Project 171474

A Novel Method for Pharmacosurveillance: Combining an Electronic Prescribing and Drug Management System and Administrative Database

171474

A Novel Method for Pharmacosurveillance: Combining an Electronic Prescribing and Drug Management System and Administrative Database

$317,187
Project Information
Study Type: Observational Cohort_Study
Therapeutic Area: Pharmacology
Research Theme: Social / Cultural / Environmental / Population Health
Disease Area: pharmacosurveillance
Data Type: Canadian
Institution & Funding
Principal Investigator(s): Tamblyn, Robyn M
Co-Investigator(s): Abrahamowicz, Michal M; Brophy, James M; Buckeridge, David L; Eguale, Tewodros; Hanley, James A; Huang, Allen R
Institution: McGill University
CIHR Institute: Population and Public Health
Program: Operating Grant
Peer Review Committee: Public, Community and Population Health - B
Competition Year: 2008
Term: 3 yrs 6 mths
Abstract Summary

Medications are the most frequent causes of preventable adverse events including illness, and death. Drugs do not have complete information on safety and effectiveness at the time of market approval. Present-day adverse drug reaction monitoring systems rely on health professionals to report and miss more than 90% of adverse drug reactions. There is an urgent need to develop better methods of monitoring the safety and effectiveness of drugs after they enter the market. The use of health administrative and electronic prescribing and health record data are two new approaches that could be used to provide a more timely and accurate detection of adverse drug effects. The purpose of this study is to evaluate the accuracy of administrative data in detecting adverse drug events, and the improvement in the accuracy of detection with the addition of electronic prescribing data. We will assess these new methods of post-market surveillance in a cohort of 2,300 patients within the primary care practices of 104 physicians using electronic prescribing systems. Patients who are newly prescribed drugs for hypertension, depression and pain will be included, as these medications are commonly prescribed and implicated in adverse drug events. We will use patient interviews and chart review to collect information about adverse effects during a 6 month follow-up period. We will use electronic prescribing orders for drug discontinuation due to adverse effects, as well as diagnostic codes in administrative records of medical visits and hospitalizations to determine whether these two sources of information can accurately detect the adverse drug events. The results of this study will be used to evaluate whether these new sources of information-administrative and electronic prescribing data-could be immediately used to institute a more effective means of monitoring the safety and effectiveness of drugs in Canada.

Research Characteristics

This project includes the following research characteristics:

Digital Health
Big Data Analytics
Health Technology Assessment
Implementation Science
Policy Evaluation
Health System Integration
Scalability Assessment
Patient Reported Outcomes
Real World Evidence
Patient Engagement
Community Based
Regulatory Pathway
Ethics Focus
Registry Linkage
Cohort Establishment
Multicenter
Knowledge Translation Focus
Safety Focus
Study Justification

"The purpose of this study is to evaluate the accuracy of administrative data in detecting adverse drug events, and the improvement in the accuracy of detection with the addition of electronic prescribing data."

Novelty Statement

"The results of this study will be used to evaluate whether these new sources of information-administrative and electronic prescribing data-could be immediately used to institute a more effective means of monitoring the safety and effectiveness of drugs in Canada."

Methodology Innovation

combining electronic prescribing and drug management systems with administrative databases for improved pharmacosurveillance and adverse drug event detection

Keywords
Adverse Drug Reactions Electronic Prescribing & Drug Managment System Ineffective Treatments Off-Label Indications Patient Safety Pharmacosurveillance