Assessment of Adverse Drug Reactions (Anti Virals & Anti-Diabetics) in a Teritiary Care Hospital – Nellore

S. Nagabharathi*, Sk. Sadiqa Tanveer, K. Bhargavi, K. Kavya, G. Pramod Kumar, U. Varsha
Ratnam Institute of Pharmacy, Pidathapolur, SPSR Nellore

A b s t r a c t
Pharmacovigilance target towards signal detection, creating warning, restricting drug use, sometimes withdrawal of drug from market & finally decreasing mortality & risk of ADRs in patients. The present study was conducted in the Department of General medicine, AC Subba Reddy Government Medical College and tertiary care teaching hospital, Nellore, Andhra Pradesh. The study was conducted for four months from December 2022 to March 2023. The study was retrospective, non-interventional and observational type, as a part of routine post-marketing surveillance. On WHO causality scale, causality of maximum ADRs was possible (92.45 %) followed with probable, in line with study of Patel et.al (2015) but in contrary to Gungam et.al (2018). As per Rawlins and Thompson’s classification Type A ADRs account for 48.11 % followed by Type –C (41.51%), type- B and no case of Type –D, E,F. Severity of ADRs as per Hartwig’s scale was found to be of mild category (100%) in line with Gungam et al study. More precise side effects data on these drugs will help in reducing the ADRs burden and ascertain patient safety.
Keywords: Pharmacovigilance, Hartwig’s scale, post-marketing surveillance, ADRs.

