Knowledge, Attitude, and Practice (KAP) on Antibiotics, Adverse Drug Reactions (ADR), and ADR Reporting: A Comprehensive Review

Abstract

Antibiotics are crucial in combating bacterial infections, yet their misuse has contributed significantly to the emergence of antimicrobial resistance (AMR) and safety concerns related to adverse drug reactions (ADRs). This review examines the spectrum of antibiotic agents, their classifications, and the mechanisms by which they exert bacteriostatic or bactericidal effects. It discusses the types of ADRs associated with antibiotics, the importance of ADR reporting systems, and the challenges encountered in pharmacovigilance, including underreporting and data quality issues. The study provides a comprehensive examination of knowledge, attitudes, and practices (KAP) concerning antibiotic use and adverse drug reactions (ADRs) across diverse populations, underscoring prevalent misconceptions, existing awareness disparities, and inconsistencies in practice across various regions and sectors within the healthcare system. Healthcare infrastructure issues and inadequate policy support hinder healthcare professionals by creating obstacles to logical antibiotic use and efficient adverse drug reaction reporting, as well as motivational and educational challenges they encounter. Improving responsible antibiotic use and robust pharmacovigilance requires consistent training and ongoing educational interventions, ultimately influencing policy and intervention strategies aimed at combating antimicrobial resistance and enhancing patient safety.

Keywords

Introduction

ADR Reporting and Pharmacovigilance

Purpose of ADR Reporting Systems

ADR reporting systems are essential for the detection, assessment, and prevention of adverse drug effects, supporting safer and more reasonable medication use. They play a critical role in identifying safety signals, informing policy, and enhancing public health.⁷ In the context of AMR, pharmacovigilance databases can highlight suspected resistance and inappropriate antibiotic use, providing valuable data for antimicrobial stewardship and policy development.⁸

Reporting Mechanisms

Spontaneous Reporting: 

Healthcare professionals and patients can submit ADR reports directly to national pharmacovigilance centres. For example, the Netherlands Pharmacovigilance Centre (Lareb) collects and codes reports using standardized MedDRA terms.⁸

Electronic and Standardized Reporting: 

Many systems now use electronic forms and standardized coding (e.g., MedDRA), facilitating data sharing with international databases such as VigiBase and Eudravigilance.^7,8

Manufacturer Reporting: 

Marketing authorization holders must report ADRs, often relying on healthcare professionals for data collection.⁸

Other Tools: 

Traditional forms and focal points in hospitals and universities are also used to gather reports.

Challenges in ADR Reporting

• Underreporting: Many ADRs go unreported due to lack of awareness or motivation among healthcare providers and patients.
• Data Quality: Reports often lack completeness, making it difficult to assess causality or identify trends.⁷
• Interpretation Issues: Spikes in reporting may reflect regulatory changes rather than true changes in drug safety, and manufacturer-submitted reports can be harder to interpret for AMR surveillance.
• System Capacity: Limited resources and regulatory capacity in some countries hinder effective ADR reporting and analysis.⁸
• External Factors: Events such as pandemics can disrupt reporting trends and system priorities.⁷

Role of Healthcare Professionals

Healthcare professionals are the primary reporters of ADRs and play a vital role in pharmacovigilance. Their reports inform national and international drug safety databases, support antimicrobial stewardship, and help shape policy. Continuous training and awareness campaigns are crucial to improve reporting rates and data quality, especially regarding AMR-relevant terms and antibiotic use^7,8.

Knowledge, Attitude, and Practice (KAP) Studies

KAP Toward Antibiotics

Knowledge, Attitudes, and Practices (KAP) related to antibiotics involves evaluating individuals’ understanding, beliefs, and actions regarding antibiotic use, covering their awareness, perceptions, and actual behaviours. Understanding the public’s knowledge, attitudes, and practices regarding antibiotics is key to developing effective strategies for promoting their responsible use. Our study revealed that people’s knowledge, attitudes, and practices regarding antibiotic use are concerning. Here’s what we found:

Knowledge: Most respondents (52.29%) had average knowledge of antibiotics, but only a small percentage (10.82%) had high knowledge. Many people know that antibiotics work for bacterial infections, but few understand the risks of antibiotic resistance.

