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Table 2 The Triggers and PPV

From: Establishment of a pediatric trigger tool based on Global Trigger Tool to identify adverse drug events of children: experience in a Chinese hospital

Modules

No.

Triggers

Interpretation

Positive triggers

ADEs

PPVa(95%CI),%

Laboratory test

L1

K<3mmol·L−1 [8, 9, 15, 17, 18]

hypokalemic drugs used

5

3

60.0(17.1~100.0)

L2

K>5.5mmol·L−1 [19]

hyperkalemic drugs used

12

4

33.3(6.7~60.0)

L3

Na<130mmol·L−1 [8, 9, 13, 14, 17]

hyponatremic drugs used

4

2

50.0(1.0~99.0)

L4

ALT≥3ULN&R≥5, ALP≥2ULN&R≤2, ALT≥3ULN,ALP≥2ULN&2<R<5 [20]

R=(ALT measured value/ALTULN)/(ALP measured value/ALPULN)

hepatotoxic drugs used

9

4

44.4(11.9~76.9)

L5

PG<2.78mmol·L−1(50 mg/dL) [21] PG<2. 2mmol·L−1(neonates) [22] PG≤3.9 mmol·L−1(diabetics) [23]

insulin or hypoglycemic drugs used

4

0

0b

L6

PG>8.33mmol·L−1(150 mg/L) [16] or fasting glucose≥7.8mmol·L−1 [18] PG>7mmol·L−1(neonates) [24]

hyperglycaemic medications use or hypoglycemic drugs used inappropriately

12

10

83.3(62.~100.0)

L7

creatinine or urea>2×baseline [9, 11, 12, 16,17,18]

nephrotoxic drugs used

2

2

100.0b

L8

partial thromboplastin time>100 s [11, 12, 14, 16,17,18]

heparin used excessively

0

-c

-c

L9

INR>3[25]

warfarin used excessively

2

1

50.0b

L10

thrombocytes<50×10 9 ·L−1 [9, 15, 18]

thrombocytopenia drugs used

16

9

56.3(31.9~80.6)

L11

TSH≥10.0mIU·L-1 [26]TSH≥20mIU·L-1(neonates)[27]

antithyroid drugs used

1

0

0b

L12

TSH<0.1mIU·L−1 [28]

hyperthyroidism drugs used

0

-c

-c

L13

WBC<12×109·L−1(neonates)[29]WBC<11×109·L−1 (6m~2y) WBC<5×109·L−1(2y~14y) WBC<4×109·L−1 (14y~18y)

drugs which induced leukopenia used

46

21

45.7(31.3~60.1)

L14

hs-TnI>0.0156µg·L−1 or CK-MB>25U·L−1(>15y)or CK-MB>37U·L−1(4y~15y) or CK-MB>45U·L−1(1y~3y) or CK-MB>58U·L−1(<1y) [30]or CK-MB/CK>5%[31](except cardiopath)

cardiotoxic drugs used

35

5

14.3(2.7~25.9)

L15

Hb>199g·L−1 (neonates) [32] Hb>100g·L−1(2m~3m) Hb>125g·L−1(3m~12m) Hb>129g·L−1 (1y~3y) Hb>137g·L−1 (4y~8y male)Hb>131g·L−1(4y~8y female) [33] Hb>152g·L−1 (9y~14y male) Hb>147g·L−1(9y~14y female) Hb>175g·L−1(15y~18y male) Hb>150g·L−1(15y~18y female) [34]

recombinant human erythropoietin used

6

0

0b

L16

BMD- Z<-2.0 & clinical fracture history [35]

anti-osteoporosis drugs used

0

-c

-c

Medication

M1

Vitamin K given (except routine neonatal dose) [8,9,10,11,12,13,14,15,16,17,18]

after warfarin administration

2

0

0b

M2

protamine given [11, 12, 14, 18]

after heparin administration

1

0

0b

M3

heparin or low-molecular-weight heparin given [8]

after coagulant(Vitamin K) administration

7

0

0b

M4

antihistamine+calglucon+glucocorticoid/adrenaline+dexamethasone given[8,9,10,11,12, 16,17,18]

after druge allergy or anaphylaxis / anaphylactic shock caused by transfusion

5

0

0b

M5

narcan (naloxone) /nalmefene given [8,9,10,11,12,13,14,15,16,17,18]

after opioids poisoning

0

-c

-c

M6

50% glucose injection (neonates 10%) [36] given

after drug-induced severe hypoglycemia

14

0

0b

M7

Antiemetic(granisetron/ ondansetro/ tropisetron /metoclopramide)given [8,9,10, 13, 16,17,18]

after surgery,chemotherapy or drugs induced vomiting

17

2

11.8(0~27.1)

M8

oral vancomycin or metronidazole [9, 10, 16]

after pseudomembranous colitis/staphylococcal enteritis caused by clostridium difficile due to long-term use of broad-spectrum antibiotics

8

0

0b

M9

laxative or stool softener given [11,12,13, 17, 18]

after drug-induced constipation

8

3

37.5(4.0~71.1)

M10

glutathione / glycyrrhizic acid preparation / polyene phosphatidylcholine given [18]

after drug-induced liver injury

31

8

25.8(10.4~41.2)

M11

flumazenil given [11,12,13, 17, 18]

after severe hypotension and sedation induced by excessive benzo two nitrogenous drugs

1

1

100.0b

M12

nystatin and sodium bicarbonate for external use [18]

candida infection associated with long-term use of antibiotics / hormones / immunosuppression

16

6

37.5(13.8~61.2)

M13

intravenous bolus≥10 ml·kg−1 colloid or crystalloid given [9, 10]

after septic shock

75

1

1.3(0.3~3.9)

Symptoms

S1

rash/itching [8, 18]

after administration of antibiotics / drugs that cause skin reactions

15

11

73.3(51.0~95.7)

S2

oversedation/hypotension/falls [16,17,18]

after administration of antihypertensive drugs, sedative hypnotics and other 7drugs

12

7

58.3(30.4~86.2)

S3

admitted to ICU /rescue [18]

ADE causes serious illness

23

7

30.4(11.6~49.2)

S4

abrupt medication stop(long-term use of anticoagulants, antihypertensives, hypolipidemic, hypoglycemic or hormones)[9, 10, 12, 15,16,17,18]

ADE causes withdrawal or ADE appears due to withdrawal

5

5

100.0b

  1. ALT alanine aminotransferase; ALP alkaline phosphatase; PG blood glucose; TSH thyroid stimulating hormone; WBC white blood cells; INR international normalized ratio; hs-TnI hypersensitive troponin I; CK-MB creatine kinase isoenzymes; CK creatine kinase; Hb hemoglobin; BMD bone mineral density
  2. aPPV=ADEs/ positive triggers.
  3. bWhen the ADEs were close to 0,or the positive triggers were too small, the 95% CI of the PPV was not statistically significant.
  4. cnone