Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital

Authors

  • Sugandha Kassere Department of Pharmacology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
  • Juhi Kalra Department of Pharmacology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
  • Anurag Rawat Department of Cardiology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India
  • Saurabh Kohli Department of Pharmacology, Himalayan Institute of Medical Sciences, Swami Rama Himalayan University, Dehradun, Uttarakhand, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20194794

Keywords:

ADRs, Anticoagulants, Cardiovascular disease, Pharmacovigilance

Abstract

Background: Cardiovascular diseases are one of the leading causes of morbidity and mortality worldwide. Anticoagulants are the most commonly implicated drugs, used in cardiology unit and they are responsible for a majority of adverse drug reactions (ADRs). The objective of the present study was to evaluate the pattern of ADRs reported with anticoagulant drugs used in the cardiology unit of a tertiary care hospital.

Methods: This observational prospective study was undertaken from September 2017 to August 2018. Causality assessment of ADRs was assessed using the WHO and Naranjo scale of probability. The severity was assessed by modified Hartwig and Siegel scale, and preventability of ADRs was assessed by Schumock and Thornton scale.

Results: Out of the total forty-one ADRs recorded, 40 (97.56%) were mild and 1 (2.44%) was reported as severe on the Hartwig and Siegel severity scale. Hematuria (68.29%) was the most common ADR followed by hemoptysis (14.63%). Among all anticoagulants, low molecular weight heparin was associated with the majority of ADRs (85.37%). The WHO causality and Naranjo Scale revealed that maximum of the ADRs (~80%) were possible. All ADRs reported was Type “A” reactions according to Wills and Brown classification of ADRs. Majority of ADRs (97.56%) were probably preventable.

Conclusions: In the present study, hematuria was the most common ADR reported. Among all anticoagulants, Low molecular weight heparin accounted for the majority of ADRs followed by acenocoumarol and heparin. Intensive monitoring and frequent reporting need to be done in cardiac units to improve patient safety.

References

World Health Organization. Safety of medicines-adverse drug reactions. 2018. Available at: https:// www.who.int/medicines/regulation/medicines-safety /M_SBN_Jun18.pdf. Assessed on 12 July 2019.

Gor A, Desai S. Adverse drug reactions (ADR) in the in patients of medicine department of a rural tertiary care teaching hospital and influence of pharmacovigilance in reporting ADR. Indian J Pharmacol. 2008;40(1):37-40.

Akalu S, Belavadi N. Pattern of adverse drug reaction to antiepileptic drugs in a tertiary care hospital. Int J Basic Clin Pharmacol. 2017;6(9):2219-23.

Sahu R, Yadav R, Prasad P, Roy A, Chandrakar S. Adverse drug reactions monitoring: prospects and impending challenges for pharmacovigilance. Springer Plus. 2014;3(1):695-8.

Chan S, Ang X, Sani L, Ng H, Winther M, Liu J, et al. Prevalence and characteristics of adverse drug reactions at admission to hospital: A prospective observational study. Br J Clin Pharmacol. 2016;82(6):1636-46.

Gholami K, Ziaie S, Shalviri G. Adverse drug reactions induced by cardiovascular drugs in outpatients. Pharm Pract. 2008;6(1):51-5.

Palaniappan M, Selvarajan S, George M, Subramaniyan G, Dkhar S, Pillai A, et al. Pattern of adverse drug reactions reported with cardiovascular drugs in a tertiary care teaching hospital. J Clin Diagn Res. 2015;9(11):1-4.

Buttar H, Li T, Ravi N. Prevention of cardiovascular diseases: Role of exercise, dietary interventions, obesity and smoking cessation. Exp Clin Cardiol. 2005;10(4):229-49.

Piazza G, Nguyen T, Cios D, Labreche M, Hohlfelder B, Fanikos J, et al. Anticoagulation-associated Adverse Drug Events. Am J Med. 2011;124(12):1136-42.

Tripathi K. Essentials of Medical Pharmacology. 8th ed. New Delhi: Jaypee Brothers Medical Publishers; 2018: 524-604.

Wills S, Brown D. A proposed new means of classifying adverse drug reactions to medicines. Pharm J. 1999;262:163-5.

The use of WHO UMC system for Standardized Case Causality assessment. Available at: http://www. who.int/medicines/areas/quality_safety/safety_efficacy/WHOcausality_assessment.pdf. Assessed on 10 August 2019.

Naranjo CA, Busto U, Sellers EM. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.

Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Schumock GT, Thornton JP. Focussing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27(6):538.

Wadhwa T, El Sheikh S, Rao PGM. Monitoring and reporting of adverse drug reactions due to cardiovascular drugs in patients admitted to a secondary care hospital in Northern Emirate- a prospective surveillance study. Indian J Pharm Pract. 2018;11(2):71-8.

Brahma D K, Wahlang JB, Sangma MC. Adverse drug reactions in the elderly. J Pharmacol Pharmacother. 2013;4(2):91-4.

Amalia L, Anggadireja K, Aprami T, Septiani V. Prevalence of adverse drug reactions in CAD STEMI patients treated in the cardiac intensive care unit at the public hospital in Bandung, Indonesia. Sci Pharm. 2016;84(1):167-79.

Antoniewicz AA, Zapała H, Poletajew Z, Borówka A. Macroscopic hematuria a leading urological problem in patients on anticoagulant therapy: is the common diagnostic standard still advisable? ISRN Urol. 2012:710-34.

Cestac P, Bagheri H, Lapeyre-Mestre M, Si P, Fouladi A, Maupas E, et al. Utilisation and safety of low molecular weight heparins. Drug Saf. 2003;26(3):197-207.

Indian Pharmacopoeia Commission. Guidance document for Spontaneous Adverse Drug Reaction Reporting. World Health Organization, 2019. Available at: http://apps.who.int/medicinedocs/documents/s23300en/s23300en.pdf. Assessed on 16 August 2019.

January CT, Wann LS, Calkins H, Chen LY, Cigarroa JE, Cleveland JS, et al. American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. 2019 AHA/ACC/HRS Focused Update of the 2014 Guideline for Management of Patients with Atrial Fibrillation. 2019. Available at: https://www.acc.org/~/media/Non-Clinical/Files-PDFs-Excel-MS-Word-etc/Guidelines/2019/2019-Afib-Guidelines-Made-Simple-Tool.pdf. Assessed on 7 August 2019.

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Published

2019-10-22

How to Cite

Kassere, S., Kalra, J., Rawat, A., & Kohli, S. (2019). Adverse drug reactions monitoring of anticoagulant drugs used in cardiac coronary care unit of a tertiary care hospital. International Journal of Basic & Clinical Pharmacology, 8(11), 2512–2516. https://doi.org/10.18203/2319-2003.ijbcp20194794

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Original Research Articles