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DQI NewsPosted: May 14, 2009
 Madagascar ranks high on pharmacovigilance—On February 12, 2009, the Centre National de Pharmacovigilance de Madagascar (CNPM), became the 94th full member of the World Health Organization (WHO) International Drug Monitoring Programme. Established 40 years ago, the WHO Programme provides a forum for qualifying national systems that monitor medicines quality and report their harmful effects. The CNPM was created in 2006, with assistance from the DQI program and Malaria Action Coalition partners, to help improve the country's drug quality assurance and drug information systems. The pharmacovigilance (PV) program focuses on adverse drug reaction (ADR) reports for artemisinin-based combination therapies (ACT) and has developed a curriculum for training health professionals from the regions to assure continuity among personnel at health facilities. Peru lab achieves ISO 17025—Peru's official medicine control laboratory, Centro Nacional de Control de Calidad (CNCC), was recently awarded ISO/IEC 17025:2005 accreditation, an internationally recognized standard for testing and calibration laboratories. The CNCC met the necessary standards in an audit by ACLASS, a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement. This accomplishment will help ensure the distribution of good quality pharmaceutical products to the people of Peru.  "The ISO/IEC 17025:2005 accreditation positions CNCC as an international reference for labs working on the quality control of pharmaceutical products," says Dr. Ruben Tabuchi, General Director of the National Center for Quality Control of the Peru's National Health Institute, which "allows us to contribute to the sustainable development of Peru and the region in public health." DQI has provided technical assistance to the CNCC since 2005 as part of the South American Infectious Disease Initiative (SAIDI) and the Amazon Malaria Initiative (AMI) partnerships. With the aid of USP's quality assurance department, DQI assessed the lab in 2006 against ISO 17025 standards, monitored its progress toward accreditation, and reviewed its Quality Manual prior to submission to ACLASS. Last summer DQI sponsored Juan Ortiz Bernaola, head of the CNCC physical chemical laboratory, on a three-month internship at USP Headquarters where he learned hands-on how USP's Quality Management System complies with ISO/IEC 17025:2005 standards. GDF looks at improving access to TB drugs—At a recent Global TB Drug Facility (GDF)/Stop TB Partnership Meeting, DQI Director Patrick Lukulay presented details of DQI's program to support manufacturers of second-line anti-TB medicines in their quest for WHO prequalification. The presentation provided an opportunity to showcase the new DQI web page that describes services DQI can provide to manufacturers and offers an online request form to apply for technical assistance.  The "Super Team" conference—held in Sao Paolo, Brazil, March 18-20—was organized to update partners on new GDF/STOP TB initiatives, open discussions with manufacturers about the procurement process, and encourage networking among those involved in increasing access to quality-assured anti-TB medicines. According to the GDF, projected orders for anti-TB medicines will increase from $16 million in 2008 to $33.8 million this year. Yet manufacturers face a number of challenges meeting the increased need, many related to regulatory bottlenecks in drug registration, country commitment to patient enrollment, difficulties with the GDF tendering process, and harmonization of quality assurance policies. Dr. Janos Pogany, a pharmacist and senior reviewer on the WHO Prequalification program, talked about the prequalification process, noting that the program objective is to build capacity of drug regulatory authorities in developing countries to assess safety, efficacy, and quality of medicines. He described the steps involved from responding to an Expression of Interest and submitting a dossier to acceptance of the dossier and inspection of the manufacturing facility. The Clinton Foundation–Drug Access team gave a presentation on their experiences in improving manufacturing processes that ultimately reduced the costs of HIV/AIDS medicines. Bolivia OMCL pursues ISO 17025, DRA may monitor more drugs—DQI staff recently conducted a mock assessment of Bolivia's official medicine control laboratory, CONCAMYT-INLASA, to evaluate the laboratory's quality management system against ISO/IEC 17025:2005 standards. The audit provided findings on areas in which the lab needs to advance to qualify for accreditation. As evidenced by its current status as ISO 9001:2000 certified, CONCAMYT-INLASA places a high priority on ensuring the quality of their services.  DQI has conducted several laboratory trainings at CONCAMYT-INLASA and has provided equipment to improve the technical capacity of the laboratory. This documentation review, mock assessment, and facility audit, which identified several technical nonconformities on which the lab will focus, was the next step toward expanding and strengthening its capabilities. Following the audit, DQI and CONCAMYT-INLASA together developed an action plan to implement corrective measures. Bolivia also actively participates in USP DQI's medicine quality monitoring program through the Amazon Malaria Initiative (AMI) and the South American Infectious Disease Initiative (SAIDI). Program Manager Adrian Barojas met with partners from the Pan American Health Organization (PAHO)-Bolivia and the National Malaria Control Program (NMCP) to plan the fourth round of antimalarial sampling and testing. This round will follow a newly updated protocol that clarifies the roles and responsibilities of the NMCP and Bolivia's medicine regulatory authority, the Unidad de Medicamentos y Tecnología en Salud (UNIMED). The group also discussed the possibility of extending monitoring to include some antibiotic and anti-tuberculosis medicines. A later meeting between UNIMED and NMCP outlined measures each agency would take to put that program in place, how results would be incorporated into the master database, and what corrective actions UNIMED will take when poor-quality medicines are identified. Ghana FDB trains for quality monitoring program—In a workshop gathering Ghana's Food and Drug Board (FDB), Malaria Control Program (MCP), Pharmacy Council, and regional FDB offices, representatives selected five sentinel sites where medicine quality monitoring activities will be established. Program Manager-Africa Mustapha Hajjou and DQI Consultant Karim Smine worked with key stakeholders to define critical program elements, set the timeline for conducting two rounds of testing at the sites in FY09, and outline the process to train staff on sampling and testing techniques.  