Access to essential health services is crucial for improving the health of citizens [
Temperature-sensitive pharmaceuticals are products of perishable nature and require beholding and distribution in a controlled environment. They include ergometrine, oxytocin, and insulin, vaccines, cold chain supplies, and diagnostic reagents (Rapid HIV test kit). Potency of these products may become less or even lost when exposed to temperature outside the recommended range. They need to be maintained between 2°C and 8°C temperature throughout the supply chain [
Cold chain management is a means of warranting proper cold chain maintenance, a continuous and cohesive process to ensure availability and maintain the potency of temperature-sensitive pharmaceuticals [
Cold chain management is still a significant challenge in developing countries, and weaknesses are often observed during the transportation and storage of cold chain medicines [
The Pharmaceuticals Fund and Supply Agency (PFSA) is a legal entity to assure uninterrupted supply of medical equipment, medical supplies, diagnostic supplies, and medicines to the public health sector. It also manages the supply and logistics of temperature-sensitive health commodities [
Measurement of cold chain performance ensures a sustainable and reliable supply of cold chain products, resulting in high-quality healthcare services [
Public Health Facilities (PHFs) in developing countries perform under unreliable electricity supply constraints, unreliable equipment, inadequate storage facilities, and improperly set up storage facilities. They also experience inadequate temperature monitoring, incorrect use of fridges at their service delivery point, weak validation system, and problems of frequent supervision and monitoring by a regulatory authority [
The study was conducted at selected public health facilities in seven administrative zones and two special districts of the Southwest Ethiopia. Three of the zones included in the study, namely, Bunno-Bedele zone, Jimma zone, and Illu Aba-Bor zone, were from the Oromia region (southwest part) while four zones (Kaffa, Sheka, Dawuro, and Bench-Maji which is now split into Bench-Sheko and West Omo zone) and two special districts (Yem and Konta special districts) were from the Southern Nation, Nationalities and Peoples region. The area is among the most remote and underdeveloped places in the country and had an estimated population of 18–20 million. It is found in a tropical region with fewer clouds and more sun most of the season. Twenty-one public hospitals, 292 health centers, and 555 health posts supplied by the Jimma PFSA hub are rendering health services in the area currently [
Study participants and units: forty-seven public health facilities providing immunization services, reproductive, maternal, neonatal, and child health services (RMCHS), diabetic care, and ART services were selected for this study. Cold chain handlers who were working at immunization, pharmacy, and laboratory units of the selected public health facilities, one central EPSA, and one EPSA hub were the study participants, while logistic records and reports in the selected facilities were the study units.
Study index products: eight WHO tracer vaccines, one ARV drug, one HIV test kit, one diabetic care medicine, and two WHO priority medicines for maternal health services were used as index products in the current study.
Institution-based cross-sectional study design was employed using both quantitative and qualitative data collection techniques. Both primary and secondary data were collected to generate information on cold chain management performances for temperature-sensitive pharmaceuticals. A list of key temperature-sensitive pharmaceuticals and cold chain management performance indicators used to determine the management performance of the supply chain is presented as the supplementary file (supplementary Tables
For the quantitative study, the sample of health facilities required for this study was determined using the Logistic Indicators Assessment Tool (LIAT) prepared by the United States Agency for International Development (USAID)/DELIVER PROJECT. The LIAT document suggested that at least 15% of the target health facilities should be selected as a sample for conducting such study [
A clustered sampling technique was employed due to a heterogeneous nature of zones available in the study area. The administrative zones were used as clusters. The sample comprised health facilities selected from each zone based on the number of health facilities found in the respective zones (i.e., proportion to size). The study units were selected using a systematic random sampling technique based on the sampling frame for each zone. Hence, the 313 public health facilities had an equal and independent chance of being included in the selected sample. Accordingly, 47 health facilities were selected. Both health facilities and informant interviewee selection process are presented in the supplementary material (Supplementary Tables
The Logistic Indicator Assessment Tool (LIAT) and Vaccine Management Assessment Tool (VMAT) were adopted to develop a quantitative structured questionnaire. A standard qualitative open-ended questionnaire for key informant interviews was developed based on the Logistic System Assessment Tool (LSAT).
