Journal of Pharmaceutical Care &

Health Systems Research Article

Cold Chain Management in Ethiopian Pharmaceutical Supply Agency: Study of

Hawassa Cluster
Habtamu Solomon Mengistu*, Kaleab Taye Haile
Department of Pharmaceutics and Social Pharmacy, University of Wolkite, Gubrei, Wolkite, Ethiopia

ABSTRACT
The cold chain refers to the storage and transportation of vaccines within the optimally required temperature starting
from the time the vaccines leave the manufacturing plant until they reach the end-users. The objective of the study
was to assess the status of the cold chain management of Ethiopian Pharmaceutical Supply Agency (EPSA), Hawassa
cluster. A facility-based cross-sectional study was employed in EPSA, Hawassa cluster to assess its cold chain
management practice. Data were collected from both primary and secondary sources to complete the assessment. Due
to the binary nature of the variables (Yes or No) data was compiled and analyzed using count and percentage. In
summary, the floor of the cold chain warehouse is not in a good condition. It has holes and breaks affecting
warehouse operation. Dedicated room and space are available for vaccine and dry products, respectively. One person
is assigned to monitor and manage cold chain warehouse operations. Based on the baseline findings, the authors
concluded that EPSA Hawassa cluster is constrained majorly by a lack of effective warehouse operations and
infrastructures, lack of manual documentation of inventories and transactions, and lack of proper stocking of
commodities.
Keywords: Measles; Measles mumps rubella; Rubella; Measles rubella

INTRODUCTION
The cold chain refers to the storage and transportation of
vaccines within the optimally required temperature starting from
the time the vaccines leave the manufacturing plant until they Figure 1: Cold chain pipeline.
reach the end-users. A successful immunization program The integrity of the cold chain depends on three essential
depends on an ample supply of vaccines, skilled health care elements that underpin the standards:
providers, and a well-functioning cold chain system. In Ethiopia,
• The people managing vaccine manufacture, storage, and
vaccines are transported and stored at various points before they distribution, and those managing the cold chain at the
reach clients. The chain begins at the Federal Ministry of Health, provider level.
followed by regional health bureaus, Zonal health desks, Woreda • The systems and processes providers use to ensure they
health offices, health centers, and health posts. Each vaccine monitor the vaccine storage conditions and actions taken if
requires a prescribed temperature level and the utmost care the vaccines are exposed to temperatures outside the required
during transportation and storage to maintain its efficacy. Thus range.
facilities and health offices that handle the vaccines are • The equipment is used for storing, transporting, and
equipped with refrigerators specifically designed for storing monitoring vaccines from the time the vaccine is delivered to
vaccines along with accessories such as iceboxes and ice packs an immunization provider to when the vaccine is administered
(Figure 1) [1]. to an individual [2].

Correspondence to: Habtamu Solomon Mengistu, Department of Pharmaceutics and Social Pharmacy, University of Wolkite, Gubrei, Wolkite, Ethiopia, E-
mail: [email protected]
Received: 04-May-2023, Manuscript No. JPCHS-23-23874; Editor assigned: 08-May-2023, PreQC No. JPCHS-23-23874 (PQ); Reviewed: 25-May-2023, QC
No. JPCHS-23-23874; Revised: 05-Jun-2023, Manuscript No. JPCHS-23-23874(R); Published: 13-Jun-2023, DOI: 10.35248/2376-0419.23.10.277
Citation: Mengistu HS, Haile KT (2023) Cold Chain Management in Ethiopian Pharmaceutical Supply Agency: Study of Hawassa Cluster. J Pharma Care
Health Sys. 10:277.
Copyright: © 2023 Mengistu HS, et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which
permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

J Pharma Care Health Sys, Vol.10 Iss.3 No:1000277 1

Mengistu HS, et al.

