Study reveals counterfeit medicine patterns in Brazil

Pharmacy imageSteroids and drugs for erectile dysfunction topped the list of counterfeited medicines seized by the authorities in Brazil between 2007 and 2010, according to a new study.

Researchers examined reports compiled by Brazil's Federal Criminal Police and found that counterfeit copies of Pfizer's Viagra (sildenafil) and Eli Lilly's Cialis (tadalafil) collectively accounted for two thirds (66 per cent) of all seizures.

The next most commonly-encountered products were two corticosteroids, namely Merck Sharp & Dohme's Sustanon (testosterone esters) and Deca Durabolin (nandrolone), as well as Unimed Pharmaceuticals' Anadrol (oxymetholone), which together counted for another 26 per cent of seizures, according to the researchers. 

Other drugs seized with lower frequency included fake versions of Pfizer's prostaglandin product Cytotec (misoprostol), Novartis' cancer treatment Gleevec (imatinib) and Roche's obesity drug Xenical (orlistat).

Over the four-year period, seizures of ED drugs actually declined as those of other medicines rose. The authors suggest that this may relate to the availability of generic sildenafil products which is cutting into the profit margins of counterfeiters.

The data also reveals an interesting trend in counterfeit seizures, with 70 cases in 2007, 139 in 2008 and 233 in 2009. In the first nine months of 2010 the number of seizures was 168, suggesting that for the full year the tally would have been similar to that seen in 2010.

The analysis also provides insight into the patterns of counterfeit distribution in Brazil, with the majority of seizures taking place in the states of Parana, Santa Catarina and Sao Paulo, all of which are in the south eastern region of the country.

The authors suggest the high rate of seizures in these areas reflect the typical trade routes for counterfeit medicines, particularly from Paraguay which they suggest has a much more informal supply chain with less regulatory oversight.

Drug counterfeiting is a serious public health problem," write the authors of the study in the journal Revista de Saude Publica (at the time of writing an epub ahead of print - in Portuguese - was available here).

"The identification of classes of counterfeit medicines in the country and the main Brazilian states with this problem can facilitate future preventative actions by the responsible Brazilian agencies."

They call for advertising campaigns to warn the public of the dangers of counterfeit medicines, as well as more rigorous monitoring of entry points in Brazil's supply chain, such as ports, airports and border crossings.

Brazil's medicines regulatory authority (ANVISA) has proposed a comprehensive traceability system for medicines, based on the use of serial numbers to identify individual packs that could be read at various points in the supply chain.

The authority is proposing a 13-digit, unique drug identifier (UDI) for each medicine pack that would be generated and managed by the regulatory body. Earlier requirements to make use of security seals for packs- provided by Brazil's mint - were dropped towards the end of 2011 (see Brazil's ANVISA drops security seal for medicine traceability).

Stopwatch and 2D code Traceability initiatives in the EU, USA and elsewhere will require pack-level coding (serialization) for prescription pharmaceuticals. SecuringPharma's just-published executive briefing explains these requirements, how they will affect your global supply chain, and what action you need to take. Order your copy here.

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