ADVERSE DRUG REACTIONS MONITORING: A PHARMACOVIGILANCE STUDY AT ERBIL AND DUHOK MAIN HOSPITALS IN KURDISTAN REGION / IRAQ
Keywords:
Adverse Drug Reaction, Hospital Based Monitoring, Pharmacovigilance
Abstract
https://doi.org/10.31386/dmj.2017.11.3
Background and objectives: Adverse drug reactions (ADRs) are recognized as a common cause of hospital admissions and they constitute a significant economic burden for the hospitals. Many disasters caused by drugs occurred in the past, after that regulation for drug approval has taken place. The aim of this study was to evaluate ADRs and assess their causality, severity and preventability in Erbil and Duhok main hospitals.
Methods: This is a retrospective cross-sectional, hospital-based study, conducted at Rizgary hospital in Erbil and Azadi hospital in Duhok from January to October 2016. Each Adverse reaction was assessed for its causality, severity and preventability using Naranjo, Hartwig and Siegel, and Schumock and Thornton assessment scales, respectively. Data were analyzed using descriptive analysis.
Results: A total of 378 patients with ADRs were reported, 57.7% females and 42.3% males. The maximum percentage of ADRs was noted in patient's age 21-40 years, 66.4% occurred in patients taking two or more medications. Common ADRs were allergic reactions (30.2%) and these involved with the gastrointestinal tract (20.6%). Antimicrobials (30.7%) and analgesics (9.0%) were the common causes of ADRs. Oral (49.47%) and intravenous (37.30%) routes of drug administration were responsible for most of ADRs. Of these cases, 47.9% were preventable, of moderate severity (52.9%), while 7.7% hospitalized, 1.1% needed surgical intervention and 2.4% died from ADRs.
Conclusions: ADRs can be frequently detected; they increase cost of treatment although about half can be prevented. These problems are essential to be reported, analyzed and interpreted, then effectively communicated with health authorities.
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References
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2. World Health Organization. The Importance of Pharmacovigilance. Safety monitoring of medicinal products. Geneva, Switzerland: World Health Organization; 2002; 2013. 9-42 p.
3. Bührlen B, Reiß T, Beckmann C, Gassner U, Gleiter C. Assessment of the European Community System of Pharmacovigilance. Stuttgart: Fraunhofer IRB Verlag; 2006. 190 p.
4. Bairu M, Chin R. Global Clinical Trials Playbook: Management and Implementation when Resources are Limited. 1st ed. London: Elsevier Science; 2012. 1 p.
5. Padmaja SY, Palanisamy S. A study on assessment, monitoring and documentation of adverse drug reactions. Int J Pharm Teach Pract. 2012;3(2):253-6.
6. Greenstone G. The revival of thalidomide: from tragedy to therapy. Brit Columb Med J. 2011;53:230-2.
7. Kim JH, Scialli AR. Thalidomide: the tragedy of birth defects and the effective treatment of disease. Toxicol Sci. 2011;122(1):1-5.
8. Suvarna V. Phase IV of drug development. Perspect Clin Res. 2010;1(2):57-60.
9. Talisuna AO, Staedke SG, D'Alessandro U. Pharmacovigilance of antimalarial treatment in Africa: is it possible. Malar J. 2006;5(50):10.1186.
10. Mann RD, Andrews EB. Pharmacovigilance. Second ed. Chichester, England: John Wiley & Sons; 2007. 1-158 p.
11. Srinivasan R, Ramya G. Adverse drug reaction-causality assessment. Int J Res Pharm Chem. 2011;1(3):606-11.
12. World Health Organization. Pharmacovigilance Indicators: a practical manual for the assessment of pharmacovigilance systems. Geneva, Switzerland: World Health Organization; 2015. 2-25 p.
13. Naranjo C, Busto U, Sellers E, Sandor P, Ruiz I, Roberts E. Naranjo ADR probability scale. Clin Pharmacol Ther. 1981;30:239-45.
14. Hartwig SC, Siegel J, Schneider PJ. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm. 1992;49(9):2229-32.
15. Schumock G, Thornton J. Focusing on the preventability of adverse drug reactions. Hosp Pharm. 1992;27(6):538-.
16. de Araújo Lobo MGA, Pinheiro SMB, Castro JGD, Momenté VG, Pranchevicius M-CS. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013;14(1):1.
17. Rademaker M. Do women have more adverse drug reactions? Am J Clin Dermatol. 2001;2(6):349-51.
18. Tenti E, Gardini AC, Frassineti L, Amadori D, Minguzzi M. Increase of reports of suspected adverse drug reactions in oncology. Int J Pharm Pharm Sci. 2014;6(9):95-6.
19. Sharma H, Aqil M, Imam F, Alam MS, Kapur P, Pillai KK. A pharmacovigilance study in the department of medicine of a university teaching hospital. Pharm Pract. 2007;5(1):46-9.
