The main provisions of the Concept logistics and quality control in the cold supply chain medicines
1. Medicinal substances and medicinal products manufactured on their basis are considered qualitative and suitable for use if their biological characteristics determined in the process of state registration correspond to the reference values included in the state registers.
2. All medicines are thermolabile. This means that their biological characteristics of quality and suitability for use are reduced depending on the duration and quantitative values of the affecting energy of heat and / or cold during the entire period preceding their use for the purpose.
3. Accelerated determination of the real quality of medicines at any point in the logistics of the «Cold Chain» should be provided with devices for express quality control and confirmed by temperature-time monitoring devices accompanying them from the moment of acceptance for quality to their intended use.
4. Products of medical equipment used in the system of storage, transportation, instrument quality control and documentary temperature-time monitoring are subject to mandatory certification.
5. Pharmaceutical enterprises meet the requirements of the standards adopted in the Russian Federation only under the condition that the biological characteristics of the drugs they produce, determined in the process of final production control, correspond to the same reference characteristics determined in the state registration process.
6. Logistics of the cold supply chain and quality control of medicines should be managed from customer's special points via digital, cellular and / or satellite communications.
7. The main document regulating the observance of proper logistics rules of the "cold" supply chain and the organization of quality control at all stages of storage and transportation of medicines from the moment of their acceptance in terms of quality to their intended use, should be a single governing document - the operating rules.
8. Competitive bidding for the procurement of medicines should be carried out according to uniform criteria for assessing their quality and under the guidance of authorized representatives of federal and regional health services.
1. Question. What caused your concern, mentioned in various publications and speeches at All-Russian conferences, especially in 2018.
Answer. The reluctance of the existing health care structures to listen to proposals for improving the existing drug supply system, without which it is impossible to effectively solve the problems of ensuring longevity, sanitary-epidemiological and, ultimately, national security of the state.
2. Question. What includes in itself medicines supply in the Russian Federation?
Answer. This is an integral part of the state policy, which, through current legislation and other regulatory and legal framework, is designed to provide healthcare, veterinary medicine and a widely branched pharmacy chain with highly effective and safe medicines.
3. Question. What is the proposed concept of quality management of medicines entering the circulation of public health and veterinary medicine?
Answer. This is a science-based and practice-supported complex of organizational and technical activates, that are uniting the organization of pharmacopoeia production, logistics of the cold supply chain and quality control of medicines. That guaranteeing its high quality, efficiently and safety of use in medicine practice.
Management conception of medicine quality includes in itself:
Firstly, attestation organization of pharmaceutical industry activates of Russian Federation according to the requirements GMP.
Secondly, mandatory organization of state registration of pharmaceutical substances used in their mass production;
In-third, mandatory organization of state registration and re-registration of reference values of biological quality characteristics, effective and safety with determining their dependency from the effects of natural factors and above all the ambient temperature;
Fourthly, mandatory organization state acceptance of manufactured medicine with using devices for express control of their biological quality characteristics;
Fifthly, the organization of the National Logistics Cold Chain;
Sixthly, the organization of competitive bidding for their purchases according to the approved criteria of biological characteristics of quality.
4. Question. What do you think is the "Cold Chain" of medicine supply logistics?
Answer. This is complex of organizational and technical activities on safety exiting of medicine quality in process of their storage and transportation from the manufacture moment until intended use.
National Logistics Cold Chain should include:
Firstly, organization of continuous, reliable and documentary, in calendar and real-time mode, monitoring compliance with optimally safe temperature-time storage and transportation of drugs from the moment of their manufacture until use for the intended purpose;
Secondly, the organization of systemic training of medical staff at all levels on its operation;
Thirdly, the mandatory state certification of medical equipment used in the «cold chain»;
Fourthly, the modernization of refrigeration and freezing equipment warehouses storage of medicines.
5. Question. What is the basis of your position about medicine supply problems?
Answer. First of all, should be mentioned:
--Four-year experience in the organization and operation of the first in the health care system of the Department of inter-regional refrigerated transport of vaccines produced by the Immunogen concern in the European part of Russia.
--Five-year experience in consulting at «Smith Klein Beecham» company.
--Participation in the outgoing regional conferences of the State Sanitary and Epidemiological Surveillance to promote the «Cold Сhain» in the system of the national program "Vaccine Prevention".
--Participation in the development of the draft Sanitary-Epidemiological Rules SP 188.8.131.528-03 and the Methodological Guidelines for the Organization of Control over the Implementation of these Sanitary Rules.
--Long-term participation in annual international conferences, round tables and exhibitions.
--Fifteen years of participation in the work of the Association of Parenteral Preparations (USA).
--Twenty years of practice in the development and production of some of the world's best medical thermocontainers and electronic instruments for documentary temperature monitoring.
