DQI News Archive

Posted: March 18, 2009

International experts help Liberia craft drug regulations—A USAID–DQI delegation in February assisted the Liberian Medicine Regulatory Committee (LMRC) in framing drug legislation that will establish a Liberian Drug Regulatory Authority and national drug quality control laboratory. Ms. Veerle Coignez (USAID/Washington Pharmaceutical Management Advisor), Dr. Karim Smine (DQI Consultant–Africa), and Dr. Eshetu Wondmeagegenhu (DQI Consultant–Pharmaceutical Quality Control) worked closely with the LMRC to ensure that their draft legislation incorporated necessary provisions in line with international norms and standards, yet is tailored to the political realities of Liberia. The drug legislation will next be for submitted to the Liberian Parliament for approval.

During the week-long training, DQI also assessed the working practices of DACA DQCTL staff and the conditions of the lab to determine what technical assistance would be needed to bring the lab up to international standards. With DACA management and USAID/Ethiopia Mission, DQI drafted a comprehensive implementation plan for DACA DQCTL describing the steps it would take to reach its ambitious four-year goal of submitting an "Expression of Interest" for the World Health Organization's (WHO) Prequalification Program. Once its Quality Management System and administrative and technical operations reach appropriate standards, the DACA DQCTL plans to apply for ISO/IEC 17025:2005 accreditation.

Dr. Smine and DQI Director Patrick Lukulay had assessed the drug quality assurance and drug quality control (QA/QC) capabilities of Liberia in November 2008 to prepare for activities the program will conduct on behalf of the President's Malaria Initiative (PMI). During the week–long assessment, the DQI team met with Liberia's Minister of Health and Social Welfare, Malaria Control Program, Pharmacy Board, National Drug Services, Medicine Regulatory Authority Committee, USAID/Liberia, and the World Health Organization to learn about all aspects of the country's current quality management system. DQI staff presented their findings and recommended capacity–building activities at a roundtable discussion of all the stakeholders

The current lack of drug regulations in Liberia negatively affects all health programs—that is the most rudimentary gap in the country's pharmaceutical system and the primary cause of widespread illegal trade of poor quality medicines. Consequently, the roundtable identified establishing drug legislation and regulations to meet the Liberia's healthcare needs and creating a drug quality control laboratory to check the quality of essential medicines in the market as the most urgent needs. The Minister of Health recognized the need to take these initiatives aimed at building capacity in Liberia and offered his full support to do what he could to get the new legislation established.

DQI to study changes in Russia/NIS prescribing practices—Drs. Kirill Burimski and Souly Phanouvong met with partners in the Russian Federation to plan a study on how antimicrobial medicines are typically prescribed. The project will assess the impact made on the prescribing practices and trends of healthcare professionals who have had access to the Infectious Diseases Textbook or the Distance e–Learning Program—two successful collaborative DQI activities supported by the USAID/Russia Mission.

The Infectious Diseases Textbook, produced with Smolensk Medical Academy and the Institute of Antimicrobial Chemotherapy, provides information on various antimicrobial agents and the rational treatment of major infectious diseases. More than 95,000 copies have been disseminated among Russian and NIS healthcare professionals over the past nine years. The Distance e–Learning Program—a collaboration with Smolensk, Vladivostok Drug Information Center, and other partners—allows healthcare professionals in remote regions of Russia and the NIS to keep up–to–date with information on antimicrobial drugs and therapies. Since 2002 some 400 candidates have completed the certificate course. The study will examine how these educational tools have effected the way antimicrobial medicines are prescribed.

While in Moscow, the DQI staff also met with members of the Russian Federation's medicines regulatory authority and tuberculosis control programs, USAID Mission, and other partners. DQI offered to provide technical assistance in drug quality toward the control of tuberculosis and other infectious diseases. Drs. Burimski and Phanouvong focused discussions on what activities would best suit the healthcare needs of the country.

Ghana addresses need to improve antimalarial medicines quality—DQI Director Patrick Lukulay and Consultant Karim Smine recently met with key stakeholders involved in the quality assurance and management of antimalarial drugs in Ghana to determine how DQI can best provide technical assistance to the country's Malaria Control Program (MCP). Funded by USAID/Ghana through the President's Malaria Initiative, Drs. Lukulay and Smine conducted a rapid assessment of the drug quality assurance and quality control (QA/QC) capacity of the Food and Drug Board (FDB) of Ghana and worked with stakeholders of the PMI program to define critical activities to implement in the coming year.

