Pennsylvania Patient Safety Advisory Anticoagulation Management Service: Safer Care, Maximizing Outcomes ABSTRACT calculations or double checks were done. The patient was transferred to the [intensive care unit (ICU)] PA-PSRS has received hundreds of Serious Event when drip was hung, heparin was set to run at to- reports between June 2004 and January 2008 asso- keep-open rate. Patient received [heparin] 25,000 ciated with anticoagulation therapy with outcomes units in a three hour [span]. having hematologic effects from thrombocytopenia to hemorrhage. The indications, dosages, strengths, Patient was noted on [admission] to have low prob- and pharmacokinetics for anticoagulants are quite ability of [heparin induced thrombocytopenia (HIT)] variable, requiring extra attention to prescribing, dis- but blood work showed antibodies to heparin. Hepa- pensing, administering, and monitoring the effects of rin 5,000 units [subcutaneously, two times per day] these medications. The complexity of anticoagulants was ordered for the patient [for 7 days] when the has resulted in patient safety compromise. Healthcare patient was transferred to the [patient care unit]. organizations have increasingly recognized the ben- [Two days later], the patient collapsed and was efits of anticoagulation management services (AMS) transferred to the ICU with diagnosis of pulmonary in the inpatient and outpatient settings. The benefits of emboli. The heparin allergy was not placed in the an AMS program include a reduction in mortality rates electronic record until [the transfer to ICU]. and bleeding complications, decreased adverse drug The Institute of Medicine stresses the importance of events, including medication errors and shortened adopting an interdisciplinary approach to patient care hospital stays, thereby producing safer patient care. by encouraging healthcare professionals to establish The key components in AMS program development teamwork, communication, and cooperation.2 The include defining the rationale for AMS development, Joint Commission’s 2008 National Patient Safety outlining issues associated with anticoagulants, defin- Goal 3E to improve the safe use of medications ing AMS scope of service and infrastructure, and includes the new requirement to reduce the likeli- outlining AMS program metrics. (Pa Patient Saf Advis hood of patient harm associated with anticoagulation 2008 Sep;5[3]:81-4.) therapy medications such as heparin (unfractionated), low-molecular-weight heparin, warfarin, and other anticoagulant drugs.3 These medications require PA-PSRS has received hundreds of Serious Event comprehensive dosing and monitoring strategies to reports between June 2004 and January 2008 associ- minimize the risks associated with their use and to ated with the prescribing, dispensing, administering, maximize patient outcomes. and/or monitoring of anticoagulation therapy (see U.S. Pharmacopeia lists anticoagulants heparin, war- Table). Patient outcomes included hematologic farin, and enoxaparin as high-risk medications and effects from thrombocytopenia to hemorrhage; many among the top 12 drugs associated with medication patients required transfusions; some patients died. errors.4 High-risk medications have greater probability Anticoagulation medications require comprehensive of causing significant harm than other medications, dosing and monitoring strategies to minimize the when used incorrectly. Standardizing anticoagulation risks associated with their use to produce optimal therapy can help to reduce bleeding complications patient outcomes.1 Healthcare organizations and and decrease the number of adverse drug events, physicians have increasingly recognized the benefits including medication errors. Optimally, this will pro- of an anticoagulation management service (AMS) in duce safer care, which contributes to the reduction in the inpatient and outpatient settings. Consider the mortality and shortened length of hospital stays. following reports submitted to PA-PSRS surrounding issues with anticoagulation therapy: Literature Supports Anticoagulation Management Services Critically ill patient diagnosed with spontaneous retroperitoneal hematoma. Physician discontinued A randomized controlled study by Wilson et al. 5 com- heparin, administered vitamin K and ordered [hema- pared outcomes when anticoagulation therapy was tocrit