Guard­ing the Rx sup­ply chain

Modern Healthcare - - OPINIONS / LETTERS -

Is­in­cerely ap­pre­ci­ated your edi­to­rial (“Un­nec­es­sary com­pro­mise,” June 10, p. 18). The ar­ti­cle thor­oughly out­lined the un­der­ly­ing points and back­ground of the de­vel­op­ing phar­ma­ceu­ti­cal sup­ply chain se­cu­rity dis­cus­sion. The ar­ti­cle men­tions the Phar­ma­ceu­ti­cal Dis­tri­bu­tion Se­cu­rity Al­liance (PDSA) and its sup­port of fed­eral leg­is­la­tion, es­pe­cially the pre-emp­tion of state bills, Cal­i­for­nia SB 1307 par­tic­u­larly, which re­quire track­ing of units through the sup­ply chain. While their ob­jec­tion is rep­re­sented as seek­ing com­mon stan­dards in­stead of a patch­work of state reg­u­la­tions, it is the item­level track in sup­ply chain, which is ab­sent in fed­eral leg­is­la­tion, that pro­vides the great­est chal­lenge and the loud­est ob­jec­tions.

I’ve been in­volved in eval­u­at­ing the de­vel­op­ing leg­is­la­tion in Congress since early last year (H.R 1919 and S. 957). I was one of the seven in­dus­try pan­elists that ad­dressed the House En­ergy and Com­merce Com­mit­tee on April 25. While all of the wit­nesses were in sup­port of im­prov­ing phar­ma­ceu­ti­cal sup­ply­chain se­cu­rity, not all saw the merit in item­level track­ing for con­tain­ers in tran­sit from man­u­fac­turer through the phar­macy.

Based upon the open­ing state­ments from the law­mak­ers and their fol­low-up ques­tions to tes­ti­mony, one would have con­cluded that they were of a like mind and that we were head­ing to­ward a more ro­bust law con­sis­tent at least with the Cal­i­for­nia leg­is­la­tion al­ready on the books. Sadly, the re­vised bill was weak and in no way rep­re­sented the com­ments we heard on the 25th. It is shock­ing that pub­lic safety has taken a back­seat to pol­i­tics.

We have con­tin­u­ally noted to leg­is­la­tors that track­ing units and read­ing the item-level codes is the most crit­i­cal part of sup­ply chain se­cu­rity, in par­tic­u­lar the read at the point of dis­pense in phar­macy, not sim­ply at re­ceipt. There are too many doc­u­mented in­stances of phar­macy-in­tro­duced coun­ter­feits, di­verted prod­uct (In­ter­net prod­uct), dis­pense of re­turned prod­uct and even dis­pense of out­dated prod­uct. Only when we check at dis­pense will th­ese events be pre­vented.

While it is un­likely this cur­rent leg­is­la­tion will in­clude the scan at point of dis­pense, there may be an­other path to achieve this level of se­cu­rity. We’ve been pro­mot­ing the con­cept that in­sur­ers (phar­macy ben­e­fit man­agers, health­care providers, the CMS, etc.) could and should re­quire the stan­dard­ized nu­meric iden­ti­fier (SNIs) for re­im­burse­ment of pre­scrip­tions. By re­quir­ing this num­ber and ver­i­fy­ing it against an in­dus­try-man­aged data­base, we will thwart bad ac­tors in phar­macy who may in­tro­duce coun­ter­feit or sub­stan­dard prod­ucts. Pre­scrip­tion fraud was a key driver for the in­tro­duc­tion of se­rial- ized phar­ma­ceu­ti­cal con­tain­ers in sev­eral Euro­pean coun­tries.

While the cur­rent Se­nate bill does es­tab­lish se­ri­al­iza­tion as an early step, which is com­mend­able, it fails to re­quire ac­tive check­ing of that se­rial num­ber in tran­sit as rec­om­mended by the Food and Drug Ad­min­is­tra­tion, and, most crit­i­cally, at dis­pense in phar­macy. This will rel­e­gate the SNI to be­ing a tool for in­ves­ti­gat­ing why a prob­lem oc­curred in­stead of pre­vent­ing the in­tro­duc­tion of coun­ter­feit and sub­stan­dard drugs. That this leg­is­la­tion seems to ig­nore the rec­om­men­da­tion of the FDA, the very en­tity charged with safe­guard­ing the phar­ma­ceu­ti­cal sup­ply chain, is trou­bling to say the least.

The bill ul­ti­mately fails to com­plete sup­ply chain se­cu­rity, which would end with the scan in phar­macy at dis­pense. The pieces are here but they are not be­ing used in con­cert to achieve the goal of a safe sup­ply chain. With­out this last scan, all the work along the way is vir­tu­ally use­less. There have been too many in­stances where phar­macy in­tro­duced coun­ter­feits, grey mar­ket prod­uct and even dis­pensed re­turned/re­called prod­uct.

The rest of the world is mov­ing steadily to­ward a se­ri­al­ized sup­ply chain for phar­ma­ceu­ti­cals. As China, In­dia, Turkey, Brazil, Ar­gentina and nu­mer­ous oth­ers tighten se­cu­rity and we con­tinue to lan­guish, you have ef­fec­tively painted a tar­get on the U.S. sup­ply chain mak­ing it a haven for global counterfeiters. With­out track and trace in tran­sit and most im­por­tantly with­out ver­i­fi­ca­tion at dis­pense in phar­macy we lose the ben­e­fit of se­ri­al­iza­tion. By fail­ing to track and fail­ing to ver­ify at dis­pense we’ve re­duced se­ri­al­iza­tion to a tool for foren­sic anal­y­sis of what went wrong. “Why did this bad drug end up be­ing in­gested by this pa­tient?”

Wal­ter Berghahn Pres­i­dent, SmartRmeds for Life Ex­ec­u­tive di­rec­tor, Health­care Com­pli­ance Pack­ag­ing Coun­cil, Bon Air, Va.

Newspapers in English

Newspapers from USA

© PressReader. All rights reserved.