Adherence to protocols for the use of reversal agents in patients treated with direct oral anticoagulants
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Published on: February 28, 2012
Darko Mitrovic1, Margriet van Elp1, Loes Visser2
1Department of Hospital Pharmacy, Tjongerschans, Heerenveen, The Netherlands.
Insights
Protocol adherence for direct oral anticoagulant reversal agents was moderate for bleeding but low for urgent procedures. Key issues included underdosing and lack of indication, highlighting areas for improved hospital protocol implementation.
Area of Science:
- Pharmacology and Therapeutics
- Clinical Pharmacy Practice
- Patient Safety
Background:
- Direct oral anticoagulants (DOACs) are widely used, necessitating clear protocols for reversal agent administration.
- Effective management of bleeding or urgent procedures in DOAC users requires adherence to established guidelines.
- Variability in protocol adherence can impact patient outcomes and healthcare resource utilization.
Purpose of the Study:
- To assess adherence to hospital protocols for reversal agent use in patients on direct oral anticoagulants (DOACs).
- To identify reasons for non-adherence to protocols concerning bleeding and urgent procedures in DOAC users.
- To provide data for improving the implementation of DOAC reversal protocols in Dutch hospitals.
Main Methods:
- Retrospective cohort study involving 290 patients across seven Dutch hospitals.
- Collection and comparison of hospital treatment protocols with patient data on reversal agent use (September 2021 - April 2022).
- Categorization of protocol adherence into four levels: poor (<45%), moderate (45-79%), high (80-89%), and full (>90%).
Main Results:
- Moderate adherence (61%) for prothrombin complex concentrate (PCC) in bleeding DOAC patients; common issues were underdosing (68%) and lack of indication (14%).
- Full adherence (96%) for idarucizumab in bleeding cases, but moderate (67%) for andexanet alfa.
- Low adherence (<45%) for PCC (45%), idarucizumab (26%), and andexanet alfa (0%) in urgent procedural settings, often due to missing lab data or lack of indication.
Conclusions:
- Overall protocol adherence for DOAC reversal in bleeding is moderate, but significantly lower for urgent procedures.
- Underdosing, off-label use, and insufficient laboratory testing are primary drivers of non-adherence.
- Findings underscore the need for enhanced implementation strategies for hospital protocols governing DOAC reversal agents.
Objectives:
This study aimed to evaluate the adherence to protocols for the use of reversal agents in direct oral anticoagulant (DOAC) users in Dutch hospitals.
Methods:
A retrospective cohort study was conducted in seven hospitals in the Netherlands. Treatment protocols for bleeding and (urgent) procedures in patients on DOAC were collected from each hospital. All patient data on the use of reversal agents were retrospectively collected from September 2021 to April 2022 and compared to the protocols. The degree of per-protocol adherence (compliance score) was categorized into four levels as follows: poor (<45%), moderate (45-79%), high (80-89%), and full (> 90%) adherence rates.
Results:
A total of 290 patients were included in our study. In patients with bleeding under DOAC, the protocol adherence for prothrombin complex concentrate (PCC) was "moderate" (61%). In the remaining cases (39%), non-adherence was mainly caused by underdosing (68%), overdosing (12%), and a lack of indication (14%). Furthermore, idarucizumab was administered for bleeding with "full" adherence (96%). For andexanet alfa, adherence to the hospital bleeding protocol was "moderate" (67%), with a lack of indication being the only reason for non-adherence. In case of reversal for an urgent procedure, the protocol adherence for PCC was "low" (45%), with underdosing, a lack of indication, and missing lab data being the main reasons for non-adherence. Missing lab data on dabigatran plasma concentration before reversal was the main reason for "low" adherence (26%) in idarucizumab. The adherence for andexanet alfa was also "low" (0%).
Conclusion:
In case of reversal for bleeding under DOAC, overall adherence to the protocol was "moderate"; however, in patients needing an urgent procedure, it was "low." The major reasons for non-adherence were underdosing, off-label use, and a lack of specific lab testing. The results of this study can assist in improving the implementation of hospital protocols.
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