Just recently we reported about the counterfeited HIV drug Viread (Tenofovir) from Gilead and how the counterfeited Viread packs had penetrated into the legal supply chain. At that time a parallel importer had detected the deviations and could therefore stop their further distribution. Now, promptly, another two cases came up which shows that counterfeiters increasingly want their products to infiltrate into the distribution of wholesale and pharmacies. So far, the problem was primarily relevant in the online trade. Once again, a parallel importer has detected the counterfeit through his controls.
As the online portal pharmacy ad hoc reports now, 23 packs of the batch 4249XD18, Humira 40 mg / 0,8 ml solution for injection in pre-filled syringes, durable until May 2016, were identified as counterfeits. The batch number is not used by the company AbbVie. The portal pharmacy ad hoc refers to a release from the German Paul Ehrlich Institute (Federal Institute for Vaccines and Biomedicines): "According to PEI the blisters have two labels, under the top label another label can be found with Turkish inscription and a total of six different batch names. In one case batch number and expiry date on the top label were missing." The origin of the products is, according to PEI, in Poland and Turkey. AbbVie identified the supplied certificates as counterfeits.
The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte - BfArM) also informs about a possible counterfeit of Pulmozyme 2,500 E./2,5 ml (Dornase alfa) in the legal distribution chain in Germany. Two batches of N0070B03 and N0066B05 which were destined for the market in Poland were discovered by the parallel importer Axicorp Pharma GmbH in Germany. A release of the AMK News states: "According to information of the company Roche the Pulmozyme ampoules were replaced with saline solution ampoules within the original boxes. The text on the ampoules refers to sodium chloride 0,9% solution (Gilbert NaCl 0,9%)."
These two new cases show once again how important the controls in the legal supply chain are. The introduction of the 2D matrix codes as well as the GDP requirements and their monitoring are therefore important steps that will increase in importance and relevance.
Sources (in German language):
Online Portal Apotheke Adhoc
Paul Ehrlich Institute
BfArM Risk Information on Medicinal Products