and hemoglobin] every six hours. [Twice], managed by anticoagulation clinics versus primary blood specimens were not collected by the nurse. The care physicians. The rates of thromboembolic, major patient arrested and died. Hemoglobin per [arterial hemorrhagic events, and patient satisfaction were blood gases] at time of arrest was 5. measured between the two groups. Eighty-six percent of the time, patients in the anticoagulation clinics Patient was admitted after a fall at home; found to were within the international normalized ratio (INR) have an acute [myocardial infarction] while in the expanded therapeutic range while patients in the [emergency department (ED)]. Heparin bolus and family physician group were within expanded thera- drip ordered. The required heparin order form was not peutic range 77% of the time. The most significant used. The order was apparently not weight based. No difference between the two groups was that patients Vol. 5, No. 3—September 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 81 Pennsylvania Patient Safety Advisory Table. Serious Events Reported to PA-PSRS related to Anticoagulation Therapy Since 2004 STAGES IN ANTICOAGULATION THERAPY* NUMBER OF SERIOUS EVENTS PERCENTAGE (%) Prescribing 35 6 Dispensing 44 7 Administering 94 16 Monitoring 202 34 Other (e.g., bleeding, falls with hematoma, pressure ulcers) 327* 55 Total Number of Reports 591† * May not be included in any stage of anticoagulation therapy † Serious events may include multiple overlapping stages throughout anticoagulation therapy managed by anticoagulation clinics resulted in fewer transfusion complications compared to institutions high-risk INR values of less than 1.5 or greater without such services. 9 This was the first large-scale than 5. Differences in major bleeding events, throm- study that evaluated the impact of pharmacist- boembolic events, and mortality rates between the managed anticoagulation services on healthcare two groups were not significant. Patient satisfaction outcomes.9 was much also higher with the anticoagulation Given the results of these studies, leaders should clinics than with routine care. The results indicated consider implementing AMS in their organizations. that anticoagulation clinics provided slightly better Ideally, creating an AMS that extends along the oral anticoagulation management than family physi- continuum of care by incorporating inpatient and cian groups.5 outpatient services will provide patients with optimal A retrospective, observational cohort study by Witt care from the first day of anticoagulation to the com- et al.6 measured the effects of a centralized clinical pletion of therapy. 10 pharmacy anticoagulation service (CPAS) on the out- Several U.S. hospitals have implemented integrated comes of anticoagulation therapy. The intervention AMS programs over the past decade.1,10-12 Other hospi- group’s anticoagulation therapy was managed by a tals have implemented AMS only for patients outside centralized, telephonic CPAS, while the control group the tertiary care settings.3,13 All program types have the was managed by primary care physicians. Thirty-nine same ultimate goal—to provide safer care and optimize percent fewer patients in the CPAS group experienced patient outcomes. anticoagulation therapy complications than patients in the control group.6 Sixty-three percent of the CPAS The following PA-PSRS reports that illustrate Seri- group had INR levels within target range compared to ous Events that occurred in the ordering, dispensing, 55.2% of those patients receiving care from personal administrating, and monitoring of anticoagulation physicians.6 The CPAS were managed by pharmacists medications. and included the use of a computerized patient moni- [A clinic patient presented] with nontherapeutic toring system that identified when patients failed to [prothrombin (PT)/INR]. Results called to physician return for subsequent INR testing. This study also office, but the Coumadin® dose was not adjusted. supported the idea that a coordinated and systematic The patient required hospitalization at another facil- approach to an AMS may be more important than the ity for PT/INR regulation. method of management (i.e., telephonic, in person). The medication [order] expired, and the physician A retrospective cohort study by Chamberlain et al.7 did not