Assessment on vaccine supply chain and logistics systems in the case of Ethiopian pharmaceuticals supply agency west

Background: Immunization helps save lives, protects serious illness and is recognized as one of the most effective public health intercessions and available today. However, the success of the programs depends heavily up on the immunization supply chain management including storage, transportation and handling of vaccines in a proper manner. It was therefore important to assess the immunization supply chain and logistics practice. Method: Institution-based cross sectional study was conducted from September to October 2019 in Ethiopian pharmaceuticals supply agency (EPSA) Jimma branch. Purposive sampling methods were used because the hub has completed the Woreda level vaccine transition and have better experience on vaccine management. Moreover, all staffs who directly engage on vaccine management were a respondent in this study. For the analysis of the quantitative data descriptive statistics supported by SPSS software version 20 was applied, and for qualitative data document analysis was done. Result: the study result shows that, the branch has sufficient positive storage capacity, but the available negative storage volume only covers 65% of negative storage capacity needed. Respondents were agreed on bundling practice during distribution of vaccines, Disagree on Refrigerated vehicle pre cold before loading of vaccines, whereas strongly disagree on temperature of vaccine is always monitored during transportation and availability of adequate number of vehicle for transportation of vaccines for which respondents remained neutral. The investigator has observed as continuous temperature loggers that track and record cold room, refrigerator and freezer temperature were not available to any of the storage facilities and the there is no complete set of temperature records. Conclusion: The study strongly indicates the need to improve vaccine logistics supply chain management practices, especially in the area of vaccine storage and handling and temperature monitoring. EPSA and development partners working on vaccine logistic and supply chain management should have intensify their technical and material support to improve the vaccine management practices.

3 Immunization helps save lives, protects serious illness and is recognized as one of the most effective public health intercessions and available today. However, the success of the programs depends heavily up on the immunization supply chain management including storage, transportation and handling of vaccines in a proper manner (Steele, 2014) Strong health supply chains are central to achieving positive health outcomes. They deliver the medicines, vaccines, and other supplies needed to save lives, prevent disease, and empower people to live healthy lives (WHO, 2018). Immunization supply chains (iSC) form a unique distribution channel due to their dependence on a well-functioning end-to-end cold chain necessary for ensuring vaccine potency to the last mile, and ultimately to every person being immunized (WHO, 2015).
Vaccine storage, transport, and handling are therefore more challenging than most other pharmaceutical products (Anonymous 2013). Immunization supply chains require supply chain workers to have specialized knowledge and competencies. They require storage facilities to have cold rooms or refrigerators and the power supply and technicians to keep them running. They require transport vehicles that are either refrigerated or able to protect cold boxes from heat extremes. And they require information systems able to track vaccine-specific data, such as vaccine vial monitor (VVM) status, or cold chain equipment (CCE) temperature excursion (CDC, 2015, CDC 2014).
Vaccine cold chain failure occurs when there is a break in any link of the chain. Cold chain failure may occur due to a power failure, staff error, equipment failure, etc. Preventing vaccine cold chain failure requires: properly functioning equipment, appropriately trained staff, clearly written procedures, and easily accessible emergency operating protocols (Anonymous, n.d.).
According to CDC`s report, the immunization supply chain and logistic (ISCL) and system, was designed in the 1980. Starting from its inception, it has supported the achievement of acceptable vaccination coverage, using coping mechanisms to overcome enduing challenges in vaccine storage, distribution and management (WHO, 2014). A strong vaccine supply chain that improves to immunization in all global alliance for vaccine initiatives (GAVI) eligible countries like Ethiopia, take good ISCL as a backbone for its mission to be achieved (Steele, 2014). In order to provide an adequate supply of effective vaccine to support the immunization program, measure need to be in 4 place to ensure the vaccine are maintained at peak efficiency, ensure they are free from bad shipment and storage. The temperature should be safe as per the standard at all point of the supply chain (from the manufacturer up to the last mile, the service delivery point. Nevertheless, failure to adhere the proper cold chain requirements will reduce vaccine potency, poor protection and even risk on the child health. CDC says "It is better to not vaccinate than to administer vaccine that has been mishandled" (CDC, 2019).
According to WHO`s report, introduction of new vaccine to African countries has also increased storage requirement escalating the existing storage problem (WHO, 2014).
Regarding personnel's engagement on the immunization supply chain logistics in all GAVI eligible Countries, generally untrained health workers are performing the task of (Steele, 2014).
According to the WHO's 2011 report, 50 percent of GAVI eligible countries reported a vaccine wastage rate in excess of WHO's recommendation and 20 percent states of Nigeria had experienced vaccine stock out. In this same report, around 2.8 million vaccine doses are lost in five countries due to cold chain failure and less than 10 percent of countries meet WHO recommendation for effective vaccine management practices. The report also dictates 5 percent of GAVI eligible countries are underperforming on ISCL and less than 25 percent of countries are operating at even a minimum standard on the criteria of maintenance, stock management and distribution. Furthermore, only 29 percent of the countries meet a minimum standard for temperature control (WHO, 2014). Vaccine wastage assessment done in India shows, wastage of all level of the supply chain for a six-month period reflects that maximum wastage occur at the session Site (BCG vaccine has the maximum wastage of 61 percent (UNICEF, 2010).
A case study done in Nairobi`s cold chain supply logistics on the safety of vaccine shows up to 52 percent of respondents conformed there was poor validation and qualification of storage facility and monitoring device. There was no different storage equipment for different vaccine up to 41 percent of the organizations and hence run a risk of cross contamination and temperature excursions during storage which has compromised the quality of vaccine. The research confirmed that validate systems with respect to calibration of storage facility temperature probes and sensors and thermometer were generally poor along the supply chain with only 34 percent having satisfactory practice (Monicah etal., 2015).
In lower income countries of Africa, efforts to implement an efficient cold chain supply process are often hampered by poor health delivery systems. Low political commitment, low levels of investment, poorly maintained cold chain, lack of human resource, poor disease surveillance and reporting systems which are key components of the logistics process are some of the bottleneck observed in the system (Monicah etal. 2015). In line with this, the existing health commodity management and information system (HCMIS) software which EPSA was using it for managing the information system for pharmaceuticals, become one of the important tool for managing the information system and inventory control of vaccines.

