DQI News Archive

Posted: November 24, 2008

Rain proves no deterrent to checking medicines quality–In September, staff from USP's International Technical Alliances Program–Lawrence Evans, Laura Krech, and Christopher Raymond–met with key partners in Cambodia to explore how the ACTWatch Drug Quality Study can complement ongoing USP DQI medicines quality monitoring activities. The trio conducted a supervisory visit to the remote sentinel site of Samrong, in Oddar Meanchey Province close to the Thai border, and learned first–hand the difficulties of travel in isolated areas.

The team went to Oddar Meanchey to evaluate the skills of Operational District pharmacists who had recently been trained by the Cambodian National Laboratory for Drug Quality Control on the use of portable Global Pharma Health Fund (GPHF) Minilabs^®. While in the area, they also traveled to the nearby border town of O'smach to collect antimalarial samples from eight medicine dispensing outlets. But the rainy season had washed out roads, making travel dependent upon the kindness of local villagers willing to help push vehicles out of the mud.

The incident pointed out the challenges surveillance staff face in collecting medicines samples from distant dispensing outlets accessible only by motorbike. Other issues arose on this sampling trip: Many of the private pharmacies they visited had only one type of antimalarial available and only one or two boxes on hand–not always enough for representative sampling. In other cases, collecting the needed sample from a small supply could cause a "stock out," potentially depriving a malaria patient of treatment.

After the sentinel site visit, USP staff met with key partners in Phnom Penh to discuss overall medicine sampling and testing activities in Cambodia. The meetings focused on how the partners involved can best work together to report and share test results so they can take prompt action when poor quality and counterfeit medicines are found. Program Manager for Southeast Asia Laura Krech and Project Coordinator in Southeast Asia Chris Raymond both work on the USP Drug Quality and Information Program – a Cooperative Agreement with the U.S. Agency for International Development. Manager of USP Drug Quality Alliances Dr. Lawrence Evans, III, directs the USP contract with Population Services International, Inc. (PSI), funded by The Bill and Melinda Gates Foundation. Dr. Evans went to observe field staff and to assess potential obstacles in the field that may affect the ACTWatch Drug Quality Study sponsored by PSI. All stakeholders are working together to improve the availability of quality medicines in areas where supplies are already limited.

Philippines studies quality of anti–TB medicines–USP DQI, the Philippines Bureau of Food and Drugs (BFAD), and the Department of Health National Tuberculosis Program are beginning a medicines quality monitoring study on antituberculosis drugs at six sentinel sites throughout the Philippines. On a recent trip to the island country, USP DQI Program Manager for Southeast Asia Laura Krech and Project Coordinator in Southeast Asia Chris Raymond visited two of the sites and met with stakeholders currently involved with medicines sampling and testing activities.

In Malolos City, the team visited a rural health center to observe the health center staff test a locally–produced fixed–dose combination (FDC) TB medicine used to treat patients in the public sector. The FDC failed disintegration testing and the thin layer chromatography test for rifampicin using the GPHF Minilab®, tests that will be repeated and sent to the BFAD for verification testing. In San Fernando City in La Union, Ilocos, the team visited the TB clinic and wards of the public hospital and purchased anti–TB drug samples from public and private legal pharmacies. One local pharmacist illegally dispensed the wrong regimen to Mr. Raymond, a violation for dispensing without a physician's prescription.

Ms. Krech and Mr. Raymond met with Dr. Eduardo C. Janairo, Director of the Center for Health Development for the Ilocos region. Dr. Janairo wholeheartedly supports the anti–TB study and hopes to expand quality monitoring activities to cover a variety of essential medicines. He would like to see monitoring become a sustainable activity and would like to build a regional reference laboratory so that verification testing can be done more rapidly.

Community pharmacists learn quality and rational use of HIV/AIDS Medicines–In the Mekong Region, the first place patients go for medicine and advice is the community pharmacy. Yet, most often, pharmacists are neither well informed on the quality and safety of medications nor trained to provide care to people living with HIV/AIDS. Forty–nine Lao and Vietnamese community and hospital pharmacists recently took the first step toward changing that situation, demonstrating how they can provide the needed support to HIV/AIDS patients in their communities.

