FROM PRODUCTION TO PATIENT: DRUG SUPPLY SYSTEM

The state priorities in the healthcare sector of Kazakhstan, focusing on the task of improving the health of citizens, in the fight against serious illnesses, and increasing life expectancy, cannot be considered without the need to ensure wide and unhindered access to effective drug therapy.

The drug supply system is a set of complex interdependent processes from manufacturers to patients:production – examination and registration – inclusion and approval of lists – planning of needs – procurement and supply – issuance.

Responsibility at each stage is shared between the organizations involved in the chain, in accordance with the competencies and assigned responsibilities.

Let's take a detailed look at each stage of the process.

The first stage of the drug supply system process is the production of medicines. After the medicines have been produced, they go through the stage of approval for use and permission to sell them on the pharmaceutical market. Medicines, depending on patent protection, are original and reproduced, trade names may differ from the name of the drug (INN), protected by copyright.

The effectiveness of treatment depends on the use of quality medicines, and this issue is given special attention in the healthcare system. If a drug is approved for use in one country, it does not mean that it is available for use in another country. There are two types of procedures - state registration and evaluation of the quality of medicines after registration.

It all starts with state registration – this is such an admission to the market. Manufacturers apply for registration. A whole system of regulatory mechanisms operates in the country so that Kazakhstanis do not encounter low-quality or counterfeit drugs.

Quality issues of medicines circulating on the market of Kazakhstan are within the competence of the Committee for Medical and Pharmaceutical Control - www.gov.kz/kmfk, which carries out the registration procedure for all medicines and medical devices manufactured in the country, as well as imported into its territory.

The registration procedure is preceded by a thorough examination, which consists of several stages. The examination and issuance of the conclusion is carried out by the National Center for Expertise of Medicines and Medical Devices - www.ndda.kz.

         At the registration stage, the effectiveness and safety of the drug, the feasibility of its presence on the market and issues of compliance with the production technology are determined. The results of preclinical, clinical and laboratory tests are being studied.

In addition, maximum prices are recorded for both free and retail. Maximum prices are formed based on manufacturers' statements and analysis of prices registered in reference countries. The National Center for Expertise of Medicines and Medical Devices - www.ndda.kz analyzes prices and sends them for approval to the Ministry of Health of the Republic of Kazakhstan.

Thus, during registration, the parameters of quality, safety, efficiency and prices are approved, the prices of which should correspond to a specific pharmaceutical product.

In the post-registration period, when each of its series is being released, it is determined to what extent a particular series of the manufactured drug meets the requirements that were established during registration and is confirmed by the issuance of a certificate of conformity.

Safety monitoring of medicines and medical devices circulating on the market is also carried out as part of the pharmacovigilance system. This is necessary so that the drugs used by citizens of Kazakhstan do not do more harm than good. The task of pharmacovigilance is to identify, analyze, evaluate and prevent undesirable consequences from the use of drugs.

If an adverse reaction or ineffectiveness of medicines and medical devices in the treatment of a disease is detected, patients can contact their doctor to fill out a yellow card-message on the website of the National Center for Expertise of Medicines and Medical Devices - www.ndda.kz.

Further, the manufacturers submit an application for the inclusion of medicines in clinical protocols. Recommendations for improving clinical protocols, drug provision are developed and included by the Joint Commission for the Quality of Medical Services of the Ministry of Health of the Republic of Kazakhstan - www.nrchd.kz.

Based on clinical protocols, the Formulary Commission of the Ministry of Health of the Republic of Kazakhstan - www.nrchd.kz considers the issue of including medicines in the Lists. Formulary Commission is a consultative and advisory body of the Ministry of Health of the Republic of Kazakhstan. The commission includes specialists from the authorized body, specialized specialists with relevant knowledge in the field of circulation of medicines, in clinical pharmacology and evidence-based medicine.

Important tasks facing the Formulary Commission are the development of recommendations for the rational use of drugs, consideration of clinical guidelines, protocols for diagnosis and treatment, treatment standards developed for use in the Republic of Kazakhstan, as well as their prices, participation in the development and approval of targeted drug supply programs, assistance ethical drug promotion.

After that, the Ministry of Health of the Republic of Kazakhstan approves the clinical protocols, the Kazakhstan National Drugs Formulary, the Lists for outpatient drug supply and the Single Distributor for procurement within the framework of the guaranteed volume of medical care and in the compulsory health insurance system, which contain: the characteristics of medicines, the international non-proprietary name and their marginal prices.

The procurement of drugs is carried out on the basis of applications submitted to the Single Distributor by medical organizations within the framework of inpatient care and the Social Health Insurance Fund - www.fms.kz within the framework of outpatient drug provision.

Medical organizations themselves determine their need by the names of medicines, volumes and delivery schedule. In accordance with these applications, the Single Distributor conducts the procurement and delivery.

Prescription sale of medicines in the Republic of Kazakhstan is regulated by the Rules for issuing, recording and storing prescriptions, approved by order of the Ministry of Health of the Republic of Kazakhstan. Prescriptions are written and dispensed by medical workers of healthcare organizations within their competence in the presence of relevant medical indications.

Thus, the appointment, dosage and amount of the dispensed medication is determined by the attending physician. Information about the provision of medicines is transmitted to the Social Health Insurance Fund - www.fms.kz, after which the Fund checks the registers and pays for the provided medicines.

In order to track issues of free drug provision and work directly with patients, the Single Distributor has a contact center with the short number 1439. It accumulates all data from the population about supply disruptions, provides information on the timing and dates of delivery of the necessary medicines dispensed free of charge. All calls are free, available for both landline and mobile phones.

Advice on compulsory social health insurance can be obtained at the contact center at 1406. Calls from mobile and landline phones throughout Kazakhstan are free.

The drug supply system is a rather laborious and long process. So, when a drug is dispensed to a patient, the drug goes through all stages of implementation. Each step is regulated by clear legal and regulatory requirements.

The main task is to organize the work in such a way that the system of providing medicines can quickly and clearly respond to changes in demand, be flexible in any emergency and focus primarily on the needs of citizens.

Providing citizens with high-quality and effective drugs has always been a priority in maintaining the health of the nation. Due to the organized system, it is possible to ensure uninterrupted access of patients to safe and affordable medicines, as well as to balance the interests of all participants in the pharmaceutical market: consumers, the state and entrepreneurs involved in the pharmaceutical business.