GUIDELINES FOR PHARMACISTS PERFORMING PRODUCT SELECTION

DISPENSING DECISIONS
APhAs Bioequivalen ! "o#$in% G#ou& #e o''en(s )ha) &ha#'a is)s onsi(e# )he *ollo+in% *a )o#s +hen sele )in% (#u% &#o(u )s )o ,e (is&ense( )o )hei# &a)ien)sNo) all o* )hese *a )o#s +ill a&&l! )o ea h si)ua)ion no# a#e )he! o* equal +ei%h)"e ,elieve i* &ha#'a is)s onsi(e# )hese &oin)s as &a#) o* )he &#o*essional .u(%'en) &#o ess +hen 'a$in% (#u% &#o(u ) sele )ions/ i) is li$el! )ha) )he ,es) in)e#es)s o* )he &a)ien)s +ill ,e se#ve(-

I) is )he #es&onsi,ili)! o* )he &ha#'a is) )o use &#o*essional .u(%'en) in sele )in% )he &#o(u )-

0- S)a)e Rules an( Re%ula)ions All s)a)es have le%al #equi#e'en)s )ha) a((#ess )he issue o* (#u% &#o(u ) sele )ionPha#'a is)s shoul( ,e o%ni1an) o* )hese #equi#e'en)s an( ho+ )he! 'a! i'&a ) )hei# #ole in (#u% &#o(u ) sele )ionS)a)e #e%ula)ions also 'i%h) &#ovi(e in*o#'a)ion an( %ui(an e in (#u% &#o(u ) sele )ion )h#ou%h &osi)ive o# ne%a)ive *o#'ula#ies2- Bioequivalen e in*o#'a)ion3O#an%e Boo$ Ra)in%s Onl! &#o(u )s +i)h &#oven ,io4equivalen e shoul( ,e sele )e( )o ,e (is&ense( in lieu o* )he innova)o# &#o(u )-

P#o(u )s ,ein% (is&ense( in #es&onse )o a &#es #i&)ion (#u% o#(e# )ha) is +#i))en %ene#i all! shoul( ,e e5&e )e( )o &#o(u e a )he#a&eu)i ,ene*i) *o# )he &a)ien) a) #easona,le os)P#o(u )s )ha) a#e lis)e( in )he FDAs A&&#ove( D#u% P#o(u )s +i)h The#a&eu)i Equivalen e Evalua)ions 67The O#an%e Boo$89 as 7A8 #a)e( shoul( ,e sele )e( +hen su h &#o(u )s a#e availa,le-

The#a&eu)i Equivalen e Evalua)ion Co(es

7A8 D#u% P#o(u )s D#u% &#o(u )s FDA onsi(e#s )o ,e )he#a&eu)i all! equivalen)/ i-e-/ (#u% &#o(u )s *o# +hi h: 0- The#e a#e no a )ual o# &o)en)ial ,ioequivalen e &#o,le'sThese a#e (esi%na)e(: AA ; O#al )a,le)s/ a&sules an( liqui(s 6all soli( (osa%e *o#'s

'us) 'ee) a&&#o&#ia)e in vi)#o )es)s9AN ; Solu)ions an( &o+(e#s *o# ae#osoli1a)ion AO ; In.e )a,le oil solu)ions AP ; In.e )a,le aqueous solu)ions AT ; To&i al/ o# 2- A )ual o# &o)en)ial ,ioinequivalen e &#o,le's have ,een #esolve( via a(equa)e in vivo an(3o# in vi)#o )es)sThese a#e (esi%na)e( AB7B8 D#u% P#o(u )s D#u% P#o(u )s FDA (oes no) onsi(e# )o ,e )he#a&eu)i all! equivalen)/ i-e-/ (#u% &#o(u )s *o# +hi h a )ual o# &o)en)ial ,ioequivalen e &#o,le's have no) ,een #esolve( ,! a(equa)e )es)in%O*)en )he &#o,le' is a'on% s&e i*i (osa%e *o#'s #a)he# )han )he a )ive in%#e(ien)sD#u% &#o(u )s a#e #a)e( 7B8 ,e ause:

