Guideline on DTC 1

8/10/2019 Guideline on DTC 1

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Working Guideine !or "#e E$"%&i$#'en" %nd O(er%"ion o)

Drug %nd T#er%(eu"i*$ Co''i""ee

1. Introduction

Drugs are such vital susta!ces that !ee" e#$ert ha!"li!g %r&' the i!ce$ti&! &% their "isc&ver( u!til the( reach

the e!" user)the $atie!t* I! such a c&'$le# a!" res&urce)c&!su'i!g $r&cess+ the eve!tualit( &% sh&rtage+ 'isuse

a!" ause+ erratic su$$l(+ a"verse reacti&!s+ irrati&!al $rescrii!g+ "is$e!si!g a!" use are c&''&!* Es$eciall(

,here there is !& viale s(ste' &% e!suri!g g&&" su$$l( 'a!age'e!t a!" rati&!al use &% "rugs+ the e#te!t &% the

$r&le' a!" its c&!se-ue!ce is i''e!se* Th&ugh it is als& c&''&! i! the "evel&$e" ,&rl"+ the 'ag!itu"e a!"

e#te!t &% the $r&le' is huge a!" chr&!ic i! 'a!( c&u!tries i! the "evel&$i!g ,&rl"*

I!ter!ati&!al e#$erie!ce has sh&,! that 'is'a!age'e!t a!" irrati&!al use &% "rugs ca! &!l( e alleviate" a!"-ualit( $har'aceutical services ca! e achieve" thr&ugh a %&r'al a!" regular c&!sultati&! et,ee! c&!cer!e"

health $r&%essi&!als i! a give! health estalish'e!t* The &$erati&! &% Drug a!" thera$eutics c&''ittee .DTC/ i!

health estalish'e!ts has ec&'e a !&r' t& e!sure g&&" 'a!age'e!t a!" rati&!al use &% "rugs* The availailit(

&% %u!cti&!al DTC i! h&s$itals is a $rere-uisite %&r accre"itati&! i! the USA+ a!" al'&st all h&s$itals i! Australia

a!" U!ite" 0i!g"&' have DTCs*


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2+ S#or" Ti"e

This Gui"eli!e 'a( e cite" as 5 6&r1i!g gui"eli!e %&r the estalish'e!t a!" &$erati&! &% Drug a!"

Thera$eutics C&''ittee 7*

+ De)ini"ion$

I! this gui"eli!e u!less the c&!te#t $r&vi"es &ther,ise8

9* 5Drug a!" thera$eutics C&''ittee7 'ea!s a gr&u$ &% health $r&%essi&!als that that a"vices a health

estalish'e!t &! 'atters relate" t& "rug 'a!age'e!t*

:* ;A"verse Drug Reacti&!7 'ea!s a !i&us a!" u!,a!te" reacti&! t& "rugs that &ccurs at a "&se use" i!

hu'a! %&r "iag!&sis+ treat'e!t &r $r&$h(la#is*


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Me"ical Direct&r)Chair $ers&!

Hea" &% the $har'ac( secti&!)Secretar(

Hea" &% the !ursi!g secti&!)Me'er

Hea"s &% !& less tha! %&ur "e$art'e!ts)'e'ers

Hea" &% a"'i!istrati&! a!" %i!a!ce secti&!) E#&%%ici& 'e'er

/+1+2 He%"#Cen"er

DTC estalishe" at Health ce!ter shall have the %&ll&,i!g 'e'ers8

Hea" &% Health ce!ter)Chair $ers&!

Hea" &% the $har'ac( secti&!)Secretar(

Hea" &% the !ursi!g secti&!)Me'er

Hea"s &% a!( &ther t,& Secti&!s)Me'ers

Hea" &% a"'i!istrati&! a!" %i!a!ce)E#&%%&ci& Me'er

/+2+A" Region%3on% 3ored% e.e5

DTC estalishe" at Region% He%"# Bure%u3on% He%"# De(%r"'en" 3ored% He%"# o))i*e shall have

the %&ll&,i!g 'e'ers8

Hea" &% the tech!ical u!it &% the regi&!3&!e3,&re"a)Chair$ers&!


