Pharmacovigilance eBriefing

About the Course

Briefing on ROUTINE PHARMACOVIGILANCE for all projects and modules on ACTIVE PHARMACOVIGILANCE for MDR TB and snake bite projects.

You have 3 topics to select from:

A. Active pharmacovigilance for MDR TB projects – Modules 1 and 2

The world of drug-resistant tuberculosis care has moved forward recently with the approval of new antibiotics and evidences on shorter and efficient treatments. As part of routine DR TB care, WHO has recommended that active drug safety management and monitoring applies to all patients treated with XDR TB regimen, novel regimen (e.g. short regimen) and MDR TB regimen with the new drugs. In this aim, the pharmacovigilance unit of MSF provides an elearning course allowing to train yourself on the minimum requirements of such active surveillance (module 1) and for some sentinel sites on the additional requirements (module 2). 

B. Active pharmacovigilance for snake bite projects

New medical database forms allow for systematic follow-up and data collection on patients suffering snake bites. These include forms allowing the collection of data on the safe use of antivenoms. This ebriefing will guide you through the data collection forms, pharmacovigilance concepts and most frequent reactions to antivenoms.

C. Routine pharmacovigilance for MSF projects

Healthcare providers working in MSF projects may encounter drug-related complications in any projects and with any type of medicines. This ebriefing will provide you with the tools, definitions and communication flow that will allow you to identify, assess and report suspected adverse drug reactions.

You can only take the course module that is relevant to your current role and then take the other modules later if they become relevant to you. If you are not working in a project with active pharmacovigilance (e.g. MDR TB or antivenoms), we recommend you take the Routine Pharmacovigilance for MSF Projects course.


Learning Objectives

A. Active Pharmacovigilance for MDR TB Projects – Modules 1 & 2

MDR TB - MODULE 1
At the end of this module, you will be able to:

  • Define what is a serious adverse event.
  • Fill in a detailed SAE Report Form.
  • Perform severity evaluation and causality assessment.

MDR TB - MODULE 2 
At the end of this course module, you will be able to:

  • Identify reportable non-serious adverse events.
  • Perform AE tracking & follow-up of TB patients.


B. Active Pharmacovigilance for Snake bite Projects
At the end of this course, you will be able to:
  • Define pharmacovigilance and the main pharmacovigilance concepts.
  • Identify and grade the most common type of reactions to antivenoms.
  • Fill in the Snakebite & Adverse Event forms of the medical database.
  • Communicate on antivenom use complications and fast track urgent information.

C. Routine Pharmacovigilance for MSF Projects
At the end of this course, you will be able to:
  • Understand what is pharmacovigilance and what are the strategies we can put in place to minimize the risks of harm from medications to patients.
  • Identify and prioritize pharmacovigilance information.
  • Use the tools and understand the flow for reporting.

List of Contents

  • MDR TB - MODULE 1 
  • MDR TB - MODULE 2 
  • SNAKE BITE PHARMACOVIGILANCE
  • ROUTINE PHARMACOVIGILANCE
CERTIFICATION

No badge or certificate available for completing this course.

WHO IS THIS COURSE FOR?

  • Medical referents from central teams.
  • Medical coordinators (or equivalent positions) and their deputies.
  • Doctors.
  • Pharmacists.
  • Nurses and other healthcare professionals involved in TB or snake bite care and/or interested in knowing more about pharmacovigilance.

METHODOLOGY

Allocate the necessary free time for you to take the elearning courses. 

For MDR TB courses, it is preferable to take module 1 before module 2 if you are working at a sentinel site and therefore need to follow both modules. 

Sit in a quiet room, take the time to read the theory, and perform all the online exercises. 

Please write down all your questions and address them to us at pvunit.gva@geneva.msf.org.