Quyết định 1730/QĐ-BYT năm 2014 hướng dẫn bảo quản vắc xin do Bộ trưởng Bộ Y tế ban hành

DECISION

PROMULGATING GUIDELINES FOR VACCINE STORAGE

MINISTER OF HEALTH

Pursuant to the Government's Decree No. 63/2012/ND-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health;

Considering the suggestion of the Director of National Institute of Hygiene and Epidemiology - Chairman of the Board of Specialties for establishing vaccination guidelines at the Official Dispatch No. 311/VSDTTU-TCQG dated March 24, 2014;

At the request of the Director General of the General Department of Preventive Medicine - the Ministry of Health,

DECIDES:

Article 1. The guidance for vaccine storage is promulgated under this Decision.

Article 2. Guidelines for vaccine storage shall apply to both state and private vaccination facilities nationwide.

Article 3. This decision takes effect as of June 01, 2014.

Article 4. The Chief of Ministerial Office, Ministerial Chief Inspector, Directors and Directors General of Departments, Bureaus and General Departments directly under the Ministry of Health; Directors of medical facilities directly under the Ministry of Health; Directors of Services of Health of central-affiliated cities or provinces; Heads of medical agencies of Ministries and sectors; Heads of relevant units shall implement this Decision./.

GUIDELINES

FOR VACCINE STORAGE(Promulgated under the Decision No. 1730/QD-BYT dated May 16, 2014 of the Minister of Health)

1. Preface

Vaccine must be stored as regulated by the law on drug storage in cold chain from manufacturers to the users.

Vaccine may be damages and its potency may be reduced or lost if it’s stored improperly. A certain types of liquid vaccines such as Hepatitis B vaccine, DPT (diphtheria – pertussis – tetanus) vaccine, TD (tetanus – diphtheria) vaccine, tetanus vaccine and typhoid vaccine, are sensitive to low temperature and may spoil easily if being frozen. A certain types of other attenuated vaccine such as oral polio vaccine (OPV), measles vaccine, measles – rubella vaccine (MR), measles – mumps – rubella (MMR) may spoil if touching high temperature or light.

If vaccine spoils, its uses may be reduced or lost. Therefore, storing vaccine at a suitable temperature is the most important condition to ensure safety and effective vaccination.

2. General provisions

Regulated subjects

- Vaccines used in the Expanded Program on Immunization (EPI)

- Vaccines used in immunization on demand.

- Vaccines used in epidemic disease control and prevention affairs.

Vaccine storage temperature

- Vaccine must be stored at the exact temperature as instructed by the manufacturer.

- Storage temperature and period of a certain types of vaccines used in the EPI shall comply with Annex 1 herewith.

Diluents storage and usage

A certain types of freeze-dried vaccines must be reconstituted with attached diluents or other liquid vaccines before use.

- Diluents that is packaged together with vaccine must be stored at temperature from +2oC to +8oC.

- If the diluents is packaged separately from vaccine, it may be stored outside the cold chain provided that, before use and reconstitution, it must be refrigerated for 01 day or a given necessary period to have the same temperature with vaccine’s storage temperature as from +2oC to +8oC.

- Not to freeze diluents.

- Diluents for what type of vaccine shall be used for that vaccine only. It should use vaccine and diluents of the same manufacturer.

- Freeze-dried vaccine, after reconstitution, is used within 6 hours. Especially, BCG vaccine shall be used within 4 hours or according to the manufacturer’s instruction.

3. Vaccine stored in cold chain

General principle for storing vaccine in cold chain

- Arrange vaccine and diluents according to classification, batch and expiry date to facilitate in delivery.

- Vaccine with short term of use shall be used first, it may be used according to order of receiving and/or according to vaccine vial monitor (VVM).

- Keep unused vaccine vials brought back from the immunization session and vaccine vials with vaccine vial monitor (VVM) whose color has been changed due to touching with high temperature in boxes with “To be used first” label. These vaccine vials shall be used first in the following immunization sessions.

- Arrange vaccine boxes in correct location to avoid freezing of vaccine and in a given distance in order that cold gas can circulate among the vaccine boxes.

