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This study aims at evaluating the implementation of clinical-pharmacist-led anticoagulation stewardship program in Egyptian tertiary hospital to promote a culture of safety around anticoagulants.
One of the high-alert medication categories that may cause significant patient harm if not used correctly is anticoagulants. It is not clear if medication errors are more common with this category in specific compared to other medication categories, but the ramifications of a medication error with the use of anticoagulation agents is without a doubt detrimental to the patient's health and more serious than most of other drug categories.
This prospective study evaluates the impact of implementing an anticoagulation stewardship program, led by clinical pharmacists, on anticoagulation therapy outcomes during patient hospitalization by the percent of medication errors reduction, percent of adverse drug events reduction, and percent of evidence-based guidelines compliance improvement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre program implementation | No Intervention | All hospitalized patients on therapeutic anticoagulant medication during the pre-implementation period of the anticoagulation stewardship program. | |
| Post program implementation | Experimental | All hospitalized patients on therapeutic anticoagulant medication during the post-implementation period of the anticoagulation stewardship program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anticoagulation Stewardship Program | Other | A clinical-pharmacist led anticoagulation stewardship program that includes:
1c.Warfarin dosage adjustment algorithms. 1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants. 5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of medication errors change | Detect the medication error according to (National Coordinating Council for Medication Errors Reporting and Prevention NCC MERP) Index for Categorizing Medication Errors using NCC MERP Index for Categorizing Medication Errors Algorithm. | one year and half |
| percent of adverse drug events change | Detect bleeding and thrombotic-related adverse drug events | one year and half |
| Percent of evidence-based guidelines compliance improvement | Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy. | one year and half |
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Inclusion Criteria:
All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Pharmacy, Ain Shams University | Cairo | 11566 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19181332 | Background | Broussard M, Bass PF 3rd, Arnold CL, McLarty JW, Bocchini JA Jr. Preprinted order sets as a safety intervention in pediatric sedation. J Pediatr. 2009 Jun;154(6):865-8. doi: 10.1016/j.jpeds.2008.12.022. Epub 2009 Feb 1. | |
| 23417781 | Background | Burnett AE, Trujillo TC. The future of inpatient anticoagulation management. J Thromb Thrombolysis. 2013 Apr;35(3):375-86. doi: 10.1007/s11239-013-0892-1. |
| Label | URL |
|---|---|
| Institute for Safe Medication Practices. (2010). ISMP's Guidelines for Standard Order Sets. | View source |
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It is not clear according to the clinical research guidelines at Faculty of Pharmacy, Ain Shams University.
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| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Quasi experimental study (separate sample pre-test post-test design)
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|
| 27998897 | Background | Dreijer AR, Kruip MJ, Diepstraten J, Polinder S, Brouwer R, Leebeek FW, Vulto AG, van den Bemt PM. Antithrombotic stewardship: a multidisciplinary team approach towards improving antithrombotic therapy outcomes during and after hospitalisation: a study protocol. BMJ Open. 2016 Dec 20;6(12):e011537. doi: 10.1136/bmjopen-2016-011537. |
| 15325949 | Background | Fanikos J, Stapinski C, Koo S, Kucher N, Tsilimingras K, Goldhaber SZ. Medication errors associated with anticoagulant therapy in the hospital. Am J Cardiol. 2004 Aug 15;94(4):532-5. doi: 10.1016/j.amjcard.2004.04.075. |
| 22315264 | Background | Garcia DA, Baglin TP, Weitz JI, Samama MM. Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines. Chest. 2012 Feb;141(2 Suppl):e24S-e43S. doi: 10.1378/chest.11-2291. |
| 25825193 | Background | Goldspiel B, Hoffman JM, Griffith NL, Goodin S, DeChristoforo R, Montello CM, Chase JL, Bartel S, Patel JT. ASHP guidelines on preventing medication errors with chemotherapy and biotherapy. Am J Health Syst Pharm. 2015 Apr 15;72(8):e6-e35. doi: 10.2146/sp150001. No abstract available. |
| Background | Levinson, D. R., & General, I. (2010). Adverse events in hospitals: national incidence among Medicare beneficiaries. Department of Health and Human Services Office of the Inspector General. Retrieved from https://oig.hhs.gov/oei/reports/oei-06-09-00090.pdf |
| 25523529 | Background | Levy JH, Spyropoulos AC, Samama CM, Douketis J. Direct oral anticoagulants: new drugs and new concepts. JACC Cardiovasc Interv. 2014 Dec;7(12):1333-51. doi: 10.1016/j.jcin.2014.06.014. |
| Background | Lucado, J., Paez, K., & Elixhauser, A. (2010). Statistical brief# 109. Journal of General Internal Medicine, 25(1), 31-38. |
| 28508323 | Background | Lysogorski MC, Hassan AK, Lampkin SJ, Geisler R. The impact of pharmacy monitoring and intervention in patients receiving intravenous heparin. Int J Clin Pharm. 2017 Aug;39(4):844-850. doi: 10.1007/s11096-017-0482-y. Epub 2017 May 15. |
| 24326411 | Background | Padron M, Miyares MA. Development of an anticoagulation stewardship program at a large tertiary care academic institution. J Pharm Pract. 2015 Feb;28(1):93-8. doi: 10.1177/0897190013514091. Epub 2013 Dec 10. |
| 25669625 | Background | Reardon DP, Atay JK, Ashley SW, Churchill WW, Berliner N, Connors JM. Implementation of a Hemostatic and Antithrombotic Stewardship program. J Thromb Thrombolysis. 2015 Oct;40(3):379-82. doi: 10.1007/s11239-015-1189-3. |
| Background | Rose, A. (Ed.). (2015). Anticoagulation Management. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-22602-6 |
| 28484587 | Background | Sharma M, Krishnamurthy M, Snyder R, Mauro J. Reducing Error in Anticoagulant Dosing via Multidisciplinary Team Rounding at Point of Care. Clin Pract. 2017 Apr 20;7(2):953. doi: 10.4081/cp.2017.953. eCollection 2017 Apr 6. |
| Background | U.S. Department of Health and Human Services, Office of Disease Prevention and Health Promotion. (2014). Anticoagulants. In National Action Plan for Adverse Drug Event Prevention. |
| Background | World Health organization, W. H., & others. (2016). Medication Errors: Technical Series on Safer Primary Care ISBN 978-92-4-151164-3. Retrieved from http://apps.who.int/iris/bitstream/10665/252275/1/9789241511650-eng.pdf |
| 27878507 | Background | Wychowski MK, Ruscio CI, Kouides PA, Sham RL. The scope and value of an anticoagulation stewardship program at a community teaching hospital. J Thromb Thrombolysis. 2017 Apr;43(3):380-386. doi: 10.1007/s11239-016-1455-z. |
| Institute for Safe Medication Practices. (2014). ISMP list of High-Alert Medications | View source |
| Institute for Safe Medication Practices (ISMP) Monitoring FDA MedWatch Reports. (2015, September). Quarter Watch (Q 3-4) 2014. Institute for Safe Medication Practices (ISMP). | View source |
| Institute for Safe Medication Practices (ISMP) ,Quarter Watch (Q4): monitoring FDA MedWatch Reports. (2017, July). Quarter Watch Q4 2016. Retrieved July 13, 2017, from http://www.ismp.org/QuarterWatch/ | View source |
| NCCMERP. (2014, July 18). Types of Medication Errors \[Text\]. | View source |
| D001145 |
| Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |