Discussions marquées : MDVP

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Update your knowledge of the Multi-dose vial policy (MDVP) with this UNICEF/WHO mini-course!

Developed jointly by UNICEF and WHO, this brief Multi-Dose Vial Policy (MDVP) mini-course provides all partners and staff working to support immunization with a better understanding of the 2014 revision of the Multi-Dose Vial Policy and how to apply it in the real world. With the complexity of today’s vaccine formulations, health workers can no longer assume that all liquid vaccines may be kept open and used for up to 28 days. In order for countries to minimize vaccine waste while at the same ensuring vaccine safety, they need to be able to determine which open vaccine vials can be safely used for extended periods of time. This course provides the know-how to make these determinations. https://www.technet-21.org/en/library/explore/service-delivery/2975-multi-dose-vial-policy-elearning-mini-course --> Complete this course by using UNICEF's Agora learning system. Select "login" and register as a guest. Enter "immunization" in the search bar for a complete list of Immunization eLearning Initiative courses that you many use to gain important knowledge.

AWAY WITH THE DOGMA 1 ! Closed Vial Wastage

AWAY WITH THE DOGMA! 1: “Monitoring Closed Vial Wastage”   This is the first Blog in a series to encourage vaccine supply chain planners to consider changes without being constrained by some, dogmatic operational policies of the Expanded Program on Immunization. Taking one issue at a time I shall explain its origin, why it is no longer helpful and suggest alternatives for us to debate.   So please, open the attached file and I look forward to your frank reactions!

Dose per Container Partnership (DPCP) an update

Dose per Container Partnership (DPCP)
The issue: Multi-dose containers are used to offer lower prices, higher supply volumes, and minimize cold chain storage and distribution requirements. As new, more expensive, vaccines are introduced in multi-dose presentations, maximizing the use of every dose in a container increases in importance. HCWs need to be more strategic about when to open a container; diligent about how they care for open containers, and potentially more active with communication and community outreach to ensure optimal attendance and timely vaccination of every child. Thus, the number of doses per container (DCP) may also impact on health systems in terms of timely, safe and equitable vaccination coverage, supply and cold chain, wastage rates, cost and HCW behavior.
Immunization stakeholders need information and tools to assess which dose per container presentations are appropriate for a country’s specific context and priorities.
Initial 2015 response: With Bill & Melinda Gates Foundation (BMGF) funding, JSI Research & Training Institute, Inc. (JSI) helped identify evidence gaps by interviewing key stakeholders and analyzing existing research. An informal network of partners interested in advancing this work was created after a consultative meeting in July 2015.
Launch of the partnership: The Dose Per Container Partnership (DPCP) was launched in March 2016 as a project, funded by the BMGF and implemented by JSI in partnership with PATH, Agence de Médecine Préventive (AMP), Clinton Health Access Initiative (CHAI), HERMES modeling team and the International Vaccine Access Center (IVAC) / Johns Hopkins University. The DPCP aims to address the complexity of vaccine product and program decision-making to include DPC considerations. Understanding and assessing the trade-offs between cost and health impact allows better informed decisions about the impact of the dose per container selected.
DPCP objectives and work streams: The DPCP project will run from February 2016 – December 2017, guided by a Technical Advisory Group (TAG), and aims to achieve two objectives:
i) To gain a deeper understanding of the decision making processes, trade-offs, data
and tools used to assess DPC decisions at global and national levels in order to recommend process improvements;
ii) To provide guidance and tools including trade-offs to be considered by countries and facilitate
sharing of best practices for country level decision makers.
These will be implemented through three technical work streams:

A global cross-country review of current DPC-related decision making tools and processes;
Prospective research studies in two African countriesl will include data collection to improve modeling efforts, economic analysis and see the actual effect on the various systems variables; and
Synthesis of data supporting global level policy and country decisions.


Stakeholders: DPCP aims to inform, support and influence stakeholders at:
a) Global level, by providing evidence that fills critical gaps in knowledge, analysis, and policy. This includes ensuring that stakeholders will continue to be informed about sustainable decisions on DPC when considering vaccine products and program designs; and
b) Country level, by producing easy-to-use and -understand guides and tools to assess DPC tradeoffs, including cost and systems impact to inform vaccine product selection
Information about the DPCP will be made available through partners engaged with the project, the JSI website, announcements via the technet forum and various formal and informal opportunities where immunization practitioners meet globally, regionally or nationally.
http://jsi.com/JSIInternet/IntlHealth/project/display.cfm?ctid=na&cid=na&tid=40&id=22641

Next generation immunization supply chains: Rethinking the denominator and the dose

