Poster Topical Area: Methods and Protocols

Location: Hall D

Poster Board Number: 667

P15-006 - Developing a systematic method to review the use of risk assessment dossiers in authorization decisions on foods and pharmaceuticals.

Monday, Jun 11
8:00 AM – 3:00 PM

Objectives

To ensure a high level of consumer protection, both in food and pharmaceutical legislation the tasks of assessing a risk and managing the decision about such risks are separated. In Europe, risk assessment is conducted by a scientific agency such as the European Food Safety Authority (EFSA) or the European Medicines Agency (EMA), whereas the risk management decision is made by the European Commission (EC). To ensure that a legitimate risk management decision can be made, the risk assessment must be of the highest standard. This study analyses whether risk assessment is valid in the case of advising the antioxidant N-acetylcysteine in managing chronic obstructive pulmonary disease (COPD) in the Netherlands, and reviews the effect of this scientific risk assessment on the final risk management decision.

Methods

The validity of the risk assessment dossier is studied by means of systematic review (to assess its completeness) and network analysis, a method newly applied in reviewing scientific assessments used in risk management decisions. The network analysis identifies the internal consistency of the risk assessment: how do data of individual studies and authors' conclusions of these studies contribute to the final decision made by the risk assessors, and which variables can influence this decision (study design, sample size, population, authors' expertise and financial support)?

Results

This case study of advising the use of N-acetylcysteine in COPD management in the Netherlands shows that the risk assessment document is far from complete. The decision to use studies in this risk assessment dossier is affected by different variables, including the study design in the preliminary analysis.

Conclusions

These results show that by means of conducting a systematic search and network analysis, the completeness and validity of the risk assessment dossier can be reviewed. This information is essential in analyzing the position of risk assessment in risk management decisions, not only in advising the use of N-acetylcysteine in COPD but also in other decisions made upon foods and pharmaceuticals. Systematic searches are essential in risk assessment and assessors should be encouraged to conduct and evaluate such searches.




Funding Source: This research has been made possible with the support of the Dutch Province of Limburg.

CoAuthors: Frits van Osch – Maastricht University; Aalt Bast – Maastricht University

Alie DE.. Boer

Assistant Professor
Maastricht University
Venlo, Limburg, Netherlands