December 2012 News Updates

First anti-TB medicine under PQM program achieves WHO Prequalification—Dong-A Pharmaceutical Co. Ltd. had its anti-tuberculosis (TB) medicine, Cycloserine 250 mg Capsules, added to the World Health Organization (WHO) List of Prequalified Medicinal Products with the November 16 Prequalification Update. This is the first finished pharmaceutical product to reach WHO Prequalification status through the Promoting the Quality of Medicines (PQM) technical assistance program for manufacturers of second-line anti-TB medicines.

PQM first conducted a mock inspection of Dong-A‘s finished pharmaceutical product and active pharmaceutical ingredient (API) facilities in October 2011 for its compliance with WHO Good Manufacturing Practices (GMP). PQM Associate GMP Specialist Jenny Derry has worked hand-in-hand with Dong-A since that time to bring its manufacturing of Cycloserine 250 Capsules up to international standards. She followed up to ensure that corrective actions/preventive actions had been remediated for the successful WHO facility inspection and, through several meetings with Dong-A over the next year, assisted the company with inquiries from WHO during the organization’s dossier review, among other things. Dong-A is also pursuing WHO Prequalification of Cycloserine API; PQM will again provide technical assistance with the API dossier review.

First zinc medicine achieves WHO Prequalification with PQM assistance—WHO added Zinc sulfate 20 mg dispersible tablets produced by Laboratoires Pharmaceutiques Rodael (France) to its prequalified list on December 4, 2012. This is the first zinc product WHO has prequalified and the first to reach that status with technical assistance from the PQM program.

Nutriset/Laboratoires Pharmaceutiques Rodael (LPR) was identified by the USP Drug Quality and Information (DQI) program, predecessor to PQM, as a manufacturer of zinc tablets and syrups that had been certified in GMP. In support of WHO and UNICEF, DQI developed pharmacopeial monographs for zinc sulfate tablets and zinc syrup, which would be used in conjunction with oral rehydration salts to manage acute diarrheal disease, a leading cause of illness and death in children under the age of five. In order to help ensure that quality zinc products can be procured in developing countries, USP DQI and the Zinc Task Force also established guidelines for production managers and manufacturers, then in 2005 began preparing Nutriset/LPR to pursue WHO Prequalification for its ZinCfant^® dispersible tablets, DQI and, later, PQM provided technical assistance to ready the company’s facility, documentation, and dossier for WHO inspection.

Laboratoires Pharmaceutiques Rodael is part of the Nutriset Zincfield^® network it launched in 2009 to partner with local companies, which produce Nutriset products in their own regions, building a sustainable system and contributing to the regions’ economic development.

Regional cooperative will strengthen ties to improve medicines quality—PQM convened a regional meeting in late August to kick off its new initiative, “Building Regional Expertise in Medicines Regulation, Information-sharing, Joint Investigation and Enforcement” (BREMERE). BREMERE aims to strengthen regional cooperation between and among the medicines regulatory authorities and law enforcement agencies in the Greater Mekong Subregion (GMS) to improve the quality of medicines in the area.

Representatives of the relevant authorities from Cambodia, Indonesia, Laos, Philippines, Thailand, and Vietnam, as well as a wide range of international and scientific organizations and academia participated in the meeting. The group drafted the Terms of Reference (TOR) that will encompass BREMERE’s governance, coordination, implementation, and complementary activities with similar efforts. By the end of the meeting, participants reached a consensus on the TOR and leadership of the initiative, and prepared a timeline for future activities. The BREMERE initiative aims to build capacity in all member countries by sharing regional expertise, and providing training and technical/financial support. In the long term, it seeks to create a regional “pool of experts” who will share information and expertise in medicines regulation, registration, post-marketing surveillance, and enforcement.

African network of quality control labs expands, moves forward—In September 2012, the Network of African Medicines Control Laboratories (NAMCOL)—the official medicines quality control laboratories of Ethiopia, Ghana, Mali, Senegal, and Uganda—gathered in Maputo, Mozambique, for its second annual meeting. Due to the success of the network, invitations were extended to six additional countries—Kenya, Nigeria, Sierra Leone, Tanzania, Zambia, and Zimbabwe—to participate in the meeting and join the network. This meeting provided an opportunity for NAMCOL members to renew their commitment to advancing quality control and to welcome new ideas and learn from the experience of the countries represented. One goal of the meeting was for the network to determine how it could become a professional organization; subsequently, the expanded membership voted to change their designation to Network of Official Medicine Control Laboratories-Africa (NOMCOL-Africa). Together, the NOMCOL directors and meeting facilitators developed a mission statement, vision, and objectives and drafted a charter to guide the network’s future. The PQM team will play an advisory role in the coming year, guiding the newly-formed secretariat of NOMCOL and supervising the drafting of by-laws. PQM expects to hand over operations of the network to the African countries involved, ensuring better long-term sustainability of the program.

