Improving the data quality of spontaneous ADR reports: a practical example from Malta.

Area of Science:

• Pharmacovigilance and Drug Safety
• Public Health
• Regulatory Science

Background:

• High-quality adverse drug reaction (ADR) data and reporting rates are essential for identifying safety concerns and informing regulatory actions.
• The study focused on enhancing ADR reporting and data quality within Malta's national pharmacovigilance system.

Purpose of the Study:

• To improve the data quality and reporting rates of adverse drug reaction (ADR) reports in Malta.
• To implement national activities aimed at strengthening the pharmacovigilance system.

Main Methods:

• Conducted a review of wholesale dealer ADR reporting forms between April 2018 and July 2019.
• Organized educational workshops for physicians and pharmacists.
• Performed a quality system audit of the Authority's ADR management process.

Main Results:

• Identified 155 areas for improvement in 12 reviewed wholesale dealer forms, particularly in incident reporting forms.
• 5 workshops were held with 62 physicians and 22 pharmacists attending; however, no increase in reporting was observed.
• Implemented the 'four-eye principle' in the Authority's ADR management process following the quality audit.

Conclusions:

• The implemented activities are expected to enhance Malta's overall pharmacovigilance system.
• The experience gained may offer valuable insights for other entities engaged in spontaneous ADR reporting.