Today is Innovation Day during World Immunization Week, and there are a lot of innovative ideas out there to reach every child. But innovation doesn’t always require radical new ideas. Sometimes it simply means challenging traditional approaches based on current information. For immunization supply chains, that means changing over 40 years of custom to embrace state-of-the-art commercial best practices.
Imagine a scenario in which a global soft drink company launches a new marketing strategy; it wants 100% of young consumers under five years old in every city, town and village around the world to drink 200 ml of its product at least once a year. The company launches a global advertising campaign and free give-away of their product to the targeted consumers to meet their goal. Imagine the company then produces sufficient quantities, and packages it in 2-litre bottles for supply chain convenience. Calculating 200 ml per person and 100 percent coverage, millions of bottles are distributed to tens of thousands of shops and community marketers based on census figures and catchment area estimates down to the last kilometer. Ethical considerations and community acceptance aside, it would never work from a supply chain perspective, because the population figures and the coverage assumptions are too inaccurate. But that is precisely the model that immunization supply chains have been following for the last 40 years.
The Weakest Link: The problem of the denominator
From the national cold store to the last kilometer, vaccine demand and supply is calculated using a denominator ontarget population size or, less commonly, expected size of immunization sessionsat each vaccination point, then aggregated up the chain. Routine immunization programs are unique in their use of demographic data to operate the supply chain. It’s no secret that the denominator is inaccurate, but immunization experts at every level—including many at the global level—remain wedded to this data point.
The reliance on coverage target data to operate the supply chain is a legacy of data-poor environments. When immunization campaigns were introduced as the primary vehicle to drive coverage, demographic estimates were the only data at hand, and the micro-plan forecast could only be determined based on campaign targets because historical consumption/use data was simply not relevant. But as EPI programs evolved to rely more on routine immunization, they have continued to rely on target coverage resupply forecasts, either because this was the familiar way of doing business, or because they didn’t know or didn’t trust other methods, or because consumption reports from SDPs and vaccinators were simply not forthcoming.
Routine immunization can use routine supply chain data. Almost every other health commodity managed in awell-designed supply chainis resupplied based on reported consumption data, receipts, and remaining stock on hand, with a buffer built in to accommodate demand variability month-to-month. This consumption-based resupply system isdesignedto ensure a full supply of antiretroviral medicines, antimalarial drugs, contraceptives, and other essential health commodities thatmustbe in full supply. This system is based on the commercial best practice of using point-of-sales data for managing fast-moving consumer products; it works, and it accommodates fluctuations in demand over time. But it only works when national inventories are sufficient to meet demand, and when data are reported from SDPs on time and in full.
If immunization programs continue to rely on inaccurate demographic data to drive the supply chain, no amount of innovation in technology or system optimization is truly going to fix the problem of supply imbalances at the service delivery point.
Unit of measure: doses vs. vials
Another flaw common to immunization supply chains is the use of doses as the unit of measure for managing the supply chain. This is particularly notable at the lower levels of the system, and is related to the previous problem; demand is based on target populations, and each client needs a particular number of doses per antigen. The use of doses rather than vials is attributed to variations in presentation—doses per vial—for the same antigen. For example,DTP comes in single dose, 10-dose, and 20-dose presentations, and countries sometimes manage two different presentations of the same antigen in a given year. But managing a supply chain based on doses is a bit like Coca Cola or Pepsi managing beverages based not on various sizes of cans, bottles, and cases but on milliliters of fluid imbibed by the average consumer; it doesn’t happen in the commercial world. Granted, vaccines are different from soft drinks, but best practice is to manage the supply chain based on stockkeeping units (SKUs) which, in vaccine terms, is the vial. Each presentation of each antigen is a unique SKU, so a 10-dose vial of DTP would be a different SKU from a 20-dose vial.
Beyond aligning with commercial and pharmaceutical supply chain best practices, managing by SKU allows supply chain analysts the ability to compare coverage against consumption. Doses administered (coverage) reported via the HMIS can be compared with vials issued (reported via LMIS) to vaccinators to provide an important quality check on coverage reporting, and can also be used to analyze open-vial wastage rates more accurately. Consumption and wastage trends can inform forecasts and procurement specifications, and the right presentation can be targeted to specific SDPs based on their specific trends. Managing by SKU becomes easier—and essential—when barcodes and other technologies are introduced to automate supply chain information systems.
Global and country stakeholders working in immunization are recognizing that immunizationsupply chains must evolve. Successful supply chains that ensure availability and potency of vaccines and related supplies demand therightdata in the right quality at the right time.
This article was reposted from JSI's The Pump

