Mid-Level Management Course for EPI Managers
BLOCK III: Logistics
Module 8: Vaccine management
1
MLM Module 8: Vaccine management
Mid-Level Management Course for EPI Managers List of course modules BLOCK I: Introductory modules Module 0: Introduction Module 1: A problem-solving approach to immunization services management Module 2: The role of the EPI manager Module 3: Communication and community involvement for immunization programmes BLOCK II: Planning/organization Module 4: Planning immunization activities Module 5: Increasing immunization coverage Module 6: Immunization financing BLOCK III: Logistics Module 7: Cold chain management Module 8: Vaccine management Module 9: Immunization safety Module 10: Transport management Module 11: Maintenance BLOCK IV: New vaccines Module 12: New and under-utilized vaccine introduction BLOCK V: Supplementary immunization Module 13: How to organize effective polio NIDs and measles SIAs BLOCK VI: Disease surveillance Module 14: How to conduct effective vaccine-preventable diseases case-based surveillance BLOCK VII: Monitoring and evaluation Module 15: Monitoring and data management Module 16: Supportive supervision by EPI managers Module 17: Conducting immunization coverage survey Module 18: Conducting assessment of the immunization programme BLOCK VIII: EPI training materials Module 19: Facilitator’s guide
4
Mid-Level Management Course for EPI Managers
BLOCK III: Logistics
Module 8: Vaccine management
5
MLM Module 8: Vaccine management
Module 8: Vaccine management ISBN 978-929023381-7 © World Health Organization 2017 Some rights reserved. This work is available under the Creative Commons Attribution-NonCommercialShareAlike 3.0 IGO licence (CC BY-NC-SA 3.0 IGO; https://creativecommons.org/licenses/by-nc-sa/3.0/igo). Under the terms of this licence, you may copy, redistribute and adapt the work for non-commercial purposes, provided the work is appropriately cited, as indicated below. In any use of this work, there should be no suggestion that WHO endorses any specific organization, products or services. The use of the WHO logo is not permitted. If you adapt the work, then you must license your work under the same or equivalent Creative Commons licence. If you create a translation of this work, you should add the following disclaimer along with the suggested citation: “This translation was not created by the World Health Organization (WHO). WHO is not responsible for the content or accuracy of this translation. The original English edition shall be the binding and authentic edition”. Any mediation relating to disputes arising under the licence shall be conducted in accordance with the mediation rules of the World Intellectual Property Organization. Suggested citation. Module 8: Vaccine management. Geneva: World Health Organization; 2017. Licence: CC BY-NC-SA 3.0 IGO. Cataloguing-in-Publication (CIP) data. CIP data are available at http://apps.who.int/iris. Sales, rights and licensing. To purchase WHO publications, see http://apps.who.int/bookorders. To submit requests for commercial use and queries on rights and licensing, see http://www.who.int/about/licensing. Third-party materials. If you wish to reuse material from this work that is attributed to a third party, such as tables, figures or images, it is your responsibility to determine whether permission is needed for that reuse and to obtain permission from the copyright holder. The risk of claims resulting from infringement of any third-party-owned component in the work rests solely with the user. General disclaimers. The designations employed and the presentation of the material in this publication do not imply the expression of any opinion whatsoever on the part of WHO concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement. The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by WHO in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters. All reasonable precautions have been taken by WHO to verify the information contained in this publication. However, the published material is being distributed without warranty of any kind, either expressed or implied. The responsibility for the interpretation and use of the material lies with the reader. In no event shall WHO be liable for damages arising from its use.
6
Contents Acknowledgements Abbreviations and acronyms Glossary 1. Introduction 1.1 Context 1.2 Purpose of the module 1.3 Target audience 1.4 Learning objectives 1.5 Contents of the module 1.6 How to use this module 2. Recognize vaccine characteristics 3. Estimate vaccine needs 3.1 Estimating vaccine needs on the basis of target population 3.2 Estimating vaccine needs on the basis of previous consumption 3.3 Estimating vaccine needs on the basis of the size of immunization sessions 3.4 Comparative advantages of the three methods of estimating vaccine needs 4. Order vaccines 4.1 Defining vaccine supply period 4.2 Calculating quantities of vaccine for a supply period 4.3 Defining safety stock level 4.4 Calculating maximum stock level 4.5 Calculating reorder stock level (or warning level) 4.6 Calculating total quantities of vaccine to be ordered 5. Manage vaccine stocks 5.1 Receiving delivered vaccines and supplies 5.2 Storage, transport and handling of vaccines 5.3 Storage, transport and handling of diluents 5.4 Organizing vaccine distribution 5.5 Inventory management and recording transactions 5.6 Physical count of vaccine stocks 6. Monitor vaccine use 6.1 What is a vaccine vial monitor? 6.2 Multi-dose vial policy (MDVP) 6.3 Monitoring vaccine use and wastage 6.4 Vaccine management report Recommended reading Annex 1: Vaccine arrival report (VAR) Annex 2: Summary calculations in vaccine management Annex 3: Selected commonly used temperature monitoring devices Annex 4: Analysis and interpretation of vaccine wastage data with vaccination coverage IV IV VI 1 1 2 2 2 2 2 3 7 7 13 14 15 17 17 18 18 19 20 21 23 23 23 31 31 33 35 37 37 39 40 43 44 45 49 51 52
III
Acknowledgements The WHO Regional Office for Africa is grateful to all the resource persons from WHO headquarters, regional, subregional and country offices who have contributed to the revision of the Mid-Level Management training modules, and also to partners, especially, the United Nations Children’s Fund (UNICEF); United States Agency for International Aid (USAID); John Snow, Inc.; Centers for Disease Control and Prevention (CDC), Atlanta; the Bill & Melinda Gates Foundation (BMGF) and the Network for Education and Support in Immunisation (NESI) for their contribution in this revision exercise.
Abbreviations and acronyms AFP BCG CCM CFC DANIDA DoV DT DTP EEFO EPI EVM FCV FIC FIFO GAPPD GIVS GSM GVAP HepB Hib HPV IMCI MDVP MMR MOH NID OPV Penta PPP RED/REC RSPI acute flaccid paralysis Bacillus Calmette-Guérin (vaccine against TB) cold chain monitoring chlorofluorocarbon Danish International Development Agency Decade of Vaccines diphtheria-tetanus (vaccine) diphtheria-tetanus-pertussis-containing (vaccine) earlier expiry first out Expanded Programme on Immunization effective vaccine management full course vaccination fully immunized child first in first out Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea Global Immunization Vision and Strategy global system for mobile communication Global Vaccine Action Plan (2011–2020) hepatitis B vaccine Haemophilus influenzae type b (vaccine) human papilloma virus Integrated Management of Childhood Illness multi-dose vial policy measles, mumps, rubella Ministry of Health national immunization day oral polio vaccine pentavalent (vaccine having five antigens) public-private partnerships Reaching Every District/Reaching Every Community Regional Strategic Plan for Immunization (2014–2020)
IV
SIAs SMT TT UNICEF VAR VPD VVM VWR WHO
supplementary immunization activities stock management tool tetanus toxoid United Nations Children’s Fund vaccine arrival report vaccine-preventable disease vaccine vial monitor vaccine wastage rate World Health Organization
V
Glossary Auto-disable syringe Bundling A specially modified disposable syringe with a fixed needle that is automatically disabled by plunger blocking after it has been used once. A concept which requires that certain items must be ordered, distributed and used together. In the case of immunization this concept applies to vaccines, syringes and safety boxes. It does not necessarily imply that things are tied together physically. The cold chain is a system of different elements, i.e. human, material and financial resources, and certain norms and standards that ensure the high quality of vaccines. The cold chain consists of different levels called links, which deal with vaccine orders and supplies, their transportation, storage and distribution from factory to the point of administration to the target population. A vaccine consisting of several components or antigens (e.g. DTP, DTP-HepB or DTP-HepB-Hib, etc.). A liquid used to reconstitute freeze-dried/lyophilized vaccine. Each such vaccine has its own diluents that cannot be used to reconstitute any other vaccine. Date after which the vaccine, diluents and other consumables (e.g. syringes, needles) should not be used for the purpose of immunization due to possible loss of potency (vaccines) or durability (consumables and other items). A variable used to measure progress towards the achievement of targets and objectives. It is used to compare performance in terms of efficiency, effectiveness and results. It is also used to measure impact of interventions. A physical count and assessment of the state and functionality of the equipment and other materials used in the cold chain. A group of operations that include procurement, delivery of vaccines and consumables to the place of their use, management and maintenance of transport and cold chain equipment. A series of technical activities (preventive and “curative”) that ensure smooth running of the equipment and transport facilities related to the cold chain. To restore to former condition of freeze-dried vaccines using specific diluents. A process to guide, support and assist service providers to carry out their duties and assigned tasks so as to achieve planned organizational goals. The process is based on observations, interviews, inspections, review of documentation etc. that help supervisors to assess the situation, and health workers to improve performance.
Cold chain
Combination vaccine Diluents Expiry date
Indicator
Inventory Logistics
Maintenance Reconstruction of vaccine Supervision
VI
1. Introduction
1. Introduction 1.1 Context The Expanded Programme on Immunization (EPI) is a key global health programme. Its overall goal is to provide effective and quality immunization services to target populations. EPI programme managers and staff need to have sound technical and managerial capacities in order to achieve the programme’s goals. The immunization system comprises five key operations: service delivery, communication, logistics, vaccine supply and quality, and surveillance. It also consists of three support components: management, financing and capacity strengthening. National immunization systems are constantly undergoing change, notably those related to the introduction of new vaccines and new technologies, and programme expansion to reach broader target populations beyond young children. The EPI programme also faces external changes related to administrative decentralization, health reforms, as well as the evolving context of public-private partnerships (PPPs) for health, among others. To ensure the smooth implementation of immunization programmes, EPI programme staff have to manage these changes. This requires specific skills in problemsolving, setting priorities, decision-making, planning and managing human, financial and material resources as well as monitoring implementation, supervision and evaluation of services. National immunization programmes (NIPs) operate within the context of national health systems, in alignment with global and regional strategies. For the current decade, 2011–2020, the key global immunization strategies are conveyed through the Global Vaccine Action Plan (2011– 2020) (GVAP) and the African Regional Strategic Plan for Immunization (2014–2020) (RSPI). These strategic plans call on countries to: • improve immunization coverage beyond current levels; • complete interruption of poliovirus transmission and ensure virus containment;1 • attain the elimination of measles and make progress in the elimination of rubella and congenital rubella syndrome;2 and • attain and maintain elimination/control of other vaccine-preventable diseases (VPDs). The key approaches for implementation of the GVAP/ RSPI include: • implementation of the Reaching Every District/ Reaching Every Community (RED/REC) approach and other locally tailored approaches and move from supply-driven to demand driven immunization services; • extending the benefits of new vaccines to all; • establishing sustainable immunization financing mechanisms; • integrating immunization into national health policies and plans; • ensuring that interventions are quantified, costed and incorporated into the various components of national health systems; • enhancing partnerships for immunization; • improving monitoring and data quality; • improving human and institutional capacities; • improving vaccine safety and regulation; and • promoting implementation research and innovation. The RSPI promotes integration using immunization as a platform for a range of priority interventions or as a component of a package of key interventions. Immunization is a central part of initiatives for the elimination and eradication of VPDs, and of the integrated Global Action Plan for the Prevention and Control of Pneumonia and Diarrhoea (GAPPD) by 2025. It is understood that while implementing the above strategies, EPI managers will face numerous challenges and constraints that they need to resolve if the 2020 targets are to be met. Building national capacity in immunization service management at all levels of the health system is an essential foundation and key operational approach to achieving the goals of the global and regional strategic plans. In view of this, the WHO Regional Office for Africa, in collaboration with key immunization partners such as the United Nations Children’s Fund (UNICEF), United States Agency for International Development (Maternal and Child Survival Program) (USAID/MCSP), and the Network for Education and Support in Immunisation (NESI), have revised the Mid-Level Management Course for EPI Managers (MLM) training modules. These modules are complementary to other training materials including the Immunization in Practice (IIP) training manuals for health workers and the EPI/Integrated Management of Childhood Illnesses (IMCI) interactive training tool.
1 WHO, CDC and UNICEF (2012). Polio Eradication and Endgame Strategic Plan 2013-2018. 2 WHO (2012). Global Measles and Rubella Strategic Plan 2012-2020.
1
MLM Module 8: Vaccine management
This module (8) titled Vaccine management is part of Block III: Logistics.
1.2 Purpose of the module The aim of this module is to update EPI managers and immunization management teams with the concepts and techniques of vaccine management. The module will also help EPI managers to renew their immunization logistics support systems in order to address operational weaknesses.
1.3 Target audience The module is intended for EPI managers at all levels of the national health system.
1.4 Learning objectives At the end of the module, the participants should be able to: • Explain the methods used in forecasting vaccine needs: ºº explain parameters used for estimating vaccine needs ºº describe methods used for estimating vaccine needs. • Apply the standards in ordering vaccines: ºº define supply parameters (supply interval, lead time) ºº determine stock levels (safety/reserve stock, maximum stock levels) ºº calculate total quantity of vaccines to be ordered.
