Detecting adverse drug events with the use of Protamine as a trigger tool
Keywords:
Adverse drug event, Trigger tool, ProtamineAbstract
Objectives: To study results of the detection of adverse drug event (ADE) from anticoagulant therapy by applying protamine as a trigger tool and to identify causes of the ADEs classified as preventable.
Methods: A retrospective, observational study collected data from a medical record review of hospitalized patients receiving protamine prescriptions from January 2016 to December 2018 at a university hospital. Evaluators included a cardiologist and 3 pharmacists. Naranjo’s algorithm and Schumock and Thornton scale were selected as assessment tools for causality and preventability of the ADEs.
Results: The medical record review of 35 patients receiving protamine prescriptions revealed that a total number of 10 events of ADEs was detected (28.6%). Out of 10 events, 6 events were classified as preventable ADEs (60%). All events were categorized as Category E according to NCC MERP index (100%). The most common causative drug was enoxaparin (50%). Inappropriate dose was most frequently found to be the cause of the events (83.3%).
Conclusion: Applying protamine as a trigger tool enhanced the detection of ADEs in comparison with spontaneous ADE reporting alone which is a standard practice in hospital. The detected ADEs were not reported from the spontaneous reporting, and were mostly categorized as preventable ADEs. The most common cause of the ADEs was ascribed to the inappropriate dose of anticoagulants when being prescribed.
References
Griffin FA, Resar RK. IHI Global Trigger Tool for Measuring Adverse Events. 2nd ed. Cambridge, MA: Institute for Healthcare Improvement; 2009.
The healthcare accreditation institute (Public organization). Trigger tool measuring adverse drug event course (HA 608; 2013 Sep 19-20; Bangkok, Thailand). Bangkok; 2013.
Yotapitak J, Songsiripong R. Identifying adverse drug events using trigger tools. In: Suansanee T, Jindavijuk B. editors. The Important keys to be the hospital pharmacists’ professional. Bangkok: The association of hospital pharmacy (Thailand); 2009. p. 140-54.
Suksanan P. case study: Using kayexalate to identify hyperkalemia in hospitalized patients. In: Suansanee T, Jindavijuk B. The Important keys to be the hospital pharmacists’ professional. Bangkok: The association of hospital pharmacy (Thailand); 2009. p. 239.
Yeesoonpan N, Tragulpiankit P, Kaeratigachakorn W, Uaviseswong T, Ninsananda T, Chaikledkaew U, et al. Detecting Adverse Drug events by Trigger tool at a Provincial Hospital in Thailand. Thai Journal of Pharmacy Practice. 2015;7(2):234-49.
Protamine sulphate LEO Pharma [package insert]. Ballerup (Denmark): LEO Pharma A/S; 2013.
Lexicomp. Drug Information Handbook: A Clinically Relevant Resource for All Healthcare Professionals. 23rd ed. Hudson, Ohio: Lexi-Comp; 2014. p. 1741-42.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45. doi: 10.1038/clpt.1981.154.
Schumock GT, Thronton JP. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27(6):538.
NCC MERP. Contemporary View of Medication Related Harm. A New Paradigm [Internet]. n.p.: NCC MERP; 2015. [cited 2017 January 23]. Available from: http://www.nccmerp.org/sites/default/files/nccmerp_fact_sheet_2015-02-v91.pdf
Moscucci M, Fox KA, Cannon CP, Klein W, López-Sendón J, Montalescot G, et al. Predictors of major bleeding in acute coronary syndromes: the Global Registry of Acute Coronary Events (GRACE). Eur Heart J. 2003;24(20):1815-23. doi: 10.1016/s0195-668x(03)00485-8.
Hirsh J, Anand SS, Halperin JL, Fuster V. Guide to Anticoagulant Therapy: Heparin A Statement for Healthcare Professionals From the American Heart Association. Circulation. 2001;103(24):2994-3018. Available from: https://www.ahajournals.org/doi/full/10.1161/01.CIR.103.24.2994
Asavaroengchai S, Sriratanaban J, Hiransuthikul N, Supachutikul A. Identifying adverse events in hospitalized patients using global trigger tool in Thailand. Asian Biomed. 2009;3(5):545–50.
Meyer-Massetti C, Cheng CM, Schwappach DL, Paulsen L, Ide B, Meier CR, et al. Systematic review of medication safety assessment methods. Am J Health Syst Pharm. 2011;68(3):227-40. doi: 10.2146/ajhp100019.
Rozich JD, Haraden CR, Resar RK. Adverse drug event trigger tool: a practical methodology for measuring medication related harm. Qual Saf Health Care. 2003;12(3):194-200. doi: 10.1136/qhc.12.3.194.
Lim D, Melucci J, Rizer MK, Prier BE, Weber RJ. Detection of adverse drug events using an electronic trigger tool. Am J Health Syst Pharm. 2016;73(17 Suppl 4):S112-20. doi: 10.2146/ajhp150481.
Patregnani JT, Spaeder MC, Lemon V, Diab Y, Klugman D, Stockwell DC. Monitoring the harm associated with use of anticoagulants in pediatric populations through trigger-based automated adverse-event detection. Jt Comm J Qual Patient Saf. 2015;41(3):108-14. doi: 10.1016/s1553-7250(15)41015-3.
Melanson P. Management of post-op cardiac surgery patients [Internet]. Quebec: Critical Care Medicine. 2001 [cited 23 July 2019]. Available from: https://www.mcgill.ca/criticalcare/teaching/protocols/cardiac
Macie C, Forbes L, Foster GA, Douketis JD. Dosing practices and risk factors for bleeding in patients receiving enoxaparin for the treatment of an acute coronary syndrome. Chest. 2004;125(5):1616-21. doi: 10.1378/chest.125.5.1616.
Thammasitboon M. Study of Medication safety management for heparin infusion. Region 11 Medical Journal. 2016;30(2):83-96.
Hardmeier B, Braunschweig S, Cavallaro M, Roos M, Pauli – Magnus C, Giger M, et al. Adverse drug events caused by medication errors in medical inpatients. Swiss Med Wkly. 2004;134(45-46):664-70.
Rozenfeld S, Giordani F, Coelho S. Adverse drug events in hospital: pilot study with trigger tool. Rev Saúde Pública. 2013;47(6):1-9.
Saya FG, Coleman LT, Martinoff JT. Pharmacist-directed heparin therapy using a standard dosing and monitoring protocol. Am J Hosp Pharm. 1985;42(9):1965-9.
Lee T, Davis E, Kielly J. Clinical impact of a pharmacist-led inpatient anticoagulation service: a review of the literature. Integr Pharm Res Pract. 2016;5:53-63. doi: 10.2147/IPRP.S93312.
Downloads
Published
How to Cite
Issue
Section
License
Copyright (c) 2022 Nakornping Hospital
This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
The articles that had been published in the journal is copyright of Journal of Nakornping hospital, Chiang Mai.
Contents and comments in the articles in Journal of Nakornping hospital are at owner’s responsibilities that editor team may not totally agree with.
