A 5 year retrospective analysis of adverse drug reactions associated with antimicrobials in a teaching hospital of Andaman and Nicobar islands

Authors

  • Mangesh Bankar Department of Pharmacology, Andaman and Nicobar Islands
  • Priyanka Pravinbhai Hotha Assistant Professor, University College of Medical Sciences, Delhi, India.
  • Nimisha Elezebeth Zachariah Pharmacovigilance associate, Department of Pharmacology, Andaman and Nicobar Islands Institute of Medical Sciences (ANIIMS), Port Blair, India

DOI:

https://doi.org/10.12928/pharmaciana.v11i3.20866

Keywords:

adverse drug reaction, antimicrobial drugs, pharmacovigilance, ceftriaxone

Abstract

Antimicrobials are used widely especially in developing countries, due to the high prevalence of various infectious diseases. Inappropriate use of antimicrobials are associated with adverse drug reactions. The present study was done to analyze the patterns of Adverse Drug Reactions (ADR) due to antimicrobials reported to Adverse Drug Reaction Monitoring Centre (AMC) during the last five years.  This was a 5 year retrospective and cross-sectional study. After collecting demographic details of patients, ADR forms, and ADR associated with the antimicrobial class of drugs, data were analyzed for further details. A total of 877 ADRs, 360 ADRs belonged to the antimicrobial group. When data was analyzed data, it revealed that the majority of ADRs (73.05%) were reported in the adult group, 75.27% of reactions belonged to A category, Ceftriaxone (17.2%) was the most common drug-associated with ADRs, majority of ADRs were related to skin (56.66%), rash (27.5%) was the most common ADR encountered with antimicrobial use, 73.61% reactions were non-serious, 69.44% of ADRs recovered, and 77.77% of ADRs were probable category. Ceftriaxone was responsible for the maximum number of ADRs. The study results provide information regarding the pattern of ADRs associated with antimicrobials, and this might be helpful for improving the awareness of healthcare providers about PvPI and subsequently increase the spontaneous reporting of ADRs.

References

Agrawal, V., Shrivastava, T., Adusumilli, P., Vivekanandan, K., Thota, P., & Bhushan, S. (2019). Pivotal role of pharmacovigilance programme of India in containment of antimicrobial resistance in India. Perspectives in Clinical Research, 10(3), 140. https://doi.org/10.4103/picr.PICR_29_18

Bansod, K., Bashir, M. M., & Ingle, S. (2020). Adverse drug reaction profile in Amravati region of India: A pharmacovigilance study. Journal of Pharmacy And Bioallied Sciences, 12(2), 155. https://doi.org/10.4103/jpbs.JPBS_226_19

Bhattacharjee, P., Vats, S., Das, L., Ghosh, R., & Bhattacharjee, S. (2019). Pattern of adverse drug reactions of antimicrobial agents in a tertiary care teaching hospital of tripura: A prospective study. International Journal of Contemporary Medical Research [IJCMR], 6(7). https://doi.org/10.21276/ijcmr.2019.6.7.38

Davies, E. C., Green, C. F., Taylor, S., Williamson, P. R., Mottram, D. R., & Pirmohamed, M. (2009). Adverse drug reactions in Hospital In-Patients: A prospective analysis of 3695 patient-episodes. PLoS ONE, 4(2), e4439. https://doi.org/10.1371/journal.pone.0004439

Dhar, K., Sinha, A., Gaur, P., Goel, R., Chopra, V. ., & Bajaj, U. (2015). Pattern of adverse drug reactions to antibiotics commonly prescribed in department of medicine and pediatrics in a tertiary care teaching hospital, Ghaziabad. Journal of Applied Pharmaceutical Science, 5((4)), 078–082. https://doi.org/10.7324/JAPS.2015.50413

Kalra, B., Sahni, P., Chawla, S., & Dharmshaktu, P. (2011). Adverse drug reaction monitoring in a tertiary care teaching hospital. Journal of Pharmacology and Pharmacotherapeutics, 2(3), 196. https://doi.org/10.4103/0976-500X.83291

Lihite, R. J., Lahkar, M., Das, S., Hazarika, D., Kotni, M., Maqbool, M., & Phukan, S. (2017). A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexandria Journal of Medicine, 53((2)), 151–156. https://doi.org/10.1016/j.ajme.2016.05.007

