New drug track­ing and safety law takes ef­fect Jan. 1

Modern Healthcare - - THE WEEK AHEAD - —Jaimy Lee

The first phase of a new “track and trace” law to help man­u­fac­tur­ers, dis­trib­u­tors, whole­salers and phar­ma­cists bet­ter mon­i­tor the phar­ma­ceu­ti­cal sup­ply chain goes into ef­fect Jan. 1.

The Drug Qual­ity and Se­cu­rity Act, which be­came law in 2013, will take a phased ap­proach to the roll­out of a na­tional drug-track­ing sys­tem us­ing se­rial num­bers. Start­ing in 2015, drugs mak­ing their way through the sup­ply chain will be re­quired to have new in­for­ma­tion, in­clud­ing lot num­bers, the names and ad­dresses of buy­ers and sell­ers, and a trans­ac­tion his­tory. The law also sets out new re­quire­ments for com­pound­ing phar­ma­cies.

The act is ex­pected to boost se­cu­rity and lessen con­cerns about coun­ter­feit and sub­stan­dard drugs end­ing up in the sup­ply chain. Man­u­fac­tur­ers and providers should be able to “un­der­stand how that drug trav­eled” through the sup­ply chain and im­prove the re­call process, said Gabrielle Cosel, man­ager of the drug-safety project at the Pew Char­i­ta­ble Trusts.

The act pre-empted a Cal­i­for­nia law sched­uled to take ef­fect in 2015 that was con­sid­ered the most com­pre­hen­sive state law ad­dress­ing drug sup­ply­chain se­cu­rity. It would have re­quired elec­tronic records of drugs. Most states reg­u­late drug sup­ply chains but not all of them re­quired drug pedi­grees, which track a drug from the man­u­fac­turer to the phar­ma­cist who then dis­penses it to the pa­tient.

Re­cent drug short­ages trig­gered re­newed calls for a track­ing sys­tem be­cause hos­pi­tals started buy­ing drugs in short sup­ply from sec­ondary dis­trib­u­tors, which raised ques­tions about safety and qual­ity as well as fed­eral over­sight of that sys­tem.

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