Spontaneous Adverse Drug Reaction Monitoring in a Tertiary Care Centre

Author(s): Kirandeep Kaur, Preet Kanwal, Pardeep Goyal, Paramjit Singh, Sahil Yakhmi, Samriti Jain, Sandeep Kaushal*

Journal Name: Current Drug Safety

Volume 15 , Issue 3 , 2020


Become EABM
Become Reviewer
Call for Editor

Graphical Abstract:


Abstract:

Background and Objective: Adverse drug reactions (ADRs) are associated with increased economic burden on the society. Monitoring of ADRs can help in decreasing the incidence of preventable adverse reactions.

Methods: Under Pharmacovigilance Program of India, collection and reporting of ADRs has been going on at Dayanand Medical College and Hospital since January 2011. Here, we have analyzed the individual case safety reports (ICSRs) reported and uploaded between January 2017 and June 2019 from our centre. The ADR form provided by PvPI was used for collecting information, and the causality assessment was done according to the WHO-UMC scale.

Results: A total of 498 ICSRs were uploaded through Vigiflow software during this period. Highest number of ADRs were recorded in the age group of 31-45 years (29.01%) and the least number of ADRs were recorded in the children less than 15 years of age (6.76%). General Medicine ward reported the highest number of ADRs and the antibiotics were most commonly associated with ADRs (26.21%), followed by antipsychotics (13.83%) and NSAIDs (12.14%). More than 90% of ADRs were non-serious (93.17%) and most of the ADRs were skin and soft tissue related (49.20%).

Conclusion: Spontaneous reporting among indoor patients shows highest number of ADRs with use of antibiotics and almost all of the ADRs were non-serious in nature. Almost half of the total ADRs were skin and subcutaneous tissue related. Continuous efforts are required for further strengthening of the pharmacovigilance program of India.

Keywords: Adverse drug reaction, pharmacovigilance, causality assessment, antibiotics, vigiflow, medical.

