LOGISTICS SYSTEM OF THE SINGLE DISTRIBUTOR

Since the establishment of SK-Pharmacy LLP (hereinafter referred to as the Single Distributor) and to the present, the distribution of medicines and medical devices within the framework of the guaranteed volume of medical care is carried out by transferring the service to outsourcing, in accordance with the Rules for the Procurement of Services for the Storage and Transportation of Medicines and Medical Devices by the Single Distributor within the guaranteed volume of free medical care and the system of compulsory social health insurance, approved by Government Decree No. 47 dated February 9, 2021 (hereinafter referred to as the Rules).

The Rules contain the concept of distribution center (hub) and it is prescribed that the service for storage and transportation through HUBs is procured in the cities of Nur-Sultan, Almaty, Shymkent and Aktobe.

In 13 regional centers, a service is procured for the storage and transportation of goods through operational warehouses.

HUBs are warehouses of class A and B, functionally designed to receive and store a large volume of 2-6 monthly needs of medicines.

Taking into account the geographical location of HUBs according to the ray principle (Figure 1), delivery from HUBs to operational warehouses is carried out within a day (EKR and Mangistau region - up to 1.5 - 2 days):

- North Kazakhstan region, Kostanay, Akmola, Karaganda, Pavlodar regions with a hub in Nur-Sultan;

- Almaty and East Kazakhstan regions with a hub in Almaty;

- Turkestan, Kyzylorda, Zhambyl regions with a hub in Shymkent;

- Atyrau, Aktobe, West Kazakhstan and Mangistau regions with a hub in Aktobe.

Operational warehouses are small warehouses, according to their functional purpose they do not carry out long-term storage of goods, they are organized to receive medicines and further send them in transit (cross docking) to medical organizations in the region.

* Система складской логистики СК-ФАРМАЦИЯ – SK-PHARMACY LLP Warehouse logistic system

4 РАСПРЕДЕЛИТЕЛЬНЫХ ЦЕНТРОВ (ХАБЫ) В НУР-СУЛТАНЕ, АЛМАТЫ, ШЫМКЕНТЕ И АКТОБЕ ОБЕСПЕЧИВАЮТ СВОЙ РЕГИОН ОБУСЛУЖИВАНИЯ (ВСЕГО 4 РЕГИОНА ОБСЛУЖИВАНИЯ) ЧЕРЕЗ ТРАНЗИТНЫЕ ОПЕРАЦИОННЫЕ СКЛАДЫ - 4 DISTRIBUTION CENTERS (HUBS) IN NUR-SULTAN, ALMATY, SHYMKENT AND AKTOBE PROVIDE THEIR SERVICE REGION (TOTAL 4 SERVICE REGIONS) THROUGH TRANSIT OPERATIONAL WAREHOUSES.

ХАБы ориентированы на хранение двухмесячного запаса ЛС и МИ для оперативного перемещения на все 17 регионов - HUBs are designed to store a two-month supply of medicines and medical devices for prompt movement to all 17 regions

In the current year, the procurement of Operational Warehouse Services in four regions (Akmola, Turkestan, Mangystau, Atyrau regions) did not take place.

At the same time, the Rules provide that in the event that the procurement of services for the storage and transportation of goods through operational warehouses is declared invalid, the distribution center provides a service for the storage and transportation of goods in such administrative-territorial units (regions) of the service region.

 Thus, the service is procured by the Single Distributor in all 17 administrative-territorial units of the Republic of Kazakhstan.

Monitoring of medicine residues

The Single Distributor on a permanent basis monitors the remnants of medicines and medical devices in the warehouses of the Single Distributor and the remnants of medicines in medical organizations.

The information system of the Single Distributor (EFIS) has a reporting form for monitoring the residues of medicines and medical devices at the stationary level in order to create a complete picture of the residues in a particular region.

As part of the reboot program, the Single Distributor proposed a model of integrated information systems of medical organizations with EFIS (Figure 2). It is expected that these targeted measures will ensure the uninterrupted supply of medicines and medical devices to the population, help to reduce delivery times by ensuring accurate planning and flow management, reducing the cost and time of processing applications.

