A pharmacovigilance Study on Critically Ill Patients Admitted In Beni-Suef University Teaching Hospital.

Document Type : Original Article

Authors

1 Pharmacology Departement, Faculty of Medicine, Beni-Suef University, Egypt

2 Medical Pharmacology Departement, Faculty of Medicine, Cairo University, Egypt.

3 Critical care, Faculty of Medicine, Beni-Suef University, Egypt.

Abstract

The significance of adverse drug reactions (ADRs) among hospitalized patients particularly fundamentally sick patients conceded in the emergency unit has now turned into a worldwide concern. Albeit numerous clinical preliminaries have been directed on medication treatment in fundamentally sick patients, there are no adequate information on the wellbeing of the medication treatment utilized.
The present work is a prospective observational study that was carried out in the ICU department, Benisuef teaching hospital, between August 2015 to December 2016, in which one hundred patients; admitted to the ICU, were enrolled. Patients who experienced drug related problems in the form of ADRs and/or adverse drug-drug interactions (DDIs) were recorded. The ADRs were analyzed regarding the incidence (88%), factors affecting the incidence, characteristics (most of ADRs were moderate, preventable, probable and type "A"). Clinically relevant adverse DDIs were analyzed regarding the incidence, mechanism, causal drugs and management plans.

Keywords

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  1. Biyabani SA, Ali MI,  Faisal SR. et al. (2018): A prospective study on adverse drug reactions in a tertiary care hospital. Journal of Drug Delivery & Therapeutics; 8(1):1-6.
  2. WHO (2002). The importance of pharmacovigilance. The WHO collaborating centre for international drug monitoring. Geneva, Switzerland. Available at http://apps.who.int/medicinedocs/.
  3. Kongkaew C, Noyce P. and Ashcroft D. (2008): Hospital admissions associated with adverse drug reactions: a systematic review of prospective observational studies. Ann Pharmacother; 42: 1017-1025.
  4. Angamo MT,  Tesfa A and  Wabe NT. (2012): “Knowledge, attitude and practice of adverse drug reaction reporting among health professionals in southwest Ethiopia,” TAF Preventive Medicine Bulletin; vol. 11, no . 4: pp. 397–406.
  5. Sundaran S, Udayan A, Hareendranath K. et al. (2018): Study on the Classification, Causality, Preventability and Severity of Adverse Drug Reaction Using Spontaneous Reporting System in Hospitalized Patients. Pharmacy;, 6, 108.
  6. Rawlins MD, Thompson JW. (1977): Pathogenesis of adverse drug reaction. Davie’s Textbook of Adverse Drug Reaction. Oxford University Press; p. 44.
  7. Soni R and Kesari B. (2014): A Review on Pharmacovigilance. Int. J. Pharm. Sci. Rev. Res; 26(2): Article No. 41, Pages: 237-241.
  8. Rabba AK and Ain MR. (2014): Pharmacovigilance Study: Exploring the Role of Community Pharmacists in Adverse Drug Reactions Reporting in Alkharj City, Saudi Arabia.Lat. Am. J. Pharm; 34 (5): 901-6.
  9. Naranjo CA, Busto U, Sellers EM. et al. (1981). A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 30: 239-45.
  10. Schumock GT and Thornton JP. (1992). Focusing on the preventability of adverse drug reactions. Hosp Pharm.; 27(6): 538.
  11. Dormann H, Muth-Selbach U, Krebs S. et al. (2000). Incidence and costs of adverse drug reactions during hospitalisation: computerised monitoring versus stimulated spontaneous reporting. Drug Saf.; 22(2): 161-8.
  12. Abubakar AR, Simbak NB and Haque M.  (2014a): Adverse Drug Reactions: Predisposing Factors, Modern Classifications and Causality Assessment. Research J. Pharm. and Tech; 7(9): 1091-1098.
  13. Gurmesa LT and Dedefo MG. (2016): Factors Affecting Adverse Drug Reaction Reporting of Healthcare Professionals and Their Knowledge, Attitude, and Practice towards ADR Reporting in Nekemte Town, West Ethiopia. Hindawi Publishing Corporation, BioMed Research International; Article ID 5728462, 6 pages.
  14. Ahmad A, Hussain A, Farhat S. et al.(2016): Prevalence and Severity of Adverse Drug Reactions (ADRs) in patients subjected to different Anti-psychotic drugs in an Out-Patient Department of a Psychiatry Hospital in Kashmir; a prospective observational study. International Journal of Pharmacology and Clinical Sciences; 5 (1 ): 12-16.
  15. Ghufran MA, Kumar TS,  Kiran B. et al. (2016 ): A prospective observational study on monitoring, evaluating and reporting of ADRs in a tertiary care hospital . World Journal of Pharmacy and Pharmaceutical Sciences; 5 (2): 736-752.
