Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India

Singh, Arpita; Jain, Abhilash; Soni, Maneesh; Shukla, Pooja; Lahon, Joonmoni; Verma, Ajay Kumar

doi:10.18203/2319-2003.ijbcp20201189

Cited by 3 publications

(2 citation statements)

References 14 publications

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“…This finding was similar to findings of numerous previous studies. 12,[16][17][18][19] The reason could be that antimicrobials are the most common class of drugs to be used in hospital settings. So, the chances of ADRs being reported due to them are also high.…”

Section: Discussionmentioning

confidence: 99%

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A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

Kumar

Singh²,

Seth³

et al. 2022

Int J Basic Clin Pharmacol

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Background: Adverse drug reactions (ADRs) are one of the prime causes of morbidity and mortality, increase in hospital stay and socioeconomic burden on the patients. Periodic monitoring aids in formulating methods for safe usage of medicines in hospitals. Identification of ADRs and their reporting pattern can provide useful information for their prevention. Hence this study was done to see the pattern of reported ADRs in Patna Medical College and Hospital, Patna in a 3 months of study.Methods: It was an observational and retrospective study carried out between July 2022 to September 2022. Both outpatients and inpatients were included in the study. The ADRs in the form of Individual Case Safety Reports (ICSRs) were sent to the nearby adverse drug reaction monitoring centre (AMC).Results: The occurrence of ADRs was more common in females (56.25%) as compared to males (43.75%). Patients of age-group 21-40 years (40.625%) were most commonly involved. Medicine department (34.375%) reported the maximum percentage of ADRs. Antimicrobials (37.50%) was the most common drug-group causing ADRs. Maximum reported ADRs (81.25%) were probable, 9.375% were possible, 6.25% were certain, while 3.125% were unlikely with the suspected drug as per Naranjo scale.Conclusions: The pattern of ADRs reported in our hospital is comparable with the results of studies conducted in hospital setup elsewhere, along with a few differences. The study results revealed opportunities for interventions in ADR management especially for the preventable ADRs to ensure safer drug use.

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Section: Discussionmentioning

confidence: 99%

“…This result was in concordance with some previous studies. 18,19 The reason for being most of the ADRs under probable or possible causality assessment was due to lack of information provided by patients on causality assessment by Naranjo scale. And also due to many ethical issues rechallenging was hardly done.…”

Section: Discussionmentioning

confidence: 99%

A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

Kumar

Singh²,

Seth³

et al. 2022

Int J Basic Clin Pharmacol

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A Prospective Observational Study of Monitoring and Reporting of Antimicrobial Drugs Associated Adverse Drug Reactions and Their Significance on Patients Safety and Health-Care Outcomes

ZEENATH UNNISSA,

MAHER UNISSA,

SHAISTA KHAN

et al. 2024

Asian J Pharm Clin Res

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Objective: Adverse drug reaction (ADR) surveillance and reporting practices are at an early stage of development within the Indian context. The pharmacovigilance rate in India falls below 1%, which is notably lower compared to the global average of 5%. India holds the position of being the fourth most significant contributor to the pharmaceutical industry worldwide. Therefore, there exists a pressing demand to enhance the pharmacovigilance framework for safeguarding the health of the Indian population. ADR is defined as the unintended, obnoxious, and unwanted reaction due to the use of a drug. The administration of antimicrobial agents causes various ADR that has been analyzed throughout the study. The main objective of the research is to monitor and report the adverse drug reaction caused by antimicrobial drugs Methods: A prospective observational study was carried out in the various departments of the hospital with duration of 3 months including 100 patients using patient profile form and ADR reporting forms and analyzing with the scales for causality, severity, and preventability assessment. Results: During the study, 29 ADRs were found among 100 patients, with an incidence rate of 9.6%, more common in females (52%) than in males (48%). ADRs were most frequently reported in the age group of 35–51 years (34%), then 18–34 years (28%), and 1–17 years (24%). The general medicine department reported the highest number of ADRs (66%), followed by the pediatric department (24%). Cephalosporins caused the most ADRs (35%). Common ADRs included constipation, diarrhea (34%) and rashes, nausea, and vomiting (34%). Naranjo scale indicated that the causality of ADRs was probable (52%). Hartwig severity scale showed 55% ADRS to be mild. Schumock and Thornton method found that 76% of ADRs were preventable.Management of most of ADRs included drug withdrawal (52%). Conclusion: The majority of cephalosporin-related side effects, which included constipation, diarrhoea, and rashes, were observed. Most of the patients got better with the help of ADR monitoring and management. Finding and treating drug-related problems early make patients feel better and keep them safe. This study shows health-care system why it is important to monitor and report ADR caused by drugs.

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Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals

Roy,

Tayal,

Haque

et al. 2023

MAMC Journal of Medical Sciences

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Introduction: Pharmacovigilance plays an important role in patient safety and rationalizing the use of medicines. It helps in identifying the frequency of adverse drug reactions (ADRs), their causes, and the associated risk factors. Pharmacovigilance activities are facilitated through adverse drug reactions monitoring centers (AMCs) in most of the institutions. Aim: The objective of this paper is to provide an overview to the health care professionals regarding ADRs reported from the associated hospitals of Maulana Azad Medical College (MAMC) and the pharmacovigilance activities undertaken. Observations: Maulana Azad Medical College, Department of Pharmacology was recognized as an AMC in 2014 under the Pharmacovigilance Program of India (PvPI). The AMC established a way for reporting ADRs both by spontaneously and through active monitoring of ADRs from different wards. The causality assessment of all ADR reports collected is done. The program was informed by a college pharmacovigilance committee, emails, and by putting posters in the hospital nursing stations. Fourteen training workshops for doctors and pharmacists and two training workshops exclusively for nurses have been conducted so far on pharmacovigilance. In 2017, a program to sensitize doctors working in the Delhi government hospital was started. A total of 854 healthcare workers have been sensitized. The center has reported a total of 2572 ADRs to the National Coordination Centre (NCC) at Indian Pharmacopoeia Commission until December 2021. ADRs reported were highest in the age group of 20 to 59 years. Most of the reports were from the department of T.B. and Chest (n = 589, 23.8%). The most common class of medicines implicated in causing ADRs was antimicrobials (n = 1100, 44%). Among the ADRs reported, the majority were mild (n = 1451, 81.1%) with 346 (18.8%) reported as serious. Conclusion: A system for reporting ADRs on campus has been established. The pattern of ADRs reported to this ADR monitoring center is comparable to the national and global data. Hospital-based ADR monitoring and reporting programs are very crucial to identify and quantify the risks associated with the use of medicines. The pharmacovigilance program at MAMC is a commitment and a small step towards patient safety.

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Pattern of adverse drug reactions reported at a tertiary care teaching hospital in northern India

Cited by 3 publications

References 14 publications

A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

A study of reporting pattern of adverse drug reactions in a tertiary care teaching hospital

A Prospective Observational Study of Monitoring and Reporting of Antimicrobial Drugs Associated Adverse Drug Reactions and Their Significance on Patients Safety and Health-Care Outcomes

Pharmacovigilance Activities in Maulana Azad Medical College and Associated Hospitals

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