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Mid-Level Management Course
for EPI Managers
Block III: Logistics
Module 10
Immunisation Safety
March 2004
Draft 2
For more up-to-date information and documentation related to immunisation training, please:
•
•
visit our website: http://www.who.int/vaccines-diseases/epitraining/
refer to the CD “Resources for Immunization Managers” version 2 (WHO/HQ, 2002).
Acknowledgements
WHO Regional Office for Africa is grateful to all partners, especially WHO/HQ, USAID and
UN Foundation, for their contribution to financing, preparation and completion of this module.
This document is not a formal publication of the World Health Organization (WHO), but all rights are
reserved by the organisation. The document may, however, be freely reviewed, abstracted, reproduced
and translated, in part or in whole, but not for sale or for use in conjunction with commercial purposes.
© 2004
Mid-Level Management Course for EPI Managers: List of the Modules
BLOCK 1: Introductory modules (0-3)
Module 0: Introduction
Module 1: Problem-solving approach to immunisation services management
Module 2: Role of the EPI manager
Module 3: Communication for immunisation programmes
Reference: Communication Handbook for Polio and Routine EPI
BLOCK II: Planning/organisation (4-6)
Module 4: Planning immunisation activities
Module 5: Increasing immunisation coverage
Module 6: Reduce drop-out and missed opportunities
Reference manual: Revised EPI Planning Guide
BLOCK III: Logistics (7-14)
Module 7: Planning, monitoring and supervising EPI logistics
Module 8: Cold chain management
Module 9: Vaccine management
Module 10:
Immunisation safety
Module 11:
Transport management
Module 12:
Logistics management for supplemental immunisation
Module 13:
Logistics for surveillance
Module 14: Maintenance
Reference material: Product Information Sheets, WHO/UNICEF, 2000
BLOCK IV: New vaccines (15)
Module 15: New vaccine introduction
BLOCK V: Supplemental immunisation (16-17)
Module 16:
How to organise effective polio NIDs
Module 17: How to conduct mass campaigns with injectable vaccines (measles, YF, TT)
Reference manuals:
1. Field guide for supplementary activities aimed at achieving polio eradication (revised version, 1996)
2. Guidelines for improving the quality of NIDs
3. AFRO field guide for quality measles SIAs
BLOCK VI: Disease surveillance (18-19)
Module 18:
How to manage cases of priority disease
Module 19:
Integrated disease surveillance and response (see IDSR modules)
Reference manuals:
1. Technical guidelines for integrated disease surveillance and response in the African Region
2. District health team surveillance data analysis
BLOCK VII: Monitoring and evaluation (20-23)
Module 20:
Monitoring and data management
Module 21:
Supportive supervision by EPI managers
Module 22:
Conducting EPI coverage survey
Module 23:
Conducting assessment of the immunisation programme
Reference: Guide for Preparation of Integrated Supervisory Checklist for Disease Prevention and Control Activities
at District Level, Oct. 2003, AFRO
BLOCK VIII: EPI training materials (24)
Module 24: Facilitator’s guide
Other Training Tools and Guides
EPI training kit
Course director’s guide
Table of Contents
Abbreviations and Acronyms ......................................................................................................................................... vi
Glossary .......................................................................................................................................................................... vii
1. Introduction ................................................................................................................................................................1
1.1 Context ...............................................................................................................................................................1
1.2 Purpose of the module .......................................................................................................................................1
1.3 Target audience ...................................................................................................................................................1
1.4 Learning objectives ..............................................................................................................................................1
1.5 Contents of the module ......................................................................................................................................2
1.6 How to use this module ......................................................................................................................................2
2. Vaccine safety and quality ..........................................................................................................................................3
2.1 Vaccine quality ....................................................................................................................................................3
2.2 Safety of the cold chain .......................................................................................................................................3
2.3 Multi-dose vial policy ..........................................................................................................................................4
2.4 The role of the diluent in immunisation ............................................................................................................5
2.5 Contraindications to vaccinations .......................................................................................................................7
2.6 Vaccine reactions ...............................................................................................................................................8
3. Injection safety .........................................................................................................................................................11
3.1 Injection safety policy ........................................................................................................................................11
3.2 Selection of equipment ....................................................................................................................................12
3.3 Develop a safety plan ........................................................................................................................................14
3.4 Implementation of planned activities ...............................................................................................................16
3.5 Training in injection safety ................................................................................................................................18
3.6 Advocacy and communication .........................................................................................................................20
3.7 Supervision, monitoring and evaluation ..........................................................................................................20
4. Monitoring Adverse Events Following Immunisation (AEFI) ...............................................................................23
4.1 Programme errors .............................................................................................................................................24
4.2 Detect and report AEFIs ..................................................................................................................................26
4.3 Investigate adverse events .................................................................................................................................26
4.4 Analyse data.......................................................................................................................................................28
4.5 Take action to manage AEFI ..........................................................................................................................29
4.6 Evaluate the quality of AEFI surveillance ........................................................................................................31
5. Safe waste disposal ...................................................................................................................................................33
5.1 Selection of methods .........................................................................................................................................33
5.2 Planning for safe waste disposal .......................................................................................................................34
5.3 Safe disposal of immunisation waste ................................................................................................................35
5.4 Training in waste disposal .................................................................................................................................36
5.5 Advocacy and communication .........................................................................................................................37
5.6 Supervision, monitoring and evaluation ...........................................................................................................37
Summary of essential issues ...........................................................................................................................................38
References .....................................................................................................................................................................40
Annexes
Annex 1:
Contraindications to EPI vaccines ........................................................................................................42
Annex 2:
How to use safe disposal equipment ....................................................................................................45
Annex 3:
De Monfort Mark 8a auto-combustion incinerator .............................................................................47
Annex 4:
AEFI report form ..................................................................................................................................48
Annex 5:
AEFI case investigation form ...............................................................................................................49
Annex 6:
AEFI summary investigation form........................................................................................................50
Annex 7:
AEFI laboratory request form ............................................................................................................51
Abbreviations and Acronyms
A-D
Auto-disable (syringes)
AEFI
Adverse Events Following Immunisation
AFP
Accute Flaccid Paralysis
DTP
Diphtheria, Tetanus, Pertussis (vaccine)
EPI
Expanded Programme on Immunisation
GAVI
Global Alliance for Vaccines and Immunisation
HepB
Hepatitis B vaccine
Hib
Haemophilus influenzae type b vaccine
HIV/AIDS
Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome
MLM
Mid-Level Management
MMR
Measles, Mumps, Rubella (vaccine)
MR
Measles, Rubella (vaccine)
OPV
Oral Polio Vaccine
PATH
Programme for Appropriate Technology in Health
TST
Time, Steam and Temperature (control spot)
UNFPA
United Nations Population Fund
UNICEF
United Nations Children’s Fund
VAPP
Vaccine Associated Paralytic Poliomyelitis
V&B
Department of Vaccines and Biologicals (WHO/HQ)
VVM
Vaccine Vial Monitor
WHO
World Health Organization
Glossary
AEFI cluster:
a cluster involves several AEFIs that occur within the same time frame with unusual
frequency, by vaccine, by type of reaction or by locality or health facility.
AEFI investigation:
a complex measures including epidemiological, statistical, laboratory methods and
observations to find out the cause of AEFI and suggest corrective or preventive
measures.
Contraindication:
a condition or a disease which makes an individual temporarily or definitely unfit for a
specific vaccination.
Programme error:
an error which is health worker related and is often caused by improper use of safety
procedures or injection techniques: handling, reconstitution or administration of
vaccine.
Reconstitution of
vaccine:
to restore to former condition of freeze-dried/lyophilized
vaccines using specific diluent.
Trigger event:
severe AEFI or unusual medical incident which stimulates a response: investigation,
hospitalization, reporting.
Vaccine:
biological product prepared from killed or attenuated (weakened) virus or bacteria or
their toxins, used for vaccinating people to induce specific immunity against an
infectious disease.
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
1.1 Context
T
he
goal
of
immunisation
is
to
protect
the
individual
and
the
public
from
vaccine-
preventable diseases. Modern vaccines are safe, especially when they are procured through a recognised,
standard quality vaccine manufacturer accredited by WHO. No vaccine is entirely without risk, however, either
because of its intrinsic properties or because of being administered in an unsafe way (programme errors). Unsafe
immunisation practices threaten not only individuals receiving the vaccine, but they also endanger health personnel
who may sustain a needle-stick injury from recapping the needle or injecting an agitated child. Moreover, members of
the community may be harmed if injection waste is not disposed of properly. Children may play with used syringes and
needles and become infected.
Using unsterile syringes and needles risk transmitting diseases such as hepatitis B, hepatitis C and HIV/AIDS. Every
year, unsafe injection practices (both clinical and preventive) and needle-stick injuries cause at least:

16-21 million cases of hepatitis-B infection

2,3-4,7 million cases of hepatitis-C infection

80,000-160,000 cases of HIV infection.
A recent study indicates that each year unsafe injections cause an estimated 1.3 million early deaths, a loss of 26
million years of life and an annual burden of US$535 million in direct medical costs. Injections given in the course of
immunisation may represent only around 3% of these statistics.
1.2 Purpose of the module
The purpose of this module is to enhance the skills of mid-level managers to guide, support and assist staff in carrying
out their duties with respect to ensuring the safety of immunisations. This training module enables the mid-level
manager to ensure immunisation safety through proper planning, implementation, communication, monitoring and
evaluation of immunisation safety at all levels.
1.3 Target audience
This module is intended for EPI managers at national and sub-national levels. However, any other health worker can
benefit from reading this module.
1.4 Learning objectives
At the end of this module, mid-level managers will be able to:

Ensure vaccine safety is carried out

Ensure injection safety is carried out

Manage/monitor adverse events following immunisation

Ensure safe waste disposal is carried out.
1.5 Contents of the module
This module is developed under four main sections
1.6 How to use this module
The module should be studied in small groups. Time should be given to work alone (read and complete exercises), in
group (role-play), or in plenary sessions (feedback or slides presentations). Additionally, facilitators will:

Make available a set of all complementary documents for the participants

Show the slide set on “Giving safe injections”

Demonstrate the correct use of A-D syringes, reconstitution syringes, and safety boxes

