What's New

Ensuring 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 (320KB) details quality assurance components a pharmaceutical supply system should consider–product selection, procurement, regular access, disposal system, storage, and distribution.

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 (19KB) and zinc sulfate oral solution (19KB).

Madagascar ramps up drug quality programs—During an extensive trip to Madagascar in June, Program Manager-Africa Dr. Mustapha Hajjou completed work on wide-ranging and comprehensive program activities to help improve the country's drug quality assurance and drug information systems. Dr. Hajjou and Dr. Karim Smine, a consultant from Pharmaceutical Quality Solutions International, LLC., provided technical assistance on laboratory procedures, sentinel sites data, pharmacovigilance reports, training, a drug information center, and validation of the sampling for Quality of Antimalarials in Sub-Saharan Africa (QAMSA) study.

The USP DQI team coordinated with the Director of L'Agence du Médicament and staff of the National Malaria Control Program to adapt the established Drug Quality Monitoring (DQM) system to include Artemisinin-based Combination Therapies (ACTs). The DQM examines the quality, efficacy, and safety of antimalarial medicines available on the market in Antananarivo and five peripheral sites using GPHF Minilabs supplied by USP DQI; the ACTs were added to ensure their quality as Madagascar implements a country-wide roll-out. Drs. Hajjou and Smine reviewed data collected from two rounds of drug sampling and testing at the sentinel sites and made recommendations to improve laboratory procedures. The data obtained will be analyzed to take appropriate action.

At the newly established National Center of Pharmacovigilance (NCPV) of Madagascar, which is responsible for postmarketing surveillance, the USP DQI team reviewed pharmacovigilance reports and discussed ways to improve the reporting process. Dr. Hajjou facilitated a training of regional trainers, which included instruction on reporting drug adverse events, to assure continuity among personnel at health facilities. The expertise of the National Center of Pharmacovigilance of Madagascar (NCPV) will eventually expand to regional sentinel sites.

Dr. Hajjou also visited Joseph Ravoahangy Hospital (Antananarivo University Hospital) where USP DQI is helping establish a Drug Information Center (DIC)—the first in the country. USP DQI procured the necessary computer and office equipment and provided training for the DIC staffs; crucial reference materials will also be supplied. The DIC will work closely with the NCPV, complementing its function by disseminating information on antimalarial drugs to health professionals as well as to consumers.

Madagascar is one of three countries USP DQI sponsors in the QAMSA study. The World Health Organization (WHO) and USP DQI are conducting the study in ten countries to identify the proportion of antimalarial drugs that meet quality standards at different points in the distribution chain in an effort to understand the trends and patterns of poor drug quality in the country. Sampling began in Madagascar in April 2008; during this trip, Dr. Hajjou and Dr. Smine validated the sampling. A total of 120 samples of ACTs and Sulfadoxine-Pyrimethamine were collected and are currently being tested using Minilab kits.

Vietnam tests drug quality in the provinces—USP DQI Program Coordinator for Southeast Asia Chris Raymond and officials from Vietnam's National Institute of Malariology, Parasitology, and Entomology (NIMPE) traveled to Thanh Hoa province, south of Hanoi, to collect medicines from provincial, district, and communal hospitals and health centers. The antimalarial, antituberculosis and antibiotic drugs collected are screened for quality at the local sentinel site using GPHF Minilab® test methods. On their site expedition, the USP DQI team also checked that the testing laboratories were following protocols for sampling, testing, and data recording to ensure harmonization among provincial sites, NIMPE, the National Institute of Drug Quality Control (NIDQC), and the Drug Administration of Vietnam (DAV). Similar samples were taken from both commune health center dispensaries and district-level storage facilities to determine whether or not products were becoming degraded due to insufficient storage conditions.

In Hanoi, Mr. Raymond presented current data from medicines quality monitoring in Lao PDR, Cambodia, and Vietnam and demonstrated the use of the GPHF Minilab® to police, customs agents, and regulatory authorities from the Mekong Region. Explaining its usefulness in testing drug quality in the field, he introduced the concept of using the portable laboratory equipment at ports-of-entry to detect substandard medicines. The drug test currently used by customs detects only the presence of narcotics in imported medicines, without revealing other illicit substances that might contaminate their quality.

Lao Government uncovers counterfeits—In the latest round of drug quality testing, the Food and Drug Quality Control Center of Laos discovered three counterfeit antimalarial medicines. The samples – labeled as artesunate 50mg tablets – actually contained no active pharmaceutical ingredient. The fake drugs were collected from three different pharmacies in Champasack Province through the routine sampling and testing under the USP DQI antimalarial drug quality monitoring program. The Laos Food and Drug Department (FDD) issued a recall, directing the Champasack provincial authority to confiscate all remaining stocks from those outlets. The FDD also sent warning notices to all provinces in the country.

Since 2003, USP DQI has been active in the Mekong region, where there is increasing concern about antimicrobial drug resistance (AMR), especially related to antimalarials. The USP DQI drug quality monitoring program helps countries fight the problem of substandard and counterfeit medicines, which contribute to the challenges of AMR.

