IoM backs track-and-trace to curb counterfeit medicines

The US Food and Drug Administration (FDA) should establish a track-and-trace system - in consultation with industry - to help tackle the problem of falsified medicines, according to an Institute of Medicine report.

Congress should authorise and fund the FDA to develop a framework for a voluntary system - likely based on unique serial numbers on packs - that meets the needs of branded and generic drugmakers, nots the wide-ranging document.

"A method of tracking individual packages of medicines from the factory to the consumer could greatly reduce the chances of a dangerous product being sold at a reputable pharmacy," says the IoM, although it notes this will not protect consumers who go outside the legitimate supply chain to unlicensed shops such as online pharmacies.

Other technological recommendations in the report include the setting up of a repository of detection, sampling, and analytical technologies to identify substandard and falsified medicines, which it suggests should be overseen by the National Institute of Standards and Technology in the US.

Also with regard to the US market, the IoM also calls for broader use of the National Association of Boards of Pharmacy (NABP) accreditation standards when states license wholesalers, adding that the FDA should develop a database to record violations.

Developing world

The report recognises that the burden of falsified medicines is faced disproportionately by countries in the developing world, and says there is a pressing need for the World Health Organization to develop definitions that makes a clear distinction between falsified drugs that are falsely represented in terms of identity and/or source, and substandard medicines resulting from quality failures. 

This is an ongoing issue for the WHO - which is struggling to redefine its role in the counterfeit medicines fight after being accused of straying beyond its public health remit into questions of intellectual property.

The WHO adopted a resolution last year to set up a member state 'mechanism' to tackle what it is currently having to call substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products, and held its first meeting to implement that in November 2012.

The IoM also wants the WHO to work with the United National Office on Drugs and Crime (UNODC) and other stakeholders to develop a transparent code of practice covering surveillance, regulation and law enforcement.

"The vast majority of problems occur in developing countries where underpowered and unsafe medicines affect millions," says the IoM report, although it notes that there are serious cases in countries with developed regulatory structure, including the US which saw negligent production at a Massachusetts compounding pharmacy kill 44 people between September 2012 and January 2013.

Among the other recommendations in the report are the establishment or strengthening of national systems and to detect substandard, falsified, and unregistered medicines and greater collaboration internationally on the issue.

Drugmakers in developing countries seeking to upgrade their production systems to meet international standards should be able to gain access to funding from the International Finance Corporation (IFC) and the Overseas Private Investment Corporation, with government action to encourage local companies to develop partnership with overseas drugmakers.

Meanwhile national medicine procurement agencies should strive to meet WHO quality assurance standards within here to five years, it notes.

FDA Commissioner Margaret Hamburg welcomed the report, saying it "spotlights a critical global public health issue" which "must be elevated to the highest levels of international discourse".

A copy of the IoM report is available for download here.