An Evaluation of Cold Chain Monitoring
The cold chain is an integral part of monitoring to keep vaccines and other vital medical products in pristine order—vaccines spoils due to any deviations in their storage and temperature conditions. Medical practitioners do know about handling vaccine life science products.
A study was conducted among general practitioners in Kelantan, Malaysia. The questionnaires have 10 items on knowledge and 11 items on attitude. This determined the knowledge, attitude, and adherence to cold chain guidelines. Following the cold chain, practice is to follow the Ministry of Health. Guidelines the type of refrigerator, dedicated refrigerator, presence of thermometer, and temperature monitoring.
Kelantan has little changes in temperature throughout the year. All districts in the state are in this study. All 248 facilities are connected by road with a few that can reach by the river. Vaccines from Kuala Lumpur are sent by air to the state-level store. Local distribution within the state is done by 4-wheel-drive motor vehicles. The vaccines are packed in cold storage containers with ice and sawdust for transport and distribution.
The study has no revisions were made in normal vaccine supplies and transportation. The staff participating in the management of the cold chain had been trained in cold chain monitoring. In April 1990 during a national workshop, as well as on-site by a WHO team.
The study dwells on what is lacking in the cold chain. What to do during power failures. Lack of knowledgeable health staff, pharmacists, storekeepers, and attendants.
The study revealed the familiarity of people within the cold chain operational level and cold chain monitoring. Tropical areas where the high environmental humid temperature is an issue. Cold chain managers keep the vaccines away from ruining the heat. Poor comprehension of the hazards of vaccine freezing contributes to the frailty of the existing cold chain. A common assumption in most vaccine handlers was keeping the vaccines cold. With less focus devoted o preventing the vaccine damage from freezing. Freezing the vaccines in the cold chain is a misconception. Results in widespread spoilage of vaccines whose preservation is the utmost concern. Vaccine exposure to temperatures excursions in the cold chain may affect the vaccine potency. Freeze-sensitive vaccines lead to a loss of revenues and places children at risk of contracting diseases.
The reason behind the spoilage is due to deep-frozen ice packs used in cold boxes. Freeze-sensitive vaccines are likely exposed to freezing temperatures during their transport.
The method used in data collection
Interactions with the GPs were made via phone call, and those who agreed signed the ‘Respondent Information and Consent Form’. A self-administered questionnaire was given followed by a refrigerator inspection by the researcher. It is advised to install the minimax thermometer on the middle shelf of the compartment. It should be during the visit to change its location.
The temperature reading was taken after 24 hours. Ministry of Health handbook on cold chain guidelines was distributed to every clinic involved. The sample size was calculated based on the prevalence of good adherence among GPs of 0.166 using single proportion formula.
Data is entered and analyzed, used to determine the knowledge, attitude, and adherence to cold chain guidelines. A suitable refrigerator type is defined as a two-door refrigerator or top-loading refrigerator. A dedicated person responsible for vaccine storage and maintaining optimal refrigerator temperature. The primary vaccine is standard in the Malaysian Immunization Programs.
What is the Cold Chain?
The Cold Chain transports and stores vaccines in potent conditions. It is starting the manufacturing facility to when it is time to administer to patients. It keeps medical products in good working order before distributing them to patients. Lack of the cold chain supply line could render the products useless and pose a danger for the end-user.
Result of the research
A total of 171 GPs joined the study. However, 61 clinics did not practice vaccination, and 21 clinics refused to participate after the study, and finally, 89 from 110 eligible clinics were involved giving a response rate of 80.9%.
The majority of the respondents have a poor attitude towards the cold chain, 79.8%. Only 5 (5.6%) clinics adhere to all four items, 23.5% adhere to three items, 31.5% adhere to two items, 30.3% adhere to one item, and 6.7% did not adhere to any item.
There is little knowledge, attitude, and adherence by the general practitioners to Malaysia’s cold chain protocols even though they contributed 20-30% of vaccination services. This research will help the Ministry of Health ensure vaccination undertaken by them follow the guideline and patients get the maximum benefit when it comes to vaccine safety.
The preservation of vaccine needs a competent cold chain infrastructure and must meet WHO standards. But the studies show that compliance with the recommended guideline is low and ranges between 0-70%. The factors contributing to its dismal results were poor knowledge, inadequate training, and physicians not using the recommended guidelines in daily practice.
