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Key components to consider when developing an anticoagulation Clinic

Introduction

Anticoagulation is a high risk treatment, which commonly leads to adverse drug events due to the complexity of dosing these medications, monitoring their effects, and ensuring patient compliance with outpatient therapy. The use of standardized practices that include patient involvement can reduce the risk of adverse drug events associated with the use of heparin (unfractionated), low molecular weight heparin (LMWH), warfarin, and other anticoagulants.


   Keeping patients on oral anticoagulants within a narrow therapeutic range requires expert dose management. Because of the intensity of the management required, anticoagulation clinics were developed to help physicians manage these patients, keeping a focus on the narrow therapeutic range required to minimize adverse events. These centralized specialty clinics with particular expertise in anticoagulation have demonstrated improvements in quality of care, improved patient compliance and reduced complications compared with routine management but estimates suggest that less than 50% of patients in the US who receive oral anticoagulants are managed by such clinics.1

However establishment of an anticoagulation clinic will require careful planning, development of high quality standards and procedures, with input from local consultants, while recognizing the barriers which exist to developing such a service.

 

1. Anticoagulation Clinic

1.1Definition

The Anticoagulation Clinic is a service established to monitor and manage the medication(s) that prevent blood clots. Physically, it is a specified location within a hospital or a medical office that is staffed by clinical pharmacists. The clinical pharmacists, working in conjunction with physician and other health care providers, will check blood test and adjust the warfarin’s dose (Coumadin ® or Jantoven ®) as well as other medicines that may be needed (such as heparin shots or Vitamin K, the antidote to Coumadin). Clinics manage parenteral anticoagulants in certain settings (e.g., acute therapy, bridging therapy, or in the rare instance of a patient unable to take warfarin), but warfarin management is the core activity of such clinics.2 

1.2The need of an anticoagulation therapy

Anticoagulants are commonly used for both the treatment and prevention of cardiac disease, cerebral vascular accident, and thromboembolism in both the inpatient and outpatient setting. Their use or misuse carries a significant potential for patient harm. Subtherapeutic levels can increase the risk of thromboembolic complications while supratherapeutic levels can increase the risk of bleeding complications. Anticoagulants have been implicated in adverse drug events due to many factors such as complexity of dosing and monitoring, patient compliance, and numerous drugs to drug and drug and food interactions. The demand for anticoagulation services is increasing, particularly in the elderly population. This is largely attributed to an increasing number of medical conditions requiring long-term anticoagulation.3 The goals of anticoagulation management, the limitations of current management and the impact of innovations on management will be discussed in the following paragraph.

1.3Goals of anticoagulation clinic

The Anticoagulation Clinic (ACC) is designed to help patients manage their anticoagulation medications. The Key elements of warfarin management are summarized in the acronym DEEARS: (1) Determine indication and duration of therapy; (2) Establish a therapeutic range; (3) Educate the patient (and other healthcare providers); (4) Assess compliance with regimen; (5)Review medications, co-morbidities, and diet; and (6) Screen for recurrence of thrombosis or bleeding events. Readily available monitoring and an organized system for patient tracking are invaluable tools to help the provider. Often, the most difficult task is assuring prompt communication and access to acute intervention for the patient. 4-8

However establishment of an anticoagulation clinic will require careful planning, development of high quality standards and procedures, with input from local consultants, while recognizing the barriers which exist to developing such a service.

2.Support and facilities required for an anticoagulation system

Support and facilities are some of the issues we should consider when we want to develop an anticoagulation system. These keys component will vary according to the commissioned service and to the composition of the health care team. The basic requirements for a standard anticoagulation therapy clinic include the following: Education mentoring support and clinical network facilities (e.g. Clinical Laboratory and all its necessary equipment); Access to educational material—clinical reference databases;Access to relevant infection control support and guidance (e.g., for finger prick tests, Hepatitis B vaccination, hand washing); Access to advice from healthcare scientists or quality assurance specialists relating to standards and maintenance of testing equipment; Anticoagulant education handout and anticoagulant treatment record form ; Coagulometers; Computer software for automated drug prescription.

Accurate and easily accessible documentation systems should be used so that information pertinent to anticoagulation therapy can be retrieved in a timely fashion. It is also possible to adapt existing computer software applications to meet anticoagulation monitoring needs or to use paper forms. The optimal anticoagulation therapy tracking system for a given healthcare environment should be dictated by factors such as the number of patients being monitored and existing information technology resources. For most settings, computerized anticoagulation tracking applications offer increased efficiency.9

 

3.Anticoagulation health care team

3.1Team Composition

Optimized anticoagulant therapy should be provided by healthcare professionals licensed in a patient-oriented field (e.g., medicine, nursing, pharmacy, clinical laboratory, nutrition, information technology) possessing core competency related to anticoagulation therapy. However the composition of the anticoagulation team may be, but for a standard anticoagulation clinic, that health care team should be a multidisciplinary working team. During the past few years, “pharmacist-managed anticoagulation clinics” has been a one of the most key words or terms used whenever it comes up to discuss about the setting of an anticoagulation clinic.

