Научная статья на тему 'FEATURES OF THE IMPLEMENTATION OF THE INTERNATIONAL STANDARD “GOOD PHARMACY PRACTICE” IN THE WESTERN REGION OF RK'

FEATURES OF THE IMPLEMENTATION OF THE INTERNATIONAL STANDARD “GOOD PHARMACY PRACTICE” IN THE WESTERN REGION OF RK Текст научной статьи по специальности «Экономика и бизнес»

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Ключевые слова
PHARMACY ORGANIZATIONS / QUALITY DRUGS / GOOD PHARMACY PRACTICE / GXP / WESTERN REGION OF THE REPUBLIC OF KAZAKHSTAN

Аннотация научной статьи по экономике и бизнесу, автор научной работы — Zhalimova Z.O., Shopabaeva A.R., Urazgaliyev K.S., Tursumatova S.L.

An information analysis of data on the Republic of Kazakhstan (hereinafter referred to as the RK) allowed to assess the status and prospects of the transition of pharmacy organizations to the international standard Good Pharmacy Practice (hereinafter GPP), during which it was revealed that the West Kazakhstan region is in the top three lagging regions. One of the most pressing problems in the pharmaceutical industry of our republic is the transition of as many pharmacy organizations as possible to the international GPP standard - good pharmacy practice. In accordance with the recommendations of the World Health Organization, in 2006, its own national standard was developed, harmonized with GPP - the State Standard “Good Pharmacy Practice”, and on May 27, 2015, Order No. 392 “On Approving Good Pharmaceutical Practices” was adopted. In the Republic of Kazakhstan, the requirements for the transition of pharmacy organizations to GPP standards by 2020 are legislatively enshrined in the Code of the Republic of Kazakhstan dated September 18, 2009 No. 193-IV “On the Health of the People and the Health Care System” (as amended on 01.01.2020) [1].

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Текст научной работы на тему «FEATURES OF THE IMPLEMENTATION OF THE INTERNATIONAL STANDARD “GOOD PHARMACY PRACTICE” IN THE WESTERN REGION OF RK»

А.А. Матжанова, А.М. Ауезова, А.Н. Нурбакыт, Н.Н. Искакова, М.Н. Жакупова, Д.Н. Маханбеткулова, Л.З. Назарова, А.М. Раушанова «КДСЖМ» Казакстандык медицина университет'1 С.Ж. Асфендияров атындат Казак, ¥лттык медицина университет'1 Эл-Фараби атындат Казак улттык университетi

АЛМАТЫ К.АЛАСЫ Т¥РЕЫНДАРЫНЫН 03 ДЕНСАУЛЫЕЫНА ЖАУАПКЕРШ1Л1К ЖЭНЕ МЕДИЦИНАЛЫК САУАТТЫЛЫК ДЕНГЕЙ1

ТYЙiн: Денсаулык сактау саласындаFы сауаттылык децгешн жоFарылату адамнын, дербестiгi мен денсаулыкты сактайтын мiнез-к¥лыктаFы мYмкiндiктерiн кецейтуге, денсаулык Yшiн жауапкершiлiктi сезiнуге, денсаулык саласындаFы сауаттылыкты жоFарылату процесiн адамнын, eмiр сYру сапасын жаксартуFа баFытталFан бeлiгi ретЫде карастыруFа болады. Халыктын, жалпы децгешнде медициналык

сауаттылыкты арттыру тен, к¥кык™ дамытуFа жэне коFамдык денсаулык сактау саласындаFы он, eзгерiстердiн, турактылы^ына сертн бередi.

ТYЙiндi сездер: Медициналык сауаттылык, салауатты eмiр салты, хабардар болу жэне ез денсауль^ына жауапкершiлiк дэрежеа, eмiр сапасы

A.A. Matzhanova, A.M. Auyezova, A.N. Nurbakyt, N.N. Iskakova, M.N. Zhakupova, D.N. Mahanbetkulova, L.Z. Nazarova, A.M. Raushanova Kazakhstan's medical university «KSPH» Asfendiyarov Kazakh National medical university Al-Farabi Kazakh National University

THE LEVEL OF HEALTH LITERACY AND RESPONSIBILITY FOR THE HEALTH OF THE POPULATION OF ALMATY

Resume: Improving the level of literacy in the field of health will contribute to the development of greater autonomy and empowerment of the person in health-saving behavior, the realization of joint responsibility for health, and the process of improving literacy in the field of health can be considered as part of an individual's development towards improving the quality of

life. Improving health literacy at the general population level will give impetus to the development of equity and sustainability of positive changes in public health.