Manage vaccines stocks ºº determine vaccine acceptance criteria ºº categorize vaccines, diluents and supplies per storage conditions ºº demonstrate vaccine and diluents arrangements ºº explain the technique of shake test ºº explain vaccine and diluents distribution principles ºº design stock recording system. • Apply the policies on monitoring vaccine use ºº interpret vaccines control indicators (vaccine vial monitor – VVM) ºº apply WHO policy on the use of opened multi-dose vials of vaccine in subsequent immunization sessions (multi-dose vial policy – MDVP) ºº categorize and calculate vaccines wastage.
•
1.5 Contents of the module This module contains the sections shown below.
1.6 How to use this module After discussing the concepts governing the management of vaccines and examining the various approaches suggested, each participant will be required to do the practical exercises. At the end of the exercises, participants will discuss the solutions with the facilitators or in plenary session.
Recognize vaccine characteristics
Estimate vaccine needs
Order vaccines
Manage vaccine stocks
Monitor vaccine use
2
2. Recognize vaccine characteristics
Recognize vaccine characteristics
Estimate vaccine needs
Order vaccines
Manage vaccine stocks
Monitor vaccine use
2. Recognize vaccine characteristics Vaccines are biological products prepared from killed or attenuated (weakened) virus or bacteria or their toxins, used for vaccinating people to induce specific immunity against an infectious disease. The vaccine products are available from different manufacturers with different characteristics targeting the same disease. The knowledge of those characteristics and their associated implications is important in order to optimally organize supply chain operations and to deliver safe vaccination services. Table 2.1 summarizes characteristics of most of the current vaccines being used in public health immunization programmes globally.
Table 2.1 Summary of different vaccines, their characteristics, presentation and recommended storage temperatures
Vaccine BCG
Characteristics Live vaccine
Route of Formulation/ inoculation3 presentation ID Lyophilized with diluents Multi-dose ampoules IM IM Liquid Multi-dose vial Liquid Multi-dose/ single-dose vial Lyophilized or liquid Multi-dose/ single-dose vial Liquid Multi-dose/ single-dose Liquid Multi-dose vial or plastic tube Liquid Prefilled syringes/multidose vial
Diphtheria Pertussis Tetanus (DPT) DPT-HepBHib (pentavalent vaccine or Penta) Hib
Inactivated vaccine toxoid Hib conjugated vaccine, HepB vaccine DPT (see above) Conjugated vaccine
Storage temperature Avoid exposure to sunlight +2°C to +8°C Diluents should be refrigerated before mixing with vaccine Diluents should never be frozen Never freeze +2°C to +8°C Never freeze +2°C to +8°C
Handling procedures
IM
HepB Oral polio (OPV)4 Inactivated polio vaccine (IPV)5
Recombinant vaccine Live attenuated virus vaccine Inactivated vaccine
IM Oral IM
Diluents should be refrigerated before mixing with vaccine Hib liquid vaccine should never be frozen Never freeze Avoid exposure to light Never freeze
+2°C to +8°C
+2°C to +8°C +2°C to +8°C (or -20°C) +2°C to +8°C
3 ID intradermal; IM intramuscular; SC subcutaneous. 4 OPV comes in trivalent formulation using Sabin Types 1, 2 and 3. Special formulations have been approved for use in polio eradication efforts; a bivalent formulation has been approved using Types 1 and 2. 5 Inactivated IPV vaccine is a trivalent formulation, Types 1, 2 and 3.
3
MLM Module 8: Vaccine management
Vaccine Yellow fever
Characteristics Live attenuated virus vaccine
Route of Formulation/ inoculation3 presentation SC Lyophilized with diluents Multi-dose/ single-dose Oral Lyophilized with diluents or liquid Single-dose plastic tube or applicator Lyophilized with diluents Multi-dose/ single-dose Lyophilized with diluents Multi-dose/ single-dose Lyophilized with diluents Single-dose/ multi-dose Liquid Multi-dose/ single-dose Prefilled syringes Liquid, singleor multi-dose Lyophilized with diluents Multi-dose vial Lyophilized with diluents Prefilled syringes Multi-dose vial Prefilled syringes Liquid Single and multi-dose vial
Rotavirus
Live attenuated virus vaccine
Storage temperature Avoid exposure to sunlight +2°C to +8°C Diluent should be (or -20°C) refrigerated before mixing with vaccine but never be frozen Avoid exposure to sunlight +2°C to +8°C Prefilled syringe and lyophilized vaccine should be refrigerated but never be frozen Avoid exposure to sunlight Diluents should be refrigerated previous to mixing with vaccine but never be frozen Avoid exposure to sunlight Diluents should be refrigerated before mixing with vaccine but never be frozen Avoid exposure to sunlight Diluents should be refrigerated prior to mixing with vaccine but never be frozen Never freeze +2°C to +8°C (or -20°C)
Handling procedures
Measles
Live attenuated virus vaccine
SC
Measles Mumps Rubella (MMR)
Live attenuated virus vaccine
SC
+2°C to +8°C (or -20°C)
Measles Rubella (MR)
Live attenuated virus vaccine
SC
+2°C to +8°C (or -20°C)
Pneumococcal
Conjugated vaccine
IM
+2°C to +8°C
Hepatitis B Meningococcal A Human rabies – Vero cell Influenza6 Influenza6 Human papilloma virus
Live attenuated virus vaccine Conjugated vaccine and Polysaccharide Inactivated vaccine Live attenuated virus vaccine Inactivated vaccine Recombinant Vaccine
IM IM
Never freeze Diluents should be refrigerated before mixing with vaccine but never be frozen Never freeze Avoid thawing/freezing Never freeze Never freeze
+2°C to +8°C +2°C to +8°C
IM Intranasal IM IM
+2°C to +8°C +2°C to +8°C +2°C to +8°C +2°C to +8°C
The storage condition for each vaccine is determined by their composition and formulation. Each vaccine has its own correct storage conditions as specified by the 4
manufacturer, the National Regulatory Authority or the World Health Organization (WHO).
3 ID intradermal; IM intramuscular; SC subcutaneous. 6 Seasonal influenza vaccine, both inactivated and live attenuated formulations contain a trivalent mix, which may change from year to year.
2. Recognize vaccine characteristics
Staff that handle vaccines should be fully informed regarding the correct storage temperature for each vaccine in order to assure that they remain potent. Failure to properly assure the required storage temperature may Exercise 1
lead to damaging the vaccine and result in not providing the expected immune response and may cause an adverse event.
For all groups. Working individually, identify vaccine characteristics and indicate in which form the antigen is presented in the following vaccines. Vaccines Yellow fever Rotavirus Measles Pneumococcal Meningococcal BCG OPV IPV Hib TT Pertussis HepB HPV Vaccine characteristics Formulation/presentation
5
MLM Module 8: Vaccine management
6
3. Estimate vaccine needs
Recognize vaccine characteristics
Estimate vaccine needs
Order vaccines
Manage vaccine stocks
Monitor vaccine use
3. Estimate vaccine needs A prerequisite for estimating vaccine needs is the availability of reliable data. These data are necessary to control future orders as well as handling and use of vaccines. It will also help to determine cold chain needs and evaluate needs in relation to the waste to be eliminated. A comprehensive vaccine management system comprises three main activities: • Estimating vaccine needs and injection accessories in line with the multi-year plan and micro-plans. • Monitoring the management of vaccine stocks and organizing vaccine distribution. • Monitoring and supervision of vaccine use and injection accessories on the ground. Common problems • Vaccine needs are normally estimated at the national level with support from UNICEF and the WHO country office, with little or no participation of the regional, district or peripheral levels. • Often there are serious discrepancies between vaccine needs forecasts and the objectives of the EPI multi-year plans. • Management of vaccines is generally inadequate; often no one is held responsible for loss of vaccines; and monitoring and control systems are weak. Vital considerations and concerns • Vaccine producers manufacture vaccines only when confirmed orders are placed. • Vaccine producers have limited manufacturing capacity. • Vaccines are becoming increasingly expensive, particularly new vaccines. Advantages of an accurate forecasting vaccine needs • Efficient control of immunization programmes by managers. • • • • • Elimination of shortages or over-stocking of vaccines. Enhancing the capacity of districts to develop more accurate micro-plans. Increased efficiency of vaccine use, and reduction of wastage. Accurate estimation of financial resources when creating budget lines for purchasing vaccines. Assist in monitoring the progress of immunization in relation to the target coverage.
Three methods are commonly used to estimate vaccine needs based on: • target population • previous consumption • size of immunization sessions.
3.1 Estimating vaccine needs on the basis of target population To estimate vaccines needs based on the target population, a number of parameters for conducting immunization activities are necessary. They include: • target population • immunization schedule, i.e. number of doses per target • immunization coverage targets • wastage rate. 3.1.1 Target population The target population is the number of recipients (children, men and/or women) within the targeted age groups for immunization. The target population in most immunization programmes consists of women (for maternal vaccinations), children (for infant vaccinations and second year of life vaccinations), adolescents (for school and HPV vaccinations) and other specific groups (for adults and risk group vaccinations).
7
MLM Module 8: Vaccine management
Table 3.1 Example of EPI target population according to type of immunization activity
Target population Children from 0–11 months Children from 0–23 months Children from 0–59 months Children from 9–59 months Children from 9 months–14 years Adolescent girls 9–15 years Pregnant women Women of childbearing age
Routine
Polio
Campaign Measles TT
MenAfriVac
School vaccination
X
X
X X
X X X X X X
X X
X
The target population will be obtained by multiplying the total population by the percentage of the corresponding age bracket. However, these age groups are purely
informative and may vary considerably from one country to the other depending on demographic pattern and the prevailing national immunization policy.
Table 3.2 Example of calculation of EPI target populations (total population – 20 000 000)
Target populations Children from 0–11 months Children from 0–59 months Children from 9 months–14 years Children 9–59 months Adolescent girls Pregnant women Women of childbearing age Meningitis A preventive SIAs 3.1.2 Immunization schedule The immunization schedule determines the age limits and the number of doses required for the full immunization of each target child and women of childbearing age for each given antigen. WHO provides countries with indicators on the number of vaccine doses per antigen that should be administered
% of total population 4 20 45 17 2 5 23 70
Number of people 800 000 4 000 000 9 000 000 3 400 000 400 000 1 000 000 4 600 000 14 000 000
to each individual in the target population to ensure that the person is fully immunized. In this regard, WHO recommends the following standard immunization schedule (Table 3.3),7 although individual countries may adapt it to their epidemiological, health and even financial situation.
8
7 http://www.who.int/immunization/documents/positionpapers/
Table 3.3 Summary of WHO position papers – recommendations for routine immunization (“Table 1”) (updated March 2017)
Table 2: Summary of WHO Position Papers - Recommended Routine Immunizations for Children Interval Between Doses 1st Exceptions HIV 4 weeks (min) with DTP1 4 weeks (min) with DTP1 4 weeks (min) with DTP2 4 weeks (min),with DTP3 4 weeks (min) with DTP3
Antigen to 2nd 2nd to 3rd 3rd to 4th
Age of 1st Dose
Doses in Primary Series Booster Dose Considerations 1 3 4
(see footnotes for details)
Recommendations for all children
BCG 1
As soon as possible after birth
Hepatitis B 2
Option 1
As soon as possible after birth (<24h)
Option 2
As soon as possible after birth (<24h)
Premature and low birth weight Co-administration and combination vaccine High risk groups
bOPV + IPV 4 weeks (min) with DTP2 4 weeks (min) with DTP3
6 weeks (see footnote for birth dose)
Polio 3 1-2 IPV 2 bOPV 4-8 weeks 4-8 weeks 4-8 weeks 4-8 weeks 4-8 weeks 3
4 (IPV dose to be given with bOPV dose from 14 weeks)
bOPV birth dose Transmission and importation risk criteria
IPV / bOPV Sequential
8 weeks (IPV 1st)
IPV
8 weeks
(see footnote)
IPV booster needed for early schedule (i.e. first dose given <8 weeks)
DTP-containing vaccine 4 3 4 weeks (min) - 8 weeks 4 weeks (min) - 8 weeks
6 weeks (min)
3 Boosters 12-23 months (DTPcontaining vaccine); 4-7 years (Td); and 9-15 yrs (Td) (see footnote)
Delayed/ interrupted schedule Combination vaccine; maternal immunization
Option 1 3 4 weeks (min) with DTP2 4 weeks (min) with DTP3
Haemophilus influenzae type b5 2-3 8 weeks (min) if only 2 doses 4 weeks (min) if 3 doses 4 weeks (min) if 3 doses 4 weeks (min) 4 weeks
Option 2
6 weeks (min) 59 months (max)
At least 6 months (min) after last dose (see footnote)
Single dose if >12 months of age Not recommended for children > 5 yrs Delayed/ interrupted schedule Co-administration and combination vaccine
Option 1 3
6 weeks (min)
Pneumococcal (Conjugate) 6 2 8 weeks (min)
Option 2
6 weeks (min)
9-15 months
Vaccine options Initiate before 6 months of age Co-administration HIV+ and preterm neonates booster Vaccine options Not recommended if > 24 months old
Rotarix 2 4 weeks (min) with DTP2
6 weeks (min) with DTP1
Rotavirus 7 3 2 1 4 weeks (min) (see footnote) 4 weeks (min) - 10 weeks with DTP2 4 weeks (min) with DTP3
Rota Teq
6 weeks (min) with DTP1
Measles 8
9 or 12 months (6 months min, see footnote)
Combination vaccine; HIV early vaccination; Pregnancy Achieve and sustain 80% coverage Combination vaccine and Coadministration; Pregnancy
Rubella 9
9 or 12 months with measles containing vaccine
HPV 10 2
As soon as possible from 9 years of age (females only)
6 months (min 5 months)
Target 9-14 year old girls; Multiage cohort vaccination; Pregnancy Older age ≥ 15 years 3 doses HIV and immunocompromised
Refer to http://www.who.int/immunization/documents/positionpapers/ for table & position paper updates.
