturers to produce high quality chlorhexidine, which is used for cord washing to prevent sepsis after childbirth. WHO is waiting on the results from a study in Bangladesh to issue recommendations on the use of chlorhexidine for cord care.

Despite economic and healthcare challenges, the government has instituted progressive policies to ensure that affordable, high quality, safe, and effective drugs and medicines are available, especially to the poor. Tuberculosis (TB) medicines were singled out as being in need of quality monitoring, so PQM established a program aimed at strengthening the country's national medicine quality assurance systems. PQM had already helped build the capacity of the Center for Drug Research, Evaluation and Studies, Inc., to become a regional Center of Excellence in the quality assurance of medicines for bioavailability/bioequivalence.

Philippine FDA analysts have been trained to determine the quality of four TB medicines and their fixed-dose combinations. Also PQM lent assistance to the Philippines' quality control laboratory to reach ISO 17025:2005 accreditation. In addition, PQM is working with local manufacturers to meet World Health Organization prequalification requirements for two medicines used to treat multidrug-resistant TB.

Although the transmission of malaria in the central plain area of Thailand has been eliminated for more than two decades, the disease remains an important public health problem along the forested international borders. Poor quality antimalarial medicines on the market in Thai-Cambodian border provinces sparked concern in both countries and with international agencies, enough to include testing medicine quality as one component in the World Health Organization and Bill and Melinda Gates Foundation study of resistant strains of malaria infection.

PQM began working in Thailand in 2003 to establish medicine quality monitoring that contributes to the regional effort of improving access to high quality essential medicines, including those for avian influenza. Monitoring activities have led to the discovery of a number of substandard and counterfeit antimalarial medicines and subsequent government enforcement action. PQM has also helped build the capacity of two laboratories to become regional Centers of Excellence in the quality assurance of medicines—Mahidol University for Good Manufacturing Practices, and Chulalongkorn University for quality control.

Vietnam has also made progress in the battle against malaria, for which the mortality rate has declined sharply since the 1990s. By 2003 the numbers had decreased from close to two million cases to just 37,416 cases. Tuberculosis, however, is on the rise and the country's maternal mortality rate is at an unacceptably high level. Vietnam was also hard hit by initial outbreaks of avian influenza with 129 deaths in two years (2004–2005), and still experiences occasional transmission to humans; consequently, the country continues to monitor avian influenza medicine quality.

The spread of HIV is comparably low in Vietnam, with only a 0.5% prevalence in adults, according to the United Nations Joint Programme on HIV/AIDS. If current levels of international migration remain high, HIV/AIDS could spread in Vietnam if appropriate interventions are not in place. To educate those who are often the first source of medical advice, PQM helped train selected community and hospital pharmacists in the many different ways that medication errors can occur and how they can prevent them.