A predesigned and pretested observation checklist was used to collect detailed data on cold chain management of 8 WHO tracer vaccines, one ARV drug, one HIV test kit, and one diabetic care medicine. The same tool was used to collect data regarding two WHO priority medicines for maternal health service cold chain medicines including their acceptable storage condition, inventory control procedures, product availability, logistics management, and wastage. Six-month data (1 November 2016 to 31 April 2017) from bin cards were used to see the pattern of stock status in the health facilities. A checklist and desk reference review was utilized to determine cold chain products' availability and stock status. The calculations for these indicators used the formulas developed by the Management Sciences for Health.
A validated observation checklist designed according to the WHO guideline for storage of cold chain products was used to check the storage condition of cold chain products and to determine the status of standard cold chain management practice. Open-ended and closed semistructured questionnaire-based face-to-face interviews with key informants were used for qualitative data collection. The interviewer took notes, and the responses obtained for different questions were later transcribed.
The quantitative data were checked for completeness, coded, entered into Epi-data version 3.1, and exported to SPSS version 22 for analysis. They were examined using descriptive statistics. A chi-square test was used to investigate the connection between variables, and a
Training was given to data collectors a head of the study. The tools used for data collection were also pretested. TA, FE, and AE reviewed tools for completeness and consistency, while DF with AJ oversaw data collection and regular activities.
Ethical approval was obtained from the Ethics Review Board of the Institute of Health, Jimma University, reference no. IHRPGC/800/207. Both written and verbal consent from respondents was obtained before conducting the study. Participants were assured about confidentiality. Personal identifiers were not used to ensure the anonymity of respondents. The authors confirm that the study was carried out following the principles of the Declaration of Helsinki.
Temperature-sensitive pharmaceuticals: any pharmaceutical good or product which, when not stored or transported within predefined environmental conditions and/or within predefined time limits, is degraded to the extent that it no longer performs as originally intended [
Good condition cold chain equipment: the cold chain equipment is intact and clean to keep vaccines within the required temperature range (2 C–8 C) [
Good refrigerator storage: a refrigerator with adequate air circulation between the vaccine boxes, vaccine kept only on the refrigerator shelves and not in the door or bottom drawer, and no food or drink stored in the refrigerator.
Acceptable/desirable/good storage and handling performance: percentage of public healthcare facilities that met more than 70% storage condition criteria/parameters of cold chain storage condition that needs to be met.
Accurate stock record: public health facility record that was considered accurate if after adjusting for recent issues and receipts (within seven days), the record balanced with the physical count of the stock on the day of visit.
Good product availability performance/adequate cold chain medicine stock:percentage of public healthcare facilities with stock available for more than 80% of products at the time of visit.
Good inventory performance: performance generated by public health facilities with an accurate stock record, good stock maintenance, and good stock status.
Temperature-sensitive medicine wastage at the PHF: the presence of sampled cold chain products damaged confirmed by vaccine vial monitoring (VVM), frozen confirmed by shake tests, expired by the date of usage at healthcare facilities that they are no longer safe to use as a result of short shelf life, improper forecasting leading to overstock, and above all, poor storage practice.
Vaccine wastage rate: it was calculated using the formula (no. of doses wasted/ no. of doses issued)
Vaccine wastage factor: it was calculated using the formula 100/(100−vaccine wastage rate) [
High cold chain product wastage: when the product wastage of healthcare facilities is found to be above tolerable wastage ranges, above 25% of products were wasted.
Good overall cold chain performance: the management performance of the supply chain is above the mean score/Z-score; public health facilities are said to be performing good when they achieved good performance in more than three of the five performance areas addressed by the study.
Thirty-five (72.3%) public health facilities were health centers (Figure
Type of public health facilities studied in Southwest Ethiopia, June 2017.
The mean availability of key temperature-sensitive pharmaceuticals in all surveyed public health facilities was 72.1% ± 14.8%, while the median stock-out duration was 23.04 ± 21 days. OPV, PENTA, and BCG were the most available key temperature-sensitive biopharmaceuticals, while khaletra (lopinavir/ritonavir fixed-dose combination) and TAT were the least available pharmaceuticals (Figure
Average stock-out duration and stock-out rate by products at public health facilities in Southwest Ethiopia, June 2017.