The Expanded Program on Immunization (EPI) was established Vaccines are fragile and must be stored properly from the time
by the World Health Organization (WHO) in 1974 to control they are manufactured until they are administered. The purpose
vaccine-preventable diseases. The EPI was designed 40 years ago of the vaccine “cold chain” is to maintain product quality from
for two types of vaccines: the time of manufacture until the point of administration by
ensuring that vaccines are stored and transported within WHO-
• Those that are heat stable but freeze sensitive
recommended temperature ranges. Storage and handling errors
• Those that is stable to freezing but heat-labile [3].
might lead to:
In Ethiopia, the EPI program was launched in 1980 to achieve
100% immunization coverage for all children under two years • Reduced potency and effectiveness
old by 1990. In 1986, the coverage target was reset to 75%, and • Cost thousands of dollars in wasted vaccine and revaccination
the target age group was changed to less than one year old but • Loss of patient confidence
progress in increasing coverage has been slow. With the
introduction of new approaches known as Reaching Every
Temperature requirements for vaccines
District (RED) and Sustainable Outreach Services (SOS) for Regular temperature monitoring is vital to proper cold chain
immunization in 2003, improvement has been documented [4]. management. Temperatures in both the freezer and refrigerator
WHO recommends that ensuring access to medicine with the units should be read twice each day, once in the morning and
right quality, quantity, time, and place and with the least once before leaving at the end of the workday. A temperature log
possible cost is an expected service from a certain should be posted on the door of the storage unit where the twice-
pharmaceutical supply chain. In this regard, the Ethiopian daily temperature readings are recorded. Center for Disease
Pharmaceutical Supply Agency (EPSA) has several problems Control (CDC) and prevention recommends keeping these
including non-availability, poor storage, lack of stock temperature logs for at least 3 years unless state statutes or rules
management, shortage of expertise, and a weak distribution require a longer period (Table 1) [6].
system including weak fleet management [5]. The assessment of
the EPSA Hawassa cluster was done using the Effective Vaccine Vaccines are grouped into six categories. Within each of these six
Management Assessment (EVMA) tool. EVMA is a diagnostic categories, the vaccines are arranged in alphabetical order, not in
tool and identifies issues in Cold Chain Logistics (CCL) system order of sensitivity to heat within the group. The most heat-
that needs to be fixed and to be sustained. sensitive vaccines are in Group A and the least heat-sensitive
vaccines are in Group F. Some vaccines are very sensitive to light
LITERATURE REVIEW and lose potency when exposed to it. Such vaccines should
always be protected against sunlight or any strong artificial light,
In 2013, the Federal Ministry of Health (FMOH) agreed to and exposure should be minimized. Vaccines that are as sensitive
begin the formal transfer of responsibility for the management to light as they are to heat include BCG, measles, measles-
of vaccines and cold chains to the Pharmaceutical Fund and rubella, measles-mumps-rubella, and rubella. These vaccines are
Supply Agency (PFSA) which is currently renamed EPSA. Key often supplied in dark glass vials that give them some protection
aspects of the transition program include: from light damage.

Parameter Recommended temperatures

Freezer Between -58°F and +5°F (-50°C to 8°C)

Refrigerator Between 35°F and 46°F (2°C to 8°C)

Average 40°F (5°C)

Table 1: Recommended temperature for vaccines.

• Detailed planning and organizing for the oversight and METHODOLOGY

management of vaccines and the cold chain by EPSA.
Study design
• Operational system and network design improvements and
capacity building with EPSA. A facility-based cross-sectional study was employed in EPSA
Hawassa cluster to assess its cold chain management practice.
• Addressing needs within EPSA’s information systems, The assessment was conducted from December 07 to 15, 2022.
including an EPI dashboard.
• Developing and utilizing monitoring mechanisms for vaccine Source and type of data
availability and cold chain effectiveness. Data were collected from both primary and secondary sources to
complete the assessment. Direct observation was employed
• Network and transport modeling and costing analysis to to inspect the cold chain infrastructure and equipment as per
provide EPSA with efficient and cost-effective approaches to the data collection tool. Professionals working in the area
vaccine distribution (vaccine management focal person and warehouse managers) were

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Mengistu HS, et al.

