A South Indian Journey on the Trivialized Healthcare Menace of Adverse Drug Reactions

Document Type : Original Article

Authors

Clinical Pharmacologist, Department of Clinical Pharmacology, Rajagiri Hospital, Kerala, India.

Abstract

Introduction:
The primary objective is to encourage HCPs to report more ADRs by bringing out data on the incidence, rate and characteristics of ADRs, ADR-related hospital admissions and by exposing their impact on patient outcomes.
Materials and Methods:
This was a record-based retrospective cross-sectional analysis undertaken to investigate ADR monitoring and reporting in a tertiary care hospital. The databases from June 2016 to May 2020 were studied to assess the characteristics, causality, severity, and incidence rate of ADRs reported by the HCPs in accordance with the accepted criteria. The data was later analyzed using descriptive statistics.
Results:
A total of 775 ADRs were identified and reported, extending over 4 years. 72.9% of the hospitalized patients experienced an ADR, 27.09% visited due to ADRs and 0.12% had a fatal ADR. The incidence of ADRs was estimated to be 1.8 per 1000 patient days, with preventable ADR constituting 0.4 per 1000 patient days. Skin (60.38%) was the most common organ system affected typically with Anti-infectives (48.38%). After causality assessment 624 (80.51%) of the cases were classified as probable while 141 (18.19%) were possible. The majority (52.7%) of the reactions were moderate in severity.
Conclusion:
It is crucial to encourage all concerned HCPs to apprehend their role and responsibility in the identification, monitoring and reporting of suspected ADRs. Educational programs, periodic dissemination of data on the reported ADRs to the healthcare practitioners, and improvement of interactions between the physicians, nurses and pharmacists may be programs to implement.

