Injection Safety and Waste Management

Adverse Event Following Immunization(AEFI) surveillance

EPI Managers Meeting

Kathmandu, June 23-25, 2003

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

INJECTION SAFETYINJECTION SAFETYKey stepsKey steps to improve safety to improve safety

Use of safe injection equipment Adequate injection technique

Disposal of used sharps in safety boxes Appropriate waste management

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

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

Not just AD syringes and safety boxes

Proper equipment is necessary, but not sufficient

Careful planning/budgeting/training needed

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

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

Waste management

Waste management is a frequently overlooked component of EPI: often neglected in planning, budgeting

Ultimate solution: development of jet-injectors, aerosols, powders

Assuring safe disposal of used injection material from campaigns

• In communities, with weak waste mgmt systems, campaign acutely and severely exacerbates this n acutely and severely exacerbates this chronic problemchronic problem

• Early planning necessary to identify options and develop achievable plans

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

WHO priority for all countries to establish and maintain AEFI

surveillance

AEFI definition: ANY adverse event that is TEMPORALY associated with immunization

AEFI

Adverse reaction to the vaccine or its components

Programmatic (human) error: more common

Coincidental

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

Programmatic errors

Non-sterile injections Incorrect vaccine preparation Injection in wrong site Incorrect vaccine transport and storage

Abcesses, cellulitis Toxic Shock Syndrome Bloodborne infections

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

Planning a campaign

1) Planning to prevent programmatic errors

2) Establish AEFI surveillance to monitor safety of your campaign

3) Have communication plan

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

1. Planning to prevent programmatic errors

Training proper reconstitution and administration proper handling of reconstituted vaccine

Plan for safe waste disposal

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

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

Afghanistan, 2002Nationwide measles campaign10.2 children vaccinated (6 mo -12 yo)Was the campaign safe?

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

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

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

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

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

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)

World Health Organization

The Safe Injection Global The Safe Injection Global Network (SIGN)Network (SIGN)

Weekly moderated E-mail list server (sign@who.int)Internet site (www.injectionsafety.org)

Mass campaignsMass campaigns

An opportunity to An opportunity to strengthenstrengthenimmunization safety immunization safety

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