A Study On Barriers Towards Reporting Of Adverse Drug Reactions Among Healthcare Professionals

Abstract

Healthcare professionals play an important role in the establishment and functionality of Pharmacovigilance in a country. Hence, it is important to understand the barriers and facilitators that could have a significant impact on Healthcare professionals (HCPs) beliefs and practices. However, barriers that lead to the underreporting of ADRs exist in all healthcare systems. For the identification of barriers and development of interventions, theoretical domains framework has been extensively been used. It consists of domains covering the main factors influencing behaviour and barriers to behavioral change. This study aimed to identify the barriers to reporting ADRs among healthcare professionals. An observational study was conducted over a period of 6 months at Srinivas Institute of Medical Science & Research Centre, Mukka, Dakshina Kannada. A self-designed questionnaire was used to collect data on the barriers faced by 70 HCPs in reporting ADRs. From the data collected, it was revealed that majority of the Healthcare professionals were aware of what ADR was and had knowledge on ADR reporting system in India, but few of the nurses (6) lacked skills in reporting ADRs. Most of the HCPs (46) had fear of litigation, majority of HCPs complained lack of time and heavy workload as a major barrier to reporting ADRs. HCPs who were part of the study also informed there was active reporting of ADRs by the HCPs in the hospital and that there was no lack of team work. Based on the data collected it was found most of the HCPs were highly motivated and they had no problem in reporting of ADRs. In this study, lack of time, heavy workload, fear of litigation and punishment were identified as the main barriers to reporting ADRs among Healthcare professionals.

Keywords

Introduction

       
           
       
    Figure 1: Healthcare Professionals involved

Table 1: Domains of identified barriers

In the category of “Knowledge” domain, the results revealed that 67 out of 70 healthcare professionals (96%) were aware of what ADR is and had knowledge on ADR reporting system in India. Lack of skills in reporting of ADRs were found in 6 out of 70 healthcare professionals (91%).  The study results showed that, interns and physicians did know about procedure of reporting ADRs and found it easy. However, reporting ADRs was reported to be not easy by few of the nurses, due to lack of skills. In “Beliefs about consequences” domain, 46 of the healthcare professionals (66%) had fear of litigation and in the "environmental constraints" domain, 50 health care professionals (71%) complained lack of time and 55 of the healthcare professionals told heavy workload (79%) as a major barrier to reporting ADRs. In “Social influences” domain all healthcare professionals participated in the informed that there was active reporting of ADRs by the healthcare professionals in the hospital and that there was sufficient team work between the healthcare professionals. No disapproval to reporting ADRs by hospital managers or by any other colleagues were reported by the participants. In "motivation and goals" domain, 45 healthcare professionals (64%) were highly motivated to report ADRs and reported that they never forget to report the suspected ADRs in the hospital. In "memory, attention and decision process" domain, 60 healthcare professionals (86%) informed that they had never forgotten to report suspected ADRs.

       
           
       
    Figure 2: Barriers identified in ADR Reporting

DISCUSSION

The study revealed that nurses, interns, and physicians in the hospital demonstrated a good understanding of what Adverse Drug Reactions (ADRs) are, as well as a comprehensive grasp of the ADR reporting system in India. This indicates that the medical staff is well-informed about the definitions and protocols associated with ADRs. In the "Skills" domain, the study found that both interns and physicians exhibited a high level of proficiency in reporting ADRs, considering the process to be straightforward and manageable. This suggests that these groups are well-equipped to handle ADR reporting efficiently as part of their routine practice. However, the study identified that some nurses encountered challenges in reporting ADRs due to skill deficiencies. This highlights a gap in training or experience among certain nursing staff, which may hinder the effectiveness of ADR reporting within the hospital setting. These findings are consistent with the results of a study conducted by Cheema E et al., [12]    In the domains of "Beliefs about Consequences," "Lack of Time," and "Heavy Workload," the study identified key barriers that hinder the reporting of Adverse Drug Reactions (ADRs) in the hospital setting. One of the major barriers noted was the fear of punishment and litigation, which discourages healthcare professionals from reporting ADRs. This fear is rooted in concerns about potential repercussions, including disciplinary action or legal consequences that might arise from acknowledging an ADR. Additionally, the study highlighted that a lack of time and increased workloads are significant obstacles to effective ADR reporting. Healthcare professionals often find themselves overwhelmed with their regular duties, leaving them with insufficient time to properly document and report ADRs. The heavy workload further exacerbates this issue, as the demands of patient care take precedence, pushing the task of ADR reporting to a lower priority. These findings align with those of a study conducted by Mirbaha F et al., which also identified fear of punishment and litigation, lack of time, and heavy workloads as primary challenges to ADR reporting among healthcare professionals. [11] In the "Social Influences" domain, the study observed that healthcare professionals in the hospital are actively engaged in reporting Adverse Drug Reactions (ADRs). There was no indication of a lack of teamwork or disapproval from hospital managers or colleagues regarding ADR reporting. This suggests a positive and supportive social environment where ADR reporting is encouraged and valued, fostering collaboration among staff and endorsement from management. On the other hand, in the "Motivation and Goals" domain, the study found that healthcare professionals were highly motivated to report suspected ADRs. Their strong commitment to patient safety and adherence to reporting protocols was evident. This high level of motivation indicates that healthcare professionals understand the importance of ADR reporting and are driven to contribute to the pharmacovigilance process.  In the "Memory, Attention, and Decision Process" domain, the study revealed that most healthcare professionals consistently remembered to report ADR cases. This consistent recollection and attention to detail highlight their dedication to maintaining accurate and timely ADR reports, ensuring that no cases are overlooked. These findings contrast with those of the study conducted by Mirbaha F et al. which reported issues related to social influences, motivation and memory, namely, challenges in team dynamics, managerial support, and the personal motivation and memory of healthcare staff, which negatively impacted ADR reporting practices. [11]

