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image of Assessment and Monitoring of Adverse Drug Reactions at a Tertiary Care Hospital

Abstract

Background

Incidences of adverse drug reactions were reported through spontaneous reporting at an ADR monitoring unit in a tertiary care hospital.

Aims

This study was conducted to describe the distribution pattern of adverse drug reaction (ADR).

Objective

The objective of this study was to monitor and report the adverse drug reactions (ADRs) occurring in a tertiary care hospital and to evaluate the incidence, causality, severity, and preventability of adverse drug reactions.

Methods

A prospective, observational study was conducted at a tertiary care hospital in Punjab for 6 months. All patients admitted to the hospital above 18 years of age were included in the study.

Results

A total of 103 ADRs were observed over the study period of 6 months. The majority of them were females (60), comprising of 58.25%. The therapeutic class of drug associated with most of the ADRs was antibiotics 18 (17.5%). Maximum number of ADRs occurred in the general medicine ward with frequency of 27 (26.2%) and were of type b 58 (56.3%). Causality was assessed using the Naranjo scale, and most of the ADRs came out to be probable 64 (62.1%) in nature. Severity was assessed using Hartwig’s severity assessment scale, and most of the cases, 66 (64.1%), were moderate in intensity. ADR preventability was assessed using the Schumock and Thornton preventability scale, and it was observed that most of the cases, 82 (79.6%), were not preventable.

Conclusion

This study seeks to strengthen the ADR database through analysis of spontaneous reporting patterns of ADRs from various clinical departments of a tertiary care teaching hospital, thereby increasing awareness and improving the reporting culture among health care practitioners. It can be concluded that continuous medication monitoring and a well-organized and committed pharmacovigilance system led by a clinical pharmacist in a hospital setting would undoubtedly lower the incidence of adverse drug reactions.