renew medication. Medication dropped off linked record review (including outpatient, inpatient, computer screen due to nonrenewal. Patient was and ED records) between two groups of patients: transferred to ICU. Staff did not realize patient had those treated in a traditional clinic and those treated been getting Lovenox®. Patient developed a [pulmo- in an AMS. The AMS group had better anticoagula- nary embolism two weeks later] due to not being on tion control than the traditional care group.7 There anticoagulants. was also less variation with INR target range with the An initial bolus of heparin and heparin nomogram AMS than with the traditional clinic. INR testing protocol were calculated on an incorrect patient was conducted more frequently with the AMS, as was weight. The heparin was calculated in the ED on follow-up care, which included patient education. an estimated patient weight of 130 kilograms. The These findings emphasize the effects of a shared AMS patient was transferred to the [patient care area] to include clear clinical guidelines and patient infor- where the [actual] weight was measured as 103 kilo- mation exchange.7,8 grams. The physician was notified immediately and In a retrospective analysis of more than 700,000 the [partial thromboplastin (PTT)] was greater than Medicare patients, institutions with inpatient antico- 150. Heparin was stopped. The patient developed agulation services had shortened lengths of stay, lower [petechiae]. Protamine was administered in addition Medicare charges, and decreased rates of bleeding and to additional laboratory testing. Page 82 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 3—September 2008 Pennsylvania Patient Safety Advisory Patient admitted and medication orders included Coumadin® 2.5 mg orally daily-hold for INR greater Accompanying Patient Safety Tools or equal to 3.5, and Lovenox 40 mg subcutaneously Visit the Pennsylvania Patient Safety Authority Web daily. No PT/INR ordered during stay until [three site to view or download a brief informational days later] when the patient was noted to have com- video based on this article that can be used for plications of bleeding. The physician was notified of educational purposes. In addition, links to com- elevated PTT and bleeding and then ordered PT/INR. panion online information are provided, including a self-assessment tool for antithrombotic therapy Nurse recorded wrong PTT result and adjusted hepa- from the Institute for Safe Medication Practices. rin rate/protocol. Adjustment scanned to pharmacy and pharmacist did not confirm correct PTT result. To view the tools, click on “Advisories and Related Nurse did not obtain co-signature of second nurse Resources” in the left-hand column of the Author- ity’s home page. Then, click on “Resources [which was] required [per] policy for heparin rate Associated with Patient Safety Articles.” adjustments. Key Components to Consider When Developing an Anticoagulation Management System be the use of automated dispensing cabinets that Patient safety committees should consider assessing interface with pharmacy information systems with anticoagulation safety to help define their organi- limited or no override capabilities, use of infusion zation’s needs before an AMS development. This pumps with drug libraries, and standard labeling self-assessment allows facilities to outline the positive techniques.15 Use the electronic medication admin- impact that an AMS program will have to provide istration record to standardize the documentation safer care and maximize patient outcomes. An indi- of coagulation laboratory results before anticoagu- vidualized AMS is based on the organization’s specific lation medication administration. needs, resources, and experiences and includes the Define AMS Scope of Service and Infrastructure following: ■ Determine team composition of AMS program. Define Rationale for AMS Development Some inpatient AMS programs are pharmacy- ■ Develop a multidisciplinary AMS program com- driven teams providing service for heparin therapy, mittee comprising physicians, pharmacists, nurses, while other AMS programs provide total manage- clinical laboratory, and information technology ment for all anticoagulant therapies through a staff.1,3,10,11 consultative process.12 Provide adequate staffing depending on program composition.10,11 ■Evaluate