Sharing the task responsibilities for effective operationalization of MDVP/OVP

Dear viewers Context: India in collaboration with development partners like WHO/UNICEF/USAID/MCHIP etc has made remarkable advances in the last ten years: introduction of Measles 2nd dose, HepB vaccine including Birth dose vaccine, JE 2 doses, Pentavalent vaccine, year 2012-13 declared as year of Intensified Routine Immunization, India with SEARO declared as Polio Free, launching of Mission Indradhanush – the flagship programme of India. Karnataka Piloted Immunogram in a difficult district in 2013. India is now entering in to a new era of introducing Injectable Inactivated Polio Vaccine under routine Immunization from 1st April 2016 as part of Global Endgame Strategic Plan. India Expert Advisory Group, based on evidences recommends 2 fractional doses of 0.1ml intradermally at 6 and 14 weeks in selected States including Karnataka. Injectable vaccine has VVM on the label and MDVP / OVP is made applicable to minimize wastage, to be operated at all levels. Background: Globally immunization programme is rapidly expanding in covering more beneficiaries from newborn to the old through children, teenagers and pregnant; administering the doses close to the recommended schedule for timely attaining adequate immunity – jointly closing population immunity gap – an aspiration of WORLD; including more and more vaccines in the National Immunization Schedule on the basis of country specific epidemiology of Vaccine Preventable Diseases (VPDs), periodically reviewed and revised / upgraded by the Expert Advisory Group / Committees of the countries, World is convinced about the advantages of vaccination in preventing morbidity and mortality form VPDs like neonatal / puerperal tetanus, crippling polio & post encephalitic residual paralysis of JE, Diphtheria, Whooping cough, measles, childhood tuberculosis, pneumonias, diarrhoea, Varicella, herpes zoster, Ca cervix, HCC, rabies etc. World has witnessed Smallpox eradication, Polio at the verge of eradication, measles under elimination – others declining and under control. But: Expenditure of vaccination is increasing & Vaccine wastage is rising. Hence: Countries all over the world expressed the concern to avoid “preventable wastage without compromising efficacy and safety” [WHO – MDVP 2014]. We wish to share the experiences of practically operationalizing MDVP / OVP guidelines in the attached planning unit - RHTC Sampaje in view of introduction of IPV in the country and the one page jobaid which we made in regional Kannada launguage, the same is now edited with new circular guideline, translated to english as suggetsed by consultants form ITSU also. This may please be edited / corrected further by the viewers. Regards Narayana Holla

Operationalizing WHO revised MDVP and open vial policy guidelines issued by the Govt

In response to revised WHO Multi-dose Vial Policy, 2014 and the circular guidelines issued by the GoI, subsequently by state govt (GoK) it was decided to operationalize the policy in the attached PHC. With literature review and on the basis of guidelines issued by the guidelines, a one pager ‘to do’ task responsibility training material cum job aider cum monitoring checklist (3 in 1) was drafted. On 6th November training workshop was held at the PHC with the consent and active participation by the district RCH officer. Presently open vial policy is not in practice as an organized structured training was not held. In the training workshop every minute detail was discussed and demonstrated as safety, efficacy and coverage are of utmost importance while preventing avoidable vaccine wastage. With rapidly expanding immunization programme, more vaccines which are freeze sensitive and costlier than the basic six vaccines MDVP is very much required. The draft was further fine tuned from the feedback obtained by the participants and district programme officer. This month is the interventional month, closely monitored to for operational research for further standardization of training workshop and to achieve expected outcome against the existing average wastage of last 12 months. Sharing with the Technet community for additional views and support.

Revised WHO Multi-dose Vial Policy, 2014

Please find at the link below the revised WHO multi-dose vial policy. Please disseminate widely to all EPI staff. Thank you.

Veuillez trouver au lien ci-dessous la nouvelle politique de l'OMS en ce qui concerne la manipulation correcte des flacons de vaccin multidoses entamés. Je vous prie de bien vouloir partager avec tous nos collègues PEV. Merci.

http://www.who.int/iris/bitstream/10665/135972/1/who_ivb_14.07_eng.pdf

Handling of Multi-dose Vaccine Vials after Opening
WHO Policy Statement: Multi-dose Vial Policy (MDVP): 2014 Revision

This document presents WHO’s official position with respect to how multi-dose vials of vaccines should be handled once opened, including the specific conditions that warrant immediate disposal, use within a maximum of six hours, and the criteria allowing for an opened vial to be can be kept and used for up to 28 days after opening. The policy statement further outlines conditions under which the MDVP can be implemented safely, including, but not limited to, adherence to good immunization practices.


Version française:

http://www.who.int/iris/bitstream/10665/135973/1/WHO_IVB_14.07F_fre.pdf

Manipulation des Flacons de Vaccin Multidoses Entamés
Déclaration de politique générale de l’OMS : La politique relative aux flacons multidoses : Revision 2014

Ce document présente la position officielle de l'OMS en ce qui concerne la manipulation correcte des flacons de vaccin multidoses une fois ouvert, y compris les conditions particulières qui justifient une élimination immédiate, utilisation dans un délai maximum de six heures, et les critères permettant un flacon ouvert d’être conservé et utilisé jusqu'à 28 jours après ouverture. La déclaration décrit en outre les conditions dans lesquelles cette politique peut être appliquée sans risque, y compris, mais sans s’y limiter, le respect des bonnes pratiques de vaccination.
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