A Prospective Observational Study on Assessment of Awareness in ADRs of Antibiotic Medications Using Knowledge, Attitude, and Practice (KAP) questionnaire

Antibiotics are substances that treat and prevent bacterial infections. World Health Organization (WHO) defines an Adverse Drug Reaction (ADR) as “A response to a drug that is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of disease, or therapy of disease, or for the modification of physiological function.”1

Macrolides, including erythromycin and azithromycin, are associated with usually reversible bilateral hearing loss or imbalance, particularly at high doses and in patients having renal or hepatic impairment. One study reported that 25% of pneumonia patients receiving 4 g/day erythromycin developed sensorineural hearing loss. Aminoglycosides may cause irreversible cochlear or vestibular damage in 10% to 20% of patients.2,3 Penicillin has been associated with low-frequency incidence of anaphylactic reactions, but it also has cross-reactivity with cephalosporins and other antibiotic classes.4 Nephrotoxic antibiotics include aminoglycosides and amphotericin B; however, other medications, including Sulfonamides, beta-lactams, acyclovir, fluoroquinolones, rifampin, and vancomycin, can also cause renal injury particularly when there is the presence of poly-medicating or other risk factors.5

Pharmacovigilance (PV) deals with the detection, collection, assessment, understanding, and prevention of adverse effects associated with drugs. pharmacovigilance’s goal is to keep drugs safe for patients by monitoring them for ADRs and reporting them when they happen. Data suggest that 0.2-24% of hospitalizations are caused directly or indirectly by ADRs, of which 3.7% result in the patient’s death. The reasons include the number of prescribed drugs, having many new drugs in the market, and inadequate PV systems for monitoring ADRs, and low levels of awareness or education among patients and healthcare providers about the need to report ADRs. Severe ADRs can increase the length of stay, treatment cost, risk of death, and may have many medical and economic implications. Reporting ADRs quickly may help to prevent patients from experiencing additional negative effects of prescription drugs. The rate of ADR reporting in India is less than 1%, while the worldwide average is around 5% due to a lack of awareness about pharmacovigilance and ADR monitoring among patients and healthcare providers.9

A KAP survey is the representative survey in a target population relative to the topic of interest. Information is collected in the form of semi-structured questionnaires or, more typically, through “Structured” or “Self-administered” questionnaires that can be administered both  qualitatively and quantitatively through either self-administration or interviewers.10

In India, other studies show that approximately 54% of all ADRs can be antibiotic-relate, with a notable proportion being severe.11

MATERIALS AND METHODS:

The tool employed to assess the knowledge, attitude, and practice (KAP) was a questionnaire. The KAP questionnaire was developed after a extensive literature review. The questionnaire was a survey model, with 25 item standard questions in Malayalam. KAP questionnaire contains 2 sections. The first section contains the demographic details. Followed section contains 3 subdivisions: knowledge related, attitude related, and practice related. A two-step validation process was accompanied for its relevance, clarity and simplicity. Face validity and content validity were employed on this questionnaire.

Step-01: the questionnaire was sent to an expert panel of 10 members via google form. They are professors and lecturers from department of pharmacy practice and were requested to evaluate the relevance, simplicity, and clarity of each item in questionnaire. The observations and suggestions were considered. Further the scale was assessed using Cronbach alpha.

Step-02: The questionnaire was pilot tested by administering it to a sample of 30 non-teaching staff at jamia salafiya pharmacy college who meet the eligibility criteria and were not aware of this study. The reliability were tested using Cronbach alpha, is 0.72 indicates acceptable

This study conducted among patients who were used antibiotics once in their lifetime. The statistical analysis was done using Microsoft excel.

RESULT AND DISCUSSION:

The study included a total of 475 participants.

 

 

Figure 1.Level of participants knowledge regarding ADRs of antibiotics

 

 

Figure 2.Level of participants attitude regarding ADRs of antibiotics

 

 

Figure 3.Level of participants practice regarding ADRs of antibiotics

A large proportion of participants had a moderate knowledge and neutral to positive attitude toward antibiotics and adverse drug reactions (ADRs), however, the majority of the participants had deficiency in safe practices was evident, with nearly 70% exhibiting poor practice score. This notable difference between what participants know and think about antibiotics compared to how they actually use them in consistent with the literature from various global KAP studies. For example, Azim et al., (2023) reported that while the general population in Bangladesh exhibited moderate knowledge and a favorable attitude towards antibiotic use and antimicrobial resistance (AMR), inappropriate practices such as self-medication and incomplete courses were prevalent, underscoring that awareness does not automatically translate into correct behavior.6 Similarly, Zhang et al., (2024) found among physicians and pharmacists managing sepsis that despite acceptable knowledge and supportive attitudes towards rational antibiotic use, gaps in implementation and inconsistent clinical practices persisted , highlighting systemic and behavioral barriers even among health professionals.7 Higuita-Gutiérrez et al., (2020) observed in Colombian medical students that, although knowledge and attitudes towards antibiotic resistance were relatively high, actual adherence to prudent antibiotic use practices lagged, reinforcing the recurring theme that educational attainment alone is insufficient to ensure optimal practices.8 In addition, the study conducted by Rayees et al., (2019) on monitoring studies on adverse drug reactions highlights the continued existence of poor practice behaviors, which includes inconsistent reporting of ADR, remain a significant challenge in clinical settings, further contributing to under-recognition and under-reporting of ADRs.4

These findings suggest that while awareness and positive attitudes are necessary components, they must be supported by targeted behavioral interventions, systematic training, and institutional strategies to effectively improve antibiotic use and ADR-related practices in both community and clinical environments.

CONCLUSION

In the study 475 patients participated. About 59.36% (n=323) of the patients were aware of the ADRs of antibiotics. Only fewer patients could identify signs of antibiotic-related ADRs. There are misconceptions persist, particularly the belief like effectiveness of antibiotics against viral infections. Practices related to antibiotics are less satisfactory.

CONFLICT OF INTEREST

The authors have no conflicts of interest regarding this study.

ACKNOWLEDGMENTS

The authors would like to express our sincere gratitude to Dr. Sirajudheen M K for providing the academic support and facilities necessary to carry out this research work successfully. The authors would like to thank Dr. Kameswaran R, Head of Department and respected guide Ms Anjali C S for their constant encouragement, valuable guidance, and thoughtful suggestions throughout the study. We are deeply extending our heartfelt thanks to Almas Hospital, where the study was conducted, for their permission and support during data collection.

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