Keywords

Main Subjects


  1. Ramakrishnaiah H, Krishnaiah V, Pundari kaksha HP, Ramakrishna VB. A prospective study on adverse drug reactions in outpatients and inpatients of medicine department in a tertiary care hospital. Available from:https:// ijbcp. com/index.php/ijbcp/article/view/783
  2. Alomar MJ. Factors affecting the development of adverse drug reactions. Saudi pharmaceutical journal 2014; 22(2): 83-94.
  3. Tandon VR, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India. Indian journal of pharmacology 2015; 47(1): 65.
  4. Haines HM, Meyer JC, Summers RS, Godman BB. Knowledge, attitudes and practices of health care professionals towards adverse drug reaction reporting in public sector primary health care facilities in a South African district. European journal of clinical pharmacology 2020; 76(7):
    991-1001.
  5. Datta S, Sengupta S. An evaluation of knowledge, attitude, and practice of adverse drug reaction reporting in a tertiary care teaching hospital of Sikkim. Perspectives in clinical research 2015; 6(4): 200.
  6. dos Santos DB, Coelho HL. Adverse drug reactions in hospitalized children in Fortaleza, Brazil. Pharmacoepidemiology and drug safety 2006; 15(9): 635-40.
  7. Lagnaoui R, Moore N, Fach J, Longy-Boursier M, Begaud B. Adverse drug reactions in a department of systemic diseases-oriented internal medicine: prevalence, incidence, direct costs and avoidability. European journal of clinical pharmacology 2000; 56(2): 181-6.
  8. Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients: a meta-analysis of prospective studies. Jama 1998; 279(15): 1200-5.
  9. Lihite RJ, 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. Alexandria journal of medicine 2017; 53(2): 151-6.
  10. Levy M, Azaz-Livshits T, Sadan B, Shalit M, Geisslinger G, Brune K. Computerized surveillance of adverse drug reactions in hospital: implementation. European journal of clinical pharmacology 1999; 54(11): 887-92.
  11. Moore N, Lecointre D, Noblet C, Mabille M. Frequency and cost of serious adverse drug reactions in a department of general medicine. British journal of clinical pharmacology 1998; 45(3): 301-8.
  12. Prince BS, Goetz CM, Rihn TL, Olsky M. Drug-related emergency department visits and hospital admissions. American Journal of Hospital Pharmacy 1992; 49(7): 1696-700.
  13. Alsaleh FM, Lemay J, Al Dhafeeri RR, AlAjmi S, Abahussain EA, Bayoud T. Adverse drug reaction reporting among physicians working in private and government hospitals in Kuwait. Saudi pharmaceutical journal 2017; 25(8): 1184-93.
  14. Sriram S, Ghasemi A, Ramasamy R, Devi M, Balasubramanian R, Ravi TK, Sabzghabaee AM. Prevalence of adverse drug reactions at a private tertiary care hospital in south India. Journal of research in medical sciences: the official journal of Isfahan University of Medical Sciences 2011; 16(1): 16.
  15. Mannesse CK, Derkx FH, De Ridder MA, Man In't Veld AJ, Van der Cammen TJ. Contribution of adverse drug reactions to hospital admission of older patients. Age and ageing 2000; 29(1): 35-9.
  16. Khan LM. Comparative epidemiology of hospital-acquired adverse drug reactions in adults and children and their impact on cost and hospital stay–a systematic review. European journal of clinical pharmacology 2013; 69(12): 1985-96.
  17. Langerová P, Vrtal J, Urbánek K. Adverse drug reactions causing hospital admissions in childhood: a prospective, observational, single‐centre study. Basic & clinical pharmacology & toxicology 2014; 115(6): 560-4.
  18. Rademaker M. Do women have more adverse drug reactions? American journal of clinical dermatology 2001; 2(6): 349-51.
  19. Brøsen K. Kønsforskelle i farmakologien. Ugeskrift for læger 2007; 169(25): 2408-11.
  20. Gupta R, Sheikh A, Strachan D, Anderson HR. Increasing hospital admissions for systemic allergic disorders in England: analysis of national admissions data. Bmj 2003; 327(7424): 1142-3.
  21. Chen L, Liu T, Zhao X. Inferring anatomical therapeutic chemical (ATC) class of drugs using shortest path and random walk with restart algorithms. Biochimica et Biophysica Acta (BBA)-Molecular Basis of Disease 2018; 1864(6): 2228-40.
  22. Gallelli L, Ferreri G, Colosimo M, Pirritano D, Guadagnino L, Pelaia G, Maselli R, De Sarro GB. Adverse drug reactions to antibiotics observed in two pulmonology divisions of Catanzaro, Italy: a six-year retrospective study. Pharmacological research 2002 ; 46(5): 395-400.
  23. Adhikari A, Bhattacharjee N, Bhattacharya S, Indu R, Ray M. Evaluation of adverse drug reactions in tertiary care hospital of Kolkata, West Bengal, India. Journal of Young Pharmacists 2017; 9(3): 311.
  24. Visacri MB, de Souza CM, Sato CM, Granja S, de Marialva M, Mazzola PG, Moriel P. Adverse Drug Reactions and quality deviations monitored by spontaneous reports. Saudi pharmaceutical journal 2015; 23(2): 130-7.
  25. Ghosh S, Acharya LD, Rao PG. Study and evaluation of the various cutaneous adverse drug reactions in Kasturba hospital, Manipal. Indian journal of pharmaceutical sciences 2006; 68(2).
  26. Hunziker T, Bruppacher R, Kuenzi UP, Maibach R, Braunschweig S, Halter F, Hoigné RV. Classification of ADRs: a proposal for harmonization and differentiation based on the experience of the Comprehensive Hospital Drug Monitoring Bern/St. Gallen, 1974–1993. Pharmacoepidemiology and drug safety 2002; 11(2): 159-63.
  27. Costa MJ, Herdeiro MT, Polónia JJ, Ribeiro-Vaz I, Botelho C, Castro E, Cernadas J. Type B adverse drug reactions reported by an immunoallergology department. Pharmacy Practice (Granada) 2018; 16(1).
  28. Mirošević Skvrce N, Macolić Šarinić V, Mucalo I, Krnić D, Božina N, Tomić S. Adverse drug reactions caused by drug-drug interactions reported to Croatian Agency for Medicinal Products and Medical Devices: a retrospective observational study. Croatian medical journal 2011; 52(5): 604-14.
  29. Bucşa C, Farcaş A, Cazacu I, Leucuta D, Achimas-Cadariu A, Mogosan C, Bojita M. How many potential drug–drug interactions cause adverse drug reactions in hospitalized patients? European journal of internal medicine 2013; 24(1): 27-33.