DQI News

Posted: January 14, 2010

Promoting the Quality of Medicines (PQM) Program

In response to the growing challenge posed by the proliferation of counterfeit and substandard medicines, the U.S. Agency for International Development (USAID) awarded the United States Pharmacopeial Convention (USP) a Cooperative Agreement to expand their joint efforts to combat this pervasive menace.

The Promoting the Quality of Medicines (PQM) Program, a five–year, $35 million collaboration, will serve as a primary mechanism to help assure the quality, safety and efficacy of medicines essential to USAID's priority health programs.

"Substandard and counterfeit medicines represent a threat to public health worldwide but pose a particular problem in developing countries, where the lack of financial, technical and other resources make it difficult to protect the drug supply chains," said Alonzo L. Fulgham, acting administrator of USAID. "Such medicines have the potential to undermine decades of investments in public health. Without good quality, safe medicines to treat diseases such as HIV/AIDS, malaria and tuberculosis, the impact of other health initiatives may be weakened. The PQM Program focuses on this critical aspect of combating these diseases."

The PQM Program will build on the successes of the Drug Quality and Information (DQI) program, implemented by USP (2000–2010) in 28 countries around the world, focusing on four key objectives:

Strengthening national quality assurance systems;
Increasing the supply of good–quality medicines for priority USAID health programs;
Combating the availability of substandard and counterfeit medicines; and,
Providing technical leadership and global advocacy on the importance of quality assurance for medicines.

By providing technical assistance to developing countries, PQM helps strengthen their medicine regulatory bodies, build local capacity in medicine quality assurance systems, and develop sustainable mechanisms to ensure the quality and safety of their medicines.

Like DQI, the PQM Program will be managed by Patrick Lukulay, Ph.D., partnering with USAID's Office of Health, Infectious Diseases, and Nutrition, under the direction of Anthony Boni.

PSA launch draws global attention–The "Pharmacide" PSAs that DQI developed with Living Films Thailand, Khmer Mekong Films, and the USAID/Cambodia Mission's Office of Public Health were shown at an official regional launch held October 8 in Cambodia. The PSAs show the life cycle of a counterfeit drug–from counterfeiter to dealer to victim. Its message, "Counterfeiting is a crime against humanity...against you," urges citizens to always use a licensed pharmacy when purchasing medicines.

Speaking at the launch ceremony, USAID Cambodia Mission director Flynn Fuller, pointed out: "Counterfeit and substandard medicines pose a grave threat to patients in Southeast Asia, but their presence in these countries remains a largely unknown problem ... a problem that USAID, USP and national authorities take very seriously, and we hope to reach patients directly through this PSA campaign."

The PSA launch drew high–ranking officials from Cambodia's National Malaria Program, Department of Drugs and Foods, and National Lab, the Pharmacists' Association of Cambodia, many nongovernmental organizations (NGO) in the USAID Public Health portfolio, and members of the press. The PSAs have been reported by numerous media including Bloomberg, PR Web, E–Drug, and Voice of America. Both the PSAs and interviews with launch attendees can be viewed on USP's YouTube Web page.

African QC laboratories form network to fight for quality medicines–The medicine quality control laboratories of five USAID–supported countries in Africa recently established the Network of African Medicines Control Laboratories (NAMCOL), a collaborative effort to resolve common challenges they face to improve medicine quality in their countries. The national quality control (QC) labs of Ethiopia, Ghana, Mali, Senegal, and Uganda plan to initiate communications that will allow them to share data, enhance their skills and capabilities, and generally recognize their mutual goal to fight counterfeit medicines and assure the quality of pharmaceuticals in their market.

NAMCOL resulted from a DQI–organized workshop that brought together the heads of the five QC labs, several DQI staff, and representatives from the U.S. Agency for International Development (USAID), World Health Organization (WHO), Ghana's Food and Drug Board (FDB) and Malaria Control program, and the regional FDB. Participants discussed everyday common problems with procuring reagents, equipment, and standards; limited human and financial resources; old or limited lab facilities; and a need for training. The heads of the labs agreed that working together and exchanging information will benefit them all and will address weaknesses faced by each.

