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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