01 introduction to aefi

1. Introduction to
Immunization Safety and AEFI Surveillance

2. OVERVIEW
Immunization safety as an emerging issue
Need for immunization safety systems
Critical elements of an immunization safety system
(including the role of the National Regulatory
Authority)

3. Anti-immunisation
lobby
WHY IMMUNISATION SAFETY ?
Changing Regulatory norms
Vaccination
campaignMishandling rumours
Unsafe injection
Inadequate monitoring

4. UNSAFE INJECTIONS:
ESTIMATED ANNUAL CONSEQUENCES
>20 billion injections annually
95% for curative purposes
>50% unsafe
8-16 million HBV
2-4.5 million HCV
75 000-100000 HIV
? millions of injection site abscesses
* Simonsen L et al. Bulletin of the World Health Organization, 1999
Unsafe injection

5. Key results of the Injection Safety Assessment
INDCLEN – Govt. of India 2003
Unsafe injection practices
67.3% of unsafe injections overall
55% of non-sterile injections
73.9% of unsafe injections in immunization

6. VACCINATION CAMPAIGNS - SPECIAL ISSUES
Apparent rise
many doses over short period of time
more vigilance/awareness
Real rise from programmatic errors
normal safe injection practices not observed
new staff unfamiliar
Adverse events generate criticism of campaign
Vaccination campaign

7. CHANGING REGULATORY NORMS
Old
empirically defined
procedure
reliance on QC
testing
field studies done
only for licensing
New
strictly defined procedure
for consistency
reliance on GMP rather
than final product testing
continuous safety and
effectiveness surveillance
Regulations are changing

8. FUNCTIONS OF A
NATIONALREGULATORY AUTHORITY
Marketing authorization and licensing
Post Marketing surveillance (PMS / AEFI
monitoring)
System of lot release
Laboratory access
Regulatory inspections for GMPs
Oversight of clinical trials

9. THE ROLE OF THE NATIONAL
REGULATORY AUTHORITY
What is the role of the NRA in vaccines safety
surveillance?
Who (within the NRA) should be responsible for
vaccines safety surveillance?
How and why should NRA and EPI work
together?

10. A few terminologies …
Adverse Events Following Immunization (AEFI)
Adverse Drug Reaction (ADR)
Post Marketing Surveillance (PMS)
Adverse Events (AE)
Severe Adverse Events (SAE)

11. OBJECTIVES OF MONITORING AEFIs
Identify urgent problems for investigation and action
Detect signals for potential follow-up and research
Estimate rates for serious AEFIs
for comparison between products
to determine risks and benefits of immunization
to validate pre-licensure data
Identify programmatic errors and batch problems
Create awareness of risks among health professionals

12. KEY ELEMENTS OF AN EFFECTIVE
IMMUNIZATION SAFETY SYSTEM
Rapid notification of the basic information
Rapid and effective evaluation of information
Rapid and effective response/action
Ensure appropriate outcome of action/response
Adequate education and training of role players

13. OBJECTIVES OF THIS WORKSHOP
To provide us with
importance of this activity in our country
knowledge and skills to develop a AEFI surveillance
system to
detect
report
assess and
respond to AEFIs (including communication)
prevent
Improve collaboration between NRA, NIP and others

14. Thank You

15. SIMILARITIES AND DIFFERENCES
BETWEEN
VACCINES AND MEDICINES

16. SIMILARITIES BETWEEN
VACCINES AND MEDICINES
Vaccines are also medicines
Potential for adverse effects
Multiple ingredients
Potential for interaction with disease and other
medicines
Also need to comply with standards of safety,
efficacy and quality

17. SPECIFIC ISSUES RELATED
TO VACCINES
Use on a large scale
Use may be mandatory
Public relations:
we promote the product!
service providers have the responsibility
safety issues can be in conflict with programme
close relationship with manufacturer

18. SPECIFIC ISSUES RELATED TO VACCINES
Procurement, storage and handling
About 30 products compared with around
20 000 drugs
Fewer manufacturers but more recipients
Maintenance of the cold chain
Imported vaccines - long distance transport

19. Promotion and Procurement: Vaccines vs
Drugs
Vaccine
Public campaigns common
Access/safety
++government procurement /
program
Collaboration UIP/Gov’t and
manufacturers critical
Drugs
Public campaigns rare
Access/safety variable
++private procurement /
programs
Drug manufacturers less
relationship to gov’t

20. Storage and Distribution
Vaccines
mainly in field, offices and
clinics
cold chain often critical
biological product-
lot variation, stability
Drugs
mainly in hospitals, clinics,
pharmacies
most a room temp
chemical product

21. SPECIFIC ISSUES RELATED TO VACCINES
EFFICACY
Given to healthy individuals
difficult to detect lack of efficacy
Perceived need depends on disease burden
Herd immunity
Goal: disease eradication
Need vaccine distribution data (batch)
Brand product specific manufacturing techniques
(each product is different)

22. Efficacy: Vaccine vs Drugs
Vaccines
healthy
prevention of disease
large population
most used in
infants and children
Drugs
ill
treat disease
small population
most used in
adults

23. SPECIFIC ISSUES RELATED TO VACCINES
SAFETY
Low public tolerance for adverse events
Adverse drug reactions are more common
Safety monitored by “promoters”
Causality assessment difficult
need special expertise
Lot-by-lot surveillance needed

24. Safety Monitoring
Vaccines vs Drugs
Need to ensure that vaccine safety monitoring
and causality assessment utilizes system that
meets vaccine specific needs
Build on strengths of drug monitoring BUT modify
and adapt to fit vaccines
WHO

25. BARRIERS TO REPORTING
Not considering the event as related to immunization
Not knowing about reporting system and process
Lethargy - procrastination, lack of interest or time,
inability to find report form
Fear that the report will lead to personal
consequences
Guilt about having caused harm and being
responsible for the event
Uncertainty about reporting an event when not
confident about the diagnosis