From this perspective, we can clearly point out that the clinical pharmacist has a great and important impact in these clinics. Further to understand the outcomes of his/her clinical input, we should master the key role of clinical pharmacist and stress out the competencies he/she is required to have in order to carry out clinical responsibilities.

3.2Pharmacist: a special component of the anticoagulation team

The value for pharmacist-managed anticoagulation clinics has been clearly established in the pharmacy literature.10-13 Improved patient outcomes, including reduced hospital admissions for preventable embolism, bleeding, or treatment of thrombosis are well documented

Stating explicitly that the clinical pharmacist cares for patients in all health care settings emphasizes two points: that clinical pharmacists provide care to their patients (i.e., they don’t just provide clinical services), and that this practice can occur in any practice setting. The clinical pharmacist’s application of evidence and evolving sciences points out that clinical pharmacy is a scientifically rooted discipline; the application of legal, ethical, social, cultural, and economic principles serves to remind us that clinical pharmacy practice also takes into account societal factors that extend beyond science.14-16 By stating that clinical pharmacists assume responsibility and accountability for achieving therapeutic goals, the definition makes it clear that they are called upon to be more than consultants.

3.3The Pharmacist’s knowledge and competencies

Clinical pharmacist is a primary source of scientifically valid information and advice regarding the safe, appropriate, and cost-effective use of medications. Establishing specific clinical pharmacist competencies is important to achieve the outcomes listed previously. However Clinical pharmacists maintain and further develop competence through practice and continued professional development. The basic competencies of clinical pharmacist are:

3.3.1Clinical Problem Solving, Judgment, and Decision Making

A combination of comprehensive therapeutic knowledge, experience, problem-solving skills, and judgment is necessary in order to be a competent clinical pharmacist. Clinical problem solving and decision making are the processes by which patient-specific data are collected, interpreted, and analyzed; medical problems are assessed; current drug therapy is evaluated; and therapeutic plans are developed. These processes are critical to optimizing medication therapy

3.3.2 Communication and Education

The ability to effectively communicate with and educate patients and health care professionals is integral to ensuring optimal patient outcomes. As with other abilities, communication is developed and refined throughout a pharmacist’s career. Communicating with patients and other health professionals about a particular issue at the appropriate level of complexity can be challenging, and pharmacists must be aware of barriers to effective communication. Because effective communication and education are so fundamental to the provision of patient care, it is imperative that these abilities be well developed.

3.3.3 Medical Information Evaluation and Management

Providing quality patient care requires a knowledge base that is continuously expanding and being updated. A clinical pharmacist must be able to identify situations beyond his or her own expertise or that require new information to reach a decision. This necessitates carefully defining the question and using a variety of information sources to derive the answer. New information is then incorporated into one’s existing knowledge base and integrated with prior clinical experiences to help develop sound clinical judgment.

3.3.4 Management of Patient Population

Many clinical pharmacists not only are involved in providing care to individual patients, but work within a health system or other organization to develop protocols and critical pathways that optimize the care of patient populations. These efforts may include analyzing drug utilization evaluations, composing protocols for disease state management, and developing organizational policies and procedures that improve patient care and resource utilization.17, 18

3.3.5 Therapeutic Knowledge

Clinical pharmacists must possess a therapeutic knowledge base of sufficient breadth and depth to effectively promote rational medication use. In general, to be considered a clinical pharmacist, one must be sufficiently knowledgeable about the diseases and principles in this list to effectively assess and treat these problems in the patient population one serves. It is important to emphasize that a clinical pharmacist must be competent in the therapeutic management of the many disease states that may affect a given patient, not simply those currently identified as active problems. To optimize a patient’s therapy, the clinical pharmacist must be able to identify and solve new problems as they arise. The Certification introduces a mechanism to implement a consistent standard of care nationwide.

4.Training for the Healthcare providers

Health care professionals involved in the management of antithrombotic therapy should be educated in a clinical discipline, trained in patient assessment and care, and licensed in a patient-oriented health care field. Technical support personnel (e.g., medical assistant, pharmacy technician, nurse technician) may assist in selected aspects of anticoagulation management, including obtaining laboratory test results, scheduling appointments, and other nonclinical duties, but should not be directly involved in patient assessment and therapy management. Because anticoagulant therapy is complex and associated with substantial risks, additional training is recommended. This training may be obtained in the work environment, through a formal didactic and/or experiential training program, or through self-study.19

Such additional training, however, should not replace the aforementioned requirements regarding clinical training and licensing necessary to provide patient care.

5.Certification for Anticoagulation Care

Certification in the field of pharmacy and especially for anticoagulation care providers is a way to demonstrate advanced knowledge and skills above and beyond a degree program or licensure. A clinic which has a health care team where most of the providers possess an anticoagulation therapy certification is a clinic with high quality health care standard, but at the same time affording this kind of certification depends from countries and areas according to the setting and the rural realities where anticoagulation systems are implemented. Nevertheless certified pharmacists have clearly demonstrated their ability to identify, resolve and prevent drug therapy problems in a specialized area of practice. Therefore, anticoagulation certification can be very rewarding on both a professional and personal level by nationally recognizing and validating anticoagulation providers who fulfill certification requirements.

