An algorithm to detect adverse drug reactions in the neonatal intensive care unit : A new approach

Journal of Clinical Pharmacology

Volumn 53, Issue 1, 2013, Pages 87-95

  Du, Wei ^a   Lehr, Victoria Tutag ^b   Lieh Lai, Mary ^a   Koo, Winston ^c   Ward, Robert M ^d   Rieder, Michael J ^e   Van Den Anker, John N ^f   Reeves, Jaxk H ^g   Mathew, Merene ^h   Lulic Botica, Mirjana ⁱ   Aranda, Jacob V ^j  

^a WAYNE STATE UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b WAYNE STATE UNIVERSITY   (United States)

^c LOUISIANA STATE UNIVERSITY HEALTH SCIENCES CENTER   (United States)

^d UNIVERSITY OF UTAH SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF WESTERN ONTARIO   (Canada)

^f GEORGE WASHINGTON UNIVERSITY   (United States)

^g UNIVERSITY OF GEORGIA   (United States)

^h Pediatrics Southwestern Medical Clinics   (United States)

ⁱ HUTZEL HOSPITAL   (United States)

^j UNIVERSITY OF NEW YORK   (United States)

more..

Author keywords

ADR algorithm; Adverse drug reactions (ADRs); Interrater reliability; Newborn infants; NICU; Validity

Indexed keywords

ACICLOVIR; ALANINE AMINOTRANSFERASE; AMINOGLYCOSIDE ANTIBIOTIC AGENT; AMPHOTERICIN B; AMPICILLIN; ASPARTATE AMINOTRANSFERASE; AZITHROMYCIN; BETAMETHASONE; CAFFEINE; CEFTRIAXONE; CISAPRIDE; CITRATE POTASSIUM; CREATININE; ERYTHROMYCIN; FLUCONAZOLE; FUROSEMIDE; INDOMETACIN; LIDOCAINE; LOPERAMIDE; LORAZEPAM; MAGNESIUM; MICAFUNGIN; MIDAZOLAM; MORPHINE; PRILOCAINE; SPIRONOLACTONE; TETRACAINE; THEOPHYLLINE; UNINDEXED DRUG; VANCOMYCIN;

ACIDOSIS; ACUTE KIDNEY FAILURE; ADVERSE DRUG REACTION; ALGORITHM; ANEMIA; APNEA; ARTICLE; BRADYCARDIA; CONSENSUS DEVELOPMENT; CORRELATION COEFFICIENT; CREATININE BLOOD LEVEL; CRITICALLY ILL PATIENT; FEMALE; GOLD STANDARD; HEPATORENAL SYNDROME; HUMAN; HYPERBILIRUBINEMIA; HYPERKALEMIA; HYPERMAGNESEMIA; HYPERTRIGLYCERIDEMIA; HYPOKALEMIA; HYPONATREMIA; HYPOTENSION; INFANT; IRRITABILITY; LEUKEMOID REACTION; MAJOR CLINICAL STUDY; MALE; METABOLIC ACIDOSIS; MYOCLONUS; NEUTROPENIA; NEWBORN; NEWBORN INTENSIVE CARE; QT INTERVAL; QUESTIONNAIRE; RASH; RELIABILITY; RESPIRATORY DISTRESS; SCORING SYSTEM; SEIZURE; SIDE EFFECT; SMALL INTESTINE PERFORATION; STOMACH HEMORRHAGE; SUPRAVENTRICULAR TACHYCARDIA; TACHYCARDIA; TELECONFERENCE; TREMOR; VALIDITY; VOMITING;

ALGORITHMS; DRUG MONITORING; DRUG TOXICITY; FEMALE; HOSPITALS, PEDIATRIC; HUMANS; INFANT; INFANT, NEWBORN; INTENSIVE CARE UNITS, NEONATAL; MALE; ONTARIO; PHARMACOVIGILANCE; REPRODUCIBILITY OF RESULTS;

EID: 84877868850     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270011433327     Document Type: Article

References (45)

