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					                    INTRODUCTION TO
                  IMMUNIZATION SAFETY




02-introvax.ppt
                         Objectives
By the end of the session you should be able to:
   Describe the impact of vaccine safety concerns on
   immunization programs
   Explain the importance of AEFI monitoring at a national &
   international level
   Describe the global initiatives being undertaken to ensure
   (improve) the safety of vaccines
   Explain the importance of an effective national regulatory
   system in ensuring the safety of vaccines
   Explain the basic elements of an AEFI surveillance
   programme
   Identify special issues relating to AEFIs occurring during
   immunization campaigns
   Know the key terminology and definitions relating to vaccine
   safety
     WHAT IS AN ADVERSE EVENT FOLLOWING
              IMMUNIZATION (AEFI)?
    A medical incident that takes place after an immunization,
    causes concern, and is believed to be caused by immunization

   Vaccine reaction - caused by vaccine’s inherent
     properties
   Programme error - caused by error in vaccine
    preparation, handling, or administration
   Coincidental - happens after immunization but not
    caused by it (a chance association)
   Injection reaction - anxiety or pain of injection not
     vaccine
   Unknown - cause cannot be determined
                   ADVERSE REACTION
                   VS. ADVERSE EVENT
                                                 Programmatic errors
   Diseases
                          Adverse event

Genetics                                                      Diet


                        Vaccine Reaction                     Other
                    (event attributed to vaccine)            factors

Other medication


                    Events not attributed to vaccine   Environment
 Compliance
          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


World Health Organization                Global Training Network Programme
             KEY ELEMENTS OF AN EFFECTIVE
               AEFI SURVEILLANCE 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



World Health Organization             Global Training Network Programme
      Global Importance Vaccine safety
Unsafe injections and injection practice continues
Mishandling of rumors and adverse event situations
Regulations are changing
Lack of access to new, safer technologies
New technologies = new safety concerns
Growing anti-immunization lobby
Inadequate monitoring systems in most countries
Globalization and the Internet
   more devastating and widespread impact of public concerns about
   harm from vaccines
EVOLUTION OF IMMUNIZATION PROGRAMMES

               Increasing Loss of  Resumption
 Pre-vaccine                                     Eradication
               coverage confidence of confidence


               Disease
                                                       Vaccination
                                                       stops
                                    Outbreak
    Vaccine
    coverage
                Adverse events
                (number and/or perception)

       Maturity of programme
                                   Adapted from: Chen RT et al, Vaccine 1994;12:542-50
                GLOBAL INITIATIVES

Strengthening National Regulatory Authorities

Global Training Network (GTN)

Immunization Safety Priority Project (1999 through 2005)

Global Advisory Committee on Vaccines Safety (GACVS)

WHO International Drug Monitoring Program (Uppsala
Monitoring Centre)

Vaccine Safety Net

Brighton Collaboration
                                    Global Advisory Committee on
                                       Vaccine Safety (GACVS)
                                   Advisory body to WHO/IVB created in
                                    Sept 1999
                                   Response to vaccine safety issues of
                                    potential global importance
                                      -   promptly, efficiently, with scientific rigour
                                   Broad expertise
                                   Independence
                                   Decisions and recommendations
                                    based on best available evidence
                                http://www.who.int/vaccine_safety/en/
Folb et al .A global perspecitve on vaccine safety and public health : the Global Advisory
committee on Vaccine Safety. American Journal of Public Health 2004;94: 1926-31.
The Uppsala Monitoring Centre
   Co-ordinating centre for WHO International Drug
   Monitoring Programme
      Manage the international adverse reaction database
   Collect, assess and communicate information from
   member countries about the benefits, harm,
   effectiveness and risks of medicines (including
   vaccines)

   Collaborate with member countries in the development
   and practice of pharmacovigilance

   Alert regulatory authorities about potential medicine
   safety problems via the WHO signal process
   (see definition of Signal later)

                 http://www.who-umc.org/
                     Vaccine Safety Net

      Initiative to encourage good information practice
      Good Information Practice criteria to determine
      credible websites:
       -   Essential criteria i.e. with respect to credibility
       -   Important criteria i.e. with respect to content
       -   Practical criteria i.e. with respect to accessibility
       -   Desired criteria i.e. with respect to design
      Reduce impact of rumours and mis-information


http://www.who.int/immunization_safety/safety_quality/vaccine_safety_
websites/en/
             The Brighton Collaboration
   Context: Lack of standardized case definitions
    -   between countries (but … WHO definitions exist for
        reporting)
    -   between national passive systems versus clinical trials
        versus industry etc.
   Goals:
    -   developing case definitions for AEFI
    -   not to filter reporting but to improve analysis and
        comparability of clinical trial and surveillance data
    -   promoting global implementation of these definitions

                         http://www.brightoncollaboration.org
              1) Exploring the Role of the NRA…




World Health Organization            Global Training Network Programme
     Overall Role and Function of the NRA

Function:
   To ensure that all medicines used within the country are safe,
   effective and of good quality

All products licensed (registered) for use in the country
need to comply with criteria for safety, efficacy & quality.
Mission and functions within the framework of a national
medicines policy and overall health policy
6 essential functions with respect to
vaccines…(depending on source of vaccine)
Must abide by principles of any public entity by being:
   transparent, fair and accountable to the public
        6 CRITICAL FUNCTIONS OF A
    NATIONAL REGULATORY AUTHORITY

