Patient safety is an important tenet of the healthcare service model. The concept refers to the absence of preventable harm or a reduction of risk in healthcare service delivery (Azam, 2018). Despite the importance of maintaining high levels of patient safety, medical errors still occur. For example, some pharmacists have trouble safely distributing medication to patients because of systemic weaknesses affecting the healthcare system. Consequently, the role of pharmacovigilance emerges (Hauben & Hung, 2016). The World Health Organization (2019) refers to pharmacovigilance as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem” (p. 1).
This research proposal aims to investigate the role of pharmacists in Saudi government hospitals through pharmacovigilance. Its findings will be instrumental in improving patient safety standards in Saudi Hospitals. At the same time, they will be useful in informing policy decisions regarding drug administration in Saudi Arabia because new knowledge regarding the discipline will be generated in the Saudi Arabian context. Broadly, the findings of this study could be useful in helping other Middle Eastern countries that share the same political, social and economic dynamics of Saudi Arabia to improve pharmacovigilance in their jurisdictions because few studies have explored the role of pharmacists in the Middle Eastern context. The aims and objectives of the study are listed below.
Aims and Objectives
- This study will help to investigate the role of pharmacists in pharmacovigilance in Saudi government hospitals.
- This study will also help to emphasise the need for role clarity in the definition of healthcare services in the Saudi Arabian health sector because most works of literature have broadly explored patient safety issues
- The study will also help to explain what the field of pharmacy has done to enhance pharmacovigilance and what could be done to improve the outcomes
- This study will also try to evaluate the Saudi Arabian health environment with a specific interest in how e-prescription services can be integrated into it to enhance service delivery and minimise human errors in dispensing medicine
- Also, this study is designed to identify the main causes of inefficiencies in the Saudi Arabian health care system that could undermine the effectiveness of pharmacovigilance
- To evaluate the Saudi Arabian healthcare environment, relative to developments in pharmacovigilance and propose ways to improve it
- To review the main types of pharmacovigilance errors affecting Saudi Arabian public hospitals and propose new ways to minimise them
- To propose the best type of healthcare technology that can be used in dispensing medicine within the Saudi Arabian healthcare context
- To evaluate the role of pharmacists in influencing the healthcare environment within the context of adopting e-prescription services
Most of the works of literature that have explored the role of pharmacists in Saudi government hospitals through pharmacovigilance suggest that their main responsibility is collecting reports relating to adverse drug reactions (ADR) (Hauben & Hung, 2016; Azam, 2018; Sardella & Belcher, 2018; Hauben, Hung, Wood, Soitkar, & Reshef, 2017; van Leeuwen, Prendergast, Edwards, & Dawson, 2017). The same pieces of literature have tried to explore the important role played by pharmacists in promoting safe drug use (Hauben & Hung, 2016; Azam, 2018; Sardella & Belcher, 2018). Their findings suggest that, relative to the role played by these professionals in drug dispensing and compliance, they can help to improve ADR reporting (Lengsavath et al., 2017; van Leeuwen et al., 2017).
A study by Alharbi, Bahnassi and Alonazie (2016) showed that many pharmacists have insufficient knowledge regarding pharmacovigilance. Despite their lack of proper awareness or experience with pharmacovigilance, most of them have a positive attitude towards it. Alharbi et al. (2016) also suggest that pharmacists have adequate knowledge regarding ADR reporting. Based on these findings, it is suggested that improvements in ADR reporting could only happen if proper training is undertaken (Alharbi et al., 2016).
A study authored by Kaeding, Schmälter and Klika (2019) suggested that the European Union has created a heightened level of sensitivity towards the detection of ADR. This is a key part of pharmaceutical implementation in most member countries (Kaeding et al., 2019). Often, the implementation of pharmacovigilance is achieved through improvements in product safety and the provision of medicinal products that have a high safety record (Borg et al., 2015; Opadeyi, Fourrier-Réglat, & Isah, 2019). Calvo, Martinez-Gorostiaga and Echevarria (2018) also emphasise the importance of improving safety records as part of the process for implementing pharmacovigilance programs in Europe.
Alhawassi et al. (2018) shed light on the negative role played by the use of low-quality medicine in the improvement of patient safety standards. Consequently, they propose that healthcare expenditure should be based on procuring technologies that meet national standards of safety, such as those provided by the Saudi Food and Drug Authority. Nonetheless, medicine quality is regarded as a product of complex laws and regulations, which are influenced by the healthcare environment, manufacturing processes and robust pharmacovigilance practices (Singh, Twomey, & Baker, 2018). Broadly, the effective improvement of patient safety standards and the advancement of pharmacovigilance will depend on the proper education of different healthcare professionals, including (but not limited to) pharmacists, physicians, hospitals and patients. More importantly, there is a need to rethink existing regulatory provisions and quality standards to enhance the oversight services provided by health authorities in the dispensation of medicine (Alhawassi et al., 2018).
van Grootheest and de Jong-van den Berg (2015) say that communities and hospitals also play an important role in pharmacovigilance. Particularly, they draw attention to the need to have a concerted approach in managing medicine administration errors in the hospital setting, as opposed to only focusing on the role of the pharmacist in minimising these errors (van Grootheest & de Jong-van den Berg, 2015). However, similar to the views of Bate, Reynolds and Caubel (2018), van Grootheest and de Jong-van den Berg (2015) also emphasise the role of pharmacists in collecting data relating to ADR. However, the role of the pharmacist is split along the lines of varying responsibilities between the community and hospital pharmacists. Both sets of professionals play an important role in promoting the safe use of drugs and ADR reporting.
