Adaptation and validation of an adverse drug reaction preventability score for bleeding due to vitamin K antagonists.
Although drug therapy is inherently associated with the risk of adverse drug reactions (ADRs), some of these events are preventable. The estimated proportion of preventable ADRs varies from one study or clinical context to another. Bleeding caused by antithrombotic agents (and particularly vitamin K antagonists, VKAs) constitutes one of the most frequent causes of ADR-related hospitalization.Hence, the objective of the present study was to adapt and validate an ADR preventability score for bleeding due to VKAs and evaluate the preventability of bleeding in 906 consecutive hospitalized, VKA-treated adult patients with a risk of major bleeding (defined as an international normalized ratio ≥5) over a 2-year period. A specific preventability scale for VKA-associated bleeding was developed by adapting a published tool.Overall, 241 of the 906 patients in the study experienced at least 1 VKA-associated bleeding event. The scale's reliability was tested by 2 different evaluators. The inter-rater reliability (evaluated by calculation of Cohen's kappa) ranged from "good" to "excellent." Lastly, the validated scale was used to assess the preventability of the VKA-associated bleeding. We estimated that bleeding was preventable or potentially preventable in 109 of the 241 affected patients (45.2%).We have developed a useful, reliable tool for evaluating the preventability of VKA-associated bleeding. Application of the scale in a prospective study revealed that a high proportion of VKA-associated bleeding events in hospitalized, at-risk adult patients were preventable or potentially preventable.
aService de Pharmacologie Clinique, Centre Régional de Pharmacovigilance, Amiens University Hospital Amiens Sud bINSERM U1088, Jules Verne University of Picardy, Amiens, France.
Sophie
S
Liabeuf
Kamel
K
Masmoudi
Lucie-Marie
LM
Scailteux
Julien
J
Moragny
Henri
H
Masson
Valérie
V
Brnet-Dufour
Michel
M
Andrejak
Valérie
V
Gras-Champel
D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000465:Algorithms; D000740:Anemia / Q000150:complications; D001281:Atrial Fibrillation / Q000150:complications / Q000188:drug therapy; D005260:Female; D005343:Fibrinolytic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D006470:Hemorrhage / Q000139:chemically induced* / Q000517:prevention & control*; D006801:Humans; D006973:Hypertension; D019934:International Normalized Ratio; D007676:Kidney Failure, Chronic / Q000150:complications; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D015203:Reproducibility of Results; D018570:Risk Assessment; D012720:Severity of Illness Index; D014812:Vitamin K / Q000037:antagonists & inhibitors*; D055815:Young Adult
D005343:Fibrinolytic Agents; D014812:Vitamin K
Therapie. 2005 Jan-Feb;60(1):39-45
15929472
Ann Pharmacother. 2002 Jul-Aug;36(7-8):1238-48
12086559
Drug Saf. 2012 Feb 1;35(2):105-26
22201475
J Gen Intern Med. 2000 Apr;15(4):211-9
10759995
Fundam Clin Pharmacol. 2015 Feb;29(1):106-11
24990220
Hosp Pharm. 1992 Jun;27(6):538
10118597
Ther Clin Risk Manag. 2015 Jul 15;11:1061-75
26203254
Chest. 2013 Jan;143(1):179-84
22722228
Therapie. 1999 Jan-Feb;54(1):21-7
10216418
Pharmacoeconomics. 1999 May;15(5):445-58
10537962
Ann Intern Med. 1988 Oct 1;109(7):582-9
3421565
JAMA. 2001 Apr 25;285(16):2114-20
11311101
N Engl J Med. 1989 Aug 17;321(7):480-4
2761585
Medicine (Baltimore). 2015 Dec;94(52):e2366
26717378
J Gen Intern Med. 1995 Apr;10(4):199-205
7790981
J Intern Med. 1990 Aug;228(2):83-90
2394974
Br J Clin Pharmacol. 2007 Feb;63(2):136-47
16803468
Biometrics. 1977 Mar;33(1):159-74
843571
Eur J Clin Pharmacol. 2000 May;56(2):181-6
10877014
Drug Saf. 2001;24(10):781-92
11676305
Psychol Bull. 1968 Oct;70(4):213-20
19673146
Drug Saf. 2002;25(14):1035-44
12408734
Therapie. 1998 Jul-Aug;53(4):365-70
9806006
JAMA. 1995 Jul 5;274(1):29-34
7791255