POST 00478E : VACCINE WASTAGE
Follow-up on Posts 00311, 00316, 00320, 00324, 00345, 00349, 00404E, 00462E
and 00473E.
23 July 2002
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Dr. Anil Varshney (mailto:[log in to unmask]), from Health Care
Consultancy Services in New Delhi, India, contributes to the discussion on
Vaccine Wastage. His concern about BCG wastage is relevant and has been
shared by many people for years. The situation is periodically reviewed and
Elisabetta Molari from UNICEF (mailto:[log in to unmask]) is sharing with
us an update on the last discussions that have taken place, summarizing
results of a cost-effectiveness study.
As Dr. Varshney also points out, the Multi-Dose Vial Policy should
contribute more to reducing wastage. However it is generally recognized
that the implementation of the policy is less than optimal in many
countries. Ãœmit Kartoglu (mailto:[log in to unmask]) from WHO is thus
providing us with a summary of the policy, practical information and the
example of one country, Bhutan.
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Vaccine wastage is a major global issue as it eats plenty of resources. My
experience and as well as studies done by Health Care Consultacy Services,
New Delhi show that wastage is at following places :
- First, at cold chain due to improper cold chain, and expiry of vaccines.
Unfortunately these two are not normaly recorded in most countries.
Approximately 40-60% savings can be made from improved vaccine management,
and these funds could be utilised for newer vaccines or improving outreach.
- Second is at the session sites. I fully endorse Dr. Sarkar’s view on BCG
20 dose vial: the majority gets wasted as attendance even if 100% will not
be greater than 3 infants in a weekly session in a population of 5000.
We have observed that wastage with DPT and Measles with 10 dose vials is
also high. The ideal vial size would be 5 for all vaccines. More detailed
studies and cost-benefit analyses can be undertaken to arrive at actual and
hypothetical situations. One way for reducing wastage is also to promote
more strongly the Multi-Dose Vial Policy (MDVP) for some vaccines.
Dr. Anil Varshney,
Health Care Consultacy Services,
New Delhi India
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In 2001 UNICEF conducted a review of the cost-effectiveness of moving from
a 20 dose vial to a 10 dose vial. Based on the information UNICEF received
from BCG vaccine manufacturers during this review, please find below the
main reasons why changing from a 20 dose vial to a 10 dose vial is not
considered by UNICEF to be a viable option for BCG vaccine supply:
1.Economical reason :
The price indicated by the BCG vaccine manufacturers for a 10 dose vial is
not much lower (between 2% and 8% less) than the price of the 20 dose vial
and therefore the price saving is not offset by the saving due to the
reduction of wastage. The fact that there is little pricing differentiation
between the two vial sizes is largely attributed to the situation that key
production economies are based on the number of vials that are produced
rather than the number of doses (including, the price of the special glass
ampoule/vial, production and lyopholization lines are based on ampoule/vial
quantities rather than doses). Therefore, it is more economical to waste
vaccine than reduce the vial size.
2. Technical reason :
According to the BCG vaccine manufacturers supplying UNICEF, the potency
and the stability of the vaccine are likely to be affected due to the
reduced quantity of vaccine in each ampoule/vial to be diluted.
Furthermore, the manufacturers claim that it would be very difficult to
fill the correct amount of vaccine for a 10 dose vial given the very
limited volume of freeze dried vaccine involved.
I hope the above clarify questions. If you have any further questions or
need additional information, do not hesitate to contact us.
Elisabetta Molari ,
UNICEF Supply Division,
Copenhagen, Denmark
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Multi dose vial policy (MDVP) previously called "open vial policy" was
first introduced in 1995 and revised in 2000 based on the scientific data
collected on the safety and potency of vaccines recommended for use in
immunization services by the WHO (WHO policy statement: The use of opened
multi dose vials in subsequent immunization sessions. WHO/V&B/00.09). The
revised policy applies only to OPV, DTP, TT, DT, hepatitis B, and liquid
formulations of Hib vaccines
- that meet WHO requirements for potency and temperature stability;
- are packaged according to ISO standard 8362-2;
- and contain an appropriate concentration of preservative, such as
thiomersal (injectable vaccines only).
Multi dose vials of OPV, DTP, TT, DT, hepatitis B, and liquid formulations
of Hib vaccines from which one or more doses of vaccine have been removed
during an immunization session may be used in subsequent immunization
sessions for up to a maximum of four weeks provided that all of the
following conditions are met:
* The expiry date has not passed;
* The vaccines are stored under appropriate cold chain conditions;
* The vaccine vial septum has not been submerged in water;
* Aseptic technique has been used to withdraw all doses;
* The VVM, if attached, has not reached its discard point.
The revised policy does not change recommended procedures for handling
vaccines that must be reconstituted, that is, BCG, measles, yellow fever,
and some formulations of Hib vaccines. 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.
Most freeze-dried (lyophilized vaccines) do not contain preservatives and
consequently must not be kept more than the manufacturer's recommended
limit and never longer than six hours after they are reconstituted. Liquid
injectable vaccines such as DTP, TT, DT and hepatitis B contain
preservatives that prevent growth of bacterial contamination. Should
contamination take place within the vial, the action of these preservatives
prevents any increase in bacterial growth over time and actually decreases
the level of contamination.
Implementation of MDVP requires a series of operational issues such as
proper training of personnel, use of MDVP with VVMs and re-evaluation of
vaccine wastage rates for vaccine forecast. It is estimated that new
wastage rates would be approximately 15-20%, but this needs to be confirmed
at country level before making any radical changes.
Haemophilus influenzae type b vaccine (Hib), now in use in the immunization
services of several countries, is available in different formulations and
combinations, including liquid single antigen, liquid combined with other
antigens, and freeze-dried for reconstitution with a diluent or with
another liquid vaccine (DTP, DTP-HepB). All liquid formulations of Hib
vaccine contain a preservative and can be used in subsequent immunization
sessions.
The freeze-dried formulation contains no preservative, and after being
reconstituted with a diluent, must be discarded at the end of the session
or within 6 hours, whichever comes first (the same as for BCG, measles, and
yellow fever). Certain formulations of lyophilized Hib vaccine are supplied
with DTP liquid vaccine. However, although these can be used safely over an
extended period, implementing a decision to use them requires additional
management and supervision activities, and is not therefore recommended in
the absence of specific training of personnel.
A well documented study of the impact of MDVP comes from Bhutan.
Implementation of multi dose vial policy in Bhutan resulted in dramatic
decreases in wastage of liquid vaccines. Compared with the baseline
districts, wastage decreased by 49% for OPV, 27% for DTP, 56% for TT and
24% for HepB vaccine. Adoption of MDVP in Bhutan is estimated to result in
annual savings of $17,760 in the cost of vaccine alone.
For details please refer to Kristensen D. : “Vaccine vial monitor impact
study results, Kingdom of Bhutan, July 1997 through November 1998.â€
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