2011 medication shortages set new record at 267

LINDA A. JOHNSON

AP Busi­ness Writer

TRENTON, N.J. — The num­ber of new pre­scrip­tion drug short­ages in 2011 shot up to 267, well above the prior record and about four times the num­ber of med­ica­tion short­ages in the mid­dle of the last decade.

Fig­ures just released by the Uni­ver­sity of Utah Drug Infor­ma­tion Ser­vice, which tracks national drug short­ages, show there were 56 more newly reported drug short­ages in the U.S. last year than in 2010, when there were 211. By con­trast, there were only 58 drug short­ages reported in 2004.

As the drug short­ages worsen, so does their impact on patient care, par­tic­u­larly in hos­pi­tals. The inabil­ity to get cru­cial med­i­cines has dis­rupted chemother­apy, surgery and care for patients with infec­tions and pain. At least 15 deaths since 2010 have been blamed on the short­ages, which have set a record high in each of the last five years.

“At the begin­ning of the year, we were on a pace of about a short­age every day,” Erin R. Fox, man­ager of the ser­vice, told The Asso­ci­ated Press. “Luck­ily, that pace has def­i­nitely diminished.”

She noted the Food and Drug Admin­is­tra­tion has said it has pre­vented more than 100 new short­ages in 2011. That’s partly because of an exec­u­tive order Pres­i­dent Obama issued on Oct. 31 to address the short­ages, with pro­vi­sions requir­ing more man­u­fac­tur­ers to report poten­tial short­ages in advance to the FDA.

But Fox is still wor­ried because many of the cur­rent short­ages won’t be resolved any­time soon, based on reports from sev­eral key man­u­fac­tur­ers that have had to shut down pro­duc­tion because of con­t­a­m­i­na­tion or other qual­ity prob­lems. For some med­i­cines, there may be only one other man­u­fac­turer, which doesn’t have the capac­ity to fill the gap imme­di­ately or completely.

In addi­tion, Fox said some of the more recently reported short­ages are very dif­fi­cult for hos­pi­tal phar­ma­cists and other staff to man­age. She noted new short­ages of seda­tives widely used in surgery, includ­ing Val­ium, Versed and lorazepam. Another big prob­lem is the recent short­age of the opi­oid painkiller fentanyl.

“It is used like water in hos­pi­tals, for every­thing from moms giv­ing birth and ICU patients to the ER,” Fox said.

Her ser­vice pro­vides hos­pi­tals with lists of alter­na­tive drugs to those in short sup­ply, but for some med­i­cines the alter­na­tives also are hard to find, and switch­ing to an unfa­mil­iar drug can result in dosage errors.

Most of the drugs in short sup­ply are ster­ile injected drugs that are the work­horses of hos­pi­tals and are nor­mally inex­pen­sive because they’ve long been avail­able as generics.

The FDA says the main rea­son for the short­ages is man­u­fac­tur­ing defi­cien­cies lead­ing to pro­duc­tion shut­downs. Other rea­sons include com­pa­nies end­ing pro­duc­tion of some drugs with tiny profit mar­gins, con­sol­i­da­tion in the generic drug indus­try and lim­ited sup­plies of some ingredients.

Besides dis­rupt­ing patient care, the short­ages have delayed clin­i­cal tri­als com­par­ing exper­i­men­tal drugs to older ones and have led to unprece­dented price goug­ing, with hos­pi­tals some­times hav­ing to pay out­ra­geous markups for scarce drugs. In one case that’s among those under inves­ti­ga­tion by Con­gress, a ven­dor out­side the nor­mal sup­ply chain offered to sell a hos­pi­tal a vial of a can­cer drug that nor­mally costs about $12 for more than $990.

The FDA and sev­eral mem­bers of Con­gress have been hold­ing hear­ings since Sep­tem­ber to iden­tify rea­sons for and pos­si­ble solu­tions to the shortages.

“I hope that we won’t have another record-breaking year” in 2012, Fox said. “But I’m not optimistic.”

Posted by AP News on Jan 4 2012. You can follow any responses to this entry through the RSS Feed. Comments can be made below.