Comply with anticoagulant management requirements

Follow phase-in schedule

By Patrice Spath, RHIT
Brown-Spath & Associates
Forest Grove, OR

Improving the safety of using medications has always been a National Patient Safety Goal. Each year the goal is reviewed by The Joint Commission and requirements are adjusted based on current priorities. The 2008 addition to Goal 3 — organizations must "reduce the likelihood of patient harm associated with the use of anticoagulation therapy" — resulted from an increasing awareness of harmful medication errors involving this type of therapy.

Anticoagulants are high-alert medications that carry a significant risk of causing serious injuries or death to patients if they are misused. Errors with these products are not necessarily more common than with other drugs, but when used or omitted in error, anticoagulants can cause life-threatening or fatal bleeding events or thrombosis.

In 2007, MEDMARX reported that from Jan. 1, 2001, through Dec. 31, 2006, 9,316 medication errors related to anticoagulants were reported to the program. This does not include errors involving heparin lock flushes. Performance deficit (40.6%) was the most frequently reported cause of all anticoagulant errors. When combined with errors caused by procedures or protocols not being followed (23.9%) this accounts for almost two-thirds of all errors associated with anticoagulants, which can be attributed to causes related to human factors issues. Other frequent errors included communication failures, omitted or inaccurate order transcription, computer entry failures, and knowledge deficit.

The anticoagulation management requirement of The Joint Commission has a one-year phase-in period with defined expectations for planning, development, testing, and milestones at three, six, and nine months in 2008, with the expectation of full implementation by Jan. 1, 2009. Hospitals must comply with the requirements at each milestone. For example, if a hospital is surveyed in May, it will receive a requirement for improvement (RFI) if it fails to meet the April 1 benchmark.

To comply, hospitals must start now to ensure full implementation by 2009. Anticoagulation therapy is a high-risk treatment because of the complexity of dosing and monitoring. This is a significant issue that requires a collaborative, system-wide effort to successfully address. The first step is to establish multidisciplinary team comprised of: a representative from administration; chief medical officer; representative from nursing management; representative from pharmacy management; quality improvement professionals; at least two nurses from different specialty areas who administer antithrombotic drugs; at least two pharmacists (clinical and distribution) who are involved in antithrombotic therapy; representative from the clinical laboratory; representative from dietary services; at least one active staff physician, preferably a hematologist, internist, or hospitalist; and representative from the antithrombotic team and/or clinic (if team or clinic exists).

This team should carefully map out a strategy for compliance and periodically meet to monitor implementation and evaluate the effectiveness of the interventions. It is important to identify who will take the lead in overseeing implementation.

Although not required by The Joint Commission consider establishing a standing task group or committee that meets regularly to analyze errors and adverse events involving anticoagulation therapy and implement improvements. This team also should be charged with evaluating the literature for new evidence-based practices and technologies and incorporating findings into the facility's practices.

Develop explicit organizational policies and procedures regarding anticoagulation therapy and services that include at least documentation of:

  • indications for anticoagulation;
  • target INR (International Normalized Ratio) range and dosing policies;
  • notification of dietary department for all patients on warfarin, with appropriate monitoring of drug-food interactions and patient education;

Once protocols and management strategies have been established, develop and implement staff education strategies. Individuals involved in caring for patients on anticoagulation therapy should receive education in anticoagulation management, including training in the application of practices or tools used in caring for patients on this type of therapy. Teaching should be repeated as needed to ensure that all new employees are instructed and to reinforce learning with experienced staff. If physicians occasionally order non-formulary antithrombotic drugs establish a process by which pharmacists can provide nurses with information on these drugs before dispensing the products to patient care areas for administration.

Provide attending physicians with education on the problems and potential pitfalls of managing anticoagulation therapy, including best practices. This information can be communicated via laminated cards, e-mail, grand-rounds conferences, and one-on-one discussions.

Develop educational strategies for patients and their caregivers. They should receive information about the purpose, action, and side effects of the therapy as well as information about the specific drugs being used, including the generic and brand (if applicable) names, strength/dose, and frequency/duration of use. Patients should receive verbal and written patient education materials appropriate to their language and reading level with an assessment of their understanding. Below are topics that should be discussed with the patient or caregiver at discharge:

  • drug interaction screening with patient's current drug regimen;
  • herb interaction screening with herbals the patient may be taking;
  • dietary considerations;
  • importance of maintaining anticoagulation;
  • signs of hypercoagulation;
  • importance of compliance and follow-up monitoring;
  • importance of medical alert identification.

Prior to discharge, patients on anticoagulant therapy should have a confirmed appointment scheduled with the lab, physician, or antithrombotic clinic and the importance of keeping appointments is discussed in discharge instructions.

By Oct. 1 the hospital must be pilot testing the anticoagulation management program in at least one unit. The purpose of this pilot test is to determine how well it is working and what, if any, components need to be revised. Evaluating the effectiveness of the program requires collection of performance data. Examples include:

  • Number of adverse drug events involving anticoagulant therapy (e.g., incidents involving high Warfarin overdose or overlooked drug interaction necessitating abrupt discontinuation of Warfarin or more frequent monitoring; bruising or bleeding from anticoagulation therapy treated with vitamin K; a PTT greater than 100 seconds; INR greater than "x" as defined by facility; platelet count less than 100,000/mm3; permanent patient harm or death.)
  • Instances of noncompliance with prescribing and administration guidelines/protocols (e.g., patients with no INR monitored as required; failure to notify dietary department for all patients on Warfarin; failure to monitor food-drug interactions.)

(Editor's note: For more resources and recommendations to prevent anticoagulant medication errors recently published by the American Society of Health-System Pharmacists visit our site, Select this issue of Hospital Peer Review.)


Examples of hospital anticoagulation guidelines and protocols can be found on-line at: