LEARNING OBJECTIVES

After completion of this chapter, the reader should be able to:

1. Identify common disease states that require anticoagulation.

2. Understand the value of an anticoagulation therapy service.

3. Evaluate the risks involved in providing anticoagulation therapy management services.

4. Evaluate the internal needs of the service including staffing and clerical support, space to assess patients, and laboratory services.

5. Develop a communication system with local health-care providers for patient referrals and patient report follow-up.

6. Understand the importance of the development of standard operating procedures for improved efficiency and effectiveness.

7. Identify potential training opportunities to ensure the delivery of optimized anticoagulant therapy.

Community pharmacies continue to expand their practice by offering innovative patient care services, specifically medication therapy management (MTM) services. The role of anticoagulation services may have a positive outcome in patients, when compared with “usual care” (i.e., personal physician) with potentials for decreases in bleeding and thromboembolism.¹ An anticoagulation service in a community pharmacy is a prime example of a MTM service that can be offered. Pharmacists providing anticoagulation services can improve patient outcomes and reduce the risk of adverse events.^2,3,4,5 New anticoagulants (i.e., Pradaxa^®/Xarelto^®) that do not require continuous international normalized ratio (INR) monitoring have recently been introduced but do not preclude the need for pharmacist-provided anticoagulation services. Warfarin is still the treatment of choice for many patients requiring anticoagulation (e.g., prosthetic valve [PV] replacement).⁶ Managing oral anticoagulation with warfarin requires comprehensive, individualized attention to interactions with a patient’s dietary patterns, OTC (over-the-counter) medications, prescription medications, and even lifestyle changes.

Warfarin is a product discovered over 60 years ago by scientists studying why cattle were spontaneously hemorrhaging and dying. The funding for much of this research came from the Wisconsin Alumni Research Foundation thus forming the first part of the name, warfarin, with the second part of the name due to it being a coumarin derivative.⁷ Clinical application later developed in 1955 when then President Dwight Eisenhower was given warfarin after suffering a myocardial infarction. Due to the narrow therapeutic window of warfarin, additional developments in monitoring were needed. Prothrombin time monitoring was initially developed and in 1982, the INR by the World Health Organization (WHO) became the standard system of anticoagulation control worldwide.⁸

DISEASE STATES REQUIRING ORAL ANTICOAGULATION

Multiple disease states necessitate the need for oral anticoagulation to prevent many adverse sequela. While a review of all of the necessary situations in which anticoagulation could be indicated is beyond the scope of this chapter, the most common clinical situations that result in oral anticoagulation management with vitamin K antagonists (e.g., warfarin) are reviewed.

Stroke prevention secondary to atrial fibrillation is one of the most common reasons patients require anticoagulation. Atrial fibrillation is a major risk factor for ischemic stroke. It is estimated that approximately 2.3 million Americans have sustained or paroxysmal atrial fibrillation. Atrial appendage embolism thrombi secondary to atrial fibrillation has been estimated to account for approximately 10% of all ischemic strokes, and a higher average in the very elderly in the United States.⁹ A valuable validated assessment tool that can be utilized to determine stroke risk in patients with atrial fibrillation is the CHADS₂ assessment.^9,10,11,12 Table 10–1 summarizes how to use the assessment tool and Table 10–2 provides the stroke risk based on the CHADS2 score.

Table 10–1. CHADS₂ Scoring¹⁰

Table 10–2. CHADS₂ Stroke Risk¹⁰

Venous thromboembolism (VTE) is a disease that includes both deep vein thrombosis (DVT) and pulmonary embolism (PE).¹³ No national VTE surveillance system is currently in place, but US estimates put the overall annual rate at 900,000 cases of clinically evident VTE, which could result in as many as 300,000 deaths annually from PE.¹⁴ There are age, race, and gender differences; however, due to variations in administrative reporting, true incidences are not known and maybe significantly underreported.^15,16 Thus, patients may be treated for acute VTE or prophylaxis of VTE secondary to some comorbid condition. Importantly, VTE is preventable when appropriate prophylaxis is implemented (Table 10–3).