Keywords: Medical literacy, a healthy lifestyle, awareness and degree of responsibility to one's health, quality of life

УДК 6615.12 (574.1)

Features of the implementation of the international standard "Good Pharmacy Practice" in the western region of RK

Z.O. Zhalimova1, A.R. Shopabaeva1, K.S. Urazgaliyev2, S.L. Tursumatova1

1Asfendiyarov Kazakh National medical university

West Kazakhstan Medical University named after M. Ospanov

An information analysis of data on the Republic of Kazakhstan (hereinafter referred to as the RK) allowed to assess the status and prospects of the transition of pharmacy organizations to the international standard Good Pharmacy Practice (hereinafter GPP), during which it was revealed that the West Kazakhstan region is in the top three lagging regions.

One of the most pressing problems in the pharmaceutical industry of our republic is the transition of as many pharmacy organizations as possible to the international GPP standard - good pharmacy practice. In accordance with the recommendations of the World Health Organization, in 2006, its own national standard was developed, harmonized with GPP - the State Standard "Good Pharmacy Practice", and on May 27, 2015, Order No. 392 "On Approving Good Pharmaceutical Practices" was adopted. In the Republic of Kazakhstan, the requirements for the transition of pharmacy organizations to GPP standards by 2020 are legislatively enshrined in the Code of the Republic of Kazakhstan dated September 18, 2009 No. 193-IV "On the Health of the People and the Health Care System" (as amended on 01.01.2020) [1]. Keywords: pharmacy organizations, quality drugs, good pharmacy practice, GXP, GPP, western region of the Republic of Kazakhstan

Introduction

Currently, in Kazakhstan, out of 8887 pharmaceutical license holders, 3% have certificates for good pharmacy practice. In

accordance with the Law of the Republic of Kazakhstan dated December 28, 2018 No. 211-VI 3PK "On Amendments and Additions to Some Legislative Acts of the Republic of Kazakhstan

on the Circulation of Medicines and Medical Devices" with Article 69, the transition for pharmaceutical license holders to the international standard GPP extended to 2023 According to the current legislation of the Republic of Kazakhstan, from January 1, 2023, all pharmacy organizations must switch to the international standard of good pharmacy practice. It is also planned to extend the validity of the GDP and GPP certificates

from 3 to 5 years after two consecutive confirmations, the third -unlimited [2].

An analysis of the data of holders of certificates of good pharmacy practice in the republic showed that the Western region of Kazakhstan belongs to the top 3 not practicing GPP standard. The leading positions in the implementation of the GPP standard are held by the cities of Almaty, Shymkent and the Karaganda region (Picture 1).

КОЛИЧЕСТВО АПТЕЧНЫХ ОРГАНИЗАЦИИ ВНЕДРИВШИХ СТАНДАРТ GPP В РК С 2018-2020 гг.

■ 2018 г-332 аптек

■ 2019 т-347 аптек

Кар Кос Ал м Тур Жа Кыз Пав Сев Аты 1КО Man Акт г.Ас А км 'X о 'X

: агн тана ати кест мбм мло лола еро- раус гнет юбн тана ОЛИ = я

иди иска иска а не лека рлн река Каз кая ау ек- иска иска п -г

екая я я кая я иска я ахст обла ая я я п U

обла обла обла обла обла я обла анс сть обла обла обла ое

сть сть СТЬ сть сть обла сть сть кая обла сть сть сть сть о N s

33 33 27 26 25 22 15 14 13 10 10 7 7 4

33 42 27 26 25 22 16 17 13 10 10 7 7 4

S3 33 55 33

Picture 1 - The number of pharmacy organizations that have implemented the GPP standard from 2018-2019

Purpose of the study

The purpose of this work is to analyze the activities of pharmacies in Aktobe for compliance with the requirements of the international GPP standard. Materials and methods

In preparing this study, methods of sociological survey (questionnaire) were used, as well as comparison methods, mathematical, statistical methods, a descriptive method, a logical method, etc.

The main materials in the study are the data on regulatory documents governing the assessment of the safety of medicines according to good pharmacy practice. Also, the results of the questionnaire of pharmacy organizations in the Aktobe region such as the Millennium pharmacy chain, Europharma, as well as pharmacy organizations at health facilities. In this study, descriptive statistics methods were used. To analyze the results, the SPSS software package (version 12.0) was used. Results and discussion

At the end of the 1st quarter of 2020, out of 347 holders of international GPP standard certificates in the republic, the West Kazakhstan region accounts for 12%.

