Archive \ Volume.13 2022 Issue 1

Strengthen the Monitoring and Reporting of Adverse Drug Reaction at a Tertiary Teaching Hospital

Khupngai Lalthanpuii , Jaspreet Kaur , Samriti Saini , Karun Bhatti , Parminder Nain
Abstract

Adverse Drug Reaction (ADR) is under-reported in India despite being the top producer of generic drugs in the world due to limited knowledge of the importance of reporting and monitoring ADR among the people of India; including the healthcare professionals. This perspective and observational study were designed to strengthen ADR monitoring over a period of six months based on medical records data analysis and personal interviews of patients. Data from various parameters were included in the evaluation like patient demographic characteristics, drug profile, and drug reaction outcomes. The severity of drug reaction and predisposing factors were also assessed. The overall incidence rate of serious ADRs in the patient population as per reports was 0.24% and gender was not significant risk factor. The highest ADR rate was 59.61% in 19-64 years and the moderate ADR rate was 19.23% in the age group of 65 years and above in general medicine wards. The most common ADR was urticaria with rashes, with an antibiotic class of drugs (42.3%). The majority of ADR (Type A reaction) had moderate severity, thus most of them require intervention, out of which 48.07% of the patients received symptomatic treatment. The most common disposing factor was poly-pharmacy (82.69%). The results obtained will contribute to the design of a new program for the Pharmacovigilance services i.e., ADR monitoring and reporting in every hospital throughout the nation. The quality and quantity of ADR reporting by clinical pharmacists will be strengthened and improved, which ensure the safer use of drugs in hospitals.



How to cite:
Vancouver
Lalthanpuii K, Kaur J, Saini S, Bhatti K, Nain P. Strengthen the Monitoring and Reporting of Adverse Drug Reaction at a Tertiary Teaching Hospital. Arch. Pharm. Pract. 2022;13(1):61-7. https://doi.org/10.51847/Zq3HaDzGqf
APA
Lalthanpuii, K., Kaur, J., Saini, S., Bhatti, K., & Nain, P. (2022). Strengthen the Monitoring and Reporting of Adverse Drug Reaction at a Tertiary Teaching Hospital. Archives Of Pharmacy Practice, 13(1),61-67. https://doi.org/10.51847/Zq3HaDzGqf

Download Citation
References

1.        Indian Pharmaceutical Industry: Current Scenario and Future Potential. 2021. Available from https://ey-ficci-indian-pharma-report-2021.pdf.

2.        Kalaiselvan V, Srivastava S, Singh A, Gupta S. Pharmacovigilance in India: Present Scenario and Future Challenges. Drug Safety. 2018;42(3):339-46.

3.        Tandon V, Mahajan V, Khajuria V, Gillani Z. Under-reporting of adverse drug reactions: A challenge for pharmacovigilance in India. Indian J Pharmacol. 2015;47(1):65-70.

4.        Pathak A. A Retrospective Analysis of Reporting of Adverse Drug Reactions in a Tertiary Care Teaching Hospital: One Year Survey. J Clin Diagn Res. 2016;10(8):FC01-4.

5.        Ogura J, Yamaguchi H, Mano N. Stimulatory effect on the transport mediated by organic anion transporting polypeptide 2B1. Asian J Pharm Sci. 2020;15(2):181-91.

6.        Ganachari M, Wadhwa T, Walli S, Khoda D, Aggarwal A. Trigger Tools for Monitoring and Reporting of Adverse Drug Reactions A Scientific Tool for Efficient Reporting. Open Access Sci Rep. 2013;2(4):1-5.

7.        Agrawal M., Singh, P, Hishikar R, Joshi U, Maheshwari B, Halwai A. Adverse drug reactions at adverse drug reaction monitoring center in Raipur: Analysis of spontaneous reports during 1 year. Indian J Pharmacol. 2017;49(6):432-6.

8.        Lihite R, Lahkar M. An update on the Pharmacovigilance Programme of India. Front Pharmacol. 2015;6:1-3.

9.        Roy D, Purkayastha A, Tigga R. Analysis of Adverse Drug Reaction in A Tertiary Care Hospital: A Retrospective Study. Asian J Pharm Clin Res. 2016;10(1):347-52.

10.      Shamna M, Dilip C, Ajmal M, Linu Mohan P, Shinu C, Jafer C, et al. A prospective study on Adverse Drug Reactions of antibiotics in a tertiary care hospital. Saudi Pharm J. 2014;22(4):303-8.

11.      Alomar M, Tawfiq AM, Hassan N, Palaian S. Post marketing surveillance of suspected adverse drug reactions through spontaneous reporting: current status, challenges and the future. Ther Adv Drug Saf. 2020;11:1-11.

12.      Shrestha S, Danekhu K, Kc B, Palaian S, Ibrahim MIM. Bibliometric analysis of adverse drug reactions and pharmacovigilance research activities in Nepal. Ther Adv Drug Saf. 2020;11:1-17.

13.      Lobo M, Pinheiro S, Castro J, Momente V, Pranchevicius M. Adverse drug reaction monitoring: support for pharmacovigilance at a tertiary care hospital in Northern Brazil. BMC Pharmacol Toxicol. 2013;14(5):1-7.

14.      Naranjo C, Busto U, Sellers E, Sandor P, Ruiz I, Roberts E, et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981;30(2):239-45.

15.      Hartwig S, Siegel J, Schneider P. Preventability and severity assessment in reporting adverse drug reactions. Am J Health Syst Pharm. 1992;49(9):2229-32.

16.      Lau P, Stewart K, Dooley M. Comment: hospital admissions resulting from preventable adverse drug reactions. Ann Pharmacother. 2003;37:303-4.

17.      Aronson J. Joining the DoTS: new approach to classifying adverse drug reactions. BMJ. 2003;327(7425):1222-5.

18.      Uchida M, Kawashiri T, Maegawa N, Takano A, Hosohata K, Uesawa Y. Pharmacovigilance Evaluation of Bendamustine-related Skin Disorders using the Japanese Adverse Drug Event Report Database. J Pharm Pharm Sci 2021;24:16-22.