Antimicrobials associated adverse drug reaction profiling: a four years retrospective study (Pharmacovigilance study)

ABSTRACT

Background

All drugs profoundly modify our biological processes and may manifest as adverse drug reactions (ADRs), which are unpredictable and inevitable consequences. Antibiotics are a common cause of ADR, necessitating stopping or change of antibiotics. The incidence of ADRs increases with the number of drugs prescribed in a prescription, and antibiotics are rarely prescribed as monotherapy.

Aim

The study aimed to assess frequency, class of antibiotics, symptoms, causality, the severity of antimicrobial-associated ADRs, and see the demographic distribution.

Methods

ADRs were collected and filled in suspected ADR forms and sent via vigiflow to the National Coordination Centre-Pharmacovigilance Programme of India (NCC-PvPI). These ADR reports, termed individual case safety reports (ICSRs), were analyzed from Jan 2016 to Dec 2019.

Results

A total of 414 (54.33%) ICSRs of 762 were identified as antimicrobial-associated. Adults in the age group 19–65 years accounted for 345 (83.09%) of ADRs. A total of 192 (46.38%) were males, and 222 (53.14%) were females. Skin and subcutaneous tissue System organ class was involved in 54% of cases. In the causality assessment, 268 (64.49%) were “probable,” 123 (29.71%) were “possible,” and 23 (5.56%) were “certain.” On severity assessment, 256 ADRs (61.83%) were mild, 133 (32.12%) were moderate, and 25 (6.03%) were severe. A total of 54 antimicrobial agents, excluding anti-tubercular drugs, were identified, and antibacterial accounted for 268 (64.73%) ADRs, followed by antiviral 90 (21.73%), antiprotozoal agents 33 (7.97%) antimalarials anti-scabicidal, antifungal accounting for the remaining.

Conclusion

Antimicrobials play a crucial role in treating infections, and utmost vigilance during antimicrobials prescription reduces the frequency and severity of the ADRs, thereby reducing the morbidity and mortality and the pharmacoeconomic burden to the health care system. Pharmacovigilance must be boosted to ensure the safe and effective use of antibiotics and reduce the occurrence of ADRs.

KEYWORDS:

• Antimicrobials
• antibiotics
• adverse drug reactions (ADRs)
• individual case safety reports (ICSRs)
• severity of ADRs
• causality assessment

Acknowledgments

The authors thank the National Coordination Centre-Pharmacovigilance Programme of India, under the Indian Pharmacopoeia Commission, and Dr. Bhim Rao Ambedkar Memorial Hospital, & Pt. Jawaharlal Nehru Memorial Medical College, Raipur, Chhattisgarh, India, for support during collection and analysis of data.

Disclosure of potential conflicts of interest

Manju Agrawal, Preeti Singh, and Usha Joshi declare that they have no competing interests.

Additional information

Notes on contributors

Manju Agrawal

Manju Agarwal, MBBSMD assistant professor pharmacology Pandit Jawaharlal Nehru medical College Raipur Chhattisgarh India. Dr. Manju Agarwal is a competent dedicated faculty in the institute with more than 10 years teaching experience in pharmacology and 15 years of experience in clinical field. She is a trained biomedical researcher with more than 25 publications in various journals of national and international repute.

Preeti Singh

Preeti Singh, is a pharmacologist, currently working as pharmacovigilance associate at ADR Monitoring Center, Deptt. of Pharmacology, Pt. Jawaharlal Nehru Memorial Medical College Raipur Chhattisgarh India 492001 under Pharmacovigilance Programme of India (PvPI). She has 3 years of teaching experience in pharmacy & pharmacology and nearly 06 years of experience in Pharmacovigilance. She has  published more than 14 articles in various journals of national and international repute. Her current h-index is 5 and i10-index is 3. She has also authored a comprehensive book on Pharmacovigilance, which is currently in press.   Her area of expertise is toxicity study and pharmacovigilance.

Usha Joshi

Usha Joshi, Professor & HOD at  Pandit Jawaharlal Nehru medical College Raipur Chhattisgarh India. She has more than 11 years of experience in teaching. She is a trained biomedical researcher with more than 15 publications in various journals of national and international repute. Under her supervision ADR Monitoring centre is running by the PvPI.