Adverse drug reactions and off-label and unlicensed medicines in children: a nested case?control study of inpatients in
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RESEARCH ARTICLE
Open Access
Adverse drug reactions and off-label and unlicensed medicines in children: a nested case–control study of inpatients in a pediatric hospital Jennifer R Bellis3*, Jamie J Kirkham2, Signe Thiesen1, Elizabeth J Conroy2, Louise E Bracken3, Helena L Mannix3, Kim A Bird4, Jennifer C Duncan3, Matthew Peak3, Mark A Turner1, Rosalind L Smyth5, Anthony J Nunn1 and Munir Pirmohamed6
Abstract Background: Off-label and unlicensed (OLUL) prescribing has been prevalent in pediatric practice. Using data from a prospective cohort study of adverse drug reactions (ADRs) among pediatric inpatients, we aimed to test the hypothesis that OLUL status is a risk factor for ADRs. Methods: A nested case–control study was conducted within a prospective cohort study. Details of all medicines administered were recorded, including information about OLUL status. The odds ratio for OLUL medicines being implicated in a probable or definite ADR was calculated. A multivariate Cox proportional hazards regression model was fitted to the data to assess the influence that OLUL medicine use had on the hazard of an ADR occurring. Results: A total of 10,699 medicine courses were administered to 1,388 patients. The odds ratio (OR) of an OLUL medicine being implicated in an ADR compared with an authorized medicine was 2.25 (95% confidence interval (CI) 1.95 to 2.59). Medicines licensed in children but given to a child below the minimum age or weight had the greatest odds of being implicated in an ADR (19% of courses in this category were implicated, OR 3.54 (95% CI 2.82 to 4.44). Each additional OLUL medicine given significantly increased the hazard of an ADR (hazard ratio (HR) 1.3 95% CI 1.2 to 1.3, P 100 courses shown, n = 7,007) Medicine (number of courses) Medicines with only authorized Cefuroxime (245) courses Cefotaxime (388)
Number of courses Number of authorized Number of off-label or Number of off-label or courses implicated in at unlicensed courses implicated courses a unlicensed (%) least one PD ADR (%) in at least one PD ADR (%) unknown 0 (0%)
15 (6.5%)
-
1 0
0 (0%)
40 (10.3%)
-
Chlorphenamine (339)
1 (0.3%)
1 (0.3%)
0
1
Diazepam (107)
1 (1.9%)
1 (1.0%)
0
0
Ibuprofen (545)
26 (4.8%)
4 (0.8%)
1 (3.8%)
0
Lactulose (272)
13 (4.8%)
7 (2.7%)
1 (0.1%)
0
Cefalexin (148)
9 (6.1%)
8 (5.8%)
1 (11.0%)
0
Metronidazole (257)
21 (8.2%)
19 (8.0%)
3 (14.3%)
0
Furosemide (110)
13 (11.8%)
13 (13.4%)
2 (15.4%)
0
Paracetamol (1786)
596 (33.4%)
1 (0.1%)
0 (0%)
2
Ondansetron (550)
290 (52.7%)
18 (8.5%)
14 (2.5%)
48
Salbutamol (146)
84 (57.5%)
3(4.8%)
10 (11.9%)
0
Ranitidine (109)
65 (59.6%)
1 (2.3%)
0 (0%)
0
Dexamethasone (166)
107 (64.5%)
7(13.5%)
3 (2.8%)
7
Fentanyl (150)
149 (99.3%)
0 (0%)
72 (48%)
0
Medicines with unlicensed courses
Fentanyl and Levobupivicaine epidural (106)
106 (100.0%)
-
47 (44.3%)
0
Medicines with off-label and unlicensed courses
Codeine Phosphate (752)
257
Medicines with off-label courses
12 (1.6%)
49 (10.1%)
0 (0%)
Morphine (50
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