Methodological substantiation of the professional functions of Responsible persons of pharmaceutical and hospital institutions

Authors

  • N. O. Vetiutneva Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine,
  • S. H. Ubohov Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine,
  • L. O. Fedorova Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine,

DOI:

https://doi.org/10.14739/2409-2932.2018.1.123723

Keywords:

medicines, quality control, Responsible person, professional competence, pharmacy, hospital institution

Abstract

The aim of the work is the content analysis and methodological justification of the professional functions of the Responsible persons for quality assurance of medicines in pharmaceutical and hospital institutions.

Materials and methods. The following research methods were used: system and comparative analysis, generalization, systematization, graphic modeling, observation. Research materials: normative legal acts, normative documents, recommendations of international organizations, information of wholesale and retail pharmaceutical companies, pharmaceutical and hospital institutions, professional non-governmental organizations, placed on official web-sites and collected in the process of direct observation.

Results. The personnel and qualification aspects of professional activity of Responsible persons of pharmaceutical and hospital institutions were discussed. On the basis of analysis of the modern legal and regulatory framework, a general list of professional functions of the Responsible persons of health care institutions had been formed. The content analysis and comparison of the number of the functions of Responsible persons performed in health care institutions of different types is carried out. The new functions of the Responsible persons of health care institutions are considered. The managerial nature of the professional functions of the Responsible persons and the expediency of their complementing with the leadership functions are substantiated. On the basis of international management standards, requirements of GPP and GPEP, systematization of the functions of the Responsible persons of health care institutions in the groups and subgroups was performed.

Conclusions. The generalization and systematization of the professional functions of the Responsible persons of health care institutions had been carried out for five classification groups of functions, namely: leadership, planning, organizational, control and information, of which the largest part is carried out at the level of wholesale pharmaceutical enterprises (79 %) and has organizational character (33.5 %). The expediency of inclusion in the list of professional functions of the Responsible person of an consultative and enlightenment function and a group of leadership functions covering the target, socio-ethical and psychological aspects of his professional activity is substantiated. Professional functions of the Responsible persons are structured in the form of a tree of functions, which is the basis for the development of typical process models of the quality assurance system of medicines in pharmaceutical and hospital institutions.

References

(2014) Likarski zasoby. Nalezhna praktyka dystrybutsii: Nastanova ST-N MOZU 42-5.0:2014 [Medicinal products. Good Distribution Practice: Guidelines ST-N MOZU 42-5.0:2014]. Kyiv: MOZ Ukrainy. [in Ukrainian].

(2015) Likarski zasoby. Nalezhni praktyky farmakonahliadu: Nastanova ST-N MOZU 42-8.5:2015 [Medicinal products. Good Pharmacovigilance Practices: Guidelines ST-N MOZU 42-8.5:2015]. Kyiv: MOZ Ukrainy. [in Ukrainian].

(2013) Nakaz MOZ Ukrainy «Pro zatverdzhennia protokoliv provizora (farmatsevta)» vid 11 zhovtnia 2013 roku №875 [Order of the Ministry of Health of Ukraine «Protocol for pharmacist» from November 10, 2013, №875]. Retrieved from: http://www.apteka.ua/article/267027. [in Ukrainian].

(2003) Nakaz MOZ Ukrainy «Pro zatverdzhennia Pravyl zberihannia ta provedennia kontroliu yakosti likarskykh zasobiv u likuvalno-profilaktychnykh zakladakh» vid 16 hrudnia 2003 roku №584 [Order of the Ministry of Health of Ukraine «Rules for storage and conduct of quality control of medicines in hospital institutions» from December 16, 2003, №584]. Retrieved from: http://zakon3.rada.gov.ua/laws/show/z0275-04. [in Ukrainian].

(2012) Nakaz MOZ Ukrainy «Pro zatverdzhennia Pravyl vyrobnytstva (vyhotovlennia) ta kontroliu yakosti likarskykh zasobiv v aptekakh» vid 17 zhovtnia 2012 roku №812 [Order of the Ministry of Health of Ukraine «Rules of production (manufacturing) and quality control of medicines in pharmacies» from October 17, 2012, №812]. Retrieved from: http://zakon2.rada.gov.ua/laws/show/z1846-12. [in Ukrainian].

(2014) Nakaz MOZ Ukrainy «Pro zatverdzhennia Poriadku kontroliu yakosti likarskykh zasobiv pid chas optovoi ta rozdribnoi torhivli» vid 29 veresnia 2014 roku №677 [Order of the Ministry of Health of Ukraine «Procedure for quality control of medicines in the wholesale and retail trade from September 29, 2014, №677]. Retrieved from: http://zakon3.rada.gov.ua/laws/show/z1515-14. [in Ukrainian].

(2011) Nalezhna aptechna praktyka. Standarty yakosti aptechnykh posluh: Spilna nastanova MFF/VOOZ vid 01 sichnia 2011 roku №897_009 [Good Pharmacy Practice. Quality standards for pharmacy services: Joint FIP/WHO Guidelines from January 01, 2011, №897_009]. Retrieved from: http://zakon3.rada.gov.ua/laws/show/897_009. [in Ukrainian].

(2016) Systemy upravlinnia yakistiu. Vymohy: DSTU ISO 9001:2015 [Quality management systems. Requirements: DSTU ISO 9001:2015]. Kyiv [in Ukrainian].

(2006) Developing pharmacy practice: A focus on patient care: WHO/FIP Handbook (2006 Edition). The Hague, The Netherlands.

(2000) Good Pharmacy Education Practice: FIP Statement of Policy approved by FIP Council in Vienna in September 2000.

How to Cite

1.
Vetiutneva NO, Ubohov SH, Fedorova LO. Methodological substantiation of the professional functions of Responsible persons of pharmaceutical and hospital institutions. CIPM [Internet]. 2018Feb.16 [cited 2023Dec.8];(1). Available from: http://pharmed.zsmu.edu.ua/article/view/123723

Issue

Section

Original research