0- The a )ive in%#e(ien)s *o# (osa%e *o#'s have ,een i(en)i*ie( ,! FDA as havin% (o u'en)e( ,ioequivalen e &#o,le's/ an( #esul)s o* a(equa)e ,ioequivalen e s)u(ies have no) ,een su,'i))e(< o# 2- The quali)! o* s)an(a#(s is ina(equa)e o# FDA (oes no) have su**i ien) ,asis *o# (e)e#'inin% ,ioequivalen e7B8 (#u%s a#e (esi%na)e(: BC ; Con)#olle( ;#elease )a,le)s/ a&sules/ an( in.e )a,les BD ; A )ive in%#e(ien)s +i)h (o u'en)e( ,ioequivalen e &#o,le's BE ; En)e#i oa)e( (osa%e *o#'s BN ; Ae#osol4ne,uli1e# (elive#! s!s)e' BP ; Po)en)ial ,ioequivalen e &#o,le's BR ; Re )al su&&osi)o#ies o# ene'as BS ; P#o(u )s havin% s)an(a#( (e*i ien ies BT4 To&i al &#o(u )s +i)h ,ioequivalen e issues

B= ; Insu**i ien) (a)a ; assu'e( in4 equivalen) un)il a(equa)e in*o#'a)ion ,e o'es availa,le

THE BIOPHARMACEUTICS CLASSIFICATION SCHEME

Class 0 Hi%h solu,ili)! Goo( &e#'ea,ili)! Class > Class 2 Lo+ solu,ili)! Goo( &e#'ea,ili)! Class ?

Hi%h solu,ili)! Lo+ solu,ili)! Poo# &e#'ea,ili)! Poo# &e#'ea,ili)!

THE RULE OF @ This #ule o* @ s)a)es )ha) &oo# a,so#&)ion o# &e#'ea)ion a#e 'o#e li$el! +hen: 0- The#e a#e 'o#e )han @ H4,on( (ono#s 6e5&#esse( as )he su' o* OHs an( NHs9 2- The#e a#e 'o#e )han 0A H4,on(

>- Dosa%e Fo#' The )!&e o* (osa%e *o#' shoul( ,e onsi(e#e( +heneve# one (#u% &#o(u ) is sele )e( *#o' a'on% 'ul)i4sou# e (#u% &#o(u )sThis is es&e iall! )#ue +i)h e5)en(e(4 o# (ela!e(4#elease 'e(i a)ionsThe O#an%e Boo$ (oes no) #a)e an! (i**e#en) (osa%e *o#'s as )he#a&eu)i all! equivalen)?- P#evious D#u% Use The#e a#e )+o ques)ions )ha) shoul( ,e onsi(e#e( #e%a#(in% &#evious (#u% &#o(u ) usa%eFi#s)/ is )he &#es #i,e( (#u% a on)inua)ion o* al#ea(! su ess*ul )he#a&!B I* i) is/ onl! a ,ioequivalen) &#o(u ) shoul( ,e sele )e(/ an( )he i'&a ) o* an! han%e in sou# e o* 'e(i a)ion shoul( ,e onsi(e#e(The &ha#'a is) shoul( also onsi(e# +hi h &#o(u ) )he &a)ien) +as usin% &#eviousl!/

