Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid...
-
Upload
seneca-college-ontario-canada -
Category
Healthcare
-
view
190 -
download
1
Transcript of Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid...
![Page 1: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/1.jpg)
The Incidence of Adverse Events (AEs) among hospital patients in Canada in 2000
Baker et al. 2004
Presented by: Carolina H.H. B.Sc, Dr. Mehran Marashian,
Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc.
Research Program Director: Professor Peivand Pirouzi
AAPSGlobal Clinical research and
Pharmacovigilance Presentation
Clinical Research and Pharmacovigilance Program
![Page 2: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/2.jpg)
Introduction
• Adverse events (AEs) – unintended injuries or complications caused by healthcare management systems including:
1. Death2. Disability3. Prolonged hospital stay
![Page 3: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/3.jpg)
Aim
• To estimate the incidence of AEs among patients in Canadian acute care hospitals
![Page 4: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/4.jpg)
Methods • Design: Retrospective Chart Review (RCR) RCR,known also as a medical record review, is a type of research design in which pre-recorded, patient-centered data are used to answer one or more research questions.• Randomly selected community hospitals in 5 Canadian
provinces (QB, AB, BC, NS, ON)• In each province:
1. Teaching hospital (1)2. Large community hospitals (1)3. Small community hospitals (2)
![Page 5: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/5.jpg)
Chart Review Process• Computerized data collection form• Training to physicians and nurses • Standard set of hospital charts and training manuals• Two stage-review process:• Stage 1: Reviewed by nurses • Identify criterion for potential AE occurrence
• Stage 2: Reviewed by physicians • Whether there is an AE• Whether AE was caused by health care management• Whether AE could be prevented
![Page 6: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/6.jpg)
(Baker et al. 2004)
![Page 7: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/7.jpg)
Results and Conclusions
• Physicians identified AEs in 255 charts out of 3750 charts screened by the Stage 1 nurses (7%)
• AE rate = 7.5 /100 admissions• 1/3 is judged to be preventable
![Page 8: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/8.jpg)
Advantages of Using RCR for Measuring Harm
• Uses readily available data from patient charts.• Quality data produced if: - proper, frequent training and monitoring is provided
to personnel for data collection (study manual) - use explicit key variables - blinding of personnel collecting the data - use inclusion/exclusion criteria for screening patient
charts.
![Page 9: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/9.jpg)
Screening Process
(Baker et al. 2004)
![Page 10: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/10.jpg)
Disadvantages of Using RCR
• Judgment of AE may be biased• Expensive • Records incomplete if training is inadequate or criterion for
assessment is not accurate.• Cannot determine causality• Hindsight biasHindsight bias, also known as the knew-it-all-along effect or creeping determinism, is the inclination, after an event has occurred, to see the event as having been predictable, despite there having been little or no objective basis for predicting it.
![Page 11: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/11.jpg)
(Baker et al. 2004)
![Page 12: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/12.jpg)
ReferencesBaker GR, Norton PG, Flintoft V, et al. The Canadian Adverse Event Study: the incidence of adverse events among hospital patients in Canada. CMAJ, 2004, 170:1678-1686.
![Page 13: Pharmacovigilance Presentation Workshop - Carolina H.H. B.Sc, Dr. Mehran Marashian, Dr. Mahshid Bagheri, Gopi Patel B.Sc., Ana Franco B.Sc., Porfessor Peivand Pirouzi](https://reader035.fdocuments.net/reader035/viewer/2022062904/587bf3d41a28ab765a8b781d/html5/thumbnails/13.jpg)
THANK YOU!