Organise a field visit to observe waste disposal options (e.g. incineration).
Components of Immunisation Safety
2. Vaccine Safety and Quality
2.1
Vaccine quality
2.2
Safety of the cold chain
2.3
Multi-dose vial policy
2.4
Role of the diluent in immunisation
2.5
Contraindications to vaccinations
2.6
Vaccine reactions
2.1 Vaccine quality
V
accine
production
is
a
biological
process
using
living
organisms,
or
their
toxins,
as
raw material. Thus, the character of each batch is subject to variation. The quality of the finished product cannot
be determined solely by laboratory testing. Quality control requires full compliance with Good Manufacturing
Practices and with Good Laboratory Practices. It is essential that quality be ensured from the first step in the
production process to the final packing of the product. Vaccine quality control is a complex and meticulous process
and not all suppliers can assure quality. No more than 25 private sector manufacturers in any country around the
world produce vaccines of a sufficient quality and quantity suitable in immunisation programmes. On the one hand, a
number of public sector producers make high quality vaccines, but most of them do not export their products. On the
other hand, many producers make vaccines of variable quality in countries with inadequate regulation of the conditions
of manufacturing and the quality of the product. With vaccines, quality is critical.
Vaccines are heat sensitive and must be stored and transported in a cold chain. Certain vaccines also are damaged by
freezing and light. Even under the most favourable conditions, vaccines have a very limited shelf life (a maximum of
two years).
Most countries now have a national regulatory authority ensuring that vaccines purchased are in compliance with
international and national standards. The quality and efficacy of the vaccine should be maintained throughout its
arrival, transportation, storage and use.
2.2 Safety of the cold chain
Vaccines must be stored at the proper temperature in order not to degrade before use. A vaccine that has deteriorated
before administration is not only useless in terms of protecting against disease it may also cause unnecessary reactions.
All vaccines are heat sensitive and need to be stored in cold conditions. Some of them (e.g. BCG, measles, polio) can
be kept in freezers, as freezing does not harm them. Liquid vaccines containing adjuvants such as aluminum salts (e.g.
DTP, TT), however, must not be frozen. The injection of a vaccine previously frozen may result in reactions and
reduced immune response. Several indicators are available to detect if the vaccines have been frozen or have been
exposed to heat.
All programme managers should attach high priority to the maintenance of the cold chain including the main
equipment (refrigerators, freezers, cold boxes, back-up generators) and cold rooms. Storekeepers and repair
technicians should receive proper training to manage this important component of the EPI. Only by doing so can the
safety of the cold chain be assured.
For more detail, refer to MLM Module 8 on Cold Chain Management.
2.3 Multi-dose vial policy
As part of a policy to reduce vaccine wastage, WHO has developed guidelines on how to continue using vials of
certain vaccines (not all vaccines!) once they have been opened.
Previous policy
The previous EPI policy stated that all vaccine vials that had been opened for an immunisation session had to be
discarded at the end of that session, regardless of the type of vaccine or the number of doses remaining in the vial.
This policy is now out of date.
Revised WHO policy
The revised policy applies only to OPV, DTP, TT, hepatitis B and liquid formulation of Hib vaccines that:

Meet WHO requirements for potency and temperature stability

Are packaged according to ISO standards

Contain an appropriate concentration of preservative, such as thiomersal (injectable vaccines only). Vaccines
supplied by UNICEF meet these requirements.
Multi-doses vials of OPV, DTP, TT, DT, hepatitis B and liquid formulations of
Hib vaccines from which one or more doses of vaccine have been removed during an immunisation session may be
used in subsequent immunisation sessions for up to
a maximum of four weeks, provided that all the following conditions are met:

The expiry date has not passed

The vaccines are stored under appropriate cold chain conditions (+2°C- +8°C)

The vaccine vial septum has not been submerged in water

Aseptic technique has been used to withdraw all doses

The vaccine vial monitor (VVM), if attached, has not reached the discard point.
The revised policy does not change recommended procedures for handling vaccines that must be reconstituted, that is,
BCG, measles, yellow fever and some formulations of Hib vaccines. Once they are reconstituted, vials of these
vaccines must be discarded at the end of each immunisation session or at the end of six hours, whichever comes first.
The rationale for changing the policy, the implications of introducing the new policy and relevant references are given
in the WHO Policy Statement (document WHO/V&B/00.09).
2.4 The role of the diluent in immunisation
Diluents supplied with a vaccine are part of the licensed product and are specific for each vaccine. The vaccine
package is not complete without the diluent. They are specifically designed for the needs of each vaccine with respect
to volume, pH and chemical properties of the final solution containing the immunising agent. Using the wrong diluent
may result in incorrect doses of vaccines, local or general reactions or even death. It is essential that diluents for
vaccines are stored, distributed and used in the proper way so that they are not the cause of damaged vaccines, adverse
events or incorrect doses.
2.4.1 Basic information on diluents
Diluents vary in their composition. Not all diluents are sterile water for injection. This is a common misconception.
Diluents may contain stabilisers that ensure heat stability of vaccines, bactericides to maintain the sterility of the
reconstituted vaccine, chemicals to assist in dissolving the vaccine into a liquid, and buffers to ensure the correct pH
(acid-alkali balance).
In the past, the practice of supplying, transporting and storing diluents separately from the vaccine has caused
confusion and resulted in shortages of the correct diluents in the field. Poorly labeled and identified vaccines and
diluents have compounded this, as has the lack of adequate training of health workers.
Tragedies have occurred, related to reconstitution of freeze-dried vaccines with insulin, muscle relaxant and other
wrong solutions. Managers should ensure that such products are not stored in the vaccine refrigerator or cold boxes.
To avoid this confusion, WHO now encourages vaccines and diluents to be distributed together.
It is likely that many vaccines of the future will continue to require reconstitution with diluents. Diluents should be
handled with the same care as vaccines, and vaccination staff should be trained to know the proper way to reconstitute
each of the vaccines. Products such as freeze dried Hib vaccine are being introduced in many countries and, as for all
freeze dried vaccines, require use of a specific diluent for reconstitution.
Recommendations for diluents





Diluents should be shipped, stored and distributed together with the vaccine vials
they will be used to reconstitute
Diluents must NOT be frozen. They must be cooled to below 8°C before
reconstitution (to prevent vaccine shock due to sudden change in temperature).
Diluents from other types of vaccine or from other manufacturers must NOT be
used
Distilled water for injection may NOT be used as a substitute for diluent
Never inject diluent for an oral vaccine. Such diluent should be marked as
suitable for oral use only.
2.4.2 Reconstitution of vaccines with diluent
Only the diluent supplied by the manufacturer should be used to reconstitute a freeze-dried vaccine. A sterile needle
and syringe must be used for adding the diluent to the powder in a single vial or ampoule of freeze-dried vaccine.
Special care must be taken in opening ampoules to avoid loss of the dry vaccine. Reconstitution should be carried out
as recommended by WHO, away from direct sunlight and the vaccine stored under a protective covering (in the foam
pad of a vaccine carrier or wrapped in paper or foil). This minimises exposure of the reconstituted vaccine to heat and
ultra-violet rays. Reconstituted vaccine should be kept on ice to preserve its potency. A sterile needle and syringe must
be used for each separate dose of reconstituted vaccine drawn from the vial. The reconstituted vaccine must not be
kept longer than six hours.
Since 2001, the pentavalent (five-component) DTP-HepB+Hib formulation is being supplied particularly to countries
supported by the Vaccine Fund/GAVI. The vaccine is distributed in two separate vials (liquid DTP-HepB in one vial
and lyophilised Hib in the second vial), but the vials are not packaged together. Lyophilised Hib vaccine (dry vaccine)
can be stored either frozen at -20 °C or refrigerated at 2 °C to 8 °C. Liquid DTP-HepB vaccine, however, must not be
frozen. To ensure that Hib is correctly reconstituted with DTP-HepB, it is recommended that both component vials
of the pentavalent DTP-HepB+Hib formulation are stored, shipped and distributed together at 2°C to 8 °C.
For reconstitution, the manufacturer recommends mixing these two vaccines, and giving DTP-HepB+Hib vaccine in
the same syringe. Since this vaccine contains a preservative, the reconstituted vaccine can be re-used safely over an
extended period after initial reconstitution. Use of the multi-dose vial policy with DTP-HepB+Hib vaccine, however, is
recommended only if specific supervision and training activities are conducted to assure that this policy is
appropriately implemented.
Cold chain officers, storekeepers and vaccinators should always:

include diluents in stock control




check that the vaccines have been supplied with the right diluent; if any error is
noted, the vaccine should not be used and the supervisor must be notified
immediately
use only the diluent that is indicated for each type of vaccine and manufacturer
ensure the volume of diluent used is correct so that the proper number of doses
per vial is obtained
ensure that no other medication or substance, which might be confused with the
vaccine or its diluent, is stored in the same refrigerator at the immunisation
centre.
2.5 Contraindications to vaccinations
EPI recommends that health workers should use every opportunity to vaccinate eligible children and avoid so-called
false contraindications. Based on numerous studies on this issue, the WHO confirms that there are only a few
absolute or true contraindications to the EPI vaccines (Annex 1).
Contraindications to vaccinations



Persons with a history of anaphylactic reactions (difficulty in breathing, swelling
of the mouth and throat, hypotension or shock) following egg ingestion should
not receive vaccines prepared on hen’s egg tissues (e.g. yellow fever vaccine and
influenza vaccine)
Children with symptomatic HIV infection (AIDS) should not be immunised with
BCG and yellow fever vaccines
A severe adverse event following a dose of vaccine (anaphylactic reaction) is a
true contraindication to a subsequent dose of the same vaccine. A second or
third DTP injection should not be given to a child who has suffered such a severe
anaphylactic reaction to the previous dose.
The risk of delaying an immunisation because of a mild illness is that the child may not return and the opportunity is
lost. Missed immunisation opportunities because of false contraindications is the major cause of delay in completing
the schedule, or of non-immunisation at all.
Those children having serious illness should be vaccinated as soon as their general condition improves and at least
before discharge from hospital. Premature babies should be vaccinated on discharge.
It is particularly important to immunise children suffering from malnutrition. Low-grade fever, mild respiratory
infection and other minor illnesses should not be considered as contraindication to immunisation.
Conditions that are NOT contraindications to immunisation

Minor illnesses such as upper respiratory infections or diarrhoea, with fever < 38.5ºC

Allergy, asthma, hay fever or sniffles

Prematurity, small-for-date infants

Malnutrition

Child being breastfed


Family history of convulsions
Treatment with antibiotics, low-dose corticosteroids or locally acting steroids (e.g.
topical or inhaled)

Dermatoses, eczema or localised skin infections

Chronic diseases of the heart, lung, kidney and liver

Stable neurological conditions, such as cerebral palsy and Down’s syndrome

History of jaundice after birth
2.6 Vaccine reactions
Mild side effects, such as local reaction, fever and systemic symptoms, can result as a part of the normal immune
response. Some vaccine components (e.g. aluminum adjuvant, antibiotics or preservatives) can lead to reactions. A
good quality vaccine (recommended by WHO) reduces these reactions to a minimum while inducing maximum
immunity. BCG often causes a local reaction, which starts two or more weeks after immunisation as a papule (lump). It
becomes ulcerated and heals after several months, leaving a scar. (Refer to Table 1 on minor vaccine reactions.)
These data are a summary of incidence rates of events observed after vaccination and not of the risk attributable to a
specific vaccine. The common reactions occur within a day or two of immunisation, except for fever and systemic
symptoms from measles/MMR that occur from 5 to 12 days after immunisation.
Source: WHO/HQ
Most of the rare vaccine reactions (e.g. febrile seizures, thrombopenia, hypotonic hyporesponsive episodes, persistent
inconsolable screaming) are self-limiting and do not lead to long-term problems. Table 2 details rare vaccine reactions.
Anaphylaxis, while potentially fatal, is treatable without leaving any long-term effects. Although encephalopathy is
included as a rare reaction to measles or DTP vaccine, it is not certain that the vaccines, in fact, cause this.
Table 2: Summary of serious rare vaccine reactions, onset interval and rates
Source: WHO/HQ
The information in tables 1 and 2 can be used to:

