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Evaluation of 4 Years of Clinical Pharmacist Anticoagulation Case Management in a Rural, Private Physician Office
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Evaluation of 4 Years of Clinical Pharmacist Anticoagulation Case Management in a Rural, Private Physician Office Michael E. Ernst and Kim B. Brandt
Objectives: To evaluate patient outcomes after 4 years of anticoagulation case management by a pharmacist and to document patient and provider satisfaction with the service. Setting: Rural, private physician office in Mt. Vernon, Iowa. Practice Description: Clinical pharmacist anticoagulation clinic. Practice Innovation: Under a protocol reviewed annually, a clinical pharmacist faculty member from the University of Iowa College of Pharmacy provides on-site, point-of-care anticoagulation dose adjustment and monitoring 1 day per week. Main Outcome Measures: Data on anticoagulation outcomes from 1998 to 2002 were obtained through retrospective review of medical charts of patients served by the clinic. A survey of patient satisfaction with the clinic was mailed to all currently active patients enrolled in the anticoagulation clinic, and a second satisfaction survey was distributed to providers and ancillary staff of the physician office. Results: Eighty patients met the criteria for evaluation of therapeutic outcomes. The mean ± standard deviation percentage of international normalized ratios in the therapeutic range (“percent therapeutic”) for the anticoagulation clinic population was 57.5 ± 17.4. The percent therapeutic for patients who had been on warfarin before enrolling in the pharmacist case management anticoagulation clinic (defined as the usual medical care group) was 37.6%, compared with 57.8% for those patients receiving care in the pharmacist case management anticoagulation clinic (P < .001). In nearly all instances, responses to the surveys indicated that patient and provider satisfaction with the anticoagulation service was extremely high. Conclusion: A clinical pharmacist can provide anticoagulation case management services safely and effectively in a private physician office, and the service is highly valued by both patients and providers. We believe case management is an optimal method for systematically monitoring outpatient anticoagulation therapies and is preferable to usual medical care.
Keywords: Pharmacists, ambulatory care, anticoagulation, anticoagulants, case management, warfarin, patient satisfaction. J Am Pharm Assoc. 2003;43:630–6.
Case management clinics are rapidly becoming the standard means for providing systematic implementation, monitoring, and adjustment of anticoagulation therapies in tertiary care facilities, health maintenance organizations, and Veterans Affairs hospitals.1 Accumulating evidence suggests that monitoring anticoagulation therapies via this method can reduce annual major bleeding rates from between 5% and 28% with “usual medical care” to an average of 6% or less.2 In many instances, anticoagulation clinic serReceived January 13, 2003 and in revised form April 4, 2003. Accepted for publication June 13, 2003. Michael E. Ernst, PharmD, BCPS, is assistant clinical professor, Division of Clinical and Administrative Pharmacy, College of Pharmacy, and Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City. Kim B. Brandt, MD, is family physician, Iowa Health Physicians–Mt. Vernon Family Practice, Mt. Vernon, Iowa. Correspondence: Michael E. Ernst, PharmD, BCPS, Department of Family Medicine/01287, PFP 200, University of Iowa, Hawkins Drive, Iowa City, IA 52242. Fax: 319-384-8515. E-mail: [email protected].
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vices are directly provided by clinical pharmacists, nurses, or physician assistants with specialty training or expertise in the area.3–6 However, in the private physician office setting, where many of the resources required to perform anticoagulation case management may not be available, the approach to monitoring this group of patients may be less systematic, with usual medical care prevailing as the standard of care. In the limited number of studies that have directly compared anticoagulation patient outcomes in the two models of care, outcomes have been more favorable in anticoagulation clinics than in usual care practices.7–13 Improved outcomes may be the direct result of a more coordinated approach to therapy. In what is probably the best-known study of anticoagulation clinics performed to date, patients whose anticoagulation therapy was monitored and adjusted by clinical pharmacists had increased time in therapeutic international normalized ratio (INR) range and less bleeding, compared with patients receiving usual medical care.2 While improved outcomes have been widely documented in hospitals and teaching facilities in which clinical pharmacists man-
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age anticoagulation, no studies have examined or described anticoagulation case management in the private physician office setting. In July 1998 the University of Iowa College of Pharmacy entered into a contractual agreement with Iowa Health Physicians–Mt. Vernon Family Practice to provide on-site, point of care (POC) anticoagulation monitoring by a clinical pharmacist 1 day per week as part of a joint teaching and patient care venture.
Objectives Our objectives were to evaluate patient outcomes after 4 years of anticoagulation case management by a pharmacist and to document patient and provider satisfaction with the service. To our knowledge, this is the first report of such a program in a rural, private physician office.
Methods This article presents a descriptive report of the outcomes of the anticoagulation service, results of a cross-sectional satisfaction survey distributed to patients currently enrolled in the anticoagulation clinic, and results of a cross-sectional provider satisfaction survey distributed to medical and ancillary staff of the physician office. Data for the descriptive report came from a retrospective review of medical records of patients served by the anticoagulation clinic conducted in July 2002.
Anticoagulation Case M anagem ent Service Description The anticoagulation service was initiated in July 1998 as a pilot program between the University of Iowa College of Pharmacy and the Mt. Vernon Family Practice. The service is housed in the physician office in Mt. Vernon, Iowa (population 3,390). The family practice has five physicians and one physician assistant on staff, and gets approximately 20,000 patient visits per year. As part of the Iowa Health Physicians network, a nonprofit, 200-member primary care physician group practice serving 400,000 patients from 30 locations in central, eastern, and northeastern Iowa, the office serves the Mt. Vernon and surrounding rural areas. Anticoagulation case management services are performed by a clinical pharmacist (MEE) who is a board-certified pharmacotherapy specialist and faculty member at the University of Iowa College of Pharmacy. The services, as described in this report, are limited to ambulatory outpatients receiving warfarin (Coumadin— Bristol-Myers Squibb) therapy who are regular patients of the physician office. Medical oversight for the anticoagulation services is provided by the anticoagulation clinic medical director (KBB) and the other clinic providers. Patients are referred for anticoagulation services by their primary provider. A standard written referral form outlines the indica-
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tion for therapy, expected duration of therapy, and goal INR. The clinical pharmacist, assisted by a pharmacy student or clinical pharmacy resident, provides on-site services 1 day per week. Anticoagulation monitoring is performed using the CoaguCheck (Boehringer Mannheim) monitor, a whole-blood capillary POC testing device. Services provided directly by the clinical pharmacist include the testing itself, interpretation of the result, dosing adjustments, and scheduling/coordination of follow-up. A written protocol, reviewed annually and signed by the providers in the office, describes clinic procedures. When patients cannot be seen on the day the clinical pharmacist is on site, or when they have an appointment with their physician on any day during the week they are due for an INR assessment, a laboratory nurse performs INR testing using the POC machine. The result is then either interpreted by the physician seeing the patient that day or called into the clinical pharmacist for dosing and follow-up instructions. The POC method of INR determination was selected to facilitate patient convenience and improve response time. Since the clinic serves predominantly rural patients, who often spend significant time traveling to and from the clinic, real-time access to laboratory values was considered important for ensuring compliance with visits and for making timely dose adjustments. In addition, the office does not have a full-service medical laboratory with capabilities of running the INR via traditional venipuncture methods. To obtain INR results from a venipuncture in the clinic, blood must be sent out by courier to a medical laboratory approximately 30 miles away, and the results are not reported until the following morning. For safety reasons, and as part of the anticoagulation clinic protocol, INRs above 4.5 on the POC machine are verified by venipuncture, since evidence exists that the accuracy of POC prothrombin time testing devices declines with INRs above approximately 4.5.14,15 Billing procedures for the anticoagulation case management service follow Medicare incident-to guidelines, with the clinical pharmacist treated as a contracted employee of the clinic. The professional fee for anticoagulation visits is coded as 99211, and a laboratory draw fee is assessed. The visit is documented in the patient’s chart using a flowsheet and a standardized form cosigned after each visit by the primary provider. A physician is on site at all times for consultation in difficult cases and should patients require immediate medical attention.