Mean availability by product at public health facilities in Southwest Ethiopia, June 2017 (
Key temperature-sensitive pharmaceuticals | Availability per health facility (mean ± SD) |
---|---|
BCG | 91.8 ± 8.2% |
OPV | 93.2 ± 6.8% |
PENTA | 93.2 ± 6.8% |
MEASLES | 90.9 ± 9.1% |
TAT | 35 ± 24.7% |
PCV | 40.4 ± 40.4% |
BEIGING WENTAI | 43.7 ± 39.8% |
ERGOMETRINE | 33.1 ± 30.4% |
OXYTOCINE | 84.1 ± 25.9% |
INSULIN-NPH | 47.3 ± 43.8% |
ANTI-RABIES | 65.4 ± 19.4% |
TT | 87.2 ± 12.8% |
KHALETRA | 14.9 ± 23.9% |
MEAN AVAILIBILTY | 72.1 ± 23.5% |
Average stock-out days of key temperature-sensitive pharmaceuticals among healthcare facilities were between 5 and 89 days. Hospitals registered 28 days, and health centers registered 30 days on average. The stock-out rate for the past six months before the data collection period was between 11% and 46%. The median stock-out rate of the key temperature-sensitive pharmaceuticals was 24.81% ± 8% for each healthcare facility, and the average stock-out rate was 26.2% ± 23% for each key temperature-sensitive pharmaceutical (Figures
Average stock-out days and stock-out rate by facility type at public health facilities in Southwest Ethiopia, June 2017.
The health facilities recorded shortage and unfortunate stock-out of some essential Revolving Drug Fund (RDF) temperature-sensitive medicines that affected the delivery of healthcare to the client. An unforeseen increase in the number of patients to the health facilities and delays in payment of suppliers were some of the explored reasons. One key informant in charge of the pharmacy department of the surveyed hospital said “
Out of 47 public health facilities, stock records reviewed in 21 (44.7%) were found to be accurate. On the other hand, less than one-third, 17 (36.2%), have shown a figure higher than the physical count. This study also revealed that the inventory record accuracy rate was between 25% and 100%. In comparison, the median inventory record accuracy rate was 39.2% while the average inventory record accuracy rate was 43.1% for each health facility (Figure
Stock record accuracy at public health facilities in Southwest Ethiopia, June 2017.
Workload was asserted as a reason for not timely record keeping at public health facilities. A key informant at one visited hospital store said that
Poor inventory management performance at health facilities was also responsible for causing shortage and stock-out of cold chain products. This was supported by one key informant saying “
Out of 47 public health facilities, the LMIS report reviewed in 30 (63.8%) were found accurate. On the other hand, less than one-third, 12 (25.5%), have shown a count figure of LMIS report higher than stock record count. This study found that the inventory record accuracy rate ranges between 25% and 100%. The median LMIS report accuracy rate was 32.5%, while the average LMIS report accuracy rate was 53.3% for each health facility (Figure
LMIS report accuracy at public health facilities in Southwest Ethiopia, June 2017.
High workload was one of the reasons the health facilities were underperforming in logistic management operations. The store manager of one of the surveyed hospitals stated that
The storage criterion that met most by the public health facilities studied was the presence of standard cold chain refrigerators and freezers, 65 (85.5%), refrigerator on recommended temperature range, 40 (90.9%), while the storage criterion that was met least was the presence of standby power supply, 20 (42.5%) (Table
Public healthcare facilities fulfilling a specific storage criterion in Southwest Ethiopia, June 2017 (
Storage condition parameters | Frequency (%) |
---|---|
Good arrangement inside refrigerators (with total refrigerators = 44) | 29 (65.9%) |
Presence of a freezer tag monitor in the freezer (with total freezers = 32) | 22 (68.7%) |
Daily monitoring and recording of temperature in chart | 26 (55.3%) |
Presence of trays which are used for arrangement | 29 (65.9%) |
No mixture of other items such as fruits and water with cold chain medicine in the refrigerator | 33 (75%) |
Presence of good storage space for the refrigerator | 28 (63.6%) |
Cold chain medicine freezer storage capacity adequate to accommodate all stocks | 23 (71.9%) |
Presence of standard cold chain medicine refrigerators and freezers ( | 65 (85.5%) |
Cold chain medicine are not found stored in the domestic freezer ( | 31 (65.9%) |
Presence of standby power supply | 20 (42.5%) |
Refrigerator maintained at the recommended temperature range (+2°C to +8°C) | 40 (90.9%) |
Presence of a working thermometer inside refrigerators | 23 (52.3%) |
Quantification performed during ordering | 41 (87.2%) |
Cold chain products freezer maintained at a temperature range of −15°C to −25°c | 28 (87.5%) |
Correct placement of icepacks in the freezer ( | 21 (65.6%) |
Cold chain products are not found frozen in refrigerators and freezers ( | 66 (86.8%) |
No expired cold chain products at the health facility at the time of observation | 31 (65.6%) |
No cold chain products stored on the refrigerator door shelf | 26 28(59.1%) |
Public health facilities were assessed based on 18 principles. The public health facility’s storage performances were regarded as acceptable or unacceptable cold chain storage. Out of 47 public health facilities, 29 (61.7%) had acceptable cold chain storage conditions (Figure
Storage performances for temperature-sensitive pharmaceuticals at public health facilities in Southwest Ethiopia, June 2017.
