Main Article Content

Abstract

Objective


Psychotropics are known to cause number of adverse drug reactions (ADRs) which often results in either nonadherence or discontinuation of therapy. Present study aimed to analyze the pattern as well as causality, preventability, severity and predictability of occurrence of ADRs in psychiatry.


Materials and Methods


This retrospective cohort study was conducted to analyze the ADRs reported spontaneously from the Department of Psychiatry at a tertiary care hospital, Bengaluru to the ADR monitoring centre, Bangalore Medical College & Research Institute. Causality of ADR was assessed by WHO-ADR probability scale, preventability was assessed using Modified Schumock& Thornton scale and severity was assessed using Hartwig and Siegel criteria. Beer’s criterion was used to identify the potentially inappropriate drugs among elderly that caused ADRs.Descriptive statistics was used for analysis.


Results


40.7% of ADRs were observed among patients aged between 31-40 years. Higher frequencies of ADRs were noted among patients diagnosed with depression (34.5%), followed by schizophrenia (28.3%). Central Nervous System (58%) was affected predominantly. Headache (12.3) was the most commonly observed ADR followed by dystonia (11.1%) and drowsiness (9.9%). Patients receiving antidepressants (48%) and antipsychotics (37%) experienced more ADRs. Fluoxetine (17%) accounted for majority of ADRs followed by risperidone (12.3%).  85% of the ADRs were of ‘probable' causality and predominantly predictable (95.1%). 9% of the ADRs were definitely preventable. 44% of ADRs required additional medical treatment. 96.3% of patients recovered completely.


Conclusions


5% of ADRs were severe, no mortality was noted which highlights the appropriate management of ADRs at our centre. Regular intensive monitoring of ADRs in psychiatry outpatient department will help to improve to the quality of care.

Keywords

Adverse drug reactions Causality Psychiatry Preventability Severity

Article Details

How to Cite
Dr. C R. Jayanthi, Dr.Debdipta Bose, & Dr.Sushma M. (2021). Evaluation of pattern, predictability, severity and preventability of adverse drug reactions in the department of psychiatry at a tertiary care hospital in bengaluru – a five years experience. International Journal of Research in Pharmacology & Pharmacotherapeutics, 6(2), 182-190. https://doi.org/10.61096/ijrpp.v6.iss2.2017.182-190

References

  1. 1. World Health Organization. Safety monitoring of medicinal products: Guidelines for setting up and running of a pharmacovigilance centre. Geneva: World Health Organization; 2000. Available from: http://apps. who.int/medicinedocs/en/d/Jh2934e/. [Last accessed on 2011].
  2. 2. Lingeswaran A, Shetty H, Lahon K, Paramel A, Sharma G. Pharmacovigilance on olanzapine. Indian J Pharmacol 42, 2010, 252-3.
  3. 3. Harmark L, Groothest van AC. Pharmacovigilance: Methods, recent developments and future perspectives. Eur J Pharmacol 64, 2008, 743-52.
  4. 4. Thomas M, Boggs AA, DiPaula B, Siddiqi S. Adverse drug reactions in hospitalized psychiatric patients. Ann Pharmacother. 44(5), 2010, 819-825.
  5. 5. Muller HJ.Ann Gen Psychiatry 7(1), 2008, S46.
  6. 6. The use of WHO-UMC system for standardise case casualty assessment. Uppsala: The Uppsala Monitoring Centre; 2005. Available from: http://www.who-umc.org/ graphics/4409.pdf Accessed on: 2013.
  7. 7. Schumock GT and Thornton JP. Focusing on the preventability of adverse drug reactions. Hosp. Pharm 27, 1992, 538.
  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. Ducharme MM, Boothby LA. Analysis of adverse drug reactions for preventability. Int. J. Clin. Pract. 61(1), 2007, 157-161.
  10. 10. American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 60, 2012, 616
  11. 11. Shivhare S C, Kunjwani H K, Manikrao A M, Bondre A V. J Chem Pharm Res 2(1), 2010, 106-112.
  12. 12. Waldemar G, Anne H, Thomas S, Renate G, Pierre B. Age and adverse drug reactions from psychopharmacological treatment. Swiss Med Wkly 143, 2013, 1-13.
  13. 13. Sridhar SB, Al-Thamer SS, Jabbar R. Monitoring of adverse drug reactions in psychiatry outpatient department of a Secondary Care Hospital of Ras Al Khaimah, UAE. J Basic ClinPharma 7, 2016, 80-6.
  14. 14. Raman P D, Rajesh S. Depressive Disorders in Indian Context: A Review and Clinical Update for Physicians. J Assoc Physicians India 62, 2014, 827-32.
  15. 15. Sharma T, Kirti V, Dhasmana D C, Ravi G, Juhi K, Upasana S. Adverse drug reaction monitoring in psychiatry outpatient department of a tertiary care teaching hospital. J K Science 16(4), 2014, 156-160.
  16. 16. Zou C, Ding X, Flaherty JH, Dong B. Clinical efficacy and safety of fluoxetine in generalized anxiety disorder in Chinese patients. Neuropsychiatr Dis Treat 9, 2013, 1661-70.
  17. 17. In: Taylor D, Paton C, Kapur S. The Maudsley Prescribing Guidelines in Psychiatry. United Kingdom: Wiley‑Blackwell; 11, 2012, 170
  18. 18. Bush SE, Hazelwood L. 5-hydroxytryptamine (serotonin) and dopamine. In: Brunton LL, Chabner BA, Knollman BJ, eds. Goodman &Gilman’s the pharmacological basis of therapeutics. New York: McGraw-Hill; 12, 2011, 335-62.
  19. 19. Nitin G K, Anuradha G M, Prakruti P P, Ram D K. An evaluation of the metabolic effects of antipsychotic medications in patients suffering from psychiatric illness. J App Pharm Sci 4(4), 2014, 14-19.
  20. 20. Kim J, MacMaster E, Schwartz TL. Tardive dyskinesia in patients treated with atypical antipsychotics: case series and brief review of etiologic and treatment considerations. Drugs Context 3, 2014, 1-9.
  21. 21. Goyal R and Devi SH. A Case of Aripiprazole Induced Tardive Dyskinesia in a Neuroleptic-Naïve Patient with Two Years of Follow Up. ClinPsychopharmacolNeurosci 12(1), 2014, 69-71.
  22. 22. D Nevena, P Milica, J Igor, and C Natasa. Second-generation antipsychotics and extrapyramidal adverse effects. BioMed Res. Int. 2014, 1-6.
  23. 23. Courtney IA, Leigh NA, Ellie E, Roger SW. Adverse drug reactions: a retrospective review of hospitalized patients at a state psychiatric hospital. Hosp Pharm 48(11), 2013, 931–935.
  24. 24. In: Taylor D, Paton C, Kapur S. The Maudsley Prescribing Guidelines in Psychiatry. United Kingdom: Wiley‑Blackwell; 11, 2012, 21.