Assessm ent of Therapeutic Outcom es Descriptive information on outcomes for anticoagulation clinic patients was manually abstracted from the medical charts in a retrospective manner. Patients were included in the descriptive analysis if they had continuous follow-up in the anticoagulation clinic (defined as a minimum duration of at least 1 month of follow-up), or if they had intermittent follow-up (defined as having at least one INR assessment performed in the clinic every 8 weeks for 3 successive months). Patients were included if they met these criteria
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at any time during the 4 years of the clinic’s existence. Patients were excluded from the analysis if they were taking warfarin and received their primary care and had INR assessments performed in the office but had their warfarin doses managed by a specialist (e.g., cardiologist) from an outside clinic. For each eligible patient, we collected information on total number of INRs obtained while he or she was being followed in the anticoagulation clinic, total number of INRs obtained for 1 year before enrollment in the clinic (if the patient was on warfarin prior to being enrolled), number of INRs in the therapeutic range (strictly within the goal range of 2.0 to 3.0 or 2.5 to 3.5, as this was considered the most conservative approach), number of INRs < 2.0, number of INRs > 5.0, and total number and type of bleeding events. Threshold levels of < 2.0 and > 5.0 were selected based on the rationale described by Chiquette et al.2 A “percent therapeutic” calculation was performed for each patient to determine the percentage of total INRs in the therapeutic range. Data for each patient were then combined and averaged to determine the percent therapeutic calculation for the entire group. Calculations were based on all INRs obtained during the period, even those obtained on days when the clinical pharmacist was unavailable and the physician had to interpret the INR and adjust doses; including these values was thought to produce the most conservative estimate. Furthermore, calculating the percent therapeutic in this manner (first calculating a mean percent for each patient then using these values to calculate a mean percent for the entire group) was felt to be a more conservative method than basing the calculation on total INRs therapeutic/total INRs obtained. If the latter method were used, a large number of easyto-manage patients with relatively stable INRs would have biased the calculation in favor of a higher percentage of patients with INRs within the therapeutic range. Our method was more sensitive to individual patient variation in the case of unstable patients. For comparison, anticoagulation data for 1 year prior to the start of the anticoagulation clinic were recorded for patients who were receiving warfarin before being enrolled into the clinic. These patients were defined as the usual medical care group. A paired t test was used to compare the percent therapeutic calculation between the usual medical care group and the anticoagulation clinic group. Information on bleeding events that occurred while the patient was under the care of the clinic was recorded according to the definitions by Chiquette et al.2 “Major” bleeding events were defined as those requiring hospitalization and transfusion of at least 2 units of blood or leading to cardiopulmonary arrest, surgical or angiographic intervention, irreversible sequelae, or death. “Significant” bleeding events were defined as those requiring evaluation or referral or being associated with a decrease of > 3% in the hematocrit or a decrease of > 1.2 gm/dL in the hemoglobin level. “Minor” bleeding events were defined as those that were of little or no clinical significance and that did not require referral or additional visits. Since information specifically related to anticoagulation care and INRs was not filed in a separate organized for-
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mat in the medical chart before the clinic opened, specific data on bleeding events that occurred before that time were not available for this analysis.
Assessm ent of Satisfaction Patient Satisfaction Survey
For purposes of quality improvement, a survey to assess patient satisfaction with anticoagulation services was developed by the clinical pharmacist and Iowa Health Physicians central office staff. The survey was based on a preexisting patient satisfaction survey developed by Iowa Health Physicians central administration that is automatically sent to each patient receiving care from the clinic after a scheduled office visit. Questions were modified or added as appropriate to make the survey specific to the anticoagulation clinic. The two-page survey was mailed from the Iowa Health Physicians central office to currently active patients enrolled in the anticoagulation clinic (n = 56). The survey presented 15 statements regarding satisfaction with the anticoagulation services provided, including, for example, satisfaction with the convenience of the clinic, time spent at each visit, and knowledge acquired during the visit. Patients used a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5) to respond to the statements. Responses were anonymously reported. The survey was sent out once; no follow-up was sent. A postage-paid return envelope was provided, and completed surveys were returned to the Iowa Health Physicians central office for collation and review. Provider Satisfaction Survey
A two-page provider satisfaction survey was developed and distributed by the clinic office manager to the medical, nursing, and administrative staff of the office (n = 30). The survey presented 18 statements regarding satisfaction with the anticoagulation services provided. Staff used a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5) to respond to the statements. Responses were anonymously reported. The survey was distributed only once.
Results Throughout the 4 years of follow-up, 98 unique patients had at least one INR determination performed by the clinical pharmacist. Of these patients, 80 met the criteria for evaluation (i.e., having received continuous or intermittent follow-up in the anticoagulation clinic). The 18 patients excluded from the analysis did not meet the minimum duration of follow-up. Typically, these were patients who had started warfarin within the last month, who had an INR test performed by the clinical pharmacist in the office but whose medication was actually adjusted by a specialist outside the
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Table 1. Demographics of and Descriptive Outcomes for the Anticoagulation Population (n = 80) Age, years Mean ± SD Range
75.6 ± 12.8 34–94
Women, no. (%)
44 (55.0)
On warfarin before establishing enrolling in anticoagulation clinic, no. (%)
61 (76.3)
Indication for anticoagulation, no. (%) Chronic atrial fibrillation Mechanical valve replacement Deep venous thrombsis/pulmonary embolism (acute or chronic) Other Anticoagulation outcomes % readings within range, b mean ± SD % readings < 2.0, mean ± SD % readings > 5.0, mean ± SD Major bleeding events, no. Significant bleeding events, no. Minor bleeding events, no. Ischemic events, no.
