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[e-drug] SIAPS launches PViMS adverse event monitoring application in Georgia

E-DRUG: SIAPS launches PViMS adverse event monitoring application in Georgia

SIAPS launches PViMS an innovative, web-based adverse event monitoring
application in Georgia

The US Agency for International Development (USAID)-funded Systems for
Improved Access to Pharmaceuticals and Services (SIAPS) Program,
implemented by Management Sciences for Health, has launched a new,
web-based pharmacovigilance management system called PViMS. PViMS enables
health programs in low- and middle-income countries to follow recent World
Health Organization (WHO) recommendations for implementing active drug
safety monitoring and management (aDSM) when introducing new tuberculosis
(TB) drugs and novel regimens.

Officially launched on July 6, 2016, PViMS helps to monitor serious adverse
events for every drug resistant (DR)-TB patient and all DR-TB medicines,
including new medicines such as bedaquiline and delamanid, in Georgia.
Georgia is the first country to adopt this groundbreaking system to support
serious adverse event monitoring for over 250 cases already enrolled on
treatment with new TB medicines.

PViMS meets all WHO recommendations for an aDSM system and provides
countries that are introducing bedaquiline with an easy-to-use electronic
solution to the challenge of drug safety monitoring. The main features of
PViMS include:

-  Improved clinical documentation
- Standardized reporting terminology
- Causality assessment process
- Reports, frequency tables, and signal detection
- Customizable components

Developed to address an unmet need for national TB programs, PViMS can be
used for all medicines across all health programs. Nino Lomtadze, Head of
the National Center for Tuberculosis and Lung Disease Surveillance and
Strategic Planning Department, observed 'It is noteworthy that the
established pharmacovigilance system can also be actively used in
monitoring of other diseases. The electronic system allows us to assign the
patients to different cohorts. Thus, the system could be also useful for
Hepatitis C, HIV and AIDS, and other programs in Georgia.'

Because it strengthens health systems, PViMS is an important tool that can
help national TB programs and pharmacovigilance professionals better manage
risks associated with anti-TB medicines and ensure improved health outcomes
for patients. 
Visit the SIAPS website 
to learn about the technical assistance SIAPS has provided to countries that are
introducing bedaquiline.

SIAPS gratefully acknowledges the invaluable support of Nino Lomtadze; Eka
Kokhreidze; Mari Buziashvili; and Dr. Zaza Avaliani, Director of the TB
Center, all of whom contributed to the successful launch of PViMS in

For more on this story, visit:

For more information on PViMS, visit 

Kelly Sawyer, MPH
Technical Associate, TB 
Systems for Improved Access to Pharmaceuticals and Services (SIAPS)
Management Sciences for Health
4301 North Fairfax Drive
Arlington, VA 22203
United States
E-mail: ksawyer@msh.org 
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