GAO: Rise in Drug Shortages Harming Patients

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A pharmacist pours Truvada pills back into the bottle at Jack's Pharmacy on November 23, 2010 in San Anselmo, California.
National Journal
Clara Ritger
Feb. 10, 2014, 1:52 p.m.

The num­ber of drug short­ages has quad­rupled in the past five years, for­cing doc­tors and phar­macists to delay or ra­tion care, as life-sav­ing med­ic­a­tions re­main in short sup­ply, ac­cord­ing to the Gov­ern­ment Ac­count­ab­il­ity Of­fice on Monday.

There were 456 drug short­ages in 2012, and the trend was con­tinu­ing, with an­oth­er 361 drug short­ages re­por­ted by the middle of 2013, ac­cord­ing to the GAO re­port.

Drug-qual­ity is­sues and man­u­fac­tur­ing delays or shut­downs re­lated to qual­ity ac­coun­ted for 70 per­cent of drug short­ages re­por­ted between Jan. 1, 2011, and June 30, 2013, ac­cord­ing to the re­port.

The scarcity of cer­tain drugs in the mar­ket has jeop­ard­ized the abil­ity of care pro­viders to sta­bil­ize trauma vic­tims, con­trol pain dur­ing sur­gery, and treat heart dis­ease, said Mar­cia Crosse, GAO’s dir­ect­or of health care, at a con­gres­sion­al hear­ing on the re­port.

“The large num­ber of short­ages re­por­ted to the FDA sug­gests the mar­ket is still at risk of sup­ply dis­rup­tions,” Crosse said.

The Food and Drug Ad­min­is­tra­tion is re­spons­ible for over­see­ing drug qual­ity-prob­lems and work­ing with man­u­fac­tur­ers to rem­edy short­ages. Con­gress gran­ted the FDA great­er over­sight powers in 2012 after it passed the Food and Drug Ad­min­is­tra­tion Safety and In­nov­a­tion Act, re­quir­ing man­u­fac­tur­ers to no­ti­fy the agency of short­ages and re­quir­ing the agency to main­tain short­age data­bases and cre­ate ac­tion plans to solve them.

GAO cred­ited the FDA with mak­ing pro­gress in its goal to in­crease the avail­ab­il­ity of drugs, par­tic­u­larly gen­er­ics, in the face of short­ages. The FDA’s ef­forts to get drugs back on the mar­ket in­clude reg­u­lat­ory flex­ib­il­ity and ex­ped­ited re­views of new drugs.

While the num­ber of over­all drug short­ages re­mains high, the num­ber of new drug short­ages is fall­ing. There were 195 new short­ages in 2012, down from 255 in 2011.

“Our next task is to un­der­stand those longer-dur­a­tion short­ages,” said Douglas Throck­mor­ton, deputy dir­ect­or of reg­u­lat­ory pro­grams at the FDA.

Roughly 64 per­cent of new drug short­ages — 722 of the 1,132 re­por­ted to the FDA between Janu­ary 2007 and June 2013 — las­ted less than one year. But 14 per­cent las­ted more than two years, and some as long as four or more.

GAO re­com­mends that the FDA im­prove its data­base of drug short­ages and use the in­form­a­tion to ana­lyze trends and identi­fy risk factors to pre­vent fu­ture de­fi­cien­cies.

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