PQM Project Update for Q3: April-June 2012

PQM provides technical leadership to build local capacity in medicines quality assurance systems, increase the supply of quality-assured medicines, combat the availability of counterfeit medicines, and advocate for medicines quality worldwide. PQM's core funding is focused on tuberculosis (TB) and malaria. In the TB area, PQM has provided support to the Global Drug Facility and the Green Light Committee to increase the availability of good quality second-line anti-TB medicines. PQM has assisted manufacturers to ensure an increased supply of quality-assured medicines globally. Currently, PQM is supporting 22 Finished Pharmaceutical Product (FPP) manufacturers and 11 Active Pharmaceutical Ingredient (API) manufacturers in different stages of compliance with World Health Organization Prequalification (WHO PQ). In the malaria area, PQM has provided support for PMI objectives by developing public standards to test existing medicines where standards did not exist before. PQM has established a network of country quality control laboratories to teach chemists about the use of the standards in compliance with Good Laboratory Practices standards. PQM is also involved in obtaining information at country levels on the extent of diversion of malaria medicines from the public to the private sector. PQM has several key activities in the third quarter of 2012. In the TB area, PQM is supporting the development of monographs for key antimalarial medicines, including DHA/PP. PQM is also providing support to assess the extent of diversion of key antimalarial medicines from the public to the private sectors in select countries. In the malaria area, PQM is supporting antimalarial medicine monitoring studies in two new sentinel sites in Kaduna and Port Harcourt, Nigeria, and five cities in Cameroon. In the maternal and child health area, PQM has been involved in the efforts of WHO, UNICEF, and USAID to roll out zinc salts as an oral rehydration salt supplement in the management of children's diarrhea. PQM performs GMP assessments of zinc manufacturers to ensure that their products are of high quality. PQM provides recommendations to strengthen their quality assurance systems and GMP programs. PQM also has several key activities in the common agenda area. PQM plans to attend selected international meetings and participate in the design of proposed activities relating to medicine quality issues. PQM will develop a field-based quality control tool with increased accuracy, sensitivity, and reliability. PQM will raise the profile of the PQM program and increase awareness about the importance of medicines quality. PQM will also produce up-to-date information about current issues in medicines quality and appropriate use. In Africa, PQM has several key activities in Benin. PQM is strengthening the capacity of the National Medicine Quality Control Laboratory by providing intensive training of the lab staff and having appropriate equipment to carry out the tests. PQM has also faced several challenges in Benin, including frequent power outages and the lack of adequate and basic laboratory supplies.