USP building database of fake & substandard meds

Using the database, which is due to launch early next year, regulators and organisations procuring essential medicines will be able monitor counterfeit and substandard drug trends. The US Pharmacopoeia (USP) is setting up the database to support more informed enforcement actions and procurement-related decisions.

Speaking to in-PharmaTechnologist at AAPS 2010 Patrick Lukulay, director of the promoting the quality of medicines (PQM) initiative at USP, outlined how timely sharing of information can support enforcement actions.

Lukulay said the database could have supported a more effective response to counterfeit medicines that spread to Mali after first being seized in Ghana. Using the database regulators in Mali would have been aware of the products, which had the same batch numbers as the products seized in Ghana, and acted accordingly.

Having created the architecture the USP is now inputting information about counterfeit or substandard drugs into the database. Listed on the database will be the name of the product, the country it was seized in, what was wrong with it and other descriptors, said Lukulay. If countries agree the database will be shared with the public.

The benefits of sharing information also underpin the USP's creation of a 'virtual forum'. This will allow users to pose questions, share alerts and discuss best practices among a network of people involved with ensuring the quality of medicines.

Real progress ​

Lukulay said the USP is starting to see real progress in enforcement actions by authorities in developing nations, such as Ghana and Cambodia. This progress has occurred as the USP has pulled back slightly to focus on its core strength, providing technical support, leading to nations taking greater ownership of enforcement.

The USP has taken this approach having done the initial groundwork to establish an understanding of the dangers of substandard medicines and the infrastructure to tackle the problem. Local stakeholders have welcomed the shift and taken a larger role in the planning and execution of data gathering.

Shifting responsibility in this way is part of working towards creation of a sustainable medicines quality programme. With a sustainable programme in place a country would be equipped in the event of a reduction in financial support from the US Agency for International Development (USAID).