- Monitor daily temperature of cold –storage room and refrigerator (including public holidays and days off) and record information on the temperature monitoring table at least twice per day on the morning when coming and the afternoon before leaving.

- Not store expired vaccines and reconstituted vaccine vials after the immunization session and vaccine vials with VVM’s color changed and requiring disposal in the cold chain.

- The cold chain is used for storing vaccine only.

- Not to store drugs, chemicals, medical waste, foods and beverage in the cold chain.

- Not to regularly open equipment of the cold chain.

- Keep hygiene: keep clean hands before hold any vaccine box or vial.

- Repeat this checking process if refrigeration equipment is replaced.

c) Checking safe vaccine storage area on the foundation of cold-storage room

- Arrange a pile of hollow carton boards with the height of about 150 cm in shelf-added vaccine storage area. Put the temperature recorder on such pile within at least 48 hours and check highest and lowest temperature.

- Types of freeze-sensitive vaccines shall be safely stored in area with temperature from + 20C to + 80C. Mark safe areas for storing vaccines by paint or adhesive tape and ensure that the marked area shall be suitable to dimension of shelves. Distance between shelves must be at least 10cm to ensure the air flow.

- If the temperature is not in the aforesaid limit, mark that area and conduct testing process at other locations until limits of safe storage area are established.

- Repeat this checking process if refrigeration equipment is replaced.

- It’s only advisable to use plastic shelves because wooden shelves may have molds and fungi, keep such plastic shelves in dry places in the warehouse for using in case of need.

- Arrange vaccine boxes on brackets of positive-temperature and negative-temperature cold-storage rooms according to types of vaccines, batches and expiry dates. Vertical distance between vaccines boxes is 5cm for differentiation and ensuring the air flow. Labels of vaccine boxes must be easily found out. Stick notes of names of vaccines, manufacturers, batches and expiry dates on the angle of the bracket.

- Distance between vaccine boxes and distance from the vaccines boxes to the wall of the cold-storage room is 5cm. Distance away from the ceiling is above 10 cm. Not to place vaccines directly on the foundation of cold-storage room.

- Certain vaccines that are stored in three-layer boxes (a large box contains vaccine boxes) shall be untouched until such boxes are opened for delivery of vaccines and moved to two-layer boxes (a small box contains vaccine vials) to facilitate in warehouse management and inventory.

dd) Process of storing vaccines on shelves/panels: (in case of storing large quantity of vaccines)

- Place the shelves on marked area on the foundation of the cold-storage room.

- Place vaccines on the shelves. Maximum height is 150cm. The edges of the shelf are not concealed by vaccine containers.

- Stick labels noting type of vaccine, manufacturer, appearance, batch number and expiry date on the vaccine container placed on the shelf.

- Move unused shelves out of the cold-storage room to facilitate in moving around.

3.3. Process of storing vaccines in chest refrigerators

- Put vaccines and diluents in the refrigerator basket. Not to remove the refrigerator basket to increase storage capacity. Leave space between lines of vaccine boxes to ensure stable air circulation.

- Put thermometer and freeze tag together with types of freeze-sensitive vaccines.

- If the refrigerator has a separate freezer compartment, this compartment shall be used to freeze ice-packs. Not to put so much of ice-packs.

- OPV, measles, BCG vaccines shall be put in the bottom of the refrigerator.

- Types of vaccines which may spoil easily due to freezing (such as VGB, DPT, DT, Td, tetanus, DPT-VGB-Hib, typhoid, cholera vaccines) shall be placed on the upper parts.

- Vaccines and diluents shall be placed as guided in Annex 2 herewith.

3.4. Process of storing vaccines in upright refrigerators

- If the refrigerator has a separate freezer compartment, this compartment shall be used to freeze ice-packs. Not to put so much of ice-packs.

- OPV, measles, BCG vaccines shall be arranged on the top shelf near the freezer compartment.

- Types of vaccines which may spoil easily due to freezing such as VGB, DPT, DT, Td, tetanus, DPT-VGB-Hib, typhoid, cholera vaccines shall be placed on the middle shelves.

- Diluents shall be arranged next to vaccines or in the bottom of the refrigerator.

- Put thermometer and freeze tag together with types of freeze-sensitive vaccines on middle shelves.

