An Evaluation of Medication Safety related Communications in the Patient Healthcare Pathway in Kuwait

Abstract

Background: Patient safety is a recognised public health issue. When post-market medication safety information emerges, the benefits and risks of the medication concerned are usually evaluated by drug regulatory agencies. The outcomes of such pharmacovigilance activities are communicated to the public, patients and other healthcare professionals (HCPs). The aim of these medication safety communications might vary from improving the intended recipients’ knowledge or attitudes to outlining specific actions to be followed by them. However, it is currently recognised that sharing medication-related information does not improve patients’ safety on its own if not accompanied by an accurate implementation of these recommendations in clinical practice. Despite their importance in protecting patient safety and subsequently affecting public health, no previous study was found to have evaluated or described the process of creating and disseminating medication safety communications by the Kuwaiti drug regulatory agency. Equally, no study was found to have investigated the impact of or the factors affecting the implementation of regulatory-related medication safety communications in Kuwait. Therefore, this thesis aimed to address these gaps in knowledge by evaluating medication safety communications in the patient healthcare pathway in Kuwait. Methods: This multiphase study was preceded by a systematic literature review of the factors affecting HCPs’ implementation of regulatory-related medication safety communications, using a narrative synthesis approach. Following the systematic review, multiphase research was initiated. This consisted of three phases, each of which focused on a specific stakeholder group involved in the process of medication safety communication. Phase 1 involved Kuwait Drug and Food Control (KDFC), an administration within the Ministry of Health (MOH), as the regulatory agency responsible for pharmacovigilance activities. This was a convergent mixed-methods study. Data collection in this phase included documents produced by KDFC or issued to KDFC relating to medication safety and three face-to-face interviews with KDFC employees involved in pharmacovigilance activities. Documents were analysed using a descriptive quantitative approach and a framework analysis technique. Phase 2 focused on healthcare professionals working in MOH hospitals in Kuwait. This phase was an exploratory mixed-methods study, where focus group discussions were conducted followed by the distribution of an online survey. The focus group discussions were analysed using a thematic analysis technique. In the second part of this phase, an online survey was developed based on Phase 1, the focus group discussions and the systematic literature review. Survey data analysis included descriptive analysis (frequency and percentile) and statistical analysis including principal component analysis (PCA) and the Kruskal–Wallis H test, which was followed by a post hoc analysis of variables that had significant results. Other statistical tests applied included Fisher’s exact test, the Mann–Whitney U Test, and multivariate regression analysis. Participants’ answers to open-ended survey questions were analysed using a conventional content analysis technique. Phase 3 was an interpretive phenomenology study. This phase involved semi-structured phone interviews with six female patients of childbearing age who used a valproate-related medication for epilepsy or migraine. These patients had been prescribed the valproate-related medication in one of six secondary hospitals and one specialist neurology hospital within the MOH hospitals. An interpretive phenomenological analysis technique was applied to analyse the transcripts. Results: The results of the systematic literature review indicated that the factors affecting HCPs’ implementation of medication safety communications occur at multiple levels. These levels included the sources or senders of the safety information (delays in the delivery of medications safety communications), healthcare institutions (hospitals’ position and interpretations of the recommendations), the HCPs (knowledge of the content of medications safety communications), and the patients and/or their carers (willingness to use the medication concerned). Phase 1 revealed a lack of legislation and a pharmacovigilance-specific policy. Results from Phase 2 reflected poor knowledge of the concept of medication safety communications within the context of pharmacovigilance and a lack of familiarity with the tools used by KDFC to communicate emerging medication information among HCPs. In the survey, although the majority of HCPs who responded were aware of the teratogenicity of VRM (65.1%, (n = 110/169)), only 2.6% had responded correctly to the statements of the VRM KDFC recommendations. More than half of the participants (57%) reported changing their practice to accommodate at least one intended KDFC recommendation. Providing female patients with written information (37.2%) and counselling female patients about contraceptive use (37.2%) were the most reported intended changes in practice. The most reported barriers to implementation included not having the capacity in terms of time and/or the infrastructure to implement the recommendations (33.8%). Four themes originating from patient interviews included (1) the timeline of the patient’s experience (2) varied knowledge and perception with valproate use, (3) patient’s expectations from HCPs and (4) experiences and preferences towards medication safety communications. Conclusion: Medication safety communications are essential tools for disseminating information related to medication safety updates to HCPs, patients and the public. This research identified challenges at the level of the sender (KDFC) and the intended recipients (HCPs and patients) that could reduce the ability of KDFC’s medication safety communications to reach clinical practices. The first step in increasing their reach is to adapt electronic methods for disseminating such information. Involving stakeholders, such as HCPs and patients, in evaluating the clarity and understandability of KDFC’s medication safety communications should be the focus of future research.