From September 22–October 1, Souly Phanouvong, Pharm.D, Ph.D., USP DQI Manager for Drug Quality Assurance and Policy Development, and local partners in Lao PDR and Vietnam conducted training workshops on the Quality, Safety, and Rational Use of HIV/AIDS Medicines. The first–of–its–kind training laid a strong foundation on the concept of rational use of HIV/AIDS medicines and the importance of medicines quality on treatment outcomes. Sessions addressed the principles of HIV/AIDS medications, prevention and care; demonstrated basic methods and techniques to identify suspicious HIV/AIDS medicines; and presented practical measures to educate patients on HIV/AIDS medicines safety.

John Santell, M.S., R.Ph., FASHP, USP Director of Practitioner Programs and Services, illustrated how easily medication errors can occur, what types of errors occur most often, and how errors can be prevented. He quizzed participants on look–alike pills and sound–alike drug names and illustrated how collecting and analyzing medication errors information can evolve to systems for preventing errors.

Kate T. Nguyen, Pharm.D, Clinical Pharmacist for Coram Healthcare, talked about successful treatments, including the multidrug–combination Highly Active Antiretroviral Treatment (HAART). The goal of treatment is to improve quality of life and prolong survival. Pharmacists can help by keeping good quality medicines available, monitoring compliance to treatment, and counseling patients about their medicines, side effects, and drug–food interactions. John F. Inciardi, Pharm.D., D.Sc., Associate Professor (retired), University of California, explained to participants how HIV/AIDS works in the body and how medicines work against it. Antiretroviral drugs cannot cure AIDS, he said, but they can allow people who are infected with HIV to live normal lives. Dr. Inciardi believes the stigma and discrimination that keeps people from being tested for HIV and seeking appropriate treatment can be combated by having a trained, informed healthcare workforce.

Antimalarial drug quality monitoring starts up in Ghana, Mali–As part of its mandate for the President's Malaria Initiative, USP DQI will be providing technical assistance to Ghana and Mali to ensure the quality of antimalarial medicines. USP DQI Director Patrick Lukulay and Consultant Abdelkrim Smine recently visited each country to assess their drug quality assurance and quality control (QA/QC) capacities.

USP DQI talks with the Ghana Food and Drugs Board (FDB) and the Malaria Control Program (MCP) revealed that medicines quality situation in the country remains challenging. Medicines are sold rampantly through illegal stores and markets and local manufacturers continue to make products without adherence to Good Manufacturing Practices (GMP). The number of brands of artesunate and artemisinin–based combination therapies (ACTs) circulating in the market defies effective control, and supporting multiple ACT regimens conflicts with the need for "uniform" therapy. The MCP's resources are limited, reducing effective response.

The USP DQI team met with key stakeholders to discuss how they can work together to strengthen pharmaceutical systems in Ghana. Overall, the drug quality control capacity in Ghana is good and the QC lab staff well qualified, but the lab facilities are critically in need of updating. During the trip, USP DQI staff advocated for FDB to the Ministry of Health, seeking financial support to complete a new building that will host the FDB laboratory. USP DQI facilitated the working group discussions that saw the partners set program objectives, identify sentinel sites based on a wide range of criteria considered as priority for health systems in Ghana, and finalize the program elements and a work plan for the year ahead. With good collaboration from local partners and adequate resources, USP DQI can offer the needed technical assistance to improve the drug quality assurance situation in Ghana.

Because of the challenging QA/QC capacities in Mali, the quality of medicines for the control of many diseases is still a major burden. Malaria, in particular, still causes a high level of morbidity and mortality throughout the country. The USP DQI team met with all the principal players involved with malaria control and medicines production, procurement, and distribution to determine how USP DQI can assist the government of Mali on the Malaria Operational Plan.

Beyond needing a strong drug quality control program, pharmacovigilance (PV) may be high priority for the Malaria Control Program (MCP). Many malaria patients reject the use of the artesunate–amodiaquine combination therapy, despite its high efficacy rate, because of the negative side effects of amodiaquine. The MCP is moving toward the use of a different combination, instead, and will need to follow its use in the general population. PV responsibilities are currently shared among several agencies, though, and need to be effectively centralized, starting with the ACTs.

The country's procurement system, the drug information system, and observance of good pharmaceutical practices are also in need of upgrading. USP DQI and local partners have formulated a work plan that addresses the gaps in Mali's quality assurance and quality control systems in priority. Together with USP DQI and the World Health Organization (WHO), all partners will be working to establish sustainable postmarketing surveillance of antimalarial drugs; create a solid pharmacovigilance program; and develop a drug information center to improve health care for the people of Mali.

Operational Guide to Ensure Drug Quality Available—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. 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.

Ensuring the Quality of Medicines in Resource–Limited Countries: An Operational Guide (2MB) can be downloaded here, 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.