TechNet-21 - Forum

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  1. Dr. Karan Singh Sagar
  2. Service delivery
  3. Monday, 20 June 2011

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

I am sharing the instructions isssued by government of India for use of open vials at facilities.Government-of-India-Guidelines-on-use-of-open-vial-at-facilities.pdf
  1. more than a month ago
  2. Service delivery
  3. # 1
TechNet Admin Accepted Answer
Admin
Dear Sir, I speak on behalf of the Vaccine Delivery Technologies Group at PATH, which examines technologies for vaccine delivery to help improve global health and well being. We are glad to see the draft open vial policy guidelines and appreciate the opportunity to comment. We agree with Michael Royal’s suggestion that the guidelines should be written broadly enough to apply to alternative filling mechanisms. Needle-free disposable syringe jet injectors are only one example of a technology using vial adapters that may be introduced to immunization programs. For example, Indian manufacturers are producing new vaccines for rotavirus (oral delivery) and influenza (nasal delivery) which will also require vial adapters, rather than needles, to pierce the vial’s septum. As a model, WHO includes instructions for both needle and needle-free syringe filling procedures in their March 2010 guidelines, “WHO Best Practices for Injections and Related Procedures Toolkit” (section 2.2.4, found here: http://whqlibdoc.who.int/publications/2010/9789241599252_eng.pdf ). Best, Courtney Jarrahian
  1. more than a month ago
  2. Service delivery
  3. # 2
Dear Michael, Thanks for this interesting piece of information. It is nice to know we will have new technology driven solutions to reduce vaccine wastage and improve immunization safety too. The current guidelines are being drafted to address vaccine wastage in the public sector in India and they can be modified at a later date when we have such technology available. But before that we need to have sound scientific data proving that this technology is effective and can be used on wider scale.
  1. more than a month ago
  2. Service delivery
  3. # 3
Narayana Holla Accepted Answer
Dear Sir Thanks for more operational information on open vial policy. Regards Holla On Thu, Jul 14, 2011 at 9:34 AM, TechNet21 wrote:
  1. more than a month ago
  2. Service delivery
  3. # 4
TechNet Admin Accepted Answer
Admin
Dear Sir, We are working, along with several leading Indian vaccine manufacturers, to introduce a needle-free jet injector suitable for routine and campaign immunization use to the Indian market. As there are no needles in the system, a filling adaptor is used to transfer contents of the primary glass vial packaging into the single-use needle-free syringes. The system has been designed to work with single or multi-dose vials. When using multi-dose vials the filling adaptor is left in place for the life of the vial, with a new, sterile syringe installed, ready to be use with the next patient. When used in this manner it forms a sealed system which can be placed back into the cold box or refrigerator between uses. I suspect that at the outset this mode of use might raise eyebrows among some in the community, but in fact it has been well accepted among immunization professionals in Brazil and the USA where it is routinely used in this manner. Prior to this mode of use, an independent microbiology lab conducted studies per GLP guidelines whereby the sealed vial-filling adaptor-syringe system was grossly contaminated with sentinel organisms and subsequent cultures done of the vial contents. When used per system guidelines, the system effectively prevents contamination. Additional studies are planned which will evaluate the ability of this configuration to maintain vial content integrity in submersion scenarios, as despite guidance to the contrary, vaccines are sometimes delivered subsequent to septum contact with ice or water. All of this is a preamble to suggesting the addition of a few words to Item 6 of the draft operational guideline. Please consider amending "or filling adaptor" after "sterile needle" in order to recognize this upcoming mode of use. Respectfully, Michael
  1. more than a month ago
  2. Service delivery
  3. # 5
Thanks for your comments Prabir, we will definitely share the next draft. We have developed job-aids for health workers on improving quality of service delivery. These cater to wide variety of themes, like cold chain, injection safety, planning etc. These are available on http://202.71.128.172/nihfw/nchrc/index.php?q=content/immunization-1 We will be using some of these for developing the pictorial guidelines, I mentioned.
  1. more than a month ago
  2. Service delivery
  3. # 6
prabirkc Accepted Answer
Good work Karan! Do send us the proposed illustrations as well. - You may need to define "facility"- Level 1 or 2 or 3 (see the Assam Toolkit on Delivery Centres). Or a separate definition- staff, infrastructure, equipment. - In case cold chain is not monitored during a holiday/ on the weekend- it may be safer to say 5 days rather than 4 weeks for Open Vials - Mention of Thiomersal may raise hackles. It would be good to see if a cost-benefit analysis has been done to show the use of open vials (and thiomersal) is really a benefit compared to throwing away unsafe vials Best of luck! Good to see you active in the forum.
  1. more than a month ago
  2. Service delivery
  3. # 7
Narayana Holla Accepted Answer
Dear sir, In a developing country using Multidose Vials electively in planned sessions is economical at the same time 'POTENCY' of the vaccine is mostly ensured. Even after having proper cold chain equipment (ILR...), proper maintenance through out the year is mandatory. During my field visits often I saw ILR without icelining, without baskets. By mere gravity all vaccines including 'T' series will be in the bottom with frozen vaccines. In the Immunization handbook it is mentioned that, if the vaccines are taken out to the field and returned 3 times - they are to be discarded. Different views are there on the effect of 'Thawing'( 'to and fro' assault when taken out from the cold chain, returned back to the ILR) and the endurance of different antigens for this type of assaults are also different which may escape VVM 'Radar'. Moreover in the private sector there is no proper cold chain equipment with critically set temperature display. Without looking in to the conditions laid down for using and discarding the open vial they may continuously use left over vaccine till the last dose. Thus there is an impending threat that more and more vaccinated but un-immunized susceptible may accumulate in the community more so in the urban area with high risk vaccination practices. By equipping with proper cold chain equipment and adequate training of all vaccination service providers prior to implementing the policy will mostly ensure immunization of the Vaccinated. A few photos are attached.
  1. more than a month ago
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  3. # 8


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