- Avoid storing vaccines on the door of the refrigerator.

- The bottom compartment of the refrigerator shall be filled with water bottles to keep temperature in case of the power cut.

- Vaccines and diluents shall be placed as guided in Annex 2 herewith.

3.5. Packaging and transporting vaccines in cold boxes and vaccine carriers

a) Preparing ice-packs

Prepare full amount of required ice-packs. Calculate necessary period for freezing ice-packs.

Preparing ice-packs:

- Step 1: Freezing the ice-packs:

+ Fill the ice-packs with water, leaving a small space for air circulation only, and put the cap on tightly.

+ Hold each ice-pack upside down and squeeze it to make sure it does not leak.

+ Put the ice-pack upright or slantingly in the freezer compartment.

+ The refrigerator's freezer compartment can freeze 6 large ice-packs or 12 ice-packs per day. It’s required more time to freeze a large amount of ice-packs.

+ Leave ice-packs in the freezer compartment at least 24 hours to freeze solid.

- Step 2: Take frozen ice-packs out of the freezer compartment.

- Step 3: Allow the frozen ice-packs to sit at room temperature or dip such frozen ice-packs in a clean basin of water until the ice begins to melt and water starts to form. Check to see if each ice-pack has been prepared properly by shaking it and listening for the sound of water moving around the ice inside. Ice-packs in which the ice has begun to melt are called conditioned ice-packs.

The following packaging method shall be used in any weather conditions during the year and for all routes of transport.

- Put conditioned ice-packs against each of the four sides and also on the bottom of the cold box or vaccine carrier.

- Packaging vaccine boxes with the lids of vaccine vials towards to the top.

- Put the vaccines and diluents into nylon bags and put such bags in the middle of the cold box or vaccine carrier.

- Put the thermometer next to vaccines (outside the nylon bags).

- In cold boxes, place conditioned ice-packs on top of the vaccines. In vaccine carriers, place a foam pad on top of the conditioned ice-packs.

- Close the lid of the cold box or vaccine carrier tightly.

- Keep cold boxes or vaccine carriers away from the sunlight or heat sources in the course of maintenance and transport.

- Put the ice into nylon bags and put such bags in the bottom of the cold boxes or vaccine carriers.

- Put cardboard to detach vaccines from ice.

- Put vaccines boxes or vials and thermometer into nylon bags (keep vaccine label unwetted and unpeeled.

- Not to put ice on the vaccines.

- Place a foam pad on top of the vaccine carriers and close the lid.

3.6. Maintaining vaccines during the immunization session

a) Preparing vaccine carriers: If vaccines have been stored in the refrigerator or cold boxes, vaccines must be moved to vaccine carriers during the immunization session.

b) Place vaccines in vaccine carriers as guided in Annex 3.5 herewith.

c) Maintaining vaccines during the immunization session

- Place vaccine carriers in a shady place.

- Close the lid of vaccine carriers tightly until you need to take vaccine out.

- There are some cuts in the foam inside the vaccine carriers to allow vaccine vials to be inserted in the pad. Opened multi-dose vaccine vials must be inserted into the cuts of the foam pad during the immunization session.

- Keep conditioned ice-packs and thermometer from +2°C to +8°C.

- The ice-pack whose ice has quite melt inside (or ice has quite melt inside vaccine carriers) should be replaced with another ice-packs or added with much ice.

- When the immunization session ends, unopened vaccine vials should be placed into the refrigerator and in the boxes noting “first-to-use" and should be used firstly in the following immunization session.

3.7. Reading vaccine vial monitor (VVM); Freeze Tag; the shake test: As regulated in Annex 3 herewith

4. Maintaining equipment and inspect vaccine storage in cold chain.

- Cold chain equipment must be properly maintained and cleaned. Refrigerator and cold-storage room must be defrosted regularly. Always dry vaccine carriers and cold boxes after use.

- Make plans for periodically inspecting operating capacity of the cold chain equipment and make plans for properly repairing or replacing in order to ensure that vaccines shall be safely kept during the storage, transport and use.

- Appoint technical officers to support and inspect the process of vaccine storage.

