The development of modern medicines has greatly improved human health and quality of life. However, alongside their undeniable benefits, all medications carry the potential for unintended side effects, known as adverse drug reactions (ADRs). ADRs can range from mild discomforts to severe, life-threatening complications, contributing significantly to patient morbidity, prolonged hospitalizations, and rising healthcare costs worldwide. Recognizing and reporting these reactions is a cornerstone of pharmacovigilance—the scientific system dedicated to detecting, assessing, understanding, and preventing adverse effects or any other drug-related problems. Despite the critical role of pharmacovigilance in ensuring medicine safety, public awareness about ADRs and available reporting mechanisms remains alarmingly low, particularly in low- and middle-income countries like India [1-4].

In India, where a vast population relies heavily on prescription    and    over-the-counter   medications,   ADR  monitoring becomes even more vital. However, limited health literacy, lack of proactive counseling by healthcare providers, and insufficient public education about pharmacovigilance programs have contributed to widespread underreporting of adverse reactions. Many individuals fail to recognize early signs of side effects or do not understand the importance of communicating these events to healthcare authorities. Moreover, awareness about accessible reporting platforms such as the Pharmacovigilance Programme of India (PvPI), dedicated helplines, or online portals remains minimal, especially in semi-urban and rural areas [5-8].

Mandi district of Himachal Pradesh, characterized by its blend of rural and urban populations, provides a pertinent setting to assess the grassroots-level understanding of ADRs and pharmacovigilance. Factors like self-medication practices, use of traditional remedies alongside modern medicines, and fragmented healthcare delivery may further complicate ADR recognition and reporting behaviors in this region. Despite the critical need, there is scant district-level data evaluating public awareness and attitudes toward ADRs and available reporting systems.

This study seeks to bridge this gap by evaluating the knowledge, perceptions, and practices related to ADRs and pharmacovigilance among residents of Mandi. By identifying existing knowledge gaps and barriers to reporting, the research aims to inform strategies that can enhance community engagement in drug safety monitoring, ultimately contributing to safer healthcare outcomes.

Study Design

This study employed a descriptive, cross-sectional survey design aimed at assessing the awareness, knowledge, and practices related to adverse drug reactions (ADRs) and pharmacovigilance among the residents of Mandi district, Himachal Pradesh. The design was chosen to capture a snapshot of community understanding and behaviors regarding ADR identification and reporting systems.

Study Area and Population

The research was conducted across various urban and rural regions of Mandi, a district with diverse socio-demographic characteristics. The target population included adult residents aged 18 years and above, representing different educational, occupational, and socioeconomic backgrounds. Both individuals with past experiences of medication use and those without prior ADR experiences were included to obtain a comprehensive overview.

Study Duration

Data collection was carried out over a period of three months, from January to March 2025. This time frame allowed for both online and offline data gathering methods to maximize reach and participation.

Sample Size and Sampling Technique

Based on a 95% confidence level, 5% margin of error, and an assumed 50% awareness rate regarding ADRs due to limited previous data, a sample size of 400 participants was targeted. Purposive and snowball sampling techniques were used, with initial respondents recruited through community health workers, healthcare centers, social groups, and online platforms such as WhatsApp and Facebook. Snowball sampling enabled the inclusion of harder-to-reach populations in remote rural areas.

Inclusion and Exclusion Criteria

Inclusion Criteria:

• Adults aged 18 years and older residing in Mandi district

• Ability to understand and respond in Hindi or English
  Voluntary provision of informed consent

Exclusion Criteria:

• Healthcare professionals (doctors, nurses, pharmacists) to prevent professional bias

• Individuals with cognitive impairments that hindered survey participation

Data Collection Tool

A structured, pre-validated bilingual questionnaire (Hindi and English) was designed in consultation with pharmacologists, public health experts, and pharmacists. The questionnaire was divided into four sections:

• Demographic Information – Age, gender, education, occupation, residential setting (urban/rural).

• Knowledge about ADRs – Definitions, recognition of symptoms, examples of common ADRs.

• Awareness of Pharmacovigilance Systems – Knowledge of PvPI, reporting forms, helplines, and mobile apps for ADR reporting.

• Practices and Attitudes – Personal experiences with ADRs, likelihood of reporting, perceived barriers to reporting, and trusted sources of information.