Table 10–3. Risk Factors for VTE^17,18,19

Systemic embolism prophylaxis secondary to PV replacement is another clinical example that necessitates oral anticoagulation with warfarin. Between 1993 and 2007, 623,039 patients underwent cardiac valve surgery in North America (excluding pulmonary valves).²⁰ Current estimates put annual PV replacement rates in the United States at 90,000 and worldwide at 280,000.²¹ With approximately half of the PV replacements being mechanical valves and half being bioprosthetic, oral anticoagulation with warfarin continues to be needed, since newly approved therapies do not carry indications for prophylaxis in patients with PV replacement. Patients may have atrial valve replacement (AVR), mitral valve replacement (MVR), or another heart valve, or even multiple heart valves replaced, all which would require anticoagulation of some type to prevent secondary embolism.⁶

WARFARIN

Warfarin continues to play a vital role in the management of VTE prophylaxis and stroke prophylaxis.^1,9,13 It is currently indicated for:²²

1. The prophylaxis and/or treatment of venous thrombosis and its extension, and PE.

2. The prophylaxis and/or treatment of the thromboembolic complications associated with atrial fibrillation and/or cardiac valve replacement.

3. To reduce the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.

Warfarin is rapidly absorbed after oral administration; however, its resultant effect on increasing INR is delayed. To understand this delay, it is important to understand the clotting factors that warfarin inhibits and their concurrent half-lives (Table 10–4).²³ It is also important to understand that certain vitamin K-dependent products are the “natural” anticoagulants of the body (i.e., protein C and protein S). Realizing that protein C having the shortest half-life will be depleted first could potentially induce a hypercoagulable state. It is clinically important to cross-cover with a more rapid acting anticoagulant (i.e., low molecular weight heparin [LMWH]), due to the delay in anticoagulant effect that is associated with warfarin.

Table 10–4. Clotting Factor Half-Lives²²

Warfarin is a racemic mixture of warfarin-R and warfarin-S. The importance of this relates to the different routes of metabolism for each enantiomer, as well as the anticoagulation potency of each. Metabolism occurs via CYP pathways and thus allows for potential drug interactions with multiple medications.¹ Understanding these interactions is vitally important when doing an MTM assessment, and potentially preventing significant adverse reactions.

VALUE OF PHARMACIST-PROVIDED ANTICOAGULATION SERVICES

Individual prescribing physicians have traditionally managed oral anticoagulation therapy in the community setting. Patients have their blood drawn either at the physician’s office, hospital, or local laboratory. The results of the INR are then transmitted to the physician’s office where the physician or a delegate will interpret the results and then contact the patient with any recommendations that need to occur. In some instances, this could be 2–3 days after the blood draw. With this method of follow-up, very little patient interaction or evaluation can effectively occur. Some of these services result in physicians being unable to bill when the follow-up is via telephone. Many patients have been lost to follow-up in this setting, either by the office not being able to contact the patient or the patient fails to obtain their blood work on a consistent basis. This has resulted in many physicians being reluctant to prescribe oral anticoagulation therapy.²⁴ These problems associated with physician monitoring of anticoagulation provide an opportunity for pharmacists to provide an anticoagulation service that benefits both patients and physicians.

Pharmacists have established anticoagulation services in community pharmacies, ambulatory clinics, and in hospitals.^25,26 Physicians have collaborated with pharmacists in caring for anticoagulation patients to ensure better monitoring and patient outcomes. Studies have shown that pharmacistmanaged anticoagulation services improve clinical and economic outcomes when compared with usual care.^{2,3,4,5,27,28,29,30} Additionally, it has been shown that both patients and physicians have a high level of satisfaction with pharmacist-managed anticoagulation services.³¹

Pharmacists wanting to implement anticoagulation services should be prepared to provide documentation of the positive benefits of these services to primary care providers, payers, and other stakeholders. Equally important will be understanding the medical–legal issues associated with anticoagulation. Anticoagulation therapy involves understanding two equally serious clinical features—over- and under-anticoagulation—as both can have life-threatening consequences.³² Thus, developing a systematic approach to the delivery of anticoagulation services can decrease the likelihood of adverse events.³³