*МониторингостатковЛСиМИ - Monitoring of residues of medicines and medical devices

ЕдиныйДистрибьютор – The Single Distributor

Производственнаялиния - Production Line

ЗапасынаскладахЕД - Stocks in the warehouses of the SD

Заказы, остаткивМО - Orders, balances in MOs

Производитель/Дистрибьютор - Manufacturer/Distributor

Поставки - Supplies

ХАБ - HUB

Оперативныйсклад - Operational warehouse

Отгрузка - Shipment

Анализпроизводственноймощностиимониторинготгрузкисогласнографикупоставки - Analysis of production capacity and monitoring of loading according to the delivery schedule

ДвухмесячныйнеснижаемыйостатокнаскладахЕдиногоДистрибьютора - Two-month minimum balance in the warehouses of the Single Distributor

НасегоднянаскладахЛСиМедизделийнасумму 21,4 млрд. тнг - Today, in the warehouses of medicines and medical products in the amount of 21.4 billion tenge

Месячный запас. На сегодня отгружено ЛС и медизделий на сумму 20 млрд. тнг. - Monthly stock. To date, medicines and medical devices have been shipped in the amount of 20 billion tenge.

АвтоматическийконтрольостатковнаХАБах, операционныхскладахЕдиногоДистрибьютора, вМОиудистрибьюторов - Automatic control of balances at HUBs, operating warehouses of the Single Distributor, in MOand at distributors

Взаимодвествиесактиматами, УправлениямиздравохраненияпоосуществлениюсверкиостатковЛСиМИ - Interaction with Aktimats, Health Departments on reconciliation of medicines and medical supplies balances

In order to preserve the quality of medicines, especially vaccines, their storage and transportation must be carried out strictly in accordance with the temperature regime specified by the manufacturer. Maintaining the so-called "cold chain" means that at each stage of the movement of the product to the final patient, strict maintenance of the temperature regime is ensured. At the same time, a responsible organization and a responsible person are assigned at each level (Figure 3).

These measures are enshrined in law, the standard of good distribution practices GDP, approved by the order of the Ministry of Health of the Republic of Kazakhstan, is provided. The Code "On the health of the people and the healthcare system of the Republic of Kazakhstan" prescribes mandatory compliance with the GDP Standard by providers of services for the storage and transportation of medicines.

In accordance with the GDP standard, in order to ensure proper storage of vaccines:

- all warehouses are equipped with refrigerating chambers with a backup uninterruptible power supply and a warning system about deviations from the set temperature;

- installed calibrated systems for continuous monitoring of temperature and humidity with sensors located in places that reflect temperature fluctuations and extreme temperatures;

- sensors are located in such a way as to minimize the influence of temporary factors (opening the door).

Transportation of vaccines is carried out by vehicles with the support of a cooling system.

* Действующая схема движения товара по холодовой цепи - The current scheme for the movement of goods through the cold chain

Хранение и транспортировка вакцин - Storage and transport of vaccines

Общие требования к хранению вакцин - General storage requirements for vaccines

-все склады оборудованы холодильными камерами с резервным источником бесперебойного питания и системой предупреждения об отклонениях от заданной температуры - all warehouses are equipped with refrigerating chambers with a backup uninterruptible power supply and a warning system about deviations from the set temperature;

-датчики расположены таким образом, чтобы свести к минимуму влияние временных факторов (открытие двери) - sensors are located in such a way as to minimize the influence of temporary factors (opening the door)

Соблюдение температурного режима на уровне ТОО СК-Фармация - Compliance with the temperature regime at the level of SK-Pharmacy LLP

Производство ЛС на условиях GMP, GOP, ISO - Production of medicines on the terms of GMP, GOP, ISO

Транспортировка от производителя на условиях DGP - Transportation from the manufacturer on the terms of the GDP

Спец. склад на условиях DGP, ISO - Special warehouse on the terms of DGP, ISO

Холодильное оборудование - Refrigeration equipment

Авторефрижератор с термоконтейнерами, DGP - Refrigerator with thermal containers, DGP