Anticipate reactions for a specific immunisation programme (type and number)

Identify coincidental events that are not related to immunisation (e.g. outside the time window)

Compare reported reactions with expected rates to assess the effectiveness of AEFI reporting

Trigger an investigation if the reported rate is greater than the expected rate.
3. Injection Safety
3.1
Injection safety policy
3.2
Selection of equipment
3.3
Develop a safety plan
3.4
Implementation of planned activities
3.5
Training in injection safety
3.6
Advocacy and communication
3.7
Supervision, monitoring and evaluation
3.1 Injection safety policy
S
ince 1985, WHO policy is to use a sterile syringe and a sterile needle for every injection.
Training materials have been developed to improve the skills of health personal in cleaning, sterilising, and
handling injection equipment. Various assessments of this policy, however, have shown that health workers often do
not implement the policy due to lack of materials, knowledge, or awareness of the risks. Sterilisation is a timeconsuming process, and its importance is not always recognised. Although new injection equipment exists that is safer
and simpler to use, it is not always available. The use of this new material is only slightly more costly. Field workers
often do not know the risk they take in recapping needles. Burning or disposing safely of waste is often considered a
boring and unrewarding task.
Use a sterile or new syringe and needle for each immunisation or do not immunise!
The role of the EPI manager is of the utmost importance in planning, implementing, monitoring, supervising and
evaluating safe immunisation procedures. The commitment of management is essential to make this material available,
develop health worker’s skills to properly use them, make workers aware of immunisation safety, improve
communication and bring about positive behaviour changes. The manager is also responsible for the safety of the
health personnel. He/she must minimise hazards to them by all means through prevention and control (good
administration, correct work practices and education on safety).
A safe injection does not harm the recipient, does not expose the
provider to any avoidable risk, and does not result in any waste that is
dangerous for any other people.
3.2 Selection of equipment
Three types of equipment can be used to administer injectable vaccines:

single-use syringes and needles

sterilisable syringes and needles

prefilled syringes.
3.2.1 Single-use syringes and needles
Single-use syringes and needles are appropriate for all types of immunisation strategies, including use in fixed clinics,
outreach sites and special campaigns. A sterile packaged syringe and needle must be used for each injection and they
must be disposed of safely immediately after use.
There are two types of single-use syringes and needles: standard disposable and auto-disable (A-D) syringes.
Standard plastic disposable syringes and needles should be used for immunisation only in settings where it is
guaranteed that they will be destroyed after a single use. This should be verified by monitoring of consumption (stock)
and supervision of disposal.
The reuse of disposable syringes places the general public
at high risk of disease and death.
A-D syringes are designed so that it is impossible to use them more than once. Consequently, they present the lowest
risk of person-to-person transmission of blood-borne pathogens.
In a joint statement, WHO-UNICEF-UNFPA-IFRC have urged that by the end of 2003 all countries should use only
A-D syringes for administering all immunisations. (Safety of injections: WHO-UNICEF-UNFPA Joint Statement on
the Use of Auto-disable Syringes in Immunisation Services, WHO/V&B/99.25.)
Auto-disable syringes virtually eliminate the risk of patient-to-people (or carrier-to-people) transmission of blood-borne
pathogens (such as hepatitis B or HIV) because they cannot be re-used. Of course, they do not prevent needle stick of
health workers, particularly if recapping still takes place. A-D syringes are now widely available at low cost (less than a
20% increase over the cost of standard disposable syringes). Indeed, A-D syringes are currently the preferred
equipment for administering vaccines, both in routine immunisation and mass campaigns.
A-D syringes are the preferred type of injection equipment for administering vaccines and should replace all
other injection equipment.
 Exercise 1: (Plenary session)
Demonstration of use of A-D syringes
Discussion on possible difficulties in handling the material
3.2.2 Sterilisable syringes and needles
Sterilisable syringes can be used in routine immunisation sessions where compliance with cleaning and sterilisation
procedures between each use can be assured.
They are neither practical nor economical for mass immunisation sessions and should not be used for this purpose.
A sterile syringe and a sterile needle must be used for each injection.
A reusable syringe lasts for 50 to 200 sterilisations, depending on the hardness of the water used. Reusable needles
have an average life span of 50 sterilisations.
Managers should be aware that for all practical reasons the sterilisable injection equipment will become more difficult
to find in the future.
Immediately after use, the reusable syringes and needles must be flushed with clean water, soaked in clean water, and
carefully cleaned by the end of the session. Then they must be steam sterilised for 20 minutes at a temperature
between 121° C and 126° C.
A TST indicator (Time, Steam and Temperature) is currently available to check if the sterilisation process has been
completed. One indicator must be included in each sterilisation cycle. Its function is to show whether a sterilisation
cycle has met the three criteria for correct sterilisation: 20 minutes at 121°C in the presence of saturated steam. The
indicator changes colour only if all three criteria are met. The colour change is irreversible.
Details on sterilisation and cleaning are described in WHO Publication: Immunisation in Practice, Module 4,
Ensuring Safe Injections (WHO/EPI/TRAM/98.04).
 Exercise 2: (Plenary session)
Demonstration of steriliser and TST control spot
Discussion on advantages and disadvantages of A-D versus sterilisable material
Traditional sterilisable syringes have many disadvantages linked to sterilisation procedures. Some have been
minimised through better design and the use of modern material. However, equipment, spare parts and accessories for
sterilisation have to be supplied and fuel has to be provided.
Reusable syringes and needles should be used only if their sterility
can be guaranteed through the correct use of appropriate sterilisation equipment
in good working condition.
3.2.3 Prefilled syringes
Prefilled syringes are single-dose packets of vaccine to which a needle has been fixed by the manufacturer. This type of
injection equipment can be used only once.
Every prefilled syringe and needle is sterilised and sealed in its own foil package by the manufacturer. Just before an
injection, the health worker removes the foil and the cap that covers the needle. After the injection, the used syringe
and needle must be disposed of safely.
3.2.4 Safety boxes
To prevent risk of infection, the safe disposal of used needles and syringes is a critical component of any vaccination
programme. Without recapping, vaccinators should place needles and syringes in safety boxes immediately after
administering vaccine. To avoid an accidental needle prick during disposal, safety boxes should not be over-filled.
When the safety box is nearly (approximately ¾’s) full, it should be securely shut and stored in a safe place until it can
be properly disposed of.
Figure 2: Safety box for used injection equipment
A 5-litre safety box can hold approximately 100 used needles and syringes. 10-, 15- and 20-litre safety boxes are also
available. Before ordering the larger safety box, check that it is able to fit through the incinerator doors. These larger
boxes may be appropriate for open pit burning. Consider also logistic issues (e.g. expected number of children to be
vaccinated per team, physical constraints of carrying larger boxes etc.). All fixed centres and mobile teams need to be
provided regularly with an adequate supply of safety boxes.
 Exercise 3: (Plenary session)
Demonstration of the safety box. Discussion on possible injuries while disposing of used
syringes and needles.
3.3 Developing a safety plan
Effective planning and management are needed to ensure the proper use of equipment and the introduction of new
equipment such as the A-D syringe. Specifically, immunisation systems must develop a comprehensive approach to
immunisation safety that includes policy statements, strategy and an annual work plan.
A policy statement can be considered as a vision or overall goal for injection safety, e.g. “The Ministry of Health
pursues the policy that 100% of injections given within EPI must be safe”. Generally, the vision cannot be achieved in a
short time. It requires a multi-year immunisation safety action plan that states yearly objectives and strategies to achieve
them. A strategy is a general overview of how objectives will be achieved, i.e. the types of services or interventions that
must be initiated.
Strategies for introduction of A-D syringes, injection safety and safe disposal of used injection equipment should be
reflected in the plan. Activities should target all levels of the immunisation service, from decision-makers to health
workers and the public.

Decision-makers should know the extent (i.e. magnitude and severity) of the threats to the public caused by
unsafe injections, as well as the feasibility of interventions required to solve them.

All health workers should have the knowledge, skills and proper equipment to administer injections safely and
to avoid occupational hazards.

Finally, the public must be educated on the need for all immunisations to be administered safely.
Planning checklist on immunisation safety for EPI managers
Your plan should include four major areas of immunisation safety:
1. Assure vaccine safety: delivery up to and through administration
 Use pre-qualified or national regulatory authority-approved vaccine and injection
material
 Check bundle vaccine with corresponding diluent, reconstitution syringes,
A-D syringes and sharp disposal boxes
 Communicate risks associated with unsafe practices
 Train health care workers in proper techniques.
2. Develop and implement an injection safety plan at national and sub-national level
 Identify stakeholders
 Assess the situation as regards injection practices
 Ensure that EPI is included in the national policy on injection safety
 Ensure injection safety through education
 Make provision of supplies and specify schedules for distribution
 Include the costs for safety component in the financial plan
 Monitor and document implementation of the plan
 Evaluate results and identify lessons learned.
3. Monitoring of AEFI
 Detection and reporting of AEFIs
 Initiate investigation and collect data
 Analyse collected data
 Take appropriate action based on your findings.
4. Manage disposal of used injection equipment

Assess local regulatory framework and options for sharps treatment and
disposal

Plan storage, transportation and disposal

Identify practical and simple solutions

Monitor disposal on a daily basis.
To ensure co-ordination and action at provincial and district levels specific immunisation safety officers should be
identified with responsibility for injection safety and the safe disposal of used injection equipment. These officers
should be sufficiently senior (e.g. deputy EPI district manager) to carry the responsibility of all aspects of safety, since
technical issues, operations and monitoring (including cold chain and logistics) are closely linked.
The designated immunisation safety officers will be responsible for managing the system, ensuring adequate supplies
and equipment are available at all levels, calculating requirements, maintaining inventories, and also controlling the
safety of immunisation injections and establishing efficient ways for disposing of used syringes and needles. At the
levels where the disposal actually takes place, operators for safe disposal should also be designated and appropriately
trained.
3.4 Implementation of planned activities
An adequate supply of all necessary injection equipment, including A-D syringes, disposable reconstitution syringes
and safety boxes, is essential. WHO and UNICEF policy states that all vaccine orders be bundled with A-D syringes
and safety boxes.
The term bundling has been chosen to define the concept of a theoretical bundle,
which must consist of each of the following items:

