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Acetaminophen Overdoses:
A Review of Intentional and Unintentional Cases
Hospital of the University of Pennsylvania
Philadelphia, PASarah Erush, PharmD, BCPS
Karen Shalaby, PharmD
Hospital of the University of Pennsylvania 700 bed tertiary academic medical facility
Level I Trauma Center/Transplant Services
Serves tri-state region
Averages 35,000 admissions per year
No pediatric admissions
Adverse Drug Event Program
Operated by Drug Information Service
Averages 600 reports per year
Spontaneous and targeted reporting methods
Acetaminophen overdoses reported despite recommendations otherwise
Unintentional overdose trend noted
Acetaminophen Case Series1998 – 2002 YTD
54 Reports
52 Charts Received
49 Reviewed
47 Acetaminophen
23 Intentional
23 Unintentional1
unknown
3 Incomplete
2 Not Acetaminophen
Psychiatry Consult Service
13/23 (56%)0/23 (0%)No Request:
10/23 (44%)23/23 (100%)
Request:
UNINTENTIONALINTENTIONAL
Patient Demographics
0102030
40506070
Age Male Female Direct Adm Transfer
(Characteristic)
(Yea
rs/%
)
Intentional Unintentional
Acetaminophen Dose
1.1 to 180.5 to 101Range (gm/day)
6.415.6Median (gm/day)
8.132Average(gm/day)
8/23 (34%)10/23 (43%)Known
15/23 (65%)13/23 (56%)Unknown
UNINTENTIONALINTENTIONAL
Acetaminophen Formulation
INTENTIONAL RX = 3
Percocet n=2 Darvocet n=1
OTC =21 Single Entity n=8 Combo Entity
n=13
UNINTENTIONAL RX = 3
Percocet n=2 Darvocet n=1
OTC = 20 Single Entity n=15 Combo Entity n=5
Causality: Unintentional Cases
9%
13% 18%
36%
PainToothacheInsomniaHeadacheHeadache/ Hip PainMenstrual CrampsHangoverFeverPruritusUnknown
Acute Exposure (< 7 days)
0
20
40
60
80
100
1 2 3 4 5 6
Days
%
Intentional n=22/ 23 Unintentional n=14/ 23
Lab Results: Average Peak Levels
INTENTIONAL UNINTENTIONAL
APAP: 115.1 mg/L 27.8 mg/L
ALT: 3,065 units/L 5,193 units/L
AST: 2,742 units/L 6,819 units/L
INR: 2.5 4
T Bili: 1.87 mg/dL 5.87 mg/dL
Length of Stay
65Median
2 to 302 to 55Range
8.97.4TOTAL Days: Average
1 to 101 to 16Range
43Median
4.43.6ICU Days: Average
UNINTENTIONALINTENTIONAL
Patient OutcomeINTENTIONAL UNINTENTIONAL
Resolved: 22/23 (96%) 16/23 (69%)
Evaluated: 9/23 (39%) 11/23 (48%)
Transplant: 0/23 (0%) 2/23 (9%)
Death: 0/23 (0%) 3/23 (13%)
Transplant and Death:
1/23 (4%) 0/23 (0%)
Risk FactorsINTENTIONAL
UNINTENTIONAL
Hepatic Disease:
1/23 (4%) 2/23 (9%)
Alcohol Use: (Acute or Chronic)
14/23 (61%) 20/23 (87%)
Drug Abuse:(Current or
Past)
10/23 (43%) 8/23 (35%)
Concomitant Disease:
1/23 (4%) 3/23 (13%)
Alcohol Use
2/23 (9%)1/23 (5%)Unknown:
6/23 (26%)10/23 (44%)None:
6/23 (26%)3/23 (13%)Acute with Chronic:
0/23 (0%)2/23 (8%)Acute:
9/23 (39%)7/23 (30%)Chronic:
UNINTENTIONALINTENTIONAL
Multiple Risk Factors
0
2
4
6
8
10
12
0 1 2 3 4
# of Risk Factors
# o
f Pati
ents
I ntentional 16/ 23 Unintentional 22/ 23
Data Summary Unintentional overdoses accounted for 50%
cases
Doses are lower and ingested over 1 to 3 days
Unintentional cases had greater toxicity when judged by LFT, INR, and length of stay
Unintentional cases had higher transplant and death rates
Data Summary cont. Influence of risk factors remains unclear
Hospital Costs (mean) Intentional: $12,671
Unintentional: $23,380
Extrapolated Cost Data
Results similar to those previously published
Recommendations
Continue availability of OTC Acetaminophen
Education of healthcare practitioners Encourage reporting of acetaminophen
overdoses Awareness of unintentional overdoses
Education of patients Awareness of potential toxicity
Recommendations cont. Labeling
Maximum dose and duration Combination products
Packaging Limit purchase size Consider unit dose application
Manufacturing Consider addition of N-Acetylcysteine to
Acetaminophen preparations.
Recommended