Соблюдение температурного режима на уровне УЗО - Compliance with the temperature regime at the RHD level

УЗ регионов (годовой объем) - HD of regions (annual volume)

Хранение в спец. холодильном оборудовании, DGP - Storage in special refrigeration equipment, DGP

Транспортировка в термоконтейнерах, DGP - Transportation in thermal containers, DGP

Соблюдение температуры хранения на уровне МО - Compliance with the storage temperature at the MO level

Хранение месячного объема в МО - Storage of the monthly volume in MO

Обеспечение пациента - Providing the patient with a vaccine

Общие требования к транспортировке вакцин - General requirements for transporting vaccines

Наличие активной системы охлаждения (авторефрижераторы) - The presence of an active cooling system (refrigerators)

Наличие встроенных датчиков контроля температуры, с возможностью распечатки температурного графика на всем пути следования транспорта - The presence of built-in temperature control sensors, with the ability to print a temperature graph along the entire route of transport

Нормативно-правовое регулирование - Legal regulation

-Статья 78 Кодекса "Условия хранения и транспортировки ЛС и МИ - Article 78 of the Code "Conditions for the storage and transportation of medicines and medical supplies

-Приказ МЗРК от 24.04.2015г. №262 "Правила хранения и транспортировки ЛС и МИ" - Order of the MHRK dated April 24, 2015. No. 262 "Rules for the storage and transportation of medicines and medical supplies"

-Приказ МЗРК от 27.06.2015г. № 392 "Об утверждении надлежащих фарм практик" - Order of the MHRK dated 27.06.2015. No. 392 "On approval of good pharmaceutical practices"

-Приказ МЗРК от 04.03.2015г. № 76 "Об утверждении Правил хранения, транспортировки и использования профилактических (иммунобиологических, диагностических, дезинфицирующих) препаратов" - Order of the MHRK dated 04.03.2015. No. 76 "On approval of the Rules for the storage, transportation and use of prophylactic (immunobiological, diagnostic, disinfectant) medicines"

Хранение и транспортировка ЛС и МИ - Storage and transportation of medicines and medical devices

Наличие разрывов ответственности в холодовой цепи диктует требование по внедрению маркировки и контролю от единого оператора по хранению и транспортировке вакцин, ЛС и МИ для исключения рисков ненадлежащего исполнения требований по хранению и транспортировке - The presence of gaps in responsibility in the cold chain dictates the requirement for the introduction of labeling and control from a single operator for the storage and transportation of vaccines, medicines and medical devices to eliminate the risks of improper fulfillment of storage and transportation requirements

As part of the reboot program, the Single Distributor carried out a pilot project to digitalize the cold chain of vaccines, with the ability to track the location and temperature during transportation of each package.

Холодовая цепь - IT решения и интеграция - Cold chain - IT solutions and integration

Холодовая цепь (единый оператор) - Cold chain (single operator)

Прослеживаемость по маркировке - Marking traceability

Телеметрия (датчики температуры) - Telemetry (temperature sensors)

Мониторинг транспорта - Transport monitoring

Производитель/дистрибьютор - Manufacturer/Distributor

Ответственность производителя/дистрибьютора - Manufacturer/Distributor Responsibility

Таможня, СВК - Customs, SVK

Склад ЕД – Warehouse of SD

Транспорт ЕД - Transport of SD

Медицинская организация - Medical organization

Ответственность МО – MO Responsibility

Интеграция IT-систем для отслеживания Холодовой цепи - Integration of IT systems for tracking the Cold Chain

-Обеспечение готовности Холодовой цепи к приему, хранению и транспортировке вакцин (COVID-19) при карйне низких температурах (до - 70 градусов Цельсия) - Ensuring the readiness of the Cold Chain to receive, store and transport vaccines (COVID-19) at extremely low temperatures (up to -70 degrees Celsius)

-Возмонжость применения RFID-меток (автоматическая идентификация объектов, в котором посредством радиосигналов считываются или записываются данные) - Possibility of using RFID tags (automatic identification of objects in which data is read or written by means of radio