During the NOMCOL meeting, participants toured the Laboratório Nacional da Qualidade de Medicamentos (LNCQM), which has made tremendous progress in its efforts to improve the quality of medicines in Mozambique. In order to publicly confirm their commitment to this goal, Dr. Isabel Chemane, head of the LNCQM, and Dr. Patrick Lukulay, PQM director, held a press conference in Maputo to educate the country about the importance of good-quality medicines and how PQM and USAID are supporting LNCQM in the fight against counterfeit and substandard medicines.

Peru expands use of three-level approach to monitor medicines quality—PQM delivered a regional training workshop on basic tests using the GPHF Minilab® for the staff of the Peru official medicines control laboratory, Centro Nacional de Control de Calidad (CNCC), Dirección General de Medicamentos, Insumos y Drogas (general directorate of medicines, supplies and drugs), and regional health authorities from the regions of Amazonas, Loreto, Madre de Dios, San Martin, and Ucayali. Twenty-five analysts participated in the hands-on training, learning how to perform sampling, visual inspection, dissolution, ultraviolet absorption, and thin-layer chromatography tests. The training focused on anti-TB medicines, such as Ciprofloxacin, Pyrazinamide, Rifampicin and others that are part of Peru’s national standard treatment guidelines for tuberculosis. This training workshop was designed as a pilot to determine whether the three-level approach for screening medicines quality is implementable and sustainable in Peru’s rural regions; progress will be followed closely. If the pilot is successful, the three-level approach will be implemented throughout the country. This is one of the mechanisms the CNCC is using to improve and ensure the quality of medicines circulating in Peru’s markets.

PQM publishes results of new research—Two articles published in the June 2012 Malaria Journal by scientists in the PQM program—“Quality of Antimalarials Collected in the Private and Informal Sectors in Guyana and Suriname” and “Implementation of Basic Quality Control Tests for Malaria Medicines in Amazon Basin Countries: Results for the 2005–2010 Period.” The articles shed new light on the quality of antimalarial medicines circulating in countries in the Amazon Basin in South America. PQM researchers coordinated these studies with country partners under the USAID Amazon Malaria Initiative. Until this new research, there had been no comprehensive studies looking at the quality of antimalarial medicines in the Americas. Both articles are “highly accessed” and have received more than 1,300 hits since they were added.

PQM closes out activities in Russia—In September 2012, the U.S. State Department announced that the United States received “the Russian Government’s decision to end USAID activities in the Russian Federation,” and all USAID/Russia activities ceased on October 1, 2012. Currently PQM is conducting close-out activities scheduled for completion by December 31, 2012.

Workshop launches comparative study of MQM in GMS—In October PQM kicked off its comparative study of existing medicines quality monitoring (MQM) sites and non-MQM sites to obtain evidence-based data on the quality and source of antimalarials and some antibiotics in “hot spot” zones of the Greater Mekong Subregion (GMS). At a workshop held in Ho Chi Minh City, Vietnam, PQM staff trained 20 members of the national malaria control programs, official medicines quality control labs, and medicines regulatory agencies of Cambodia, Laos, Thailand, and Vietnam on sampling protocol, testing methodology, and data reporting. Participants played an active role in planning the study, providing insightful information for its successful implementation and developing the protocol and detailed budgets. The workshop considered all aspects of the study, and those attending agreed on goals and objectives, study design and methods, roles and responsibilities of the study teams, site selection, sampling, testing, reporting, and timelines. The study aims to evaluate the progress and impact of MQM activities in the region.

PQM exhibits at U.S. Embassy in Vietnam—After giving his opening speech at a health fair held for the embassy staff and their families, David B. Shear, U.S. Ambassador to Vietnam, stopped by the PQM exhibit booth to learn more about the program and its activities. PQM consultant Vuong Tuan Anh represented PQM, explaining how PQM supports various government agencies to ensure the quality of the country’s medicines and combat the availability of counterfeit medicines. Approximately 300 guests visited the health fair, which was designed to raise awareness of the embassy staff and U.S. Department of State in Hanoi about U.S. programs operating in Vietnam.