Project 171474
A Novel Method for Pharmacosurveillance: Combining an Electronic Prescribing and Drug Management System and Administrative Database
A Novel Method for Pharmacosurveillance: Combining an Electronic Prescribing and Drug Management System and Administrative Database
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: | |
| 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:
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