E-DRUG: WHO Pharmacovigilance Indicators: practical manual for assessment
of PV systems (2)
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Dear Shanti,
Thank you for sharing the news about the WHO Pharmacovigilance Indicators
manual. I was wondering
(1.) What is the difference between the MSH's Indicator-based
Pharmacovigilance Assessment Tool that has been used for the assessment of
PV systems in many countries for some time now.
(2. ) Why was there a need for re-inventing another tool?
(3.) Could we have done it with an update of the MSH tool?
A quick look seems to indicate that both these tools have similarity
dividing the indicators into core and supplementary/complementary, and both
use the types Structural, Process and Outcome indicators. I understand that
MSH's PV indicators were first published in 2009 but the new WHO PV
indicators manual barely mentions the MSH's indicators.
Best wishes,
Rizwan
Syed Rizwanuddin Ahmad, MD, MPH, FISPE, FCP
Pharmacovigilance Consultant with a Special Interest to Strengthen
National Medicines Regulatory Authorities in Resource-limited Settings
Ex-Consultant/Safety Reviewer, U.S. FDA (1998-2013)
Associate Professor (adjunct), Rutgers School of Public Health, NJ, USA
Assistant Professor (adjunct), Georgetown University School of Medicine,
Washington, DC, USA
www.drugsafetyconsultant.com