1 / 7

: Adverse Drug

PHA-000-2-002-01

Reactions: ADR
:

(. )

(.. )

1.
1.1

1.2

1.3

1.4
: Stevens Johnson Syndrome (SJS) , Toxic
Epidermal Necrolysis (TEN)

2.

3.

ADR

ADR
ADR

ADR


ADR

PHA-000-2-002-01

 2 / 7

: Adverse Drug Reactions: ADR

4.

(Adverse Event: AE)

(Adverse Drug Reaction: ADR)
Adverse Drug Reactions: ADR

()
(Drug Allery or Drug Hypersensitivity)

(Immune-mediated ADRs)
(Repeated ADR type B)

Side effect



Toxic reaction

Hypersensitivity

Idiosyncrasy

enzymatic defect


: PHA-000-2-002-01
: Adverse Drug Reactions: ADR
Drug interaction

Erythremamultiforme (EM)


3-7 [target lesion, iris lesion]


10 %

3 4

Steven Johnson Syndrome (SJS)

714 EM
30 %

SJS
2
Toxic epidermal necrolysis (TEN)
SJS
30% SJS

Cotrimoxazole,

sulfadiazine, salazopyrin, Carbamazepine, phenobarbital,

phenytoin nevirapine(NVP), GPO-virs30, allopurinal
5.

5.1
.
(). :
. 2449
5.2 ().
Adverse Drug Reaction. :
. 2550
5.3 WHO Publication: Safety of medicine. A guide to
detecting and reporting adverse drug reactions. Geneva:
World Health Organization, 2002. Available at URL:
http://WWW.cdmubengal.org/other_infor/WHOSafetyOfMedi
cinesGuide.pdf. Access date: Dec 26, 2005.

PHA-000-2-002-01

4 / 7

: Adverse Drug Reactions: ADR

5.

ADR

1.
1.1

ADR

ADR

ADR
-
ADR

(
OPD) Chart ( IPD)
ADR

ADR
- OPD
card ( OPD)
Chart ( IPD)
-

1.2

ADR

1.3

ADR

1.4

ADR

2.

3.

ADR

ADR

3.1
ADR
-

ADR
ADR

(Naranjo algorithm)
- ADR

/ADR

PHA-000-2-002-01

5 / 7

: Adverse Drug Reactions: ADR

3.2 ADR

- ADR

- ,

ADR
-



-
ADR

4.
-

-

- IPD
drug
profile
5.
SLS
TEN

ADR

PHA-000-2-002-01

6 / 7

: Adverse Drug Reactions: ADR

intensive

6.

-

- ADR

ADR
- ( IPD)

Chart

- ( IPD)

Copy order

7. ADR

-

ADR

- ADR

ADR
- OPD card
ADR (
)
15-18 4
( 2)

- ADR

10650

8.

9.

ADR

ADR

PHA-000-2-002-01

7 / 7

: Adverse Drug Reactions: ADR

1)

2)

6.

6.1
6.2
6.3 ADR (PHA-004-4-003-00)
6.4
(ADR) (PHA-004-4-004-00)
6.5(PHA-004-4-005-00)
6.6
(NARANJO ALGORITHM) (PHA-004-4-006-00)

6.7

(PHA-004-4-007-00)

6.8
(PHA-004-4-008-00)
6.9
Order
6.10

(PHA-004-4-009-00)

6.1

 OPD Card

ADR


OPD Card Chart

ADR*

/
10165 ()*
/ ADR* ,OPD Card

/ADR

OPD Card

6.2

OPD Card

()

Chart

OPD Card,
ADR
08.00 24.00 .

Copy Order

Copy Order

24.00 08.00 .

 (
)

/ADR

OPDCard, Chart

ADR 24.00

08.00 . Anaphylaxis 10165

6.3 A D R
ADVERSE DRUG REACTION


......................................................................HN..................
........................
/

PHA-004-4-00300

6.4 (ADR)
...........................................................................HN.
.AN..
........ ......... ........cm.
......./ .........................

...................................


.............................
................................

: ....................................................................................................
....................................

: ...
.....

.......................
:

............................................................................................................
...................................................

:.......................................................................................................
................................
............................................................................................................
...................................................

: .
..

(, ,

):

/ ( ADR):
.

: .................................................................................................
...............
: ..:
.
(

)
1. ...........................................................
.................................
2. ...........................................................
.................................
3. ...........................................................
.................................
4. ...........................................................
.................................
5. ...........................................................
.................................
6. ...........................................................
.................................
7. ...........................................................
.................................
:
..

: ................................................................................................
...........................................

....................................................

PHA-004-4004-00

: (


):
...
............................................................................................................
............................................................................................................
.....................................................................................................

CASE REPORT

........

............................................................................................................
............................................................................................................
............................................................................................................
............................................................................................................
.............................................

...............................................................
CERTAIN
POSSIBLE

PROBABLE/LIKELY

UNLIKELY

................................................................................................

...................................................................

 ADR
Myopathy & elevated liver enzyme Colchicine,
Depakine induce Steven-Johnson syndrome
:

:
, ,

PHA-004-4-004-00

6.5
/

//

PHA-000-4-005-00

6.6 Naranjo's algorithm:

........
..
.

1.

+1

+2

-1

+1

+2

-1

-1

+2

-1

+1

2.

3.



(specific antagonist)

4.

5.

()

6.

7.

+1

+1

+1

+1

()

8.

9.

10.


(objective evidence)

9
5-8
1-4

Definite
Probabl
e
Possibl
e

Doubtfu
0

........................................................


......................................................................
..
037395085-6
...............................................
PHA-004-4-00600

(PHA-004-4-007-00)

6.8

**

**

**

**

**

**

**

**

**

**

**

**

**

**

**

**

**

**

(PHA-004-4-008-00)

6.9
Order

......................
........................

6.10

.............................................................
....................

(PHA-004- ........................................
.....()

4-009-00)