Monitoring Efek Samping Obat 12

8/17/2019 Monitoring Efek Samping Obat 12

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Monitoring Efek Samping

Obat


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Managing ADRsManaging ADRs


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Dr. Donald Brodie, 1965 :

“ The ultimate goal of the

Services of Pharmacmust !e

the S"#$ %S$ of D&%'S

! the Pu!lic “


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Efek Samping Obat (ADR)

• ADR : an eect which is noxious anunintene! an which occurs atoses use in man for proph"#axis!iagnosis or therap" ($%O)

• Adverse drug event : an in&ur"resu#ting from meica# inter'entionre#ate to a rug (ates et a#!

**+b)• Medication error : an error in

orering! transcribing! ispensing!aministering a meication


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De,nitions

• Quality of life (Schron - Schumaker)

a mu#tiimentiona# concept referring to a person.s tota#we##/being inc#uing his or her ps"cho#ogica#! socia# anph"sica# hea#th status

the 'a#ue assigne to uration of #ife as moi,e b" theimpairments! functiona# status! perception an socia#opportunities that are in0uence b" iseases! in&ur"!treatment or po#ic" (1atrick - Erickson)

HEALTH OUTCOME =

HEALTH-RELATED QUALT! O" L"E


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2334 #atient-$%eci&c 5#inica#1harmac" Ser'ices in %ospita#s

Pharmacokinetic ConsultationPharmacokinetic Consultation 87%87%

ADR Management ADR Management 81%81%

Drug Protocol ManagementDrug Protocol Management 77%77%

Drug Therapy MonitoringDrug Therapy Monitoring 6%6%

Me!ical Roun!s ParticipationMe!ical Roun!s Participation "1%"1%

Drug Therapy CounselingDrug Therapy Counseling #6%#6%

TP$ Team ParticipationTP$ Team Participation #"%#"%

CPR Team ParticipationCPR Team Participation 7%7%

A!mission Drug istories A!mission Drug istories 7&"%7&"%

'on! CA( Raehl( C)& Pharmacotherapy *++8,*8-1./101&


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6 %ospita# 5#inica# 1harmac"Ser'ices Sa'e 7i'es

• Drug use e'a#uation

• 8n/ser'ice eucation

• A'erse rug reaction management• 1articipation on 51R team

• Drug protoco# management

• 1articipation on meica# rouns• Amission rug histories

'on! CA( Raehl C)& Clinical Pharmacy er2ices( Pharmacy ta33ing(

an! ospital Mortality Rates& Pharmacotherapy *++7,*7-#./#810#4&


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5#inica# 1harmac" Ser'ices8mpro'e 5are

• Decrease 5 A'erse rug e'ents

5 A'erse meication reactions

5 Meication errors

• 8mpro'e 5 Meication aherence

5 Drug know#ege

5 Appropriate meication use

• Shortene #ength of hospita# sta"

9abo#i 1 et a#; 5#inica# 1harmacists an 8npatient Meica# 5are:

A S"stematic Re'iew;

Arch 8ntern Me; 2334


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ESO

• SE>8A1 E?E9 OA> @ D1>MEMA%A@A9AB C MER89AB S81EMA9A8! AB8B @ D89ABDB

MA1B A@8 @ AR 7A%8R• ESO 8B8! @8C E?E9 SAM18B 1D DOS8S

BORMA7 B>; >AB 1RO?87A9S8S!D8ABOS8S MA1B 1EBOA>AB;

• 1EBBAAB OA> @ MEB8B9A>DOS8S MA1B ?RE9; B@A A1> AD89S8

A D8MAS99AB D7M ESO


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AB9A 9EAD8AB

• %AM18R SEMA OA> @ E?E9>8?D1> MEB8M79AB ESO


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1EB@EA ESO

REA9S8 A98A> 9E7A8ABAB A$AABA7ER8 :>D 9RB ME9AB8SME 8MBO7O8!

S8?A>: >D9A ADA %; DB S8?A>?ARMA9O7O8! >8M7 1D DOS8S 9E587

ESO 9RB 9E7A8BAB EBE>89

ESO 9RB 9E7A8BAB @ D8DA1A>! E:ADAB@AABAB %A>8 @

MEBAB DE>O9S8?89AS8 OA>!ABAB 8BA7 @ MEBABE78M8BAS8 OA> M8SA7 EB>AM8S8B8SA MEB@EA9AB >78;


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1EB@EA ESO

• 9E7A8BAB A98A> EB>9 SER>A5ARA 1EMER8AB OA> 5 R @ >D A98A> 1ERA%AB

8OAFA8A7878>AS! A>A 5ARA1EMER8AB @ 9RAB >E1A> : M8SA7E?E9A D8>8?! A%AB 1E7AR>!1EBA$E> @ D8>AMA%9AB SAA>

1EMA>AB OA>• 8B>ERA9S8 OA>


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?A9>OR 1RED8S1OS8S8 >8M7B@A ESO