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M&!it&rs the &ccurre!ces &% a"verse "rug reacti&!s .ADR/+ 1ee$ rec&r" a!" se!"s re$&rt t& a res$&!sile

&"(*

Deci"es &! the classi%icati&! &% "rugs as $rescri$ti&! &r OTC &! the asis &% the !ati&!al list &! such

categ&riati&! at Health i!stituti&! level* A!" %urther categ&ries ,hich "rugs sh&ul" e $rescrie" (

,h&'*

Evaluates&4ectivel( cli!ical "ata regar"i!g !e, "rugs &r age!ts $r&$&se" %&r use i! the health

i!stituti&!+ a%ter ta1i!g i!t& c&!si"erati&! &%8

A! i!"e$e!"e!t literature search+ ,hich i!clu"es the use &% the $har'ac&l&gical age!t

a!" &ther treat'e!t &$ti&!s %&r the $articular c&!"iti&! is c&!"ucte"*

The evi"e!ce utiliati&! &utc&'es

A! ec&!&'ic a$$raisal &% the !e,er $har'ac&l&gical "rug is c&!"ucte"+ ,here $&ssile

A c&'$aris&! ,ith the treat'e!t &$ti&!s $rese!tl( use" is "&!e*

Desig!s a!" &rga!ies e"ucati&!al $r&gra's regar"i!g "rugs a!" "rug use*

Rec&''e!" a""iti&!s a!" "eleti&!s %r&' the list &% "rugs acce$te" %&r use i! the health

estalish'e!ts

Facilitates the estalish'e!t &% Drug i!%&r'ati&! u!it a!" assess its i'$act i! the $r&'&ti&! &% rati&!al

"rug use*


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Prese!ts $er%&r'a!ce re$&rt t& the Health estalish'e!t 'a!age'e!t

Re$rese!ts the c&''ittee i! the 'a!age'e!t 'eeti!gs a!" &ther releva!t eve!ts

Calls regular a!" e#tra&r"i!ar( 'eeti!gs

Chairs the 'eeti!gs*

6+2+ Se*re"%ri%"

The secretariat &% the DTC shall e the hea" &% the $har'ac( secti&! &% the health estalish'e!t*

6+2+1+ Du"ie$ %nd Re$(on$i&ii"ie$ o) "#e $e*re"%ri%"

The secretar( ,ill have the %&ll&,i!g res$&!siilities

I! c&!sultati&! ,ith the chair$ers&!+ $re$ares the !&tice a!" age!"a %&r all 'eeti!gs*

Pre$ares the 'i!utes &% all 'eeti!gs a!" "isse'i!ates these t& all 'e'ers*

F&ll&,s u$ the acti&! $la!s &% the c&''ittee*

C&!"uct literature searches a!" "isse'i!ate the 'aterial at least seve! "a(s e%&re the

c&''ittee 'eets*

E!sures that the "ecisi&!s ta1e! ( the c&''ittee are su'itte" t& the hea" &% health

t li h t % hi 3h ti%i ti


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The c&''ittee 'a( i!vite t& its 'eeti!gs $ers&!s ,ithi! &r &utsi"e the health i!stituti&! ,h& ca!

c&!triute %r&' their s$ecialie" 1!&,le"ge &r e#$erie!ce*

Issues t& e "iscusse" ,ill e "eter'i!e" 4&i!tl( ( the chair$ers&! a!" the secretar(*

A! age!"a is "esirale a!" sh&ul" e $re$are" a!" su'itte" t& 'e'ers &% the c&''ittee i!