Dr. Paul Psychas, Team Leader of the President's Malaria Initiative in Ghana, emphasized the importance of all involved–countries, donors, governments, and nongovernmental organizations–pulling together resources to combat the threat of counterfeit and substandard medicines in African markets. The participants set objectives for collaboration, created work plans for the coming year, and committed to working through NAMCOL to assure that safe and efficacious essential medicines of good quality are available in their countries' markets.

PQM team finds Rwanda in need of an MRA–After conducting an initial assessment of the quality assurance and quality control (QA/QC) systems in Rwanda November 9–13, the PQM team found the country's greatest need to assure its medicine quality is to establish a formal medicine regulatory authority (MRA) and strengthen its quality control laboratory. Despite the absence of an MRA, however, the team acknowledged that the Ministry of Health Pharmacy Taskforce has been very successful in controlling the pharmaceutical market. No informal medicine market exists in Rwanda.

Based on their findings, the assessment team–Dr. Mustapha Hajjou, PQM Program Manager; Ms. Veerle Coignez, Pharmaceutical Management Advisor, USAID/Global Health Bureau, Office of Health, Infectious Diseases and Nutrition; and Dr. Karim Smine, PQM Consultant–expressed their confidence that, with the technical assistance and financial support, Rwanda will be able to make great strides in introducing evidence–based QA, including medicines quality control (QC), in the coming years.

The Rwandan stakeholders, including the Malaria Control Program, are well aware of the need to establish an MRA with access to medicine quality control capability. The PQM team recommended what priority measures could be taken to strengthen the QA/QC in Rwanda immediately–building capacity at the University of Rwanda laboratory and helping the University develop a QA/QC post–graduate curriculum.

The assessment was requested by the President's Malaria Initiative of USAID/Rwanda to strengthen the quality control of antimalarial medicines used in the country. PQM also submitted a proposal to the President's Emergency Plan for AIDS Relief (PEPFAR) team in Rwanda offering technical assistance that will help achieve PEPFAR's objectives in building systems and developing human resources to better assure the quality of the country's medicines.

PQM determines Kenya's need for QA/QC–PQM staff conducted a similar QA/QC assessment in Kenya during November. The Pharmacy and Poisons Board (PPB), which regulates the practice of pharmacy and trade in medicines in Kenya, among other things, was concerned about increasing counterfeit and substandard medicines circulating in the market. In fact, a study on antimalarials by the PPB, Department of Pharmacovigilance, and Division of Malaria Control (May 2006) found that, of the products sampled, 42.6% were not registered; most of the unregistered products were from Kenya and India.

PQM director Patrick Lukulay, Regional Manager–Asia Souly Phanouvong, and Program Coordinator–Africa Latifa El–Hadri assessed the medicines quality assurance systems and, with the Department of Malaria, developed an action plan to establish a national medicines quality monitoring (MQM) program in Kenya. The MQM program will obtain information on the quality of registered antimalarial products as well as the proportion of unregistered products circulating in the market. The data supplied through MQM will provide evidence for enforcement actions.

Lukulay speaks at All–Africa conference–PQM program director Patrick Lukulay addressed malaria researchers at the 5th MIM Pan–African Malaria Conference in Nairobi on "The State of Antimalarial Medicine Quality in Sub–Saharan Africa: Challenges and Prospects." Dr. Lukulay noted that the major constraint of treating diseases is not always the lack of funds, but the lack of coordination of funds and efforts on the part of donors, regulators, distributors, procurement officers and everyone involved. He suggested that a medicine quality assessment can identify weaknesses in the system, while better coordination and better oversight are needed to strengthen systems.

Dr. Lukulay took part in a symposium sponsored by the Wellcome Trust that discussed the growing evidence that poor quality antimalarials are a major impediment to malaria control, and key aspects of antimalarial medicine quality relevant to malaria control in Africa. The Multilateral Initiatives on Malaria (MIM) Conference is one of the largest malaria meetings worldwide, gathering malaria researchers, control experts, science administrators, private foundations, governments, and international organizations throughout the world. More than 2,000 scientists attended the 2009 MIM Conference.

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