Good quality vaccines

Auto-disable syringes

Safety boxes
None of the component items can be considered alone; each component must be
considered as part of a bundle containing the other two. Bundling does not
necessarily mean that the items are actually packaged together in the same
container however.
Estimates for equipment requirements
EPI managers should ensure that health workers get the proper amount of material needed (A-D syringes and needles,
reconstitution syringes and needles, safety boxes). If the proper material is not available, the use of sterilisable
equipment is acceptable.
Estimates for equipment requirements can be calculated using the following example and should be repeated and
completed for each injectable vaccine in the national immunisation schedule.
At the district level, the estimation of material needed for injectable vaccines is made based on the following steps:

The number of children under one year of age and the number of pregnant women (if no data are available
use 3% of the general population)

The anticipated coverage (the number of children and pregnant women) targeted for vaccination

The number of doses of each vaccine according to the national vaccination schedule per child (e.g., 1 BCG, 3
DTP-Hib, 3 Hep B, 1 Measles/MMR)

Estimate wastage rate (usually 50% for BCG, 15-25% for DTP-Hib-HepB combined vaccine and
measles/MMR)

The buffer stock* (usually 25% of the doses required)

The total number of doses (including buffer stock)

The number of doses per vial (10-20 for BCG, 2 for DTP-Hib-HepB, 10-20 for DTP, 10-20 for measles
vaccine)

The total number of vials

The number of A-D syringes required ([number of doses equal to number of A-D syringes + 10% wastage**]
+A-D syringes buffer stock [usually 25% of the total number required])

Total number of A-D syringes needed (including buffer stock)

Reconstitution syringes (disposable): one per vial of vaccine + 10% (wastage)

Safety boxes (1 box for 100 syringes + 10% wastage)

Number of required incinerators, burning pits (as per micro-planning exercises)

Fuel required for incinerators and burning pits.
 Exercise 4: (In small groups)
Estimate the requirements for the 1st and 2nd year for A-D syringes, reconstitution syringes
and safety boxes in your own district or province for DTP-HepB+ Hib vaccine. Use your
district data (target population, growth rate, planned coverage rate) and fill in the boxes of
the table opposite.
If you do not have your district/province data, use an example of a district with the
following data:
Target population
-
10,000
Growth rate
-
2.5%
Planned coverage
-
80%
Some of the above data are already inserted in the table on the following page. Continue
the exercise and fill other empty boxes. When finished, check your answers with the
facilitator.
1st Year
a)
b)
c)
d)
e)
f)
g)
Number of children under one year of age
Planned coverage (%)
Number of children targeted for vaccination (a x b)
Number of doses of each vaccine per child
Estimated wastage factor for vaccines
Number of doses required (c x d x e)
Doses for buffer stock (f x 25%)
10000
80
3
1.32
2nd Year
h)
i)
j)
k)
l)
m)
Total no. of doses (f + g)
Number of doses per vial
Total number of vials (h ÷i)
Number of A-D syringes needed= number of doses +10% wastage
Reconstitution syringes (disposable) (j + 10%)
Safety boxes [(k+l) ÷100] +10%
2
For items K,L,M also estimate total cost using the following price list
A-D syringes 0.05 ml for BCG
A-D syringes 0.5 ml for all other vaccines
Reconstitution syringes (5 ml disposable)
Safety boxes
0.06 US$ each
0.06 US$ each
0.05 US$ each
1.00 US$ each
It may also be useful to estimate the storage volume requirement for all these items, according to the following
basic information:
100 A-D syringes ( 0.05 or 0.5 ml)
1600 reconstitution syringes (5 ml)
25 safety boxes
0.006 m3
0.106 m3
0.02 m3
An efficient stock-management and distribution system needs to be developed to ensure continuous, sufficient
availability of injection safety equipment in all health facilities. Spreadsheets should be issued at national, and district
level to clarify distribution procedures and ensure the correct delivery up to the point of use.
3.5 Training in injection safety
Training in injection safety and safe disposal is an essential requirement for the introduction of A-D syringes. To
ensure across-the-board collaboration, relevant partners such as non-governmental organisations and private
practitioners need to be included in training activities. Training institutions should revise their curricula to include
injection safety so that the pre-service training of health professionals follows the national standards for safe injection
practices.
The three main components of injection safety should be underlined:
A safe injection

does not harm the recipient

does not expose the provider to any avoidable risk

does not result in any waste that is dangerous for any other people.
The main messages of good injection practices are described in the PATH training manual and illustrated in the set of
slides.
Good injection practices


Use a sterile A-D syringe and needle to vaccinate each child
Use a A-D syringe and needle for each injection (check the package for any
possible damages)

Use a disposable syringe and needle to reconstitute each vaccine

Prevent contamination of equipment and vaccines

For each injection, prepare a clean designated area where blood or body fluid
contamination is unlikely

Always pierce the septum of multi-dose vials with a sterile needle

Do not leave a needle in the stopper

Protect fingers with small gauze pad when opening ampoules






Discard a needle that has touched any non-sterile surface (hands, environmental
surfaces)
Prevent needle sticks
Anticipate and take measures to prevent sudden patient movement during and
after injection
Do not recap needles after injection
Collect used syringes and needles at the point of use in a safety box, enclosed
sharps container, that is sealed when ¾ full (do not over fill safety boxes)
Prevent access to used needles.
Seal safety boxes for transport to a secure area. Do not open or empty. Do not reuse
them. It is useful to attach a sign that says CAUTION: CONTAMINATED SHARPS



Prevent accidents in personnel in charge of waste disposal
Do not overload the personnel in charge of waste disposal with other work
Put only potentially contaminated material in the safety boxes. Do not put the
following material in the box: empty vials (they may explode while burning),
cotton pad, dressing material, latex gloves, etc.
Other recommendations:

Hand hygiene
•
Wash or disinfect hands before preparing vaccines and giving injections
•
Cover small cuts
•
Gloves are not needed to give injections

Swabbing vial top or ampoules with an antiseptic or disinfectant is not recommended

Skin preparation before injection and skin conditions
•
Wash skin that is visibly soiled or dirty
•
Swabbing of the clean skin before giving an injection is unnecessary
•
If swabbing with an antiseptic is selected
use a clean single-use swab
maintain product-specific recommended contact time, and
do not use cotton balls stored wet in a multi-use container.
•
Avoid giving injections in the injection site if skin integrity is compromised by local infection or weeping
dermatitis.
 Exercise 5: (Plenary session)
Demonstration of correct and incorrect practices followed by a discussion.
3.6 Advocacy and communication
Advocacy strategies for injection safety must be developed to target not only EPI managers but also government
decision–makers and other managers, health workers and the general population. The basis for safe use of injections is
a behaviour change strategy that involves consumers, workers in public and private sectors and traditional healers.
Communication on injection safety should be included in the day-to-day information given by the immunisation
providers to the family and the community. Parents should know that new materials such as A-D syringes are modern
and safe technologies they cannot be re-used and are properly disposed of after single use.
3.7 Supervision, monitoring and evaluation
Regular supervisory visits and monitoring are essential to ensure that safe injection practices are implemented.
The following should be supervised in both routine and mass campaign settings:

Adequate supplies of A-D syringes, needles, and safety boxes at each immunisation site

Safety boxes are properly assembled (i.e. top is closed)

Needles and syringes are placed immediately in safety boxes after use and are not recapped

Empty vaccine vials are not thrown into the safety boxes

Safety boxes are not opened and the content is not transferred to other containers or other safety boxes

Safety boxes are filled only to appropriate levels (i.e. approximately ¾’s full, no needles are sticking out of the
box) and are properly closed.
All accidents and hazardous situations should be reported and the supervisor should be informed about them. Given
the importance of injection safety, the EPI manager should select a few key indicators for evaluating performance.
The following are examples of indicators related to safe injection practices that could be monitored regularly and
evaluated periodically:



Adequacy of syringe and needle supplies at the health facility level
•
Number of A-D syringes equal to number of vaccine doses
•
Proportion of facilities provided with A-D syringes
•
Adequate stock of A-D syringes
•
Frequency of deliveries of supplies to each facility
Disposal of injection equipment
•
Number of safety boxes adequate to number of syringes (proportion should be 1/100)
•
Proportion of health facilities with adequate stock of safety boxes
•
Availability of appropriate waste disposal options (e.g. proportion of health facilities with incinerators for
waste disposal)
•
Presence of unattended used syringes and needles at the facility: in wastes, around health centres, or
presence in municipal waste dumps where access to the public is not controlled
Proportion of AEFI monitored

Proportion of health workers trained in safe injection practices

Proportion of health facilities with focal person for injection safety.
Evaluation activities that take place after an immunisation campaign can provide important learning opportunities to
identify areas for improvement of injection safety. Results from the evaluation should be shared with the health
workers to encourage safe injection practices.
Furthermore, national immunisation programmes are encouraged to integrate information about injection safety in the
regular, routine reporting forms. They have the same level of importance as immunisation coverage data or data on
disease surveillance.
 Exercise 6: (Plenary discussion on the following topics)


Do you monitor and evaluate injection safety in your province/district?
What monitoring and evaluation methods do you use?

How often do you monitor and evaluate injection safety issues?

Have you encountered any shortcomings in injection safety practices in your country?

Can you describe any violation of safety requirements in your work area?

If yes, what were the improvements?
4. Monitoring Adverse Events Following Immunisation (AEFI)
T
4.1
Programme errors
4.2
Detect and report AEFIs
4.3
Investigate adverse events
4.4
Analyse data
4.5
Take action to manage AEFI
4.6
Evaluate the quality of AEFI surveillance
he
goal
of
immunisation
is
to
protect
the
individual
and
the
public
from
vaccine-
preventable diseases. Although modern vaccines are safe, no vaccine is entirely without risk. After immunisation,
some people experience reactions ranging from mild local reactions to life-threatening, but rare, illnesses. In some
cases, these reactions are caused by the vaccine; in others, they are caused by an error in the administration of the
vaccine; and in others, there is no causal relationship.
Thus, the causes of AEFIs can be categorised as follows:

Programme errors, i.e. an error in handling, reconstitution or administration of the vaccine

Nature of the vaccine (vaccine properties) or individual response to the vaccine itself

Coincidence, when there is no causal association between the immunisation and the medical condition of the
child or women. The latter just coincides with immunisation.

