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May 10, 2021
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May 10, 2021
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Abstract

Background


Adverse Drug Reactions (ADRs) are commonly encountered at hospitals where poly pharmacy is practiced due to increased chances of drug interactions. Nowadays there is growing interest in reporting ADRs. Yet, there is a paucity of data regarding adverse drug reaction monitoring in India.


Aim


The present study was done to analyze all the reported ADRs at Tripura Medical College & Dr. BRAM Teaching Hospital (TMC).


Materials & Methods


A retrospective, observational study of all the reported cases of ADRs that occurred in both Outpatients Departments (OPD)&In patients Departments(IPD) at TMC in last 18 months (Jan 2017 to June 2018) are included in the study. All the ADRs that were reported by different OPDs & IPDs were recorded in Suspected Adverse Drug Reaction Reporting Forms of Indian Pharmacopoeia Commission (IPC). The reports were recorded as per the standard guidelines fixed by PharmacovigilanceProgramme of India (PvPI). WHO-UMC scale was used to assess the causality of suspected ADRs.


Results/observations


A total of 204 ADRs were reported from 177 patients. Out of 177 patients, 30 patients were admitted in IPD with different ADRs, 55 ADR cases were treated in OPD and 82 patients developed ADRs during their hospital stay with other ailments. Adult male patients were mostly affected.  Commonest form of manifestation was skin & appendages disorders, second common is gastrointestinal system disorders followed by psychiatric& nervous system


 


disorders.  Maximum cases had mild reactions that recovered after discontinuation of medications, two patients had disability and nine patients developed life threatening ADRs that needed intensive care with prolonged hospital stay.


Conclusion


The present study shows ADRs are commonly encountered at this tertiary health care set up. Many ADRs are life threatening type B reactions, but the higher incidence of type A reactions means that these can be avoided.

Keywords

ADR CAUSALITY INCIDENCE

Article Details

How to Cite
Datta M, Majumdar G, Ghosh R, & Das L. (2021). Pattern of adverse drug reactions reported at a tertiary care teaching hospital in north east India: a retrospective observational study conducted under pharmacology department. International Journal of Research in Pharmacology & Pharmacotherapeutics, 7(4), 304-312. https://doi.org/10.61096/ijrpp.v7.iss4.2018.304-312
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References

  1. [1]. Zhang M, Holman CDJ, Preen DB, Brameld K. Repeat adverse drug reactions causing hospitalization in older Australians: a population - based longitudinal study 1980-2003. Br J ClinPharmacol 63, 2007, 163-70
  2. [2]. Davies EC, Green CF, Taylor S, Williamson PR, Mottram DR, Pirmohamed M. Adverse drug reactions in hospital in- patients: A prospective analysis of 3695 patient- episodes . PLoSONE 4, 2009, e4439.4.
  3. [3]. Kaur S, Kapoor V, Mahajan R, Mohan Lal. Monitoring of incidence , severity and causality of adverse drug reactions in hospitalized patients with cardiovascular disease .Indian J Pharmacol , 43(1), 2011 , 22-26
  4. [4]. Prakash S. Pharmacovigilance in India. Indian J Pharmacol; 39, 2007, 123
  5. [5]. Biswas P, Biswas AK. Setting standards for proactive pharmacovigilance in India: The way forward. Indian J Pharmacol 39, 2007, 124-8
  6. [6]. Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res 54, 2006, 226- 33.
  7. [7]. The Uppsala Monitoring Centre- Vigiflow User Guide version 5.2, Sweden (www. who-umc,org)
  8. [8]. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm 49, 1992, 2229-32.
  9. [9]. Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, editor. Textbook of adverse drug reactions. Vol 10. Oxford: Oxford University Press; 1977.
  10. [10]. Edwards IR , Aronson JK . Adverse drug reactions: Definition , diagnosis and management . Lancet 356, 2000, 1255-9.
  11. [11]. Medical council of India: Minimum requirements for 150 MBBS Admissions Annually Regulations (Amendment), No. MCI . 34(41) / 2009 -Med./ 20072 , Jul 8. 2009 ; 76 Available from : http :// mciindia . Org / helpdesk / how to start / STANDARD % 20 FOR % 20150.pdf [ last cited 2009]
  12. [12]. Chan M, Nicklason F, Vial JH. Adverse drug events as a cause of hospital admission in the elderly. Intern Med J 31, 2001, 199-205.
  13. [13]. Davies DM. History and epidemiology. In: Davies DM, editor .Textbook of adverse drug reactions. Oxford : Oxford University press ;1, 1977, 7
  14. [14]. Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, et al. The costs of adverse drug events in hospitalized patients. Adverse Drug Events Prevention Study Group JAMA. 277, 1997, 307- 11
  15. [15]. Bates DW, Miller EB, Cullen DJ, Burdick L, Williams L, Laird N, et al. Patient risk factors for adverse drug events in hospitalized patients. Arch Intern Med. 159, 1999, 2553 -60.
  16. [16]. Hughes SG. Prescribing for the eiderly patients: Why do we need to exercise caution? Br J ClinPharmacol . 46, 1998 , 531- 3
  17. [17]. Vander Hooft CS, Sturkenboom MC, Van Grootheest K, Kingma HJ, Stricker BH. Adverse drug reaction related hospitalization: A nationalwide study in the Netherlands. Drug Saf. 29, 2006, 161- 8.
  18. [18]. Schwartz JB. The influence of sex on pharmacokinetics. Clin Pharmacokinetic. 42, 2003, 107
  19. [19]. Meibohm B, Beierle I, Derendorf H. How important are gender differences in pharmacokinetics? ClinPharmacokinet . 41, 2002, 329 -42.