INTRODUCTION:

A person is made immune or resistant to an infectious disease by administration of a vaccine. Body’s own immune system is stimulated by vaccine to protect the person against subsequent infection or disease. Immunization is very useful in controlling and eliminating life-threatening infectious diseases. It is estimated that it can control between 2 to 3 million deaths each year and is one of the most cost-effective investments in health sector which can make it accessible to even the most hard-to-reach populations. [1]

Immunization is the most precious gift that a health care worker can give a child and it remains the most cost-effective preventive health intervention. Vaccines are very sensitive biological substances whose potency gradually decreases with time. This loss of potency may get accelerated when they are stored at a temperature that is out of the recommended range. Any loss of potency in a vaccine is permanent and irreversible. Thus, a proper storage of vaccines at the recommended temperature conditions is vital so that vaccine’s potency is retained up to the moment of administration.[2]

Success of an immunization programme depends on a system that ensures that vaccines are not thermally damaged during transportation and storage. A vaccine is a biological preparation that improves immunity to a disease. A vaccine contains an agent that is similar to a disease-causing microorganism and is often made from weakened or killed forms of the microbe, toxins of microbes or any of its surface proteins. These agents stimulate body’s immune system to recognize the agent as foreign so that they destroy it or remember it. The immune system can easily recognize and destroy any of these microorganisms when it later encounters.[3]

National Immunization Programme (NIP) is one of the priority programs of Child Health Division of Nepal and is one of the successful public health interventions of Nepal. Currently eleven antigens are provided through the routine immunization under National Immunization programme of Nepal.

The national policy for vaccine storage and transportation of Nepal is “Cold Chain and Vaccine Management Strategy”. “Standard Operating Procedure” is available as guideline for cold chain and vaccine management.

Vaccines are delicate biological substances. If exposed to temperatures above or below those recommended, vaccines may be irreversibly damaged and cannot be relied upon to provide the expected level of protection against the disease/s for which they were designed.

As the cost of vaccines is rising and also it requires greater storage capacity at every level of the cold chain, countries must maintain lower stock levels, reduce wastage, accurately forecast vaccine requirements, and prevent equipment breakdowns. This requires a consistently high standard of supply chain management, which can only be achieved if all the links in the supply chain comply with current good storage and distribution practices.[4]

METHODS:

Research design:

It is a descriptive and qualitative study. Desk review was done for guidelines related to vaccines and cold chain. Primary sources of data were collected using semi-structured questionnaires.

Sampling site and technique:

Department of Health Service (DHS) store, Teku as central vaccine warehouse, Eastern Regional Medical Store, Biratnagar; three DPHO one from Mountain region (Sindhupalchowk), one from Hilly region (Bhaktapur) and one from Terai region (Jhapa) and at least two selected health posts and/or hospital under each DPHO where vaccine storage facility was available. Interview was taken, and on-site observation was done with health workers/storekeepers.

Data collection methods

a. National guideline for vaccine transportation and storage of Nepal was reviewed and recorded.

b. WHO recommendation regarding cold chain maintenance was also reviewed and recorded.

c. The selected institutions were visited and interviewed using semi-structured questionnaire and observation check list for each institution.

Qualitative analysis of the following indicators was done;

i. Vaccine Arrival Procedures

ii. Temperature Monitoring

iii. Storage and Transport Capacity

iv. Buildings, Equipment and Transport

v. Maintenance

vi. Stock Management

vii. Distribution

viii. Vaccine Management

ix. Information System and Supportive Management Functions

Among above nine indicators vaccine arrival procedure and distribution was analyzed by interview and all other seven indicators was analyzed using interview and on-site observation.

RESULTS:

Vaccine Arrival Procedures:

The vaccines are transported to Nepal through airways.

Temperature Monitoring:

Knowledge of store keeper about temperature:

The correct storage temperature ranges (for each of the vaccines in the national immunization calendar) were known by all 12 storekeepers or health workers interviewed at all institutions assessed.