1. Knight M. Adverse drug reactions in neonates. J Clin Pharmacol . 1994;34(2):128-135.
2. Gurwitz JH, Field TS, Harrold LR, et al. Incidence and preventability of adverse drug events among older persons in the ambulatory setting. JAMA . 2003;289(9):1107-1116.
3. Department of Health and Human Services, Agency for Healthcare Research and Quality (AHRQ). Report on Hospital Admissions and Adverse Drug Reactions . Rockville, MD: AHRQ; 2010.
4. Agency for Healthcare Research and Quality (AHRQ), Center for Delivery, Organization, and Markets. Healthcare Cost and Utilization Project, Nationwide Inpatient Sample and Nationwide Emergency Department Sample . Rockville, MD: AHRQ; 2008.
5. Kaushal R, Bates DW, Landrigan C, et al. Medication errors and adverse drug events in pediatric inpatients. JAMA . 2001; 285(16):2114-2120.
6. Impicciatore P, Choonara I, Clarkson A, Provasi D, Pandolfini C, Bonati M. Incidence of adverse drug reactions in paediatric in/out-patients: a systematic review and meta-analysis of prospective studies. Br J Clin Pharmacol . 2001;52:77-83.
7. Gonzalez-Martin G, Caroca CM, Paris E. Adverse drug reactions (ADRs) in hospitalized pediatric patients: a prospective study. Int J Clin Pharmacol Ther . 1998;36(10):530-533.
8. Le J, Nguyen T, Anandi V, Hodding L, Hodding J. Adverse drug reactions among children over a 10-year period. Pediatrics . 2006;118:555-562.
9. Agarwal S, Classen D, Larsen G, et al. Prevalence of adverse events in pediatric ICUs in the United States. Pediatr Crit Care Med . 2010;11(5):568-578.
10. Burny I, Lieh-Lai MW, Gaynor KN, Thomas RL, Sarnaik AP. Pattern of medication use and errors in a tertiary care children's hospital intensive care unit. J Pharm Technol . 2006;22:326-331.
11. Jacubeit T, Drisch D, Weber E. Risk factors as reflected by an intensive drug monitoring system. Agents Actions Suppl . 1990;29: 117-125.
12. Aranda JV, Cohen S, Neims AH. Drug utilization in a newborn intensive care unit. J Pediatr . 1976;89(2):315-317.
13. Aranda JV, Portuguez-Malavasi A, Collinge JM, Germanson T, Outerbridge EW. Epidemiology of adverse drug reactions in the newborn. Dev Pharmacol Ther . 1982;5(3-4):173-184.
14. Macedo AF, Marques FB, Ribeiro CF, Teixeira F. Causality assessment of adverse drug reactions: comparison of the results obtained from published decisional algorithms and from the evaluations of an expert panel. Pharmacoepidemiol Drug Saf . 2005;14(12): 885-890.
15. Arimone Y, Begaud B, Miremont-Salame G, et al. Agreement of expert judgment in causality assessment of adverse drug reactions. Eur J Clin Pharmacol . 2005;61(3):169-173.
16. Naranjo CA, Busto U, Sellers EM, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther . 1981;30(2):239-245.
17. Warrier I, Du W, Natarajan G, Salari V, Aranda J. Patterns of drug utilization in a neonatal intensive care unit. J Clin Pharmacol . 2006;46:449-455.
18. Lindell-Osuagwu L, Korhonen MJ, Saano S, Helin-Tanninen M, Naaranlahti T, Kokki H. Off-label and unlicensed drug prescribing in three paediatric wards in Finland and review of the international literature. J Clin Pharm Ther . 2009;34(3):277-287.
19. Leeder JS. Developmental and pediatric pharmacogenomics. Pharmacogenomics . 2003;4(3):331-341.
20. Kane-Gill SL, Van Den Bos J, Handler SM. Adverse drug reactions in hospital and ambulatory care settings identified using a large administrative database. Ann Pharmacother . 2010;44(6):983-993.
21. Raju TNK, Gautham S, Higgins RD. Patient safety in the context of neonatal intensive care: research and educational opportunities. Pediatr Res . 2011;70(1):109-115.
22. Aagaard L, Weber CB, Hansen EH. Adverse drug reactions in the paediatric population in Denmark: a retrospective analysis of reports made to the Danish Medicines Agency from 1998 to 2007. Drug Saf . 2010;33(4):327-339.