Marketing authorization and activities licensing
Postmarketing surveillance
System of Lot release
Laboratory access
Regulatory inspections (Good manufacturing
practices)
Oversight of clinical trials
                             National Regulatory Functions
                              Depend on Vaccine Source

                                      Source of vaccines
Regulatory functions          UN agency    Procure     Produce
Regulatory system                                        
                                
 Marketing Authorization &
 Activities licensing                                   
Postmarketing: AEFI
                                                        
Lot release                    Functions
                              undertaken
                                                         
Laboratory access
                              by WHO on                  
                               behalf of      Functions
Regulatory inspections        UN agencies    undertaken
                                                by the
                                                          
Supervision of                or producing
clinical trials                 countries
                                              producing
                                               country
                                                          
  TO ACHIEVE THESE CRITICAL FUNCTIONS
          NRAs NEED TO HAVE…
Sound regulatory infrastructure with ability to enforce
regulations
Good epidemiology to assess risk, PMS
Understanding of critical parts of production process
Competent inspectors
Ability to evaluate documentation
Technical expertise with research training
Government funding and commitment
Good communication systems
FUNCTIONS OF NRA IN ENSURING IMMUNIZATION
                 SAFETY
 Ensure safety and quality of vaccines used in
 immunization programme
   Assist in developing the tender for vaccine products used
   Supplier qualification and selection
   Receipt and release of vaccines
   Vaccine testing when indicated during investigations
   Ensure regulatory action against manufacturer or
   distributor when needed
      E.g. Can cancel registration or require withdrawal of
      potentially unsafe products
 Surveillance for safety and efficacy of vaccine
   Maintain up-to-date data (local and international) on
   products licensed
 ESTABLISHING A BENCHMARK:
 Assessment tools & AEFI indicators
     8 main AEFI indicators with sub-indicators
1.   Guidelines and procedures in place
2.   Roles of key players established
3.   Information and training for staff
4.   Regulatory review of safety & efficacy
5.   Responses and feedback
6.   Capacity to detect, investigate and assess AEFIs
7.   Process for action to be taken with reference to
     performance
8.   Provision for post-marketing surveillance
 What are the Common Goals of National
  Regulatory Authority and the National
       Immunization Programme?



                  Promote public health
 Minimise the risk of harm associated with immunization
Ensure safe, effective and good quality vaccines are used
Consider the following questions when
   developing/ improving on your
 National AEFI Surveillance system!
DEVELOPING THE AEFI SURVEILLANCE SYSTEM
Who should be responsible for monitoring AEFI – Immunization
programme/regulator/both?

What is the role (i.e. function and activities) of the NRA in AEFI
surveillance?
   Who/ which department/s in the NRA should be responsible for AEFI
   surveillance?

What is the role of the immunization programme in AEFI
surveillance?

How and why should NRA and EPI work together?


How can duplication of efforts & responsibility be avoided?
VACCINATION CAMPAIGNS - SPECIAL ISSUES


Apparent rise
  many doses over short period of time
  more vigilance/awareness                    Vaccination campaign

Real rise from programmatic errors
  pressure results in normal safe injection practices not observed
  new staff inadequately trained
Increased risk of negative impact of rumours
Adverse events generate criticism of campaign
Different age groups
Opportunity to launch or reinforce AEFI surveillance
Key Vaccine Safety Terminology and
            Definitions
            Key Vaccine Safety Terminology:
             Serious adverse event/reaction
A serious adverse event or reaction:
   results in death
   results in hospitalisation or prolongation of existing
   hospitalisation (e.g., encephalopathy, seizures, aseptic
   meningitis)
   results in persistent or significant disability or incapacity
   (e.g., paralysis)
   is life-threatening

'Serious' is not synonymous with 'severe' (i.e., intensity or severity of the
event)
Source: WHO International Drug Monitoring Programme, 1991
       Key Vaccine Safety Terminology:
WHO: Additional AEFIs Warranting Special Attention


 Events that may have been caused by programme error
     (e.g. bacterial abscess, severe local reaction, high fever or
     sepsis, BCG lymphadenitis, toxic shock syndrome, clusters of
     AEFIs)

 Significant events (e.g., by clinical severity) of unexplained
  cause occurring within 30 days after a vaccination

 Events causing significant parental or community concern
             Key Vaccine Safety Terminology:
                Cluster of adverse events




WHO: A cluster of AEFIs is two or more cases of the same
adverse event related in time, place or vaccine administered.


                     WHO Aide Memoire: AEFI Investigation, 2004
               Examples of AEFI clusters
Note: The exact nature of the relationship between the AEFI cases
(e.g., duration of "time", proximity of "place") will differ by the
nature of the events and the circumstances within which they
occur.
• Two (or more) cases of abscess following vaccination in a
  single immunization session, fixed or outreach. (Time in hours)

• Two (or more) cases of deaths following measles vaccination
  during a mass immunization campaign over several days,
  vaccinated in a single or several vaccination sites.

• Two (or more) cases of disseminated BCG infection in a district
  or province in a month. (Relationship in place and time
  depend on background rate of risk factors for the event e.g.,
  severe immune deficiency, population size etc.)
              Key Vaccine Safety Terminology:
                          Signal

      Reported information on possible causal relationship
       between an adverse event and vaccine (or drug)
      Relationship previously unknown or incompletely
       documented
      Usually more than a single report required to generate a
       signal – depends on seriousness of the event and the
       quality of the information.




    Source: WHO International Drug Monitoring Programme, 1991

				
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