Detec­tion of coun­ter­feit medi­ci­nes

The Fede­ral Office for Drugs and Medi­cal Devices (BfArM) is curr­ent­ly war­ning against coun­ter­feit medi­ci­nes. The secur­Ph­arm sys­tem reco­gni­zes such coun­ter­feits and makes it pos­si­ble to iden­ti­fy the­se pro­ducts at who­le­sa­lers or upon deli­very to phar­maci­es and remo­ve them from cir­cu­la­ti­on. With a man­da­to­ry check by means of a scan imme­dia­te­ly befo­re dis­pen­sing to pati­ents, it can be ruled out that they are being dis­pen­sed via the regu­lar trade. With the secur­Ph­arm sys­tem, phar­maceu­ti­cal manu­fac­tu­r­ers and phar­maci­es in Ger­ma­ny are imple­men­ting the EU’s Fal­si­fied Medi­ci­ne Direc­ti­ve (FMD). The task of the secur­Ph­arm sys­tem is to check a medi­ci­ne pack using an indi­vi­du­al pack num­ber. This ensu­res that it has legal­ly ente­red the sup­p­ly chain of the respec­ti­ve Euro­pean coun­try. Every phar­maceu­ti­cal manu­fac­tu­rer is obli­ged to assign an indi­vi­du­al pack num­ber to each indi­vi­du­al pack and to trans­fer this to a hig­her-level data­ba­se, which in Ger­ma­ny is the secur­Ph­arm sys­tem. Secu­ri­ty checks ensu­re that only aut­ho­ri­zed com­pa­nies can upload data to the sys­tem. When a medi­ci­ne is dis­pen­sed by a phar­ma­cy, the cha­rac­te­ristic is che­cked. If it matches and the medi­ci­ne is dis­play­ed as “not boo­ked out”, the phar­ma­cy can rest assu­red that the pack is safe and can be dis­pen­sed to pati­ents. In the event of devia­ti­ons, a cor­re­spon­ding and unam­bi­guous war­ning mes­sa­ge is issued. In such cases, the phar­ma­cy is obli­ged to qua­ran­ti­ne the pack and not dis­pen­se it. The fol­lo­wing the­r­e­fo­re appli­es to pati­ents: the­re are very high safe­ty stan­dards for medi­ci­nes that are obtai­ned via the legal dis­tri­bu­ti­on chain. The safest way for pati­ents is to obtain them direct­ly from a phar­ma­cy. On the other hand, anyo­ne who obta­ins medi­ci­nes from non-legal sources, e.g. via unaut­ho­ri­zed dea­lers on the Inter­net, runs the risk of acqui­ring coun­ter­feit or sto­len medi­ci­nes, the effects of which can be hazar­dous to health. In the cur­rent case, secur­Ph­arm is in cont­act with the respon­si­ble regu­la­to­ry aut­ho­ri­ties and sup­ports them in their inves­ti­ga­ti­ons with appro­pria­te eva­lua­tions and infor­ma­ti­on.