A Pharmacovigilance Study on Causality and Severity Assessment of Adverse Drug Reactions in a Teaching Hospital
Objectives: The main purpose of the study is to assess the causality, severity, preventability of ADRs and factors associated with ADRs in chronic disease patients of tertiary care teaching hospital.
Study setting and Design: A Prospective observational longitudinal study was conducted in a tertiary care teaching hospital at Hyderabad, India, for 3 years.
Materials and Methods: Patients of age group > 18 years were included in the study. All the patients were distributed according to their gender, age, number medications used, disease condition, and socioeconomic state. The reported ADRs were analyzed by WHO-UMC causality, Hartwig’s Siegel’s scale and modified Shumock and Thornton criteria respectively. Statistical analysis used: Descriptive statistical analysis was used.
Results: A total of 691 patients enrolled in the study, in that 391 patients reported with 510 ADRs. Of these 37.0% are in-patients and 62.9% are out-patients. Majority of the patients are female category (58.0%) and 45.8% of ADRs reported from adults (41-60 years). 65.8% patients are non-adherent to medication. Life style habits, economic status and education are found to be predictors for ADRs. WHO-UMC scale showed 42.9% of ADRs probable. Hartwig’s and Siegel’s severity scales shown 13.1 % ADRs are severe followed by 33.7% moderate ADRs and 40% of ADRs were preventable.
Conclusion: Hence our study advises that there is a need of improvement in ADR reporting from health care professionals. This study also suggests further research in India for the improvement of possible intervention strategies to reduce burden and cost of ADR.
Keywords: Prospective, ADR reporting, WHO-UMC, Hartwig’s Siegel’s scale, Shumock and Thornton.
2. Pharmacovigilance Programme of India (PvPI) for Assuring Drug Safety. Available from http://cdsco.nic.in/pharmacovigilance_intro.htm
3. Boyd CM, Darer J, Boult C, Fried LP, Boult L, Wu AW. Clinical practice guidelines and quality of care for older patients with multiple comorbid diseases: implications for pay for performance. JAMA. 2005; 294(6):716–24. doi: 10.1001/jama.294.6.716.
4. IDF. Diabetes Atlas. 4th ed. Brussels, Belgium: International Diabetes Federation; 2009.
5. Ramachandran A, Snehalatha C. Current scenario of diabetes in India. J Diabetes. 2009;1(1):18-28.
6. Coren J, Overbeck K, Filipetto F. Evaluating medications and adverse drug reactions in older patients, 2011. Available from: http:// www.cecity.com /aoa/healthwatch/may_11/print2.pdf. [Last cited on 2015 Nov 07].
7. Michel Joffres et al., Hypertension prevalence, awareness, treatment and control in national surveys from England, the USA and Canada, and correlation with stroke and ischaemic heart disease mortality: a cross-sectional study. British Medical Journal 2013; 3: e003423.
8. Degli Esposti E, Sturani A and Di Martino N: Long term persistence with anti-hypertensive drugs in new patients. Journal of Human Hypertension 2002; 16: 439-444.
9. Degli Esposti L, Degli Esposti E and Valpiani G: A retrospective, population- based analysis of persistence with anti-hypertensive drug therapy in primary care practice in Italy. Clinical Therapeutics 2002; 24: 1347-1357.
10. Iseman MD. Treatment of multidrug-resistant tuberculosis. N Engl J Med. 1993; 329:784–91.
11. Drobniewski FA, Balabanova YM. The diagnosis and management of multiple-drug-resistant-tuberculosis at the beginning of the new millenium. Int J Infect Dis. 2002; 6(Suppl 1):S21–31.
12. Shin SS, Pasechnikov AD, Gelmanova IY, Peremitin GG, Strelis AK, Mishustin S, et al. Adverse reactions among patients being treated for MDR-TB in Tomsk, Russia. Int J Tuberc Lung Dis. 2007; 11:1314–20.
13. Bhabhor PH, Patel TK, Vahora R, Patel PB, Desai N. Adverse drug reactions in a tertiary care teaching hospital in India: Analysis of spontaneous reported cases. Int J Basic Clin Pharmacol 2014; 3(6):1078-85.
15. Purohit P: A cross-sectional study of type -2 diabetic females at a higher CVD risk owing to a strong correlation of Systolic hypertension to CVD risk factors. Int J Biol Med Res. 2012; 3:1905-1909.
16. Haugbolle LS, Sorensen EW: Drug-related problems in patients with angina pectoris, type 2 diabetes and asthma–interviewing patients at home. Pharm World Sci 2006, 28(4):239–247.
17. Rajeshreddy SGSV, V., Lokesh V. Patil. Causality assessment and the severity of the adverse drug reactions in tertiary care hospital: a pharmacovigilance study, Int J Basic Clin Pharmacol. 2017; 6(12):2800-2803.
18. Patel PB, Patel TK, Anturlikar S, Khatun S, Bhabhor P, Saurabh MK. Adverse drug reactions reporting by undergraduate medical students in a tertiary care teaching hospital of India: Content and quality analysis in comparison to physician reporting. Perspect Clin Res 2017; 8:137-44.
19. Ratan J. Lihite, Mangala Lahkar, Sukirti Das, Debeeka Hazarika, Murali Kotni, Mudasir Maqbool, Swapna Phukan. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alexandria Journal of Medicine. 2017 53, 151–156.
20. Rehan HS, Chopra D, Sah RK, Mishra R. Adverse drug reactions: trends in a tertiary care hospital. Curr Drug Saf 2012; 7:384–8.
21. Murphy BM, Frigo LC. Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital, Hosp Pharm. 1993; 28(12):1199-204.
22. Hettihewa LM, Sirisena B. Casualty assessment and the severity of the adverse drug reactions (ADR) actively detected in hospital-in patients in tertiary care hospital Sri Lanka: Prospective observational survey. Asian Journal of Research in Biological and Pharmaceutical Sciences. 2014; 2(1):1-10.
23. Asawari L Raut, Palak Patel, Chintan Patel and Atmaram Pawar. Preventability, Predictability and Seriousness of Adverse Drug Reactions amongst Medicine Inpatients in a Teaching Hospital: A Prospective Observational Study, ijpcs, Vol. 1 (3) Jul-Sep 2012.
24. S. ponnusankar, m. tejaswini and m. chaitanya. ADR Assessment Based on Spontaneous Signaling, Indian J Pharm Sci 2015; 77(4):490-493.
25. Dindayal Patidar, Mithun S. Rajput, Nilesh P. Nirmal, Wenny Savitri. Implementation and evaluation of adverse drug reaction monitoring system in a tertiary care teaching hospital in Mumbai, India, Interdiscip Toxicol. 2013; 6(1):41–46.
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