General Objective
To assess the immunization supply chain and logistics practice at EPSA Jimma branch

Specific Objectives
To assess the storage practice of vaccines at EPSA Jimma To evaluate the positive and negative temperature storage capacity at EPSA Jimma To review the transportation means and adequacy of fleet for distribution To assess the knowledge and skill of staffs engaged on immunization supply chain management practice.
To assess the temperature monitoring practice during storage and transportation of vaccines from center to hub and from hub to Woreda/health facility Methods Institution-based cross sectional study design was conducted to assess and describe the nature; condition and degree of the present situation of immunization supply chain practice of the agency, mainly the storage and distribution of vaccines. A descriptive design is ideal for studies that will be carried out in a limited geographical scope and hence is logistically easier and simpler to conduct considering the limitations of this study (Kothari, 2004). The study was conducted from September to October 2019 in Ethiopian pharmaceuticals supply agency (EPSA) Jimma branch. EPSA Jimma branch is located 554 km away from Addis Ababa in south western part of Ethiopia with responsibility to serve public and private health facilities found in south western part of Ethiopia. The study populations were staffs involved on immunization supply chain management; these are the stock and distribution officers, vaccine focal person, cold room managers, refrigerated truck drivers, vaccine delivery personnel and the CCE maintenance technician.
Purposive sampling methods were used because the hub has completed the Woreda level vaccine transition and have better experience on vaccine management. Moreover, all staffs who directly engage on vaccine management were a respondent in this study. The primary data was collected by 7 using structured questionnaires and Standard check list observation. In addition, secondary data was collected from documents and recordings from the manual and electronic recording tools. Qualitative and quantitative data was collected and analyzed according to its type. For the analysis of the quantitative data descriptive statistics supported by SPSS software version 20 was applied, and for qualitative data document analysis was done. SPSS mean and standard deviation was used to calculate and show the experts experience on immunization supply chain practices, and frequency and percentage were considered to present the respective practices

Results
The general characteristics of the respondent gives the clue that respondents have the necessary understanding and knowledge about subject matter and understand the objective of the study to respond each item in questionnaire. experience in the job were found to be 1 to 5, 6-10 and more than 10 years for 57.1%(4), 28.6%(2), and 14.3 %(1) of the respondents' respectively with most of them spent 1-5 years in EPSA Jimma.

