First experiences with a tool to measure the level of clinical information present in adverse drug reaction reports

ABSTRACT

Background: To make a proper causality assessment of an adverse drug reaction (ADR) report, a certain level of clinical information is necessary. A tool was developed to measure the level of clinical information present in ADR reports. The aim of this study was to test the validity and reliability of the clinical documentation tool (ClinDoc) in an international setting.

Methods: The tool was developed by a panel of pharmacovigilance experts. It includes four domains: ADR, chronology of the ADR, suspected drug and patient characteristics. The final score categorizes reports into: excellent, well, moderately or poorly documented.

In two rounds, eight pharmacovigilance assessors of different countries made a total of 224 assessments using the tool, with the expert panels judgement as a standard. Sensitivity and specificity were calculated.

Results: The tool with four outcome-categories demonstrated low sensitivity. A lack of distinctiveness was demonstrated between the categories moderate and well. Results for the second round were re-analysed using three categories. This demonstrated a better validity.

Conclusion: This is the first tool to give insight in the level of relevant clinical information present in ADR reports. It can be used internationally to compare reports coming from different reporting methods and different types of reporters in pharmacovigilance.

KEYWORDS:

• Pharmacovigilance
• adverse drug reaction
• ADR
• report
• clinical information
• completeness

Acknowledgments

The authors would like to thank the assessors who helped us testing the clinical documentation tool: Morana Pavičić and Željana Margan Koletić of HALMED; Agency for Medicinal Products and Medical Devices of Croatia, Ola Caster and Rebecca Chandler of the Uppsala Monitoring Centre, Julia Cowen and Natalie Bandoo of the UK Medicines & Healthcare products Regulatory Agency and Anne-Marie van Gorp and Annet van Boekel of the Netherlands Pharmacovigilance Centre Lareb.

Furthermore, we would like to thank Dr. Niklas Noren of the Uppsala Monitoring Centre for his creative input during the development of the tool.

Declaration of interest

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Supplemental data

Supplemental data for this article can be accessed here

Additional information

Funding

The development of the Clinical Documentation tool was part of the WEB-RADR project (www.web-radr.eu) which is a public private partnership coordinated by the Medicines and Healthcare products Regulatory Agency. The WEB-RADR project has received support from the Innovative Medicine Initiative Joint Undertaking (www.imi.europa.eu) under Grant Agreement n° 115632, resources of which are composed of financial contribution from the European Union’s Seventh Framework Programme (FP7/2007-2013) and EFPIA companies’ in kind contribution.