Vaccine Storage and Management

Abstract

Proper storage and management of vaccines are crucial to ensure safe and effective vaccination. Vaccines that are stored outside the recommended temperature range can lose their potency, reducing the efficacy of the vaccines and leading to wasteful expenditure. Furthermore, mishandling vaccines can lead to inadequate and a low rate of vaccination and potentially increase the spread of infectious disease. Therefore, for a successful vaccination program, it is imperative to retain the efficacy vaccines by ensuring their optimal storage from production to inoculation. It is recommended that for better handling of vaccines, the institutions should designate a responsible individual for daily management and safekeeping of vaccines as per standardized storage protocols. The use of appropriate storage equipment, regular temperature checks with monitoring devices, and proper maintenance of the equipment are crucial components of this process. Moreover, managing vaccine expiration dates is a vital aspect of ensuring safe vaccination. The designated individual should diligently manage the vaccine inventory from the moment of receipt until its usage or disposal. Moreover, managing vaccine expiration dates is a vital aspect of ensuring safe vaccination. Further, contingency plans should be prepared and backup storage equipment should be made available for rapid response during emergency. In this article, we will delve into the principles of vaccine storage and handling that are essential for safe and effective vaccination.

Key messages

① What is known previously?

It is important to properly store and manage vaccines for safe vaccination.

② What new information is presented?

The vaccine handling agency guides on how to properly store the vaccine and explains how to respond quickly in an emergency.

③ What are implications?

Active cooperation from vaccine management personnel is required for safe and effective vaccination.

Introduction

Vaccines are temperature-sensitive biologics and require proper storage and management to ensure safe immunization. Deviations from recommended temperatures can diminish the effectiveness of the vaccine, reducing the efficacy of immunization. Furthermore, mishandled vaccines may need to be discarded or re-administered, which is costly. Errors in vaccine storage and handling can also reduce recipient confidence, which can lead to lower vaccination rates and eventually, outbreaks. In essence, the foundation of an immunization project hinges on the appropriate storage and management of vaccines, which must be upheld from the moment it is manufactured until the point of inoculation into the recipient (Figure 1).

Figure 1. Cold-chain flowchart.

When vaccines are produced or imported, they are transported via a distribution network so that they can reach vaccination sites. The cold chain system plays a pivotal role in maintaining low temperatures from the point of production to the point of use, safeguarding shelf-life until the vaccine can be used. Therefore, the responsibility of preserving vaccine quality through meticulous cold chain management falls upon the manufacturer (importer), the distributor, and the healthcare provider. Each healthcare provider should be committed to systematic vaccine management in its respective areas. This article aims to discuss the principles of vaccine storage and management necessary for safe and effective immunization.

Methods

1. Developing a Vaccine Storage and Management Plan

Given that any healthcare provider who handles vaccines must guarantee their appropriate storage and management under routine circumstances, as well as respond effectively in the event of an emergency, it becomes crucial to ensure that all employees are well-informed about the relevant procedures. To achieve this, healthcare providers are encouraged to develop a vaccine storage and management plan, along with standard operating procedure (SOP) guidelines. These resources should be readily accessible to all staff and kept near the vaccine storage equipment.

Routine vaccine management should include procedures for ordering and receiving vaccines, temperature monitoring, vaccine storage, and inventory management. It is advisable to appoint responsible individuals for each of these tasks, maintain a checklist outlining the required actions, and consistently oversee its execution.

Further, it is also necessary to establish an emergency response plan, which should include having additional equipment or designating an alternative location for the storage of vaccines. The plan should include instructions on how to operate power-maintaining equipment, such as a generator or uninterruptible power supply (UPS), in the event of a power outage and how to transport vaccines to the appropriate location in the event of storage equipment failure, ensuring prompt and precise resolution of any issues that may arise.

There should be a vaccination officer who would be responsible for the proper storage and handling of vaccines, and at least one backup officer in case of absence of the primary officer. Vaccination officers should conduct training on vaccine storage and handling to ensure that all individuals working with vaccines are familiar with the principles of vaccine storage and handling. Therefore, training should include the entire process of ordering, receiving, and managing vaccines, including temperature logs, inventory management, and storage equipment management, and guidance on managing each step. Training should be conducted on a regular basis and should be updated with any changes in the storage and handling of vaccines, such as when new staff are hired or new vaccines are received [1].

