Short­ages of medicines: a com­plex global chal­lenge

Middle East Business (English) - - FRONT PAGE - WHO re­port by Andy Gray & Henri R. Manasse Ac­knowl­edge­ments ... /...

Short­ages of es­sen­tial medicines, among them generic in­jectable chemo­ther­apy agents, are caus­ing in­creas­ing con­cern in the United States of Amer­ica (USA)( 1,2).

How­ever, the prob­lem is far wider, af­fect­ing other classes of medicines in­clud­ing in­jectable anaes­thetic agents, such as propo­fol, in­tra­venous nu­tri­tion and elec­trolyte prod­ucts, en­zyme re­place­ment prod­ucts and ra­dio­phar­ma­ceu­ti­cals(

3 5). Medicine short­ages have also


been noted in Aus­tralia and Canada

6,7). A re­cent com­men­tary in a


Bel­gian phar­macy jour­nal claims that the prob­lem is global – “from Afghanistan to Zim­babwe” – list­ing 21 coun­tries af­fected by a va­ri­ety of sup­ply prob­lems 8). A short­age of


the in­jectable an­tibi­otic strep­to­mycin was re­ported in 15 coun­tries in 2010, with 11 more coun­tries pre­dict­ing their stocks would run out be­fore they could be re­plen­ished 9).


This prob­lem does not seem to be that new: con­cern about pre­scrip­tion medicine short­ages was raised in the USA at least a decade ago( 10). The Amer­i­can So­ci­ety of Health-Sys­tem Phar­ma­cists’ web site (avail­able at: http:// www. ashp. org) shows 208 prod­ucts were not avail­able, with an­other 114 short­ages re­solved and 21 prod­ucts re­moved from the mar­ket in the USA ( as of 9 De­cem­ber 2011). A Novem­ber 2011 re­port from the IMS In­sti­tute for Health­care In­for­mat­ics showed that medicine short­ages in the USA were con­cen­trated in just five dis­ease ar­eas ( on­col­ogy, anti- in­fec­tives, car­dio­vas­cu­lar, cen­tral ner­vous sys­tem and pain man­age­ment) and that more than 80% in­volved generic in­jecta­bles( 11). How­ever, on a global scale, other mar­kets may be par­tic­u­larly “frag­ile”, fail­ing to meet de­mands for suit­able prod­ucts, such as pae­di­atric dosage forms for HIV/ AIDS and tu­ber­cu­lo­sis 12).


There is a wide range of causes for medicine sup­ply short­ages, some of which could be dealt with by govern­ment agen­cies. How­ever, no medicines’ reg­u­la­tory agency can man­date that a man­u­fac­turer pro­duce a spe­cific prod­uct. Man­u­fac­tur­ing qual­ity prob­lems have been im­pli­cated in short­ages of prod­ucts pro­duced by a lim­ited num­ber of sup­pli­ers, such as propo­fol,( imiglucerase

3) and agal­si­dase β and in­fluenza vac­cine( 10). Over­all, 43% of 127 short­ages in­ves­ti­gated by the United States Food and Drug Ad­min­is­tra­tion were at­trib­uted to man­u­fac­tur­ing qual­ity prob­lems( 13).

Where man­u­fac­tur­ing is de­pen­dent on a small num­ber of fa­cil­i­ties, shut­downs for var­i­ous rea­sons may cause prob­lems, as has been the case with some ra­dio­phar­ma­ceu ticals( 5). Changes in pro­cure­ment prac­tices ( such as in­sis­tence on World Health Or­ga­ni­za­tion pre­qual­i­fi­ca­tion sta­tus or reg­is­tra­tion with a strin­gent reg­u­la­tory au­thor­ity) may in­val­i­date a pre­vi­ous sup­plier, as hap­pened with strep­to­mycin.(


In­creased global de­mand, con­sol­i­da­tion of generic pro­duc­tion at a few sites, and changes in reg­u­la­tory stan­dards re­quir­ing up­grad­ing of man­u­fac­tur­ing plants are all pos­si­ble rea­sons for short­ages of in­jectable generic medicines in the USA. The IMS In­sti­tute for Health­care In­for­mat­ics re­port showed that two- thirds of the prod­ucts with sup­ply prob­lems only had three or fewer sup­pli­ers( 11). Gates­man and Smith have claimed that “the main cause of drug short­ages is eco­nomic”, point­ing par­tic­u­larly to per­verse con­se­quences of Medi­care re­im­burse­ment poli­cies, which have dis­cour­aged the use of low-cost generic chemo­ther­apy agents; how­ever, this as­ser­tion re­mains to be proven 1). A re­port


by the United States Depart­ment of Health and Hu­man Ser­vices blamed “a sub­stan­tial ex­pan­sion in the scope and vol­ume of prod­ucts pro­duced by the in­dus­try that has oc­curred over a short pe­riod of time, with­out a cor­re­spond­ing ex­pan­sion in man­u­fac­tur­ing ca­pac­ity”( 14). It pointed out that man­u­fac­tur­ing ca­pac­ity took time to es­tab­lish, and that ex­ist­ing man­u­fac­tur­ers ap­peared to be mak­ing “strate­gic de­ci­sions about where to de­ploy pro­duc­tion ca­pac­ity”. How­ever, the causes of some short­ages have not been iden­ti­fied. In Septem­ber 2011, the Coun­cil of the In­ter­na­tional Phar­ma­ceu­ti­cal Fed­er­a­tion called on “all stake­hold­ers, in­clud­ing gov­ern­ments, phar­ma­ceu­ti­cal man­u­fac­tur­ers, phar­macy whole­salers, phar­ma­ceu­ti­cal pur­chas­ing agen­cies, medicine in­sur­ance plans, phar­ma­ceu­ti­cal reg­u­la­tors and the phar­macy pro­fes­sion to ur­gently eval­u­ate th­ese is­sues and work to en­sure con­ti­nu­ity of med­i­ca­tion sup­ply so that the ap­pro­pri­ate treat­ment of pa­tients can be ini­ti­ated and main­tained” 15). The


United States Food and Drug Ad­min­is­tra­tion states on its web­site that it can­not re­quire firms to re­port the rea­son for short­age or du­ra­tion of the short­age or any other in­for­ma­tion about short­ages. Draft leg­is­la­tion to ad­dress this is­sue has been brought for­ward in both houses of the United States Congress( 16,17).

How­ever, a longer- term so­lu­tion may lie in care­ful pol­icy-mak­ing that avoids win­ner-takes-all pro­cure­ment de­ci­sions, that pro­motes the de­vel­op­ment of a sus­tain­able lo­cal and global phar­ma­ceu­ti­cal man­u­fac­tur­ing ca­pac­ity, and that iden­ti­fies and pro­tects par­tic­u­larly frag­ile mar­kets. While there have been pre­dictable lib­er­tar­ian calls for lift­ing price con­trols to pro­mote in­vest­ment( 18),

gov­ern­ments have a re­spon­si­bil­ity not only to en­sure the qual­ity of medicines and ac­cess to es­sen­tial medicines, but also to cre­ate the nec­es­sary con­di­tions for a sus­tain­able, pro­duc­tive and re­spon­si­ble phar­ma­ceu­ti­cal in­dus­try. In this case, lais­sez faire will not suf­fice.

Both au­thors are of­fice- bear­ers of the In­ter­na­tional Phar­ma­ceu­ti­cal Fed­er­a­tion (FIP).

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