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6PHARMACEUTICAL SCIENCES
SOME ASPECTS OF FUNCTIONING OF THE QUALITY MANAGEMENT SYSTEM IN THE MEDICAL WAREHOUSES OF THE MINISTRY OF DEFENSE OF UKRAINE
Drozdov D.
https://orcid. org/0000-0002-7769- 750X
Bilous M.
Ukrainian Military Medical Academy, Kyiv https://orcid. org/0000-0002-4370-8813
ABSTRACT
Medical supplies - medical equipment has a number of distinctive characteristics, primarily related to its suitability for transportation, warehousing, loading and unloading, storage, etc., which affects the level of logistics costs. These differences are exacerbated by the presence of a pharmaceutical group, which requires even more attention at all stages of the promotion of medical equipment in the supply chain.
Keywords: military medical supply, medical warehouses of the Ministry of Defense of Ukraine, quality management system.
Introduction. The highest financial losses of the medical staff of the Ministry of Defense of Ukraine may be borne by the costs associated with the deterioration of medical supplies, which may be the result of non-compliance with regulations on the preservation of certain groups of medical property.
Related to this is the high percentage of the indicator - losses from the aging of stocks of medical equipment (expiration date) of pharmaceutical products [13].
The purpose of the study is to determine and analyze the prevention of financial losses from non-compliance with the term and rules of storage and development of organizational and methodological measures for effective management of the quality system of the medical staff of the Ministry of Defense of Ukraine.
Materiali ta metodi doslidjenni
To achieve the goal of the study, an analysis of domestic and foreign scientific sources and the current regulatory framework of Ukraine was conducted. During the research the methods of information search, sys-tematization, comparison and generalization were used.
Rezultat i doslidzennya ta obgovorenni
In accordance with paragraph 7 of section I of the Procedure for quality control of medicines during wholesale and retail trade, approved by the order of the Ministry of Health of Ukraine from 29.09.2014 № 677 "Procedure for quality control of medicines during wholesale and retail trade", (hereinafter - Procedure), the business entity is obliged to create an effective quality system of medicines with an approved plan of urgent action, defining measures to ensure compliance with orders of the Ministry of Health of Ukraine and / or orders of the central executive body implementing state policy in quality control and safety of medicines, including medical immunobiological drugs, medical equipment and medical devices, and trafficking in narcotic drugs, psychotropic substances and precursors, combating their illicit trafficking, in relation to the circulation of medicines [4].
The activities of pharmaceutical companies to create a quality management system are an integral part of the functioning of logistics, as their goals are consistent
and affect all aspects of logistics management (financial, personnel and others) [5].
Therefore, the warehouse, as a structural unit of the pharmaceutical company, should be formed a holistic and transparent management system, which includes activities to ensure product quality. Building a management system according to ISO requirements meets the principles of GDP and, conversely, if the entire company already has a quality system in accordance with GDP requirements.
The principle is that ISO does not set requirements for product quality, but for a management system that is designed to achieve a stable level of product quality and the enterprise as a whole. This system should become the basis for building an integrated management system and should apply to all activities to ensure the quality of medical products.
Factors of strategic development "quality" and "safety" can be regulated only when the priorities of quality are an incentive for the development of the enterprise at all levels of activity. To do this, the company selects and implements a quality management system -a quality management system, including in warehouses. Medical staff of the Ministry of Defense of Ukraine is no exception in this aspect.
Problems of forming a quality management system have become the subject of scientific research and discussions in the formation of a quality system in accordance with the requirements of GDP.
Numerous researchers emphasize the urgency of this problem in their works. According to scientists (Panchenko MO, Brovkova OG, 2014) the quality management system is part of the overall management system at the enterprise, which operates to ensure stable quality of products or services. The quality management system (QMS) is a tool that allows you to predict, measure the impact of approved decisions and events in various areas of business on the quality of services. It is the indicators by which you can track the impact of events on the quality of services, mechanisms for their definition, the relationship between cause and effect, and are the objects of implementation in the establishment of QMS in the enterprise. The standard defines
general methods that should be used in the construction of such a quality system to ensure full satisfaction of consumer needs. The standard applies to the quality system, not to the final product or service. The implementation of the quality system should be determined by the tasks, products, processes and individual characteristics of a particular organization [6].
Yu.B. Kabakov [7] outlines the sequence of the first steps in the development of QMS:
1. Understand what QMS is, its place in the enterprise and the role of the first leader in it. (2nd principle);
2. Create an organizational structure that will deal with this project (including its employees and consultant), organize staff training (Principle 3);
3. Develop the structure of processes, parameters that characterize their effectiveness and efficiency, the matrix of responsibility, the structure of QMS documentation, while analyzing problem areas in the enterprise and planning measures to eliminate them (4, 5, 7th principle).