CONCLUSION

The important barriers assessed by the study were related to seven domains of Knowledge, Skills, beliefs about consequences, Motivation and goals, Environmental constraints, Social influences and Memory, attention and decision process. In this study, lack of time, Heavy workload, fear of litigation and punishment were identified as the chief barriers to ADR reporting ADRs. To overcome these barriers a comprehensive intervention should include time management training, strategies such as revising and shortening of reporting procedures and also to provide help in reporting of ADRs. To overcome fear of litigation and punishment we found that there is a need to educate healthcare professionals. Analysis of the study results indicates barriers to reporting highlights areas for focused effortOverall, this study provides a foundation for future initiatives aimed at enhancing ADR reporting practices, ultimately contributing to the goal of safeguarding patients' well-being and reducing healthcare costs.

REFERENCES

1. Gupta A, Kaur A, Shukla P, Chhabra H. Adverse drug reactions pattern in a tertiary level teaching hospital: A retrospective study. Indian Journal of Pharmacy Practice. 2017;10(1):27–31.
2. Iftikhar S, Sarwar MR, Saqib A, Sarfraz M. Causality and preventability assessment of adverse drug reactions and adverse drug events of antibiotics among Hospitalized patients: A multicenter, cross-sectional study in Lahore, Pakistan. Public Library of Science ONE. 2018;13(6).
3. Hussain R, Akram T, Hassali MA, Muneswarao J, Rehman Aur, Hashmi F, et al. Barriers and facilitators to pharmacovigilance activities in Pakistan: A healthcare professionals-based survey. Public Library of Science ONE. 2022; 17(7).
4. Belhekar MN, Tondare SB, Pandit PR, Bhave KA, Patel TC. A prospective study on causality, severity and preventability assessment of adverse drug reactions in a tertiary care hospital in India. International Journal of Basic & Clinical Pharmacology. 2019;8(1):104-10.
5. Shanmugam H, Panneerselvam N, Lawrence A. Adverse drug reactions of cardiovascular drugs in intensive cardiac care unit in a tertiary care hospital: A prospective study. Biomedical and Pharmacology Journal 2019;12:1079-83.
6. Sushma M, Kavitha R, Divyasree S, Deepashri B, Jayanthi CR. Questionnaire study to assess the knowledge, attitude and practice of pharmacovigilance in a paediatric tertiary care centre. Journal of Chemical and Pharmaceutical Research 2011; 3:416-22.
7. Kochhar DrAM. Pharmacovigilance Programme of India (PvPI) and Advantages of Enrolment as Adverse Drug Reaction Monitoring Centre (AMC) under PvPI. 2021. 
8. Thakare V, Dongerkery K, Langade D. Prospective observational study to evaluate adverse drug reactions pattern in a tertiary level teaching hospital. National Journal of Physiology, Pharmacy and Pharmacology. 2019;9(5):434–7.
9. Ferlie EB, Shortell SM. Improving the quality of health care in the United Kingdom and the United States: a framework for change. Milbank Quarterly. 2001;79(2):281–315.
10. Eccles M, Grimshaw J, Walker A, Johnston M, Pitts N. Changing the behavior of healthcare professionals: the use of theory in promoting the uptake of research findings. Journal of Clinical Epidemiology. 2005;58(2):107–12.
11. Mirbaha F, Shalviri G, Yazdizadeh B, Gholami K, Majdzadeh R. Perceived barriers to reporting adverse drug events in hospitals: A qualitative study using theoretical domains framework approach. Implementation Science. 2015;10(1):1–10.

Cheema E, Haseeb A, Khan TM, Sutcliffe P, Singer DR. Barriers to reporting of Adverse Drugs Reactions: A cross sectional study among community pharmacists in United Kingdom. Pharmacy Practice. 2017; 15(3)