Spe­cial re­port: A bet­ter way to han­dle de­vice and drug re­calls

Providers are tak­ing the lead in re­vamp­ing sys­tem for han­dling ques­tion­able drugs and med­i­cal de­vices

Modern Healthcare - - Front Page - Jaimy Lee

The high-pro­file drug and de­vice re­calls of re­cent years have set the back­drop for health­care or­ga­ni­za­tions to es­tab­lish more efficient, proac­tive sys­tems that can bet­ter iden­tify early signs of trou­bled prod­ucts.

Drug and de­vice re­calls have been con­tin­u­ally cited as causes for in­creased scrutiny of the Food and Drug Ad­min­is­tra­tion’s de­vice ap­proval process be­cause of safety con­cerns, as well as for the drug short­ages af­fect­ing hos­pi­tals and health sys­tems.

The FDA noted in a letter to gov­ern­ment of­fi­cials that it has ex­pe­ri­enced “sig­nif­i­cant in­creases” in the num­ber of re­calls for the drugs, de­vices and di­ag­nos­tics that are reg­u­lated by the fed­eral agency.

“In re­cent years, the agency has ex­pe­ri­enced sig­nif­i­cant in­creases in the num­ber of re­calls of FDA-reg­u­lated prod­ucts, some of which in­volve the largest and most com­plex re­calls in FDA his­tory,” the agency wrote.

Robert Pezzin, in­terim vice pres­i­dent of sup­ply chain for Nex­era, the sup­ply-chain man­age­ment and con­sult­ing firm owned by the Greater New York Hos­pi­tal As­so­ci­a­tion, says the fi­nan­cial bur­den of a re­call, in­clud­ing de­vel­op­ing the sys­tems to man­age a re­call along with the costs when a prod­uct is re­called, of­ten falls to hos­pi­tals, rather than man­u­fac­tur­ers.

Pezzin works on-site at West Penn Al­legheny Health Sys­tem, based in Pitts­burgh.

“What we see is ev­ery or­ga­ni­za­tion is bur­dened with de­vel­op­ing its own process and sys- tem,” Pezzin says. “That takes con­sid­er­able re­sources and fi­nances. Right now, you don’t see that be­ing funded by the man­u­fac­tur­ers or by the FDA to as­sist hos­pi­tals in stan­dard­iz­ing this prac­tice.”

Along with the costs in­curred for the la­bor and ex­pense of pulling prod­ucts from shelves and re­turn­ing them to a man­u­fac­turer—some com­pa­nies will re­fund the freight cost—find­ing al­ter­na­tive drugs or de­vices can carry ad­di­tional costs.

“A sub­sti­tute prod­uct could carry a pre­mium over what you were us­ing be­fore,” Pezzin says.

Re­calls have pushed hos­pi­tals and health sys­tems to es­tab­lish au­to­mated re­sponses rather the man­ual sys­tems that many fa­cil­i­ties still have in place, says Kathy DeLa­cio, di­rec­tor of pro­cure­ment and ad­min­is­tra­tion for cor­po­rate con­tract­ing at West Penn Al­legheny. De­pend­ing on the prod­uct and the na­ture of the re­call, it can take be­tween a few days to a month to get a re­sponse to a re­call from a ven­dor about a re­turn au­tho­riza­tion.

The FDA’s role is to over­see a man­u­fac­turer’s man­age­ment of the re­call, ac­cord­ing to the GAO, but other stake­hold­ers that take part in the re­call ef­forts in­clude man­u­fac­tur­ers, distrib­u­tors, hos­pi­tals and pa­tients.

“There is the need to au­to­mate and com­press the time­frame from which a hos­pi­tal or a health­care sys­tem is no­ti­fied of a re­call,” DeLa­cio says. “By the time you get it out to all your end users, es­pe­cially when you have im­planta­bles in­volved, time is of the essence.”

John­son & John­son is one ex­am­ple of a phar­ma­ceu­ti­cal and de­vice man­u­fac­turer that has re­ported nu­mer­ous re­calls over the past sev­eral years.

With J&J al­ready deal­ing with a num­ber of over-the-counter prod­uct re­calls, DePuy Orthopaedics, a sub­sidiary of the New Brunswick, N.J.-based com­pany, re­called its ASR hip sys­tem in Au­gust 2010. The com­pany said the im­plant had a high early fail­ure rate, which led to more re­vi­sion surg­eries. The re­call prompted hun­dreds of law­suits.

“DePuy has a com­pre­hen­sive process in place for eval­u­at­ing and acting on any con­cern­ing prod­uct per­for­mance data and rapidly alert­ing cus­tomers if nec­es­sary,” DePuy spokes­woman Mindy Tins­ley said in a state­ment re­spond­ing to an in­ter­view re­quest. “We con­stantly eval­u­ate our pro­cesses for im­prove­ment.”

The re­calls, in­clud­ing the hip im­plant, were a key com­plaint in al­le­ga­tions of wrong­do­ing from J&J share­hold­ers in a re­cent law­suit. The re­call for the im­plantable de­vice af­fected 93,000 pa­tients world­wide.

The ASR hip sys­tems re­call is ex­pected to cost J&J $184 mil­lion in “rea­son­able and cus­tom­ary costs of test­ing and treat­ment associated with the re­call” over the next five years, ac­cord­ing to a com­pany re­port.

Re­cent re­calls have also put the FDA un­der ex­am­i­na­tion. Fol­low­ing a Se­nate hear­ing in April that ad­dressed the agency’s hand­ing of re­calls, the Gov­ern­ment Accountability Of­fice re­leased a re­port two months later that rec­om­mends the fed­eral agency take a more proac­tive stance in

—Gov­ern­ment Accountability Of­fice re­port

“Sev­eral gaps in the med­i­cal de­vice re­call process lim­ited firms’ and FDA’s abil­i­ties to en­sure that the high­est-risk re­calls were im­ple­mented in a timely and ef­fec­tive man­ner. For many high-risk re­calls, firms faced chal­lenges, such as lo­cat­ing spe­cific de­vices or de­vice users, and thus could not cor­rect or re­move all de­vices.”

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