This table summarizes the WHO vaccination recommendations for children.The ages/intervals cited are for the development of country specific schedules and are not for health workers.
National schedules should be based on local epidemiologic, programmatic, resource & policy considerations. While vaccines are universally recommended, some children may have contraindications to particular vaccines.
P.1 / 10
3. Estimate vaccine needs
9
10 (updated March 2017)
Table 2: Summary of WHO Position Papers - Recommended Routine Immunizations for Children Interval Between Doses 1st to 2nd 2nd to 3rd 3rd to 4th Booster Dose (see footnotes for details)
Antigen
Age of 1st Dose
Doses in Primary Series Considerations
Recommendations for children residing in certain regions 2 generally 4 weeks (generally) Vaccine options and manufacturer’s recommendations; Pregnancy; Immunocompromised 1 1 1
MLM Module 8: Vaccine management
Japanese Encephalitis 11
Inactivated Vero cellderived
6 month
Live attentuated
8 months
Live recombinant
9 months
Yellow Fever 12
9-12 months with measles containing vaccine 3 1-3 months FSME-Immun and Encepur 1-7 months TBE-Moscow and EnceVir 5-12 months FSME-Immun and Encepur 12 months TBE-Moscow and EnceVir At least 1 Every 3 years (see notes)
Tick-Borne Encephalitis 13
≥ 1 yr FSME-Immun and Encepur ≥ 3 yrs TBE_Moscow and EnceVir
Definition of high-risk Vaccine options Timing of booster
Recommendations for children in some high-risk populations 1 3 or 4 (see footnote) 1 day ≥ 7 days (min) < 6 weeks (max) 14 days ≥ 7 days (min) < 6 weeks (max) 1 day 1 day 3 (2-5 years) 2 (≥6 years) 2 1 2 1 2 1 At least 1 3 3 6 months 7 days 14-21 days 6 months (see footnote) 12 weeks 8 weeks After 1 year Every 3 years Every 3-7 years Every 6 months Every 2 years After 2 years Definition of high risk Definition of high risk
Vi PS
2 years (min)
Typhoid 14
Ty21a
Capsules 5 years (min) (see footnote)
Cholera 15
Dukoral (WCrBS)
2 years (min)
Shanchol and mORCVAX
1 year (min)
Minimum age Definition of high risk
MenA conjugate
9-18 months (5µg)
Definition of high risk; Vaccine options; 2 doses if < 9 months with 8 week interval Definition of high risk; Vaccine options Definition of high risk; Vaccine options Level of endemicity; Vaccine options; Definition of high risk groups Definition of high risk, booster Seroprevalence
Meningococcal 16
MenC conjugate
2-11 months
≥12 months
Quadrivalent conjugate
9-23 months
≥2 years
Hepatitis A 17
1 year
Rabies 18
As required
Dengue (CYD-TDV) 19
9 years (min)
Recommendations for children receiving vaccinations from immunization programmes with certain characteristics 2 1 month (min) to school entry 4 weeks Revaccinate annually: 1 dose only (see footnotes) Coverage criteria > 80%; Combo vaccine Priority risk groups, especially pregnant women Lower dosage for children 6-35 months 4 weeks to 3 months per manufacturer recommendations Achieve & sustain ≥ 80% coverage Pregnancy Co-admin with other live vaccines
Mumps 20
12-18 months with measles containing vaccine 2 ( <9 years) 1 ( ≥ 9 years)
Seasonal influenza (inactivated tri- and qudri-valent) 21
6 months (min)
Varicella22 1-2
12-18 months
P.2 / 10
3. Estimate vaccine needs
3.1.3 Immunization coverage objectives The objective in terms of annual coverage for each antigen is generally dictated by the national immunization action plan, or the micro-plan at district level. These
plans determine the percentage of each group of the target populations to be vaccinated. Table 3.4 gives an example of immunization coverage by antigen and applied strategy.
Table 3.4 Example calculation of the population to be vaccinated according to the coverage objectives, based on total population of 20 000 000
Vaccine
Age group
Target population 740 000 800 000 800 000 800 000 800 000 800 000 800 000 4 600 000 4 000 000 3 400 000 9 000 000
BCG Polio DTP-HepBHib Measles PCV Rota TT TT Polio Measles Measles
0–11 months 0–11 months 0–11 months 0–11 months 0–11 months 0–11 months Pregnant women Childbearing age women 0–59 months 9–59 months 9 months–14 years
Vaccination coverage (%) 90 90 80 80 80 80 25 75 100 100 100
Vaccination strategy Routine Routine Routine Routine Routine Routine Routine Campaigns NIDs Campaigns Campaigns
Number of children and women to be vaccinated 666 000 720 000 640 000 640 000 640 000 640 000 200 000 3 450 000 4 000 000 3 400 000 9 000 000
Note: the above calculation should also take into consideration the annual population growth rate to determine the target population for each planning year.
3.1.4 Vaccine wastage rate and wastage factor During immunization, the number of vaccine doses consumed is generally higher than the number of individuals vaccinated. The number of doses in excess represents “lost doses” or vaccine wastage. There are two types8 of vaccine wastage in immunization programmes: • The remaining doses of vials opened thrown away after the immunization session, in line with the WHO multi-dose vial policy (MDVP). • Unopened/closed vials discarded during storage, handling, and transportation of the vaccines due to temperature damage or expiry. These two types of vaccine wastage should be taken into account in the estimation of vaccine needs. The opened vial wastage will depend on both the characteristics of the vaccine used (vial size, status of MDVP) and the context
of service delivery (session size and frequency). This should be established based on experience. Although modelling9 can help to determine the anticipated opened vial wastage for each immunization programme. The unopened/closed vial wastage should account for a maximum of 1% per supply chain level, as per the effective vaccine management (EVM) indication. Currently, the use of the wastage rate for estimating vaccine needs is rather a matter of what each and every immunization programme experiences. Vaccine wastage should be monitored at all levels and data used for forecasting future needs. However, when there is uncertainty in the monitoring of vaccine wastages, for the purpose of estimating vaccine needs, some guiding figures could be used (see Table 3.5).
8 WHO (2003). WHO/V&B/03.18. Monitoring of vaccine wastage, Guidelines for programme managers. 9 WHO/EPI is developing a modelling for estimating opened vial wastage that countries can use when available.
11
MLM Module 8: Vaccine management
Table 3.5 WHO indicative wastage rates used for planning purposes
Vaccine presentations Single dose 2 or 5 dose, regardless the status of MDVP 10 or 20 dose – if opened vial can be reused in subsequent sessions
10 or 20 dose – if opened vial must be discarded at end of session 20 dose or more – if opened vial must be discarded at end of session Knowing the wastage rate helps to determine the wastage factor, which is one of the parameters used to estimate vaccine needs.
Wastage rate Routine Campaigns 5% 5% 10% 10% 20% 15% 40% 50% 15% 20%
The formula to calculate the wastage factor on the basis of wastage rates:
Wastage factor =
(100 - wastage rate)
100
Where: “100” is the total number (100%) of vaccine doses supplied and “wastage rate” is the number of doses (in %) waste Example:
Wastage rate = 30% Wastage factor =
(100 - 30)
100
100 70
= 1.43
Exercise 2 Complete the table by calculating the wastage factor corresponding to the wastage rates given. Wastage rates (%) Wastage factors 5 10 15 20 25 30 35 40 45 50 55 60 65 70
At the end of your calculations, check your answers with the facilitator. Once the parameters have been determined, it is possible to calculate vaccine needs based on the target population. Formula for calculating vaccine needs based on target population:
Parameters for calculating vaccine needs (doses) Target population Number of doses in the schedule Vaccination coverage targeted Wastage factor Annual needs in vaccines = Pt x Dn x Ct x Wf
Code Pt Dn Ct Wf
12
3. Estimate vaccine needs
Example: Calculation of annual needs of DTP-HepB-Hib vaccines for a given target population
Pt Children from 0–11 months 10 000
x
Dn Penta doses of the immunization x schedule 3
Ct Vaccination coverage (%) 90% (0.9)
x
Wf Children from 0–11 months 1.05 (Wf 5%)
=
Needs Total doses/year 28 350
Note: For SIAs only this method is used. Remarks: The manager must be aware that overestimation of vaccine quantities can lead to over stocking and hence high wastage. However, underestimation can lead to shortage of vaccine. When using this method, managers should use the most accurate population estimate, realistic coverage and validated wastage rate.
3.2 Estimating vaccine needs on the basis of previous consumption The method of estimating vaccines needs based on previous vaccines consumption consists of calculating retrospectively the quantity of vaccines consumed during the previous period. The resulting quantity is thereafter adjusted if necessary (for instance when there is a growth in the population) for the current or any future period. This method is based on a relatively stable demand supported by reliable stocks management data.
The data required for estimating vaccines needs based on previous consumption are: • stock available at the beginning of a given period; • vaccines received during the same period; • stock at the end of the given period; and • number of unopened vaccines vials lost (destroyed, frozen or affected by high temperatures or expired during the same period).
Formula for calculating vaccine needs based on the previous consumption:
Parameters for calculating vaccine needs (doses) Initial stock at the beginning of the period Vaccines received during the period Stock remaining at the end of the period Lost, destroyed or expired doses Vaccines needs = (I+R) - (F+L)
Code I R F L
Example: Calculation of annual needs of DTP-HepB-Hib on the basis of previous consumption
I Initial stock at the beginning of the year 10 000
+
R Quantity received during the year 50 000
F Stock at the - end of the year 20 000
L Quantity lost - during the year 5 000
=
Needs Total annual doses needed 35 000
13
MLM Module 8: Vaccine management
This method may be difficult to apply for periods exceeding one year, but it is useful when making shortterm orders. The method cannot take into consideration changes that may occur during the course of the
planning period (e.g. seasonal migrations, change of the number of target population during immunization campaigns, etc.).
3.3 Estimating vaccine needs on the basis of the size of vaccination sessions The data required for estimating needs based on the size of vaccination sessions are: • number of vaccination posts/sites in the catchment area;
• • •
number of optimal sessions per post/site for defined period; estimated target population per post/site for the same period; and formula for monthly needs.
For vaccines which can be used for subsequent sessions: {(Target population/number sessions) / vial size} x number doses schedule = number vials For vaccines which should be discarded at end of session {(Target population x number doses schedule) / number sessions)/vial size} x number sessions = number vials
Number of weeks of operation in the year • number of vaccination sessions per week • number of vials opened per session (average) • number of doses per vial.
To estimate the frequency and adequacy of vaccination sessions, the following data could be used: • number of organized vaccination sessions • number of children vaccinated per session.
Formula for calculating vaccines needs based on the size of past vaccination sessions:
Parameters for calculating vaccine needs (doses) Number of vaccination posts Number of weeks of operation in the year Number of vaccination sessions per week Number of vials opened per vaccination session Number of doses per vial Vaccines needs = posts x weeks x sessions x vials x doses
Code Posts Weeks Sessions Vials Doses
Example: Calculation of annual needs of DTP-HepB-Hib according to past vaccination sessions
Number of vaccination posts 20
x
Number of weeks in operation 48
x
Number of sessions per week 3
x
Number of vials per session 2
x
Number of doses per vial 10
=
Total annual doses needed 57 600
This method may be appropriate for programmes that cannot determine their vaccine wastage rates or control their vaccine stock management. But it helps to control
the size of the sessions, thereby limiting the number of vials opened per vaccination session.
14
3. Estimate vaccine needs
3.4 Comparative advantages of the three methods of estimating vaccine needs If target population data are available (accurate or not), the preferred option at national, regional, district and service delivery levels is the target population method. If target population data are not available, the preferred option is the “consumption” method – if there is good
inventory management system without significant stock-outs. The third option is the “session” method. At service delivery level, the target population method should be applied for annual forecasting while the “session” method would be more appropriate to calculate monthly needs. Table 3.6 summarizes the comparative advantages of the three methods for estimating vaccine needs.
Table 3.6 Comparative advantages of vaccine needs forecasting methods
Method based on: Target population
Advantages Facilities active and accurate planning Assists in monitoring vaccine wastage Adequate for short periods Does not depend on target population data
Previous consumption
Vaccination session
Makes it easy to control the size of immunization sessions
Preferred application Unreliable Can be used for both Central and demographic data short- or long-term intermediate levels planning Supplementary immunization activities (SIA) Difficult to apply for Can be used for both Countries with short- or long-term a stable EPI and long periods good vaccine stock Planning is passive. planning management system In some cases the Convenient to use previous high or low at subnational and consumption may health facility levels be occasional thus with high coverage misleading when the next year needs are calculated Not convenient for At the fixed health Reduces health national level facility level (fixed workers’ interest in posts) the results Outreach posts Promotes passive planning Monitoring of vaccine wastage rates is not involved
Constraints
Comments
Note: Remember that vaccine orders are placed at time intervals that need to be determined by the programme manager when developing the distribution plan.
15
MLM Module 8: Vaccine management
Exercise 3 For all groups. Task 1: Using the data below, estimate the vaccine needs using the target population method discussed above. The total population is 725 000 inhabitants. Task 2: Discuss the challenges of the three methods you may have in your country/within your group. Vaccine BCG OPV IPV Penta Measles/MR PCV Rota TT/Td Target population (%) 4% 3.8% 3.8% 3.8% 3.8% 3.8% 3.8% 4% Number of doses in calendar 1 4 1 3 2 3 2 2 Coverage targeted 90% 90% 90% 90% 90% 90% 90% 80% Wastage rate 60% 20% 40% 10% 30% 5% 5% 20% Vaccine needs
16
4. Order vaccines
Recognize vaccine characteristics
Estimate vaccine needs
Order vaccines
Manage vaccine stocks
Monitor vaccine use
4. Order vaccines Every order for vaccines should take into account the following considerations: • Avoid stock shortages. • Avoid situations where vaccines expire during their storage period due to stock excess. • Ensure that there are adequate cold chain storage facilities (with adequate capacity and at appropriate temperature). • Ensure that vaccines ordered are in conformity with standards recommended by the national regulatory authority, or by WHO and UNICEF. • Ensure that stocks of consumables (e.g. diluents, syringes and safety boxes) are available and sufficient. • Ensure that the WHO and UNICEF’s “bundling” strategy is adopted. Since all the annual quantities of vaccine cannot be used or stored at once, portions of the total annual need are supplied periodically to each storage/service point. A formal requisition/dispatch process should be put in place and followed to implement these deliveries. Stock levels will also be determined and used as triggers for placing orders. Remember: Long storage periods risk expiration of vaccines! For example, a health post will have a shorter period of vaccines supply (one to two weeks) than a district store (one month), where the cold chain is more reliable. Similarly, a regional vaccine store will have shorter period of supply than the central stores, because the regional store is more likely to experience power cuts or generator breakdowns. Table 4.1 Generally recommended standard periods for vaccines supply
Location of the store Central store Regional/provincial store District store Health centre
Supply period Six months Three months One to three months One to two months
Avoid hoarding vaccines and storing them for too long. Depending on the geographic accessibility and season of the year, the above periods could be revised to suit local conditions.
4.1 Defining vaccine supply period Placing the orders and subsequent deliveries should be programmed and implemented in the most efficient way to meet demand. This implies defining periods of vaccine supply, which will depend on: • supply chain level (national, subnational, service delivery) • quality of the cold chain • availability of cold storage capacity • performance of stock management system, including vaccine monitoring and distribution. If the cold chain is not reliable or does not have enough capacity, the supply period should be adjusted to minimize the quantity of the stock. 17
MLM Module 8: Vaccine management
4.2 Calculating quantities of vaccine for a supply period The needs for a specific supply period or interval can be calculated using the following formula: Formula: Qperiod = (Qyear/12) x Psupply Where: Qperiod = Vaccines needs for the period Qyear = Annual vaccines needs Psupply = Supply period or interval (in months) 12 represents the number of months in the year Note: The period/interval may be expressed in weeks, in this case 52 will be used, as the number of weeks in the year.
Example:
Number of doses required for 52 weeks (for a year) Number of doses required for one week Number of doses required for 12 weeks Sequence of calculation: Number of doses required per year (52 weeks) 10 000 : Number of weeks per year 52 x Established supply period (12 weeks) 12
10 000/52 193 x 12
= = =
10 000 193 2308
=
Number of doses for the desired supply period 2316
4.3 Defining safety stock level The “safety” stock, also called “reserve” or “buffer” stock, is a provision made to cover unforeseen fluctuations of demand and unexpected delays in the delivery schedule. It can be established as a certain percentage of the supply period needs. It cannot be more than the supply period needs. The percentage is an indication of uncertainties with the supply at each supply chain level in each country. The more uncertainties, the higher the percentage should be set. The safety or minimum stock can be established using the following formula: However, the safety stock should not be too low in order to avoid stock-out when there is unforeseen delay in delivery and/or unexpected increase in demand on one hand, and on the other hand it should not be too high to avoid over stocking. It is also referred to in this module as “minimum stock”.
Formula: Sreserve = Qperiod x Reserve% (to be determined for each facility)* * In previous modules, 25% was used for reserve stock but this amount should not be considered as standard applicable for all! In this case, the reserve stock was taken as a quarter of the quantity of supply period.
18
4. Order vaccines
Note: The safety or minimum stock is not supposed to be consumed under normal circumstances. However, it should not be managed as a separate physical stock put aside in the store. It is a virtual amount and the entire physical stock should be managed and distributed according recommended principles, i.e. earlier expiry first out (EEFO), VVM status, first in first out (FIFO).
Example:
Number of doses required for a given supply period Percentage desired as reserve stock Reserve or minimum stock (doses) Sequence of calculation: Number of doses required for a given supply period 10 000 x Percentage desired as reserve stock 50% =
10 000 x 0.50
=
= =
10 000 50% 5000
Number of doses of reserve stock (doses) 5000
4.4 Calculating maximum stock level The “maximum” stock is the maximum number of vaccine doses that should be found in the store after a supply delivery. The maximum stock is the sum of the supply period needs plus the safety stock. The maximum stock will help to determine the storage capacity needed. The maximum stock can be calculated using the following formula:
Formula: Smaxi = Qperiod + Sreserve Example:
Quantity of doses required for a given supply period Reserve stock (doses) Maximum stock (doses) Quantity of doses required for a given supply period 10 000 Sequence of calculation: x Quantity of doses of reserve stock 5000 =
10 000 + 5000
=
= =
15 000
10 000 5000
Quantity of doses of the maximum stock 15 000
19
MLM Module 8: Vaccine management
4.5 Calculating reorder stock level (or warning level) The reorder stock or warning level is determined by the quantity of vaccine doses in stock at the time when it is absolutely necessary to place a new order. The reorder stock level takes into account the amount of vaccine that will be consumed between the placement of the order and the receipt/arrival of the new consignment, called the lead time. The lead time is therefore the time interval between the day the vaccines are ordered and the day they are delivered and received at the store. This precaution is necessary to prevent the vaccine stock from dropping below the reserve (minimum) level before the new arrival. Ideally, a new consignment should arrive in the store just when the stock reaches the reserve or minimum stock level.
The lead time includes, the following: • time for administrative processing the request • time for preparing the consignment, including packaging, labelling • time for shipment, including transport, transit, clearance and storing. At the central level, the lead time may be up to three months and more. Within the same country, except for areas with really difficult access, the period from ordering and receiving vaccines at different levels of the supply chain (central to provincial, provincial to district or district to service points) should not exceed one to two weeks. The reorder stock or warning level can be established using the following formula:
Formula: Sreorder = Sreserve + (Qperiod x Leadtime/ Psupply) Where: Leadtime = Time interval between the placement of order and the receipt of the consignment The term Qperiod x Leadtime /Psupply represents the amount of vaccines consumed between the time when Note: The supply period and lead time should be expressed in the same units (months or weeks). the vaccines are ordered and the time when they are received.
Example:
Reserve stock (in doses) Sequence of calculation: Doses required for a supply interval 10 000 x
Quantity of doses required for a supply interval of 12 weeks Lead time (in weeks)
Reorder level (in doses)
10 000 x 2/12 +5000
=
=
= =
10 000 2
6667
5000
Lead time over supply interval 2/12
+
Reserve stock 5000
=
Reorder stock 6667
Note: This formula is applicable to the central level where large quantities of vaccines are stored, and where the lead time is generally longer. For regional and district stores, where the quantities of vaccines are relatively smaller, and the lead times relatively shorter, one may consider the reserve stock equals to the reorder level. 20
4. Order vaccines
4.6 Calculating total quantities of vaccine to be ordered Once the above critical stock levels are established, the vaccine quantities to be ordered are calculated taking into account the stock balance in store at the time of placing the order, the maximum stock and the lead time. The supply of vaccine may be based either on the reorder or warning stock level, or on a fixed delivery schedule, including, half-yearly, quarterly and monthly. Experience has shown that it is difficult to uphold the periodicity of
vaccines supply since the consumption levels vary during the course of the year. A stock shortage may occur before the end of the period. It is therefore recommended that an order be placed as soon as the stock of one vaccine reaches the reorder level. In this case, the order should cover all vaccines, including those that have not reached the reorder level. The number of vaccine doses to be ordered can be calculated using the following formula:
General formula: Qorder = Smaxi - Savailable + (Qperiod x Leadtime/ Psupply) Example:
Needed doses for the supply period Maximum stock (in doses) Reorder stock
= =
Available stock (in doses) Supply period (in weeks) Lead time (in weeks) Quantity to be ordered (in doses) Sequence of calculation: Maximum stock 15 000 Stock available 4000 +
15 000 - 4000 + (10 000 x 2/12)
= = = =
=
10 000 15 000
4000 12 2 12 667
6667
Doses required for the lead time 10 000 x (2/12) = 1667
=
Quantity to be ordered 12 667
Note: Within the same country, except under special accessibility conditions, it takes only a few days from requisition to delivery of vaccines between the different administrative levels (central stores to provincial stores or, provincial stores to district stores). Hence, the term (Qperiod x Leadtime/ Psupply) becomes quite negligible, which explains why it is not taken into account in the formula used to order vaccines at these different levels. In this case, a short formula is used:
Short formula: Qorder = Smaxi - Savailable
21
MLM Module 8: Vaccine management
Once the number of vaccine doses to be ordered is determined, it is necessary to convert these doses into numbers of vials. The same vaccine may be available in different vial sizes (2, 5, 6, 10, 20, 50 doses etc.). The decision to order such and such vial size for a particular vaccine will have a direct impact on the cost, the Figure 4.1 Graph of the vaccine order parameters
vaccination strategies, wastage rate and the required storage capacity in the cold chain. Figure 4.1 illustrates time to order level, which is determined on the basis of the maximum and minimum stock levels and according to the trend of vaccine consumption in weeks.
Smaxi Doses/units
Maximum stock
Qorder = Smaxi - Savailable + QLeadtime
Sreorder Stock on hand
Ordering point
RE-order level
QLeadtime = {Qperiod x
Leadtime } Supply_interval Safety stock
Ssafety
Reception Lead time
0
1
2
3
4
5
6 Weeks/months
Exercise 2 Complete the table by calculating the wastage factor corresponding to the wastage rates given. Vaccines BCG OPV Penta Measles Target population 2700 2 700 2 700 2 700 Number of doses 1 4 3 1 Target coverage 95 90 90 80 Wastage factors 2 1.33 1.05 1.43 Stock at hand To be det. To be det. To be det. To be det. Minimum Duration stock of storage 50% 50% 50% 50% 3 months 3 months 3 months 3 months Number of doses/ vials 20 20 1 10
Considering that the stocks available are taken into account at the time of placing the order, calculate the vaccine needs as follows: a) quantity that you intend to use within three months b) minimum stock c) maximum stock d) reorder level e) quantity to be ordered f ) number of vials to be ordered per antigen. To encourage participation in your group in this exercise and for saving time, form small subgroups within the group and assign each vaccine line to a subgroup for calculations. At the end of your work, show facilitator your results. Refer to Annex 2 which provides summary calculations in vaccine management discussed above. 22
5. Manage vaccine stocks
Recognize vaccine characteristics
Estimate vaccine needs
Order vaccines
Manage vaccine stocks
Monitor vaccine use
5. Manage vaccines stocks The control of vaccines stocks is one of the main tasks of vaccine management. It consists of receiving and accepting vaccines, ensuring the required storing conditions and controlling the distribution of vaccines through the different structures (intermediary stores and immunization units) in order to ensure the quality of vaccines for immunization programmes. • • Check the status of shipping indicators/ temperature monitors for vaccine in all boxes. All the noted inconsistencies must be brought to the attention of the supervisor and the supplier for replacement if necessary.
5.1 Receiving delivered vaccines and supplies A vaccine arrival report (VAR) is attached to each UNICEF vaccine international shipment. It is the responsibility of the programme manager, with support from UNICEF or WHO officers to ensure that all sections of the VAR are completed and returned to the UNICEF country office within the prescribed time. During transport and transit, the integrity of vaccines must be ensured through a reliable cold chain. Recipient agencies and governments should only accept vaccines if shipment procedures and quality assurance during the shipment have been guaranteed and followed. It is the responsibility of the programme manager to clear shipments through customs authorities upon arrival and prompt transfer to central vaccine stores. The VAR is a register for recording possible anomalies in vaccine shipment and the conditions of vaccines upon delivery. It is a basic and important document for claims in cases of litigation. A model of VAR and guidelines for completing it can be found in Annex 1. On arrival of vaccines or supplies, only qualified personnel should accept the delivery by following the steps below: • • • • • • • Verify that all necessary documents are present and properly filled in. Check if the delivery address is correct. Check the status of the packaging (to see if the parcels have been opened and/or damaged). Check if the packaging conditions are met. Check the expiry dates of vaccines/supplies in all boxes. Check if the content is the same as written on the delivery slip and other accompanying documents. Check if the diluent is correct and its quantity corresponds to the vaccine.
5.2 Storage, transport and handling of vaccines Vaccines are delicate biological substances that lose their potency when they are exposed to incorrect temperatures. Once a vaccine has lost its potency through exposure to heat, for example, it is not possible to restore it even if the vaccine is later kept in normal temperatures. Note: Countries who do not procure vaccines through UNICEF should adapt the VAR. Figure 5.1 illustrates the time limit of vaccine storage and the required storage temperatures.
23
MLM Module 8: Vaccine management
Figure 5.1 WHO recommended storage temperatures and storage durations for vaccines and diluents
(up to 6 months)
National
(up to 3 months)
Sub-national
(up to 1 month)
District
(up to 1 month)
Service
+8°C
Liquid
Lyophil
Liquid
Lyophil
Liquid
Lyophil
Liquid
Lyophil
All
All
+2°C -15°C All Acceptable Acceptable
OPVs
OPVs
-25°C
OPVs
Lyophil
All
OPVs
Lyophil
Lyophil
Lyophilized vaccines BCG Hib (freeze-dried) Japanese Encephalitis (live attenuated) Measles Measles - Mumps - Rubella (MMR) Measles - Rubella (MR) Meningococcal A Rabies (freeze-dried) Rotavirus (freeze-dried) Varicella Yellow fever
Liquid
Liquid vaccines Cholera DT DTP DTP - HepB DTP - HepB - Hib Hep A Hep B Hib (liquid) HPV IPV In uenza Meningococcal ACYW Pneumo conjugate vaccine (PVC) Rabies (liquid) Rotavirus (liquid) Tetanus toxoid Td Typhoid PS
Note : Diluents should never be frozen. If diluents are packaged with vaccine, the product should be stored at +2°C to +8°C. Bundled lyophilized - liquid combination vaccines should never be frozen and should be stored at +2°C to +8°C.
5.2.1 Vaccine control indicators Vaccines should be stored and transported at controlled temperatures. Temperature monitoring devices have been developed to indicate if vaccines have been stored and transported under the appropriate conditions. Temperature monitoring devices are tools for providing information on the vaccine storage temperature inside cold chain equipment. Users can determine the action to be taken based on the temperatures and other information provided by these devices. The following are examples are given for illustration. If the temperature monitors show alarm for freezing: • conduct “shake test” • report the incident • take actions to solve the problem (refer to Module 1: A problem-solving approach to immunization services management). 24
If the temperature monitor shows alarm for heat exposure: the VVM will indicate if the vaccine should be discarded or not. If the VVM status is at discard point or beyond the vaccine should not be removed from the cold chain and marked DO NOT USE. • record the quantity in the stock register/card • report the incident to upper level • take/implement actions to solve the problem. If there is no VVM: • report to upper level of the situation • keep the vaccines in the cold chain and not use until instructions are given • take/implement action to solve the problem. Vaccine to be discarded should be clearly marked DO NOT USE and removed from the cold chain.
5. Manage vaccine stocks
5.2.2 End-to-end temperature monitoring In order to maintain vaccine quality, it is essential to monitor the temperature of vaccines throughout the supply chain. • Transportation of vaccine from the vaccines producer/supplier to the national (central) store in the country. • Storage of the vaccine at the national (central) store. • Transportation of vaccine along each step in the cold chain (subnational, regional, provincial, district stores) until and including the lowest distribution level. • Storage of vaccine at each step of the cold chain (subnational, regional, provincial, district stores) until and including the lowest distribution level. • Transportation of the vaccine from the lowest distribution level to the service delivery point (health centre or health post). • Storage at the service delivery point (health centre or health post). • Storage in passive containers (vaccine carriers or cold boxes) during transportation for outreach vaccination sessions. • Storage in passive containers (vaccine carriers or cold boxes) during outreach vaccination sessions. Effective monitoring and record keeping achieves the following objectives: • Verification that vaccine storage temperatures are within the acceptable ranges of +2°C to +8°C in cold rooms and vaccine refrigerators and -25°C to -15°C in freezer rooms and vaccine freezers.
• •
Detection of out-of-range storage temperatures so that corrective action can be taken. Detection of out-of-range transport temperatures so that corrective action can be taken.
Well-maintained records can be used to assess the quality of the vaccine supply chain, monitor the performance of cold chain equipment over time and demonstrate compliance with good storage and distribution practices. In primary vaccine stores, continuous temperature monitoring is required; it is recommended in small subnational stores and health facilities. Regardless of the temperature monitoring device used, temperatures in fixed storage locations should continue to be recorded manually twice a day, seven days a week in large vaccine stores and at least five days a week in smaller subnational vaccine stores and health facilities. Recording temperatures twice daily manually ensures that there is a staff member tasked with monitoring cold chain equipment performance and who can act to resolve issues quickly. Different temperature monitoring devices are available from different manufacturers. WHO recommends temperature monitoring devices based on the specific cold chain equipment application and the intended monitoring purpose. They can be categorized into three: condition indicators, temperature readers and temperature recorders.
Figure 5.2 Categories of vaccine temperature monitoring devices Condition indicators • Cold chain monitors (CCM) • Freeze indicators (watch, tags) • Vaccine vial monitors (VVMs)
Temperature readers • Dial, steam • Minimum/maximum, laser • Electronic thermometers
Temperature recorders • Data loggers • 7-day temperature chart recorder • 30-day e-temperature recorders
25
MLM Module 8: Vaccine management
Table 5.1 presents minimum requirements for temperature monitoring devices to be used for different cold chain equipment at different levels of the supply chain. Table 5.1 Temperature measuring devices recommended for the cold chain
Cold chain equipment Freezer rooms and vaccine freezers in primary or subnational stores
Temperature monitoring devices Recommended devices Minimum requirement Electronic continuous External digital thermometer or gas/vapour pressure dial temperature monitoring and permanent record system, wired thermometer Audio temperature alarm system or wireless Stem thermometer as back up device only PLUS Temperature excursion alarm system with external communications facility (GSM or other)
PLUS Permanent on site or remote data storage arrangement Cold rooms and vaccine refrigerators Electronic continuous External digital thermometer in primary or subnational stores temperature monitoring and or gas/vapour pressure dial permanent record system, wired thermometer or wireless Electronic freeze indicator(s) Temperature alarm system PLUS stem thermometer Temperature alarm system with 30-day electronic refrigerator external communications facility temperature logger (GSM or other) PLUS Permanent on site or remote data storage arrangement Electronic freeze indicators Vaccine freezers in small subnational Alcohol stem thermometer stores Vaccine refrigerators in small 0-day electronic refrigerator subnational stores and health temperature logger with facilities integrated visual or external communications alarm Electronic freeze indicators
Alcohol stem thermometer Alcohol stem thermometer Electronic freeze indicator
26
5. Manage vaccine stocks
Annex 3 provides a description of selected commonly used temperature monitoring devices.
Table 5.2 lists temperature fluctuations in cold chain equipment and provides suggested actions to resolve temperature irregularities.
Table 5.2a Cold rooms, vaccine refrigerators, refrigerated trucks, cold boxes, vaccine carriers
Temperature fluctuations Temperature between +2°C and +8°C Temperature at or below 0°C
Suggested actions • Situation is normal, no action necessary • • • Vaccine at risk: Take immediate action to correct the low temperature and ensure that the problem does not arise again Inspect the freeze-sensitive vaccines and/or carry out a shake test to establish if any of the vaccines has been frozen Frozen vaccine has to be tested in order to establish whether it is still potent or destroyed. Report should be made to your supervisor If there has been a temporary power failure, no further action is necessary Check that the refrigeration unit is working, monitor the situatin closely and take appropriate action if the temperature is not within the normal range at the time of the next inspection Vaccine at risk: Sample a few batches and check the VVM status Take immediate action to implement the agreed contingency plan (taking into account that the PQS fridge test protocol does allow temperature excursions to 20°C for up to 20% of time in any five-day consecutive period), and make a report
Temperature between +8°C and +10°C Temperature above +10°C
• • • •
Table 5.2b Freezer rooms and freezers
Temperature fluctuations Temperature between -25°C and -15°C Temperature below -25°C Temperature above -15°C
Suggested actions • Situation is normal, no action necessary • • • • • • Adjust thermostat. Check that the temperature is within the normal range at the time of the next inspection If there has been a temporary power failure, no further action is necessary A temporary rise to +10°C is permissible following an extended power cut Check that the refrigeration unit is working, monitor the situation closely and take appropriate action if conditions are not normal at the time of the next inspection Vaccine at risk: Sample a few batches and check the VVM status Take immediate action to implement the agreed contingency plan, and make a report
Temperature above +10°C
27
MLM Module 8: Vaccine management
Figures 5.3 Devices for temperature monitoring by level
Regardless the type of temperature monitoring device used, the following should be kept in mind: • Selection of the device should be based on the application and the capacity to manage and analyse the data provided by the device. • The device is calibrated correctly and is providing reliable data. • Temperature devices for use in the cold chain should be standardized to reduce management and inventory costs.
• •
Users will require training when any new device is introduced. Supervisors should routinely review the temperature data recorded at different levels of the cold chain to identify problems and take action to correct them.
Exercise 5 For all groups. All three parts should be conducted during the same session. Task 1: A country monitors the temperature of its cold chain from end to end. It plans, however, to introduce a new vaccine that will require additional cold chain capacity. Additional cold chain equipment is required at all levels of the cold chain to accommodate the new vaccine. Will any new temperature monitoring equipment be required? If so, what equipment would be appropriate to ensure “end-to-end” monitoring and where should this equipment be installed or used? Task 2: A health facility has outreach activity four days per month to vaccinate a target population of 2500 infants in the 0–11 month age group. For outreach activity freeze-sensitive vaccines are placed in cold boxes and other vaccines are placed in vaccine carriers. What measures are required to ensure end-to-end temperature monitoring for this outreach activity? Task 3: Vaccine is shipped from a supplier to a country having a central store with 11 cold rooms (which includes two freezer rooms). The supplied vaccines are then distributed by air to 45 regional cold rooms for storage prior to eventual transfer to districts with vaccine refrigerators and ice pack freezers. Are temperature monitoring devices required during transport of vaccines from the supplier to the central store and from the central store to the regional stores to ensure end-to-end monitoring? If so, what would be the specification and quantities of these devices?
28
5. Manage vaccine stocks
5.2.3 Arranging vaccines in refrigerators Vaccines should be arranged in such a way as to facilitate air circulation and the reading of their identification and expiry date. Hence, vaccines whose expiry date is closest will be used first (EEFO principle). Vaccines whose expiry dates have passed should not be preserved. Opened and partially used vials of vaccines that satisfy the opened vial policy requirements brought back from a vaccination session should be marked with a sign and arranged separately. They will be used first. The refrigerator with vaccines should only be opened in case of necessity. Leaving the refrigerator open for too long must be rigorously avoided. Note: Label all equipment in the vaccine store to indicate the content (type of vaccine, batch number, expiry date). These labels will facilitate the search for vaccines to be delivered and help to avoid unnecessary opening of equipment. The arrangement of vaccines in the refrigerator should follow the general storage guidelines given above. The arrangement will also depend on the type of cold chain equipment. Figure 5.4 Vaccine handling in a vertical refrigerator
Figure 5.5 Vaccine handling in a chest refrigerator
The vaccines should always be arranged in the baskets provided for that purpose. • The YF, OPV, BCG and measles vaccine vials should be packed in the lower section of the refrigerator’s compartment, above the reserve ice packs. • The Penta, DTP and TT/Td vials should be arranged in the upper basket, away from the bottom where they may be exposed to freezing temperatures. The diluents for BCG, measles and YF will also be stored near the Penta, DTP and TT/Td vials. 5.2.4 Preparing vaccines for transportation Due to the high risk of freezing for some vaccines, transportation of vaccines should consider the following: • Freeze-sensitive vaccines to be packed with conditioned or cold water packs. • Non-freeze-sensitive vaccines to be packed either with frozen packs separately from freezesensitive vaccines or with conditioned or cold water packs. If conditioned packs are used for transportation of freezesensitive vaccines, a freeze indicator should be placed in each cold box/vaccine carrier. How to condition frozen packs: • Remove the frozen packs from the freezer and let them defrost at room temperature. • Shake frequently until you can hear water inside the pack. • Place in the cold box/vaccine carrier.
The arrangement procedure for a vertical refrigerator is as follows: • The YF, OPV, measles and BCG vials should be arranged on the highest shelves, close to the freezing compartment. • The Penta, DTP and TT/Td vials will be kept on the middle shelf away from the freezing compartment. Diluents for BCG, measles and YF will also be arranged near the Penta, DTP and TT/Td vials.
29
MLM Module 8: Vaccine management
5.2.5 Safekeeping vaccines during immunization sessions The importance of preserving vaccines during immunization sessions cannot be over emphasiszed. Because vaccines are very sensitive to heat and light, the following principles and guidelines must be strictly adhered to during immunization sessions: • The actual vaccination must be done in the shade. • Antigen vials must be taken out one at a time. • The vaccine carrier must remain closed throughout. • Open vials (including reconstituted vaccines) must not be placed on top of ice packs. Use the foam pad on the top of the vaccines carrier instead. • Vaccine vials must not be placed in a bowl with water and/or ice. This causes labels and VVM to come off. • Vaccines should be reconstituted in the presence of the person to be vaccinated with appropriate diluents in sterile conditions. • Follow the septic requirements when administering vaccines. • Water packs that are unfrozen/warm must not be returned to the vaccines carrier with vaccines. 5.2.6 Shake test: Method for testing frozen vaccine vials By shaking the vial it can be easily established whether TT/Td, DT DTP/HepB/Hib liquid and PCV vaccines were frozen or not. When any of these vaccines is suspected to have been frozen, it is recommended to apply a shake test as follows: 1. Prepare a frozen control sample: Take a vial of vaccine of the same type and batch number and from the same manufacturer as the vaccine you Figure 5.6 Reading the shake test results
want to test. Freeze the vial until the contents are solid, (at least 10 hours at -10°C) and then let it thaw. This vial is the control sample. Mark the vial clearly so that it is easily identifiable and will not be used by mistake. 2. Choose a test sample: Take a vial(s) of vaccine from the batch(es) that you suspect has been frozen. This is the test sample. 3. Shake the control and test samples: Hold the control sample and the test sample together in one hand and shake vigorously for 10–15 seconds. 4. Allow to rest: Leave both vials to rest. 5. Compare the vials: View both vials against the light to compare the sedimentation rate. If the test sample shows a much slower sedimentation rate than the control sample, the test sample has most probably not been frozen and can be used. If the sedimentation rate is similar and the test sample contains flakes, the vial has probably been damaged by freezing and should not be used. Note: Some vials have large labels which conceal the vial contents. This makes it difficult to see the sedimentation process. In such cases, turn the sample and reference vials upside down and observe sedimentation taking place in the neck of the vial. If the test procedure indicates that the test sample has been damaged by freezing, you should notify your supervisor immediately. Standard operating procedures should then be followed to ensure that all damaged vaccine is identified.
Frozen test vial
Frozen control vial
Non-frozen test vial
Almost clear
If the sediments in the suspect vial settle slower than the control vial, then the vaccine in the suspect vial has not been damaged by freezing and can be used
thick sediments
30
5. Manage vaccine stocks
Figure 5.7 Shake test images
Start
10:25 am
10:28 am
10:31 am
10:33 am
5.3 Storage, transport and handling of diluents The most frequently used diluents are those for BCG, measles, MR, MMR, yellow fever and meningitis vaccines. • Diluents from different suppliers and for different vaccines should not be interchanged, because they might contain different components. It is a requirement that vaccines, must always be accompanied by diluents from the same supplier. • Diluents can be stored in a depot adjacent to the cold chain and do not need to be kept at cool temperatures until the day before they are due for use. At service delivery, diluents should be kept in cold chain. • Liquid temperature sensitive medicines must be properly labelled before they can be stored in the fridge with vaccines. For instance, products like insulin can easily be mistaken for a vaccine diluent if not properly labelled. When vaccines are reconstituted with insulin or other unsuitable products, the end result could be lethal for the vaccinated person. • Reconstituted vials should be discarded at the end of the immunization session or after six hours whichever comes first. • Biological specimens and other infectious substances (stools specimens and body fluids) should not be kept in the fridge with vaccines. If needed, they can be stored temporary at the facility using appropriate passive containers with coolant packs. • It is strictly forbidden to keep drinks and foods in a fridge for vaccines.
It is dangerous to keep reconstituted vaccines beyond the recommended time or for the following day.
5.4 Organizing vaccine distribution The efficiency of a vaccine distribution system depends on adequate transportation system, proper documentation and budgeting. It also depends on the regular effective supervision. A proper documentation of vaccine stocks and flow is key to the effective monitoring of immunization activities. The system needs minimum requirements as follows: • vaccine stock registers with columns for batch number, manufacturer, expiry date, stock balance, origin and destination, etc.) • vaccine requisition/issuing forms • supervision register • cold chain maintenance register • distribution plan • session plan at delivery point 5.4.1 Requisition vouchers A vaccine requisition voucher should, as a minimum, include the following elements: • reference number of the order/requisition • minimum/maximum stock levels for each vaccine and diluents • stock in hand for each vaccine and diluents • quantities requested for each vaccine and diluents • where syringes, needles and safety boxes are supplied with vaccines they should be included in the form • name and signature of EPI manager (the person issuing the order). 31
MLM Module 8: Vaccine management
5.4.2 Issuing forms • number or reference of the order form • number or reference of issuing form (where it is separate from requisition form) • quantities requested for each vaccine, diluents and safe injection material • quantities delivered for each vaccine, diluents and safe injection material • presentation (doses/vial) • batch number, expiry dates and manufacturer for each vaccine delivered. Figure 5.8 Model order form
The issue form should be issued in two copies. The original will accompany the consignment and serve as delivery voucher to acknowledge receipt at destination. The copy will be recorded by the vaccine store manager in the register and archived. Requisition and issue vouchers can be single ledger in triplicate.
Request section Voucher No: Article No Request Commodity name B Previous month's Consumption C Quantity in hand (doses) D Quantity requested (doses) E Batch number F
Issue section Issue Expiry date G Freeze indicator H VVM status I Amount (doses) J Freeze indicator K
Receive section Receive VVM status L Amount (doses) M Remarks
A 1 2 3 4 5 6 7 8 10 Requesting facility: Requested by Name: Title: 9
N
Issuing facility: Approved by Name: Title:
Receiving facility: Received by Name: Title: Date :
Requisition date : Signature :
Approval date : Signature :
Signature :
Exercise 6 For all groups. Participants should design a model order form and a model delivery form, adapting them to their own situation. Discussions on the proposed formats in the group should follow to identify the strong points and weaknesses in the forms.
32
5. Manage vaccine stocks
5.5 Inventory management and recording transactions In stock management, all movements of stocks should be recorded for both transparency and traceability. The stock recording can be organized in different ways according to the administrative level: • At the store as a working document for the storekeeper: Individual stock sheets are used for each batch of vaccines. These individual sheets for batches of the same antigen will be filed in a single folder with the name tag of the given antigen. December November October September August July June May April March Februrary January
should be used in combination or replace the manual system. Different software applications are available and can be adopted by countries upon accessibility. A simple MS Excel-based computerized stock management tool (SMT) is available from WHO. 5.5.1 Templates for manual recording of stock transactions Vaccine stock cards or registers are the main manual recording tools used in the store. They should be kept with the vaccines in the same premises (or nearby). An individual stock card will be kept for each batch of vaccines to record all the transactions of the batch. Individual stock cards for batches of each vaccine will be filed in a single folder with the name tag of the vaccine. A stock summary sheet will be created to aggregate the stock for all batches of each vaccine. A vaccine file will therefore be composed of individual batch cards of that vaccine. Individual batch card template Each individual batch card contains the following information: • Heading indicating: ºº name of the vaccine ºº batch number ºº expiry date ºº manufacturer ºº presentation (number of doses per vial). • Table with the following columns: ºº date of the transaction ºº origin (for incoming), destination or purpose (for outgoing) ºº quantity received (arrival, returns from the lower levels, excess from physical count) ºº quantity issued (dispatch, loss adjustment, missing from physical count) ºº stock balance ºº remarks and observations.
Immunization Reminder Box Year: 2018
•
At all vaccine storage levels: A single register can be used to record all movements of vaccine stocks. From central to lowest distribution level a vaccine register composed of two sections could be used: one for the general reception/ entry of all vaccines and another one for requisition issues for individual vaccines.
Manufacturer
Date of delivery
Informations
Manufacturer
Date of delivery
Informations Section Section Section Section Section
At the national and subnational stores, a computerized vaccine management system is more appropriate and 33
MLM Module 8: Vaccine management
Figure 5.9 Example individual batch card
VACCINE BATCH CARD VACCINE: BATCH No: DATE OF EXPIRATION MANUFACTURER PRESENTATION OF VACCINE doses per vial
QUANTITIES (vials) DATES ORIGIN / DESTINATION OR UTILIZATION RECEIVED ISSUED
BALANCE (vials)
OBSERVATIONS COMMENTS
Vaccine stock summary sheet A vaccine stock summary sheet is created for each vaccine to present the overall situation of all batches received to date. The content of this vaccine stock summary sheet includes the following: • Heading with: ºº name of the vaccine ºº critical stock levels (min/max and reorder) ºº date of the update. Figure 5.10 Example vaccine stock summary sheet
•
Table with the following columns: ºº date of reception of batch ºº batch number ºº expiry date ºº presentation (number of doses per vial) ºº quantity received ºº quantity issued ºº stock balance of the current batch ºº total stock balance of the vaccine ºº storage location in the cold chain.
VACCINE SUMARY CARD Critical stocks (doses) Reserve Re-order Maximum MONTH: DATES Reception Expiry BATCH No: Presentation doses/vial QUANTITIES (vials) RECEIVED ISSUED YEAR: VACCINE
Stock balance Stock balance per batch (vials) total (doses)
STORAGE LOCATION
TOTAL
34
5. Manage vaccine stocks
Exercise 7 Ask each participant to design a model vaccine stock sheet for the intermediate and peripheral levels. Discuss the proposals in the group and identify strong points and weaknesses. Vaccine stock registers Vaccine stock registers are booklet format, designed to record in a single table all transactions of the same vaccine. Dividers can be inserted to identify dedicated section per vaccine. The vaccine stock register will contain the following information (see Figure 5.11): • name of the vaccine • critical stock levels (min/max and reorder) • date of transactions • origin/destination Figure 5.11 Example vaccine stock register page
• • • • • • •
purpose of the operation (NID, campaign, epidemic control, etc.) batch number expiry date quantities received quantities issued stock balances: ºº stock balance for the current batch ºº total stock balance of the antigen remarks and observations.
VACCINE
Critical Stocks doses
Reserve
Re-order
Maximum
DATES
ORIGIN DESTINATION
Stock Presentation balance (dose/vial)) per batch Received Issued Batch No. Expiry date (doses)
Number of vials Identi cation of the vaccine
Stock balance total (doses)
Observations remarks
Exercise 8 Ask each participant to design a model vaccines movement register for the intermediate and peripheral levels. Discuss the proposals made by the group.
5.6 Physical count of vaccine stocks The physical count should be conducted in all vaccines stores. The periodicity of the physical count will depend on the frequency of vaccine supplies. Generally, it varies between one to six months. The physical count should be done for each batch. The real stock should be recorded in the stock register/card by adjusting number of doses missing or in excess. A sample of vaccine physical count form is shown in Figure 5.12. 35
MLM Module 8: Vaccine management
Figure 5.12 Example stock physical count form
VACCINE STOCK COUNTING FORM VACCINE DATE : COUNTED BY : ROOM/DEVICE : SUPERVISED BY :
BATCH No
EXPIRY DATE
BOXES No
VIALS per BOX
VIALS in OPENED BOX
VIAL SIZE
TOTAL DOSES COUNTED DOSES ON STOCK CARD DIFFERENCE (Doses)
TOTAL
The vaccine stock records should be adjusted following the results of the physical count. The following stock adjustments are recommended: For registers: • If the actual quantity from the physical count is more than the theoretical stock in the records, the difference should be recorded under received/arrival (incoming stocks) and indicated as “excess” or “surplus” in the affiliation of origin column. • If the actual quantity from the physical count is less than the theoretical stock, the difference should be recorded under issued (outgoing stocks) and indicated as “missing” in the affiliation of destination column. Exercise 9
For individual batch sheets: • If the actual quantity from the physical count is more than the theoretical stock in the records, the difference should be recorded under received/arrival (incoming stocks) and indicated as “excess” or “surplus” in the origin/ destination column. • If the actual quantity from the physical count is less than the theoretical stock, the difference should be recorded under issued (outgoing stocks) and indicated as “missing” in the origin/ destination column.
Optional. Ask each participant to update the different management tools after taking a physical inventory of vaccine stocks. Discuss the proposals in a group.
36
6. Monitor vaccine use
Recognize vaccine characteristics
Estimate vaccine needs
Order vaccines
Manage vaccine stocks
Monitor vaccine use
6. Monitor vaccine use Each programme manager must ensure that the following vaccine management and utilization policies are adopted and effectively implemented: • The use of the vaccine vial monitor. • The application of the policy of the opened/ partially used vaccine vial. • Monitoring the utilization and wastage of vaccines. • The combined effects of time and temperature cause the inner square of the VVM to darken, gradually and irreversibly. A direct relationship exists between the rate of colour change and temperature.
6.1 What is a vaccine vial monitor? The accumulated exposure of vaccines to heat can now be monitored with the VVM, placed on the vaccine vial. • A VVM is a label containing a heat-sensitive material which is placed on a vaccine vial to register cumulative heat exposure over time. Figure 6.1 VVM
The VVM is a square placed within a circle and is sensitive to heat (Figure 6.1). If after being exposed to heat for a period of time the square takes the same colour or becomes darker than the circle, the vial should be discarded. Figure 6.2 explains how the VVM works.
Vaccine vial monitors USE DO NOT USE
Square is lighter than outer circle The colour of the inner square of the VVMs begins with a shade that is lighter than the outer circle and continues to darken with time and/or exposure to heat.
Square matches circle
Square is darker than circle
DISCARD POINT
Once a vaccine has reached or exceeded the discard point, the colour of the inner square will be the same colour or darker than the outer circle.
