product+selection(2)

8/13/2019 Product+Selection(2)

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GUIDELINESFOR

PHARMACISTS PERFORMINGPRODUCT SELECTION

DISPENSING DECISIONS

APhAs Bioequivalen! "o#$in% G#ou&

#eo''en(s )ha) &ha#'ais)s onsi(e# )he

*ollo+in% *a)o#s +hen sele)in% (#u% o(u)s )o

,e (is&ense( )o )hei# &a)ien)s-

No) all o* )hese *a)o#s +ill a&&l! )o eah si)ua)ion

no# a#e )he! o* equal +ei%h)-

"e ,elieve i* &ha#'ais)s onsi(e# )hese &oin)s as

&a#) o* )he o*essional .u(%'en) oess+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(-


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P#o(u)s ,ein% (is&ense( in #es&onse )o a

es#i&)ion (#u% o#(e# )ha) is +#i))en

%ene#iall! shoul( ,e e5&e)e( )o o(ue 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

Equivalene Evalua)ions 67The O#an%e

Boo$89 as 7A8 #a)e( shoul( ,e sele)e( +hen

suh o(u)s a#e availa,le-

The#a&eu)i Equivalene

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)iall! equivalen)/ i-e-/ (#u%

o(u)s *o# +hih:

0- The#e a#e no a)ual o# &o)en)ial

,ioequivalene o,le's-

These a#e (esi%na)e(:

AA ; O#al )a,le)s/ a&sules an(

liqui(s 6all soli( (osa%e *o#'s


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'us) 'ee) a&oia)e in vi)#o

)es)s9-

AN ; Solu)ions an( &o+(e#s *o#

ae#osoli1a)ionAO ; In.e)a,le oil solu)ions

AP ; In.e)a,le aqueous solu)ions

AT ; To&ial/ o#

2- A)ual o# &o)en)ial ,ioinequivalene

o,le's have ,een #esolve( via

a(equa)e in vivo an(3o# in vi)#o )es)s-

These a#e (esi%na)e( AB-

7B8 D#u% P#o(u)s

D#u% P#o(u)s FDA (oes no) onsi(e# )o,e )he#a&eu)iall! equivalen)/ i-e-/ (#u%

o(u)s *o# +hih a)ual o# &o)en)ial

,ioequivalene o,le's have no) ,een

#esolve( ,! a(equa)e )es)in%-

O*)en )he o,le' is a'on% s&ei*i

(osa%e *o#'s #a)he# )han )he a)ivein%#e(ien)s-

D#u% o(u)s a#e #a)e( 7B8 ,eause:


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0- The a)ive in%#e(ien)s *o# (osa%e

*o#'s have ,een i(en)i*ie( ,! FDA as

havin% (ou'en)e( ,ioequivalene

o,le's/ an( #esul)s o* a(equa)e,ioequivalene 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**iien) ,asis

*o# (e)e#'inin% ,ioequivalene-

7B8 (#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

(ou'en)e( ,ioequivaleneo,le's

BE ; En)e#i oa)e( (osa%e *o#'s

BN ; Ae#osol4ne,uli1e# (elive#!

s!s)e'

BP ; Po)en)ial ,ioequivalene

o,le's

BR ; Re)al su&&osi)o#ies o# ene'asBS ; P#o(u)s havin% s)an(a#(

(e*iienies

BT4 To&ial o(u)s +i)h

,ioequivalene issues


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B= ; Insu**iien) (a)a ; assu'e( in4

equivalen) un)il a(equa)e

in*o#'a)ion ,eo'es availa,le


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THE BIOPHARMACEUTICS

CLASSIFICATION

SCHEME

Class 0

Hi%h solu,ili)!

Goo(

&e#'ea,ili)!

Class 2

Lo+ solu,ili)!

Goo( &e#'ea,ili)!

Class >

Hi%h solu,ili)!

Poo# &e#'ea,ili)!

Class ?

Lo+ solu,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

6e5esse( as )he su' o* OHs an(

NHs9

2- The#e a#e 'o#e )han 0 H4,on(


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>- 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)s-

This is es&eiall! )#ue +i)h e5)en(e(4 o#

(ela!e(4#elease 'e(ia)ions-

The O#an%e Boo$ (oes no) #a)e an! (i**e#en)

(osa%e *o#'s as )he#a&eu)iall! 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%e-

Fi#s)/is )he es#i,e( (#u% a on)inua)ion o*

al#ea(! suess*ul )he#a&!