Unknown cause. Sometimes the cause of AEFI remains uncovered. With increased quality of investigations,
most of the unknown causes probably will be classified in one of the above three categories.
Whatever the cause, when an adverse event following an immunisation (AEFI) upsets people to the extent that they
refuse further immunisations for their children, the children are put at risk from vaccine-preventable diseases and their
consequences.
Staff should be trained in diagnosing, treating and reporting of AEFIs, and differentiating between mild, non-significant
reactions and more serious events.
Typical non-significant reaction to vaccines include fever, redness or swelling at the injection site, and rash.
Remember, children in the immunisation age group may have symptoms unrelated to immunisation due to common
infections at the same time. Training must be designed so that the health worker can practice the relevant skills until
mastery. Materials for training in immunisation skills are available from WHO/EPI Geneva. (See “Immunisation in
Practice”, WHO/EPI.)
The purpose of this section is to provide training that will allow managers to increase immunisation acceptance and
improve the quality of services through the proper surveillance of AEFIs and a reduction of AEFIs to a minimum.
Now that mass campaigns may include injectable vaccines such as measles, measles and rubella (MR) and measles,
mumps and rubella (MMR), additional precautions must be taken to ensure that the campaigns are conducted safely
and adverse events are kept to a minimum.
At the end of the chapter, the participant will be able to:
Detect and report AEFIs
Investigate AEFIs
Analyse reports of AEFIs
Take appropriate action following reports of AEFIs
Evaluate the reporting system for AEFIs
Prevent AEFIs in routine immunisation and mass campaigns
4.1 Programme errors
An adverse event following immunisation is a medical incident that takes place after an immunisation and is believed
to be caused by the immunisation. Although people often think that a medical incident after an immunisation must be
caused by the immunisation, many such incidents are coincidental. Another belief – that vaccine is the most common
cause of AEFIs – is also mistaken. Programme error, which can be prevented, is more often the cause.
A programme or programmatic error is usually person-based rather than vaccine – or technology-based (e.g. injection
site abscess). It can generally be prevented through proper staff training and an adequate supply and proper use of safe
injection equipment. In addition, regular supervision will greatly contribute to the reduction of this unwanted
phenomenon.
BASIC RULES TO AVOID PROGRAMME ERRORS


Reconstitute your vaccine only with the diluent supplied by the manufacturer
Discard reconstituted vaccines at the end of each immunisation session and never
retain them. (Remember, opened vial policy applies only to liquid formulation of
vaccines!)

Do not keep drugs or other substances in the vaccine refrigerator

Use sterile needle and sterile syringe for each injection

Full investigation of an AEFI is needed to pinpoint the cause and to correct
inappropriate immunisation practices
 Exercise 7: (Role-play)
You have been asked to give a half-hour talk to graduating nurses on how to minimise
AEFIs in immunisation programmes during routine and supplementary activities. List 10
points you would make in the talk.
4.2 Detect and report AEFIs
To find the cause of an AEFI, the events must first be detected and reported. Countries may not have the resources to
include all AEFIs in their surveillance systems, and it is not necessary to do so. Managers have choices in terms of
which ones to report, how they are reported, what is reported, and when. In this chapter, these choices are discussed
and recommended practices examined.
All immunisation programmes should monitor at least the following AEFIs:
1.
All injection site abscesses
2.
All cases of BCG lymphadenitis
3.
All deaths that are thought by health workers, or the public, to be related to immunisation
4.
All cases requiring hospitalisation that are thought by health workers, or the public, to be related to
immunisation
5.
Other severe or unusual medical incidents that are thought by health workers, or the public, to be related to
immunisation.
These five categories of AEFIs are sometimes called trigger events because their presence stimulates or triggers a
response.
In many reporting systems, peripheral and hospital health workers submit a routine surveillance report that includes
AEFIs to their supervisors at the district level. The district supervisors then compile the data for reporting to higher
levels using a summary form. Managers should consider whether AEFIs, and which of them, should be reported
directly to the central level.
Refer to Annex 4 for an example of AEFI report form.
 Exercise 8: (Small group discussions)
What is a trigger event? Why do we emphasize it?
You are the immunisation programme manager. List the AEFIs to be notified through your
surveillance system. If your list is different from the one above, give reasons. Discuss your
list with your facilitator.
To where and to whom will AEFIs be notified in your area of responsibility? Give reasons
for your choice.
List the actions that will be taken on receipt of a report for each of the AEFIs on your list.
4.3 Investigate adverse events
The purposes of investigating AEFI episodes

To confirm reported diagnosis or suggest other possible diagnoses

Clarify the outcome of the medical incident/s

To record the specifications of the vaccine (batch number, expiry date etc.) which has been used for
immunising the patient/s with AEFI

To examine the operational aspects of the programme. Even if an event seems to be vaccine-induced or
coincidental, programme errors may have increased its severity.

To determine whether a reported event was a single incident or a cluster and, if so, number of people
affected, where the immunisations were given and what vaccines and diluents were used and their
specifications.

To determine whether unimmunised people in the same area are experiencing the same medical incidents.
Investigation should begin ideally within 24 hours of detection by a health worker, to identify any programme errors
that might still be present, to correct them as soon as possible before other people are exposed. Immediate action is
also important to assure members of the community that their health and concerns are taken seriously.
Stocks of reporting forms should be maintained and distributed as needed. Clusters of non-serious AEFIs should be
investigated and a decision taken whether to report them to a higher level. Following a report of a serious AEFI, the
district managers should be responsible for investigation, collection and reporting of data. This may be under the
overall supervision of a national team.
In planning an investigation


Who should be involved in the investigation?
What data should be collected?
• data on each patient
• data on the vaccine involved in the episode
• data on other persons in the area who received the same vaccine?
•



programme-related data such as vaccination practices in the health centre
– how is reconstitution carried out?
– sterilisation practices
– storage of vaccine and condition of the cold chain
– skills of health workers in vaccination techniques
– has the health worker who administered vaccine been trained and when?
Is there a need to collect samples for laboratory examinations?
Source of data to be collected
How should data be collected, recorded and analysed?
See annexes 4-6 for various AEFI investigation and specimen collection forms.
 Exercise 9: (Small group discussions)
Two children have been admitted to the same hospital on the same day, following routine
vaccination with measles vaccine. The initial telephone call indicates that one child
probably had convulsions, and it is not clear why the second one was admitted.
Describe in detail how you would carry out an investigation based on this report.
4.4 Analyse data
Analysis of data on AEFIs consists of reviewing the case investigation report for each patient, other data about the
event and the community in which it took place, reviewing laboratory results, making a final diagnosis, and identifying
the probable cause. This is not an exact science: it might not be possible to make a diagnosis, the cause might not be
evident, or there might be more than one cause. Managers should try to get as much information as they can from the
collected data. If the manager feels that additional data are required he or she should re-examine initial sources to
clarify the facts.
Data analysis can be carried out initially by the health worker who detects the AEFI and conducts the case
investigation. Other health workers, such as epidemiologist, clinician, laboratory technician or other specialists who
have taken part in the case investigation, should also participate in the analysis. In certain cases, consultations may be
required with local or international experts, WHO collaborating institutions etc.
In addition, a regional or national AEFI review committee can be convened to assist in the analysis and to review
reports. They can play a major role in determining the cause and in classifying the event. The central level manager
responsible for AEFIs should direct and monitor the process.
Aspects of the investigation for the review committee

How was the case diagnosed (method of diagnosis): clinical, epidemiological, by the laboratory?

Is the diagnosis correct? Does the case fit into case definition of the AEFI in question?

If the diagnosis is correct, how can cause be classified?

•
programme-related
•
vaccine-induced
•
coincidental
•
unknown
If it is a suspected case, what additional investigations are needed to confirm the case:
•
Is laboratory testing needed?
•
Are there any additional clinical signs or symptoms that can fine tune the clinical diagnosis?
•
Should AEFI focal point continue interviews with the patient; with the mother or caretaker or with the
community member?
•
Is there a need to contact the manufacturer (or WHO/UNICEF) to inquire if similar reports on the
same vaccine have been reported from other countries?
 Exercise 10: (Small group discussions)
On quick inspection of the monthly reports of AEFI surveillance coming from the clinics in
the district, the district supervisor noticed what appears to be a cluster of abscess reports.
Describe in detail how he or she would analyse the reports from the clinics and what
action should be taken as a response to these reports.
4.5 Take action to manage AEFI
For the credibility of immunisation services to remain high, the EPI manager must ensure that AEFI detection,
investigation and analysis lead to action. Actions include: treatment of the affected person/s, correction of programme
error if any, communication with the community, and research. The required action to be taken by a peripheral health
worker when faced with an AEFI is outlined in Figure 3.
Of first priority is the correct treatment of the patient’s condition in outpatient clinics or, in severe cases, through
hospitalisation. All the effort so far is wasted if action is not taken to correct the error. If an AEFI was caused by
programme error, such as improper handling of vaccines or faulty immunisation technique, the actions to be taken will
probably include one or more of the following:

Logistics. Improving logistics will be the appropriate response if investigations indicate lack of supplies or
equipment or failure of the cold chain. Managers should investigate suspected faults in the cold chain to find
the cause and take appropriate measures. These might also include training or supervision, or the problem
might be solved by providing additional equipment (needles, syringes, sterilisers, vaccine carriers, cold packs),
vaccine or diluent.

Training. Training is often used to solve operational problems: lack of skills and knowledge and poor attitude
of health workers. Effective immunisation services call for health workers who can detect AEFIs and provide
immunisation services safely. When an AEFI has been caused by service delivery errors and the investigator
identifies the specific error, training can focus on correcting that error. If the investigator finds out that the
error was caused by one health worker, that health worker’s immunisation activities should be terminated
immediately, at least until he or she undergoes a training and masters the missing skills.

Supervision. Non-serious AEFIs (e.g. abscesses) reported by peripheral health workers should be supervised
by site visits. Supervisors should give immediate feedback (during the same supervisory visit) to health
workers on the quality of their AEFI monitoring, routine surveillance, case investigation and reports.
Wherever AEFIs are reported, supervision should be intensified. If past training or supervision in the relevant
skills has been weak, the problem could be widespread and clusters of AEFIs may be prevalent. Therefore,
supervisors throughout the country should be alerted to watch for any problem (e.g. in sterilisation of
equipment or vaccine storage) that has caused a cluster of AEFIs.

Communication. Supervisors and health workers should inform parents and the community about AEFIs,
assure them of immunisation safety. Health workers should be prepared to respond quickly to rumours and
public inquiries. At central level, there may be a need for a press release, which should be prepared with great
care to prevent panic among population. This publication should include scientific evidence of the advantages
of immunisation and possibility of AEFIs in certain individuals due to vaccines or programme errors. The
article should end with a positive note about the need to continue with immunisation.
The district manager or another knowledgeable person in authority should set up the means for continuous
communication between health workers (investigators, peripheral health workers, supervisors and managers) and the
community, directly and through the press. The public should be informed frequently about what is being done during
an investigation. When it is over, conclusions and recommendations should be shared, and the public told on
problems found and what is being done to remedy them.
The key to maintaining confidence in health services is to be honest. If the cause of the AEFI has not been identified,
people should be told. If the cause has been insufficient sterilisation of needles and syringes or some other programme
error, the actions being taken to remedy the problem should be explained.
 Exercise 11: (Small group discussion)
As district supervisor, you are suddenly called to a nearby immunisation clinic. The urgent
telephone call described a child who had just collapsed, only minutes after being given
measles vaccine. Describe what action you would take immediately, over the next 24 hours,
and over the next month.
When death occurs because of a programme error, special precautions may have to be taken to protect health workers
from harm by the community. Health workers who are implicated in the error might have to be removed from the
scene before the findings are communicated.
A vaccine-induced AEFI can be a sensitive communication problem. The public needs to be assured that severe
vaccine-induced events are rare, although this may not comfort the patient’s family. In some cases, managers may find
it appropriate to provide technical information on the low incidence of these events. In many contexts, however,
statistics may be almost meaningless and the best that can be done is to show genuine sympathy and concern.
Figure 3: Taking action by peripheral-level health worker
Source: WHO/HQ
4.6 Evaluate the quality of AEFI surveillance
AEFI surveillance should be evaluated regularly and should lead to remedial actions.
Most of the indicators for evaluating AEFI surveillance are similar to those used to measure the performance of the
disease surveillance system in general. Others are specific for AEFIs:

timeliness, completeness, and accuracy of routine AEFI surveillance reports

swiftness with which case investigation begins after a trigger event is reported

appropriateness of actions taken to avoid further programme errors

participation of communities in immunisation programmes.
How should the system be evaluated?

Completeness, timeliness, and accuracy of reporting. Every month supervisors should check if all expected
monthly surveillance reports are received in the district office and, in turn, in the central office (completeness
of reporting). Checking of the report receipt dates is also useful to districts and higher levels to monitor
timeliness of reporting.

Accuracy. On visits to health facilities, supervisors should periodically check the accuracy of routine disease
surveillance reports by comparing them to the facility’s patient register. They should talk to health workers
and observe their work to make sure that recommended improvements have become a part of daily practice.

Swiftness. At the end of each AEFI investigation, the senior manager should evaluate how quickly the
response to the reported AEFI was done, using the following parameters:
whether the AEFI was reported within 24 hours of detection
whether an investigation begun within 48 hours after the report was received.

Appropriateness of actions taken to avoid further programme errors. Managers should review case
investigation and event description reports to see that the actions proposed for the elimination of programme
errors are adequate. Supervisory visits should find out whether the actions were actually taken and if so, their
results.

Participation in immunisation programmes by communities. Over time, a good AEFI surveillance should
result in an increase in immunisation coverage due to increased community participation. There is no
paradox in this. If the health worker reduces the programme errors to a minimum or even to nil, if he or she
takes immediate and appropriate measures when AEFI occurs, if communities are well informed on causes of
AEFIs, the confidence in immunisation and in the staff will grow in the community, resulting in increased
participation. The extent to which this is achieved is a good sign of the impact of the surveillance system and
should be measured every three to five years. Monthly AEFI surveillance reports, AEFI annual reports, and
coverage data can be used for this assessment.
 Exercise 12: (Small-group discussions)
As EPI manager, you introduced a surveillance system in your area of responsibility last
year. After a year in operation, you would like to evaluate the effectiveness of the AEFI
surveillance system. Describe the steps you should take to assess your surveillance system.
5. Safe Waste Disposal
T
5.1
Selection of methods
5.2
Planning for safe waste disposal
5.3
Safe disposal of immunisation waste
5.4
Training in waste disposal
5.5
Advocacy and communication
5.6
Supervision, monitoring and evaluation
he
EPI
manager
is
responsible
for
organising
safe
immunisation
waste
disposal
at
national and sub-national levels. The proper disposal of used equipment is one of the most important issues in
assuring immunisation safety.
The overall objective of this chapter is to give EPI managers the tools to ensure safe waste disposal, specifically for
immunisations at national and sub-national levels. At the end of this section, the participants should be able to select
safe disposal options, plan, implement, monitor/supervise and evaluate various options and advocate for their
introduction in their programmes. They will also have skills to train staff on the issue.
5.1 Selection of methods
There is no perfect generic method for safely disposing of used injection equipment. Each immunisation program
must assess local conditions and find appropriate waste disposal solutions. Any selected method of waste disposal must
comply with national and sub-national environmental health regulations and by-laws.
In many countries, installation of incinerators at the district level has proven to be practical and effective (for both
routine immunisation and mass campaigns). Used needles and syringes are collected from health centres and mobile
teams and transported to a district health facility that has a well-functioning incinerator. To facilitate collection, some
countries are using exchange strategy, whereby new needles, syringes and safety boxes are given in exchange for safety
boxes filled with used syringes and needles.
Other options are available or are being developed, such as needle destruction, melting syringes autoclave, steam
sterilisation, microwaving (with shredding) etc. These may not be appropriate for the district level, as they still are
either experimental or expensive. Such methods, however, will probably play an important role in the future as costs of
this equipment will come down over time.
5.2 Planning for safe waste disposal
Although there is no single, universally accepted disposal method, a locally acceptable solution needs to be identified
by the EPI manager and agreed upon by all partners.
The following planning steps are proposed:

Plan for transportation, storage and treatment of sharps waste

Identify centres having access to incinerators

Identify centres without any access to incinerators and decide on methods of safe disposal

Identify practical, simple solutions to be implemented during campaigns. Use the waste disposal plan and
system developed for routine sharps disposal in the future (possibilities include incineration, burning,
recycling, safe burial). During campaigns, safety boxes should be numbered in order to verify their return to
destruction point through a checklist.

Assess local possibilities of sharps treatment and disposal (e.g. identify functioning incinerators, sites for
burning, re-cycling, safe burying, etc.) Construct incinerators where needed. Meantime work out an
arrangement to transport waste to an available incinerator.

Prepare clear instructions and guidelines for health staff on sharps disposal and waste management

Instruct personnel on practices recommended and monitor the compliance

Estimate equipment or transport needs and elaborate a budget.
Each vaccination site should know who will collect the waste and when. Sometimes, vaccinators are responsible for
waste disposal and should include this activity in their timetable.
As already mentioned there are no completely pollution-free methods for destroying used A-D syringes and needles.
Therefore, they should never be disposed of along with non-infectious waste or dumped in open areas where they
might injure adults or children.
Annex 2, on safety of mass immunisation campaigns, may assist you to prepare the detailed plan for safe sharps waste
management.
 Exercise 13: (Individual work)
Consider local conditions, availability of incinerators and number of used syringes and
needles in your districts. Choose the proper disposal systems at peripheral and district
levels according to their advantages and disadvantages.
When finished, share your findings with the facilitator.
5.3 Safe disposal of immunisation waste
Waste may be safely disposed of by incineration, burning in a metal drum, open burning or burying without burning.
The methods are described below and in Annex 2).
Incineration
Incineration can completely destroy needles and syringes by burning at temperatures above 800°C. The high
temperature kills microorganisms and reduces the volume of waste to a minimum. Properly functioning incinerators
ensure the most complete destruction of syringes and needles, and produce less air pollution than burning at lower
temperatures. Some hospitals have on-site incineration while other use incinerators at other facilities, such as cement
factories.
Some incinerators models available in the market are de Monfort, SICIM and Medicin 400.
Available incinerator options
Burners
Burners prepared locally using local materials e.g., brick burns. (See Annex 3 for an example of a locally produced
burner).
Burning in a metal drum (container burning)
If no incinerator is available, burning in a metal drum or protected hearth is another way to dispose of used injection
equipment and contaminated needles.
Open pit burning
Open pit burning is not recommended because it can scatter waste. If safety boxes are placed in an open pit, the pit
should not be so deep that people have to crawl down into the pit to start the fire. They could also be pricked by the
remaining stubs of previously burned needles.
Burying without burning
Burying filled safety boxes is probably the least effective way to protect people from contaminated sharps. It is often
difficult to find a place to bury the boxes and it may be difficult to dig a pit large enough for the bulky boxes. If
contaminated A-D syringes somehow escape from the box and are carried into streams or fields, people may step on
them and children may play with them.
5.4 Training in waste disposal
The EPI manager should ensure that personnel are appointed to be in charge of waste disposal. Generally, these are
either specific personnel in large health centres or hospitals, or personnel from the vaccination team in small facilities.
Training should give such personnel technical skills and an awareness of the importance of their role in assuring their
own safety, safety of their colleagues and the safety of the community.
5.5 Advocacy and communication
The EPI manager should emphasise the importance of safe disposal of waste to health staff and the community. The
health staff should be sensitized to the potential risks related to recapping needles after inoculation and the need to use
safety boxes systematically. The community should be aware of the risks of manipulating used needles and syringes
and of the efforts made by the health personnel to prevent accidents. The public should know that used material is
stored and disposed of regularly and safely. Well-informed community members should spread the message on
prevention of accidents caused by sharps among other community members, especially preventing children to play
with used sharps. School health programme should also include talks on the issue in their educational sessions. The
prevention of accidents caused by sharps may also be an ideal educational topic for essay by schoolchildren.
5.6 Supervision, monitoring and evaluation
During every supervisory visit, safe waste disposal practices should be looked into and monitored by the EPI manager.
Meetings with health personnel from time to time should include an item about safe disposal of the immunisation
waste. This will help to sensitise the staff and offer an opportunity to share experiences on waste disposal in their work
place. EPI managers should discuss problems or challenges and solve them together, then communicate those
solutions to all the staff in the country using various channels of communications (newsletters, circular letters etc.).
Evaluation of safe disposal practices is clearly a part of the manager’s functions and it should be included in the overall
evaluation exercise of safe injection practices.
The following indicators could be regularly monitored and periodically assessed in the health facilities:

Availability of appropriate and affordable waste disposal options

Presence of used syringes and needles around health facility, in the clinical/immunisation waste, close to the
health centre or present in the municipal waste dumps where access to public is not controlled

Proportion of health facilities implementing immunisation waste disposal practices according to the
established procedures

Proportion of districts with well-maintained and functioning incinerators

Proportion of districts/provinces with adequate supply of safety boxes
Number of districts reporting a shortage of safety boxes during the year.

 Exercise 14: (Small-group discussions and plenary session)
What are the current evaluation methods of safe waste disposal in your province/district?
Have you registered any weaknesses in these methods and what are the possible ways of
improving them?
Review the above list of monitoring indicators and suggest 3-5 more indicators to monitor
waste disposal practices in your district/province or country.
After you have finished the exercise, report to the plenary.
Summary of Essential Issues
I
mmunisation
safety
has
increasingly
been
recognised
as
an
important
element
of
every
immunisation programme. EPI managers are responsible for safety of injections and waste disposal in their area of
responsibility. They are also responsible for ensuring immunisation safety through planning, implementation and
training. They should systematically include observation of immunisation safety practices, interviews, control of
supplies related to safe vaccine administration and safe waste management as they supervise and monitor the
performance of staff in this area. By ensuring that surveillance of AEFIs is carried out properly, EPI managers are
contributing to the image of the programme, especially relating to the quality of the EPI. This ensures sustainability
and credibility of immunisations for a long time to come. Managers should also promote immunisation safety through
advocacy aimed at both the public and the health staff. A high standard of immunisation safety practice will contribute
to a high quality of other services being delivered to the public, the safety of health workers and the safety of the
environment.
Communication, advocacy and social mobilisation in immunisation are also important tasks of mid-level management.
Immunisation programmes need to work with other programmes, e.g. HIV/AIDS and clinical/curative care, to use
appropriate communication strategies for immunisation safety.