• SAA> >8M7B@A REA9S8

5 ESO DA1A> >8M7 1D A$A71EBOA>AB (A@O9 ABA?87A9S8S 9RB

1EMER8AB 1EB8S878B) 5 SE>E7A% 1EBOA>AB ER7ABSB

7AMA (RE>8BO1A>8 9RB 1EBOA>ABDB 97ORO98B)

5 >8M7 7AMA SE>E7A% OA> D8%EB>89AB( 9ARS8BOMA A98A> 1EMER8ABD8E>87S>87ES>ERO7)


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MR8BS8DEB ESO MEB8B9A> 1D 1EBDER8>A

MDA - S8A 7AB> 9OBD8S8 1A>O?8S8O7O8S

EERA1A 1EB@A98> @ MEB@ER>A81EBDER8>A 8SA MEROA%

?ARMA9O98BE>89 OA>! ( %A>8 G 1RMER8ABE>A 7O9ER 1D ORAB ASMA)

M7A% OA> @? D8ER89AB1EBOA>AB @ >ER7A7 7AMA 8SA

MEB5E>S9AB >8M7B@A ESO

EB8S 9E7AM8B%AS87 1EBE78>8AB : $AB8>A 7E8% MDA%

MEBA7AM8 ES8 D8D 7A98H


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• R8$A@A> A7ER8 SEE7MB@A 5 1EBDER8>A DB R8$A@A> A7ER8 S7MB@A

7E8% 1E9A MEBDA1A> R; ESO EREB>9A7ER8 DAR 1EBDER8>A BORMA7

• M7>817E DRS >%ERA18 5 MA98B AB@A9 M7A% OA> @ D8ER89AB

MA98B I 9EMB98BAB 9EBA ESO

• ?A9>OR RAS8A7 A>A EBE>89 5 D8DA ADA 1EBAR% RAS8A7 C EBE>89

B>9 >8M7B@A ESO >ER>EB>


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Masa#ah / DAM1A9

• Assessment SEARA% E?E9 SAM18B! MR!EBE>89

• 1AS8EB >D9 MEBDA1A> 8B?O 591 >EB>ABE?E9 SAM18B

• 8DEB>8>ASC1EBABDA 1ERBA% MEBA7AM8E?E9 SAM18B

• E?E9 SAM18B A98A> >8DA9 MEBDA1A> OA> @AB >E1A>

• MOR8D8>AS >RB• 8A@A


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Macam ADR

• T!#E A' intrinsic 5 (isa di%redi)si' di*ung)in)an

%encega+an 5 Ada +u,ungan dengan dosis

5 $ering teradi ./01-2013' td) fatal• T!#E (' idiosyncratic 5 $u)ar di%redi)si 5 Td) tergantung dosis 5 $ering)ali fatal

5 Me*erlu)an %o%ulasi ,esar untu)*engeta+ui )eadian 5 U*u*nya individual se)ali' td) ta*%a)

dl* ,inatang

• AD4E' 5idra5al events


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Efek Samping Obat!9enapa per#u iMonitor J

• Merupakan ampak negatif aripengobatan

• 9ontra prouktif terhaappengobatan rasiona#

• >ingkat ke&aian re#atif keci#

• Dipengaruhi faktor ini'iua# pasien• 9eterbatasan preiksi a#am proses

pengembangan obat baru


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>he phases of rug e'e#opment in the S (Smith! *6K< 9ait#in et a#;!*K6< an @oung et a#;! *KK)

1RE578B85A7 >ES>8B Anima#

578B85A7 >ES>8B1%ASE 8 : Borma# 'o#unteers1%ASE 88 : se#ecte patients1%ASE 888 : #arge samp#e of

se#ecte patients

BDA REF8E$

1OS>MAR9E>8B SRFE877AB5E1%ASE 8F :

1atients gi'en rug for therap"

8n 'itro

Safet"!bio#ogica# eects!

Metabo#ism!9inetics!

Drug interactions

ADR!patterns of rug uti#iLation!


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?A9>OR @ ER1EBAR% >8M7B@AE?E9 SAM18B

DRU6 DO$E ROUTE DURATO7

#RE#ARATO7 #ATE7T

#HARMACO87ETC 9ARA(LE$ A6E 6E7ETC$

ALLER6! 7"ORMATO7

A($E7T OR 7 ADEQUATE


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1ERAB ?ARMAS8S th E?E9 SAM18B J

• MEMA%AM8 ADR DB 8B?O >ER98B8

• MEBEBA78 ADR

• 8B>ERFEBS8 5 S>O1C>E>A1 OA>

5 9OBSE78B

51EBABDA

• E?E9>8? ME7A1OR9AB 9EAD8AB

• S8S>EM MESO


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?7O$5%AR> O? ASSESSMEB>ABD MABAEMEB> O? AB ADR

DETECTO7O" #O$$(LE ADR

#U(L$HED LTERATURE RE9E4 #ATE7T-$#EC"C DATA

CO7T7UE DRU6

DECHALLE76E

RE5%A77EBE

COM#ARE #: REACTO7 TODE$CR#TO7 7 THE LTERATURE

E9ALUATE $E9ERT!

