Alsubaie, Mohammed
(2024)
Understanding of factors affecting the reporting and reporting quality of medication-related patient safety incidents in primary care in the UK: a critical realist approach.
PhD thesis, University of Nottingham.
Abstract
Improving the rate and quality of medication-related patient safety incident (MRPSI) reporting is key to improving patient safety and learning from medication incidents. The research aimed to evaluate the evidence of the effectiveness of interventions identifying or reporting MRPSI. The research aimed to understand factors affecting the reporting and reporting quality of medication-related patient safety incidents (MRPSIs) in community pharmacy in the UK. This research aimed to define what constitutes high-quality MRPSI reporting and determine the types of information that should be covered in an incident report. The critical realist research approaches of semi-structured qualitative interviews using framework analysis followed by descriptive quantitative questionnaires and qualitative content analysis of MRPSI reporting forms were employed to answer the research questions and to achieve research purposes. The research was carried out in four phases, each with specific aims and key findings.
The first phase of this research was a systematic review of the effectiveness of interventions to identify or report MRPSI in primary care. The systematic review identified nine Randomised Controlled Trials (RCTs); all were complex interventions conducted in general practices between 2012 and 2021. Three studies were conducted in the UK. The nine RCTs were classified into two categories; five had an intervention to identify MRPSIs, whilst four reported interventions to increase the number of incident reports. Evidence showed that complex interventions are effective in identifying or reporting MRPSIs. No evidence was found to improve the quality of MRPSI reporting. Patient Medical Records could be used to identify and encourage MRPSI reporting. The organisational culture plays a significant role in determining the effectiveness of the incident reporting systems.
Phase two of this research involved qualitative interviews to explore factors affecting the reporting of MRPSI in the UK community pharmacy settings. These semi-structured qualitative interviews were analysed using a theoretical framework of factors affecting patient safety incident reporting. In-depth face-to-face and telephone interviews were conducted with 15 participants (community pharmacists, Medication Safety Officers, and NHS stakeholders). Lack of feedback and a blame culture were organisational barriers to reporting. Pharmacist training was a skill barrier to reporting. The complexity of the reporting process was a system barrier to reporting. Work environment, fear of adverse consequences, and incident characteristics were barriers to reporting. Critical facilitators to engagement in reporting included organisational learning and improvement, knowledge of MRPSIs definition, anonymity in reporting, presence of a standardised reporting system, team members' support and encouragement to report, and professional ethics. The quality of the MRPSI report was affected negatively by factors of contents of the report, context around incidents, delayed report, lack of information to complete the report, reporting format, time required to complete an incident report and tensions in error reporting.
Phase three of this research was quantitative questionnaires to gather community pharmacists’ perspectives to examine factors affecting MRPSI reporting and to determine factors acting as facilitators or barriers to an incident report. A cross-sectional survey methodology was conducted in the UK community pharmacy with 45 participants. The overall questionnaire items had a high internal consistency of 0.873. Pharmacists generally provided positive responses concerning knowledge, skills, ethics, pharmacist characteristics, team factors, work environment, process and systems of reporting and organisational factors. Responses ranged from positive and neutral to negative for fear of adverse consequences; however, responses were negative for the incident characteristics.
Phase four of this research was a qualitative content analysis of MRPSI reporting forms aimed to define high-quality MRPSI reports and determine the types of information that should be covered in an incident report. A qualitative study using content analysis of the MRPSI reporting systems worldwide was carried out with 20 participating countries. Using mandated minimum data sets as a quasi-definition for minimum data reporting was interpreted as a definition of high-quality MRPSI reports. The information that should be covered in the MRPSI report includes a structured categorical part and a free-text part description of the incident. The structured categorical part included patient information (age, sex), incident time, incident location, causes of the incident, contributing factors, mitigating factors, incident type, incident outcome, resulting actions, and reporter’s role.
This study has identified multi-factorial circumstances that inhibit and facilitate the reporting of MRPSIs. Understanding of the factors can help develop MRPSI reporting improvement programmes targeting the key priority areas of high-risk situations, polypharmacy, and care transitions. The development of metrics aims to improve MRPSI management and a repository of good practice examples on medication safety. This work helps develop interventions to improve the quality of MRPSI reports. Factors affecting the quality of MRPSI reports, training needs, incident characteristics, and feedback following submitting an incident report should be prioritised.
The quality and characteristics of MRPSI reports in the UK national reporting system should be described. This descriptive study aims to identify the characteristics of the national reporting system database and evaluate the quality of MRPSI reports using the WHO Minimal Information Model for Patient Safety.
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