Data Collection Procedure

Data were gathered through a combination of face-to-face interviews for participants with limited literacy and self-administered questionnaires for literate participants. Online surveys via Google Forms were also used for urban and tech-savvy respondents. Trained field investigators provided assistance where necessary, especially in rural and low-literacy areas, to ensure inclusivity and accuracy.

Scoring and Data Classification

Knowledge and awareness questions were scored with one point for each correct response and zero for incorrect or "unsure" responses. Based on cumulative scores, participants were classified into four categories: Very Good (≥80% correct responses), Good (60–79%), Fair (41–59%), and Poor (<40%). Practices and attitudes were analyzed through frequency distributions and cross-tabulated against demographic variables.

Data Analysis

Data were compiled in Microsoft Excel and analyzed using SPSS version 26.0. Descriptive statistics, such as frequencies and percentages, were used for initial analysis. 

Ethical Considerations

The study adhered strictly to ethical principles. Participation was voluntary, with informed consent obtained digitally or verbally before questionnaire administration. Anonymity and confidentiality were maintained throughout the study. 

The study surveyed a total of 400 participants from Mandi district, with the majority (39.0%) falling within the 26–35 years age group, followed by 25.3% in the 36–45 years group and 23.5% aged 18–25 years, indicating a predominantly young to middle-aged population. Females slightly outnumbered males, accounting for 52.8% of respondents. Educational backgrounds varied, with 35.5% having completed secondary education and 29.0% holding undergraduate degrees, whereas 8.0% had no formal education. In terms of occupation, homemakers comprised the largest segment at 33.5%, followed by self-employed individuals (22.8%) and students/unemployed (21.3%).  A   strong   rural   representation  was  observed, with 65.3% of participants residing in rural areas compared to 34.8% from urban settings, emphasizing the study’s focus on grassroots public health awareness across different living environments.

Table 1: Socio-Demographic Characteristics of Participants

Table 2: Awareness and Knowledge of Adverse Drug Reactions (ADRs) and Pharmacovigilance Among Participants

Table 3: Knowledge Score Classification

The assessment of awareness and knowledge regarding ADRs and pharmacovigilance revealed encouraging yet incomplete understanding among participants. A high percentage (77.0%) correctly identified ADRs as unintended side effects, and 73.5% recognized that any medicine could potentially cause ADRs. Awareness of pharmacovigilance was moderate, with only 60.3% correctly understanding it as drug safety monitoring, and knowledge about PvPI’s role was lower at 59.0%. Most participants (79.3%) understood that ADRs can be life-threatening, and 82.0% agreed that ADRs should be reported to healthcare providers. Additionally, 75.8% acknowledged self-medication as a risk factor, and 78.0% disagreed with ignoring mild side effects. However, less than two-thirds (55.8%) were aware of the existence of a helpline for ADR reporting, and only 59.8% knew that patients could directly report ADRs to PvPI. These findings highlight good fundamental awareness but notable gaps regarding reporting procedures and formal pharmacovigilance systems.

Based on overall knowledge scores, 42.8% of participants demonstrated a "Good" level of understanding (60–79% correct responses), while 29.5% achieved a "Very Good" score (≥80%), reflecting a reasonably positive baseline awareness of ADRs and pharmacovigilance concepts. However, 19.8% of participants exhibited only "Fair" knowledge (41–59%), and 8.0% were categorized under "Poor" knowledge (<40%), indicating a significant minority with substantial knowledge deficiencies. These results emphasize the need for more targeted and comprehensive educational initiatives to address misconceptions and to empower the public with the skills needed for effective ADR recognition and reporting.

The present study offers critical insights into the current state of public awareness regarding adverse drug reactions (ADRs) and pharmacovigilance systems among the residents of Mandi district, Himachal Pradesh. In an era where drug safety is an essential pillar of public health, it is encouraging that a substantial proportion of participants demonstrated good baseline knowledge about ADRs. Notably, 77% of respondents correctly identified ADRs as unintended drug side effects, and over 79% recognized that such reactions could be life-threatening. Furthermore, 82% acknowledged the importance of reporting ADRs to healthcare providers, underscoring a promising level of community engagement with basic drug safety principles.