Attitudes: Most participants (67.84%) had a neutral attitude toward antibiotics, while some had negative (20.12%) or positive (12.04%) attitudes.

Responsible Use: Many people agree that antibiotics should be used responsibly, such as not taking them without a doctor’s advice or storing unused antibiotics for future use.

Misconceptions: Unfortunately, many people have misconceptions about antibiotics, such as thinking they can help with fever recovery or seeking another doctor if one does not prescribe them.

Practices: Approximately half of the respondents used antibiotics, while some had poor practices. People are more likely to seek medical advice for certain conditions but self-medicate for others.⁹

KAP Toward ADRs of Antibiotics

Medications can cause serious side effects, known as adverse reactions, which can affect anyone taking them. These reactions can be mild, severe, or life-threatening.¹⁰ Healthcare professionals require enhanced knowledge and training in the area of Adverse Drug Reaction (ADRs) reporting and administration. 

Attitudes: Motivating healthcare professionals to report ADRs is crucial, and some providers must be more proactive in changing treatment plans when ADRs occur.

Practices: While spontaneous reporting is fairly good in some settings, there is room for improvement in consistent reporting, documentation, and adherence to antibiotic guidelines.¹¹

KAP Toward ADR Reporting

Adverse Drug Reactions (ADRs) are harmful effects of medicines that meet to be reported to en

Knowledge: Pharmacists generally understood the ADR definition (88.8%), but a significant number (59.6%) misunderstood the reporting time for new/serious reactions. Higher education, professional titles, and training were associated with better knowledge scores.

Attitude: Most participants held positive attitudes (e.g., ADR monitoring is beneficial, reporting is a responsibility, willingness to undergo training). However, nearly half (48.4%) see reporting as an additional workload. Higher education and training were associated with more positive attitudes.

Practice: Although 70.9% of pharmacists encountered ADRs, only 67.3% reported them. Key barriers to reporting include uncertainty about the suspected drug, inability to definitively determine if it’s an ADR, and the complexity of the reporting process.¹²

Summary of the findings from the existing literature

Knowledge, Attitude, and Practice (KAP) Findings Across Different Populations (Comparative analysis)

Clinicians in Eastern India

• Knowledge: All surveyed clinicians understood the perceived risks of ADRs, but only 82.1% felt the need to report them.

Inadequate knowledge about drug interactions was also identified as a major factor contributing to ADRs

• Attitude: While 82.1% of clinicians recognized the need to report ADRs, 79.7% believed that only serious, unlabelled, or newly launched drug ADRs should be reported.

Attitudinal surveys worldwide have revealed similar observations to those in this study.

• Practice: Despite 87.7% of clinicians having encountered an ADR in their clinical practice, only 4.4% (6 of 138) had actually reported it, either to pharmaceutical companies or by publishing in a medical journal, and none had contacted regulatory authorities¹³ 

Hospital Pharmacists in Central China

• Knowledge: A high percentage of participants (88.8%) had a clear understanding of the ADR definition. However, 59.6% misunderstood the reporting time for new and serious ADRs. Pharmacists with higher education, professional titles and those who attended training, particularly clinical pharmacists, demonstrated higher knowledge scores. Conversely, pharmacists with lower academic qualifications, junior professional titles, and those without training had lower knowledge scores
• Attitude: Most pharmacists displayed positive attitudes toward ADR reporting. Almost all, being 95.1%, believe that monitoring adverse drug reactions benefits public health, and 84.9% view reporting them as a part of their duties. A small minority, 91.2%, disagree that severe adverse drug reactions alone should be reported, and 94.5% are willing to undergo training, yet a substantial 48.4% believe reporting adverse drug reactions will lead to extra workload. Male pharmacists and those under 35 years old showed slightly less positive attitudes
• Practice: While 70.9% of the pharmacists had encountered ADRs, 67.3% of them had reported these reactions. Clinical pharmacists had higher practice scores than dispensing pharmacists¹⁴