--The result of almost thirty years of practice is the study and implementation of modern approaches to ensuring the quality assurance of medicines.
6. Question. What makes you carry this heavy load?
Answer. First of all, the desire to help the state in the implementation of its policy to ensure the accessibility of the population to medicines of guaranteed quality.
We should also mention the desire to promote the implementation of the national program "Vaccine Prevention", without which Russia cannot have reliable prospects in ensuring high life expectancy, in ensuring the sanitary-epidemiological and national security of the state.
7. Question. Is there a difference in the wording of the term medicine quality in your wording and in the wording of Federal Law No. 61-FZ (Article 4, paragraph 22)?
Answer. In my proposed version of the term quality, the focus is on ensuring the effectiveness, safety and thermal stability of the biological characteristics of the quality of medicines. As for the wording of the term quality in law, in my opinion, it is empty and it is impossible to make demands on it, much less ensure the priority of state quality control of drugs (article 1, paragraph 2) of the same law.
8. Question. What, in your opinion, is the term "quality of medicine according to the GMP standard"?
Answer. This quality does not exist, at least for the following reasons.
GMP are European good manufacturing practices that:
Firstly, they require certified substances with high biological activity;
Secondly, they require confirmation that the biological characteristics of the preparations determined at the output production control stage correspond to the analogous reference characteristics determined at the state registration stage.
This is not ensured today, since subparagraph 5, paragraph 5, article 13, chapter 6 of the Federal Law No. 61-FZ does not provide for registration of pharmaceutical substances, and given today's practice this confirmation is not required.
So, without a proper approach, the most modern pharmaceutical industries are transformed into enterprises for the production of medicines of uncertain quality.
9. Question. And what about the quality of products produced at Russian enterprises certified by GMP?
Answer. All hope is that domestic pharmacopoeia, built far from always on the most high-tech equipment, still produce products of uncertain, but not always of poor quality and, if we add to this, the packaging, packaging and labeling that do not affect the quality, that is, hope the fact that the medicine will be suitable for use.
10. Question. What determines a huge variety of medicine?
Answer. First of all, their quality is reduced under the influence of ambient temperatures. For Russia with its unfavorable climatic conditions, a large length of transport routes, a poorly developed network of aviation and refrigerated transport, the imperfection of the existing logistics of transportation, instrumental quality control and documentary temperature monitoring - these factors are decisive in the system of quality assurance of medicines used in health care and veterinary medicine.
11. Question. Can you trust the expiration dates of the medicine listed on the individual packages?
Answer. They can be trusted only if the actual quality of each series of manufactured products is determined by comparing their biological characteristics determined by the results of final production control with similar reference characteristics determined during the state registration process.
This will be the beginning of substantive work on improving the «Cold
Chain» and creating an effective quality management system not only for medicine, but also for donor organs, donor blood and its components, as well as the rest of the thermostable medical and social products.
12. Question. How to determine the compliance of pharmacopoeia with GMP requirements?
Answer. There are two solutions of the problem.
1.A problematic solution: it is to stop production and attract professional engineering and technical personnel for these purposes.
2.Easy and always valid solution – to compare biological characteristics of medicine at the stage of their final production control with similar reference characteristics.
13. Question. In Russia, many pharmaceutical companies have been certified for compliance with GMP requirements, and therefore the quality of their products meets GMP?
Answer. If the standards of medicine are purchased from their manufacturers, and not in the supervision services or in the Ministry of Health of Russia, then their quality should be asked only from the Lord God.
14. Question. How much time and money will be needed to create an effective quality management system for your medicines?
a) As for the timing, everything will depend on how the tool that was presented to President Putin V.V. will work. President of Kazakhstan. Approximately two to three years.
b) As for the allocation of funds, they may be required in amounts negligible for the state. I think that what was saved on not purchasing medicines of uncertain quality or lost their quality will be quite enough not only to create an effective quality management system for medicines, but also to provide free medicines for young children, seniors and disabled people of all categories.
If you carefully study the above, we can conclude that the causes of the problems of medicine supply should be sought not in the lack of funding, but in the organization of work itself and low demands on the state of affairs in the assigned area.
Without creating an effective quality management system for medicines, Russian healthcare will always resemble an ostrich in a desert that lacks sand and "green".
15. Question. Is there any hope of Russian pharmaceuticals entering the WTO (World Trade Organization) markets?
Answer. You should be aware that in order to enter the WTO markets, the Russian pharmaceutical production should strictly comply with European GMP, which is almost impossible. Therefore, it is easier for them to acquire Russian technology than to allow a potential competitor to their market. Therefore, they acquire Russian-made products and only those that are trusted and tested.
