US Pharmacopeial Convention initiative in Sub-Saharan Africa to fight substandard and counterfeit drugs
In an effort to increase the number of experts and available tools to combat falsified, substandard and counterfeit medicines in countries in Sub-Saharan Africa, the US Pharmacopeial Convention (USP) has launched the Centre for Pharmaceutical Advancement and Training (CePAT) in Accra, Ghana.
The new centre is the beginning of a series of global health initiatives to equip national and local regulatory authorities and officers, quality assurance and quality control professionals, manufacturers, and others in the pharmaceutical industry with knowledge and skills to promote access to good quality medicines. It is being launched as a Commitment to Action through the Clinton Global Initiative (CGI).
'CePAT is a natural extension of USP’s core mission of establishing public standards for the quality of medicines, foods and dietary supplements. As USP has become increasingly active throughout the world, the need to support efforts to provide good quality medicines to everyone who requires them has become more important,' said Dr Roger L. Williams, USP’s chief executive officer.
'CePAT is a positive step in that direction, and has been realised in part through our strong working relationships with the Ghanaian and other Sub-Saharan African medicines regulatory authorities.'
Ghanaians and many in Sub-Saharan Africa currently face a serious problem when it comes to accessing quality medicines. A 2013 report on the quality of uterotonics (oxytocin and ergometrine) in Ghana found that over 90% of the samples tested by USAID-USP Promoting the Quality of Medicines Program (PQM) failed either the test for the active ingredient or sterility, and only three of the 26 products tested were officially registered with the Ghana Food and Drug Authority (FDA).
A 2010 study on the quality of antimalarials in African countries, collaboratively conducted between the World Health Organization (WHO) and PQM, revealed that 44% of the samples collected in Senegal failed to meet quality standards. In Madagascar and Uganda, 30% and 26% of the samples failed, respectively. These reports underscore the seriousness of the issue and the need for trained professionals to improve access to quality medicines, which CePAT hopes to help ensure.
'Serious public health issues related to poor quality medicines have been linked to lack of trained human resources, in countries with limited resources,' said Dr Patrick H. Lukulay, vice president of USP’s Global Health Impact Programs (GHIP), who also oversees CePAT operations. 'With the centre, we want to bring the opportunity to improve local quality assurance systems by training national regulatory agencies and quality control professionals so they can fight the problem of fake and substandard medicines in a sustainable way.'
CePAT’s first course offerings are on Medicines Dossier Evaluation, Quality Control (including hands-on laboratory training) and Good Manufacturing Practices for Pharmaceuticals. Applications are subject to a pre-evaluation to ensure that the appropriate candidates are chosen, based on their potential role in providing access to good quality medicines in the Sub-Saharan African region. For more information and selection criteria, contact firstname.lastname@example.org.