Lombardi, N., Crescioli, G., Bettiol, A., Marconi, E., Vitiello, A., Bonaiuti, R., Calvani, A. M., Masi, S., Lucenteforte, E., Mugelli, A., Giovannelli, L., & Vannacci, A. (2018). Characterization of serious adverse drug reactions as cause of emergency department visit in children: a 5-years active pharmacovigilance study. BMC Pharmacology and Toxicology, 19(1), 16. https://doi.org/10.1186/s40360-018-0207-4

Milind Pore, S., Ramchandra Burute, S., Dinkar Shinde, A., & Jaiprakash Ramanand, S. (2018). Pattern of adverse drug reactions reported with use of antimicrobial drugs in a tertiary care hospital. Journal of Young Pharmacists, 10(2), 213–217. https://doi.org/10.5530/jyp.2018.10.47

Patel, T., Thakkar, S., & Sharma, D. (2014). Cutaneous adverse drug reactions in Indian population: A systematic review. Indian Dermatology Online Journal, 5(6), 76. https://doi.org/10.4103/2229-5178.146165

Patil, S. B., Raikar, S. R., H N, B., Janardhan, M., Rao, Y. V., & V, V. (2016). A study of adverse drug reactions in patients treated with penicillins in a rural tertiary care hospital. International Journal of Pharmacology and Clinical Sciences, 5(2), 41–44. https://doi.org/10.5530/ijpcs.5.2.1

Raja, S., R, J. R., & P, K. (2017). Pattern of adverse drug reactions in a tertiary care teaching hospital: a cross-sectional study. Asian Journal of Pharmaceutical and Clinical Research, 10(3), 170. https://doi.org/10.22159/ajpcr.2017.v10i3.15972

Richa, Tandon, V., Sharma, S., Khajuria, V., Mahajan, V., & Gillani, Z. (2015). Adverse drug reactions profile of antimicrobials: A 3-year experience, from a tertiary care teaching hospital of India. Indian Journal of Medical Microbiology, 33(3), 393–400. https://doi.org/10.4103/0255-0857.158564

Saikia, N., Moradhvaj, & Bora, J. K. (2016). Gender denditure: evidence from India Human Development Survey. PLOS ONE, 11(7), e0158332. https://doi.org/10.1371/journal.pone.0158332

Shalviri, G., Yousefian, S., & Gholami, K. (2012). Adverse events induced by ceftriaxone: a 10-year review of reported cases to Iranian Pharmacovigilance Centre. Journal of Clinical Pharmacy and Therapeutics, 37(4), 448–451. https://doi.org/10.1111/j.1365-2710.2011.01321.x

Shamna, M., Dilip, C., Ajmal, M., Linu Mohan, P., Shinu, C., Jafer, C. P., & Mohammed, Y. (2014). A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharmaceutical Journal, 22(4), 303–308. https://doi.org/10.1016/j.jsps.2013.06.004

Sharma, R., Dogra, D., & Dogra, N. (2015). A study of cutaneous adverse drug reactions at a tertiary center in Jammu, India. Indian Dermatology Online Journal, 6(3), 168. https://doi.org/10.4103/2229-5178.156384

Singh, P., Agrawal, M., Hishikar, R., Joshi, U., Maheshwari, B., & Halwai, A. (2017). Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year. Indian Journal of Pharmacology, 49(6), 432. https://doi.org/10.4103/ijp.IJP_781_16

Venkatasubbaiah, M., Dwarakanadha Reddy, P., & Satyanarayana, S. V. (2018). Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alexandria Journal of Medicine, 54(4), 597–603. https://doi.org/10.1016/j.ajme.2018.10.005

Vijaishri, R., & Andhuvan, G. (2018). A Prospective Study on Antibiotics-associated Spontaneous Adverse Drug Reaction Monitoring and Reporting in a Tertiary Care Hospital. Asian Journal Of Pharmaceutics, 11((4, S)), S834--S840. https://doi.org/https://doi.org/10.22377/ajp.v11i04.1723

Watson, S., Caster, O., Rochon, P. A., & den Ruijter, H. (2019). Reported adverse drug reactions in women and men: Aggregated evidence from globally collected individual case reports during half a century. EClinicalMedicine, 17, 100188. https://doi.org/10.1016/j.eclinm.2019.10.001

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Published

2021-10-23

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Section

Clinical and Community Pharmacy