The Impact of COVID-19 Pandemic on Drug Use: Implications for Regulatory Intervention Impact Studies

Study identification

• EU PAS number:
  EUPAS105538
• Study ID:
  105539
• Official title and acronym:
  The Impact of COVID-19 Pandemic on Drug Use: Implications for Regulatory Intervention Impact Studies
• DARWIN EU® study:
  No
• Study countries:
  Lithuania

  Netherlands

  United Kingdom
• Study description:
  In the European Union (EU), regulatory interventions known as risk minimisation measures (RMMs) are governed by the guidelines called Good pharmacovigilance practices (GVP). The current GVP guidelines also highlight the necessity to assess the impact of these regulatory interventions. However, in practice, implementing regulatory interventions depends on national and international authorities and might be affected by overlapping events, such as introducing a new competitor medicine. Medicine shortages can also cause perceived changes in medicine use. Therefore, it is challenging to discern whether the observed outcomes are directly caused by the intervention or are part of pre-existing secular trends. The COVID-19 pandemic introduced additional complexity to drug utilisation patterns disrupting the usual prescription and dispensation of medicines which caused changes in drug utilisation and health outcome patterns. In this study, we aim to explore whether the periods of strict pandemic restrictions (e.g. curfews and school closings) impacted drug utilisation patterns. Furthermore, we examine the implications of any disruptions for impact studies using data that includes the COVID pandemic period in the selected countries.
• Study status:
  Planned

Research institutions and networks

Institutions

Division of Pharmacoepidemiology & Clinical Pharmacology (PECP), Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University

Netherlands

Study timelines

Date when funding contract was signed

Planned: 15/06/2023

Study start date

Planned: 15/06/2023

Data analysis start date

Planned: 01/12/2023

Date of final study report

Planned: 01/12/2024

Sources of funding

Other

More details on funding

Utrecht University (PhD project)

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable