Nigeria sets five-year objective for medicines traceability

Within the next five years, Nigeria wants a medicine track-and-trace system to be in place for at least 70 per cent of pharmaceuticals sold in the country.

That was the message delivered by Prof Mojisola Christianah Adeyeye, director-general of the National Agency for Food and Drug Administration and Control (NAFDAC), at the second African GS1 Healthcare Conference held in Lagos last week.

There is an urgent need to implement traceability for medicines in Nigeria as the latest estimates are that around 17 per cent of drugs distributed in the country are substandard or falsified. While that is an improvement on the 40 per cent rate seen in the early 2000s, it is still far too high, said Adeyeye.

Nigeria has deployed various technologies to try to curb counterfeit medicines, including a mobile authentication system (MAS) that was piloted in 2010 and deployed in 2012 for antimalarial and antibiotic medicines, including both imports and drugs manufactured within the country.

MAS seems to have had a profound impact, with the failure rate for antimalarials falling form nearly 20 per cent in 2010-2012 to just 1.3 per cent in a March 2019 results, but “the time is right for traceability in the supply chain using global standards,” Adeyeye told the conference.

The objective is to improve the visibility of product status “from plant to patient”, by using serialized barcodes to track drugs through the legitimate supply chain and to “identify and authenticate drugs dispensed at “service delivery points in the public and private sectors.”

Around 10 companies are already using bar codes compliant with GS1 standards in Nigeria for verification only, but Adeyeye stressed that elevating that to full traceability will be a capital-intensive project that will require significant funds.

The intention is to start a scalable project that will build gradually to national implementation, following one of two possible models.

One option is for the manufacturer of a medicine to put product master data and serialized product information on the secondary package, which can be verified by the patient or healthcare provider using a smartphone app in a ‘bookend’ approach by checking the serial number against a centralised database.

Another more complex option would be to use the serialized barcodes on secondary packs – possibly linked to shipping containers – to capture traceability information as products move through the supply chain via wholesalers and distributors.

Once again a centralised database would be needed, and in this case the healthcare provider would capture receipt and dispense information, said Adeyeye.

Implementing a traceability system of this type would “probably be one of the greatest legacies to bequeath to the future Nigeria and Africa,” she told the conference.

The meeting also hosted the official launch of a call to action by 25 African regulatory authorities and six health financing and donor organisations for an ‘African strategy for pharmaceutical traceability’.

The call to action is seeking the adoption of global standards for medicine traceability that can be rolled out across Africa in order to improve the availability of quality medicines, ensure greater visibility of products within the supply chain and enable improved patient care.

“Across Africa medicine regulatory authorities work hard to protect patients and provide access to quality medicines,” said Adeyeye.“Today we affirm medicine traceability as a key tool in our collective efforts to support healthy populations and more effective supply chains.”