Storekeepers or health workers in all 12 institutions assessed demonstrated correct reading of all types of thermometer and/or temperature recording device(s) used in the institutions assessed.

Temperature data logger:

The official responded that six out of eight (75%) indicators were followed while door open sensor and auto dialer were failed to follow by central vaccine store which could be verified by observation. The temperature data logger in regional medicinal store, Biratnagar was not functioning and it was in process of maintenance.

Figure I: Temperature Data Logger

Storage and Transport Capacity:

The positive storage capacities available for vaccines were sufficient with current immunization calendar in both central vaccine store, Teku (85m³ or 85000 litre) and regional medicinal store, Biratnagar (14430 litre).

The negative storage capacities available for vaccines were also sufficient with current immunization calendar in both central vaccine store, Teku (30 m³ or 30000 litre) and regional medicinal store, Biratnagar (950 litre/ required 360 litre).

Refrigerated vehicles were not available at RMS to transport vaccine from region to districts.

SOP which sets out a contingency plan in the events of equipment failure or other emergencies were present at CVS Teku, RMS Biratnagar, and all three DPHO assessed. The officials responded that all seven indicators of contingency plan for emergency were followed in both CVS and RMS which could be verified by observation except at the regional medicinal store, Biratnagar the official could not show us the documentation.

The DPHO official responded that four indicators of contingency plan were followed by all institutions and one indicator was not followed by one institution which could be verified upon observation. The same questions were asked to six health posts and one hospital. They responded that satisfactory SOP was not followed by any institutions, proper storage condition was followed by only one institution out of seven, level on exposed vaccine was followed by two institutions, documentation was done in three institutions and all the institutions have the emergency contact details; which can be verified by observation.

Buildings, Equipment and Transport:

Vaccine stores in all institutions assessed was easily reached by delivery vehicles. None of the store had protective clothing for staff working in cold rooms and freezer rooms.

Five out of twelve (41.66%) of stores had all equipment CFC-free. In RMS Biratnagar and DPHO Jhapa, one refrigerator contains CFC.

Five out of six (83.33%) health posts were found using domestic refrigerator where Dhulabari Health Centre, Jhapa also have a WHO specified refrigerator. Also, all hospital assessed have a WHO specified refrigerator.

Seven out of twelve (58.33%) vaccine stores of assessed institutions have generators installed, out of which 1 store have solar generator installed.

Two out of seven (28.57%) stores where a generator is installed met all requirements for standby generator:

i. The generator was in working order

ii. The generator has a working auto-start system

iii. The generator was able to start all the connected equipment in the vaccine store

iv. The fuel tank was large enough

v. There were sufficient reserve supplies of fuel

vi. The generator was in a secure compound

At CVS Teku, there were no reserve supplies of fuel due to budget constraints. At DPHO Bhaktapur the generator did not have auto-start system. At DPHO Sindhupalchowk, although the generator was installed but it was not connected to the equipment and it did not have auto start system and was not in secure compound.

Neither CVS Teku nor RMS Biratnagar met all requirements for quality control test for cold chain storage facility (as guided by WHO, PQS quality control protocol 2006)

Table I: Indicators of Quality Control Test

Indicators	Central	Regional
Run test	Y	N
High alarm test	Y	N
Low alarm test	Y	N
Door-open' sensor test	N	Y
Voltage sensor test	N	Y
Auto-dialer test	Y	N
Acceptance criteria: zero failure	N	N

In CVS Teku Door-open sensor was in progress and voltage sensor was absent while in RMS Biratnagar High alarm test was damaged in one room and absent in other two and Low alarm test and auto dialer was absent.

Neither CVS Teku nor RMS Biratnagar met all requirements for fundamental requirements for WIC and WIF rooms:

Table II: Indicators of Requirements for WIC and WIF Rooms

Indicators	Central		Regional
	Response	Observation	Response	Observation
calibrated thermostat to ITS-90	N	N	N	N
holder over time	Y	Y	Y	Y
Lighting	Y	Y	N	N
CFC free refrigerant	Y	Y	Y	Y
Compressors fitted with hour meter	N	N	Y	N

In CVS Teku, thermostat calibrated to ITS-90 and compressor fitted with hour meter was absent while in RMS Biratnagar LED lights were fitted instead of tungsten filament light; and thermostat calibrated to ITS-90 was absent.