16. Question. The emergence of Russian-made pharmaceutical products in the WTO markets is impossible?
Answer. It will be possible only when the sale of pharmaceutical products on the WTO markets will not be carried out at negotiated prices, but according to the criteria of a comparative assessment of the biological characteristics of the quality of preparations of the same purpose from different manufacturers and at a contractual price that meets these criteria.
17.Question. What is, in its most general form, the concept of the quality of medicines that you offer?
Answer. I will try briefly, and, in essence, using the basic axioms, provisions that do not require proof, logistics «Сold Сhain», to answer the question.
1. Pharmaceutical substances and medicinal products manufactured on their basis are subject to mandatory state registration with the determination of reference values of their biological quality characteristics and their dependence on the duration and quantitative values of environmental factors and, above all, temperature.
2. The biological characteristics of the quality, efficacy and safety of each series of pharmaceuticals manufactured at pharmaceutical enterprises certified by GMP must correspond to the same reference characteristics determined in the process of their state registration.
3. Acceptance of the quality of manufactured medicines must be carried out using devices for express control of their biological quality characteristics.
4. Packaging and delivery of products to the customer is carried out in certified medical thermocontainers, recommended for use by WHO (World Health Organization), and according to programs and methods agreed with it.
5. Monitoring of compliance with temperature and time storage and transportation of drugs from the moment of their acceptance and before use for the intended purpose is carried out using instruments certified in laboratories certified by WHO, and according to programs and methods agreed with it.
6. Recipients of drugs are granted the right to control their suitability for use with express quality control devices.
18. Question. What are your wishes for the leadership of the health care structures of the Russian Federation?
Answer. 1. So that the government officials responsible for drug supply would have time and desire to get acquainted with this interview.
2. To hear their reasoned assessment of my proposals for resolving the existing problems of the quality of medicines and the logistics of the «Cold Chain» of their storage and transportation.
about the priority tasks of creating in Russia a modern system of quality management of medicinal products entering and being in circulation of public health and veterinary medicine
1. To organize the discussion and development of the draft state concept for the quality management of medicines entering and being in circulation of public health and veterinary medicine.
2. To develop the Logistics Regulation of the "cold" supply chain and quality control of medicines.
3. To organize the re-registration of drugs included in the state registries.
4. To create Centers for the standardization of the quality of medical immunobiological preparations led by the director of the FGBU "Scientific Center for Examination of Medical Devices" at the Ministry of Health of Russia (formerly the T.L.
5. To create Working groups on health care, medical and medicinal provision at the Business Councils of BRICS, EAEU, SCO with the obligatory participation of representatives of the National Association of Honored Doctors of Russia in them.
6. Create Committees to promote small and medium-sized businesses in the healthcare and medical industry at the Chambers of Commerce and Industry of the Russian regions.
7. To restore the activity of the Committee on New Medical Equipment under the Ministry of Industry and Trade of Russia, with the responsibility for developing innovations in healthcare and certifying medical devices.
8. To ensure the completion of the development and organization of the serial production of devices for express control of the biological characteristics of the quality of drugs developed by the Institute of Biological Instrumentation of the Russian Academy of Sciences (Pushchino, Moscow Region).
9. To ensure the completion of the development and conduct of industrial testing programs and methods for determining the biological characteristics of the quality of drugs and their life on existing thermal calorimeters imported.
10. Distribute personal responsibility areas in the health care and oversight structures for ensuring the quality assurance of medicines, the functioning of the cold chain logistics, the organization and widespread introduction of instrumental methods for monitoring the biological characteristics of the quality of medicines, organizing end-to-end documentary temperature monitoring of optimally safe storage and transportation from the moment of acceptance and before the application as intended.
11. Create a National Health Inspectorate, charged with the responsibility of monitoring the implementation of current legislation in the field of drug supply, health care, and veterinary medicine in Russia.
Taking this opportunity, I would like to appeal to the leadership of the Chamber of Commerce and Industry of the Russian Federation with a proposal to organize the first working meeting on creating an effective drug quality management system in Russia with the obligatory invitation to participate in its work of representatives:
- Chambers of Commerce and Industry of Russia and Moscow Region;
- The Ministry of Health of the Russian Federation, Roszdravnadzor and Rospotrebnadzor;
- The Ministry of Industry and Trade of Russia;
- Rostec State Corporation and the National Immunobiological Company (Natsimbio);
- Institutes of Bioorganic Chemistry and Biological Instrument Engineering of the Russian Academy of Sciences, Federal State Budgetary Institution "Scientific Center for Examination of Means of Medical Use" of the Ministry of Health of the Russian Federation (earlier, the T. L. A. Tarasevich GISC);
- National Association of Honored Doctors of Russia;
- Russian Union of Industrialists and Entrepreneurs.