Qualitative study undertaken to explore the reasons that contributed to undesirable store management performance came up with different findings. Most key informants said inadequate in-service training on cold chain management, storage and handling of cold chain medicines, and record keeping to be the most common reasons. High workload was also among the explored reasons why health facilities were underperforming in storage management operations. The store manager of one of the surveyed hospitals stated that
Product expiry was observed in more than half of the hospitals (53.8%) and around one-third of health centers visited (29.4%) during the assessment period. The expiry was high at the hospitals than at health centers. Wastage rate due to expiry was 9.2 with a standard deviation of 8.9 for all study public health facilities. Purchases were made in bulk in anticipation of the NPD cold chain price increase, but sometimes, close to half of the items would expire. A supply officer stated,
The pharmacy unit head and facility store managers disclosed that there are times when the regional PFSA hub compels the facilities to push items that are unneeded and close to expiry. The head of a pharmacy unit in one hospital lamented that
Six vaccines (BCG, OPV, DPT, TT, Measles, and PCV) that were given to children resulted in an unacceptable wastage rate and wastage factor (WF) (Table
Wastage rate of WHO tracer vaccines at public health facilities in Southwest Ethiopia, June 2017 (
Vaccine’s name | Number of doses in a vial vaccine | Doses used | Number of children vaccinated | Doses wasted | Wastage rate(WR) (%) | Wastage factor (WF) |
---|---|---|---|---|---|---|
BCG vaccine | 10- dose vial | 7826 | 3352 | 4474 | 57 | 2.32 |
Oral polio vaccine | 20- dose vial | 12345 | 7652 | 4693 | 38 | 1.61 |
Penta vaccine | 10- dose vial | 14536 | 10854 | 3682 | 25 | 1.33 |
Measles vaccine | 5- dose vial | 4289 | 3479 | 810 | 19 | 1.23 |
TT | 10- dose vial | 6059 | 3984 | 2075 | 34 | 1.52 |
PCV | 10- dose vial | 5182 | 3847 | 1335 | 26 | 1.35 |
A significant sum of PHFs were practicing desirable storage conditions (63.8%) and accurate LMIS reports (63.1%), while some had poor/inaccurate stock records (56.9%) and high product wastage (55.3%) (Table
Summary of overall cold chain management performance for key temperature-sensitive pharmaceuticals at public health facilities in Southwest Ethiopia, June 2017 (
Summary characteristics | Performance category | Frequency(%) |
---|---|---|
PHF product availability | Good/adequate stock | 17 (36.2%) |
Poor/inadequate stock | 30 (63.8%) | |
PHF inventory recording and control | Good/accurate stock records | 20 (42.6%) |
Poor/inaccurate stock records | 27 (57.4%) | |
PHF storage and handling | Good/desirable storage condition | 30 (63.8%) |
Poor/undesirable storage condition | 17 (36.2%) | |
Product wastage management | Good/low product wastage | 21(44.7% |
Poor/high product wastage | 26 (55.3%) | |
LMIS performance | Good/accurate LMIS reports | 30 (63.8%) |
Poor/inaccurate LMIS reports | 17 (36.2%) | |
Overall supply management performance | Good | 20 (42.6%) |
Poor | 27 (57.4%) |
The main challenges experienced were inadequate budget for cold chain equipment maintenance, electric power interruption, shortage of cold chain equipment, and lack of timely maintenance. With regard to budget shortage, one key informant stated that
Limited training for cold chain handlers was blamed to hamper health facilities’ performances. For instance, an EPI focal person at one hospital noted,
Lack of cold chain guideline and its utilization (where the guideline was available) for cold chain management at some hospitals was also brought up as a problem in acquiring supplies. “
Most of the key informants agreed that capacity building, distribution of cold chain equipment with adequate spare parts, solving electric power interruption, and strict adherence to cold chain management manual should be carried out to minimize cold chain management problems. Others suggested the way to achieve properly performing cold chain management operations; some outlined how to improve temperature-sensitive pharmaceutical storing, handling, and management. One key informant stated,
The availability of cold chain equipment such as fridge tags and solar refrigerators was deemed critical for successful vaccine cold chain management. One key informant supported this issue pointing
Another key informant described that
