Welcome | Date: 29 June 2010
Better Regulation of Medicines Initiative (BROMI) Vigilance Workstream
Monitoring time spent on handling Anonymised Single Patient Reports (ASPRs)/Individual Case Safety Reports (ICSRs) and data quality issues.
Background:
The quality of data and the volume of Anonymised Single Patient Reports (ASPRs) and electronic equivalent, E2B Individual Case Safety Reports (ICSRs) have been identified by the BROMI Vigilance workstream as areas where efficiencies could be made. In order that the burden on the pharmaceutical industry can more fully be understood, some evidence of the effort spent on handling and processing these reports is required
The MHRA are to change the logic for how adverse drug reaction reports received are sent out to companies as ASPRs/ICSRs aiming to reduce the burden and reduce the number of irrelevant ASPRs/ICSRs received.
Pharmaceutical companies are asked to monitor their current effort handling and processing ASPRs/ICSRs over a 6 week period before the changes are made. The estimated date for implementing the new logic is early August. Effort should be recorded using the accompanying spreadsheet template, the data will then be collated to determine the cumulative impact on time/resource/costs. This exercise will be repeated over another six week period after implementation of the new logic to identify the benefit of the changes.
In the spreadsheet, each company should record the number of ASPRs received, and time taken to process/handle each day (time should be recorded in decimal format e.g. one and a quarter hours as 1.25). Additional columns are provided where the number of the ASPRs which were either irrelevant to the company, caused duplication of ADR reports already received, or required some additional effort can be recorded. The following reasons for irrelevant duplicated ASPRs/ICSRs are defined as follows:
- Duplicates from literature - ASPR/ICSR received was a duplicate, based on an ADR from a literature article
- Other duplicates - ASPR/ICSR was a duplicate, but for any reason other than the source being a literature article
BROMI Vigilance - Workshop on Data Quality - Minutes
Draft BROMI Best Practice Guide on Classification of ICSRs
BROMI ASPR effort quality template briefing