Marketing safety to health workers and the community, using as a focus public concern about HIV/AIDS
transmission and the personal benefit that health workers will gain from increased safety. The communication
strategy should be adapted to the socio-cultural settings.

Strengthening communication and advocacy activities by recruiting expertise for communication campaigns

Strengthening capacity of inter-agency co-ordinating committees to address immunisation safety

Emphasizing safety in WHO regional and inter-country meetings by placing it as priority issue at EPI
managers meetings

Capitalising on the WHA resolution on patient safety to raise awareness of health personnel on safety issues.
Immunisation safety issues should have the same level of importance in the evaluation and monitoring of an
immunisation programme as the coverage and the surveillance of diseases, because they characterise the quality of the
programme.
Case Studies on AEFI
In 1997 in country A, four separate AEFI clusters of collapse occurred up to five minutes following immunisation with
measles vaccines. All 14 cases presented with hypotonia; 11 became pale; seven cases had cyanosis, dyspnœa and
increased saliva secretion; three patients had depressed respiration and one patient died; others recovered in less than
one hour. In two of the clinics, vials that contained muscle relaxant were found stored with vials containing diluent, and
of the same size and shape; labels on a number of vials recovered could not be read. Infrared spectrophotometry of
the urine of one of the cases and thin layer chromatographic analysis of a reconstituted vaccine from one of the
implicated vials showed the presence of muscle relaxant.
Cause: Use of muscle relaxant instead of diluent
In one hospital in 1992 in country B, five neonates collapsed a few minutes following immunisation with BCG and
OPV. Four were resuscitated and one died. Muscle relaxant was found in the refrigerator.
Cause: Use of insulin instead of DTP vaccine
In 1997 in country C, 21 infants died out of 70 supposedly given DTP vaccine. Insulin was stored in similar vials and
in the same refrigerator as DTP vaccine.
Cause: Non sterile injection
Three infants died, in 1995 in country D, after administration of measles vaccine. Symptoms, developing within five
hours post immunisation, were fever, rash, vomiting, and diarrhoea, described by the attending health worker as toxic
shock syndrome. Reconstituted vaccine was routinely kept until it was used, and syringes were never sterilised, but
washed with ordinary water and wiped with cotton wool. No testing could be done.
Cause: Non-sterile injection (contaminated reconstituted vaccine)
In 1996 in country E, four children died and a fifth was hospitalised after receiving measles vaccine from the same vial.
Vial was not refrigerated, and was transported house to house for immunisation. Reactions began four to five hours
after vaccination, with vomiting, unconsciousness, and meningeal irritation. Staphylococcus aureus was cultivated from
the incriminated vial.
Cause: Coincidental event
In response to a severe diphtheria outbreak in country F in 1996, DT was delivered to children in a mass campaign.
The death of a seven-year-old girl, two to three days following immunisation was reported. The symptoms reported
included convulsions that might have been attributable to a vaccine reaction. Upon investigation, it was found that the
girl had a history of convulsions and neurological symptoms unrelated to immunisation.
Cause: Coincidental event
In 1998, a mass measles immunisation campaign in children from 6 months to 15 years was piloted in an area. AEFI
reporting and investigation was instituted for the programme. Of the 30 reports of AEFIs, nearly half were anxiety
reactions, and of the other 16 events that were investigated, a further 11 events also were found to be anxiety reactions.
References
Additional reading/references/resource materials
Injection safety









First, do no harm: Introducing auto-disable syringes and assuring injection safety in national immunisation
systems, Final draft, June 21 2002.
Giving safe injections: Introducing auto-disable syringes. Training manual and set of slides, October 2000
Path. (http://path.org/resources/safe-inj-pdf.htm)
Good injection practices save lives (WHO leaflet).
Planning for a safe syringe disposal system for immunisation service delivery. Part I: Options for syringe waste
disposal. Part II: Weighing the options.
Best injection control practices for skin-piercing, intradermal, subcutaneous, and intramuscular needle
injections. WHO/Safe Injection Global Network/International Council of Nurses (leaflet) November 2001.
Immunisation in practice, Module 4: Ensuring safe injections (WHO/EPI/TRAM/98.04).
WHO-UNICEF-UNFPA joint statement on the use of auto-disable syringes in immunisation services
(WHO/V&B/99.25).
Tool for the assessment of injection safety (WHO/V&B/01.30, WHO/BCT/01.02).
Safety of injections in immunisation programmes: WHO recommended policy (WHO/EPI/LHIS/96.05
rev.1).
Safe waste disposal


Good waste disposal practices save lives (leaflet).
Proper handling and disposal of auto-disable syringes and safety boxes. A training module for clinic managers
and immunisation providers. Prototype for in-country adaptation. Draft 2, Children’s Vaccine Program at
Path, April 2002.
Vaccine safety


WHO Policy Statement: The use of opened multi-dose vials of vaccine in subsequent immunisation sessions
(WHO/V&B/00.09).
Good cold chain practices save lives (leaflet).
Monitoring and minimising AEFIs




Supplementary information on vaccine safety. Part 1: Field issues (WHO/V&B/00.24).
Supplementary information on vaccine safety. Part 2: Background rates of adverse events following
immunisation (WHO/V&B/00.36).
Surveillance of adverse events following immunisation. Field guide for managers of immunisation
programmes (WHO/EPI/TRAM/93.02 rev 1).
Immunisation safety surveillance: Guidelines for managers of immunisation programmes on reporting and
investigating adverse events following immunisation (WPRO/EPI/99.01).
Websites
WHO Websites
• Environmental Health: http://www.healthcarewaste.org
• EPI training: http:///www.who.int/vaccines-diseases/epitraining
• ISP (Immunisation Safety Project): http://www.stage/vaccines-surveillance/ISPP
• SIGN (Safe Immunisation Global Network): http://injectionsafety.org
• V&B (Vaccines and Biologicals): http://www.vaccines.who.int
Other Websites:
Centers for Disease Control and Prevention, USA: http://www.cdc.gov/nip/vacsafe
Annexes
Annex 1: Contraindications to EPI Vaccines
The risk of delaying an immunisation because of an intercurrent illness is that the child may not return and the
opportunity is lost. Throughout the world, missed immunisation opportunities because of false contraindications are a
major cause of delay in completing the schedule, or of non-immunisation.
In general, the EPI recommends that health workers should use every opportunity to immunise eligible children;
vaccines should be given to all eligible children attending outpatient clinics. Children who are hospitalised should be
immunised as soon as their general condition improves and at least before discharge from hospital. In areas of measles
transmission, measles vaccine should be given on admission to hospital because of the risk of nosocomial measles
transmission.
Generally speaking, live vaccines should not be given to individuals with immune deficiency diseases or to individuals
who are immuno-suppressed due to malignant disease, therapy with immuno-suppressive agents, or irradiation. Both
measles and oral poliomyelitis vaccines should be given to an HIV-infected person however. Children with
symptomatic HIV infection should not be immunised with BCG and yellow fever vaccines. Individuals with moderate
immune deficiency have generally been recommended to have the measles vaccine if there is even a low risk of
contracting wild measles from the community. Nevertheless, a child who is already severely affected by the HIV virus
may be considered in the same way as any child who is seriously ill: it makes sense to avoid immunisation. If the child
dies soon after administration of the vaccines, it may incorrectly be assumed that the vaccine caused death.
A severe adverse event following a dose of vaccine (anaphylactic reaction) is a true contraindication to a subsequent
dose of the same vaccine. Such events can be recognised easily by the mother and the health worker.
A second or third DTP injection should not be given to a child who has suffered such a severe anaphylactic reaction to
the previous dose. Because these events are so rare, it is not known which component of the combined DTP (or
additional antigens in the combination vaccines) is responsible for allergic reactions. Therefore, no further dose of any
of the vaccine components should be given unless assessment implicates the responsible antigen.
Pertussis component has often been incriminated in the past. High fever within 48 hours after vaccination attributed to
vaccination and not to intercurrent illness indicates the likelihood of recurrence of fever with subsequent doses. Febrile
convulsions may be more likely in a susceptible child who develops high fever. Acetaminophen prophylaxis reduces
the incidence of fever and may reduce febrile convulsions temporally related to pertussis vaccination. Persistent,
inconsolable crying and an unusual high-pitched cry after pertussis vaccination are not associated with any sequelae
and are likely pain response at the site of injection in young infants. These reactions do not preclude further pertussis
vaccination. Acetaminophen prophylaxis may reduce discomfort with subsequent doses. Hypotonic-hyporesponsive
episodes are not a contraindication to the use of pertussis vaccine. Continued immunisation with all antigens is
recommended. Onset of encephalopathy temporally related to pertussis vaccination does not indicate that the vaccine
was the cause. Encephalopathy itself from whatever cause is not a contraindication to pertussis vaccination. Deferral of
pertussis immunisation for children with evolving neurological conditions is no longer necessary, because of the
availability of acellular pertussis vaccine.
Persons with a history of anaphylactic reactions (difficulty in breathing, swelling of the mouth and throat, hypotension,
or shock) following egg ingestion should not receive vaccines prepared on hen’s egg tissues (e.g. yellow fever and
influenza vaccines). Vaccine viruses propagated in chicken fibroblast cells (measles or combined measles-mumpsrubella vaccines) can usually be given to such individuals without problems. Allergies to measles vaccine have rather
been shown to be related to the hydrolysed gelatin used as a stabiliser.
Before immunisation, check for contraindication by asking about known allergies and previous adverse reactions to
vaccines. In the case of a possible serious allergy, check with the appropriate supervisor before giving vaccine. This
procedure will minimise the occurrence of anaphylaxis but will not remove the risk altogether.
Recognition and treatment of anaphylaxis is described in Immunisation Safety Surveillance: Guidelines for managers
of immunisation programmes on reporting and investigating adverse events following immunisation
(WPRO/EPI/99.01).
Anaphylaxis is a rare and potentially life-threatening allergic complication of vaccination that should be anticipated in
every vaccine injection. Prevention is the best approach. To identify this contraindication, prevaccination examination
should include questions about possible allergy to any component of the product being considered. As avoidance is
not always possible, every vaccine provider should be familiar with the symptoms of anaphylaxis and be ready to
initiate management and administer the appropriate medications.
Anaphylaxis is one of the rarer events reported in the surveillance system and range from 0.11 to 0.31 reports per
100,000 doses of vaccines distributed. In the case of anaphylaxis, changes develop over several minutes and usually
involve multiple body systems (affecting the skin, respiration, blood circulation).
The cardinal features of anaphylaxis are