- Establish a plan providing against emergencies (broken refrigerator, fire, flood, power cut), stating methods for taking actions against emergencies, name and telephone number of technical officer in charge. This plan must be approved by the leadership, disseminated and glued at a noticeable and legible place.

5. Taking notes and reports: Comply with the Circular No. 12/2014/TT-BYT dated March 20, 2014 of the Minister of Health providing guidance on vaccine usage in vaccination.

Annex 1: Storage temperature and period of a certain types of vaccines used in the Expanded Program on Immunization (EPI) at all levels

1. Temperature for storing vaccines in the EPI

2. Storage period of vaccines used in the EPI at levels

- Regulations on period for storing vaccines at levels are to make plans for ensuring the timely and continuous provision of vaccines in the EPI. This storage period shall not cause influence on expiry date or quality of vaccines that has been announced by the manufacturer.

- Maximum storage period of vaccines at warehouses is as follows:

+ National and regional EPI vaccines warehouse: 12 months

+ Warehouses of protective medical centers of provinces or cities: 6 months

+ Warehouses of protective medical centers of districts: 3 months

+ Medical facilities: 1 month

- Taking actions against the cases that vaccine storage period at levels is over the storage period stipulated above because the use of vaccines is suspended or vaccines were left from the EPI campaigns:

+ Vaccines that are unexpired and stored in a proper manner as regulated shall be kept for further use or transferred to another immunization session.

+ Vaccines that expire or are not allowed to be kept for further use must be discarded as regulated.

Annex 2. Guidelines for storing vaccines in chest refrigerators and upright refrigerators

Notes:

- Always store vaccines in the refrigerator basket.

- If the refrigerator has no basket, place freeze-sensitive vaccines at 20cm away from the bottom of the refrigerator by chocking with empty ice-packs in the bottom.

- Avoid placing vaccines touched the walls of the refrigerator.

- Not to place freeze-sensitive vaccines or diluents in the bottom.

Annex 3. Guidelines for reading vaccine vial monitor (VVM); Freeze Tag; and shake test

1. Directions for reading vaccine vial monitor (VVM)

The vaccine vial monitor (VVM) is a label that attaches to vaccine vial and changes colour when the vaccine vial has been exposed to high temperature over a period of time. Before opening a vaccine vial, the status of the VVM must be checked to see whether the vaccine has been damaged by heat.

Manufacturers attach VVMs to vials of most vaccines. The VVM is printed on the label or cap of vaccine vial. It looks like a square inside a circle. As the vaccine vial is exposed to more heat, the square becomes darker.

Only use vaccine vial where the inner square in the VVM is lighter in colour than the outside circle.

Vaccine vials with VVMs in which the inner square has begun to darken, but is still lighter than the outer circle should be used first.

Notes: VVM cannot tell that whether vaccine has been exposed to freezing temperatures.

2. Directions for reading Freeze tag

Freeze Tag is a device used to monitor whether vaccine storing temperatures are under 0oC. If the freeze-tag is exposed to a temperature below 0oC for 60 minutes, the display will change from the V mark to the X mark, and in this case, the shake test should be used to check whether freeze-sensitive vaccines have been damaged.

3. The shake test

The shake test shows that whether freeze-sensitive vaccines (DPT, DT, Td, UV or Hepatitis B) which may be damaged by touching freezing temperatures must be discarded. After vaccines have been frozen, precipitation occurs, it tends to leave sediments in the bottom of the vial after shaking. The sedimentation may be quicker in frozen vials than that of non-frozen vial of the same manufacturer. This test should be used for all vaccine boxes whose freeze-tags show that vaccines have been exposed to the temperatures below 0°C or recorded temperatures are lower than allowed limits.

To perform the shake test, follow the steps below:

Some vials have large labels that conceal the vial contents. In this case, turn the control and test vials upside down and observe sedimentation taking place in the neck of the vials.

If the shake test shows that the test vaccine has been damaged by freezing, it should be promptly reported to the supervisor. Vaccine vials that have probably been frozen must be determined and placed separately for ensuring that such vaccines shall not be distributed and used.

Notes: Frozen test vaccine used in the shake test must be taken from the same type and batch of vaccine, and from the same manufacturer.

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