解决方法的根本原因：解决仿制药短缺问题的政策建议.docxVIP

Rootcausestosolutions:Apolicyproposaltoaddressgenericdrugshortages

February2025

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Introduction

IntheUnitedStates(US),drugshortageshavebecomeapersistentpublichealthissue,

negativelyimpactingpatientcareandoutcomes.iShortagesaredefinedbytheFoodandDrug

Administration(FDA)as“aperiodoftimewhendemandorprojecteddemandforadrugwithintheUSexceedsthesupplyofthedrug.”iiInthelastdecade,thefrequencyoftheseshortageshas

continuedtorise,with271identifieddrugshortagesbyyear-end2024,asignificantincreasefrom185in2015(seeFigure1).

Figure1.RiseinUSdrugshortages2015-2024iii

Numberofdrugshortages

350

300

250

200

150

301295

301

264271

264

260

251

246

185183

185

176

2015201620172018201920202021202220232024Year

Source:AmericanSocietyofHealth-SystemPharmacists,DrugShortagesStatistics,2015-2024Error!Bookmarknotdefined.

Shortagesaffectmanydiseaseareasincludingcardiovascular,neurology,andchronicpain,as

wellasdifferentpatientpopulationssuchaspediatrics.Shortagesdisproportionatelyimpact

genericdrugs1(withgenericscomprisingupto84%ofallongoingshortages).ivOfgenericdrugs,genericsterileinjectables(GSIs),whichincludesalineforIVs,life-savingcancertherapies,andessentialantibiotics,areparticularlyvulnerable,withGSIsaccountingfor67%ofdrugshortagesin2023.vAlthoughshortagesareusuallytemporary,theyareasignificantandwidespread

problemintheUS,withsomelastingoverayear.

Intermsofpatientimpact,itisestimatedthatupto75%ofpatientsadmittedtohospitalsareatriskofneedingadrugthatisinshortage,however,thereislimitedpublicawarenessofthe

1Genericdrugsarerequiredtocontainthesameactiveingredientas