Modules | No. | Triggers | Interpretation | Positive triggers | ADEs | PPVa(95%CI),% |
---|---|---|---|---|---|---|
Laboratory test | L1 | 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 | 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 | nephrotoxic drugs used | 2 | 2 | 100.0b | ||
L8 | heparin used excessively | 0 | -c | -c | ||
L9 | INR>3[25] | warfarin used excessively | 2 | 1 | 50.0b | |
L10 | thrombocytopenia drugs used | 16 | 9 | 56.3(31.9~80.6) | ||
L11 | 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 | 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 | after pseudomembranous colitis/staphylococcal enteritis caused by clostridium difficile due to long-term use of broad-spectrum antibiotics | 8 | 0 | 0b | ||
M9 | 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 | 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 | after administration of antibiotics / drugs that cause skin reactions | 15 | 11 | 73.3(51.0~95.7) | |
S2 | 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 |