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NewsWhat's NewEnsuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide illustrates how to incorporate drug quality assurance in every aspect of medicines procurement, production, and distribution—regardless of limited human and financial resources. Available for download from the USP DQI Resources tab or request a copy. Rapid Assessment of Pharmaceutical Supply System Medicinal Zinc Monograph Now Available—Zinc Task Force Guidelines on production of zinc sulfate tablets and oral solutions that are tolerable to children, and the and USP monographs and reference standards developed for them are now available for download: zinc sulfate tablets  © 2008 Mark Hammond Field visits reveal substandard drugs along Cambodian-Thai border—In a week-long overland trip to villages along the border of Cambodia and Thailand, Mr. Christopher Raymond and Mrs. Mam Boravann, Deputy Chief–Essential Drug Bureau of the Cambodian Department of Drugs and Foods, collected a number of known counterfeits and expired drugs from the local pharmacies. The two traveled from Phnom Penh to a number of villages in the provinces of Battambang, Paillin and Pursat of Cambodia, and Chanthaburi and Trat provinces of Thailand, in preparation for the Thai-Cambodia cross-border study on antimalarial quality that USP DQI will conduct in collaboration with the World Health Organization and the Bill and Melinda Gates Foundation. Mr. Raymond and Ms. Boravann went to oversee the final selection and sampling strategy for the study and to ensure that the GPHF Minilabs® provided at the surveillance sites are being used properly, documentation is in order, and reagents are well stocked. The study intends to obtain an objective estimate of the prevalence of poor-quality antimalarials circulating in those cross-border provinces and should provide more information about the association between antimalarial drug quality and drug resistance of the malaria parasite in this locale.  © 2008 Chris Raymond Cambodia raises public awareness of counterfeit medicines—His Excellency Dr. Yim Yann, president of the Pharmacists Association of Cambodia (PAC), spoke with USP DQI's Christopher Raymond on March 18 about the challenges of assuring the quality of medicines in today's markets. Dr. Yann described the nature of the counterfeit medicine "industry" in Cambodia and what the government has been doing to combat it. According to Dr. Yann, approximately 1,000 legal pharmacies operate nationwide in Cambodia, but probably twice as many operate illegally. The Ministry of Health is working steadily to improve quality controls, but about 10 percent of the drugs circulating in the country are counterfeit, some are substandard, and others are unregistered or sit on pharmacy shelves past their expiration date. Dr. Yann pointed out several PAC Bulletins that instruct pharmacists on pertinent topics, such as the government's use of registration stickers for registered products, how to spot counterfeits, and which products have undergone recall. He urges Cambodian citizens to buy their medicines from a legal pharmacy to assure that they are getting a safe, good quality product. USP DQI has provided technical assistance to Cambodia since 2003 to establish postmarketing surveillance on the quality of antimalarial medicines. As a result of the program, the Ministry of Health has closed some retail outlets, issued warning and fines to others, and seized questionable products. Raymond's filmed interview with Dr. Yann — who was just awarded the title of "His Excellency" and promoted to official Advisor of the Ministry of Health — will be made available on the USP DQI Web site in the near future.  © 2008 Mark Hammond PSAs will alert Mekong Region to dangers of counterfeit meds—As one element of Cambodia's public awareness campaign, three public service announcements (PSAs) were recently filmed advertising the dangers of counterfeit medicines to the public health. Funded by the USAID/Cambodia Mission, USP DQI and Thai production company Living Films developed scripts illustrating the possible consequences of using substandard counterfeit medicines in the treatment of illnesses common to the region, such as malaria. Filming of representative versions that will air in Cambodia, Laos, Thailand, and Vietnam — each in the country's native language — wrapped up in early April in Chiang Mai, Thailand. USP DQI and the Mission hope to circulate the PSAs on government and private television, village media presentations in collaboration with other NGOs, as well as through Web sites and downloads to cellular phones. USAID launches Regional Distribution Center for AI commodities—Demonstration of a GPHF Minilab® drew keen attention at the USAID Avian Influenza Partners Meeting held March 25-27 in Bangkok, Thailand. USP DQI's Christopher Raymond showed participants how the kits will be used to quickly test the quality of oseltamivir phosphate, the active ingredient in the antiviral medication Tamiflu®, as part of the drug quality monitoring program that USP DQI has initiated for oseltamivir stockpiles throughout Southeast Asia. He presented posters  © 2008 USPDQI staff USP DQI trains Bolivian lab on Karl Fischer—Bolivia's national quality control laboratory, the Laboratorio de Control de Calidad de Medicamentos y Toxilogia (CONCAMYT), recently received a Karl Fischer titrator donated by the USP research and development laboratory. Karl Fischer titration quantifies the water content in pharmaceutical ingredients, which is vital to accurately analyzing the potency, efficacy, and stability of a medicine. USP DQI Program Manager Adrian Barojas installed