Transcript Poster presentation

Author Name: Kannika Inpra
Email: [email protected]
Presenter Name: Kannika Inpra
Authors: Inpra K., Suwankesawong W., Kaewvichit S.
Institution: Phrae Hospital, Phrae, Thailand
Title: Preventable Adverse Drug Reactions in Hospitalized Patients: A Study in 21 Selected Thai Hospitals
Problem Statement: The high incidence of and costs associated with adverse drug reactions (ADRs) have influenced health care
policy and economics. To minimize this problem, it is essential to gain knowledge of preventable ADRs and develop intervention
programs to tackle the problem. In this study, the extent of preventable ADRs in Thailand was explored.
Objective: To determine the incidence and characteristics of preventable ADRs in hospitalized patients.
Design: Prospective observational study.
Setting and Study Population: All case report forms of patients more than 18 years old admitted to the Department of Medicine in
21 secondary and tertiary care hospitals located throughout Thailand from February 1, 2002, through March 8, 2002, were examined.
Results: From 13,781 case reports, 363 ADR reports were analyzed. From this group, 114 (31.4%) were classified with Schumock
and Thornton criteria as preventable ADRs. Mean age ± SD was 55.36 ± 6.44 years. More than twice as many females as males
(68:31) had ADRs. The top three underlying diseases were hypertension, diabetes mellitus, and tuberculosis. Eighty-one (71.1%)
preventable ADRs were related to hospital admission. The median length of stay was four days (range, 0–34 days), with 82 (71.9%)
reports considered severe enough to require initial or prolonged hospitalization.[1] The relationship of preventable ADRs to drug
exposure was determined to be probable or possible in 100%. Half of ADRs occurred in the gastrointestinal, metabolic and
nutritional, central and peripheral nervous, liver and biliary, and skin and appendages systems. The most common outcome (65.7%)
was recovery without sequelae. Other chemotherapeutics, metabolism, and miscellaneous were the top three classes of drugs causing
preventable ADRs. The four highest-priority causes of preventable ADRs accounted for 89% of all reports: (1) required therapeutic
drug monitoring or other necessary laboratory tests were not performed or not performed frequently enough (46.8%); (2) dose, route,
or frequency of administration was not appropriate for the patient’s age, weight, or disease criteria (16.0%); (3) drugs prescribed
were not appropriate for the patient’s clinical condition criteria (13.2%); and (4) noncompliance was associated with the reaction
criteria (13.2%).
Conclusions: Further studies are needed to identify and determine ADR-associated factors and to develop strategies to avoid
preventable ADRs in hospitalized patients.
Problem Statement
The high incidence and costs
associated with
adverse drug
reactions : ADRs have influenced
health care policy and economics. To
minimize this problem, it is essential
to gain knowledge of preventable
ADRs and develop intervention
programs to tackle the problem. In
this study, the extent of preventable
ADRs in Thailand were explored.
Objectives
To determine the incidence and
characteristics of preventable ADR
in hospitalized patients.
Design
Prospective observational study
Setting and Population
All case report forms of
patient more than 18 years old
admitted to the department of
medicine in secondary and tertiary
care hospitals located through out
Thailand during February 1, 2002
to March 8, 2002 were explored.
Adverse Drug Reaction : ADR
WHO definition (1966 )
Criteria for Determining
Preventability of an ADR
Answering “YES” to one or more of
the questions
• Was the dose, route, and frequency of
administration not appropriate for the
patient’s age, weight and disease state ?
• Was required therapeutic drug
monitoring or other necessary laboratory
test not performed ?
• Was the drug involved in the ADR not
considered appropriate for the patient’s
clinical condition ?
• Schumock GT and Thornton JP. Focusing on the preventability of adverse drug reactions.
Hosp Pharm. 1992;27:538-9.
Criteria for Determining
Preventability of an ADR
cont.
• Was there a history of allergy or previous
reactions to the drug ?
• Was a drug interaction involved in the
reaction ?
• Was a toxic serum drug level documented ?
• Was poor compliance involved in the
reaction ?
Schumock GT and Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm.
1992;27:538-9.
Results
• From 13,781 case reports, 363
ADRs reports were analyzed. From
this group, 114 (31.4 %) were
classified with Schumock and
Thornton criteria as preventable
ADRs.
• The relationship of preventable
ADRs to drug exposure was
determined to be probable or
possible in 100%.
• Most outcome (65.7%)
recovered without sequelae.
was
Table l
Preventable and Non-preventable Adverse Drug Reaction ( ADRs ) Categorized by
Patient and ADR Variables
Variable
No.( %)
Preventable
ADR
( n = 114,
31.40% )
No.( %)
Non-preventable
ADR
( n = 249, 68.60%
)
Age group
18-38
39-58
59-78
79-98
22 ( 19.30 )
35 ( 30.70 )
51 ( 44.74 )
6 ( 5.26 )
60 ( 24.10 )
78 ( 31.33 )
92 ( 36.95 )
19 ( 7.63 )
Age
Mean  SD
Range
Mode
Median
55.36  6.44
87-21
60
58.5
53.92  18.53
93-19
74
55
Gender
Male
Female
36 ( 31.58 )
78 ( 68.42 )
123 ( 49.40 )
126 ( 50.60 )
Table ll
Distribution of preventability Code
Preventabilit
y Code
Criteria
No. times code
used
(% total uses)
1
Drugs involved were not
appropriate for the
patient’s clinical
condition.
22
( 13.02 )
2
Dose, route, or frequency
of administration was not
appropriate for the
patient’s age, weight or
disease.
27
( 15.98 )
3
Required therapeutic drug
monitoring or other
necessary laboratory tests
were not performed or not
performed frequently
enough.
79
( 46.75 )
4
Patient has a history of
allergy or previous
reaction to the drug
13
( 7.69 )
5
A known drug interaction
was the suspected cause of
the reaction
2
( 1.18 )
6
A serum drug
concentration above the
therapeutic range was
documented
4
( 2.37 )
7
Noncompliance was
associated with the
reaction
22
(13.02 )
Most top three underlying diseases
• Hypertension
• Diabetes mellitus
• Tuberculosis
Half of them occurred in
•
•
•
•
•
Gastro-intestinal
Metabolic and nutritional
Central & peripheral nervous
Liver and biliary
Skin and appendages system
Most top three classes of drugs
causing preventable ADRs
• Other chemotherapeutics
• metabolism
• miscellaneous
Table II
Preventable and Non-preventable Adverse Drug Reaction ( ADRs ) Categorized
by Admissions due to ADR, Length of stay and Drug Allergy History
Variable
No. ( %)
Preventable
ADR
No. ( %)
Non-preventable
ADR
Admissions due to ADR
Yes
No
81 ( 71.05 )
33 ( 28.95 )
115 ( 46.18 )
134 ( 53.82 )
Length of stay
Min – Max
Mean SD
Median
Range
0 - 34
7.03  7.82
4
34
0 – 154
10.2  13.30
6
154
missing data = 3
missing data = 9
14 ( 12.28 )
100 ( 87.72 )
28 ( 11.67 )
212 ( 88.33 )
Drug Allergy History
Yes
No
missing data = 9
Discussion



The percentage of pADRs 31%
The percentage of admission that were
classified as preventable 71.05%
Values previously reported as being
preventable 28-80%
Conclusions
Further studies are needed to
identify and determine ADR
associated factors and to develop
strategies
for prevention
of
preventable ADRs in hospitalized
patients