01 introduction to aefi
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Transcript of 01 introduction to aefi
Introduction to Immunization Safety and AEFI Surveillance
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)
Anti-immunisation lobbyAnti-immunisation lobby
WHY IMMUNISATION SAFETY ?
Changing Regulatory norms Changing Regulatory norms
Vaccination campaignVaccination campaignMishandling rumoursMishandling rumours
Unsafe injectionUnsafe injection
Inadequate monitoringInadequate monitoring
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 injectionUnsafe injection
Key results of the Injection Safety AssessmentINDCLEN – 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
VACCINATION CAMPAIGNS - SPECIAL ISSUES
Apparent risemany 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 campaignVaccination campaign
CHANGING REGULATORY NORMS
Oldempirically defined procedure
reliance on QC testing
field studies done only for licensing
Newstrictly defined procedure for consistency
reliance on GMP rather than final product testing
continuous safety and effectiveness surveillance
Regulations are changingRegulations are changing
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
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?
A few terminologies …
Adverse Events Following Immunization (AEFI)
Adverse Drug Reaction (ADR)
Post Marketing Surveillance (PMS)
Adverse Events (AE)
Severe Adverse Events (SAE)
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
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
OBJECTIVES OF THIS WORKSHOP
To provide us withimportance 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
Thank You
Thank You
SIMILARITIES AND DIFFERENCES
BETWEEN
VACCINES AND MEDICINES
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
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
SPECIFIC ISSUES RELATED TO VACCINES
Procurement, storage and handling
About 30 products compared with around 20 000 drugsFewer manufacturers but more recipientsMaintenance of the cold chain Imported vaccines - long distance transport
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
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
SPECIFIC ISSUES RELATED TO VACCINES
EFFICACY
Given to healthy individualsdifficult to detect lack of efficacy
Perceived need depends on disease burdenHerd immunityGoal: disease eradication Need vaccine distribution data (batch)Brand product specific manufacturing techniques (each product is different)
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
SPECIFIC ISSUES RELATED TO VACCINES
SAFETYLow public tolerance for adverse eventsAdverse drug reactions are more common Safety monitored by “promoters”Causality assessment difficult
need special expertiseLot-by-lot surveillance needed
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