Itchy, urticarial rash (in over 90% of cases)

Progressive, painless swelling (angioedema) about the face and the mouth, which may be preceded by
itchiness, tearing, nasal congestion or facial flushing

Respiratory symptoms, including sneezing, coughing, wheezing, and laboured breathing; upper way swelling
(indicated by hoarseness and/of difficulty swallowing) possibly causing airway obstruction

Hypotension, which generally develops later in the illness and can progress to cause shock and collapse.
It must be differentiated from fainting, anxiety and breath holding which are more common and benign reactions.
The main steps of management of anaphylaxis are:
1.
Place the patient in a recumbent position (elevated feet)
2.
Establish an oral air way if necessary
3.
Check respiration and pulse
4.
Promptly administer 0.01 ml/kg (maximum 0.5 ml) of aqueous epinephrine 1:1000 by subcutaneous or
intramuscular injection in the limb (opposite limb to where the vaccination was given); speedy intervention is
of paramount importance. Dosing can be repeated at 20-minute interval if necessary.
5.
Monitor vital signs and reassess the situation frequently, to guide medication use.
6.
Arrange for rapid transportation to an emergency department.
Since anaphylaxis is rare, epinephrine vials and other emergency supplies should be checked on a regular basis and
replaced if outdated.
False contraindications
Many immunisation programmes have long lists of contraindications, most of which are inappropriate. Low-grade
fever, mild respiratory infections and other minor illnesses should not be considered as contraindications to
immunisation. Diarrhoea should not be considered a contraindication to OPV. It is particularly important to
immunise children suffering from malnutrition.
Annex 2: How to Use Safe Disposal Equipment
How to use a container burning
1.
Choose an unused part of the compound for the container-burning site, as far from the buildings as possible.
2.
Fence off and clear the area
3.
Make the drum incinerator:
•
Place four bricks on the ground in a square pattern
•
Place a metal screen or grate on top of the bricks
•
Remove both ends of a 210 litter (55 US gallon) steel drum. This will allow more air to flow through the
drum and better burn the contents. The cylinder could also be constructed from sheet metal, bricks or
clay. You can add a chimney to the (removable) top end of the drum.
•
Place the drum on top of the metal screen
4.
Take the filled safety boxes to the burning site just before burning
5.
Place the filled safety boxes into the metal drum. Mix paper, leaves, or other flammable material among the
safety boxes to help them burn
6.
Sprinkle a small amount of kerosene on the boxes and other material in the drum, if available
7.
Place a fine metal screen over the top of the drum to reduce flying ashes
8.
Place wood, paper, or other flammable material under the drum and ignite it
9.
Warn people to stay away and to avoid smokes and fumes from the fire
10. Allow the fire to burn until all the boxes have been destroyed
11. Once the fire is out and the residue at the bottom of the drum has cooled, dig a small pit and bury the
residue. Handle the residue carefully, since it contains needles and other sharps. Cover the residue with at
least 13 cm of soil. Be sure to select a site where people will not dig to plant crops or establish latrines. When
the pit is full cover the site with concrete to prevent digging in the future.
12. Container burning should always be carried out under the supervision of a qualified staff member. Do not
leave this vital task to unqualified people!
How to use open burning
If open burning must be done, health workers should:
1.
Choose an unused part of the compound for burning site, as far from buildings as possible. Be sure to select a
site where people will not dig to plant crops or establish latrines
2.
Fence off and clear the area
3.
Dig a pit at least 1 meter deep
4.
Take the filled safety boxes to burning site just before burning. Do not open or empty the boxes
5.
Place the filled safety boxes into the pit. Mix paper, leaves, or other flammable material among the safety
boxes to help them burn
6.
Sprinkle a small amount of kerosene on the boxes in the pit, then ignite the fire
7.
Warn people to stay away and avoid smoke and fumes from the fire
8.
Allow to burn until all the boxes have been destroyed
9.
Once the fire is out and the residue at the bottom of the pit has cooled, cover the residue with at least 13 cm
of soil. Cover the site with concrete when the pit is full to prevent digging in the future
10. Open burning should always be carried out under the supervision of a qualified staff member. Do not leave
this vital task to unqualified people!
Technique of burying without burning
If you cannot burn your safety boxes prior to burying:
1.
Choose a site where people will not dig or establish latrines in the future
2.
Fence off and clear the area
3.
Dig a pit at least 2 meters deep. Make sure that the material will not escape from the pit (during the rainy
season, for example).
4.
Take the filled safety boxes to pit site just before burying. Do not open or empty the boxes
5.
Place the filled safety boxes into the pit
6.
Cover the boxes with at least 30 cm of soil. When the pit is full cover the site with concrete to prevent digging
in the future
7.
Burying without burning should always be carried out under the supervision of a qualified staff member. Do
not leave this vital task to unqualified people!
Annex 3: De Monfort Mark 8a Auto-combustion Incinerator
INCINERATOR
Annex 4: AEFI Report Form
(Adapted from WPRO/EPI/99.01 document)
1. Personal Data
Family name:
First name:
Date of birth:
Sex:
Ethnicity:
Resident /__/
Address:
District:
Visitor /__/ (tick)
Province:
2. Description of AEFI
Please tick:
/__/ Toxic shock/Collapse
/__/ Convulsions
/__/ Sepsis•
/__/ Abscess•
/__/ Lymphadenitis•
/__/ Severe local reaction•
/__/ Vaccine reaction(specify):
/__/ Other AEFI (specify):
/__/
/__/
/__/
/__/
/__/
/__/
Anaphylaxis
Encephalitis/Meningitis•
hospitalised
sterile
or
>1.5 cm
or
>3 days
/__/ High fever ?
/__/ hospitalised
/__/ hospitalised
/__/ bacterial
/__/ draining sinus
/__/ hospitalised
3. History and outcome
Past medical history (similar reactions or other allergies. Please specify):_____________
/__/ Recovered
/__/ Hospitalised
/__/ Died
4. Vaccine data
Vaccine/s given
and dose number
Route
Site
Lot number
Manufacturer
Expiry date
5. Important dates
Date immunised
Date AEFI started
Onset interval
Date of reporting
Health Facility __________________________________ Name/Title of reporting officer __________________________
Date report received _____________________________ By whom __________________________________________
Proposed action (Please specify):
Annex 5: AEFI Case Investigation Form
(Adapted from Uganda EPI document)
1. Personal Data
Family name:
Sex:
Guardian’s name:
Address:
First name:
Ethnicity:
District:
Date of birth:
Resident /__/ Visitor /__/ (tick)
Occupation:
Province:
2. Important dates
Date
immunised
Date AEFI started
Onset interval
(days, hours)
Date of
notification
Date of
investigation
3. Information on the AEFI
Please tick:
/__/ Toxic shock/Collapse
/__/ Convulsions
/__/ Sepsis ?
/__/ Abscess ?
/__/ Lymphadenitis ?
/__/ Severe local reaction ?
/__/ Vaccine reaction(specify):
/__/ Other AEFI (specify):
/__/ Anaphylaxis
/__/ Encephalitis/Meningitis ?
/__/ hospitalised
/__/ sterile
or
/__/ >1.5 cm
or
/__/ >3 days
/__/ High fever ?
/__/ hospitalised
/__/ hospitalised
/__/ bacterial
/__/ draining sinus
/__/ hospitalised
4. History and outcome
Past medical history (similar reactions or other allergies. Please specify):_____________
/__/ Treatment given
/__/ Recovered
/__/ Hospitalised
/__/ Died
/__/ Specimen collected• Date ____________ Type ____________ Sent to _____________ Date sent ____________
5. Suspected vaccine/s and details of diluent
Vaccine/s and
diluent given and
dose number
Route
Site
Lot/batch
number
Manufacturer
Expiry
date
How long the
lot/batch has
been in use
6. Name/Title of the health worker who administered vaccine ________________________________
/__/ Has he/she been trained in EPI? If yes when? __________________
7. Name/title of Investigator ___________________________________ Date __________________________
Annex 6: AEFI Summary Investigation Form
(Adapted from WPRO/EPI/99.01 document)
Complete this summary form at the end of investigation. File with your field report and AEFI reporting form. Submit to your
supervisor.
A. General information
Date investigation started:
Date investigation ended:
Describe the nature of AEFI:
Suspect vaccine/diluent involved:
Batch number/s:
Diagnosis/case definition of AEFI:
Clinical investigation carried out:
Yes ________
No _________ (tick)
Laboratory investigation carried out:
Yes ________
No _________ (tick)
Yes ________
No _________ (tick)
If yes, key results:
Community investigation carried out:
If yes:
•
number of persons with AEFI vaccinated with suspect vaccine __________________
•
number of persons having the same (AEFI-like) symptoms but
not vaccinated with suspect vaccine ________________
B. Assessment based on investigation
Conclusion on cause of AEFI (tick categories below; rank if more than one cause):
/_/
/_/
/_/
/_/
/_/
/_/
Programme error
•
non-sterile injection
vaccine prepared
incorrectly
incorrect site or
administration
incorrect vaccine
transportation/storage
other causes
/_/ Vaccine reaction
•
/_/ vaccine lot problem
/_/ known vaccine
reaction at expected
rate
/_/ others
Please indicate if the above cause you ticked is:
certain
Corrective action taken:
/_/ probable
/_/ yes
/_/ no
/_/ yes
/_/ no
If yes, specify nature of action:
Further action recommended:
/_/ Coincidental
•
/_/ similar event
in unimmunised
persons
/_/ other coincidental
events
/_/ Cause
unknown
/_/ possible /_/
If yes, specify type of action:
Investigator:
Title:
Date:
Annex 7: AEFI Laboratory Request Form
(Adapted from Uganda EPI document)
1. Personal data
Family name:
Sex:
Guardian’s name:
Address:
First name:
Ethnicity:
Date of birth:
Resident /__/
Occupation:
Visitor /__/ (tick)
District:
Province:
2. Important dates
Date immunised
Date AEFI started
Date of collection
of specimen/s
3. Information on samples and tests
Name of the laboratory where specimen/s are being sent:
Precise description of the samples (e.g. ampoules, syringe, stool, pus swab, culture tube etc.):
How are the specimen/s sent (e.g. with dry ice, ice pack, vaccine carrier etc.):
Tests requested:
Suspected vaccine/product involved:
Preliminary clinical diagnosis:
4. Name of person to whom laboratory results should be sent:
5. His/her complete address, telephone/e-mail numbers ___________________________
6. Referring Health Facility:
7. Name /title of person sending the samples for laboratory examination:
8. Date
Date specimen/s
sent to laboratory