DECIDING TO DEVELOP ANTICOAGULATION SERVICE—BUSINESS PLAN

When deciding to implement an anticoagulation service in a community pharmacy, it is important to plan. This should include strategic planning and business planning. First, the pharmacist needs to consider whether the implementation of MTM services related to oral anticoagulation relates to the overall mission of the pharmacy or clinic. Second, the need for this service in the community must be determined. How many patients are prescribed warfarin? Is there an anticoagulation monitoring service available to providers and patients in the area? Is there at least one provider willing to refer patients to an anticoagulation monitoring service? Writing a business plan for the service will help determine the need and feasibility of developing and implementing the service. A business plan should include an environmental analysis, goals for the service, a description of the service to be offered, a description of the physical facilities used to offer the service, a target market description, a pricing plan, and a promotion strategy. During the business planning of the anticoagulation service, it is important for the pharmacy management to determine if the necessary resources are available and the expected time line for financial sustainability (or profitability) of the clinic.^34,35,36

An environmental analysis, which could include a SWOT (Strengths, Weaknesses, Opportunities, Threats) analysis, should be performed, prior to any serious planning. The strengths and weaknesses of the SWOT analysis are focused on the internal aspects of developing the service. What are the strengths of the pharmacy for developing and implementing an anticoagulation service? And alternatively, what are the weaknesses? Examples of strengths may be, location, a well-trained pharmacist with experience in anticoagulation monitoring, private counseling area in pharmacy, pharmacy management supportive of development of patient care services, and already established relationships with providers. The opportunities and threats are the external factors influencing the development of the service. Examples of opportunities include a documented need in the community, overwhelmed or overly busy providers, and availability of third-party reimbursement or payment structure. It is extremely important to evaluate the potential use of the clinic by the local providers, the expected workload within the clinic, and the current structural layout of the clinic (e.g., do you have a private counseling area to perform lab work). Obtaining provider support for the clinic is important since they will be the source of your referrals. It is also important to assess the potential threats to the new service. Evaluating all these factors will provide insight into whether the service should be developed and if so, how the service should be developed.^37,38

Initiating a clinical service from scratch can be a daunting task; therefore, during your initial assessment consider reviewing the current literature for examples of services similar to what you desire to develop. What are some of the issues faced when the authors initiated their services? How were they able to overcome the various obstacles they encountered in the beginning? Identifying these issues will assist in preparing the overall business plan. A good resource for assistance is a publication by Ansell et al: Managing Oral Anticoagulant Therapy (2nd Edition).³⁹ It is important to realize that every clinic has its own specific issues and problems that will develop, but identifying potential ones, and having a plan in place to overcome them, will put you a step ahead in development. Contacting professionals who have started a service similar to the one being developed is also beneficial. A list of registered anticoagulation services with contact information can be found at www.acforum.org. Professional organizations and schools of pharmacy may assist with implementation strategies as well.^40,41,42 A one-on-one discussion can facilitate the steps necessary to start a service. Ask the pointed questions as to the different challenges faced when establishing a clinical service. Utilize their experience to assist you in shaping the focus of your service and overcome the potential barriers. Additionally, some professional organizations will have workshops and seminars related to the implementation of patient care services and/or anticoagulation services.^40,42 These workshops often will provide helpful hints and networking opportunities that will be invaluable.

Once it is decided that it is feasible and desirable to develop and implement an anticoagulation service, the target market must be considered and the 4Ps of marketing evaluated: the product, the place, the price, and the promotion of the service. With your marketing strategy, you want to be able to differentiate yourself from other pharmacies in the area. The fact that you are implementing clinical services is a significant differentiator. You are creating a different service level within your market and trying to improve the overall quality of patient care. With this, you are creating higher expectations of your pharmacy and the overall services that are delivered.⁴³

TARGET MARKET

Identify patients:

Who will your patient be?

Where will they come from?

How many could there be?

How many can you handle?

In the case of the target market, consider the referring provider. The pharmacist can look at their prescription records to see how many warfarin patients already patronize the pharmacy and who prescribes the warfarin. Identifying a provider with multiple patients already utilizing your pharmacy may be an optimal starting point for your service. Starting small and growing with this subset of patients could assist you in identifying a provider champion for your services.