I* i) is/ onl! a ,ioequivalen) o(u) shoul( ,esele)e(/ an( )he i'&a) o* an! han%e in

sou#e o* 'e(ia)ion shoul( ,e onsi(e#e(-

The &ha#'ais) shoul( also onsi(e# +hih

o(u) )he &a)ien) +as usin% eviousl!/


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inlu(in% an! 'e(ia)ions in hos&i)al i* )he

&a)ien) +as #een)l! (isha#%e(-

Seon(/+as )he o#i%inal o(u) (is&ense( a%ene#i o(u) I* so/ e*e#ene 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#'ais) shoul( onsi(e# ho+ +ell

on)#olle( )he &a)ien) is an( ho+ suse&)i,le

)ha) &a)ien) 'i%h) ,e )o s'all han%es in (#u%

a,so#&)ion-

I* a &a)ien) has la,ile on)#ol o# hase5&e#iene( %#ea) (i**iul)! in ahievin%

on)#ol/ )he &ha#'ais) shoul( on)inue

)he#a&! +i)h a o(u) *#o' a sin%le sou#e

)h#ou%hou) )he#a&!-

- Disease

The se#iousness o* )he (isease an( i)s

&o)en)ial i'&a) on )he &a)ien) 'a! in*luene

)he +illin%ness )o han%e o(u)s-


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- D#u% Class o# Ca)e%o#!

D#u%s +i)h na##o+ )he#a&eu)i #an%esan(

+i)h $no+n liniall! si%ni*ian)

,ioavaila,ili)! o,le's shoul( ,e

su,s)i)u)e( +i)h a#ean(3o# a*)e# (isussion

+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

Bloo(

Con-

To5i

Bloo(

Con-

Si(e E**e)s

Theo&h!lline @40@ %3'L 0@

%3'L

0@42

%3'L

242@

%3'L

Fe+ s!'&)o's

Nausea/

vo'i)in%

Nausea/

vo'i)in%

T#e'o#/


11/13

2@4>

%3'L

>4?

%3'L

?4@

%3'L

@%3'L

e5essive

,#onho##hea

Sei1u#es

Sei1u#es/

)ah!a#(ia/

&al&i)a)ions

Dea)h

Phen!)oin 042

%3'L

?

%3'L

Live# (a'a%e/

a#(ia

i##e%ula#i)ies/

)#e'o#s/

onvulsions

Di%o5in -@40-@

n%3'L

0-

n%3'L

Hea(ahe/

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


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an( h!&o4

'a%nesia 'a!

&o)en)ia)e

)o5ii)!-

Li(oaine 2-4@-

%3'L

?4

%3'L

4

%3'L

Mil( si(e

e**e)s

CNS an(

a#(iovasula#

(eession/

o'a-

Li)hiu' -@40-@

''ol3L

2-

''ol3

L

Dia##hea/

vo'i)in%/

onvulsion/

*all in ,loo(

essu#e/

o'a-

A'ino%l!osi(e

s

@-4-

%3'L

0

%3'L

Ne&h#o)o5ii)

!/ o)o)o5ii)!

- Cos)

The os)o* )he o(u)/ +hile an i'&o#)an)

onsi(e#a)ion/ shoul( ,e a seon(a#!


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onsi(e#a)ion in sele)in% a'on% o(u)s

.u(%e( ,! )he &ha#'ais) )o ,e ,ioequivalen)-

- Pa)ien) O&inion

An in*o#'e( &a)ien)/ oo&e#a)in% +i)h a

&h!siian an( &ha#'ais) 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'es-

The &ha#'ais) shoul( )a$e in)o aoun) )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 onsequenes assoia)e( +i)h

al)e#na)e o(u) sele)ions-

P#o*- D#- Su+al(i Ma#)o(iha#(.o/ M-S-/

A&)-

Faul)! o* Pha#'a!4Ga(.ah Ma(a

Unive#si)!

Jo%.a$a#)a

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