Understanding factors influencing the implementation of medicine risk communications by healthcare professionals in clinical practice: a systematic review using the Theoretical Domains Framework.

BACKGROUND: Adverse drug reactions (ADRs) are known to cause hospitalisation, longer hospital stays, as well as higher healthcare costs and mortality. Unrecognised ADRs are anticipated throughout the medicine lifecycle as, before the medicine reaches the market, clinical trials are conducted for a short period on a limited number of people, who might underrepresent the actual population. After the medicine reaches the market, emergent information that could affect its benefit-to-risk balance is usually shared by regulatory agencies and pharmaceutical companies through medicine risk communications. Medicines risk communications aim to prevent harm to patients by targeting their behaviour, knowledge, and attitudes, as well as those of health care professionals (HCPs). Despite their important role in translating these communications into their clinical practice, HCPs do not always adhere to the recommendations provided in risk communications. Measurement of medicine risk communications' effectiveness does not necessarily guarantee their implementation, cost-effectiveness, or transferability in real-world situations. To enhance the impact of drug regulatory interventions, implementation science has been encouraged. However, implementation science was not previously used to identify factors affecting HCPs' implementation of medicines risk communications. A recently widely used framework is the Theoretical Domain Framework (TDF). In this systematic review, the TDF was employed to categorise a range of different factors that could affect HCPs' implementation of medicine risk communications within their clinical contexts. METHODS: The search strategy involved a set of predefined search terms and fifteen databases, such as EMBASE, PubMed, Web of Science and CINAHL PLUS. Searches were conducted from April to May 2018 and updated in June 2021 using PubMed, Scopus, and CINAHL PLUS. A second reviewer independently conducted the screening process of the initial search. The total number of records screened was 10,475. A study was included if it reported any factors influencing HCPs' uptake of medicine risk communications. Only studies with English or Arabic abstracts were included. Those studies that did not include pharmacovigilance-related medicine risk communications were excluded. Additionally, studies only assessing HCPs' practice or evaluating the effectiveness of risk minimisation measures were excluded. Likewise, studies related to occupational hazards, case reports, interventional studies, and studies not involving HCPs were excluded. In case the published information was insufficient to decide whether to include or exclude a study, the authors were contacted. Furthermore, the authors of seven eligible abstracts were contacted for full-text articles. The mixed method appraisal tool (MMAT) was used to evaluate the quality of the included studies. All included studies were assessed by one reviewer, and a total of 16 studies were assessed by two reviewers independently. Disagreements were resolved through discussion. Using thematic analysis and concept mapping, a narrative synthesis was performed, followed by a critical reflection on the synthesis process. This review presents the results of the concept mapping, which involved matching the identified factors to the TDF. RESULTS: A total of 28 studies were included. Eleven domains influenced HCPs' implementation of medicine risk communications. A large number of studies included factors related to the "Knowledge" domain (n = 23), followed by "Beliefs about Consequences" (n = 13), "Memory, Attention and Decision Processes" (n = 12) and "Environmental Context and Resources" domains (n = 12). Seven studies reported "social influences" and six studies included factors relating to "Goals", followed by four studies involving factors related to "Social/Professional Role and Identity". Underrepresented domains included "Emotion" (n = 2), "Beliefs about Capabilities" (n = 2), "Behavioural Regulation" (n = 1), and "Reinforcement" (n = 1). On the other hand, none of the identified factors were related to the "Skills", "Optimism", or "Intentions" domains. Except for "Beliefs about Consequences", most studies contributing to the other three most commonly reported domains ("Knowledge"; "Environmental Context and Resources"; and "Memory, Attention and Decision Processes") scored low (1 or 2 out of 5) on the MMAT quality assessment. Moreover, the same number of studies (n = 5) contributing to the "Beliefs about Consequences" domain had low (1 or 2 out of 5), and intermediate (3 out of 5) scores on the MMAT. CONCLUSION: Medicines risk communications are important tools for disseminating information that may influence the benefit-to-risk balance of medicines. Even though HCPs are required to implement the recommendations of these communications, they do not always adhere to them. Using the TDF enabled the categorization of the range of factors that affect whether or not HCPs implement the recommendations provided in a medicine risk communication. However, most of these factors relate to four domains only ("Knowledge"; "Beliefs about Consequences"; "Memory, Attention and Decision Processes"; and "Environmental Context and Resources"). Additionally, most of the studies contributing to three of these four domains were of low quality. Future research should focus on using implementation science to identify target behaviours for actionable medicine risk communications. Regulators should use such science to develop cost-effective strategies for improving the implementation of medicines risk communication by HCPs.

