(171) Unintended Impact of Medicines Regulatory Interventions: A Systematic Review Focusing on Data and Methods

Friday, August 26, 2022

8:00 AM – 6:00 PM CEST

Location: Hall C

Publication Number: 502

Presenting Author(s)

Tomas Lasys
– Utrecht University, Utrecht, Netherlands

Co-Author(s)

Yared Santa-Ana-Tellez
– Utrecht University, Netherlands
Satu SIISKONEN
– Department of Obstetrics, WKZ Birth Centre, Division Woman and Baby, UMC Utrecht, Utrecht, the Netherlands., Netherlands
Rolf H.H. Groenwold
– Department of Clinical Epidemiology, Leiden University Medical Center, Netherlands
Helga Gardarsdottir, PhD, FISPE
– Associate Professor, University of Utrecht, Utrecht, Netherlands

Background: In 2012, the Pharmacovigilance legislation was implemented. A set of practical guidelines called the Good pharmacovigilance practices (GVP) was developed to support this legislation. The EMA update of the GVP in 2017 emphasised the need to assess the possible unintended impact of risk minimisation measures (RMMs) when measuring their impact. So far, it is unknown to what extent studies measuring impact of RMMs include assessments of unintended impacts.

Objectives: To assess whether and how unintended impact of drug regulatory interventions was measured in the EU Member States since 2012, focusing on the methodological aspects of these studies.

Methods: A systematic literature review was conducted in MEDLINE and EMBASE, from 1 January 2012 until 13 December 2021, to identify studies that investigated the impact of RMMs implemented at least on a national level in any EU country. We excluded articles using data from surveys and questionnaires as well as impact studies of regulations not directly linked to pharmacovigilance. From the eligible studies, we extracted information on regulatory interventions, drugs, data sources, outcomes of interest, methodology, and key findings.

Results: Our search identified 3505 articles, of which 97 articles were included for full-text review. The unintended impact of RMMs was assessed in only 12 out of selected 97 studies (12%). Drug classes in unintended impact studies included antipsychotics (n=4), hypnotics (n=2), antibiotics (n=2), and others (n=6). The most frequently used method for assessing the unintended impact of RMMs was interrupted time series (n=5), followed by descriptive statistics with significance testing (n=4), descriptive statistics (n=2) and generalised linear models (n=1). Outcome measures for unintended impact were the use of drug substitutes (n=9) and changes in health outcomes (n=4), with only one study assessing both.

Conclusions: This systematic review shows that only a minority of impact studies of RMMs measured unintended impact of these interventions during 2012-2021.