A Guide to The Best Practices in Handling Vaccines
A guide to the best practices and industry standards when handling temperature sensitive vaccines. The challenge in vaccine handling lies in its sensitivities. Because vaccines are temperature-sensitive and light-sensitive, the process of transporting and storing them is more challenging than other types of supply chains.
Handlers, health personnel, and all other members of the vaccination community must properly observe these rules, as they determine the success of vaccine delivery.
Best Practices When Receiving Vaccines from the Manufacturers
On the day of receipt, designated persons should check the following criteria:
- Order discrepancies – The number of vaccines must match the needs of the stores or the distributors.
- Vaccine Leakages – Make sure there are no spilled substances from vaccine vials or elsewhere.
- Vaccine Damages – Check for all possible transport-related damages such as broken containers or vials.
Upon checking the above criteria, list the following information in a stock control book:
- Vaccine types and brands
- Batch number
- Expiry date
- Date and time of receipt
- Signature of the person receiving the vaccines
Best Practices When Storing Vaccines
a. Checking Vaccine Stocks
Vaccine stocks must be monitored at all times. Some vaccines have short expiry dates, so avoid over-ordering or stockpiling. Vaccines in refrigerators should be arranged in a way that those with the shortest and earliest expiry dates are used first. They should be moved to the front, most visible line. Regular stock checking ensures that expired products are disposed of immediately, to avoid using them mistakenly.
Store the vaccines in more than one fridge. Keeping one type of vaccine in one fridge is risky, hence they must be spread out. Spreading one type of vaccine across many fridges avoids wasting most of them in case of power outages.
Stock checking requires the use of a stock control book or any database with a suitable backup. In this way, the information will always be available without the need to open the refrigerator door for long periods just to examine the stock. The stock control book should have the following information:
- Vaccine orders,
- Vaccine expiry dates
- Running totals of vaccines.
- Incorporating the temperature monitoring chart from the refrigerator
- Keeps information of just one fridge. (One book per fridge)
Vaccines must always be stored in their original packaging. The original packaging prevents light exposure and maintains temperature. It also contains expiry dates, batch numbers, patient information leaflets, and a summary of product characteristics.
Vaccines must be protected from freezing temperatures, hot temperatures, and ultraviolet light. All vaccines are sensitive, to a certain extent, to hot and cold. While vaccines normally lose potency through time, heat speeds up this process. Freezing, on the other hand, clumps the chemicals in the vaccines, causing deterioration. Freezing can also cause cracks in the ampoules, and vials that are pre-filled, exposing contents to contamination.
b. Using Refrigerators
Ideally, temperatures inside the fridge should be monitored twice a day, or at least once a day. Temperatures must be logged as:
- minimum reading
- maximum reading
- current reading
The maximum stands for the highest temperature of the day; the minimum is for the lowest temperature recorded, and the current is the temperature at the time of the logging.
Below is an example of a temperature logging card:
To determine the temperature, monitors and sensors such as thermometers, must be placed inside each refrigerator. Digital thermometers that have a probe inside a vaccine vial are the preferred ideal. Thermometers need periodically to be reset or replaced, depending on the manufacturer’s guidance.
Although some fridges have an external electronic display, they still need a digital thermometer in case of emergencies such as the failure of the built-in thermometer or loss of electrical power.
Some power losses are caused by neglect of plugs and sockets. This can be prevented by using switchless sockets, and placing warning notices on the sockets and the plugs.
A picture of a vaccine refrigerator with a thermometer is displayed below.
Ordinary or domestic refrigerators are not suitable for vaccine storage. There are specialized refrigerators made just for pharmaceuticals, vaccines, and diluents. The fridge must contain exclusively vaccines, with no food and drinks allowed inside. Opening the door must also be kept to a minimum to avoid raising the temperature inside.
Refrigerators must be located far from radiators or other heat sources to allow proper air ventilation and cooling. Air must also flow freely inside the refrigerators to prevent overheating.