At opening ceremonies of the training workshop, FDB Chief Executive Officer Emmanuel Agyarko welcomed the DQI team and participants, emphasizing the importance of monitoring the quality of antimalarial drugs at the peripheral level. He encouraged the participants to do their best to make this program successful. DQI trained the sentinel site teams on standard procedures for sampling, basic testing using GPHF Minilabs®, and data reporting. DQI supplied each of the sentinel sites with a Minilab® and each team will carry out two complete rounds of sampling and testing in FY09, including confirmatory testing at Ghana's National Drug Quality Control Laboratory. DQI trains DRA and DQ Lab in Ethiopia—DQI program manager Adrian Barojas and DQI consultant Abdelkrim Smine recently trained eight members of Ethiopia's Drug Administration and Control Authority (DACA) Drug Quality Control and Toxicology Laboratory (DQCTL) on good laboratory practices, high performance liquid chromatography, and dissolution. The training, held in Addis Ababa in January, focused on improving DACA DQCTL compliance with compendial requirements and advancing their documentation practices. 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.  Nepal manufacturers prepare for next phase of zinc roll-out—DQI recently visited three zinc sulfate manufacturers in Kathmandu, Nepal, to assess their progress toward compliance with Good Manufacturing Practices (GMP). DQI Program Manager/GMP Specialist Edwin Toledo declared that Deurali-Janta Pharmaceuticals Pvt. Ltd., Nepal Pharmaceutical Pvt. Ltd., and CTL Pharmaceuticals meet USP zinc sulfate quality standards and are operating at an acceptable level of GMP compliance recognized by local regulatory authorities. Mr. Toledo commended the companies' management for their commitment toward quality and encouraged them to continue improving their quality systems. Each of the companies is working toward WHO prequalification status for the medicine. The Nepal Child Health Division (CHD) of the Department of Health Services recently launched a zinc roll-out for the treatment and prevention of acute diarrheal diseases using products made by Nutriset; however, during the next phases, they intend to use products manufactured locally. While in Nepal, Mr. Toledo also conducted a full GMP audit of Lomus Pharmaceutical to identify any gaps in their systems and to help the manufacturer pursue WHO prequalification for zinc sulfate and chlorhexidine products. The antimicrobial agent chlorhexidine, used as a cleanser at birth, has be found to prevent newborn death. Mr. Toledo determined that Lomus complies with local GMP standards, and it will follow DQI recommendations to further develop both formulations in order to pursue WHO prequalification.  USAID introduces new health program in Cambodia—U.S. Ambassador Carol A. Rodley reaffirmed the "commitment of the United States to improving the health of all Cambodians" at the launch of USAID's new $77 million program that will support the goals of the country's national health plan for 2008-2015. At a DQI exhibit booth at the launch ceremonies, held March 26 in Phnom Penh, DQI Consultant for Southeast Asia Chris Raymond highlighted DQI contributions to advancing the Cambodian healthcare system. He called attention to DQI medicine quality monitoring that has improved detection of poor-quality medicines circulating in the Cambodian marketplace; equipment, supplies, and training provided to strengthen medicine quality control and assurance systems of the National Laboratory for Drug Quality Control; an expanded and improved national pharmacovigilance system; and participation in special investigations to prevent access to counterfeit medicines and close down illegal distribution. Mr. Raymond ran the public service announcements produced by DQI, Living Films and USAID/Cambodia that are intended to raise awareness among the general public about medicine quality issues. With the additional funding, USAID plans to expand their existing programs on HIV, tuberculosis and other infectious diseases that have played a positive role in Cambodia's improving health indicators. It will also focus on helping improve the management of the country's health system and providing technical training to address continuing challenges, such as maternal mortality and tuberculosis.  DQI visits sites in Cambodia, Thailand and Vietnam—Manager-Drug Quality Assurance Souly Phanouvong, Program Manager-Southeast Asia Laura Krech, and DQI Consultant Christopher Raymond traveled through Cambodia and Thailand in January/February, meeting with Ministries of Health and local coordinators of the DQI medicine quality monitoring (MQM) program and Cross-border Study. The DQI staff team introduced Cambodia's new Secretary of State for Health, His Excellency Dr. Chou Yin Sim, and his staff to DQI activities in Cambodia, and urged him to continue supporting activities to fight the proliferation of counterfeit and substandard medicines in Cambodia. The team also went to sites in Preah Vihear, Rattanakiri and Stung Treng provinces, which DQI staff had not visited previously. There they experienced first-hand some of the challenges to sampling and testing—difficulty reaching isolated areas, lack of space, insufficient samples available—that provincial investigators had reported in meetings. Ms. Krech and Mr. Raymond continued on to Central Vietnam, where they collected and tested medicines with local staff from Quang Tri province and Ho Chi Minh City for the MQM program. They sampled antimalarial, antibiotic, and other medicines from public clinics and private pharmacies in the towns of Huong Hoa (Khe Sahn) and Lao Bao, and from the district hospitals of Huong Hoa and Da Krong. DQI observed how the sentinel sites operated, watched the lab efficiently analyze the samples they collected, and learned what actions are being taken when sampled medicines are found to be counterfeit or substandard.  Dr. Bui Thi Hoa, Vice Director of Vietnam's National Institute of Drug Quality Control, said that 32 samples from the last two rounds of testing proved to be of poor quality; one was counterfeit, but most others seemed to be substandard as a result of storage problems rather than manufacturing deficiencies. DQI later offered technical assistance to the Government of Vietnam to determine the quality of stockpiled oseltamivir (Tamiflu®) and learn more about the status of oseltamivir manufacturing, distribution, and quality testing in Vietnam.
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Copyright © 2009 The United States Pharmacopeial Convention
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