MCP Director Dr. Constance Marfouk acknowledged that the quality of antimalarial drugs in Ghana is still of major concern. She pointed out numerous factors that impede effective control—medicines sold in illegal markets, local manufacturers not operating in compliance with Good Manufacturing Practices, too many brands being marketed, and multiple treatment regimens being followed. She also drew attention to the need for MCP to improve malaria diagnostics; malaria is still epidemic in all of Ghana despite decreased mortality resulting from MCP prevention and control activities.

Members of the MCP, FDB registration and inspection departments, World Health Organization–Ghana, and national quality control laboratory (NDQCL) worked together to set up a medicines quality monitoring program in five selected sentinel sites. The group determined that drug quality control capacity in Ghana is good and NDQCL personnel are well qualified; however, the condition of the laboratory facilities handicaps further advancement. The DQI team encouraged the Minister of Health's advisor to move the NDQCL to a new facility as soon as possible, allowing them to better perform their vital role in controlling the quality of medicines, food, and cosmetics.

DQI Chemist Dr. Daniel Bempong reported DQI activities for the previous year and presented program targets for FY09 at the Malaria Initiative Partners Meeting in Ghana two months after the assessment. Following the meeting, Dr. Bempong met with FDB Acting Deputy CEO Rev. Jonathan Martey, who arranged for him to tour the NDQCL. Rev. Martey described the structure of the FDB and elaborated on plans for the new site being built for the agency. He indicated to Dr. Bempong that, though construction had come to standstill, funds were recently allotted to complete the sections that will house the NDQCL.

DQI provides data for INTERPOL sting—USP DQI collaborated with INTERPOL and the World Health Organization (WHO) in a highly successful mission to thwart counterfeit medicines production in Southeast Asia. "Operation Storm" targeted manufacturers and distributors of antimalarial, anti–tuberculosis, anti–HIV/AIDS medicines and antibiotics for pneumonia and child–related illnesses. Data from the USP DQI medicines quality monitoring program in Cambodia, Laos, Thailand, Vietnam, and the Philippines were used in covert operations to identify fake medicines, which resulted in 27 arrests and the seizure of $6.65 million of counterfeit medicines.

According to INTERPOL, "A key part of Operation Storm was the provision of training to customs, drug regulatory agency and police officials to assist them in counterfeit identification and sample handling techniques." USP DQI introduced enforcement officers to the GPHF Minilab® and conducted several laboratory trainings on analysis of medicines to screen for counterfeits.

Operation Storm was the first of its kind to actively involve Ministries of Health (drug regulatory agencies), Ministries of the Interior (police and customs), national police, international organizations, and the private sector in a criminal investigation. Using forensic evidence from a variety of sources—including data from USP DQI surveillance sites—the groups worked hand–in–hand to identify counterfeit medicines, trace their production and distribution routes, and make arrests. USP DQI continues to support INTERPOL as an active partner in its mission to ensure quality medicines in Southeast Asia, along with its partners in Operation Storm—Eli Lily, Sanofi Aventis, the World Customs Organization, and the Medicine Regulatory Authorities of countries in the region.

AMI offers QA workshop to Central American countries—Partners in the Amazon Malaria Initiative (AMI) conducted a regional workshop in Guatemala inviting Spanish–speaking countries of Central America to learn how they might improve the management of supply and quality assurance systems (QA) of malaria medicines. Participants from six countries responsible for the procurement, surveillance, quality assurance/control, and storage/distribution aspects of their national malaria control programs described their current management supply and QA systems and identified potential areas of improvement. The partners shared lessons learned from the AMI program, demonstrating how similar approaches could be applied to systems in the Central American region.

DQI's Manager of Latin America Programs, Dr. Victor Pribluda, and Program Manager Adrian Barojas chaired the Working Group session on QA/QC and developed a flow process diagram with each of the teams from Costa Rica, El Salvador, Guatemala, Honduras, Nicaragua, and Panamá. From that activity, the DQI staff performed a gap analysis of each country's QA/QC systems, identifying areas in need of strengthening and possible technical assistance.

The workshop was coordinated by the AMI partners responsible for access and use of malaria medicines—Management Sciences for Health/ Strengthening Pharmaceutical Systems (MSH/SPS), Pan American Health Organization (PAHO), and DQI.

