— Real-Time Safety Surveillance of Dabigatran Among VA Users

Dong D, Department of Veterans Affairs, Pharmacy Benefits Management Services Center for Medication Safety (VAMedSAFE); Cunningham F, Department of Veterans Affairs, Pharmacy Benefits Management Services Center for Medication Safety (VAMedSAFE); Longo L, Department of Veterans Affairs, Pharmacy Benefits Management Services Center for Medication Safety (VAMedSAFE); Jiang R, Department of Veterans Affairs, Pharmacy Benefits Management Services Center for Medication Safety (VAMedSAFE); Glassman P, Department of Veterans Affairs, Pharmacy Benefits Management Services Center for Medication Safety (VAMedSAFE),; Good CB, Department of Veterans Affairs, Pharmacy Benefits Management Services Center for Medication Safety (VAMedSAFE);

Objectives:
To conduct real time safety surveillance of dabigatran in Veterans

Methods:
Veterans with at least one prescription of dabigatran from 11/1/2010- 6/30/2011 were identified. VA prescription and Patient Care databases were linked to identify safety outcomes (GI bleeding) and contraindications (patients with a history of heart valve replacement, hypercoagulable state, hepatitis or liver disease or coagulation impairment). Near real time surveillance was conducted monthly to assess the rate of GI bleeding in dabigatran patients and dabigatran’s use outside of FDA indications and patients with potential contraindications.

Results:
Characteristics of the Study Patients and Patterns of Use A total of 693 patients were prescribed dabigatran in the VA. The mean age of patients on dabigatran was 71 and 98 % were men. 9.7 percent of patients received dabigatran outside of FDA indications. Patients with potential contraindications to dabigatran were also identified. Out of 693 patients receiving dabigatran, 16 (2.3%) had heart valve replacement, 21 (3%) were identified with a hypercoagulable state, 6(0.9%) had active hepatitis or liver disease, and 23 (5.9%) patients had coagulation impairment. Safety Outcome A total of 7 patients without a history of GI bleeding developed a GI bleed after dabigatran initiation as identified by a primary ICD-9 code. The event rate following dabigatran initiation was 101/10,000 patients (mean number of days to GI bleed was 43 following index date).

Implications:
A small percentage of dabigatran was used outside of FDA indications. Of note is the signal for GI bleeding which must be further evaluated and compared to current therapy. Although no definitive inferences can be drawn, this evaluation provides valuable information about the safe use of dabigatran in close to real time. Neither the FDA nor other health care systems have the ability to track the safety of dabigatran in close to real time.

Impacts:
VA databases can be used to conduct close to real-time drug safety surveillance.