Hospital Pharmacists in Saudi Arabia

• Knowledge: Most pharmacists were aware of the pharmacovigilance (PV) concept (96.5%) and its functions (87.2%). Most also knew that a side effect is an ADR (86.5%) and that ADRs can be preventable or non-preventable (90%). A significant knowledge gap was identified in the PV field, with most participants struggling to provide accurate information about enhanced drug reactions, self-administered ADR treatment, global ADR locations, or the WHO's online platform for reporting adverse drug reactions, with only 2.1% of participants having the necessary information. 
• Attitude: A generally positive attitude was observed. 96.9% were interested in ADR reporting, agreeing that it is crucial for safe drug usage. All participants agreed that pharmacists should assist physicians in reporting. All pharmacists were encouraged to report ADRs if they were serious. However, 31.5% were worried about legal problems, and another 31.5% perceived reporting as time-consuming with no outcome
• Practice: 69.2% had received training in ADR reporting, and 70% reported ADRs more than once a week. Most hospitals had established systems for ADR reporting (74.7%) and standardized forms readily available (100%). The majority (96.5%) reported ADRs only when they were serious or life-threatening¹⁵

In Germany, a comparative analysis of reports shows that the majority originated from consumers (51.9%), with physicians accounting for 30.0% and pharmacists 18.2%. The number of reports from physicians and pharmacists steadily decreased from 2018 to 2021, while consumer reports increased from 2018 to 2020 before a slight decrease in 2021¹⁶

Knowledge Gaps

Across different populations and regions, a common thread is that while the basic awareness of ADRs and their importance is generally high, specific knowledge gaps persist. For clinicians in India, it was awareness of the procedure and whom to report to.¹³ For pharmacists in China, it was reporting time for serious/new ADRs.¹⁴ For pharmacists in Saudi Arabia, it was detailed PV concepts like augmented drug reactions or international databases¹⁵

Role of training and educational interventions

Training consistently emerges as a significant factor. Pharmacists who attended training in Central China showed higher knowledge, attitude, and practice scores.¹⁴ Similarly, the Saudi Arabian study noted that many pharmacists had not attended recent medication safety seminars or PV workshops, implying a need for more continuous education¹⁵

Barriers to Improve Antibiotic Use and Antimicrobial Resistance

Systemic Barriers

• External policy environment: Lack of national policies, weak enforcement, and insufficient resources hinder the effect of antibiotic use.
  • Inner setting: Infrastructure limitations, lack of data management technology, and inadequate government structures interfere with antimicrobial care programs.
• Available resources: Financial constraints, human resource shortages, and limited technological support hinder program implementation.
• Culture: Rigid structure, inter-professional disconnects, and patient–doctors tension creates barriers to effective collaboration and education.

Behavioural Barriers

Ø Knowledge and Beliefs: Limited awareness and uncertainty about intervention, resistance change, and established precipitation about practice hinder behaviour change.

ØMotivation: Lack of motivation, fear of patient complaints, and pressure from patient to prescribe antibiotics contribute to behavioural barriers.¹⁷

CONCLUSION

Antibiotics remain indispensable in modern medicine, but their misuse has led to rising antimicrobial resistance and preventable adverse drug reactions. While many healthcare professionals and the public understand the importance of antibiotic safety, there are clear gaps in knowledge, reporting practices, and attitudes toward pharmacovigilance. Strengthening education, simplifying reporting systems, and promoting responsible antibiotic use are essential steps to safeguard public health and enhance treatment outcomes.

ACKNOWLEDGMENTS

We are thankful to C S Anjali, Associate Professor, for her academic input and continuous support during the preparation of this manuscript.

The authors express their heartfelt gratitude to Prof. R. Kameswaran, Head of the Department of Pharmacy Practice, and Mr. M. K. Sirajudheen, Principal, Jamia Salafiya Pharmacy College, for their constant encouragement and valuable guidance throughout this work.

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