Cold Chain Of Medicines

The preservation of a medicine is one of the factors that can vary its stability from its manufacture to the moment of its use.

All medications must be kept in the temperature range recommended by the laboratory.The storage conditions of medicines vary.

Depending on the recommendation of the laboratory, medications may be stored differently:

Most oral medications can withstand room temperature. Thermolabile drugs are those that must be kept in the refrigerator, between 2ºC and 8ºC. Some examples are insulins, vaccines, certain eye drops, some antibiotics.

So we will deal with the process that ensures that the medicines are properly preserved, within the established temperature ranges, so that they maintain their original properties: the cold chain.

The cold chain is the set of logistic types of process that assures the correct conservation, storage, transport and distribution of the thermolabile medicines during all the useful life of the drug, from its manufacture to its administration.

The purpose of this process is to ensure that the drugs are properly preserved within established temperature ranges, so that they maintain their original properties.

In the Dominican Republic, Decree No. 246-06 regulates, inter alia, the manufacture, distribution, storage, dispensing and registration of medicines. In Section II, Article 47 provides that applications for health records for biological medicines and release of batches of vaccines must be submitted to the Directorate-General of Drugs and Pharmacies, accompanied by a letter of commitment specifying the measures to be taken to ensure the cold chain from the site of origin to the final distributor.

In the same decree, in Section III 3 Article 159, it is established that the activity of the pharmaceutical or distribution establishment consists of the acquisition, conservation, storage and distribution of medicines and pharmaceutical products.

Therefore, the maintenance of the cold chain for the conservation of medicines, during the whole process of storage and distribution is a responsibility shared by the laboratory and the companies dedicated to the logistics of transport. 

Once the medicine is received by the Pharmacy Service, it is its responsibility to take the necessary measures for the conservation of the medicines, especially the thermolabile medicines.

It is advisable for the pharmacist, when receiving thermolabile medicines, to check that the medicines are in perfect condition. That the medicines have not been exposed to undesirable temperatures, checking the temperature indicators.

Check the temperature of the refrigerator regularly. Thermometers are useful for measuring the temperature, allowing you to know the maximum and minimum temperature, regardless of what they mark at the time of monitoring.

What happens if the cold chain breaks?

Accidental breaks in the cold chain compromise, depending on their characteristics, several parameters:

• The therapeutic pharmacological effects, i.e. the response that the drug causes or develops in the body.
• The stability of the drug, which is the capacity of a product or active ingredient to maintain its original properties for a certain period of time, within its physical, chemical, microbiological, therapeutic and toxicological specifications
• The efficacy of the drug, which is the maximum potential therapeutic response that a drug can induce
• Safety margin: the difference between the usual effective dose and the dose that causes serious or life-threatening adverse reactions.

It is important for the pharmacist to consider removing units of medication that have undergone sudden changes in temperature or are unaware of the time they have been at a temperature different from that indicated by the laboratory, so as not to compromise the patient's health.

How to store thermolabile medicines to avoid breaking the cold chain?

It is advisable to take the following measures

• To have refrigeration equipment that allows the correct conservation of thermolabile medicines within the established temperature ranges.
• It is advisable to continuously record temperatures in a logbook
• To ensure the correct preservation of the medicines, we must choose the most appropriate place to store them. In the first grill are stored those vaccines that in case of accidental freezing do not suffer deterioration: oral polio, measles/RH/SRP and yellow fever. In the second grid, DPT, TT, TD, Td, BCG, pentavalent and hepatitis B are stored.
• Do not put medicine in the refrigerator door and open the refrigerator only as many times as necessary.
• Place bottles filled with salt water or saline on the last shelves of the refrigerator, these help to stabilize the internal temperature of the refrigerator.

Image of the management course for the effective management of the Expanded Program of Immunization (EPI) Module III PAHO Cold Chain. 

Remember

A cold chain that is kept intact guarantees a consumer that the consumer product he or she receives is not out of a given temperature range.

It is the pharmacist's responsibility to advise the customer-patient who purchases the medication of the importance that thermolabile medications are not kept outside the refrigerator, as the medications may lose their effectiveness and/or safety. Therefore, the transport of refrigerated medicines should follow the guidelines indicated by the pharmacist.

Dra. Heiry Mercedes