42 (52.5) 9 (11.3) 13 (16.3) 16 (20.0) Anticoagulation clinic (n = 80) 57.5 ± 12.8 c 23.3 ± 16.3 c 1.0 ± 1.9 1d 0 8 2e
Usual medical care a (n = 39) 37.6 ± 22.0 45.2 ± 27.0 2.1 ± 4.3 Unknown Unknown Unknown Unknown
SD = standard deviation. a Data were available for only 39 of the patients who had been receiving warfarin before the anticoagulation clinic opened. These patients constituted the usual medical care group. Data were reviewed for 1 year prior to their enrollment in the clinic. Data were not available on the remaining 22 patients who received warfarin before the clinic was started because these patients were initially followed by their specialist (e.g., cardiologist) outside the office before being transferred into the clinic. Records were not obtained fromthe specialists for review. b Only values that were strictly within the goal range of 2.0 to3.0 or 2.5 to 3.5 were considered therapeutic. c P < .001, compared with usual medical care. d This patient suffered a hemorrhagic stroke shortly after being discharged fromthe hospital after being treated for pneumonia; of note, the patient was not reentered into the anticoagulation service after discharge. e One patient suffered a stroke off warfarin therapy while hospitalized for gallbladder surgery and was not under the care of the anticoagulation service at the time of the stroke; the other patient was receiving warfarin for a history of transient ischemic attack (TIA)/stroke, and she experienced a TIA while subtherapeutic on her warfarin.
office (e.g., cardiologist), or who had started warfarin but either discontinued it or were transferred to a nursing home within the first month. The mean age of participants was 75.6 years (range, 34–94); 45% (n = 36) were men. Seventy-six percent of patients (n = 61) were on warfarin prior to being enrolled in the clinic. A slim majority (52.5%) of patients (n = 42) were on warfarin for the indication of chronic atrial fibrillation. A total of 2,710 INR determinations were performed for these patients during the 4 years of clinic operation. Table 1 summarizes the demographics of and descriptive outcomes for the anticoagulation population. The mean percentage of INRs within the therapeutic range for the entire population was 57.5% ± 17.4%. An average of 23.3% ± 16.3% of INRs were subtherapeutic (below the threshold value of 2.0 defined by Chiquette et al.2), while only 1% ± 1.9% of INRs were supratherapeutic (above the critical value of 5.0 defined by Chiquette et al.2). For the before-and-after comparison of patients who had been on warfarin before enrolling in the clinic, the percent therapeutic was 37.6% versus 57.8% (P < .001). Bleeding and ischemic events occurred rarely in the anticoagulation clinic group. Tables 2 and 3 show the responses to the patient and provider satisfaction surveys. The response rate was 91.1% (51 of 56) for
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the patient survey and 73.3% (22 of 30) for the provider survey. In nearly all instances, patient and provider satisfaction with the anticoagulation services was extremely high.
Discussion Taken as a whole, our experience indicates that anticoagulation therapy can be safely and effectively managed by a clinical pharmacist in a private physician office setting. Monitoring in this manner improves time in therapeutic range and reduces the number of INRs above and below critical threshold values. Patient safety does not appear compromised when a nonphysician oversees dosing adjustments and follow-up each time. Our results are consistent with previously published studies describing successful anticoagulation monitoring by clinical pharmacists in more populous settings.2,4,5,7–9,13 In the largest study of clinical pharmacist anticoagulation services to date, the percent time within range was 50.4% for the anticoagulation clinic group.2 Several explanations could account for the improved time in the therapeutic range observed in our clinic relative to the usual medical care. More time for patient counseling can lead to improved patient knowledge about how to correctly take medication and to
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Table 2. Results of the Patient Satisfaction Survey (n = 51) Statement
% Agree or Strongly Agree
1. The pharmacist is courteous and friendly.
100.0
2. W orking with the pharmacist has increased my knowledge about my specific condition and the reason for taking Coumadin.
94.1
3. After each appointment, I understand how to take my Coumadin.
98.0
4. The pharmacist is flexible about scheduling or rescheduling my appointments.
100.0
5. It is more convenient for me to get the results of my protime and dosing instructions right away.
100.0
6. The pharmacist spends enough time with me at each visit.
98.0
7. I am usually seen on time for my appointments.
98.0
8. I prefer having my blood checked using the fingerstick machine instead of drawing it out of my arm.
98.0
9. It is easy to schedule an appointment with the pharmacist for a protime.
100.0
10. If it was appropriate, I would recommend a friend/family member on Coumadin be seen by the pharmacist.
96.1
11. The pharmacist listens to my cares and concerns about Coumadin/protimes and his answers to my questions are helpful.
96.1
12. I feel confident that the pharmacist will work (or has worked in the past) with my doctor to resolve any problems that might come up. 13. Please rate your overall satisfaction with your Coumadin care.
96.0 100.0
14. W ere you on Coumadin before you started seeing the pharmacist for protimes?
Yes = 32 (62.7)
Additional questions asked only of the patients receiving anticoagulation therapy prior to being enrolled in the anticoagulation clinic (n = 32) 15. Compared to the old way, I would rate my Coumadin/protime care with the pharmacist as much better. 16. Compared to before, I feel safer about taking Coumadin.
better adherence. Also, a more structured review of medication regimens can help identify potential drug–drug interactions and suggest alternatives. Improved continuity of follow-up helps ensure that patients have regular office visits not only for anticoagulation but their other medical problems as well. Lastly, coordinating care and having the clinical pharmacist provide the service on site in the physician office affords opportunities to discuss difficult cases and communicate about medical care of the patient, which may influence selection of pharmacotherapeutic regimens less prone to interfere with warfarin therapy. Importantly, clinic patients were very supportive of the services. Based on the survey responses, this was probably influenced by the convenience of the POC method, the short turnaround time for results, and the one-on-one attention provided by clinic staff. The improved continuity of care likely enhances patient adherence to prescribed therapies. The providers also expressed support for the anticoagulation service. It appeared to reduce their time spent dealing with questions related to anticoagulation, and they believed it improved continuity of follow-up. While the limitations of this type of research are discussed below, several strengths are worth noting. First, we used the most conservative estimate of percent therapeutic by categorizing only those INR values in the exact range (i.e., 2.0–3.0 or 2.5–3.5) as therapeutic. This probably explains the overly high percentage (23.3%) of subtherapeutic values, since this categorization method would result in INR values of 1.8 to 1.9 (for goal 2.0–3.0) and 2.3
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Yes = 29 (90.6) 21 (67.7)
to 2.4 (for goal 2.5–3.5) being recorded as subtherapeutic. Many clinicians would argue that occasional values such as those are not important enough to require a change in maintenance dose if the patient is otherwise stable and INRs are therapeutic on the same dose at previous measurements. Yet, even after using a conservative method to calculate the percent of values as therapeutic, a significant difference was observed between the clinic patients and patients receiving usual medical care. Second, our data collection and reporting represents a real-world strategy that could be used in most private physician practices. We made use of simple beforeand-after comparisons. It would be quite difficult to perform a more rigorous, systematic comparison between usual medical care and case management in this type of setting. It is also important to note that this is the first report to describe and evaluate anticoagulation case management performed by a clinical pharmacist in a private physician office. Although the sample was small, the therapeutic outcomes were consistent with those observed in larger settings, such as health maintenance organizations and large hospital practices. If similar programs were established across the country in private offices, and our results extrapolated to the number of patients that could be affected by such a service, it is clear that the safety and efficacy of anticoagulation therapies could be improved significantly. And although our service embodies a unique relationship between a college of pharmacy and a private physician office, a similar model using community pharmacies to perform INR testing and dose adjustment has been previously described.16 Future research should investi-
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Table 3. Results of the Provider Satisfaction Survey (n = 22) Statement
% Agree or Strongly Agree
1. Since starting the anticoagulation clinic, the number of phone calls from patients with questions about anticoagulation has decreased.
63.6
2. The anticoagulation clinic is convenient for patients and staff.
90.9
3. The anticoagulation clinic provides increased safety and efficacy for patients.
95.5
4. Patients like having their protimes handled through the anticoagulation clinic.
95.5
5. The anticoagulation clinic provides better continuity of care for dealing with protimes.
100.0
6. The anticoagulation clinic runs efficiently.
100.0
7. Compared to other doctor’s offices I’ve worked in, the anticoagulation clinic is a definite enhancement to the clinic’s services.