The other key informant suggested special consideration for handling and managing cold chain pharmaceuticals stating that
Setting proper information flow and building smooth relationship with the surrounding health facilities and suppliers ensure interdepartmental and facility reliance on one another in times of need. A pharmacist in charge at one hospital stated that,
The supply coordinator in charge of one surveyed hospital stressed the importance of proper information flow. He said “…
Cold chain management performance has not been extensively evaluated in Ethiopia similar to many developing countries. Therefore, the current study is believed to give some insights into and will help to improve the cold chain management performances at public health facilities in the study area and other regions with similar characteristics to the studied facilities.
The primary reason for holding stock in the pharmaceuticals supply system is to ensure the availability of essential items almost all the time. The mean availability of temperature-sensitive medicines in public health facilities in the current study was 72.1%. This finding corroborates a nationwide survey of the pharmaceutical sector in Ethiopia, Dar es Salaam, and Tanzania’s mainland [
The average duration that the key temperature-sensitive pharmaceuticals are out of stock indicates the capacity of a system to maintain constant supply of products over time. The median stock-out duration was 23.04 days for the health facilities while the average stock-out duration was 29.30 days for each public health facility in the current study. These results show the logistics system in public health facilities in Southwest Ethiopian region (SWE) supplied by the Jimma EPSA hub was not performing well. Such conclusion is partially made on the basis that the median stock-out duration should ideally be zero [
Accurate inventory record keeping is essential for proper inventory management at all levels of public facilities. Inaccurate recording increases the risk of stock-outs, leaks, and expiry [
Cold chain medicine wastage indicates the inefficiency of logistics system management performance. Qualitative findings in this regard indicated lack of proper documentation when moving expired items and poor practice of dealing with discarded old and damaged products. Vaccines such as BCG, Measles, and OPV were wasted the most followed by TAT and oxytocin in some public healthcare facilities. The unusable stock of NPH insulin was also found in other public healthcare facilities visited. One of the main reasons for the wastage of vaccines at public health facilities was the temperature sensitivity attributed to frequent power outage.
Proper storage is vital to maintain the purity, potency, safety, and effectiveness of cold chain medicines [
Slightly less than two-thirds of the visited healthcare facilities’ stores had good arrangement practices. Around one-tenth of them were found using domestic refrigerators for vaccines storage. Around one-third of public health facilities on average had stored other items such as fruits and water with temperature-sensitive medicines in refrigerators. This storage practice is improper and not recommended at all. This finding is similar to a study from the coast region of Tanzania [
Poor storage conditions of vaccines on transit and in public healthcare facilities, nonadherence to good storage practices, and shortage of service providers at some public health facilities were among the problems found in the current study. Infrastructure-related issues such as lack of reliable transportation, unreliable electricity, and lack of alternative power sources during electricity outage and poor quantification and forecasting were also found hindering proper management of cold chain products similar to studies from India [
The availability of key temperature-sensitive pharmaceuticals in public health facilities was inadequate. A majority of public health facilities were inefficient as temperature-sensitive pharmaceutical wastage was high. A significant sum of public health facilities failed to meet desirable storage conditions for the studied products. An unreliable power supply appears to be the main problem in maintaining the recommended temperature range for proper cold chain storage. Adherence to good storage practices also needs attention from cold chain handlers. Overall, supply chain performance of the studied facilities was not adequate and budget constraints require attention of the top management.