Antimicrobial stewardship implementation before and during the COVID-19 pandemic in the acute care settings: a systematic review.

INTRODUCTION: Antibiotics are widely administered for various indications, leading to increased antimicrobial resistance (AMR) in acute care hospitals. Since the onset of the COVID-19 pandemic, Antimicrobial Stewardship (AMS) effective strategies should be used to maintain the rational use of antibiotics and decrease the threat of Antimicrobial Resistance (AMR). AIM: This systematic literature review aims to investigate the AMS intervention Before-the-pandemic (BP) and During-the-pandemic (DP) from the literature. DESIGN AND SETTING: Systematic literature review of primary studies on AMS implementation in acute care settings. METHODS: Relevant studies published between 2000 and March 2021 were obtained from Medline (via PubMed), OVID, CINAHL, International Pharmaceutical Abstracts, Psych Info, Scopus, Web of Science, Cochrane Library, OpenGrey, and Google Scholar, using a comprehensive list of search terms. Public Health England (PHE) toolkit was agreed upon as a gold standard for the AMS implementation. RESULTS: There were 8763 articles retrieved from the databases. Out of these, 13 full-text articles met the inclusion criteria for the review. The AMS implementation was identified in the included studies into AMS strategies (Core strategies & Supplemental strategies), and AMS measures BP and DP. CONCLUSION: This Systematic literature review summarises AMS implementation strategies and measures all over the previous 20 years of research. There are many lessons learnt from COVID-19 pandemic. The proper selection of the AMS implementation strategies and measures appeared to be effective in maintaining the appropriate use of antibiotics and decreasing the AMR threat, especially during the COVID-19 pandemic. Further studies are required to provide empirical data to evaluate the AMS implementation and identify which of these strategies and measures were effective BP and DP. In order to be prepared for any emergency/crisis or future pandemics.

Factors influencing the implementation of medicine risk communications by healthcare professionals in clinical practice: A systematic review.

BACKGROUND: Regulatory medicines risk communications aim to prevent patient harm through the dissemination of safety information to healthcare professionals (HCPs), patients, and the public. Evidence suggests that in addition to implementing the required changes, HCPs also respond to these communications through unintended and unwarranted actions and behaviours such as stopping medicine courses unnecessarily, and blanket actions spilling over to unintended patients' populations. Misunderstanding and mis-implementation of medicines risk communications could jeopardise patients' safety and clinical outcomes. Therefore, it is important to understand the determinants that affect HCPs responses to medicines risk communications. This systematic review aims to identify the factors that affect the implementation of risk communications by healthcare professionals. METHODS: Fifteen databases, including EMBASE, PubMed, Scopus, Web of science, CINAHL PLUS were searched in April-May 2018, and the search was updated again in June 2021 to identify studies reporting on factors influencing HCPs' uptake of medicine risk alerts. We used keywords such as risk communication, safety update, and safety regulation. Studies were excluded if they did not involve pharmacovigilance or patient safety alerts; or if they only focused on measuring HCPs' practice after alerts; or evaluating the effectiveness of risk minimisation measures without reporting on factors affecting HCPs' actions. Studies relating to occupational hazards, case reports, interventional studies, and studies not involving HCPs were also excluded. The Mixed Method Appraisal Tool (MMAT) was used to assess the quality of the included studies. A Narrative synthesis approach was undertaken using thematic analysis and concept mapping, followed by a critical reflection of the synthesis. RESULTS: Twenty-eight studies met our criteria and were included in the synthesis. We identified four themes summarising the factors influencing HCPs' implementation of risk communications. These include HCPs: knowledge of medicine alerts; perceptions of alerts; attitudes, and concerns regarding medicine alerts; and the self-reported impact of these alerts. Our concept mapping exercise identified key interactions between different stakeholders, and these interactions determine HCPs' implementation of medicine risk communications. These stakeholders comprise of alert developers, including the sources and senders of safety information, and the receivers of safety information including health care institutions, HCPs, patients and their carers. CONCLUSIONS: Healthcare professionals are crucial to translating risk communication messages into clinical practice. However, if they have inadequate information about the content of the alert, and have inaccurate perceptions about the alert, they may not implement the required clinical changes as intended. Communication of medicine risk alerts does not always translate into improved patient care, due to a complex interaction between stakeholders involved in the creation and implementation of these alerts. These complex interactions should be the subject of future research efforts to understand the alert-implementation trajectory and identify the mediators for change and interventions to improve implementation.