Inform your supervisor Cumulative heat exposure over time
VVM
VVM
Ampoule of freeze-dried vaccine
Vial of freeze-dried vaccine
VVM Vial of liquid vaccine
37
MLM Module 8: Vaccine management
Figure 6.2 The impact of cumulative heat exposure on the VVM
Cumulative heat exposure
VVM start colour
Discard point
..............
...............
............ Beyond discard point Square colour is darker than the outer circle
........
VVM start colour of the square is never snow-white, it always has a bluish-grey tinge. From then on, until the temperature and/or duration of heat reaches a level known to degrade the vaccine beyond acceptable limits, the inner square remains lighter than the outer circle.
USE THIS VACCINE
DO NOT USE THIS VACCINE INFORM YOUR SUPERIOR
There are different types of VVMs, all of them using the same principle but using different time periods for the colour change. Table 6.1 VVM reaction rates by category of heat stability
VVM type VVM 30: High stability VVM 14: Medium stability VVM 7: Moderate stability VVM 2: Least stable
Number of days to end point at +37°C 30 14 7 2
Number of days to end point at +25°C 193 90 45 N/A
Time to end point at +5°C >4 years >3 years >2 years 225 days
Note: VVM (Arrhenius) reaction rates are determined at two temperature points. Same vaccines from different manufacturers may be assigned to different categories due to different stability data. Example the DTP-HepB-Hib from one manufacturer could have VVM14 whilst the DTPHepB-Hib from another manufacturer could have VVM7.
38
6. Monitor vaccine use
Examples where VVM could be used as a daily management or decision-making tool The VVM may be used to reduce vaccine wastage and identify problems or breakdowns in the cold chain. The VVM enables the user to determine at any time whether a vaccine vial can still be used despite possible disruptions in the cold chain. The vaccine may be used without any risk outside the cold chain until the VVM reaches the discard point. The period of use will depend on the ambient temperatures and the quality of the cold chain. Vaccine vials least exposed to heat, as evidenced by VVM colour changes, can be sent to distant outreach posts conducting vaccination campaigns or remote areas with fewer vaccination sessions. Vaccine vials with VVM close to the discard point must be used immediately or be sent to health facilities where they can be used quickly. The elimination of large quantities of vaccine because of the VVM colour change to discard point may lead to a survey on the cold chain. The data may also be used to take decisions on the choice of appropriate cold chain equipment. Health workers and stock management officers may refrain from declaring that the VVM reached the discard point for fear of being reprimanded for the ignorance that caused substantial vaccine wastage. Based on the VVM’s status, health and administrative staff can take appropriate corrective measures. Repeated misuse of this valuable tool by health workers or vaccine management staff can indicate the need for staff training in cold chain. For vaccines that are not prequalified by WHO, independent determinations on preservative efficacy, sterility, presentation and stability may not have been made by a functional national regulatory authority. Consequently, this could mean that the vaccine does not meet the WHO requirements on safety and efficacy, which form the minimum recommended standard for keeping multi-dose vaccine vials opened for more than six hours. Therefore, WHO recommends using nonWHO-prequalified vaccines as soon as possible after opening, and respecting the time limit for using opened vials as indicated by the manufacturer’s instructions in the package insert. If this information is not indicated in the package insert, WHO recommends discarding all non-WHO-prequalified vaccine products within six hours after opening or at the end of the immunization session, whichever comes first. If the expiry date has not elapsed, then one should look for damage caused by heat, cold or contamination. Before applying the MDVP, safe injection practices should be in place. This policy applies equally to all opened vials of vaccine to be used during outreach strategy or mass vaccination campaigns on conditions that standard procedures required for handling these vials are strictly followed. The direct impact of MDVP in the field may be a substantial reduction of wastage for liquid vaccine with preservative. 39
6.2 Multi-dose vial policy (MDVP) An opened multi-dose vial is a vial containing several doses of vaccine from which one or more doses have been taken. To ensure the optimal use of vaccines, WHO has issued policies end guidance documents authorizing the re-use, “under certain conditions”. 6.2.1 What is the WHO multi-dose vial policy? All opened WHO-prequalified multi-dose vials of vaccines should be discarded at the end of the immunization session or within six hours of opening, whichever comes first, unless the vaccine meets all four of the criteria listed below. If the vaccine meets the four criteria, the opened vial can be kept and used for up to 28 days after opening. The criteria are as follows. 1. The vaccine is currently prequalified by WHO. 2. The vaccine is approved for used up to 28 days after opening the vial, as determined by WHO. 3. The expiry date of the vaccine has not passed. 4. The vaccine vial has been, and will continue to be stored at WHO- or manufacturer-recommended temperatures; furthermore, the vaccine vial monitor, if one is attached, is visible on the vaccine label and is not past its discard point, and the vaccine has not been damaged by freezing.
MLM Module 8: Vaccine management
6.2.2 Location of VVM The WHO vaccine prequalification programme has worked with vaccine manufacturers to define VVM placement guidelines so that the VVM, if attached to the vial, can serve as a visual trigger to assist a health worker in properly applying the MDVP. There are two different locations for VVMs and each is associated with specific guidance for handling opened multi-dose vials of vaccine. 1. WHO-prequalified vaccines where the VVM, if attached, is on the label of the vaccine. The vaccine vial, once opened, can be kept for subsequent immunization sessions for up to 28 days, regardless of the formulation of the product (liquid or lyophilized). 2. WHO-prequalified vaccines where the VVM is attached in a different location than on the label (e.g. cap or neck of ampoule). In this instance, the vaccine vial, once opened, must be discarded at the end of the immunization session or within six hours of opening, whichever comes first. This is regardless of the formulation of the product (liquid or lyophilized) and would apply, for example, to a reconstituted product of which the vaccine vial cap, which has a VVM attached, has been discarded after opening. Table 6.2 Vaccine wastage – lost and sacrificed doses
6.3 Monitoring vaccine use and wastage Monitoring the use of vaccines is a priority activity for the immunization manager. This will ensure the quality of immunization services and keep the vaccine wastage under control. The goals of monitoring are two-fold: • To detect management problems during vaccine use at different levels and find appropriate solutions. • To contribute to the EPI planning by providing data on vaccines needs and vaccines wastage rates. 6.3.1 What is vaccine wastage? It is important that the managers understand and are able to explain clearly to other health staff under their supervision what vaccine wastage is in order to avoid misinterpretations leading to inappropriate actions. There are generally two concepts10 of vaccine wastage (see Table 6.2). While the doses sacrificed in the course of good practice vaccination (good reasons) should be minimized, doses wasted without purpose must be avoided!
Vaccine doses lost for no good reason Doses wasted for no good reason are essentially unopened vials or opened vial wastage. These are: • Unopened vials that have expired, damaged or suffered from excessive heat exposure, freezing or improper handling. • Losses due to poor implementation of the MDVP: discarding opened vials of vaccines eligible for reuse because of misuse/misinterpretation or ignorance of the MDVP. • Losses due to non-adherence to national immunization schedule leading to incorrect administration of doses, at wrong age and with wrong interval between doses.
Vaccine doses sacrificed for good reason! Doses sacrificed for good reason can be only opened vial wastage. These are: • Doses discarded from opened vial in accordance with the MDVP, i.e. reconstituted vaccine or liquid vaccine with no preservative at the end of session or in line with MDVP (e.g. after four weeks). • Administration of vaccines to persons outside target age group.
40
10 Souleymane Kone. Notes d’informations sur les pertes de vaccines (WHO/ICP/Abidjan, 2002, WHO/HQ, 2015).
6. Monitor vaccine use
Exercise 10 For all groups. Discuss in small groups and classify the following vaccine loss in “lost doses” or “sacrificed doses”: • doses of BCG administered to children aged four years • doses of frozen DTP vials • doses in expired vials • doses of TT administered to the informal sector • OPV vials with VVM reached discard point • Penta vaccine doses administered in two-week interval between doses • Penta vaccine doses administered with a 23-day interval between doses • measles vaccine from a 20-dose vial used only for two children • opened OPV vials thrown away at the end of vaccination sessions • opened yellow fever vaccine vials thrown away after six hours. This exercise deserves a plenary presentation – prepare for it! 6.3.2 Vaccine wastage and usage rates Sound vaccines management should endeavour to avoid vaccine losses and minimize sacrificed doses. This can be achieved only when the use of vaccines is monitored efficiently. The two indicators for monitoring vaccine use are: vaccine wastage rate (VWR) and vaccine usage rate. Vaccine wastage rate: The quantity of vaccine taken from the inventory, but not administered to the target population is the total amount of lost and sacrificed doses. Depending on whether one is a supervisor or user, monitoring vaccines wastages rate can be both simple and tedious. At user level the calculation of vaccine wastage rate is relatively easy. It can be presented in graphical form in the same way as a vaccination coverage monitoring chart, plotted at each facility. The vaccine wastage rate is calculated for each vaccine. For one vaccine, the wastage rate is calculated by considering the total doses from the different presentations (1, 2, 4, 5, 6, 10 or 20 doses) used in the programme. Vaccine wastage should be calculated and monitored according to their typology: unopened/closed vial wastage and opened vial wastage. Monitoring vaccine wastage by typology relates to the causes of the wastage and the results will help solving any underlined problems. 1. Unopened/closed vial vaccine wastage formula The unopened vial wastage within a given time period is calculated using the following formula:
Wastageunopened vials = [∑ⁿDoseswasted / ∑ⁿDosessupplied] x 100 Where: ∑ⁿDoseswasted = Cumulative doses of unopened vials discarded from the inventory ∑ⁿDosessupplied = Cumulative total number of vaccine doses supplied
Unopened vial wastage should be calculated during each physical inventory! The successful implementation of effective vaccine management practices will avoid unopened vial vaccine wastages. Proper vaccine stock monitoring should be established for early detection of risk of unopened/ closed vial wastage so anticipated corrective actions can be taken.
Note: Effective vaccine management (EVM) limits to 1% the unopened vial wastage per storage facility and, subsequently, per supply chain level. The maximum unopened vial wastage should be considered while estimating vaccine needs for the immunization programme. Each national immunization programme should establish a system for recording and reporting unopened vial wastage. 41
MLM Module 8: Vaccine management
2. Opened vial vaccine wastage formula The wastage in opened vials within a given time period is calculated using the following formula:
Wastageopened = [(∑ⁿDosesopened - ∑ⁿDosesadministred)/ ∑ⁿDosesopened] Where: ∑ⁿDosesadministred = Cumulative doses administered to the target population ∑ⁿDosesopened = Cumulative number of doses of the vaccine vials opened for vaccination Opened vial wastage can occur only at the service delivery point with multi-dose presentations. These are unavoidable wastages. Undue pressure on health workers to reduce wastage may push them to erroneously refrain from opening multi-dose vials when the number of children is insufficient. This can lead to a reduction of coverage and must be avoided. National immunization programmes should monitor opened vial wastage with the vaccination coverage. Regular monitoring of opened vial wastages will stimulate proper planning and management of services and contributes to eliminate the unfounded fear of wastage that may affects coverage.
Note: There are no maximum wastages established globally for opened vial wastage. Doses discarded with multidose vials may be high depending on the vial size, the status of MDVP, local setting and type of vaccination service delivery. With the cost of vaccines increasing, programme managers need to take the required action to reduce vaccine wastage rates to an absolute minimum without comprising efforts to protect children.
3. Performance of immunization services – coverage and wastage targets The vaccine wastage rate is a performance indicator of the immunization services. Each national immunization programme should establish its own wastage targets to be
achieved and maintained. Four classes11 of performance combining coverage and wastage targets are suggested to guide the monitoring of the utilization of vaccines in national immunization.
Class A: Health facilities and districts achieving and maintaining both coverage and wastage targets. These are highperforming facilities and districts with efficient utilization of vaccines. Class B: Facilities and districts achieving and maintaining coverage targets with wastage higher than expected. These are high-performing health facilities and districts albeit with high wastage rates. Class C: Facilities and districts that are not reaching the target coverage, although the wastage is lower than expected. These are low-performing health facilities and districts with low wastage rates. Class D: Health facilities or districts not achieving coverage or wastage targets. These are poorly performing facilities and districts. Annex 4 gives an example showing how the above classification was used in one of the country in the African Region with suggestions to improve vaccine management and utilization practices. The targets for both vaccination coverage and wastage should be considered dynamic – as immunization programmes evolve. Originally established programme targets should be adjusted to reflect changing context. And thus, the distribution of facilities and districts across vaccine utilization performance classes should be adjusted accordingly.
42
11 This classification was proposed by Dr Clément Glèlè Kakai, national immunization officer (EPI/Benin) and Dr Mary Traoré, Inter-country logistics officer (AFRO/IST West Africa). This classification is currently adopted and used in the DVD-MT to monitor performance of national immunization service delivery.
6. Monitor vaccine use
6.4 Vaccine management report Periodic vaccine management reporting should occur at each level of the cold chain as prescribed by the EPI manager. A vaccine management report should be integrated into the facility’s monthly report. The vaccine management report should highlight, for a given period, the overall situation on: • Inventory of vaccines and supplies (details for each vaccine, diluents and safe injection equipment): ºº quantity in stock at the beginning of the period for each batch ºº quantity received during the period ºº quantity in stock at the end of the period for each batch ºº number of days of stock availability (stockout or over-stocking for each vaccine, diluents and safe injection equipment). Status of distribution of vaccines and supplies to recipients: ºº quantity distributed per month ºº total quantities distributed by destination since the beginning of the year ºº coverage for reporting period and cumulative coverage of achievement or rate of vaccine use by recipient.