2. Receiving Vaccines (Warehousing)

Effective vaccine management begins as soon as vaccines arrive at the healthcare provider’s facility. Since vaccinations must be administered in the presence of a vaccination officer, the vaccination officer must coordinate with the carrier to ensure that the vaccine is transported during working hours. In addition, proactive steps should be taken to ensure immediate notification to vaccination officers when vaccines arrive. Upon receiving the vaccines, the packaging and contents of the product should first be checked. After ensuring that the products match the order and that no products are nearing their expiration date, they should immediately be placed in storage equipment that maintains the suitable temperature. In addition, the vaccination officer (receiver) should check and receive the shipment certificate of the biological product, keeping it for at least 2 years. Any temperature deviations during the transport of vaccines should be checked, and an inventory log should be maintained for vaccine management. The log should include the product name, quantity, manufacturer, lot number, and date of receipt of each vaccine, as well as the amount used and remaining [2].

3. Vaccine Storage Management (Vaccine Placement and Sorting, Equipment Management)

Vaccines are temperature-sensitive biologics; therefore, it is important to store them within the appropriate temperature range (typically 2–8℃, at an average of 5℃). Therefore, the use of a vaccine-specific refrigerator or freezer for vaccine storage is recommended (Figure 2). While general household refrigerators and freezers with separate refrigeration and freezing compartments can be used, dormitory-style refrigerators (one-door) with integrated refrigeration and freezing functions cannot be used for vaccine storage as they may freeze the vaccines.

Figure 2. Examples of vaccine refrigerators.

Vaccine refrigerators and freezers should be equipped with digital temperature control, automatic temperature recording, and alarm functions for temperature deviation. If an automatic temperature recorder is not available, a digital temperature recorder or a regular thermometer may be used. In this case, vaccine storage equipment temperatures should be checked at least twice daily (once in the morning and once before or after the end of the work day). A temperature log should be posted on the door of the storage unit to record the results.

Even when using a continuous automatic temperature monitoring device or a refrigerator or freezer with a digital temperature recorder, manual temperature monitoring should be conducted at least twice daily to account for possible failures. Thermometers that measure the temperature of vaccine storage units should have a verified Certificate of Traceability and Calibration (CTC), and thermometers in use should be recalibrated periodically. The vaccine refrigerator or freezer should also have a powerful fan or multiple vents inside to allow air circulation within the refrigerator or freezer so that it can quickly recover from temperature deviations. Vaccine storage equipment should be installed in a well-ventilated room, away from windows, with at least 10 cm of space between walls and at least 2.5 cm to 5.0 cm between the floor and the base of the vaccine storage equipment, leveled, and securely fastened. Furthermore, as most vaccine storage equipment works best at room temperatures between 20–25℃, the room temperature should be checked before installation. For newly installed or repaired storage equipment, it is necessary to ensure the temperature is stable for at least 2 days before use. After stabilizing the internal temperature before storing the vaccines, the temperature should be measured at several points inside the device, and vaccines should be stored at a point where the temperature remains stable. If cold or hot spots are identified in a refrigerator, it should not be used for storing vaccines. When using a household refrigerator or freezer as a dedicated vaccine refrigerator or freezer, avoid storing it near the cooling vent and in areas where it cannot maintain a stable temperature, such as fruit drawers and door shelves. Storing water bottles at the bottom of the top shelf or on the door shelf can help maintain internal temperatures if the machine door is opened and closed frequently or in case of a temporary power outage. Items other than vaccines, including food and beverages, should be stored in a separate unit from the vaccine storage refrigerator. Storing food and beverages with the vaccine and opening the refrigerator door frequently can lead to temperature fluctuations and overexposure to light. Additionally, vaccines should not be stored with food or beverages to avoid the risk of loss or contamination. Some vaccine refrigerators or medical refrigerators distributed in the Republic of Korea have glass doors. However, refrigerators with glass doors are not advisable for storage of live attenuated vaccines such as the chickenpox vaccine, measles-mumps-rubella vaccine (MMR), and rotavirus vaccine to avoid their direct exposure to sunlight. This is important because exposure to direct sunlight can reduce the titer of these vaccines.

