PATTERN OF SUSPECTED ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL- A CROSS SECTIONAL STUDY

  • DR LIMA K M Assistant Professor of Pharmacology
  • DR DHANYA T H Assistant Professor of Pharmacology
  • DR SANALKUMAR K B Professor and HOD Pharmacology

Abstract

 


 


Abstract


Objective: To study the pattern of suspected adverse drug reactions (ADRs) in a tertiary care hospital.


Methods: This is a Cross sectional study conducted in the Department of Pharmacology of a tertiary care teaching hospital, Kerala. As part of Pharmacovigilance activities, the adverse drug reactions were collected inCentral Drug Standard Control Organization (CDSCO) Suspected ADR reporting form fromvarious departments during a period of 3 months and recorded in Pharmacovigilance register maintained by the Pharmacology department. As part of our study, we collected the details like patient’s initials, age, gender, reporting department of hospital, description of the ADR, duration of the reaction, name of suspected adverse drug reactionand outcome from the Pharmacovigilance register.Descriptive statistics will be used for data analysis by statistical package for the social science for windows 16.


Results: Two hundred and twenty-two ADR from 141 patients obtained during a period of 3 months.The maximum ADR reports were in more than 50 years of age. The skin and appendages were most affected followed by gastrointestinal tract.  Antineoplastic drugs accounted for 59.7% of drug class suspected for ADRs followed by  use of more than one drug (14.1%). Among antineoplastic drugs, cyclophosphamide and carboplatin accounted for majority causes of ADR. The antibiotics accounted for 12.7% of all drugs. Among the antibiotics Penicillin and Cephalosporins caused most of the ADRs.


Conclusion: The maximum number of ADR reported in our study was with the use of Antineoplastic drugs and most common ADR reported was alopecia.


Keywords: Adverse drug reactions, Pharmacovigilance, Antineoplastic drugs


 


 


 

Keywords: Adverse drug reactions, Pharmacovigilance, Antineoplastic drugs

Author Biographies

DR LIMA K M, Assistant Professor of Pharmacology

Assistant Professor of Pharmacology

Government Medical College, Thrissur, Kerala

DR DHANYA T H, Assistant Professor of Pharmacology

Assistant Professor of Pharmacology

Govt Medical College Thrissur

DR SANALKUMAR K B , Professor and HOD Pharmacology

Professor and HOD Pharmacology

Government Medical College Manjeri, Kerala

References

REFERENCES
1. World Health Organization for International Drug Monitoring. Glossary of Terms Used in Pharmacovigilance. Sweden: Uppsala Monitoring Centre; 2015. Available from: http:// www.who-umc.org/graphics/28401.pdf. [Last cited on 2016 Aug 06].
2. Pirmohamed M, Breckenridge AM, Kitteringham NR, Park BK. Adverse drug reactions. BMJ. 1998;316(7140):1295-8.
3. Kharb P, Mittal N, Gupta MC. An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance program of India in a tertiary care hospital of Haryana. International Journal of Basic & Clinical Pharmacology. 2017 Jan 18;4(3):556–60.
4. Rehman S, Qadrie Z L and Wafai Z A. Risk evaluation in routine Pharmacovigilance activities in SKIMS: Analysis of 3 year data. IJPR. 2015; 5(3): 69-74.
5. Joseph S G, Badyal D K. Spontaneous Adverse drug reaction monitoring in a tertiary care hospital in Northern India. JK science. 2016; 18(2): 103-106.
6. Pradeep S, Jitha S. Study on the adverse drug reactions in patients at a tertiary care centre. Int J Med Pharm Sci. 2015;5(9):1-7.
7. Dilip C, Lisa MM, Saraswathi R, Divya R. Adverse drug reaction monitoring in a tertiary level referral hospital, Kerala. Indian J Pharm Pract. 2012;5(2):28-32.
8. Pradeep S, Jitha S. Study on the adverse drug reactions in patients at a tertiary care centre. Int J Med Pharm Sci. 2015;5(9):1-7.
9. Kumar VR, Ram VR, Prasad BG, Mohanta GP, Manna PK. A study of adverse drug reactions due to antihypertensive drugs in a tertiary care teaching hospital. Int J Pharm Life Sci. 2011;2(5):767-72.
10. Gray SL, Mahoney JE, Blough DK. Adverse drug events in elderly patients receiving home health services following hospital discharge. Ann Pharmacother. 1999;33(11):1147-53.
11. Shet A, Antony J, Arumugam K, Kumar Dodderi S, Rodrigues R, DeCosta A.Influence of adverse drug reactions on treatment success: Prospective cohort analysis of HIV-infected individuals initiating first-line antiretroviral therapy in India. PLoS One. 2014;9(3):e91028.
12. Alomar MJ. Factors affecting the development of adverse drug reactions. Saudi Pharm J. 2014;22(2):83-94.
13. Lihite RJ, Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M, et al. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexandria Journal of Medicine. 2017 Jun 1; 53(2):151–6.
14. Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2008 Feb; 65(2): 210–216.
15. SasidharanPalappallil D, Nathan Ramnath S, Gangadhar R. Adverse drug reactions: Two years’ experience from a tertiary teaching hospital in Kerala. National Journal of Physiology Pharmacy and Pharmacology. 2017 Jan 7; 7: 403–11.
16. Pramod Kumar Sharma, Arup Kumar Misra, Ajay Gupta, Surjit Singh, Puneet Dhamija, Puneet Pareek. A retrospective analysis of reporting of adverse drug reactions to oncology drugs: An experience from a national center of clinical excellence
Statistics
7 Views | Downloads
How to Cite
KORUTHARA1. L. K. M., DR DHANYA T H, and DR SANALKUMAR K B. “PATTERN OF SUSPECTED ADVERSE DRUG REACTIONS IN A TERTIARY CARE HOSPITAL- A CROSS SECTIONAL STUDY”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 14, no. 2, Jan. 2021, https://innovareacademics.in/journals/index.php/ajpcr/article/view/40161.
Section
Original Article(s)