Provider Referral

Obtaining provider support is vital to any pharmacy service. Identify advocates who will refer to you. Consider the various providers in your area who may prescribe warfarin as well as hospital discharge referrals. It is a good idea to start small, working with one or two providers initially and then begin branching out. Starting small also allows you to evaluate your procedures and make any necessary changes early on to assist in streamlining your clinic. It is recommended to develop a referral form so that providers can quickly refer a patient to the anticoagulation service and provide the necessary information needed (see Appendix 10-A for sample referral form).

Once a patient is referred, communication with the referring provider must be maintained, informing the referring provider of current anticoagulation status and changes made via protocol are crucial. Whether this communication should occur through electronic means, facsimile, or verbally should be decided between you and each provider. When you establish your collaborative practice agreements, it is important to remember to have all communication with various providers the same. This will assist you with standardizing your procedures.

Upon receiving a referral, a process in the pharmacy will need to be in place to ensure an appointment is made. This can be accomplished by having a standard policy in place that all referrals are responded to within one business day. This is crucial, as new anticoagulation patients need prompt follow-up to ensure appropriate anticoagulation is achieved and overanticoagulation does not occur. This could be an opportunity to utilize pharmacy technicians or clerks to schedule new patients upon referral.

ANTICOAGULATION SERVICE—GOALS AND SCOPE OF SERVICE

At the patient’s initial visit, plan on spending between 30 and 45 minutes to provide adequate time for history and medication review. A patient history and medication form should be used to collect and document information needed to properly provide MTM and anticoagulation monitoring services (refer to Chapter 4 for more detail related to MTM services). Also during the initial visit, the patient needs to sign a HIPAA form, and if one has not been previously signed, a release of information form. This will allow you to obtain vital information from health-care providers as necessary and to payers as needed. Once patients are seen at the pharmacy, follow-up appointments need to be scheduled. An operational calendar for when the clinic will be in session should be maintained. This type of work could be delegated to a pharmacy technician or clerk. Additional items that can be managed by a pharmacy staff member other than a pharmacist could include missed appointment tracking, appointment reminder phone calls, and quality assurance reporting.

Protocol Development

Probably the most important aspect of the establishment of clinical services related to oral anticoagulation is the development of a protocol.^37,40 It is important to realize that the protocol should contain what the clinic can do, but also what the clinic cannot do. If anticoagulation services and diabetes management services are offered within the same pharmacy, separate protocols are required for each. It will be important to evaluate the regulations that your state would require prior to protocol development.

Within the protocol, the goals and the scope of service provided should be clearly defined. A process of care should be integrated that (1) uses time efficiently, (2) maintains low overhead costs by simplifying patient management, (3) improves patient adherence, and (4) most importantly improves patient outcomes. During protocol development, take the time to review literature resources and attempt to identify what has worked and what has failed.

The protocol should spell out specific procedures and patient flow during their entire time in your care. The initial visit should be detailed so that collaborating providers will be aware of exactly what will occur during patient visits. By mapping this initial visit, it also gives you the template needed to ensure that all the pertinent information is completely covered. Due to the amount of education required for correctly utilizing warfarin, pharmacists may want to develop personalized education materials and include these within the protocol.

Within the protocol you should reference the accepted INR goals as published in Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidenced-Based Clinical Practice Guidelines (9th Edition), published as a supplement to Chest journal in February 2012. This evidence-based guideline will assist you in providing the most up-to-date evidence for practical INR goals. It is important to recognize that these guidelines are periodically updated, thus protocol updates would need to take place when guideline updates are published. Also, there will be situations in which a provider may want to deviate from the recommended goals, and this should be documented within a specific patient referral.

Management of INR elevations should also be documented within the protocol. It is important to understand that the evidence changes with regard to the most appropriate way to manage patients who are experiencing overanticoagulation, thus maintaining up-to-date evidence-based guidelines is crucial.⁴⁴

A sample anticoagulation protocol is available for review in Appendix 10-B.

