Drug short­ages hurt ERs

In­jecta­bles are in high de­mand but make small profit.

The Denver Post - - NATION & WORLD - By Erin Blake­more

Emer­gency rooms are health care’s front line — in the United States, nearly 45 out of 100 peo­ple visit an ER in any given year. But there’s an is­sue brew­ing be­hind the scenes in emer­gency med­i­cal fa­cil­i­ties, one that can’t be fixed by a sim­ple stitch or ban­dage. A new study pub­lished in the jour­nal Aca­demic Emer­gency Medicine shows that drug short­ages in ERs across the U.S. in­creased by more than 400 per­cent be­tween 2001 and 2014.

The study an­a­lyzed data from the Univer­sity of Utah Drug In­for­ma­tion Ser­vice, which re­ceives drug short­age re­ports sub­mit­ted through a pub­lic site ad­min­is­tered by the Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists. Two prac­tic­ing emer­gency room physicians as­sessed whether the re­ported short­ages had to do with drugs used in ERs, then looked at whether they were as­so­ci­ated with life­sav­ing or acute con­di­tions.

Of the nearly 1,800 drug short­ages re­ported be­tween 2001 and 2014, nearly 34 per­cent were used in emer­gency rooms. More than half (52.6 per­cent) of all re­ported short­ages were of life­sav­ing drugs, and 10 per­cent of short­ages af­fected drugs with no sub­sti­tute. The most com­mon drugs on short­age are used to treat in­fec­tious dis­eases, re­lieve pain and treat pa­tients who have been poi­soned. Though the num­ber of short­ages fell be­tween 2002 and 2007, they’ve risen by 435 per­cent be­tween 2008 and 2014.

That’s noth­ing less than a pub­lic health cri­sis, said Jesse Pines, di­rec­tor of the of­fice for clin­i­cal prac­tice in­no­va­tion at Ge­orge Wash­ing­ton Univer­sity School of Medicine & Health Sci­ences and the study’s se­nior au­thor. Short­ages “are real, they’re hap­pen­ing, and they’re get­ting worse,” he said. Pines, who prac­tices emer­gency medicine, said that though emer­gency rooms are im­ple­ment­ing things like pro­vid­ing posters with quick al­ter­na­tive drug op­tions, there’s no ob­vi­ous way to cut short­ages.

The pri­mary rea­sons given for short­ages were man­u­fac­tur­ing de­lays (25.6 per­cent), sup­ply and de­mand (14.9 per­cent), and avail­abil­ity of raw ma­te­ri­als (4.4 per­cent). Phar­ma­ceu­ti­cal com­pa­nies listed “busi­ness de­ci­sion” as the rea­son for a short­age 2.1 per­cent of the time. But in over 46 per­cent of the short­ages stud­ied, there was no rea­son given.

Phar­ma­ceu­ti­cal Re­search and Man­u­fac­tur­ers of Amer­ica (PhRMA), an in­dus­try group, points the fin­ger at sec­ondary whole­salers. “The man­u­fac­turer of a drug has no in­flu­ence or con­trol over the prices charged by a sec­ondary whole­saler to a hos­pi­tal or phar­macy,” the group said in a state­ment on its web­site. Sup­ply chain is­sues and raw ma­te­ri­als short­ages can also play into short­ages. The Health­care Dis­tri­bu­tion Man­age­ment As­so­ci­a­tion, a whole­saler in­dus­try group, writes that “many fac­tors” may re­sult in prod­uct short­ages and that they typ­i­cally hap­pen with “in­suf­fi­cient warn­ing and of­ten (re­quire) sig­nif­i­cant time and re­sources to man­age.”

Could Food and Drug Ad­min­is­tra­tion in­ter­ven­tion solve the prob­lem? Not ex­actly: Though the FDA has is­sued a long-term strate­gic plan to pre­vent drug short­ages, it ad­mit­ted it can­not re­quire phar­ma­ceu­ti­cal com­pa­nies to make cer­tain drugs, pro­duce more of a drug or change the amount dis­trib­uted. “There are a num­ber of fac­tors that cause or con­trib­ute to drug short­ages that are out­side of FDA’s con­trol,” the agency wrote in an in­fo­graphic about the is­sue.

Iron­i­cally, in­creased FDA over­sight might even cre­ate more short­ages — re­searchers note that rather than in­vest in in­fra­struc­ture or sub­mit to en­hanced in­spec­tions, busi­nesses may de­cide sim­ply to stop pro­duc­ing drugs. “This is one of the byprod­ucts of a fo­cus on cost in health care,” ex­plained Pines. “There may be a de­mand for med­i­ca­tion, but it may not be in a com­pany’s best in­ter­est to pro­duce it be­cause the amount they can charge is of­ten lower than the amount it costs to man­u­fac­ture it.”

It seems sim­ple enough: If com­pa­nies pro­duce more drugs, more drugs will be avail­able to ERs. But given that the ma­jor­ity of drugs on short­age in emer­gency rooms are ster­ile in­jecta­bles with low profit mar­gins, don’t ex­pect that to hap­pen any­time soon. “There are many ways to mit­i­gate drug short­ages, but there’s no magic bul­let to solve them,” said Pines. “This could and po­ten­tially will get worse.”

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