66.7
8. Patients speak highly of the services provided in the anticoagulation clinic.
100.0
9. Since starting the anticoagulation clinic, the time I spend dealing with protimes/questions has decreased.
100.0
10. The anticoagulation clinic frees up my time to be able to take care of more patients, rather than having to deal with protimes. 11. Having on-site results and interpretation of protimes provides a greater margin ofsafety to patients.
92.9 100.0
12. I am confident my patients’ anticoagulation needs are taken care of in the anticoagulation clinic.
92.9
13. Since starting the anticoagulation clinic, problems related to anticoagulation have decreased.
71.4
14. Since starting the anticoagulation clinic, patients’ protimes are better controlled.
71.4
15. Having the anticoagulation clinic provides additional value to our patient care services.
100.0
16. I prefer to have my anticoagulation patients handled through the anticoagulation clinic.
92.9
gate the potential physical, legal, professional, and financial obstacles to systematically providing such services directly in private physician offices on a broader scale.
elderly, rural patients in Iowa, the sort of group that, in the experience of the authors, tends to be more compliant than other groups of patients.
Limitations
Conclusion
A number of limitations regarding our results need to be recognized. Most importantly, it is unknown whether the improved time in therapeutic range actually resulted in fewer bleeding and/or ischemic events, since no data on bleeding events among usual medical care patients were available for comparison. Thus, the question of whether anticoagulation case management by pharmacists improves morbidity and mortality remains unanswered. Anecdotally, there appeared to be no increase in bleeding or ischemic events, and none of the physicians could remember a clinic patient dying or being hospitalized for complications related to warfarin therapy between 1998 and 2002. Many of the patients were already on warfarin before the anticoagulation service was established. It is possible that their dose requirements had been previously determined and that their knowledge and experience taking warfarin resulted in improved time in therapeutic range once they enrolled in the clinic. This is unlikely, however, given the significantly fewer therapeutic INRs observed for patients receiving usual medical care. The overall numbers served by the clinic are small in comparison with larger institutions, and only one clinician provided the services, making it possible to generalize the results only to small, private practice offices. Lastly, the clinic serves predominantly
A clinical pharmacist can provide anticoagulation case management services safely and effectively in a private physician office, as indicated by the high degree of therapeutic INRs and few adverse events observed in our experience. The service is highly valued by both patients and other health care providers in the clinic. We believe that the innovative practice and teaching experience described in this report represents a mutually beneficial relationship between rural private practice and academia, one that ultimately benefits patients.
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The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. The authors thank the staff of Iowa Health Physicians–Mt. Vernon Family Practice for their generous support in helping make this program possible.
References 1. Ansell J, Hirsh J, Dalen J, et al. Managing oral anticoagulant therapy. Chest. 2001;119(suppl):22S–38S. 2. Chiquette E, Amato MG, Bussey HI. Comparison of an anticoagulation clinic with usual medical care. Arch Intern Med. 1998;158:1641–7. 3. Gassmann A, Gameraos V, Bingham K, et al. Cardiology nurse-directed outpatient anticoagulation. Circulation. 1978;58(suppl 2):123.
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4. Conte RR, Kehoe WA, Nielson N, et al. Nine-year experience with a pharmacist-managed anticoagulation clinic. Am J Hosp Pharm. 1986;43:1460–4. 5. Bussey HI, Rospond RM, Quandt CM, Clark GM. The safety and effectiveness of long-term warfarin therapy in an anticoagulation clinic. Pharmacotherapy. 1989;9:214–9. 6. Seabrook GR, Karp D, Schmitt DD, et al. An outpatient anticoagulation protocol managed by a vascular nurse—clinician. Am J Surg. 1990;160:501–4. 7. Cohen IR, Hutchinson TA, Kirking DM, Shue ME. Evaluation of a pharmacist-managed anticoagulation clinic. J Hosp Pharm. 1985;10:167–75. 8. Garabedian-Ruffalo SM, Gray DR, Sax MJ, Ruffalo RL. Retrospective evaluation of a pharmacist-managed warfarin anticoagulation clinic. Am J Hosp Pharm. 1985;42:304–5. 9. Gray DR, Garabedian-Ruffalo SM, Chretien SD. Cost-justification of a clinical pharmacist-managed anticoagulation clinic. Drug Intell Clin Pharm. 1985;19:575–80. 10. Hamilton GM, Childers RW, Silverstein MD. Does clinic management of anticoagulation improve the outcome of prosthetic valve patients? [abstract]. Clin Res. 1985;3:832A.
P H A R M A CY
11. Pell JP, McIver B, Stuart P, Malone DNS, Alcock J. Comparison of anticoagulant control among patients attending general practice and a hospital anticoagulant clinic. Br J Gen Pract. 1993;43:152–4. 12. Cortelazzo S, Finazzi P, Viero P, et al. Thrombotic and hemorrhagic complications in patients with mechanical heart valve prosthesis attending an anticoagulation clinic. Thromb Haemost. 1993;69:316–20. 13. Wilt VM, Gums JG, Ahmed OI, Moore LM. Pharmacy operated anticoagulation service: improved outcomes in patients on warfarin. Pharmacotherapy. 1995;15:732–9. 14. McCurdy SA, White RH. Accuracy and precision of a portable anticoagulation monitor in a clinical setting. Arch Intern Med. 1992;152:589–92. 15. Tripodi A, Arbini AA, Chantarangkul V, et al. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the international normalized ratio? Thromb Haemost. 1993;70:921–4. 16. Knowlton CH, Thomas OV, Williamson A, et al. Establishing community pharmacy-based anticoagulation education and monitoring programs. J Am Pharm Assoc. 1999;39:368–74.
T H R O U GH T H E A GES
The Grand Triumvirate at an Early APhA Conference This photograph, dated 1916, shows three of the most influential and versatile American pharmacists of the period together at the American Pharmaceutical Association’s (APhA) annual meeting in Atlantic City. Each of them was a leader in science, education, literature, and the practice of pharmacy. C. Lewis Diehl was a German-born American pharmacist who was involved in many phases of practice. Perhaps his greatest contributions were the Reports on The Progress of Pharmacy. Each year, he gathered information on advances in pharmacy from Europe and America and distilled it into his official Reports, which were published as an integral part of the Proceedings of the American Pharmaceutical Association for nearly 40 years. These extensive reports frequently comprised several hundred pages of small type in the Proceedings. Joseph P. Remington was an early graduate of the Philadelphia College of Pharmacy and worked for a period with E.R. Squibb and Powers and Weightman before purchasing a pharmacy. He returned to his alma mater as a teacher in 1871 and became its dean in 1893. Remington served in a number of roles with the United States Pharmacopoeia (USP) from the 1880s until his death in 1918. He published the first edition of Remington’s Practice of Pharmacy in 1885. Upon his death, the APhA New York branch created the Remington Honor Medal, the highest professional accolade in American pharmacy. John Uri Lloyd served pharmacy with distinction as a researcher, publisher, and manufacturer. He served as APhA president in 1887/88. In 1920 he became the second recipient of the Remington Medal. Dennis B. Worthen, PhD, Lloyd Scholar, Lloyd Library and Museum, Cincinnati, Ohio. Photograph published with permission of the Lloyd Library and Museum.
