Abstract
Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or other drug-related problems (World Health Organization, 2002). PV programmes place a responsibility and moral and ethical burden on doctors, nurses and other healthcare professionals.
Nurses have the potential to play an important role in recognising and reporting adverse drug reactions (ADRs) as they are routinely involved in drug administration within healthcare settings and are therefore often the first to observe adverse reactions and notify other members of the healthcare team.
However, their role in pharmacovigilance has not been widely explored, particularly in Southeast Asian countries, as the majority of previous studies on pharmacovigilance reporting have involved the role of physicians and pharmacists.
In this paper, the authors assessed hospital nurses’ Knowledge, Attitudes and Practice (KAP) in relation to PV activities. Barriers and facilitators impacting ADR reporting among hospital nurses in Malaysia were also examined in the study as were the relationships between demographic characteristics and predictors of KAP among hospital nurses in Malaysia.
This study showed that the participants (nurses) in this study had poor ADR knowledge (37.4%) and poor reporting practices (48.9%), but that increasing age and longer duration of work experience positively impacted ADR knowledge and reporting practices. This is worthy of further research to understand the factors involved in increasing age and duration of work experience.
It is noteworthy that more than 75% of the nurses verbally reported an ADR to either a relevant person or directly to the hospital pharmacy or hospital management. This may indicate an important evolving role for verbal reporting to a ‘relevant authority’ in hospitals as nurses may feel more comfortable making a verbal report. However, to reduce errors, a more formal and written reporting system could be built upon this if the reporting relationship is already in place informally.
The context of ‘a just culture’ has been adopted widely in other sectors such as the aviation industry to allow lessons to be learned from ‘near miss’ events (https://www.caa.co.uk/ghost/just-culture/#:~:text=We%20need%20an%20atmosphere%20of,law%20requires%20us%20to%20). It is important to explore if such a culture would work in the context of pharmacovigilance. Regulators need to play a key role here. The Health Products Regulatory Authority (HPRA) in Ireland has a simple webpage that members of the public can use to report ADRs with clear signage to the appropriate personal https://www.hpra.ie/homepage/about-us/contact-us.
This could easily be replicated in hospital settings. Mandatory reporting could also be explored with the appropriate support systems, policies and infrastructure in place.
Operational issues, such as lack of time, emerged as a barrier in this paper to reporting, and this needs consideration by hospital managers. It should be relatively speaking easier to address.
Cultural shifts, where reporting becomes the default or normal response on the other hand, are much harder to achieve and slower to implement, but with focused attention, investment and a top-down and ground-up approach can be successfully achieved https://www.pharmexec.com/view/building-a-thriving-culture-of-innovation-in-pharmacovigilance
https://www.frontiersin.org/articles/10.3389/fdsfr.2023.1257732/full
Emphasising of the importance of PV/ADR reporting to lay and non-lay populations through scientific and non-scientific multi-media may also be a useful strategy to improve reporting rates. This area could also be a good target for Continuous Professional Development programmes provided funding is provided to nurses from their employers to attend the training.
This study was conducted in hospital settings in Malaysia – this is only a fraction of the total numbers of patients taking medication in Malaysia. It is outside the scope of this paper, but more people take medications outside of hospital so the undetected adverse effects are potentially wider than discussed in the paper.