The transition to the international standard in the Republic of Kazakhstan occurred in 2016, but in the Western region,

implementation began only in 2017 [3]. In 2017, the number of pharmacy organizations that implemented the standard was 27. In 2018, the situation changed and the number of pharmacies that switched to the standard doubled, which amounted to 3.2%. A sociological survey was conducted in order to identify the main causes and levers that inhibit pharmacy organizations in the transition to an international standard, characteristic of the Western region of Kazakhstan.

As a result of the examination and analysis of the results of the work done as part of the implementation of good pharmacy practice, about 100 pharmacists and heads of pharmacy organizations were interviewed. The survey was conducted among pharmacists and pharmacy managers in the public and commercial sectors. The study involved pharmacists with work experience from 6 months to 35 years [4]. To the question "Do you know in which year the main provisions of the GPP were adopted in our country?", 85% of respondents said that they were aware, 10% had difficulty answering and 5% were not aware of the international GPP standard, which tells us that 15% of respondents are not aware of the standard of good pharmacy practice.

Picture 2 "Do you know in which year the main provisions of the GPP were adopted in our country?"

Vestnik KazNMU №2-2020

We also asked respondents to evaluate at what stage the The superior number of respondents in pharmacy organizations

implementation of GPP is their pharmacy organization at the in the commercial and public sectors, namely 39%, said that their

moment. organization was at the initial stage of GPP implementation and

27% said they were half ready (Picture 3).

WHAT STAGE OF GPP IMPLEMENTATION IS VOI R PHARMACY ORGANIZATION AT THIS TIME?

Picture 3 - Analysis of the implementation stage of the GPP standard in the western region of Kazakhstan

The diagram below presents the main reasons for the long the development of standard operating procedures (hereinafter

transition of pharmacy organizations to the GPP standard in the SOPs) makes it difficult, 26% on the need for pharmacists to learn

Western region of Kazakhstan. 38% of respondents agreed that GPP standards (Picture 4).

WHAT DIFFICULTIES DO YOUR PHARMACEUTICAL ORGANIZATION TESTED OR TESTING AT THE IMPLEMENTATION OF NAP?

5% 2% 2%

1%

1 SOP compilation

1 Lack of financial resources due to redevelopment of premises

1 GPP standards training 1 Not experiencing 1 Difficult to answer Implementation period 1 All of the above 1 Not ready yet Special training and financing

Picture 4 - The main difficulties in the transition to the international standard GPP

We also asked managers and pharmacists themselves to assess awareness of the main provisions of the international GPP standard. In most cases, managers and heads of pharmacy organizations replied that pharmacists were partially aware of the

international standard NAP. Although 77% of pharmacists themselves are confident that they are aware of all aspects of the standard, in spite of the fact that they do not practice international standards of good pharmacy practice.

ARE YOU AWARE OF THE BASIC PROVISIONS OF THE GPP INTERNATIONAL STANDARD?

Picture 5 - Awareness of pharmaceutical workers on the main provisions of the international GPP standard

For a more detailed study of the knowledge of pharmacy employees about NAP standards, we asked to answer the question: What can be taken as a documentary basis for the

development of standard operating procedures? 50% of respondents say that the basis of the document is to take job descriptions.

WHAT CAN BE TAKEN AS THE BASIS FOR THE DEVELOPMENT OF

SOP DOCUMENT?

50%

6%

32%

i job descriptions

internal normative document

normative - technical document

state standard of the RK

all of the above

Picture 6 - Documentary basis for the development of standard operating procedures as part of the transition to the international GPP standard

Despite the fact that pharmacists are aware of the main provisions of the international GPP standard, they still do not understand the basic mechanism for writing standard operating procedures, and, therefore, will not be able to provide the population with proper

pharmaceutical assistance to the population and qualitatively implement medicines, as modern pharmaceutical development trends are required our state's market as part of the transition to the international GPP standard.

WHICH OF SOP NEED TO BE DESCRIBED IN YOUR PHARMACY ORGANIZATION?

Picture 7 - Standard operating procedures that need to be described according to respondents in their pharmacy organizations

To the question, "What standard operating procedures do you need to describe in your pharmacy organization?", 30% of the respondents answered the procedure for storing drugs, MI and MT, and about 40% answered the procedure for dispensing drugs, MI and MT to the population. An analysis of the data showed that

one of the main factors in the long transition is the lack of on-site training of employees in the modern requirements for the provision of pharmaceutical care according to GPP standards. Although according to 63% of respondents, pharmacy organizations have a person in charge of compiling SOPs.