Vaccines should be stored at the right temperature and in their original packaging until the time of administration. They should also be properly arranged and categorized such that vaccines of the same type are stored in the same location as much as possible and vaccines close to the expiration date are used first. Vaccines and accompanying solvents can be stored in their original packaging in storage containers, boxes, etc., with enough space between each container of vaccines to avoid product mix-ups and allow good internal air circulation. Vaccines and accompanying solvents should be placed 5 to 8 cm away from walls, ceilings, floors, and doors of storage equipment. If other medicines and biological products are stored in the same storage equipment as vaccines, they should be clearly labeled and stored in separate containers or bins from the vaccines. In particular, items that can cause contamination (blood, urine, feces, etc.) should be stored separately under the vaccine storage compartment to prevent leakage.

Containers used for vaccine storage should be clearly labeled. Where feasible, color coding can be employed to distinguish between different vaccine types, age groups, and other relevant categories. In addition, similar-looking vaccines (DTaP, Tdap) should be kept as separate as possible, as storing them close to each other can lead to their potential misidentification and thus, inappropriate administration [3].

4. Vaccine Inventory Management

Ordering an excess of vaccines can lead to wastage, as unused vaccines may ultimately have to be discarded. Thus, it is important to keep track of the inventory and order vaccines appropriately. The vaccine inventory log should be documented and updated at least weekly. It can be kept next to the storage equipment so that records can be made every time the vaccine is used. When recording, it is necessary to check if the correct number is recorded as well as if the remaining amount is correct. Not only vaccines but also diluents should be managed separately by checking inventory, usage, and remaining amounts. To manage vaccine inventory efficiently, vaccines should be arranged in storage equipment by type, with those with the earliest expiration dates upfront so that they can be used first. At least once a week, the vaccination officer should check the expiration date of the vaccines, place the soon-to-be expired vaccines in the front for use, and immediately remove any expired vaccines from the storage equipment to prevent their usage.

5. Emergency Responses

Vaccine storage is susceptible to unforeseen emergencies, ranging from equipment failure, power outages, and natural disasters. To prepare for such emergencies, each healthcare provider should have a response plan in place and be able to respond quickly when the situation arises. It is advisable to incorporate redundancy in storage equipment or arrange for alternative storage with other healthcare providers (such as hospitals and health centers) in the event of failure of the primary storage equipment. In situations where securing additional storage equipment or an alternative storage facility poses challenges, packaging dishes and portable vaccine refrigerators or freezers that are suitable for vaccine storage can be an alternative. With a generator or UPS, the vaccine storage equipment can be powered to keep vaccines safe during an outage.

In the event of an emergency during vaccine storage, the vaccination officer should be notified immediately. The vaccination officer should measure the room temperature, the temperature inside the vaccine refrigerator, and record the range and length of time the vaccine was outside the recommended temperature. If storage equipment fails and vaccine storage is compromised, vaccines should be moved to spare storage equipment or an alternate storage facility, or if spare equipment is not available, to secondary storage equipment such as ice packs or coolers. Vaccines that have been out of the recommended temperature should be removed and stored separately and not used until it is determined whether they can be safely used, a decision that should be made in consultation with the vaccine manufacturer. If an anomaly occurs over a weekend or holiday and the exact time of the temperature deviation is not known, the refrigerator temperature and time of discovery, the room temperature, and the last checked vaccine refrigerator temperature and time should be recorded, followed by consultation with the vaccine manufacturer to determine the vaccine’s usability. It is recommended that a digital data logger (DDL) be used to immediately identify any temperature deviations that occur outside of business hours and that the appropriate personnel be alerted immediately.

6. Vaccine Disposal

Opened vaccines, broken vials, and syringes are not returnable and should not be returned to the manufacturer or distributor. Vaccines that have expired or are unusable due to temperature deviation or damage must be immediately removed from storage, stored separately to prevent accidental administration, and properly disposed of in accordance with the Waste Management Act, and other applicable guidelines instead for better readability and clarity [4].

Conclusion

Vaccines may lose their potency and effectiveness if stored outside of the recommended temperature range. Proper vaccine storage and handling can increase the effectiveness of immunization. This article outlines the general requirements for the proper storage and handling of vaccines. More detailed regulations for vaccine storage and handling can be found in the “Vaccine Storage and Transport Management Guidelines (Ministry of Food and Drug Safety)” and the “Vaccine Storage and Management Guidelines (Korea Disease Control and Prevention Agency).” In order to uphold vaccine quality and optimize disease prevention, vaccination officers are urged to pay heightened attention to vaccine storage and management practices.