MMV aims to improve access to antimalarials—Heads of malaria control programs in Africa and donor organizations gathered in Accra, Ghana, for the Eighth Annual Stakeholder's Meeting of the Medicines for Malaria Venture (MMV). The meeting spotlighted the need for improved access to malaria medicines, particularly to Artemisinin Combination Therapies (ACTs). In fact, the MMV is currently embarking on pilot programs in Uganda and Malawi to test models for increasing access to antimalarial medicines.

Before the meeting, attendees visited the Korle Bu Polyclinic in Accra, for patients with malaria and other tropical diseases, to learn first-hand some of the challenges of treatment adherence. Healthcare workers intimated that patients may take only one of the Artesunate tablets from co-blistered packages, may refuse to take the Amodiaquin because of its side effects, or may take partial doses in order to minimize costs. Having fixed-dose combination drugs, in which the two drugs are co-formulated, will prevent these unsafe practices.

Mrs. Dora Akunyili, Director General of Nigeria's National Agency for Food and Drug Administration and Control, opened the Third Annual MMV Access Symposium, held in conjunction with the Stakeholder's Meeting. The Symposium focused on "Expanding Reach of ACTs in the Private Sector: Dialogue with Countries." Authorities from Senegal, Nigeria and Ghana discussed country experiences in increasing access, and Dr. Lawrence Barat, Senior Malaria Advisor to the President's Malaria Initiative (PMI), discussed PMI's successes in increasing access in the private sector in select African countries. Director Patrick Lukulay represented USP DQI at the meeting.

Cambodia establishes pharmacovigilance center—Government officials from the Kingdom of Cambodia assembled in Phnom Penh May 29–30 to develop a national action plan for monitoring the safety of the country's medicines. More than 40 representatives from international, nongovernmental, academic, and humanitarian organizations met with members of the Cambodian Ministry of Health, hospital directors, and national and provincial public health leaders to create the structures needed to establish the Cambodian Pharmacovigilance (PV) Center.

At the opening ceremonies, His Excellency Dr. Tep Lun, Director–General of the Ministry of Health, recognized Cambodia's need for the PV Center: "The purpose of pharmacovigilance is to promote safety, contribute to assessing adverse drug reactions, monitor drug effectiveness, safety, and rational use, and raise awareness of counterfeit and substandard medicines." Establishing a PV Center demonstrates the Cambodian government's commitment to advancing the public healthcare system.

The United States Pharmacopeia Drug Quality and Information Program (USP DQI), World Health Organization (WHO), Cambodian Ministry of Health (MOH), and Department of Food and Drugs (DDF) organized the two-day workshop, with financial support from the United States Agency for International Development (USAID) Cambodia Mission. During the meeting, working groups discussed the logistics of establishing a PV center, determined what training would be needed, and structured a system for reporting adverse drug reactions (ADR). PV experts from the Moroccan Poison Control and Pharmacovigilance Centre, a WHO Collaborating Center, and the Philippines facilitated the workshop.

The PV Center is the latest element in Cambodia's campaign to combat the proliferation of counterfeit medicines. Other measures include drug quality monitoring, taking actions against pharmacies and manufacturers found selling counterfeit medicines, publishing articles and VCDs to raise awareness among Cambodian health professionals, and producing public service announcements to alert citizens to the dangers of buying and using counterfeit medicines.

Assuring Antimalarial Medicines Quality in Uganda—Most areas in Uganda are malaria endemic, yet a recent study by the American Enterprise Institute revealed that almost 35% of antimalarial drugs sampled from randomly selected pharmacies in Kampala were counterfeit or substandard. So the training course on Basic Tests Using Minilab® kits that USP DQI staff conducted May 19–23 in Kampala was especially timely. Program Manager Dr. Natalia Davydova and Chemist Sanford Bradby presented the workshop which focused on evaluating the quality of selected antimalarial drugs using visual inspection, simple disintegration, and thin–layer chromatography. Twenty–five associates from the National Drug Authority (NDA) and the National Drug Quality Control Laboratory (NDQCL) participated.

The training is in preparation for the antimalarial postmarketing surveillance program being established at the central and the periphery levels in Uganda. USP DQI will supply five Minilabs® that will be located in the five regional offices of Nakawa, Jinja, Tororo, Mbarara and Hoima/Lira. Samples will be collected from government hospitals, private hospitals, dispensaries, pharmacies, and drug shops in all regions of the country. Uganda was selected as one of the first three countries to participate in the President's Malaria Initiative (PMI), a five–year plan to scale up malaria prevention and treatment interventions in high–burden sub–Saharan African countries. USP DQI supports Uganda's efforts under this plan by increasing the NDQCL's technical capacity for drug quality control and strengthening the NDA's drug regulatory functions.

