Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program

Atrial Fibrillation Clinical Trial

Official title:

Implementation of Clinical Pharmacist-led Inpatient Anticoagulation Stewardship Program in An Egyptian Tertiary Care Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03812848
• Other study ID #: 165
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: June 5, 2022

Study information

• Verified date: September 2022
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 233
• Est. completion date: June 5, 2022
• Est. primary completion date: June 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

All hospitalized patients on therapeutic anticoagulant medication during their hospitalization period.

Exclusion Criteria:

1. Patients whose age is less than 18 years old.

2. Patients who were admitted for less than 24 hours for patient on parenteral anticoagulants and less than 48 hours for patient on warfarin.

3. Patients already admitted for bleeding or thrombosis.

4. Malignancy patients.

Related Conditions & MeSH terms

• Atrial Fibrillation
• Deep Vein Thrombosis
• Mitral Valve Disease
• Thrombosis
• Venous Thrombosis

Intervention

Other:
• Anticoagulation Stewardship Program
A clinical-pharmacist led anticoagulation stewardship program that includes: Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication. 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.

Locations

Country	Name	City	State
Egypt	Faculty of Pharmacy, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (17)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. Review. Erratum in: Chest. 2012 May;141(5):1369. Dosage error in article text. Chest. 2013 Aug;144(2):721. Dosage error in article text. — View Citation

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. — View Citation

Hug BL, Witkowski DJ, Sox CM, Keohane CA, Seger DL, Yoon C, Matheny ME, Bates DW. Adverse drug event rates in six community hospitals and the potential impact of computerized physician order entry for prevention. J Gen Intern Med. 2010 Jan;25(1):31-8. doi: 10.1007/s11606-009-1141-3. Epub 2009 Nov 6. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Rose, A. (Ed.). (2015). Anticoagulation Management. Cham: Springer International Publishing. https://doi.org/10.1007/978-3-319-22602-6

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. — View Citation

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.

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

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	percent of adverse drug events change	Detect bleeding and thrombotic-related adverse drug events	one year and half
Primary	Percent of evidence-based guidelines compliance improvement	Detect health care providers' adherence to evidence-based guidelines for anticoagulation therapy.	one year and half

External Links

•   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/
•   Institute for Safe Medication Practices (ISMP) Monitoring FDA MedWatch Reports. (2015, September). Quarter Watch (Q 3-4) 2014. Institute for Safe Medication Practices (ISMP).
•   Institute for Safe Medication Practices. (2010). ISMP's Guidelines for Standard Order Sets.
•   Institute for Safe Medication Practices. (2014). ISMP list of High-Alert Medications
•   NCCMERP. (2014, July 18). Types of Medication Errors [Text].