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Evaluation of 4 Years of Clinical Pharmacist Anticoagulation Case Management in a Rural, Private Physician Office Michael E. Ernst and Kim B. Brandt
Objectives: To evaluate patient outcomes after 4 years of anticoagulation case management by a pharmacist and to document patient and provider satisfaction with the service. Setting: Rural, private physician office in Mt. Vernon, Iowa. Practice Description: Clinical pharmacist anticoagulation clinic. Practice Innovation: Under a protocol reviewed annually, a clinical pharmacist faculty member from the University of Iowa College of Pharmacy provides on-site, point-of-care anticoagulation dose adjustment and monitoring 1 day per week. Main Outcome Measures: Data on anticoagulation outcomes from 1998 to 2002 were obtained through retrospective review of medical charts of patients served by the clinic. A survey of patient satisfaction with the clinic was mailed to all currently active patients enrolled in the anticoagulation clinic, and a second satisfaction survey was distributed to providers and ancillary staff of the physician office. Results: Eighty patients met the criteria for evaluation of therapeutic outcomes. The mean ± standard deviation percentage of international normalized ratios in the therapeutic range (“percent therapeutic”) for the anticoagulation clinic population was 57.5 ± 17.4. The percent therapeutic for patients who had been on warfarin before enrolling in the pharmacist case management anticoagulation clinic (defined as the usual medical care group) was 37.6%, compared with 57.8% for those patients receiving care in the pharmacist case management anticoagulation clinic (P < .001). In nearly all instances, responses to the surveys indicated that patient and provider satisfaction with the anticoagulation service was extremely high. Conclusion: A clinical pharmacist can provide anticoagulation case management services safely and effectively in a private physician office, and the service is highly valued by both patients and providers. We believe case management is an optimal method for systematically monitoring outpatient anticoagulation therapies and is preferable to usual medical care.
Keywords: Pharmacists, ambulatory care, anticoagulation, anticoagulants, case management, warfarin, patient satisfaction. J Am Pharm Assoc. 2003;43:630–6.
Case management clinics are rapidly becoming the standard means for providing systematic implementation, monitoring, and adjustment of anticoagulation therapies in tertiary care facilities, health maintenance organizations, and Veterans Affairs hospitals.1 Accumulating evidence suggests that monitoring anticoagulation therapies via this method can reduce annual major bleeding rates from between 5% and 28% with “usual medical care” to an average of 6% or less.2 In many instances, anticoagulation clinic serReceived January 13, 2003 and in revised form April 4, 2003. Accepted for publication June 13, 2003. Michael E. Ernst, PharmD, BCPS, is assistant clinical professor, Division of Clinical and Administrative Pharmacy, College of Pharmacy, and Department of Family Medicine, Roy J. and Lucille A. Carver College of Medicine, University of Iowa, Iowa City. Kim B. Brandt, MD, is family physician, Iowa Health Physicians–Mt. Vernon Family Practice, Mt. Vernon, Iowa. Correspondence: Michael E. Ernst, PharmD, BCPS, Department of Family Medicine/01287, PFP 200, University of Iowa, Hawkins Drive, Iowa City, IA 52242. Fax: 319-384-8515. E-mail: [email protected].
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vices are directly provided by clinical pharmacists, nurses, or physician assistants with specialty training or expertise in the area.3–6 However, in the private physician office setting, where many of the resources required to perform anticoagulation case management may not be available, the approach to monitoring this group of patients may be less systematic, with usual medical care prevailing as the standard of care. In the limited number of studies that have directly compared anticoagulation patient outcomes in the two models of care, outcomes have been more favorable in anticoagulation clinics than in usual care practices.7–13 Improved outcomes may be the direct result of a more coordinated approach to therapy. In what is probably the best-known study of anticoagulation clinics performed to date, patients whose anticoagulation therapy was monitored and adjusted by clinical pharmacists had increased time in therapeutic international normalized ratio (INR) range and less bleeding, compared with patients receiving usual medical care.2 While improved outcomes have been widely documented in hospitals and teaching facilities in which clinical pharmacists man-
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age anticoagulation, no studies have examined or described anticoagulation case management in the private physician office setting. In July 1998 the University of Iowa College of Pharmacy entered into a contractual agreement with Iowa Health Physicians–Mt. Vernon Family Practice to provide on-site, point of care (POC) anticoagulation monitoring by a clinical pharmacist 1 day per week as part of a joint teaching and patient care venture.
Objectives Our objectives were to evaluate patient outcomes after 4 years of anticoagulation case management by a pharmacist and to document patient and provider satisfaction with the service. To our knowledge, this is the first report of such a program in a rural, private physician office.
Methods This article presents a descriptive report of the outcomes of the anticoagulation service, results of a cross-sectional satisfaction survey distributed to patients currently enrolled in the anticoagulation clinic, and results of a cross-sectional provider satisfaction survey distributed to medical and ancillary staff of the physician office. Data for the descriptive report came from a retrospective review of medical records of patients served by the anticoagulation clinic conducted in July 2002.
Anticoagulation Case M anagem ent Service Description The anticoagulation service was initiated in July 1998 as a pilot program between the University of Iowa College of Pharmacy and the Mt. Vernon Family Practice. The service is housed in the physician office in Mt. Vernon, Iowa (population 3,390). The family practice has five physicians and one physician assistant on staff, and gets approximately 20,000 patient visits per year. As part of the Iowa Health Physicians network, a nonprofit, 200-member primary care physician group practice serving 400,000 patients from 30 locations in central, eastern, and northeastern Iowa, the office serves the Mt. Vernon and surrounding rural areas. Anticoagulation case management services are performed by a clinical pharmacist (MEE) who is a board-certified pharmacotherapy specialist and faculty member at the University of Iowa College of Pharmacy. The services, as described in this report, are limited to ambulatory outpatients receiving warfarin (Coumadin— Bristol-Myers Squibb) therapy who are regular patients of the physician office. Medical oversight for the anticoagulation services is provided by the anticoagulation clinic medical director (KBB) and the other clinic providers. Patients are referred for anticoagulation services by their primary provider. A standard written referral form outlines the indica-
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tion for therapy, expected duration of therapy, and goal INR. The clinical pharmacist, assisted by a pharmacy student or clinical pharmacy resident, provides on-site services 1 day per week. Anticoagulation monitoring is performed using the CoaguCheck (Boehringer Mannheim) monitor, a whole-blood capillary POC testing device. Services provided directly by the clinical pharmacist include the testing itself, interpretation of the result, dosing adjustments, and scheduling/coordination of follow-up. A written protocol, reviewed annually and signed by the providers in the office, describes clinic procedures. When patients cannot be seen on the day the clinical pharmacist is on site, or when they have an appointment with their physician on any day during the week they are due for an INR assessment, a laboratory nurse performs INR testing using the POC machine. The result is then either interpreted by the physician seeing the patient that day or called into the clinical pharmacist for dosing and follow-up instructions. The POC method of INR determination was selected to facilitate patient convenience and improve response time. Since the clinic serves predominantly rural patients, who often spend significant time traveling to and from the clinic, real-time access to laboratory values was considered important for ensuring compliance with visits and for making timely dose adjustments. In addition, the office does not have a full-service medical laboratory with capabilities of running the INR via traditional venipuncture methods. To obtain INR results from a venipuncture in the clinic, blood must be sent out by courier to a medical laboratory approximately 30 miles away, and the results are not reported until the following morning. For safety reasons, and as part of the anticoagulation clinic protocol, INRs above 4.5 on the POC machine are verified by venipuncture, since evidence exists that the accuracy of POC prothrombin time testing devices declines with INRs above approximately 4.5.14,15 Billing procedures for the anticoagulation case management service follow Medicare incident-to guidelines, with the clinical pharmacist treated as a contracted employee of the clinic. The professional fee for anticoagulation visits is coded as 99211, and a laboratory draw fee is assessed. The visit is documented in the patient’s chart using a flowsheet and a standardized form cosigned after each visit by the primary provider. A physician is on site at all times for consultation in difficult cases and should patients require immediate medical attention.
