The purpose of introducing the formulary system is to ensure the priority use of effective, safe and economically affordable medicinal products, and to develop and implement a cost-effective system for the use of medicinal products and material resources at all levels.
The need to create and implement a formulary system was first declared in Resolution of the Cabinet of Ministers of Ukraine of 25.07.2003 No. 1162 “On Approval of the State Program for Providing the Population with Medicinal Products for 2004–2010” (hereinafter - the State Program). In fulfillment of this program, a working group on the standardization of pharmacotherapy and the creation of a formulary system was formed at the State Enterprise “State Pharmacological Center” (hereinafter - the Center), headed by Doctor of Medical Sciences, Professor Volodymyr Ivanovych Maltsev. The following worked productively in the working group: Doctor of Medical Sciences, Professor Pariy V.D., Doctor of Medical Sciences, Professor Stepanenko A.V., Doctor of Medical Sciences, Professor Zimenkovsky A.B., Doctor of Pharmaceutical Sciences, Professor Yakovleva L.V., Doctor of Medical Sciences, Professor Zviahintseva T.V., and Dumenko T.M., expert of the Clinical Trials Expert Evaluation Department.
In order to improve the methodological and organizational foundations for implementing the formulary system in Ukraine, on the basis of the results of the working group’s activities, the Central Formulary Committee (hereinafter – CFC) was established by order of the Ministry of Health of Ukraine (hereinafter – MoH of Ukraine) of 18.04.2008 No. 216. This order approved the structure and composition of the CFC; the first chair of the CFC was appointed the First Deputy Director of the Center, Doctor of Medical Sciences, Professor Anatolii Mykolaiovych Morozov, who held this position until September 2013. In subsequent years, the CFC’s activities were provided under the leadership of Doctor of Medical Sciences, Professor, Head of the Department of Healthcare Management of O.O. Bohomolets National Medical University, Valentyn Dmytrovych Pariy; and Doctor of Medical Sciences, Professor, Head of the Department of Clinical Pharmacology and Clinical Pharmacy of the National University of Pharmacy, Ihor Albertovych Zupanets.
The CFC, with the involvement of the MoH of Ukraine chief freelance specialists, other specialists by area and employees of the Center, developed the first edition of the State Formulary of Medicinal Products, which was approved by MoH of Ukraine order of 17.03.2009 No. 173.
The State Formulary was developed in accordance with the adapted methodology of the World Health Organization (WHO) and following the example of the classic model of national formularies, the British National Formulary. The draft of the first edition underwent WHO expert evaluation. The positive assessment of the methodological quality of the document is confirmed by the placement of the State Formulary of Ukraine on the official WHO website.
The basic organizational and methodological principles of the State Formulary System are set out in MoH order of 22.07.2009 No. 529 “On Establishing a Formulary System for Providing Medicinal Products to Healthcare Facilities” (as amended).
Since 2009, the document has been reviewed, updated, and improved annually in accordance with the Methodology for Creating Medicinal Product Formularies. As of 2022, the 14th edition of the State Formulary has been approved.
Pursuant to the decision of the Board of the Ministry of Health of Ukraine of 09.12.2010 No. 01.02.2011, the Department of Rational Pharmacotherapy and Support of the State Formulary System was established, which provided scientific, methodological, organizational and technical support for the implementation of the state formulary system, in particular such medical technological documents on rational pharmacotherapy as the State Formulary. Currently, these tasks are performed by the Department of Health Technology Assessment and Rational Pharmacotherapy.
In accordance with Art.14-1 of the Fundamentals of Ukrainian Legislation on Health Care, the medicinal formulary is classified as part of the system of sectoral standards in the field of health care.
The infrastructure of the State Formulary System currently operates, consisting of the Central Formulary Committee (CFC) of the MoH of Ukraine, regional formulary committees, and pharmacotherapeutic committees of healthcare institutions. Since 2018, the CFC has been headed by Iryna Nizhenkovska, Head of the Department of Medicinal Chemistry and Pharmaceutical Toxicology of O.O. Bogomolets National Medical University, Doctor of Medical Sciences, Professor, Honored Worker of Science and Technology of Ukraine.
To determine the effectiveness of the formulary system, annual monitoring of the formulary system is carried out, which includes regular collection and recording of data for observing key elements of the formulary system using criteria for assessing the quality of the formulary system implementation process and monitoring indicators (in accordance with the MoH order of 28 October 2010 No. 918).
The formulary system is a set of health care management methods that ensures the use of rational, organizationally and economically effective methods of supplying and using medicinal products in order to ensure, in specific conditions, high-quality medical care and optimal use of available resources; an information-economic doctrine of rational use of medicinal products. The basic principle of the formulary system is the use of medicines with proven effectiveness in a particular pathological process.
Functions of the formulary system:
- Medical – defining and developing methods of rational pharmacotherapy of common diseases.
- Pharmacological – ensuring control over the correct use of medicinal products and taking measures to prevent and correct iatrogenic errors.
- Social – providing patients with medicines of proven clinical efficacy.
- Economic – use of the most clinically and economically effective medicinal products.
- Informational – dissemination of objective information on the efficacy and safety of medicinal products.
- Professional and educational function – improving the competence and qualifications of doctors of various specialties, clinical pharmacists, pharmacists, and mid-level medical and pharmaceutical personnel.