Picture 8 - The objectives of the pharmacy organization that introduced the international GPP standard in 2020

Many employees of the pharmacy organization have difficulty in additional types of pharmaceutical assistance to the population within the framework of the GPP standard. One of them, the

presence of a separate office for consultation on certain issues with the consumer.

Picture 9 - Analysis of the types of pharmaceutical assistance to the population that cause difficulties for pharmacists

According to changes in the resolution of the Minister of Health and Social Development of the Republic of Kazakhstan dated May 27, 2015 No. 392 "On the Approval of Good Pharmaceutical Practice", mandatory diagnostic tests and other provisions on medical services performed in accordance with the requirements of the Standard of Good Pharmaceutical Practice (GPP) were excluded.

Despite the fact that the date of mandatory compliance with the GPP standard has been postponed to a later date, pharmacy motivation tools are being introduced in the Ministry of Health of the Republic of Kazakhstan. For example, the European Bank for Reconstruction and Development (hereinafter EBRD), together with the Government of the Republic of Kazakhstan, provides grants of up to 10 thousand euros for a partial reimbursement of the company for the implementation of international standards

(GxP) [5]. This shows that our state provides pharmacy organizations with the opportunity to solve the financial component as part of the transition to international standards of good pharmacy practice. Conclusion

Thus, having studied and analyzed the process of introducing the GPP standard by drug users, it can be concluded that the main reasons for the West Region of the Republic of Kazakhstan in the top 3 lagging areas are, firstly, the lack of awareness of pharmacists in the provisions of the GPP standard, the most knowledgeable are the administrative and managerial personnel. Secondly, the compilation of SOPs causes difficulty, despite the fact that there are responsible persons in pharmacy organizations. Thirdly, the lack of monetary resources for redevelopment of premises according to the requirements of the GPP standard.

REFERENCES

1 The state standard of the Republic of Kazakhstan "Good pharmacy practice". 1615-2006.

2 A.R. Shopabaeva, O.N. Evtushenko, A.R. Tulegenova Analysis of the readiness of the transition of Kazakhstan pharmacies to GPP standards // Bulletin of KazNMU. - 2014. - №5 - P. 165-167.

3 Order of the Minister of Health and Social Development of the Republic of Kazakhstan dated May 27, 2015 No. 392 "On approval of good pharmaceutical practices". URL: http://adilet.zan.kz

4 No. 193-IV 3PK "On the health of the people and the healthcare system" with add. and rev. for 2020 // The Code of the Republic of Kazakhstan dated. - 2009. - P. 2-6.

5 Kaydar E.K., Kenesova A.A., Yurchenko I.V., Sabyrov The health of the population of the Republic of Kazakhstan and the activities of healthcare organizations in 2017. - 2018: Statistical collection. -Astana: Ministry of Health of the Republic of Kazakhstan, 2018. -353 p.

З.О. Жалимова1, А.Р.Шопабаева1, К.Ш. Уразгалиев2, Ш.Л. Турсуматова1 'Казахский национальный медицинский университет имени С.Д. Асфендиярова, Казахстан Кафедра организации, управления экономики фармации и клинической фармации 2Западно-Казахстанский медицинский университет имени М.Оспанова

ОСОБЕННОСТИ ВНЕДРЕНИЯ МЕЖДУНАРОДНОГО СТАНДАРТА GOOD PHARMACY PRACTICE В ЗАПАДНОМ РЕГИОНЕ РК

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Резюме: Информационный анализ данных по Республике в ходе которого было выявлено, что в топ трёх отстающих

Казахстан (далее РК) позволил оценить состояние и областей входит Западно-Казахстанский регион.

перспективы перехода аптечных организации на Ключевые слова: аптечные организации, качественные ЛС,

международный стандарт Good Pharmacy Practice (далее GPP), надлежащая аптечная практика, GXP, GPP, западный регион

РК

З.О. Жалимова1, А.Р.Шопабаева1, К.Ш. Уразгалиев2, Ш.Л. Турсуматова1 С.Ж. Асфендияров атындат Казак ¥лттык медицинауниверситет'1, Казахстан Фармация жэне клиникалык фармацияны уйымдастыру, баскару бвл1м1

Vestnik KazNMU №2-2020

2Марат Оспанов атындат Батыс ^аза^стан медицина yHueepcumemi

ХАЛЫК.АРАЛЫК, СТАНДАРТТЫ XY3ErE ТИ1МД1Л1К КАЗАХСТАН РЕСПУБЛИКАСЫНЫН, БАТЫС АЙМАЕЫНДА GOOD PHARMACY PRACTICE

Тушн: Казак,стан Республикасы (будан api - КР) бойынша акпараттык мэлiметтеpдi талдау фармацевтикалык уйымдардын Good Pharmacy Practice (будан api - GPP) халык,аралык, стандартына кешуЫщ кlазipгi ж^дайы мен болаш^ын баFалауFа мYмкiндiк берд^ осы зерттеу барысында

Батыс Казакстан облысы артта калFан Yш аймактын, катарында екендiгi аныкталды.