Two out of two institutions assessed (CVS Teku and RMS Biratnagar) met all the requirements for prefabricated rooms:

i. Doors located in the middle of the long walls

ii. The side and back of the room with the minimum of 100mm from the existing building wall

iii. Installation done on the levelled concrete floor

iv. The leveling/base evenness of rooms are +/- 3mm/3m and +/- 5mm/5m

v. Distance of door entrance to the installation area: 900mm

Two out of twelve (16.67%) stores met all the requirements for proper storage equipment given by WHO-UNICEF:

i. Store vaccine in refrigerator and freezer unit

ii. Back-up units in the event of power failure

iii. Use only calibrated thermometer with certificate

Maintenance:

Planned preventive maintenance was not documented in all 12 institutions surveyed. All assessed locations (12 out of 12) lack planned preventive maintenance. None of the store had a written planned preventive maintenance (PPM) programme.

Stock Management:

CVS, RMS, DPHO have a computerized stock management system in use.

Nine out of twelve (75%) of the institutions assessed met all the requirements for recording information about newly arrived vaccines in vaccine log documentation:

· Vaccine name and number of doses received

· Date of vaccine receive

· Checking of vaccine condition when received (VVM status)

· Vaccine manufacturer and lot number

· Vaccine expiration date

In Dhulabari Health Centre, Jhapa, the vaccine log documentation was not kept and in Kakarvitta Health Post and Thimi Health Post vaccine manufacturer and lot number was not recorded.

None of the stores recorded all information required by WHO-UNICEF for all vaccines and diluents:

i. Type of vaccine/diluents

ii. Vial size

iii. Quantity received in doses

iv. Manufacturer

v. Manufacturing batch or lot number

vi. Expiry date of each batch

vii. VVM status where applicable

viii. Location in the store

Figure II: Vaccine Stock Control Register

Distribution:

In the stores using cold boxes or other passive containers knowledge of coolant preparation and packing of cold boxes, vaccine carriers and other passive containers was assessed on:

i. Icepack use in accordance with WHO guidelines

ii. Packing in accordance with SOP

iii. For freeze sensitive vaccine only: use of freeze indicator with deliveries

iv. Cold climate only: staff have knowledge to prevent vaccine freezing during transport

In all 12 stores staff provided correct answer to first two questions. None of the store uses freeze indicators for freeze sensitive vaccine and in 2 out of 3 stores assessed in cold climate staff knows how to prevent vaccines from freezing during transport.

Only national store in Teku had refrigerated vehicles at the time of the study but the official at CVS Teku informed that they were in a process of buying refrigerated vehicle for each RMS.

Vaccine Management:

Only five out of twelve (58.33%) health workers knew how and when to conduct a shake test. Health workers of all six-health post and one hospital did not know how and when to conduct a shake test.

Eight out of nine (88.89%) health workers stated that diluents always kept in the cold chain before and during every immunization session. Written instructions on the use of VVMs, such as posters and stickers, were available to storekeepers and health workers in 5 out of 12 (41.67%) institutions assessed. All 12 storekeepers/health workers knew how to read VVM status. Eleven out of twelve (91.67%) store keeper/health workers use VVM status for vaccine management purpose (they use stage 2 vaccine before stage 1). Eleven out of twelve (91.67%) stores reported having vaccine wastage records present. Among the institutions assessed, only RMS Biratnagar did not have wastage record because of lack of reporting. Eleven out of twelve (91.67%) heath workers /storekeeper knew how to explain unopened vial wastage and calculate the wastage rate.

Information System and Supportive Management Functions:

Although English version of standard operating procedures was finalized and translated in Nepali language, it was not printed and distributed to all staff, which carries out the procedures. Health workers at health posts/hospital level did not have SOP.

Vaccine needs forecasting was done by a standard method in DPHO, RMS and CVS.