E9ALUATE #ATE7T


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(%$ST)*+ $S +*

D*

+*T

-+*

9.1.1 "re there /revious conclusive re/orts on

this reaction0

1 2 2

9.1.3 Did the adverse event a//ear after the

sus/ected drug 4as administered0

3 1 2

9.1. Did the adverse reaction im/rove 4hen the

drug 4as discontinued or s/ecific

antagonist 4as administered0

1 2 2

29.1.7 Did the adverse reaction rea//ear 4hen the

drug 4as readministered0

3 1 2

9.1.5 "re there alternative causes 8other than the

drug that could on their o4n have caused

the reaction0

1 3 2

9.1.6 Did the reaction rea//ear 4hen a /lace!o4as given0

1 1 2

9.1. as the drug detected in the !lood 8or

other fluids in concentration ;no4n to !e

to


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1enekatan 1E7A1ORABMESO

• 9oluntery' 5 ,ai) untu) %ene*uan E$O ,aru

5 Le,i+ *enani)an dari %ende)atan lain

• Co+ort study 5 8erasa*a ti* .do)ter' far*asis' %era5at3

5 "re)uensi Eso sela*a ra5at

• Mandatory 5 8e+arusan ,edasar as%e) legal

5 Data tinggi' validitas diragu)an• Record lin)age

5 Catatan *edi)' ,ervariasi E$O terli%ut

5 Data terlalu ,ervariasi


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1e#aporan MESO RA$A> A7AB RSethesa

KELOMPOK FARMAKOLOGI

N = 29 kasus (Juni - Des 2004)

52

00

!"

0#

!

Antiin3eksitot kelet en!i

al& $apas

P

ar!io2askuler

al& Cerna

ormon

MANIFE$%A$I E$O

N=29 kasus (Juni-Des 2004)

!9

2"

!

&0

&0

!# 8ulit

1aluran Cerna

1aluran $apas

1istem sara3

8ar!io2askuler

Mata

9:tremitas


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;hat is the role o3 pharmacist in PTC

N Managing adverse drug reactions .ADRs3

/ the pharmacist must aress the issue of a'erse rug reactions on a regu#ar basis since hospita#

amissions resu#ting from a'erse rug reactions accounts for /6P of patients; >hese o not

inc#ue errors of aministration! which wou# on#" increase the tota# incience of morbiit" an morta#it";


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Managing ADRs

#+ar*acists s+ould facilitate ;

/ ana#"sis of each reporte ADR/ ientif" the rug an patient at high risk for being in'o#'e in ADRs

/ e'e#op po#icies an proceures for ADR monitoring an reporting program/ use ADR program for eucationa# purposes/ e'e#op! maintain an e'a#uate ADR recors within the organiLation/ report serious ADR to Ministr"! ?DA or manufacturer


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Manfaat pe#aporan

• 1erubahan 9ebi&akan Basiona7

(9asus penarikan obat ppa/?DA)

• 1erubahan 9ebi&akan 7oka# ( rumahsakit)

• 1raktisi waspaa a#am farmakoterapi

• Mencegah timbu#n"a efek samping

beru#ang

• 8nformasi muncu#n"a efek samping"ang baru an membaha"akan


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Manfaat k#inik

• 8nformasi penting a#ampengambi#an keputusan : Rasio*anfaat ter+ada% resi)o

• 8nformasi terkini untuk penekatankonisi pasien terhaap respon obat

• Mencegah ke&aian kemba#i paa

kasus serupa• Menurunkan morbiitas an

morta#itas


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9er&asama

9eamanan mas"arakat a#am aspekobat aa#ah tanggung profesikesehatan

• 1er#u sistem ker&asama enganmas"arakat #uas an 18%A9 >ER9A8>(1emerintah)

• >erbuka untuk komunikasi nasiona#maupun internasiona#


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A#amat pe#aporan

2?

R$/@/1


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Safe use ofprescription

meication• A'oi agents / either foo!a#coho#! other rugs / thatma" ecrease eecti'eness orincrease sie eects;

• RecogniLe sie eects anknow what to o if the" occur;

• nerstan inications anexpectations for theprescribe agents

• 1erioica##" re'iewmeications

• et prescription re,##e ina'ance

Documents

Monitoring Efek Samping Obat 12