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

From Assessment to Planning

Injection Safety Assessments coordinated by WHO/Vaccines and Biologicals

in the Eastern Mediterranean Region

Carsten Mantel, MD, MPH

WHO STC

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

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

Assessment of Injection Safety: Tool C Rationale

Describes injection practices in a standardised and representative way

Identifies detailed problems in injection practices

Identifies local issues to design effective, efficient interventions

Provides baseline information and indicators for monitoring progress

Assessment of Injection Safety: Tool C Objectives To determine if a facility meets necessary requirements for staff competence, equipment, supplies, and waste

disposal.

To assess if injections are administered according to recommended best practices.

To identify the unsafe practices that may lead to infections and that should be targeted by interventions.

To estimate the proportion of health-care facilities where injection practices are safe.

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.

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

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

Representative of the country

With around 10% precision of the estimate

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

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

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

Results: Injection Equipment

20 country reports available as of June 2002

Sterilizable equipment in majority of facilities8/20

AD-syringes for all immunizations2/20

Disposable equipment for curative injections 20/20

Results: Risk to Injection Recipients

100% use of sterile equipment for all observed injections: 4/18 countries

100% use of sterile equipment for all observed immunization injections: 9/17 countries

Results: Risk to Injection Recipients

Countries using disposable equipment (n=12): In 9 countries 100% of immunizations are safe

Countries using sterilizable equipment (n=8): In 1 country 100% of immunizations are safe In all facilities leaking sterilizers, no regular use

of time-steam-temperature spots

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)

Results: Risk to the Health Care Worker

Use of safety-boxes 0 - 89%

No sharps in open containers 5 - 66%

No two-hands recapping 29 - 84%

No needle-stick injuries in the last 12 month 21 - 82%

Mean number of needle sticks per person and year 1 - 9

Results: Risk to the Community

No sharps in the surroundings 7 - 91%

Open burning or unsupervised dumping of sharps waste 18 - 64%

Health care waste policy 0 - 9%

Discrepancy between IS policy and actual findings (Country 1)

Country policy: Use of disposable injection equipment

84% of the injections are given with sterilizables

Sterilizers without leaks only in 84%, only in 23% spare parts and in 7% TST spots available to register sterility

Discrepancy between IS policy and actual findings (Country 2)

Country policy: Use of sterilizable injection equipment for immunizations

Only 4% of health facilities in the country are using sterilizable equipment

Clients are purchasing the injection material locally

WHO Eastern Mediterranean Region

23 countries with 482 Mio. total population (2000)

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)

Palestine

Bahrain

WHO/EMR: Injection Safety Assessments

Covering 65% of EMR population

WHO/EMR: Risk to Injection Recipients

Proportion

Safe immunisation injection 74%

Safe therapeutic injection 61%

Proportions weighted by population figures

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

WHO/EMR: Equipment and Supplies

Proportion

One week’s supply of disposable injection equipment 82%

Any shortage of disposable injection equipment 27%

Reuse without sterilisation 7%

Proportions weighted by population figures

Palestine

Bahrain

WHO/EMR: AD Injection Equipment

At least partially available for 51% of EMR population

WHO/EMR: Risk to Health Care Workers

Mean Range

Number of needle sticks per health careworker and year

4 0 - 79

Data from 7 countries -weighted by population figures

Palestine

Bahrain

WHO/EMR: Safety Boxes

At least partially available for 93% of EMR population

WHO/EMR: Risk to Health Care Workers

Proportion

Sharps in safety boxes (immunization) 33%

Sharps in safety boxes (therapeutic) 11%

Sharps in open containers 71%

Two-hands recapping performed in HF 60%

Needle stick injuries in last 12 months 50%

Proportions weighted by population figures

WHO/EMR: Risk to the Community

Proportion

Used sharps around the health facility 49%

Proportion weighted by population figures

WHO/EMR: Sharps Waste Disposal

Proportion

Dumping 44%

Open burning 39%

Proper incineration 9%

Safe collection and disposal 5%

Other (burying, public waste, needle cutters) 3%

Proportions weighted by population figures

WHO/EMR: Summary Estimates

Weighted Proportion

Risk to Recipients (EPI and curative): Non-sterile injections 34%

Risk to Health Care Workers: Sharps in open containers 71% Two-hands re-capping 60% Needle-stick injuries (admitted) 50%

Risk to the Community: Unsafe sharps waste disposal 85%

Pakistan Summary Estimates

% 95% CI Risk to Patients:

Non-sterile injections 64% (54 - 73)

Risk to Health Care Workers: Sharps in open containers 92% (85 - 96) Two-hands re-capping 83% (71 - 92) Needle-stick injuries (admitted) 46% (33 - 60)

Risk to the Community: Unsafe sharps waste disposal 94% (86 - 98)

Planning or „Quality“ Cycle

Benchmarking

Implementation

Assessment

PlanningMonitoring

Evaluation

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.

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.

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.

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.

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

WHO/EMR: Regional Injection Safety Milestones and Indicators

Milestones set for 2003 - 2005

Measurable indicators (input, process, outcome) suggested for regional and country level

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