GoI is planning to put in place open vial policy at the facility level. In that context I would like to get comments from the members on a draft opertional guideline. This has been prepared from WHO and other resources on open vial policy. We intend to draft a pictorial guidlines covering following points. Please let us know if you have comments (please note these are India specific, so some points differ from standard guidelines e.g. keeping of reconstituted vaccines for 4 hrs etc).
1) Liquid DPT, TT, HepB, Hib and OPV opened in a fixed clinic may be used at more than one immunization session up to four weeks provided that
a) The expiry date has not passed.
b) The vaccines are stored under appropriate cold chain conditions.
c) The vaccine vial septum has not been submerged in water.
d) Aseptic technique has been used to withdraw all doses.
e) The vaccine vial monitor (VVM), if attached, has not reached the discard point.
f) Opened vials of measles, BCG and JE vaccine cannot be used after an initial immunization session, (even if the VVM has not reached the discard point.). BCG and Measles must be discarded within four hours of reconstitution and JE after two hours or at the end of the session, whichever comes first.
2) The revised policy applies only to OPV, DPT, TT, hepatitis B, and liquid formulations of Hib vaccines that:
a) meet WHO requirements for potency and temperature stability;
b) are packaged according to ISO standards (ISO Standard 8362-2); and
c) Contain an appropriate concentration of preservative, such as thiomersal (injectable vaccines only).
Note: Vaccines supplied via UNICEF meet these requirements.
3)
4) Multi-dose vials from which at least one dose has been removed may be at risk of contamination of the vial septum. These vials should never, therefore, be allowed to be submerged in water (from melted ice for example) and the septum should remain clean and dry. NOTE: Well-sealed icepacks should be used in vaccine carriers and water should not be allowed to accumulate where the vials are stored.
5) Discard vaccine vial
a) discard if expired
b) VVM reached discard point (for freeze dried vaccine, before reconstitution only)
c) no label or label not legible
d) Any vial thought to be exposed to non-sterile procedure for withdrawal
e) open vials that have been under melted water
6) If multi-dose vials must be used, always pierce the septum with a sterile needle.
7) Inspect for and discard medications with visible contamination or breaches of integrity (e.g. cracks, leaks).
8) Health workers must be able to distinguish between vials that can be used in subsequent sessions and vials that must be discarded. Training and supervision materials should be revised to reflect the policy change
9) Mark with date & time opened
10) Observe correct temperature storage, store in ILR at 2-8C
11) Monitor ILR temperature regularly (twice daily)
12) Dedicated ILR section fridge for opened vials
13) Observe first in first out policy –FIFO and stock rotation.
14) Keep stock up to date, don’t overstock or understock vaccines and diluents
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