Organization of the quality assurance system of compounding pharmacies in Ukraine: results of the survey

Authors

  • O. A. Zdoryk National University of Pharmacy, Ukraine

DOI:

https://doi.org/10.24959/nphj.14.1993

Keywords:

compounding preparations, quality assurance system, survey

Abstract

To meet the needs of patients for treatment of a number of diseases compounding preparations are often used. The aim of our study was to determine the possibility of introduction of the international experience of forming the quality assurance system for compounding preparations in conditions of compounding pharmacies of Ukraine. For this purpose the survey of employees of compounding pharmacies regarding organization of the quality assurance system for compounding preparations has been conducted. In the survey 93 employees of compounding pharmacies took part. The research was conducted in 12 regions of Ukraine in 2013-2014. The questionnaire contained 44 questions, which represented the statements of organization of the quality assurance system of compounding pharmacies of Ukraine and compounding preparations. The statements were divided into 10 groups: personnel and training, premises and equipment, documentation, production, complaints and product recalls, self audits, in-pharmacy quality control, work contracted out, the necessary requirements of the State Pharmacopoeia, overarching statements. For the collection and processing of data 4-point Likert scale was used. The statement was considered to be accepted if more than 50% of respondents chose “A – strongly agree” or “B – agree”. The survey of employees of compounding pharmacies concerning the possibility of introducing the international experience of the quality assurance system for compounding preparations has allowed to determine and estimate their attitude to the statements proposed, to identify the points of discussion. Processing of the results of the survey has shown that all 44 statements were approved by more than 71.0% of the respondents. Each statement received an average of 94.9% of “A” or “B”. And 22 statements (50.0%) had 100.0% agreement “A” + ”B”.

Author Biography

O. A. Zdoryk, National University of Pharmacy

 

References

Валиев А.Х., Георгиянц В.А., Здорик А.А. // Зб. наук. праць співробіт. НМАПО ім. П.Л.Шупика. – 2012. – Т. 4, №21. – С. 203-210.

Вимоги до виготовлення стерильних лікарських засобів в умовах аптек: Метод. рекоменд. / За ред. О.I.Тихонова, Т.Г.Ярних. – К.: МОЗ України, 2005. – 76 с.

Вимоги до виготовлення нестерильних лiкарських засобiв в умовах аптек: Метод. рекоменд. / За ред. О.I.Тихонова, Т.Г.Ярних. – К.: МОЗ України, 2005. – 98 с.

Здорик О.А., Георгіянц В.А., Зімін С.М. та ін. // Клінічна фармація. – 2013. – №2. – С. 46-51.

Здорик О.А., Георгіянц В.А., Товмасян Є.К. та ін. // Фармаком. – 2013. – №1. – С. 52-58.

Здорик А.А., Штримайтис О.В., Георгиянц В.А. // Вісник фармації. – 2014. – Т. 63, №1. – С. 16-21.

Здорик О.А. // Фармац. журн. – 2013. – №6. – С. 42-47.

Здорик О.А., Георгіянц В.А. // Фармац. журн. – 2014. – №1. – С. 22-27.

Євтіфєєва О.А. // Вісник фармації. – 2013. – №1. – С. 9-18.

Євтіфєєва О.А., Проскуріна К.І., Здорик О.А. та ін. // Фармаком. – 2012. – №1/2. – С. 63-71.

Настанова СТ-Н МОЗУ 42-4.0:2014. – Лікарські засоби. Належна виробнича практика / М.Ляпунов, О.Безугла, М.Пасічник та ін. – К.: МОЗ України, 2014. – 302 с. – Режим доступу до настанови: http://www.moz.gov.ua

Соловйов О. // Фармац. кур’єр. – 2011. – №7. – Режим доступу до журналу: http://www.pharmcourier.org

A guide for compounding practitioner USP 35 – NF 30. – The United States Pharmacopeial Convention. – Rockville, 2012. – 317 p.

Allen Loyd V.Jr. // IJPC. – 2012. – №2 – P. 146-150.

Armstrong E. // IJPC. – 2002. – №3. – P. 168-170.

British Pharmacopoeia. – London: The Stationary Office, 2001. – Vol. 1-2. – 3199 p.

Fields Sh.W. // IJPC. – 2006. – №6. – P. 417-418.

Final Basel Statements. FIP Global Conference on the Future of Hospital Pharmacy // 68th Intern. Congr. of FIP, Basel, Switzerland, 30-31 August 2008. – 10 p.

Fonseca S.C. // IJPC. – 2006. – №2. – P. 122-127.

Loresco F., Vermeulen L.C. / Am. J. Health-Syst. Pharm. – 2009. – Vol. 66, Suppl. 3. – P. 13-19.

Lutz E., Pauletti G., Carvalho M. et al. // IJPC. – 2014. – №1. – P. 6-12.

McNulty J.P., Muller G. // IJPC. – 2014. – Vol. 18, №3. – P. 190-200.

PIC/S Guide to Good Practices for the Preparation of Medicinal Products in Healthcare Establishments / Ed. by PIC/S Secretariat. – 2014. – 56 p.

Vail J. // IJPC. – 2004. – №6. – P. 443-447.

Downloads

Published

2014-12-01

Issue

Section

Organization and Economy of Pharmacy