A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study


  • S. Sre Akshaya Kalyani Department of Clinical Pharmacy, Vaageswari College of Pharmacy, Karimnagar, Telangana
  • Pendota Srihitha Department of Clinical Pharmacy, Vaageswari College of Pharmacy, Karimnagar, Telangana
  • Katnapally Abhinay Sharma Department of Clinical Pharmacy, Vaageswari College of Pharmacy, Karimnagar, Telangana
  • Porandla Dharanija Department of Clinical Pharmacy, Vaageswari College of Pharmacy, Karimnagar, Telangana
  • Sandeep Kumar Bheemreddy Department of Clinical Pharmaceutics, Vaageswari College of Pharmacy, Karimnagar, Telangana




Adverse drug reaction, Adverse drug reaction reporting form, Naranjo’s and WHO causality assessment scales, Hartwig and Seigel scale, ADR incidence, CDSCO reporting form


Background: An adverse drug reaction (ADRs) is determined as response to a drug that is noxious unintended excludes therapeutic failures, overdose, drug abuse, noncompliance, and medication errors. The main aim of the study is to detect, understand and report ADR’S.

Methods: This study is prospective observational study conducted for 6 months in in-patient setting in a tertiary care hospital. Naranjo’s, WHO causality scale, Siegel scale, Schumock and Thornton scale are used to assess ADR. Graph Pad Prism and SAS software’s are used.

Results: Data was collected from a total of 1000 patients of which 121 (12.1%) patients were effected with 150 ADRs. Among 121 patients AdrAd was 60.66% and AdrIn was 39.33%. Of 121 patients 97 patients with single ADR, 28 patients with 2 ADRs, 10 patients were with three ADRs. ADR onset divides acute (10%), Latent (39%) and sub-acute (51%). ADR occurred are recovered (54%), Recovering (13%). Naranjos scale interprets definite (0.9%), probable (50.9%), possible (42.97%). According to WHO scale certain (2.7%), unlikely (2.7%), possible (38.84%). Hartwig and Siegel scale results are mild (12.4%), moderate (66.12%) and severe (12.4%). Schumock and Thornton preventability results are definitely (25.45%), probably (68.18%) and not preventable (6.36%).

Conclusions: Every health care professional should be aware of the Pharmacovigilance principles and also should be aware of suspected ADR reporting form of PVPI. By applying the above scales it is easy for health care professionals to assess an ADR.

Author Biography

S. Sre Akshaya Kalyani, Department of Clinical Pharmacy, Vaageswari College of Pharmacy, Karimnagar, Telangana

department of clinical pharmacy


Parthasarathi G, Olsson S. Adverse drug reactions. In: Parthasarathi G, Karin, Hansen N, Nahata MC, editors. A Textbook of Clinical Pharmacy Practice: Essential concepts and skills, Inc; 2004: 84-102.

American Society of Hospital Pharmacists. ASHP Assistance Bulletin on Hospital Drug Distribution and Control. Am J Hosp Pharm. 1980;37:1097-103.

Malhotra S, Karan RS, Pandhi P, Jain S. Role of adverse drug reactions and non-compliance Postgrad Med J. 2001;77:703-7.

Calis KC. National Institutes of Health Clinical Analysis of Adverse Drug Reactions. Hospital Pharmacy. 2004;39(7):697-712.

Kessler DA. Introducing MedWatch, using FDA for 3500. A New Approach to Reporting Medication and Device Adverse Effects and Product problems. JAMA. 1993;269:2765-68.

Bates DW, Boyle DL, Vander Vliet MB, et al. Relationship between medication errors and adverse drug events. J Gen Intern Med. 1995;10:199-205.

Katzung BG, Trevor AJ Development and regulation of drugs. In: Katzung BG. Ed. Basic and Clinical Pharmacology. 10th edn. Lange Medical Books/McGraw-Hill, New York. 2007.

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;28:1199-204.

Lazarou J, Pomeranz BH, Corey PN. Incidence of adverse drug reactions in hospitalized patients-a meta-analysis of prospective studies. JAMA. 1998;279:1200-5.

El-Eraky H, Thomas SHL. Effects of sex on the pharmacokinetic and pharmacodynamic properties of quinidine. Br J Clin Pharmacol. 2003;56:198-204.

Hermida RC, Ayala, DE, Calvo, C, Lopez, JE. Aspirin administered at bedtime, but not on awakening has an effect on ambulatory blood pressure in hypertensive patients. J Am Coll Cardiol. 2005;46:975-83.

Ahmed B, Nanji K, Mujeeb R, Patel MJ. Effects of polypharmacy on adverse drug reactions among geriatric outpatients at a tertiary care hospital in Karachi: a prospective cohort study. PloS One. 2014;17;9:e112133.

Rawlins MD, Thompson JW. Pathogenesis of adverse drug reactions. In: Davies DM, ed. Textbook of adverse drug reactions. Oxford: Oxford University Press; 1977: 10.

Arulmani R, Rajendran SD, Suresh B. Adverse drug reaction monitoring in a secondary care hospital in South India. Br J Clin Pharmacol. 2007;65:210-16.

