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How to Minimize the Risks of the “New” Anticoagulants

By Frank Federico | Friday, February 6, 2015

Used appropriately, medications can change patients’ lives for the better. When not managed well, however, all medications can have unintended (and sometimes potentially dire) consequences. In this post, IHI Executive Director Frank Federico, RPh, warns of the risks of newer anticoagulants designed to help manage stroke and VTE. He is faculty for the IHI Patient Safety Executive Development Program and helped to develop the upcoming IHI Expedition on Improving Medication Safety from the Patient's Perspective.


We constantly search for new technologies and new medications to improve the care we deliver. Warfarin, the most widely used anticoagulant in the world, has been around for about 60 years. As beneficial as it can be, warfarin also causes many adverse drug events and hospitalizations, most commonly from bleeding. And warfarin’s interactions with other drugs and foods can negatively affect its mechanism of action.

Care providers must monitor patients regularly to ensure their INR [short for “international normalized ratio” – a measure of coagulation] is within range. The frequency of this monitoring is a burden to both patients and the health care system. However, without this monitoring, we run the risk of either over- or under-coagulating patients, which results in harm.

The search for safer anticoagulants has resulted in a new group of drugs (i.e., Factor Xa inhibitors and direct thrombin inhibitors) which are supposedly safer and do not require monitoring. The new drugs claim to be less risky to patients than warfarin. Yet, there have been a number of reports of patients harmed while using these medications.

The Quality and Patient Safety Division of the Commonwealth of Massachusetts Board of Registration in Medicine recently issued an advisory on the “New” Anticoagulants. In addition to offering case examples with lessons learned, the advisory recommends five areas for which health care providers should develop processes to minimize the opportunity for harm. These include:

  1. Stroke and bleeding risk assessment. Recommendations include patient engagement and communication among providers.
  2. Patient characteristics and choice of anticoagulation therapy. Particular attention should be paid to different modes of action and especially vulnerable patient populations.
  3. Non-adherence or poor medication adherence. Caregivers must consider potential barriers to adherence in the outpatient setting.
  4. Managing transitions. Include consideration of changes in location, medications, and clinical status.
  5. Bleeding risk. There are no antidotes or inhibitors for the medications in the event of uncontrollable bleeding.

As the advisory notes, “With any new medication or technology, providers must understand the indications, limitations and potential complications of these new types of anticoagulants in order to maximize patient safety.” We must also develop reliable processes to ensure we are providing safe care to patients. As with any change, it is our duty to minimize the impact of potential new problems.

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