20. Sönnichsen A, Trampisch US, Rieckert A, Piccoliori G, Vögele A, Flamm M, et al. Polypharmacy in chronic diseases–Reduction of Inappropriate Medication and Adverse drug events in older populations by electronic Decision Support (PRIMA-eDS): study protocol for a randomized controlled trial. Trials. 2016;17(1):1.
21. Patidar D, Rajput MS, Nirmal NP, Savitri W. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India. Interdiscip Toxicol. 2013;6(1):41-6.
22. Simons FER, Ebisawa M, Sanchez-Borges M, Thong BY, Worm M, Tanno LK, et al. 2015 update of the evidence base: World Allergy Organization anaphylaxis guidelines. World Allergy Organ J. 2015;8(1):1.
23. Malladi P. A study of adverse drug reactions reported to the adverse drug reaction monitoring centre at a tertiary care teaching hospital, Kuppam. W J Pharm Pharmaceut Sci. 2016;5(10):804-10.
24. Shrivastava M, Uchit G, Chakravarti A, Joshi G, Mahatme M, Chaudhari H. Adverse drug reactions reported in Indira Gandhi government medical college and hospital, Nagpur. J Assoc Physicians India. 2011;59:296-9.
25. Demoly P, Viola M, Gomes E, Romano A. Epidemiology and causes of drug hypersensitivity. In: Pichler WJ, editor. Drug Hypersensitivity. Basel: Karger Publishers; 2007. p. 10.
26. Ravichandar R, Jamuna Rani R, Varadarajan S. Study of adverse drug reactions in a tertiary care teaching hospital. Int J Basic Clin Pharmacol. 2016;5(1):209-12.
27. 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):687-98.
28. Kumar A, Majhee L, Gari M. Causality, severity and preventability assessment of adverse drug reactions in patients received anti-retroviral therapy in a tertiary care hospital: A retrospective study. Natl J Physiol Pharm Pharmacol. 2016;7(2):1-3.
29. Mouton JP, Mehta U, Parrish AG, Wilson DP, Stewart A, Njuguna CW, et al. Mortality from adverse drug reactions in adult medical inpatients at four hospitals in South Africa: a cross‐sectional survey. Br J Clin Pharmacol. 2015;80(4):818-25.
30. Hakkarainen KM, Hedna K, Petzold M, Hägg S. Percentage of patients with preventable adverse drug reactions and preventability of adverse drug reactions–a meta-analysis. PLoS One. 2012;7(3):e33236.
31. Padmavathi S, Manimekalai K, Ambujam S. Causality, severity and preventability assessment of adverse cutaneous drug reaction: a prospective observational study in a tertiary care hospital. J Clin Diagn Res. 2013;7(12):2765.
32. Rydberg DM, Holm L, Engqvist I, Fryckstedt J, Lindh JD, Stiller C-O, et al. Adverse drug reactions in a tertiary care Emergency Medicine Ward-prevalence, preventability and reporting. PLoS One. 2016;11(9):e0162948.
33. Peter JV, Varghese GH, Alexander H, Tom NR, Swethalekshmi V, Trauman C, et al. Pattern of adverse drug reaction in the medical wards of a teaching hospital: A prospective observational cohort study. Curr Drug Saf. 2016;11(2):164-5.
34. McDonnell PJ, Jacobs MR. Hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother. 2002;36(9):1331-2.
35. Al Hamid A, Ghaleb M, Aljadhey H, Aslanpour Z. A systematic review of hospitalization resulting from medicine‐related problems in adult patients. Br J Clin Pharmacol. 2014;78(2):202-17.
36. Bouvy JC, De Bruin ML, Koopmanschap MA. Epidemiology of adverse drug reactions in Europe: a review of recent observational studies. Drug Saf. 2015;38(5):437-51.
37. Jose J, Rao PG. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacol Res. 2006;54(3):226.
38. Sultana J, Cutroneo P, Trifirò G. Clinical and economic burden of adverse drug reactions. J Pharmacol Pharmacother. 2013;4(5):73.
39. 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. PLoS One. 2009;4(2):e4439.
40. Hug BL, Keohane C, Seger DL, Yoon C, Bates DW. The costs of adverse drug events in community hospitals. Jt Comm J Qual Patient Saf. 2012;38(3):120-6.
Published
2018-02-08
How to Cite
SULAIMAN, M., MOHAMMAD, F., & ALHASSANI, A. (2018). ADVERSE DRUG REACTIONS MONITORING: A PHARMACOVIGILANCE STUDY AT ERBIL AND DUHOK MAIN HOSPITALS IN KURDISTAN REGION / IRAQ. Duhok Medical Journal, 11(1), 19-32. Retrieved from http://dmj.uod.ac/index.php/dmj/article/view/3
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