Abstract
Background and Objectives: There is a paucity of integrated knowledge regarding legal considerations required to ensure patient safety through safe medicines management. This study explores the legal considerations surrounding medicines management, providing a synthesis of existing knowledge. An integrative systematic review of the current international knowledge was performed. Materials and Methods: The search encompassed the online databases of PubMed (including Medline), Scopus, CINAHL, and Web of Science using MeSH terms and relevant keywords relating to the legal considerations of medicines management in healthcare settings. Results: The search process led to the identification of 6051 studies published between 2010 and 2020, of which six articles were found to be appropriate for data analysis and synthesis based on inclusion criteria. Research methods were varied and included qualitative interviews, mixed-methods designs, retrospective case reports and cross-sectional interrupted time-series analysis. Their foci were on the delegation of medicines management, pharmacovigilance and reporting of adverse drug reactions (ADRs) before and after legislation by nurses, physicians and pharmacists, medico-legal litigation, use of forced medication and the prescription monitoring program. Given the heterogenicity of the studies in terms of aims and research methods, a meta-analysis could not be performed and, therefore, our review findings are presented narratively under the categories of ‘healthcare providers’ education and monitoring tasks’, ‘individual and shared responsibility’, and ‘patients’ rights’. Conclusion: This review identifies legal aspects surrounding medicines management, including supervision and monitoring of the effects of medicines; healthcare providers’ knowledge and attitudes; support and standardised tools for monitoring and reporting medicines’ adverse side effects/ADRs; electronic health record systems; individual and shared perceptions of responsibility; recognition of nurses’ roles; detection of sentinel medication errors; covert or non-voluntary administration of medication, and patient participation.
Highlights
Estimates show that 421 million hospitalizations take place worldwide every year and that during hospitalization about 42.7 million adverse events occur, and 18.3% of adverse events are attributed to medication errors [5]
This systematic review, through integrating the findings of empirical qualitative and quantitative studies, augments our knowledge regarding the legal considerations for medicines management in healthcare settings
Knowledge of the law and legal considerations surrounding medicines management is often under-represented in healthcare curricula [34]
Summary
Health care is a complex system in which patients often experience harm resulting from the healthcare process itself [1,2]. It is too frequently accompanied by adverse events and medical errors [3], which are often preventable [4]. Estimates show that 421 million hospitalizations take place worldwide every year and that during hospitalization about 42.7 million adverse events occur, and 18.3% of adverse events are attributed to medication errors [5]. A systematic review of 25 studies conducted in 27 countries showed that 2.9–21.9% of patients were affected by at least one adverse event, many of which were medication-related, and
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