Asian Center of Excellence conducts GMP workshop—USP DQI and Mahidol University School of Pharmacy conducted a workshop on Good Manufacturing Practices (GMP) for 10 participants from Thailand's government, military, and private pharmaceutical industry in Bangkok May 6–9. Representatives from the Thai Food and Drugs Administration, government manufacturing facilities, and private manufacturers learned about general GMP principles, air unit and water system validation, risk management, risk analysis, and statistical software application for the manufacturing process. The workshop was supported by the United States Agency for International Development (USAID) Regional Development Mission for Asia (RDMA).

Mahidol Vice President Dr. Napatawn Banchuin, Dr. Chansuda Wongrichanalai (Infectious Diseases Strategic Information Specialist, USAID/RDMA), and Dr. Charles Delacollette (Coordinator, World Health Organization Mekong Malaria Programme, Bangkok) welcomed participants at the opening ceremonies. USP DQI Program Manager Laura Krech also spoke, emphasizing the opportunity for interaction, discussion, and the sharing of experiences on GMP new trends and compliance this workshop afforded the trainees. Following the opening comments, Dr. Ampol Mitrevej began with lectures on Quality Management and asked participants to point out common GMP deviations in the Thailand pharmaceutical industry. USP DQI Program Manager/GMP Specialist Edwin Toledo was on hand in later discussions to explain the importance of a robust quality system and management in overcoming any challenge in the pharmaceutical industry.

Using a training module on GMP developed by Mahidol University, the workshop was designed to improve the technical capability of participating organizations and teach manufacturers how to become GMP–compliant. For the past two years USP DQI, with the support of USAID/RDMA, has been involved in capacity–building with the Mahidol University Faculty of Pharmacy, a member of the Asian Network of Excellence in Quality Assurance of Medicines, enabling them to serve as a regional resource for drug quality assurance in GMP. USP DQI has provided specific on–site trainings, technical assistance, and laboratory supplies and equipment.

Thai provinces learn drug testing methods using Minilabs®—USP DQI, together with the Thai Bureau of Drugs and Narcotics (BDN) Laboratory and the Ministry of Public Health/Bureau of Vector Borne Diseases, conducted a weeklong training workshop in May on Monitoring the Quality of Anti–infective Medicines. Some 20 staff members from six regional health offices in Thailand took part in the training; four additional analysts participated from provinces taking part in a Thai/Cambodian cross–border study. The workshop was organized with Kenan Institute's Borderless Action Against Microbes (BAAM), World Health Organization Mekong Malaria Programme (MMP), and Global Pharma Health Fund (GPHF) and held at the BDN Laboratory. The Minilabs® used in the training will be shipped to the six new regional test sites, expanding drug quality training from 6 to 12 locations in Thailand.

Dr. Souly Phanouvong, USP DQI Manager of Drug Quality Assurance, conducted the training in Thai to accommodate the primarily non–English–speaking participants. Dr. Richard Jähnke, Minilab® Project Manager for German Pharma Health Fund (GPHF) e.V.– inventor of the GPHF–Minilab®–was on hand throughout the training to explain the theory and history of the self–contained mobile laboratory that can be used to test the quality of medicines in the field. Testing involves a four–stage plan that employs visual inspection, simple disintegration, simplified color reactions for ensuring a drug's identity, and thin–layer chromatography. USP DQI Program Manager Laura Krech, Southeast Asia Program Coordinator Christopher Raymond, and several trainers from the BDN facilitated the training.

USP DQI assesses Indian drug manufacturers for GMP—As part of a Global TB Drug Facility (GDF)/World Health Organization (WHO) adjudication team, USP DQI staff recently conducted baseline GMP assessments for two producers of antituberculosis medicines in India. The facilities of Kilitch Drug Limited (KDL) in Paonta Sahib and Karnataka Antibiotics & Pharmaceutical Limited (KAPL) in Bangalore were audited to evaluate their compliance with international GMP standards in the manufacture of Capreomycin and Kanamycin powder for injection. USP DQI was able to identify gaps in the systems and will help the manufacturers pursue WHO pre–qualification.

In 2007, USP DQI assisted the GDF and the Green Light Committee (GLC) by designing a questionnaire that would facilitate their evaluation of manufacturers of priority second–line anti–TB drugs when they applied for WHO prequalification status. The aim is to increase the overall number of manufacturers of good quality second–line anti–TB drugs for procurement purposes by national disease programs. Through the collaboration of the GDF, USP DQI and USAID, the selected manufacturers will receive technical assistance to improve their GMP compliance.

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.

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

(45KB) illustrating how USP DQI, in collaboration with Global Pharma Health Foundation (GPHF), developed and validated basic testing

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.

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.

With support from the U.S. Agency for International Development, the Operational Guide was developed by a collaboration of international experts in pharmaceutical standards and management, as well as officials from four national medicines regulatory authorities. A CD–ROM included with the Guide offers search capability of the official PDF and provides additional reference materials pertinent to specific topics. Ensuring the Quality of Medicines in Resource-Limited Countries: An Operational Guide

(2MB) will be broadly disseminated to public health organizations and individuals; it can also be downloaded from the USP DQI Web site, or a copy of the book can be requested from USP DQI, U.S. Pharmacopeia, 12601 Twinbrook Parkway, Rockville, MD 20852 USA.; email: .

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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