National experience of formation the storage and distribution of drugs requirements
DOI:
https://doi.org/10.15587/2313-8416.2016.65079Keywords:
pharmacy, storage of drugs, distribution of drugs, Good Storage Practice, quality managementAbstract
Aim. The aim was to study national experience of drugs storage and distribution organization for the nation’s pharmaceutical maintenance further improvement.
Methods. The authors used the analysis and synthesis method considered as general scientific. Comparative, structural and functional, logical and semantic methods, as well as system analysis methods have been used.
Results. The main tendencies of formation the essential requirements to storage and distribution of drugs have been examined, and functions of responsible person to meet Good Storage Practice requirements have been systematized. It has been found, that the beginning of harmonization of the normative base of Ukraine’s pharmaceutical segment with European and international legislation happened in 2003, and besides, the closest cooperation may be observed in the last three years; and now the place and role of professional responsibility becomes more clear in national legislation.
Conclusion. Systematization of requirements to responsibility under Good Storage Practice conditions has been carried out. It has been determined, that pharmaceutical specialist’s responsibility during storage of drugs has not yet been adjusted by national pharmaceutical legislation, and it needs further processing
References
Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms (1996). WHO Technical Report Series, № 863. Available at: http://new.paho.org/hq/dmdocuments/2008/6_Annex_5_report_34
WHO Expert Committee On Specifications For Pharmaceutical Preparations (2003). WHO Technical Report Series. Available at: http://www.gmp-compliance.org/guidemgr/files/WHO_TRS_908.PDF
Guide to good storage practices for pharmaceuticals (2003). World Health Organization. Available at: http://apps.who.int/prequal/info_general/documents/TRS908/WHO_TRS_908-Annex9.pdf
Nastanova. Likars'ki zasoby. Nalezhna praktyka zberihannya [Guidance. Medicines. Good storage practices] (2011). ST-N MOZU 42-5.1:2011. – Ministerstvo ohorony zdorov’ja Ukrai'ny. Available at: http://gmpua.com/World/UA/nastanova42512011.pdf
Nakaz MOZ Ukrayiny vid 16.03.1993. № 44 [Order Ministry of Health number 44] (2011). Ezhenedel'nyka APTEKA. Available at: http://www.apteka.ua/article/91510
Pro zatverdzhennya Pravyl zberihannya ta provedennya kontrolyu yakosti likars'kykh zasobiv u likuval'no-profilaktychnykh zakladakh [On approval of Rules of storage and quality control of medicines in health care settings] (2003). MOZ Ukrai'ny; Nakaz, Pravyla vid 16.12.2003, № 584. Available at : http://zakon2.rada.gov.ua/laws/show/z0275-04
Pro zatverdzhennya Poryadku kontrolyu yakosti likars'kykh zasobiv pid chas optovoyi ta rozdribnoyi torhivli [On approval of quality control of medicinal products in wholesale and retail trade] (2014). MOZ Ukrai'ny; Nakaz, Porjadok, Rejestr; vid 29.09.2014, № 677. Available at: http://zakon2.rada.gov.ua/laws/show/z1515-14
Guidelines for Temperature Control of Drug Products during Storage and Transportation (GUI-0069) (2011). Health Products and Food Branch Inspectorate. Available at: http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui-0069-eng.php
Przechowywanie leków (2013). Ministerstwo zdrowia. Available at: http://www.mz.gov.pl/leki/produkty-lecznicze/przechowywanie-lekow
National Medication PRACTICE STANDARDS (2009). Ministry of Health and Family. Available at: http://www.health.gov.mv/standards/9_National%20Medication%20Practice%20Standards.pdf
Derzhliksluzhba povidomlyaye pro zatverdzhennya zmin do Nastanovy «Likars'ki zasoby. Nalezhna praktyka dystrybutsiyi» [State Service of medicines announces approval of amendments to the Guidelines "Drugs. Good distribution practice "] (2014). Pres-sluzhba Derzhavnoi' sluzhby z likars'kyh zasobiv. Available at: http://www.kmu.gov.ua/control/uk/publish/article?art_id=247575977&cat_id=244277212
Pro zatverdzhennya Litsenziynykh umov provadzhennya hospodars'koyi diyal'nosti z vyrobnytstva likars'kykh zasobiv, optovoyi, rozdribnoyi torhivli likars'kymy zasobamy [On approval of the license conditions of the business of drug manufacturing, wholesale and retail sale of medicines] (2011). MOZ Ukrai'ny; Nakaz, Umovy, Forma typovogo dokumenta; vid 31.10.2011, № 723. Available at: http://zakon2.rada.gov.ua/laws/show/z1420-11/page
Pro zatverdzhennya Poryadku perevirky pered vydacheyu litsenziyi na provadzhennya hospodars'koyi diyal'nosti z vyrobnytstva likars'kykh zasobiv, optovoyi, rozdribnoyi torhivli likars'kymy zasobamy [On approval of checks before issuing licenses for the business of drug manufacturing, wholesale and retail sale of medicines] (2012). MOZ Ukrai'ny; Nakaz, Porjadok, Forma typovogo dokumenta; vid 11.07.2012, № 513. Available at: http://zakon2.rada.gov.ua/laws/show/z1262-12/paran14#n14
Schmitt, W. (2011). Guideline on Good Distribution Practice with major Changes. The European Compliance Academy. Available at: http://www.gmp-compliance.org/eca_news_2702_7132,6872,6935,6996,6742.html
Downloads
Published
Issue
Section
License
Copyright (c) 2016 Ольга Олександрівна Молодожонова, Григорій Пилипович Суховий, Інна Володимирівна Бушуєва
This work is licensed under a Creative Commons Attribution 4.0 International License.
Our journal abides by the Creative Commons CC BY copyright rights and permissions for open access journals.
Authors, who are published in this journal, agree to the following conditions:
1. The authors reserve the right to authorship of the work and pass the first publication right of this work to the journal under the terms of a Creative Commons CC BY, which allows others to freely distribute the published research with the obligatory reference to the authors of the original work and the first publication of the work in this journal.
2. The authors have the right to conclude separate supplement agreements that relate to non-exclusive work distribution in the form in which it has been published by the journal (for example, to upload the work to the online storage of the journal or publish it as part of a monograph), provided that the reference to the first publication of the work in this journal is included.