References

• Kumar, S., Badruddeen., Singh, S.P. (2016). Pharmacovigilance: An inevitable path toward drug safety in India. International Research Journal of Pharmacy. 7(10), 1-7.
• Murphy, B.M., Frigo, L.C. (1993). Development, implementation, and results of a successful multidisciplinary adverse drug reaction reporting program in a university teaching hospital. Hospital Pharmacy. 28, 1199–1204.
• Tripathi, K.D. (2013). Essentials of Medical Pharmacology. Adverse drug effects (pp.82). New Delhi, India:Jaypee Brothers Medical Publishers (P) Ltd .
• Nimesh,S., Ashwlayan,V.D. (2018). Pharmacovigilance: An Overview. International Journal of Pharmacovigilance. 3 (1), 1-6.
• Ghosh, S., Leelavathi, D., Acharya , R. (2006). Study & evaluation of various cutaneous adverse drug reactions in kasturba hospital, Manipal. Indian Journal of Pharmaceutical. Sciences. 68 (2), 212-215.
• Chhetri, A. K., Saha, A., Verma S.C., Palaian, S., Mishra, P., Shankar, P.R. (2008). A study of adverse drug reactions caused by first line anti-tubercular drugs used in Directly Observed Treatment, Short course (DOTS) therapy in western Nepal, Pokhara. Journal of the Pakistan Medical Association. 58 (10), 531-536.
• Padmaja, U., Adhikari, P., Pereira, P. (2009). A Prospective Analysis of Adverse Drug Reactions in a South Indian Hospital. Online Journal of Health & Allied Sciences. 8 (3), 12.
• Rajesh, R., Vidyasagar, S., Nandakumar, K. (2011). Highly active antiretroviral therapy induced adverse drug reactions in Indian human immunodeficiency virus positive patients. Pharmacy Practice. 9 (1), 48-55.
• Divakar, B., Mistry, S. D., Kantharia, N. D., Mamtarani. (2012). The study of adverse drug reactions (ADR’s) in HIV patients taking highly active antiretroviral therapy in ART Centre, NCH, Surat, India. International Journal of Medicine & Pharmaceutical Sciences. 3 (2), 9-18.
• Mishra, S., Swain ,T.R., Mohanty, M. (2013). Drug reaction monitoring of antidepressants in the psychiatry outpatients department of a tertiary care teaching hospital. Journal of Clinical and Diagnostic Research. 7(6), 1131-1134.
• Shi, Q.P., Jiang, X.D., Ding, F., Yu, M.L., Zhang, S.Q. (2013). Adverse drug reactions & pattern use of cephalosporins: A retrospective review of hospitalized patients during 5 years. International journal of Pharmacology. 9 (1), 66-73.
• Joshi, N., Prajapati, H.K., Solanki ,K.C., Sukhlecha, A., Trivedi, H.R., Gajera, M.V., et.al. (2013). Pattern of adverse events following immunization in an Indian teaching hospital. International Journal of Medical Science and Public Health. 2 (1), 62-68.
• Vijayakumar, T.M., Dhanaraju, M.D. (2013). Description of adverse drug reactions in a multi-specialty teaching hospital. International Journal of Integrated Medicine. 1, 26.
• , Pinheiro., Castro., Momente., Pranchevicius. (2013). Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. Biomed central Pharmacology and Toxicology. 14, 5.
• Shamna, M., Dilip, C., Ajmal, M., Mohan, P.L., Shinu, C., Jafer, C.P., et.al. (2014). A prospective study on adverse drug reactions of antibiotics in a tertiary care hospital. Saudi Pharmaceutical Journal. 22 (4), 303–308.
• Susmitha Uppugalla , Kavitha Rajesh , Amareswarapu V Surendra , Kiran Kumar Y , Mohammed Gayasuddin , Sriram N , Prasad P Nadedkar. Effect Of Pisonia Alba Root Extract On Cafeteria Diet-Induced Obesity In Rats. Journal of Pharmaceutical Negative Results [Internet]. 2022 Dec. 1 3732-9.
• N Sriram , Susmitha Uppugalla , Kavitha Rajesh , S. Someshwara n , B Senthil Kumar , Prasad P Nadedkar , Shanta K Adiki. Cognitive Enhancing And Antioxidant Activity Of Ethyl Acetate Soluble Fraction Of The Methanol Extract Of Pisonia Alba Leaves In Scopolamine-Induced Amnesia. Journal of Pharmaceutical Negative Results [Internet]. 2022 Dec. 1 [cited 2023 Feb. 15];:3740-9.
• Purnachandra reddy guntaka , Sriram N , Sarad Pawar Naik Bukke , Kiran Kumar Y , H. Parameshwar , Saravanan Jaganathan , Susmitha uppugalla. Formulation And Evaluation Of Sustained Release Matrix Tablets Of Glimipride Using Natural Polymers Tamarind Seed Mucilage And Guar Gum. Journal of Pharmaceutical Negative Results [Internet]. 2022 Dec. 13: 5256-67.
• A Sivaranjini , Maya Ramteke , PK Senthilkumar , Alla Narayana Rao , D Phaneendra Pavan , A Gnanasekaran , N Sriram , Susmitha uppugalla. Antimicrobial properties of morinda reticulata gamble extracts against antibiotic-resistant pathogenic bacteria and toxin producing molds. Journal of Pharmaceutical Negative Results [Internet]. 2023 Jan. 1: 6633-9.
• Susmitha uppugalla , Chiranjib Bhattacharjee , Arunabha Mallik , N Sriram , G Sumithira , S Kameshwaran , S Sathya. Anticataleptic And Antiepileptic Activity Of Ethanolic Extract Of Leaves Of Morinda Reticulate : A Study On Role Of Dopaminergic System In Epilepsy In Albino Rats. Journal of Pharmaceutical Negative Results 2022 Dec. 10: 4987-91.
• Nirojini, P.S., Yemineni, R., Nadenla, R.R. (2014). Monitoring and reporting of adverse drug reactions in a south Indian tertiary care hospital. International Journal of Pharmaceutical Sciences Review and Research. 24(1), 259-262.
• Bhuvana, K.B., Hema, N.G., Sangeetha. (2014). A prospective observational study of adverse drug reactions to antiretroviral therapy: type and risk factors in a tertiary care teaching hospital. International Journal of Basic & Clinical Pharmacology. 3 (2), 380- 384.
• Purnachandra reddy guntaka, Sriram N, Sarad Pawar Naik Bukke, Kiran Kumar Y , H. Parameshwar, Saravanan Jaganathan, Susmitha uppugalla. Formulation and Evaluation of Sustained Release Matrix Tablets of Glimipride Using Natural Polymers Tamarind Seed Mucilage and Guar Gum. Journal of Pharmaceutical Negative Results. 2022 Dec. 13: 5256-67. | Google Scholar | Abstract |
• A Sivaranjini, Maya Ramteke, PK Senthilkumar, Alla Narayana Rao, D Phaneendra Pavan, A Gnanasekaran, N Sriram, Susmitha uppugalla. Antimicrobial Properties of Morinda Reticulata Gamble Extracts Against Antibiotic-Resistant Pathogenic Bacteria And Toxin Producing Molds. Journal of Pharmaceutical Negative Results, 2023 Jan. 1: 6633-9. | Google Scholar | Abstract |
• Susmitha uppugalla , Chiranjib Bhattacharjee, Arunabha Mallik, N Sriram, G Sumithira, S Kameshwaran, S Sathya. Anticataleptic and Antiepileptic Activity of Ethanolic Extract of Leaves of Morinda Reticulate: A Study on Role of Dopaminergic System in Epilepsy in Albino Rats. Journal of Pharmaceutical Negative Results, 2022 Dec. 10: 4987-91. | Google Scholar | Abstract |
• Koteswara Rao, P., Vikram Babu, B., Rama Krishna, A., Sushma Reddi, M., Sathish Mohan, B., Anjani Devi, K., Susmitha, U., Raghava Rao. T, Green Synthesis of Silver Nanoparticles using Litsea glutinosa L. Leaves and Stem Extracts and their Antibacterial Efficacy, . Journal of Water and Environmental Nanotechnology, 2022, 7(4): 363-369. | Google Scholar | Abstract |
• Susmitha Uppugalla , Kavitha Rajesh , Amareswarapu V Surendra , Kiran Kumar Y , Mohammed Gayasuddin , Sriram N , Prasad P Nadedkar. Effect of Pisonia Alba Root Extract on Cafeteria Diet-Induced Obesity in Rats. Journal of Pharmaceutical Negative Results. 2022 Dec. 1 3732-9. | Google Scholar | Abstract |
• N Sriram, Susmitha Uppugalla , Kavitha Rajesh, S. Someshwara N , B Senthil Kumar, Prasad P Nadedkar, Shanta K Adiki. Cognitive Enhancing And Antioxidant Activity Of Ethyl Acetate Soluble Fraction of The Methanol Extract of Pisonia Alba Leaves In Scopolamine-Induced Amnesia. Journal of Pharmaceutical Negative Results. 2022 Dec. 1: 3740-9. | Google Scholar | Abstract |