Assessm ent of Therapeutic Outcom es Descriptive information on outcomes for anticoagulation clinic patients was manually abstracted from the medical charts in a retrospective manner. Patients were included in the descriptive analysis if they had continuous follow-up in the anticoagulation clinic (defined as a minimum duration of at least 1 month of follow-up), or if they had intermittent follow-up (defined as having at least one INR assessment performed in the clinic every 8 weeks for 3 successive months). Patients were included if they met these criteria
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at any time during the 4 years of the clinic’s existence. Patients were excluded from the analysis if they were taking warfarin and received their primary care and had INR assessments performed in the office but had their warfarin doses managed by a specialist (e.g., cardiologist) from an outside clinic. For each eligible patient, we collected information on total number of INRs obtained while he or she was being followed in the anticoagulation clinic, total number of INRs obtained for 1 year before enrollment in the clinic (if the patient was on warfarin prior to being enrolled), number of INRs in the therapeutic range (strictly within the goal range of 2.0 to 3.0 or 2.5 to 3.5, as this was considered the most conservative approach), number of INRs < 2.0, number of INRs > 5.0, and total number and type of bleeding events. Threshold levels of < 2.0 and > 5.0 were selected based on the rationale described by Chiquette et al.2 A “percent therapeutic” calculation was performed for each patient to determine the percentage of total INRs in the therapeutic range. Data for each patient were then combined and averaged to determine the percent therapeutic calculation for the entire group. Calculations were based on all INRs obtained during the period, even those obtained on days when the clinical pharmacist was unavailable and the physician had to interpret the INR and adjust doses; including these values was thought to produce the most conservative estimate. Furthermore, calculating the percent therapeutic in this manner (first calculating a mean percent for each patient then using these values to calculate a mean percent for the entire group) was felt to be a more conservative method than basing the calculation on total INRs therapeutic/total INRs obtained. If the latter method were used, a large number of easyto-manage patients with relatively stable INRs would have biased the calculation in favor of a higher percentage of patients with INRs within the therapeutic range. Our method was more sensitive to individual patient variation in the case of unstable patients. For comparison, anticoagulation data for 1 year prior to the start of the anticoagulation clinic were recorded for patients who were receiving warfarin before being enrolled into the clinic. These patients were defined as the usual medical care group. A paired t test was used to compare the percent therapeutic calculation between the usual medical care group and the anticoagulation clinic group. Information on bleeding events that occurred while the patient was under the care of the clinic was recorded according to the definitions by Chiquette et al.2 “Major” bleeding events were defined as those requiring hospitalization and transfusion of at least 2 units of blood or leading to cardiopulmonary arrest, surgical or angiographic intervention, irreversible sequelae, or death. “Significant” bleeding events were defined as those requiring evaluation or referral or being associated with a decrease of > 3% in the hematocrit or a decrease of > 1.2 gm/dL in the hemoglobin level. “Minor” bleeding events were defined as those that were of little or no clinical significance and that did not require referral or additional visits. Since information specifically related to anticoagulation care and INRs was not filed in a separate organized for-
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mat in the medical chart before the clinic opened, specific data on bleeding events that occurred before that time were not available for this analysis.
Assessm ent of Satisfaction Patient Satisfaction Survey
For purposes of quality improvement, a survey to assess patient satisfaction with anticoagulation services was developed by the clinical pharmacist and Iowa Health Physicians central office staff. The survey was based on a preexisting patient satisfaction survey developed by Iowa Health Physicians central administration that is automatically sent to each patient receiving care from the clinic after a scheduled office visit. Questions were modified or added as appropriate to make the survey specific to the anticoagulation clinic. The two-page survey was mailed from the Iowa Health Physicians central office to currently active patients enrolled in the anticoagulation clinic (n = 56). The survey presented 15 statements regarding satisfaction with the anticoagulation services provided, including, for example, satisfaction with the convenience of the clinic, time spent at each visit, and knowledge acquired during the visit. Patients used a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5) to respond to the statements. Responses were anonymously reported. The survey was sent out once; no follow-up was sent. A postage-paid return envelope was provided, and completed surveys were returned to the Iowa Health Physicians central office for collation and review. Provider Satisfaction Survey
A two-page provider satisfaction survey was developed and distributed by the clinic office manager to the medical, nursing, and administrative staff of the office (n = 30). The survey presented 18 statements regarding satisfaction with the anticoagulation services provided. Staff used a 5-point Likert scale ranging from strongly disagree (1) to strongly agree (5) to respond to the statements. Responses were anonymously reported. The survey was distributed only once.
Results Throughout the 4 years of follow-up, 98 unique patients had at least one INR determination performed by the clinical pharmacist. Of these patients, 80 met the criteria for evaluation (i.e., having received continuous or intermittent follow-up in the anticoagulation clinic). The 18 patients excluded from the analysis did not meet the minimum duration of follow-up. Typically, these were patients who had started warfarin within the last month, who had an INR test performed by the clinical pharmacist in the office but whose medication was actually adjusted by a specialist outside the
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Table 1. Demographics of and Descriptive Outcomes for the Anticoagulation Population (n = 80) Age, years Mean ± SD Range
75.6 ± 12.8 34–94
Women, no. (%)
44 (55.0)
On warfarin before establishing enrolling in anticoagulation clinic, no. (%)
61 (76.3)
Indication for anticoagulation, no. (%) Chronic atrial fibrillation Mechanical valve replacement Deep venous thrombsis/pulmonary embolism (acute or chronic) Other Anticoagulation outcomes % readings within range, b mean ± SD % readings < 2.0, mean ± SD % readings > 5.0, mean ± SD Major bleeding events, no. Significant bleeding events, no. Minor bleeding events, no. Ischemic events, no.
42 (52.5) 9 (11.3) 13 (16.3) 16 (20.0) Anticoagulation clinic (n = 80) 57.5 ± 12.8 c 23.3 ± 16.3 c 1.0 ± 1.9 1d 0 8 2e
Usual medical care a (n = 39) 37.6 ± 22.0 45.2 ± 27.0 2.1 ± 4.3 Unknown Unknown Unknown Unknown
SD = standard deviation. a Data were available for only 39 of the patients who had been receiving warfarin before the anticoagulation clinic opened. These patients constituted the usual medical care group. Data were reviewed for 1 year prior to their enrollment in the clinic. Data were not available on the remaining 22 patients who received warfarin before the clinic was started because these patients were initially followed by their specialist (e.g., cardiologist) outside the office before being transferred into the clinic. Records were not obtained fromthe specialists for review. b Only values that were strictly within the goal range of 2.0 to3.0 or 2.5 to 3.5 were considered therapeutic. c P < .001, compared with usual medical care. d This patient suffered a hemorrhagic stroke shortly after being discharged fromthe hospital after being treated for pneumonia; of note, the patient was not reentered into the anticoagulation service after discharge. e One patient suffered a stroke off warfarin therapy while hospitalized for gallbladder surgery and was not under the care of the anticoagulation service at the time of the stroke; the other patient was receiving warfarin for a history of transient ischemic attack (TIA)/stroke, and she experienced a TIA while subtherapeutic on her warfarin.
