1. From Assessment to Planning Injection Safety Assessments coordinated by WHO/Vaccines and Biologicals in the Eastern Mediterranean Region Carsten Mantel, MD, MPH WHO STC

2. WHO/V&B/VAM Assessment of Injection Safety WHO/V&B Tool C: Rationale, Objectives, Methods Experience from 22 country assessments 2000-2002 WHO/EMR: Regional Injection Safety Assessment Regional Injection Safety Strategy Regional Injection Safety Plan of Action

3. Injection Safety: Critical Issues The risk to the recipient Re-use of syringes or needles Use of non-sterile equipment Risk to the health care worker Inappropriate waste collection Risk to the community Inappropriate waste disposal Reuse of equipment Unsafe collection Unsafe disposal

4. Assessment of Injection Safety: Tool C Rationale zDescribes injection practices in a standardised and representative way zIdentifies detailed problems in injection practices zIdentifies local issues to design effective, efficient interventions zProvides baseline information and indicators for monitoring progress

5. Assessment of Injection Safety: Tool C Objectives z To determine if a facility meets necessary requirements for staff competence, equipment, supplies, and waste disposal. z To assess if injections are administered according to recommended best practices. z To identify the unsafe practices that may lead to infections and that should be targeted by interventions. z To estimate the proportion of health-care facilities where injection practices are safe.

6. Assessment of Injection Safety: Tool C Methods Standardized and representative method to allow for: Measuring and documenting progress Comparison across countries Simple/structured and flexible (2-3 weeks) To be adjusted to country needs (other issues at health facility can be looked at simultaneously) Need to link with change plan of action.

7. Assessment of Injection Safety: Tool C Development Collaboration between SIGN, BASICS and WHO/V&B Ohio State University: Statistical advice on sampling strategy Computer simulation studies of sampling design

8. Assessment of Injection Safety: Tool C Sampling Cross-sectional observational study Two-stage cluster sampling with probability proportional to size of population 8 districts randomly selected 10 health care facilities visited in each district èRepresentative of the country èWith around 10% precision of the estimate

9. Assessment of Injection Safety: Tool C Data Collection Observation of supplies: Type and number of syringes and needles Number of safety boxes, sharps containers Type of waste disposal Observation of injections: Immunisation and curative departments Interview of healthcare workers: With injection provider With the supervisor of the centre

10. Assessment of Injection Safety: Tool C Data Analysis Data Entry in Epi Info Data Analysis in Epi Info and e.g. Stata: Calculation of means and proportions Calculation of 95% confidence intervals (binomial) Cluster sampling design taken into account

11. Assessments planned Assessments done Tool C Injection Safety Assessments 2000-2002 Burkina Faso, Chad, Djibuti, Egypt, Eritrea, Ethiopia, Gambia, Guinea, Honduras, Kyrgyzstan, Morocco, Nepal, Niger, Oman, Pakistan, Paraguay, Syria, Sudan, Tunesia, Yemen, Zambia, Zimbabwe

12. Results: Injection Equipment 20 country reports available as of June 2002 zSterilizable equipment in majority of facilities8/20 zAD-syringes for all immunizations2/20 zDisposable equipment for curative injections 20/20

13. Results: Risk to Injection Recipients z100% use of sterile equipment for all observed injections: 4/18 countries z100% use of sterile equipment for all observed immunization injections: 9/17 countries

14. Results: Risk to Injection Recipients Countries using disposable equipment (n=12): yIn 9 countries 100% of immunizations are safe Countries using sterilizable equipment (n=8): yIn 1 country 100% of immunizations are safe yIn all facilities leaking sterilizers, no regular use of time-steam-temperature spots

15. Results: Risk to Injection Recipients Relative Risk for safe immunization injections for countries using disposable equipment v.s countries using sterilizable equipment OR 14.0 (95% CI: 1.3 - 156)

16. Results: Risk to the Health Care Worker zUse of safety-boxes 0 - 89% zNo sharps in open containers 5 - 66% zNo two-hands recapping 29 - 84% zNo needle-stick injuries in the last 12 month 21 - 82% zMean number of needle sticks per person and year 1 - 9

17. Results: Risk to the Community zNo sharps in the surroundings 7 - 91% zOpen burning or unsupervised dumping of sharps waste18 -64% zHealth care waste policy 0 - 9%

18. Discrepancy between IS policy and actual findings (Country 1) zCountry policy: Use of disposable injection equipment z84% of the injections are given with sterilizables zSterilizers without leaks only in 84%, only in 23% spare parts and in 7% TST spots available to register sterility