su%%icie!t ti'e e%&re the 'eeti!g*

Mi!utes sh&ul" e 1e$t ( the secretar( a!" sh&ul" e 'ai!tai!e" i! the $er'a!e!t rec&r"s &% the

health i!stituti&!*

Rec&''e!"ati&!s &% the Drugs a!" Thera$eutics C&''ittee shall e $rese!te" t& 'a!age'e!tc&''ittee %&r a"&$ti&! &% rec&''e!"ati&!s*

&% the 'e'ershi$ &% the c&''ittee ,ill c&!stitute a -u&ru' %&r a!( 'eeti!g*

C&rres$&!"e!ce shall e a""resse" t& the secretariat &% the c&''ittee*

7+ SCOPE

The DTC is !&t i!te!"e" t& i!terve!e i! the a"'i!istrati&! &% the health estalish'e!t ut t&

act &! tech!ical a!" u"getar( .O!l( Drug Bu"get/ as$ects &% "rug su$$l( 'a!age'e!t a!"

use*

The DTC is res$&!sile t& 'a1e cl&se %&ll&,)u$ &% the i'$le'e!tati&!s &% its a$$r&ve"

" ti th t th t %% I% th t %% " t i l t th

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A((endi8

Roe$ o) "#e Drug$ %nd "#er%(eu"i*$ Co''i""ee5

The following activities would be applied as appropriate to the level of Health establishment in which

the DTC is established:

1+POST MAR9ETING SUR:EIANCE

P&st)Mar1eti!g Surveilla!ce is a s(ste'+ ,hich is c&!cer!e" ,ith the c&llecti&!+ a!al(sis+ a!" "isse'i!ati&! &%

i!%&r'ati&! &! the &ccurre!ce &% a"verse reacti&!s &r the relative sa%et(+ e%%icac( a!" -ualit( &% "rugs+ at a!( ti'e

a%ter the( are 'ar1ete"*

Thi i i i " i " h A h i i% i " h .Ph " Th i

>


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a* The Drug De%ect Re$&rt F&r' .See A!!e# :/ !ee" t& e %ille" at each level &% the health i!stituti&!

( Phar'ac( $r&%essi&!als &r chie% &% the Phar'ac( secti&! &r ( &ther health $r&%essi&!als a!"

sh&ul" e re$&rte" t& the Phar'ac( Thera$eutic C&''ittee*

* The Phar'ac( Thera$eutics c&''ittee sh&ul" the! se!" "irectl( t& Drug A"'i!istrati&! a!"

c&!tr&l Auth&rit( &r its !earest ra!ch a!" 'a1e a c&$( &% the re$&rt t& the 2&!al health

"e$art'e!t3regi&!al health ureau*

c* The Drug A"'i!istrati&! a!" C&!tr&l Auth&rit(+ c&llects a!" a!al(es the re$&rt a!" %&r,ar"s the

i!%&r'ati&! t& the 'a!u%acturer &r i'$&rters a!" "istriut&rs i!v&lve" %&r their reacti&! .the

auth&rit( ca! als& ta1e acti&!/ a!" $r&vi"es %ee" ac1 t& the re$&rter ,ith a$$reciati&!*

+ In Pro'o"ing R%"ion% U$e o) Drug$

O!e &% the 'a4&r activities u!"erta1e! ( Drug A"'i!istrati&! a!" C&!tr&l Auth&rit( i! &r"er t&

rati&!alie the use &% "rugs i!clu"i!g Narc&tic "rugs Ps(ch&tr&$ic Susta!ces is the $r&visi&! &%

$ri!te" $rescri$ti&! $a$ers .seriall( !u'ere"+ c&"e" se$arate %&r &r"i!ar( "rugs+Narc&tics

Ps(ch&tr&$ic/ t& e use" at all levels e it $rivate+ $ulic &r &,!e" ( N&! G&ver!'e!tal

