Latin America and the Caribbean

Despite the availability of effective drugs, the struggle against infectious diseases continues. The emergence of antimicrobial resistance (AMR), particularly in developing countries, threatens to undermine the fight against the spread of infectious diseases. AMR has several root causes, including environmental changes, rapid population growth, and the adaptation of the microbes themselves. Beyond that, the problem of AMR is exacerbated by malnutrition, poor sanitation, overcrowding, and a lack of clean water. Even in cases where drugs are available, misuse, incorrect or insufficient information, and the poor quality of available drugs serve to further amplify the problem. Furthermore, the emergence of drug resistant strains of malaria-causing parasites has been a real obstacle to the success of all malaria control programs. As with AMR, the burden of malaria is exacerbated by poverty, limited access to medicines, poor sanitation and poor malaria control strategies.

All of these factors come into play in the Amazon Basin. Currently, USP DQI participates in two initiatives to help combat AMR in the region: Amazon Malaria Initiative (AMI) and South American Infectious Disease Initiative (SAIDI).

Latin America

Amazon Malaria Initiative

In 2002, USP DQI was invited to participate in the Amazon Malaria Initiative (AMI), supported by the United States Agency for International Development (USAID). The Pan American Health Organization (PAHO), the Centers for Disease Control and Prevention (CDC), and Management Sciences for Health (MSH) also participate in the Initiative, along with eight AMI country members: Bolivia, Brazil, Colombia, Ecuador, Guyana, Peru, Suriname, and Venezuela. The objective of the program is to improve malaria control at the sub-regional level and contribute to decreasing morbidity and mortality at the national level.

AMI takes a regional approach in all interventions for the surveillance of antimalarial drug resistance and for the formulation of evidence-based national policies and strategies for the use of adequate and good quality drugs. AMI also encourages more "south-to-south" cooperation among partner countries. USP DQI collaborates with existing national drug quality control laboratories in AMI countries to assure the quality of antimalarial drugs, especially those newly introduced by countries that have changed their drug policies. Laboratory testing of samples from registration, post-marketing surveillance, and inspections are critical, as most AMI countries do not have strong antimalarial drug quality control policies in place.

With USP DQI assistance, each participating country develops a process to monitor the quality of antimalarial drugs, which will be checked at selected sentinel sites using basic laboratory tests. Subsets of the collected drugs are tested according to specific pharmacopeial monographs at central labs for drug quality control. USP DQI also conducts training seminars on proper sampling and testing methods, as ell as on quality data reporting.

All AMI countries have now adopted the use of basic testing as a way to control the quality of antimalarial drugs in selected sentinel sites. Four countries (Brazil, Colombia, Ecuador, and Venezuela) have already begun collecting and testing antimalarial drugs on a regular basis. The remaining countries are just beginning to implement the quality control program. In addition to quality control at the peripheral level, USP DQI is also building capacity at the central level by strengthening drug quality control laboratories and drug registration in collaboration with local drug regulatory authorities.

Latin America

South American Infectious Disease Initiative

In 2004, as a response to the growing problem of AMR, USP DQI and several partners jointly implemented the South American Infectious Disease Initiative (SAIDI) in three countries: Paraguay, Peru, and Bolivia. Other partners in this effort, which is supported by the U.S. Agency for International Development (USAID), include Management Sciences for Health (MSH), the Centers for Disease Control and Prevention (CDC), Alliance for the Prudent Use of Antibiotics (APUA), Pan American Health Organization (PAHO), and Links Media.

SAIDI strives to work with health professionals and other colleagues in each country, both at the national and community levels, to contain the spread of AMR. Toward this goal, SAIDI has two primary objectives: 1) to assess the current state of AMR at the national level based on gathered information; and 2) to help each country develop effective and sustainable interventions to contain AMR.

For its part, USP DQI focuses its activities on the quality of antibiotic and anti-tuberculosis (TB) medicines, two commonly used classes of medicines whose poor quality might contribute significantly to the development of AMR. As a member of SAIDI, USP DQI helps national quality control laboratories realize a sampling plan for collecting and testing samples of antibiotic and anti-TB medication from different sectors in the market, public and private. After analysts from local, regional, and national labs participate in hands-on USP DQI training, they use their new skills to assess the quality of drugs on the market, allowing drug regulatory authorities to take any action to improve conditions.

The three SAIDI countries have finished sampling the first set of drugs, and they are in the process of testing them. USP DQI provides all technical assistance needed and participates in testing a portion of the drugs collected. The information gathered about the quality of antimicrobials, together with the information regarding drug use practices, will be the first complete data set collected at the community level to better understand the determinants of AMR in SAIDI countries.