All 5 institutions assessed met all the requirements of vaccines need forecasting:

i. Use of standard method to estimate annual vaccine need

ii. Use of standard evidence-based target population data in the calculation

iii. Use of evidence-based coverage data in the calculation

iv. Use of evidence-based vaccine wastage data in the calculation

DISCUSSION:

A research published in BMC research notes by Yakum, M.N., et al., shows that 81.5% out of 65 health facilities had at least one functional vaccine refrigerator. And in our study nine out of twelve health facilities had at least one WHO specified functional vaccine refrigerator, which is nearly similar findings.

According to the research done by Yakum, M.N., et al., the national guideline of EPI was not present in 33.9% health facilities. But in this study Standard Operating Procedure (National guideline of Nepal) was not present in seven out of twelve health institutions assessed. There was no SOP in any of the health facility under districts level because of the lack of information regarding the use of SOP.

In the same study done by Yakum, M.N., et al., Seventeen (28.3%) personnel did not know the correct vaccine storage temperature. According to this research all 12 personnel knew the correct vaccine storage temperature. This shows that the level of awareness regarding the vaccine storage temperature was good maybe due to the trainings as well as limiting numbers of vaccines to be stored in deviation from the cold temperature.[2]

Y. Berhane and M. Demissie, studied on Cold Chain Status at Immunisation Centres in Ethiopia and found that the major source of power for the refrigerators was electricity in all urban centres and kerosene in the majority of rural centres whereas major source of power for the refrigerators in Nepal was also electricity and in case of power failure the alternative source was kerosene and solar power.

According to Y. Berhane and M. Demissie, Kerosene shortages were reported by 42.9% of the 21 health institutions using this form of power. In contrast, there were no reserve supplies of fuel due to budget constraints at CVS Teku.

A study by Y. Berhane and M. Demissie shows functional freezer necessary to prepare ice packs for outreach services was available in 54.7% of the functioning centers, almost similar findings was found in our study where six out of twelve of the health institutions assessed had functional freezer. [5]

CONCLUSION:

The national policy and guideline for cold chain and vaccine management are “Cold Chain and Vaccine Management Strategy” and “Standard Operating Procedure” respectively. Cold storage facility was not available at the Tribhuvan International Airport. Refrigerator vehicle were not available at RMS to transport vaccine from region to districts. There is sufficient storage capacity in both CVS, Teku and RMS, Biratnagar according to national immunization calendar. SOP was not available at any health post. Both CVS, Teku and RMS, Biratnagar met all the requirements for prefabricated rooms.

The health workers at health post level did not know how and when to conduct a shake test. None of the store had a written planned preventive maintenance (PPM) programme. None of the store uses freeze indicators for freeze sensitive vaccine during transportation of vaccines. Vaccine need forecasting is done in accordance with WHO-UNICEF guideline.

ACKNOWLEDGEMENT:

The authors are grateful to the authorities of Department of Health Service (DHS) store, Teku, Eastern Regional Medical Store, Biratnagar, DPHO of Sindhupalchowk, Bhaktapur and Jhapa and all the faculty members of CiST College.

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

REFERENCES:

1. WHO Vaccines. Available from: http://www.who.int/topics/ vaccines/en/.

2. Yakum, M.N., et al., Vaccine storage and cold chain monitoring in the North West region of Cameroon: a cross sectional study. BMC research notes, 2015. 8(1): p. 145.

3. WHO Types of Vaccines. Available from: https://www. niaid.nih.gov/research/vaccine-types.

4. Nepal EVM Assessment 2014 Available from: http://dohslmd.gov.np/wp-content/uploads/2016/11/EVM-Assessment-Report.pdf.

5. Berhane, Y. and M. Demissie, Cold chain status at immunisation centres in Ethiopia. East African medical journal, 2000. 77(9).

Received on 19.02.2020 Modified on 08.03.2020

Asian J. Res. Pharm. Sci. 2020; 10(2): 90-94.

DOI: 10.5958/2231-5659.2020.00017.X