Adverse drug reaction monitoring in patients of hypertension at a tertiary care hospital, Aurangabad, Maharashtra, India
Keywords:Hypertension, ADR monitoring, Causality assessment
Background: Hypertension is one of the highest prevailing diseases worldwide. Due to long term therapy antihypertensive drugs are commonly associated with adverse drug reactions (ADRs). Therefore, the study was conducted with the objective to examine the incidence of different types of ADRs in drug treated hypertensive patients.
Methods: Present study was a prospective cross sectional observational study carried out in the outpatient of department of medicine of MGM hospital, a tertiary care teaching hospital, in Aurangabad. 320 diagnosed hypertensive patients were studied. Questionnaire was asked and their prescription were analysed and follow up was done.
Results: Among 320 patient’s 75 patients were reported ADR. Males accounted for higher percent of ADRs 46 (61%) than females 29 (38.6%). Most of the patients 147 (55.9%) were on mono therapy. Calcium channel blocker was the frequently used class of drug, showed maximum number of ADR (30.6%) followed by ACE inhibitor (28%) and ARB (21.3%). As per WHO-UMC scale, type of reactions and their percentage were as certain (9.3%), Probable/ Likely (64%), possible (22.6%), and unlikely (4%). According to Naranjo scale most of the reactions were possible (64%). severity assessment is done by Hartwig and Siegel scale. No lethal ADR were reported. 4% reactions were severe, 32% were of moderate category and 64% were mild reactions.
Conclusions: Such type of studies are helpful in selection of appropriate medicines for hypertensive patients, enhancing patient adherence with the therapy by selecting medicines of lesser ADR profile, reducing unnecessary economic burden to the patients due to unwanted effects of the therapy.
Sudhakar R, George MK, Yasaswini B, Sundararajan N, Mariyam MAS. Adverse drug reactions associated with anti-hypertensive drugs and its management. Int J Pharm Sci Res. 2016;7(3):898-905.
Kumar RV, Raghu RV, Prasad BG, Mohanta GP, Manna PK. A study of adverse drug reactions due to antihypertensive drugs in a tertiary care teaching hospital Int. J Pharm Life Sci. 2011;2(5):767-72.
Olowofela AO, and Isah AO. A Profile of adverse effects of antihypertensive medicines in a tertiary care clinic in Nigeria. Ann Afr Med. 2017;16(3):114-9.
Joffres M, Falaschetti E, Gillespie C, Robitaille C, Loustalot F, Poulter N, 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. BMJ Open. 2013;3(8):003423.
International drug monitoring: the role of national centres. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1972;498:1-25.
Kumar VR, Ram VR, Prasad BG, Mohanta GP, Manna PK. A study of adverse drug reactions due to antihypertensive drugs in a tertiary care teaching hospital. Int J Pharm Life Sci. 2011;2(5):767-72.
Wallander MA, Dimenas E, Svardsudd K, Wiklund I. Evaluation of three methods of symptom reporting in a clinical trial of felodipine. Eur J Clin Pharmacol. 1991;41:187-96.
Parthasarathi G, Olsson S. Adverse drug reactions. In: Parthasarathi G, Nyfort-Hansen K, Nahata MC, eds. A textbook of clinical pharmacy practice. 1st ed. Chennai: Orient Longman Pvt Ltd; 2004: 84-102.
Garg KC, Singhal KC, Kumar S. Monitoring the adverse profile of atenolol a collaborative study. Indian J Physiol Pharmacol. 1993;37(3):213-6.
Uppsala Monitoring Centre. Fact sheet: The use of the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) system for standardised case causality assessment, 2006. Available at: http://who-umc.org/graphics/4409.pdf. Accessed on 6 April 2021.
Dhikav V, Singh S, Anand KS. Adverse drug reaction monitoring in India. J Indian Acad Clin Med. 2004;5(1):27-3.
Riley J, Wilton LV, Shakir SA. A post marketing observational study to assess the safety of mibefradil in the community of England. Int J Clin Pharmacol Ther. 2002;40(6):241-8.
Singh RB, Suh IL, Singh VP, Chaithiraphan S, Laothavorn P, Sy RG, et al. Hypertension and stroke in Asia: Prevalence, control and strategies in developing countries for prevention. J Hum Hypertens. 2000;14(10-11):749‐63.
Naranjo CA, Busto U, Sandor P, Ruiz I, Roberts EA, Janecek E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.
Amit S, Tanpreet KB, Vishal G, Mahendra SR, Manik C. Drug utilization study on hypertensive patients and assessment of medication adherence to jnc-8 guidelines in north indian tertiary care hospital: a cross-sectional study. Adv Res Gastroentero Hepatol. 2018;9(1):555751.
Tasneem S, Fouzia N. Drug utilization study in ischemic heart diseases associated with diabetes and hypertension. International J Pharma Biosci. 2010;1(3):1-4.
Khurshid F, Aqil M, Alam MS, Kapur P Pillani KK. Monitoring of adverse drug reactions associated with antihypertensive medicines at a university teaching hospital in New Delhi. Daru. 2012;20(1):34.
Mohd AH, Mateti UV, Konuru V, Parmar MY, Kunduru BR. A study on prescribing patterns of antihypertensives in geriatric patients. Perspect Clin Res. 2012;3(4):139-42.
James PA, Oparil S, Carter BL, Cushman WC, Himmelfarb CD, Handler J, et al. Evidence-based guideline for the management of high blood pressure in adults. Report from the panel members appointed to the eighth joint national committee (JNC 8). JAMA. 2014;311(5):507-20.
Paudel S, Chetty MS, Laudari S, Subedi ND. Adverse drug reactions of antihypertensive agents at tertiary care hospital in central Nepal. JCMS Nepal. 2017;13(2):284-9.
Ramesh M, Pandit J, Parthasarathi G. Adverse drug reactions in a south Indian hospital–their severity and cost involved. Pharmacoepidemiol Drug Saf. 2003;12:687-92.
Brunton L, Chabner B, Knollman B. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 12th ed. Boston: McGraw Hill; 2011.
Ganachari MS, Wadhwa T, Walli S, Disha AK, Aggarwal A. Trigger tools for monitoring and reporting of adverse drug reactions: A Scientific tool for efficient reporting. Open Access Scientif Rep. 2013;2:1-5.
Singh H, Kumar BN, Sinha T, Dulhani N. The incidence and nature of drug-related hospital admission: a 6-month observational study in a tertiary health care hospital. J Pharmacol Pharmacother. 2011;2(1):17-20.