Conclusion

Anticoagulation therapy, although potentially life-saving, has inherent risks. Whether a patient is managed in a solo practice or a specialized anticoagulation management service, a systematic approach to the key elements outlined herein will reduce the likelihood of adverse events. It is really important to consider the key component while developing an anticoagulation system. However establishment of an anticoagulation clinic will require careful planning, development of high quality standards and procedures, with input from local consultants, while recognizing the barriers which exist to developing such a service.

The need for continued research to validate optimal practices for managing anticoagulation therapy is highly acknowledged

 

 

 

References

1.Ansell JE, Hughes R. Evolving models of warfarin management: anticoagulation clinics, patient self-monitoring, and patient self-management.Am Heart J. 1996; 132:1095-1100.

2.Ansell J, Hirsh J, Poller L, Bussey H, Jacobson A, Hvlek E. The pharmacology and management of the vitamin K antagonists: the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy. Chest 2005; 126 (Suppl): 204S-233S

3.Fitzmaurice DA, Hobbs FDR, Murray JA. Monitoring oral anticoagulation in primary care.Br Med J 1996; 312:1431-2

4.Sophie Testa, Adriano Alatri, Oriana Paoletti, Giampietro Morstabilini, Maria Anunzia Medagliani, Nadia Denti, Emanuela Martellenghi. Reorganisation of an anticoagulation clinic using a telemedicine system: description of the model and preliminary results. Intern Emerg Med 2006, Vol 1 No 1

5.B. Gail Macik MD. The Future of Anticoagulation Clinics. Journal of Thrombosis and Thrombolysis 16(1/2), 55–59, 2003.

6.Witt DM, Sadler MA, Shanahan RL, et al. Effect of a centralized clinical pharmacy anticoagulation service on the outcomes of anticoagulation therapy. Chest 2005 May; 127:1515-22

7.Viercinski J, Thomson L, Wilson J, et al. Establishing an inpatient anticoagulation service: a step by step review. J Thromb Thrombolysis 2008 Feb; 25(1):67-71.

8.Ansell JE, Buttaro ML, Thomas OV, et al. Consensus guidelines for coordinated outpatient oral anticoagulation therapy management. Ann Pharmacother 1997 May; 31(5):604-15.

9.Oertel L, Mungall D. Software applications in anticoagulation management. In: Ansell J, Oertel L, Wittkowsky A, eds. Managing oral anticoagulation therapy. 2nd ed. St. Louis: Wolters Kluwer Health, Inc, 2005:5A-2, 1-11.

10.Garwood CL, Dumo P, Baringhaus SN, Laban KM. Quality of anticoagulation care in patients discharged from a pharmacist-managed anticoagulation clinic after stabilization of warfarin therapy. Pharmacotherapy. 2008 Jan; 28(1):20-6

11.Gray DR, Garabedian-Ruffalo SM, Chretien SD. Cost-justification of a clinical pharmacist-managed anticoagulation clinic. Ann Pharmacother. 2007 Mar; 41(3):496-501. Epub 2007 Mar 6.

12.Poon IO, Lal L, Brown EN, Braun UK. The impact of pharmacist-managed oral anticoagulation therapy in older veterans. J Clin Pharm Ther. 2007Feb; 32(1):21-9.

13.Locke C, Ravnan SL, Patel R, Uchizono JA. Reduction in warfarin adverse events requiring patient hospitalization after implementation of a pharmacist-managed anticoagulation service. Pharmacotherapy.2005 May; 25(5):685-9.

14.Phillips KW, Wittkowsky AK. Survey of pharmacist-managed inpatient anticoagulation services. Am J Health-Syst Pharm 2007 Nov 1; 64(21):2275-8.

15.Bond CA, Raehl CL. Pharmacist-provided anticoagulation management in United States hospitals: death rates, length of stay, medicare charges, bleeding complications, and transfusions. Pharmacotherapy 2004 Aug; 24(8):953-63.

16.Dager WE, Gulseth MP. Implementing anticoagulation management by pharmacists in the inpatient setting. Am J Health-Syst Pharm 2007 May 15; 64:1071-9.

17.American Society of Health-System Pharmacists. ASHP guidelines on the pharmacist’s role in the development, implementation, and assessment of critical pathways. Am J Health-Syst Pharm 2004; 61:939–45.

18.Dobesh PP, Bosso J, Wortman S, et al, for the American College of Clinical Pharmacy. Critical pathways: the role of pharmacy today and tomorrow. Pharmacotherapy 2006; 26(9):1358–68

19.Dager WE, Branch JM, King JH, et al. Optimization of inpatient warfarin therapy: impact of daily consultation by a pharmacist-managed anticoagulation service. Ann Pharmacother 2000; 34:567-72. DOI 10.1345/aph.18192

Article By: Guy-Armel BOUNDA; Cosette Ngarambe
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