in lu(in% an! 'e(i a)ions in hos&i)al i* )he &a)ien) +as #e en)l! (is ha#%e(Se on(/ +as )he o#i%inal &#o(u ) (is&ense( a %ene#i &#o(u )B I* so/ &#e*e#en e shoul( ,e %iven )o on)inuin% )o (is&ense )he sa'e %ene#i &#o(u ) *#o' )he sa'e sou# e@- Pa)ien) S)a)us The &ha#'a is) shoul( onsi(e# ho+ +ell on)#olle( )he &a)ien) is an( ho+ sus e&)i,le )ha) &a)ien) 'i%h) ,e )o s'all han%es in (#u% a,so#&)ionI* a &a)ien) has la,ile on)#ol o# has e5&e#ien e( %#ea) (i**i ul)! in a hievin% on)#ol/ )he &ha#'a is) shoul( on)inue )he#a&! +i)h a &#o(u ) *#o' a sin%le sou# e )h#ou%hou) )he#a&!C- Disease The se#iousness o* )he (isease an( i)s &o)en)ial i'&a ) on )he &a)ien) 'a! in*luen e )he +illin%ness )o han%e &#o(u )s-

D- D#u% Class o# Ca)e%o#! D#u%s +i)h na##o+ )he#a&eu)i #an%es an( +i)h $no+n lini all! si%ni*i an) ,ioavaila,ili)! &#o,le's shoul( ,e su,s)i)u)e( +i)h a#e an(3o# a*)e# (is ussion +i)h )he &#es #i,e#-

Sele )e( D#u%s +i)h Na##o+ The#a&eu)i In(e5

D#u% The#a&eu)i To5i Bloo( Bloo( Con Con Si(e E**e )s

Theo&h!lline

@40@ E%3'L F 0@ Fe+ s!'&)o's E%3'L Nausea/ 0@42A vo'i)in% E%3'L Nausea/ 2A42@ vo'i)in% E%3'L T#e'o#/

2@4>A e5 essive E%3'L ,#on ho##hea Sei1u#es >A4?A E%3'L Sei1u#es/ )a h! a#(ia/ ?A4@A &al&i)a)ions E%3'L Dea)h G @A E%3'L Phen!)oin 0A42A E%3'L ?A Live# (a'a%e/ E%3'L a#(ia i##e%ula#i)ies/ )#e'o#s/ onvulsions G 0-D n%3'L Hea(a he/ vo'i)in%/ (eli#iu'/ i##e%ula# &ulse- Di%o5in e5hi,i)s a ve#! lo+ 'a#%in o* sa*e)!/ an( i) has ,een sho+n )ha) h!&o$ale'ia

Di%o5in

A-@40-@ n%3'L

an( h!&o4 'a%nesia 'a! &o)en)ia)e )o5i i)!Li(o aine 2-A4@-A E%3'L ?4C Mil( si(e E%3'L e**e )s C4H CNS an( E%3'L a#(iovas ula# (e&#ession/ o'aLi)hiu' A-@40-@ ''ol3L 2-A ''ol3 L Dia##hea/ vo'i)in%/ onvulsion/ *all in ,loo( &#essu#e/ o'a-

A'ino%l! osi(e @-A4H-A s E%3'L

0A Ne&h#o)o5i i) E%3'L !/ o)o)o5i i)!

H- Cos) The os) o* )he &#o(u )/ +hile an i'&o#)an) onsi(e#a)ion/ shoul( ,e a se on(a#!

onsi(e#a)ion in sele )in% a'on% &#o(u )s .u(%e( ,! )he &ha#'a is) )o ,e ,ioequivalen)I- Pa)ien) O&inion An in*o#'e( &a)ien)/ oo&e#a)in% +i)h a &h!si ian an( &ha#'a is) in his o# he# (#u% )he#a&!/ is an i'&o#)an) ele'en) in ensu#in% )he ,es) &ossi,le )he#a&eu)i ou) o'esThe &ha#'a is) shoul( )a$e in)o a oun) )he &a)ien)s nee(s +hen sele )in% *#o' 'ul)i4 sou# e (#u% &#o(u )s an( in*o#' )he &a)ien) o* an! &o)en)ial onsequen es asso ia)e( +i)h al)e#na)e &#o(u ) sele )ionsP#o*- D#- Su+al(i Ma#)o(iha#(.o/ M-S -/ A&)Fa ul)! o* Pha#'a !4Ga(.ah Ma(a Unive#si)! Jo%.a$a#)a