Quality Control/Quality Assurance

Continuous quality control and assurance is necessary to ensure that appropriate outcomes are seen with anticoagulation services. Evaluating the overall incidence of adverse events (bleeding or thrombotic episodes) is the optimal way to evaluate quality; however, in a small anticoagulation service, patient numbers would not be sufficient to statistically validate the outcomes. Thus, an intermediate way to measure outcomes and thus quality is needed.⁴⁵ One of the ways to evaluate quality of anticoagulation is to measure “Time in Therapeutic Range” (TTR).^46,47 Another simpler measure of quality is calculating the percentage of patients within therapeutic range over a period of time.⁴⁵ This type of data can be presented to referring healthcare providers as a means to show the value you provide to patients. Quality does not start or stop with INR control; it also needs to be assessed with how laboratory values are obtained. Continuous assessment of how blood samples are obtained, how point-of-care (POC) monitors are maintained, and storage of all essential laboratory materials are needed including refrigerator temperature logs. Quality improvement is a continuous process that requires due diligence in its development.^{22,24,47,48,49,50,51,52}

Resources Needed

Staff

Ensuring the pharmacist(s) and support staff who are adequately trained in anticoagulation monitoring is essential. Residency training in an ambulatory care setting that is involved in anticoagulation therapy could be beneficial. Otherwise, a systematic review of the current anticoagulation guidelines would need to be undertaken to ensure the best outcome for the patients referred to your service.

Pharmacy Design

Workflow design will need to be considered when developing the service. When a pharmacist is providing anticoagulation services, appropriate pharmacist coverage for your other pharmacy services will be needed. Thus, decisions about when the anticoagulation service is offered and staffing concerns will need to be considered. Likewise if a clinic patient comes without an appointment because of a concern, how this will be handled should be discussed and established.

Point-of-Care Monitors and Supplies

POC monitors are a significant capital investment, thus it is important to evaluate which monitor is the most optimal for your service. Other considerations that need to be reviewed are: storage for strips as many of them will require refrigeration and security for monitors. Other supplies that need to be available include sharps containers, alcohol pads, cotton balls, gloves, and bandages. A biohazard waste removal service will also be needed to dispose of medical waste that is inherently involved with managing an anticoagulation service.

When using POC monitors, it is important to understand the Clinical Laboratory Improvement Amendments (CLIA) of 1988.^30,53 These were enacted to ensure that all medical laboratories are meeting quality standards. CLIA is administered by the Centers for Medicare and Medicaid Services (CMS) and each individual site is responsible for registration. It is important to choose a POC device that is CLIA waived. Your pharmacy/clinic has to complete a certificate of waiver if interested in performing a waived test. Once you have completed the registration, CMS will assign the pharmacy/clinic a CLIA number and send a CLIA fee-remittance coupon.⁵⁴ A biannual fee of $150–$200 is required to receive a CLIA waiver certificate. By doing this, the pharmacist providing the waived tests agree to follow manufacturer instructions, perform quality control procedures, and store and monitor reagents properly. For more information see https://www.cms.gov/CLIA/downloads/HowObtainCertificateofWaiver.pdf⁵⁴

OR

https://www.cms.gov/clia/05-CLIA_Brochures. aspTopOfPage⁵³

Educational Materials

Personalized patient education material that contains your service name or logo is an easy way to distinguish your involvement in MTM services (see, e.g., Appendix 10-C) This can also assist you with marketing your pharmacy services in the community. Patients can take the education materials with them to subsequent physician visits to help identify your service as being an integral part of patient care. These materials can be warfarin dosage reminder cards, pamphlets related to foods high in vitamin K, or drug interaction wallet cards that patients can carry with them anytime another health-care provider will be seen who might prescribe a medication. Standardization of education materials will also benefit the service, as all patients will be educated similarly. This could help improve the overall quality of the education provided.⁵⁵

Documentation System

Documentation is the process for gathering and integrating the information from a patient visit for future reference and specific managerial needs. Because documentation is critical to the success of the service, one should consider purchasing a software system to support MTM, anticoagulation service documentation, and all anticipated expansions of clinic services offered. There are various systems available. It is also recommended to use the software system for appointment scheduling.

In regard to anticoagulation services, complete and accurate documentation is necessary for several reasons, simply put, if it is not documented, it did not happen.

1. When caring for patients on oral anticoagulation, documentation of the INR over several visits will allow you to see any trends in the intensity of anticoagulation

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