4. In parallel to determine the requirements of customers and the level of their satisfaction, to develop the first version of the Policy, goals and plans of the enterprise. (1st principle).
At the same time, it should always be remembered that QMS is not something done once and for all, but a system that itself is constantly improving and contributes to the continuous improvement of the whole enterprise (Principle 6) and take into account the interests of suppliers (Principle 8).
The QMS of a pharmaceutical company is a management system that guides and controls the activities of the company related to the quality of medicines. The objects of management are the factors and conditions that affect the quality of medicines, as well as the processes of forming the quality of medicines at different stages and stages of the logistics process.
Thus, after analyzing the existing regulatory and information base, it is established that one of the important steps is to identify participants in the system.
In the system of management of the supply of medical property in the Armed Forces of Ukraine there are institutions and units of medical supply. Therefore, the contingency plans should specify the procedure for obtaining information by authorized persons of these business entities on medicinal products that are prohibited in Ukraine, unregistered medicinal products in Ukraine and the division of responsibilities and coordination of actions of authorized persons of medical supply facilities and units. providing information to the territorial body of the central executive body, which implements the state policy in the field of quality control and safety of medicines.
Given Ukraine's course towards European integration in developing a pharmacy quality system, it is necessary to analyze the Joint IFF / WHO good pharmacy practice and develop the above document based on the general provisions of this Guideline, taking into account national legislation in this area. (Order of the Ministry of Health of Ukraine dated 30.05.2013 №» 455) [8].
The quality system of Ministry of Defence Ukraine medical warehouses, which is based on good
distribution practice, good storage practice and includes quality risk management, should be fully documented, approved and subject to periodic monitoring to confirm its effectiveness [9].
In the quality system should address the following General provisions:
• the personnel of the enterprise (the list of persons responsible for carrying out the input quality control of medicines, eligibility requirements, their rights, duties, responsibilities, accountability and procedures for monitoring the performance of their duties);
• the order of the input quality control of medicines, in particular through its reflection in the plan for urgent action, defining measures that ensure the fulfillment of orders of Ministry of Health of Ukraine and/ or orders of the State Medical Service;
• the order of dispensing of medicines;
• the conditions and characteristics of the storage and placement of medicines and medical devices depending on external conditions (light, temperature, humidity, etc.); groups of drugs and formulations; leave conditions; shelf life; location at the premises for storage of drugs of different groups;
• the review of the quality system to confirm its effectiveness.
The procedure for quality control of medicines during wholesale and retail trade is brought in line with the Licensing Conditions of Business Activities for the Production of Medicines, Wholesale and Retail Trade in Medicines, Import of Medicines (except for active pharmaceutical ingredients) [10].
An authorized person must be appointed by both the distributor and the pharmacy to meet the requirements of the above regulations. At the same time, their powers are virtually identical, except for the specific conditions of the activity.
Authorized person - a specialist with a complete higher pharmaceutical education and work experience in the specialty of at least 2 years, who is responsible for effective management of the quality system of medicines in their wholesale trade, conducting incoming quality control of medicines.
Some researchers develop job descriptions for the authorized person and point to the need for secondary specialization in Analytical and Control Pharmacy, but this contradicts the current regulations governing the activities of pharmaceutical workers, namely: the position of "authorized person" is not approved, and the Order "On changes to the order of the Ministry of Health of Ukraine from 07.12.98 N 346 »Order 24.04.2008 N 230 [11], specialization for the authorized person is not entered. Therefore, we have developed the Instruction on the performance of duties of the authorized person of the medical staff of the Ministry of Health of Ukraine to optimize the management of the quality system of medical supplies.
According to Art. 23 of the Law of Ukraine "On Medicinal Products", low-quality medicines, including those whose expiration date has expired, are subject to disposal and destruction. Rules for disposal and destruction of drugs approved by the Order of the Ministry of Health from 24.04.2015 № 242 "On approval of the Rules for disposal and destruction of drugs" [12].
Medicines that are not subject to further use acquire the status of "waste" and are transferred for disposal or disposal to economic entities that have the appropriate licenses to conduct business in the field of hazardous waste management directly or through suppliers, if provided by the relevant contractual conditions.