Orga!iati&!s* A gui"eli!e+ has ee! issue" t& all c&!cer!e" u!its a!" health i!stituti&!s &! the

h h "li tili ti t % th i ti


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%* The Phar'ac( a!" Thera$eutic C&''ittee 'a(

$artici$ate i! c&!tr&l &% illegal+ c&u!ter%eiti!g &r susta!"ar" "rugs*

4+ In De.eo(ing E'ergen*; Drug$ i$"$

Because i! '&st e'erge!cies ti'e is &% the esse!ce+ it is i'$erative that e'erge!c( "rug &r ;stat; es

c&!tai!i!g "rugs a!" su$$lies e rea"il( availale i! the e'erge!c( r&&'* The Phar'ac( a!"

Thera$eutic C&''ittee sh&ul" "evel&$ a list &% "rugs a!" su$$lies+ ,hich &ught t& e i! a! e'erge!c(

* The c&''ittee sh&ul" i!%&r' the $har'acist a!" the hea" !urse &% their 4&i!t res$&!siilit( t& have

the rea"( %&r use at all ti'es*

I! &r"er t& "evel&$ e'erge!c( "rug list+ the Phar'ac( a!" Thera$eutic C&''ittee ca! use the Nati&!al

Drug List &r the Nati&!al Esse!tial Drug List a!"3&r the su)lists &r the health i!stituti&!Js Drugs list*

O!ce the e'erge!c( es have ee! $lace" &! the e'erge!c( r&&'+ regular chec1i!g ( the Phar'ac(Pr&%essi&!al &r ( the Nursi!g Su$ervis&r is 'a!"at&r(*

/+ In Drug U"ii%"ion Re.ie

Drug utiliati&! is "e%i!e" as the 'ar1eti!g+ "istriuti&!+ $rescri$ti&! a!" use &% "rugs i! a s&ciet( ,ith

i l h i th lti "i l i l " i i Cl l th it " %

@


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"is$e!si!g ta1es $lace* The!+ $eri&"icall( "rug utiliati&! ,ithi! the health i!stituti&!s c&ul"+ e

assesse"* The result &% the assess'e!t serves the Phar'ac( Pr&%essi&!als t& gai! tech!ical

$r&%essi&!al i!%&r'ati&! a!" als& hel$s health i!stituti&! t&8

0!&, the actual "rug c&!su'$ti&!

Deter'i!e "rug u"get

I"e!ti%( the $revale!t "iseases

Select "rugs ase" &! the $revale!t "isease

Assess "rug utiliati&! .e*g* $rescrii!g $ractice/ ,ithi! the health i!stituti&!

0!&, the actual "rug c&!su'$ti&!

The result &% the "rug utiliati&! revie, !ee"s t& e $rese!te" t& the Phar'ac( Thera$eutics

C&''ittee+ s& as t& use it i! $r&'&ti!g rati&!al "rug use*

9


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Anne8 1

A"verse Drug Reacti&! Re$&rti!g F&r'

Patie!tKs Na'e8.I!itials &!l(/ Car" N&8


13/15

Treat'e!t &% reacti&!8

Outc&'e8 Die" "ue t& a"verse reacti&! Die"+ "rug 'a( e c&!triut&r( Die" U!relate" t& "rug

N&t (et rec&vere" Rec&vere" ,ith &ut se-uelae Rec&vere" ,ith s-ueal U!1!&,!

S-ueale"8


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Fr&'


15/15

Anne8

P%"ien" Pre$*ri("ion Regi$"r%"ion BookSer*

N&*

Date Patie!t Na'e &% Car"

Nu'er

Age Se# Diag!&sis Treat'e!t .Na'e

Stre!gth D&sage

%&r' D&se &%

Drugs

Free3Pa(i!g ,rite

;F; &r ;P;

U!it Price 6rite ; N; %&r Ne,

&r ;R; %&r Re$eate"

Patie!ts

Re'ar1

Birr C

9?

Guideline on DTC 1

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