A Saudi Arabian study authored by Alharf et al. (2018) suggests that pharmacovigilance is important in the proper functioning of the country’s healthcare system. The researchers also suggest that having a robust healthcare system is integral to counteracting most of the hazards that exist in the administration of medicines (Alharf et al., 2018). These authors suggest that before the establishment of the Saudi Food and Drug Authority, pharmacovigilance activities were rarely reported in Saudi Arabia (Alharf et al., 2018). The establishment of the authority has helped to create the National Pharmacovigilance and Drug Safety Centre, which has helped to bolster the effectiveness of pharmacovigilance services. Notably, the government and associated health agencies have taken proactive steps to improve its performance, such as establishing pharmacovigilance guidelines to enhance work effectiveness. They have also enhanced communication and reporting tools, which have been instrumental in reducing the incidents of adverse drug events and their related effects (Alharf et al., 2018). Similar to other studies, which have highlighted the role of proper training in the management of pharmacovigilance studies, Alharf et al. (2018) additionally pointed out that the Saudi Food and Drug Authority has enhanced training opportunities for concerned staff and healthcare service providers.
Alshammari, Alshakka and Aljadhey (2017) also emphasised the role of the Saudi Food and Drug Authority in promoting pharmacovigilance services in the country. However, they say that stakeholders in the Saudi Arabian healthcare system have also integrated health institutions and marketing authorisation holders in promoting pharmacovigilance, regardless of their intensity of involvement in the process (Alshammari et al., 2017).
A South African study authored by Joubert and Naidoo (2016) provide a different perspective of pharmacovigilance by saying that all countries should ensure that the risks associated with drug use should not surpass known benefits (Joubert & Naidoo, 2016). They also underscore the role of pharmacists in information gathering. However, unlike other studies highlighted in this paper, they do not expressly draw reference to the collection of information relating to adverse drug events (Joubert & Naidoo, 2016).
The above-mentioned findings show that although many wealthy western countries have fully adopted and integrated the concept of pharmacovigilance, it is still a relatively new concept in Saudi Arabia (Alshammari et al., 2017). Almandil (2016) also supports the same view by saying many healthcare service professionals in Saudi Arabia still poorly understand the concept. Therefore, there is a need for all stakeholders to collaborate in making the concept successful. More importantly, researchers highlight the role played by marketing authorisation holders in supporting the process (Alshammari et al., 2017).
Broadly, many pharmacists are aware of pharmacovigilance but they have made little progress in reporting adverse drug events. Therefore, although they fully support pharmacovigilance, they are still unsure about the role they should play in the process. At the same time, a majority of pharmacists admit that because they would like to see improvements in the pharmacovigilance system, they want to undergo extra training to better understand and complement its goals. Broadly, these studies show that the role of pharmacists is largely limited to the task of reporting adverse drug events but their potential exists in improving their involvement beyond this task.
As highlighted in this paper, the current study will explain the role of pharmacists in Saudi hospitals through pharmacovigilance. The data collection process will be triangulated because there will be three key pillars of information inflow as outlined below.
Document Review: Information will be gathered from published documents, such as medical reports, institutional data, government publications and the likes. This source of data will help the researcher to understand the background and context of the role of pharmacists in pharmacovigilance.
Interviews: As a key source of primary data, information will be gathered from interviews that will be done on doctors and pharmacists that work in Saudi Arabian public hospitals.
Questionnaires: Another key source of primary data will be questionnaires, which will be distributed electronically and as a survey to four public health institutions in Saudi Arabia. The surveys will have closed questions because they will make it easier for the researcher to compare responses.
The biggest limitation to the above-mentioned data collection techniques is the difficulty associated with gathering information from busy respondents working in the Saudi Arabian health sector. However, the immense experience of the researcher in the country’s health service will be help to overcome this challenge.
Critical Justification of Methodology
As highlighted above, the proposed methods of data collection are listed below.
- Published and unpublished documents
- Key informant interviews
The first step in the data collection process will be to review information from the document review process. This procedure is adopted because secondary information will be used to structure the interview and survey questions. However, the researcher will use both sets of data (primary and secondary) to compare the merits and demerits of each technique and provide a basis for counter-checking both sets of information.
The proposed study will involve a large sample size for the survey (350 people) and a small sample size for the interview (11 people).
Data relating to the three sources of data highlighted in this proposal will be analysed to evaluate how they meet the study objectives.
Data will be obtained anonymously and the questionnaires translated to Arabic. Approvals to conduct the study will be sought from Saudi authorities and hospital administrators. Overall, the study will be undertaken in Saudi Arabia.
The proposed study is designed to improve the overall understanding of the role of pharmacists in Saudi government hospitals through pharmacovigilance. The study focus is supposed to improve the adoption of pharmacovigilance in Saudi government hospitals by explaining how it could be better integrated into the country’s healthcare system to address patient safety issues that may arise as a result.
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