  16. Vijayakumar TM and Dhanaraju MD. (2013): Description of Adverse Drug Reactions in a Multispecialty Teaching Hospital. Int. j. integr. Med; 1(26): 1-6.
  17. Liu XK, Katchman A, Drici MD. et al. (1998). Gender difference in the cycle length-dependent QT and potassium currents in rabbits. J Pharmacol Exp Ther; 285: 672-9.
  18. Laz EV, Sugathan A and Waxman DJ. (2009): Dynamic in vivo binding of STAT5 to growth hormone-regulated genes in intact rat liver. Sex-specific binding at low- but not high-affinity STAT5 sites. Mol Endocrinol; 23: 1242-54.
  19. Hotha PP, Jadav SP and Trivedi HR. (2016):  Adverse drug reactions: a retrospective review of hospitalized psychiatric patients at tertiary care hospital. Int J Basic Clin Pharmacol.;5(5): 2051-2060.
  20. Singh HDulhani NKumar B. et al. (2010). A pharmacovigilance study in medicine department of tertiary care hospital in chhattisgarh (jagdalpur), India. J Young Pharm. 2(1): 95-100.
  21.  Davies EC,  Green CF,  Taylor S. et al. (2009): Adverse Drug Reactions in Hospital In-Patients: A Prospective Analysis of 3695 Patient-Episodes; PLoS One. 2009; 4(2): e4439.
  22. Giardina C, Cutroneo PM, Mocciaro E. et al. (2018): Adverse Drug Reactions in Hospitalized Patients: Results of the FORWARD (Facilitation of Reporting in Hospital Ward) Study.Frontiers in pharmacology; 9:350.
  23. Prybys K, Melville K, Hanna J. et al. (2002): Polypharmacy in the elderly: Clinical challenges in emergency practice: Part 1: Overview, etiology, and drug interactions. Emerg Med Rep; 23: 145–53.
  24. Lobo MGA, Pinheiro SMB, J Castro JGD. et al. (2013):  Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacology and Toxicology; 14:5.
  25. Ribeiro MR, Motta AA, Marcondes-Fonseca LA. et al. (2018): Increase of 10% in the Rate of Adverse Drug Reactions for Each Drug Administered in Hospitalized Patients. Clinics.;73:e185.
  26. Vora MB, Trivedi HR, Shah BK. et al. (2011). Adverse drug reactions in the inpatients of the internal medicine wards at a tertiary care hospital: A prospective cohort study. Journal of Pharmacology and Pharmacotherapeutics. 2(1): 21-25.
  27. Alomar MJ. (2014): Factors affecting the development of adverse drug reactions. Saudi Pharmaceutical Journal;  (22): 83–94.
  28. Reis AM and Cassiani SH. (2011): Adverse drug events in an intensive care unit of a university hospital. Eur J Clin Pharmacol; 67(6): 625-32.
  29. Kathiria JM, Sattigeri BM, Desai PM. et al. (2013). A study of adverse drug reactions in patients admitted to intensive care unit of a tertiary care teaching rural hospital.  Int J Pharm Pharm Sci. 5 (1): 160-163.
  30. Shamna M,  Dilip C,  Ajmal M. et al. (2014): A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital Saudi Pharm J; 22(4): 303–308.
  31. Patel NH, Padhiyar J, Shah YB. et al. (2015): Study of Causality, Preventability and Severity of Cutaneous Adverse Drug Reactions in a Tertiary Care Institute. GCSMC J Med Sci; Issue 6, Vol (IV) No (I).24-27.
  32. Padmavathi S, Manimekalai K and Ambujam S. (2013): Causality, severity and preventability assessment of adverse cutaneous drug reaction: A prospective observational study in a tertiary care hospital. J Clin Diagn Res; (7):2765–67.
  33. Hettihewa LM and Sirisena B. (2014): Causality assessment and the severity of the adverse drug reactions actively detected in hospital –in patients in tertiary care Hospital Srilanka.Asian Journal of Research in Biological and Pharmaceutical Sciences; 2(1): 1 - 10.
  34. Palanisamy S, Kottur SG, Kumaran A.  et al. (2011): A Study on Assessment, Monitoring and Reporting of Adverse Drug Reactions in Indian Hospital. Asian J Pharm Clin Res; 4(3): 112-6.
  35. Moulya MV, Dinesh R and Nagesh Raju G. (2015): Pattern of adverse drug reaction in teaching care hospital in southern India: A retrospective study. World Journal of  Pharmaceutical Research; 4(6):1429-1439.
  36. Sunny S, Thampi A, Johnkennedy. et al. (2017): Assessment of Adverse Effects of Most Commonly Prescribed Anticancer Drugs in a Tertiary Care Teaching Hospital. Indian Journal of Pharmacy Practice; 10 (4): 270-275.
  37. Fettah H, Moutaouakkil Y, Sefrioui MR.  et al. (2018): Detection and analysis of drug–drug interactions among hospitalized cardiac patients in the Mohammed V Military Teaching Hospital in Morocco.  Pan African Medical Journal; 29 (225).
  38. Mousavi S and Ghanbari G. (2017): Potential drug-drug interactions among hospitalized patients in a developing country.  Caspian J Intern Med; 8(3):282-288.