Injection Safety and Waste Management Adverse Event Following Immunization (AEFI) surveillance

1. Injection Safety and Waste Management Adverse Event Following Immunization(AEFI) surveillance EPI Managers Meeting Kathmandu, June 23-25, 2003

2. Burden of unsafe injections • In a year, unsafe injections may be responsible for: • 8 to 16 Million cases of Hepatitis B • 2 to 5 Million cases of Hepatitis C • 80,000 to 160,000 cases of HIV • EPI injections represent 10% all injections

3. INJECTION SAFETY Key stepsto improve safety Use of safe injection equipment Adequate injection technique Appropriate waste management Disposal of used sharps in safety boxes

4. WHO/UNICEF/UNFPA joint statement • WHO, UNICEF,UNFPA urge that, by the end of 2003, all countries should use only auto-disable syringes for immunization

5. Campaigns: Auto-Disable (AD) Syringes • Eliminate the risk of infection between vaccine recipients • Do not eliminate risk of needle stick injuries for health care workers • Do not solve potential infection of community

6. Not just AD syringes and safety boxes • Proper equipment is necessary, but not sufficient • Careful planning/budgeting/training needed

7. Injection safety: need for training • Preventing needlestick injury • Do NOT recap needles • Do NOT bend needles • Do NOT manually remove needles from syringes • Do NOT transport without sharp container or safety boxes

8. MAJOR CAUSES OF UNSAFE INJECTIONS • Ignorance of health-workers, consumers and the community at large • Poor/No supervision on safe injection practices • Inadequate supplies of syringes & needles • Poverty- leading to re-use/resale of used syringes and needles • Campaign: time pressure

9. Waste management • Waste management is a frequently overlooked component of EPI: often neglected in planning, budgeting • Ultimate solution: development of jet-injectors, aerosols, powders

10. Assuring safe disposal of used injection material from campaigns • In communities, with weak waste mgmt systems, campaign acutely and severely exacerbates this chronic problem • Early planning necessary to identify options and develop achievable plans

11. Options for disposing of used injection material during campaigns • Burial • Open burning and burying • High temperature incineration • Dumping in pit latrine or other secure pit • Transport for off-site treatment • New technologies/recycling • No “one-size-fits-all” solution, need local assessment, simple local solutions

12. AEFI definition: ANY adverse event that is TEMPORALY associated with immunization WHO priority for all countries to establish and maintain AEFI surveillance

13. AEFI • Adverse reaction to the vaccine or its components • Programmatic (human) error: more common • Coincidental

14. Adverse reactions associated with the vaccine • Local reaction at injection site: 0-2 days: common • Fever and rash in 5-15% of vaccinees, usually 7-12 days after vaccination, lasts 1-2 days • Encephalopathy < 1/1,000,000 doses • Thrombocytopenia <1/30,000 doses • Anaphylaxis 1 per 100,000 to 1 per million doses

15. Programmatic errors • Non-sterile injections • Incorrect vaccine preparation • Injection in wrong site • Incorrect vaccine transport and storage • Abcesses, cellulitis • Toxic Shock Syndrome • Bloodborne infections

16. AEFI rates: Campaign Different from Routine • Real rise in adverse events may occur through programmatic errors (overworked health workers) • Apparent rise • Large number of doses over a short period of time • Better surveillance • Campaign targets different age groups than routine immunization • Media more alert

17. Planning a campaign • 1) Planning to prevent programmatic errors • 2) Establish AEFI surveillance to monitor safety of your campaign • 3) Have communication plan

18. 1. Planning to prevent programmatic errors • Use only quality vaccine (WHO-licensed), bundled with AD syringes and safety boxes • Ensure proper distribution of vaccine, diluent and injection supplies • Keep track of vaccine lot distribution

19. 1. Planning to prevent programmatic errors • Training • proper reconstitution and administration • proper handling of reconstituted vaccine • Plan for safe waste disposal

20. 2. AEFI Surveillance • Planning • Case definitions for reporting • Reporting channels (e.g. phone and/or fax, messenger) • Reporting, investigating forms, AEFI line list • Analyze data quickly • Provide feed back on weekly basis • Consider creating a review committee

21. 3. Communication • Prepare information leaflet for parents / caretakers • Prepare Qs and As for health care workers • Designate focal person for AEFI surveillance • EPI manager and MoH spokesperson should be immediately informed of situation/allegations • Be ready to respond to national and international media • Ensure coordination among partners

22. Afghanistan, 2002 Nationwide measles campaign 10.2 children vaccinated (6 mo -12 yo) Was the campaign safe?

23. Northeastern Province: cluster of abcesses • End of September, for 14 days: measles campaign conducted in the district • 3 weeks later, NID monitors “discovered” cluster of abcesses in a few villages • 10 days later: MOPH/UNICEF/WHO investigation team

24. Investigation results • 150 children (all ages) with fever and abcesses on arm in 4 villages; no death; same team vaccinate children • Average time from vaccination to symptoms/signs: 2.7 days • Team run out of diluent • “Sterile” water bought at local market to replace missing diluent • Improper vaccine reconstitution: “sterile water” bought at the local market

25. Consequences • Vaccinator in hiding, villagers threatened to kill him • SCA health clinic: vaccinated 100 children /month before campaign;after campaign: 8/month • Potential to derail immunization program

26. Programmatic errors leading to cluster of 150 abscesses • Inadequate supply: not enough diluent • Improper reconstitution, incorrect and contaminated diluent; use of same needle and syringe to reconstitute vaccine • Time constraints/ staff under pressure • Lack of supervision • Delayed reporting: no AEFI monitoring

27. MOPH/UNICEF/WHO Response • Investigation team • Medical follow-up provided to all • Re-training of vaccinators • Social mobilization of influential community members to restore confidence in vaccines • MOPH: Guidelines AEFI reporting and investigating, national policy, strategy and plan of action

28. Review articles • Ensuring injection safety during measles campaigns: more than just AD syringes and safety boxes (B Hersh et al, JID 2003) • Monitoring vaccine safety during measles mass campaigns: clinical and programmatic issues (R Pless et al, JID 2003)

29. The Safe Injection Global Network (SIGN) World Health Organization Weekly moderated E-mail list server (sign@who.int) Internet site (www.injectionsafety.org)

30. Mass campaigns An opportunity to strengthen immunization safety

31. Immunization safety: a priority • DUTY for all of us to ensure safety:- Researchers: safest vaccine possible- Manufacturers: safe vaccine production- Program implementers: vaccine administered safely, AEFI monitoring