Special Issue "Drug Safety and Pharmacovigilance"

Guest Editor
Dr. Tomomi Kimura
Head of Epidemiology, Janssen Pharmaceutical K.K., 5-2, Nishi-kanda 3-chome, Chiyoda-ku, Tokyo 101-0065, Japan
E-Mail: tkimura1@its.jnj.com
Phone: +81 3 4411 5958
Interests: clinical epidemiology; database research; ethnic sensitivities

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• pharmacovigilance
• drug safety
• active surveillance
• signal detection
• pharmacoepidemiology
• database
• algorithm
• validation
• outcomes

Type of Paper: Article
Title: Safety of Oral Anticoagulant Therapy in Primary Care
Authors: Jacob Dreiher, Mira Maram-Edry, Ranit Djerassi, et al.
Affiliation : Clalit Health Services, Tel Aviv, Israel
Abstract: Background: Oral anticoagulants are associated with a high rate of complications. The study's goal was to assess the quality of follow-up and control of patients treated with oral anticoagulants. Methods: The study was conducted in Clalit Health Services, the largest health care provider organization in Israel. All adult patients receiving oral anticoagulant medications for at least 6 months in 2009 were included. Data regarding timing and results of INR tests, demographics, chronic diagnoses and indications for therapy were collected. Outcomes included irregular INR testing, irregular INR testing following abnormal results and poorly controlled INR. Results: 25,557 patients treated with oral anticoagulants who underwent 387,487 INR tests were included (mean age: 72 ± 13, 49% males). 64% of results were within the desired range (2-4), 32% were lower than 2 and 4% were higher than 4. Only 21% of patients were regularly tested. In a multivariate analysis, lack of regular INR testing was associated with younger age, male gender and obesity. A high number of providers, chronic renal failure, history of pulmonary embolism and hypothyroidism were associated with better follow-up. Only 66% of patients experiencing an INR above 5 performed an INR test within 1 week. Only 42% of patients experiencing an INR below 1.5 performed an INR test within 2 weeks. 35% had poorly controlled INR (<50% of results in therapeutic INR range 2-4). Poor INR control was associated with age <60 years or >80 years, female gender, congestive heart failure, COPD, dementia, diabetes, history of pulmonary embolism and irregular INR testing. Valvular heart disease was associated with better control. Conclusions: Follow-up and control of patients taking oral coagulants is far from being optimal. Implementing a multifaceted intervention and utilizing clinical quality indicators to monitor improvement could lead to better follow-up and control of these patients.