the equipment and trained 15 members of the CONCAMYT staff on its use. As part of the process of helping CONCAMYT build its capacity, Mr. Barojas also assessed the lab and identified areas of their quality management system where USP DQI might be able to provide technical assistance. CONCAMYT and several peripheral sites conduct postmarketing surveillance of selected antibiotic and antituberculosis medicines in Bolivia under the South American Infectious Disease Initiative (SAIDI). While in-country, Mr. Barojas met with CONCAMYT and the country's drug regulatory authority, Unidad de Medicamentos (UNIMED), to review the data obtained during the first two rounds of postmarketing surveillance activities. Discussions focused on corrective actions for non-conforming medicines and plans for future sampling and analysis. International collaborators foil malaria drug counterfeiters—"A Collaborative Epidemiological Investigation into the Criminal Fake Artesunate Trade in South East Asia," an article published February 12 in the journal PLoS Medicine, describes the collaborative effort of police, chemists, criminal analysts, palynologists, and health professionals to shut down the manufacture of some fake artesunates in Southeast Asia. Working through the World Health Organization Western Pacific Regional Office (WPRO) and the International Criminal Police Organization (INTERPOL), the team analyzed medicine samples collected from markets in Southeast Asia to determine pharmaceutical authenticity. Researchers then used chemical, biological, mineralogical and physical packaging evidence to track down where the fake and substandard products had been manufactured. This is the first time forensic palynology – the study of spores, pollen and certain algae – has been used to discover the manufacturing locations of pharmaceuticals and their ingredients. Based on the forensic evidence, the Chinese Government acted quickly to arrest the criminal drug traders and seize the counterfeit medicines. The availability of counterfeit artesunate has become a serious health problem in Southeast Asia, leading to deaths, economic losses, and possible artemisinin resistance. USP DQI was instrumental in this collaborative effort in terms of initiating the investigation process, planning the course of action, and providing some key samples, data and data analysis. Dr. Souly Phanouvong, Manager of Drug Quality Assurance and Policy Development, and former USP DQI Director Ms. Nancy Blum were among the co-authors of the article. The story, which was also reported in BioEd Online, can be viewed online.  USP DQI helps in control of Avian Influenza-Dr. Natalia Davydova created a poster presented at the 2008 Bangkok International Conference on Avian Influenza describing "Simple, rapid basic tests for evaluation of quality of oseltamivir." The poster discusses a field manual USP DQI developed jointly with the Global Pharma Health Fund which outlines simple, inexpensive techniques that resource-limited countries can incorporate into their routine drug quality assurance system to monitor oseltamivir quality. Since oseltamivir is the first-line treatment for highly pathogenic avian influenza (HPAI) outbreaks, the need for quality assurance of the medicine is paramount. Simple, field-based quality monitoring techniques in countries where oseltamivir is stockpiled can aid in the control of HPAI. More than 700 delegates from 70 countries attended the "Integration from Knowledge to Control" themed conference, held January 23-25, which focused on disseminating cutting-edge research and technology applications in the control of avian influenza. Nepalese Zinc Manufacturers Assessed for GMP-Members of the USP DQI staff traveled to Nepal, January 13-23, to assess three local manufacturers of zinc sulfate tablets. USP DQI Director Dr. Patrick Lukulay, GMP Specialist Edwin Toledo, and Chemist Sanford Bradby inspected facilities of the pharmaceutical companies to evaluate their compliance with Good Manufacturing Practices (GMP) and conformance to the USP Zinc Sulfate monograph in the production of the tablets, which supplement oral rehydration therapy to prevent and treat acute diarrheal disease in children.  Nepal is the first country to rollout Zinc Sulfate for the public as part of their national health policy. The Ministry of Health is considering obtaining the medicine through local manufacturers rather than procuring it from outside sources. USP DQI found all three Nepalese manufacturers in compliance with the USP monograph and they are now pursuing UNICEF prequalification. USP DQI will provide recommendations to the manufacturers to strengthen their quality assurance systems and GMP programs and lend technical assistance to help them reach their goal. Operational Guide to Ensure Drug Quality published—Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide emphasizes the importance of medicines quality from initial policy decisions to dispensing to the consumer. Chapters address how to incorporate drug quality assurance when developing and enforcing drug regulations, establishing medicines registration systems, testing drugs in central and field laboratories, inspecting drug distribution facilities, and monitoring medicines in the marketplace. The Operational Guide was developed to assist governments, donor organizations, pharmaceutical manufacturers, procurement agencies, wholesalers, and distributors to produce, select, purchase, and distribute only high-quality medicines, despite limited human and financial resources. Shelys Pharmaceuticals moves toward WHO prequalification—USP DQI staff conducted a Good Manufacturing Practices (GMP) audit for Shelys