Study attempts to separate falsified from substandard meds

Researchers in the US have attempted to sort out a longstanding issue when trying to monitor medicines quality – is a sample that fails quality testing falsified, or substandard?

While either scenario is a serious issue for patient health, separating the two categories is important when it comes to investigating fraudulent activities and trying to identify the bad actors behind them.

In their study, the team from the University of North Carolina reviewed data on substandard and falsified essential medicines intercepted in low- and middle-income countries – a collective sample size of more than 95,000 across almost 100 studies – to see if the levels of active pharmaceutical ingredient (API) in the medicines could serve as a proxy for whether they were falsified for substandard.

According to World Health Organization (WHO) definitions, falsified medicines are those that deliberately/fraudulently misrepresent their identity, composition or source, while substandard medicines are those that are manufactured legitimately, but fail to meet quality standards.

Their analysis concludes that a quarter of the medicines that failed quality tests had SAPI levels of less than 80 per cent, and 12.5 per cent were found to have no API at all or an incorrect ingredient – not too far from the WHO estimate that 10 per cent of all medicines are fake.

Overall, one in seven of the samples were likely to be falsified as they had API levels of 50% of normal or less or a different API entirely, and were found to be more common in Asia (23 per cent of samples) than Africa (11 per cent).

The remaining six of seven were considered substandard as they had higher levels of API that pointed for example to a failure in production or subsequent storage in unsuitable conditions. Most of the studies did not however report whether the product authenticity was confirmed by the manufacturer.

A majority of the studies concentrated on antibiotics and antimalarials, which seemed to be most prone to falsification, but some also covered painkillers, anti-inflammatories and blood pressure drugs, amongst other medicines.

"This is an important finding because falsified medicines dealing with criminal activity tend to attract more attention than substandard medicines," write the researchers in the American Journal of Tropical Medicine and Hygiene.

"Yet our results demonstrate that medicines with reduced API are also a pervasive problem, one that governments and policy makers need to allocate more resources toward combatting," they continue.

"Because both substandard and falsified medicines pose a threat to public health, it is critical to direct resources at them differently."

They recommend that API levels be included in official reports of low-quality medicines, something that is not currently done routinely, and call for a standardised approach as there are inconsistencies "across countries, medicines, and sampled locations."

They also recommend that attempts are made to communicate with the manufacturer to confirm the original source.

For medicines below the 80 per cent API threshold but not below 50 per cent, they advise that studies are undertaken to look for evidence of degradation, indicating a problem after manufacturing.

"Governments and policy makers should use these results to target interventions to mitigate the threats of substandard and falsified medicines," they conclude.

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