International Journal of Pharmaceutical Investigation, 2018, 8, 2, 69-73.
DOI: 10.4103/jphi.JPHI_24_18
Published: April 2018
Type: Original Article
Authors:
Siavash Shahbazi Nia
Department of Pharmacy Practice, Al‑Ameen College of Pharmacy, Bengaluru, Karnataka, India.
Shadan Modaresahmadi
Department of Pharmacy Practice, Al‑Ameen College of Pharmacy, Bengaluru, Karnataka, India.
Armin Eisa Zaei
Department of Pharmacy Practice, Al‑Ameen College of Pharmacy, Bengaluru, Karnataka, India.
ABSTRACT
Introduction: Adverse drug reactions (ADRs) are unavoidable and are considered as the fourth‑to‑sixth leading causes of death. It makes it essential to detect and monitor the ADRs. Hence, this study was aimed to identify the agents involved in the occurrence of ADRs and to identify and monitor the ADRs occurred in inpatients of a tertiary care hospital. Materials and Methods: It was a descriptive, prospective, observational study conducted for 2 years at a tertiary care hospital in Bengaluru, India. The ADRs were detected and monitored by interviewing the patients and reviewing the laboratory tests and medical charts. All the collected data were tabulated in Microsoft Excel 2016 and analyzed for possible results. Using Naranjo scale and Hartwig and Seigel’s severity assessment scale, the probability and severity of the reactions have been identified. Results: In this study, it was observed that majority of ADRs occurred in females. Patients belonging to the age group of 21–50 years old experienced higher number of ADRs than the patients in other age groups. The most commonly reported ADRs were associated with antimicrobial and cardiovascular agents. The most commonly reported ADRs were elevated liver function test (LFT) (12.2%) followed by diarrhea (9.5%). The gastrointestinal system was the most commonly affected organ system followed by fluid and electrolytes. Majority of the ADRs (55.1%) were found to be probable. In addition, the majority of the reported ADRs (84.2%) were mild. Conclusion: The results of this study provide a database of ADRs, which aids clinicians in optimized and safer use of medicines and this, in turn, might lead to an enhanced level of patient care.
Keywords: Adverse drug reactions, Hartwig and Seigel’s scale, Naranjo scale, Pharmacovigilance.