Cold Chain Medicine

• Different types of products include biologics or biological products such as vaccines, blood, blood components, allergenics, somatic cells, gene therapy, tissue and recombinant therapeutic proteins, etc.

• Biologics can be composed of sugars, proteins, nucleic acids or through complex combinations of these components or from biological materials such as cells and tissues.

• Biologics are isolated from a variety of natural sources such as the human body, animals, or microorganisms and are prepared through biotechnology and other cutting-edge technologies.

• Gene-based and cellular biologics are often at the forefront of biomedical research and are used to treat a variety of diseases where no other treatment exists.

Most drugs are chemically synthesized and their chemical composition can be easily found out. On the other hand, most biologics are complex compounds so their composition or properties are not easily identifiable. All biological products prepared using biotechnology are heat sensitive and prone to microbial contamination. Hence it is necessary to use complete aseptic principals or sterilization principles from the very first stage of the manufacturing process which is different from the conventional drug manufacturing process.

• A supply chain where temperature, humidity and light are controlled for products that require maintaining a specific temperature limits for supply and storage is called cold chain. In particular, the supply chain through which temperature controlled medicinal products are managed, transported and stored is called the cold chain.

• World Health Organization (WHO) recommends that almost all vaccines (which are a type of biological product) be kept between 2 to 8 degree Celsius.

• Vaccines and other biologics should be stored in a refrigerator that maintains a temperature of 2 to 8 degrees Celsius at all times and the refrigerator should be kept in a secure location where access to the public without permission is reserved.

• Medicines for which cold chain to be maintained to preserve the quality and effectiveness are called cold chain medicine.

• Maintaining the cold chain is very important for the patient's well-being.

• If the cold chain is not maintained, the effectiveness of the medicine will decrease and it will be ineffective. E.g.-

  • If the temperature of the medicine drops below 2 degrees C, it may freeze which may adversely affect the effectiveness of the medicine. In addition, frozen drug vials or syringes may burst.

  • If the temperature of the drug rises above 8°C, the effectiveness of the drug may decrease too.

• Failure to maintain a cold chain may result in ineffective treatment of the disease, may result in the death of the patient.

• Failure to maintain a continuous cold chain of any dose during patient treatment, may result in the entire treatment ineffective. As a result, re-starting treatment can lead to financial loss. This can have a negative impact on the mental health of the patient or their family.

Always buy cold chain medicines only from chemists, pharmacies or home delivery service provider person or company who buy medicines directly from authentic sources.

• Check before buying whether cold chain medicine is kept in refrigerator.

• Check with chemist, pharmacy or home delivery service provider person about how cold chain is maintained during load shedding especially when their chemist shop, pharmacy or sales depot is closed.

• Buy cold chain medicines from those who have 24 hours power backup facilities.

• Check with chemists, pharmacies or home delivery service provider person about how the temperature of refrigerators where cold chain medicines are stored is monitored.

• Buy cold chain medicine from those who have refrigerator temperature monitoring system.

• Do not accept cold chain medicine without proper packaging i.e. ice pack inside thermophore box.

• Do not accept cold chain medicine in polythene bag.

• Polythene bags cannot protect your medicine from exposure to sunlight.

• Always check with your chemist, pharmacy or home delivery service provider person or company for how long the packaging will maintain the required temperature for cold chain medicine. And ensure the use or storage of the medicine within that period.

Always collect the invoice or bill of the medicine and check the expiry date to ensure that the medicine is within the usage expiry date. Never take the medicine if it is broken, torn or opened previously.

• If you want to store cold chain medicine at home, remember that cold chain medicine must be stored in the refrigerator.

• Refrigerator refers to the part of your home refrigerator where we usually store raw vegetables or fruits and vegetables and its temperature lies between 2 to 8 degrees C.

• Cold chain medicine should never be stored in the freezer.

• Freezer is the part of your home refrigerator where we usually store raw fish or meat and its temperature is well below 0 (zero) degree Celsius. So, food items placed in this area freezes.

• Cold chain medicine stored in the freezer may freeze and become ineffective.

• Do not store cold chain medicine on the refrigerator door. Because the medicine is exposed to room temperature immediately when the refrigerator door is opened or closed.

• Do not store cold chain medicine against the inside wall of the refrigerator. Because this can cause ice to accumulate on the medicine.

• Cold chain medicine can be stored in the refrigerator for up to 4 hours if there is no electricity. In that case, the refrigerator door should always be closed.

Reference

1. [Internet; cited 2019, July 14]. Retrieved from

2. [Internet; cited 2019, July 14]. Retrieved from https://www.who.int/immunization/documents/IIP2015_Module2.pdf

3. [Internet; cited 2019, July 14]. Retrieved from