ТYЙiндi сездер: дэpiхана уйымдары, сапалы дэpi-дэpмектеp, жаксы дэpiхана практикасы, GXP, GPP, Казакстан Республикасынын батыс аймаFы

УДК 616.379-008.64(51)

Половозрастная распространенность сахарного диабета 2 типа по г. Алматы

Г.П. Касымова1, М.А. Жузенова2

Казахстанский медицинский университет «ВШОЗ»

'профессор кафедры «Менеджмент здравоохранения и фармации»

2докторант по специальности «6й''0200 - Общественное здравоохранение»

Сахарный диабет 2 типа, несмотря на высокие технологии в области диагностики и достижения в лечении влечет за собой высокие проценты инвалидности и летальные исходы вследствие глюкозотоксичности. Рост сопутствующих факторов риска в виде избыточного веса или ожирение усиливает показатели распространенности заболевания.

Цель данного исследования изучение половозрастной распространенности сахарного диабета 2 типа по г.Алматы, РК. Полученные результаты свидетельствуют об актуальности реализации мер по укреплению здоровья населения на межсекоральном уровне учитывая административно- территориальные и половозрастные различия сахарного диабета 2 типа для создания «Здорового города Алматы» и внедрения международных систем долгосрочного моделирования, прогнозирования развития заболевании на региональном и национальном уровнях.

Ключевые слова: сахарный диабет 2 типа, распространенность, половозрастные данные, город Алматы Республика Казахстан

Введение

По оценкам Всемирной организации здравоохранения, в 2014 году диабетом страдали 422 миллиона взрослых во всем мире по сравнению с 108 миллионами в 1980 году, что отражает увеличение уровня заболеваемости диабетом в два раза с 1980 года от 4,7% до 8,5% среди взрослого населения. [1]. Дифференцировать диабет типа 1 и 2 не всегда легко, поскольку для определения функции поджелудочной железы зачастую требуется проведение достаточно сложных лабораторных исследований. Именно поэтому не существует глобальных оценок распространенности отдельно диабета типа 1 и типа 2. Большинство людей с диабетом имеют второй тип. Ранее диабет 2 типа наблюдался практически только среди взрослых людей, но теперь он поражает и детей. [2] Согласно данным Всемирной Организации Здравоохранения, приведенные по профилям сахарного диабета в странах 2016 года общая численность населения Республики Казахстан 17 625 000 человек, рейтинг по уровню доходов средне -высокий. Тенденции стандартизованной по возрасту распространенности сахарного диабета 1 и 2 типов неуклонно возрос выше от 5% к 1980 году до более 10% к 2014году, как среди мужчин, так и среди женщин. Распространенность сахарного диабета по Республике Казахстан составил всего населения 11,5%, среди мужчин 11,3%, среди женщин 11,7%. Сопутствующие факторы риска в виде избыточного веса или

ожирения пропорционально увеличиваются с показателями распространенности сахарного диабета: избыточный вес всего населения 58,7%, среди мужчин 59,8%, среди женщин 57,7%; Ожирение всего населения 23,5%, среди мужчин 21,3%, среди женщин 25,4%; Недостаточная физическая активность всего населения 20,0%, среди мужчин 18,8%, среди женщин 21,0%. [3]

Цель исследования

Вышеупомянутые данные обусловили изучение половозрастной распространенности сахарного диабета 2 типа по городу Алматы Республики Казахстан. Материалы и методы

Статистический анализ распространенности сахарного диабета 2 типа среди населения города Алматы проведен по материалам Национального регистра сахарного диабета с 2012 года по 2019 год, популяционных данных статистического сборника «Здоровье населения Республики Казахстан и деятельности организации здравоохранения» 2016 год, 2017 год, 2018 год.

Инструментом для анализа послужила программа Microsoft Office Excel.

Закономерность изменения числа случаев заболеваний во времени изучалась при помощи анализа динамических рядов по базисному и среднему показателям - абсолютный прирост, темп роста в сравнении относительно 2019 году, темп

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