office (e.g., cardiologist), or who had started warfarin but either discontinued it or were transferred to a nursing home within the first month. The mean age of participants was 75.6 years (range, 34–94); 45% (n = 36) were men. Seventy-six percent of patients (n = 61) were on warfarin prior to being enrolled in the clinic. A slim majority (52.5%) of patients (n = 42) were on warfarin for the indication of chronic atrial fibrillation. A total of 2,710 INR determinations were performed for these patients during the 4 years of clinic operation. Table 1 summarizes the demographics of and descriptive outcomes for the anticoagulation population. The mean percentage of INRs within the therapeutic range for the entire population was 57.5% ± 17.4%. An average of 23.3% ± 16.3% of INRs were subtherapeutic (below the threshold value of 2.0 defined by Chiquette et al.2), while only 1% ± 1.9% of INRs were supratherapeutic (above the critical value of 5.0 defined by Chiquette et al.2). For the before-and-after comparison of patients who had been on warfarin before enrolling in the clinic, the percent therapeutic was 37.6% versus 57.8% (P < .001). Bleeding and ischemic events occurred rarely in the anticoagulation clinic group. Tables 2 and 3 show the responses to the patient and provider satisfaction surveys. The response rate was 91.1% (51 of 56) for
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the patient survey and 73.3% (22 of 30) for the provider survey. In nearly all instances, patient and provider satisfaction with the anticoagulation services was extremely high.
Discussion Taken as a whole, our experience indicates that anticoagulation therapy can be safely and effectively managed by a clinical pharmacist in a private physician office setting. Monitoring in this manner improves time in therapeutic range and reduces the number of INRs above and below critical threshold values. Patient safety does not appear compromised when a nonphysician oversees dosing adjustments and follow-up each time. Our results are consistent with previously published studies describing successful anticoagulation monitoring by clinical pharmacists in more populous settings.2,4,5,7–9,13 In the largest study of clinical pharmacist anticoagulation services to date, the percent time within range was 50.4% for the anticoagulation clinic group.2 Several explanations could account for the improved time in the therapeutic range observed in our clinic relative to the usual medical care. More time for patient counseling can lead to improved patient knowledge about how to correctly take medication and to
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Table 2. Results of the Patient Satisfaction Survey (n = 51) Statement
% Agree or Strongly Agree
1. The pharmacist is courteous and friendly.
100.0
2. W orking with the pharmacist has increased my knowledge about my specific condition and the reason for taking Coumadin.
94.1
3. After each appointment, I understand how to take my Coumadin.
98.0
4. The pharmacist is flexible about scheduling or rescheduling my appointments.
100.0
5. It is more convenient for me to get the results of my protime and dosing instructions right away.
100.0
6. The pharmacist spends enough time with me at each visit.
98.0
7. I am usually seen on time for my appointments.
98.0
8. I prefer having my blood checked using the fingerstick machine instead of drawing it out of my arm.
98.0
9. It is easy to schedule an appointment with the pharmacist for a protime.
100.0
10. If it was appropriate, I would recommend a friend/family member on Coumadin be seen by the pharmacist.
96.1
11. The pharmacist listens to my cares and concerns about Coumadin/protimes and his answers to my questions are helpful.
96.1
12. I feel confident that the pharmacist will work (or has worked in the past) with my doctor to resolve any problems that might come up. 13. Please rate your overall satisfaction with your Coumadin care.
96.0 100.0
14. W ere you on Coumadin before you started seeing the pharmacist for protimes?
Yes = 32 (62.7)
Additional questions asked only of the patients receiving anticoagulation therapy prior to being enrolled in the anticoagulation clinic (n = 32) 15. Compared to the old way, I would rate my Coumadin/protime care with the pharmacist as much better. 16. Compared to before, I feel safer about taking Coumadin.
better adherence. Also, a more structured review of medication regimens can help identify potential drug–drug interactions and suggest alternatives. Improved continuity of follow-up helps ensure that patients have regular office visits not only for anticoagulation but their other medical problems as well. Lastly, coordinating care and having the clinical pharmacist provide the service on site in the physician office affords opportunities to discuss difficult cases and communicate about medical care of the patient, which may influence selection of pharmacotherapeutic regimens less prone to interfere with warfarin therapy. Importantly, clinic patients were very supportive of the services. Based on the survey responses, this was probably influenced by the convenience of the POC method, the short turnaround time for results, and the one-on-one attention provided by clinic staff. The improved continuity of care likely enhances patient adherence to prescribed therapies. The providers also expressed support for the anticoagulation service. It appeared to reduce their time spent dealing with questions related to anticoagulation, and they believed it improved continuity of follow-up. While the limitations of this type of research are discussed below, several strengths are worth noting. First, we used the most conservative estimate of percent therapeutic by categorizing only those INR values in the exact range (i.e., 2.0–3.0 or 2.5–3.5) as therapeutic. This probably explains the overly high percentage (23.3%) of subtherapeutic values, since this categorization method would result in INR values of 1.8 to 1.9 (for goal 2.0–3.0) and 2.3
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Yes = 29 (90.6) 21 (67.7)
to 2.4 (for goal 2.5–3.5) being recorded as subtherapeutic. Many clinicians would argue that occasional values such as those are not important enough to require a change in maintenance dose if the patient is otherwise stable and INRs are therapeutic on the same dose at previous measurements. Yet, even after using a conservative method to calculate the percent of values as therapeutic, a significant difference was observed between the clinic patients and patients receiving usual medical care. Second, our data collection and reporting represents a real-world strategy that could be used in most private physician practices. We made use of simple beforeand-after comparisons. It would be quite difficult to perform a more rigorous, systematic comparison between usual medical care and case management in this type of setting. It is also important to note that this is the first report to describe and evaluate anticoagulation case management performed by a clinical pharmacist in a private physician office. Although the sample was small, the therapeutic outcomes were consistent with those observed in larger settings, such as health maintenance organizations and large hospital practices. If similar programs were established across the country in private offices, and our results extrapolated to the number of patients that could be affected by such a service, it is clear that the safety and efficacy of anticoagulation therapies could be improved significantly. And although our service embodies a unique relationship between a college of pharmacy and a private physician office, a similar model using community pharmacies to perform INR testing and dose adjustment has been previously described.16 Future research should investi-
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Table 3. Results of the Provider Satisfaction Survey (n = 22) Statement
% Agree or Strongly Agree
1. Since starting the anticoagulation clinic, the number of phone calls from patients with questions about anticoagulation has decreased.
63.6
2. The anticoagulation clinic is convenient for patients and staff.
90.9
3. The anticoagulation clinic provides increased safety and efficacy for patients.
95.5
4. Patients like having their protimes handled through the anticoagulation clinic.
95.5
5. The anticoagulation clinic provides better continuity of care for dealing with protimes.
100.0
6. The anticoagulation clinic runs efficiently.
100.0
7. Compared to other doctor’s offices I’ve worked in, the anticoagulation clinic is a definite enhancement to the clinic’s services.