District health administrators can better provide comprehensive training on record keeping and cold chain storage management at a reasonable interval to cold chain handlers. Chief executive directors (CEDs) of hospitals and directors of health centers are required to undertake internal supervision of their respective health facilities. Store managers need to monitor their stock of temperature-sensitive pharmaceutics daily through updating stock cards, registers, and LMIS reports. Supply chain coordinators ought to review the stocks delivered against the minimum stock levels before ordering temperature-sensitive pharmaceuticals. Cold chain handlers also need to reduce freezing and stock-out of cold chain medicines by utilizing effective logistics and inventory management techniques while delivering and receiving temperature-sensitive pharmaceuticals.
Due to the short evaluation period (six months and on the spot), this study could only represent the current availability of temperature-sensitive medicines and did not indicate changes in the availability in the study area. The findings of this study and their application are limited to the public healthcare facilities surveyed in SWE, not the entire country. More meaningful results would have been achieved had the scope of the study been broadened to cover the performance of cold chain management at public health facilities across the country. Further research has to be carried out to develop comprehensive findings that can be generalized to the country.
The key areas of cold chain management performance were equally weighted when estimating the overall supply performance for key cold chain products. At the same time, they might not have the same effect on the health facility’s overall performance. Still, all elements of the performance were appreciated and the scoring used was validated. However, the study showed exciting results to improve cold chain management performance for key temperature-sensitive pharmaceuticals at public health facilities supplied by the Jimma PFSA hub, Southwest Ethiopia.
Diphtheria, Pertussis, Tetanus, Hepatitis B, and Influenza type
Crude odds ratio
Chief executive director
Expanded program on immunization
Early expiry first out
First to expiry first out
First in first out
Federal Ministry of Health
Key informant interview guide
Logistic Management Information System
Management Sciences for Health
Logistic Indicators Assessment Tool
Logistic System Assessment Tool
Oral polioviruses vaccine
Pharmaceutical Fund and Supply Agency
Public health facility
Reproductive, maternal, neonatal, child, and adolescent health services
Tetanus toxoid vaccine
United Nations Children’s Fund
Vaccine Management Assessment Tool
Vaccine vial monitoring
World Health Organization.
The datasets generated and/or analyzed during the present study are available from the corresponding author on reasonable request.
Ethical approval was obtained from the Ethics Review Board of the Institute of Health, Jimma University (reference no: IHRPGC/800/207). The authors confirm that the study was carried out according to the Declaration of Helsinki principles.
Both written and verbal consent was obtained from respondents before conducting the study. Participants were assured about confidentiality. Anonymity of the responses was ensured through excluding personal identifiers during data collection and analysis.
The authors declare no conflicts of interest.
All principal investigators made a vital contribution to the conception, study design, and acquisition, analysis, and interpretation of the data; they participated in drafting, rewriting, or critically reviewing the article. All authors gave final approval of the version of the article to be published and agreed on the journal to which the article has been submitted. They also agreed to be accountable for all aspects of the work.
The authors would like to thank Jimma University, Institute of Health and Faculty of Health Sciences, for giving them the greatest opportunity of life time to undertake this research. The authors also like thank data collectors and all study participants (focal person, supply chain coordinators, cold chain handlers, health facilities’ heads, and directors of the Central Ethiopian Pharmaceuticals Supply Agency and coordinators and managers of the Jimma EPSA hub) who contributed to the generation of valuable information during data collection.
Supplementary Table 1: list of 13 key temperature sensitive medicines (8-WHO tracer vaccines and 5 other global lifesaving temperature sensitive medicines) at public health facilities in Southwest Ethiopia, June 2017. Supplementary Table 2: indicator used to evaluate supply chain performances of cold chain products at public health facilities in Southwest Ethiopia, June 2017. Supplementary Table 3: distribution of public health facilities in different zones of two Ethiopian regional states supplied by the Jimma Pharmaceuticals Fund and Supply agency (PFSA) hub, Southwest Ethiopia, June 2017. Supplementary Table 4: sampling strategy for key informant interviews at public health facilities in Southwest Ethiopia, June 2017.