approached to gather the required data. Secondary data was The second step was reviewing the presence of relevant
collected from reviewing relevant documents and reports documents and records related to the assessment. The following
(temperature logbook, contingency plan, vaccine requisition document and formats were included in the review: The
form, Health Commodities Management Information System presence of Standard Operating Procedures (SOPs), contingency
(HCMIS) software). plan, a temperature logbook for each cold room, freeze room
and CCEs and stock register; temperature recording practice
Data analysis (twice daily, on holidays, Sundays); documentation of damaged
and expired vaccines; vaccine wastage rate calculation for each
The collected data were summarized and analyzed to result in vaccine; the presence of planned preventive maintenance plan.
baseline information about cold chain practice. Due to the
binary nature of the variables (Yes or No) data was compiled and The third step was interviewing the warehouse manager to assess
his/her knowledge of handling vaccines. In addition to oral
analyzed using count and percentage. During interpretation of
inquiry, he/she was asked to demonstrate how to read Vaccine
the data, scoring 1(100%) to a specific parameter means the
Vial Monitoring (VVM) and to perform a shake test. Information
facility has full filled that specific criterion. Whereas scoring
that could not be collected by direct observation and document
0(0%) refers to the facility doesn’t fulfill that specific parameter
review was also collected from the warehouse manager
(unless and otherwise it is indicated in the remark section).
(information related to supportive supervision, whether temperature
monitoring and mapping study has been conducted or not).
The procedure of data collection
The first step was visiting and inspecting the cold chain
RESULTS AND DISCUSSION
warehouse per the assessment tool. The following parameters The baseline assessment of the cold chain system of the Hawassa
were inspected: Number and the functional status of cold cluster was completed using a prepared assessment tool
rooms, freeze rooms, and CCEs (DFs and ILRs); the cold chain comprising ten requirements (Tables 2-12). The ultimate goal of
infrastructure; vaccine store building; vaccine storage and this study is to improve lower performances and to achieve the
handling and stock status of vaccine (availability or stock out). targets score. The target score for each parameter is 100%.

Parameter Yes/No

What type of cold chain equipment is used in the store? (Select one or
more options):

Freezer room and/or cold room are used for storing vaccine. Y

Freezers and/or refrigerators are used for storing vaccine. N

Freezer room, cold room, freezers or refrigerators are used for freezing Y
icepacks or cooling cool water packs.

Table 2: Type of equipment.

Parameter Yes (%) No (%)

Dedicated space/room available for cold chain 1 (100) 0

at the facility

Dedicated room/space for dry storage at facility 1 (100) 0

Dedicated table for conditioning of ice packs 0 1 (100)

Dedicated clean clothes for wiping of icepacks 0 1 (100)

after conditioning

Power backup available/stand by generator 1 (100) 0

available

One person assigned to monitor cold chain 1 (100) 0

Guideline they utilize (WHO, EPI, MOH) 1 (100) 0

Table 3: Cold chain infrastructure.

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Mengistu HS, et al.

Parameter Yes (%) No (%) Remark

How many refrigeration units are 5 4 cold room and 1 freeze room
there?

How many were fully operational at 5 (100) 0

the time of inspection?

Are all cold room and freezer room 1 (100) 0

enclosures in good condition at
time of inspection?

Do all rooms have continuous 4 (80) 0 One of the cold rooms does not
temperature recorders? have

Are all cold rooms and all freezer 0 1 (100)

rooms fitted with dual refrigeration
units?

Can doors be locked from the 1 (100) 0

outside but freely opened from the
inside?

Are all rooms fitted with sufficient 0 1 (100)

good quality shelving?

Table 4: Cold rooms and freezer rooms.

Parameter Yes (%) No (%)

Is the vaccine store building suitable for the 1 (100) 0

climate?

Is the roof free of leaks? 19 (100) 0

Are the external walls free of severe cracks or 1 (100) 0

other major damage?

Are windows and external doors in good 1 (100) 0

condition and secure (grilles and/or locks)?

Are floors dry and reasonably level? 0 1 (100)

Are there any fire extinguishers and have they 1 (100) 0

been tested in the past 12 months?

Is the air-conditioning system working? Score 0 1 (100)

'n/a' in climates where a/c is not required.

