Electronic supplementary

ESM1: Summary of Products Characteristics

In France, authorization to market a drug requires to define a Summary of Products Characteristics (SPC), including: chemical composition, clinical indications, dosage schedule and route of administration, contra-indications, special warnings, special precautions for use, interactions, recommendations on use in pregnancy and in lactation, effect on the ability to drive or use machines, adverse effects and pharmacodynamic properties. This SPC is easily accessible to all prescribers, in paper or electronic versions.

ESM2: Training of physician

Before the beginning of the study, the four investigators were especially trained for the determination of causality (i.e. was the admission to the ICU related to an IE or not) and preventability. This training involved three interactive sessions about (a) terminology and documentation of iatrogenic events, (b) causality and (c) preventability assessments, based on exercises with standardized methods used for adverse drug events (ADEs) [1,2].

ESM3: Collection of data

  • Number of physicians treating the patient was defined on the basis of at least one consultation or hospitalization in the last year. A hospital team counted as one physician.
  • Number of prescribed drugs was taking into account on admission and within 15 days before admission to the ICU.
  • Admission type was defined as medical (no surgery within one week of admission), scheduled surgical (patients for whom surgery was scheduled at least 24 hours in advance), and unscheduled surgical (patients added to operating schedule within 24 hours of the operation).
  • Organ failures were recorded as (a) shock (whatever the type) and multiple organ failure, (b) single organ failure (respiratory, renal or neurological), (c) absence of organ failure but need for intense observation.
  • The Mac Cabe score is a third level score evaluating the severity of the underlying medical condition (0 = not fatal, 1 = ultimately fatal within 5 years, 2 = ultimately fatal within 1 year)
  • The Knaus score is a four classes index of general health status ( A = prior good health, B = mild to moderate limitation of activity, C = serious restriction of activity, D = severe restriction of activity).
  • The Simplified Acute Physiology Score (SAPS II) and the Logistic Organ Dysfunction (LOD) score were calculated 24 hours after admission to the ICU as an index of disease severity and as a reflection of organ failure, respectively.
  • The following information was recorded during ICU stay: therapeutic interventions (mechanical ventilation, dialysis, vasoactive drugs, parenteral nutrition, tracheotomy, right heart catheterization, and blood transfusion), length of stay in the ICU, final outcome.

Additional references

  1. Bégaud B, Evreux JC, Jouglard J, Lagier G (1985). Imputation of the unexpected or toxic effects of drugs. Actualization of the method used in France. Therapie 40:111-118.
  2. Imbs JL, Pletan Y, Spriet A (1998) Assessment of preventable iatrogenic drug therapy: methodology. Therapie 53:365-370.

Results: Additional tables

Table S1. Comparison of preventable and non-preventable iatrogenic events.

Preventable
Iatrogenic Events
(n=76) / Non-preventable
Iatrogenic Events
(n=27) / p
SAPS II
Cause of iatrogenic event
ADEs (%)
Medical or surgical procedure
Excessive delay
Non-surgical nosocomial infections
Type of admission (%)
Medical
Scheduled surgical
Unscheduled surgical
Organ failure (%)
MOF or shock
Single
No organ failure
Place involved in iatrogenic event (%)
Home-acquired IEs
Hospital-acquired IEs / 41.0±22.5
32 (42.1)
32 (42.1)
8 (10.5)
4 (5.3)
53 (69.7)
14 (18.4)
9 (11.9)
25 (32.9)
34 (44.7)
17 (22.4)
27 (35.6)
49 (64.4) / 41.7±23.1
18 (66.7)
6 (22.2)
0
3 (11.1)
23 (85.2)
3 (11.1)
1 (3.7)
15 (55.6)
11 (40.7)
1 (3.7)
3 (11.1)
24 (88.9) / 0.72
0.04
0.34
0.06
0.03

ADEs = Adverse Drug Events

MOF = Multiple Organ Failure