However, the study also revealed significant knowledge gaps, particularly regarding the formal mechanisms available for ADR reporting. Less than 60% of participants were aware of the Pharmacovigilance Programme of India (PvPI) and its helpline or online reporting avenues. Alarmingly, only 59.8% knew that patients themselves could directly report ADRs without solely relying on healthcare professionals. These findings highlight a critical disconnect between awareness of ADRs and familiarity with the practical tools needed to contribute to pharmacovigilance efforts. Given that pharmacovigilance is not just a healthcare provider’s responsibility but a shared societal obligation, empowering patients with accessible, user-friendly knowledge about reporting systems is urgently needed.

The demographic analysis provides further nuances to these findings. Higher awareness levels were generally observed among younger and better-educated individuals, aligning with previous research suggesting that education significantly influences health literacy. Nevertheless, the strong rural representation (65.3%) in this study points to a persistent rural-urban divide. In rural settings, limited access to qualified healthcare providers, higher reliance on self-medication, and use of traditional remedies may exacerbate underreporting of ADRs. While 75.8% of participants identified self-medication as a risk factor for ADRs, ongoing practices suggest that knowledge does not always translate into safe behaviors. Moreover, the combination of herbal remedies and prescribed medicines—recognized by only 64.5% as a potential ADR risk—remains an underappreciated danger in traditional communities.

Another crucial finding is the misconception surrounding the severity of side effects. Although most respondents understood that even mild ADRs should not be ignored, a substantial portion still believed that mild symptoms could be self-resolved without intervention. This misperception may lead to delays in recognizing serious complications or in reporting crucial safety signals. Similarly, awareness that ADRs are more common among elderly patients (67.8%) and that proper reporting improves drug safety (79.0%) was relatively moderate, suggesting room for strengthening targeted education efforts, particularly for high-risk groups.

Behavioral practices and reporting attitudes were equally revealing. Despite recognizing the importance of ADR reporting, actual utilization of available channels remains questionable, as evidenced by the low awareness of the PvPI helpline and the passive approach towards self-reporting. This discrepancy suggests that interventions should not merely focus on raising knowledge but must also address practical barriers such as fear of repercussions, uncertainty about what constitutes an ADR worth reporting, and lack of trust in reporting efficacy.

Overall, the findings emphasize the urgent need for community-based educational interventions that go beyond awareness-building to foster proactive engagement with pharmacovigilance systems. Simple, culturally sensitive educational campaigns through local health workers, pharmacists, and digital platforms could demystify ADR reporting. Introducing ADR education into school health programs, incorporating counseling about side effects during every clinical prescription, and making PvPI reporting mechanisms more visible and accessible—such as mobile apps or SMS-based reporting for rural populations—could dramatically enhance community participation in drug safety monitoring.^8-10

While the study's cross-sectional design and exclusion of healthcare professionals ensured unbiased community-level insights, limitations exist. The reliance on self-reported data may introduce social desirability bias, and the purposive sampling technique may limit broader generalizability. Nevertheless, the robust sample size, rural-urban balance, and bilingual, inclusive data collection methods lend strength to the study's conclusions.

While Mandi district shows encouraging levels of basic ADR awareness, major gaps persist in practical pharmacovigilance knowledge and behavior. Bridging these gaps through sustained, grassroots-level interventions will be critical in enhancing patient safety, optimizing medication use, and strengthening India's national pharmacovigilance framework.

This study highlights that while a significant proportion of Mandi’s residents demonstrate a reasonable foundational understanding of adverse drug reactions (ADRs) and the importance of pharmacovigilance, critical gaps persist—particularly regarding the awareness of formal reporting mechanisms and the role of patients in contributing to drug safety surveillance. Although encouraging levels of knowledge were observed regarding the identification and dangers of ADRs, limited familiarity with the Pharmacovigilance Programme of India (PvPI) and low awareness of patient-led reporting channels point to an urgent need for targeted educational interventions. Rural populations, individuals with lower educational attainment, and those relying heavily on self-medication remain particularly vulnerable to underreporting and mismanagement of ADRs. To bridge the knowledge-practice gap, community-based awareness campaigns, proactive counseling by healthcare providers, integration of ADR education into local health initiatives, and widespread promotion of accessible reporting tools are essential. Strengthening pharmacovigilance participation at the grassroots level will be pivotal in improving medication safety outcomes, empowering patients, and fostering a more resilient and responsive healthcare system in India.

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