23. Carleton BC, Poole RL, Smith MS, et al. Adverse drug reaction active surveillance: developing a national network in Canada's children's hospitals. Pharmacoepidemiol Drug Saf . 2009;18:713-721.
24. Vassilev ZP, Chu AF, Ruck B, Adams EH, Marcus SM. Adverse reactions to over-the-counter cough and cold products among children: the case managed out of hospitals. J Clin Pharm Ther . 2009;34(3):313-318.
25. Karch FE, Smith CL, Kerzner B, Mazzullo JM, Weintraub M, Lasagna L. Adverse drug reactions: a matter of opinion. Clin Pharmacol Ther . 1976;19(5, pt 1):489-492.
26. Koch-Weser J, Sellers EM, Zacest R. The ambiguity of adverse drug reactions. Eur J Clin Pharmacol . 1977;11(2):75-78.
27. Bonati M, Marchetti F, Zullini MT, Pistotti V, Tognoni G. Adverse drug reactions in neonatal intensive care units. Adverse Drug React Acute Poison Rev . 1990;9(2):103-118.
28. Leary PM. Adverse reactions in children: special considerations in prevention and management. Drug Saf . 1991;6:171-182.
29. Lehmann LS, Puopolo AL, Shaykevich S, Brennan TA. Iatrogenic events resulting in intensive care admission: frequency, cause, and disclosure to patients and institutions. Am J Med . 2005;118(4):409-413.
30. Mittmann N, Knowles SR, Gomez M, Fish JS, Cartotto R, Shear NH. Evaluation of the extent of under-reporting of serious drug reactions. Drug Saf . 2004;27(7):477-487.
31. Begaud B. Standardized assessment of adverse drug reactions: the method used in France. Special workshop-clinical. Drug Inf J . 1984;18(3-4):275-281.
32. Benichou C, Danan G. A new method for drug causality assessment: RUCAM. In: Christian B, ed. Adverse Drug Reactions: A Practical Guide to Diagnosis and Management . New York, NY: John Wiley; 1994:277-283.
33. Blanc S, Leuenberger P, Berger JP, Brooke EM, Schelling JL. Judgments of trained observers on adverse drug reactions. Clin Pharmacol Ther . 1979;25(5, pt 1):493-498.
34. Emanueli A, Sacchetti G. An algorithm for the classification of untoward events in large scale clinical trials. Agents Actions Suppl . 1980;7:318-322.
35. Hutchinson TA. Bayesian assessment of adverse drug reactions. CMAJ . 2000;163(11):1463-1464.
36. Jones JK. Adverse drug reactions in the community health setting: approaches to recognizing, counseling, and reporting. Fam Community Health . 1982;5(2):58-67.
37. Karch FE, Lasagna L. Toward the operational identification of adverse drug reactions. Clin Pharmacol Ther . 1977;21(3):247-254.
38. Kramer MS, Leventhal JM, Hutchinson TA, Feinstein AR. An algorithm for the operational assessment of adverse drug reactions, I: background, description, and instructions for use. JAMA . 1979;242(7):623-632.
39. Maria VA, Victorino RM. Development and validation of a clinical scale for the diagnosis of drug-induced hepatitis. Hepatology . 1997;26(3):664-669.
40. Turner WM. The Food and Drug Administration algorithm. Special workshop-regulatory. Drug Inf J . 1984;18(3-4):259-266.
41. Zapater P, Such J, Perez-Mateo M, Horga JF. A new Poisson and Bayesian-based method to assign risk and causality in patients with suspected hepatic adverse drug reactions: a report of two new cases of ticlopidine-induced hepatotoxicity. Drug Saf . 2002;25(10): 735-750.
42. Dharnidharka VR, Kandoth PN, Anand RK. Adverse drug reactions in pediatrics with a study of in-hospital intensive surveillance. Indian Pediatr . 1993;30(6):745-751.
43. Lamabadusuriya SP, Sathiadas G. Adverse drug reactions in children requiring hospital admission. Ceylon Med J . 2003;48(3): 86-87.
44. Weiss J, Krebs S, Hoffmann C, et al. Survey of adverse drug reactions on a pediatric ward: a strategy for early and detailed detection. Pediatrics . 2002;110(2, pt 1):254-257.
45. Long AL, Horvath MM, Cozart H, Eckstrand J, Whitehurst J, Ferranti J. Infants with "trigger" laboratory data or predetermined rules would be screened via health care system computer system and have identifying "trigger" in electronic medical record. Qual Saf Health Care . 2010;19(5):e40.