APPRAOCH
USP will open the first Center for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana to provide training and capacity building for quality assurance and quality control (QA/QC) of medicines in the sub-Saharan African (SSA) region. USP has committed to invest $3.7 million toward CePAT's phase 1 pilot. Through the creation of a company limited by guarantee established under USP, offices have been leased and outfitted as a training center with fully functional lab space, and local talent has been hired to run the facility. USP is the sole, scientific, standard-setting authority in the United States, recognized by the FDA, and thus the standards set for medicines, dietary supplements, and food ingredients will be leveraged to support the technical expertise and capacity of the center. USP will commit to providing all of the initial funding, program and curriculum design, scientific expertise, monitoring systems, and overall management of the facility and its courses.
CePAT will offer comprehensive training through both lectures and practicum, and will encompass: 1.) quality control laboratory procedures (theory and practice) and laboratory quality management systems; 2.) current Good Manufacturing Practices (GMPc); 3.) medicine dossier evaluation; 4.) laboratory equipment preventive maintenance and servicing; and, 5.) best practices with respect to laboratory infrastructure and resources.
CePAT will dedicate a small group of chemists in its lab to conduct full monograph testing of medicines for donor agencies and procurement organizations in SSA.
CePAT will offer regulatory, laboratory, supply chain and industrial consulting services to medicines regulators (for dossier evaluation and other medicines regulatory matters), procurement organizations and donor agencies (for proficiency testing and auditing of laboratories), governments and organizations involved in supply chain management, and industry (for design of manufacturing facilities and labs).
Through constant monitoring and evaluating, CePAT will be able to modify, improve and scale its activities.
ACTION PLAN
CePAT will open in May of 2013. Training begins in July of 2013.
The training program is designed to provide a cumulative learning experience with time between courses to permit the participants to apply their knowledge in their home countries. Thus, there will be two training sessions per year for each of the three modules (GMP, Dossier Evaluation and Quality Control modules). Trainees will visit the center starting in July for the Dossier Evaluation module which will last for two weeks and additional trainees will visit the center in August to take the GMP module which will also last for two weeks and the quality control module in September lasting for two weeks. The training cycle will repeat in October where the trainees that attended in July will return to take the remaining courses for in Dossier Evaluation module and this will continue for the other modules.
OMCL staff will be subsidized, while staff from private industry will cover their own expenses. Training for private industry will occur in the fiscal quarters when OMCL trainings are not in session. A total of 40 trainees (per year from public sector) will be trained at the expense of USP and other funding partners per year-15 in quality control, 10 in GMP, and 15 in dossier evaluation-for two weeks per session, two sessions per fiscal year for each technical area starting in July, August and September and then in October, November and December.
Depending on demand, trainees from the private pharmaceutical industry would also attend, funded by their companies. Approximately 20 trainees from industry are expected to obtain training each year.
Substandard and counterfeit medicines are flooding international markets, threatening the integrity of global health systems, accelerating drug resistance and claiming millions of lives each year. While falsified medicines are deliberately and fraudulently produced and sold, substandard medicines most often result from inadequate capacity to distribute and/or produce medicines that meet public health safety standards. The differences are significant; however the threat to the patient is the same: drugs are unsafe, ineffective and life threatening.
Developing countries are disproportionately vulnerable and have the highest rates of poor quality medicine. In Sub-Saharan Africa (SSA), the confluence of weak regulation and enforcement, porous borders, heavy reliance on imports, and shortages of resources undermine safe drug markets. This is compounded by a tremendous deficit in the trained local workforce to conduct Quality Control in an already overburdened and under-resourced supply chain.
The World Health Organization indicates that nearly one million Africans die from consuming fake anti-malarial or tuberculosis drugs every year. This staggering figure is amplified further by the fact that substandard medicines not only fail to produce health outcomes; they also contribute to the development of antimicrobial resistance and exacerbation of threatening illnesses that may otherwise be treatable such as malaria, tuberculosis, and HIV.
Quality is often perceived as a choice or preference; however, quality of medicine relates to basic functionality and patient safety. For a new mother who receives unrefrigerated or adulterated Oxytocin, quality is all that matters. SSA countries have found over 55% of the Oxytocin in supply is substandard when tested; an unfortunate reality that contributes to the region's highest maternal mortality rates in the world. Building local capacity for quality control is essential to ensuring both positive health outcomes and the effectiveness of international donor commitments in SSA.
