Implementing Pharmacovigilance at Bathalapalli Hospital to Monitor Adverse Drug Reactions and Improve Patient Care

Kommanuru Venkata Ramakrishna Teja; Yiragamreddy Padmanabha Reddy; Nayakanti Devanna

Kommanuru Venkata Ramakrishna Teja Research Scholar, Department of Pharmaceutical Sciences, Jawaharlal Nehru Technological Sciences Anantapur, Ananthapuramu, Andhra Pradesh, India.
Yiragamreddy Padmanabha Reddy Raghavendra Institute of Pharmaceutical Education and Research (RIPER)-Autonomous, K. R. Palli Cross, Ananthapuramu-and Jawaharlal Nehru Technological Sciences Anantapur, Ananthapuramu, Andhra Pradesh, India.
Nayakanti Devanna Department of Chemical Engineering, Jawaharlal Nehru Technological Sciences Anantapur, Ananthapuramu, Andhra Pradesh, India.

Keywords: Adverse Drug Reaction, Awareness, Hospital, Patients, Pharmacovigilance

Abstract

Introduction: Although adverse drug reaction (ADR) monitoring is widely known, it is not practised in underdeveloped nations due to a lack of awareness and the absence of a central coordinating agency. The recent implementation of the National Pharmacovigilance Programme has encouraged ADR monitoring in some centres.

Methods: The purpose of this study was to evaluate the sternness of described ADRs, the additional financial costs associated with ADRs, and the present load of ADRs at a Rural Development Trust (RDT) Hospital in Bathalapalli, Andhra Pradesh, India. The study was carried out over 26 months of inpatient admissions to the medical wards.

Results: 37 of the 74 adverse drug events (ADEs) that were reported by 56 individuals were indeed ADRs. There were 521 patients admitted, and 9.7% of those ADRs occurred during hospitalisation. Males (56%) had ADRs more often than females (44%). During the hospital stay, no discernible difference between males and females was seen. ADR rates were 19.0%, 20.0%, and 61.0 % for paediatric, geriatric, and adult patients, respectively. Based on ADR severity, more than half of the reported reactions (76.49%) were in the moderate category, followed by mild (13.51%) and severe (10%) categories. 39.6% of patients recovered from the incident. The majority of the responses showed that the ADRs were unexpected and possibly avoidable.

Conclusion: According to the study’s findings, 90% of ADRs might be prevented, saving the health system money and decreasing patient expenditures. To prevent unknown and severe ADRs, new medications should be continuously monitored.

References

Zazzara MB, Palmer K, Vetrano DL, Carfì A, Onder G. Adverse drug reactions in older adults: a narrative review of the literature. Eur Geriatr Med. 2021;12(3):463-73. [PubMed] [Google Scholar]

Chouchana L, Preta LH, Tisseyre M, Terrier B, Treluyer JM, Montastruc F. Kidney disorders as serious adverse drug reactions of remdesivir in coronavirus disease 2019: a retrospective case–noncase study. Kidney Int. 2021;99(5):1235-6. [PubMed] [Google Scholar]

Micaglio E, Locati ET, Monasky MM, Romani F, Heilbron F, Pappone C. Role of pharmacogenetics in adverse drug reactions: an update towards personalized medicine. Front Pharmacol. 2021;12:651720. [PubMed] [Google Scholar]

Jwalapuram R, Ahad HA, Haranath C, Thadipatri R, Varshitha C, Kumar YB. A desktop reference to the solubility enhancement of drugs with the aid of surfactants. Int J Life Sci Pharma Res. 2020;11(5):11-6.

Choi JY, Choi JH, Kim MG, Rhie SJ. Signal detection of adverse drug reactions of cephalosporins using data from a national pharmacovigilance database. Pharmaceuticals (Basel). 2021;14(5):425. [PubMed] [Google Scholar]

Kumar YB, Ahad HA, Haranath C, Sumanth G, Pasupuleti DS, Reddy SS. Platelet rich plasma therapy: a quick note for every health care professional. Int J Life Sci Pharma Res. 2020;10(5):84-9. [Google Scholar]

Brabete AC, Greaves L, Maximos M, Huber E, Li A, Lê ML. A sex-and gender-based analysis of adverse drug reactions: a scoping review of pharmacovigilance databases. Pharmaceuticals (Basel). 2022;15(3):298. [PubMed] [Google Scholar]

