Shortages of essential medicines can harm patients by increasing the risk of prescribing errors, side effects, or even death. To mitigate its impact, the European Medicine Agency (EMA) started monitoring medicine shortages that may affect more than one European Union country and have been reporting it into a public catalogue since 2016.
This study aims to describe prescribing by UK general practioners (GP) of medicines with (suggested) shortages, and their alternatives, between 2010-2023. We will examine how prescribing varies by healthcare setting, patient characteristics, and over time. We will also describe the characteristics of patients receiving a new or repeat prescription for these medicines, including the condition for which they are being treated, treatment duration, and dosage, as well as other underlying conditions.
This study is part of a project from the European Health Data Evidence Network (EHDEN), a network of data sources standardized to the Observational Medical Outcomes Partnership Common Data Model (OMOP-CDM). The same study will be conducted separately in each data source. The aim is to improve our understanding of drug shortages in routine health care delivery by showing trends over time as well as patient characteristics. The results will contribute to the European efforts to monitor use of critical medicines as part of the global fight against medicine shortage.
AIM
To improve our understanding of drug shortages in routine health care delivery.
OBJECTIVES
(1) To investigate the incidence and prevalence of use of medicines with (suggested) shortages and their alternatives.
(2) To describe the incident and prevalent patients of medicines with (suggested) shortages stratified by calendar year, in order to observe changes in patient’s profiles.
METHODS
Data: CPRD GOLD and CPRD AURUM standardized to the Observational Medical Outcomes Partnership Common Data Model.
Exposure(s): medicines with (suggested) shortages, including those listed as ongoing in the European Medicine Agency shortages catalogue for ≥1 year, and their alternatives.
Participant(s): incident and prevalent users of medicines of interest.
Study period: 2010-2023
Analysis:
- Incidence rates and period prevalence of the use of medicines with (suggested) shortages and their alternatives by calendar year, age groups (<18, 18-64, 65+ years), sex and healthcare setting.
- Characterisation of incident and prevalent users of medicines with (suggested) shortages (including but not limited to duration of usage of the medicines of interest, the potential indication for prescribing/dispensing it, and dosage) by calendar year.
PUBLIC HEALTH BENEFITS
This project will be used to improve our understanding of drug shortages in routine health care delivery by showing trends over time as well as patient characteristics. The results will contribute to the European efforts to monitor use of critical medicines as part of the global fight against medicine shortage.
The main outcomes of this study are:
> Incidence rates of the use of medicines with (suggested) shortages and their alternatives
> Period prevalence of the use of medicines with (suggested) shortages and their alternatives
> Characteristics of incident and prevalent users of medicines with (suggested) shortages, including but not limited to:
- Age
- Sex
- Duration of usage of the medicines of interest
- Potential indication for prescribing/dispensing the medicines of interest
- Dosage of the medicines of interest
Marta Pineda Moncusi - Chief Investigator - University of Oxford
Theresa Burkard - Corresponding Applicant - University of Oxford
Antonella Delmestri - Collaborator - University of Oxford
Daniel Dedman - Collaborator - CPRD
Daniel Prieto-Alhambra - Collaborator - University of Oxford
Edward Burn - Collaborator - University of Oxford
Martí Català Sabaté - Collaborator - University of Oxford
Wai Yi Man - Collaborator - University of Oxford
Zara Cuccu - Collaborator - CPRD