What is the effect of packaging vitamin-K antagonists via Multidose Drug Dispensing compared to regular dispensing on the time in therapeutic range of patients under the supervision of the anticoagulation Clinic Leiden?

The effect of the Multidose Drug Dispensing (MDD) on health outcomes is unknown. Although the effect of MDD is unknown, MDD is frequently used in the Netherlands to support mostly the elderly with their medication. MDD can be used to improve patients adherence or support the patient with complex medications regimes. In this study the effect of MDD is investigated in patients using vitamin K-antagonists (VKA). Patients with VKA's are under the supervision of anticoagulation clinics in the Netherlands. Despite the strict supervision of anticoagulation clinics not all patients achieve a stable control of their INR expressed in the Time in Therapeutic Range (TTR). One possible explanation for the unstable control is reduced adherence to the complex dosing regimen of VKA’s. In this study the effect of MDD on the TTR of patients with a TTR < 65 % will be investigated.
Patients under the supervision of the Anticogulation Clinic Leiden with a TTR < 65% during the past six months will be invited to participate in the study. After informed consent patients are randomised to the intervention or control group. In the intervention group patient will receive the medication via MDD including the VKA. Patients in the control group will receive the vitamin K-antagonist as they are used to, via regular dispensing. After six months the TTR over the study period is determined and compared between the two groups. It’s estimated that patients receiving medication via MDD have an improved TTR compared to the control group.

The study starts at 01-6-2016 and 19 community pharmacies in the catchment area of the Anticoagulation Clinic Leiden participate in the study. The study is a collaboration between the SIR Institute for Pharmacy Practice and Policy, Utrecht University and the Anticoagulation Clinic Leiden.

Patients using vitamin K-antagonists are under intensive supervision of anticoagulation clinics in the Netherlands. Despite the supervision, not all patients achieve a time in therapeutic range above 65%. A proposed reason is a reduced adherence to the complex medication regime of VKA. Multidose Drug Dispensing can support the patient with their medication regime. What the effect on TTR is of Multidose Drug Dispensing is unknown. What is the effect packaging vitamin-K antagonists via Multidose Drug Dispensing compared to regular dispensing on the time in therapeutic range?

Inclusion t=0

- TTR over the past six months using the method described by Rosendaal.

- BMQ, MARS, GFI, Mini-Cog, Questionnaire possible adherence problems

After six months t=1 (end of study)

- TTR over the past six months

- MARS

- average number of vitamin K doses

- average number of control visits at Anticoagulation Clinic

- proportion of patients with thromboembolic events

- proportion of patients with serious bleeding

Patients with a low TTR (<65%) will be randomised to the intervention or control group. The intervention group will receive the medication, including the vitamin K-antagonist, via Multidose Drug Dispensing. The control group will receive the vitamin K-antagonist as the patient is used to (via regular dispensing).