Chiappini S, Vickers-Smith R, Guirguis A, Corkery JM, Martinotti G, Harris DR, Schifano F. Pharmacovigilance signals of the opioid epidemic over 10 years: data mining methods in the analysis of pharmacovigilance datasets collecting adverse drug reactions (ADRs) reported to EudraVigilance (EV) and the FDA Adverse Event Reporting System (FAERS). Pharmaceuticals (Basel). 2022;15(6):675. [PubMed] [Google Scholar]

Ahad HA, Chinthaginjala H, Sai VS, Jyothi VN, Tarun K, Reddy GS. A review on enzyme activated drug delivery system. Res J Pharm Technol. 2021;14(1):516-22. [Google Scholar]

Salvador MR, Monteiro C, Pereira L, Duarte AP. Quality of spontaneous reports of adverse drug reactions sent to a regional pharmacovigilance unit. Int J Environ Res Public Health. 2022;19(7):3754. [PubMed] [Google Scholar]

Bates DW, Spell N, Cullen DJ, Burdick E, Laird N, Petersen LA, Small SD, Sweitzer BJ, Leape LL. The costs of adverse drug events in hospitalized patients. JAMA. 1997;277(4):307-11. [PubMed] [Google Scholar]

Alshabi AM, Shaikh MA, Shaikh IA, Alkahtani SA, Aljadaan A. Knowledge, attitude and practice of hospital pharmacists towards pharmacovigilance and adverse drug reaction reporting in Najran, Saudi Arabia. Saudi Pharm J. 2022;30(7):1018-26. [PubMed] [Google Scholar]

Wang F, Xu G, Rong C, Wu X. Association between potentially inappropriate medication and adverse drug reactions in hospitalized elderly patients. J Clin Pharm Ther. 2021;46(4):1139-47. [PubMed] [Google Scholar]

Shravani Y, Ahad HA, Haranath C, Poojitha BG, Rahamathulla S, Rupasree A. Past decade work done on cubosomes and its factorial design: a fast track information for researchers. Int J Life Sci Pharma Res. 2021;11(1):124-35. [Google Scholar]

Coleman JJ, Pontefract SK. Adverse drug reactions. Clin Med (Lond). 2016;16(5):481. [PubMed] [Google Scholar]

Schurig AM, Böhme M, Just KS, Scholl C, Dormann H, Plank-Kiegele B, Seufferlein T, Graff I, Schwab M, Stingl JC. Adverse drug reactions (ADR) and emergencies: the prevalence of suspected ADR in four emergency departments in Germany. Dtsch Ärztebl Int. 2018;115(15):251. [PubMed] [Google Scholar]

Davies EA, O’Mahony MS. Adverse drug reactions in special populations–the elderly. Br J Clin Pharmacol. 2015;80(4):796-807. [PubMed] [Google Scholar]

Chung WH, Wang CW, Dao RL. Severe cutaneous adverse drug reactions. J Dermatol. 2016;43(7):758-66. [PubMed] [Google Scholar]

Kwan AS, Barry C, McAllister IL, Constable I. Fluorescein angiography and adverse drug reactions revisited: the Lions Eye experience. Clin Exp Ophthalmol. 2006;34(1):33-8. [PubMed] [Google Scholar]

Le J, Nguyen T, Law AV, Hodding J. Adverse drug reactions among children over a 10-year period. Pediatrics. 2006;118(2):555-62. [PubMed] [Google Scholar]

Kumar DP. Patterns of adverse drug reactions: a study in tertiary care. Int J Basic Clin Pharmacol. 2019;8(7):1497-502.

Nayak S, Acharjya B. Adverse cutaneous drug reaction. Indian J Dermatol. 2008;53(1):2. [PubMed] [Google Scholar]

Jung IY, Kim JJ, Lee SJ, Kim J, Seong H, Jeong W, Choi H, Jeong SJ, Ku NS, Han SH, Choi JY, Song YG, Park JW, Kim JM. Antibiotic-related adverse drug reactions at a tertiary care hospital in South Korea. Biomed Res Int. 2017;2017:4304973. [PubMed] [Google Scholar]

Lihite RJ, Lahkar M, Das S, Hazarika D, Kotni M, Maqbool M, Phukan S. A study on adverse drug reactions in a tertiary care hospital of Northeast India. Alex J Med. 2017;53(2):151-6. [Google Scholar]

Giardina C, Cutroneo PM, Mocciaro E, Russo GT, Mandraffino G, Basile G, Rapisarda F, Ferrara R, Spina E, Arcoraci V. Adverse drug reactions in hospitalized patients: results of the FORWARD (Facilitation of Reporting in a Hospital Ward) study. Front Pharmacol. 2018;9:350. [PubMed] [Google Scholar]