Knowledge, Attitude, and Practice of Adverse Drug Reaction Reporting among Community Pharmacists in India: A Review

INTRODUCTION

According to the World Health Organization (WHO), pharmaceutical companies are legally required in all countries to test their drugs on both healthy volunteers and patients before making them widely available. These clinical trials determine the efficacy of a drug for a specific disease and assess potential harms; however, such trials offer limited information about broader, untested populations that may differ in age, gender, health status, or ethnic background.

WHO further emphasizes that, especially for complex medicinal products, safety monitoring must continue beyond the manufacturing phase. Ongoing medicine safety requires systematic patient monitoring and continued scientific data collection, a process referred to as postmarketing surveillance. The organization notes that the effectiveness of national postmarketing surveillance systems is critically dependent on the active participation of healthcare professionals. Since physicians, pharmacists, nurses, and dentists are uniquely positioned to observe patients in routine care, WHO recommends that they report all suspected Adverse Drug Reactions (ADRs) even when uncertainty exists regarding the causal relationship between the drug and the reaction (World Health Organization).

Pharmacovigilance, defined as the science and practice of detecting, assessing, understanding, and preventing adverse effects or other medicine or vaccine-related problems, is a vital component of modern healthcare systems (World Health Organization, n.d.). Healthcare professionals occupy a pivotal position in pharmacovigilance by detecting, documenting, and reporting adverse drug reactions, educating patients, ensuring data quality, and contributing to risk communication and policy development. Their active engagement is indispensable for strengthening drug safety surveillance and ensuring patient protection.

The Pharmacovigilance Programme of India (PvPI) is India’s national drug safety monitoring program, launched in 2010 by the Ministry of Health and Family Welfare, to collect and analyze reports of ADRs and medication safety issues to protect patient safety and welfare (Pharmacovigilance Programme of India, n.d.).

In many countries, including India, the scope of ADR reporting has been expanded beyond physicians to include hospital pharmacists, community pharmacists, nurses, and even patients, in an effort to enhance reporting rates. Given their frequent interactions with the public and their involvement in dispensing over-the-counter medications, community pharmacists are well-positioned to identify potential ADRs. Consequently, they can play a pivotal role in the detection, management, and reporting of ADRs, thereby making a significant contribution to the PvPI (Selvam et al., 2024).

Despite many initiatives aimed at strengthening pharmacovigilance, underreporting of ADRs continues to pose a significant global challenge. In the context of community pharmacy practice, underreporting is frequently linked to a poor understanding of the concept and procedures of ADR reporting, which limits pharmacists’ active participation in the pharmacovigilance systems. Lack of adequate training, uncertainty regarding the causal relationship between a drug and a reaction, and limited awareness of reporting mechanisms further contribute to this problem (M S and R, 2018).

Specifically, this review aims to identify the current level of awareness and understanding of ADR reporting among community pharmacists, assess their attitudes toward pharmacovigilance activities, and examine their reporting practices. Furthermore, the review seeks to highlight the barriers and challenges that hinder effective ADR reporting and to explore the potential role of community pharmacists in strengthening the PvPI. As a final step, this review intends to provide evidence-based recommendations to enhance the participation of community pharmacists in ADR reporting, thereby contributing to the overall improvement of drug safety in the country.

This review adopted a narrative approach, synthesizing published studies found in electronic databases such as PubMed and Google Scholar, covering the period between 2012 and 2025. The selection criteria focused on studies specifically assessing the knowledge, attitude, and/or practice of ADR reporting among community pharmacists in India. Eight articles were selected, published between 2012 and 2024 (Table 1). Six studies were cross-sectional questionnaire-based surveys, while two studies used interventional approaches to assess the impact of education on awareness and practices. The total number of pharmacists participating across all included studies was 3,417, with individual study sample sizes varying significantly from 49 to 2,205 participants. Diploma in Pharmacy (DPharm) holders consistently represented most participants across most studies, with proportions ranging from 78% to nearly 98%.

Knowledge of Community Pharmacists Regarding ADR Reporting

Knowledge levels were found to be variable and often inadequate, as illustrated in Figure 1 and Table 2.

ADR Definition and Drug Safety

While a high proportion of pharmacists in one study (Article 7) reported knowing what an ADR is (91.4%), the ability to correctly define it was low in others (e.g., 37.5% in Article 4 and 14.7% in Article 3). Furthermore, a substantial percentage in some studies (e.g., 58.6% in Article 7) incorrectly believed that all dispensed or marketed drugs are completely safe, highlighting a fundamental misconception about the need for pharmacovigilance.

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CONCLUSION

Community pharmacists in India exhibit a positive attitude toward ADR reporting, overwhelmingly recognizing it as an essential professional duty that contributes to patient safety. However, this positive attitude is undermined by significant knowledge gaps, particularly a lack of awareness of the national PvPI system and inadequate training leading to suboptimal reporting practices. The primary barriers are a lack of awareness of the reporting system, a lack of time, and concerns about legal issues or professional image.

The evidence strongly suggests that regular and ongoing educational intervention programs are the crucial strategy for strengthening pharmacovigilance by improving pharmacists' knowledge, confidence, and adherence to reporting procedures.

Acknowledgement

None.

Conflict of Interest

The authors declare that there is no conflict of interest.