19. Discrepancy between IS policy and actual findings (Country 2) zCountry policy: Use of sterilizable injection equipment for immunizations zOnly 4% of health facilities in the country are using sterilizable equipment zClients are purchasing the injection material locally

20. WHO Eastern Mediterranean Region 23 countries with 482 Mio. total population (2000)

21. WHO/EMR: Injection Safety Situation Standardised assessments performed in 9/23 countries representing 65% of EMR population Additional data used: WHO/UNICEF Joint Reporting Forms on vaccine-preventable diseases SIGN reports ATT reports GAVI applications re: injection safety Expert knowledge (Delphi estimates) of national EPI managers Published scientific papers (Egypt, Pakistan)

22. Palestine Bahrain WHO/EMR: Injection Safety Assessments Covering 65% of EMR population

23. WHO/EMR: Risk to Injection Recipients Proportions weighted by population figures

24. Palestine Bahrain WHO/EMR: Immunization Safety 2002 > 95% safe injections 91- 95% safe injections 81- 90% safe injections 71- 80% safe injections 70% safe injections

25. WHO/EMR: Equipment and Supplies Proportions weighted by population figures

26. Palestine Bahrain WHO/EMR: AD Injection Equipment At least partially available for 51% of EMR population

27. WHO/EMR: Risk to Health Care Workers Data from 7 countries - weighted by population figures

28. Palestine Bahrain WHO/EMR: Safety Boxes At least partially available for 93% of EMR population

29. WHO/EMR: Risk to Health Care Workers Proportions weighted by population figures

30. WHO/EMR: Risk to the Community Proportion weighted by population figures

31. WHO/EMR: Sharps Waste Disposal Proportions weighted by population figures

32. WHO/EMR: Summary Estimates Weighted Proportion Risk to Recipients (EPI and curative): Non-sterile injections34% Risk to Health Care Workers: Sharps in open containers71% Two-hands re-capping60% Needle-stick injuries (admitted)50% Risk to the Community: Unsafe sharps waste disposal85%

33. Pakistan Summary Estimates % 95% CI Risk to Patients: Non-sterile injections64%(54 - 73) Risk to Health Care Workers: Sharps in open containers92%(85 - 96) Two-hands re-capping83%(71 - 92) Needle-stick injuries (admitted)46%(33 - 60) Risk to the Community: Unsafe sharps waste disposal94%(86 - 98)

34. Planning or Quality Cycle Benchmarking Implementation Assessment PlanningMonitoring Evaluation

35. WHO/EMR Regional Injection Safety Goals Ensure the safety of all immunization injections in all member countries. Extend successful injection safety strategies and activities to other parts of health care services.

36. WHO/EMR: Regional Injection Safety Targets All countries of the EMR will... have reliable baseline data on injection safety by the end of 2003. have declared their political commitment to injection safety and have developed national policies, guidelines and plans of action on injection safety by the end of 2003. have sustained public information and communication activities and behaviour change strategies to increase injection safety by the end of 2005.

37. WHO/EMR: Regional Injection Safety Targets All countries of the EMR will... have strengthened their management capacity and improved human resources development in all issues related to injection safety by the end of 2004. have assured that no reuse of injection equipment occurs at any time and that safe injection equipment and safety boxes are supplied bundled with all vaccines by the end of 2004.

38. WHO/EMR: Regional Injection Safety Targets All countries of the EMR will... have assured the safe collection, treatment and destruction of sharps waste by the end of 2005. have a regular reporting system and the capacity to supervise, monitor and evaluate injection safety programmes by the end of 2005. have extended successful injection safety strategies and activities from immunization services to other parts of the health care services by the end of 2005.

39. WHO/EMR: Regional Injection Safety Plan of Action Eight main activities according to established targets Additional resource requirements 2002-2005: for regional-level activities: 655,000 USD for country-level activities: 805,000 USD

40. WHO/EMR: Regional Injection Safety Milestones and Indicators Milestones set for 2003 - 2005 Measurable indicators (input, process, outcome) suggested for regional and country level

41. Acknowledgements Dr. Julia Fitzner, WHO/V&B/VAM Dr. Phillipe Duclos, WHO/V&B/VAM Dr. Ezzedine Mohsnie, WHO/EMRO Dr. Yvan Hutin, WHO/BCT All collaborators, counterparts in Ministries of Health, field workers, health facility staff, patients and vaccinees