Because vaccines are Prescription Only Medicines (POM), they must be secured at all times. Access doors must be located in a locked room or have a locking refrigerator door.
Ice should not be allowed to build up, as this may subject the vaccines to freezing. To prevent this, personnel must regularly defrost the fridge following the manufacturers’ guidelines.
Personnel must also keep the records of the fridge information:
Take note: Always ready a spare fridge or cooling containers in case of fridge failure, power loss, or other emergencies relating to the fridge performance.
c. What to do during a disruption of Cold Chain?
Not every cold chain process will be smooth and problem-free. Temperature excursions are bound to happen. During those occasions, here are the best things to do:
- Immediately check the temperature and how long the power was gone.
- When the fridge fails, transfer all of its contents to the spare fridge or vaccine containers. Make sure to label them accordingly.
- Do not use vaccines involved in the cold chain disruption until advice has been given by the manufacturer.
- Check the plug connection. It might be because of a loose plug, etc.
- Determine whether the problem is electricity failure. If so, use the generator.
- Inform the designated person in charge of the refrigerators and call the repair engineer.
- Inform your immunization coordinator. The vaccine may still be used despite a cold chain failure.
- List all the vaccines that have been affected by the cold chain disruption.
- Call the vaccine manufacturers and seek their advice on whether the vaccines should be disposed of or could still be used for immunization.
Some of the vaccine manufacturers’ hotline:
- Glaxo Smith Kline on (0808) 100 9997
- Sanofi Pasteur on (01628) 587693
- Novartis on (08457) 451500
- Baxter Healthcare on (01635) 206345
When you call your vaccine manufacturers, provide the following information:
- The maximum period of cold chain disruption
- The actual, minimum, and maximum temperature readings
- The type of vaccines
- The date and time of the next immunization
- The number of vaccines required urgently
When the advice from the manufacturers comes positive, place the vaccines in correct storage conditions, and mark them for immediate use.
If the advice comes out negative, so the vaccines must not be used, do the following:
- Replace the destroyed stock with new stocks
- Record the failures and the reasons for the failures
- Create a critical incident report
Best Practices When Transporting Vaccines
While refrigerators are useful during storage, transporting vaccines requires different containers. Passive packaging is useful during “last-mile” delivery where the vaccines are distributed to the recipient.
Validated cool boxes with maximum-minimum thermometers and cool packs from a recognized medical supply company must be used.
Vaccines need to be kept in the original packaging when placed in the containers. The cool packs must be covered with bubble wrap or any insulation (whatever is recommended by the manufacturers) to prevent direct contact with the vials, thus preventing freezing. To minimize air circulation, the space in the containers must be filled.
Water-packs must be frozen between -25°C to -10°C (-13°F to 14°F) for 24 hours. Then, they must be conditioned—where they de-freeze to 0°C—because very low temperatures may freeze the vaccines.
Vaccines must be loaded into the containers as closely as possible before departure. This will minimize their time of exposure outside of the fridge while also prolonging the cold life of the containers.
When vaccines arrive at the destination, they should be transferred immediately to the fridge from the passive containers. When not yet at the destination, they must be kept in the cold boxes. If vaccines need to be stored overnight, they must be placed in a dedicated freezer that can maintain the required temperature.
The temperature-sensitivity of vaccines has made them difficult products to transport. Because vaccines are life-saving products, their safe delivery, however challenging, must be done efficiently. The loss of vaccine stability can spell disaster as the loss of immunity and the increased incidence of local disease transmission may occur. To prevent these from happening, best practices should always be properly observed.
Several solutions are available in the market. Because temperature plays a vital factor in the cold chain, having temperature solutions is indeed necessary. One of the big players in the market is AKCP. Their temperature monitoring solutions across different countries, and have already established a very good reputation. They offer several devices and systems that may reduce temperature excursions.