In addition to these provisions, it is necessary to include clarifying requirements of the Order of the Ministry of Health of 29.09.2014 № 677 [4]:
• medicines of dubious quality - medicines that are stored, transported and sold in violation of current norms and rules, have lost their marketability, do not meet the requirements of analytical normative documents / methods of quality control on visual indicators, for which there is information on non-compliance with other batches of this drug the fact of prohibition in other countries, medicines accompanied by improperly issued quality certificates of a series of medicines, which revealed discrepancies in the accompanying documents and violations of the established conditions for the manufacture of medicines in pharmacies on prescription, etc .;
• low-quality medicines - medicines whose quality does not meet the requirements of regulatory documents, medicines that have undergone mechanical, chemical, physical, biological or other effects that prevent their further use, as well as expired medicines.
Thus, the conducted research also allowed to develop the Plan of urgent actions: Rules of utilization and destruction of medicines. It is planned to conduct further analysis of the organization and management of medical property to optimize the management of the quality system of medical property.
Conclusions
The analysis of prevention of financial losses from non-compliance with the term and rules of storage and previously obtained results of previous studies allowed, on the basis of current regulations, to develop organizational and methodological measures for effective management of the quality system of medical staff of the Ministry of Defense of Ukraine. of the authorized person of the medical staff of the Ministry of Defense of Ukraine and the Plan of urgent actions: Rules of utilization and destruction of medicines.
References
1. Ashok Kumar, M.P. Cariappa, Vishal Marwaha, Mukti Sharma, Manu Arora. [Improving medical stores management through automation and effective communication] Medical Journal Armed Forces India. 2016; 72(1): 61-66. Available from: https://doi.org/10.1016/j .mjafi.2015.01.011
2. Xiaohuan Xiang, Juntao Li, Xingxiang Tao. [Research of a Pharmaceutical Enterprise Warehouse
Management System Based on RFID Technology] Science Research. 2016; 4(2): 43-47. Available from: doi: 10.11648/j.sr.20160402.14
3. Posylkina O.V., YU. YE. Novyts'ka, R.V. Sa-haydak-Nikityuk [Metodychni pidkhody do otsinyuvannya vytrat na upravlinnya zapasamy v optovo-rozdribniy lantsi farmatsiyi] Upravlinnya, ekonomika ta zabezpechennya yakosti v farmatsiyi. 2015; 2(40): 47-52.
4. Poryadok kontrolyu yakosti likars'kykh zasobiv pid chas optovoyi ta rozdribnoyi torhivli: nakaz Minis-terstva okhorony zdorov"ya Ukrayiny vid 29.09.2014 № 677 Available from: URL: https://za-kon.rada.gov.ua/laws/show/z 1515-14
5. Zimon, D., Malindzák, D., Zatwarnicka-Ma-dura, B., Dysko, D. [Quality management model in the supply chain] Production Management and Engineering Sciences. 2016; 4:333-336. Available from: https://doi.org/10.9774/GLEAF.9781315673790_59
6. Panchenko M.O., Brovkova O.H. [Metodyka vprovadzhennya systemy menedzhmentu yakosti na pidpryyemstvi] Innovatsiyna ekonomika. 2014; 6: 224227.
7. Kabakov Yu.B. Systemy menedzhmentu yakosti: z choho rozpochaty. Available from: URL: https://www.uaq.org.ua/docs/article9.pdf
8. NALEZHNA APTECHNA PRAKTYKA: Standarty yakosti aptechnykh posluh (Spil'na nastanova MFF/VOOZ z NAP). Available from: URL: https://zakon.rada.gov.ua/laws/show/897_009/print
9. Pro zatverdzhennya dokumentiv z pytan' zabezpechennya yakosti likars'kykh zasobiv: nakaz Minis-terstva okhorony zdorov"ya Ukrayiny vid 16.02.2009 № 95 Available from: URL: https://za-kon5.rada.gov.ua/rada/show/v0095282-09
10. Litsenziyni umovy provadzhennya hospo-dars'koyi diyal'nosti z vyrobnytstva likars'kykh zasobiv, optovoyi ta rozdribnoyi torhivli likars'kymy zasobamy, importu likars'kykh zasobiv (krim aktyv-nykh farmatsevtychnykh inhrediyentiv): postanova Kabinetu ministriv Ukrayiny vid 30.11.2016 № 929. Available from: URL: https://za-kon.rada.gov.ua/laws/show/929-2016-%D0%BF
11. Pro vnesennya zmin do nakazu Ministerstva okhorony zdorov"ya Ukrayiny vid 07.12.98 № 346: nakaz Ministerstva okhorony zdorov"ya Ukrayiny vid 24.04.2008 № 230. Available from: URL: https://za-kon.rada.gov.ua/rada/show/v0230282-08
12. Pravyla utylizatsiyi ta znyshchennya likars'kykh zasobiv: nakaz Ministerstva okhorony zdo-rov"ya Ukrayiny vid 24.04.2015 № 242. Available from: URL: https://za-kon.rada.gov.ua/laws/show/z0550-15
