1. Documenting (Driving) Progress in Immunization Injection Safety Philippe Duclos, WHO Presented at the SIGN annual meeting, Cairo, Egypt, Oct 23-24 th, 2000

2. Immunization Safety Priority Project: a growing partnership to support countries Target: Establish a comprehensive system to ensure the safety of all immunizations given by national immunization services Four areas of work: R&D of safer/simpler delivery technologies Access to safe vaccine delivery technologies and their disposal Vaccine safety up through point of use Risks identification & management

3. Safe and efficient vaccine administration and disposal technologies Example of milestones By 2000: All syringes purchased by donor-partners for immunization purposes, are AD or sterilizable Cost-effectiveness studies on alternative injection technologies conducted By 2001: All syringes purchased for immunization and funded by national budgets, procured directly or through UNICEF, are AD or sterilizable At least twenty of poorest countries use safe or safer injection devices and implement safer and more effective immunization practices By 2003: AD syringes are used globally Indicators Percentage of countries with national safe-injection plans, including a sharps waste management component detailed down to district level

4. Different ways to collect information on immunization safety Routine vaccination activities Supplementary activities Routine data collection AssessmentsRoutine data collection Assessments Vaccine Safety Injection safety Monitoring AEFI

5. WHO/UNICEF joint annual reporting process

7. Important elements to add? Regulatory framework Safe injection plans including a sharps waste management component Assessment of injection practices Use of auto-disable syringes

8. Assessment of injection safety practices: various issues Standardized and representative method to allow for: Comparison across countries Measuring progress Simple/structured and flexible 3 weeks Tool to be used at different levels Injections versus injection practices (risk for patients, providers, communities)

9. Development of tool © to assess injection safety: process Collaboration between SIGN, BASICS and V&B (immunization context versus overall injections) Extensive consultations Ohio State University: statistical advice and sampling strategy Pilot studies in a number of countries/regions Computer simulation studies of sampling design Keep all info so as to allow different scoring to be applied to same data

10. Tool to assess injection safety: design - cross sectional study Two stage cluster sampling Each country divided into non-overlapping regions such as districts which will serve as clusters and health facilities will serve as sampling units Randomly select 8 geographic regions with probability proportional to size of total population Within each cluster select randomly 10 health facilities  Administer standard data collection instrument  Combination of interview and structured observations  Scoring process

11. World Health Organization (WHO) BASICS Safe Injection Global Network (SIGN) Tool "C" for the Assessment of Injection Safety This document was developed as an additional tool to the "Injection Practices Rapid Assessment and Response Guide" and was discussed during a workshop of expert consultants held at BASICS, Arlington, VA, USA in March 2000. It constitutes a dated draft circulated for comments and suggestions. Although it is made widely available at an early stage, it is not yet intended to be a “how-to” manual for field use. Later versions of this document will be adapted for wider readership level once consensus has been reached on broad concepts and after field testing.. Comments and suggestions on this documents or orders of the "Injection Practices Rapid Assessment and Response Guide" should be directed to: The Secretariat of the Safe Injection Global Network (SIGN), World Health Organization, Department of Blood Safety and Clinical Technology, Avenue Appia 20, Geneva 27, Switzerland 1211. Fax +41 22 791 4836. E-mail: sign@who.ch sign@who.ch

12. Vaccines, Immunization and Biologicals: 2000-2003 Strategy Critical indicator: Proportion of targeted countries implementing satisfactory safe injection practices as defined by the WHO standardized survey As of March 2000, survey in six countries and none implementing satisfactory safe injection practices In consultation with regions, 60 countries/states will be identified and targeted for assessments