current anticoagulation processes to clearly define the future AMS program develop- ■ Create communication and documentation sys- ment, targeting those patients with the greatest tems that extend along the continuum of care and need.1,10,12 Review prior Incidents (near misses) and incorporate both the inpatient and outpatient Serious Events related to anticoagulation medica- AMS.3,8-11 tions. This data will provide additional justification ■ Develop policies, guidelines, written protocols, for AMS development. heparin dosing algorithms, and safe scope of Outline Issues Associated with Anticoagulation evidence-based practice, including supervision for Medications physicians and pharmacists.1,3,9-11,14,16 ■ Review literature relating to the use of anticoagula- ■ Develop formal anticoagulation competencies for tion agents. Using medical record audit, review physicians, pharmacists, and nurses to assess base- your organization’s trends in timeliness to achieve line and ongoing knowledge about anticoagulation therapeutic anticoagulation levels, laboratory therapy, thromboembolism, HIT, and allergies results monitoring capabilities, the use of overlap including a competency demonstration process to anticoagulants (including anticoagulation manage- assess ability to apply safe practice concepts.9,11-13 ment when patients require an invasive procedure), Identify key interdisciplinary champions.10 and adequacy of anticoagulation therapy at dis- ■ Use an electronic tracking system to integrate and charge. These measurable outcomes demonstrate bridge medical records of outpatient- or commu- the difficulty in effectively managing anticoagula- nity-based programs, inpatient medical records, tion therapy.12,14 laboratory studies, and medication records.3,8-11 ■ Standardize the use of anticoagulants.10,15 This Develop a well-designed anticoagulation patient ■ may include but is not limited to standardization and family educational program to help increase of anticoagulation medications concentrations; compliance and contribute to improved patient formulary limits; use of only commercially or outcomes.14 pharmacy filled heparin flushes and intravenous solutions; use of a pharmacy profiled, reconciled AMS Program Metrics computerized prescriber order entry with alerts for ■ Define AMS program outcomes for future mea- duplicate therapy, drug contraindication, and drug surement. Consider measurement of target INR and food interactions. Other considerations may levels, INR levels associated with hemorrhagic Vol. 5, No. 3—September 2008 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Page 83 Pennsylvania Patient Safety Advisory complications and thromboembolism rates, deaths, 7. Chamberlain MA, Sageser NA, Rutz D. Comparison of minor and major bleeding episodes, use of ED anticoagulation clinic patient outcomes from traditional visits and hospital admissions associated with care in a family medicine clinic. JABFP 2001 Jan-Feb; anticoagulation problems, hospital length of stay, 14(1):16-21. patient satisfaction, and reimbursement.12,14 8. Holm T, Lassen JF, Husted SE, et al. A randomized controlled trial of shared care versus routine care for ■ Develop a quality program that monitors and patients receiving oral anticoagulant therapy. J Int Med generates annual reports (more often as deemed 2002 Oct;252(4):322-31. necessary) to document metrics, to improve per- 9. Bond CA, Raehl CL. Pharmacist-provided anticoagula- formance including error reduction rates, and to tion management in United States hospitals: death rates, manage any unanticipated risks.9-12,14 length of stay, medicare charges, bleeding complications, and transfusions. Pharmacotherapy 2004 Aug;24(8):953-63. Notes 10. Dager WE, Gulseth MP. Implementing anticoagulation 1. Phillips KW, Wittkowsky AK. Survey of pharmacist-man- management by pharmacists in the inpatient setting. Am aged inpatient anticoagulation services. Am J Health-Syst J Health-Syst Pharm 2007 May 15;64:1071-9. Pharm 2007 Nov 1;64(21):2275-8. 11. Schneider BL, Gulseth MP, Cusick MA, et al. Computer 2. Kohn LT, Corrigan JM, Donaldson MS, eds. To err is program to assist pharmacy management of an inpatient human: building a safer health system. Washington (DC): warfarin dosing service. Am J Health-Syst Pharm 2005 Nov 15;62:2393-6. National Academy Press, 2000. 