The World Health Organization defines an adverse drug reaction (ADR) as “a response to a drug which is noxious and unintended, and which occurs at doses normally used in man for the prophylaxis, diagnosis, or therapy of disease, or for the modification of physiological function.” The fact that drugs might have effects on humans other than the ones intended has been known for many years. During the six month study period, a total 232 patients visited the tertiary care hospital and Celestee skin and hair Clinic. Highest number of patients were from the age group of 21-30 i.e. 33.81%. Majority of the ADRs were from the drug class antibiotics 24 (25.35%). According to Naranjo’s causality assessment scale, out of 71 ADRs the dechallenge was done in all cases, out of which 45 cases (63.3%) were probable and 14 cases (19.7%) were possible where as remaining 12 cases (16.9%) were in unlikely category. We also assessed the severity by using Hartwig and Siegel severity assessment scale; it shows that highest number of cases i.e.,42 (59.15%) fall into moderate type and 10 cases(14.08%) were mild type whereas 19cases (26.76%) fall into severe ADRs.

Keywords: Adverse drug reactions, Pharmacovigilance.

1.      TF Pearson, SR Mullis et.al. Factors associated with preventable adverse drug  reactions. American Journal of Health-System Pharmacy September 1994, 51 (18) 2268-2272;

2. Routledge, P. A., O'Mahony, M. S. and Woodhouse, K. W. (2004), Adverse drug reactions in elderly patients. British Journal of Clinical Pharmacology, 57: 121–126.
3. Alvarez-Requejo, A., Carvajal, A., Bégaud, B. et al. Under-reporting of adverse drug reactions Estimate based on a spontaneous reporting scheme and a sentinel system. EJ Clin Pharma col(1998)54:483.

4.      AJ Forster et.al. Pharmacist  surveillance  of  adverse  drug events. American  Journal of Health-System Pharmacy July 2004, 61 (14) 1466-1472;

5. Lazarou J, Pomeranz BH, Corey PN al. Incidence of Adverse Drug Reactions in Hospitalized Patients A Meta-analysis of  Prospective Studies. JAMA. 1998;279(15):1200-1205.
6. Arulmani, R., Rajendran, S.D. and Suresh, B. (2008), Adverse drug reaction monitoring in a secondary care hospital in South India. British Journal of Clinical Pharmacology, 65: 210–216.
7. Samuel, S. A., Rajendran, S. D., Ebenezzar, S., Jayaharan, S. and Azir, P. (2002), Surveillance of adverse drug reactions at two multidisciplinary hospitals and an outpatient specialty clinic in India. International Journal of Pharmacy Practice, 10: 115–120.
8. Jimmy Jose, PadmaG.M.Raoet.al. Pattern of adverse drug reactions notified by spontaneous reporting in an Indian tertiary care teaching hospital. Pharmacological Research Volume 54, Issue 3, September 2006, Pages 226-233
9. Herdeiro, M.T., Figueiras, A., Polónia, J. et al. Influence of Pharmacists’ Attitudes on Adverse Drug Reaction Reporting Drug-Safety (2006) 29: 331.
10. Adverse Drug Reactions, 2nd edition (ISBN: 0 85369 601 2) © Pharmaceutical Press 2006 Drug-induced skin reactions Anne Lee and John Thomson http://www.pharmpress.com/ files/docs/ADRe2Ch05.pdf.
11. Arndt KA, et al. 1976. Rates of cutaneous reactions to drugs. A report from the Boston Collaborative Drug Surveillance Program. J Am Med Assoc.,235:918–922.
12. Baldo BA, Pharm NH 1994. Structure-activity studies of drug- induced anaphylactic reactions. Chem Res Toxi col., 7:703– 721.
13. Coleman JW, Blanca M. 1998. Mechanisms of drug allergy. Immunol Today, 19:196–198.
14. Hafner JW, Belknap SW, Squillante MD, Bucheit KA. 2002. Adverse drug events in emergency department patients. Ann Emerg Med., 39:258-67.
15. Leyva L. 2000. Anticonvulsant-induced toxic epidermal necrolysis: monitoring the immunologic response. J Allergy Clin Immunol., 105:157–165.
16. Martin T and Li H. 2008. Severe cutaneous adverse drug reactions: a review on epidemiology, etiology, clinical manifes-tation and pathogenesis. Chin Med J (Engl), 121:756–61. (PubMed: 18701033)
17. Mauri-Hellweg D, 1995. Activation of drug-specific CD4+ and CD8+ T cells in individuals allergic to sulfonamides, phenytoin, and carbamazepine. J Immunol.,155:462–472.
18. Noel MV, Sushma M, Guido S. 2004. Cutaneous adverse drug reactions in hospitalized patients in a tertiary care centre. Indian J Pharmacol., 36:292-5.
19. Pichler WJ, et al. 1998. Role of T cells in drug allergies. Allergy, 53:225–232.
20. 2015 KIDS Symposium; ADR causality assessment and relief system in Asia, November 19, 2015.
21. Profile and Pattern of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis in a General Hospital in Singapore: Treatment Outcomes Acta Derm Venereol 2012; 92: 62–66Robert V. Sager, M.D.1936. Arch Intern Med (Chic). 57(4):666-694.
22. Sharma VK, Sethuraman G, Kumar B. 2001. Cutaneous adverse drug reactions: Clinical pattern and causative agents-A six-year series from Chandigarh, India. J Postgrad Med., 47: 95-9
23. Solensky R, Mendelson LM. 2001. Systemic reactions to antibiotics. Immunol Allergy Clin N Am., 21:679-97
24. Sulfanilamide Disaster FDA Consumer magazine June 1981Issue:https://wfda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SulfanilamideDisaster/ucm2007 257.html
25. Takahashi H and Yakushigaku  Zasshi, 2009. The history of adverse drug reactions, relief for these health damage and safety measures in Japan. 44 (2):64-70.

MK.Misbahuddin

Pharm-D, Bhaskar Pharmacy College, Yenkapally Village,

Moinabad, Hyderabad, Telangana, India