DQI shows PMI coordinator the ropes in border sites—DQI staff was honored to escort Admiral Tim Ziemer, Coordinator of the President's Malaria Initiative and the USAID/Global Health Bureau's Malaria activities, and his Deputy, Dr. Bernard Nahlen, to surveillance sites in two cross–border provinces—Chanthaburi, Thailand, and Pailin, Cambodia—taking part in a study of antimalarial drug quality. Admiral Ziemer had expressed PMI's desire "to see first–hand what is actually happening at the regional, national, and field levels to control malaria and contain resistance." He hoped this visit would provide insight to the U.S. Government of what kind of support is most effective and fits the needs of this region. The three–day venture proved enlightening.

Dr. Souly Phanouvong, Manager for Drug Quality Assurance, and Mr. Christopher Raymond, Consultant for Southeast Asia, first presented an overview of DQI global activities and specific achievements in the Mekong Region at a meeting with Dr. John MacArthur, Infectious Diseases Team Leader for USAID Regional Development Mission–Asia. The group then visited a Center of Excellence in medicines quality assurance created through the DQI program, where the DQI team showed the video Dealers in Death and a dramatic public service announcement (PSA) DQI produced with USAID/Cambodia and RDM–A Missions depicting a local transaction with counterfeit medicines.

Admiral Ziemer's entourage made the six–hour road trip to Chanthaburi in eastern Thailand, where they were warmly welcomed by the Pong Nam Ron district health authority and by staff at the Ban Laem Pong Nam Ron District Malaria Clinic. The group was escorted across the border to Pailin, a small municipality in the western region of Cambodia, to meet with Dr. Doung Socheat, Director of National Center for Malariology, Entomology and Parasitology. Dr. Socheat appreciated his visitors making the long and difficult trip and thanked USAID for its financial support, saying that the situation with counterfeit and substandard medicines has greatly improved due to DQI assistance.

The group also visited the Pailin Health Department Office and the Medicines Quality Monitoring site in Pailin, where Dr. Phanouvong demonstrated how Minilab® testing was conducted and how data was reported. He noted the poor room conditions—inadequate for proper quality assurance; Mr. Oeurn Samuth of Cambodia's Food and Drugs Department indicated that many other provincial sites face the same working conditions. Visits followed to the O'Chra Health Center, site of a joint Therapeutic Efficacy Study with WHO and the Global Fund to fight AIDS, Tuberculosis and Malaria, and to Bor Hui Village where Adm. Ziemer and Dr. Nahlen took part in a bed–nets distribution ceremony conducted by the village malaria workers. The visit to the highest malaria–resistance emergence area in the region concluded with a return across the border and back to Bangkok. DQI was very pleased to have been part of this important visit by the PMI Team and Dr. MacArthur, who has steadfastly supported the DQI program and promoted the importance of integrating drug quality into malaria programs.

Madagascar programs get a tune–up—During a two–week trip to Madagascar, DQI Manager of Africa Programs Dr. Mustapha Hajjou managed to supervise a Minilab® training, review drug quality monitoring results for the QAMSA Study, visit the country's Drug Information Center, and plan for future activities in pharmacovigilance. According to Dr. Hajjou, all systems seem to be operating with continued success, due to the dedication of the staff of l'Agence du Medicament de Madagascar (AMM) and continuous support from USAID.

Dr. Hajjou supervised a Training–of–Trainers session for analysts who will conduct testing at the sentinel sites throughout the country. Five analysts from the national drug quality control laboratory (NDQCL) conducted the training, teaching 14 participants how to carry out a full set of basic tests using GPHF Minilabs®. The national drug quality control laboratory (NDQCL) performs confirmatory testing for samples from the sentinel sites and has carried out one round of sampling and testing for the Quality of Antimalarials in Sub–Saharan Africa (QAMSA) study. AMM Director Dr. Jean René Randriasamimanana expressed concern that many drugs currently circulating in the market are not registered, an issue confirmed by the NDQCL which found a high incidence of non–registered drugs, especially for quinine sulfate and sulfadoxine–pyrimethamine, among the test samples. DQI will work with AMM to strengthen their drug registration system.

DQI helped establish Madagascar's regional pharmacovigilance (PV) system, which is now expanding to the district level. An upcoming series of PV trainings for district–level health workers will extend to 32 new malaria sentinel surveillance sites that the Global Fund and President's Malaria Initiative (PMI) will establish by the end of 2009. PV will be particularly important in the island of Nosy Be where a study will be conducted on Artequick supplemented with Primaquine, an antimalarial combination therapy that currently lacks safety data. Dr. Hajjou recommended that the training include health workers in the Ambanja district, as well, since it will serve as a control in the Nosy Be study.