Pattern and incidence of adverse drug reactions observed in cardiac clinic of tertiary hospital, Hakeem Abdul Hameed Centenary Hospital, Jamia Hamdard, New Delhi
Keywords:Adverse drug reaction, Coronary artery disease, Naranjo’s scale, Pharmacovigilance program of India
Background: The aim of the present study was to monitor the incidence and pattern of adverse drug reactions (ADRs) in cardiac care unit at Hakeem Abdul Hameed (HAH) Centenary Hospital.
Methods: Study was conducted with the permission of Institutional Ethics Committee. Patients visiting medicine outpatient department, cardiac clinic, medical ward, and emergency departments over a period of 15 months were recruited. ADRs were recorded on the prescribed form. Causality assessment was done using Naranjo probability scale. 223 patients of hypertension and stable coronary artery disease were enrolled of which 48.9% were males and 51.1% females. The most common prescribed drugs were ace-inhibitors, angiotensin receptor blocker, and beta-blockers. Other prescribed drugs were calcium channel blockers, statins, nitrates, and antiplatelets.
Results: A total of 44 ADRs were recorded. 26 ADRs were seen in females and 18 in males. Statins were the commonest drug associated with ADRs (29.5%) in our study. The most common organ system associated with ADRs in the present study was central nervous system followed by skin 15.9% each. The incidence of ADRs was about 20% of which 20% ADRs were probable, and 80% were possible. Maximum ADRs occurred in patients prescribed statins followed by beta-blockers and angiotensin receptor blockers.
Conclusion: There is a need for conducting such studies in more and more patients to see the pattern of ADRs in cardiac patients. More information will help in reducing the ADR occurrence and making drug use more rational and safe for patients.
Wikipedia. Demographics of India, 2015. Available at https://www.en.wikipedia.org/wiki/Demographics_of_India. Accessed 2 August 2015.
International drug monitoring: the role of national centers. Report of a WHO meeting. World Health Organ Tech Rep Ser. 1972;498:1-25.
Gupta SK. Pharmacovigilance: current status and future challenges (Editorial). Indian J Med Spec. 2013;4(1):1-4.
Gupta SK. Role of pharmacovigilance in ensuring safety of patients (Editorial). Indian J Med Spec. 2015;6(2):39-45.
Pharmacovigilance Programme of India. Indian Pharmacopoeia Commission, Ghaziabad; 2013. Available at http://www.ipc.gov.in/PvPI/pv_about.html. Accessed 2 August 2015.
Amrita P, Kharbanda B. Knowledge, attitude and skills of nurses of Delhi towards adverse drug reaction reporting. Indian J Pharm Pract. 2012;5:45-51.
Gupta R, Guptha S. Strategies for initial management of hypertension. Indian J Med Res. 2010;132:531-42.
Gupta R, al-Odat NA, Gupta VP. Hypertension epidemiology in India: meta-analysis of 50 year prevalence rates and blood pressure trends. J Hum Hypertens. 1996;10(7):465-72.
Kaul U, Bhatia V. Perspective on coronary interventions and cardiac surgeries in India. Indian J Med Res. 2010;132(5):543-8.
Kaur S, Kapoor V, Mahajan R, Lal M, Gupta S. Monitoring of incidence, severity, and causality of adverse drug reactions in hospitalized patients with cardiovascular disease. Indian J Pharmacol. 2011;43(1):22-6.
Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.
Mulkalwar S, Worlikar PS, Munjal N, Behera L. Pharmacovigilance in India. Med J DY Patil Univ. 2013;6(2):126-31.
Gholami K, Ziaie S, Shalviri G. Adverse drug reactions induced by cardiovascular drugs in outpatients. Pharm Pract (Granada). 2008;6(1):51-5.
Mohebbi N, Shalviri G, Salarifar M, Salamzadeh J, Gholami K. Adverse drug reactions induced by cardiovascular drugs in cardiovascular care unit patients. Pharmacoepidemiol Drug Saf. 2010;19(9):889-94.
Mahadevan L, Yesudas A, Sajesh PK, Revu S, Kumar P, Santhosh D, et al. Prevalence of genetic variants associated with cardiovascular disease risk and drug response in the Southern Indian population of Kerala. Indian J Hum Genet. 2014;20(2):175-84.
Alomar MJ. Factors affecting the development of adverse drug reactions (Review article). Saudi Pharm J. 2014;22(2):83-94.
Ofotokun I, Pomeroy C. Sex differences in adverse reactions to antiretroviral drugs. Top HIV Med. 2003;11(2):55-9.
Klotz U. Pharmacokinetics and drug metabolism in the elderly. Drug Metab Rev. 2009;41(2):67-76.
Fedacko J, Singh RB, Chaithiraphan S, Vargova V, Tomlinson B, Meester FD, et al. Clinical manifestations of adverse effects of statins, oxidative stress and possible role of antioxidants in prevention? Open Nutraceuticals J. 2010;3:154-65.
Karimzadeh I, Namazi S, Shalviri G, Gholami K. Cardiovascular drug adverse reactions in hospitalized patients in cardiac care unit. African J Pharm Pharmacol. 2011;5(4):493-9.
Singhal R, Khaleel A, Santani DD. Reporting and monitoring of adverse drug reactions with cardiac drugs. IRJP. 2011;2(7):116-9.