• •
Vaccines status at reception and distribution (VVM, cold chain monitoring indicators, etc.). Cold chain performance (number of days with inadequate temperature, number of days of breakdown, etc.).
Vaccine management performance is measured by: • Vaccine storage quality: ºº storage temperatures, including temperature alarms ºº cold chain storage capacity ºº cold chain infrastructure, equipment and transport ºº cold chain maintenance. • Vaccine stock management. • Efficient vaccine shipment and distribution. • Proper use of diluents. • Correct utilization of VVM. • Correct use of MDVP. • Reduction of vaccine wastage. The above periodic report on vaccine management should be submitted to the EPI manager. It will be used as an EPI management tool to facilitate not only the followup and control of vaccine stock; but also to monitor the implementation of immunization activities. The analysis of the report should enable the programme to identify, on time, potential problems (imminent danger of shortages or expiry, interruption or slowdown of activities, wastage, etc.) and suggest appropriate solutions. It is important to give feedback on the report, which should include what support could be given from the upper level or the immediate supervisor. Periodic EVM assessments will assist the EPI manager in measuring progress and identifying recurrent problems in vaccine management.
•
Based on the above data, the stock management officer prepares a narrative report (one to two pages) indicating: • Vaccines available for immunization activities (quantities in stock and consumption period to be covered). • Stock-outs or over-stocking of vaccines, according to the established minimum and maximum stock levels.
43
MLM Module 8: Vaccine management
Recommended reading PATH/WHO (2013). Optimize. Delivering vaccines: A cost comparison of in-country vaccine transport container options. Seattle (WA): Program for Appropriate Technology in Health; Geneva: World Health Organization. WHO (2005). Monitoring vaccine wastage at country level: Guidelines for programme managers. WHO/ V&B/03.18. Rev.1. Geneva: World Health Organization. WHO (2008). Training for mid-level managers (MLM). 1. Cold chain, vaccines and safe-injection equipment management. WHO/IVB/08.01. Geneva: World Health Organization. [check if need this] WHO (2014). WHO policy statement: Multi-dose vial policy (MDVP). Handling of multi-dose vaccine vials after opening. WHO/V&B/14.07. Geneva: World Health Organization. WHO (2015). WHO vaccine management handbook. Module VMH-E2-01.1. How to monitor temperatures in the vaccine supply chain. WHO/IVB/15.04. Geneva: World Health Organization. WHO (2015). WHO vaccine management handbook. Module VMH-E7-02.1. How to use passive containers and coolant-packs for vaccine transport and outreach operations. WHO/IVB/15.03. Geneva: World Health Organization. WHO (2017). Mid-level management course for EPI managers. Module 7: Cold chain management. Brazzaville: World Health Organization Regional Office for Africa. WHO (2017). Performance, Quality, Safety (PQS) Catalogue. Geneva: World Health Organization. http://apps.who.int/immunization_standards/vaccine_quality/pqs_catalogue/ (accessed 12 May 2017). Websites WHO – Immunization, Vaccines and Biologicals (Vaccine position papers): http://www.who.int/immunization/documents/positionpapers/ WHO – Immunization, Vaccines and Biologicals (Effective Vaccine Management Initiative): http://www.who.int/immunization/programmes_systems/supply_chain/evm/en/ WHO – Immunization, Vaccines and Biologicals (Vaccine management and logistics support): http://www.who.int/immunization/programmes_systems/supply_chain/resources/tools/en/ WHO – Immunization, Vaccines and Biologicals (Immunization training resources): http://www.who.int/immunization/documents/training/en/
44
Annex 1: Vaccine arrival report (VAR) Guidelines for completing the vaccine arrival report The vaccine arrival report (VAR) is a comprehensive record of cold chain conditions during transport and of compliance with shipping instructions. Recipient governments, UNICEF country offices and the UNICEF Supply Division are responsible for the report and for taking appropriate action if problems are reported (e.g. follow up with the manufacturer, forwarding agent, WHO, etc.). Use one report form for each shipment and for each vaccine in the shipment: In shipments containing diphtheriatetanus-pertussis (DTP)-hepatitis B (HepB) and Haemophilus influenzae type b (Hib) vaccines, use one form for DTP-HepB and a separate form for Hib. In the case of short shipments (where parts of the original quantities are not delivered), complete a separate report for each part delivered. Complete the form as described below. In the header boxes at the top of the form, enter the name of recipient country, report number and details of place and date of inspection and storage. The report number is an internal number for organizing records and is compiled as follows: country code-year-number for each report (e.g. BUR2005-001 for one vaccine; BUR-2005-002 for a second vaccine etc.). In the case of a short shipment, the numbers for the separate deliveries would be, for example, BUR-2005-003.1, BUR-2005-003.2 etc. Part I: Advance notice I.1 Enter dates and details of documents received in advance of the vaccine shipment. Part II: Flight arrival details II.1 Fill in details of expected and actual arrival times for the shipment. II.2 Fill in the names: a) of the clearing agent b) for whom the agent acts (e.g. the ministry of health or UNICEF). Part III: Details of vaccine shipment III.1 Fill in details of the order (purchase order number, consignee, vaccine description etc.). III.2 For each batch of vaccine included in the shipment, record: a) number of shipping boxes b) number of vials c) expiry date. The number of boxes you enter should always match the number of boxes shown in the packing list. If it does not, note (under Comments) if advance notice of a change in the quantity was provided. It is not necessary to count the number of individual vaccine packs in each shipping box for this report. III.3 For the diluents and droppers (if included) with each batch of vaccine in the shipment, record: a) number of shipping boxes b) number of vials c) expiry date. The information for III.2 and III.3 is also in the packing list. Note: Diluents for freeze-dried vaccine and droppers for or a polio vaccine (OPV) are integral parts of the vaccine, so always include them on the same form. If diluent/droppers are delivered separately, consider it a short shipment. Part IV: Documents accompanying shipment The packing list should indicate which box contains the shipping documents (usually Box 1). IV.1 If this information is not included in the packing list or in documents sent separately by courier, pouch or other means, note this under Comments. IV.2 Verify that all necessary documents are present and complete the form accordingly. Note: If the lot release certificate is missing, do not use the vaccines; keep them on hold in cold storage until the relevant document has been obtained from the vaccine manufacturer.
45
MLM Module 8: Vaccine management
Part V: Status of shipping indicators Inspect the temperature monitors in all boxes before putting vaccines into cold storage. For very large shipments or when immediate storage in the shipping boxes is required, check a representative number of boxes before placing the shipment in the cold store. Complete inspection of all boxes the next day, or as soon as possible thereafter; under Comments, note the date and time when the complete inspection took place. Note: In this report, enter the information below (V.1) only for boxes in which the temperature monitors how a change that indicates potential damage to vaccines (vaccine vial monitor stages 3 and 4, cold chain monitor card as per vaccine/threshold table in card, or alarm indication in the electronic device). V.1 Enter: a) number of boxes inspected (this should equal the total number in the shipment) b) type of coolant used c) details of any temperature exposure, if detected. V.2 Photocopy or scan LCD screens in electronic devices that show alarm status and attach to report. V.3 Clearly identify vaccines in boxes in which the indicators show exposure to temperatures that risk damage and keep them in the cold room for further assessment of their condition. Do not discard vaccines until assessment is completed. Part VI: General conditions of shipment VI.1 Indicate if the shipping boxes were received in good condition and if all necessary labels on the outside of the shipping boxes were present; add any comments. Part VII: Name and signature VII.1 The authorized person responsible for the inspection and the central store manager or the EPI manager should sign this report. VII.2 Send the form, completed and signed, to the UNICEF country office within three days of arrival of the vaccine; they will forward it to the UNICEF Supply Division (Immunization Team, Fax: +45 35269421).
46
47
MLM Module 8: Vaccine management
48
Annex 2: Summary calculations in vaccine management Calculation of annual vaccine needs for a health facility Children aged 0–11 months (number) 2700 2700 2700 2700 2700 2700 A
x
x B Doses in the immunization schedule 1 4 3 1 3 2
C Wastage factor 2 1.17 1.17 1.54
x
D Coverage rate (%) 95% 90% 90% 80%
=
E Total doses/ year 5140 11 370 8530 3330
BCG OPV DTP/HepB/ Hib Measles PCV Rota
Calculation of quantity to be used during the supply period Total doses required/ year 11 370 8530 3330 5140 E
x
F Duration of storage (3 months) (3/12) 0.25 0.25 0.25 0.25
=
G Total doses required for a given period (quarter) 1300 2850 2140 830
BCG OPV DTP/HepB/ Hib Measles PCV Rota
Determination of minimum stock Total doses required for a given period (3 months) 1300 2850 2140 830 G
x
H Reserve stock (%) 25% 25% 25% 25%
=
BCG OPV DTP/HepB/ Hib Measles PCV Rota
Minimum or reserve stock (doses) 320 710 540 210
49
MLM Module 8: Vaccine management
Determination of maximum stock Total doses required for a given period (3 months) 1300 2850 2140 830 G
+
BCG OPV DTP/HepB/ Hib Measles PCV Rota
Minimum or reserve stock (doses) 320 710 540 210
=
L Maximum stock (doses) 1620 3560 2680 1040
Calculation of critical stock Total doses required for a given period (3 months) BCG OPV DTP/HepB/ Hib Measles PCV Rota 1300 2850 2140 830 G
x
J Order/storage period (1.5/3) 0,5 0,5 0,5 0,5
+
Minimum or reserve stock (doses) 320 710 540 210
=
K Critical stock (doses) 980 2140 1610 630
Calculation of quantities to be ordered Maximum stock (doses) 1620 3560 2680 1040 L
BCG OPV DTP/HepB/ Hib Measles PCV Rota
K Quantity in stock (doses) 960 2420 1810 510
M Stock to be ordered (doses)
50
Annex 3: Selected commonly used temperature monitoring devices Cold room temperature indicators One data logger which is not WHO/PQS prequalified is currently available for monitoring cold room temperatures and generating GSM alarms. The available model is offered with an auto-dialer accessory that facilitates global system for mobile communication (GSM) alarm dial out. The accessory must be specified. Channel models 8, 12 and 16 are available and are appropriate for continuous monitoring of temperature in one, two or three cold rooms respectively, each of up to 40 m3 if they are situated within approximately 100 m of each other. This also allows provision for monitoring room temperature in cold room proximity and electrical supply from a national or local grid or generating set. The data logger senses temperatures at user defined intervals and an aggregate of sensed temperatures is stored and transferred to a dedicated desktop computer mounted in the immediate proximity of the data logger which has two full-sized PCI ports available and is powered through an uninterruptable power supply to prevent data loss should power to the computer be interrupted during a data save cycle. The data logger has a built in battery backup. The data logger, which can be configured by the user, automatically generates reports of temperature excursions, and a graphical history of temperatures. Data are stored as a permanent record on the computer hard disk and can be communicated via USB modem or wi-fi to other locations for centralized monitoring. All cold rooms should be equipped with data loggers that monitor temperatures continuously and store data as a permanent record. Specific training is required for setting up, reporting and fault diagnosis of these data loggers. Installation by qualified technicians is required. Fridge temperature monitors An electronic temperature indicator is used to monitor the correct storage temperature of vaccines and other perishable goods in refrigerators. It shows if a product, such as vaccine, has been exposed to temperatures beyond assigned alarm settings described above. While the temperature is within the allowed range, the OK sign is shown on the display. If the indicator is exposed to an out-of-range temperature the ALARM sign appears on the display. The device shows the actual temperature (in °C/°F); all alarm violations over the previous 30 days (on a rolling basis); the daily minimum and maximum temperature of the last 30 days; and the time duration of any violation. The useful life is approximately two to three years (see PQS).
Freeze indicators A freeze indicator is a digital monitor showing if the vaccine has been exposed to temperatures below 0°C for a certain time. Once an alarm is indicated, the device cannot be reset for reuse; it must be replaced. The monitor is designed for freeze-sensitive vaccines such as Penta/HepB/Hib liquid/PCV/Rota/TT/DT/Td vaccines. Freeze indicators monitor freeze-sensitive vaccines during storage and transport. They can be used continuously or many times over their shelf life (five years) if not exposed below 0°C for more than a 60-minute period. They change from “check” to “cross” when exposed below 0°C for more than a 60-minute period. When the indicator shows a “cross” they must be discarded. To ensure end-to-end temperature monitoring, continuous monitoring of vaccine temperatures is required rather than occasional monitoring or twice daily spot checks. Thermometers are still used extensively to monitor temperature twice daily, but continuous monitoring devices will progressively replace these. No thermometers are prequalified except ones designed specifically for cold rooms.
51
MLM Module 8: Vaccine management
Annex 4: Analysis and interpretation of vaccine wastage data with vaccination coverage Refer to the monthly rows to see the monthly movements of districts from class A (high coverage/low vaccine wastage rates) to class D (low coverage/high vaccine wastage rates). Assessment of districts by class performance (e.g. of monthy monitoring from Ghana)
52
http://www.afro.who.int/