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2024-10-07
2024-11-26

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References

  1. Safety of medicines – Adverse drug reactions. Available from: https://www.who.int/docs/default-source/medicines/safety-of-medicines--adverse-drug-reactions-jun18.pdf?sfvrsn=4fcaf40_2
  2. Zazzara M.B. Palmer K. Vetrano D.L. Carfì A. Onder G. Adverse drug reactions in older adults: A narrative review of the literature. Eur. Geriatr. Med. 2021 12 3 463 473 10.1007/s41999‑021‑00481‑9 33738772
    [Google Scholar]
  3. Shiva Kumar M Sathish Kumar D. A prospective study of pattern of adverse drug reactions reported at a tertiary care hospital. J Cardiovasc. Dis. Res. 2022 13 4 Available from: https://www.jcdronline.org/admin/Uploads/Files/639bc2d38efe35.14712835.pdf
    [Google Scholar]
  4. Parvathy Shobha. Sunitha Messaline. Pattern of cutaneous adverse drug reactions in an adverse drug monitoring center at a tertiary care hospital in Kerala. Natl. j. physiol. pharm. pharmacol. 2023 13 2 434 437 10.5455/njppp.2023.13.12610202213012023.
    [Google Scholar]
  5. Raju S.K. Geetha S. A prospective, observational study of the spontaneous reporting patterns of adverse drug reactions in a tertiary care teaching hospital. J Pharmacol Pharmacother. 2022 13 4 0976500X2211308 10.1177/0976500X221130841.
    [Google Scholar]
  6. Rele H.S. Pate A. Patil D.Y. Pharmacovigilance programme of India : An overview. Pharma. Reson. 2023 5 2 Available from: https://pharmacy.dypvp.edu.in/pharmaceutical-resonance/downloads/vol-5-issue-II/PR-0012-115-121.pdf
    [Google Scholar]
  7. Venkatesan R. Ravisankar S. Lakshminarasu M. Rajendran S.D. Intensive monitoring of adverse drug reaction in hospitalized patients in a South Indian tertiary care hospital. Int J Pharm Pharm Sci 2014 5 1 19
    [Google Scholar]
  8. Geer M.I. Koul P.A. Tanki S.A. Shah M.Y. Frequency, types, severity, preventability and costs of adverse drug reactions at a tertiary care hospital. J. Pharmacol. Toxicol. Methods 2016 81 323 334 10.1016/j.vascn.2016.04.011 27109493
    [Google Scholar]
  9. Yadesa T.M. Kitutu F.E. Deyno S. Ogwang P.E. Tamukong R. Alele P.E. Prevalence, characteristics and predicting risk factors of adverse drug reactions among hospitalized older adults: A systematic review and meta-analysis. SAGE Open Med. 2021 9 10.1177/20503121211039099 34422271
    [Google Scholar]
  10. Vamsi Krishna V.N. Vamsi Krishna V.N. A review on adverse drug reactions. Int. J. Pharm. Clin. Res. 2021 2021 4 76 78 10.61427/jcpr.v1.i4.2021.46
    [Google Scholar]
  11. Pranav Vinodkumar M. Narula S. Journalism and management practices Anveshana’s international journal of research in regional studies. Soc. Sci. 2021 6 11
    [Google Scholar]
  12. Sharma M. Baghel R. Thakur S. Adwal S. Surveillance of adverse drug reactions at an adverse drug reaction monitoring centre in Central India: A 7-year surveillance study. BMJ Open 2021 11 10 e052737 10.1136/bmjopen‑2021‑052737 34607871
    [Google Scholar]
  13. Chopra D. Sah R K. Mishra R. Adverse drug reactions: Trends in a tertiary care hospital. Curr. Drug Saf. 2013 7 5 384 388 10.2174/1574886311207050011
    [Google Scholar]
  14. Adhikary J. Bhandare B. e A. v S. A study to assess knowledge, attitude and practice of adverse drug reaction reporting among physicians in a tertiary care hospital. J. Evol. Med. Dent. Sci. 2013 2 9 1027 1034 10.14260/jemds/374
    [Google Scholar]
  15. Arulmani R. Rajendran S.D. Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br. J. Clin. Pharmacol. 2008 65 2 210 216 10.1111/j.1365‑2125.2007.02993.x 17662089
    [Google Scholar]
  16. Sriram S. Ghasemi A. Ramasamy R. Devi M. Balasubramanian R. Ravi TK. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. J Res Med Sci. 2011 16 1 16 25 21448378
    [Google Scholar]
  17. Dang A. Bhandare PN. The profile of voluntary reported adverse drug reactions at a tertiary care hospital: A fifteen month prospective study. J Clin Diagn Res. 2012 6 9 1504 9 10.7860/JCDR/2012/4340.2544.
    [Google Scholar]
  18. Gor A.P. Desai S.V. Adverse drug reactions (ADR) in the inpatients 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 10.4103/0253‑7613.40488 21264160
