Revision of the Multi Dose Vial Policy MDVP

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Revision of theMulti Dose Vial Policy (MDVP)

• Presentation to the TechNet Consultation
• Tunis, 2 4 Dec 2008
• Dr Rudi Eggers, EPI, WHO/HQ Geneva

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WHO policy statement 2000The use of opened
multi-dose vials of vaccine in subsequent
immunization sessions (WHO/VB/00.09)
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Why was a MDVP originally developed?
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Impact of MDVP Tunisia vaccine wastage

• Before 2000, DTP vaccine in 20-dose vials only
• Range of measures were implemented including mix
  of 20 10-dose vials, session planning to reduce
  wastage without significant impact on vaccine
  wastage
• 2005 phased introduction of MDVP and extension to
  the whole country in 2006
• MDVP had the most significant impact on wastage
  reduction (DTP vs Measles)
• Since MDVP introduced, no change in AEFI
  reporting from the field.

Source Dr M. Ben Ghorbal, EPI, DSSB, MPH,
Tunisia, Update August 2008
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Trend of DTP vaccine demand - Tunisia
Source Dr M. Ben Ghorbal, EPI, DSSB, MPH,
Tunisia, August 2005-2008
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Implications of MDVP implementation

• Performance reduced missed opportunities
  contributed to improve coverage.
• Management implementation has greatly reduced
  vaccine wastage.
• Quality Safety from 2000 up to date, no report
  was received on adverse events due to
  implementation of the policy.

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MDVP policy 2000Liquid vaccines

• Applies only to OPV, DTP, TT, DT, Hepatitis B,
  and liquid Hib vaccines that
• meet WHO requirements for potency and temperature
  stability
• are packaged according to ISO standards, and
• contain an appropriate concentration of
  preservative, such as thimerosal (injectable
  vaccines only)

• Multi-dose vials of these vaccines may be used
  for up to a maximum of 4 weeks.
• Conditions
• expiry date not passed
• stored under appropriate cold chain conditions
• vial septum not submerged in water
• aseptic technique to withdraw all doses
• VVM, if attached, not reached discard point

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MDVP policy 2000Lyophilized vaccines

• BCG, YF, Measles
• Once they are reconstituted, vials of these
  vaccines must be discarded
• at the end of each immunization session or
• at the end of six hours, whichever comes first.

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Practically, this is how the rule is applied

• If vaccine carries VVM
• Liquid vaccine VVM on label KEEP
• Freeze dried vaccine VVM on cap DISCARD
• If vaccine does not carry VVM
• Liquid vaccine KEEP
• Freeze dried vaccine DISCARD

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Challenges to current application of the MDVP

• Absence of VVM on some vaccines and in some
  regions
• Inadequate cold chain at service delivery
  problems storing opened vials for reuse
• Perception of poor quality' of reusing opened
  vials of liquid vaccine among some service
  providers

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Challenges to current application of the MDVP

• Different instructions from vaccine package
  insert
• Same type of vaccine may have different
  instructions of use
• package insert not always available to service
  provider (obstacle of re-packaging for in-country
  distribution)
• Add difficulties to the message to the field

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Challenges to MDVP package insert-1
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Challenges to MDVP package insert-2
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New challenges with use of MDVP

• SITUATION 1
• Multi-dose liquid vaccines containing reduced
  amounts of thiomersal may not meet the
  requirements of the MDVP
• Multi-dose liquid vaccines containing alternative
  preservatives may not meet the requirements of
  the MDVP
• Two-dose vials of novel vaccines (pneumococcal,
  human papilloma virus) in liquid formulations
  without containing any preservative
• Using several fractional doses from a single dose
  vial eg by adoption of intradermal route (1 dose
  vial becomes a 5 dose vial)

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New challenges with use of MDVP

• Vaccines that are not adequately preserved may
  mistakenly be kept because they are liquid
  vaccines

SAFETY RISK
MDVP has become too unsafe
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New challenges with use of MDVP

• SITUATION 2
• Reconstituting a lyophilized component (eg. Hib)
  of a combination vaccine with a liquid component
  containing preservative in adequate amounts (eg.
  DTP-Hep B)
• Future liquid-liquid combinations where one
  component contains sufficient preservative

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New challenges with use of MDVP

• Vaccines that are adequately preserved will
  not be kept because they are freeze dried or
  used to reconstitute a freeze dried component of
  the combination

UNNECESSARY WASTAGE
MDVP has become too wasteful
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TLAC on the Multi-dose Vial Policy

• TLAC Discussion
• Extant 2000 MDVP may soon be obsolete and
  potentially wasteful and/or dangerous
• Premature discarding of safe and potent vaccine
• Use of contaminated vaccine kept too long
• Caveats about VVMs
• Use and location on vial not controlled by
  WHO/UNICEF
• Not designed to indicate presence of preservative
  or post-opening microbial contamination
• WHO/UNICEF might better control VVM symbology by
  trademarking
• New symbology needed for MDVP guidance to health
  workers
• Preliminary recommendations
• TLAC MDVP Sub-group
• WHO should commission thorough review of the
  complex issues
• ? consultant contracted, started work

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Conclusions

• There is a clear positive impact of successful
  implementation of MDVP
• Vaccines (DTP, OPV) used for more sessions ?
  increase coverage
• Vaccine demand reduction. A potential exist for
  LMIC and for newer vaccines ? greater efficiency
• Improving quality safety of services by
  ensuring that recommended practice is implemented
  ? no increase in AEFI
• However there are challenges and limitations to
  overcome and to maximize the benefit of MDVP
• There is a need for a simple, continuous and
  universal message

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Acknowledgments

• Nora Dellepiane, WHO
• Solo Kone, WHO
• Darin Zehrung, PATH