The cross-sectional research conducted between April and November 2010. Included are all the GPs who provide the vaccination services in Kelantan and did not include those who did not store vaccines in the clinic and part-time doctors.
Cold chain management weaknesses often occur during transportation and storage of the vaccines.
These Factors includes:
- Delays during transportation
- Quality of refrigerators
- Method of storage
- An extended time of storage
- Improper use of refrigerators
- Power interruption
- Equipment breakage
- Lack of trained personnel
Cold chain system consists of a series of storage and transport links designed to keep vaccines within an acceptable temperature range until it reaches the users. The cold chain remains a vulnerable point for national immunization programs in developing countries, especially those with tropical climates.
What needs to correct?
The principles to good vaccine storage and proper maintenance of the cold chain are:
⦁ Availability of trained staff
⦁ Proper vaccine transport
⦁ Good vaccine storage facilities
Equipment for vaccine storing must be selected and proper usage. A home refrigerator is appropriate if it has a separate door for its chiller and freezer compartment. Vaccines should not be kept together with laboratory specimens, drugs, food, and drinks. However, reverse findings were found.
Vaccines are placed in a perforated tray and space around 1-2 cm between vaccine lines to allow air circulation. They cannot touch the refrigerator floor because it would result in a vaccine to solidify. To ensure good ventilation, the refrigerator must be located about 40 cm from the wall. The refrigerator cannot be placed near heat sources. This is to prevent a refrigerator’s temperature from going higher.
In developed countries, trained personnel in charge of cold vaccine chains are commonly available than in developing countries. Their work in clinics will be two to three times more likely to perform daily temperature monitoring and improved storage condition.
In developing countries, sometimes there were issues when vaccines were not available or obsolete old refrigerators. Also, there was no cold storage in the state-level store. In addition to inadequate equipment to store the vaccines. Some thermometers were not in working order, or vehicles for transporting vaccines were not temperature controlled; some centers did not keep temperature records or had expired vaccines in stock, and potency tests were carried out irregularly. This study’s results should help managers and health planners rectify these conditions, which will improve the cold chain.
Attitude on cold chain monitoring
The success of cold chain management depends very much on how handlers’ attitude towards carrying it out. The present study showed that the attitude of general practitioners in Kelantan was poor. A majority of the respondents had a negative attitude towards cold chain vaccines, with only 20.2% perceived cold chain management is crucial. This is inconsistent with the study in China where the health care providers perceived that service delivery of vaccination is essential. However, they believed that it was influenced by hard service delivery (59.9%) due to geographical factors and the poor condition of cold chain equipment (87.7%).
75-85% agreed to place an adequate number of ice packs in the cold box to maintain optimal temperature. Putting ‘Open When Needed’ label at every refrigerator door stores vaccines to minimize heat exposure. But they are not bothered if the refrigerator is opened three times per day.
For good vaccine care, only 4.5% believed they could place vaccines together with food, drinks, and laboratory specimens. The majority were concerned with vaccine potency if medicines and samples are placed together. This shows that respondents have a good understanding of potential harm if vaccines are not kept in one dedicated refrigerator. Unfortunately, only 11.2% of respondents perceived that the vaccine placement in the refrigerator door shelf could damage the vaccine. Shake test has 100% accuracy in the predictive value in detecting freeze damaged vaccine. However, in the present study, only 16.9% of respondents perceived that doing a shake test is vital to determine vaccine potency. These findings were consistent with others.
Data on daily temperature monitoring non-existent. Respondents did not try to do so, it is recommended for charting temperature twice daily. Most believed that using a special thermometer to measure internal refrigerator temperature. Still, reading should be done without taking the thermometer out of the refrigerator.
Adherence to recommended guideline
Adherence to recommended guidelines in the present study was poor despite that most GPs have good knowledge. It is possible that this result could be explained by the negative attitude of GPs on cold chain management. A study observed 79% compliance at a primary health center using a different method. Temperature monitoring used charts to improve training and to revise the cold chain points.
Despite the high percentage of right knowledge, most GPs have a poor attitude and poor adherence to cold chain guidelines. Staff training and activities on vaccines and thermometers may improve quality within the cold chain.
The study indicates a knowledge gap among health workers on cold chain management. A need to augment the knowledge and practice of cold chain management is improved supervision and training at healthcare system levels.