    [Google Scholar]
  19. Baheti T. Nandal D.H. Mahajan S.N. Narwane S.P. Kunkulol R.R. Baheti T. Study of ADR (Adverse Drug Reactions) reporting in Pravara Rural Hospital, Loni. 2019 11 1 4 7 Available from: https://www.researchgate.net/publication/370636015_Study_of_ADR_Adverse_Drug_Reactions_Reporting_in_Pravara_Rural_Hospital_Loni
    [Google Scholar]
  20. Vora M.B. Trivedi H.R. Shah B.K. Tripathi C.B. Adverse drug reactions in inpatients of internal medicine wards at a tertiary care hospital: A prospective cohort study. J. Pharmacol. Pharmacother. 2011 2 1 21 25 10.4103/0976‑500X.77102 21701642
    [Google Scholar]
  21. Peter JV. Varghese GH. Alexander H. Tom NR. Kumar TR. Truman C. 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 10.2174/1574886311666160225150106.
    [Google Scholar]
  22. Jose J. Rao P.G.M. Archana B. Implementation and results of an adverse drug reaction reporting programme at an Indian teaching hospital. Indian J. Pharmacol. 2006 38 4 293 294 10.4103/0253‑7613.27032
    [Google Scholar]
  23. Ganesan S. Sandhiya S. Subrahmanyam D. Frequency of ADRs and their economic impact in a tertiary care public sector hospital in South India. SBV J. Basic Clin. Appl. Health Sci. 2020 3 1 23 31 10.5005/jp‑journals‑10082‑02235.
    [Google Scholar]
  24. Jose J. Rao P. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol. Res. 2006 54 3 226 233 10.1016/j.phrs.2006.05.003 16781163
    [Google Scholar]
  25. Priyanka P.D. Vithya T. Hiremath S.R.R. Prasad S. Incidence and assessment of adverse drug reactions at a tertiary care hospital. J. Pharm. Pract. Comm. Med. 2020 6 1 15 17 10.5530/jppcm.2020.1.5
    [Google Scholar]
  26. Sivanandy Dr. Palanisamy. Arul Kumaran K.S. Rajasekaran A. A study on assessment, monitoring and reporting of adverse drug reactions in Indian hospital. Asian j. pharm. clin. res. 2011 4 3 112 116 Available from: https://www.researchgate.net/publication/286496964_A_study_on_assessment_monitoring_and_reporting_of_adverse_drug_reactions_in_Indian_hospital
    [Google Scholar]
  27. Mudasir Maqbool I. Zehravi M. Maqbool R. Ara I. Study of adverse drug reactions in pulmonary medicine department of a Tertiary care hospital, Srinagar, Jammu & Kashmir, India. TANG [HUMANITAS MEDICINE] 2021 11 2 1 5 10.5667/CellMed.2021.0008
    [Google Scholar]
  28. Grohmann R. Hippius H. Müller-Oerlinghausen B. Rüther E. Scherer J. Schmidt L.G. Strauss A. Wolf B. Assessment of adverse drug reactions in psychiatric hospitals. Eur. J. Clin. Pharmacol. 1984 26 6 727 734 10.1007/BF00541933 6149127
    [Google Scholar]
  29. Sivanandy Dr. Palanisamy. Arul Kumaran K.S.G. Rajasekaran A. A study on assessment, monitoring, documentation and reporting of adverse drug reactions at a multi-specialty tertiary care teaching hospital in South India. 2009 1 4 1519 1522 Available from: https://www.researchgate.net/publication/290047761_A_Study_On_Assessment_Monitoring_Documentation_and_Reporting_Of_Adverse_Drug_Reactions_at_A_Multi-Specialty_Tertiary_Care_Teaching_Hospital_In_South_India
    [Google Scholar]
  30. Srivastava P. Dhamija P. Bisht M. Rishikesh A. Kant R. Adverse drug reaction surveillance study in patients visiting a tertiary care hospital in North India. 2020 5 2 20 28 Available from: https://www.researchgate.net/publication/346629786_Adverse_Drug_Reaction_Surveillance_Study_in_Patients_Visiting_a_Tertiary_Care_Hospital_in_North_India
    [Google Scholar]
  31. Ramakrishnaiah H. Krishnaiah V. Pundarikaksha H.P. Ramakrishna V.B. A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital.. Int. J. Clin. Pharmacol. Res. 2015 4 3 515 521 Available from: https://imsear.searo.who.int/items/7522b707-3483-4345-ab73-7521e91de324
    [Google Scholar]
  32. Sundaran S. Udayan A. Hareendranath K. Eliyas B. Ganesan B. Hassan A. Study on the classification, causality, preventability and severity of adverse drug reaction using spontaneous reporting system in hospitalized patients. Pharmacy 2018 6 4 108 10.3390/pharmacy6040108.
    [Google Scholar]