Description of vaccine storage practice:
Respondents were asked to rate the vaccine storage practice on a five point Likert scale (strongly disagree, disagree, neutral, agree and strongly agree).
The mean was computed and utilized with the following assumption: if the mean value is between 0 to 1.5 this implies the respondents strongly disagreed, if the mean value is between 1.5 to 2.5 it implies the respondents' disagreed, if the mean value is between 2.5 to 3.5 it implies the respondents were neutral, if the mean value between 2.5 to 3.5 it implies the respondents were neutral, if the mean value between 3.5 to 4.5 implies the respondents' agreed and a mean value 4.5 and above indicates the respondents' strongly agreed   The temperature of vaccine is always monitored during transportation 7 1.1429 There is bundling practice during distribution of vaccines (integrating vaccine with its consumables) Insert Figure 1 here   Vaccines storage and handling practice: From one to one interview and document review, the investigator has observed as continuous temperature loggers that track and record cold room, refrigerator and freezer temperature were not available to any of the storage facilities and the there is no complete set of temperature record. Temperature-sensitive alarms that alert the cold chain officer via SMS during prolonged exposure to out-of-range temperatures were also not available at the storage areas. Temperature mapping and devices calibration was not done for all cold rooms, freezers and refrigerators. The correct number and placement of ice packs inside the cooler is important because too few ice packs can fail to maintain the internal cooler temperature and too many ice packs have the potential to freeze the vaccine and in this facility it is found to be sufficient storage capacity fore icepacks.

Knowledge of Respondents on Sensitivity of Vaccines to Freeze and Light, Shake Test, Vaccine Vial Monitor (VVM), WHO MDV Policy and Conditioning Ice Pack.
A written contingency plan in case of equipment failure, natural disaster, or major power outage should be available. The contingency plan, prepared well in advance, should be prominently located, be freely accessible, and include: Contact information for the relevant stakes, their role and the elements or conditions. In the study area there was well organized contingency plan was in place.

Discussion
The result above showed that there are rooms for improvement in order to ensure recommended Vaccines need specialized storage because of the very sensitive nature of these biological products.
As a result, the type of equipment used for storing vaccines needs to be specialized according to different temperature zones, and the service level of storage. Storage capacity needs to be sufficient to meet the immunization needs, and transport containers must keep the vaccines in optimal condition throughout the journey. The study was concerned about one aspect of cold storage whether or not the existing storage capacity is adequate to accommodate all vaccines (4 months stock with 25% buffer stock in relation to its target population) need. This assessment, therefore, tried to calculate the storage capacity based target population, birth infant (265,568) and surviving infant (246,435) for all available cold stores (Cold rooms, refrigerators and freezers) and compared with WHO recommended storage capacity needed and the branch has sufficient positive (+ 2 0C to + 8 0C ) storage capacity, but the available negative storage volume only covers 65% of negative storage capacity needed (WHO, 2014).
Immunization supply chains require supply chain workers to have specialized knowledge and competencies. They require storage facilities to have cold rooms or refrigerators and the power 13 supply and technicians to keep them running. They require transport vehicles that are either refrigerated or able to protect cold boxes from heat extremes. And they require information systems able to track vaccine-specific data, such as vaccine vial monitor (VVM) status, or cold chain equipment (CCE) temperature excursion (UNOPS, n.d).

Limitations of the study
This study focuses on the immunization supply chain practice mainly the storage, handling and transportation of vaccines from center to hub and from hubs to service delivery level (Woreda and health facilities). Therefore, as the study area is limited to Jimma hub, it will have limitation on representativeness of the agency as a whole.

Recommendations
EPSA and development partners should have to work more to improve storage practices, by providing on job training/class room training, continuing supportive supervision, by Temperature mapping and calibrating cold rooms, freezers and refrigerators EPSA and development partners working in immunization logistics and supply chain management should invest more on negative cold store devices.
EPSA need to strengthen the transport system of cold chain vaccines according to their optimum temperature ranges, because the temperature may affect their quality.
EPSA -Need to supply freezer tags to all cold chain warehouses which can help in monitoring and recording temperature even when the store managers in charge were absent.
There must be a systematic temperature monitoring study been carried out for the cold rooms.
There must be a complete set of manual temperature records for each and every cold room, freezer room, vaccine refrigerator and vaccine freezer.
There must be a complete set of temperature recorder traces and/or temperature logger printouts for each and every refrigerated vehicle.
Temperature records should be formally reviewed at least once a month in order to identify temperature excursions and their causes.

Ethics approval and consent to participate
Ethical clearance was obtained from the Research and Ethical Committee of Leadstar University Collage cooperates with Ashland University/Ohio/USA. Informed consent was obtained in written form, and all participants agreed to participate in the study.

Not applicable
Availability of data and materials: The dataset collected and analyzed for the current study is available from corresponding author and can be obtained on a reasonable request.

Competing interests
The author declares that they have no competing interests.

Funding
The authors did not receive any funding for this study.

Author's contributions
TAW has initiated the idea, wrote the proposal, select the study design, methods, collect data, analyze, interpret and produce this manuscript