12. Viercinski J, Thomson L, Wilson J, et al. Establishing an 3. The Joint Commission. Reducing anticoagulation- inpatient anticoagulation service: a step by step review. related adverse drug events: closely monitoring and J Thromb Thrombolysis 2008 Feb;25(1):67-71. managing risks for patients on warfarin. Jt Comm Perspect 13. Bungard TJ, Archer SL, Hamilton P, et al. Bringing the Patient Saf 2006 Jul;6(7):3-4. benefits of anticoagulation management services to the 4. U.S. Pharmacopeia. Top 50 drug products* associated community. Can Pharm J 2006 Mar-Apr;139(2):58-64. with medication errors [online]. [cited 2008 June 18]. 14. Ansell JE, Buttaro ML, Thomas OV, et al. Consensus Available from Internet: http://www.usp.org/hqi/ guidelines for coordinated outpatient oral anticoagu- patientSafety/resources/top50DrugErrors.html. lation therapy management. Ann Pharmacother 1997 May;31(5):604-15. 5. Wilson SJ-A, Wells PS, Kovacs MJ, et al. Comparing the quality of oral anticoagulant management by anticoagu- 15. Institute for Safe Medication Practices (ISMP). ISMP’s medication safety self assessment® for antithrombotic lation clinics and by family physicians: a randomized therapy in hospitals [online]. 2005 [cited 2008 Jul 18]. controlled trial. CMAJ 2003 Aug;169(4):293-8. Available from Internet: http://www.ismp.org/ 6. Witt DM, Sadler MA, Shanahan RL, et al. Effect of a selfassessments/asa2006/ASAISMPAssessment.pdf. centralized clinical pharmacy anticoagulation service 16. Weitz JI, Hirsh J, Samama MM. New anticoagulant drugs: on the outcomes of anticoagulation therapy. Chest 2005 the seventh ACCP conference on antithrombotic and May;127:1515-22. thrombolytic therapy. Chest 2004 Sep;126(3):265S-86S. Page 84 REPRINTED ARTICLE - ©2008 Pennsylvania Patient Safety Authority Vol. 5, No. 3—September 2008 PENNSYLVANIA PATIENT SAFETY ADVISORY This article is reprinted from the Pennsylvania Patient Safety Advisory, Vol. 5, No. 3—September 2008. The Advisory is a publication of the Pennsylvania Patient Safety Authority, produced by ECRI Institute and ISMP under contract to the Authority as part of the Pennsylvania Patient Safety Reporting System (PA-PSRS). Copyright 2008 by the Pennsylvania Patient Safety Authority. This publication may be reprinted and distributed without restriction, provided it is printed or distributed in its entirety and without alteration. Individual articles may be reprinted in their entirety and without alteration provided the source is clearly attributed. This publication is disseminated via e-mail. To subscribe, go to https://www.papsrs.state.pa.us/ Workflow/MailingListAddition.aspx. To see other articles or issues of the Advisory, visit our Web site at http://www.psa.state.pa.us. Click on “Advisories” in the left-hand menu bar. THE PENNSYLVANIA PATIENT SAFETY AUTHORITY AND ITS CONTRACTORS The Patient Safety Authority is an independent state agency created by Act 13 of 2002, the Medical Care Availability and Reduction of Error (“Mcare”) Act. Consistent with Act 13, ECRI Institute, as contractor for the PA-PSRS program, is issuing this publication to advise medical facilities of immediate changes that can be instituted to reduce Serious Events and Incidents. For more information about the PA-PSRS program or the Patient Safety Authority, see the An Independent Agency of the Commonwealth of Pennsylvania Authority’s Web site at www.psa.state.pa.us. ECRI Institute, a nonprofit organization, dedicates itself to bringing the discipline of applied scientific research in healthcare to uncover the best approaches to improving patient care. As pioneers in this science for nearly 40 years, ECRI Institute marries experience and independence with the objectivity of evidence-based research. More than 5,000 healthcare organizations worldwide rely on ECRI Institute’s expertise in patient safety improvement, risk and quality management, and healthcare processes, devices, procedures and drug technology. The Institute for Safe Medication Practices (ISMP) is an independent, nonprofit organization dedicated solely to medication error prevention and safe medication use. ISMP provides recommendations for the safe use of medications to the healthcare community including healthcare professionals, government agencies, accrediting organizations, and consumers. ISMP’s efforts are built on a nonpunitive approach and systems-based solutions.