Validity of UK general practice prescribing safety indicators in predicting adverse events

Study type
Protocol
Date of Approval
Study reference ID
16_029
Lay Summary

Inappropriate prescribing of medications can lead to increased numbers of hospital visits and, in some cases, death. A set of "indicators" that describe specific prescribing practices that may lead to harm in patients has been developed by agreement among a group of UK doctors. This study aims to investigate how well these indicators can predict whether or not someone will have a side-effect or similar problem due to poor prescribing.

Technical Summary

This study aims to examine the predictive validity of the published UK GP prescribing safety indicators for estimating the risk of adverse events and hospitalisations. CPRD data, linked to integrated HES data, will be used to examine the association between 12 different prescribing safety indicators, plus a composite indicator, and the risk of adverse events and hospitalisations. The primary outcome will be adverse events of interest related to the indicators, including asthma exacerbation events, heart failure exacerbation events, gastrointestinal bleeding, acute kidney injuries, and falls. Secondary outcomes of interest will include total number of hospitalisations and total number of hospitalisations with a diagnosis of an adverse drug reaction. People will be followed up commencing 1 January 2013 with the exposure groups to be defined using data from a 3-month exposure period prior to start of follow-up. The total number of events during follow-up in the exposed and unexposed groups will be compared using Poisson regression to investigate whether having a safety prescribing indicator increases the likelihood of having an adverse event.

Health Outcomes to be Measured

Total number of asthma exacerbation
events
Total number of heart failure exacerbation
events
Total number of diagnoses for gastrointestinal bleeding
Total number of diagnoses for acute kidney injury
Total number of diagnoses for falls
Total number of hospital admissions, and total number of hospital admissions for an adverse drug reaction

Collaborators

Rupert Payne - Chief Investigator - University of Bristol
Rupert Payne - Corresponding Applicant - University of Bristol
Angela Wood - Collaborator - University of Cambridge
Ellie Paige - Collaborator - The Australian National University
Kirsty Rhodes - Collaborator - University of Cambridge

Linkages

HES Admitted Patient Care;Patient Level Index of Multiple Deprivation;Practice Level Index of Multiple Deprivation