[1]
WHO. WHO | Pharmacovigilance In: WHO. World Health Organization 2015. Available from: https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/ [cited 16 Oct 2019]. Available:
[2]
Desai CK, Iyer G, Panchal J, Shah S, Dikshit RK. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting among prescribers at a tertiary care hospital. Perspect Clin Res 2011; 2(4): 129-36.
[http://dx.doi.org/10.4103/2229-3485.86883] [PMID: 22145123]
[3]
UMC The story of UMC and the WHO Programme ; [cited 16 Oct 2019] Available: 2019.https://www.who-umc.org/global-pharmacovigilance/who-programme/the-story-of-umc-and-the-who-programme/
[4]
WHO. WHO | adverse drug reactions monitoring in: WHO. World Health Organization 2015; [cited 3 Oct 2019]. Available: 2015.https://www.who.int/medicines/areas/quality_safety/safety_efficacy/advdrugreactions/en/
[5]
Kalaiselvan V, Kumar P, Mishra P, Singh GN. System of adverse drug reactions reporting: What, where, how, and whom to report? Indian J Crit Care Med 2015; 19(9): 564-6.https://dx.doi.org/10.4103%2F0972-5229.164819
[PMID: 26430348 ]
[6]
Kalaiselvan V, Thota P, Singh GN. Pharmacovigilance Programme of India: recent developments and future perspectives. Indian J Pharmacol 2016; 48(6): 624-8.https://dx.doi.org/10.4103%2F0253-7613.194855
[PMID: 28066097]
[7]
Parathasarathy G, Harugeri A, Undela K. Pharmacovigilance research in india: a five-year literature review. Proc Indian Natl Sci Acad 2018; 84: 225-32.
[http://dx.doi.org/10.16943/PTINSA/2017/49230]
[8]
Suke SG, Kosta P, Negi H. Role of pharmacovigilance in India: an overview. Online J Public Health Inform 2015; 7(2)e223
[http://dx.doi.org/10.5210/ojphi.v7i2.5595] [PMID: 26392851]
[9]
Oosterhuis I, Taavola H, Tregunno PM, et al. Characteristics, quality and contribution to signal detection of spontaneous reports of adverse drug reactions via the WEB-RADR mobile application: a descriptive cross-sectional study. Drug Saf 2018; 41(10): 969-78.
[http://dx.doi.org/10.1007/s40264-018-0679-6] [PMID: 29761281]
[10]
Thota P, Thota A, Medhi B, et al. Drug safety alerts of pharmacovigilance programme of India: a scope for targeted spontaneous reporting in India. Perspect Clin Res 2018; 9(1): 51-5.
[http://dx.doi.org/10.4103/picr.PICR_29_17] [PMID: 29430420]
[11]
Commission IP suspected adverse drug reaction reporting form Indian pharmacopoeia commission. Avaiable from: http://ipc.nic.in/writereaddata/mainlinkFile/File416.pdf
[12]
Edwards IR, Aronson JK. Adverse drug reactions: definitions, diagnosis, and management. Lancet 2000; 356(9237): 1255-9.
[http://dx.doi.org/10.1016/S0140-6736(00)02799-9] [PMID: 11072960]
[14]
Peter JV, Varghese GH, Alexander H, et al. Patterns of adverse drug reaction in the medical wards of a teaching hospital: a prospective observational cohort study. Curr Drug Saf 2016; 11(2): 164-71.
[http://dx.doi.org/10.2174/1574886311666160225150106] [PMID: 26916785]
[15]
Sengupta G, Bhowmick S, Hazra A, Datta A, Rahaman M. Adverse drug reaction monitoring in psychiatry out-patient department of an Indian teaching hospital. Indian J Pharmacol 2011; 43(1): 36-9.
[http://dx.doi.org/10.4103/0253-7613.75664] [PMID: 21455419]
[16]
Sen M, Singh A, Misra M. Retrospective analysis of adverse drug reactions reported at ADR monitoring centre under PvPI in a tertiary care hospital. Int J Basic Clin Pharmacol. Medip Academy 2018; 7: 303.
[http://dx.doi.org/10.18203/2319-2003.ijbcp20180103]
[17]
Geer MI, Koul PA, Tanki SA, Shah MY. Frequency, types, severity, preventability and costs of adverse drug reactions at a tertiary care hospital. J Pharmacol Toxicol Methods. Elsevier Inc 2016; 81: 323-4.
[http://dx.doi.org/10.1016/j.vascn.2016.04.011] [PMID: 27109493]
[18]
Gummadi T, Harave VS, Aiyar LN. RajaLekshmi SG, Kunnavil R. Adverse drug reaction monitoring in a tertiary care psychiatry setting: a comparative study between inpatients and outpatients. Indian J Psychol Med. Indian J Psychol Med 2017; 39(3): 306-11.
[http://dx.doi.org/10.4103/0253-7176.207328] [PMID: 28615765]
[19]
Lucca JM, Madhan R, Parthasarathi G, Ram D. Identification and management of adverse effects of antipsychotics in a tertiary care teaching hospital. J Res Pharm Pract 2014; 3(2): 46-50.
[http://dx.doi.org/10.4103/2279-042X.137063] [PMID: 25114936]
[20]
Singh P, Agrawal M, Hishikar R, Joshi U, Maheshwari B, Halwai A. Adverse drug reactions at adverse drug reaction monitoring center in Raipur: analysis of spontaneous reports during 1 year. Indian J Pharmacol 2017; 49(6): 432-7.
[http://dx.doi.org/10.4103/ijp.IJP_781_16] [PMID: 29674797]
[21]
Konda VCR, Pilla SSDD, Surekha A, Subash KR, Rao KU. Analysis of spontaneously reported cutaneous adverse drug reactions in a tertiary care teaching hospital in South India. Int J Basic Clin Pharmacol. Medip Academy 2018; 8: 27.
[http://dx.doi.org/10.18203/2319-2003.ijbcp20185085]
[22]
Vinutha S, Kamala K, Suresh N. A study of patterns of adverse drug reactions in a tertiary care hospital of Andhra Pradesh, India. Int J Basic Clin Pharmacol. Medip Academy 2019; 8: 860.
[http://dx.doi.org/10.18203/2319-2003.ijbcp20191542]
[23]
Padmavathi S, Manimekalai K, Ambujam S. Causality, severity and preventability assessment of adverse cutaneous drug reaction: a prospective observational study in a tertiary care hospital. J Clin Diagn Res 2013; 7(12): 2765-7.
[24]
Lahon K, Shetty HM, Paramel A, Sharma G. Adverse drug reaction monitoring of antipsychotics, antidepressants and mood stabilizers in the psychiatric outpatient unit of a teaching hospital - A retrospective study. Int J Pharma Bio Sci 2012; 2(3): 237-42.
[25]
Kaushik S, Chopra D, Sharma S, Aneja S. Adverse drug reactions of anti-epileptic drugs in children with epilepsy: a cross-sectional study. Curr Drug Saf 2019; 14(3): 217-24.
[http://dx.doi.org/10.2174/1574886314666190311112710] [PMID: 30854975]
[26]
Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol 2008; 65(2): 210-6.
[http://dx.doi.org/10.1111/j.1365-2125.2007.02993.x] [PMID: 17662089]


Rights & PermissionsPrintExport Cite as

Article Details

VOLUME: 15
ISSUE: 3
Year: 2020
Published on: 17 November, 2020
Page: [215 - 221]
Pages: 7
DOI: 10.2174/1574886315666200731172405
Price: $65

Article Metrics

PDF: 17
HTML: 1