Does it have a functioning alarm system 0 1 (100)

Can delivery vehicles easily reach the store(s)? 0 1 (100)

Table 5: Vaccine store building.

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Mengistu HS, et al.

ILRs and DFs Yes (%) No (%) Remark

Separate functional thermometer 0 1 (100)

inside every functional equipment

Cold chain equipment (ILRS and 0 1 (100)

DFs) placed on wooden blocks

Cold chain equipment (ILRs and 1 (100) 0

DFs) at least 10 cm away

Each equipment is connected 0 1 (100)

through functional Voltage
Stabilizer

Functional thermometer placed 0 1 (100)

correctly

Temperature log book

Each CCE is having separate 1 (100) 0

temperature log book

Temperature is recorded twice daily 1 (100) 0

Temperature is recorded on 1 (100) 0

Sundays and holiday

Record of power failure maintained 1 (100) 0

in temp. log book

Records of defrosting/cleaning 0 1 (100)

maintained in Temp.log book

Temp. Log book reviewed by DIO 0 1 (100)

in last three months

Temp. Log book reviewed 0 1 (100)

periodically by facility in charge

ILRs

Functional ILR within the 1 (100) 0

temperature range (+2°C to + 8°C)

Correct placement of vaccine from N/A ILRs are used only for freezing
top to bottom inside ILRs icepacks

Diluents placed in ILR, at least 24 N/A

hours before distribution

DFs

Deep freezer within the normal 1(100) 0

temperature range (-15 to -25)

Correct placement of ice packs 0 1(100)

inside DFs (crisscross)

Ice pack are filled up to the mark 0 1(100)

and capped

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Mengistu HS, et al.

Vaccines

Nil stock of any vaccine found 0 1 (1000 No vaccine was stock out
during the visit

All vaccine vials have proper 1 (100) 0 Sample taken

readable label

All vaccine found within expiry 1 (100) 0

dates

All the vaccines with usable VVM 1 (100) 0

(I and II)

Any vaccine found in frozen 0 1 (100)

condition

Any open vaccine vial stored inside N/A -

ILRs

Open vaccine vial are stored in N/A -

separate box/zipper bag

Date and time of opening is N/A -

written on the vial

All open vaccine vial are of <28 N/A -

days duration

Table 6: Vaccine storage and handling.

Parameter Know/not

VVM Y

Shake test Y

Cold chain prayer Y

Time of use of reconstituted vaccine N/A

Timing of placement of diluents inside ILRs N/A

Vaccine requiring diluents Y

Open vial policy Y

Freeze sensitive vaccines Y

Table 7: Knowledge and cold chain handlers.

Parameter Yes (%) No (%) Remark

Is stock register in use for vaccine 0 1 (100) HCMIS do this function

and logistics as per norm?

All parameters for vaccines, logistics 0 1 (100) No record for diluents

and diluents are recorded?

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Mengistu HS, et al.

Returned vials from the field are N/A

entered in the stock register?

Is distribution register in use for 1 (100) 0

vaccine and logistics as per norm?

Expired and wasted vaccines are 1 (100) 0 Posted on the wall

documented in Stock register

Physical counting of vaccine stock 1 (100) 0

is done at least once in last 3
months?

Physical stock of (BCG/measles) is 0 1 (100) Done for measles

matching the stock register for that
day?

Vaccine and Logistics stock 1 (100) 0

management updated till last
transaction

Chart/SOP on ILR/DF/vaccine/ 1 (100) 0 SOP available

ice pack arrangements available

Table 8: Management information system and supporting system at cold chain points.

Parameter Yes (%) No (%) Remark

Has a temperature monitoring 0 1 (100)

study has been carried out in the
past five years

Has the recommendation of this 0 1 (100)

study been implemented

How many vaccines freezer rooms 1 and 4

and cold rooms are there?

How many of the rooms have a 0 1 (100) None of them

fully documented temperature
mapping study?

Table 9: Temperature monitoring and mapping study.

Parameter Yes (%) No (%) Remark

Is there a satisfactory SOP which 1(100) 0

sets out a contingency plan in the
event of equipment failure or
another emergency?

