POST 00478E : VACCINE WASTAGE

POST 00478E : VACCINE WASTAGE Follow-up on Posts 00311, 00316, 00320, 00324, 00345, 00349, 00404E, 00462E and 00473E. 23 July 2002 _________________________________________________________________________ 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. _________________________________________________________________________ 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 __________________________________________________ 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 ____________________________________________________ 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€