ABSTRACT
Introduction: High interest in the last two years was globally put by Health Authorities on the recording, coding, and reporting of medication errors to ensure the safety and effectiveness of the use of medicines and to provide reliable information to healthcare professionals and patients. Medical coding is a prerequisite for efficient, effective, and reproducible data outputs. Objective(s): Not applicable. Method(s): A sample of medication error coding results was assessed for accuracy and consistency of MedDRA coding and identification of main types of coding errors. It included 1500 coded reported terms for COVID-19 vaccines medication errors, assigned to MedDRA codes by national regulatory authorities or pharmacovigilance centers and drawn from the Uppsala Monitoring Centre (UMC) VigiBase through August 25, 2021. Result(s): One-third of the records could not be assessed due to incomplete or unclear verbatims. In one-third, code assignments were correct, but another third of the sample was not adequately coded. Most frequent coding errors corresponded to vague PT assignments, while more detailed information was available for a more precise coding. This observation is similar to the EudraVigilance database, where some of the most assigned MedDRA terms for medication errors also represent vague concepts. Conclusion(s): These findings indicate that understanding of medication error documentation and assessment and of MedDRA content and coding guidelines need to be reinforced. The MedDRA Maintenance and Support Services Organization (MSSO) offers several MedDRA coding trainings, including coding of medication errors. The authors provide valuable references to the latter, to the applicable ICHEndorsed Guides for MedDRA Users, and to relevant EMA guidance.
ABSTRACT
Introduction: High interest in the last two years was globally put by Health Authorities on the recording, coding, and reporting of medication errors to ensure the safety and effectiveness of the use of medicines and to provide reliable information to healthcare professionals and patients. Medical coding is a prerequisite for efficient, effective, and reproducible data outputs. Objective: Not applicable. Methods: A sample of medication error coding results was assessed for accuracy and consistency of MedDRA coding and identification of main types of coding errors. It included 1500 coded reported terms for COVID-19 vaccines medication errors, assigned to MedDRA codes by national regulatory authorities or pharmacovigilance centers and drawn from the Uppsala Monitoring Centre (UMC) VigiBase through August 25, 2021. Results: One-third of the records could not be assessed due to incomplete or unclear verbatims. In one-third, code assignments were correct, but another third of the sample was not adequately coded. Most frequent coding errors corresponded to vague PT assignments, while more detailed information was available for a more precise coding. This observation is similar to the EudraVigilance database, where some of the most assigned MedDRA terms for medication errors also represent vague concepts. Conclusion: These findings indicate that understanding of medication error documentation and assessment and of MedDRA content and coding guidelines need to be reinforced. The MedDRA Maintenance and Support Services Organization (MSSO) offers several MedDRA coding trainings, including coding of medication errors. The authors provide valuable references to the latter, to the applicable ICHEndorsed Guides for MedDRA Users, and to relevant EMA guidance.
ABSTRACT
The aim of this study was to explore staff perceptions of the impact of the COVID-19 pandemic on mental health service delivery and outcomes for women who were pregnant or in the first year after birth ('perinatal' women). Secondary analysis was undertaken of an online mixed-methods survey open to all mental health care staff in the UK involving 363 staff working with women in the perinatal period. Staff perceived the mental health of perinatal women to be particularly vulnerable to the impact of stressors associated with the pandemic such as social isolation (rated by 79.3% as relevant or extremely relevant; 288/363) and domestic violence and abuse (53.3%; 192/360). As a result of changes to mental health and other health and social care services, staff reported feeling less able to assess women, particularly their relationship with their baby (43.3%; 90/208), and to mobilise safeguarding procedures (29.4%; 62/211). While 42% of staff reported that some women engaged poorly with virtual appointments, they also found flexible remote consulting to be beneficial for some women and helped time management due to reductions in travel time. Delivery of perinatal care needs to be tailored to women's needs; virtual appointments are perceived not to be appropriate for assessments but may be helpful for some women in subsequent interactions. Safeguarding and other risk assessment procedures must remain robust in spite of modifications made to service delivery during pandemics.