66.7
8. Patients speak highly of the services provided in the anticoagulation clinic.
100.0
9. Since starting the anticoagulation clinic, the time I spend dealing with protimes/questions has decreased.
100.0
10. The anticoagulation clinic frees up my time to be able to take care of more patients, rather than having to deal with protimes. 11. Having on-site results and interpretation of protimes provides a greater margin ofsafety to patients.
92.9 100.0
12. I am confident my patients’ anticoagulation needs are taken care of in the anticoagulation clinic.
92.9
13. Since starting the anticoagulation clinic, problems related to anticoagulation have decreased.
71.4
14. Since starting the anticoagulation clinic, patients’ protimes are better controlled.
71.4
15. Having the anticoagulation clinic provides additional value to our patient care services.
100.0
16. I prefer to have my anticoagulation patients handled through the anticoagulation clinic.
92.9
gate the potential physical, legal, professional, and financial obstacles to systematically providing such services directly in private physician offices on a broader scale.
elderly, rural patients in Iowa, the sort of group that, in the experience of the authors, tends to be more compliant than other groups of patients.
Limitations
Conclusion
A number of limitations regarding our results need to be recognized. Most importantly, it is unknown whether the improved time in therapeutic range actually resulted in fewer bleeding and/or ischemic events, since no data on bleeding events among usual medical care patients were available for comparison. Thus, the question of whether anticoagulation case management by pharmacists improves morbidity and mortality remains unanswered. Anecdotally, there appeared to be no increase in bleeding or ischemic events, and none of the physicians could remember a clinic patient dying or being hospitalized for complications related to warfarin therapy between 1998 and 2002. Many of the patients were already on warfarin before the anticoagulation service was established. It is possible that their dose requirements had been previously determined and that their knowledge and experience taking warfarin resulted in improved time in therapeutic range once they enrolled in the clinic. This is unlikely, however, given the significantly fewer therapeutic INRs observed for patients receiving usual medical care. The overall numbers served by the clinic are small in comparison with larger institutions, and only one clinician provided the services, making it possible to generalize the results only to small, private practice offices. Lastly, the clinic serves predominantly
A clinical pharmacist can provide anticoagulation case management services safely and effectively in a private physician office, as indicated by the high degree of therapeutic INRs and few adverse events observed in our experience. The service is highly valued by both patients and other health care providers in the clinic. We believe that the innovative practice and teaching experience described in this report represents a mutually beneficial relationship between rural private practice and academia, one that ultimately benefits patients.
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The authors declare no conflicts of interest or financial interests in any product or service mentioned in this article, including grants, employment, gifts, stock holdings, or honoraria. The authors thank the staff of Iowa Health Physicians–Mt. Vernon Family Practice for their generous support in helping make this program possible.
References 1. Ansell J, Hirsh J, Dalen J, et al. Managing oral anticoagulant therapy. Chest. 2001;119(suppl):22S–38S. 2. Chiquette E, Amato MG, Bussey HI. Comparison of an anticoagulation clinic with usual medical care. Arch Intern Med. 1998;158:1641–7. 3. Gassmann A, Gameraos V, Bingham K, et al. Cardiology nurse-directed outpatient anticoagulation. Circulation. 1978;58(suppl 2):123.
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4. Conte RR, Kehoe WA, Nielson N, et al. Nine-year experience with a pharmacist-managed anticoagulation clinic. Am J Hosp Pharm. 1986;43:1460–4. 5. Bussey HI, Rospond RM, Quandt CM, Clark GM. The safety and effectiveness of long-term warfarin therapy in an anticoagulation clinic. Pharmacotherapy. 1989;9:214–9. 6. Seabrook GR, Karp D, Schmitt DD, et al. An outpatient anticoagulation protocol managed by a vascular nurse—clinician. Am J Surg. 1990;160:501–4. 7. Cohen IR, Hutchinson TA, Kirking DM, Shue ME. Evaluation of a pharmacist-managed anticoagulation clinic. J Hosp Pharm. 1985;10:167–75. 8. Garabedian-Ruffalo SM, Gray DR, Sax MJ, Ruffalo RL. Retrospective evaluation of a pharmacist-managed warfarin anticoagulation clinic. Am J Hosp Pharm. 1985;42:304–5. 9. Gray DR, Garabedian-Ruffalo SM, Chretien SD. Cost-justification of a clinical pharmacist-managed anticoagulation clinic. Drug Intell Clin Pharm. 1985;19:575–80. 10. Hamilton GM, Childers RW, Silverstein MD. Does clinic management of anticoagulation improve the outcome of prosthetic valve patients? [abstract]. Clin Res. 1985;3:832A.
P H A R M A CY
11. Pell JP, McIver B, Stuart P, Malone DNS, Alcock J. Comparison of anticoagulant control among patients attending general practice and a hospital anticoagulant clinic. Br J Gen Pract. 1993;43:152–4. 12. Cortelazzo S, Finazzi P, Viero P, et al. Thrombotic and hemorrhagic complications in patients with mechanical heart valve prosthesis attending an anticoagulation clinic. Thromb Haemost. 1993;69:316–20. 13. Wilt VM, Gums JG, Ahmed OI, Moore LM. Pharmacy operated anticoagulation service: improved outcomes in patients on warfarin. Pharmacotherapy. 1995;15:732–9. 14. McCurdy SA, White RH. Accuracy and precision of a portable anticoagulation monitor in a clinical setting. Arch Intern Med. 1992;152:589–92. 15. Tripodi A, Arbini AA, Chantarangkul V, et al. Are capillary whole blood coagulation monitors suitable for the control of oral anticoagulant treatment by the international normalized ratio? Thromb Haemost. 1993;70:921–4. 16. Knowlton CH, Thomas OV, Williamson A, et al. Establishing community pharmacy-based anticoagulation education and monitoring programs. J Am Pharm Assoc. 1999;39:368–74.
T H R O U GH T H E A GES
The Grand Triumvirate at an Early APhA Conference This photograph, dated 1916, shows three of the most influential and versatile American pharmacists of the period together at the American Pharmaceutical Association’s (APhA) annual meeting in Atlantic City. Each of them was a leader in science, education, literature, and the practice of pharmacy. C. Lewis Diehl was a German-born American pharmacist who was involved in many phases of practice. Perhaps his greatest contributions were the Reports on The Progress of Pharmacy. Each year, he gathered information on advances in pharmacy from Europe and America and distilled it into his official Reports, which were published as an integral part of the Proceedings of the American Pharmaceutical Association for nearly 40 years. These extensive reports frequently comprised several hundred pages of small type in the Proceedings. Joseph P. Remington was an early graduate of the Philadelphia College of Pharmacy and worked for a period with E.R. Squibb and Powers and Weightman before purchasing a pharmacy. He returned to his alma mater as a teacher in 1871 and became its dean in 1893. Remington served in a number of roles with the United States Pharmacopoeia (USP) from the 1880s until his death in 1918. He published the first edition of Remington’s Practice of Pharmacy in 1885. Upon his death, the APhA New York branch created the Remington Honor Medal, the highest professional accolade in American pharmacy. John Uri Lloyd served pharmacy with distinction as a researcher, publisher, and manufacturer. He served as APhA president in 1887/88. In 1920 he became the second recipient of the Remington Medal. Dennis B. Worthen, PhD, Lloyd Scholar, Lloyd Library and Museum, Cincinnati, Ohio. Photograph published with permission of the Lloyd Library and Museum.
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