Lang DM, Alpern MB, Visintainer PF, Smith ST. Increased risk for anaphylactoid reaction from contrast media in patients on beta‐adrenergic blockers or with asthma. Ann Intern Med. 1991;115:270-76.

Petri M, Allbritton J. Antibiotic allergy in systemic lupus erythematosus: a case‐control study. J Rheumatol. 1992;19:265‐9.

Gholami K, Shalviri G. Factors Associated with Preventability, Predictability, and Severity of Adverse Drug Reactions. Ann Pharmacother. 1999;33:236-40.

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;30:239-45.

World Health Organization (WHO). The Use of the WHO-UMC System for Standardised Case Causality Assessment. Geneva: WHO, 2014.

Hartwig SC, Siegel J, Schneider PJ Preventability and severity assessment in reporting adverse drug reactions. Am J Hosp Pharm. 1992;49:2229-32.

Tiwari P, Anuradha, D’Cruz S, Sachdev A Adverse Drug Reaction Monitoring in a North Indian Public Teaching Hospital. J Pharma Care Health Sys. 2016;3:164.

Amrinder R, Kaur I, Singh J, Kaur T, Monitoring of Cutaneous Adverse Drug Reactions in a Tertiary Care Hospital. J Pharmacovigilance. 2016;4:207.

Kharb P, Mittal N, Gu MC. An evaluation of adverse drug reactions monitoring at a Pharmacovigilance unit under Pharmacovigilance program of india in a tertiary care hospital of Haryana. Int J Basic Clin Pharmacol. 2015;4(3):556-60.

Lihite RJ, Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M, et al. A Study on adverse drug reactions in a tertiary care hospital of northeast india, Alexandria J Med. 2017;53(2):151-6.

Laskar JI, Chakravarty P, Dewan B. A study on incidence of adverse drug reactions with commonly prescribed drugs and causality assessment in Silchar Medical College and Hospital, Int J Basic Clin Pharmacol. 2017;6(5):1175-83.

Hardmeier B, Braunschweig S, Cavallaro M, Roos M, Pauli-Magnus C, Giger M, et al. Adverse drug events caused by medication errors in medical inpatients. Swiss Med Wkly. 2004;134(45-46):664-70.

Shamna M, Dilip C, Ajmal M, Mohan PL, Shinu C, Jafer CP. A prospective study on adverse drug reactions of antibiotics in a tertiary care hospital, Saudi Pharm J. 2014;22(4):303-8.

Goyal RK, Bhatt PA, Burande MD. Adverse drug reactions and Pharmacovigilance: Elements of Clinical Pharmacy: published by S. B Shah, 3rd edition: 2006: 126-7.

Gohel D, Bhatt SK, Malhotra S. Evaluation of Dermatological Adverse Drug Reaction in the Outpatient Department of Dermatology at a Tertiary Care Hospital. Indian J Pharm Pract. 2014;7(3):42-9.

Singh H, Dulhani N, Kumar BN, Singh P, Tewari P, Nayak K. A Pharmacovigilance Study in Medicine Department of Tertiary Care Hospital in Chhattisgarh (Jagdalpur), India. J Young Pharm. 2010;2(1):95-100.

Suman A, Devesh, Gosavi D. Study of Adverse Drug Effects of Antiepileptic Drugs used in Pediatric Patients in a Tertiary care rural Hospital-a Pharmacovigilance Study. J Young Pharm. 2017;9(1):60-4.

Bhabhor PH, Patel TK, Vahora R, Patel PB, Desai N. Adverse drug reactions in a tertiary care teaching hospital in India: analysis of spontaneously reported cases, Int J Basic Clin Pharmacol. 2014;3(6):1078-85.

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):2765-67.

Gaur S, Paramjeet S, Srivastava B, Bhardwaj R, Ahuja S, Gunjita B. Evaluation of Adverse Drug Reactions in teaching hospital in Kumoun Region. JMSCR. 2016;4(8):12139-45.

Pendota S, Kalyani SSA, Katnapally AS, Porandla D, Bheemreddy S. Classification and applying pharmacovigilance principles to study adverse drug reaction and its management. Int J Basic Clin Pharmacol. 2017;6(11):2537-44.

Kalyani. SSA and Srihitha.P, An Epidemiological Study on Adverse Drug Reactions in Indian Population: Meta-Analysis. Int J Pharm Clin Res. 2017;9(10):654-9.

Kalyani SSA, Pendota S, Katnapally AS, Porandla D, Bheemreddy S. Cross sectional study on prevalence and medication adherence of hypertension and diabetes in a tertiary care hospital in Karimnagar, India. Int J Basic Clin Pharmacol. 2018;7(4):807-12.




How to Cite

Kalyani, S. S. A., Srihitha, P., Abhinay Sharma, K., Dharanija, P., & Bheemreddy, S. K. (2019). A prospective observational study on incidence of adverse drug reactions in a tertiary care teaching hospital: a pharmacovigilance study. International Journal of Basic & Clinical Pharmacology, 8(11), 2423–2433. https://doi.org/10.18203/2319-2003.ijbcp20194778



Original Research Articles