  33. Kumar A. Kansal D. Sharma K. Bhardwaj A. Sawaraj S. To study the pattern of adverse drug reactions among patients hospitalized in the medical wards of a tertiary care hospital. Int J Basic Clin Pharmacol 2016 10.18203/2319‑2003.ijbcp20163221.
    [Google Scholar]
  34. Venkatasubbaiah M. Dwarakanadha Reddy P. Satyanarayana S.V. Analysis and reporting of adverse drug reactions at a tertiary care teaching hospital. Alex. J. Med. 2018 54 4 597 603 10.1016/j.ajme.2018.10.005
    [Google Scholar]
  35. Kharb P. Mittal N. Gupta M.C. An evaluation of adverse drug reactions monitoring at a pharmacovigilance unit under pharmacovigilance program of India in a tertiary care hospital of Haryana. Int J Basic Clin Pharmacol 2015 10.18203/2319‑2003.ijbcp20150039.
    [Google Scholar]
  36. Doshi MS. Patel PP. Shah SP. Dikshit RK. Intensive monitoring of adverse drug reactions in hospitalized patients of two medical units at a tertiary care teaching hospital. J Pharmacol Pharmacother. 2012 3 4 308 13 10.4103/0976‑500X.103687.
    [Google Scholar]
  37. James J. Rani J. A prospective study of adverse drug reactions in a tertiary care hospital in south India. Asian j. pharm. clin. res. 2019 10.22159/ajpcr.2020.v13i1.36028
    [Google Scholar]
  38. Ramesh M. Pandit J. Parthasarathi G. Adverse drug reactions in a South Indian hospital—their severity and cost involved. Pharmacoepidemiol. Drug Saf. 2003 12 8 687 692 10.1002/pds.871 14762985
    [Google Scholar]
  39. Giardina C. Cutroneo P.M. Mocciaro E. Russo G.T. Mandraffino G. Basile G. Rapisarda F. Ferrara R. Spina E. Arcoraci V. Adverse drug reactions in hospitalized patients: Results of the FORWARD (facilitation of reporting in hospital ward) study. Front. Pharmacol. 2018 9 APR 350 10.3389/fphar.2018.00350 29695966
    [Google Scholar]
  40. Bond C.A. Raehl C.L. Adverse drug reactions in United States hospitals. Pharmacotherapy 2006 26 5 601 608 10.1592/phco.26.5.601 16637789
    [Google Scholar]
  41. Lobo M.G.A.A. Pinheiro S.M.B. Castro J.G.D. Momenté V.G. Pranchevicius M-C.S. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol. Toxicol. 2013 14 1 5 10.1186/2050‑6511‑14‑5
    [Google Scholar]
  42. Alexopoulou A. Dourakis S.P. Mantzoukis D. Pitsariotis T. Kandyli A. Deutsch M. Archimandritis A.J. Adverse drug reactions as a cause of hospital admissions: A 6-month experience in a single center in Greece. Eur. J. Intern. Med. 2008 19 7 505 510 10.1016/j.ejim.2007.06.030 19013378
    [Google Scholar]
  43. Roy P. Nadig P. Jayashankar C. Adverse drug reaction monitoring through active surveillance in the inpatients of general medicine ward of a tertiary care hospital. APIK J. Int. Med. 2022 10 1 22 27 10.4103/ajim.ajim_7_21.
    [Google Scholar]
  44. Lalthanpuii K. Kaur J. Saini S. Bhatti K. Nain P. Strengthen the monitoring and reporting of adverse drug reaction at a tertiary teaching hospital. Arch. Pharm. Pract. (Mumbai) 2022 13 1 61 67 10.51847/Zq3HaDzGqf
    [Google Scholar]
  45. Abu Esba L.C. Al Mardawi G. AlJasser M.I. Aljohani B. Abu Alburak A. Adverse drug reactions spontaneously reported at a tertiary care hospital and preventable measures implemented. J. Clin. Pharm. Ther. 2021 46 2 460 469 10.1111/jcpt.13306 33285001
    [Google Scholar]
  46. Xavier A. Santhosh Kumar D. Ramaiah B. A prospective study on assessment and reporting of adverse drug reactions in a tertiary care hospital. Int. j. pharm. res. appl.
    [Google Scholar]
  47. Lihite R.J. Lahkar M. Das S. Hazarika D. Kotni M. Maqbool M. Phukan S. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alex. J. Med. 2017 53 2 151 156 10.1016/j.ajme.2016.05.007
    [Google Scholar]
/content/journals/adctra/10.2174/0126673371294052240827063621
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Assessment and Monitoring of Adverse Drug Reactions at a Tertiary Care Hospital
Bentham Science Publishers ; https://doi.org/10.2174/0126673371294052240827063621
/content/journals/adctra/10.2174/0126673371294052240827063621
/content/journals/adctra/10.2174/0126673371294052240827063621
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  • Article Type:     Research Article
Keywords: naranjo ; reporting ; vigiflow ; Adverse drug reactions ; monitoring

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