HOW THE COLD CHAIN SYSTEM IS COMPLIED AT SK-PHARMACEUTICALS

SK-PHARMACEUTICALS

Today, the global medical community pays special attention to the availability of high-quality and safe medicines.

Kazakhstan is no exception, and therefore our drug supply system is regularly improved to guarantee the quality and safety of medicines.

The national regulatory system plays an important role in market access, which includes mandatory state registration of medicines, comprehensive examination and ongoing pharmacovigilance in accordance with international standards.

As for free drug supply within the framework of the GVFMC and OSHI, this includes drugs that have passed the Formulary Commission to assess their safety and effectiveness. Purchases and deliveries for medical organizations are carried out by SK-Pharmaceuticals, which delivers drugs based on requests from medical institutions, which in turn independently determine their needs.

The key point in this process is the transportation of medicines; the entire delivery process, known as the "cold chain", requires strict adherence to the temperature regime at each stage.

We suggest separately understanding how the Unified Distributor's "cold chain" system is arranged. The cold chain is a set of continuously implemented measures aimed at creating and maintaining a certain temperature regime for the storage and transportation of thermolabile medicines, including vaccines, throughout the entire route from the manufacturer to the consumer.

The cold chain consists of four links:

1. From the manufacturer to the warehouses of the Unified Distributor;

2. From the warehouses of the Unified Distributor to the pharmacy warehouses of local health authorities;

3. From the pharmacy warehouses of local health authorities to medical organizations;

4. Storage in medical organizations until use by patients.

At each stage, responsibility is distributed between the participants in the chain. If at least one link in the cold chain is violated, then all other efforts will be of no use. Violation of the temperature regime of drugs can affect the original qualities and provoke undesirable reactions after administration into the human body. To prevent such incidents from happening, the full readiness of the climate control equipment has been checked at the warehouses of the Unified Distributor, both inside the warehouse premises and in specialized vehicles with the observance of the regulated temperature regime.

All warehouses of the Unified Distributor comply with the standard of good distribution practice GDP.

Cold and freezing chambers in warehouses are equipped with temperature sensors with automatic response in case of temperature deviation. If the temperature deviates from the norm, an alarm is triggered and an SMS notification is sent to the responsible person. Information from all sensors is transmitted to the central temperature and humidity control system.

Transportation is of particular importance in the "cold chain". At all links of transportation, registration of receipt and further dispatch is carried out with recording of temperature readings in the accompanying documents. Thermolabile drugs are transported by special motor transport - a refrigerated truck, which is pre-validated. Refrigerated trucks are equipped with temperature sensors with the ability to unload and print out the history of temperature and humidity values during transportation to the recipient. If the distances are small, for example, within a populated area, a thermal container is used to transport vaccines, protecting against changes in ambient temperature, into which thermal indicators are placed, indicating the storage temperature of the products during transportation.

For SK-Pharmaceuticals, ensuring the quality and safety of vaccines is a priority. We continue to improve logistics, maintaining the continuity of the cold chain at all links.