Drug short­ages lead to ac­tion

Modern Healthcare - - The Week In Healthcare - Jaimy Lee

Grow­ing concern about drug short­ages in hos­pi­tals has prompted in­dus­try groups to ad­vo­cate for leg­isla­tive and regu- la­tory ac­tion that would ad­dress what they say is a bur­geon­ing cri­sis.

Nearly half of the hos­pi­tals sur­veyed by the Amer­i­can Hos­pi­tal As­so­ci­a­tion in June have dealt with short­ages of 21 or more drugs in the past six months. Al­most ev­ery one of the 820 hos­pi­tals sur­veyed—99.5%— said they had ex­pe­ri­enced at least one drug short­age in the past six months.

“It has been an is­sue that’s come up be­fore, but it’s never been as bad as it is now,” said Roslyne Schul­man, AHA’s di­rec­tor of pol­icy de­vel­op­ment.

The Univer­sity of Utah Drug In­for­ma­tion Ser­vice has recorded 156 drug short­ages in 2011 as of June 20, com­pared with 211 in all of 2010. The Food and Drug Ad­min­is­tra­tion, which mea­sures short­ages for “med­i­cally nec­es­sary” drugs, re­ported 178 drug short­ages in 2010. The num­ber of cur­rent short­ages was not avail­able.

Last month, the FDA re­quested that U.S. drug­mak­ers pro­vide warn­ings about pro­duc­tion short­ages for med­i­cally nec­es­sary drugs, such as on­col­ogy drugs, anes­thet­ics, “crash cart” drugs used in emer­gen­cies and elec­trolytes for pa­tients who are fed in­tra­venously.

Al­though warn­ings to providers and the FDA can mit­i­gate the ef­fects of short­ages, they don’t ad­dress the root prob­lem. In­dus­try and FDA of­fi­cials agree that the causes be­hind the short­ages in­clude phar­ma­ceu­ti­cal con­sol­i­da­tion, qual­ity is­sues, in­creased de­mand and some cor­po­rate ex­its of less prof­itable prod­uct ar­eas.

Hospira, one of the largest man­u­fac­tur­ers of generic drugs in the U.S., pro­vides daily up­dates on short­ages of its prod­ucts to the FDA, said Hospira spokes­woman Tareta Adams. The com­pany has vol­un­tar­ily dis­closed to the FDA a num­ber of short­ages, which have been posted on the agency’s web­site.

As a re­sult of the re­cent short­ages, 92% of hos­pi­tals sur­veyed told the AHA that drug costs have in­creased. Seventy-four per­cent have bought a more ex­pen­sive ver­sion of the prod­uct di­rectly from the man­u­fac­turer, and 42% have sought out an­other group pur­chas­ing or­ga­ni­za­tion to buy prod­ucts at a higher cost.

An anal­y­sis from the Premier health­care al­liance said U.S. hos­pi­tals that are forced to buy more ex­pen­sive generic or ther­a­peu­tic drugs could pay up to 11% more.

The AHA sup­ports leg­is­la­tion in the House and Se­nate that would re­quire the FDA to no­tify providers about drug short­ages. Those bills, how­ever, would not en­tirely rid hos­pi­tals of the is­sue.

“It will pro­vide FDA with more tools to help ad­dress short­ages and po­ten­tially even to pre­vent a few,” she said. “It’s not the to­tal so­lu­tion.”

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