Pharmaceuticals Ltd. in Dar es Salaam, Tanzania, November 5-9, 2007. Dr. Joyce Carpenter and Mr. Edwin Toledo assessed Shelys' progress toward achieving World Health Organization (WHO) pre-qualification status for the production of zinc sulfate tablets, a recommended treatment supplement for severe childhood diarrhea. USP DQI has been working with Shelys for the past year to bring them up to an acceptable level of compliance with WHO GMP standards; based on this inspection, the manufacturer could be in a position to qualify as soon as December 2008. Both WHO and UNICEF recommend zinc supplementation to oral rehydration salts (ORS) therapy to combat the effects of diarrheal disease, which causes more than three million children's deaths each year in developing countries. USP DQI and USAID support the WHO pre-qualification program for manufacturers and work to ensure that only high quality zinc products are produced, procured, and used for that purpose. Study to examine antimalarial quality along Cambodia-Thailand border—USP DQI staff recently met with central and provincial health authorities, pharmaceutical bureau officials, and malaria control program managers of Thailand and Cambodia to plan a study on the quality of antimalarial medicines along the countries' mutual border. The study will use randomized sampling methodology in five selected cross-border provinces to obtain an estimate of the prevalence of substandard and counterfeit antimalarial medicines. It will also identify any association between substandard/counterfeit medicines and antimicrobial resistance on both sides of the border. Mekong Subregion examines common health issues—Dr. Phanouvong and Mr. Raymond also traveled to Vientiane, Laos, to attend the First Greater Mekong Subregion Regional Public Health Forum organized by the Regional Cooperation for Communicable Diseases Control and the Asian Development Bank. Over 100 high level managers of public health and communicable disease programs, scientists and program managers from countries in Southeast Asia met November 5-7, 2007, to better understand and share experiences about regional public health challenges. USP DQI took part in sessions on the preparedness and response capacity to avian influenza and on implementing control strategies for communicable diseases in border areas, particularly relevant to USP DQI activities in the region. Dr. Phanouvong urged meeting participants to include assuring the quality of anti-infective medicines as a priority agenda for the region as an integral effort in addressing communicable diseases. WHO Briefing focuses on essential medicines—Building on a strong history of collaboration with the World Health Organization (WHO), USP DQI's Laura Krech participated in the WHO/UNICEF Technical Briefing Seminar on Essential Medicines Policies held in Geneva on October 8-12. The seminar this year focused on common problems occurring in the pharmaceutical sectors of developing and transitional countries and how WHO and the UNICEF Supply Division can support these countries. Participants resolved that the best approach to making essential medicines of good quality available to all who need them is by working through national drug policies. Discussions emphasized the importance of rational use of quality medicines and explored such current issues as pharmacovigilance, pricing, traditional medicines, and counterfeit medicines.  DDF Director Tea Kim Chhay and training organizers Center of Excellence conducts first BA/BE training—The University of Santo Tomas Center for Drug Research, Evaluation, and Studies (UST CeDRES), assisted by USP DQI, conducted a seminar and workshop on "Bioavailability/Bioequivalance (BA/BE) Studies" at the Department of Drugs and Food in Siem Reap, Cambodia, September 26-28. Thirty-two BA/BE researchers, medicine regulatory agency officers, and private pharmaceutical industry representatives from Cambodia and Vietnam learned to perform BA/BE studies and interpret BE reports for medicines registration. The training discussed the complexities of analyzing a fixed-dose tuberculosis drug combination and examined a case study done at UST CeDRES to register a generic version of Rifampicin. BA/BE testing determines whether a generic product is chemically equivalent to the innovator product it emulates. USP DQI staff members Ms. Laura Krech, Dr. Mustapha Hajjou, and Mr. Christopher Raymond observed the training, provided feedback to the UST CeDRES training staff, and answered questions from participants. USP DQI also assisted the Cambodian Department of Food and Drugs with the training logistics. This BA/BE training was the first conducted by a Center of Excellence member of the Asian Network of Excellence in Quality Assurance of Medicines (ANEQAM). USP DQI has helped build capacity, provided technical assistance, and furnished laboratory supplies and equipment to these institutions.
 VOA Offers Health Journalism CD—The Voice of America Health Journalism CD–ROM serves as a support and teaching tool for journalists, students, and journalism educators. The CD allows resident journalists to access up–to–date information about topics such as HIV/AIDS and the health consequences of natural disasters. Using text, graphics, audio, video, and animation, the CD–ROM contains basic information that allows users to improve interviewing, reporting, and editing techniques to produce accurate, objective, fact–based stories. The CD is available free in Spanish and English from the VOA Web site. |
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Copyright © 2008 The United States Pharmacopeial Convention
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