Are emergency contact details 1(100) 0

posted in the vaccine store?

Do staffs know what to do in the 1(100) 0 Sample

event of an emergency?

Table 10: Vaccine store contingency planning.

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Mengistu HS, et al.

Parameter Yes (%) No (%) Remark

Is there a written multi-year 1 (100) 0 But not multiyear plan

Planned Preventive Maintenance
(PPM) program?

Is there documentary evidence that 0 1 (100) Posted PPM was for the year 2010
the program is being followed?

Is there visual evidence that 0 1 (100)

maintenance is taking place?

Is somebody assigned to carry out 1 (100) 0

routine maintenance?

Is there evidence that cold rooms/ 0 1 (100) Evidence of frosting was seen
refrigerators/freezers have recently
been cleaned and defrosted?

Table 11: Planned preventive maintenance.

Parameter Yes (%) No (%) Remark

Do you calculate wastage rates for 1 (100) 0

each vaccine?

Is there a standard form used to 1 (100) 0

record wastage?

Is there a complete set of wastage 1 (100) 0

records for the review period?

Are these data used to monitor 1 (100) 0 According to vaccine focal person
vaccine management performance?

Table 12: Wastage rate calculation.

In summary, the floor of the cold chain warehouse is not in a factors that have limited their ability to meet immunization
good condition. It has holes and breaks affecting warehouse program requirements. The major challenges include:
operation. The cold chain warehouse does not have an air
conditioning system. The cold chain warehouse does not have a Insufficient cold chain capacity
functioning temperature excursion alarm system. There is no When the required capacity is absent new vaccine introductions
prepared space/table for conditioning ice packs. The cold chain can be delayed and can disrupt service delivery.
warehouse (receiving and dispatch areas) is not easily accessible
by vehicle. Thermometers are not placed in Deep Freezers (DFs) Causes of insufficient capacity: Poor understanding of current
and Ice Lined Refrigerators (ILRs). Poor arrangement of cold chain equipment status: most cold chain inventories do not
icepacks in DFs and ILRs (didn’t follow the standard procedure) have systems for routine data collection, which limits the
DFs and ILRs are not connected to voltage stabilizers which put existence of accountability structures and inhibits accurate and
them in danger during power fluctuation. Supervisors don’t regular inventory updates. Insufficient forecasting of future
check the temperature log book periodically. No scheduled capacity requirements: anticipating future needs is essential,
deforesting and records of deforesting in previous periods. particularly given the lead times for procurement. Inadequate
Health and pharmaceutical supply chain managers are being implementation systems: even when sufficiency gaps are
trained at the national level (Jimma and Addis Ababa identified, immunization programs often lack the systems and
University). There is a development of new software and resources to fill them.
applications and implementation of the Kaizen principle in the Lack of latest technology or optimal equipment
cluster. In many low-income countries, vaccine delivery systems
have remained largely unchanged due to challenging contextual The performance of cold chains has been hampered by large

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Mengistu HS, et al.

quantities of outdated equipment, which fails to provide the and merged to make the tool as comprehensive as possible.
protective benefit of more recent designs. Secondly, it was difficult to determine the cost of installing air
conditioning and temperature excursion alarm system. Few
Causes for weak adoption of better technologies: Insufficient
experts in the area were asked and they replied as it is difficult
awareness and recognition of the benefits of these new features:
for them to estimate unless they visit the actual place (which was
Lack of awareness regarding the relevance of new features and
not possible). Regardless of the limitation, this study would be
benefits of upgrading equipment in individual countries is
an important document input to fill actual gaps observed in
among the most significant barriers to the adoption of new
EPSA Hawassa cluster.
technology.
Switching costs: concerns about the performance and reliability FUNDING
of latest generation units can also inhibit the uptake of newer
technology. This research received no specific grant from any funding agency
in the public, commercial, or not-for-profit sectors.
Expensive product offerings: countries have favored older
technologies as optimal units are initially more expensive.
CONFLICT OF INTEREST
Inadequate temperature monitoring and
The authors have no conflicts of interest to declare.
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