Outcomes, Health Policy, and Managed Care Is long-term pharmacist-managed anticoagulation service efficient? A pragmatic randomized controlled trial Lyne Lalonde, PhD, a, b, c Josée Martineau, MSc, BCPS, d Normand Blais, MD, FRCP(C), e Martine Montigny, MD, FRCP(C), d Jeffrey Ginsberg, MD, FRCP(C), f Martine Fournier, MSc, c Djamal Berbiche, PhD, c Marie-Claude Vanier, MSc, a, b, d Lucie Blais, PhD, a Sylvie Perreault, PhD, a and Isabel Rodrigues, MD, MPH d, g Montreal and Laval, Quebec and Hamilton, Ontario, Canada Background Some pharmacist-managed anticoagulation services (PMAS) provide initial follow-up to patients on oral anticoagulant, who are transferred to their physician once they are stabilized. This may be as effective as and less expensive than long-term PMAS follow-up. Methods Once PMAS patients were stabilized and ready for discharge, they were randomized to be transferred to their physician or stay with the PMAS. Quality of international normalized ratio (INR) control, incidence of complications, health-related quality of life, use of health care services, and direct incremental cost of PMAS follow-up were evaluated. Results One hundred thirty-eight physicians and 250 patients participated. Patients were initially followed at the PMAS for a mean of 11.3 weeks and afterwards were followed by their physician (n = 122) or by the PMAS pharmacists (n = 128) for a mean of 14.9 and 14.5 weeks, respectively. Pharmacist-managed anticoagulation services' and physician's patients were within the exact target range 77.3% and 76.7% of the time (95% CI of the difference -4.9% to 6.0%) and within the extended range 93.0% and 91.6% of the time (95% CI -2.1% to 4.7%), respectively. Pharmacist-managed anticoagulation services patients have seen their family physician less often (95% CI -3.1 to -0.1 visit per year). Number of INR tests, incidence of complications, and health-related quality of life were similar in both groups. The incremental cost of PMAS follow-up was estimated at CAN$123.80 per patient year. Conclusion Once PMAS patients are well stabilized, maintaining a PMAS follow-up or transferring them to their physician is associated with excellent INR control. However, long-term PMAS follow-up may be more expensive. (Am Heart J 2008;156:148-54.) Oral anticoagulants, such as the coumarin derivatives, are effective in preventing and treating a number of thromboembolic disorders. 1-3 Patients taking them should be closely monitored to maximize time spent within the international normalized ratio (INR) thera- peutic range. 4 To optimize follow-up, pharmacist-mana- ged anticoagulation services (PMAS) have been created in which pharmacists provide patient education and moni- toring of anticoagulation treatment. Observational studies underscore the superiority of PMAS over a less structured model of physician care in managing anticoagulated patients. 5-10 However, these results may be influenced by selection, information, and confounding biases. Two randomized controlled trials (RCT) suggest that PMAS follow-up may be associated with what is at best a modest improvement in the quality of INR control. 11,12 Because the risk of treatment complications is high and patients' monitoring is particularly intense during the first few weeks of treatment, some PMAS provide only initial follow-up, and patients are transferred to their primary- care physician once their INR values and dosing regiments are well stabilized. They may be referred back to the PMAS temporarily if they become unstable or From the a Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada, b Sanofi-Aventis Endowment Chair in Ambulatory Pharmaceutical Care, Faculty of Pharmacy, University of Montreal, Montreal, Quebec, Canada, c Research Team in Primary Care, Centre de santé et de services sociaux de Laval, Laval, Quebec, Canada, d Centre de santé et de services sociaux de Laval, Laval, Quebec, Canada, e Centre hospitalier de l'Université de Montréal, Hôpital Notre-Dame, Montreal, Quebec, Canada, f Department of Medicine, McMaster University, Hamilton, Ontario, Canada, and g Faculty of Medicine, University of Montreal, Montreal, Quebec, Canada. Randomized clinical trial registration number: ISRCTN76463647 (http://www.controlled- trials.com/ISRCTN76463647/anticoagulation). This project was made possible by research grants from the Canadian Institutes of Health Research and Taro Pharmaceuticals, Inc/Optima Pharma. Dr Lalonde is a scientist supported by the Fonds de la recherche en santé du Québec. Submitted November 2, 2007; accepted February 14, 2008. Reprint requests: Lyne Lalonde, PhD, Research Team in Primary Care, Hôpital de la Cité-de- la-Santé, Centre de santé et de services sociaux de Laval, 1755 René-Laennec Blvd., Room D-S145, Laval, Quebec, Canada H7M 3L9. E-mail: lyne.lalonde@umontreal.ca 0002-8703/$ - see front matter © 2008, Mosby, Inc. All rights reserved. doi:10.1016/j.ahj.2008.02.009